Medicine, patients and the law

CONTEMPORARY ISSUES IN BIOETHICS, LAW AND MEDICAL HUMANITIES

Contemporary Issues in Bioethics, Law and Medical Humanities, edited by Rebecca Bennett and Simona Giordano, of the University of Manchester, was established to publish internationally respected book-length works – primarily monographs and edited collections, but also specialist textbooks – in contemporary issues in bioethics, law and the medical humanities and as such welcomes proposals from thisrange of academic approaches to pertinent issues in this area. The series focuses on the strong foundations and reputation of the University of Manchester’s world-leading scholars in bioethics and law, and its internationally respected Centre for Social Ethics and Policy. Works from across the humanities, brought to bear on contemporary, historical, and indeed future bioethical questions of the highest social and moral concern and interest, will find a perfect home within this series.

From reason to practice in bioethics

An anthology dedicated to the works of John Harris

Edited by John Coggon, Sarah Chan, Søren Holm and Thomasine Kushner

Margaret Brazier and Emma Cave

Medicine, patients and the law

Sixth edition

Manchester University Press

Copyright © Margaret Brazier and Emma Cave 2016

The rights of Margaret Brazier and Emma Cave to be identified as the authors of this work have been asserted by them in accordance with the Copyright, Designs and Patents Act 1988.

Published by Manchester University Press

Altrincham Street, Manchester M1 7JA

www.manchesteruniversitypress.co.uk

British Library Cataloguing-in-Publication Data A catalogue record for this book is available from the British Library Library of Congress Cataloging-in-Publication Data applied for

ISBN 978 1 7849 9136 4 paperback

First published 2016

The publisher has no responsibility for the persistence or accuracy of URLs for any external or third-party internet websites referred to in this book, and does not guarantee that any content on such websites is, or will remain, accurate or appropriate.

Contents

Preface

Introduction

Table of cases

Table of statutes

Table of statutory instruments

Table of European and international material

Part I

MEDICINE, LAW AND SOCIETY

Chapter 1

THE PRACTICE OF MEDICINE TODAY

Tiers of regulation

The National Health Service

Angels or demons?

Whistle-blowing

A duty of candour

Entitlement to practise

A tradition of self-regulation – to be consigned to history?

Composition of the General Medical Council

Advisory function

Medical education

Maintaining a register

Revalidation

Disciplining doctors – fitness to practise

Appeals to the High Court and the Professional Standards Authority

Regulating the NHS

Supervising, managing and protecting employees

Governance

Specialist regulators

Whither the NHS?

Chapter 2

DOCTORS’ RESPONSIBILITIES: PATIENT’S RIGHTS

The impact of the Human Rights Act 1998

How the Human Rights Act works

Who can be sued?

Who can sue?

Convention rights

Article 2

Article 3

Article 5

Article 6

Article 8

Article 9

Article 10

Article 12

Convention on Human Rights and Biomedicine

NHS Constitution

Access to healthcare

NICE

Challenging NHS resource allocation decisions

Top-up treatment

Timely treatment

Treatment abroad

Chapter 3

MEDICINE, MORAL DILEMMAS AND THE LAW

Ethics not etiquette

Respect for autonomy – self-determination

Beneficence – do good

Non-maleficence – do no harm

Justice

Autonomy and patients’ responsibilities

Virtue ethics and the ethics of care

To whom (or what) do we owe ethical obligations

The sanctity of life: Judaeo-Christian tradition

The sanctity of life in a secular society

Sanctity of life: a different perspective

Sanctity of life and the medical profession

The beginning and end of life

Killing and letting die

Sanctity of life and the law

Chapter 4

A RELATIONSHIP OF TRUST AND CONFIDENCE

Breach of confidence: medical privacy

Disclosure after death

Justifying disclosure

The General Medical Council

Disclosure with consent

Disclosure where the patient lacks capacity

Disclosure to protect the patient

Compulsory disclosure

Disclosure in the public interest

Serious crime

Serious communicable diseases

Freedom of the press

Genetic information and confidentiality

Genetic privacy

Liability for failure to disclose

Data Protection Act 1998

An EU Data Protection Regulation

The right to be forgotten

Anonymised data

The Health and Social Care Information Centre

Care.data

Patients’ access to records

Part II

MEDICAL MALPRACTICE

Chapter 5

AGREEING TO TREATMENT

Emergencies

A right to say no?

What is meant by consent?

Does it matter who operates?

How much must the doctor tell the patient: informed consent?

Negligence and a duty to inform

Bye bye Bolam

Sidaway

The road from Sidaway

The impact of Pearce

Montgomery: autonomy reigns?

Alternative treatments

What about understanding?

The therapeutic exception

Causation

Rights, partnership and informed consent

Chapter 6

CAPACITY, CONSENT AND COMPULSION

Not just about healthcare

Not altogether new

The threshold of capacity

Treating adults who lack mental capacity

F v West Berkshire Health Authority

Defining best interests

‘Best interests’ survives: the Mental Capacity Act

Modified best interests

Serious medical treatment

Use of restraint and detention

Deprivation of Liberty Safeguards

The role of the family?

Advance directives

Lasting powers of attorney

Deputies

Court of Protection

Mental health legislation

Compulsory treatment under the 1983 Act

Vulnerable patients: the inherent jurisdiction

Protecting the public

Criminal liability

The uncooperative patient

Chapter 7

CLINICAL NEGLIGENCE

Duty of care

Psychiatric harm

Medical examinations

Responsibility for harm inflicted by ‘dangerous’ patients

The medical standard of care

Junior doctors

Ascertaining the standard of care: Bolam

Bolitho: a new dawn?

‘Responsible practice’ means current practice

Protocols and guidelines

Diagnosis

Treatment

Overtired, overworked doctors

Relating the injury to medical negligence: problems of causation

Modifying the ‘strict rules’

Loss of a chance

General practice

Prescription errors

Contributory negligence

Private patients

Criminal liability

Wilful neglect

Corporate manslaughter

Chapter 8

MALPRACTICE LITIGATION

Funding a lawsuit: public funding

Conditional fee agreements

Defending claims

Whom should the patient sue?

Extending direct liability

Private patients

General practitioners

When must proceedings be started?

Civil justice reform: the Woolf and Jackson Reports

The Clinical Negligence Protocol and case management

Openness, candour and obtaining health records

Proving negligence: the role of the expert

May the burden of proof shift to the doctor?

Awards of compensation

Periodical payments – structured settlements

Malpractice crisis: reality or illusion?

Defensive medicine

Financial costs to the NHS

Wider ‘costs’ to the NHS

Chapter 9

COMPLAINTS AND REDRESS

Health Service public inquiries

Aligning complaints and redress

Complaints procedures – a troubled history

Raising a concern

Local resolution

The Parliamentary and Health Service Ombudsman (PHSO)

Private treatment

The power of apology

Redress

An attack on tort

Alternatives to tort

No-fault compensation abroad

The rejection of no-fault compensation in England

Causation

Deterrence and accountability

Cost

Reforming the torts system

Chapter 10

MEDICAL PRODUCTS LIABILITY

Product liability and drugs

Consumer-buyers: most favoured claimants

The remedy in negligence

Strict liability: the Consumer Protection Act

A v National Blood Authority

Development risks

Collective actions

vCJD-contaminated blood products

Causation

Prevention better than cure?

Off-label drug use

Holding regulators to account

Claims brought abroad

Vaccine damage: a special case?

Part III

MATTERS OF LIFE AND DEATH

Chapter 11

CONTRACEPTION, PREGNANCY AND CHILDBIRTH

Reproductive autonomy and reproductive health

Contraceptives: patients’ rights

Sterilisation

Involuntary sterilisation

Conception to birth

Can parents sue?

Congenital Disabilities (Civil Liability) Act 1976

Drugs and damage to the fetus

Suing a doctor

Antenatal screening

Wrongful life

Wrongful birth

Children damaged by pre-conception events

Pre-pregnancy advice and genetic counselling

What if a parent realises the risk?

Must a mother consider abortion?

Maternal immunity: discriminating against fathers?

Criminal liability

Childbirth: how much choice?

Hospital birth

Maternal autonomy/fetal welfare

Chapter 12

ASSISTED CONCEPTION

Regulating human fertilisation and embryology

Licensing fertility treatment

In vitro fertilisation: opening Pandora’s box?

Access to fertility treatment: the welfare of the child

Access to fertility treatment: post-menopausal mothers

Access to treatment on the NHS

A right to reproduce?

Access and prisoners

Gamete donation and parental status: meaning of ‘father’

Gamete donation: the meaning of ‘mother’

Gamete donation: same sex couples

On the horizon?

Artificial insemination by husband (AIH) or partner (AIP)

Posthumous gamete donation

Gamete donation: supply and demand

Storing gametes and embryos

Disputes and stored embryos

Preimplantation genetic diagnosis

PGD and ‘saviour siblings’

PGD: selecting for ‘disability’

PGD: social sex selection

What should the child be told?

Liability for disability

Reproductive cloning

Surrogacy

Who are the parents?

Parental orders and adoption

Prohibiting ‘commercial’ surrogacy

‘Custody’ of the baby

Foreign surrogacy arrangements

Surrogacy in need of reform

Chapter 13

ABORTION AND EMBRYO RESEARCH

Criminal abortion

The Abortion Act 1967

Abortion on demand or request?

Post-coital birth control

The status of the embryo and embryo research: the debate

Embryo research: the Human Fertilisation and Embryology Act 1990 (as amended)

Embryo research and ‘cloning’

Hybrid (‘human admixed’) embryos

Artificial gametes

Mitochondrial treatment

Embryo to fetus: fetus to baby

Selective reduction: selective feticide

Nurses and abortion

Conscientious objection

Fathers and abortion

Girls under 16

Mentally incapacitated women

Fetal status: Vo v France and A, B and C v Ireland

Fetal status: research and ectogenesis

Chapter 14

DOCTORS AND CHILDREN

At the threshold of viability

Proposals for reforms of law and practice

The courts and sick infants

Deliberate killing

Withholding and withdrawing treatment

‘Best interests’: a balancing exercise

Disputing best interests

Scruple or dogma?

Responsibilities not rights?

Disputing best interests: parental demands

Not just life or death

The limits of parental consent

Procedures to protect children

The views of the child

Family Law Reform Act 1969

The Gillick case

Children under 16 and consent to treatment: Gillick competence

The general problem of consent

The special problem of contraception

A right to say no?

Authorising a deprivation of liberty

Confidentiality and children under 16

Chapter 15

HEALTHCARE RESEARCH

What is clinical research?

Research governance

Clinical trials

Research ethics committees

A troubled history

The future: EU Clinical Trials Regulation 536/2014

Consent to participation in trials

Innovative therapy

Young people in medical research programmes

Adults who lack mental capacity

Emergency research

Randomised controlled trials

Compensation for mishap

No-fault compensation

Research misconduct

Confidentiality and medical research

Genetic privacy

Chapter 16

DEFINING DEATH

Defining death

The law

Should there be a statutory definition of death?

Chapter 17

ORGAN AND TISSUE TRANSPLANTATION

The Human Tissue Act – an overview

Live donor transplantation

Adult donors

Child donors

Mentally incapacitated ‘donors’

Cadaver transplantation

Presumed consent

Beating- and non-beating-heart donors

The Human Tissue Act 2004

Violating the Human Tissue Act 2004

Some practical problems: the coroner

Some practical problems: establishing death

A market in organs

Other inducements

Conditional donations

Xenotransplantation

Liability for mishaps

Fetal tissue and neonatal transplants

Transplantation: the future

Chapter 18

THE HUMAN BODY AND ITS PARTS

Removal of body parts from the dead

Post-mortem examinations

The law before 2004: complex and obscure

The Coroners and Justice Act 2009

The Human Tissue Act 2004: the dead

The Human Tissue Act 2004: the living

‘Appropriate consent’

Regulation

Ownership of body parts

Chapter19

THE END OF LIFE

Murder, suicide and assisting suicide

Double effect

Is there a ‘right’ to die?

Assisted dying

The patient who cannot commit suicide

Death tourism

The DPP’s policy for prosecutors

Challenging the prohibition on assisted suicide in court

Prosecution policy on physician assisted suicide

The assisted dying debate

Legislating to allow physician assisted suicide

Active euthanasia

The unconscious patient

Bland: crossing the Rubicon?

After Bland: PVS to ‘near PVS’

Minimally conscious state

A right to ANH?

The Mental Capacity Act 2005

The role of the courts

DNACPR notices

Conclusion

Index

Preface

The pace of change in the National Health Service (NHS), Parliament and the law courts has not slowed down since our last edition in 2011. The sixth edition of Medicine, Patients and the Law grapples with significant legal change on issues including assisted dying, informed consent and healthcare research. As ever, there are areas of law in flux. A new EU Clinical Trials Regulation will come into force in due course, but the Directive it repeals remains relevant. Further attempts to reform the law on innovative treatment and assisted dying wait in the wings. We can only apologise to our readers for the number of times they will encounter the phrase ‘at the time of writing’. We have tried to identify sources to guide the reader through this tumultuous period of medical law reform. As ever, the drafts of each chapter have flown to and fro across the Pennines from Manchester to Durham and vice versa. Emma would like to express her heartfelt gratitude to Margot for sharing Medicine, Patients and the Law since its fourth edition. Margot would wish to acknowledge with thanks that she could not have been joined by a more supportive and insightful co-author.

The first edition of this book was published in 1987. There was much less medical law to write about then, and in 2016 it often seems as though every chapter of the book could easily grow into a book in its own right. We cannot cover every key issue in the depth that we might wish to. We hope that the work remains readable to a broad audience, and offers a picture of the way that law and medicine relate to each other that will engage the interest of students, lawyers, health professionals and the general public. We are all affected by how law regulates medicine. As before, we do not attempt to cover mental health law as such. To do so would double the length of the book. We do, in Chapter 6, address complex and seemingly intractable questions about vulnerable patients, mental capacity and consent to treatment. We do not attempt to cover the immense body of case law from the Court of Protection, instead choosing illustrative examples. As medical care involves women and men, as both doctors and patients, we use the pronouns she and he interchangeably. We could not be comfortable with the ‘old’ legal tradition of using only the male pronoun, and he/she (or s/he) seems intolerably clumsy.

The sixth edition marks a departure from Penguin, which has gradually reduced its UK academic services. We are proud to be part of the Contemporary Issues in Bioethics, Law and Medical Humanities series at Manchester University Press and grateful to our editor Tony Mason and our section editors, Rebecca Bennett and Simona Giordano for their continued support. We remain in debt to Professors Harry Street and Gerald Dworkin who were initially to have co-written this work with Margaret Brazier. Harry Street’s untimely death, and Gerald Dworkin’s many other commitments, prevented those original plans coming to fruition. We want to thank all our colleagues at Manchester, Durham and elsewhere for their unstinting help and advice. Colleagues from the disciplines of law, bioethics and medicine have listened patiently as we tried out ideas on them, and advised us as the work progressed. We owe a particular debt over many years to Neil Allen, Sarah Devaney, Kirsty Keywood and Suzanne Ost, and also to Dr Peter Gooderham who so sadly died in February 2011. We owe special thanks to Sara Fovargue, Danielle Griffiths, Alexandra Mullock and Craig Purshouse who have patiently read draft chapters for us. We also thank our students (a number of whom are doctors and nurses) who challenge our views and force us to think again on many issues. We are especially grateful to Beverley Clough who helped us with Chapter 6 and Laura Pritchard Jones who assisted us with research for Chapters 7 and 8. Many thanks too to Sacha Waxman and David Lawrence who conducted research into many chapters and prepared the tables and index for us. And we thank Gary Lee, a Manchester law graduate, who is now a New York attorney for his generous donation which funded the research assistance from Sacha and David. Finally, this edition could not have been written without the support, patience and encouragement of our families, Rodney and Victoria Brazier, and Simon, Hannah and Tom Cave.

Any criticism of medical practice in this book is the result of academic endeavour and not personal experience. We are grateful for the care our families have received from general practice and NHS hospitals. We care passionately about the NHS. Were all care of the standard that we have received, this book would be shorter.

No book on this subject is ever wholly up to date. This book is (we trust) up to date to 31 July 2015.

Introduction

The law’s relationship with medicine has become a highly publicised affair. Rarely a day passes without media coverage of some new controversy surrounding medical practice, or medical ethics. Cases relating to the rights and responsibilities of doctors and patients feature regularly in the Law Reports. The medical profession finds itself in the limelight. One day the doctor is hailed as a saviour. The next she is condemned as authoritarian or uncaring. Advances in medical science, extending life at one end and bringing new hope to the childless at the other, have given rise to intricate problems of law and ethics. At every level of medical practice, law plays a role. Doctors cannot escape the reach of the law. For many medical practitioners, the rise in the number of malpractice claims is their main concern. Despite legislation designed to tackle a perceived ‘compensation culture’ doctors still fear an epidemic of US proportions. Notwithstanding the ‘duty of candour’, some doctors refuse to risk an apology or even to explain what went wrong lest their careers and reputations suffer should the patient choose to litigate. Patients still find the pursuit of any grievance frustrating. In 2016, people also seek a greater say in their own treatment, and in doing so have the backing of the Supreme Court in Montgomery v Lanarkshire Health Board.¹ Patients are no longer prepared to be patient. The Supreme Court noted that not only are ‘patients now widely regarded as persons holding rights’ but are also ‘widely treated as consumers exercising choices’. At the same time, how far patients who claim rights are also subject to responsibilities is increasingly debated.

It is not only the narrow question of our own health needs that concerns people today. Many of the recent scientific developments are controversial. Research on embryos, ‘saviour siblings’, human cloning, mitochondrial treatment – all excite controversy. Older controversies about abortion, organ donation and assisted dying get no less difficult with time. The purpose of this book is to examine how medical practice is regulated, to analyse the rights and responsibilities of doctors and patients, to look at the provision of compensation for medical wrongdoing or error, and to explore the framework of legal rules governing those delicate questions of life and death when medicine, morals and the law overlap. It is easy to perceive law’s relationship with medicine as one of conflict, mirroring conflict between doctors and their patients. We suggest that this is a ‘false’ conflict. What the medical profession, patients and

the public have a need for are:

(1)  that the medical profession be properly regulated;

(2)  that where possible, the rights and obligations of patients, doctors and other health professionals are clearly defined;

(3)  that there is an adequate, fair and rational system of compensation for patients suffering injury;

(4)  that there are effective means of investigating medical accidents and errors;

(5)  that the law (together with professional guidelines) offers comprehensive guidance on those areas of medical practice of moral and ethical sensitivity.

Sources of law

In contrast to most European countries, the law of England is not neatly encapsulated in any Code. The task of the non-lawyer seeking to establish her rights, or ascertain his duties is far from easy. The law relating to medical practice is to be discovered from a variety of sources. Parliament has enacted a number of statutes governing medical practice. The regulation of medical practice and the disciplining of the defaulting doctor have traditionally been entrusted by Act of Parliament to the General Medical Council (GMC), by virtue of the Medical Act 1983: an Act that has been substantially amended. The organisation of the health service has been governed by countless statutes on the National Health Service (NHS), consolidated in the National Health Service Act 2006, and subject to major reform in the Health and Social Care Act 2012. The Medicines Act 1968 (also heavily amended) is concerned with the safety of drugs. A number of other Acts of Parliament, such as the Abortion Act 1967 and the Human Fertilisation and Embryology Act 1990 (as amended), the Human Tissue Act 2004 and the Mental Capacity Act 2005, are crucially relevant to questions about medicine, patients and the law. An Act of Parliament can create only a general framework of legal rules. Acts of Parliament, therefore, commonly empower government ministers to make subsidiary regulations known as statutory instruments. These regulations may determine crucial questions. For example, most of the duties of general practitioners within the NHS are dealt with by regulations and not by Act of Parliament.

It is impossible today to understand the legal rules governing the practice of medicine without reference to European law. In matters within the jurisdiction of the Treaty of Rome and subsequent treaties, notably the Treaty of Amsterdam, the European Union is empowered to make laws affecting all Member States. This may be by way of regulations which immediately and directly become law in the United Kingdom, or by way of directives which oblige the United Kingdom government to introduce an appropriate Act of Parliament to give effect to the directive. In 1985, a Community directive on liability for unsafe products resulted in the Consumer Protection Act 1987 which, as we shall see in Chapter 10, introduced strict liability for defective drugs. The Data Protection Directive, considered in Chapter 4, will soon be replaced by a Data Protection Regulation, likely to come into force in 2018. Similarly, the Clinical Trial Regulation 2014 replaces the 2001 Clinical Trials Directive, which obliged the United Kingdom to introduce reforms of the law governing medical research. New scientific innovations and pressure to facilitate medical research provide strong incentives for reform. Regulatory harmonisation reflects an increasingly global research environment. Provisions of the European Union treaties themselves may be invoked to make a case for greater rights for patients. This is how Diane Blood won her case to be allowed to be inseminated with her dead husband’s sperm abroad.

The European Union must not be confused with the European Convention on Human Rights. That Convention is a separate treaty to which the United Kingdom is a party. The Convention seeks to establish the rights of the individual and directly addresses questions such as rights to life, to privacy, and to found a family. The Human Rights Act 1998 renders rights granted by the Convention enforceable against public authorities in the United Kingdom. Domestic courts must take into account the jurisprudence of the European Court of Human Rights. As we shall see, the Act has transformed areas of medical law and, as a living instrument, that potential has not diminished with time. If the Conservative government repeals the Human Rights Act 1998, the Convention will remain relevant and any change to medical law resulting from repeal of the 1998 Act is likely to be gradual and incremental.

Conventions, statutes and statutory regulations alone, be they UK or European legislation, by no means paint the whole picture of English medical law. Much of English law remains judge-made; the common law of England. Decisions, judgments handed down by the courts, form precedents for determining later disputes and define the rights and duties of doctors and patients in areas untouched by statute. The common law largely governs compensation for medical accidents, the patient’s right to determine her own treatment, parents’ rights to control medical treatment of their children and, as we shall see, several other vital matters.

We deal with English law. The common law is not confined to England. Decisions of courts in the USA, Canada and elsewhere are mentioned from time to time. Such judgments do not bind an English court. They can be useful as examples, or warnings, showing us how the same basic principles of law have developed elsewhere. Finally it must be remembered that for the lawyer, Scotland counts as a foreign country. Scotland maintains its own independent legal system and, post-devolution, enjoys the power to legislate independently on most issues relating to medical care. Scotland has, for example, enacted its own Human Tissue (Scotland) Act 2006. On many of the questions dealt with in this book, English and Scots law coincide. Occasionally, the law in England and Scotland diverges. We confine ourselves in general to stating the law as it applies in England and Wales, noting that the Welsh Assembly has gained increased powers to legislate independently of the Westminster Parliament. Notably Wales has now enacted its own Human Transplantation (Wales) Act 2013 which entered into force in December 2015 and provides for an opt-out system for cadaver organ donation in Wales. The problems of law and medicine addressed in this book are common to the United Kingdom as a whole and well beyond the shores of this country. We hope that the discussion of how the law in England responds to the challenges of modern medicine is instructive to readers outside the United Kingdom and prompts productive comparisons of how different jurisdictions address similar problems.

Part I

Part I of this book begins by seeking to examine the overall framework of medicine today. How does the law seek to ensure that patients are treated by competent, qualified doctors practising ethical medicine? Does the GMC, which has regulated the medical profession since 1858, meet patients’ needs in 2016? What rights do we enjoy in the context of healthcare and how has the Human Rights Act affected medical law? Law can, at best, only set basic standards of behaviour. So we explore some of the ethical principles and dilemmas in modern medicine. Then in the final chapter of Part I, we examine that critical component of any doctor–patient relationship, the necessity for trust and confidence. Can we be assured that our doctors will respect our privacy so that we can feel confident enough to be wholly frank with them? In what exceptional circumstances should that duty of confidence be breached to fulfil some more pressing responsibility to others?

Part II

In Part II, we examine what remedies the law affords a patient dissatisfied with the medical care which he or she has received. A patient may feel that he has not been fully consulted or properly counselled about the nature and risks of treatment. He may have agreed to treatment and ended up worse, not better. Consequently the patient may seek compensation from the courts. Or he may simply want an investigation of what went wrong, and to ensure that his experience is not suffered by others. It is the rise in litigation that has caused so much anxiety among doctors.

The law relating to medical errors, often described as medical malpractice, operates on two basic principles. (1) The patient must agree to treatment. (2) Treatment must be carried out with proper skill and care on the part of all the members of the medical profession involved. Any doctor who operated on or injected, or even touched, an adult patient against her will might commit a battery, a trespass against the patient’s person. A doctor who was shown to have exercised inadequate care of his patient, to have fallen below the required standard of competence, would be liable to compensate the patient for any harm he caused her in the tort of negligence. In short, to obtain compensation, the patient must show that the doctor was at fault. And if she sues for negligence, she must show that the doctor’s ‘fault’ caused her injury. Three overwhelming problems are inherent in these two simple statements.

First, how do courts staffed by lawyer-judges determine when a doctor is at fault? We shall see that the judges in England used to defer largely to the views of the doctors. Recent case law suggests judges are now more ready to scrutinise medical practice. Establishing what constitutes good practice will still cause the court some difficulty. The courts remain dependent on expert evidence and a clash of eminent medical opinions is not unusual.

Second, as liability, and the patient’s right to compensation, is dependent on a finding of fault, doctors naturally feel that a judgment against them is a body blow to their career and their reputation. Yet a moment’s reflection will remind the reader of all the mistakes she has made in her own job. A solicitor overlooking a vital piece of advice from a conference with a client can telephone the client and put things right when he has a chance to check what he has done. A carpenter can have a second go at fixing a door or a cupboard. An overtired, overstrained doctor may commit a momentary error which is irreversible. He is still a good doctor despite one mistake.

Finally, the doctor’s fault must be shown to have caused the patient harm. In general, whether a patient is treated within the NHS or privately, the doctor only undertakes to do his best. He does not guarantee a cure. The patient will have a legal remedy only if he can show that the doctor’s carelessness or lack of skill caused him injury that he would not otherwise have suffered. So if you contract an infection and are prescribed antibiotics which a competent doctor should have appreciated were inappropriate for you or your condition, you can sue the doctor only if you can show either: (1) that the antibiotic prescribed caused you harm unrelated to your original sickness, for example, brought you out in a violent allergy; or (2) that the absence of appropriate treatment significantly delayed your recovery. And in both cases you must prove that had the doctor acted properly, the harm would have been avoided.

We shall see therefore that the law is a remedy only for more specific and serious grievances against a doctor. It is in any case an expensive and unwieldy weapon. Many patients have complaints, particularly about hospitals, which do not amount to actionable negligence. They complain about being kept waiting, inadequate visiting hours, or rudeness on the part of NHS staff. We shall look in Part II at extra-legal methods of pursuing complaints against a hospital or a doctor, and we consider whether the whole system for compensating medical errors should be replaced by a no-fault compensation scheme. Nor do we limit our examination to faults alleged against medical practitioners. Many medical mishaps arise from the dangers inherent in certain drugs. We consider the liability of the drug companies and attempts by government to ensure that available medicines are safe.

Finally, we should say a word about legal ‘language’ today. The person who initiates a legal action, for example, the patient suing a doctor for battery or negligence, used to be referred to as the plaintiff. When Lord Woolf recommended radical reforms of the civil justice system, some of which are discussed in Chapter 8, he also proposed that old-fashioned language should be changed into plain English. So, today, the patient bringing a claim against a doctor is simply called the claimant. Where we discuss cases decided before 1999, we use the old term plaintiff. Defendants, thankfully, remain just that, defendants.

Part III

Parts I and II of this book focus on the relationship between doctors and patients, both the framework of that relationship and how the law deals with conflict when a patient is dissatisfied with the care that he has received. Part III looks at the dramatic questions in medical law where what is at stake is not only what an individual patient may be entitled to, but also what society should allow. The range of questions addressed is broad. Others are omitted simply on grounds of space. We consider whether parents who find themselves with an unplanned child after receipt of negligent medical advice or treatment, should receive compensation to meet the cost of raising that child. What duties are owed to an unborn child, and should pregnant women continue to enjoy legal immunity from liability to their future children? We venture into the troubled waters of the reproductive technologies, seeking to explain and analyse the law governing such matters as the creation of ‘saviour siblings’, human cloning, hybrid embryos. We also attempt to address practical questions – how to define parental status, what happens when surrogacy arrangements go wrong, and access to information about gamete donors. Medical research, transplantation and the especial problems around the medical care of children are addressed. We end (appropriately) by examining laws relating to the end of life, and debates about assisted dying.

Law matters

Medical law has altered beyond recognition in the nearly thirty years since the first edition of this book. No one who reads a newspaper or watches television can be unaware of the sorts of questions which we address. On an almost weekly basis, new initiatives or new laws are proposed. Sometimes it seems as though the dizzying pace of reform reflects little thought about the whole picture. More attention is paid to policy and ethical debate than law. There is insufficient rigorous analysis of what the limits of the law’s remit should be. One set of lawyers, doctors and patients groups address the adequacy (or inadequacy) of malpractice litigation. Ethicists, journalists and legal theorists join doctors and theologians in debating the grand moral dilemmas of medicine. Lay people tend not to get much of a chance to have their say until some controversy breaks, such as the scandals around poor standards of care at Mid Staffordshire Foundation Trust. For all these reasons, this book seeks to concentrate more on law than ethics as such, and to attempt to locate our discussions of the law in a practical context. We hope that we can dispel the myth that law is ‘boring’. We hope that our discussion may cast some light on what the role of the law should be in the context of modern medicine.

¹  [2015] UKSC 11.

Table of cases

A

A, Re [1992] 3 Med LR 303
3.14, 16.3

A (A Child) [2015] EWHC 443 (Fam)
16.4

A (Children) (Conjoined Twins: Surgical Separation), Re [2001] Fam 147, [2000] 4 All ER 961, [2001] 2 WLR 480, [2000] 3 FCR 577, [2001] 1 FLR 1, [2001] Fam Law 18, 57 BMLR 1, [2000] Lloyd’s Rep Med 425, 9 BHRC 261, CA
3.5, 14.5, 14.8, 14.9

A (Medical Treatment: Male Sterilisation), Re [2000] 1 FCR 193, [2000] 1 FLR 549, [2000] 02 LS Gaz R 30, CA
6.6

A v A Health Authority [2002] EWHC 18 (Fam/Admin), [2002] Fam 213, [2002] 3 WLR 24, [2002] 1 FCR 481, [2002] 1 FLR 845 (2002) Times, 11 March, 146 Sol Jo LB 37, [2002] All ER (D) 187 (Jan)
6.17

A v C [1985] FLR 445, [1984] Fam Law 241, CA
12.20

A v National Blood Authority [2001] 3 All ER 289, [2001] Lloyd’s Rep Med 187, 60 BMLR 1, [2001] All ER (D) 298 (Mar)
10.1, 10.6, 10.7, 17.18

A (A Child) v University Hospitals of Morecambe Bay NHS Foundation Trust [2015] EWHC 366 (QB)
8.15

A and B (Parental Order: Domicile) [2013] EWHC 426 (Fam)
12.28

A, B and C v Ireland [2010] ECHR 25579/05
2.2, 2.7, 2.11, 12.8, 13.1, 13.19

A National Health Service Trust v D (2000) 2 FLR 677
14.7

AA, Re [2012] EWHC 4378 (COP)
5.4, 11.21

AB v CD (1851) 14 D 177
4.5

AB v CD (1904) 42 SLR 213, 7 F 72, 12 SLT 599, Ct of Sess
4.5

AB v CD [2013] EWHC 1418 (Fam)
12.12

AB v CD (Surrogacy: Time Limit and Consent) [2015] EWFC 12
12.28

AB v Glasgow and West of Scotland Blood Transfusion Service (1989) 15 BMLR 91, 1993 SLT 36, Ct of Sess
4.9

AB v John Wyeth & Brother Ltd [1996] 7 Med LR 267; affd [1997] 8 Med LR 57, CA
10.1

AB v Leeds Teaching Hospital NHS Trust [2004] EWHC 644 (QB), [2004] 3 FCR 324, [2004] 2 FLR 365, [2004] Fam Law 501, 77 BMLR 145, [2004] NLJR 497 (2004) Times, 12 April, [2004] All ER (D) 506 (Mar), sub nom Organ Retention Group Litigation, Re [2005] QB 506, [2005] 2 WLR 358
5.1, 5.15, 18.8

AB v Scottish National Blood Transfusion Service 1990 SCLR 263, Ct of Sess
17.18

Abouziad v Mothercare (UK) Ltd (2001) Times, 20 February
10.1, 10.5

ACCG v MN [2013] EWHC] 3859 (COP)
6.17

Adoption Application (Surrogacy), Re [1987] 2 All ER 826
12.28, 12.29

Aintree University Hospitals Foundation Trust v James [2013] UKSC 67
6.9, 19.4, 17.17, 19.19

Airedale NHS Trust v Bland [1993] AC 789, [1993] 1 All ER 821, [1993] 2 WLR 316, [1994] 1 FCR 485, [1993] 1 FLR 1026, [1993] Fam Law 473, [1993] Crim LR 877, [1993] 4 Med LR 39, 12 BMLR 64, [1993] NLJR 199, HL
2.7, 3.14, 5.3, 14.6, 16.3, 16.4, 19.1, 19.3, 19.14, 19.15, 19.17

AK (Medical Treatment: Consent), Re [2001] 2 FCR 35, [2001] 1 FLR 129, [2000] Fam Law 885
6.4

AK v Latvia (Application No 33011/08) ECHR (2014)
11.10

Al Hamwi v Johnson [2005] EWHC 206
5.14, 11.10

Alcock v Chief Constable of South Yorkshire Police [1992] 1 AC 310, [1991] 4 All ER 907, [1991] 3 WLR 1057, 8 BMLR 37, [1992] 3 LS Gaz R 34, 136 Sol Jo LB 9, HL
7.3

Allan v New Mount Sinai Hospital (1980) 109 DLR (3d) 634, 28 OR (2d) 356, 11 CCLT 299, Ont HC; revsd (1981) 125 DLR (3d) 276, Ont CA
5.1

An NHS Foundation Hospital v P [2014] EWHC 165
14.21

An NHS Trust v A [2013] EWHC 2442
6.12, 6.18, 6.19, 6.20

An NHS Trust v ABC and a Local Authority [2014] EWHC 1445 (Fam)
13.17, 14.21

An NHS Trust v B [2006] EWHC 507 (Fam), [2006] Fam Law 445, 150 Sol Jo LB 400, [2006] All ER (D) 213 (Mar), sub nom An NHS Trust v MB [2006] 2 FLR 319
14.7, 14.9, 14.11

An NHS Trust v Child B and Others [2014] EWHC 3486 (Fam)
14.1

An NHS Trust v D [2012] EWHC 885 (COP)
19.19

An NHS Trust v DE [2013] EWHC 2562 (Fam)
6.9, 11.4

An NHS Trust v J [2006] All ER (D) 73 (Dec)
15.9

An NHS Trust v MB [2006] EWHC 507 (Fam)
14.7, 14.9, 14.11

An NHS Trust v Ms X [2014] EWCOP 35
19.4

An NHS Trust v SR [2012] EWHC 3842 (Fam)
14.1, 14.10

An NHS Foundation Trust v VT [2013] EWHC B26 (Fam)
19.17

Anderson v Forth Valley Health Board (1998) 44 BMLR 108, 1998 SLT 588, 1998 SCLR 97, OH
11.12, 11.14

Appleby v Sleep [1968] 2 All ER 265, [1968] 1 WLR 948, 66 LGR 555, 112 Sol Jo 380
10.3

Appleton v Garrett [1997] 8 Med LR 75, 34 BMLR 23, [1996] PIQR P 1
5.6

Argyll (Duchess of) v Duke of Argyll [1967] Ch 302, [1965] 1 All ER 611, [1965] 2 WLR 790
4.2

Ashan v University Hospitals Leicester NHS Trust [2006] EWHC 2624
6.9

Ashcroft v Mersey Regional Health Authority [1983] 2 All ER 245; affd [1985] 2 All ER 96n, CA
9.11, 9.13

Aston Cantlow and Wilmcote with Billesley Parochial Church Council v Wallbank [2003] UKHL 37, [2004] 1 AC 546, [2003] 3 All ER 1213, [2003] 3 WLR 283, [2003] 33 LS Gaz R 28, [2003] NLJR 030, 147 Sol Jo LB 812 (2003) Times, 27 June, [2003] All ER (D) 360 (Jun)
2.4

A-G v Able [1984] QB 795, [1984] 1 All ER 277, [1983] 3 WLR 845, 78 Cr App Rep 197, [1984] Crim LR 35, 127 Sol Jo 731, DC
19.5

A-G v Jonathan Cape Ltd [1976] QB 752, [1975] 3 All ER 484, [1975] 3 WLR 606, 119 Sol Jo 696
4.2

A-G v Observer Ltd [1990] 1 AC 109, [1988] 3 WLR 776, [1988] NLJR 96, [1988] LRC (Const) 938, sub nom A-G v Guardian Newspapers Ltd (No 2) [1988] 3 All ER 545, HL
4.2

A-G v X [1992] 2 CMLR
13.19

A-G’s Reference (No 2 of 2003) [2004] EWCA Crim 785, [2005] 3 All ER 149, [2004] 1 WLR 2062, 84 BMLR 1, [2004] 17 LS Gaz R 30 (2004) Times, 21 April, [2004] All ER (D) 08 (Apr)
12.2

A-G’s Reference (No 3 of 1994) [1996] QB 581, [1996] 2 All ER 10, [1996] 2 WLR 412, [1996] 1 Cr App Rep 351, [1996] 2 FLR 1, [1996] Fam Law 464, [1996] Crim LR 268, 140 Sol Jo LB 20, CA; affd [1998] AC 245, [1997] 3 All ER 936, [1997] 3 WLR 421,[1998] 1 Cr App Rep 91, [1997] Crim LR 829, [1997] 36 LS Gaz R 44, [1997] NLJR 1185, HL
11.18, 11.19, 14.5

Auckland Area Health Board v A-G [1993] 4 Med LR 239, [1993] 1 NZLR 235
19.4

Aventis Pasteur SA v OB (2009) C-358/08 ECJ (Grand Chamber)
10.5

AVS v An NHS Trust, Re [2010] EWHC 2746 (COP)
19.19

Axon v Secretary of State for Health [2006] EWHC 37, sub nom R (on the application of Axon) v Secretary of State for Health (Family Planning Association intervening) [2006] EWHC 37 (Admin), [2006] QB 539,[2006] 2 WLR 1130, [2006] 1 FCR 175, [2006] 2 FLR 206, [2006] Fam Law 272, 88 BMLR 96, [2006] 08 LS Gaz R 25 (2006) Times, 26 January, [2006] All ER (D) 148 (Jan)
2.11, 13.17, 14.21, 14.22

B

B (A Child) (Immunisation), Re [2003] EWCA Civ 1148, [2003] 3 FCR 156, [2003] 2 FLR 1095, 73 BMLR 152, 147 Sol Jo LB 934, [2003] All ER (D) 498 (Jul), sub nom C (a Child) (Immunisation: Parental Rights), Re (2003) Times, 15 August
14.12, 14.14

B (A Minor) (Wardship: Abortion), Re [1991] 2 FLR 426
13.17

B (A Minor), Re [2008] EWHC 1998 (Fam)
14.11, 19.21

B (A Minor) (Wardship: Medical Treatment), Re (1981) [1990] 3 All ER 927, [1981] 1 WLR 1421, 80 LGR 107, 3 FLR 117, 12 Fam Law 25, 125 Sol Jo 608, CA
14.4, 14.6

B (A Minor) (Wardship: Sterilisation), Re [1988] AC 199, [1987] 2 All ER 206, [1987] 2 WLR 1213, 86 LGR 417, [1987] 2 FLR 314, [1987] Fam Law 419, 131 Sol Jo 625, [1987] NLJ Rep 432, HL
6.6, 14.13

B (Parentage), Re [1996] 3 FCR 697, [1996] 2 FLR 15, [1996] Fam Law 536
12.10

B v Barking, Havering and Brentwood Community NHS Tryst [1999] 1 FLR 106
6.19

B v C and others [2015] EWFC 17
12.26, 12.28

B v Croydon Health Authority [1995] Fam 133, [1995] 1 All ER 683, [1995] 2 WLR 294, [1995] 1 FCR 662, [1995] 1 FLR 470, [1995] Fam Law 244, 22 BMLR 13, [1994] NLJR 1696, [1995] PIQR P 145, CA
6.19

B v NHS Hospital Trust [2002] EWHC 429 (Fam), [2002] 2 All ER 449, [2002] 2 FCR 1, [2002] 1 FLR 1090, 65 BMLR 149 (2002) Times, 26 March, [2002] All ER (D) 362 (Mar)
3.14, 5.3, 6.4, 19.1, 19.4

B (Nancy) v Hotel-Dieu de Quebec (1992) 15 BMLR 95, 86 DLR (4th) 385
19.4

Badger v Ministry of Defence [2005] EWHC 2941
7.20

Bailey v Ministry of Defence [2008] EWCA Civ 883
7.15

Baker v Kaye (1996) 39 BMLR 12
7.4

Barker v Corus UK Ltd [2006] UKHL 20, [2006] 2 AC 572, [2006] 3 All ER 785, [2006] 2 WLR 1027, [2006] ICR 809, 89 BMLR 1, [2006] NLJR 796, [2006] PIQR P390 (2006) Times, 4 May, [2006] 5 LRC 271, [2006] All ER (D) 23 (May)
7.15, 10.1, 10.10

Barnett v Chelsea and Kensington Hospital Management Committee [1969] 1 QB 428, [1968] 1 All ER 1068, [1968] 2 WLR 422, 111 Sol Jo 912
7.1

Bartley v Studd (1995), unreported
5.1

Baxter v Montana No DA 09-0051 (Montana Supreme Court, 2009)
19.12

Best v Wellcome Foundation [1993] 2 IR 421
10.15

Biles v Barking Health Authority [1988] CLY 1103
11.1

Birch v University College London Hospital NHS Foundation Trust [2008] EWHC 2237
5.13

Birmingham Assizes (1914) 78 JP 604
4.11

Birmingham Children’s NHS Trust v B & C [2014] EWHC 531 (Fam)
14.1, 14.10

Bluck v The Information Commissioner and Epsom and St. Helier University NHS Trust [2007] 98 BMLR 1
4.3

Blyth v Bloomsbury Health Authority [1993] 4 Med LR 151, 5 PN 167, CA
5.10

BM, Re [2014] EWCOP B20
6.16

Bolam v Friern Hospital Management Committee [1957] 2 All ER 118, [1957] 1 WLR 582, 101 Sol Jo 357, 1 BMLR 1
5.8, 5.10, 5.12, 5.17, 6.6, 7.6, 7.8, 7.10, 7.16, 8.20

Bolitho v City and Hackney Health Authority [1998] AC 232, [1997] 4 All ER 771, [1997] 3 WLR 1151, 39 BMLR 1, [1997] 47 LS Gaz R 30, [1998] Lloyd’s Rep Med 26, 141 Sol Jo LB 238, [1998] PNLR 1, HL
5.10, 7.8, 7.9, 7.16, 8.20, 11.2, 11.9

Bolton Hospitals NHS Trust v O [2003] 1 FLR 824, [2003] Fam Law 319
5.3, 11.21

Border v Lewisham and Greenwich NHS Trust [2015] EWCA Civ 8
5.1

Bouvia v Superior Court (1986) 225 Cal Reptr 297
19.4

Bravery v Bravery [1954] 3 All ER 59, [1954] 1 WLR 1169, 98 Sol Jo 573, CA
11.1

Breen v Williams [1995] 6 Med LR 385, 186 CLR 71, 138 ALR 259, 70 ALJR 772, Aus HC
5.17

Brooks v Home Office [1999] 2 FLR 33, 48 BMLR 109
7.14

Brown v Scarborough and North East Yorkshire Healthcare NHS Trust [2009] EWHC 3103 (QB)
11.2

Bruggeman and Scheuten v Federal Republic of Germany (1981) 3 EHRR 244
2.7

BSM Geraets-Smits v Stichting Ziekenfonds VGZ [2002] QB 409, [2001] ECR I-5473, [2003] All ER (EC) 481, [2002] 2 WLR 154, [2002] 2 CMLR 460, 62 BMLR 101 (2001) Times, 4 September, [2001] All ER (D) 152 (Jul), ECJ
2.20

Buck v Norfolk and Waveney Mental Health NHS Foundation Trust [2012] Med LR 266
7.5

Bull v Devon Area Health Authority [1993] 4 Med LR 117, 22 BMLR 79, CA
8.5

Burke v United Kingdom (App No 19807/06) (2006)
2.8, 19.1, 19.18

Burne v A [2006] EWCA Civ 24
7.8, 7.9

C

C, Re (Application by Mr and Mrs X under s 30 of the Human Fertilisation and Embryology Act 1990) [2002] EWHC 157 (Fam), [2002] 1 FLR 909, [2002] Fam Law 351, [2002] All ER (D) 352 (Feb)
12.28

C (A Child) (HIV Testing), Re [2000] Fam 48, [2000] 2 WLR 270, [1999] 3 FCR 289, [2000] Fam Law 16, 30 BMLR 283, [1999] All ER (D) 1004, [1999] 2 FLR 1004
14.12

C (A Child) (Immunisation: Parental Rights), Re. See B (A Child) (Immunisation), Re [2003] 2 FLR 1095, CA
14.12, 14.14

C (A Minor) (Detention for Medical Treatment), Re [1997] 3 FCR 49,[1997] 2 FLR 180, [1997] Fam Law 474
6.11, 14.22

C (A Minor) (Wardship: Medical Treatment), Re [1990] Fam 26, [1989] 2 All ER 782, [1989] 3 WLR 240, [1990] FCR 209, [1990] 1 FLR 252, [1990] Fam Law 60, 133 Sol Jo 876, [1989] 28 LS Gaz R 43, [1989] NLJR 612, CA
14.7, 14.11

C (A Minor) (Wardship: Surrogacy), Re [1985] FLR 846, [1985] Fam Law 191, [1985] NLJ Rep 106
12.29

C (Adult: Refusal of Treatment), Re [1994] 1 All ER 819, [1994] 1 WLR 290, [1994] 2 FCR 151, [1994] 1 FLR 31, [1994] Fam Law 131, 15 BMLR 77, [1993] NLJR 1642
6.4

C v Cumbria University Hospitals NHS Trust [2014] EWHC 61
8.5

C v S [1988] QB 135, [1987] 1 All ER 1230, [1987] 2 WLR 1108,[1987] 2 FLR 505, [1987] Fam Law 269; affd [1988] QB 135, [1987] 1 All ER 1230, [1987] 2 WLR 1108, [1987] 2 FLR 505, [1987] Fam Law 269, 131 Sol Jo 624, [1987] LS Gaz R 1410, CA
13.12, 13.16

Callery v Gray [2001] EWCA Civ 1246, [2001] 4 All ER 1, [2001] 1 WLR 2142, [2001] 35 LS Gaz R 33 (2001) Times, 24 October, 145 Sol Jo LB 204, [2001] All ER (D) 470 (Jul); affd [2002] UKHL 28, [2002] 1 WLR 2000, [2002] 3 All ER 417, [2003] RTR 71 (2002) Times, 2 July, [2002] NLJR 1031, [2002] All ER (D) 233 (Jun)
8.2

Campbell v Mirror Group Newspapers Ltd [2002] EWCA Civ 1373, [2003] QB 633, [2003] 1 All ER 224, [2003] 2 WLR 80 (2002) Times, 16 October, [2003] EMLR 39, [2002] All ER (D) 177 (Oct),[2002] IP & T 944; revsd [2004] UKHL 22, [2004] 2 AC 457, [2004] 2 All ER 995, [2004] 2 WLR 1232, [2004] 21 LS Gaz R 36, [2004] NLJR 733 (2004) Times, 7 May, 148 Sol Jo LB 572, 16 BHRC 500, [2004] IP & T 764, [2005] 1 LRC 397, [2004] All ER (D) 67 (May)
2.3, 2.11, 2.13, 4.2, 4.4

Canterbury v Spence (1972) 464 F 2D 772
5.8

Capital and Counties plc v Hampshire County Council [1997] QB1004, [1997] 2 All ER 865, [1997] 3 WLR 331, 95 LGR 831, [1997]2 Lloyd’s Rep 161, [1997] NLJR 599, 141 Sol Jo LB 92, CA
7.2

Carter v Canada 2015 SCC 5
19.9

Cassidy v Ministry of Health [1951] 2 KB 343, [1951] 1 All ER 574, 95 Sol Jo 253, [1951] 1 TLR 539, CA
7.14, 8.6, 8.14

Cattanach v Melchior [2003] HCA 38, [2003] 5 LRC 1
11.12

CH (Contact: Parentage), Re [1996] 1 FCR 768, [1996] 1 FLR 569, [1996] Fam Law 274
12.10

Chappel v Hart [1999] Lloyd’s Rep Med 223, 72 ALJR 1344, [1999] 2 LRC 341, Aus HC
5.16

Chatterton v Gerson [1981] QB 432, [1981] 1 All ER 257, [1980]3 WLR 1003, 124 Sol Jo 885, 1 BMLR 80
5.4, 5.6, 5.8

Cheatle v GMC (2009) EWHC 645 (Admin)
1.15

Chester v Afshar [2004] UKHL 41, [2005] 1 AC 134, [2004] 4 All ER 587, [2004] 3 WLR 927, 81 BMLR 1, [2004] 43 LS Gaz R 34, [2004] NLJR 1589 (2004) Times, 19 October, 148 Sol Jo LB 1215, [2005] 2 LRC 688, [2004] All ER (D) 164 (Oct)
5.1, 5.7, 5.10, 5.11, 5.16, 7.16, 7.17, 10.10

Chewings v Williams [2009] EWHC 2490
8.15

Child A v Ministry of Defence [2004] EWCA Civ 641
8.5, 8.6

Chin Keow v Government of Malaysia [1967] 1 WLR 813, 111 Sol Jo 333, PC
7.13, 7.18

Clive Roberts v Nottinghamshire Healthcare NHS Trust [2008] EWHC 1934
4.23

CM v The Executor of the Estate of EJ (deceased) [2013] EWHC 1680 (Fam)
17.10, 18.6, 18.7

Coakley v Rosie [2014] EWHC 1790 (QB)
7.15

Colak v Germany [2009] ECHR 77144/01
4.16

Coles v Reading and District Hospital Management Committee (1963) Times, 30 January
7.18

Collins v Hertfordshire Corporation [1947] 1 KB 598
7.13

Commission v Ireland
1.17

Commission v UK (Case C-300/95) [1997] ALL ER (EC) 481
10.7

Connolly v Croydon Health Service NHS Trust [2015] EWHC 1339 (QB)
5.1, 5.2, 6.4, 11.21

Constable v Salford and Trafford HA and Kerr [2005] EWHC 2967 (QB)
11.14

Cooper v Merck Sharp & Dohme [2012] CSOH 48
10.14

Cooper v Royal United Hospital Bath NHS Trust [2005] EWHC 3381
5.14

Corby Group Litigation v Corby DC [2009] EWHC 1944 (TCC)
11.6

Corder v Banks (1960) Times, 9 April
7.13

Cornelius v De Taranto [2001] EWCA Civ 1511, 68 BMLR 62, [2002] EMLR 112, [2001] All ER (D) 227 (Oct)
4.2

Costa and Pavan v Italy (Application No 54270/2010) ECHR 2012
2.2, 11.12

Costello-Roberts v United Kingdom (Application 13134/87) (1993) 19 EHRR 112, [1994] 1 FCR 65, [1994] ELR 1, ECtHR
2.4

CP (A Child) v Criminal Injuries Compensation Authority [2014] EWCA Civ 1554
11.18

Crawford v Board of Governors of Charing Cross Hospital (1953) Times, 8 December, CA
7.10

Creutzfeldt-Jakob Disease Litigation, sub nom Group B Plaintiffs v Medical Research Council (1997) 41 BMLR 157
10.1

Cruzan v Director Missouri Department of Health 110 S Ct 2841 (1990, USA)
19.13

D

D, Re [1986] 1 ALL ER 326
14.13

D (A Child), Re [2005] UKHL 33. See R (A Child) (IVF: Paternity of Child), Re D (A Child), Re [2014] EWHC 2121 (Fam)
12.27, 12.31

D (A Child) (Deprivation of Liberty) [2015] EWHC 922 (Fam)
14.22

D (Adult: Medical Treatment), Re [1998] 1 FCR 498, [1998] 1 FLR 411, 38 BMLR 1
6.4, 19.16

D (Medical Treatment: Mentally Disabled Patient), Re [1998] 2 FCR 178, [1998] 2 FLR 22, 41 BMLR 81, [1997] 48 LS Gaz R 30, 142 Sol Jo LB 30
19.16

D v An NHS Trust (Medical Treatment Consent: Termination) [2003] EWHC 2793 (Fam), [2004] 1 FLR 1110, [2004] Fam Law 415
2.11, 13.18

D v National Society for the Prevention of Cruelty to Children [1978] AC 171, [1977] 1 All ER 589, [1977] 2 WLR 201, 121 Sol Jo 119, HL
4.9

Davies v Countess of Chester Hospital [2014] EWHC 4294 (QB)
7.1

Davies v Eli Lilly & Co [1987] 1 All ER 801, [1987] 1 WLR 428, 131 Sol Jo 360, [1987] LS Gaz R 826, CA
10.1

Davies v University Hospital of North Staffordshire NHS Trust [2014] EWHC 4004 (QB)
7.9

DB v DW [2015] EWCOP 16
6.16

DD (No 4) (Sterilisation), Re [2014] EWCOP 8, [2014] EWCOP 11, [2014] EWCOP 13, [2014] EWCOP 44, [2015] EWCOP 4
6.9, 6.10, 11.4

Defreitas v O’Brien [1993] 4 Med LR 281, Mayor’s and City of London’sCt; affd [1995] 6 Med LR 108, 25 BMLR 51, [1995] PIQR P 281, CA
7.8

Department of Health v Information Commissioner [2011] EWHC 1430 (Admin)
4.20, 15.17

Devi v West Midlands Area Health Authority [1980] 7 CL 44
5.1, 11.3

DH NHS Foundation Trust v PS [2010] EWHC 1217 (Fam)
6.9, 11.4

Dickson v United Kingdom (Application No 44362/04) [2006] 2 FCR 1, [2006] 2 FLR 449, [2006] Fam Law 532 (2006) Times, 16 May,21 BHRC 236, [2006] All ER (D) 219 (Apr), ECtHR (2007) 46 EHRR 41; [2008] 46 EHRR 41
2.13, 12.8, 12.13

Distillers Co (Biochemicals) Ltd v Thompson [1971] AC 458, [1971] 1 All ER 694, [1971] 2 WLR 441, 115 Sol Jo 144
10.14

DL v A Local Authority & Others [2012] EWCA Civ 253
6.1, 6.20

Dobson v North Tyneside Health Authority [1996] 4 All ER 474, [1997] 1 WLR 596, [1997] 1 FLR 598, [1997] Fam Law 326, [1996] 31 LS Gaz R29, [1996] NLJR 1458, 140 Sol Jo LB 165, sub nom Dobson v North Tyneside Health Authority and Newcastle Health Authority [1997] 2 FCR 651, CA
18.10

Donoghue (or McAlister) v Stevenson. See M’Alister (or Donoghue) v Stevenson [1932] AC 562
10.4

Doodeward v Spence (1908) 6 CLR 406, 15 ALR 105, 95 R (NSW) 107, Aus HC
18.4, 18.10

Douglas v Hello! Ltd [2001] QB 967, [2001] 2 All ER 289, [2001] 2 WLR 992, [2002] 1 FCR 289, [2001] 1 FLR 982, [2001] 3 LRC 756, [2000] All ER (D) 2435, [2001] IP & T 391, 9 BHRC 543, CA
4.2

Dudgeon v United Kingdom (Application 7525/76) (1981) 4 EHRR 149, ECtHR
2.5

Duffy v Lanarkshire Health Board [1998] SCLR1142
7.9

Dunn v South Tyneside Health Care NHS Trust [2003] EWCA Civ 878, [2003] All ER (D) 01 (Jul)
7.9

Dunning v United Liverpool Hospitals’ Board of Governors [1973] 2 All ER 454, [1973] 1 WLR 586, 117 Sol Jo 167, CA
8.12

Durant v Financial Services Authority [2003] EWCA Civ 1746 (2004) Times, 2 January, [2004] IP & T 814, [2003] All ER (D) 124 (Dec)
4.17

Durham v BAI (Run off) Ltd [2012] UKSC 14
10.10

Dwyer v Rodrick (1983) 127 Sol Jo 806, [1983] LS Gaz R 3003, CA
7.13, 7.19, 10.4

E

E (A Minor), Re (1990) 9 BMLR 1
14.9, 14.21

E (Medical Treatment: Anorexia), Re [2012] EWHC 1639 (COP)
2.8, 14.21

E and F (Children) (Assisted Reproduction) Re [2013] EWHC 1418 (Fam)
12.3, 12.10, 12.12

Edward Wong Finance Co Ltd v Johnson Stokes & Master [1984] AC 296, [1984] 2 WLR 1, 127 Sol Jo 784, PC
7.8

Eisai Ltd v National Institute for Health and Clinical Excellence [2008] EWCA Civ 438
2.18

Elberte v Latvia (Application Number 61243/08) (2015)
18.3

Emeh v Kensington and Chelsea and Westminster Area Health Authority(1983) Times, 3 January; revsd [1985] QB 1012, [1984] 3 All ER 1044, [1985] 2 WLR 233, 128 Sol Jo 705, CA
11.16

Emerald Supplies Ltd. v British Airways Plc. [2010] EWCA Civ 1284
10.7

Enhorn v Sweden (Application 56529/00) (2005) 41 EHRR 30, 19 BHRC 222, ECtHR
6.21

Enright v Blackpool Victoria Hospital NHS Trust [2003] EWHC 100 (QB)
11.14

ES v Chesterfield North Derbyshire Royal Hospital NHS Trust [2003] EWCA Civ 1284
8.13

Evans v Amicus Healthcare Ltd [2003] EWHC 2161 (Fam), [2005]Fam 1, [2003] 4 All ER 903, [2004] 2 WLR 713, [2003] 3 FCR 577, [2004] 1 FLR 67, [2003] Fam Law 879, 75 BMLR 115, [2003] 39 LS Gaz R 38, [2003] NLJR 1519, 147 Sol Jo LB 1151 (2003) Times, 2 October, [2003] All ER (D) 21 (Oct); affd [2004] EWCA Civ 727, [2005] Fam 1, [2004] 3 All ER 1025, [2004] 3 WLR 681, [2004] 2 FCR 530, [2004] 2 FLR 766, [2004] Fam Law 647, 78 BMLR 181 (2004) 148 Sol Jo LB 823, Times, 30 June, [2004] All ER (D) 309 (Jun)
12.18

Evans v United Kingdom (Application 6339/05) [2006] 1 FCR 585, [2006] 2 FLR 172, [2006] Fam Law 357, [2006] NLJR 456 (2006) Times, 17 March, [2006] All ER (D) 82 (Mar), ECtHR; [2008] 46 EHRR 34
2.11, 12.8, 12.16, 12.18

Eweida, Chaplin, Ladele and Macfarlane v United Kingdom (2013) 57 EHRR 8
2.12

Eyre v Measday [1986] 1 All ER 488, [1986] NLJ Rep 91, CA
7.21, 11.3

F

F, Re [1988] Fam 122, [1989] 2 All ER 193, [1988] 2 WLR 1288, [1988] FCR 529, [1988] 2 FLR 307, [1988] Fam Law 337, 132 Sol Jo 820, [1988] NLJR 37, CA
11.21

F, Re [1990] 2 AC 1, [1989] 2 WLR 1025, [1989] 2 FLR 376, [1989] Fam Law 390, 133 Sol Jo 785, [1989] NLJR 789, sub nom F v West Berkshire Health Authority (Mental Health Act Commission intervening) [1989] 2 All ER 545, 4 BMLR 1, HL
11.4, 19.15

F, Re (Case No 11649371) (2009, unreported)
6.4

F (Mother) v F (Father) [2013] EWHC 2683
14.12, 14.21

F v West Berkshire Health Authority (Mental Health Act Commission intervening) [1989] 2 ALL ER 545, See F, Re
2.9, 6.6, 11.4, 19.15

Fairchild v Glenhaven Funeral Services Ltd (1978) Ltd [2002] UKHL 22, [2003] 1 AC 32, [2002] 3 All ER 305, [2002] ICR 798, [2002] IRLR 533, 67 BMLR 90, [2002] NLJR 998 (2002) Times, 21 June, [2003] 1 LRC 674, [2002] All ER (D) 139 (Jun)
7.15, 10.1, 10.10

Farraj v King’s Healthcare NHS Trust [2006] EWHC 1228
11.10

Farraj v King’s Healthcare NHS Trust [2009] EWCA 1203 CA
7.12, 8.6

Farraj v King’s Healthcare Trust and Cytogenic Data Services [2008] EWHC 2468 (QB)
11.10, 11.12

Finlayson v HM Advocate 1979 JC 33, 1978 SLT (Notes) 60, HC of Justiciary (Sc)
16.3

Foster v Biosil (2000) 59 BMLR 178, Cty Ct
10.5

FP v Taunton and Somerset NHS Trust [2009] EWHC 1965 (QB)
11.14

Freeman v Home Office (No 2) [1984] QB 524, [1983] 3 All ER 589, [1984] 2 WLR 130, 127 Sol Jo 825, 133 NLJ 726; affd [1984] QB 524, [1984] 1 All ER 1036, [1984] 2 WLR 802, 128 Sol Jo 298, CA
5.1, 5.6

Frenchay Healthcare NHS Trust v S [1994] 2 All ER 403, [1994] 1 WLR 601, [1994] 3 FCR 121, [1994] 1 FLR 485, [1994] Fam Law 320, 17 BMLR 156, [1994] NLJR 268, CA
19.16

Froggatt v Chesterfield and North Derbyshire Royal Hospital NHS Trust [2002] All ER (D) 218 (Dec)
7.3

G

G (A Child) (Sperm Donor: Contact Order): Re Z (A Child) (Sperm Donor: Contact Order), Re [2013] EWHC 134 (Fam)
12.12

G (Children), Re [2006] UKHL 629
12.12

G (Children) (Shared Residence Order: Biological Mother of Donor Egg Children), Re [2014] EWCA Civ 336
12.12

G (Surrogacy: Foreign Domicile), Re [2007] EWHC 2814
12.27, 12.31

G v E and Others [2010] EWHC 621 (Fam), [2010] EWHC 2512
6.2, 6.16

G and JG and JF and JFG [2015] EWHC 564 (Fam)
2.10

Gardner v Northampton General Hospital NHS Trust [2014] EWHC 4217 (QB)
7.14, 7.15, 7.16

Gartside v Outram (1856) 26 LJ Ch 113, 3 Jur NS 39, 5 WR 35, 28 LTOS 120
4.4

Gascoine v Ian Sheridan & Co (a firm) and Latham [1994] 5 Med LR 437
7.10

Gaskin v United Kingdom (Application 10454/83) (1989) 12 EHRR 36, [1990] 1 FLR 167, ECtHR
12.23

General Dental Council v Savery and others [2011] EWHC 3011 (Admin)
4.9

General Medical Council v Meadow [2006] EWCA Civ 1390
1.15, 8.13

Gillick v West Norfolk and Wisbech Area Health Authority [1986] AC 112, [1985] 1 All ER 533, [1985] 2 WLR 413, [1985] FLR 736, [1985] Fam Law 165, 129 Sol Jo 47, [1985] LS Gaz R 762, [1985] NLJ Rep 81, CA; revsd [1986] AC 112, [1985] 3 All ER 402, [1985] WLR 830, [1986] 1 FLR 224, [1986] Crim LR 113, 129 Sol Jo 738, 2 BMLR 11, [1985] LS Gaz R 3551, [1985] NLJ Rep 1055, HL
13.17, 14.1, 14.10, 14.17, 14.18, 14.19, 14.20, 14.21, 14.22, 15.10, 17.5, 18.6

Glass v United Kingdom (Application 61827/00) [2004] 1 FCR 553, [2004] 1 FLR 1019, [2004] Fam Law 410, 77 BMLR 120 (2004) Times, 11 March, [2004] All ER (D) 166 (Mar), ECtHR
2.11, 5.1, 14.10

GM, Re, [2013] EWHC 2966 (COP)
6.16

Godden v Kent and Medway Strategic Health Authority [2004] EWHC 1629 (QB), [2004] Lloyd’s Rep Med 521, [2004] All ER (D) 114 (Jul)
8.8

Godfrey v Gloucestershire Royal Infirmary NHS Trust [2003] EWHC 549
8.9

Gold v Haringey Health Authority [1988] QB 481, [1987] 2 All ER 888, [1987] 3 WLR 649, [1988] 1 FLR 55, [1987] Fam Law 417, 131 Sol Jo 843, [1987] LS Gaz R 1812, [1987] NLJ Rep 541, CA
5.10

Gonzales v Oregon (04–623) 546 US 243 (2006)
19.12

Google Spain SL, Google Inc v Agencia Espanola de Protectcion de Datos, Mario Costeja Gonzalez [2014]
4.19

Gray v Germany (Application number 49278/09) ECtHR 2014
1.12

Great Western Hospitals NHS Foundation Trust v AA & Others [2014] EWHC 132 (Fam)
11.21

Greater Glasgow Health Board v Doogan [2014] UKSC 68
2.12, 13.14, 13.15

Gregg v Scott [2005] UKHL 2, [2005] 2 AC 176, [2005] 4 All ER 812, [2005] 2 WLR 268, 82 BMLR 52 (2005) Times, 28 January, 149 Sol Jo LB 145, 2005] 5 LRC 408, [2005] All ER (D) 269 (Jan)
7.17, 10.10

Gross v Switzerland [2013] ECHR 429 (2nd Sect), [2014] ECHR 1008 (Grand chamber)
19.6

Group B Plaintiffs v Medical Research Council. See Creutzfeldt–Jakob Disease Litigation Gudanaviciene v Director of Legal Aid [2014] EWCA 1622
8.1

H

H (A Patient), Re [1998] 3 FCR 174, [1998] 2 FLR 36, [1998] Fam Law 460, 38 BMLR 11
19.16

H v S (Surrogacy Agreement) [2015] EWHC 36 (Fam)
12.30

H (A Healthcare Worker) v Associated Newspapers Ltd [2002] EWCA Civ 195, [2002] Lloyd’s Rep Med 210, 65 BMLR 132 (2002) Times, 19 March, [2002] EMLR 425, [2002] All ER (D) 371 (Feb)
4.13

H (A Healthcare Worker) v N (A Health Authority) [2002] EWCA Civ 195, [2002] Lloyd’s Rep Med 210, 65 BMLR 132 (2002) Times, 19 March, [2002] EMLR 425, [2002] All ER (D) 371 (Feb)
4.13

Hamilton and Others v Merck Sharp & Dohme Ltd [2012] CSOH 144
10.14

Hardman v Amin (2000) 59 BMLR 58, [2000] Lloyd’s Rep Med 309
11.12, 11.14

Has v Switzerland [2011] 53 EHRR 33
19.6

HE v A Hospital NHS Trust [2003] EWHC 1017 (Fam), [2003] 2 FLR 408, [2003] Fam Law 733
6.14

Heart of England NHS Foundation Trust v JB [2014] EWHC 342 (COP)
6.4

Heil v Rankin [2001] QB 272, [2000] 3 All ER 138, [2000] 2 WLR 1173, [2000] Lloyd’s Rep Med 203, [2000] IRLR 334, [2000] NLJR 464, [2000] PIQR Q 187, 144 Sol Jo LB 157, CA
8.15, 8.18

Heneghan v Manchester Dry Docks Limited and others [2014] EWHC 4190
10.10

Herczegfalvy v Austria (Application 10533/83) (1992) 15 EHRR 437, 18 BMLR 48, ECtHR
2.8, 6.1, 6.11

Hills v Potter [1983] 3 All ER 716, [1984] 1 WLR 641n, 128 Sol Jo 224
5.6

HIV Haemophiliac Litigation, Re (1990) 41 BMLR 171
8.12

HL v United Kingdom (Application 45508/99) (2004) 40 EHRR 761, 81 BMLR 131 (2004) Times, 19 October, 17 BHRC 418, [2004] All ER (D) 39 (Oct), ECtHR
6.11

HL v United Kingdom (2005) 40 EHRR 32, ECtHR
2.5, 2.9, 6.1

HM Advocate v Kelly (2001), unreported
6.22

Holdich v Lothian Health Board [2013] CSOH 197
18.10

Hollis v Dow Corning corporation (1995) 129 DLR (4th) 609 (Canada)
10.4

Holloway v Transform Medical Group (CS) Ltd [2014] EWHC 1641 (QB)
10.8

Hoppw v Germany [2003] 1 FCR 176
14.21

Horsley v Cascade Insulation Services and Others [2009] EWHC 2945 (QB)
7.20

Hotson v Fitzgerald [1985] 3 All ER 167, [1985] 1 WLR 1036, 129 Sol Jo 558; affd sub nom Hotson v East Berkshire Area Health Authority [1987] AC 750, [1987] 1 All ER 210, [1987] 2 WLR 287, 130 Sol Jo 925, [1987] LS Gaz R 37, [1986] NLJ Rep 1163, CA; revsd [1987] AC 750, [1987] 2 All ER 909, [1987] 3 WLR 232, 131 Sol Jo 975, [1987]LS Gaz R 2365, [1987] NLJ Rep 638, HL
7.17

Housecroft v Burnett [1986] 1 All ER 332, CA
8.15

Hucks v Cole [1993] 4 Med LR 393, 112 Sol Jo 483, 118 NLJ 469, CA
7.8, 7.13

Hunter v Hanley 1955 SC 200, 1955 SLT 213, Ct of Sess
7.10, 7.12

Hunter v Mann [1974] QB 767, [1974] 2 All ER 414, [1974] 2 WLR 742, [1974] RTR 338, 59 Cr App Rep 37, [1974] Crim LR 260, 118 Sol Jo 171, DC
4.2, 4.9

Hutcheson (formerly KGM) v News Group Newspapers Ltd [2011] EWCA Civ 808
4.2

I

I v Finland (2008) 48 EHRR 740
4.6

IEG v Zurich Insurance Plc [2013] EWCA] Civ 39
10.10

In the Estate of Park [1954] P 112
6.4

In the Matter of Ashya King [2014] EWHC 2964
14.12

In the Matter of MN (Adult) [2015] EWCA Civ 411
6.17

Independent News and Media Ltd v A [2009] EWHC 2858, [2010] EWCA Civ 343
6.16

Initial Services Ltd v Putterill [1968] 1 QB 396, [1967] 3 All ER 145, [1967] 3 WLR 1032, 2 KIR 863, 111 Sol Jo 541, CA
4.11

J

J (A Minor) (Wardship: Medical Treatment), Re [1991] Fam 33, [1990] 3 All ER 930, [1991] 2 WLR 140, [1991] FCR 370, [1991] 1 FLR 366, [1990] 2 Med LR 67, 6 BMLR 25, [1990] NLJR 1533, CA
14.7, 14.11, 19.21

J (A Minor) (Wardship: Medical Treatment), Re [1993] Fam 15, [1992] 4 All ER 614, [1992] 3 WLR 507, [1992] 2 FCR 753, [1992] 2 FLR 165, [1993] Fam Law 126, 9 BMLR 10, [1992] 30 LS GazR 32, [1992] NLJR 1123, 136 Sol Jo LB 207, CA
19.1

J (Child’s Religious Upbringing and Circumcision), Re [2000] 1 FCR 307, [2000] 1 FLR 571], [2000] Fam Law 246, 52 BMLR 82, sub nom J (A Child) (Prohibited Steps Order: Circumcision), Re [1999] 47 LS Gaz R 30, CA
14.12

J v G [2013] EWHC 1432 (Fam)
2.12, 12.29

JA (Medical Treatment: Child Diagnosed with HIV), Re [2014] EWHC 1135 (Fam)14.21:741
12.27, 12.28

Janaway v Salford Area Health Authority [1989] AC 537, [1988] 3 All ER 1079, [1988] 3 WLR 1350, [1989] 1 FLR 155, [1989] Fam Law 191, 3 BMLR 137, [1989] 3 LS Gaz R 42, HL
13.15

JB v KS [2015] EWHC 180 (Fam)
12.12

JCM v ANA 2012 BCSC 584
18.10

JE v DE [2006] EWHC 3459 (Fam)
6.12

Jehovah’s Witnesses of Moscow v Russia (2011) 53 EHRR 4
5.1

Jepson v Chief Constable of West Mercia Police Constabulary [2003] EWHC 3318
13.12

Johansen v Norway (1996) 23 EHRR 33
14.21

Johnson v Havering London Borough Council and Secretary of State of Affairs [2007] EWCA Civ
2.3

Johnson v Medical Defence Union (2007) 96 BMLR 99
4.17

Jones v Kaney [2011] UKSC 13
8.13

Jones v Manchester Corpn [1952] 2 QB 852, [1952] 2 All ER 125, 116 JP 412, [1952] 1 TLR 1589, CA
7.7, 7.13

Jones v North West Strategic Health Authority [2010] EWHC 178 Civ
5.16

Jones v Secretary of State for Energy and Climate Change [2012] EWHC 2936 (QB)
10.10

JP v LP and others (Surrogacy Arrangement: Wardship) [2014] EWHC 595 (Fam)
12.26, 12.27, 12.28, 12.29

JS v Lothian Health Board [2009] CSOH 97
11.12

Juhnke v Turkey (2009) 49 EHRR 24 ECtHR
5.1

JV and OV v AR [2014] EWHC 4756 (Fam)
12.28, 12.29

K

K (Minors), Re [2010] EWHC 1180 (Fam)
12.31

Kapfunde v Abbey National plc [1999] ICR 1, [1998] IRLR 583, 46 BMLR 176, CA
7.4

Kay v Ayrshire and Arran Health Board [1987] 2 All ER 417, sub nom Kay’s Tutor v Ayrshire and Arran Health Board 1987 SC (HL) 145, 1987 SLT 577, HL
7.15

Kay v Lambeth London Borough Council [2006] UKHL 10, [2006] 2 AC 465, [2006] 2 WLR 570, [2006] 2 FCR 20, sub nom Lambeth LondonBorough Council v Kay [2006] 4 All ER 128, [2006] All ER (D) 120 (Mar)
2.3

Kay’s Tutor v Ayrshire and Arran Health Board. See Kay v Ayrshire and Arran Health Board
7.15

KB (Adult) (Mental Patient: Medical Treatment), Re (1994) 19 BMLR 144
6.19

Kelly v Kelly [1997] 2 FLR 828, 1997 SLT 896, [1997] SCLR 749, Ct of Sess
13.16

Kent v Griffiths [2001] QB 36, [2000] 2 All ER 474, [2000] 2 WLR 1158, [2000] Lloyd’s Rep Med 109, [2000] 07 LS Gaz R 41, [2000] NLJR 195, 144 Sol Jo LB 106, CA
7.2

Kitson v Playfair (1896) Times, 28 March
4.11

King’s College Hospital NHS Foundation Trust v Y and MH [2015] EWHC 1966 (Fam), [2015] EWHC 1920 (Fam)
14.8

Knight v Home Office [1990] 3 All ER 237, 4 BMLR 85, [1990] NLJR 210
7.14

Koch v Germany [2012] ECHR 1621
19.6

Kralj v McGrath [1986] 1 All ER 54, [1985] NLJ Rep 913
11.20

Kulkarni v Milton Keynes Hospital NHS Trust [2009] EWCA Civ 789
2.10

L

L (A Minor), Re [2010] EWHC 3146 (Fam)
12.29, 12.31

L (An Adult: Non-consensual Treatment) [1997] 1 FCR 609, [1997] 2 FLR 837, [1997] Fam Law 325, 35 BMLR 44
11.21

L (Vulnerable Adults with Capacity: Court’s Jurisdiction) (No 2), Re [2013] Fam 1
6.20

L v Human Fertilisation and Embryology Authority [2008] EWHC 2149
2.3, 12.15

L v L [1949] 1 All ER 141. See REL (otherwise R) v EL
12.13

L (A Child) v West Midlands Strategic Health Authority [2009] EWHC 259
7.10

LA v SB, AB and MB [2010] EWCA Civ 1744
14.8

Lambert and Others v France (Application Number 46043/14) (Grand Chamber) 2015
19.1, 19.14, 19.18

Lambeth London Borough Council v Kay. See Kay v Lambeth London Borough Council Landeshauptstadt Kiel v Jaeger [2003] ECR I-8389, [2004] All ER (EC) 604, [2003] 3 CMLR 493, [2004] ICR 1528, [2003] IRLR 804, 75 BMLR 201 (2003) Times, 26 September, [2003] All ER (D) 72 (Sep), ECJ
1.17

Langley v Campbell (1975) Times, 6 November
7.12, 7.18

Laughton v Shalaby [2014] EWCA Civ 1450
8.13

Lazenvnick v General Hospital of Munro City Inc F Supp 146 (Md, 1980)
11.13

LB Haringey v CM [2014] EWCOP B23
6.16

Lee v South West Thames Regional Health Authority [1985] 2 All ER 385,[1985] 1 WLR 845, 128 Sol Jo 333, [1985] LS Gaz R 2015, [1985] NLJ Rep 438, CA
8.12

Leeds City Council v Price [2006] UKHL 10, [2006] 2 AC 465, [2006] 2 WLR 570, [2006] 2 FCR 20, sub nom Price v Leeds City Council [2006] 4 All ER 128, [2006[ All ER (D) 120 (Mar)
2.3

Leeds Teaching Hospital NHS Trust v A [2003] EWHC 259 (QB), [2003] 1 FCR 599, [2003] 1 FLR 1091, [2003] Fam Law 396, 71 BMLR 168, [2003] NLJR 351 (2003) Times, 28 February, [2003] All ER (D) 374 (Feb)
12.3

Less and Carter v Hussain [2012] EWHC 3513
11.12

Lewis v Secretary of State for Health [2008] EWHC 2196
4.3, 4.5

Lillywhite v University College London Hospitals’ NHS Trust [2005] EWCA Civ 1466, [2005] All ER (D) 110 (Dec)
7.9, 7.12, 7.13, 8.14

Lim Poh Choo v Camden and Islington Area Health Authority [1980]
16.2

Lion Laboratories Ltd v Evans [1985] QB 526, [1984] 2 All ER 417, [1984] 3 WLR 539, 128 Sol Jo 533, CA
4.4

Local Authority v A [2010] EWHC 1549
5.3

Local Authority v E [2012] EWHC (COP) 1639
6.4. 19.4

Local Authority v K [2013] EWCOP 242
11.4

Local Authority v MA, NA and SA [2005] EWHC 2942 (Fam)
6.20

Local Authority v WMA [2013] EWHC 2580 (COP)
6.9

London and Quadrant Housing Trust v R (on the application of Weaver) and Equality and Human Rights Commission [2009] EWCA Civ 587
2.4

Loveday v Renton [1990] 1 Med LR 117
7.15, 10.15

LT (Vulnerable Adult) (Decision Making: Capacity), Re [2010] EWHC 1910 (Fam)
6.4

Lumba (WL) v Secretary of State for the Home Department [2011] UKSC 12
11.12

Luthra v General Medical Council [2013] EWHC 240 (Admin)
1.8

Lybert v Warrington Health Authority [1996] 7 Med LR 71, 25 BMLR 91, [1995] 20 LS Gaz R 40, [1996] PIQR P 45, CA
5.10

M

M (Child: Refusal of Medical Treatment), Re [1999] 2 FCR 577, [1999] 2 FLR 1097, [1999] Fam Law 753, 52 BMLR 124, [1999] All ER (D) 798
14.21

M (Incapacitated Adult) (Best Interests Declaration: Potential Contempt), Re, [2015 EWCOP 3
6.17

M v Calderdale Health Authority [1998] Lloyd’s Rep Med 157
8.6

M v F and another [2013] EWHC 1901 (Fam)
12.2, 12.3, 12.26, 12.28

M v F [2015] EWFC 22
12.10

M’Alister (or Donoghue) v Stevenson [1932] AC 562, 101 LJPC 119, 37 Com Cas 350, 48 TLR 494, 1932 SC (HL) 31, sub nom Donoghue (or McAlister) v Stevenson [1932] All ER Rep 1, 1932 SLT 317, sub nom McAlister (or Donoghue) v Stevenson 76 Sol Jo 396, 147 LT 281, HL
10.4

McAllister v Lewisham and North Southwark Health Authority [1994] 5 Med LR
5.10

McFall v Shrimp (1978) 10 Pa D & C 3d
17.4

McFarlane v Tayside Health Board [2000] 2 AC 59, [1999] 4 All ER 961, [1999] 3 WLR 1301, [2000] 1 FCR 102, 52 BMLR 1, [1999] NLJR 1868, 2000 SLT 154, [2003] UKHL 53 11.1: 504
11.2, 11.12, 11.16

McInerney v MacDonald (1992) 137 NR 35 (Can SC), 93 DLR (4th) 415, Can SC
5.17

McKay v Essex Area Health Authority [1982] QB 1166, [1982] 2 All ER 771, [1982] 2 WLR 890, 126 Sol Jo 261, CA
11.11, 11.13, 11.14, 11.16, 12.24

Mahon v Osborne [1939] 2 KB 14, [1939] 1 All ER 535, 108 LJKB 567, 83 Sol Jo 134, 160 LT 329, CA
8.14

Mail Newspapers plc v Express Newspapers plc [1987] FSR 90
16.3

Malette v Shulman (1988) 63 Or (2d) 243 (Ontario High Court)
5.2

Manning v King’s College Hospital NHS Trust [2008] EWHC 1838
7.9, 7.12, 7.17

Marriott v West Midlands Health Authority [1999] Lloyd’s Rep Med 23
7.9, 7.1

Mary McGill v Royal Group of Hospitals [2010] NIQB 10
7.21

MASM v MMAM and others [2015] EWCOP 3
6.12, 12.30

Mattu v University Hospitals of Coventry and Warwickshire NHS Trust [2012] EWCA Civ 641
2.10

Maynard v West Midlands Regional Health Authority [1985] 1 All ER 635, [1984] 1 WLR 634, 128 Sol Jo 317, [1984] LS Gaz R 1926, 133 NLJ 641, HL
7.6, 7.8, 7.12

MB (An Adult: Medical Treatment), Re [1997] 2 FCR 541, [1997] 2 FLR 426, [1997] Fam Law 542, [1997] 8 Med LR 217, 38 BMLR 175, [1997] NLJR 600, CA
5.3, 6.4, 11.20, 11.21

Mehmet Senturk and Bekir Senturk v Turkey (Application no 13423/09) 2013 ECtHR
2.7

Meiklejohn v St George’s Healthcare NHS Trust [2014] EWCA Civ 120
5.13, 7.6

Mental Health Trust v DD [2014] EWCOP 11, [2014] EWCOP 13
6.4, 11.21

Merck Sharp & Dohme (Australia) Pty Ltd v Peterson [2011] FCAFC 128
10.10

Mezey v South West London and St Georges Mental Health NHS Trust [2010] EWCA Civ 293
1.14

Michael and others v The Chief Constable of South Wales Police and another [2015] UKSC 2
7.2

Miller v Greater Glasgow NHS Board [2010] CSIH 40
7.13, 8.6

Miller v Imperial College Healthcare NHS Trust [2014] EWHC 3772 (QB)
8.15

Mindy Hymowitz v Eli Lilly & Co (1989) 541 NYS 2d 941 (NY, CA)
10.1

Ministry of Justice v Carter [2010] EWCA Civ 694
7.9

MM (Medical Treatment), Re [2000] 1 FLR 224, [2000] Fam Law 92
14.11

Montgomery v Lanarkshire Health Board [2015] UKSC 11
iv, 2.1, 2.11, 3.3, 5.1, 5.4, 5.7, 5.8, 5.9, 5.10, 5.11, 5.12, 5.13, 5.14, 5.15, 5.16, 5.17, 7.8, 11.1, 11.2, 11.12, 11.19, 15.8, 18.8

Moore v Regents of the University of California 793 P 2d 479 (Cal 1950)
18.10

Morris v Blackpool Victoria Hospital NHS Trust [2003] EWHC 1744
7.9

Mosley v News Group Newspapers [2008] EWHC 1777
4.5

Moyes v Lothian Health Board [1990] 1 Med LR 463, 1990 SLT 444, Ct of Sess
5.9

MP and others v Romania (No 39974/10) ECHR (2014)
11.12

Mrs A v East Kent Hospitals University NHS Foundation Trust [2015] EWHC 1038 (QB) ...
11.12

MS v Sweden (1997) 28 EHRR 313, 45 BMLR 133, 3 BHRC 248, ECtHR
4.2, 15.18

Multiple Claimants v Sanifo-Synthelabo [2007] EWHC 1860 (QB); [2009] EWHC 95 (QB)
11.6, 11.8

MW (Adoption: Surrogacy), Re [1996] 3 FCR 128, [1995] 2 FLR 759, [1995] Fam Law 665
12.30

N

N (A Child), Re [2007] EWCA Civ 1053
12.30

N v UK Medical Research Council [1996] BMLR 83
8.9

Nancy B v Hotel Dieu de Quebec (1992) 86 DLR (4th) 385 Canada
19.4

Nash v Eli Lilly & Co [1991] 2 Med LR 169, Times, 13 February; on appeal sub nom Berger v Eli Lilly & Co [1993] 4 All ER 383, [1993] 1 WLR 782, [1992] 3 Med LR 353, 14 BMLR 1, CA
10.1

Nash v Kingston and Richmond Health Authority (1996) 36 BMLR 123
9.11

Nathanson v Barnet and Chase Hospitals NHS Trust [2008] EWHC 460
5.14

Naylor v Preston Area Health Authority [1987] 2 All ER 353, [1987] 1 WLR 958, 131 Sol Jo 596, [1987] LS Gaz R 1494, [1987] NLJ Rep 474 (1987) Times, 14 April (1987) Independent, 9 April, CA
8.12

Nederlandse Jurisprudentie 1973 No 183 District Court of Leeuwarden (1973)
19.13

Nettleship v Weston [1971] 2 QB 691, [1971] 3 All ER 581, [1971] 3 WLR 370, [1971] RTR 425, 115 Sol Jo 624, CA
7.6

Newcastle upon Tyne Hospitals Foundation Trust v LM [2014] EWHC 454 (COP)
5.2, 5.3, 6.4, 6.14

Newell and Newell v Goldenberg [1995] 6 Med LR 371
5.10

Newman v Maurice [2010] EWHC 171
7.9

Newton v Newton’s Model Laundry (1959) Times, 3 November
7.12

NHS Manchester v Fecitt and others [2012] IRLR 64 (CA)
1.6

NHS Trust v D [2000] 2 FCR 577, [2000] 2 FLR 677, [2000] Lloyd’s Rep Med 411
2.7

NHS Trust v J [2006] All ER (D) 290 (Nov)
15.9

NHS Trust v MB [2006] EWHC 507 (Fam)
14.7, 14.9, 14.11

NHS Trust v T (Adult Patient: Refusal of Medical Treatment) [2004] EWHC 1279 (Fam), [2005] 1 All ER 387, [2004] 3 FCR 297, 80 BMLR 184, [2004] All ER (D) 188 (Jun)
5.3, 6.4

NHS Trust A v M [2001] Fam 348, [2001] 1 All ER 801, [2001] 2 WLR 942, [2001] 1 FCR 406, [2001] 2 FLR 367, [2001] Fam Law 501, 58 BMLR 87, [2001] 4 LRC 1, [2000] All ER (D) 1522
2.7, 19.18

Nicholas v Imperial College NHS Trust [2012] EWHC 591
5.13, 5.16

Nicklinson and Lamb v the United Kingdom (Application number 2478/15, 1787/15) ECtHR July 2015
2.11, 19.1, 19.2, 19.6, 19.9, 19.11, 19.12, 19.22

NM v Lanarkshire Health Board [2013] CSIH 3
5.11, 5.16

Norfolk and Norwich Healthcare (NHS) Trust v W [1997] 1 FCR 269, [1996] 2 FLR 613, [1997] Fam Law 17, 34 BMLR 16
6.1, 11.21

North Glamorgan NHS Trust v Walters [2002] EWCA Civ 1792
7.3

Nottinghamshire Healthcare NHS Trust v RC [2014] EWHC 1317 (COP)
2.7, 5.3, 6.4, 6.14

Nunnerley v Warrington Health Authority [2000] Lloyd’s Rep Med 170
11.12

O

O’Brien v Cunard SS Co 28 NC266 (Mass. 1981)
5.2

O’Byrne v Sanofi Pasteur MSD Ltd: C-127/04 [2006] All ER (EC) 674, [2006] 1 WLR 1606, [2006] 2 CMLR 656, 91 BMLR 175 (2006) Times, 15 February, [2006] All ER (D) 117 (Feb), ECJ, [2010] UKSC 23
10.1, 10.5

O’Malley-Williams v Board of Governors of the National Hospital for Nervous Diseases [1975] 1 BMJ 635
5.8

Oliver v Williams [2013] EWHC 600 (QB)
7.3, 7.6, 7.10

Open Door Counselling and Dublin Well Woman v Ireland (Applications 14234/88, 14235/88) (1992) 15 EHRR 244, ECtHR
2.5

Organ Retention Group Litigation, Re. See AB v Leeds Teaching Hospital NHS Trust

Osman v United Kingdom (1998) 29 EHRR 245, [1999] 1 FLR 193, [1999] Fam Law 86, [1999] Crim LR 82, 5 BHRC 293, ECtHR
2.7

OT (A Baby), Re [2009] EWHC 635 (Fam), [2009] EWCA Civ 409
2.11, 14.10, 14.11

P

P, Re [2011] EWHC] 1266
7.20

P (Adult Patient: Consent to Medical Treatment), Re [2008] EWHC 1403 (Fam)
6.2, 6.9

P (A Minor), Re (1986) 80 LGR 301, [1986] 1 FLR 272, [1982] CLY 2077
13.17

P (Medical Treatment: Best Interests), Re, [2003] EWHC 2327 (Fam)
14.21

P (Minors) (Wardship: Surrogacy), Re [1988] FCR 140, [1987] 2 FLR 421, [1987] Fam Law 414
12.30

P (Surrogacy: Residence), Re [2008] 1 FLR 179
12.30

P (Vulnerable Adult) (Capacity: Appointment of Deputies), Re [2010] EWHC 1592 (Fam)
6.16

P v Cheshire West and Chester Council and another; P and Q v Surrey County Council [2001] EWCA Civ 1257, [2014] UKSC 19
2.9, 6.12, 14.22

P v Leeds Teaching Hospital NHS Trust [2004] EWHC 1392
11.10

P v UK (Application no 1529/10) ECtHR (2014) 58 EHRR SE
2.7

Palmer v Tees Health Authority [1998] 45 BMLR 88 (CA)
7.5

Palmer v Tees Health Authority [1999] Lloyd’s Rep Med 351
4.16

Parkinson v St James and Seacroft University Hospital NHS Trust [2001] EWCA Civ 530, [2002] QB 266, [2001] 3 All ER 97, [2001] 3 WLR 376, [2002] 2 FCR 65, [2001] 2 FLR 401, [2001] Fam Law 592, [2001] Lloyd’s Rep Med 309, 61 BMLR 100, 145 Sol Jo LB 118, [2001] All ER (D) 125 (Apr)
11.12, 11.14, 12.24

Paton v British Pregnancy Advisory Service Trustees [1979] QB 276, [1978] 2 All ER 987, [1978] 3 WLR 687, 142 JP 497, 122 Sol Jo 744
13.16

Paton v British Pregnancy Advisory Service Trustees [1981] 2 EHRR 408
2.7

Paton v United Kingdom [1980] 3 EHRR 409, ECtHR
13.16

Pearce v United Bristol Healthcare NHS Trust (1999) 48 BMLR 118, [1998] CLY 3986, [1999] PIQR P 53, CA
5.10, 5.13, 11.2

Penney v East Kent Health Authority [2000] Lloyd’s Rep Med 41, 55 BMLR 63, [1999] 47 LS Gaz R 32, [2000] PNLR 323 (1999) Times, November 25, [1999] All ER (D) 1271, CA
7.9, 7.12

Peslinski, Re 226 NW 2d 180 (1975)
17.6

Petrova v Latvia (Application number 4605/05) (2014)
17.8

Pfizer Corpn v Ministry of Health [1965] AC 512, [1965] 1 All ER 450, [1965] 2 WLR 387, [1965] RPC 261, 109 Sol Jo 149, HL
10.3

Philips v William Whiteley Ltd [1938] 1 All ER 566, 82 Sol Jo 196, 54 TLR 379
7.6

Pickett v British Rail Engineering Ltd [1980] AC 136, [1979] 1 All ER 774, [1978] 3 WLR 955, [1979] 1 Lloyd’s Rep 519, 122 Sol Jo 778, HL
8.15

Pidgeon v Doncaster Health Authority [2002] LRM 130
7.20

Piper v JRI (Manufacturing) [2006] EWCA Civ 1344
10.6

P-M (Parental Order: Payments to Surrogacy Agency) [2013] EWHC 1561 (Fam)
12.29

Portsmouth City Council v King [2014] EWHC 2964 (Fam)
14.1, 14.12

Portsmouth Hospitals NHS Trust v Wyatt [2005] EWHC 117 (Fam), [2005] All ER (D) 294 (Jan)
14.11

Portsmouth NHS Trust v Wyatt. See Wyatt (A Child) (Medical Treatment: Parents’ Consent), Re [2004] EWHC 2247 (Fam)
14.11, 19.20

Portsmouth NHS Trust v Wyatt. See Wyatt, Re [2005] EWHC 319 (Fam)
14.11

Potts v North West Regional Health Authority (1983) Guardian, 23 July
5.6

PP v Health Executive Service [2014] IEHC 622
16.4

Prendergast v Sam & Dee Ltd [1989] 1 Med LR 36, CA
7.13, 10.4

Press Association v Newcastle Upon Tyne Hospitals Foundation Trust [2014] EWCOP 6
4.3, 4.13

Pretty v United Kingdom (Application 2346/02) (2002) 35 EHRR 1, [2002] 2 FCR 97, [2002] 2 FLR 45, 12 BHRC 149, 66 BMLR 147, [2002] All ER (D) 286 (Apr), [2002] ECHR 2346/02, ECtHR
2.8, 10.1, 19.6

Price v Leeds City Council. See Leeds City Council v Price
2.3

Price v UK (2001) 34 EHRR 1285
2.17

Prince Albert v Strange (1849) 41 ER 1171
4.2

PSA v GMC [2014] EWHC 1903 (Admin)
1.15

Q

Q (Parental Order), Re [1996] 2 FCR 345, [1996] 1 FLR 369, [1996] Fam Law
12.10, 12.29

Quinlan, Re 355 A 2d 664 (NJ, 1976)
6.5, 19.14

R

R (A Child) (IVF: Paternity of Child), Re [2003] EWCA Civ 182, [2003] Fam 129, [2003] 2 All ER 131, [2003] 2 WLR 1485, [2003] 1 FCR 481, [2003] 1 FLR 1183, [2003] Fam Law 394, 71 BMLR 157, [2003] 13 LS Gaz R 27, [2003] NLJR 317 (2003) Times, 20 February, [2003] All ER (D) 266 (Feb); affd sub nom D (a child), Re [2005] UKHL 33, [2005] 2 FCR 223, [2005] NLJR 797 (2005) Times, 13 May, [2005] All ER (D) 164 (May), sub nom R (a child) (IVF: Paternity of Child), Re [2005] 2 AC 621, [2005] 2 WLR 1158, [2005] 2 FLR 843 (2005) Times, 13 May, sub nom R (a child), Re [2005] 4 All ER 433
12.10

R (Adult: Medical Treatment), Re [1996] 3 FCR 473, [1996] 2 FLR 99, [1996] Fam Law 535, 31 BMLR 127
19.21

R (A Minor), Re [1992] Fam 11, [1991] 4 All ER 177, [1991] 3 WLR 592, [1992] 2 FCR 229, [1992] 1 FLR 190, [1992] Fam Law 67,[1992] 3 Med LR 342, 7 BMLR 147, [1991] NLJR 1297, CA
6.4, 14.1, 14.21

R v Adams [1957] Crim LR 773
19.3

R (A Minor), Re [1993] 2 FCR 544
14.9

R v Adomako [1994] QB 302, [1993] 4 All ER 935, [1993] 3 WLR 927, 98 Cr App Rep 262, [1993] 4 Med LR 304, 15 BMLR 13, [1993] 25 LS Gaz R 36, 137 Sol Jo LB 145, CA; affd [1995] 1 AC 171, [1994] 3 All ER 79, [1994] 3 WLR 288, 158 JP 653, [1994] Crim LR 757, [1994] 5 Med LR 277, 19 BMLR 56, [1994] NLJR 936, [1994] 2 LRC 800, HL
7.22

R v Bala Subrahmanyam Kovvali [2013] EWCA Crim 1056
7.22

R v Bateman (1925) 19 Cr App Rep 8, 89 JP 162, 94 LJKB 791, 28 Cox CC 33, [1925] All ER Rep 45, 69 Sol Jo 622, 133 LT 730, 41 TLR 557, CCA
7.22, 11.19

R (Otley) v Barking and Dagenham NHS PCT [2007] EWHC 1927 (Admin)
2.19

R (Watts) v Bedford PCT and the Department of Health [2004] EWCA Civ 166, CA
2.20

R (on the application of Watts) v Bedford Primary Care Trust [2006] QB 667, [2006] All ER (EC) 835, [2006] 3 WLR 213, [2006] 3 CMLR 102, 90 BMLR 150 (2006) Times, 19 May, [2006] All ER (D) 220 (May), ECJ
2.20

R (on the application of C) v Berkshire West PCT [2011] EWCA Civ 247
2.19

R v Bourne [1939] 1 KB 687, [1938] 3 All ER 615, 108 LJKB 471, CCA
13.2, 13.12

R v Bournewood Community and Mental Health NHS Trust, ex p L [1999] 1 AC 458, [1998] 3 All ER 289, [1998] 3 WLR 107, [1998] 2 FCR 501, [1998] 2 FLR 550, [1998] Fam Law 592, 44 BMLR 1, [1998] 29 LS Gaz R 27, [1998] NLJR 1014, 142 Sol Jo LB 195, HL 2.9: 68
6.11

R v Brain (1834) 6 C & P 349
14.5

R v Brown [1994] 1 AC 212, [1993] 2 All ER 75, [1993] 2 WLR 556, 97 Cr App Rep 44, 157 JP 337, [1993] Crim LR 583, [1993] NLJR 399, [1993] 3 LRC 707, HL
5.1, 6.22, 17.4

R v Burstow [1998] AC 147, [1997] 4 All ER 225, [1997] 3 WLR 534, [1998] 1 Cr App Rep 177, [1998] 1 FLR 105, [1998] Fam Law 137, [1997] Crim LR 810, [1997] NLJR 1273, HL
6.22

R v Cambridge Health Authority, ex p B [1995] 2 All ER 129, [1995] 1 WLR 898, [1995] 2 FCR 485, [1995] NLJR 415, sub nom R v Cambridge District Health Authority, ex p B [1995] 1 FLR 1055, [1995] Fam Law 480, 23 BMLR 1, CA
2.19

R (Tracey) v Cambridge University Hospitals NHS Foundation Trust and Others [2014] EWCA Civ 822
19.21

R v Canons Park Mental Health Review Tribunal, ex p A [1995] QB 60, [1994] 2 All ER 659, [1994] 3 WLR 630, 18 BMLR 94, [1994] 13 LS Gaz R 35, 138 Sol Jo LB 75, CA
6.18

R v Central Birmingham Health Authority, ex p Collier (6 January 1988, unreported)
2.19

R v Central Birmingham Health Authority, ex p Walker (1988) Times, 6 November
2.19

R (on the application of Marper) v Chief Constable of South Yorkshire [2004] UKHL 39, [2004] 4 All ER 193, [2004] 1 WLR 2196, [2005] Crim LR 136, [2004] 34 LS Gaz R 29, [2004] NLJR 1183 (2004) Times, 23 July, 148 Sol Jo LB 914, 21 BHRC 408, [2005] 2 LRC 627, [2004] All ER (D) 392 (Jul)
15.18

R (on the application of S) v Chief Constable of South Yorkshire [2004] UKHL 39, [2004] 4 All ER 193, [2004] 1 WLR 2196, [2005] Crim LR 136, [2004] 34 LS Gaz R 29, [2004] NLJR 1183 (2004) Times, 23 July, 148 Sol Jo LB 914, 21 BHRC 408, [2005] 2 LRC 627, [2004] All ER (D) 392 (Jul)
15.18

R v Clarence (1888) 22 QBD 23, 53 JP 149, 58 LJMC 10, 16 Cox CC 511, 37 WR 166, [1886–90] All ER Rep 133, 59 LT 780, 5 TLR 61, CCR
5.6, 6.22

R v Collins, ex p Brady [2000] Lloyd’s Rep Med 355
3.7, 6.4, 6.5, 6.19

R v Coney (1882) 8 QBD 534, 46 JP 404, 51 LJMC 66, 15 Cox CC 46, 30 WR 678, 46 LT 307, CCR
5.1

R v Cox (1992) 12 BMLR 38
19.1

R (on the application of TB) v CPS and South Staffordshire Healthcare NHS Trust [2006] EWHC 1645 (Admin)
2.3, 4.4, 4.9

R v Crozier (1990) 12 Cr App Rep (S) 206, [1991] Crim LR 138, 8 BMLR 128, CA
4.4

R v D [1984] AC 778, [1984] 2 All ER 449, [1984] 3 WLR 186, 79 Cr App Rep 313, [1984] FLR 847, [1984] Fam Law 311, [1984] Crim LR 558, 128 Sol Jo 469, [1984] LS Gaz R 2458, HL
14.19

R v Department of Health, ex p Source Informatics Ltd [2001] QB 424, [2000] 1 All ER 786, [2000] 2 WLR 940, [2001] FSR 74, 52 BMLR 65, [2000] COD 114, [1999] All ER (D) 1491, [2000] Lloyd’s Rep Med 76, CA
4.4, 4.20, 15.17

R v Dica [2004] EWCA Crim 1103, [2004] QB 1257, [2004] 3 All ER 593, [2004] 3 WLR 213, [2004] 2 Cr App Rep 467, [2004] Crim LR 944, 77 BMLR 243, [2004] 21 LS Gaz R 35 (2004) Times, 11 May, 148 Sol Jo LB570, [2005] 1 LRC 187, [2004] All ER (D) 45 (May)
5.1, 6.22, 17.18

R (on the application of N) v Doctor M [2003] 1 FLR 667
6.6

R (Kenward) v DPP [2015] EWHC 3508
19.10

R (on the application of Purdy) v DPP [2009] EWCA Civ 92, [2009] UKHL 45
2.3, 2.11, 19.6, 19.7

R (AM) v DPP and another (CNK Alliance Ltd and another intervening) [2014] UKSC 38, [2015]
19.9, 19.10

R (on the application of Pretty) v DPP (Secretary of State for the Home Dept intervening) [2001] UKHL 61, [2001] EWHC (Admin) 788, [2002] 1 AC 800, [2002] 1 All ER 1, HL, [2001] 3 WLR 1598, [2002] 2 Cr App Rep 1, [2002] 1 FCR 1, [2002] 1 FLR 268, [2002] Fam Law 170, 11 BHRC 589, 63 BMLR 1, [2001] NLJR 1819 (2001) Times, 5 December, [2002] 3 LRC 163, [2001] All ER (D) 417 (Nov)
2.2, 2.8, 19.1, 16.6, 19.13

R v Ethical Committee of St Mary’s Hospital (Manchester), ex p H (or Harriott) [1988] 1 FLR 512, [1988] Fam Law 165, [1987] NLJ Rep 1038
15.14

R v Gaud (unreported)
6.22

R (AM) v General Medical Council [2015] EWHC 2096 (Admin)
19.10

R (on the application of Burke) v General Medical Council [2004] EWHC 1879 (Admin), [2005] QB 424, [2005] 2 WLR 431, [2004] 3 FCR 579, [2004] 2 FLR 1121, 79 BMLR 126 (2004) Times, 6 August, [2004] All ER (D) 588 (Jul); revsd [2005] EWCA Civ 1003, [2006] QB 273, [2005] 3 WLR 1132, [2005] 3 FCR 169, [2005] 2 FLR 1223, [2005] Fam Law 776, 85 BMLR 1, [2005] NLJR 1457 (2005) Times, 2 August, [2005] All ER (D) 445 (Jul)
2.8, 6.4, 14.11, 19.1, 19.18

R v Gibbins and Proctor (1918) 13 Cr App Rep 134, 82 JP 287, CCA
14.6

R v Golding [2014] EWCA (Crim) 899
6.22

R v Gore [2007] EWCA Crim 2789
11.18

R v Hallstrom, ex p W (No 2) [1986] QB 824. See Waldron, ex p [1986] QB 824
6.19

R v Hamilton (1983) Times, 16 September
13.12

R v Holloway [1994] QB 302, [1993] 4 All ER 935, [1993] 3 WLR 927, 98 Cr App Rep 262, [1993] 4 Med LR 304, 15 BMLR 13, [1993] 25 LS Gaz R 36, 137 Sol Jo LB 145, CA
7.22

R v Horncastle [2009] UKSC 14,
2.2

R v Howe [2014] EWCA Crim 114
19.8

R (Richmond Pharmacology Ltd) v HRA and Sense about Science [2015] EWHC 2238 (Admin)
15.7

R v Human Fertilisation and Embryology Authority, ex p Blood [1999] Fam 151, [1997] 2 All ER 687, [1997] 2 WLR 806, [1997] 2 FCR 501, [1997] 2 FLR 742, [1997] Fam Law 401, 35 BMLR 1, [1997] NLJR 253, CA
2.3. 5.4, 12.15

R (AB) v Human Fertilisation and Embryology Authority [2014] EWHC 1528 (Admin)
12.15

R (on the application of Assisted Reproduction and Gynaecology Centre) v Human Fertilisation and Embryology Authority [2002] EWCA Civ 20, [2003] 1 FCR 266 (2002) Times, 21 March, [2002] All ER (D) 306 (Jan)
12.3

R (on the application of IM and another) v Human Fertilisation and Embryology Authority [2015] EWHC 1706 (Admin)
12.15

R (on the application of Quintavalle) v Human Fertilisation and Embryology Authority [2002] EWHC 2785 (Admin), [2003] 2 All ER 105, [2003] 1 FCR 664, 70 BMLR 236, [2003] NLJR 57 (2003) Times, 20 January, [2002] All ER (D) 330 (Dec); revsd sub nom R (on the application of Quintavalle) v Human Fertilisation and Embryology Authority (Secretary of State for Health intervening) [2003] EWCA Civ 667, [2004] QB 168, [2003] 3 All ER 257, [2003] 3 WLR 878, [2003] 2 FCR 193, [2003] 2 FLR335, [2003] Fam Law 565, 73 BMLR 116, [2003] 27 LS Gaz R 37, [2003] NLJR 824 (2003) Times, 20 May, 147 Sol Jo LB598, [2003] All ER (D) 231 (May); affd sub nom R (on the application of Quintavalle) v Human Fertilisation and Embryology Authority [2005] UKHL 28, [2005] 2 AC 561, [2005] 2 All ER 555, [2005] 2 WLR 1061, [2005] 2 FCR 135, [2005] 2 FLR349, [2005] Fam Law 613, 83 BMLR 143, [2005] NLJR 689 (2005) Times, 29 April, [2005] All ER (D) 407 (Apr)
12.19, 12.20, 12.25

R v Inglis [2010] EWCA Crim 2637
19.1

R v Ireland [1998] AC 147, [1997] 4 All ER 225, [1997] 3 WLR 534, [1998] 1 Cr App Rep 177, [1998] 1 FLR 105, [1998] Fam Law 137, [1997] Crim LR 810, [1997] NLJR 1273, HL
5.1, 6.22

R v Kelly [1999] QB 621, [1998] 3 All ER 741, [1999] 2 WLR 384, 51 BMLR 142, [1998] All ER (D) 215, CA
18.10

R v Konzani [2005] EWCA Crim 706, 2 Cr App Rep 13, [2005] All ER (D) 292 (Mar)
6.22

R v Lennox-Wright [1973] Crim LR 529
17.7

R v Lowe [1973] QB 702, [1973] 1 All ER 805, [1973] 2 WLR 481, 57 Cr App Rep 365, 137 JP 334, 117 Sol Jo 144, CA
14.6

R v McShane (1977) 66 Cr App Rep 97, [1977] Crim LR 737, 121 Sol Jo 632, CA
19.5

R v Malcherek [1981] 2 All ER 422, [1981] 1 WLR 690, 73 Cr App ep 173, [1981] Crim LR 401, 125 Sol Jo 305, CA
16.3

R v Matthew Fletcher [2014] EWCA (Crim) 1876
13.2

R (N) v Mental Health Review Tribunal [2006] QB 468, CA
1.14

R v Mental Health Review Tribunal, ex p Macdonald (1998) Crown Office Digest 205
6.18

R v Mid Glamorgan Family Health Services Authority, ex p Martin [1995] 1 All ER 356, [1995] 1 WLR 110, [1995] 2 FCR 578, [1995] 1 FLR 283, [1994] 5 Med LR 383, 21 BMLR 1, [1994] 38 LS Gaz R 42, 138 Sol Jo LB 195, CA
4.23

R (HSE) v Mid Staffordshire NHS Foundation Trust 2014 (unreported)
1.1

R (on the application of Nicklinson) v Ministry of Justice [2012] EWHC 2381, [2013] EWCA Civ 961, [2014] UKSC 38
2.11, 19.1, 19.9, 19.22

R v Misra [2004] EWCA Crim 2375, [2005] 1 Cr App Rep 328 (2004) Times, 13 October, 148 Sol Jo LB 1213, [2004] All ER (D) 107 (Oct)
7.22

R v Misra [2004] All ER (D) 150 (Oct), CA
7.22

R (on the application of Booker) v NHS Oldham and Direct Line Insurance PLC [2010] EWHC 2593 (Admin)
2.19

R (on the application of Bristol-Myers Squibb Pharmaceuticals Ltd) v NICE [2009] EWHC 2722 (Admin)
2.18

R v North and East Devon Health Authority, ex p Coughlan (Secretary of State for Health and another intervening) [2001] QB 213, [2000] 3 All ER 850, [2000] 2 WLR 622, 97 LGR 703, [1999] Lloyd’s Rep Med 306, 51 BMLR 1, [1999] 31 LS Gaz R 39, 2 CCL Rep 285, 143 Sol Jo LB 213, [1999] All ER (D) 801, CA
2.19

R v North Derbyshire Health Authority, ex p Fisher [1997] 8 Med LR 327, 38 BMLR 76, 10 Admin LR 27, 1 CCL Rep 150
2.19

R (on the application of Condliff) v North Staffordshire PCT [2011] EWCA Civ 910
2.17

R v North West Lancashire Health Authority, ex p A [2000] 1 WLR 977, [2000] 2 FCR 525 (1999) Times, 24 August, [1999] All ER (D) 911, CA
2.8, 2.11, 2.19

R v North West Lancashire Health Authority, ex p D [2000] 1 WLR 977, [2000] 2 FCR 525 (1999) Times, 24 August, [1999] All ER (D) 911, CA
2.8, 2.17, 2.19

R v North West Lancashire Health Authority, ex p G [2000] 1 WLR 977, [2000] 2 FCR 525 (1999) Times, 24 August, [1999] All ER (D) 911, CA
2.8, 2.11, 2.19

R (Osborn) v Parole Board [2013] UKSC 61
2.1, 2.3

R (on the application of S) v Plymouth City Council [2002] EWCA Civ 388, [2002] 1 WLR 2583, [2002] LGR 565, [2002] 1 FLR 1177, [2002] All ER (D) 414 (Mar)
4.7

R v Portsmouth Hospitals NHS Trust, ex p Glass [1999] 3 FCR 145, [1999] 2 FLR 905, [1999] Fam Law 696, 50 BMLR 269, [1999] 32 LS Gaz R 31, 143 Sol Jo LB 220, [1999] All ER (D) 836, CA
14.10

R v Poulton (1832) 5 C & P 329, 172 ER 997
14.5

R v Prentice [1994] QB 302, [1993] 4 All ER 935, [1993] 3 WLR 927, 98 Cr App Rep 262, [1993] 4 Med LR 304, 15 BMLR 13, [1993] 25 LS Gaz R 36, 137 Sol Jo LB 145, CA
7.22

R v Price [1969] 1 QB 541, [1968] 2 All ER 282, [1968] 2 WLR 1397, 52 Cr App Rep 295, 132 JP 335, 112 Sol Jo 330, CA
13.4

R (on the application of JK) v Registrar General for England and Wales [2015] EWHC 990 (Admin)
12.13

R v Richardson [1999] QB 444, [1998] 3 WLR 1292 (1998) 43 BMLR 31, [1998] 2 Cr App Rep 200, [1999] Crim LR 62, [1998] 17 LS Gaz R 30, 142 Sol Jo LB 131, CA
5.6

R (on the application of BAPIO Action Ltd) v Royal College of General Practitioners, General Medical Council [2014] EWHC 1416 (Admin)
1.11

R (on the application of B) v S [2005] EWHC 1936 (Admin), [2005] All ER (D) 38 (Sep); affd [2006] EWCA Civ 28, [2006] 1 WLR 810, 90 BMLR 1, [2006] 07 LS Gaz R 24 (2006) Times, 2 February, 150 Sol Jo LB 163, [2006] All ER (D) 200 (Jan)
2.5

R v St Mary’s Hospital Ethical Committee (Manchester), ex p H(Harriott) [1988] 1 FLR 512
2.19, 12.7

R (on the application of Murphy) v Salford PCT [2008] EWHC 1908 (Admin)
2.19

R (on the application of Axon) v Secretary of State for Health (Family Planning Association intervening) [2006] EWHC 37 (Admin), [2006] QB 539, [2006] 2 WLR 1130, [2006] 1 FCR 175, [2006] 2 FLR 206, [2006] Fam Law 272, 88 BMLR 96, [2006] 08 LS Gaz R 25 (2006) Times, 26 January, [2006] All ER (D) 148 (Jan)
2.11, 14.21, 14.22

R (McVey) v Secretary of State for Health [2010] EWHC 437 (Admin)
10.9

R (on the application of Quintavalle) v Secretary of State for Health [2001] EWHC Admin 918, [2001] 4 All ER 1013, 63 BMLR 167, [2001] NLJR 1732 (2001) Times, 5 December, [2001] All ER (D) 215 (Nov); revsd [2002] EWCA Civ 29, [2002] QB 628, [2002] 2 All ER 625, [2002] 2 WLR 550, [2002] 2 FCR 140, 64 BMLR 72, [2001] NLJR 1732 (2002) Times, 25 January, 146 Sol Jo LB 30, [2002] All ER (D) 104 (Jan); affd [2003] UKHL 13, [2003] 2 AC 687, [2003] 2 All ER 113, [2003] 2 WLR 692, [2003] 1 FCR 577, 71 BMLR 209, [2003] NLJR 439 (2003) Times, 14 March, [2003] All ER (D) 178 (Mar)
13.8

R (Roche Registration Limited) v Secretary of State for Health [2014] EWHC 2256
10.12

R (on the application of Rose) v Secretary of State for Health [2002] EWHC 1593 (Admin), [2002] 3 FCR 731, [2002] 2 FLR 962, [2003] Fam Law 19, 69 BMLR 83, [2002] LS Gaz R 38 (2002) Times, 22 August, [2002] All ER (D) 398 (Jul)
12.23

R (on the application of SPUC) v Secretary of State for Health [2002] 2 FLR 146
11.1

R (on the application of Watts) v Secretary of State for Health [2004] EWCA Civ 166, [2004] 2 CMLR 1273, 77 BMLR 26, [2004] All ER (D) 349 (Feb); refd sub nom R (on the application of Watts) v Bedford Primary Care Trust: C-372/04 [2006] QB 667, [2006] All ER (EC) 835, [2006] 3 WLR 213, [2006] 3 CMLR 102, 90 BMLR 150 (2006) Times, 19 May, [2006] All ER (D) 220 (May), ECJ
2.20

R (on the application of Mellor) v Secretary of State for the Home Department [2001] EWCA Civ 472, [2002] QB 13, [2001] 3 WLR 533, [2001] 2 FCR 153, [2001] 2 FLR 1158, [2001] Fam Law 736, 59 BMLR 1, 145 Sol Jo LB 117, [2001] All ER (D) 34 (Apr)
2.14, 12.9

R v Secretary of State for Social Services, ex p Hincks (1980) 1 BMLR 93, CA
2.19

R v Senior (1832) 168 ER 1298
11.18

R v Senior (1832) 1 Mood CC 346, CCR
11.19

R v Senior [1899] 1 QB 283, 63 JP 8, 68 LJQB 175, 19 Cox CC 219, 47 WR 367, [1895–9] All ER Rep 511, 43 Sol Jo 114, 79 LT 562, 15 TLR 102, CCR
14.6

R v Sheffield Health Authority, ex p Seale (1994) 25 BMLR 1
2.19, 12.7

R (Moore) v Skipton Fund Ltd [2010] EWHC 3070 (Admin)
10.9

R v Smith (John) [1974] 1 All ER 376, [1973] 1 WLR 1510, 58 Cr App Rep 106, 138 JP 175, 117 Sol Jo 774, CA
13.4

R v Sockett (1908) 1 Cr App Rep 101, 72 JP 428, 52 Sol Jo 729, 24 TLR 893, CCA
13.2

R v Southampton University Hospitals NHS Trust (11 April 2006, unreported)
1.15. 7.22, 7.23

R v Steel [1981] 2 All ER 422, [1981] 1 WLR 690, 73 Cr App Rep 173, 125 Sol Jo 305, CA
16.3

R (on the application of Rogers) v Swindon NHS Primary Care Trust [2006] EWCA Civ 392, [2006] 1 WLR 2649, 89 BMLR 211, [2006] NLJR 720, 150 Sol Jo LB 575, [2006] All ER (D) 181 (Apr)
2.7, 2.19

R v T [2015] EWFC 22
12.31

R v Tabassum [2000] 2 Cr App Rep 328, [2000] Crim LR 686, [2000] Lloyd’s Rep Med 404, Times, 26 May 2000, [2000] All ER (D) 649, CA
5.5, 5.6

R (on the application of Elizabeth Rose) v Thanet Clinical commissioning Group [2014] EWHC 1182 (Admin)
2.18

R (G) v The Governors of X School [2011] UKSC 30
2.10

R (on the application of Heather) v The Leonard Cheshire Foundation[2001] EWHC Admin 429, [2001] All ER (D) 156 (Jun); affd sub nom R (on the application of Heather) v Leonard Cheshire Foundation [2002] EWCA Civ 366, [2002] 2 All ER 936, [2002] HLR 893, 69 BMLR 22 (2002) Times, 8 April, [2002] All ER (D) 326 (Mar)
2.3

R v Webb [2011] EWCA Crim 152
19.2

R v West (1848) 175 ER 329
11.18

R (Ross) v West Sussex PCT [2008] EWHC 2252 (Admin)
2.19

R v Whitchurch (1890) 24 QBD 420, 54 JP 472, 59 LJMC 77, 16 Cox CC 743, [1886–90] All ER Rep 1001, 62 LT 124, 6 TLR 177, CCR
13.2

R v Woollin [1999] 1 AC 82, [1998] 4 All ER 103, [1998] 3 WLR 382, [1999] 1 Cr App Rep 8, [1998] Crim LR 890, [1998] 34 LS Gaz R 32,[1998] NLJR 1178, 142 Sol Jo LB 230, HL
19.3

R and S v T [2015] EWFC 22
12.7

Rabone v Pennine Care NHS Trust [2009] EWHC 1827 (QB), [2010] EWCA Civ 698, [2012] UKSC 2
2.7, 5.2, 6.1

Rance v Mid-Downs Health Authority [1991] 1 QB 587, [1991] 1 All ER 801, [1991] 2 WLR 159, [1991] Fam Law 24, [1990] 2 Med LR 27, 5 BMLR 75, [1990] NLJR 325
13.12

Rand v East Dorest Health Authority [2000] Lloyd’s Rep 181
11.12

Ratcliffe v Plymouth and Torbay Health Authority [1998] PIQR P 170, [1998] Lloyd’s Rep Med 162, CA
8.14

RB (A Child), Re [2009] EWHC 3269 (Fam)
14.11

Rees v Darlington Memorial Hospital NHS Trust [2002] EWCA Civ 88, [2003] QB 20, [2002] 2 All ER 177, [2002] 2 WLR 1483, [2002] 1 FCR 695, [2002] 1 FLR 799, 65 BMLR 117, [2002] NLJR 281 (2002) Times, 19 February, 146 Sol Jo LB 53, [2002] All ER (D) 176 (Feb); revsd [2003] UKHL 52, [2004] 1 AC 309, [2003] 4 All ER 987, [2003] 3 WLR 1091, [2003] 3 FCR 289, [2004] 1 FLR 234, [2004] Fam Law 22, 75 BMLR 69, [2003] NLJR 1599 (2003) Times, 21 October, [2004] 4 LRC 102, [2003] All ER (D) 271 (Oct)
11.1, 11.12

Regina v A [2010] EWCA Crim 1949
13.2

Reibl v Hughes [1980] 2 SCR 880, 114 DLR (3d) 1, 14 CCLT 1 (Can SC), Can SC
5.6, 5.8

REL (otherwise R) v EL [1949] P211, sub nom L v L [1949] 1 All ER 141, [1949] LJR 275, 93 Sol Jo 42, 65 TLR 88, P, D and Admlty
12.13

Respondent Michael Schiavo’s Opposition to Application for Injunction (Case No 04A-825) (24 March 2005, unreported)
6.5

Reynolds v North Tyneside Health Authority [2002] Lloyd’s Rep Med 453
7.9

Richards v Swansea NHS Trust [2007] EWHC 487
8.14

Richardson, Re (1973) 284 So 2d 185
17.6

Richardson v LRC Products Ltd (2000) 59 BMLR 185, [2000] Lloyd’s Rep Med 280
10.1, 10.5, 10.7, 11.2

Robert Allan Odes v GMC [2010] EWHC 552
1.15

Robertson v East Kent Health Authority [1999] Lloyd’s Rep Med 123
8.5

Rochdale Healthcare (NHS) Trust v C [1997] 1 FCR 274, [1996] 3 Hempson’s Lawyer 505
5.3, 11.21

Rochdale Metropolitan Borough Council v KW [2014] EWCOP 45
6.12

Rodriguez v A-G of British Columbia (1993) 82 BCLR 2d 273, 50 BMLR 1, [1993] 3 SCR 519, 158 NR 1, [1993] 7 WWR 641, 85 CCC (3d) 15, 107 DLR (4th) 342, 17 CRR (2d) 193, 24 CR (4th) 281, 34 BCAC 1, 56 WAC 1, Can SC
2.8

Roe v Minister of Health [1954] 2 QB 66, [1954] 1 WLR 128, 98 Sol Jo 30; affd [1954] 2 QB 66, [1954] 2 All ER 131, [1954] 2 WLR 915, 98 Sol Jo 319, CA
7.10, 7.13, 8.6, 8.14

Roe v Wade (1973) 93 S Ct 705
13.12

Rogers v Whittaker [1993] 4 Med LR 79, 16 BMLR 148, 175 CLR 479, 109 ALR 625, 67 ALJR 47, Aus HC
5.8

Royal College of Nursing of the United Kingdom v Department of Health and Social Security [1981] AC 800, [1981] 1 All ER 545, [1981] 2 WLR 279, 125 Sol Jo 149, 1 BMLR 40, HL
13.14

Royal Wolverhampton Hospitals NHS Trust v B [2000] 2 FCR 76, [2000] 1 FLR 953
14.11

Ruscillo v Council for the Regulation of Health Care Professionals; the GMC and another [2004] EWCA Civ 1356
1.15

S

S (Adult: Refusal of Medical Treatment), Re [1993] Fam 123, [1992] 4 All ER 671, [1992] 3 WLR 806, [1992] 2 FCR 893, [1993] 1 FLR 26, [1993] Fam Law 221, [1993] 4 Med LR 28, 9 BMLR 69, [1992] 43 LS Gaz R 31, [1992] NLJR 1450, 136 Sol Jo LB 299
5.3, 11.21

S (Adult: Sterilisation), Re [1999] 1 FCR 277, [1998] 1 FLR 944, [1998] Fam Law 325
11.4

S (Adult Patient: Sterilisation), Re [2001] Fam 15, [2000] 3 WLR 1288, [2000] 2 FCR 452, [2000] Fam Law 711, [2000] All ER (D) 683, CA
6.7, 14.14

S (A Minor) (Consent to Medical Treatment), Re [1994] 1 FCR 604, [1994] 2 FLR 1065, [1995] Fam Law 20
14.21

S (A Minor) (Medical Treatment), Re [1993] 1 FLR 376, [1993] Fam Law 215
2.12, 14.9

S (Parental Order), Re [2009] EWHC 2977 (Fam)
12.29

S (Specific Issue Order: Religion: Circumcision), Re [2004] EWHC 1282 (Fam), [2005] 1 FLR 236
2.12

S v Distillers Co (Biochemicals) Ltd [1969] 3 All ER 1412, [1970] 1 WLR 114, 113 Sol Jo 672
11.6

S v S [1972] AC 24, [1970] 3 All ER 107, [1970] 3 WLR 366, 114 Sol Jo 635, HL
15.10

S and Marper (2009) 48 EHRR 50
15.18

St George v Home Office [2008] EWCA 1068
7.20

St George’s Healthcare NHS Trust v P & Q [2015] EWCOP 42
19.17

St George’s Healthcare NHS Trust v S [1999] Fam 26, [1998] 3 All ER 673, [1998] 3 WLR 936, [1998] 2 FCR 685, [1998] 2 FLR 728, [1998] Fam Law 526, 44 BMLR 160, [1998] 22 LS Gaz R 29, [1998] NLJR 693, 142 Sol Jo LB 164, [1998] CCL Rep 410, CA
2.7, 5.3, 11.16, 11.21

Salih v Enfield Health Authority [1991] 3 All ER 400, [1991] 2 Med LR 235, 7 BMLR 1, CA
11.12

Saunders v Leeds Western Health Authority [1993] 4 Med LR 355, 129 Sol Jo 225, [1985] LS Gaz R 1491
8.14

Savage v South Essex Partnership NHS Foundation Trust (2008) UKHL 74, [2010] EWHC 285
2.7

Scialacqua v Italy (1998) 26 EHRR CD 164
2.17

Scienkiewicz v Grief [2009] EWCA 1159
10.10

Secretary of State for the Home Department v Robb [1995] Fam 127, [1995] 1 All ER 677, [1995] 2 WLR 722, [1995] 1 FCR 557, [1995] 1 FLR 412, 22 BMLR 43, [1994] NLJR 1695
5.3

Selwood v Durham CC, Tees, Esk and Wear Valleys NHS FT and Northumberland, Tyne and Wear NHS FT [2012] EWCA Civ 972
4.16, 7.5

Servier Laboratories v NICE [2010] EWCA Civ 346
2.18

SH and Others v Austria (Application number 55813/00) November 15 2007
12.8

SH and Others v Austria (Application number 57813/00 2011)
2.2

Sheffield City Council v E [2005] 2 WLR 953
6.4

Sheffield Teaching Hospitals NHS Foundation Trust v TH & Anor [2014] EWCOP 4
6.9

Shortall v Mid Essex Hospital Services NHS Trust [2014] EWHC 246 (QB)
7.11

Shorter v Surrey & Sussex NHS Healthcare Trust [2015] EWHC 614 (QB)
7.3

Sidaway v Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital [1984] QB 493, [1984] 1 All ER 1018, [1984] 2 WLR 778, 128 Sol Jo 301, [1984] LS Gaz R 899, CA; affd [1985] AC 871, [1985] 1 All ER 643, [1985] 2 WLR 480, 129 Sol Jo 154, 1 BMLR 132, [1985] LS Gaz R 1256, HL
5.1, 5.6, 5.7, 5.9, 5.17, 7.8

Sienkiewicz v Greif [2011] UKSC 10
10.10

Simmons v Castle [2012] EWCA Civ 1039
8.3, 8.18

Simms v Simms (a child) [2002] EWHC 2734 (Fam), [2003] Fam 83, [2003] 1 All ER 669, [2003] 2 WLR 1465, [2003] 1 FCR 361, 71 BMLR 61, [2003] NLJR 21, [2002] All ER (D) 263 (Dec)
6.7, 15.9

Sindell v Abbott Laboratories (1980) 26 Cal 3d 588, 607 P 2d 924
10.1, 10.10

Sindicato de Medicos de Asistencia Publica (SiMAP) v Conselleria de Sanidad y Consumo de la Generalidad Valenciana [200] ECR 1-7963
1.17

Sion v Hampstead Health Authority [1994] 5 Med LR 170, CA
7.3

Smith v Leicestershire Health Authority (1996) 36 BMLR 23, [1998] Lloyd’s Rep Med 77
8.9

Smith v Littlewoods Organisation Ltd. See Maloco v Littlewoods Ltd [1987] 1 ALL ER 710
4.16

Smith (by her mother and next friend) v Secretary of State for Health [2002] EWHC 200 (QB), 67 BMLR 34 (2002) Times, 11 March, [2002] All ER (D) 196 (Feb)
10.12

Smith v Tunbridge Wells Health Authority [1994] 5 Med LR 334
5.10, 5.17

Smith v West Yorkshire Health Authority (formerly Leeds Health Authority) [2004] EWHC 1592 (QB), [2004] All ER (D) 410 (May)
7.9

Southall v GMC [2009] EWHC 1155 (Admin)
1.15

South Glamorgan County Council v W and B [1993] 1 FCR 626, [1993] 1 FLR 574, [1993] Fam Law 398, 11 BMLR 162
14.21

Spencer v Hillington Hospital NHS Trust [2015] EWHC 1058 (QB)
5.12

SS (An Adult: Medical Treatment: Late Termination), Re [2002] 1 FCR 73, [2002] 1 FLR 445, [2002] Fam Law 102, [2001] All ER (D) 220 (Oct)
13.18

Stephens v Avery [1988] Ch 449, [1988] 2 All ER 477, [1988] 2 WLR 1280, [1988] FSR 510, 132 Sol Jo 822, [1988] NLJR 69
4.2

Stevens v Yorkhill NHS Trust 2001 SCLR 606
18.10

Stovin v Wise (Norfolk County Council, third party) [1996] AC 923, [1996] 3 All ER 801, [1996] 3 WLR 388, 95 LGR 260, [1996] RTR 354, [1996] 35 LS Gaz R 33, [1996] NLJR 1185, 140 Sol Jo LB 201, [1996] 3 LRC 361, HL
10.12

Strunk v Strunk (1969) 35 ALR (3d) 683
17.6

Superintendent of Family and Child Service and Dawson, Re (1983) 45 DLR (3d) 610, BC SC
14.11

Szuluk v United Kingdom [2009] ECHR 36936/05
2.11, 4.4

T

T, Re (14 May 1987, unreported)
6.5

T (A Child) (Surrogacy: Residence Order) [2011] EWHC F 33 (Fam)
12.30

T (A Minor) (Wardship: Medical Treatment), Re [1997] 1 All ER 906, [1997] 1 WLR 242, 96 LGR 116, [1997] 2 FCR 363, [1997] 1 FLR 502, 35 BMLR 63, [1996] 42 LS Gaz R 28, [1996] NLJR 1577, 140 Sol Jo LB 237, CA
14.8, 14.9, 14.21

T (Adult: Refusal of Treatment), Re [1993] Fam 95, [1992] 4 All ER 649, [1992] 3 WLR 782, [1992] 2 FCR 861, [1992] 2 FLR 458, [1993] Fam Law 27, 9 BMLR 46, [1992] NLJR 1125, CA
5.2, 5.3, 6.14, 15.8, 19.4

T v T [1988] Fam 52, [1988] 1 All ER 613, [1988] 2 WLR 189, [1988] 1 FLR 400, 131 Sol Jo 1286, [1987] LS Gaz R 2456
6.5, 13.18

Taaffee v East of England Ambulance Service NHS Trust [2012] EWHC 1335
7.2

Tameside and Glossop Acute Services Trust v CH [1996] 1 FCR 753, [1996] 1 FLR 762, [1996] Fam Law 353, 31 BMLR 93
6.19, 11.21

Tarasoff v Regents of University of California (1976) 551 P
4.16

Taylor v Somerset Health Authority [1993] 4 Med LR 34, 16 BMLR 63, [1993] PIQR P262
7.3

Taylor v Worcester and District Health Authority [1991] 2 Med LR 215
7.13

TC (A Minor) Re (1993) 2 MLR 376
16.3

Tesco Stores v Pollard (A Minor) [2006] EWCA 393
10.5

Thake v Maurice [1986] QB 644, [1984] 2 All ER 513, [1985] 2 WLR 215, 129 Sol Jo 86, [1985] LS Gaz R 871; revsd [1986] QB 644, [1986] 1 All ER 497, [1986] 2 WLR 337, 129 Sol Jo 894, [1986] LS Gaz R 123, [1986] NLJ Rep 92, CA
7.21, 11.3

The Assisted Reproduction and Gynaecology Centre and the Reproductive Genetics Institute v HFEA [2013] EWHC 3087 (Admin)
12.3

The NHS Trust v L and Others [2012] EWCOP 2741
19.4

Thomas v Curley [2013] EWCA Civ 117
8.14

Thompson v Sheffield Fertility Centre (24 November 2000, unreported), QBD
7.21

Thompstone v Tameside and Glossop Acute Services NHS Trust [2008] EWCA Civ 5
8.16

Tomlinson v Congleton Borough Council [2003] UKHL 47, [2004] 1 AC 46, [2003] 3 All ER 1122, [2003] 3 WLR 705, [2003] 34 LS Gaz R 33, [2003] NLJR 1238, [2003] 32 EGCS 68 (2003) Times, August, 147 Sol Jo LB 937, [2003] All ER (D) 554 (Jul)
8.17

Tuffil v East Surrey Area Health Authority (1978) Times, 15 March
7.12

TW v Enfield Borough Council [2014] EWCA Civ 362
4.4

Tysiac v Poland (2007) 45 EHRR 42
13.19

U

U v W (A-G intervening) [1998] Fam 29, [1997] 3 WLR 739, [1997] 2 CMLR 431, [1998] 1 FCR 526, [1997] 2 FLR 282, 38 BMLR 54, [1997] 11 LS Gaz R 36, 141 Sol Jo LB 57…
12.10

Udale v Bloomsbury Area Health Authority [1983] 2 All ER 522, [1983] 1 WLR 1098, 127 Sol Jo 510
11.12

Uren v Corporate Leisure and Others [2010] All ER (D) 132
7.6

Urry v Bierer (1955) Times, 15 July, CA
7.13

V

V, Re (1987) Times, 4 June
6.6

Vadera v Shaw (1998) 45 BMLR 162, CA
11.2

VC v Slovakia (2014) 59 EHRR 29
11.4

Vidal-Hall v Goggle Inc [2015] EWCA Civ 311
4.2

Vioxx Litigation, Re, 395 NJ Super 358 (Sup Ct NJ, App Div, 2007)
10.15

Vo v France (Application 53924/00) [2004] 2 FCR 577, 79 BMLR 71, 16 BHRC 1, [2004] ECHR 326, ECtHR
2.7, 13.19

W

W (A Minor) (Medical Treatment), Re [1993] Fam 64, [1992] 4 All ER 627, [1992] 3 WLR 758, [1992] 2 FCR 785, [1993] 1 FLR 1, [1992] Fam Law 541, 9 BMLR 22, [1992] NLJR 1124, CA
13.17, 14.21, 15.10, 17.5

W (Minors), Re [1991] FCR 419, [1991] 1 FLR 385, [1991] Fam Law 180
12.28

W v Egdell [1990] Ch 359, [1990] 1 All ER 835, [1990] 2 WLR 471, 134 Sol Jo 286, 4 BMLR 96, [1990] 12 LS Gaz R 41, CA
4.2, 4.4, 4.5, 4.10, 4.11

W v M and Others [2011] EWHC 2443
19.17, 19.20

W v M (An Adult Patient) [2011] EWHC 1197 (COP)
4.13

W Healthcare NHS Trust v H [2004] EWCA Civ 1324 (2004) Times, 9 December, [2005] All ER (D) 94 (Jan)
6.14, 19.16

Wainwright v Home Office [2003] UKHL 53, [2004] 2 AC 406, [2003] 4 All ER 969, [2003] 3 WLR 1137, [2004] IP & T 78, [2003] 45 LS Gaz R 30 (2003) Times, 20 October, 147 Sol Jo LB 1208, [2004] 4 LRC 154, [2003] All ER (D) 279 (Oct), 15 BHRC 387
2.3, 4.2

Waldron, ex p [1986] QB 824, [1985] 3 WLR 1090, 129 Sol Jo 892, [1986] LS Gaz R 199, sub nom R v Hallstrom, ex p W [1985] 3 All ER 775, CA
6.19

Walker-Smith v General Medical Council [2012] EWHC 503 (Admin)
1.15, 7.9, 10.15, 15.5

Wallace v Kam [2013] HCA 19 (2013) 87 ALJR 648
10.10

Warren v Care Fertility (Northampton) Ltd [2014] EWHC 602 (Fam)
12.17

Watson v Buckley Osborne Garrett & Co Ltd and Wyrovoys Products Ltd [1940] 1 All ER 174
10.4

Waugh v British Railways Board [1980] AC 521, [1979] 2 All ER 1169, [1979] 3 WLR 150, [1979] IRLR 364, 123 Sol Jo 506, HL
8.12

Webley v St George’s NHS Trust and the Metropolitan Police [2014] 299 (QB)
7.5

Wells v Surrey Area Health Authority (1978) Times, 29 July
11.3

Wells v Wells [1999] 1 AC 345, [1998] 3 All ER 481, [1998] 3 WLR 329, [1998] IRLR 536, [1998] 2 FLR 507, [1998] Fam Law 593, 43 BMLR 99, [1998] NLJR 1087, [1998] PIQR Q 56, 142 Sol Jo LB 245, [1998] All ER (D) 352, HL
8.15

Wertheim, Nederlandse Jurisprudentie 1982 No 163, RCC
19.13

West London Mental Health NHS Trust v Chhabra [2013] UKSC 80
1.14

Whiteford v Hunter [1950] WN 553, 94 Sol Jo 758, HL
7.10

Whitehouse v Jordan [1981] 1 All ER 267, [1981] 1 WLR 246, 125 Sol Jo 167, HL
7.8, 8.13

Wild v Southend University Hospital NHS Trust [2014] EWHC 4053
7.3

Williams v Williams (1882) 20 Ch D 659, 46 JP 726, 51 LJ Ch 385, 15 Cox CC 39, 30 WR 438, [1881–5] All ER Rep 840, 46 LT 275
18.4

Williamson v East London and City Health Authority [1998] Lloyd’s Rep Med 6, 41 BMLR 85
5.1, 5.10

Wilsher v Essex Area Health Authority [1987] QB 730, [1986] 3 All ER 801, [1987] 2 WLR 425, 130 Sol Jo 749, [1986] LS Gaz R 2661, [1986] NLJ Rep 1061, CA; revsd [1988] AC 1074, [1988] 1 All ER 871, [1988] 2 WLR 557, 132 Sol Jo 418, [1988] 15 LS Gaz R 37, [1988] NLJR 78, HL
7.7, 7.14, 7.15, 9.11

Winterwerp v Netherlands (Application 6301/73) (1979) 2 EHRR 387, sub nom Winterwerp v Netherlands (Art 50) (1981) 4 EHRR 228, ECtHR
6.11

Wood v Thurston (1951) Times, 25 May
7.12

Woodland v Essex County Council [2013] UKSC 66
8.6, 8.14

Worsley v Tambrands Ltd [2000] PIQR P 95
10.5

Wright (A Child) v Cambridge Medical Group [2011] EWCA Civ 669
7.6, 7.17

Wright v Dunlop Rubber Co (1972) 13 KIR 255, CA
10.4

WT (Foreign Surrogacy), Re, [2015] EWHC 1303 (Fam)
12.31

Wyatt, Re [2005] EWHC 2902, [2005] EWHC 117, [2005] EWHC 693
14.11

Wyatt (A Child) (Medical Treatment: Parents’ Consent), Re [2004] EWHC 2247 (Fam), 84 BMLR 206, [2004] NLJR 1526, [2004] All ER (D) 89 (Oct), sub nom Portsmouth NHS Trust v Wyatt [2005] 1 FLR 21
14.11, 19.20

Wyatt (No 3) (A Child) (Medical Treatment: Continuation of Order), Re [2005] EWHC 693 (Fam), [2005] Fam Law 614, [2005] All ER (D) 278 (Apr), sub nom Wyatt v Portsmouth NHS Trust [2005] 2 FLR 480, [2005] EWCA Civ 1181; affd sub nom Wyatt (A Child) (Medical Treatment: Continuation of Order), Re [2005] EWCA Civ 1181, [2005] 3 FCR 263, 86 BMLR 173, [2005] All ER (D) 107 (Oct), sub nom Wyatt v Portsmouth NHS Trust [2005] 1 WLR 3995, [2006] 1 FLR 554
14.7, 14.11

Wyatt v Curtis [2003] EWCA Civ 1779, [2003] All ER (D) 493 (Oct)
5.10

Wyatt v Wilson (1820), unreported
4.2

X

X (A Child) (Capacity to Consent to Termination) [2014] EWHC 1871 (Fam)
13.17

X (A Child) (Surrogacy: Time Limit) [2014] EWHC 3135
12.28

X (Court of Protection Practice), Re (2015) EWCA Civ 599
6.12

X v St Bartholomew’s Hospital Centre for Reproductive Medicine [2015] EWFC 13

X v Y [1988] 2 All ER 648, [1988] RPC 379, 3 BMLR 1, [1987] NLJ Rep 1062
4.4, 4.10

X and Ors (Deprivation of Liberty), Re [2014] EWCOP 25
6.12

X and Ors (Deprivation of Liberty) (Number 2), Re [2014] EWCOP 37
6.12

X and Y (Foreign Surrogacy), Re [2008] EWHC 3030 (Fam)
12.29, 12.31, 12.3, 12.10

XCC v A [2013] 2 ALL ER 988
6.20

XYZ v Schering Health Care Ltd [2002] EWHC 1420 (QB), 70 BMLR 88, [2002] All ER (D) 437 (Jul)
10.1, 10.8, 10.10, 10.12

Y

Y (Mental Incapacity: Bone Marrow Transplant), Re [1997] Fam 110, [1997] 2 WLR 556, [1997] 2 FCR 172, [1996] 2 FLR 787, [1997] Fam Law 91, 35 BMLR 111
17.6

YA (F) v A Local Authority [2010] EWHC 2770
6.17

Yeager v Bloomington Obstetrics and Gynaecology, Inc 585 NW2d 696 (Ind, 1992)
11.13

Yearworth v North Bristol NHS Trust [2009] EWCA Civ 37
12.15, 18.1, 18.10

YL v Birmingham City Council [2007] UKHL 27
2.4

Yousef v the Netherlands (2003) 36 EHRR 345
14.21

Z

Z (A Child) (Sperm Donor: Contact Order), Re [2013] EWHC 134 (Fam)
12.12

Z (An Adult: Capacity), Re [2004] EWHC 2817 (Fam)
19.7

Z v Finland (application 22009/93) (1997) 25 EHRR 371, 45 BMLR 107, ECtHR
15.18

Z v United Kingdom (2001) 34 EHRR 97
2.8

ZH (A Protected Party) v Commissioner for Police for the Metropolis [2013] EWCA Civ 69
4.2, 6.1, 6.8

Decisions of the European Court of Justice are listed below numerically.

These decisions are also included in the preceding alphabetical list.

C-87/14 Commission v Ireland | 1.17
C-131/12 Google Spain SL, Google Inc v Agencia Espanola de Protectcion de Datos, Mario Costeja Gonzalez [2014] | 4.19
C-303/98 Sindicato de Medicos de Asistencia Publica (SiMAP) v Conselleria de Sanidad y Consumo de la Generalidad Valenciana [2000] ECR 1-7963 | 1.17
C-358/08: Aventis Pasteur SA v OB [2009] | 10.5
C-157/99: BSM Geraets-Smits v Stichting Ziekenfonds VGZ [2002] QB 409, [2001] ECR I-5473, [2003] All ER (EC) 481, [2002] 2 WLR 154, [2002] 2 CMLR 460, 62 BMLR 101 (2001) Times, 4 September, [2001] All ER (D) 152 (Jul), ECJ | 2.20
C-151/02: Landeshauptstadt Kiel v Jaeger [2003] ECR I-8389, [2004] All ER (EC) 604, [2003] 3 CMLR 493, [2004] ICR 1528, [2003] IRLR 804, 75 BMLR 201 (2003) Times, 26 September, [2003] All ER (D) 72 (Sep), ECJ | 1.17
C-127/04: O’Byrne v Sanofi Pasteur MSD Ltd [2006] All ER (EC) 674, [2006] 1 WLR 1606, [2006] 2 CMLR 656, 91 BMLR 175 (2006) Times, 15 February, [2006] All ER (D) 117 (Feb), ECJ | 10.5
C-372/04: R (on the application of Watts) v Bedford Primary Care Trust [2006] QB 667, [2006] All ER (EC) 835, [2006] 3 WLR 213, [2006] 3 CMLR 102, 90 BMLR 150 (2006) Times, 19 May, [2006] All ER (D) 220 (May), ECJ | 2.20

Table of statutes

Abortion Act 1967 | 3.16, 11.11, 13.1, 13.3, 13.5, 13.12
s 1(1)(d) | 15.17
s 1(3) | 13.3,13.5
s 4 | 13.3, 13.15
s 5(1) | 13.12
Access to Health Records Act 1990 | 4.23
Access to Justice Act 1999 | 8.2
Administration of Justice Act 1982, s 5 | 8.15
Adoption Act 1976 | 12.2
s 51(2) | 12.23
Adoption Act 2002 | 12.28
s 95 | 12.28
Adoption and Children Act 2002 | 12.10, 12.29, 12.31
s 95 | 12.29
Adult Support and Protection (Scotland) Act 2007 | 2.8, 4.8
s 5(3) | 4.8
Anatomy Act 1832 | 18.1
Anatomy Act 1984 | 17.2, 18.4, 18.6
Care Act 2014 | 1.6, 2.4, 2.8, 4.9, 7.22, 8.12, 9.9, 15.5
s 42 | 2.8, 4.8
s 73(2) | 2.4
s 81 | 1.6, 7.22, 8.12, 9.9
s 108 | 15.3
s 109 | 15.3
s 112(3) | 15.5
ss 115–116 | 15.5
s 117 | 4.9
Care Standards Act 2000 | 6.12
Care Standards Act 2014 | 6.22
Children Act 1989 | 11.4, 12.10, 14.6, 14.8, 14.14
s 4 | 12.10, 14.14
s 8 | 12.12, 14.14
s 31(2) | 14.6
s 100 | 14.8
Children Act 2004,s 11 | 4.1
Children and Families Act 2014 | 14.14
Children and Young Persons Act 1933 | 14.6
s 1(1) | 14.6
Compensation Act 2006 | 7.6, 9.9, 10.1
s 1 | 7.6
s 2 | 8.5, 9.9
s 3 | 7.16, 10.1, 10.10
Congenital Disabilities(Civil Liability) Act 1976 | 11.7, 11.11, 11.13, 11.14, 11.16, 11.21, 12.24
s 1 A | 11.13
s 1(2) | 11.21
s 1(2)(a) | 11.8
s 1(2)(b) | 11.8, 11.11
s 1(4) | 11.15
s 1(5) | 11.9
s 1(7) | 11.16
s 2 | 11.7
Consumer Protection Act 1987 | 9.14, 10.1, 10.3, 10.5, 10.15, 11.2, 11.8, 15.15, 17.18
ss 1– 2 | 10.5, 11.20
s 3 | 11.8
s 4(1)(e) | 10.7
s 22 A | 10.5
Part I | 10.1
Consumer Rights Act 2015 | 8.7, 10.3
ss 9–18 | 10.3
s 49 | 8.7
Corneal Tissue Act 1986 | 17.2, 17.7
Coroners and Justice Act 2009 | 11.18, 16.3, 18.5, 19.1, 19.5
s 1 | 18.5
ss 2–4 | 18.5
s 14 | 18.5
s 15 | 16.3
s 35 | 18.1
s 40 | 18.5
s 57 | 11.18
s 59(2) | 19.1
Sch 8 | 18.1
Sch 10 | 18.5
Corporate Manslaughter and Corporate Homicide Act 2007 | 1.17
s 8 | 7.23
s 9 | 7.23
Counter-Terrorism and Security Act 2015 | 4.11
s 26 | 4.11
Courts and Legal Services Act 1990 | 8.3
Criminal Justice Act 2003 | 7.22
Criminal Justice and Courts Act 2015 | 1.17, 7.23
s 20 | 1.17
ss 20–25 | 7.23
s 21 | 1.17
Criminal Law Act 1967
s 3 | 6.23
s 5(1) | 4.11
s 5(5) | 4.11
Damages Act 1996 | 8.15
ss 2–2A–B | 8.16
s 3 | 8.15
Data Protection Act 1998 | 4.2, 4.17, 8.12, 15.17, 15.18
s 7 | 4.23
s 10 | 4.17
s 13 | 4.17
s 30(1) | 4.23
s 51(7) | 4.17
s 68(2) | 4.17
s 69 | 4.17
Sch 2 | 4.17
Enduring Powers of Attorney Act 1985 | 6.15
Enterprise Regulatory Reform Act 2013 | 1.5
Family Law Act 1996 | 15.10
Family Law Reform Act 1969 | 14.16, 14.21
s 8 | 14.16
s 8(3) | 14.16, 14.21
Fatal Accidents Act 1976 | 8.15
Fatal accidents and Sudden Deaths Inquiry(Scotland) Act 1976 | 18.1
Freedom of Information Act 2000 | 15.17
Gender Recognition Act 2004 | 17.20
Health Act 1999 s 60 A | 1.14
Health Act 2006 s 60 | 4.9
Health Act 2009 | 1.18
s 1 | 2.16
ss 8–10 | 1.18
Health and Social Care Act 2001, s 60 | 15.8
Health and Social Care Act 2008 | 1.8, 6.21
s 145 | 2.3
Part 3 | 6.21
Health and Social Care Act 2012 | 1.10, 1.18, 9.1, 15.18
s 5 | 1.14
s 33–34 | 1.3
s 98 | 1.8
s 116 | 1.3
s 181 | 9.5
s 182 | 9.5
s 222 | 1.2, 1.15
s 232 | 2.18, 3.6
s 237 | 2.18
s 238 | 2.18
s 251A | 4.6
s 252 | 4.21
s 256 | 4.21
s 260 | 4.21
s 263 | 4.21
Part 3ss 61–7 | 1.3
Part 3ss 115–127 | 1.3
Part 8 | 2.18
Part 9ss 252–27 | 1.3
Sch 1 | 1.3
Health and Social Care(Community Health and Standards) Act 2003 | 1.18
s 41 | 1.18
Health and Social Care(Safety and Quality) Act 2015 | 1.1, 4.6
s 251 A | 4.6
s 251 B | 4.6
Health Service Commissioners Act 1993 | 9.7
s 3(1) | 9.7
s 4(1)(b) | 9.7
ss 10–12 | 9.7
Health Service Commissioners (Amendment) Act 1996 | 9.7
Human Fertilisation and Embryology Act 1990 | 1.19, 3.14, 12.1, 12.5, 12.10, 12.11, 12.15, 12.16, 12.21, 12.27, 13.3, 13.7, 13.12, 13.14, 13.20, 18.10
s 1(1)(a) | 13.8
s 1(2)(a) | 12.2
s 1(5) | 12.2
s 3 | 12.2, 12.15
s 3(1) | 13.7
s 3(1)(d) | 12.25
s 3(2) | 12.2, 13.7
s 3(3)(a) | 13.7
s 3(3)(b) | 13.7
s 3(3)(d) | 13.8
s 3(6) | 3.14
s 3A | 12.16
s 4 | 12.2, 12.17
s 4(1)(b)(ii) | 12.2
s 5 | 1.19, 12.2
s 12(e) | 12.16
s 13(5) | 12.1, 12.5
s 13(8)–(10) | 12.21
s 24(4) | 12.15
s 27 | 12.10, 12.27
s 28 | 12.10, 12.27
s 28(2) | 12.4, 12.10
s 28(3) | 12.10
s 28(5) A–I | 2.3, 12.15
s 28(6) | 12.15
s 28(6)(b) | 2.3
s 31 | 12.23
s 31(4)(a)–(b) | 12.23
s 31(5) | 12.23
s 33 | 12.11
s 34 | 12.24
s 35(4) | 12.24
s 37 | 13.3, 13.12
s 37(3) | 13.5
s 37(5) | 13.13
s 38 | 13.14
ss 39–41 | 12.15
s 44 | 12.24
Sch 3 | 12.16, 12.18
Human Fertilisation and Embryology Act 2008 | 2.3, 12.1, 12.2, 1211, 12.12, 12.15, 12.16, 12.19, 12.21, 12.25, 12.29, 13.1
s 1(1) | 12.25
s 3(2) | 12.2, 12.15
s 3ZA | 12.2, 13.7
s 3ZA(5) | 12.2
s 4 | 12.17
s 4A(4) | 13.9
s 14(1)(c) | 12.17
s 14(3)–(4) | 12.17
s 14(5) | 12.17
s 33 | 12.17
s 35 | 12.10, 12.27
ss 36–38 | 12.27
s 36 | 12.10
s 36(d) | 12.27
s 37 | 12.10
s 38 | 12.27
s 41 | 12.10
s 42 | 12.10, 12.12
s 48(2) | 12.12
s 54 | 12.28
s 54(8) | 12.29
s 59 | 12.29
Sch 2 1ZA | 12.19, 12.20, 13.10
Sch 2 1ZB | 12.22
Sch 2 Para 3A | 13.8
Sch 2 Para 3(4) | 13.7
Sch 3A | 13.8
Sch 3 Para 4A(4) | 12.18
Human Fertilisation and Embryology (Deceased Fathers) Act 2003 | 2.3, 12.15
Human Reproductive Cloning Act 2001 | 4.14, 12.25, 13.8, 13.14
Human Rights Act 1998 | 2.1, 2.3, 4.2, 6.16, 14.7, 19.1
s 2(1) | 2.3
s 3 | 2.3
s 4(2) | 2.3
s 6 | 2.3
s 6(3)(b) | 2.3
s 6(5) | 2.3
s 7 | 2.3
s 8 | 2.2
s 10 | 2.3
s 11 | 2.3
Human Tissue Act 1961 | 18.4, 18.6, 18.9
s 1(2) | 18.4
s 2(2) | 18.4
Human Tissue Act 2004 | 12.16, 12.21, 15.18, 16.4, 17.1, 17.2, 17.9, 17.10, 18.1, 18.4, 18.6, 18.7, 18.8, 18.10
s 1 | 17.4, 18.6
s 1(d)–(f) | 18.7
s 1(7)–(9) | 18.7
s 2 | 17.5, 18.6
s 2(3) | 17.5, 18.6
s 2(5) | 5.4
s 3 | 17.4, 18.6
s 3(4) | 18.6
s 3(5) | 5.4, 18.6
s 3(6) | 17.10
s 4 | 17.10, 18.6
s 5(1) | 17.11, 18.9
s 5(2) | 17.11, 18.9
s 6 | 17.6, 18.6
s 7 | 18.7
s 7(4) | 15.18
s 9 | 18.9
ss 13–15 | 17.2
s 16(2)(a) | 18.9
s 17 | 18.9
s 18 | 18.9
s 25 | 18.9
s 26 | 18.8
s 26(2)(d) | 16.4
s 27 | 18.6
s 27(4) | 17.10
s 27(6) | 17.10
s 27(8) | 17.10, 18.6
s 32 | 17.14, 18.10
s 32(9)(c) | 18.10
s 33 | 17.4
s 43 | 17.9
s 53 | 17.2, 18.7
s 54(8) | 17.10
Sch 1 | 17.2, 18.6, 18.7
para 2, 3 | 18.6
Sch 2 | 17.2, 18.6
Human Tissue Act (Northern Ireland) 1962 | 17.2
Human Tissue (Scotland) Act 2006 | 17.1
Human Transplantation (Wales) Act 2013 | 17.1
s 2 | 17.8
s 4(4)(b) | 17.8
s 5(3) | 17.8
Infanticide Act 1938 | 11.18
s 1(1) | 11.18
Infant Life(Preservation) Act 1929 | 13.12, 13.16
Injury Prevention, Rehabilitation and Compensation Act 2001 | 9.13
s 32 | 9.13
Inquiries Act 2005 | 9.2
s 2 | 9.2
s 15 | 9.2
Law of Property Act 1925, s 184 | 16.2
Law Reform(Contributory Negligence) Act 1945 | 7.20
Law Reform (Personal Injuries) Act 1948, s 2(4) | 8.15
Legal Aid, Sentencing and Punishment of Offenders Act 2012 | 2.10, 8.2, 8.18, 9.1, 10.2
s 10 | 2.10
s 10(3) | 8.2
s 21 | 8.2
Sch 1 Part I | 8.2
Limitation Act 1980 |
s 11 | 8.9
s 14 | 8.9
Local Government and Public Involvement in Health Act 2007 |
s 221 | 9.5
Medical Act 1969 | 1.8
Medical Act 1983 | 1.8, 6.18, 11.21
s 1A | 1.8
s 5 | 1.11
Pt III(ss 19–29) | 1.8, 6.18
s 35 | 1.10
s 35C(2) | 1.14
s 35 C(6) | 1.15
s 35C(8) | 1.14
s 35D(3) | 1.14
s 40(7) | 1.15
s 41A | 1.14
s 49 | 1.8
Medicines Act 1968 | 10.11
s 2 | 10.11
s 21(5) | 4.11
s 28 | 10.11
Mental Capacity Act 2005 | 4.4, 4.7, 5.2, 6.1, 6.4, 6.12, 6.23, 7.23, 11.4, 11.21, 12.15, 13.18, 14.14, 14.21, 15.10, 15.11, 17.9, 19.1, 19.17, 19.18, 19.19, 19.21
s 1(5) | 11.4
s 1(6) | 11.4
s 2 | 11.21, 14.21
s 2(1) | 6.4, 11.4
s 2(3)(b) | 11.21
s 2(5) | 5.2, 11.4
s 3 | 4.4, 6.4
s 3(2) | 6.4
s 4 | 4.4, 6.9, 11.4, 12.15, 19.17
s 4(1) | 6.9
s 4(3)(4) | 6.9
s 4(5) | 6.10, 19.18
s 4(6) | 6.9, 11.4
s 4(6)(a)(b) | 19.19
s 4(7) | 4.7, 5.2, 6.9, 11.4
s 4(10) | 19.19
s 5 | 5.2, 6.1, 6.7, 6.8, 11.4
s 6 | 6.10
s 9 | 6.8, 6.15
ss 9–14 | 19.19
s 10 | 19.19
s 11(8)(a) | 19.19, 19.21
ss 12–14 | 19.19
s 15 | 6.16
s 16 | 6.12, 6.16
ss 17–19 | 6.16
s 20 | 6.16
s 21 | 6.16
s 24 | 5.2, 6.14
ss 24–26 | 19.19
s 24(2) | 2.7, 5.3, 6.14
s 25 | 2.7, 5.2, 6.14
s 25(1) | 6.14, 19.19
s 25(3)(4) | 6.14
s 25(5) | 19.19
s 25(6) | 6.14, 19.19
s 26 | 2.7, 6.14
s 26(1) | 6.14
s 30 | 6.10, 15.11
s 30(4) | 15.11
s 30(2)–(4) | 6.10
s 31 | 6.10
s 31(5)(6) | 6.10, 15.11
s 32 | 6.10
s 32(8) | 6.10, 15.11
s 32(9) | 15.12
s 33 | 6.10
s 34 | 6.10
s 42(4)(5) | 6.4
s 44 | 7.23
ss 46–61 | 6.16
s 64(5) | 2.9
Sch A1 | 2.9
Sch 1A | 2.9, 6.12
Mental Health Act 1983 | 4.4, 6.18, 6.19, 6.23, 7.23, 11.21, 14.21
Pt II(ss 2–34) | 6.18
s 1(2) | 6.18
s 1(4) | 6.18
s 1(2A) | 6.18
s 2 | 6.18
s 3 | 6.18, 6.19
s 4 | 6.18
s 11(4) | 4.4
s 13 | 4.4
Pt IV(ss 56–64) | 6.18
s 57 | 6.19
s 57(1)(2) | 6.19
s 58 | 6.19
s 58A | 6.19
s 58(1)(2) | 6.19
s 63 | 6.5, 6.18, 6.19
s 127 | 7.23
s 145 | 6.18
Mental Health Act 2007 | 2.9, 6.18, 14.21
s 4A | 6.12
s 4B | 6.12
s 50 | 6.1
Sch A1 | 6.12
Sch 1A | 6.12
Misuse of Drugs Act 1971 | 4.9
National Assistance Act 1948 | 2.4
s 47 | 6.22
National Assistance(Amendment) 1951 | 6.22
National Health Service Act 1977 | 18.2
s 1 | 9.1
s 2 | 18.2
s 84 | 9.1
National Health Service Act 2006 | 2.17, 2.20, 4.9, 15.8, 15.17, 15.18
s 1E | 15.18
ss 6A–6B | 2.20
s 3 | 2.17
s 14C | 2.17
s 14P | 2.17
s 14T | 2.17
s 14Y | 15.18
s 223H | 2.17
s 251 | 4.9
s 251(12) | 15.17
s 252 | 15.8, 15.17
National Health Service Reform and Health Care Professions Act 2002, ss 25–28 | 1.8
NHS Redress Act 2006 | 9.1, 9.3, 9.18
Nurses, Midwives and Health Visitors Act 1997, s 16 | 11.19
Offences Against the Person Act 1861 | 6.22, 11.18, 13.2, 13.20
s 20 | 6.22
s 23 | 11.18
s 58 | 13.2, 13.20
Oregon Death with Dignity Act 1994 | 19.5, 19.12
Police and Criminal Evidence Act 1984 | 4.9
ss 8–14 | 4.9
Sch 1 | 4.9
Protection of Freedoms Act 2012 | 15.18
Protection of Life During Pregnancy Act(Ireland) 2013 | 2.10, 13.20
Public Bodies Act 2011 | 1.19
Public Health(Control of Diseases) Act 1984 | 4.4, 4.9, 6.21
s 11 | 4.12
s 45A | 4.9, 6.21
ss 45B–E | 6.21
s 45G | 6.21
Part 2A | 6.21
Public Interest Disclosure Act 1998 | 1.5
Road Traffic Act 1998 s 172 | 4.11
Sale of Goods Act 1979 | 10.8
s 14(2)(3) | 10.8
Senior Courts Act 1981 | 8.12
s 32A | 8.15
s 33 | 8.12
s 35 | 8.13
Serious Crime Act 2015 | 4.11, 13.4
ss 70–75 | 4.11
s 84 | 13.4
Sexual Offences Act 1956 | 14.20
Sexual Offences Act 2003 | 14.19, 14.20
s 14 | 14.20
s 73 | 14.20
Social Services and Well-being (Wales) Act 2014 | 2.8, 4.8
s 106(1) | 4.7
Suicide Act 1961 | 19.1, 19.4, 19.22
s 2(1) | 19.1
s 2(4) | 19.1
Surrogacy Arrangements Act 1985 | 12.29
s 54(8) | 12.29
Terrorism Act 2000 s 19 | 4.11
Tribunals of Inquiry(Evidence) Act 1921 | 9.2
Unfair Contract Terms Act 1977 s 2 | 7.21
Vaccine Damage Payments Act 1979 | 10.12
Vermont Patient Choice and Control and End of Life Act 2013 | 19.5
Washington State Death with Dignity Act 2009 | 19.5

Table of statutory instruments

Care Act 2014 (Health Education England and the Health Research Authority) (Consequential Amendments and Revocations) Order 2015, SI 2015/137 | 15.3
Care Quality Commission (Additional Functions) Regulations 2009, SI 2009/410 | 1.18
Care Quality Commission (Membership) Regulations 2015, SI 2015/1479 | 1.18
Care Quality Commission (Registration) Regulations 2009, SI 2009/3112 | 1.1, 1.18
Civil Procedure Rules 1998, SI 1998/3132 | 8.10
Pt 31 (rr 31.1–31.23)
r 31.7 | 8.13
r 31.16 | 8.12
r 31.7 ss 1 | 8.12
Pt 35 (rr 35.1–35.15)
r 35.1 | 8.13
r 35.3 | 8.13
r 35.7 | 8.13
Coroners (Investigation) Regulations, SI 2013/1269 | 18.5
reg 13 | 18.6
reg 14 | 18.6
Court of Protection (Amendment) Rule 2015, SI 2015/548 | 6.12
Data Protection (Assessment Notices) (Designation of National Health Service Bodies) Order 2014, SI 2014/3282 | 4.18
Data Protection (Subject Access Modification) (Health) Order 2000, SI 2000/413
art 5(1) | 4.23
General and Specialist Medical Practice (Education, Training and Qualifications) Order 2010, SI 2010/234 | 1.8, 1.11
General Medical Council (Constitution) Order 2008 SI 2008/2554 | 1.9
General Medical Council (Constitution) (Amendment) Order 2012, SI 2012/1654 | 1.9
General Medical Council (Fitness to Practice) Rules Order of Council 2004, SI 2004/2608 | 1.14
General Medical Council (Fitness to Practise and Over-arching Objective) and the Professional Standards Authority for Health and Social Care (References to Court) Order 2015, SI 2015/794 | 1.14
General Medical Council (License to Practise and Revalidation) Regulations Order of Council 2012, SI 2012/2685 | 1.8 1.12, 1.13
General Medical Council (License to Practise and Revalidation) (Amendment) Regulations Order of Council 2014, SI 2014/1273 | 1.8, 1.12
General Medical Council (Maximum Period of Provisional Registration) Regulations Order of Council 2015, SI 2015/92 | 1.12
General Medical Council (Registration Appeals Panels Procedure) Rules Order of Council 2010, SI 2010/476 | 1.12
Health Education England Regulations 2012, SI 2012/1290 | 1.11
Health Education England Regulations 2014, SI 2014/3215 | 1.11
Health Protection (Notification) Regulations 2010, SI 2010/659 | 4.9, 6.21
reg 2 | 6.21
Health Service (Control of Patient Information) Regulations 2002, SI 2002/1438 | 4.9
Health and Social Care Act 2008 (Regulated Activities) Regulations 2010, SI 2010/781 | 9.8
reg 16 | 9.8
Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, SI 2014/2936 reg 20 | 1.6, 1.18, 8.12, 9.9, 9.18
Health and Social Care Act 2008 (Registration of Regulated Activities) Regulations 2009, SI 2009/660 | 1.18
Health and Social Care Information Centre (Functions) Regulations 2013, SI 2013/259 | 4.21
Health Protection (Notification) Regulations 2010, SI 2010/659 | 4.9
Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015, SI 2015/572 | 3.1, 3.14, 12.2, 13.11
Human Fertilisation and Embryology (Parental Orders) (Consequential, Transitional and Saving Provisions) Order 2010, SI 2010/986 | 12.30
Human Fertilisation and Embryology (Research Purposes) Regulations 2001, SI 2001/188 | 12.25, 13.8
Human Fertilisation and Embryology (Statutory Storage Period for Embryos) Regulations 1996, SI 1996/375 | 12.17
Human Medicines Regulations 2012, SI 2012/1916 | 10.11
Part 14 | 10.11
Human Tissue Act 2004 (Ethical Approval, Exceptions from Licensing and Supply of Information about Transplants) Regulations 2006, SI 2006/1260 | 18.7
Human Tissue Act 2004 (Persons Who Lack Capacity to Consent and Transplants) Regulations 2006, SI 2006/1659 | 15.18, 17.4, 17.6, 18.7
reg 1.12 | 17.4
reg 3 | 18.7
reg 8 | 18.7
reg 12(2)(a) | 17.5
Human Tissue (Quality and Safety for Human Application) Regulations 2007, SI 2007/1253 | 17.2
Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations, SI 2014/2883 | 17.2
Human Transplantation (Wales) Act 2013 (Consequential Provision) Order 2015, SI 2015/865 | 17.8
Local Authority Social Services and National Health Service Complaints (England) Regulations 2009, SI 2009/309 | 9.4
reg 14 | 9.6
Medical Act 1983 (Amendment) (Knowledge of English) Order 2014, SI 2014/1101 | 1.8, 1.12
Medical Devices Regulations 2002, SI 2002/618 | 10.1
Medicines for Human Use (Advanced Therapy for Medicinal Products and Miscellaneous Amendments) Regulations 2010, SI 2010/ 1882 | 10.1, 15.2
Medicines for Human Use (Clinical Trials) Regulations 2004, SI 2004/1031 | 15.4, 15.6, 15.8, 15.10, 15.11, 15.16
reg 5 | 15.5
reg 11(3) | 15.4
reg 15(5) | 15.6
reg 49 | 15.5
reg 50 | 15.16
reg 52 | 15.16
Sch 1 | 15.8
Pt 1
para 3(1) | 15.8
Pt 2 | 15.8
para 9 | 15.8
Pt 3 | 15.8
Pt 4 | 15.6, 15.10
para 4 | 15.12
para 9 | 15.10
para 10 | 15.11
Pt 5 | 15.11
para 4 | 15.12
para 9 | 15.11
para 11 | 15.11
Medicines for Human Use (Clinical Trials) Amendment (No 2) Regulations 2006, SI 2006/2984 | 15.12
Mental Capacity Act 2005 (Independent Mental Capacity Advocate) (General) Regulations 2006, SI 2006/1832
reg 4 | 6.10
Mental Capacity Act 2005 (Loss of Capacity During Research Project) (England) Regulations 2007, SI 2007/ 679 | 15.10
Mental Health (Hospital Guardianship and Consent in Treatment) Regulations 1983, SI 1983/893 reg 16(2) | 6.19
National Health Service (Clinical Negligence Scheme) Regulations 1996, SI 1996/251 | 8.4
National Health Service (Complaints) Amendment Regulations 2006, SI 2006/2084
reg 3A, 3B | 9.4
National Health Service (Complaints) Regulations 2004, SI 2004/1768 | 9.4
National Health Service (Concerns, Complaints and Redress Arrangements) (Wales) Regulations SI 2011/704 | 9.1, 9.3, 9.18
National Health Service (Direct Payments) Regulations 2013, SI 2013/1617 | 1.3
National Health Service (Licence Exemptions) Regulations 2013, SI 2013/2677 | 1.18
National Health Service (Licence Exemptions) (Amendment) Regulations 2015, SI 2015/190 | 1.18
National Health Service (Procurement, Patient Choice and Competition) Regulations 2013, SI2013/257 and SI 2013/500 | 1.18
National Health Service (Reimbursement of the Cost of EEA Treatment) Regulations 2010, SI 2010/915 | 2.20
National Health Service (Venereal Diseases) Regulations 1974, SI 1974/ 29 | 2.18, 4.9
National Health Service Bodies and Local Authorities Partnership Arrangements Regulations 2000, SI 2000/617 | 1.3
National Health Service Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) Regulations 2012, SI 2012/2996 | 1.3, 2.20
reg 34 | 2.18
Part 9 s 45 (2) | 7.2
National Health Service Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) (Amendment) Regulations 2013, SI 2013/2891 and SI 2014/1611 | 1.3
National Health Service Trust Development Authority (Establishment and Constitution) Order 2012, SI 2012/901 | 1.3
National Institute for Clinical Excellence (Establishment and Constitution) (Amendment) Order 2005, SI 2005/497 | 2.18
National Institute for Health and Care Excellence (Constitution and Functions) and the Health and Social Care Information Centre (Functions) Regulations 2013, SI 2013/259 | 2.18
reg 9 (3) | 2.18
Postgraduate Medical Education and Training Order 2010, SI 2010/473 | 1.12
Postgraduate Medical Education and Training (Amendment) Order of Council 2012, SI 2012/344 | 1.12
Quality and Safety of Organs Intended for Transplantation Regulations 2012, SI 2012/1501 | 17.2
Quality and Safety of Organs Intended for Transplantation (Amendment) Regulations, SI 2014/1459 | 17.2
Vaccine Damage Payments Act 1979 Statutory Sum Order 2007, SI 2007/1931 | 10.15

Table of European and international material

Primary material treaties and agreements

Treaty Establishing the European Community (Treaty of Rome) (1957)

art 59, 60
12.15

Conventions

Convention on Human Rights and Biomedicine (Oviedo 4.IV., Spain 1997) | 2.14, 4.14, 17.1
art 10(2) | 4.14
art 21 | 17.14
Additional Protocol concerning Biomedical Research (Strasbourg, 2005)
art 9 | 15.13
art 23(3) | 15.13
European Convention on Human Rights and Fundamental Freedoms (Strasbourg, 1950)
art 2 | 2.2, 2.7, 13.19, 14.7, 14.21, 15.7, 19.1, 19.6, 19.18
art 2(1) | 19.6, 19.18
art 3 | 2.5, 2.7, 2.8, 19.1, 19.6, 19.11, 19.18
art 5 | 2.3, 2.5, 6.1, 14.22
art 5(1) | 2.9
art 5(1)(e) | 6.1, 6.11, 6.21
art 5(4) | 6.11
art 6 | 2.10
art 6(1) | 2.3
art 7 | 7.22
art 8 | 2.2, 2.3, 2.7, 2.8, 2.10, 2.17, 4.2, 4.15, 11.10, 12.8, 12.9, 12.13, 12.15, 12.17, 12.18, 12.23, 13.1, 13.19, 14.10, 14.21, 15.18, 19.1, 19.6, 19.11, 19.18, 19.21
art 8(1) | 2.2, 2.3, 2.10, 4.2, 14.21
art 8(2) | 2.2, 4.4, 4.10, 4.15, 12.8, 12.9, 12.18, 14.12, 14.21
art 9 | 14.12, 19.6
art 10 | 2.13, 4.2, 4.13
art 12 | 12.8, 12.9, 12.18
art 14 | 2.8, 2.17, 12.8, 12.14, 12.18, 19.6, 19.18
First Protocol arts 1–3 | 2.3
Sixth Protocol art 2 | 2.3
United Nations Convention on the Rights of the Child | 14.21

Secondary material

Declarations

Declaration of Helsinki (World Medical Association, 1964) | 15.5, 15.8
art 23 | 15.5
art 26 | 15.8
Declaration of Helsinki (World Medical Association, 2013) | 15.7, 15.13
art 33 | 15.13

Directives

Commission Directive 2005/28/EC (Good Clinical Practice Directive) | 15.1
Council Directive 85/374/EEC (Products Liability Directive) | 10.5
Council Directive 95/46/EC (Processing Personal Data) | 4.17, 15.17, 15.18
Council Directive 2001/20/EC (Clinical Trials Directive) | 10.10, 15.1, 15.7, 15.12
art 5(a) | 15.12
Council Directive 2001/83/EC (Relating to
Medicinal Products for Human Use) amended by Directives 2002/98/EC, 2003/63/EC/2004/24/EC and 2004/2/EC | 10.11
Council Directive 2005//36/EC (Recognition of Professional Qualifications) amended by Directive 2013/55/EU | 1.12
Directive of the European Parliament and the Council on the Application of Patients’ Rights in Cross Border Healthcare (2011) 2011/24/EU | 2.20
European Working Time Directive 93/103/EC | 1.17

Regulations

EC Regulation 726/2004 | 15.9
art 83 | 15.9
EC Regulation 883/2004 | 2.20
EU Regulation on Medicinal Products for Paediatric Use Regulation (EC) 1901/2006 art 41 | 15.10
EU Clinical Trials Regulation 536/2014 | 15.7, 15.8, 15.9, 15.11
art 28(2) | 15.8
art 29(1) | 15.8
art 29(2)(c) | 15.8
art 29(6) | 15.8
art 30 | 15.8
art 31 | 15.11
art 31(1)(e) | 15.11
art 31(1)(f) | 15.11
art 32(1)(g) | 15.10
art 32(3) | 15.10
art 35 | 15.12
art 7 (3) | 15.14
Implementing Regulation 987/2009 (EC) | 2.20

Part I

MEDICINE, LAW AND SOCIETY

Chapter 1

THE PRACTICE OF MEDICINE TODAY

1.1 In 2016, medicine and healthcare in England appear immersed in crisis after crisis. An account of how the law regulates medicine thus must begin by examining, if briefly, the context within which medicine, patients and the law interact. In 2004, the distinguished physician Professor Ray Tallis could confidently note that few professions still stood so high in public esteem as medicine.¹ A series of scandals revealing poor care and sometimes disregard of patients’ welfare have put health professionals under much critical scrutiny. A barrage of reforms designed to improve patient safety did not prevent appalling suffering at Stafford Hospital between 2005 and 2009. Three inquiries ensued. The first report, in 2010, featured distressing accounts made by patients and their families. There was evidence of filthy conditions, food and water left out of reach of patients, and indifference to patient needs. The report focused on the failings of the Trust, highlighting the ill-effects of a strategic focus on financial targets.² The second inquiry considered the failure of monitoring arrangements to put things right.³ In combination, the two reports revealed:

a culture of fear in which staff did not feel able to report concerns; a culture of secrecy in which the trust board shut itself off from what was happening in its hospital and ignored its patients; and a culture of bullying, which prevented people from doing their jobs properly.⁴

The third – the ‘Francis Inquiry’– in which over 250 witnesses and over a million pages of documentary material were considered, investigated why the NHS system failed to detect these problems earlier.⁵ Constant NHS reorganisation, regulatory gaps and ineffective communication contributed to the problem. Care of patients was not at the heart of the work of the Mid Staffordshire NHS Foundation Trust. Further policy change, reorganisation and the identification of scapegoats, it was concluded, will not bring about the necessary change. Culture change, ‘a refocusing and recommitment of all who work in the NHS – from the top to the bottom of the system – on putting the patient first’,⁶ must be brought about through clear standards, transparency, support for nursing, strong leadership and accurate information.⁷

In April 2014, Mid Staffordshire NHS Foundation Trust was fined £200,000 for breaches of the Health and Safety at Work Act which led to the death of a diabetic patient, Gillian Astbury.⁸ Days after the sentence was passed, it was announced that the Trust would be dissolved.

The crisis at Stafford Hospital tops a list of scandals that have dealt blow after blow to the reputation of the medical profession in the United Kingdom. Surgeons carrying out cardiac operations on infants in Bristol were found to have continued to operate despite incurring higher death rates for such surgery than their peers.⁹ The Bristol Inquiry¹⁰ uncovered a ‘club culture’.¹¹ Staff were caring and well motivated, but care was badly organised; the standard of care was poor and there was a lack of effective communication. In Bristol, and in Liverpool,¹² evidence emerged of hospitals retaining children’s organs without their parents being told that only parts of their children’s bodies were returned to them for burial. Subsequently, it became apparent that organ retention in relation to children and adults was a widespread practice.¹³ Harold Shipman was convicted of fifteen counts of murder and later found to have killed at least 215 of his patients.¹⁴ Appalling reports of degrading treatment of learning disabled people in NHS establishments surfaced in 2006¹⁵ and mistreatment of patients at Winterbourne View hospital in 2011 resulted in criminal prosecutions and imprisonment of staff.¹⁶ In 2015 an independent inquiry into the deaths of mothers and babies at Furness General Hospital between 2004 and 2013 found twenty instances of significant or major failures of care. Staff colluded to conceal the truth and the regulators missed a series of opportunities to act.¹⁷ The same year, a Greater Manchester nurse, Victorino Chua, was convicted of murdering two patients and poisoning twenty others by injecting insulin into saline bags.¹⁸ These so-called ‘scandals’ reflect poorly on individuals, but also on the NHS, which promises to ensure a safe service of the quality that patients and their families are entitled to expect.¹⁹ That the crisis at Stafford Hospital occurred at all is bad enough. That it occurred post-Bristol Inquiry indicates systemic failure. The Francis Inquiry has led to change across the tiers of regulation.²⁰ The Health and Social Care (Safety and Quality) Act 2015²¹ now imposes an obligation on the Secretary of State to ensure that no avoidable harm is caused to service users. This has the effect of transferring additional powers to the Secretary of State to make relevant regulations.

Tiers of regulation

1.2 Four distinct tiers of regulation have been identified. First, personal regulation involves a doctor’s individual commitment to a code of ethics, found in part in documents such as the Hippocratic Oath and the General Medical Council’s Good Medical Practice guidance.²² We consider the ethical responsibilities of doctors in Chapter 3. Second, team-based regulation requires all healthcare professionals to take responsibility for their team’s performance and conduct. Third, professional regulation, which we consider in the below, is undertaken by statutory regulators such as the General Medical Council (GMC) and the Nursing and Midwifery Council (NMC)²³ which are overseen by the Professional Standards Authority (PSA)²⁴ which monitors nine healthcare regulators, sets standards and enhances consistency. Finally, work-based regulation involves a system of clinical governance and performance management, which we consider in the latter half of this chapter.

In recent years the medical profession has witnessed an unprecedented increase in all four types of regulation. Reforms of the GMC continue apace. Recent work-based regulations emphasise monitoring designed to ensure good practice rather than simply reacting to bad practice. The Health and Social Care Act 2012 removed tiers of management and streamlined arm’s-length bodies. The Act aimed to give doctors control – to ‘liberat[e] the NHS from central control and political interference’.²⁵ It was hoped that transparency, competition and choice would promote a rise in standards and patient safety. The Francis Inquiry showed that this was not enough. In the wake of the 2012 reforms, the spotlight is very much on the healthcare regulators.

The various tiers of regulation do not always work in harmony. Work-based regulation is designed not only to enhance patient safety, but also to ensure the economic accountability of NHS organisations. Job freezes and staff cuts have an impact on the level of care a hospital can provide. Economy may compromise safety and reduce the ability of the individual doctor to offer the kind of care that she might wish to deliver.

The National Health Service

1.3 How well doctors can do their job is in part dictated by the environment in which they work. In England, most healthcare is still provided within the NHS. While spending on healthcare in the UK has more than doubled in cash terms in the last decade, this is offset by the ever growing capacity of technology, an ageing population and increased incidence of chronic disease. As the government imposes freezes and cuts in funding in order to reduce the fiscal deficit, measures to increase efficiency are increasingly prominent.

Since 1974, the NHS has been subject to a steady stream of political reform.²⁶ Such constant change does not help doctors and nurses do their jobs. In 1991, NHS Hospital trusts were first created and the NHS divided into ‘purchasers’ and ‘providers’. The Conservative government introduced the internal ‘market’ and GP fundholding in 1995. GP fundholding was abolished by the incoming Labour government in 1997. Twenty-eight Strategic Health Authorities (SHAs) were created in 2001 to manage the performance of the NHS locally and 303 Primary Care Trusts (PCTs) provided health services. New emphasis was placed on decentralisation: a patient-led NHS. Focus on patient choice led to the reinstatement of competition between Trusts in 2004, and in 2006 the existing SHAs merged into 10 and the 303 PCTs merged into 152, reminiscent of the regional offices and Health Authorities abolished in 2001.

Commissioning is central to the NHS.²⁷ Primary care is the ‘front line’ of the NHS. The local surgery is often the patient’s first point of contact. There she can see a range of healthcare professionals, such as a nurse, GP or midwife and access a range of services. PCTs were established in 2000 to plan and commission services for the locality. From April 2003, 75 per cent of the NHS budget devolved to PCTs.²⁸ PCTs could devolve their responsibilities to GP practices (or groups of GP practices) which were given indicative budgets and allowed to commission services (‘Practice Based Commissioning’).²⁹

A much bigger transfer of power followed the enactment of the Health and Social Care Act 2012.³⁰ During the passage of the Bill, the weight of criticism forced the government to make an unprecedented ‘pause to listen’. Despite the concessions that followed, the Act remains the biggest overhaul of the NHS in living memory. The 2012 Act removed much of the strategic management of the NHS from governmental control. Around 170 organisations were disbanded and 240 new ones created.³¹ The Act abolished SHAs and PCTs³² and brought about a wholesale devolution of commissioning powers to local consortia of GP practices called ‘Clinical Commissioning Groups’. The transformation took place in waves between 2012 and 2013. The market framework which allows private companies to bid for NHS work (subject to regulations) has been much criticised.³³

The £95 billion commissioning budget is now the responsibility of a body (set up in April 2013) called NHS England.³⁴ NHS England determines the services required and sets a pricing structure. The Act also extends the responsibilities of the Independent Regulator of NHS Foundation Trusts, Monitor,³⁵ to incorporate the setting and publication of ‘the national tariff’.³⁶ The two bodies work in conjunction to consult upon and publish the tariff.³⁷

NHS England commissions specialist and GP services,³⁸ but its primary role is to empower and support³⁹ around 200 Clinical Commissioning Groups which take on the majority of commissioning of NHS Services in England. To facilitate the integration of health and social care, regulations provide for pooled budgets across Clinical Commissioning Groups and the health-related and social care functions of local authorities.⁴⁰ Commissioning is also undertaken by a new executive agency, Public Health England, which alongside local authorities commissions public health services.

To hold the commissioning bodies to account, a series of Outcomes Frameworks have been developed: one each for the NHS, public health, adult social care and health education. The Public Health Outcomes Framework⁴¹ focuses on patient longevity and quality of life. Quarterly online publication of results uses a ‘traffic light’ system⁴² indicating trends across the region. The NHS Outcomes Framework⁴³ includes five key indicators:

(1)  preventing people from dying prematurely;

(2)  enhancing quality of life for people with long-term conditions;

(3)  helping people to recover from episodes of ill health or following injury;

(4)  ensuring that people have a positive experience of care; and

(5)  treating and caring for people in a safe environment and protecting them from avoidable harm.

The focus of the fourth and fifth outcomes (on satisfaction and safety) moves beyond the tradition of improving ‘health’ in the narrow sense, to a new emphasis on ‘well-being’. The Frameworks are intended to operate not only as a performance indicator but as a means of driving improvements in quality through a new commitment to transparency and openness. This is aided through the creation of a new non-departmental public body: the Health and Social Care Information Centre,⁴⁴ which has powers to require health and social care bodies to provide and publish information.

Data collected in compliance with the Outcomes Frameworks is used to hold the various sectors of the health service to account. It is also used to inform patients and help them make a range of choices about their providers, clinicians and treatment. The powers to choose are described in the annually updated NHS Choice Framework.⁴⁵ For people who are not in hospital but have continuing health needs, it is possible to agree with relevant healthcare professionals a personal health budget giving the patient the power to prioritise certain well-being outcomes and to spend in line with the plan.⁴⁶

Patients needing to go to hospital for treatment or diagnosis can choose to which hospital they want to be referred by their GP. A website allows patients to look at the performance of individual hospitals. This potentially creates a perverse incentive to hide adverse events, but hospitals with a lower-than-expected rate of adverse incidents are followed up.⁴⁷

In some circumstances, patients might choose a different type of provider: NHS England commissions services from ‘any qualified provider’ (AQP). To qualify, the provider must register with the Care Quality Commission or meet equivalent requirements, and must be willing to comply with the NHS Standard Contract, for the price set in either the national tariff or by local commissioners.

Patients also have choices to make about primary care. Whereas previously, patients chose a GP practice from within their catchment area, since January 2015 they can register with a participating practice most convenient to them. They might, for example, choose a practice that is nearer to work than home. The responsibility to offer home visits to patients outside their GP’s practice boundary falls to NHS England and this inevitably impacts on their ability to plan services. Will more affluent patients seeking treatment that not all GPs provide travel to a practice which does, leaving poorer, less mobile patients with much more limited choices?

New freedoms in commissioning are matched by increased autonomy for providers. Foundation Trusts (FTs) were established by the Health and Social Care (Community Health and Standards) Act 2003.⁴⁸ They are authorised and regulated by ‘Monitor’; an independent regulator established in 2004.⁴⁹ FTs differ from NHS Trusts in a number of ways. While subject to NHS inspection and standards, they are independent, not-for-profit public benefit corporations with unique governance arrangements. Led by an independent Board of Directors, they are more locally accountable. Investment from both the public and private sectors is encouraged.⁵⁰

The aim was for all NHS Trusts to be given the opportunity to apply for Foundation Trust status by 2008. Momentum was lost, but rekindled with the passage of the 2012 Act following which the NHS Trust Development Authority (TDA) was set up⁵¹ to guide NHS Trusts seeking FT status. Hopes that most NHS trusts would become FTs by 2014, proved ill founded. At the end of 2013 there were 147 Foundation Trusts with 98 Trusts yet to achieve FT status. NHS Trusts are finding it difficult to meet the standards set by Monitor. There is no formal cut-off point, but the Secretary of State has the power to abolish remaining NHS Trusts. And their difficulties do not end with the achievement of FT status. In 2015 it was reported that the net deficit of Foundation Trusts is £321m (a staggering £269m behind plan).⁵² A shortage of emergency beds and increase in people attending Accident and Emergency departments compounded the pressures on operational performance.

The NHS operates in a system of finite – and increasingly limited – resources. A Health Committee review in 2013 found that the NHS reforms had indeed resulted in savings but questioned their sustainability.⁵³ The NHS Forward View⁵⁴ in October 2014 set out a plan to address this problem. New efficiency measures might account for two-thirds of the £30bn shortfall up to 2020, but investment of around £8bn must come from government.

Angels or demons?

1.4 Good medical care requires more than sets of regulatory rules. Great demands are made of individual health professionals. Praised to the skies for their triumphs, few individuals attract greater public odium than the doctor or nurse who falls from her pedestal. The revulsion occasioned by Nazi atrocities in the concentration camps was nowhere as marked as in the case of Dr Mengele. That he used his skills as a doctor, taught to him that he might heal and comfort the sick, to advance torture and barbarism caused horror.

Public passion is rightly aroused by the likes of Mengele and Shipman. Passion is never far away from everyday relationships between doctor and patient. When doctors meet their patient’s expectations, they are rewarded by admiration and affection. Woe betide them if they do not. One error, one moment of exasperation or insensitivity, may transform a beloved doctor into a hate figure. Consultants were once accorded godlike status. They inspired awe visiting the ward attended by a retinue of junior doctors and nurses. Their exalted status insulated them from personal contact with patients and protected them from the sort of complaints voiced freely to nursing staff. They paid a price. Gods are expected to work miracles. They are not expected to be subject to human error. When a consultant proved to be human, when medicine could not cure, the patient found it hard to comprehend failure and rightly or wrongly, often wrongly, regarded the doctor as personally incompetent.

Medical attitudes are changing. Family doctors are becoming a different breed. Many try hard to persuade patients to see their doctor as a partner in promoting good health. Doctors are urged to prescribe less freely and to talk more to their patients. The good GP is as interested in the prevention of ill-health as its cure. A new generation of consultants is taking over in the hospitals. They are (in most cases) less grand and more prepared to listen to patients and nursing staff.

One, or even several, ‘bad apples’ should not destroy the reputations of thousands of other medical practitioners who do their job diligently and compassionately. All professions have their miscreants. The medical profession should not be punished for Shipman’s bizarre and apparently motiveless murders. The heart of the problem and the damage to the ‘image’ of medicine is that too little is sometimes seen to be done by the profession and its regulators to identify and remedy doctors’ failings. It seems amazing that no colleague noted or acted on evidence of the number of apparently healthy patients on Shipman’s list who died suddenly, in certain cases even in his surgery.

There are features of the profession of medicine which will render doctors more vulnerable to attack than other professionals. The doctor deals with the individual’s most precious commodity, life and health. On a mundane level she may determine whether patient X is to be sanctioned to enjoy seven days off work for nervous exhaustion brought about by overwork, or classified as another malingerer.⁵⁵ At the other end of the scale, the doctor may hold in his hands the power of life and death. He is the man with the skill and experience. In his hands, as the patient sees it, rests the power to cure. As Ian Kennedy has said, the patient appears before the doctor ‘naked both physically and emotionally’.⁵⁶ It is hard to overstate the power vested in doctors. The price of power is that those who exercise it must expect constant scrutiny from those subject to it and from the public at large. The age of deference is past. Doctors cannot be surprised when failure, incompetence or controversy attracts equal notoriety. Unfortunately, representatives of the profession sometimes react in an over-defensive manner, exacerbating the original criticism or complaint.

Whistle-blowing

1.5 When healthcare goes badly wrong it will often be a health professional who brings the problems to public attention. The Public Interest Disclosure Act 1999 is designed to protect whistle-blowers, but whistle-blowing at Mid Staffordshire proved woefully inadequate.⁵⁷ Progress is evident. The Enterprise and Regulatory Reform Act 2013 safeguards whistle-blowers and protects employers from spurious claims.⁵⁸ It extends the circumstances in which an employer can be held vicariously liable when a whistle-blower is harmed by the acts of other employees⁵⁹ and rules out ‘gagging orders’ which had reportedly become prevalent.⁶⁰ But underlying cultural issues limit effectiveness. An NHS staff survey in 2015 revealed that only 68 per cent of staff were confident that it is safe to raise a concern.⁶¹ Policies encouraging openness are not matched with appropriate support. An independent review chaired by Sir Robert Francis QC⁶² listed the principles and actions that regulators and employers need to take to initiate change. The review also recommended additional legal protections for whistle-blowers.⁶³

A duty of candour

1.6 Increasing protections for whistle-blowers are accompanied by new emphasis on the duty of individual healthcare professionals and providers to report errors and incidents. The ‘duty of candour’ is (since 2013) a prominent feature of both the NHS Constitution and NHS Standard Contract. Furthermore, recognition that the duty of candour extends to providers is reflected in licensing and registration requirements by which healthcare providers must abide.⁶⁴ Section 81 of the Care Act 2014 makes provision for a new statutory duty of candour.⁶⁵ It came into force from November 2014 for NHS providers and April 2015 for independent providers.⁶⁶ There are now financial implications for failing to be open with patients and families and a criminal offence is committed when providers required by law to give information, do so in a false or misleading manner. The GMC and NMC produced joint guidance for professionals in 2015.⁶⁷

Entitlement to practise

1.7 One of the crucial functions of regulation is to ensure the competence of professionals offering services to the public. So who is entitled to practise medicine? The GMC maintains a register of medical practitioners and in 2009 the licence to practise was introduced⁶⁸ as part of reforms aiming to monitor doctors in order to assess their accordance with principles of Good Medical Practice.⁶⁹ Only registered practitioners can apply for a licence. Both registration and a licence are required to perform certain tasks such as writing prescriptions or signing death certificates and a criminal offence is committed when a person deliberately and falsely represents himself as being a registered and licensed practitioner or having a medical qualification.⁷⁰ However, unregistered and unlicensed practitioners can still use the title ‘doctor’. No law expressly prohibits any unregistered, unlicensed or unqualified person from practising most types of medicine or even surgery. The rationale of the criminal law is that people should be free to opt for any form of advice or treatment, however bizarre, but must be protected from rogues claiming a bogus status and from commercial exploitation of untested ‘alternative’ medicine.

A tradition of self-regulation – to be consigned to history?

1.8 By virtue of the Medical Act 1983, the regulation of the medical profession was entrusted to the profession itself acting through the GMC, continuing a tradition of self-regulation, endorsed by Parliament, dating back to 1858. Prior to 1858, there were in effect three separate medical professions, the physicians, the surgeons, and the apothecaries. The Royal Colleges of Physicians and Surgeons wielded great power. Those colleges, joined later by others, for example, the Royal College of Obstetricians and Gynaecologists, continued to control specialist education and specialist practice. Self-regulation has long been the hallmark of the learned professions. Doctors’ patients and lawyers’ clients were increasingly unconvinced that the professional regulators protected public interests. The GMC came under especially vigorous attack. Its composition was seen as too biased in favour of the doctors, and its capacity to ensure that patients were treated by competent doctors truly fit to practise was doubted. Thus although the Medical Act 1983 remains on the statute book, it has been radically amended by statutory instruments in 2002, 2006, 2007, 2008, 2010 and 2014.⁷¹

The Medical Act 1983 (Amendment) Order 2002 sets out the central tenet of all attempts to reform the GMC. It amends section 1 of the 1983 Act so that section 1A says simply:

The main objective of the General Council in exercising their functions is to protect, promote and maintain the safety of the public.

Over time, a second role has developed: to promote public confidence in the profession. This has received judicial recognition⁷² and is now incorporated in legislation. The Health and Social Care (Safety and Quality) Act 2015 gives certain health and social care regulators an overarching objective of ‘public protection’⁷³ and requires them to have regard to this objective in fitness-to-practise proceedings. Public protection includes promoting and maintaining safety and public confidence in the profession.

Historically, while the GMC has policed admission to the medical register, little was done to ensure that a doctor continued to be competent, and up to date, in her practice. She remained ‘licensed’ to practise, unless disciplinary proceedings, or health or performance procedures were invoked against her. Amendments to Part III of the 1983 Act introduce a scheme for revalidation of medical competence. The GMC issues doctors a licence to practise on first registration. Doctors are required to renew that licence periodically, proving their continued competence through a scheme of continuing evaluation of practice. Delayed by the restructuring of the NHS, the long-awaited revalidation scheme was rolled out from 2012.⁷⁴ The GMC hopes to complete the first wave of revalidations by March 2016.

If the absence of processes to monitor doctors’ competence caused public concern, what were seen as feeble and apparently prejudiced disciplinary proceedings to deal with complaints against doctors aroused anger.⁷⁵ The historic concept of ‘infamous conduct in a professional respect’ was replaced by the notion of ‘serious professional misconduct’ in the Medical Act 1969. Critics still argued that the threshold of what constituted such misconduct was set too high, and when a finding of misconduct was made, penalties were too lenient. Thus, in 2002 the whole of the existing system for disciplining defaulting doctors, dealing with sick doctors, and addressing under-performing doctors was revised.

The critics were far from satisfied. Dame Janet Smith’s inquiry⁷⁶ into the Shipman debacle led to a review of medical regulation by the Chief Medical Officer (CMO), Sir Liam Donaldson. The CMO published a consultation document Good Doctors, Safer Patients in 2006, concluding that the GMC is ‘too secretive, too tolerant of sub-standard practice and too dominated by the professional interest, rather than that of the patient’.⁷⁷ Sir Liam recommended a further shake-up of the GMC. The Health and Social Care Act 2008 provided for a new independent body, the Office of the Health Professions Adjudicator (OPHA) to take over the adjudication of fitness-to-practise cases.⁷⁸ But a U-turn in 2010 led instead to new measures designed to strengthen the GMC processes. Mark Davies argues that, while the GMC has responded to challenges to its powers with inventiveness, reforms, such as revalidation, are increasingly state-led.⁷⁹ A watered-down state of self-regulation endures.

Composition of the General Medical Council

1.9 Who the regulators are influences how confident the public will be in the process and objectivity of the regulatory framework. In 1983, the GMC comprised 104 members. The lay element was less than 25 per cent. Doctors chosen by their peers dominated the Council. Such a large Council is on any analysis an unwieldy organisation to govern any profession, and in 2008 the numbers were whittled down to twelve lay members and twelve medical members,⁸⁰ and in 2012 numbers were halved again to six medical and six lay members.⁸¹

So what does the GMC do? The Medical Act lists four principal functions of the GMC:

(1)  to provide advice for doctors on ethics and standards of professional conduct;

(2)  to oversee medical education;

(3)  to maintain a register of qualified doctors, licence doctors and to ‘revalidate’ them; and

(4)  to investigate and (in some form) adjudicate allegations about the fitness to practise of doctors.

Advisory function

1.10 First, the Council is charged with providing advice for doctors on ethics and standards of professional conduct, standards of professional performance and medical ethics.⁸² Reference to this advice is made throughout this book. The core guidance is contained in Good Medical Practice, which was first produced in 1995 and was comprehensively revised in 2006. The 2006 version emphasised the importance of partnership between doctors and patients, and placed new weight on equality and diversity. Most importantly, it clarified the standard of professional conduct that underpins the GMC’s fitness-to-practise procedures. The aim was to achieve greater certainty and consistency in both patient expectations and doctors’ professional standards. In 2013, the guidance was updated and restructured around the four domains used to appraise doctors undergoing revalidation. Good Medical Practice (2013) is accompanied by a series of explanatory guides,⁸³ interactive case studies and learning materials.⁸⁴

Medical education

1.11 Second, the Council sets standards and outcomes for medical education.⁸⁵ In the past the GMC was responsible for undergraduate medical training and the first year of foundation training. The Postgraduate Medical and Education Training Board (PMETB) looked after the second year of foundation training and specialty training.

Following the Tooke report,⁸⁶ a merger took place in 2010⁸⁷ and the GMC became the sole regulator of medical education throughout the different stages of training. The PMETB was abolished in April 2010 and the GMC created three boards: the Undergraduate Board; Postgraduate Board and Continued Practice Board. A new independent body, NHS Medical Education England, provided guidance on education and training.

The Health and Social Care Act 2012 replaced NHS Medical Education England with a new Special Health Authority; Health Education England (HEE).⁸⁸ An accompanying Education Outcomes Framework⁸⁹ forges stronger links between medical education and healthcare outcomes. HEE holds to account thirteen Local Education and Training Boards (LETBs), which are set up to plan locally responsive training. HEE works alongside the GMC, which sets and upholds standards by approving and monitoring curricula and assessments. The Care Act 2014 reconstituted HEE as a non-departmental public body from April 2015, putting it on a firm statutory footing and clarifying duties and powers.⁹⁰

Requirements for undergraduate training are set out in Tomorrow’s Doctors.⁹¹ On completion of the medical degree, section 10A of the Medical Act 1983 requires that provisionally registered, newly qualified doctors receive two years of foundation training to bridge the gap between medical school and specialist or GP training.⁹² At the end of Foundation 1 (F1), full registration and a licence to practise is dependent upon demonstration of outcomes set by the GMC’s Education Committee. Year F2 is the doctor’s first year as a fully registered, licensed doctor. At the end of the F2 year, doctors compete for training in their chosen speciality or GP training. The Joint Royal Colleges of Physicians Training Board (JRCPTB) sets specific standards of specialist training to complement the GMC’s generic standards. Trainees are required to register with the JRCPTB so that their progress can be reviewed and they can be awarded a Certificate of Completion of Training (CCT). The CCT confirms that the doctor has completed his training and can be entered onto the GP Register or the Specialist Register.

In the case of BAPIO,⁹³ the British Association of Physicians of Indian Origin challenged by way of judicial review the Clinical Skills Assessment (CSA); an exit exam for trainee general practitioners. The failure rate is significantly higher for foreign graduates. It was alleged that the differences in outcome resulted from discrimination against South Asian and BME (black and minority ethnic community) doctors. The claim was raised against the Royal College of General Practitioners (as assessor) and the GMC (as regulator). Mitting J dismissed the claim: there was no breach of the Equality Act 2010 and the requirement to pass the CSA had not been unlawfully racially discriminatory. The stringent requirements are considered essential to protect patient safety. But an anomaly in the pass rates is made clear in the BAPIO case.⁹⁴ The importance of diversity of the medical profession and the significant contribution of international medical graduates to the NHS cannot be overstated.

Maintaining a register

1.12 Third, the GMC is charged with the maintenance of the ‘list of registered medical practitioners’ and provides licences to practise. Doctors listed on the medical register have full, provisional,⁹⁵ specialist or GP registration.⁹⁶ All are accessible online. The GP register is a list of GPs eligible to work in the UK. It provides information for patients and aids pre-employment checks. The Specialist Register identifies medical practitioners by their specialties, accreditation and qualifications. Equivalent qualifications from other Member States of the EU must be recognised by the Joint Royal Colleges of Physicians Training Board.⁹⁷

The GMC assess the language skills and clinical competence of doctors coming from outside the EU,⁹⁸ but were restricted in relation to EU doctors. The GMC sought a change in the rules after a German doctor, Daniel Ubani, on his first shift as an out-of-hours GP, prescribed a fatal dose of morphine to a pensioner in 2010.⁹⁹ At a fitness-to-practise hearing, Dr Ubani was struck from the register. The Medical Act 1983 was amended in 2014, to allow the Council to refuse a licence to practise when a medical practitioner from the EU has insufficient English language skills. The 2014 Order also introduced a new fitness-to-practise category of impairment due to language incompetence.¹⁰⁰ From 2014 the GMC raised the score on the International English Language Testing System required of both international and EU doctors.

Registration alone used to be sufficient to permit a doctor to practise medicine and hold herself out as a medical practitioner. Amendments to the Medical Act¹⁰¹ additionally require that doctors hold a licence to practise.¹⁰² The licence is granted by the GMC at registration and is required of any doctor, private or NHS, part-time or full-time, if they wish to work in the NHS, write prescriptions or sign death certificates.

Doctors need to show that their fitness to practise is not impaired at the point of registration and licensing with the GMC. Failure to declare relevant factors could lead to the doctor being struck from the register and losing his licence to practise. Doctors are also required to carry professional indemnity or insurance cover from the point of registration and failure to do so could amount to impaired fitness to practise. Since 2010, doctors can appeal against decisions to withdraw or refuse registration or a licence to practice under Schedule 3A of the Medical Act 1983.¹⁰³

Revalidation

1.13 Licensing was the first step towards ‘revalidation’ whereby doctors are appraised to ensure their general fitness to practise and compliance with Good Practice guidance. It was envisaged that revalidation would be introduced as early as 2005,¹⁰⁴ but the 5th Report of the Shipman Inquiry highlighted a number of serious concerns.¹⁰⁵ The CMO recommended a more rigorous scheme of revalidation¹⁰⁶ involving separate evaluations for re-licensing and recertification. But this complex system was dropped in favour of simpler and streamlined revalidation introduced, at last, in 2012.¹⁰⁷

Revalidation forms a continuous assessment based largely on local systems of annual appraisal. Doctors form a connection to a single organisation (their ‘designated body’) each of which appoints a senior doctor (a ‘responsible officer’) to oversee the governance systems and appraisals. At annual appraisals, doctors present a portfolio of supporting information. Every five years, all doctors licensed to practise in the UK must show that they are up to date and fit to practise. This is judged according to an Appraisals Framework¹⁰⁸ based on the GMC’s Good Medical Practice guidance.

How has revalidation been received? Responsible officers and appraisers are supportive, ‘but this is not yet shared universally among doctors: some of whom feel that the system is not relevant to their needs’.¹⁰⁹ The GMC points to a positive change in culture and practice¹¹⁰ flowing from the proactive nature of revalidation.

Disciplining doctors – fitness to practise

1.14 The doctor’s employer, like any other employer, may initiate disciplinary proceedings and as a result a doctor may face suspension or dismissal.¹¹¹ The courts will not micro-manage NHS employers, but have proved willing to grant injunctive relief where there is evidence of irregularities.¹¹² The disciplinary procedures are complex¹¹³ and will not be dealt with in any detail here. However, note that being sacked from an NHS hospital will not of itself stop the errant or incompetent doctor practising medicine. She may simply move to the private sector. Only the GMC can act to ensure that an ‘unsafe’ doctor can no longer practise.

Complaints about doctors – whether they emanate from patients, other doctors or their organisations – can thus be put to the GMC, which may then investigate whether or not the doctor is fit to practise.¹¹⁴ Once a complaint reaches the GMC, there are two stages to the fitness-to-practise process – investigation and adjudication. Until recently, the GMC was responsible for both stages. The dual role of prosecutor and adjudicator resulted in a loss of public confidence. Following three public consultations¹¹⁵ a new independent tribunal service was launched in 2012. The GMC investigates, while the Medical Practitioners Tribunal Service (MPTS) chaired by a judge adjudicates. In 2015, the MPTS was put on a statutory footing, further enhancing its independent status.¹¹⁶

Fitness-to-practise proceedings have been subject to several reforms. In 2004 three separate streams of health, performance and conduct were abandoned and complaints about doctors were analysed ‘in the round’.¹¹⁷ Further reforms in 2009, 2013 and 2014¹¹⁸ have been consolidated in a guide published by the GMC in 2014.¹¹⁹ The focus is now on whether the doctor’s fitness to practise is ‘impaired’; that is, whether by misconduct, health or other stated cause, the doctor can be considered unable to practise safely and effectively. In reaching a conclusion, regard must be had to the overarching objective of public protection, which incorporates the obligation to promote a safe NHS in which there is public confidence.¹²⁰

Under section 35C(2) of the Medical Act 1983, as amended, impairment can result from all or any of the following:

(1)  misconduct;

(2)  deficient performance;

(3)  a criminal conviction or caution in the British Isles (or elsewhere for an offence which would be a criminal offence if committed in England or Wales);

(4)  adverse physical or mental health;

(5)  a determination by a regulatory body either in the British Isles or overseas; or

(6)  not having the necessary knowledge of English.¹²¹

At the investigation stage, the case examiners (one medical and one lay) can refer the doctor to an Interim Orders Panel where there is a clear need to protect patients or the public interest.¹²² The panel has the power to impose an interim order restricting or suspending the doctor’s right to practise pending the full investigation.¹²³ Where the public interest is not threatened, a single test which emphasises the GMC’s duty to the public¹²⁴ is applied to determine whether a doctor should be referred to a fitness-to-practise panel for a full hearing:

In exercising their discretion, the Committee or the case examiners must have in mind the GMC’s duty to act in the public interest, which includes the protection of patients and maintaining public confidence in the profession in considering whether there is a realistic prospect of establishing that a doctor’s fitness to practise is impaired to a degree justifying action on registration.¹²⁵

At this stage the GMC may conclude the case, agree undertakings with the doctor or issue a warning;¹²⁶ a measure introduced for cases which call for an official response, but which are not serious enough to justify restrictions on the doctor’s registration, when either ‘there has been a significant departure from Good Medical Practice’ or ‘a performance assessment has indicated a significant cause for concern’. Alternatively, the GMC can refer the case to the MPTS for a fitness-to-practise panel hearing. The Manchester-based MPTS is operationally separate to the GMC. In its first year of operation it heard over 350 cases.¹²⁷

There are three stages to the hearing: the finding of facts; the decision on impairment; and the decision on sanction. At the first stage, the Tribunal considers whether there is sufficient evidence of the facts alleged. In some cases, the facts will be disputed. The burden of proof rests with the GMC, which makes the allegations. The Health Act 1999 (as amended) replaces the criminal standard of proof (which was thought to be inappropriate and potentially too lenient on doctors) with a civil standard.¹²⁸ Doctors are now judged on the balance of probabilities rather than establishing proof ‘beyond reasonable doubt’. The civil standard is a sliding standard that can be flexibly applied.¹²⁹ The more serious the matter, the greater the degree of probability required.

At the second stage, a decision on impairment is made. The Tribunal asks whether, on the basis of the facts, fitness to practise is impaired. If the answer is ‘no’, then, in common with the investigation stage, a warning can be issued,¹³⁰ or no further action taken. If the answer is ‘yes’, then the Tribunal proceeds to stage three and in camera makes a decision on sanction. There are four options:

(1)  undertakings;

(2)  conditions (maximum 3 years);

(3)  suspension (maximum 1 year); and

(4)  erasure from the register.¹³¹

New rules to speed up the process and reduce the stress for those involved were introduced in 2013. There is no longer a requirement to read out the written allegations at the start of a hearing and witnesses can submit evidence remotely.

Appeals to the High Court and the Professional Standards Authority

1.15 Doctors have two routes to appeal. If they have received a warning, they can seek judicial review. If the MPTS panel has found that the doctor’s fitness to practise is impaired, the doctor has twenty-eight days to appeal to the High Court under section 40 of the Medical Act 1983.

The court will decide if the decision of the fitness-to-practise panel was ‘wrong’.¹³² For example, the panel may have acted improperly or the sanction might be disproportionate. In the latter case the court is entitled to prioritise the public interest – in particular public confidence and the standing of the profession.¹³³ The court has a range of powers. It can dismiss the appeal, quash, amend or substitute the direction, or remit the case back to the GMC fitness-to-practise panel.¹³⁴

In 2010, Professor Walker-Smith and Dr Wakefield’s names were erased from the register following a finding of serious professional misconduct. They were both involved in a paediatric clinical trial, following which Dr Wakefield publicly made the link between the triple ‘measles, mumps and rubella’ (MMR) vaccination and autism, while Professor Walker-Smith made clear his support for the governmental policy on MMR. Dr Wakefield abandoned his appeal, but in 2012 Professor Walker-Smith’s registration was restored after a successful appeal.¹³⁵ The panel had made errors and applied ‘inadequate and superficial reasoning’. The GMC accepted the decision and has subsequently made changes to its fitness-to-practise procedures as outlined above.

Doctors can appeal if they feel they have been dealt with harshly.¹³⁶ So too the Professional Standards Authority for Health and Social Care (PSA)¹³⁷ may appeal to the High Court under section 29 of the National Health Service Reform and Health Care Professions Act 2002, where it considers a decision to be unduly lenient. Alternative dispute resolution reduces the number of cases that make it to court. The PSA appealed one (out of 397 GMC cases reviewed) in 2012 and two (out of 219 cases reviewed) in 2013.¹³⁸ In 2013, the PSA announced that it would challenge the finding that a chief nurse who worked at Stafford Hospital between 1998 and 2006 was unduly lenient. Ms Harry was initially given a five-year caution by the Nursing and Midwifery Council for her role in the hospital crisis. In 2014, legal agreement was reached and she was struck from the register.¹³⁹

Section 29 orders have caused disquiet on the basis that the criteria for determining undue leniency include the ‘maintenance of public confidence in regulation’ which might potentially go beyond the merits of the case.¹⁴⁰ In 2004, the Court of Appeal clarified the PSA’s (formally the Council for Healthcare Regulatory Excellence) powers.¹⁴¹ Not only may it refer cases to the High Court when it is of the view that regulators have acted too leniently in applying ‘penalties’, but it may also do so when the regulator acquits a healthcare professional. Thus, even if a doctor is acquitted by the GMC, the PSA may refer her to the High Court, which can impose a sanction. Mason and Laurie point out that the element of double jeopardy such doctors are subjected to has potential to offend their rights under Article 6 of the European Convention of Human Rights.¹⁴² In 2014 the double jeopardy argument was raised by a psychiatrist who was found not guilty of misconduct in relation to an online advice blog he ran.¹⁴³ The GMC found the doctor’s advice deficient, but did not consider that the blog amounted to ‘medical practice’. The PSA appealed the decision, arguing that it was too lenient and their view was accepted by the GMC. The psychiatrist raised the issue of double jeopardy, but the appeal was nonetheless allowed on the basis that it was not unlawful double jeopardy. In a 2015 referral to the High Court on the issue of leniency, Lang J stated: ‘[R]eference to having regard to double jeopardy when considering whether a sentence is unduly lenient is not … really apposite where the primary concern is for the protection of the public’.¹⁴⁴

Regulating the NHS

1.16 The first part of this chapter examined the regulation of individual doctors. We now turn to methods by which NHS organisations are regulated. In 2012 the Health Committee referred to the regulatory landscape as ‘cluttered and opaque’. Attempts to streamline and simplify such a complex body as the NHS continue to challenge the reformers.

Supervising, managing and protecting employees

1.17 Individual doctors face sanctions when they fall short of good medical practice. But what of the employing organisation? Poor treatment often has several causes. Poor doctors are created by poor systems. In 2000, a 31-year-old father was admitted to hospital for minor knee surgery. The operation was a success, but he went on to develop an infection which resulted in toxic shock syndrome from which, tragically, he died. Doctors Misra and Srivastava had failed to diagnose the infection and were convicted of gross negligence manslaughter in 2003,¹⁴⁵ and suspended from the medical register by the GMC in 2005. In 2006, Southampton University Hospital NHS Trust became the first NHS Trust to be prosecuted under the Health and Safety at Work Act 1974 for failing to manage the two junior doctors adequately. The Trust pleaded guilty to a charge of improper supervision and was fined £100,000 and ordered to pay £10,000 costs.¹⁴⁶

The Corporate Manslaughter and Corporate Homicide Act 2007,¹⁴⁷ while not creating any new duties, may improve accountability of companies and organisations, including healthcare businesses,¹⁴⁸ for fatalities that result from system failures. Penalties include fines, publicity orders (whereby the organisation must publicise its prosecution) and remedial orders (where the organisation must take steps to ensure the mistake will not be repeated).¹⁴⁹ Furthermore, the Criminal Justice and Courts Act 2015 creates new offences of ill-treatment or wilful neglect. Individual care workers can be held so liable under section 20 and the organisation as a whole can be considered to be guilty of the offence under section 21.¹⁵⁰

Organisations must safeguard their patients, but also have a duty to protect their employees. Work-related stress among NHS staff is widespread.¹⁵¹ Long working hours exacerbated the problem. The European Working Time Directive¹⁵² imposed a 48-hour week, but this puts pressures on the finite resources of the NHS. More doctors are needed to fill the rotas; there are more time-consuming handovers to make at the end of a shift; and there is less time for training. The problem was aggravated by the European Court of Justice (ECJ) rulings in SiMAP¹⁵³ and Jaeger:¹⁵⁴ on-call staff, resident at work out-of-hours, are considered to be ‘working’ while on duty, whether or not they are called to the bedside. In 2010, NHS Medical Education England reviewed the effects of the Directive on medical training, concluding that the problems are worst when the trainee doctor is involved in emergency care or has a significant ‘out of hours’ workload.¹⁵⁵ In 2014 an independent taskforce chaired by Professor Norman Williams, President of the Royal College of Surgeons, made several recommendations designed to tackle the current lack of flexibility.¹⁵⁶ One is to protect education and training time and another is to consider encouraging wider use of the right to opt out of the restricted hours.¹⁵⁷ The former method may gain support after a July 2015 judgment of the ECJ. The Commission alleged that Ireland’s standard contract for junior doctors was in breach of the Directive. Ireland argued that training time during which doctors are not required to be physically present for the purpose of providing care does not constitute working time. In a judgment that will surprise many, the ECJ dismissed the Commission’s claim for lack of evidence.¹⁵⁸ Meanwhile, the European Commission launched a public consultation on the Directive in 2014 and is likely to form proposals for further consultation in 2016.¹⁵⁹

Governance

1.18 NHS organisations are responsible for a rigorous system of clinical governance, the central aim being to ensure continuous quality improvement and consistency between organisations. A formal requirement for clinical audit in the NHS was first introduced in 1989.¹⁶⁰ Since that time there has been a bewildering array of reforms designed to enhance and monitor quality in the NHS.

Historically, the Commission for Health Improvement issued ‘star ratings’ to providers from 2003. This body was replaced with the Commission for Health-care Audit and Inspection (the ‘Healthcare Commission’) in 2004¹⁶¹ which abandoned the star ratings in favour of an ‘annual health check’. The Health and Social Care Act 2008 established the independent Care Quality Commission (CQC) which, in April 2009, took over the regulation of both health and social care, in NHS, private and voluntary organisations.¹⁶² From April 2010 all providers of adult healthcare were required to register with the CQC.¹⁶³ GPs and other primary medical services were required to register by 2013. Registration is dependent upon demonstration that the provider reaches outcomebased standards.¹⁶⁴ The registration status of Trusts is published on the CQC website. Monitoring is achieved through audit, annual quality accounts¹⁶⁵ and scheduled, responsive and themed visits. Failure leads to sanctions.¹⁶⁶

The CQC monitors, inspects and regulates health and care providers but it is not the only regulator of providers in the NHS. The NHS Trust Development Authority, a Special Health Authority, is responsible for NHS Trusts’ performance management (including governance and clinical quality) and Monitor – an executive non-departmental public body – regulates health services. Monitor was set up under the Health and Social Care (Community Health and Standards) Act 2003 to authorise and monitor Foundation Trusts. Its role was considerably expanded following the Health and Social Care Act 2012. From April 2014, Monitor assumed responsibility (in conjunction with NHS England), for the system that reimburses providers of NHS-funded care, setting prices, promoting competition and limiting anti-competitive practices.¹⁶⁷

Subject to exemptions, providers of NHS services require a licence.¹⁶⁸ New providers apply for the Monitor licence and CQC registration through a single process. If the conditions of a licence are flouted, Monitor can impose fines or revoke the licence. Monitor, however, is responsible for providing continuity of services and so the emphasis is firmly on resolving the situation. For example, though Monitor acknowledged in 2014 that ‘with the benefit of hindsight it was a mistake to grant the trust foundation status [in 2008]’,¹⁶⁹ it did not withdraw the troubled Mid Staffordshire NHS Foundation Trust’s licence. A special administrator appointed by Monitor recommended that the Trust be dissolved and the services taken over by other organisations.¹⁷⁰

The current model of regulation has limitations. The Francis Inquiry’s concerns about effectiveness¹⁷¹ and low public confidence in the CQC¹⁷² led to a call for greater clarity of objectives, standards and results.¹⁷³ The CQC was at the centre of a scandal in 2013 when accused of failing to investigate a series of serious adverse incidents in maternity care at Furness General Hospital.¹⁷⁴ In the words of the Secretary of State, ‘defensiveness and secrecy were put ahead of patient safety and care’.¹⁷⁵ Further reforms ensued. The CQC now focuses more centrally on assessing quality and providing the information necessary to allow the NHS Trust Development Authority and Monitor to make the necessary improvements. The frameworks of the three regulators are better aligned.¹⁷⁶ From April 2015 new and simplified ‘fundamental standards’¹⁷⁷ centre on five core issues: safety, effectiveness, care, leadership and responsiveness¹⁷⁸ and sector-specific guidance clarifies responsibilities. In a move reminiscent of the 2003 star ratings, the CQC now publishes ratings for all health and care providers.¹⁷⁹

The Health and Social Care Act 2012 devolved powers away from the Department of Health. Scrutiny of arm’s-length bodies is now achieved through triennial reviews: all Special Health Authorities, Executive Non-Departmental Public Bodies, Advisory Non-Departmental Bodies and Executive Agencies are subject to assessments of their continuing need, fit for purpose, effectiveness, governance and capability.

Specialist regulators

1.19 As we have seen, work-based regulation involves a system of clinical governance and performance management. Much of this sort of ‘regulation’ has been decentralised. To ensure common standards across the country, special ‘regulators’, such as Monitor and the CQC, may be created to monitor local activity. Most are independent of government, though to varying degrees. There are three broad types of arm’s-length bodies (ALBs): non-ministerial departments (led by a chief executive rather than a minister), Executive Agencies (carrying out executive functions) and non-departmental public bodies (distinct legal personalities).

In 2011, the Public Bodies Act led to sweeping changes (a ‘bonfire of the quangos’) to cut costs and reduce bureaucracy. There are now two Executive Agencies: the Medicines and Healthcare Products Regulatory Agency (MHRA) and Public Health England. Public Health England was set up in 2012, to protect and improve the nation’s health and well-being. The MHRA was set up in 2003 to license and regulate medicines and devices. We examine its role in licensing products in Chapter 10 and in monitoring and regulation of clinical research in Chapter 15. The MHRA is advised by specialist boards and a range of expert advisory groups.

We have outlined the roles of several non-ministerial departments in the course of this chapter, including the CQC, Monitor, the Health and Social Care Information Centre and NHS England. In addition, the National Institute for Health and Care Excellence provides information, guidelines and standards on conditions, treatments and technologies. The Human Fertilisation and Embryology Authority (HFEA),¹⁸⁰ is discussed in Chapters 12 and 13.

Other ALBs include Health Education England (above 1.11) the Health Research Authority (discussed in Chapter 15), which balances the interests of the public and patients in medical research and the protection of research participants; and the NHS Litigation Authority (Chapter 8), which manages negligence claims against the NHS.

Whither the NHS?

1.20 The NHS does not stand still, nor should it. It is an organisation for the people and must evolve to take account of changing needs. But the scale and pace of reform have proved a great burden at a time of intense financial pressure. We have briefly examined systems of regulation at local, organisational, and national levels. Regulation serves a variety of purposes, which do not always coincide. Economic accountability may result in a health service that represents value for money. Resource allocation decisions and their local variations will inevitably result in injustice to some. Aggrieved patients may look to the law for redress, either if they are denied treatment, or if they are harmed by sub-standard treatment. There remains much to do to ensure confidence in both the ‘new’ systems for regulating medical professions, and the NHS itself.

¹  See R Tallis, Hippocratic Oaths: Medicine and Its Discontents (2004) Atlantic Books, p 102.

²  Healthcare Commission, Investigation into Mid Staffordshire NHS Foundation Trust (2009), p 11.

³  Independent Inquiry into Care Provided by Mid Staffordshire NHS Foundation Trust, chaired by Robert Francis QC (February 2010).

⁴  Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry Executive Summary (February 2013), para 12.

⁵  Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry, chaired by Robert Francis QC, HC947 (February 2013).

⁶  Press statement, Robert Francis QC (February 2013). Accessible at www.midstaffspublicinquiry.com/sites/default/files/report/Chairman%27s%20statement.pdf

⁷  See further C Newdick, ‘From Hippocrates to Commodities: Three Models of NHS Governance: NHS Governance, Regulation, Mid Staffordshire Inquiry, Health Care as a Commodity’ (2014) 22(2) Medical Law Review 162.

⁸  R (HSE) v Mid Staffordshire NHS Foundation Trust, Stafford Crown Court, 28 April 2014.

⁹  But see criticism of the GMC’s Professional Conduct Committee which found three doctors guilty of serious professional misconduct: PM Dunn, ‘The Wiseheart Affair: Paediatric Cardiological Services in Bristol 1990–95’ (1998) 317 BMJ 1144, complains (inter alia) that the committee did not include anyone with experience of cardiac surgery, and given that many of the charges against the surgeons were dropped or not proved, the finding was prompted largely by public and political pressure. See alternative view: SN Bolsin, ‘The Wiseheart Affair: Responses to Dunn’ (1998) 317 BMJ 1579.

¹⁰  Learning from Bristol, The Report of the Public Inquiry into Children’s Heart Surgery at the Bristol Royal Infirmary 1984–1995 CM 5207 (1) (2001) (hereafter the Bristol Inquiry). At the time of writing, a new independent review of children’s cardiac services at Bristol is under way. Chaired by Eleanor Grey QC, Sir Ian Kennedy is Consultant Adviser. Accessible at: www.thebristolreview.co.uk

¹¹  The Bristol Inquiry, Summary, para 3.

¹²  Royal Liverpool Children’s Inquiry Report HC 12–11 (2001).

¹³  See Redfern Inquiry into Human Tissue Analysis in UK Nuclear Facilities (2010) on radiochemical analysis of organs removed at post-mortem between 1960 and 1992.

¹⁴  Shipman Inquiry, Safeguarding Patients: Lessons from the Past – Proposals for the Future. 5th report (Cm 6394) (2004).

¹⁵  Healthcare Commission and the Commission for Social Care Inspection, Joint Investigation into the Provision of Services for People with Learning Disabilities at Cornwall Partnership NHS Trust (2006).

¹⁶  Department of Health (DH), Transforming Care: A National Response to Winterbourne View Hospital: Final Report (London, 2012). Group litigation is pending: see Ministry of Justice, ‘The Winterbourne View Group Litigation’ No 91 Gov.uk (2013) 27 February. And see also Welsh Government, In Search of Accountability: A Review of the Neglect of Older People Living in Care Homes Investigated as Operation Jasmine (July 2015).

¹⁷  Dr Bill Kirkup CBE, Report of the Morecambe Bay Investigation (March 2015).

¹⁸  BBC News, ‘Stepping Hill Nurse Victorino Chua Guilty of Murdering Patients’ (2015) 18 May.

¹⁹  See NHS Constitution (updated 2015) s 3(a).

²⁰  See DH, Culture Change in the NHS: Applying the Lessons of the Francis Inquiries, CM 9009 (February 2015).

²¹  Amending the Health and Social Care Act 2008, ss 20(1) and 2(2).

²²  GMC, Good Medical Practice (2013). In essence, the doctor must seek to be a good person, a tradition dating back to the work of the nineteenth-century physician, Thomas Percival; see at 3.2.

²³  We concentrate on the role of the GMC. Other professional regulators include the General Chiropractic, Dental, Optical, Pharmaceutical and Osteopathic Councils, the Nursing and Midwifery Council, Pharmaceutical Society of Northern Ireland and the Health and Care Professions Council. The PSA oversees them all. The Law Commissions of Scotland, Northern Ireland and England produced Draft Regulation of Health and Social Care Professions etc Bill 2014 proposing to replace the various regulations with a single statute, providing a broad framework for all nine regulatory bodies and the PSA. In 2014, progress stalled due to lack of parliamentary time. The Health and Social Care (Safety and Quality) Act 2015, s 5 enhances consistency by introducing a new overarching objective of public protection: see 1.8.

²⁴  Section 222 of the Health and Social Care Act 2012 replaced the Council for Health-care Regulatory Excellence (set up under ss 25–29 of the NHS Reform and Health Care Professions Act 2002), with the new PSA.

²⁵  A Lansley, Secretary of State for Health, in Transparency in Outcomes – A Framework for the NHS (2010), p 3.

²⁶  The numerous NHS Acts were consolidated into the NHS Act 2006; the NHS (Wales) Act 2006 and the NHS (Consequential Provisions) Act 2006.

²⁷  See for example section 2(a) NHS Constitution which states: ‘You have the right to expect your local NHS to assess the health requirements of the local community and to commission and put in place the services to meet those needs as considered necessary’.

²⁸  DH, Sustaining Innovation through New PMS Arrangements (2004), ref: 2545, p 7.

²⁹  DH, Commissioning a Patient-Led NHS, ref: 5312 (2005).

³⁰  See (2014) 22(2) Medical Law Review, a special edition dedicated to the reforms. Editorial: V Chico, T Hervey, R Stirton, A Warren-Jones, ‘Markets and Vulnerable Patients: Health Law after the 2012 Act’ (2014) 22(2) Medical Law Review 157.

³¹  National Audit Office, The Performance of the Department of Health 2012–13 (March 2014), 1.4.

³²  Health and Social Care Act 2012, ss 33–34.

³³  A Private Member’s Bill to repeal the 2012 Act got as far as the Second Reading: see the NHS (Amended Duties and Powers) Bill 2014–15, sponsored by Clive Efford.

³⁴  Previously called the NHS Commissioning Board.

³⁵  Health and Social Care Act 2012, Part 3, chapter 1, ss 61–71.

³⁶  Ibid, chapter 4, ss 115–127.

³⁷  As required by s 116 (ibid).

³⁸  NHS Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) Regulations 2012 SI 2012/2996 (amended SIs 2013/2891, 2014/91; 2014/1661, 2015/415, 2015/1430).

³⁹  Technical support is provided by Commissioning Support Groups and Clinical Senates.

⁴⁰  NHS Bodies and Local Authorities Partnership Arrangements Regulations 2000, SI 2000/617 (amended SI 2009/278). See BBC News, ‘Greater Manchester Councils “to Control £6bn NHS Budget”’ (2015) 15 February; and Cities and Local Government Devolution Bill [HL] 2015–16. Proposals to incorporate primary care were consulted upon in 2015: NHS Bodies and Local Authorities Partnership Arrangements (Amendment) Regulations 2015 Public Consultation (February 2015).

⁴¹  DH, Public Health Outcomes Framework 2013 to 2016 (updated 2015).

⁴²  Ibid, see www.phoutcomes.info

⁴³  DH, NHS Outcomes Framework 2016/16 (December 2014).

⁴⁴  Health and Social Care Act 2012, Part 9, chapter 2, ss 252–275 and Schedule 18. See 4.21.

⁴⁵  DH, Choice Framework 2015–16 (March 2015). And the MyNHS website (accessible at www.nhs.uk/service-search/performance/search) displaying key performance data was launched in 2014.

⁴⁶  NHS Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) (Amendment) Regulations 2013, SI 2013/2891 and SI 2014/1611; NHS (Direct Payments) Regulations 2013, SI 2013/1617 (amended SI 2013/2354).

⁴⁷  See N Triggle, ‘One-fifth of Hospitals “May Be Covering up Mistakes”’ BBC News (2014) 24 June.

⁴⁸  Consolidated in the NHS Act 2006, chapter 5 (ss 30–65).

⁴⁹  See 1.18.

⁵⁰  Raising concerns about creeping privatisation: ACL Davies, ‘This Time, It’s for Real: The Health and Social Care Act 2012’ (2013) 76(3) MLR 564.

⁵¹  NHS Trust Development Authority (Establishment and Constitution) Order 2012, SI 2012/901 (amended SI 2013/260).

⁵²  Monitor, Performance of the Foundation Trust Sector: Executive Summary (February 2015).

⁵³  Health Committee, Public Expenditure on Health and Social Care (February 2014), p 41.

⁵⁴  NHS England, Five Year Forward View (October 2014).

⁵⁵  I Kennedy, The Unmasking of Medicine (1981) Allen & Unwin, ch 1, p 9ff.

⁵⁶  Ibid, p 8.

⁵⁷  P Gooderham, ‘Changing the Face of Whistleblowing’ (2009) 338 BMJ b2090.

⁵⁸  And see guidance from National Whistleblowing Helpline, Raising Concerns at Work: Whistleblowing Guidance for Workers and Employers in Health and Social Care (April 2014).

⁵⁹  In contrast to the position taken in NHS Manchester v Fecitt and others [2012] IRLR 64 (CA).

⁶⁰  D Hughes, ‘NHS Hospitals Spend £2m on Gagging Orders Preventing Staff Speaking out’ The Independent (2013), 12 June.

⁶¹  NHS Staff Surveys, Briefing Note: Issues Highlighted by the 2015 NHS Staff Survey in England (2015), p 7. And note that 13 per cent of staff experienced harassment, bullying or abuse from staff in the last twelve months. Accessible at www.nhsstaffsurveys.com

⁶²  Sir Robert Francis QC, Report on the ‘Freedom to Speak up?’ Review into Creating an Open and Honest Reporting Culture in the NHS (February 2015).

⁶³  The report recommends amendment of the Employment Rights Act 1996, Equality Act 2010 and an extension of the list of prescribed bodies/persons under the Public Interest Disclosure Act 1999 to include NHS England, Clinical Commissioning Groups and Local Education and Training Boards.

⁶⁴  See 1.18.

⁶⁵  DH, Consultation: Introducing the Statutory Duty of Candour (March 2014); DH, Hard Truths: The Journey to Putting Patients First, Cm 8777 (January 2014), pp 12–13; Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry, HC947 (February 2013), rec 181.

⁶⁶  Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, SI 2014/2936 (amended SI 2015/64), reg 20. See CQC, Regulation 5 and Regulation 20: Guidance for NHS Bodies (November 2014).

⁶⁷  GMC and NMC, Openness and Honesty When Things Go Wrong: The Professional Duty of Candour (July 2015). The guidance urges employers to create conditions encouraging healthcare professionals to be open about mistakes.

⁶⁸  GMC (Licence to Practise) Regulations Order of Council 2009, SI 2009/2739, under powers derived from the Medicines Act 1983, Part IIIA, s 29A(2).

⁶⁹  GMC, Good Medical Practice (2013).

⁷⁰  Medical Act 1983, s 49; and see Younghusband v Luftig [1949] 2 KB 354; Wilson v Inyang [1951] 2 KB 799; BBC News, ‘Banned Doctor Levon Mkhitarian Jailed after Treating 3,000 Patients’ (2015) 17 July.

⁷¹  SIs 2002/3135, 2006/1914, 2007/3101, 2008/1734; 2008/3131, 2010/234, 2014/ 1101.

⁷²  See for example Luthra v GMC [2013] EWHC 240 (Admin), [5].

⁷³  Amending the NHS Reform and Health Care Professions Act 2002, s 25.

⁷⁴  GMC (Licence to Practise and Revalidation) Regulations Order of Council 2012, SI 2012/2685; GMC (Licence to Practise and Revalidation) (Amendment) Regulations Order of Council 2014, SI 2014/1273.

⁷⁵  See D Irvine, A Doctors’ Tale (2003) Radcliffe Medical Press, in particular sections 3 and 4. Sir Donald Irvine was the President of the GMC from 1995 to 2002.

⁷⁶  Shipman Inquiry, Safeguarding Patients: Lessons from the Past – Proposals for the Future 5th report (Cm 6394) (2004) (hereafter Shipman Inquiry).

⁷⁷  DH, CMO’s Report, Good Doctors, Safer Patients: Proposals to Strengthen the System to Assure and Improve the Performance of Doctors and to Protect the Safety of Patients (2006), para 60.

⁷⁸  Health and Social Care Act 2008, s 98.

⁷⁹  M Davies, ‘The Demise of Professional Self-Regulation? Evidence from the “Ideal Type” Professions of Medicine and Law’ (2010) 26(1) Professional Negligence 3, p 9.

⁸⁰  GMC (Constitution) Order 2008, SI 2008/2554.

⁸¹  GMC (Constitution) (Amendment) Order 2012, SI 2012/1654.

⁸²  See Medical Act 1983, s 35 as amended by the 2002 Order.

⁸³  At the time of writing there are thirty-four explanatory guidelines promulgated by the GMC; see www.gmc-uk.org/guidance/ethical_guidance.asp

⁸⁴  Accessible at www.gmc-uk.org/guidance/20706.asp

⁸⁵  GMC, Outcomes for Graduates (Tomorrow’s Doctors) (2015). And see GMC, Consultation on Draft Standards for Medical Education and Training (January 2015) and revision of the Quality Improvement Framework, expected 2016.

⁸⁶  Professor Sir John Tooke, Final Report of the Independent Inquiry into Modernising Medical Careers (2008).

⁸⁷  General and Specialist Practice (Education, Training and Qualifications) Order 2010, SI 2010/234.

⁸⁸  Health Education England Regulations 2012, SI 2012/1290.

⁸⁹  DH, Education Outcomes Framework (March 2013).

⁹⁰  Health Education England Regulations 2014, SI 2014/3215. And see SIs 2014/3186, 2014/3125, 2014/3218, 2015/127.

⁹¹  Outcomes for Graduates (Tomorrow’s Doctors) (2015).

⁹²  Medical Act 1983 (Amendment) and Miscellaneous Amendments Order 2006, SI 2006/1914, Art 21 amends the Medical Act 1983, s 5 accordingly.

⁹³  R (on the application of BAPIO Action Ltd) v Royal College of General Practitioners, GMC [2014] EWHC 1416 (Admin).

⁹⁴  Ibid, [51] per Mitting J.

⁹⁵  See the GMC (Maximum Period of Provisional Registration) Regulations Order of Council 2015, SI 2015/92 setting a maximum period of provisional registration of 1,125 days.

⁹⁶  Both set up under SI 2003/1250, Pt IV. Categories of doctors eligible for inclusion in the specialist register and GP registers are set out in the Postgraduate Medical Education and Training Order 2010, SI 2010/473; the Postgraduate Medical Education and Training (Amendment) Order of Council 2012, SI 2012/344.

⁹⁷  Within the EU, the free movement of professionals is protected in Directive 2005/36/ EC on the recognition of professional qualifications, amended in Directive 2013/55/ EU. Regulation EU 2015/983 sets out procedures for issue of a European Professional Card for mobile professions including general nurses. Subject to further assessment, it may in future also be rolled out to doctors.

⁹⁸  The English language requirements changed on 1 February 2011. See www.gmc-uk.org

⁹⁹  And see Gray v Germany App no 49278/09 (ECHR, 2014).

¹⁰⁰  Medical Act 1983 (Amendment) (Knowledge of English) Order 2014, SI 2014/1101; GMC (Licence to Practise and Revalidation) (Amendment) Regulations Order of Council 2014, SI 2014/1273.

¹⁰¹  Medical Act 1983 (Amendment) Order 2002, SI 2002/3135, Pt V, inserts a new Pt IIIA ‘Licence to Practise and Revalidation’ into the Medical Act 1983.

¹⁰²  GMC (Licence to Practise) Regulations Order of Council 2009, SI 2009/2739 were revoked and replaced by the GMC (Licence to Practise and Revalidation) Regulations Order of Council 2012, SI 2012/2685 (amended SIs 2014/1273; 2015/1375) (see 1.13).

¹⁰³  Under Medical Act 1983, Schedule 3A (registration) and s 29F(1) (licence). The GMC (Registration Appeals Panels Procedure) Rules Order of Council 2010, SI 2010/476 sets out the procedure.

¹⁰⁴  Medical Act 1983 (Amendment) Order 2002, SI 2002/3135, Pt V.

¹⁰⁵  Shipman Inquiry, ch 26 and paras 27.261–27.262.

¹⁰⁶  CMO, Medical Revalidation – Principles and Next Steps (2008).

¹⁰⁷  GMC (Licence to Practise and Revalidation) Regulations Order of Council 2012, SI 2012/2685 (amended SI 2014/1273; SI 2015/1375).

¹⁰⁸  GMC, The Good Medical Practice Framework for Appraisal and Revalidation (2011) updated (2013).

¹⁰⁹  NHS Revalidation Support Team, The Early Benefits and Impact of Medical Revalidation (March 2014), 6.

¹¹⁰  Health Committee, Accountability Hearing with the GMC (March 2014); summary, accessible at: www.publications.parliament.uk/pa/cm201314/cmselect/cmhealth /897/ 89703.htm.

¹¹¹  The frameworks for each designated body are listed in: Revalidation Support Team, Supporting Doctors to Provide Safer Healthcare: Responding to Concerns about a Doctor’s Practice (March 2013).

¹¹²  See, for example, West London Mental Health NHS Trust v Chhabra [2013] UKSC 80.

¹¹³  See Mezey v South West London & St George’s Mental Health NHS Trust [2010] EWCA Civ 293, discussed in A White, ‘What the Doctor Ordered’ 154(19) (2010) Solicitor’s Journal 17.

¹¹⁴  Alternatively a complaint can be made through the NHS complaints process outlined in Chapter 9.

¹¹⁵  GMC, The Future of Adjudication: Making Changes to our Fitness to Practise Rules and Our Constitution of Panels and Investigation Committee Rules (2012); Reform of the Fitness to Practise Procedures at the GMC – Changes to the Way We Deal with Cases at the End of an Investigation (2011); The Future of Fitness to Practise Adjudication and the Establishment of the Medical Practitioners Tribunal Service (2011).

¹¹⁶  GMC (Fitness to Practise and Over-arching Objective) and the Professional Standards Authority for Health and Social Care (References to Court) Order 2015, SI 2015/794.

¹¹⁷  GMC (Fitness to Practise) Rules 2004, SI 2004/2608.

¹¹⁸  SIs 2009/1913, 2013/815, 2014/1270.

¹¹⁹  GMC, Guidance to the GMC’s Fitness to Practise Rules 2004 (as amended) (April 2014). The guide is not legally binding. Accessible at: www.gmc.uk.org/Guidance_to_FTP_Rules_NEW.pdf_56716060.pdf

¹²⁰  Health and Social Care (Safety and Quality) Act 2015, s 5.

¹²¹  GMC, Guidance to the GMC’s Fitness to Practise Rules 2004, para 4.

¹²²  Medical Act 1983, s 35C(8).

¹²³  Ibid, s 41A.

¹²⁴  Professionalism is increasingly defined by reference to the maintenance of serviceusers’ trust: see D Mangan, ‘The Curiosity of Professional Status’ (2014) 30(2) Professional Negligence 74.

¹²⁵  GMC, Guidance to the GMC’s Fitness to Practise Rules 2004, para 20.

¹²⁶  Medical Act 1983, s 35C(6).

¹²⁷  MPTS, press release, ‘First Anniversary for MPTS with More Reform Ahead’ (June 2013).

¹²⁸  Health Act 1999, s 60A.

¹²⁹  R (N) v Mental Health Review Tribunal [2006] QB 468, CA.

¹³⁰  Medical Act 1983, s 35D(3).

¹³¹  MPTS, Information for Doctors Whose Cases Are Due to Be Heard by a Fitness to Practise Panel (June 2013).

¹³²  GMC v Meadow [2006] EWCA Civ 1390, [125–128].

¹³³  See Robert Allan Odes v GMC [2010] EWHC 552 (Admin); Cheatle v GMC (2009) EWHC 645 (Admin).

¹³⁴  Medical Act 1983, s 40(7).

¹³⁵  Walker-Smith v GMC [2012] EWHC 503 (Admin).

¹³⁶  See for example Southall v GMC [2009] EWHC 1155 (Admin). The Court of Appeal referred the case back to the GMC, which found him not guilty of serious misconduct in 2011. And see 8.14.

¹³⁷  The Council for Healthcare Regulatory Excellence changed its name to the PSA in 2012, pursuant to the Health and Social Care Act 2012, s 222 (and see SI 2012/2672).

¹³⁸  Health Committee, Accountability Hearing with the GMC (March 2014), para 46.

¹³⁹  NMC press release: ‘Former Mid Staffordshire Director of Nursing Struck-off’ (January 2014).

¹⁴⁰  See, for example, editorial, ‘Concerns Raised about CHRE’s Powers and Its Use of Spin Doctors’ (2004) 273 Pharmaceutical Journal 578.

¹⁴¹  Ruscillo v Council for the Regulation of Health Care Professionals; the GMC and another [2004] EWCA Civ 1356.

¹⁴²  JK Mason, GT Laurie, Mason and McCall Smith’s Law and Medical Ethics (9th edn, 2013), 1.44. And see A Samanta, J Samanta, ‘Referring GMC Decisions to the High Court’ (2005) 330 BMJ 103.

¹⁴³  PSA v GMC [2014] EWHC 1903 (Admin).

¹⁴⁴  [2015] EWHC 1304 (Admin), [9].

¹⁴⁵  See 7.22. See also O Quick, ‘Medicine, Mistakes and Manslaughter: A Criminal Combination’ (2010) Cambridge Law Journal 186.

¹⁴⁶  R v Southampton University Hospital NHS Trust [2006] EWCA Crim 2971.

¹⁴⁷  See 7.22.

¹⁴⁸  A Samuels, ‘The Corporate Manslaughter and Corporate Homicide Act 2007: How Will It Affect the Medical World?’ (2007) 75(2) Medico-Legal Journal 72.

¹⁴⁹  At the time of writing there have been several successful prosecutions. See, for example, PJ Brearey-Horne ‘Maternity Services and the Impact of the Corporate Manslaughter and Corporate Homicide Act 2007’ in D Griffiths and A Sanders (eds) Bioethics, Medicine and the Criminal Law (2013) Cambridge University Press, p 2.

¹⁵⁰  See 7.23.

¹⁵¹  DH, Issues Highlighted by the 2014 NHS Staff Survey in England (2015): ‘37% of all staff reported feeling unwell due to work-related stress and pressure.

¹⁵²  93/104/EC. Implemented in SI 1998/1833.

¹⁵³  Case C-303/98 Sindicato de Medicos de Asistencia Publica (SiMAP) v Conselleria de Sanidad y Consumo de la Generalidad Valenciana [2000] ECR 1-7963.

¹⁵⁴  Case C-151/02 Landeshauptstadt Kiel v Norbert Jaeger [2003] ECR I-8389.

¹⁵⁵  Prof Sir J Temple, Time for Training: A Review of the Impact of the European Working Time Directive on the Quality of Training (2010).

¹⁵⁶  Independent Working Time Regulations Taskforce to the DH, The Implementation of the Working Time Directive and Its Impact on the NHS and Health Professionals (March 2014). The recommendations were accepted by the government July 2014.

¹⁵⁷  And see M Holehouse, ‘David Cameron to Demand Opt-out on EU Work Law in Referendum Negotiations’ The Telegraph (2015) 10 July.

¹⁵⁸  Commission v Ireland Case C-87/14. And see Court of Justice of the European Union, Press Release No 80/15, Luxembourg, 9 July 2015.

¹⁵⁹  European Commission, Public Consultation on the Review on the Working Time Directive (Directive 2003/88/EC) (December 2014).

¹⁶⁰  Secretaries of State for Social Services, Wales, Northern Ireland and Scotland, Working for Patients, Cm 555 (HMSO, 1989).

¹⁶¹  Set up under the Health and Social Care (Community Health and Standards) Act 2003, s 41.

¹⁶²  Care Quality Commission (Additional Functions) Regulations 2009, SI 2009/410; Care Quality Commission (Membership) Regulations 2008, SI 2008/2252, revoked and replaced by SI 2015/1479.

¹⁶³  Health and Social Care Act 2008 (Registration of Regulated Activities) Regulations 2009, SI 2009/660; see also SI 2009/3112; SI 2010/49; SI 2012/921; SI 2012/1186; SI 2013/1413.

¹⁶⁴  Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, SI 2014/2936, Part 3 (amended SI 2015/64); Care Quality Commission (Registration) Regulations 2009, SI 2009/3112, Part 4 (amended SI 2012/921, SI 2012/1186). And see CQC, Guidance for Providers on Meeting the Regulations (March 2015).

¹⁶⁵  Health Act 2009 ss 8–10; the NHS (Quality Accounts) Regulations 2010, SI 2010/279 (amended SI 2011/269, SI 2012/3081) and see the NHS (Clinical Commissioning Groups – Payments in Respect of Quality) Regulations 2013, SI 2013/474.

¹⁶⁶  Health and Social Care 2008 Act as amended by the Care Act 2014 lists sanctions. See in particular ss 17 (cancellation), 18 (suspension), 29 (warning notices) and 30–32 (urgent procedures and appeals). Sections 33–27 list offences. And see CQC, Enforcement Policy (February 2015).

¹⁶⁷  In accordance with the Competition Act 1998 and the NHS (Procurement, Patient Choice and Competition) Regulations 2013 No 1, SI 2013/257 and No 2, SI 2013/500.

¹⁶⁸  Exceptions are set out in the NHS (Licence Exemptions, etc) Regulations 2013, SI 2013/2677 (amended SI 2015/190).

¹⁶⁹  Monitor, Securing the Future of Services for Patients in Mid Staffordshire: An Overview of Monitor’s Regulatory Approach to a Troubled NHS Foundation Trust (January 2014), 2. Note that the National Audit Office Monitor: Regulating NHS Foundation Trusts (February 2014) stated: 2.8 ‘Overall, our view is that Monitor’s process for assessing applicants for foundation trust status is rigorous and thorough’.

¹⁷⁰  DH, Mid Staffordshire NHS Foundation Trust Special Administration – Written Statement to Parliament (26 February 2014).

¹⁷¹  Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry, chaired by Robert Francis QC, HC947 (February 2013).

¹⁷²  Health Committee, Accountability Hearing with the Care Quality Commission, HC 592 (December 2012).

¹⁷³  DH, Hard Truths: The Journey to Putting Patients First, Cm 8777 (January 2014).

¹⁷⁴  Secretary of State for Health, Jeremy Hunt, Oral Statement on Morecambe Bay (2013) 18 June, accessible at: www.gov.uk/government/speeches/oral-statement-on-morecambe-bay

¹⁷⁵  Ibid. And see Dr Bill Kirkup CBE, The Report of the Morecambe Bay Investigation (March 2015) pp 170–171, suggesting that while the CQC ‘clearly failed to deal adequately with the Trust’ there was not evidence of a deliberate cover-up.

¹⁷⁶  Monitor, CQC, TDA, Well-Led: Statement of Intent (2013), accessible at: www.ntda.nhs.uk/wp-content/uploads/2014/05/Well-led-statement-of-intent.pdf

¹⁷⁷  DH, Introducing Fundamental Standards: Consultation on Proposals to Change CQC Registration Regulations (January 2014).

¹⁷⁸  CQC, Raising Standards, Putting People First: Our Strategy for 2013 to 2016 (2013).

¹⁷⁹  CQC, Annual Report and Accounts 2014/15, p 4: between 2014 and April 2015, the CQC inspected 7,038 providers/locations using its new inspection model; 3,180 had led to ratings.

¹⁸⁰  Created by the Human Fertilisation and Embryology Act 1990, s 5.

Chapter 2

DOCTORS’ RESPONSIBILITIES: PATIENTS’ RIGHTS

2.1 When we are ill we want to be treated by competent doctors – that is why debates about regulation of the medical profession are so crucial. However, we may also wish to assert our own rights, especially in the context of decision-making. In the 2015 Supreme Court decision of Montgomery v Lanarkshire Health Board,¹ Lord Kerr and Lord Reed highlighted the effects of human rights discourse on the doctor–patient relationship:

[P]atients are now widely regarded as persons holding rights, rather than as the passive recipients of the care of the medical profession. They are also widely treated as consumers exercising choices: a viewpoint which has underpinned some of the developments in the provision of healthcare services.²

Patients are no longer content to be passive recipients even of ‘good’ care. They want a say in what ‘good’ care comprises. The pace of medical developments is such that, particularly in the context of reproductive medicine and genetics, new questions surface daily around the implications of certain kinds of treatment. These may concern entitlement to treatment, or how far choices about treatment belong to individual patients alone. Or they may focus on the role of the state. Or the interests of commerce may be involved. How does the law begin to address patient rights today? What relevance have human rights to medicine?

The United Nations General Assembly adopted the Universal Declaration of Human Rights in 1948. Article 25 protects an individual’s ‘right to a standard of living adequate for the health and well-being of himself and of his family’ and incorporates a right to medical care and security in the event of sickness and disability. A series of nine human rights treaties (and their optional protocols) articulate the rights of certain groups. An individual whose rights are breached can complain to the monitoring body of each Convention, provided their state has ratified the Treaty and recognised the competence of the Committee (usually by becoming a party to the optional protocols). In 1991, the UK ratified the Convention on the Rights of the Child 1989 (discussed in Chapter 14). The Convention on the Rights of Persons with Disabilities 2006 (noted in Chapter 6) and optional protocol were ratified in 2009. Neither Convention has been incorporated into law in England, but a duty incumbent on ministers to have regard to the Convention on the Rights of the Child was introduced in Wales in 2014.³

The forty-seven Member States of the Council of Europe are bound by the provisions of the European Convention on Human Rights (ECHR), arbitrated by the European Court of Human Rights (ECtHR).⁴ The ECtHR is an international court which sits in Strasbourg and hears applications from individuals and Member States on potential breaches of the Convention. The Court is divided into various Chambers, which can make a judgment or, in very important or controversial cases, send the case to the Grand Chamber. Following a Chamber judgment, parties have three months to request referral to the Grand Chamber before the decision is considered final. The Grand Chamber can reconsider the case, but referrals are accepted only on an exceptional basis.

The Human Rights Act 1998 (HRA) came into effect in 2000. It gives domestic effect to the Human Rights Convention. In practice, the English courts referred to, and deferred to, the Convention for several years prior to 1998, in developing the common law. The HRA does not replace or eliminate existing common law principles. As Lord Reed made clear in 2013, the Convention is relatively broad and unspecific and cannot ‘be treated as if it were Moses and the prophets’.⁵

The common law relating to healthcare developed piecemeal, with an apparent emphasis on wrongs rather than rights. Nevertheless, in many instances the existing law may suffice to vindicate rights endorsed in the Convention. So far, decisions of the English courts that have addressed the HRA have tended not to declare new rights, but to review whether the existing common law ‘rights’ are sufficient in the light of the Convention.

Though some have expressed consternation about the way the Convention changes English common law, controversial decisions often stem not from the Convention itself, but from the Strasbourg Court’s changing interpretation of its Articles. The Convention is a ‘living instrument’ and this affords the Court significant discretion, which has proved contentious.⁶ A growing faction seeks to distance English law from the Convention.⁷ Some argue for a wholesale decoupling, while others have suggested ‘nudge’ legislation to guide the courts.⁸ Even if we remain party to the Convention, the HRA is under attack.⁹ The majority of the Commission on a Bill of Rights, reporting in 2012,¹⁰ concluded that a UK Bill of Rights could replace the HRA, incorporating the UK’s obligations under the ECHR while improving the sense of public ownership of the human rights regime.¹¹

The form of human rights protection may be subject to change, but the legacy of the Convention and HRA in the context of medical law is likely to endure. It is to this we now turn.

The impact of the Human Rights Act 1998

2.2 Medical law, Ian Kennedy and Andrew Grubb declared,¹² is essentially ‘a sub-set of human rights law’. The fundamental nature of the relationship between doctors and patients amply proves their point. At stake within the realm of medical law, is our right to make our own decisions about how we live our lives and how we die. Our interests in privacy and in family life, in having or not having children, are central to our dealings with health professionals.

We should note that the ECHR addresses only a limited range of rights. There is no positive right to healthcare; there is no equivalent to Article 25 in the Universal Declaration of Human Rights. In a number of instances what the Convention confers are negative rights – ie prohibitions against certain kinds of infringement of basic freedoms, although the jurisprudence of the Convention is moving to a greater recognition of positive rights. The HRA does not (whatever the media says) incorporate the Convention into English law. It renders the Convention enforceable against public authorities. The Act is relevant to disputes about enforced treatment or arguments that the government is violating patients’ privacy. Where what is at stake is a failure by the NHS to provide certain sorts of care, or concerns about allowing, for example, insurers to demand medical details about you, the utility of the Act is diminished.

Even when a patient can bring her claim squarely within the ambit of a Convention right, she may find that the violation of her right is found to be justified. Many Convention rights are qualified. A good example is Article 8(1) – the right to respect for private and family life. In certain circumstances, Article 8(2) provides that infringement of the right may be justifiable; a violation of a patient’s privacy could be held justified on grounds of public health, or for the protection of health or morals, as long as that infringement is proportionate. That means that interference with the individual’s right must be shown to be ‘necessary in a democratic society’. Moreover, Articles of the Convention may ‘contradict’ each other in certain circumstances, for example, Article 2 (life) and Article 8 (privacy). Finally, the jurisprudence of the ECtHR expressly endorses a doctrine oddly entitled the ‘margin of appreciation’. That is, national jurisdictions are allowed a degree of freedom in defining their own criteria of public policy (morality).¹³ English courts enjoy some degree of discretion to determine English views of ethical dilemmas in medicine.

Nor should you expect the ECtHR itself to be startlingly radical in relation to healthcare. Many European countries adopt a conservative approach to health-care rights. For example, in relation to fertility treatment and embryology, France restricts access to heterosexual couples where the woman is of normal childbearing age,¹⁴ and Italy enacted legislation radically curtailing options for fertility treatment and effectively giving the force of law to Roman Catholic doctrine.¹⁵ Be wary of arguments that English law violates the Convention where a consequence would be that other European countries are also in breach.¹⁶ Remember that as the supreme arbiter of the Convention, the ECtHR, is an international court with judges representing several jurisdictions.

How the Human Rights Act works¹⁷

2.3 Understanding how the HRA works is important to assess how the Act may affect healthcare law. The Act does not directly incorporate the Human Rights Convention. In a claim against a private litigant, the claimant cannot sue for violation of Convention rights. The Act, first, requires that primary and subordinate legislation be interpreted where possible in a way which is compatible with Convention rights¹⁸ and renders it ‘unlawful for a public authority to act in a way which is incompatible with a Convention right’.¹⁹

‘Convention rights’ are the fundamental rights and freedoms²⁰ set out in Articles 2 to 12 and 14 of the Convention, Articles 1 to 3 of the First Protocol (concerning rights to property, education and free elections) and Articles 1 and 2 of the sixth Protocol (abolishing the death penalty). Section 11 of the Act makes it crystal clear that Convention rights are in addition to, not in substitution for, rights and freedoms already endorsed at common law. It may seem odd that no express provision of the Act requires that judges develop the common law in a manner consistent with Convention rights. However, as noted above, English judges already, wherever possible, seek to ensure that the common law is consistent with such rights. More importantly, section 6 of the Act, which makes it unlawful for any public authority to act in a way incompatible with Convention rights, provides that courts are classified as public authorities. A judge hearing a patient’s claim must, by virtue of section 6, consider compatibility with Convention rights and ensure consistency between common law and Convention rights.

However, the domestic rules on precedent are unaffected. If a decision of the Court of Appeal contradicts a decision of the ECtHR, the Court of Appeal in subsequent cases is bound by its previous decision. Only a higher court, the Supreme Court in this example, could hold that the Court of Appeal case was wrongly decided on the basis that it conflicts with a decision in the ECtHR.²¹ For example, when Debbie Purdy argued that a lack of guidance on assisted suicide breached her rights under Article 8, the Court of Appeal²² held that they were bound by the House of Lords’ decision in Pretty²³ where it had been found that Article 8(1) was not engaged under these circumstances. This is despite the fact that, subsequently, the ECtHR found that Dianne Pretty’s Article 8(1) rights were engaged.²⁴ It was for the House of Lords (in their final decision before the Supreme Court was established) to ‘untie the knot’. In a landmark ruling, the Law Lords allowed Debbie Purdy’s appeal, so aligning domestic law with the Strasbourg jurisprudence.²⁵

Not only do the rules of precedent delay the application of Strasbourg rulings in domestic cases, section 2(1) of the HRA requires that domestic courts must ‘take into account’ ECtHR jurisprudence, not follow it slavishly. The court can provide reasons why a Strasbourg decision should not be followed where aspects of the domestic law were not fully appreciated.²⁶ The Supreme Court has also affirmed that it can look to the common law even if the jurisprudence of the European Court suggests a different interpretation of a Convention Article. In R (Osborn) v Parole Board,²⁷ the Supreme Court considered the relationship between domestic common law and Convention rights. Lord Reed made clear that Convention and common law are not distinct.²⁸ English law is and has long been permeated by human rights:

The importance of the [Convention] is unquestionable. It does not however supersede the protection of human rights under the common law or statute, or create a discrete body of law based upon the judgments of the European court.²⁹

Where a dispute falls within the domain of a Convention Article, the solution does not ‘begin and end with the Strasbourg case law’.³⁰ Osborn is an important assertion of the primacy of the common law a source of human rights law.

Similarly, where a claim alleging violation of a Convention right involves legislation, section 3 of the Act requires any court or tribunal to seek to interpret that rule in a way which is compatible with the relevant Convention right. However, if such an interpretation is not possible, the courts are not granted powers to strike down legislation. The judicial role remains limited by doctrines of parliamentary sovereignty.³¹ Section 4(2) provides that:

If the court is satisfied that the provision is incompatible with a Convention right, it may make a declaration of that incompatibility.

The government should then act to amend legislation to ‘cure’ the relevant incompatibility. Section 10 enables them to do so by secondary legislation making a ‘remedial order’. Failure to act to remove the stated incompatibility would give rise to a claim against the United Kingdom before the ECtHR at Strasbourg. The dissatisfied patient could bring another claim suing the government itself.

This can be illustrated by considering a controversial provision of the Human Fertilisation and Embryology Act 1990, which was the subject of a declaration of incompatibility. Section 28(6)(b) of the Act prior to its amendment by the Human Fertilisation and Embryology Act 2008 provided that if the sperm of any man was used after his death, he was not to be treated as the father of the child. Diane Blood³² fought a long battle to be able to undergo insemination with her deceased husband’s sperm. She ultimately gave birth to two sons after fertility treatment abroad. Section 28(6)(b) meant that the boys’ birth certificates recorded the father as ‘unknown’. Mrs Blood and her sons succeeded in their contention that the Act violated their rights to respect for private and family life endorsed by Article 8 and, in response, Parliament enacted the Human Fertilisation and Embryology (Deceased Fathers) Act 2003.³³ The 2003 Act is now repealed but the 1990 Act has been amended to the same effect.³⁴

For the healthcare professional, the most crucial element of the Act is the provision that ‘Convention rights’ are directly enforceable against public authorities, and that an individual who considers that her rights have been violated by a public authority can sue for damages. Where an individual considers that a public authority has acted in breach of Convention rights, a number of rather different outcomes must be considered. First, in many cases, the self-same rights conferred by the Convention are already recognised by the law of torts. For example, Article 5 provides for a right to liberty and security and protects the citizen against arbitrary detention. The ancient tort of false imprisonment protects that same fundamental interest. A patient alleging unlawful detention in hospital may not need to resort to claiming a breach of Article 5. He can sue in false imprisonment. In determining whether his detention was lawful, the court will be mindful of the provisions of Article 5 and the jurisprudence of the ECtHR.

The position is more complex when a Convention right is not so well established in domestic law. Privacy was not, though the common law is developing rapidly. The claimant might then choose to bring his claim directly under the Act alleging breach of Article 8, which requires respect for private and family life. If he elects for a Convention remedy alone, he can sue under the Act only if the defendant is a public authority. Were we to discover that the Department of Health was bugging our offices, suing a government department would be straightforward. What if a tabloid newspaper splashed our medical history all over its front page? There is an argument that the newspaper, too, might be classified as a public authority, for section 6(3)(b) classifies as a public authority ‘any person certain of whose functions are functions of a public nature’.³⁵

Suppose, however, a private individual, a colleague, for example, invades our privacy by steaming open our private correspondence and finds letters from our doctors revealing an embarrassing medical complaint. What then? In practical terms, often some common law remedy may be found within which to frame a cause of action. The ‘snooper’ who peers through windows or opens our mail could be liable for harassment, or trespass to goods. If no common law remedy can be identified so that the defendant appears to be immune from liability, Article 6 of the Convention comes into play. Article 6 grants a right that, in determination of his civil rights and obligations, everyone is entitled to a fair trial. It grants a right of access to justice. If no remedy for violation of Article 8 (right to privacy) appears to exist, the court must in effect develop a remedy,³⁶ or the court acts unlawfully in failing to implement Article 8. And the government is in breach of the Convention in failing to provide a legal remedy, violating the citizen’s right to access to justice.

Article 6 will affect the development of the English law in two ways. Relatively rarely, Article 6 will come into play because the common law offers no remedy for violation of a Convention right. More commonly, the Article will be invoked in order to overcome some restriction on the claimant’s common law right. For example, in one case, the High Court ruled that there was a breach of Article 6(1) when a 14-year-old witness was called upon at short notice and without legal representation to consent to the disclosure of her medical records as evidence in a sexual abuse case.³⁷ The High Court held that the child’s right to privacy under Article 8(1) had been breached.

Who can be sued?

2.4 As we have seen, the Act does not define public authority. Section 6(3) provides that public authority includes: (a) a court or tribunal, and (b) any person certain of whose functions are of a public nature. What does this mean for the NHS? National Health Service trusts, including Clinical Commissioning Groups are public authorities. So are bodies such as NHS Research Ethics Committees. ‘Quangos’ such as the Care Quality Commission are equally clearly public authorities, as are regulatory bodies such as the General Medical Council (GMC). Individual health professionals, doctors and nurses working within the NHS, are performing functions of a public nature and face potential claims under the Act (although normally such claims would be brought against their employer). GPs and other non-employed NHS personnel might be more directly in the firing line. Professionals in private practice and private hospitals raise tricky questions. While a doctor is a public authority in relation to their NHS functions, the same does not apply to doctors in private practice. So if patient A contracts with Dr B to carry out surgery at Clinic C paying out of his own pocket, or via private health insurers, the relationship is entirely private. However, if patient A later sues Dr B or Clinic C, in determining the nature of his redress, the court must seek to develop the common law consistently with the Convention on Human Rights. If this is not possible, patient A may have redress against the government under Article 6 for violating his right to a fair trial to determine his civil rights and obligations.

Do private clinics treating NHS patients perform functions of a public nature? They will not be regarded as ‘core’ public authorities under section 6, but might they be viewed as ‘hybrid bodies’ under section 6(3)(b)? As we have seen, under section 6(3)(b) a public authority includes ‘any person certain of whose functions are functions of a public nature’. However, section 6(5) provides that: ‘In relation to a particular act, a person is not a public authority … if the nature of the act is private’. The test therefore, relates to the particular act of which complaint is made.³⁸ The ECtHR has held, for example, that by delegating responsibilities to private schools, the UK government cannot escape liability under the Convention.³⁹ The question is whether the act is a private act, or the discharge of a public function?⁴⁰

It was held in R (Heather) v Leonard Cheshire Foundation (Cheshire)⁴¹ that a charity responsible for providing a home and care for a number of disabled people paid for by the local authority was neither a ‘core’ nor a ‘hybrid’ public authority for the purposes of the HRA. It was created by private individuals. It was not obliged to accept publicly funded residents, nor was it closely regulated by the state.⁴²

In 2007, the House of Lords went further still in YL v Birmingham City Council.⁴³ The Law Lords held (Lord Bingham and Baroness Hale dissenting)⁴⁴ that a private care home was not performing functions of a public nature even though the care of the patient had been arranged by the local authority. Mrs YL was an 84-year-old patient with Alzheimer’s. The state had a statutory duty to provide care for her. Because they contracted with a private sector provider, Mrs YL lacked the protections of the Convention when the care home threatened to evict her.

The resulting injustice was partially resolved when section 145 of the Health and Social Care Act 2008 effectively reversed the ruling. Accordingly, private care homes providing services arranged by local authorities under the National Assistance Act 1948 fell within section 6 of the HRA. But the 2008 Act did not resolve the situation regarding care services that fell outside the National Assistance Act 1948.⁴⁵ An amendment to the Care Act 2014,⁴⁶ introduced during parliamentary ‘ping-pong’,⁴⁷ extends the application of the HRA to cover all care arranged by or paid for (directly or indirectly, and in whole or in part) by an authority.⁴⁸ Is the application of the Act to largely private arrangements, a step too far? We think not. The Francis Inquiry⁴⁹ serves as a stark reminder of the need to ensure that all people subjected to poor standards of care, regardless of how it is funded, are able to assert their human rights.

Who can sue?

2.5 Only a person who is a ‘victim’ of the alleged violation of the Convention can bring a claim under the 1998 Act. The concept of victim derives from the Convention and jurisprudence of the ECtHR. A victim must be actually and directly affected by the act or omission which is the subject of the complaint. There is no direct provision for interest groups to sue to vindicate Convention rights.

What does this mean in practice? Obviously a claimant who is detained in hospital against her will, can ground a claim on Article 5 (although a claim in false imprisonment may suffice).⁵⁰ A person who alleges that he has been experimented on without consent may have a claim under Article 3 (prohibiting inhuman or degrading treatment) or Article 8.⁵¹ However it may be difficult for individuals to fund claims about important principles. Interest groups will want to use the Convention to challenge and change existing law (for example, the ban on voluntary euthanasia). Will they be able to do so, given interest groups cannot sue as groups? It is not necessary to show that a claimant has actually already suffered from the consequences of an alleged violation. ‘Victims’ need only show a real risk of being directly affected by a breach. Gay men in Northern Ireland were allowed to challenge laws criminalising all homosexual conduct.⁵² Abortion centre counsellors acting with women wishing to receive advice successfully challenged Irish laws prohibiting dissemination of any information about abortion.⁵³ Representative interest groups involving groups of victims are able to gain standing under the Act.

Convention rights

2.6 Reference will be made to relevant Convention rights throughout the chapters that follow. All that we do now is give a brief overview of those Convention rights that are likely to have the most significant impact in the rights and obligations of doctors and patients in England.⁵⁴

Article 2

2.7 Article 2 provides that ‘Everyone’s right to life shall be protected by law’. Gross failures to provide care that result in the patient’s death may breach Article 2.⁵⁵ It might also be invoked to challenge a number of entrenched principles of English law. Consider the following questions. Could a patient whose life (health) is endangered by refusal of treatment (for example denied expensive chemotherapy) use Article 2 to obtain a court order demanding that he be given priority in treatment?⁵⁶ Article 2 imposes on the state a positive obligation to intervene to protect people whose lives are at real and immediate risk.⁵⁷ In Savage, the House of Lords made a preliminary ruling concerning a mentally ill patient who absconded from a hospital where he was compulsorily detained. It was held that actual or constructive knowledge of a patient’s risk of self harm could breach Article 2 if the trust failed to do all that could reasonably be expected to avoid the risk.⁵⁸ In the subsequent trial⁵⁹ it was held that the trust had breached its positive obligation under Article 2 when the patient went on to commit suicide.

In 2012, the positive obligation was extended in the case of Rabone v Pennine Care NHS FT.⁶⁰ The Supreme Court allowed an appeal by the parents of a psychiatric patient who was informally admitted to hospital after trying to commit suicide and was assessed as being at risk of further suicide attempts. Twenty-four-year old Melanie Rabone had been permitted to take home leave, whereupon she committed suicide. Her parents claimed that she should not have been allowed home⁶¹ and that the trust was responsible for Miss Rabone’s death. The Court of Appeal, however, made a distinction between involuntary and voluntary patients, holding that the operational duty did not apply in the latter case. The Supreme Court, allowing the appeal, held that there was a real risk of suicide and that ‘the difference between her position and that of a hypothetical detained psychiatric patient … [was] one of form, not substance’.⁶² The parents recovered damages of £5,000 each for non-pecuniary loss.

Thus, Article 2 is likely to be engaged in cases where death has or may have been caused by a lack of adequate systems to protect the lives of psychiatric patients, whether formally or informally admitted to hospital. The ECtHR held in P v UK, that it is unlikely to apply in non-fatal cases, even if there is a high risk of suicide.⁶³ In this case there was disagreement as to the correct diagnosis of a young man who persistently self-harmed. As a result of criminal activity he was detained in a young offenders’ institution and eventually moved to a psychiatric institution whereupon his representatives sought a review of what had occurred and sought damages for breach of (inter alia) Article 2. The Strasbourg Court found that Article 2 was not engaged: there was no imminent risk to life. In such cases, as we shall see in Chapter 7, patients or their relatives may sue in negligence.

Does the positive obligation under Article 2 extend to situations in which a person objects to the treatment needed to save his life? In Nottinghamshire Healthcare NHS Trust v RC,⁶⁴ Mostyn J reasserted the right of those with mental capacity to choose to harm or kill themselves. A Jehovah’s Witness with a history of self-harm was admitted to a psychiatric hospital having cut the brachial artery in his arm. He made repeated attempts to reopen the wound and signed an advance directive⁶⁵ withholding consent to blood products, even if his life was at risk. Mostyn J quoted John Stuart Mill’s essay On Liberty:

That the only purpose for which power can be rightfully exercised over any member of a civilised community, against his will, is to prevent harm to others. His own good, either physical or moral, is not a sufficient warrant … Over himself, over his body and mind, the individual is sovereign.⁶⁶

Mostyn J found that RC had capacity to refuse blood products.⁶⁷ There is a duty on public authorities to give effect to the right to life of persons under state control, but provided a patient has capacity, he retains the right to ‘opt-out of the right to life granted to him by Article 2’.⁶⁸

What limits may or must be placed on the right to life? When does such a right crystallise? Is it an absolute right entitling the patient to any possible treatment? How are competing rights of other patients to be addressed? Remember that such a right would necessarily impose an obligation to provide publicly funded care. The ECtHR has made it clear that where protection from disease requires use of state resources, individual countries are left considerable freedom to assess their own aims and priorities.⁶⁹

Article 2 will also affect legal issues surrounding allowing patients to die. It was suggested that Article 2 might render decisions that it is lawful to withhold/withdraw treatment in certain circumstances unlawful, in particular that Article 2 might alter the law on withdrawing artificial nutrition and hydration from patients in a persistent vegetative state.⁷⁰ However, in NHS Trust A v M, NHS Trust B v H,⁷¹ the then President of the Family Division (Elizabeth Butler Sloss P) has ruled that Article 2 does not impose an obligation to prolong life in such cases.

Finally, could Article 2 affect laws permitting abortion or case law denying fetuses any legal personality?⁷² Refusing to strike down national abortion laws, the European Commission has not applied Article 2 to fetuses in the first trimester of pregnancy.⁷³ In Vo v France⁷⁴ the ECtHR confirmed that the question of when a right of life accrued fell within the margin of appreciation allowed to contracting states. And in A, B and C v Ireland⁷⁵ the European Court found that the Republic of Ireland violated the Convention by failing to implement the existing constitutional right to abortion when a woman’s life is at risk.

Article 3

2.8 Article 3 provides that ‘No one shall be subjected to torture or inhuman or degrading treatment or punishment’. It has been suggested that this could be used to challenge failure to provide treatment or poor quality treatment. Does being left on a trolley constitute degrading treatment? It seems unlikely.⁷⁶ More disturbing cases, such as the appalling standards of care and resulting morbidity and mortality at Mid Staffordshire NHS Foundation Trust;⁷⁷ neglect in care homes reported in 2011 by the Equality and Human Rights Commission; and severe mistreatment of residents of Winterbourne View hospital revealed by the BBC Panorama programme in 2011,⁷⁸ might.⁷⁹

Are laws prohibiting voluntary euthanasia contrary to Article 3? An argument might run linking Articles 3 and 8. The case could be put, for example, that a patient dying of some terrible degenerative disease or suffering acute pain from terminal cancer was, by being denied the option of active euthanasia, subjected to inhuman and degrading treatment, contrary to Article 3. Moreover, if her doctor, or some other third party, was willing to help her die, preventing them from doing so might violate her privacy contrary to Article 8. We shall see that when Dianne Pretty,⁸⁰ a woman dying of motor neurone disease, sought to invoke Article 3 and 8 to support her claim that her husband should be granted immunity from prosecution if he helped her to commit suicide, her claim failed. The House of Lords refused to interpret Article 3 to affirm a right to die with dignity. Her further appeal to the Strasbourg Court also failed.⁸¹ Nor can Article 3 be relied upon to compel doctors to continue futile or inappropriate treatment. Leslie Burke, who suffered from a degenerative neurological condition, cerebellar ataxia, fought for the right to artificial nutrition and hydration in the event that he is unable to voice his wishes. He unsuccessfully sought to invoke Articles 2, 3, 8 and 14 to challenge guidance from the GMC which stated that where a patient’s disease is severe and the prognosis poor, artificial nutrition and hydration will not always be appropriate, even if death is not imminent.⁸² The Court of Appeal and the ECtHR turned his claim down.⁸³ Doctors cannot be forced to administer treatment which they believe to be clinically unnecessary, futile or inappropriate.

Article 3 will raise other questions about our existing common law. Might certain forms of non-consensual treatment fall foul of Article 3?⁸⁴ Consider cases relating to feeding anorexic patients.⁸⁵ What effect might Article 3 have on principles relating to consent to clinical research and research involving patients incapable of giving consent? And how far does Article 3 impose obligations on healthcare professionals to intervene in order to prevent harm caused by other individuals in the case of abuse or neglect?⁸⁶

Article 5

2.9 The relevant parts of Article 5(1) provide:

Everyone has the right to liberty and security of person. No one shall be deprived of his liberty save in the following cases and in accordance with a procedure prescribed by law …

(e)  the lawful detention of persons for the prevention of the spreading of infectious diseases, or persons of unsound mind, alcoholics or drug addicts or vagrants.

The common law tort of false imprisonment already gives protection to the liberty and security of persons. A lacuna in mental health law came to light in R v Bournewood Community and Mental Health Trust ex p L.⁸⁷ L was a 49-year-old man who had autism and lacked capacity. He was an in-patient at Bournewood Hospital but was not detained under the provisions of the Mental Health Act 1983. Instead he was detained in his best interests, under the common law doctrine of necessity.⁸⁸ The High Court held that L’s detention was lawful and proper. But the case was successfully challenged in the ECtHR in HL v United Kingdom:⁸⁹ detention under the common law was arbitrary and lacked sufficient safeguards. It was incompatible with Article 5. A change to the Mental Capacity Act 2005 was introduced in the Mental Health Act 2007, closing the ‘Bournewood gap’ and introducing (in 2009) Deprivation of Liberty Safeguards (DoLS).⁹⁰

The safeguards apply to people over the age of 18 who lack capacity to make decisions about their care, have a mental health condition and are in hospital, a care home or supported living arranged by the local authority. A deprivation of liberty, defined by reference to Article 5,⁹¹ can be authorised by either the NHS and adult care services or the Court of Protection.

DoLS have proved controversial. The bureaucratic process and poor understanding led, at first, to underuse of the safeguards. In 2014, the Supreme Court in P v Cheshire West and Chester Council,⁹² after an extensive analysis of the jurisprudence of the ECtHR, ruled that a deprivation of liberty occurs whenever a person who lacks capacity is subject to continuous control and lacks the option to leave. This is so even if the individual does not object and the restriction is ‘normal’ for their level of disability. Unsurprisingly, the decision led to a huge rise in applications.⁹³ In 2015, the Law Commission consulted on proposals for wholesale change.⁹⁴ If their recommendations are accepted, a new ‘protective care’ scheme will replace the maligned DoLS.

Article 6

2.10 Article 6 provides that:

In the determination of his civil rights or obligations or of any criminal charge against him, everyone is entitled to a fair and public hearing within a reasonable time by an independent and impartial tribunal established by law.

Article 6 incorporates a right to bring a civil case to court. As we shall see in Chapter 8, the scope of legal aid in clinical negligence cases was vastly reduced in the Legal Aid, Sentencing and Punishment of Offenders Act 2012 (LASPO). Does this have potential to breach Article 6? It is unlikely: section 10 of LAPSO operates as a ‘human rights safety net’ allowing funding in exceptional cases, though its limitations have led to sharp criticism.⁹⁵

Article 6 also demands that proceedings are conducted fairly. In Kulkarni,⁹⁶ Smith LJ said (obiter) that Article 6 was engaged when a doctor faced disciplinary proceedings. The proceedings constituted exceptional circumstances because they were equivalent to a criminal charge. The doctor was therefore entitled to legal representation. However, in Mattu,⁹⁷ an NHS trust’s disciplinary action against a doctor did not engage his Article 6 right to a fair hearing. Stanley Burton LJ in the Court of Appeal held that the disciplinary proceedings involved the employer exercising a contractual power rather than the determination of a civil right within the meaning of Article 6. In essence, while the right to continue one’s profession is a civil right engaging Article 6, the disciplinary action Dr Mattu faced did not affect his registration with the GMC. Though he might find it more difficult to practise, the disciplinary proceedings did not bar Dr Mattu from so doing.

Article 8

2.11 Article 8 has had far-reaching effects. Article 8(1) provides: ‘Everyone has the right to respect for his private and family life, his home and his correspondence’. Note the wording, the right is a right to respect. Does that connote an absolute claim to privacy? As with Article 2, the question arises of what kind of obligations Article 8 creates. Does it impose positive obligations on the state to act to promote a right to privacy or simply a duty not to interfere with privacy?⁹⁸ It is clear that some sort of positive obligation is imposed by Article 8. Then we have to consider how to define parameters of private and family life. Prohibition of contraception, for example, obviously constitutes an interference with that right – interfering with intimate relationships. However, does regulation of third parties involved in assisted conception fall into the same category? In some cases, one person’s right to private life may conflict with another’s right to family life. Imagine A tests positively for an inherited form of bowel cancer. A’s children have a one in four chance of inheriting the condition also, but A refuses to inform her estranged daughter of this possibility. Does respecting A’s privacy violate her daughter’s right to family life or her right to life under Article 2?

What is clear is that Article 8 is strongly influencing the development of medical law, as was recognised by Coleridge J in 2003:⁹⁹

The advent of the Human Rights Act 1998 has enhanced the responsibility of the court to positively protect the welfare of these patients and, in particular, to protect the patient’s right to respect for her private and family life under Art 8 (1) of the European Convention …

Article 8 has contributed to a gradual shift away from medical paternalism.¹⁰⁰ In Glass v United Kingdom,¹⁰¹ the Strasbourg Court held that a child’s rights under Article 8 were breached when he was given diamorphine against the wishes of his mother. Doctors believed the 12-year-old boy was dying and sought to administer the drug as a palliative measure. His mother disagreed and argued that diamorphine would diminish his chances of recovery. Doctors administered it nonetheless. They did not seek a court order, though they had ample time to do so. In these circumstances, their failure to secure a declaration from the court that such treatment was lawful contravened Article 8(1).¹⁰² Article 8(1) was also instrumental in a notable victory for Debbie Purdy who sought clarification of the Director for Public Prosecution’s guidance on prosecution in cases of assisted suicide. Not only were Debbie Purdy’s rights under Article 8(1) engaged, but the breach could not be justified under Article 8(2).¹⁰³ The DPP issued new guidelines in 2010.¹⁰⁴ As we shall see in Chapter 19, though the Supreme Court recently upheld the prohibition on assisted suicide in R (on the application of Nicklinson) v Ministry of Justice,¹⁰⁵ it did so with the caveat that Parliament should review the issue. The Assisted Dying Bill 2014–15 got further than previous Bills, but ultimately failed. The Assisted Dying Bill 2015–16 lacked the government support needed to make it law.

We will see in Chapter 4 that the common law duty of confidentiality has changed in terminology, if not in substance, to the extent that, in 2004, Lord Nicholls recommended that the tort should be renamed, the ‘misuse of private information’.¹⁰⁶ Could Article 8 be used to prevent certain information ever being sought from individuals? Article 8(2) graphically illustrates the qualified nature of certain Convention rights. It provides:

There shall be no interference by a public authority with the exercise of this right except such as is in accordance with the law and is necessary in a democratic society in the interests of national security, public safety or the economic well-being of the country, for the prevention of disorder or crime, for the protection of health or morals, or for the protection of the rights and freedoms of others.

Note the width of potential exceptions to Article 8(1). The jurisprudence of the European court illustrates both the complexity of Article 8 and judicial conservatism on its part of the ECHR. In Evans v United Kingdom,¹⁰⁷ the Grand Chamber held that the UK had not exceeded its margin of appreciation under Article 8(1) in relation to the requirement under the Human Fertilisation and Embryology Act 1990 that her partner’s consent be required to implant their embryo in her uterus. Natalie Evans and her partner stored the embryos after cancer treatment, but sadly their relationship ended and he refused consent to the implantation of the embryos.

Breach of Article 8(1) must be proportionate. Consider Szuluk v United Kingdom.¹⁰⁸ A prisoner with a severe neurological condition, complained that his confidentiality with regard to his medical correspondence had not been respected. A prison officer was able to read all his letters in order to ensure that he was not planning criminal activity. The ECtHR held that the breach of his rights was not justified under Article 8(2). Mr Szuluk should be allowed uninhibited contact with his medical practitioner. There was no danger that the letters would lead to criminal activity.

In 2010 three women alleged that Irish abortion laws breached their rights under Article 8. The law provides that abortion is unlawful except where the mother’s life is at risk.¹⁰⁹ The women sought to exercise their rights according to this law. Two of the women’s cases failed on the basis that their health rather than their lives were at risk. The third woman feared that her pregnancy posed a risk of a rare cancer returning. She complained that there was no effective legal procedure by which she could establish her right to abortion. The Court ruled in her favour.¹¹⁰ Ireland’s Protection of Life During Pregnancy Act 2013¹¹¹ makes limited concessions within the narrow confines of the eighth amendment of the Irish Constitution. Termination is sanctioned, under certain conditions, where the woman’s life would be in danger if the pregnancy goes to full term, or in cases where she is suicidal in such instances as rape or incest.¹¹²

Article 9

2.12 Article 9 protects religious freedom and conscience¹¹³ providing:

Everyone has the right to freedom of thought, conscience and religion; this right includes freedom to change his religion or belief and freedom, either alone or in community with others and in public or private, to manifest his religion or belief, in worship, teaching, practice and observance.

Freedom to manifest one’s religion or beliefs shall be subject only to such limitation as are prescribed by law and are necessary in a democratic society in the interests of public safety, for the protection of public order, health or morals, or for the protection of the rights and freedoms of others.

This has a bearing on medical treatment decisions in a number of ways.¹¹⁴ In Re J, ¹¹⁵ for example, the rights and freedoms of a non-practising Christian mother and the welfare of the child were balanced against a Muslim father’s wish to manifest his religion by having his son circumcised. The Court of Appeal held that a failure to sanction the operation did not offend his rights under Article 9.

As we shall see, English courts have on a number of occasions overruled parental objections to treatment of their children contrary to their faith.¹¹⁶ The classic example is where a court orders that a blood transfusion is given to a child of Jehovah’s Witness parents. The parents might argue that requiring that their child undergo a transfusion violates the family’s religious freedom and their right to respect for their family life (Article 8). Do the rights of the child, especially her right to life under Article 2, trump the parents’ claims?

Article 9 is a qualified right. In Chaplin, the ECtHR upheld a UK judgment preventing a nurse from wearing a crucifix. The restriction was necessary to protect the health and safety of patients.¹¹⁷ Article 9 protects doctors’ rights to conscientious objection and freedom of thought and religion. As we shall see at 13.15, section 4 of the Abortion Act 1967 provides that no person is under a duty ‘to participate in any treatment authorised by this Act to which he has a conscientious objection’.¹¹⁸ In Greater Glasgow and Clyde Health Board v Doogan¹¹⁹ two Roman Catholic midwives objected to having any involvement in the process of terminating pregnancy. Focusing on the statutory construction of section 4 rather than the ambit of Article 9, the Supreme Court distinguished hands-on roles in terminations from administrative dealings. The latter are not covered by the right to conscientious objection.

Article 10

2.13 Nor must Article 10 be overlooked. Article 10 guarantees freedom of expression, a right embracing freedom of the press. All too often Articles 8 and 10 conflict and the courts must embark on a delicate balancing exercise.¹²⁰

Article 12

2.14 Finally, Article 12 might be thought to guarantee a right to reproduce as it states that:

Men and women of marriageable age have the right to marry and found a family according to the national laws governing the exercise of that right.

Could Article 12 be used to challenge limitations on access to fertility treatment? It has been held by the Court of Appeal and the Strasbourg Court that Articles 8 and 12 were not infringed when a prisoner was refused the right to services which would enable the artificial insemination of his wife.¹²¹

Convention on Human Rights and Biomedicine

2.15 Patients’ rights are not centre-stage in the ECHR. To raise a question about patients’ rights, the relevant dispute must somehow be fitted into the pigeonhole of general rights. A further European convention, the ECHR and Biomedicine¹²² (the Bioethics Convention) directly addresses doctor–patient relationships. This Convention (agreed in 1997) by states party to the (main) Human Rights Convention has not been signed or ratified by the United Kingdom. We are not yet a party to that treaty. Even if and when the United Kingdom does ratify this Convention, it will not have direct force. A patient will not be able to sue for violation of a right granted by the Convention. Nor is there any right of individual petition to the ECtHR at Strasbourg. Nonetheless, articles of the Human Rights Convention may be interpreted with reference to the much fuller explanations and definitions of human rights offered in the Bioethics Convention.

NHS Constitution

2.16 Section 1 of the Health Act 2009 made provision for the NHS Constitution.¹²³ Published in 2009,¹²⁴ and updated in 2012, 2013 and 2015, it applies to the NHS in England. The Constitution covers principles, values, pledges, patient rights and responsibilities and staff rights and responsibilities. Patient rights focus on:

•  quality of care and environment;

•  respect, consent and confidentiality;

•  Informed choice;

•  involvement in your healthcare and in the NHS;

•  complaint and redress;

•  access to health services;

•  nationally approved treatments, drugs and programmes.¹²⁵

These key areas will be explored throughout this book, but we will turn to the last two in the next sections.

Access to healthcare¹²⁶

2.17 As we saw in Chapter 1, the reorganisation of the NHS in 2013 involved the transfer of most of the commissioning of NHS services to Clinical Commissioning Groups (CCGs).¹²⁷ They are under a duty to commission the services necessary to meet the reasonable requirements of the population.¹²⁸ There is flexibility within the legislative framework as to how they go about this, but CCGs must have regard to the needs to promote the NHS Constitution¹²⁹ and to reduce inequalities between patients with respect to their ability to access health services.¹³⁰ Crucially, they must also operate within their prescribed budget:¹³¹ tough resource allocation decisions result.

Provided a decision is made fairly and rationally, the ECtHR is reluctant to interfere with the rationing decisions of Member States.¹³² Article 3 might be invoked if the refusal of treatment constitutes ‘inhuman or degrading treatment’¹³³ and Article 14 if the decision discriminates on the ground of disability or age. It has been held that Article 8 does not impose a positive obligation to provide treatment.¹³⁴ In Condliff,¹³⁵ a patient sought a gastric band operation to address his morbid obesity. The trust’s policy, however, was to perform the procedure only when the patient’s body mass index was over 50. Mr Condliff therefore had to make an Individual Funding Request (IFR), which was denied. The trust’s decision was based on purely clinical factors. Social factors, including the adverse effect on his private and family life, were not considered relevant. Mr Condliff alleged that this policy breached his Article 8 rights. The Court of Appeal disagreed. Article 8 was not engaged and, even if it were, there were ‘legitimate equality reasons’ for the policy.¹³⁶ Mr Condliff subsequently made a second successful IFR based on relevant clinical factors.¹³⁷

If the ECHR fails to endorse a direct unequivocal right to healthcare, can we construct such a right from other sources? How are rationing decisions made in the NHS?

NICE

2.18 The Health and Social Care Act 2012 established an independent executive non-departmental public body called the National Institute for Health and Care Excellence (NICE).¹³⁸ This replaced the National Institute for Health and Clinical Excellence,¹³⁹ and expanded its remit to incorporate social care.¹⁴⁰ The functions of NICE are now set out in legislation.¹⁴¹ The Institute’s primary role is to provide health and social care professionals with national guidance, advice and standards on providing care.¹⁴² Compliance rates feed into measures designed to monitor and improve outcomes. NICE makes an independent consideration of the evidence and recommends how to proceed. The Institute is best known for its ‘technology appraisals’: assessments of the effectiveness of (mainly) new technologies, such as medicines, procedures and diagnostics. These assessments oblige the NHS to fund the recommended treatments and medicines.¹⁴³ This is reinforced in the NHS Constitution as a patient right.¹⁴⁴

NICE currently makes technology appraisals on the basis of the cost per quality adjusted life year (QALY). One QALY is equal to a year of optimal health. A calculation is made based on the estimated QALYs a person will have following a particular procedure or treatment and the likely cost per QALY.¹⁴⁵ QALYs have equal value, regardless of the nature of the problem they are designed to treat.

Where the cost per QALY gained is over £30,000, a strong case must be made for funding.¹⁴⁶ Where the cost per QALY is between £20,000 and £30,000, the Institute sets out a list of factors that must be taken into account,¹⁴⁷ including consideration of certain non-health factors, and special consideration for life-extending treatment at the end of life.¹⁴⁸ This goes some way towards addressing the problems which flow from the subjectivity of the QALY assessment and the prioritisation of population health over the worst off.¹⁴⁹ Critics argue that the technology appraisals focus too heavily on cost¹⁵⁰ (rather than clinical) effectiveness.¹⁵¹

The media react sharply when NICE fails to approve a new medicine.¹⁵² Equally, a recommendation can put additional stress on the strained resources of providers. Since 2002, NHS organisations are required, normally within three months, to fund treatments recommended by NICE in its technology guidance. A person aggrieved by a technology appraisal can bring an appeal on grounds that:

in making the assessment that preceded the recommendation, NICE:

(i)  failed to act fairly, or

(ii)  exceeded its powers; or

(b)  the recommendation is unreasonable in the light of the evidence submitted to NICE.¹⁵³

Appeals have been lodged against a significant proportion of technology appraisals. NICE’s decisions are also subject to judicial review.¹⁵⁴ For example, in Eisai Ltd v National Institute for Health and Clinical Excellence¹⁵⁵ the manufacturer of an Alzheimer’s drug complained that the drug should be extended to mild sufferers of the disease. It was held that NICE acted unfairly in failing to make a full version of their economic model available during the appraisal process.¹⁵⁶

Though most of the guidance published by NICE is not mandatory, there is a public law obligation to make rational decisions. In Rose it was held that a CCG which declined to offer treatment recommended by NICE must justify their policy as a rational exception to the guidance.¹⁵⁷ The CCG cannot refuse treatment simply because it disagrees with the evidence base set out by NICE. Elizabeth Rose was 25 and required treatment for Crohn’s disease which might leave her infertile. NICE had issued guidance in 2004 recommending oocyte cryopreservation treatment, but the CCG declined to offer the procedure in light of evidence that the success rate is low. The High Court did not quash the refusal of treatment, but did rule that the CCG’s general policy of denying funding for oocyte cryopreservation was unlawful. General policies which conflict with NICE guidance will need careful justification in future.

A review of NICE in 2015 considered the affordability and impact of NICE decisions at a time of limited resources and increased demand.¹⁵⁸ Recommendations focused on reducing overlap and costs, raising awareness and improving communication. The review recommended that the functions of NICE continue and that it retains the status of non-departmental public body. The future of NICE seems secure but an Accelerated Access Review¹⁵⁹ seeks to speed up access to transformative health technologies.

Challenging NHS resource allocation decisions¹⁶⁰

2.19 In the domestic courts, early attempts to challenge decisions about access to healthcare met little success. In 1979, four patients who had spent long periods vainly awaiting hip-replacement surgery went to court alleging that the minister had failed in his duty (then imposed by the National Health Service Act 1977) to promote a comprehensive health service and to provide hospital accommodation and facilities for orthopaedic surgery. The patients alleged: (1) that their period on the waiting list was longer than was medically advisable, and (2) that their wait resulted from a shortage of facilities, caused in part by a decision not to build a new hospital block on the grounds of cost. The patients asked for an order compelling the minister to act, and for compensation for their pain and suffering. The Court of Appeal¹⁶¹ held that: (a) the financial constraints to which the minister was subject had to be considered in assessing what amounts to reasonable requirements for hospital and medical services; (b) the decision as to what was required was for the minister, and the court could intervene only where a minister acted utterly unreasonably so as to frustrate the policy of the Act. An individual patient could not claim damages from the minister for pain and suffering. The patients lost the immediate legal battle. They gained valuable publicity. And the courts did not entirely abdicate control over the minister. A public-spirited patient resigned to getting no damages himself, could (by way of an application for judicial review) still challenge a minister whom he alleges had totally subverted the health service (for example, a minister using his position and powers exclusively to benefit private medicine at the expense of the NHS).¹⁶²

The Court of Appeal rejected any legally enforceable right to healthcare actionable by a patient for his own benefit. Did any such right exist against local health providers? In 1987, the parents of two sick babies who needed cardiac surgery sought to enforce such a right on their sons’ behalf. They applied to the Divisional Court for a court order that their sons be operated on. The health authority explained that lack of resources and lack of trained nurses meant that each baby kept missing out on his operation to other more urgent cases. The court refused to make an order that the operation be carried out immediately.¹⁶³ The parents had no right to demand immediate treatment for their sons. The health authority could do only what was reasonable within their limited resources, human and financial. It is difficult to see what else the court could have done in these cases. The court could not provide the resources needed to operate on all sick babies. In effect, the judges were being asked to decide that baby X needed surgery more urgently than baby Y, and judges are not qualified to make clinical judgements.

In R v Cambridge District Health Authority ex p B,¹⁶⁴ the Court of Appeal again demonstrated reluctance to become involved in questions of allocation of resources. B was a 10-year-old girl suffering from non-Hodgkin’s lymphoma. In 1994, she received a bone marrow transplant from her sister. In 1995, she became ill again. The doctors treating her considered no further treatment should be given to prolong B’s life. B’s father obtained advice that there was a possible course of treatment. With further intensive chemotherapy, B stood a 10 per cent to 20 per cent chance of remission sufficient to allow a second bone marrow transplant to succeed. The transplant itself stood a 10 per cent to 20 per cent chance of success, offering B at best a 4 per cent chance of ‘recovery’. The treatment package would cost about £75,000. The health authority refused to fund B’s treatment. They argued: (1) that such ‘experimental’ treatment was not in B’s best interests; and (2) that given the minimal prospects of successful treatment the cost could not be justified. Other demands on the limited budget took priority.

The trial judge, Laws J, was not convinced by the authority’s case. He issued an order requiring the authority to reconsider the evidence in support of their decision not to treat B. They must do more than ‘merely toll the bell of tight resources’.¹⁶⁵ The authority appealed. The Court of Appeal backed them unequivocally, rejecting Laws J’s attempt to require greater transparency in decisions about allocating resources. The appeal court rested its decision largely on clinical grounds, on evidence from the doctors that the aggressive treatment proposed was not in B’s interests, despite the contrary view of B’s father and the child herself. Sir Thomas Bingham MR summed up judicial attitudes to problems in allocation of healthcare resources when he commented:

Difficult and agonising judgements have to be made as to how a limited budget is best allocated to the maximum advantage of the maximum of patients. That is not a judgement which the court can make. In my judgement, it is not something that a health authority can be fairly criticised for not advancing before the court.¹⁶⁶

So when will the courts intervene to question decisions about whom to treat, or what treatment patients may be entitled to? Judges do assert the power to assess the reasonableness of decision-making by NHS authorities, just as they will hold other public bodies to account for the reasonableness of their decision-making processes. In R v St Mary’s Hospital Ethical Committee ex p Harriott,¹⁶⁷ Mrs Harriott had been refused treatment by the IVF unit. The unit’s informal ethical advisory committee had supported the doctors’ decision not to treat Mrs Harriott because she had been rejected by the local social services department as a potential adoptive or foster mother and because she had convictions for prostitution offences. She challenged their decision. The judge held that the grounds for refusing her treatment were lawful. But he said refusal of treatment on non-medical grounds could be reviewed by a court. It would be unlawful to reject a patient because of her race or religion or other irrelevant grounds. A patient denied renal dialysis or surgery because the consultant in charge refuses to treat divorced people, or Labour Party members, might well have a remedy. However, judges, it must be remembered, tend to be conservative. In R v Sheffield Health Authority ex p Seale,¹⁶⁸ the judge refused to interfere with the health authority’s decision to refuse fertility treatment to older women, defined as any woman over 35.

Successful challenges to decisions about provision of healthcare often depend on the patient identifying some obvious flaw in the decision-making process.¹⁶⁹ In R v North Derbyshire Health Authority ex p Fisher,¹⁷⁰ the health authority refused to fund the costly drug beta-interferon for any patient with multiple sclerosis. They operated a blanket ban on provision of the drug, failed to make any assessment of individual patients’ needs and ignored a circular from the Department of Health advising that serious consideration be given to providing beta-interferon to certain categories of patients with multiple sclerosis. The judge held that the authority failed to take a reasoned decision after consideration of all the relevant factors.

In Booker¹⁷¹ it was held that an insurance pay-out following a road traffic accident which enabled the claimant to purchase private care, did not absolve the NHS of its responsibility for providing a tetraplegic patient with nursing care. The decision was unlawful and irrational. The NHS Constitution provides that care is provided on the basis of clinical need. If the NHS wishes to recoup the costs of caring for a patient who is the victim of a tort, legislation is required.

A notable ‘victory’ for patients denied access to treatment is found in R v North West Lancashire Health Authority ex p A, D & G.¹⁷² The defendant health authority refused to pay for gender-reassignment surgery for the applicants. Such surgery was classified by the authority as a low priority along with cosmetic procedures such as facelifts or hair transplants. Transgender patients should be offered psychiatric and psychological services, but the authority would not ‘commission drug treatment or surgery that is intended to give patients the physical characteristics of the opposite gender’. Statements in the policy document about exceptional cases based on overwhelming clinical need made it abundantly clear that in reality such a case would never be conceded. No one would be a sufficiently exceptional case to qualify. The Court of Appeal quashed the decision to refuse treatment to the applicant as ‘irrational’. The authority had failed to evaluate the medical evidence relating to transsexuality. They paid lip-service to the notion that the applicant’s condition constituted illness, but dismissed forms of effective treatment without proper consideration. The authority did not:¹⁷³

in truth treat transsexualism as an illness, but as an attitude or state of mind which does not warrant medical treatment … [T]he ostensible provision that it makes for exceptions in individual cases and its manner of considering them amount effectively to the operation of a ‘blanket policy’ against funding treatment because it does not believe in such treatment.

However, in R (on the application of C) v Berkshire West PCT,¹⁷⁴ the Court of Appeal found that the trust’s decision not to offer breast augmentation for gender identity disorder was reasonable. C was born male and had started the gender reassignment process with hormone treatment. Breast augmentation did not fall within the trust’s definition of ‘core’ surgical procedures it would treat under its gender dysphoria policy. Nor did the trust consider C an exceptional case. While the court was sympathetic to C’s case, it did not consider the trust’s decision irrational.

Another patient victory, this time in relation to unlicensed drugs, occurred in R (Rogers) v Swindon NHS Primary Care Trust.¹⁷⁵ The Court of Appeal, overturning the High Court decision, held that Swindon Primary Care Trust’s funding policy for the (as yet) unlicensed drug, Herceptin, was irrational and unlawful. Herceptin was licensed for late-stage HE-II, an aggressive form of breast cancer. Ann Marie Rogers (the applicant) was in the early stage of the disease. Some trusts provided Herceptin in such cases, despite the fact that it was neither licensed nor approved by NICE. The Health Secretary, Patricia Hewitt, had previously announced that Herceptin, which costs £26,000 a course, should not be refused purely on grounds of cost. Trusts would still be able to refuse treatment where cost is a factor, but in this case, Swindon PCT had declared that cost was irrelevant to its decision. The court held that there was therefore no rational basis for refusing to treat Mrs Rogers. What then would provide a rational basis for refusal of unlicensed treatment? Resource availability, combined with clinical need and individual circumstances.

One option open to the court in cases where an irrational policy has led to treatment being refused, is to remit the case back to the commissioning body. The correctly applied procedure will not necessarily result in the patient being provided the treatment he seeks.¹⁷⁶ In other cases the application of a lawful, rational policy is irrational. R (Otley) v Barking and Dagenham NHS Primary Care Trust (PCT)¹⁷⁷ concerns one such example. Victoria Otley had purchased cancer treatment privately, because the drug was not licensed in England and Wales. The drug proved effective and she tolerated it well. She sought a further five cycles of the expensive drug, funded by her PCT. The policy was that the NHS body can refuse to fund treatment (taking into account financial restraints and the patient’s circumstances) unless the circumstances are exceptional. The PCT decided that Victoria Otley’s case should not be viewed as ‘exceptional’. This policy was approved as fair and rational. However, it was applied irrationally. The court held that, because there were no other treatment options, her case was indeed exceptional.

A similar finding was made in R (Ross) v West Sussex PCT¹⁷⁸ where the refusal of a trust to fund potentially life-saving cancer treatment was one which ‘no reasonable Trust could have made’. What constitutes ‘exceptional’ circumstances must necessarily be considered on a case-by-case basis. The courts have shown themselves prepared to scrutinise the process by which healthcare providers make decisions about what kinds of treatment they will provide and who will have access to such treatment.¹⁷⁹ However, if the healthcare provider can demonstrate that it has fully considered the case made to it, and addressed all the relevant considerations, but ultimately determined that other treatments and other claims must be given priority, courts remain unlikely to intervene.

NHS England is responsible for ensuring equality in access to and outcomes of healthcare, but decentralisation of budgets and commissioning freedom has the potential to result in regional inconsistencies. Generic commissioning policies aim to ensure fair and consistent decision-making across the board, but there will inevitably be further recourse to the courts.

Top-up treatment

2.20 What if patients want to buy treatment to ‘top up’ their NHS treatment? Will NHS treatment be withdrawn if the patient opts for parallel private treatment? Until 2008 this was the case. The issue came to the fore when cancer patients were refused drugs considered too expensive by the NHS and sought to obtain the drugs privately. Some patients could just about afford the extra drugs but not pay for all their care privately. In 2008 the Richards Report¹⁸⁰ made recommendations which were implemented in NHS guidance.¹⁸¹ Top-up payments were endorsed: ‘The NHS should continue to provide free of charge all care that the patient would have been entitled to had he or she not chosen to have additional private care’.¹⁸² In addition to this, patients can purchase private treatment which must be delivered separately to the NHS care.

The policy has been criticised. While the guidance stipulates that patients should not be charged for NHS care and private care should never be subsidised by NHS care, it will be difficult in practice to keep the two separate. Jackson warns that it may constitute a step towards the NHS being regarded as a core, basic service.¹⁸³ The media questioned whether it might signal the end of the NHS.¹⁸⁴ The arguments for top-up payments focus on patient choice and reluctant acceptance that tightening resources and an ageing population mean that the days of a comprehensive service that is free at the point of delivery are numbered.¹⁸⁵ In practice, doctors will find it difficult to judge precisely when to raise the possibility of privately funded treatment, especially if they practise private medicine and stand to profit if the patient pays for their top-up treatment.

Timely treatment

2.21 Quality treatment is timely treatment. Section 3(a) of the NHS Constitution states that patients:

have the right to access certain services commissioned by NHS bodies within maximum waiting times, or for the NHS to take all reasonable steps to offer a range of suitable alternative providers if this is not possible.

The NHS has obligations to provide treatment within a specified time-frame (at the time of writing, eighteen weeks for non-urgent referrals and two weeks for urgent cancer referrals). Waiting times data is collated by NHS England and this is used to monitor compliance with national standards.¹⁸⁶ The rules only apply to consultant-led treatment, so a patient needing a hearing test, for example, may have to wait longer. There are also exceptions where there are clinical reasons for delay (for example, obesity). In January 2016, the compliance rate was around 90 per cent.¹⁸⁷

Competition provides a disincentive to breach targets. Results are published and patients can choose their preferred provider. Where the eighteen-week target is not met, dissatisfied patients can access the NHS Complaints Procedure. If the delay is severe (more than fifty-two weeks), NHS England might also impose contractual penalties. The onus is on the patient to contact the provider and ask for alternative arrangements to be made – some patients will choose to accept the delay. Others may attempt to avoid delay by requesting treatment in another country within the European Economic Area.

Treatment abroad

¹⁸⁸

2.22 Pursuant to Article 49 of the EC Treaty, which prohibits restrictions on the freedom to provide services across borders within the Community, Article 22 of Regulation 1408/71¹⁸⁹ established the E112 form, which allowed EU nationals to travel to other Member States for treatment, at the cost of their Member State.

According to section 3(a) of the NHS Constitution:

You have the right, in certain circumstances, to go to other European Economic Area countries or Switzerland for treatment which would be available to you through your NHS commissioner.

A patient requiring a knee-replacement might be sent to Belgium or Germany rather than waiting in pain for months in the UK. But first he may require authorisation. Much publicity was given to the decision of the European Court of Justice¹⁹⁰ that if a patient living in one Member State of the European Union faced undue delay in receiving treatment in his home country, his state insurance system must be prepared to pay for him to have treatment in another Member State where treatment is available more speedily.

In R (Watts) v Bedford PCT and the Department of Health,¹⁹¹ a 74-year-old woman was informed by Bedford Primary Care Trust (PCT) that she would have to wait a year for a bilateral hip replacement. She applied to have the operation in France under the (since replaced) E112 scheme, but the PCT refused, and reduced her wait to four months. Mrs Watts, who was wheelchair-bound and in constant pain, went ahead with the operation in France, without the PCT’s authorisation. The PCT refused to reimburse her because four months was the ‘normal’ waiting time for a hip replacement. Did the ‘normal’ four month wait constitute ‘undue delay’?

The Court of Appeal referred the matter to the European Court of Justice,¹⁹² which held that when determining whether a proposed waiting time is acceptable, Member States must apply ‘an objective medical assessment of the clinical needs of the person concerned in the light of all of the factors characterising his medical condition’.¹⁹³ If patients wait longer than doctors advise, regardless of NHS targets, the NHS must refund the costs where patients pay for treatment elsewhere in Europe.

¹⁹⁴

Post-Watts, cross-border healthcare may be authorised at the discretion of the Secretary of State for Health, if treatment cannot be given without ‘undue delay’, which was left undefined, and will depend on the particular circumstances of the case. Today there are two routes to receiving care in another Member State. Since 2013, both are administered by NHS England on behalf of the Secretary of State. The first (‘S2’)¹⁹⁵ route covers direct arrangements between states for state-provided care. The patient might not have to pay anything up front, but all healthcare must be authorised in advance. The second (‘EU Directive on Cross-Border Healthcare’)¹⁹⁶ route also extends to private care. Patients must pay up front, but prior authorisation is only required in certain cases set out in legislation.

We move ever closer to a ‘European’ right to healthcare.

¹  [2015] UKSC 11. Discussed at 5.12.

²  Ibid, [75].

³  Rights of Children and Young Persons (Wales) Measure 2011, s 1.

⁴  On the relationship between the ECtHR and the ECHR note Opinion 2/13 Re EU Accession to the ECHR [2014] ECR I 2454 (18 December 2014).

⁵  R (Osborn) v Parole Board [2013] UKSC 61 [56], discussed at 2.3.

⁶  Lord Lester of Herne Hill QC, ‘European Court of Human Rights and the Human Rights Act: British Concerns’ (2012) 17(1) Judicial Review 1.

⁷  See D Maddox, ‘Scotland Exempt from Tories’ Human Rights Act Axe’ The Scotsman (2014) 2 October.

⁸  J Rozenberg, ‘Labour Plan to Shift Power Back to Courts: A Nudge in the Wrong Direction?’ (2014) Guardian, 5 June.

⁹  See Conservatives, Protecting Human Rights in the UK: The Conservatives’ Proposals for Changing Britain’s Human Rights Laws (October 2014).

¹⁰  Commission on a Bill of Rights, A UK Bill of Rights? – The Choice before Us (December 2012).

¹¹  See critique in H Fenwick, ‘Conservative Anti-HRA Rhetoric, the Bill of Rights “Solution” and the Role of the Bill of Rights Commission’ in R Masterman, ID Leigh, The United Kingdom’s Statutory Bill of Rights Constitutional and Comparative Perspectives (2013) Oxford University Press.

¹²  I Kennedy, A Grubb, Medical Law (3rd edn, 2000) Oxford University Press, p 3.

¹³  See A, B and C v Ireland [2010] ECHR 25579/05, discussed at 2.7 and 13.19.

¹⁴  C Cho, ‘Defining Parenthood: Assisted Reproduction in France’ (2011) 7 Yale Law Journal 19.

¹⁵  Statute on Assisted Reproduction (Law 40/2004), discussed in R Fenton, ‘Catholic Doctrine versus Women’s Rights: The New Italian Law on Assisted Reproduction’ (2006) 14 Medical Law Review 73. Though see Costa and Pavan v Italy Application No 54270/2010 (ECHR, 28 August 2012), discussed in S Biondi, ‘Access to Medical-Assisted Reproduction and PGD in Italian Law: A Deadly Blow to an Illiberal Statute? (2013) 21(3) Medical Law Review 474.

¹⁶  SH v Austria, Application No 57813/00 (ECHR 2011) discussed in S McGuinness, ‘Health, Human Rights and the Regulation of Reproductive Technologies in SH and Others v Austria’ (2013) 21(1) Medical Law Review 146.

¹⁷  An excellent introductory text to the Act is: J Wadham, H Mountfield, E Prochaska, C Brown, Blackstone’s Guide to the Human Rights Act 1998 (6th edn, 2011) Oxford University Press. And see the Equality and Human Rights Commission’s guidance for public bodies, Human Rights: Human Lives. A Guide to the Human Rights Act for Public Authorities (July 2014) (based on a Ministry of Justice Guide, 2006).

¹⁸  Human Rights Act 1998, s 3.

¹⁹  Ibid, ss 6–8.

²⁰  Ibid, s 7.

²¹  Kay v Lambeth London Borough Council, Price v Leeds City Council [2006] UKHL 10. Applied in Johnson v Havering London Borough Council and Secretary of State Affairs [2007] EWCA Civ 26. For analysis, see S Pattinson, ‘The Human Rights Act and the Doctrine of Precedent (2015) 35(1) Legal Studies 142.

²²  R (on the application of Purdy) v Director of Public Prosecutions [2009] EWCA Civ 92.

²³  R (Pretty) v DPP [2002] 1 AC 800, HL.

²⁴  Pretty v United Kingdom (Application No 2346/02) (2002) 35 EHRR 1.

²⁵  R (on the application of Purdy) v Director of Public Prosecutions [2009] UKHL 44.

²⁶  R v Horncastle [2009] UKSC 14.

²⁷  [2013] UKSC 61.

²⁸  Ibid, [54]–[63]; [101]–[113].

²⁹  Ibid, [57].

³⁰  Ibid, [63].

³¹  For an introductory account of how the Act works, see H Fenwick, G Phillipson, R Masterman, Judicial Reasoning under the Human Rights Act (2011) Cambridge University Press.

³²  R v Human Fertilisation and Embryology Authority, ex p Blood [1999] Fam 151. Mrs Blood brought an application for judicial review of s 28(6)(b) and the incompatibility of that provision with Convention rights was conceded; see JK Mason, GT Laurie, Mason and McCall Smith’s Law and Medical Ethics (9th edn, 2013) Oxford University Press, at 3.33, and see 12.15.

³³  And see the similar case of L v Human Fertilisation and Embryology Authority [2008] EWHC 2149 (Fam), discussed at 12.15.

³⁴  See now Human Fertilisation and Embryology Act 1990, ss 28(5) A–I.

³⁵  See 2.4.

³⁶  Campbell v Mirror Group Newspapers [2004] UKHL 22. But see Wainwright v Home Office [2003] UKHL 53 where the Court deferred any responsibility for the creation of a tort of privacy to Parliament.

³⁷  R (on the application of TB) v CPS and South Staffordshire Healthcare NHS Trust [2006] EWHC 1645 (Admin). See 4.9.

³⁸  See for example London and Quadrant Housing Trust v R (on the application of Weaver) and Equality and Human Rights Commission [2009] EWCA Civ 587.

³⁹  See Costello-Roberts v United Kingdom (1993) 19 EHRR 112, para 27.

⁴⁰  See Aston Cantlow Parish Church Council v Wallbank [2003] UKHL 37, per Lord Nicholls at para 16.

⁴¹  [2001] EWHC Admin 429.

⁴²  And see Aston Cantlow PCC v Wallbank [2003] UKHL 37 in which the House of Lords held that a parish church council was not a public authority.

⁴³  YL v Birmingham City Council [2007] UKHL 27.

⁴⁴  And see criticism of majority opinion: L Williams, ‘Contracting Out and “Functions of a Public Nature”’ (2008) 4 European Human Rights Law Review 524; and B Hale, ‘Dignity’ (2009) 31(2) Journal of Social Welfare and Family Law 101.

⁴⁵  For critique, see S Choudhry, ‘Children in “Care” after YL – The Ineffectiveness of Contract as a Means of Protecting the Vulnerable’ July (2013) Public Law 519.

⁴⁶  Section 73(2).

⁴⁷  The amendment was contentious. The Lords’ proposed amendment of the Bill to extend application of the HRA was defeated at the Commons Committee Stage. A new amendment, proposed by the Joint Commission on Human Rights, was initially rejected at the Commons at Report Stage.

⁴⁸  Though not to privately arranged and funded residential and domiciliary care.

⁴⁹  Discussed in Chapter 1.

⁵⁰  But see HL v United Kingdom (2005) 40 EHRR 32 and the Deprivation of Liberty Safeguards. See 2.9 and 6.11–6.12.

⁵¹  For a discussion of the application of Article 3 and 8 in this context, see R (on the application of B) v S [2005] EWHC 1936 (Admin), where a patient contested a decision by doctors that he lacked capacity to decide and could therefore be forced to undergo treatment in his best interests.

⁵²  Dudgeon v United Kingdom (1982) 4 EHRR 149.

⁵³  Open Door and Dublin Well Women v Ireland (1992) 15 ECHR 244.

⁵⁴  See T Murphy, Health and Human Rights (2011) Hart; E Wicks, Human Rights and Healthcare (2007) Hart.

⁵⁵  Mehmet Şentürk and Bekir Şentürk v Turkey (application no 13423/09), 19 March 2013 (ECtHR).

⁵⁶  This argument was raised in R v Swindon NHS PC Trust [2006] EWCA Civ 392 (see 2.19) but the court found that the policy of the PCT to refuse to fund the appellant with the breast-cancer drug, Herceptin, was irrational and therefore unlawful. Therefore it did not need to go on to consider whether the PCT breached Article 2 or Article 14 of the European Convention on Human Rights: at [83] per Sir Anthony Clarke MR.

⁵⁷  See Osman v United Kingdom (1998) 29 EHRR 245.

⁵⁸  Savage v South Essex Partnership NHS Foundation Trust [2008] UKHL 74.

⁵⁹  Savage v South Essex Partnership NHS Foundation Trust [2010] EWHC 285.

⁶⁰  [2012] UKSC 2. See J Varuhas, ‘Liability under the Human Rights Act 1998: The Duty to Protect Life, Indirect Victims and Damages’ (2012) 71(2) Cambridge Law Journal 263.

⁶¹  They claimed that she should have been denied home leave. There was no suggestion that Melanie Rabone ought to have been detained under the Mental Health Act.

⁶²  [2012] UKSC 2, [34] per Lord Dyson.

⁶³  P v UK (Application No 1529/10), ECtHR (2014) 58 EHRR SE.

⁶⁴  [2014] EWHC 1317 (COP).

⁶⁵  Properly witnessed, as required under ss 24–26 Mental Capacity Act 2005.

⁶⁶  [2014] EWHC 1317 (COP), [8] per Mostyn J.

⁶⁷  Ibid, [42].

⁶⁸  Ibid, [19] per Mostyn J. See 5.3.

⁶⁹  Osman v United Kingdom (1998) 29 EHRR 245.

⁷⁰  Airedale NHS Trust v Bland [1993] 1 All ER 821, HL.

⁷¹  [2001] 1 All ER 801. And see NHS v D [2000] 2 FCR 577.

⁷²  See 11.21.

⁷³  See Bruggeman and Scheuten v Federal Republic of Germany [1977] EHRR 24; Paton v BPAS [1981] 2 EHRR 408. See 13.16.

⁷⁴  [2004] ECHR 326. See 13.19.

⁷⁵  [2010] ECHR 2032. See 13.19.

⁷⁶  See R v North West Lancashire Health Authority ex p A, D & G [2000] 1 WLR 977, CA.

⁷⁷  In Z v United Kingdom (2001) 34 EHRR 97, neglect and abuse of four children and failure of the state to protect them was deemed capable of violating Article 3.

⁷⁸  See DH, Transforming Care: A National Response to Winterbourne View Hospital: Final Report (London, 2012).

⁷⁹  Equality and Human Rights Commission, Close to Home: An Inquiry into Older People and Human Rights in Home Care (2011), p 28.

⁸⁰  See R (on the application of Pretty) v DPP [2001] UKHL 61 (discussed at 19.6); and see Rodriguez v British Columbia A-G (1993) 82 BCLP (2d) 273.

⁸¹  Pretty v UK [2002] 2 FLR 45.

⁸²  GMC, Withholding and Withdrawing Life-Prolonging Treatments: Good Practice in Decision-Making (2002). Paragraph 16 provides: ‘Doctors must take account of patients’ preferences when providing treatment. However, where a patient wishes to have a treatment that – in the doctor’s considered view – is not clinically indicated, there is no ethical or legal obligation on the doctor to provide it’. The guidance has since been updated. See at 19.18.

⁸³  R (on the application of Burke) v GMC [2005] EWCA Civ 1003; Burke v UK [2006] Application No 19807/06.

⁸⁴  See Herczegfalvy v Austria (1992) 18 BMLR 48. See R (N) v M [2003] 1 WLR 562, CA.

⁸⁵  Re E (Medical Treatment: Anorexia) [2012] EWHC 1639 (COP), [126] per Jackson J.

⁸⁶  Note that the Care Act 2014, s 42 imposes a duty on local authorities to make enquiries where an adult is at risk of abuse or in need of care. Contrast with the Social Services and Well-being (Wales) Act 2014 and the Adult Support and Protection (Scotland) Act 2007 which also impose such a duty on healthcare professionals.

⁸⁷  [1998] 3 All ER 299, HL.

⁸⁸  F v West Berkshire Health Authority [1989] 2 A11 ER 545.

⁸⁹  (2005) 40 EHRR 32.

⁹⁰  Mental Capacity Act 2005, Schedule A1 and 1A.

⁹¹  Section 64(5) of the Mental Capacity Act states that: ‘In this Act, references to a deprivation of a person’s liberty have the same meaning as in article 5(1) of the Human Rights Convention’.

⁹²  P v Cheshire West and Chester Council and another; P and Q v Surrey County Council [2014] UKSC 19 (hereafter Cheshire West).

⁹³  See 6.12.

⁹⁴  Law Commission, Mental Capacity and Deprivation of Liberty Consultation Paper 222 (July 2015).

⁹⁵  For example, Mostyn J describes the ‘safety net’ as a ‘fig leaf’ in G and JG and JF and JFG [2015] EWHC 564 (Fam), [14]; and at [20] states: ‘[I]t can be said that in the field of private children law the principle of individual justice has had to be sacrificed on the altar of the public debt … [I]t can reasonably be predicted that the phenomenon of the massive increase in self-representation will give rise to the serious risk of the court reaching incorrect, and therefore unjust, decisions’.

⁹⁶  Kulkarni v Milton Keynes Hospital NHS Trust [2009] EWCA Civ 789.

⁹⁷  Mattu v University Hospitals of Coventry and Warwickshire NHS Trust [2012] EWCA Civ 641. Applying R (G) v The Governors of X School [2011] UKSC 30.

⁹⁸  See R v North West Lancashire Health Authority ex p A, D & G [2000] 1 WLR 977, CA.

⁹⁹  D v NHS Trust (Medical Treatment: Consent: Termination) [2003] EWHC (Fam) 2793, [31].

¹⁰⁰  See Montgomery v Lanarkshire [2015] UKSC 11, [80] per Lord Kerr and Lord Reed.

¹⁰¹  (2004) 1 FLR 1019.

¹⁰²  And see Re OT (A Baby) [2009] EWHC 635 (Fam), discussed at 14.10, 14.11.

¹⁰³  R (on the application of Purdy) v DPP [2009] UKHL 45.

¹⁰⁴  DPP, Policy for Prosecutors in respect of Cases of Encouraging or Assisting Suicide (2010).

¹⁰⁵  [2014] UKSC 38, per Lord Neuberger [76], [99]–[110]. The subsequent ECtHR case was dismissed but left the door open for further domestic challenges: Nicklinson and Lamb v the United Kingdom (Application Nos 2478/15 and 1787/15), ECtHR 16 July 2015.

¹⁰⁶  Campbell v MGN [2004] UKHL 22, [14]. And see R (on the application of Axon) v Secretary of State for Health (2006) EWHC 37.

¹⁰⁷  (6339/05), May 2 2007, ECtHR (Grand Chamber).

¹⁰⁸  [2009] ECHR 36936/05. See 4.4.

¹⁰⁹  Irish Constitution, s 40.3.3.

¹¹⁰  A, B and C v Ireland [2010] ECHR 2032.

¹¹¹  And see F de Londras, L Graham ‘Impossible Floodgates and Unworkable Analogies in the Irish Abortion Debate’ (2013) 3(3) Irish Journal of Legal Studies 4.

¹¹²  But see H MacDonald, ‘Ireland: Woman Forced to Give Birth by Caesarean after Being Denied Abortion’ Guardian (2014) 17 August.

¹¹³  For a full exploration of the role of conscience and the limits of conscientious refusal to participate in healthcare practices, see ‘Conscience and Proper Medical Treatment’, a special edition of Medical Law Review May (2015).

¹¹⁴  See J McHale, ‘Health and Health Care Law, Faith(s) and Beliefs: New Perspectives and Dilemmas’ 9(4) (2009) Medical Law International 279; M Fox, M Thomson, ‘Older Minors and Circumcision: Questioning the Limits of Religious Actions’ 9(4) (2009) Medical Law International 283; J McHale, ‘Health Care Choices, Faith and Belief in the Light of the Human Rights Act 1998: New Hope or Missed Opportunity’ (2009) 9(4) Medical Law International 331.

¹¹⁵  Re J (Child’s Religious Upbringing and Circumcision) [2000] 1 FLR 571 per Thorpe LJ, para 12. And see Re S (Specific Issue Order: Religion: Circumcision) [2004] EWHC 1282 (Fam). Female circumcision was prohibited in the UK under the Prohibition of Female Circumcision Act 1985 replaced by the Female Genital Mutilation Act 2003. See generally, AR Gatrad, A Sheikh, H Jacks, ‘Religious Circumcision and the Human Rights Act’ (2002) 86 Archives of Childhood Diseases 76.

¹¹⁶  See Re S (A Minor) (Medical Treatment) [1993] 1 FLR 376. See 14.9.

¹¹⁷  Eweida, Chaplin, Ladele and McFarlane v United Kingdom (2013) 57 EHRR 8. See discussion in I Leigh, A Hambler, ‘Religious Symbols, Conscience, and the Rights of Others’ (2014) 3(1) Oxford Journal of Law and Religion 2.

¹¹⁸  See NHS England Standard General Medical Services Contract (May 2014), para 9.7.1(c) ‘where the Contractor has a conscientious objection to the termination of pregnancy, prompt referral to another provider of primary medical services, who does not have such conscientious objections’; and see discussion of Greater Glasgow Health Board v Doogan [2014] UKSC 68 at 13.15.

¹¹⁹  [2014] UKSC 68.

¹²⁰  Graphically illustrated in Campbell v Mirror Group Newspapers [2004] UKHL 22.

¹²¹  R (on the application of Mellor) v Secretary of State for the Home Department (2001) EWCA Civ 472; Dickson v Premier Prison Service Ltd (2004) EWCA Civ 1477 and Dickson v United Kingdom, Application No 00044362/04 (ECHR, 2006). And see H Codd, ‘Regulating Reproduction: Prisoners’ Families, Artificial Insemination and Human Rights’ (2006) 1 European Human Rights Law Review 39.

¹²²  See HDC Roscam Abbing, EH Hondius, JH Hubben (eds) Health Law, Human Rights and the Biomedicine Convention (2005) Martinus Nijhoff.

¹²³  See the NHS (Revision of NHS Constitution Guiding Principles) Regulations 2015, SI 2015/1462 modifying two of the guiding principles.

¹²⁴  See also NHS, The Handbook to the NHS Constitution (2009), revised (March 2013).

¹²⁵  Effectiveness is analysed in DH, Report on the Effect of the NHS Constitution (July 2015), concluding that awareness has stagnated since 2012.

¹²⁶  See C Newdick, Who Should We Treat? Rights, Rationing and Resources in the NHS (2nd edn, 2005) Oxford University Press.

¹²⁷  National Health Service Act 2006 s 14C as amended by the Health and Social Care Act 2012.

¹²⁸  Ibid, s 3.

¹²⁹  Ibid, s 14P.

¹³⁰  Ibid, s 14T.

¹³¹  Ibid, s 223H.

¹³²  See E Jackson, Medical Law: Texts and Materials (2013) Oxford University Press, pp 88–90. See for example Scialacqua v Italy (1998) 26 EHRR CD164.

¹³³  Note that in Price v UK (2001) 34 EHRR 1285 the prison authorities breached Article 3 in their deficient care of a prisoner who was a thalidomide victim.

¹³⁴  R v North West Lancashire Health Authority ex p A, D and G [2000] 1 WLR 977, CA.

¹³⁵  R (on the application of Condliff) v North Staffordshire PCT [2011] EWCA Civ 910.

¹³⁶  Ibid, per Toulson LJ, [52].

¹³⁷  Note in 2014 NICE drafted guidance to expand weight loss surgery: news ‘NICE Draft Guidance Recommends Lowering Body Mass Threshold for Weight Loss Surgery’ (2013) 349 BMJ g460.

¹³⁸  Section 232.

¹³⁹  See the National Institute for Clinical Excellence (Establishment and Constitution) Order 1999, SI 1999/220 (amended SI 2005/497).

¹⁴⁰  Health and Social Care Act 2012, Part 8.

¹⁴¹  National Institute for Health and Care Excellence (Constitution and Functions) and the Health and Social Care Information Centre (Functions) Regulations 2013, SI 2013/259, pursuant to the Health and Social Care Act 2012, s 237(1). And see NICE Charter (April 2013). Accessible at www.nice.org.uk/Media/Default/About/Who-we-are/NICE_Charter.pdf

¹⁴²  Ibid, reg 5.

¹⁴³  NHS Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) Regulations 2012, reg 34.

¹⁴⁴  NHS Constitution (updated 2013), section 3(a), ‘You have the right to drugs and treatments that have been recommended by NICE for use in the NHS, if your doctor says they are clinically appropriate for you’.

¹⁴⁵  NICE website: Glossary. Accessible at www.nice.org.uk/Glossary?letter=Q

¹⁴⁶  NICE, Guide to the Methods of Technology Appraisal (2013), para 6.3.5.

¹⁴⁷  Ibid, 6.3.3.

¹⁴⁸  Ibid, 6.2.10.

¹⁴⁹  For analysis of competing goals, see T Ottersen, ‘Lifetime QALY Prioritarianism in Priority Setting’ (2013) 39(3) Journal of Medical Ethics 175.

¹⁵⁰  According to H Dakin et al, The Influence of Cost-Effectiveness and other Factors on NICE Decisions (HERC Research Paper 05/14, 2014), ‘Cost-effectiveness alone correctly predicted 82% of decisions; few other variables were significant’.

¹⁵¹  Health Committee – Eighth Report National Institute for Health and Clinical Excellence (January 2013), paras 19–24. And for industry perspective, see News, ‘NICE Uses Wrong Comparator to Assess Cost Effectiveness of New Drugs, Report Says’ (2014) 248 BMJ g2134.

¹⁵²  See, for example, L Armitstead, ‘Too Many Drugs Being Blocked from NHS, Say Pharma Giants’ The Telegraph (2013) 14 November.

¹⁵³  National Institute for Health and Care Excellence (Constitution and Functions) and the Health and Social Care Information Centre (Functions) Regulations 2013, SI 2013/259, reg 9(3), pursuant to Health and Social Care Act 2012, s 238.

¹⁵⁴  An example of successful judicial review of a NICE decision is Servier Laboratories v NICE [2010] EWCA Civ 346.

¹⁵⁵  [2008] EWCA Civ 438. See C Brasted, H Dedman, ‘A Model Consultation’ (2009) 159 (7373) New Law Journal 850; K Syrett, ‘NICE and Judicial Review: Enforcing “Accountability for Reasonableness” through the Courts?’ (2008) 16(1) Medical Law Review 127.

¹⁵⁶  But see R (in the application of Bristol-Myers Squibb Pharmaceuticals Ltd) v NICE [2009] EWHC 2722 (Admin).

¹⁵⁷  R (on the application of Elizabeth Rose) v Thanet Clinical Commissioning Group [2014] EWHC 1182 (Admin).

¹⁵⁸  DH, Triennial Review of the NICE (July 2015). All non-departmental bodies undergo three-yearly reviews.

¹⁵⁹  See Hugh Taylor, Accelerated Access Review: Interim Report (2015).

¹⁶⁰  For a comparative perspective, see KJ Syrett, Law, Legitimacy and the Rationing of Healthcare: A Contextual and Comparative Perspective (2007), Cambridge University Press.

¹⁶¹  R v Secretary of State for Social Services, ex p Hincks (1980) 1 BMLR 93, CA. And see R v N and E Devon Health Authority ex p Coughlan [1999] Lloyds Rep Med 306, CA.

¹⁶²  Chances of success are not high, and the government of the day could always change the law, but they can be made to do it openly and not be permitted to pay lip-service to a duty to a public health service which may have been abandoned.

¹⁶³  R v Central Birmingham Health Authority ex p Walker (1998) Times, 26 November; R v Central Birmingham Health Authority ex p Collier (1988) Times, 6 January, CA. See the highly critical analysis of Collier by Newdick, Who Should We Treat?, pp. 98–100.

¹⁶⁴  [1995] 2 All ER 129, CA.

¹⁶⁵  (1995) 25 BMLR 16, at 17.

¹⁶⁶  [1995] 2 All ER 129, at 137.

¹⁶⁷  R v St Mary’s Ethical Committee ex p Harriott [1988] 1 FLR 512.

¹⁶⁸  (1994) 25 BMLR 1.

¹⁶⁹  See Newdick, Who Should We Treat?, ch 5.

¹⁷⁰  [1997] 8 Med LR 327.

¹⁷¹  R (on the application of Booker) v NHS Oldham and Direct Line Insurance PLC [2010] EWHC 2593 (Admin).

¹⁷²  [2000] 1 WLR 977, CA.

¹⁷³  [2000] 1 WLR 977, CA, per Auld LJ.

¹⁷⁴  [2011] EWCA Civ 247.

¹⁷⁵  [2006] EWCA Civ 392. See J King ‘The Justiciability of Resource Allocation’ (2007) 70(2) Modern Law Review 197; C Newdick, ‘Judicial Review: Low Priority Treatment and Exceptional Case Review’ (2007) 15(2) Medical Law Review 236.

¹⁷⁶  As in R (on the application of Murphy) v Salford PCT [2008] EWHC 1908 (Admin).

¹⁷⁷  [2007] EWHC 1927 (Admin).

¹⁷⁸  [2008] EWHC 2252 (Admin).

¹⁷⁹  But how should exceptionality be defined? See A Ford, ‘The Concept of Exceptionality: A Legal Farce’ (2012) 20(3) Medical Law Review 304.

¹⁸⁰  DH, Improving Access to Medicines for NHS Patients: A Report for the Secretary of State for Health by Professor Mike Richards (2008).

¹⁸¹  DH, Guidance on NHS Patients Who Wish to Pay for Additional Private Care (2009).

¹⁸²  Ibid, p 5.

¹⁸³  E Jackson, ‘Top-up Payments for Expensive Cancer Drugs: Rationing, Fairness and the NHS’ (2010) 73(3) Modern Law Review 399.

¹⁸⁴  S Crompton, ‘Do Medication Top-up Fees Mean the End of the NHS?’ (2008) Times, 8 November.

¹⁸⁵  M Girach, R Irwin, ‘How Patients Could Benefit from Top-up Payments’ Health Services Journal (2012) 12 July.

¹⁸⁶  Set out in the NHS Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) Regulations 2012, SI 2012/2996, Part 9. And see DH, Referral to Treatment Consultant-led Waiting Times: Rules Suite (April 2014). Subject to parliamentary approval, a new rules suite will come into effect on 1 October 2015 in compliance with SI 2015/1430, amending SI 2012/2996.

¹⁸⁷  NHS Referral to Treatment Waiting Times Data (January 2016). Accessible at www.england.nhs.uk/statistics/wp-content/uploads/sites/2/2014/06/Statistical-press-notice-PDF-74K.pdf

¹⁸⁸  See JV McHale, T Hervey, European Union Health Law: Themes and Implications (2015) Cambridge University Press; and see Mason, Laurie, Mason and McCall Smith’s Law and Medical Ethics, ch 3 (by M Aziz and updated by M Earle).

¹⁸⁹  Council Regulation on the cross-border application of social security schemes 1408/71 (EC).

¹⁹⁰  BGM Geraets-Smits v Stichting Ziekenfonds VGZ and HTM Case C-157/99.

¹⁹¹  [2004] EWCA Civ 166, CA.

¹⁹²  R (Watts) v Bedford PCT and the Secretary of State for Health [2006] Case C-372/04. See JV McHale, ‘Rights to Medical Treatment in EU Law’ (commentary) 15(1) (2007) Medical Law Review 99.

¹⁹³  [2006] Case C-372/04, [79].

¹⁹⁴  [2006] Case C-372/04, [113–114].

¹⁹⁵  Regulation 883/2004 (EC) and Implementing Regulation 987/2009 (EC).

¹⁹⁶  Directive of the European Parliament and the Council on the Application of Patients’ Rights in Cross-Border Healthcare (2011) 2011/24/EU. Regulations pre-empted the Directive and implemented the Watts judgment: the NHS (Reimbursement of the Cost of EEA Treatment) Regulations 2010, SI 2010/915 inserted a new section 6A and 6B into the NHS Act 2006.

Chapter 3

MEDICINE, MORAL DILEMMAS AND THE LAW

3.1 Medical and bioethics make news, but are far from new. From the formulation of the Hippocratic Oath in Ancient Greece, doctors have debated among themselves the codes of conduct which should govern the art of healing. Today, philosophers, theologians, lawyers and journalists insist on joining the debate. Outside interest, or interference as doctors sometimes see it, is not new. Hippocrates was a philosopher. The Christian churches through the centuries asserted the right to pronounce on medical matters of spiritual import, such as abortion and euthanasia and to uphold the sanctity of life. All other major religions across the world similarly pronounce on matters of medical ethics.¹ In the UK, in considering the impact of faith on medical ethics and practice greater attention needs to be paid to traditions other than Christianity.²

The Hippocratic Oath makes interesting reading. Its first premise is that the doctor owes loyalty to his teachers and his brethren. Obligations to exercise skill for the benefit of patients’ health come second. Abortion, direct euthanasia and abetting suicide are prohibited. Improper sexual relations with patients are banned. Confidentiality in all dealings with patients is imposed. In 2,500 years these basic precepts of medical practice changed little. Dramatic changes in the kinds of moral and ethical problems confronting the doctor came only in the last fifty years or so. The art of the Greek philosopher physician became a science for many practitioners.

Science has given the doctor tools to work marvels undreamed of by earlier generations. In vitro fertilisation and gamete donation to assist infertile couples to have children are no longer extraordinary. The technology to create artificial gametes is on the horizon.³ So a man who produces no natural sperm might be able to father a child via sperm ‘constructed’ from other cells in his body. In 2015 the House of Commons voted in favour of allowing the world’s first ‘three-parent’ IVF babies. The Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015 allow the technique of mitochondrial transfer to be used to create IVF babies free of mitochondrial disease. Ectogenesis may become a reality so that the fetus could be gestated in an artificial womb.⁴

Creating a human clone looks technically feasible now mammalian cloning has proved possible. Reproductive cloning attracts much media attention and disapproval. It is the potential for therapeutic cloning, better described as stem cell therapy, which excites doctors and scientists. The possible uses of embryonic stem cells hold out the hope of being able to replace damaged cells in patients with diseases such as Parkinson’s disease. Scientists are making progress growing new organs from stem cells to replace diseased kidneys or livers and engineering tissue based on collagen matrices to support tissue regeneration for skin grafts, ligaments and bone.

Babies born at ever earlier stages in gestation, or born with severe abnormalities, can be offered a chance of survival by amazing developments in neonatal intensive care. Some forms of fetal handicap are correctable by surgery carried out while the baby is still in the womb. Transplant surgery saves kidney, liver and heart patients from certain death. New ‘smart drugs’ to enhance cognition raise questions about whether enhancements are moral or desirable. The list of technological ‘miracles’ is endless. They have placed in the hands of the doctors powers which humanity once ascribed to God alone.

Technological progress has been matched by social change. People are less willing to accept without question the decisions of those who exercise power, be they judges, politicians or doctors. Paternalism is out of fashion. Lawyers and philosophers, not to mention parents, wonder why the doctor is best qualified to judge whether a baby’s quality of life is such as to make life-saving surgery desirable. The power of the doctor to end life, whether by switching off a ventilator, or by deciding not to put a patient on the active transplant list, disturbs us all. These moral dilemmas are just as acutely felt by doctors. Their difficulties are accentuated by the fact that the new technology cannot be made available to all those in need. There is just not enough money or resources in the NHS. Above all, the medical profession today faces a society more deeply divided on virtually every moral question than ever before. The public demands a say in medical decision-making on sensitive ethical issues. Yet from the hot potato of whether doctors should help couples to have a ‘saviour sibling’ to help their dying child, through to the debates on abortion to euthanasia, the doctor who seeks guidance from public opinion will discover division, bitterness and confusion.

Questions of medical ethics arise throughout the whole field of medical practice. Most medical students receive education in ethics as an integral part of their studies.⁵ Specialist bioethics training and academic courses offer further development.⁶ Several texts address medical ethics in detail.⁷ Increasingly, those scholars who address the ethics of medicine speak of bioethics rather than medical ethics. The change of terminology is not merely semantic. The most difficult dilemmas begin in the laboratory, not at the bedside. Consider xenotransplantation, whereby animals might be genetically engineered to produce organs compatible for transplant into humans with organ failure.⁸ The essential question is whether science should continue to pursue the research that may transform such possibilities into reality. Scientists need education in ethics as much as doctors. Equally importantly, the term bioethics is seen as less doctor-centred than medical ethics. All health professionals confront ethical dilemmas. This book focuses on doctors. Much of what we say is relevant to other health professionals too, but each health profession faces its own particular variant of ethical debate.⁹ The ethics of the doctor–patient relationship are touched on throughout this book. It is not and does not purport to be a book about medical ethics, or bioethics. Miola challenges the commonly held assumption that law and ethics form a cohesive unit.¹⁰ They may clash or create a ‘regulatory vacuum’ where the law hands over the responsibility for decision-making to medical ethics, and professional guidance leaves matters to the conscience of the doctor. We focus primarily on the role of the law.

Ethics not etiquette

3.2 Were you to peruse the ethical guidance provided for doctors in the nineteenth and early twentieth century, what you might find would have scant relationship to what most of us today think of as medical ethics. Two sorts of advice predominated. First, the physician was envisaged as an English gentleman.¹¹ As long as he behaved in a gentlemanly and benevolent fashion, his own conscience and integrity would guide him towards ethical solutions in dilemmas surrounding how to treat a patient.¹² Formal advice from professional bodies, notably the General Medical Council (GMC), offered somewhat more concrete advice.¹³ Doctors were prohibited from sexual relationships with their patients or their patients’ wives. They should not take advantage of their privileged access to patients’ homes. They must avoid misuse of alcohol or drugs. They were not to tout for custom, nor must they disparage other doctors. They must refrain from any sort of collaboration with unqualified practitioners.¹⁴ Advice centred on gentlemanly behaviour and without doubt some of the injunctions issued in earlier days had beneficial effects on patient care. However, what was styled ethics had at its core a code of etiquette. Doctors should conduct themselves in a particular way, they should show professional solidarity, and practise benevolent paternalism.

The scale of grossly unethical abuse of medicine revealed in the wake of the Second World War destroyed any complacent culture of paternalist medicine. A series of codes of medical ethics were promulgated internationally. Moral philosophers began to subject medicine to a much more rigorous critical analysis. ‘Critical’ medical ethics emerged offering a framework within which ethical dilemmas could be the subject of debate and reflection. Beauchamp and Childress’s seminal book Principles of Biomedical Ethics proved especially influential.¹⁵

Beauchamp and Childress formulated four basic principles, autonomy, beneficence, non-maleficence and justice, as a framework for ethical conduct. The four principles are a fashionable subject for attack.¹⁶ They do not, and never sought to, provide easy answers to particular questions or to offer a comprehensive ethical analysis. They do, as Gillon says, ‘help us bring more order, consistency and understanding to our medico-moral judgements’.¹⁷ The influence of the four principles, and their delicate relationship with legal principles, make it important that in any study of the law relating to healthcare a brief account is given of the four principles.

Respect for autonomy – self-determination

3.3 Autonomy literally means self-rule, as opposed to heteronomy – rule by others. We should respect autonomous choices made by other people. Crude paternalism is the antithesis of respect for autonomy. Non-consensual treatment of a patient, even for her own good, violates her autonomy. Gradually, as we shall see in Chapters 5 and 6, English law, via principles governing consent to treatment, clothed the moral principle of autonomy in legal reality.¹⁸ The principle lies at the heart of the doctrine of informed consent. The landmark ruling of the Supreme Court in Montgomery v Lanarkshire Health Board,¹⁹ explored in Chapter 5, made abundantly clear that patients are rights holders and the doctor’s duty to disclose information ‘takes its precise content from the needs, concerns and circumstances of the individual patient’.²⁰

Respect for autonomy does not demand unthinking deference to any choice made by another human being. To demand respect, a choice must be a maximally autonomous choice – an informed and free choice made by someone with the capacity to make such a choice. A very young child will ‘choose’ not to go to the dentist and ‘choose’ not to be injected with antibiotics. His choice will be dictated by the nastiness of the procedure involved. He is not able to weigh the benefits of good dental care, or antibiotics to cure his streptococcal infection, against the immediate unpleasantness. An older person with severe mental disabilities may be similarly disabled from making any real choice. A paranoid schizophrenic may be constrained by his ‘voices’ to refuse treatment because he knows that the doctor is Satan. The preferences expressed in such cases are not autonomous choices.

In setting boundaries of mental capacity, the law struggles with the concept of what constitutes an autonomous choice. The temptation to regard a choice you disagree with as non-autonomous is strong. The outcome of the choice should be irrelevant. A woman who rejects surgery for breast cancer where the prospects of complete recovery were good but she could not tolerate any mutilation of her breast makes a decision that we see as bizarre. The Jehovah’s Witness rejecting blood transfusion does so on the basis of an interpretation of the Bible which not all of us share. Their choices remain autonomous choices, made by people able to reason and on the basis of adequate information.

Beneficence – do good

3.4 An injunction to act beneficently requires doctors to frame their actions to benefit their patients. The needs of the patient should be the professional’s pre-eminent concern. Patients should never be a means to an end. What does such a pious hope mean in practice? The ethics of clinical research have attracted much philosophical attention. The failure of doctors to act beneficently and treatment of human subjects as little more than research tools explains that emphasis on research ethics. Ethical professionals should put the individual’s welfare first, even if to do so conflicts with their own interests, for example, their research objectives.

Another problem with beneficence might be that it could be seen as just another name for paternalism. The beneficent doctor does what he thinks is best for the patient. If natural childbirth is dangerous for the patient and the child she carries, must the beneficent doctor perform a caesarean section whether she likes it or not? The answer is no, because beneficence demands respect for autonomy. The professional should offer his judgement on what is good for the patient, but doing good for her requires that ultimately he accepts her decisions on what is good for her.

Translating the ethical imperative of beneficence into legal principle is tricky. The law imposes a duty of care owed by doctor to patients. That duty however generally involves not doing me any harm. English law does not impose any duty to be a Good Samaritan. Once a patient is admitted to hospital, staff must provide him with adequate and competent care. A doctor or nurse who witnesses a road accident but passes by on the other side commits no legal wrong. Yet if she fails to help when she could easily do so, she fails to act beneficently.²¹

Beneficence illustrates an important point about law and ethics. Ethics demands a higher standard of behaviour than the law requires. A competent surgeon who removes a patient’s gallstones without mishap fulfils her legal duty of care. If she dismisses the patient’s complaints of pain with scorn, makes him feel like a child, and treats him as just another patient number, is she acting ethically?

Non-maleficence – do no harm

3.5 Raanan Gillon²² says of non-maleficence: ‘Among the shibboleths of traditional medical ethics is the injunction Primum non nocere – first (or above all) do no harm’. Gillon does not challenge the principle of non-maleficence as such. Its importance is self-evident, what he rightly points out is that principle cannot be absolute. Medicine often involves doing harm. Removing an inflamed appendix inevitably involves a degree of harm – risk, pain and scarring. The benefits obviously outweigh the harm in that case. Practices which avoid all risk have ultimately done more harm than good. Sometimes agonising dilemmas arise as was the case in relation to the conjoined twins, Jodie and Mary, separated by surgeons in Manchester in 2000.²³ Without surgery, both girls would die. Separating Mary from her sister would and did result in her death. ‘Do no harm’ to Mary meant not doing good for Jodie.

Justice²⁴

3.6 ‘[T]he idea that justice is a moral issue that doctors can properly ignore is clearly mistaken’.²⁵ Few would dissent from a proposition that doctors should treat patients justly. Justice in this context might be interpreted as meaning that patients are entitled to be treated fairly and equally by their doctors. The Queen should be treated no differently from a homeless person brought into Casualty after he is found unconscious in a doorway. Health professionals should not show preference for patients who enjoy a particular status, or provide sub-standard care for patients of whom they disapprove.

Alas justice is much more complex. Within the NHS resources are limited. Not every treatment can be offered to every patient who may derive clinical benefit from such treatment. Imagine that the Queen and the homeless person both needed a liver transplant. The demand for donor livers far exceeds supply. How should a just decision be made about whether either of them should receive a transplant? The Queen turns 90 in April 2016, but enjoys good health. The homeless person is 35, but an alcoholic. His general health is poor. Other contenders compete for livers, a number of them younger than the Queen and in better health than the homeless person.

We might agree then the Queen should not get a transplant just because she is the Queen.²⁶ We might agree that the homeless person should not be refused a transplant just because he is homeless. Is it relevant that if he continues to drink after surgery, the transplant is likely to fail? Even if he overcame his addiction his lifestyle may militate against success. Poor diet and no settled home will make it difficult for him to comply with the post-operative regime necessary to avoid rejection of the donor liver. There is a lively debate about how far lifestyle and/or ‘fault’ should affect access to NHS resources.²⁷

The complexity of notions of distributive justice in healthcare, coupled with scarcity of resources, has resulted in health economists entering the debate. They have advanced the merits of an exercise based on ‘quality adjusted life years’ (QALYs) which measure health as years of life after treatment weighted by the patient’s quality of life. QALYs embody an attempt to provide an objective framework to assess how society should determine priorities for treatment.

Both the Queen and the homeless person may do badly on a QALY test. Life post transplant is unlikely to generate for anyone years of full health. Let us award the Queen seven years²⁸ of 0.75 health and the homeless person twenty years at 0.25 health, the cost being the same for both ‘patients’. The Queen scores 5.25; the homeless person scores 5; both will almost certainly lose out to younger, fitter patients. QALYs trigger another question. Should anyone get a liver transplant? Compare liver transplants with hip replacements. A woman of 50 having a hip replacement for arthritis may generate 15–20 QALYs at lower cost. Yet arthritis is not life-threatening. It is perhaps not surprising that the English courts have been reluctant to engage in questions of health resources.

NICE²⁹ has had no such option. The National Institute for Clinical Excellence was set up as a special health authority in 1999 to assess the clinical and financial viability of treatment and services and promote transparency of research allocation decisions. It became the National Institute for Health and Care Excellence in 2013, incorporating social care within its remit.³⁰ Sir Andrew Dillon, the Chief Executive of NICE is reported to have said:

QALYs are not perfect, and they do have limitations ... However, they are practical, as the calculations can be carried out in a reasonable time frame, and they are a good way to make comparisons between treatments.³¹

NICE is revising the formula it uses to determine cost-effectiveness. A proposed ‘value-based assessment’ aims to improve transparency by taking account of the burden of illness and wider societal benefits. Some questioned whether this might leave some (particularly older) patients worse off. A consultation³² indicated the need for more comprehensive change. At the time of writing, NICE is seeking a wider role in the development, evaluation and use of drugs in the NHS.

Autonomy and patients’ responsibilities

3.7 Of Beauchamp and Childress’s four principles, autonomy became de facto the dominant principle, especially in legal debate. So dominant did that one principle become that Daniel Callaghan declared: ‘Nothing has exasperated me so much as the deference given in bioethics to the principle of autonomy’.³³ The emphasis on autonomy has meant, as Draper and Sorrell explain: ‘Medical Ethics is one-sided. It dwells on the ethical obligations of doctors to the exclusion of those of patients’.³⁴ And in R v Collins and Ashworth Health Authority ex p Brady,³⁵ Kay J commented:

it would seem to me a matter of deep regret if the law has developed to a point in this area where the rights of the patient count for everything and other ethical values and institutional integrity count for nothing.

The notion of autonomy became distorted. Autonomy was wrongly understood as simply a right to what ‘I want’. The doctor became little more than a technician delivering what the consumer-patient demands.³⁶ As Onora O’Neill³⁷ has eloquently pointed out, such an interpretation of autonomy is mistaken. Autonomy involves ‘privacy, voluntariness, self-mastery, choosing freely, choosing one’s moral position and accepting responsibility for one’s choices’.³⁸ O’Neill adds to that list ‘self-control’ and ‘self-determination’.³⁹ Expressing a non-reflective preference is not a manifestation of autonomy. Responsibility requires reflection on how our choices affect others. Making a case that patients owe ethical duties to others, including their doctors is relatively easy. Clothing such ethical responsibilities with legal force is a harder task.⁴⁰ Reflecting, however, on patients’ responsibilities forces us to consider the growing support for a view of communitarian ethics.⁴¹ In judging the ethics of a particular course of action, the impact on the community, not just the individual, must be evaluated. The most recent iteration of the NHS Constitution balances patient rights with their responsibilities.

The dominance of autonomy in bioethics is tempered by an increasing shift from an individual to a relational model,⁴² which recognises the ‘social-embeddedness’ of autonomy and the impact of a person’s relationships and dependencies on the value of autonomy. There has also been a recent resurgence of both soft⁴³ and hard⁴⁴ forms of paternalism. An example of the former is the government’s adoption of Thaler and Sunstein’s theory⁴⁵ to ‘nudge’ people towards beneficial health choices.⁴⁶

Virtue ethics and the ethics of care

3.8 Virtue ethicists counter the dominance of autonomy in medical ethics by stressing the benefit of doing the right or virtuous thing in a given situation.⁴⁷ If your friend asks you for money with which he might travel to Switzerland to engage the services of the assisted-suicide clinic because he is suffering intolerably from a terminal condition, you may agree to help him because you respect his right to make his own choices, or, alternatively, from a virtue ethics standpoint, you might help simply because benevolence, kindness and generosity requires it. Principalists revere autonomy, but it has less relevance to a virtue ethicist who might argue that decisions about death or abortion should be based on compassion.⁴⁸

Feminists too find conventional theory lacking on the basis that it fails to take account of gender-specific disparities. Attention is directed to areas where women’s interests have traditionally been neglected, such as birth control and pregnancy. But the resulting theories have significance far beyond reproductive issues. Harvard psychologist Carol Gilligan’s ‘Ethic of Care’⁴⁹ emphasises the importance to women of relationships. Instead of basing ethical theory on abstract principles, such as autonomy, the ethic of care addresses issues at a personal level. Health must be contextualised; physical and emotional needs must be taken into account.

To whom (or what) do we owe ethical obligations?⁵⁰

3.9 Principles of medical ethics often conflict. If an obstetrician performs a caesarean section without the woman’s consent, he violates her autonomy. If he does not intervene and the child dies or is born severely disabled, he has done harm to the child. Withdrawing treatment from a patient in a vegetative state may be seen to harm him. Yet continuing to keep him alive can equally be classified as harming him. Money spent on sustaining such a patient over several years, deprives others of treatment in a cash-strapped NHS. Keeping X alive may be an injustice to Y. The trump card invoked to demand that the fetus and the patient in PVS be accorded priority centres around beliefs in sanctity of life. What we mean by sanctity of life, whether it is a trump card, is hotly debated.

The sanctity of life: Judaeo-Christian tradition⁵¹

3.10 For the devout Roman Catholic sanctity of life is straightforward. Human life is a gift from God and is literally sacred. Any act which deliberately ends a life is wrong. Life begins at conception and therefore abortion, and research on, or disposal of, an artificially created embryo, a test-tube embryo, is never permissible. Life ends when God ends it. No degree of suffering or disability justifies a premature release effected by us.

Yet even so there remain grey areas in the application of belief that life is sacred. Abortion is banned because the only intent of that operation is to kill the child. The Roman Catholic Church forbids abortion even when pregnancy threatens the woman’s life. However, a pregnant woman with cancer of the womb may be allowed a hysterectomy, albeit that the child will then die. This is called the doctrine of double effect. The operation for cancer incidentally destroys the child but that was not its primary purpose.

At the other end of life, the Church, while condemning euthanasia, does not demand that extraordinary means be taken to prolong life. Where is the line drawn? Should a severely disabled baby be subjected to painful surgery with a low success rate? Must antibiotics be administered to the terminal cancer patient stricken with pneumonia? The doctrine of double effect, and the application of a distinction between ordinary and extraordinary means to preserve life have generated substantial literature and debate.⁵² Nonetheless, the orthodox Roman Catholic remains fortunate in the security of her beliefs on the sanctity of life, beliefs shared by many fundamentalist Christians of the Protestant tradition.

Other practising Christians, who subscribe in essence to the doctrine of the sanctity of life, see further problems once they seek to apply their faith. Contraception is morally acceptable to the majority, and to many Roman Catholics now, although still officially prohibited by the Church. The exact point when life begins and becomes sacred becomes of the utmost importance to determine the morality of certain contraceptive methods. Abortion to save the mother’s life is accepted by many Christians, as it always has been in the Jewish and Muslim faiths. The child’s life deserves protection but not at the expense of his mother’s. This step taken, the extent to which the child’s life may be sacrificed to his mother’s has to be ascertained. Is a threat to the mother’s mental stability sufficient? What about the women who suffer rape? What is the status of the early embryo created in the test tube? These and many other issues caused dissent within many Christian traditions. For example, a number of eminent Anglican theologians⁵³ argued that research on the early embryo is acceptable and raised no conflict within Christian doctrine. Other Anglicans remained adamantly opposed to any form of destructive research on embryos.⁵⁴ Nonetheless the adherent of any religious faith enjoys a framework of belief. The sanctity of life has meaning for them because that life was given by God.

The sanctity of life in a secular society

3.11 Many still subscribe to some form of belief in a divinity or higher power. Churches are popular for weddings and funerals and thriving communities of Jews and Muslims remain committed to their traditions. Britain today is an overwhelmingly secular society where the majority of the population is uncommitted to any religious creed and those people practising any religious faith are a minority.⁵⁵ How many people retain a general belief in God as the Creator is open to question. For those who do not, what meaning has the sanctity of life? If life is not bestowed by God, on what grounds is it sacred?

Belief in the sanctity of life does survive the absence of religious belief. Taking life is as reprehensible to many agnostics and atheists as it is to the Christian or the Jew. Many non-believers have been more consistent in fighting for the sanctity of life than have certain warmongering Christian priests, or those ‘Christians’ who in the USA gather round the jails to celebrate the death penalty’s return. What in a secular society is the basis of the sanctity of human life? To most people who are not philosophers the answer is simple. There is a deep and embedded instinct that taking human life is wrong. Life is a most precious possession.⁵⁶ All other possessions, all potential joys, depend upon its continued existence. An attack on one individual’s right to life which goes unchecked threatens us all. Our autonomy is undermined. Our security becomes precarious. The move away from a concept of life as God-given, however, has certain consequences. If at the basis of belief in the sanctity of life is a perception of the freedom of the individual, of the joy that life can bring, then the quality of life comes into account. The right of the fetus to come into possession of his own life must be balanced against his mother’s rights over her own life and body. When pain and disability cause an individual to cease to wish to live, then he should be free to end that life. It is his to do with as he wishes. Individual choice becomes central to applying the concept of the sanctity of life. No one must interfere with an adult’s choices on continued life. Whether any other adult can be compelled to assist a fellow to end his life raises more difficult questions. The concept of freedom of choice offers little guidance where an individual is incapable of choice. Nevertheless this uncertain position commands a fair degree of generous support. People have an intrinsic right to life. Life is sacred, but not ‘inviolable’. A new term, ‘reverence for life’ may better encapsulate the value of human life and bridge gaps between different philosophical viewpoints.⁵⁷

Sanctity of life: a different perspective⁵⁸

3.12 A number of philosophers attack the very notion that ‘taking human life is intrinsically wrong’. Life is seen as having no inherent value. Life has value only if it is worth living. Taking life is wrong because ‘it is wrong to destroy a life which is worth living’.⁵⁹ Side by side with a move to concentrate attention on the quality of life alone comes a redefinition of human life deserving of protection. It is persons,⁶⁰ not all human animals, whose lives have value. Unless there is capacity for self-awareness, for the individual to recognise himself as a functioning human person able to relate to other persons, he has no life of the quality and kind which must be preserved. Certain consequences follow. A person who can reason must be allowed to judge for himself whether continued life is worth it. A human who cannot reason for himself, who is not a person, may have that judgement made for him by others. Providing painless release for a person who considers his life not worth living, or an individual whose capacity for self-awareness has gone, so that he has ceased to be a person, becomes a moral action. The unborn are not persons. They have no rights against their mothers who are persons. Abortion is moral and it may even be considered immoral not to abort a seriously damaged fetus. Research on embryos to benefit existing persons, whether by improving treatment for infertility or seeking a cure for congenital disease, is not only morally permissible, but almost a moral imperative. Euthanasia of the hopelessly brain-damaged with no prospect of recovery is acceptable and may, in strictly controlled circumstances, be non-voluntary.

Sanctity of life and the medical profession

3.13 No doubt the disparity of views among the general population is reflected in the personal views of many doctors. Doctors, however, have to take decisions on matters others merely debate. How far and in what fashion is the sanctity of life a central medical ethic? The Declaration of Geneva⁶¹ included the following undertaking: ‘I will maintain the utmost respect for human life from time of conception; even under threat, I will not use my medical knowledge contrary to the laws of humanity’.

When the Declaration was first formulated in 1947, ‘the utmost respect for human life’ no doubt imported to most doctors a prohibition on abortion, at any rate where the mother’s life was not in danger, and a complete ban on any form of euthanasia. The Declaration was amended and updated in Sydney in 1968. By 1968, abortion on grounds other than immediate danger to the mother had been legalised in Britain and parts of the USA. Within a decade debate was to flourish within respected medical circles as to whether keeping alive all disabled babies was right, and whether prolonging the life of the sick and elderly had not been taken to extremes by modern medicine. The Declaration was amended again in 1984, 1994, 2005 and 2006. The most recent version contains an undertaking which simply reads: ‘A physician shall always bear in mind the obligation to respect human life’.

What then does the obligation to respect human life entail? What it does not entail, and what has never existed in any code of medical ethics, is an injunction to preserve life at any price. The prevention of suffering is as much the doctor’s task as the prolongation of life; the two cannot always be complementary. The doctor struggling to interpret and apply his obligation to respect life faces a number of quandaries.

The beginning and end of life

3.14 An admonition to respect human life would be easier to adhere to if there were agreement as to when life begins and ends. Few biologists see the fertilisation of the woman’s egg as the beginning of a new life. They argue that egg and sperm are living organisms and point out that many fertilised eggs fail to implant. The fertilised egg may split into two, and in rare cases grow not into a baby but a hydatidiform mole. Fertilisation is just one step in a continuing process. At what stage then does life begin and attract respect? We have noted the argument that the fetus has no status because it is not a person. A growing view appears to be that the fetus as potential life attracts increased status as it grows to full human likeness.⁶² This gradualist perception of the embryo resulted in the support for embryo research from most doctors’ organisations in 1990 helping to ensure that Members of Parliament eventually voted to permit research for a period of up to fourteen days in the Human Fertilisation and Embryology Act 1990.

The influence of the medical profession is discernible too in debates on human cloning. Nuclear substitution is a technique in which a nucleus with its complete complement of DNA is removed from a cell taken from the organism to be cloned. The nucleus is inserted in an egg cell that has had its own nucleus removed. The egg cell, now carrying the DNA from the first organism is encouraged to divide and develop into an embryo that is genetically identical to the donor of the DNA. Experiments on mammals, such as those who produced Dolly, the most famous sheep in the world, suggest that it will be possible to produce human clones using this process. It need not be taken as far as reproductive cloning producing a new person. It is also possible to collect stem cells, undifferentiated cells with the potential to divide indefinitely and give rise to more specialised tissue cells, from the cloned embryo. As we have noted, such therapeutic cloning, stem cell therapy could be used to provide tissue grafts, or ultimately transplant organs, to treat the donor of the DNA. Doctors and scientists mostly oppose reproductive cloning, but back therapeutic cloning. Their views carried the day with the UK government.⁶³ In 2015 new regulations allowed mitochondrial transfer;⁶⁴ a process which has the potential to stop parents passing on genetic conditions such as muscular dystrophy to their children. There are two methods, both of which involve genetic material from three parents: the mother, father and a donor. This and the fact that the genetic modifications will be passed down the generations make the procedure controversial.

The end of life too has no definite marker any more. It can no longer be equated with the cessation of breathing and heartbeat.⁶⁵ The development of life-support machines to replace heart and lung functions during surgery or after traumatic injury demonstrate that life can go on although the heart has stopped. When then does death occur? A definition of death as the irreversible cessation of all activity in the brain stem⁶⁶ is generally accepted within the medical profession, although some doctors still occasionally express public doubts. For the lay public the decision to agree to switch off the life-support machine of a relative causes individual anguish, and anxiety occasionally surfaces that a desire for organs for transplantation might prompt too swift a pronouncement of death.⁶⁷ The moral dilemma relating to dying arises a stage before brain-stem death. A person may suffer irreversible brain damage, be irreversibly comatose and yet still show signs of some activity in the brain stem. He is not dead according to the current definition of death. Some argue that this definition should be extended to include the irreversibly comatose.

For those who regard human life as of value only where the individual can recognise himself as a person, loss of consciousness is equated with physical death.⁶⁸ If a patient is in PVS having lost all cortical function should we regard him as dead? Was Tony Bland alive in any real sense?⁶⁹ Is such a move euthanasia by the back door? The question of continuing to keep alive the unkindly named ‘human vegetable’ will not go away. It must be faced, not by a surreptitious moving back of the moment of death but by addressing ourselves to the question of whether the doctor may ever kill.⁷⁰

Killing and letting die

3.15 Caring for a patient as he dies in peace may be the last service his doctor can perform for him. Doctors and nurses tending the terminally ill in hospices are accorded the highest respect. The doctor’s obligation to relieve suffering may on occasion cause him to refrain from prolonging life. Asked whether a doctor should invariably invoke every weapon of medical progress to prevent death, people of every shade of opinion would answer, no. For the Roman Catholic, the test would be whether ‘extraordinary means’ must be resorted to in order to prolong that life. Extensive surgery on a dying cancer patient offering him only weeks more life would be ruled out. Antibiotics to cure a sudden, unrelated infection pose a more difficult moral dilemma. Nevertheless for most of us, religious or irreligious, this satirical rhyme sums up our attitude:

Thou shalt not kill; but needst not strive

Officiously to keep alive.

Scratch the surface of this popular attitude and problems emerge. What amounts to ‘officiously’ keeping alive? Is the doctor alone to judge when a life is worth living? Lawyers and philosophers often enjoy the argument such issues generate, doctors on the whole do not. They have to provide answers. Where a patient is sane, conscious and an adult, the dilemma has today a relatively easy answer, albeit no less painful. The patient decides whether treatment continues. The doctor, if he has been frank with the patient, has little choice but to leave it to the patient. He cannot lawfully give treatment without the patient’s consent.⁷¹ Once a patient has decided to reject further treatment, the doctor must normally desist. Suicide, if refusing treatment can be so classified, is no longer a crime. The freedom of the individual to make his own moral choices, where he is able to, is largely unquestioned. A more acute dilemma arises where the patient cannot make his own decision. Here the distinction between killing and letting die takes a central role. Asked if a doctor, or anyone else, should be allowed to smother a brain-damaged patient, the average person may recoil in horror. When a parent at the end of his tether does the same to his dying and profoundly disabled child he may attract public sympathy and understanding, though public attitudes to ‘mercy killing’ are not consistent.⁷²

Not surprisingly, then, the distinction between killing and letting die has not been allowed to go unchallenged. It is subject to a three-pronged attack: (1) technology makes the distinction between letting die and killing difficult if not impossible to put into practice; (2) it is argued that there is no valid moral distinction between killing and letting die; and (3) some writers have maintained that directly and painlessly killing a patient is a morally superior decision to leaving him to a slow undignified death.⁷³

The problems posed for the doctor by the technology at his disposal cannot be sidestepped. An accident victim rushed into hospital is put on a life-support machine. All that can be done is done for him. He proves to be irreversibly brain-damaged but not brain-dead. Failing to put him on a machine would have meant allowing him to die. Is disconnecting the machine killing him⁷⁴ (though comatose patients disconnected from life-support machines have lived on for several years in some cases)?⁷⁵ Into which category, killing or letting die, does not feeding the patient fall? A newborn baby with severe disabilities may never demand food, may be unable to feed naturally from breast or bottle. Is omitting to tube-feed that baby killing or letting die? Into which category does failure to perform delicate and painful surgery to relieve hydrocephalus (water on the brain) fall? The difficulties of applying the distinction in practice can be enumerated endlessly.

So, why not abandon the distinction altogether? Several apparently persuasive arguments can be made in favour of such a change of direction.⁷⁶ The concept of the value of human life as dependent on self-awareness and the quality of life renders it moral to end a life once self-awareness has gone, or, as in the case of a newborn baby, where it has never developed. A patient still able to reason but living in pain, distress and disability retains the right to make his own judgement on his quality of life. If he is unable to reason, the decision may be taken from him. Once quality of life, not life itself, is the determining factor, it follows that directly killing the patient may be a moral imperative. For if the patient’s quality of life is such that life has no instrumental value, is it not kinder to end that life painlessly than let him drag on for more days, weeks or months in undignified ‘sub-human’ misery? If one accepts the basic premise that the value of human life is solely dependent on life being objectively ‘worth living’, then logically progress to acceptance that a doctor may sometimes kill his patient must follow.

Pure logic does not, however, govern most human reactions. Involuntary⁷⁷ euthanasia, ending a patient’s life without any direction from him or a proxy acting on his behalf and without reference to his interests, is universally excoriated. Non-voluntary euthanasia, ending a life on the invitation of a proxy speaking for the patient and on the basis of a considered judgement of his best interests receives some support,⁷⁸ often invoking the justification of beneficence. Voluntary euthanasia, assisting a competent patient who desires to die, has a growing number of committed advocates. Nonetheless, any form of active euthanasia causes some disquiet and fears of a slippery slope that modest legalisation of voluntary euthanasia in limited circumstances may metamorphose into a ready acceptance of less than voluntary euthanasia.⁷⁹ The arguments against are dismissed with some scorn by the philosophers proposing a change of attitude. Suggestions that doctors are ‘playing God’ cut little ice unless you believe in God. Fear that powers to kill may be misused could be alleviated by proper controls. Instinctive revulsion is seen as an uninformed response.

The distinction between killing and letting die is unlikely to go away. First, the conception of life as in some sense ‘sacred’ has a greater hold on the population as a whole than its detractors concede. Fewer people in the UK may now subscribe to belief in the God of the Bible, the Talmud or the Koran. Belief in a Creator of sorts is more widespread. Belief that humanity must set limits on what humanity may do is deeply ingrained. Killing those who cannot speak for themselves remains taboo. Second, the vision of the slippery slope to euthanasia (real or illusory)⁸⁰ for the unfortunate and the dissenter operates to deter acceptance of non-voluntary euthanasia. Today the hopelessly brain damaged, tomorrow the mentally disabled, the day after opponents of the government, is the fear of many. Finally, and practically most importantly, even if the exercise of judging objectively quality of life is carried out in all good faith, how can it be achieved? Who will sit in judgement?

Sanctity of life and the law⁸¹

3.16 Legislating on moral and ethical issues created fewer problems for the Victorian parliamentarian. Applying the common law posed no dilemma for the judge. He knew what was right and what was wrong. The Victorian was unperturbed by doubt, unconcerned by any feeling that his decision should mirror the moral attitudes of society as a whole. Divisions in moral attitudes, although they did exist, were not as deep as those pertaining today. Nor were the problems of medicine as complex. Death remained then an independent agent largely beyond the doctor’s skill to combat.

Despite the plethora of ethical problems created daily by modern medicine and the changed moral climate, the law changes slowly. No statute expressly addresses the fate of the newborn infant with multiple disabilities who in an earlier age would have died whatever had been done for her.⁸² Every attempt to legislate on euthanasia has stalled in its progress through Parliament. The first test-tube baby, Louise Brown, was born in July 1978. Twelve years later Parliament finally enacted the Human Fertilisation and Embryology Act 1990 regulating IVF. Before that Act, the Abortion Act 1967 stood alone as a legislative attempt specifically designed to tackle developments in medicine and altered moral outlooks. And the Abortion Act was piloted through Parliament not by the government of the day, but by David Steel MP by means of a Private Member’s Bill. The troubled history of that Act, a compromise which pleases few, perhaps explains why governments of all political colours shy away from entering the battlefields on sanctity of human life. Attempts to amend the Human Fertilisation and Embryology Act 1990 relating to the time-limit for abortion⁸³ unleashed an outburst of vitriolic abuse unknown in even the most hard-fought party political battle.

Political disinclination to engage in debate on the sanctity of life means that to a large extent the regulation of the medical profession on issues of life and death has been left to the judges. In drawing up and applying codes of practice on the treatment of the critically ill newborn, the brain-damaged and the dying, the medical profession acts within the constraints of the criminal law of murder and manslaughter. The doctor’s exposure to the law can be brutal. The law holds its hand from laying down the code of practice within which he works. Struggling to decide on whether treatment should continue he acts within guidelines agreed within his own profession, but lacking statutory force. Ninety-nine times out of a hundred he can comfort himself with the thought that no one will question his decision in these grey areas between living and dying. On the hundredth occasion he may face the spectre of prosecution for murder or attempted murder. The distinction between killing and letting die does not operate in the criminal law to debar a charge of murder. Allowing a patient to die, when it was the doctor’s duty to treat him and the doctor knew that and intended that death would ensue, is as much murder as stabbing the patient to death.

The crucial issue once more is what is the content of the doctor’s duty? When is it his obligation to prolong life? Left to decide that issue according to conscience and professional opinion most of the time, doctors not unnaturally are resentful that intervention when it comes may take the form of criminal prosecution for murder. Doctors do not see themselves as murderers. Even the most vehement and passionate member of ‘pro-lifer’, believing that medical decisions as to the care of the newborn are frequently wrong, and err too often on the side of withholding treatment, would not place the doctor on the same moral plane as the man murdering in the course of robbery.

The reaction of the medical profession has often been that the law should keep out of medical ethics. Proposals to replace the existing and hazy common law with detailed legislative rules attract little enthusiasm.⁸⁴ Procedural rules about consultation, reference to codes of practice and the keeping of records of decision-making appear more acceptable. What doctors might welcome is such legislation that additionally promises immunity from prosecution to the doctor following the correct process. Such legislation would check the maverick. It would ensure that no one doctor whose standards deviate markedly from his fellows could pursue a course of treatment or non-treatment of patients unacceptable to the majority. However it would enshrine in the law a principle that such decisions are for the doctors alone. The rest of us would be excluded from any right to a say on these matters of life and death.

The ultimate decisions about life and death are not simply medical decisions. This was the view expressed in an editorial in the British Medical Journal over twenty-five years ago.⁸⁵ We concur. The meaning and application of the sanctity of life is not a matter to be left for the doctors to decide and for the philosophers to argue over. The law’s involvement to ensure that society’s expectations are met is inevitable. The law is far from perfect in its operation. Reform in a society divided in its moral judgements is hard to formulate. Detailed legislation is probably undesirable even if such legislation could be agreed on. The variation in the circumstances confronting the doctor is too great. Rules cannot be invented that would meet every possible dilemma the doctor may face. The doctor’s judgement cannot and should not be excluded. What can be done, if there is a will to do so, is to stimulate greater debate on the codes of practice under which the doctor works. Greater legal and lay involvement in their development should be encouraged. The gap between lawyer and doctor needs to be bridged. Doctors complain that laypeople do not understand the full implications of the problems presented by the disabled and the dying and do not appreciate the complexity of modern medical technology. Greater openness and a greater willingness to involve those outside the medical profession in decision-making bring about better understanding and better understanding of the problems of medicine will bring about better law-making.

However much any government might prefer to remain aloof from debates on medicine and morals, the developments in the uses of human tissue, genetics, embryology and assisted conception have forced the British, and other European and Commonwealth governments, to legislate:

(1)  Legislation may be designed to protect patients from possible abuses, to prevent what is perceived as an undesirable practice creating risks of injury or exploitation.

(2)  Legislation may be needed or need to be amended because gaps in the existing law place people in a legal limbo. As we shall see in Chapter 12, the provisions of the Human Fertilisation and Embryology Act 2008 relating to legal parenthood create chaos in the context of surrogacy. Questions of family law and status may be complex and sometimes controversial. Clear statutory answers are essential to safeguard the interests of the child.

(3)  Developments in genetics and biotechnology may create, or exacerbate, several legal problems. Who owns genetic information, and how should access to that information be controlled? What property rights accrue from body products? If cells from a patient’s body are used to develop a remedy to some disease, can she claim the ensuing profit made by a drug company? If a healthy gene taken from a patient’s embryo is used and inserted to replace a defective gene from his sister’s embryo, to whom does the gene belong? Can human genes be patented? All these questions require a legal answer and, if legislation does not provide the answer, expensive litigation will proliferate.

(4)  Inadequate unclear laws generate distrust and anger. The fuzzy, toothless provisions of the now repealed Human Tissue Act 1961 contributed immensely to the outrage and agony occasioned by revelations of organ retention practices.⁸⁶

(5)  Finally, the most difficult of all aspects of legislation in this area is to decide what kinds of procedures are acceptable in our society. Are there medical advances whose implications are such that, though possible, they should be prohibited by law? The United Kingdom sanctions strictly controlled stem cell therapies, ie therapeutic cloning. Most of Europe outlaws cloning altogether.

Legislating on what is permissible is fraught with difficulty. Emotions run high. In 1990 anti-abortion campaigners flooded Parliament with model fetuses. Pro-embryo research lobbies played to the cameras with touching and well-timed stories of the joy brought to previously infertile women by their ‘test-tube’ babies. The scientific possibilities are hard to grasp and science fiction scenarios abound. Test-tube-baby technology creates fears of Aldous Huxley’s Brave New World. Above all, each side in the moral debate is convinced they are right and the other is irretrievably wrong. What tends to be overlooked is this. In many ethical debates today there is no answer that will be accepted as unchallengeably right. The question for legislators is not to find a right answer, to achieve a moral consensus, but to determine how in a liberal, democratic society legislation can be formulated in the absence of such consensus. To evade that task is to leave the scientists free rein to do as they see fit. To criticise them with hindsight is unfair and unproductive. Theologians, ethicists, lawyers and indeed all citizens must be prepared to grapple with these awkward moral dilemmas and, probably, be ready to compromise.

¹  See, for example, DE Guinn, Handbook of Bioethics and Religion (2006) Oxford University Press.

²  J McHale, ‘Faith, Belief, Fundamental Rights and Delivering Health Care in a Modern NHS: An Unrealistic Aspiration’ (2013) 21 Health Care Analysis 224 explores the challenges raised by the fundamental rights to faith and belief in the delivery of healthcare as society becomes increasingly multicultural and multi-faith.

³  A Smajdor, D Cutas, ‘Will Artificial Gametes End Infertility? (2013) Healthcare Analysis 1.

⁴  See A Alghrani, M Brazier, ‘What Is It? Whose Is It? Repositioning the Fetus in the Context of Research’ (2011) 70 Cambridge Law Journal 51.

⁵  See G Stirrat, ‘Teaching and Learning Medical Ethics and Law in UK Medical Schools’ (2010) 5 Clinical Ethics 156; GMC, Outcomes for Graduates (Tomorrow’s Doctors) (2015) Outcomes 3: The Doctor as a Professional, para 20.

⁶  DM Dudzinski, R Rhodes, A Fiester, ‘Pedagogical Goals for Academic Bioethics Programs’ (2013) 22(3) Cambridge Journal of Healthcare Ethics 284.

⁷  Excellent texts on medical ethics include: TL Beauchamp, JF Childress, Principles of Biomedical Ethics (7th edn, 2013) Oxford University Press; J Jackson, Ethics in Medicine (2005) Polity; JM Harris, The Value of Life (1985) Routledge; and see generally, H Kuhse, P Singer (eds), A Companion to Bioethics (2nd edn, 2009) Wiley-Blackwell; B Steinbock, The Oxford Handbook of Bioethics (2009) Oxford University Press. For a succinct introduction to bioethics in the context of medical law, see E Jackson, Medical Law: Text, Cases and Materials (3rd edn, 2013) Oxford University Press, ch 1.

⁸  S Fovargue, Xenotransplantation and Risk Regulating a Developing Biotechnology (2011) Cambridge University Press.

⁹  See for example J Tingle, A Cribb (eds), Nursing Law and Ethics (4th edn, 2013) Wiley-Blackwell; S Shorthose, Bird & Bird LLP, Guide to EU Pharmaceutical Regulatory Law (4th edn, 2013) Kluwer Law International; M Brennan, R Oliver, B Harvey, G Jones, Ethics & Law for the Dental Team (2012) PasTest.

¹⁰  J Miola, Medical Ethics and Medical Law: A Symbiotic Relationship (2007) Hart.

¹¹  This model of ‘ethics’ was initiated by the Manchester physician, Thomas Percival, in his book Medical Ethics, first published in 1808; see CD Leake (ed), Percival’s Medical Ethics (1927) Williams & Wilkins.

¹²  See Gillon, Philosophical Medical Ethics, ch 5.

¹³  See GMC archived ethical guidance from 1963 at www.gmc-uk.org/guidance/archive.asp

¹⁴  See, for example, GMC ‘Bluebook’, Professional Conduct: Fitness to Practise (1985). And see at 1.10 on GMC’s current advisory function.

¹⁵  Beauchamp, Childress, Principles of Biomedical Ethics. See also HT Engelhard, The Foundation of Bioethics (2nd edn, 1996) Oxford University Press.

¹⁶  For example, K Clouser, B Gert, ‘A Critique of Principlism’ (1996) 15 Journal of Medicine and Philosophy 219. And see J Savelescu et al, ‘Festschrift Edition of the Journal of Medical Ethics in Honour of Raanan Gillon’ (2003) 29 Journal of Medical Ethics 265.

¹⁷  See Gillon, Philosophical Medical Ethics (1986) Wiley, p viii.

¹⁸  Note the language of Mostyn J in Nottinghamshire National Healthcare NHS Trust v RC [2014] EWHC 1317.

¹⁹  [2015] UKSC 11.

²⁰  Ibid, [73] per Lord Reed and Lord Kerr.

²¹  Though she may face disciplinary proceedings as GMC guidance requires that in an emergency a doctor must provide to anyone at risk the assistance she could reasonably be asked to provide. GMC, Good Medical Practice (2013), para 26.

²²  See Gillon, Philosophical Medical Ethics, p 80.

²³  See Re A (Minors) (Conjoined Twins: Separation) [2000] Lloyd’s Rep Med 425, CA. See 14.5.

²⁴  See generally, C Newdick, Who Should We Treat? Law Patients and Resources in the NHS (2nd edn, 2005) Oxford University Press.

²⁵  See Gillon, Philosophical Medical Ethics, p 87.

²⁶  She can of course simply opt for private care. Is it unjust that those who can pay can obtain whatever treatment they desire?

²⁷  K Sharkey, L Gillam, ‘Should Patients with Self-inflicted Illness Receive Lower Priority in Access to Healthcare Resources? Mapping out the Debate’ (2010) 36 Journal of Medical Ethics 661.

²⁸  Given her mother’s longevity (101) this does not seem an unreasonable assumption.

²⁹  See 2.18.

³⁰  Health and Social Care Act 2012, s 232.

³¹  J Wise, ‘NICE Recommended Four in Five Drugs It Evaluated in Past Decade’ (2010) 341 BMJ 3935.

³²  NICE, Methods of Technology Appraisal Consultation (March 2014).

³³  D Callaghan, ‘Can the Moral Commons Survive Autonomy?’ (1996) Hastings Centre Report 41.

³⁴  H Draper, T Sorrell, ‘Patients’ Responsibilities in Medical Ethics’ (2002) 16 Bioethics 335.

³⁵  [2000] Lloyds Rep Med 355, at 367.

³⁶  See M Brazier, ‘Do No Harm: Patients Have Responsibilities Too?’ (2006) 65 Cambridge Law Journal 397; and see G Laurie, JK Mason, ‘Waxing and Waning: The Shifting Sands of Autonomy on the Medico-Legal Shore’ in C Stanton, S Devaney, A-M Farrell, A Mullock (eds), Pioneering Healthcare Law: Essays in Honour of Margaret Brazier (2016) Routledge, ch 2.

³⁷  See O O’Neill, Autonomy and Trust in Bioethics (2002) Cambridge University Press and A Question of Trust (2002) Reith Lectures.

³⁸  See R Faden, T Beauchamp (in collaboration with NMP King), A History and Theory of Informed Consent (1986) Cambridge University Press, p 7.

³⁹  See O’Neill, Autonomy and Trust in Bioethics, p 22.

⁴⁰  See Brazier, ‘Do No Harm’, 397.

⁴¹  Note that JK Mason and GT Laurie declare their ‘partial adherence to community ethics’. See JK Mason and GT Laurie, Mason and McCall Smith’s Law and Medical Ethics (9th edn, 2013) Oxford University Press, at 1.20. And see D Callaghan, ‘Principalism and Communitarianism’ (2003) 29 Journal of Medical Ethics 287; A Etzioni, ‘Authoritarian versus Responsive Communitarian Bioethics’ (2011) 37 Journal of Medical Ethics 17.

⁴²  See for example A Maclean, Autonomy, Informed Consent and Medical Law: A Relational Challenge (2009) Cambridge University Press; S McLean, Autonomy, Consent and the Law (2009) Taylor & Francis.

⁴³  N Levy, ‘Forced to Be Free? Increasing Patient Autonomy by Constraining It’ (2014) 40 Journal of Medical Ethics 293.

⁴⁴  S Conly, Against Autonomy: Justifying Coercive Paternalism (2012) Cambridge University Press; A Caplan, ‘Why Autonomy Needs Help’ (2014) 40 Journal of Medical Ethics 301.

⁴⁵  RH Thaler, CR Sunstein, Nudge: Improving Decisions about Health, Wealth and Happiness (2009) Yale University Press.

⁴⁶  I Johnston, ‘How the Government’s Successful “Behaviour Insights Team” Has Had a Profound Effect on Whitehall’ The Independent (2014) 9 February.

⁴⁷  See generally, R Hursthouse, On Virtue Ethics (1999) Oxford University Press.

⁴⁸  See, for example, L Van Zyl, Death and Compassion: A Virtue-based Approach to Euthanasia (2000) Ashgate; R Hursthouse, ‘Virtue Ethics and Abortion’ (1991) 20 Philosophy and Public Affairs 223.

⁴⁹  C Gilligan, In a Different Voice (1982) Harvard University Press.

⁵⁰  See Gillon, Philosophical Medical Ethics, chs 7 and 8.

⁵¹  See J Finnis, Natural Law and Natural Rights (1980) Oxford University Press; O O’Donovan, Begotten or Made (1984) Oxford University Press.

⁵²  See, for example, the debate between J Finnis and J Harris in J Keown (ed), Euthanasia Examined: Ethical, Clinical and Legal Perspectives (1995) Cambridge University Press.

⁵³  See, for example, K Ward, ‘An Irresolvable Debate’ in A Dyson, J Harris (eds), Experiments on Embryos (1989) Routledge, ch 7.

⁵⁴  And note opposition to mitochondrial transfer procedures: BBC News, ‘Churches Oppose Three-Person Baby Plan’ (2015) 30 January.

⁵⁵  On the secularisation of bioethics, see Jackson, Medical Law: Text, Cases and Materials, pp 9–25.

⁵⁶  See R Dworkin, Life’s Dominion: An Argument about Abortion and Euthanasia (1993) Harper Collins.

⁵⁷  M Brazier, S Ost, Bioethics, Medicine and the Criminal Law Volume 3: Medicine and Bioethics in the Theatre of the Criminal Process (2013) Cambridge University Press, p 89. And see discussion by A Mullock, R Heywood, ‘The Value of Human Life in Healthcare Law’ in Stanton et al, Pioneering Healthcare Law, ch 4.

⁵⁸  See in particular, two persuasive and lively works: J Glover, Causing Death and Saving Lives (1977) Penguin; JM Harris, The Value of Life (1985) Routledge & Kegan Paul. And see H Kuhse (ed), Unsanctifying Human Life: Essays on Ethics (2001) Blackwell.

⁵⁹  Glover, Causing Death and Saving Lives, ch 3.

⁶⁰  Harris, The Value of Life, ch 1.

⁶¹  Adopted by the 2nd General Assembly of the World Medical Association, Geneva, Switzerland, September 1948.

⁶²  See, for example, T Martin, Interests in Abortion: A New Perspective on Foetal Potential and the Abortion Debate (2000) Avebury.

⁶³  The Human Reproductive Cloning Act 2001 prohibited the placing in a woman of an embryo created otherwise than by fertilisation. This legislation became obsolete when the Human Fertilisation and Embryology Act 2008 amended the Human Fertilisation and Embryology Act 1990 to prohibit reproductive cloning (see s 3(6)).

⁶⁴  Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015, SI 2015/572. Discussed at 12.2.

⁶⁵  Note that Britain’s former Chief Rabbi, Jonathan Sacks argued that death occurs upon irreversible cessation of the heartbeat. This has connotations for organ transplantation. See J Sacks, ‘Organ Donor Cards Are Not Incompatible with Jewish Law’ Guardian (2011) 14 January.

⁶⁶  Re A [1992] 3 Med LR 3033.

⁶⁷  See Chapter 16.

⁶⁸  Glover, Causing Death and Saving Lives, pp 43–5.

⁶⁹  See Airedale NHS Trust v Bland [1993] AC 789 HL. See 19.1, 19.15.

⁷⁰  See Chapter 19.

⁷¹  See B v NHS Hospital Trust [2002] 2 All ER 449.

⁷²  See 19.2.

⁷³  And see Lord Browne-Wilkinson in Airedale NHS Trust v Bland [1993] AC 789, at 885.

⁷⁴  B v NHS Hospital Trust [2002] 2 All ER 449.

⁷⁵  See I Kennedy, ‘The Karen Quinlan Case: Problems and Proposals’ (1976) 2 Journal of Medical Ethics 3.

⁷⁶  J Coggon, ‘On Acts, Omissions and Responsibility’ (2008) 34 Journal of Medical Ethics 576.

⁷⁷  On the problems of terminology, see 19.1; and see Mason, Laurie, Mason and McCall Smith’s Law and Medical Ethics, at 18.01–18.05.

⁷⁸  See L Doyal, ‘Dignity in Dying Should Include the Legalisation of Non-Voluntary Euthanasia’ (2006) 2 Clinical Ethics 65.

⁷⁹  See J Keown, Euthanasia, Ethics and Public Policy: An Argument against Legalisation (2002) Cambridge University Press, ch 1.

⁸⁰  See S Smith, ‘Evidence for the Practical Slippery Slope in the Debate on Physician-Assisted Suicide and Euthanasia’ (2005) 13 Medical Law Review 17.

⁸¹  See G Williams, The Sanctity of Life and the Criminal Law (1958) Faber & Faber; PDG Skegg, Law, Ethics and Medicine (1984) Clarendon Press.

⁸²  See Nuffield Council on Bioethics, Critical Care Decisions in Fetal and Neonatal Medicine, (2006).

⁸³  But ultimately resulted in a ‘liberalisation’ of the law on late abortions: see section 37 of the 1990 Act (and see 13.12).

⁸⁴  J Havard, ‘Legislation Is Likely to Create More Difficulty than It Resolves’ (1983) 9 Journal of Medical Ethics 18. And see 14.3.

⁸⁵  [1981] BMJ 569.

⁸⁶  Royal Liverpool Children’s Inquiry Report (2001) HC 12-11. See 18.2.

Chapter 4

A RELATIONSHIP OF TRUST AND CONFIDENCE

Whatever, in connection with my professional practice, or not in connection with it, I see or hear in the life of men, which ought not to be spoken of abroad, I will not divulge, as reckoning that all such should be kept secret.

The Hippocratic Oath

I will respect the secrets which are confided in me, even after the patient has died.

Declaration of Geneva (as amended 2006)

4.1 Doctors, like priests and lawyers, must be able to keep secrets. For medical care to be effective, for patients to trust their doctor, they must have confidence that they can talk frankly to her. In its latest guidance to doctors, the General Medical Council (GMC) puts it this way:

Confidentiality is central to trust between doctors and patients. Without assurances about confidentiality, patients may be reluctant to give doctors the information they need in order to provide good care.¹

An obligation of confidence to patients lies at the heart of all codes of ethics, but a comparison of the quotations above shows that the obligation is not necessarily absolute. The Ancient Greek physician undertook not to divulge that which ‘ought not to be spoken of abroad’. He judged what fell into that category. The Declaration of Geneva is more stringent. Must any information given by a patient in confidence be kept secret for ever? A moment’s reflection reveals the problems inherent in both absolute and relative obligations of confidence. An absolute obligation leaves the doctor powerless to do anything but try to persuade his patient to allow him to take action if, for example, a patient tells him he is HIV-positive but is still having unprotected sex with his wife who knows nothing of his condition, or when a depressed mother confesses her violent impulses towards her baby.² On the other hand, a relative obligation, which leaves the doctor free to breach confidence when she judges that some higher duty to another person or to society applies, may deter patients from seeking necessary treatment. This may damage not only the patient but also those very people vulnerable when the doctor treats and does not ‘tell’. The wife whose husband receives no advice about ‘safe sex’ and HIV, and the baby whose mother seeks no counsel may be more vulnerable if fears of breach of confidence prevent the husband and the mother getting any help at all because they are afraid to confide in a doctor.

In this chapter we look at the law on confidentiality as it affects doctors and adult patients, and examine the role of the medical profession in enforcing the ethical obligation of confidence. The special problems affecting confidentiality and parents and children are considered in Chapter 14. Issues relating to confidentiality in medical research are considered in Chapter 15. The complexity of the law may surprise some. The number of occasions when the law allows or compels the doctor to breach confidence may shock many. The chapter also explores what the patient is entitled to be told. From the patient’s viewpoint the doctor’s obligation of confidence exists to prevent the doctor passing on information about the patient to third parties. A relationship of trust requires that this should not happen. Trust also requires that the doctor be frank with the patient. Information about the patient should generally not be withheld from him. It is ‘his’ information not the doctor’s, and so we also ask how far the patient is entitled to frankness from his doctor.

Breach of confidence: medical privacy

4.2 English law on breach of confidence³ developed haphazardly.⁴ The core obligation requiring doctors to respect patient confidences derives from the common law. Judges have shown themselves willing to act to prevent the disclosure of confidential information in a wide variety of circumstances. A duty to preserve confidences has been imposed in settings as diverse as trade or research secrets confided to employees,⁵ marital intimacies,⁶ intimate disclosures to close friends⁷ and Cabinet discussion.⁸ Often the obligation of confidence arises as an implied term of a contract, as is the case with the employee bound by his contract of employment to keep his employer’s business to himself. But the obligation of confidence can equally arise where no contract exists, or has ever existed, between the parties.

Confidentiality is not only a strong private interest, there is a public interest in keeping certain types of information private, and this is particularly true of medical information. In a very early case, action was taken to prevent publication of a diary kept by a physician to George III.⁹ Much later, in 1974, a judge put the doctor’s duty thus:

in common with other professional men, for instance a priest and there are of course others, the doctor is under a duty not to disclose, [voluntarily] without the consent of his patient, information which he, the doctor, has gained in his professional capacity, save … in very exceptional circumstances.¹⁰

Today any attempt to understand the law governing medical confidentiality must take account of a bewildering array of sources. In addition to the case law, it is necessary to take account of Articles 8 (right to privacy) and 10 (freedom of expression) of the European Convention on Human Rights, the Data Protection Act 1998, and voluminous guidance from regulatory bodies and the NHS. In 2012, the European Commission proposed major reform of the framework on the protection of personal data. A new European regulation was approved in 2015.

Article 8(1) of the ECHR states that: ‘Everyone has the right to respect for his private and family life, his home and his correspondence’. The ECtHR has consistently upheld the right to privacy in relation to medical records. But it is not an unqualified right. The court has upheld seizure of medical records in criminal proceedings¹¹ and use of records in connection with social security benefits.¹² In Z v Finland the Court said:

Respecting the confidentiality of health data is a vital principle in the legal systems of all the Contracting Parties to the Convention. It is crucial not only to respect the sense of privacy of a patient but also to preserve his or her confidence in the medical profession and in the health services in general.¹³

In England, the Human Rights Act 1998 renders the Convention Articles enforceable against public authorities. In the United States of America, and many civil law jurisdictions an all-inclusive cause of action for invasion of privacy is recognised. No right of privacy as such is even now recognised in English domestic law,¹⁴ but the various aspects of English law which protect privacy, including the common law action for breach of confidence, have developed to take account of Article 8. The terminology has changed, leading Lord Nicholls to call for the renaming of the tort:

The continuing use of the phrase ‘duty of confidence’ and the description of the information as ‘confidential’ is not altogether comfortable. Information about an individual’s private life would not, in ordinary usage, be called ‘confidential’. The more natural description today is that such information is private. The essence of the tort is better encapsulated now as misuse of private information.¹⁵

The common law principles developed incrementally by the judiciary long before the Human Rights Act remain important to an understanding of medical confidentiality, but now have to be applied with due regard for Convention rights. So in Campbell v Mirror Group Newspapers,¹⁶ to which we shall return, the House of Lords balanced human rights, Article 8 versus Article 10, rather than the traditional concepts of private and public interests, but Lord Hope commented that: ‘It seems to me that the balancing exercise to which that guidance is directed is essentially the same exercise, although it is plainly now more carefully focused and more penetrating’.¹⁷

Article 8 of the Human Rights Act strengthens the principles long contained in the common law action for breach of confidence in which the basic general principles are these:

(1)  The courts will intervene to restrain disclosure of information where the information is confidential in nature and not a matter of public knowledge, or trivial in nature.

(2)  Where information is found to be private and confidential, any non-consensual disclosure requires justification in the public interest.¹⁸

(3)  Once an obligation of confidence is created it binds not only the original recipient of the information but also any other person to whom disclosure is made by the recipient when that other person knows of the confidential status of the information.¹⁹ As well as acting in advance to prevent the disclosure of confidential information, the courts may where appropriate award compensation after information has been improperly disclosed.²⁰

In AG v Guardian Newspapers (No 2),²¹ Lord Goff broadened the scope of breach of confidence stating that when information is entrusted to another person in circumstances imposing an obligation not to use or disclose that information without the consent of the giver of the information an initial confidential relationship is not required.²² In Campbell v MGN ²³ (which did not involve a doctor–patient relationship), the Law Lords ruled that the circumstances in which the information was obtained were irrelevant. The nature of the information was of paramount importance. The ‘old’ test of a confidential relationship covered the relationship of doctor and patient. Applying the new terminology, it remains the case that a ‘reasonable expectation of privacy’²⁴ can be established when a patient divulges information about her health to her doctor, and may extend to a broader class of health information.

Disclosure after death

4.3 Does death terminate any obligation of confidence to a deceased patient?

You might ask why this should matter but consider just two examples. A senior Cabinet minister dies and within weeks her GP publishes a bestselling book highlighting her multiple medical problems in graphic and prurient detail. A famous married actor dies and his doctor tells the tabloid press all about his battle with HIV and bisexuality. Should the first doctor be allowed to profit from the abuse of his professional relationship? Do the widow and children of the actor have a claim to consideration? For many years the GMC has instructed doctors that ‘Your duty of confidentiality continues after a patient has died’.²⁵ It was less clear whether the law imposed such an obligation surviving the patient until in Lewis v Secretary of State for Health²⁶ Foskett J took the view that the ‘obligation of confidence is capable of surviving the death of the patient’.²⁷ Such he said were the expectations of the public and the profession. The legal obligation is not necessarily permanent and the period of survival will depend on the sensitivity of the information in issue and the prospect of any harm done to surviving relatives.

Does the protection of a deceased person’s private medical information extend beyond the doctor–patient relationship? In Press Association v Newcastle upon Tyne Hospitals Foundation Trust,²⁸ the Court of Protection considered whether a reporting restriction order in relation to a hospital patient could continue after the patient had died. The Press Association sought to publish the name of LM (deceased). LM had been the subject of a declaration that it would be lawful for hospital doctors to withhold a blood transfusion which LM had refused on religious grounds. Peter Jackson J lifted the restriction on the grounds that there was a proper interest in LM’s identity and any wider harm would be minimal, but he also made it clear that death does not automatically lead to a loss of protection of privacy and each case must be decided on its merits.²⁹

Justifying disclosure

4.4 The challenging questions about medical confidentiality do not however lie in establishing a general duty of confidence, or expectation of privacy, but in determining what amounts to ‘very exceptional circumstances’ justifying breach of that duty.

First, disclosure will always be justified legally when the doctor is compelled by law to give confidential information to a third party. This may be by way of an order of the court to disclose records in the course of some civil proceedings. Doctors, unlike lawyers, enjoy no professional privilege entitling them to refuse to give evidence in court. Or it may be under some statutory provision, such as those Acts of Parliament requiring that specified diseases be notified to the health authorities.³⁰

Second, it is clear that the doctor may voluntarily elect to disclose information in certain circumstances. Where there is a public interest in disclosure of confidential and private information, the court will consider whether harm (to either physical or moral integrity) may be caused to someone as a result.³¹ The public interest in disclosure must be balanced with the public and private interests in maintaining confidentiality. Thus, disclosure of private information requires justification.

In early judgments, the public interest ‘defence’ tended to concern disclosure of crime; ‘there is no confidence in the disclosure of iniquity’.³² Gradually it has been accepted that that defence is not limited to crime, or even misconduct. In Lion Laboratories Ltd v Evans (which considered the disclosure of confidential information suggesting that a breathalyser device, the Intoximeter, was unreliable), Griffiths LJ said:

I can see no sensible reason why this defence should be limited to cases where there has been wrongdoing on the part of the plaintiffs … it is not difficult to think of instances where, although there has been no wrongdoing on the part of the plaintiff, it may be vital in the public interest to publish a part of his confidential information.³³

Two major cases remain central to an understanding of when public interests will justify a breach of medical confidentiality. In X v Y³⁴ a tabloid newspaper acquired, in breach of confidence from a health authority employee, information identifying two general practitioners who were continuing to practise after having been diagnosed as HIV-positive. The authority sought an injunction prohibiting publication of their patients’, the doctors’, names. The newspaper argued that the general public and the doctors’ patients in particular, had an interest in knowing that the doctors were HIV-positive. Rose J reviewed the evidence about transmission of HIV from doctor to patient where the doctor had received proper counselling about safe practice. He found that the risk to patients was negligible. Far greater risks arose from the possibility that if they could not rely on confidential treatment, people with AIDS, or who feared they might have AIDS, would not seek medical help. The judge, granting the injunction, said:

In the long run, preservation of confidentiality is the only way of securing public health; otherwise doctors will be discredited as a source of education, for future individual patients will not come forward if doctors are going to squeal on them. Consequently, confidentiality is vital to secure public as well as private health, for unless those infected come forward they cannot be counselled and self-treatment does not provide the best care.³⁵

By contrast in W v Egdell,³⁶ the Court of Appeal sanctioned a breach of confidence by a psychiatrist. W had been convicted of the manslaughter of five people and of wounding two others. He was ordered to be detained indefinitely in a secure hospital. He could be released only by order of the Home Secretary if he were found to be no longer a danger to public safety. As a step towards eventual release he sought to transfer to a regional secure unit. The transfer was not approved by the Home Secretary and W then applied to a mental health review tribunal for a conditional discharge. In support of his application his solicitors arranged for an independent psychiatric report from Dr Egdell. Dr Egdell’s report was not favourable. He judged that W was still a dangerous man with a psychopathic personality, no real insight into his condition and a morbid interest in explosives. Unsurprisingly, W’s solicitors withdrew their application for his discharge but they did not pass on the report to the tribunal or the hospital where W was detained. Dr Egdell was concerned by the fact that his report was not passed on. He ultimately sent his report to the medical director of W’s hospital and agreed that a copy of that report should be forwarded to the Home Secretary. W sued Dr Egdell for breach of confidence.

The Court of Appeal made it crystal clear that Dr Egdell did owe W a duty of confidence. Had he sold his story to the press or discussed the case in his memoirs, Dr Egdell would have been in breach of confidence. But the duty of confidentiality is not absolute. The public interest in medical confidentiality must be balanced against the public interest in public safety. If Dr Egdell’s diagnosis was right, W remained a source of danger to others and he was entitled to communicate his findings to the director of the hospital now detaining W, and to the Home Secretary, who would have the final say on if and when W should be released into the community.

X v Y and W v Egdell did not mean that a doctor may never disclose that a patient is HIV-positive, or that he may always disclose his concerns about a patient’s mental health.³⁷ In each case the powerful interest in maintaining confidentiality must be balanced against the danger ensuing if confidentiality is not breached. Only where there is a clear and significant risk of the patient causing harm to others which cannot be abated by any other means may confidence be breached.

As we have noted, more recently judicial assessment of public and private interests has involved the careful balancing of Convention rights. Campbell v Mirror Group Newspapers Ltd³⁸ involved the disclosure of information concerning the health of a famous fashion model. Although the information was disclosed by the Mirror newspaper, rather than a medical practitioner, there are clear implications for medical privacy. At first instance, Naomi Campbell was awarded £3,500 in damages, but the Court of Appeal reversed the decision holding that disclosure was in the public interest. The House of Lords balanced Campbell’s right to privacy under Article 8, protected by the common law duty of confidentiality, with the freedom of the press, protected under Article 10. Both are qualified rights and neither has pre-eminence over the other. Campbell had previously falsely stated that she was not a drug addict. She was powerless to object, therefore, when the Mirror newspaper published information to the contrary. However, she did object to the publication of furtively taken photographs and articles proving that she was attending Narcotics Anonymous. This, she maintained, was a breach of confidence for which she was entitled to compensation under the Data Protection Act 1998. By a majority, the House of Lords found in her favour, overturning the decision of the Court of Appeal. The special nature of medical information was recognised by Baroness Hale who stated:

It has always been accepted that information about a person’s health and treatment for ill health is both private and confidential. This stems not only from the confidentiality of the doctor–patient relationship but from the nature of the information itself.³⁹

Baroness Hale made the following points:

(1)  The information about Campbell’s attendance at Narcotics Anonymous was private and confidential ‘because it related to an important aspect of Miss Campbell’s physical and mental health and the treatment she was receiving for it. It had also been received from an insider in breach of confidence’.

(2)  Because it was private, its publication required specific justification.

(3)  ‘Some [types of speech] are more deserving of protection in a democratic society than others’. Where disclosure carries little risk of harm to a person’s physical or moral integrity, where for example ‘a public figure has a cold or a broken leg’, it might be justifiable. Note however, that Baroness Hale was balancing Article 8 and Article 10 rights. Her words do not necessarily imply that less protection will be given to the breach of confidence relating to ‘trivial’ health matters where there is no competing public interest in their disclosure.

(4)  The breach of confidence had potential to cause Miss Campbell harm. Her Article 8 privacy rights took priority over the public interest in freedom of the press under Article 10.

In TW v Enfield Borough Council⁴⁰ breaching confidence had the potential to cause harm but so too did non-disclosure. This Court of Appeal case involved an approved social worker who was required to consult the ‘nearest relative’ (in this case TW’s father), before making an application to compulsorily admit a patient to hospital under section 13(1) of the Mental Health Act 1983.⁴¹ Section 11(4) of the Mental Health Act recognises that the duty to consult does not apply where it is ‘not reasonably practicable or would involve unreasonable delay’. The social worker decided it was not reasonably practicable to consult TW’s father because TW had previously demanded complete patient confidentiality and consultation would breach her Article 8(1) rights to a private life. But TW subsequently argued that her father should in fact have been consulted.

The case turned on the meaning of the words ‘not reasonably practicable’. Aikens LJ reasserted the statutory duty under section 3(1) of the Human Rights Act 1998 to give effect to section 11(4) of the Mental Health Act in such a way as to comply as far as possible with Articles 5 and 8 of the European Convention on Human Rights. On the facts, the required balancing exercise between the Article 5(1) right not to be detained unless by a procedure that is in accordance with the law and the Article 8(1) right to privacy had not taken place and the appeal was allowed. Article 8(1) must be balanced with other Convention rights.

Article 8, like the common law, imposes only a relative obligation of confidence.⁴² Article 8(2) provides:

There shall be no interference by a public authority with the exercise of this right except such as is in accordance with the law and necessary in a democratic society in the interests of national security, public safety or the economic well-being of the country, for the prevention of disorder or crime, for the protection of health or morals, or for the protection of the rights and freedoms of others.⁴³

In Szuluk v United Kingdom,⁴⁴ the European Court of Human Rights has emphasised that states invoking Article 8(2) to justify a violation of medical privacy must demonstrate a necessity corresponding to a pressing social need and one proportionate to the aim pursued. While in prison, first on remand and then serving a fourteen-year sentence, Mr Szuluk had to undergo major neurosurgery twice and needed regular monitoring. He wished to be able to correspond with his consultant confidentially and sought assurances from the prison governor that his correspondence would not be opened and read by prison staff. Prison rules provided that normally all letters to and from prisoners may be opened and read. The governor’s initial decision to accede to Mr Szuluk’s request was overruled and arrangements made for the prison medical officer to read this correspondence. After the Court of Appeal ruled in favour of the prison authorities, Mr Szuluk took his case to the ECtHR and won. While Article 8(2) allowed for interferences with privacy for the prevention of crime and the protection of the rights and freedoms of others and so would justify some degree of interference with prisoners’ correspondence to prevent escapes or complicity in crimes, the state must show that interference with medical correspondence with a named doctor of impeccable character was truly necessary to avoid the risk of criminal activity or breaches of security. Mr Szuluk was not a Category A prisoner and the court stressed that ‘uninhibited’ medical correspondence with his doctors on the part of a prisoner suffering from a life-threatening condition should be afforded no lesser protection than prisoners’ correspondence with their lawyers or MPs.

The General Medical Council⁴⁵

4.5 A doctor facing a practical dilemma about whether she can lawfully disclose information in the public interest will want more specific guidance than that available from the judgments of the courts. A primary source of such advice is the GMC whose latest guidance Confidentiality was issued in 2009. At the time of writing, the guidance is undergoing revision. The GMC plays two roles in enforcing confidentiality. First the courts will give due regard to the profession’s own view of the ethical obligations owed by its members in formulating consequential legal obligations.⁴⁶ That does not mean GMC guidelines are in any sense law or that the courts will slavishly follow the profession’s view. But the guidance may be a good indicator of how the courts will resolve dilemmas as they come before them.

Second, aggrieved patients may prefer to complain to the GMC rather than take legal action in the courts. The doctor in breach of confidentiality could face a finding of impaired fitness to practise and removal from the register. The civil action for breach of confidence is an excellent weapon for restraining threatened breaches of confidence. It may be less effective in offering redress to the victim of a breach of confidence, except in a commercial setting. If a trade secret is revealed by an employee and the employer loses profits, his loss can be measured by the courts and appropriate compensation ordered. The defendant may be obliged to hand over all his illegal profits. A breach of medical confidence rarely results in monetary loss, but will give rise to indignity and distress for the patient. It used to be unclear if mental distress could give rise to damages for breach of confidence. In Cornelius v De Taranto⁴⁷ the judge at first instance awarded the claimant £3,000 in damages for mental distress caused by ‘unauthorised disclosure of the confidential information’ and subsequent cases have followed suit. However, legal action may be expensive and the damages low.⁴⁸ The legal claim itself may attract unwelcome publicity and complaining to the GMC may remain a preferred option for many victims of breach of medical confidence.

The GMC makes it clear that patients have a right to expect that information about them will be held in confidence by their doctors.⁴⁹ We consider first information where the identity of the patient is disclosed, what the GMC describes as personal information. The doctor’s duty is to maintain confidentiality strictly. The guidance warns doctors to be vigilant in protecting confidential information. It rightly notes that ‘[M]any improper disclosures of information are unintentional’.⁵⁰ Technologies such as tele-medicine, email and smartphone apps facilitate new ways to communicate with patients and share information, but they also create new challenges around confidentiality. Notes should not be left lying around. Consultations with patients should not take place where they can be overheard by other patients or by staff not involved in the care of the patient. Doctors responsible for the management of records must make sure that all staff understand their responsibilities to secure patient confidentiality.

Disclosure with consent

4.6 Disclosure is self evidently lawful if the patient expressly consents to disclosure. The doctor must ensure that the patient understands what is to be disclosed, the reasons for disclosure and the consequences thereof. The patient must be told to whom information will be given and how much information will be disclosed. Some patients prefer to make decisions as part of a family group and the law’s foundations in privacy and individual autonomy can rest uneasily alongside a relational autonomy approach.⁵¹

In a number of instances consent may be implied rather than explicit. Health-care in the NHS is usually provided by a team of professionals and sharing information within that healthcare team will normally be lawful on the basis that patients usually understand that a number of different health professionals will play a role in their care.⁵² The GMC makes clear that efforts must be made to ensure that patients are aware of this practice and that their wishes are respected should they decide to withhold consent.⁵³ Doctors must make sure that everyone within the team to whom information is disclosed understands that they are bound by a legal obligation of confidence. Moreover the sharing of confidential information should be restricted to staff who are directly involved in personal care⁵⁴ but surveys have suggested that in practice a growing number of non-medical staff have access to confidential records.⁵⁵

The jurisdiction of the GMC is limited to medical practitioners. The Nursing and Midwifery Council (NMC) enforces similar stringent ethical rules for nurses. Doctors as well as patients have expressed concern that a patient’s notes are seen by an unnecessary number of persons. They complain that decisions as to when to disclose records are taken too often by administrators, and that administrators are not subject to the control of the GMC or the NMC. Doctors fear they may be less concerned about confidentiality. Such fears are misguided. All NHS staff are subject to the law on confidence. Information confided by the patient to her doctor remains legally confidential when passed by the doctor to NHS administrators for storage. The NHS England Confidentiality Policy 2014⁵⁶ makes it clear that confidentiality binds everyone working within the NHS.⁵⁷ Disclosure within the service is justified only if required in the context of the patient’s healthcare. Disclosure to third parties outside the service is permissible only with the patient’s consent, save in exceptional cases. The exceptions, for example, where disclosure is required by law or in case of serious crime, correspond closely to the exceptions sanctioned by the GMC. Generally, decisions on disclosure should always be taken by a medically qualified person and where possible it should be the doctor caring for the patient. Guidelines are enforced by the sanction of disciplinary action, or even dismissal, against staff members who break them.⁵⁸

Concerns about privacy have led to risk aversion among healthcare professionals. To encourage responsible data sharing, the NHS has endorsed the use of the NHS Number instead of the patient’s name as the primary identifier in clinical correspondence. The Health and Social Care (Safety and Quality) Act 2015 inserts a new section 251A into the Health and Social Care Act 2012 requiring that a ‘consistent identifier’ – the NHS Number – be used to identify individuals.⁵⁹ There are several exceptions to the rule, which only applies where it is in best interests of an individual who does not object. Section 251A does not permit anything that is inconsistent with either the common law duty of confidentiality or the Data Protection Act 1998.

Disclosure where the patient lacks capacity

4.7 What about the patient who lacks capacity to authorise disclosure of information, be she unconscious in a Casualty department or suffering from some long-term intellectual impairment. A key question will be how much information doctors can share with family or carers. Under the Mental Capacity Act 2005 there is a presumption of capacity. A person will only be shown to lack capacity in relation to a specific decision where she is unable to make a decision for herself⁶⁰ by virtue of the fact that she cannot understand, retain, weigh or use the information relevant to the decision.⁶¹ Under section 5, those providing care for someone who lacks capacity will not incur legal liability, provided they have properly assessed her capacity, and act in her best interests. The Act provides a checklist for determining best interests.⁶² So the question becomes: is the disclosure of information in the incapacitated patient’s interests? And in many cases it will be.⁶³

Under section 4(7) of the Mental Capacity Act, the doctor has a duty, where practicable, to consult appropriate persons about her treatment. Discussing the condition of an unconscious patient in Casualty and seeking advice on her treatment with colleagues and family members is proper and lawful.⁶⁴ However, where a patient is conscious and objects to disclosure, doctors should be wary of releasing information to the family in her ‘medical interests’. Under section 4, best interests include, but are not limited to, medical interests. The patient’s beliefs, values, and past and present wishes must also be taken into account. Only information that it is essential to share should be disclosed and in general there will no need or justification to give details of past healthcare.⁶⁵ So if a patient is unconscious having suffered serious head and abdominal injuries, it may be lawful to discuss with her family her current condition, and prognosis but not to disclose that examinations show that some years before she had terminated a pregnancy.

Disclosure to protect the patient

4.8 Doctors may sometimes wish to disclose information to protect their patient and the GMC guidance is clear that if a patient who lacks capacity may be at risk of neglect or abuse the doctor must inform⁶⁶ an appropriate person or authority promptly. She must act to protect her patient. What if a patient is vulnerable or very ill, but retains capacity? Consider the dying patient. Not long ago, it was considered acceptable to ignore a patient’s plea to keep knowledge of her illness from her family, or even to ‘spare the patient pain’ by telling her family, but not her, how close she is to death. Earlier GMC guidance expressly allowed doctors, albeit ‘rarely’, to bypass the patient and entrust information which might be upsetting to her to her family. Information could even be withheld from the patient. The GMC today is clear that where the patient retains capacity, information may only be shared with the family with her consent.⁶⁷ There is no legal basis for compassionate paternalism. But what if death or serious injury may result to the patient, for example, the doctor becomes aware that his patient is the victim of escalating domestic abuse but the patient refuses to allow him to contact the police or social services? Can disclosure to protect the patient be made in such circumstances? Paragraph 51 of the GMC Guidance advises:

It may be appropriate to encourage patients to consent to disclosures you consider necessary for their protection and to warn them of the risk of refusing to consent, but you should usually abide by a competent adult’s refusal to consent to disclosure, even if their decision leaves them, but nobody else, at risk of serious harm. [our emphasis]

Note the word ‘usually’ may be seen as allowing for a truly exceptional case. A competent patient is free to refuse advice in his own interests as he is free to refuse treatment even when his life is at risk. Only if the threat to the patient poses risk to others can a competent refusal to disclose information be overruled. So if the doctor reasonably concludes that the husband who has battered his wife repeatedly also poses a risk to the children in the family, he may contact the police in ‘the public interest’ but if the evidence suggests he remains a loving father whose violence is directed only towards his wife, the traditional principles of the common law suggest that he cannot act against the woman’s wishes.⁶⁸

The Social Services and Well-being (Wales) Act 2014⁶⁹ and the Adult Support and Protection (Scotland) Act 2007⁷⁰ expressly require doctors and other agencies to notify local authorities where an adult is at risk of abuse. Section 42 of the (English) Care Act 2014 imposes a duty on local authorities to make inquiries where it has a reasonable suspicion that an adult is experiencing or is at risk of abuse or neglect, but the duty does not extend to doctors.⁷¹ Yet recent Department of Health (England) guidance⁷² on safeguarding vulnerable adults appears to suggest that health professionals not only may but should disclose information to the police or social services if they suspect that a vulnerable patient is suffering abuse or neglect regardless of whether or not she retains mental capacity. Any adult in receipt of healthcare is defined as vulnerable. The guidance illustrates the inevitable tension between a desire to protect patients at risk and respect for autonomy.

Compulsory disclosure

4.9 When a disclosure of confidential information or production of medical records is required by law, the doctor has no choice but to comply, and compulsory disclosure is mandated in a variety of circumstances.

First, a doctor must give any information required by a court.⁷³ Privilege, in the sense of being free to refuse to give evidence relating to professional dealings with clients, is something usually enjoyed by lawyers alone and not shared by any other professional colleagues.⁷⁴ A doctor can be subpoenaed to give evidence about his patient’s health and may be forced to reveal intimate information. He cannot withhold information from the court and he may be ordered to produce the patient’s records. He does not have to volunteer his views or expertise but whatever questions he is asked he must answer. The protection for medical confidentiality in the courtroom lies in the judge’s discretion. Judges will try to ensure that confidence is breached only to the extent necessary for the conduct of the trial. The doctor may be unhappy at having to break trust with his patient. He can be reassured that he is at no legal risk. Any breach of confidence made as a witness in court is absolutely privileged.

In exercising their powers to order disclosure of evidence or documents, courts strive to balance justice and confidentiality, giving due regard to Article 8 of the Convention. In D v NSPCC⁷⁵ the plaintiff sought to compel the NSPCC to disclose who had mistakenly accused her of child abuse. The court refused to make the order. The public interest in people feeling free to approach appropriate authorities to protect young children outweighed the plaintiff’s private interest in unearthing her accuser. Thus there will be some cases where the courts may refuse to help a party seeking to discover who gave damaging information about him to the police or some other authority. The courts may find that the public interest outweighs the private rights of the affected party.

Particularly sensitive information may be allowed to be withheld from the court in the public interest. In AB v Glasgow and West of Scotland Blood Transfusion Service⁷⁶ a Scottish court refused to order disclosure of the identity of a blood donor who had allegedly supplied infected blood. In R (on the application of TB) v CPS and South Staffordshire Healthcare NHS Trust⁷⁷ the High Court held that the Crown Court breached TB’s right to privacy contrary to Article 6(1). TB was a 14-year-old witness in a criminal case against a man alleged to have sexually abused her. The Crown Court ordered disclosure of her medical records relating to psychiatric counselling she had received. In accordance with the Criminal Procedure Rules 2005 (which are under review leading May LJ to confine his decision to the facts), the application was served on the NHS trust, but not on TB. The trust was concerned that releasing the records without giving TB a chance to make oral representations would breach their duty of confidence. In response the Crown Court judge called TB at short notice whereupon, unrepresented, she reluctantly agreed to the disclosure. TB sought judicial review of the Crown Court decision to order disclosure. The High Court held that TB’s right to privacy under Article 8(1) had been breached. Neither was the interference justified within the terms of Article 8(2).

Next, the doctor may be compelled to hand over information to the police or other authorities before any trial commences. Several statutes demand that the doctor answers questions if the police come and ask him. If a statute imposes a duty on ‘any person’ to answer police questions, any person includes a doctor.⁷⁸ His profession confers no exemption or privilege upon him. Where no specific statutory power aids the police in their investigation of a crime the question becomes whether, if they believe a doctor holds records or other material constituting evidence of a crime on the part of a patient, they can search the doctor’s premises and seize the relevant material. The Police and Criminal Evidence Act 1984 grants police access to medical records, but imposes certain safeguards. A search warrant to enter and search a surgery, hospital or clinic for medical records or human tissue or fluids taken for the purposes of medical treatment may be granted only by a circuit judge⁷⁹ and not, as is usually the case, by lay magistrates. The judge is directed to weigh the public interest in disclosure of the material against the general public interest in maintaining confidentiality.

Beyond the scope of the criminal law, several further examples of compulsory disclosure must be noted. Provision is made for compulsory notification of certain highly infectious diseases and of sexually transmitted disease.⁸⁰ Section 45A of the Public Health (Control of Disease) Act 1984 makes expansive provision for compulsory notification of certain specific diseases such as cholera or typhoid and also provides that doctors should notify the appropriate authorities of any infection or contamination that ‘presents or could present significant harm to human health’.⁸¹ Successive governments resisted pressure to make HIV/AIDS a notifiable disease.⁸² Again the question is one of balancing the competing public interests, the interest in patients seeking advice and treatment for disease, and the interest in protecting the health of those at risk from infection. HIV is not in the same league as diseases such as cholera. The cholera carrier immediately places his casual contacts at risk; if he is untreated, he can do little to minimise that risk. Cholera spreads like wildfire. HIV is much less infectious, and by acting responsibly, the patient can reduce the risk to others. To act responsibly he needs professional help and should not be deterred from seeking help by fear that his doctor will be forced to ‘squeal’ to the authorities.

Abortions must be reported. Details of drug addicts are required under the Misuse of Drugs Act 1971. Births and deaths have to be notified by doctors as well as registered by families.

Finally, a number of organisations concerned with health administration may require information in the course of performing their functions. These include the NHS Ombudsman, the Department of Health and other NHS authorities.⁸³ Examining the individual items on the long list of circumstances when a doctor can be forced to hand over information concerning his patients, many can be justified on grounds of public interest. The trouble is that the list grows haphazardly.

Section 251 of the National Health Service Act 2006 (previously section 60 of the Health and Social Care Act 2001), grants the Secretary of State further powers to dilute patient confidentiality providing that:

(1)  The Secretary of State may by regulations make such provision for and in connection with requiring or regulating the processing of prescribed patient information for medical purposes as he considers necessary or expedient –

(a)  in the interests of improving patient care, or

(b)  in the public interest.

The Health Service (Control of Patient Information) Regulations 2002⁸⁴ implement this power. In a concession to opponents of the move, a Patient Information Advisory Group (PIAG) was initially established with whom the minister was required to consult on any regulations to be made under Section 60. The PIAG was replaced first by the Ethics and Confidentiality Committee of the National Information Governance Board for Health and Social Care and subsequently (in 2013) by the Confidentiality Advisory Group (CAG) of the Health Research Authority.⁸⁵ CAG approval is subject to review every twelve months.

Disclosure in the public interest

4.10 As we have seen, the case law makes it clear that the public interest can justify disclosure of confidential information without consent.⁸⁶ Article 8(2) sets out a list of exceptions to the right to respect for privacy, a list that, at first sight, looks broad enough to encompass a host of exceptions to the rule. So we need to examine carefully just when a competing public interest is sufficient to outweigh the public interest in medical confidentiality. The GMC explains the public interest in disclosure as designed ‘to protect the individual or society from risks of serious harm, such as serious communicable diseases or serious crime or to enable medical research education or other secondary uses of information that will benefit society over time’.⁸⁷ We deal with the use of information for research and other secondary purposes in Chapter 15. Our focus here is on disclosure to protect individuals and society from harm. The doctor is faced with a balancing exercise weighing the harm done to the patient and the pubic trust by breaching confidence against the harm posed to others by the patient if he fails to act. A simple example will illustrate the point. A patient whose sight is failing and who has had several mini strokes insists on continuing to drive. She refuses to accept that she is medically unfit to drive, or to contact the Driver and Vehicle Licensing Agency (DVLA). She poses a risk of death or injury to other road users whenever she is out on the road. The GMC advises doctors that in such a case they not only may, but should, contact the DVLA.

Serious crime

4.11 An obvious example of a public interest justifying breach of confidence is the prevention of crime. But does this include any suspicion of a criminal offence that a doctor may learn of in the course of caring for his patients? When may, or must, doctors inform the police about criminal conduct on the part of a patient? If fifteen years after the event, and plagued by guilt a depressed patient confesses to non-violent crimes committed in her youth, is her doctor obliged to inform on her? Contrary to popular myth, a doctor is under no general obligation to contact the police. Unless a statute specifically so provides, a doctor does not commit any offence by failing to tell the police of any evidence he may have come across professionally which suggests that a patient may have committed, or is contemplating some crime.⁸⁸ A criminal offence is usually committed only when a doctor or anyone else accepts money to conceal evidence of crime.⁸⁹ Section 19 of the Terrorism Act 2000 imposes a duty on everyone, including doctors, to inform the police if they believe or suspect certain offences concerning funding terrorist activity have been committed.⁹⁰ There are several Acts of Parliament that require doctors to disclose information if asked to do so by police,⁹¹ but they are not compelled to volunteer that information. In many cases, a doctor will nonetheless judge that he should do so where others are at risk and in its latest guidance the GMC sometimes imposes a professional obligation to contact the police.

If a doctor has reason to believe that the patient or a third party may commit a serious crime placing others at risk then, as with Dr Egdell, the doctor may lawfully contact the police or other appropriate authorities. So if a doctor makes a judgement that a new mother with acute postnatal depression is likely to harm her baby and he cannot persuade her to seek help, he acts lawfully in contacting social services and even in extreme cases the police and/or her family to protect the child. Many disclosures to prevent crime will however entail a breach of confidence with someone other than the ‘criminal’. A rape victim refuses to go to the police but the evidence of the brutal attack on her indicates that other women may be at risk. In such cases, disclosure may be justifiable and the GMC advises doctors that of others are at risk from offenders using weapons or from domestic violence then the patient’s refusal to involve the police may be overridden.⁹² In relation to gunshot and knife wounds, the GMC goes further and requires doctors to contact the police swiftly and make a judgement as to whether they also need to disclose personal details about their patient (the victim) including his identity.⁹³ In practice there would seem to be little the police could act on without such personal information and the GMC is virtually mandating disclosure in such cases.

What of cases where the public interest is not so much in the prevention of crime, but in the detection or prosecution of crime? The Serious Crimes Act 2015 ss 70–75 requires health and social care professionals to report cases of female genital mutilation in girls under eighteen. In many other cases, the choice remains the doctor’s The judges early last century were divided on the issue of whether a doctor was justified in going to the police after attending a woman who had undergone a criminal abortion. Hawkins J condemned such a course as a ‘monstrous cruelty’ and doubted whether such a breach of confidence could ever be justified,⁹⁴ where Avory J saw the doctor’s duty to assist in the investigation of serious crime as always outweighing his duty to his patient.⁹⁵

In the context of confidential relationships outside the medical field, some case law would suggest that the public interest justifies disclosure of any crime or misdeed committed or contemplated.⁹⁶ Within the doctor–patient relationship, should freedom to disclose in the public interest be more limited in scope? Unless commission of any crime disentitles the patient from normal standards of medical care, disclosure should be strictly limited. Doctors who suspect that another person is at risk of physical injury at their patient’s hands must be free to act to protect that person. Preventing harm to others outweighs the private and public interests in confidentiality. Volunteering evidence of less serious crimes, or crimes committed long ago, to the police may be seen as less straightforward. The GMC advises that disclosure is defensible in relation to serious crime,⁹⁷ ‘especially crimes against the person’. What the doctor should not do is hand over to the police information on each and every patient who transgresses the law. Parliament has legislated in numerous cases to compel breach of medical confidence. The courts should not be zealous to add to that list.

The flaw in this argument is whether a doctor found to be in breach of confidence for disclosing a crime could be condemned by a court for taking steps to combat crime, performing a moral duty cast on every citizen. The doctor is distinguished from other citizens by the presence of a positive legal duty to his patient. Enforcing his duty to his patient benefits the public as well as the patient. The Court of Appeal has robustly recognised a public interest in the maintenance of medical confidentiality.⁹⁸ Medical confidentiality is at the root of good healthcare. Should the courts, however, find that as upholders of the law they cannot condemn those who help bring lawbreakers to justice, the alternative solution is to fall back on the professional standard set by the GMC, and hold that breach of confidence is justified only in case of serious crime. The doctor may not break the law if he discloses details of petty crimes. He may be held accountable for professional misconduct. The legal and ethical standards do not need to be exactly the same.

Serious communicable diseases

4.12 Section 11 of the Public Health (Control of Disease) Act 1984 requires doctors to notify the proper authorities about certain infectious diseases but can doctors go further and warn those individuals who might be at risk from a patient with a serious communicable disease? May a GP alert a wife to the fact that her husband is HIV-positive? The GMC advises that doctors may (not must) disclose such information to known sexual contacts.⁹⁹ Doctors are urged to do all they can to persuade the infected person to inform sexual partners. If persuasion fails, then the doctor should consider whether he should inform any sexual partner at risk of infection. Would the law support a doctor who did so? In defamation, a defence protects any communication which the maker has a duty to impart and the recipient a legitimate interest in receiving. This defence does not apply in breach of confidence.¹⁰⁰ Here, the defence is that the public interest demands disclosure. Private interests alone are not usually enough. However, where a genuine risk of physical danger, of injury or disease is posed to any third party, the public interest in individual security is sufficient to justify disclosure to that person so that she can protect herself appropriately. When the doctor reasonably foresees that non-disclosure poses a real risk of physical harm to a third party he ought to be free to warn that person, especially if that person is also his patient. Courts should not be overzealous to prove him wrong. Similarly, in such cases, if the doctor thinks it more appropriate to contact the third party’s GP, he should not be condemned. Nonetheless, risk of harm must be established. A simple belief that someone else, spouse or relative, is entitled to information is insufficient, even if they have an interest, and not merely a prurient interest, in the matters at stake.¹⁰¹ That is not enough. The balance of public interest in favour of preserving confidentiality should be displaced only by a significant danger of physical harm.

And what of the risk a doctor may pose to patients? As we have seen in X v Y, the judge granted an injunction banning an account in the media of two GPs diagnosed as HIV-positive on the basis that the risk to patients in that case was negligible. There was no public interest in disclosure founded on the protection of others. That does not mean that it is never in the public interest to disclose information relating to individuals who have a serious communicable disease and pose a risk of transmission to others. It is not uncommon for surgeons to cut themselves in the course of surgery so that there is blood-to-blood contact between surgeon and patient. Certain forms of surgery, now styled exposureprone procedures, carry a risk of cross-infection.¹⁰² Such a risk is not limited to HIV. Hepatitis B¹⁰³ for instance is much more infectious than HIV but transmitted in the same manner. Other diseases with different modes of transmission may endanger patients, for example a health worker with untreated TB places all her patients at risk. The GMC gives very specific guidance¹⁰⁴ to doctors treating fellow health workers whose own ill health may endanger their patients either because they suffer from disease that they might pass on to patient or because their judgement or performance may be impaired, eg by the onset of a neuro-degenerative disease. First, the affected worker has an obligation to seek and follow advice to protect his patients,¹⁰⁵ but if he fails to do so the doctor treating him should inform the health worker’s employers or contracting body, or where appropriate the relevant regulator.¹⁰⁶ When there is a real risk of transmission of disease or a health professional’s illness renders him unsafe to practise, the public interest in patient safety prevails, and the doctor acts lawfully in bringing the risk to the attention of those authorities charged to protect patient welfare.¹⁰⁷

Freedom of the press

4.13 We have seen that, exceptionally, doctors may disclose information about patients with serious communicable diseases to protect others. The common law and Article 8(2) prioritise the protection of those others. What effect however does Article 10 of the ECHR have in such cases? Can the media rely on the right to freedom of expression in making public debates about HIV or other burning issues that could compromise patient confidentiality? Openly identifying an individual healthcare worker who is HIV-positive is highly unlikely to be lawful. A more difficult question arose in H (A Health-care Worker) v Associated Newspapers Ltd and N (A Health Authority).¹⁰⁸ H tested positive for HIV while working as a healthcare professional for a health authority, identified in court proceedings only as N. The health authority proposed to carry out a ‘look back’ exercise to notify patients treated by H and invite them to undergo HIV testing if they so chose. H sought an injunction to prevent N from notifying his patients and carrying out the ‘look back’ study. He provided details of at least some of his NHS patients with the utmost reluctance, and refused to supply any information about his private patients. H argued that, in his particular case, the risk to patients of HIV was so low that it did not justify breach of his or his patients’ clinical confidentiality.

Before H’s case against the health authority could be heard, the Mail on Sunday heard about the case. The newspaper planned to publish a story about H’s condition and his dispute with the health authority. He sought a second injunction to prevent publication of any details identifying him personally, or identifying either the health authority that employed him or his medical speciality. A temporary injunction was granted to him in the terms he sought. The newspaper retaliated with the headline ‘Judge’s Gag over Aids Threat to Patients’.

Gross J upheld the ban on publishing details of H’s identity, but would have allowed publication of the health authority’s identity and H’s speciality. H appealed. He argued that if the nature of his speciality and the name of his employing authority were in the public domain, he himself would be readily identifiable by a significant number of people, including some of his patients. The Court of Appeal acknowledged that H’s case involved a difficult balancing exercise. They concluded that a ban on identifying the health authority should be imposed. Disclosing N’s (the health authority’s) identity would be likely to ‘set in train a course of events’ that could result in disclosure of H’s identity and compromise his first action against the health authority to prevent the health authority conducting the ‘look back’ study. Patients might also be harmed by discovering the risk to themselves without immediate access to proper advice and counselling. The appeal court, however, was not convinced that a ban on identifying H’s speciality was necessary. Such a restraint would inhibit legitimate debate on a matter of public interest. The Court of Appeal in H granted more weight to the interest in freedom of expression and public debate about the risks of HIV transmission and infected health workers than Rose J did in X v Y.

The influence of Article 10 of the European Convention on Human Rights (guaranteeing freedom of expression) is plainly seen in Press Association v Newcastle upon Tyne Hospitals Foundation Trust,¹⁰⁹ when the Court of Protection lifted reporting restrictions after the death of a Jehovah’s Witness who had refused a blood transfusion. However, in W v M (An Adult Patient)¹¹⁰ the mother, sister and partner of a woman in a minimally conscious state indicated they would be likely to drop their case if the press intruded on their privacy. The Court of Protection had to consider whether it was lawful to withhold M’s artificial nutrition, so the matter was clearly of public importance. Baker J held that the claims under Article 8 of M and her family took priority over Article 10 rights of freedom of expression and reporting restrictions were imposed.

Genetic information and confidentiality¹¹¹

4.14 Especially difficult questions touching on medical privacy arise in relation to genetic screening and genetic counselling. This is a complex subject to which we can give only cursory attention.¹¹² Consider the following scenario: genome sequencing of a patient is undertaken in the hope of identifying the cause of a mild chronic condition. The test reveals ‘incidental’ information: the patient is at risk of hereditary breast cancer. We might agree that the doctor should pass on this information to the patient, especially if it will allow the patient to take precautions against breast cancer. But what if the patient has specifically requested that such information is not disclosed? Article 10(2) of the Oviedo Bioethics Convention states:

Everyone is entitled to know any information collected about his or her health. However, the wishes of individuals not to be so informed shall be observed.¹¹³

Uncertainty surrounding the extent of the right not to know, its conceptual origins and relevance beyond genetics – to end-of-life care and healthcare research, for example – are the subject of much debate.¹¹⁴

Tests which reveal that the individual patient suffers from or is a carrier of a genetic disease often indicate that other family members are at risk of the same disease.¹¹⁵ Consider another example. Jenny, a medical student, having completed her initial course in genetics, becomes concerned about her family history. There appears to be a pattern of paternal relatives succumbing to dementia and premature death. After counselling, she consents to a test for Huntington’s chorea. The test proves positive. Huntington’s is an autosomal dominant genetic disease which means that if a parent has the affected gene, any child has a 50 per cent chance of inheriting Huntington’s. The disease does not manifest itself until early middle age when the affected person succumbs over several years to progressive dementia and early death. Jenny’s diagnosis necessarily means that one of her parents must also have the affected gene, and that each of her siblings is at 50/50 risk, as will be any child whom Jenny may bear. If Jenny refuses to consent to genetic counsellors contacting her family, would the interests of those family members justify a breach of confidence? If Jenny’s elder brother had just married and he and his wife were hoping to start a family, would the potential harm to the child justify disclosure?¹¹⁶ The 2009 GMC guidance¹¹⁷ suggests that in rare cases the doctor may overrule the patient’s refusal to share information with relatives at risk ‘[F]or example where family relationships have broken down or natural children have been adopted’. Breach of confidence might be justified by a duty to protect the at-risk relative from serious harm. Some thought needs to be given to what constitutes harm. Telling Jenny’s parents that one of them has Huntington’s may itself cause harm. They may prefer to remain in ignorance, and as there is no cure for Huntington’s their knowledge will not assist them to avoid or minimise the impact of the disease.¹¹⁸ Contrast this scenario with another. If one sister tests positive for the BRCA 1 gene, there is a 50 per cent chance that any sister of hers will also carry the gene and women with the gene are at 80 to 85 per cent risk of developing breast cancer. Regular screening and even an elective mastectomy can reduce the risk substantially. In this example it seems more likely that informing the sister at risk is justifiable to avoid serious harm as her health and life are at stake.¹¹⁹

Heather Widdows¹²⁰ has argued that individualistic ethical frameworks are flawed in the context of genetics – a view shared by an increasing number of ethicists. Lucassen and Parker have proposed a solution to the dilemmas posed by familial interests in genetic information.¹²¹ According to their ‘joint account’ model, some types of genetic information are akin to a joint bank account and one family member cannot bar access to another. Their model has found much support.¹²²

Genetic privacy¹²³

4.15 Genetic information also helps us note the limits of confidentiality and that it falls short of a guarantee of privacy. An obligation of confidentiality binds the recipient of the confidence to keep private information secret. Imagine this scenario. X undergoes genetic tests to establish whether she has a gene rendering her susceptible to breast cancer. The test proves positive. A potential employer or insurer seeks to ascertain if she has undergone such a test and to find out the results. Doctors breach confidence if they release test results without the patient’s consent. So the employer or insurer will simply demand that information from the patient herself. She is free to refuse to divulge her test results. The consequence will be that she is turned down for the job, or refused insurance. Her ‘right’ to privacy means little. Genetic information is becoming more and more important in everyday life, as understanding of the role genetics play in disease increases. Knowledge will enable individuals to lower their risk by adapting their lifestyle. It is already possible for a person to have the whole of her genome decoded.

Could Article 8 establish a right to keep personal information secret and make it unlawful to ask X questions about genetic test results? Alas, an employee or insurer may seek to invoke one of the justifications for violating privacy set out in Article 8(2). In X’s case, where what is established by tests is a susceptibility to breast cancer, a ‘defence’ based on the protection of the health or freedom of others invoked by an employer is unlikely to succeed. Were she a potential airline pilot with a genetic susceptibility to heart failure the balance of argument might be different. Another argument that might be advanced in X’s particular case might be on protection of ‘economic well-being’. Can employers or insurers be forced to take on poor risks? Note though that Article 8(2) speaks of the economic well-being of the country, not of individual businesses. A further twist to the tale is this. Does X’s daughter have any right to information about X? Could she argue that her right to life (Article 2) and ‘family life’ (Article 8(1)) impose an obligation on X to disclose information to her, to inform her decisions about whether to seek genetic testing?¹²⁴ Defining the scope of a right to medical privacy will prove more difficult than establishing that such a right exists.

Being able to control access to genetic information is important and if employers and insurers have unrestricted access to genetic information, the risk arises of the creation of a genetic underclass who struggle to find work and cannot for example gain the life insurance that any sensible person wants before taking on a mortgage. UK insurance companies have agreed a voluntary moratorium on seeking access to genetic test results in relation to life insurance policies worth less than £500,000, income protection policies worth less than £30,000 a year and other insurance policies worth less that £300,000.¹²⁵ In relation to policies above the higher thresholds, the only government test approved (at the time of writing) is for Huntington’s. Should we have laws to protect genetic privacy? Section 45 of the Human Tissue Act 2004 already outlaws the taking and analysis of DNA samples without consent. Or would it make sense to legislate more generally to safeguard medical privacy? As we shall see (at 4.18), a draft Data Protection Regulation is likely to come into force in 2018. Article 81a makes, for the first time, express provisions concerning the processing of genetic data. Draft Article 4(10)¹²⁶ defines genetic data and subjects it to requirements of lawful processing under draft Articles 9(1) and (2).

Liability for failure to disclose

4.16 There are clearly circumstances when the doctor’s duty of confidence to his patient may be overridden by his duty to safeguard a third party from serious harm. If he mistakenly decides the question of this conflict of duty in the patient’s favour, and the risk of harm to someone else materialises, is the doctor at risk of a lawsuit by the injured party? In a highly publicised case in the USA, the student medical centre at the University of California was held liable for failing to warn a young woman of the risk posed to her by one of their patients.¹²⁷ The girl’s rejected lover sought psychiatric help at the centre. He told staff there of his violent intentions towards the girl and that he had a gun. The staff warned the campus police, who decided to take no action. The medical centre said nothing to the girl. She was murdered by their patient soon afterwards. Her family sued the university for negligence. The medical centre was found liable for failing to breach their patient’s confidence and warn the girl of the threat to her life.

On similar facts, we suggest that an English court would be less likely to find a doctor negligent. First the court would have to determine whether, given the value attached to medical confidentiality, a duty to breach confidence could be countenanced; the conflict of duty facing the doctor is stark.¹²⁸ Remember however that the GMC has in a number of instances made it clear that the doctor not only may, but should, act to disclose information to protect others at risk from the patient. So if a GP knowing that his patient is a surgeon with a neuro-degenerative disease impairing her manual dexterity, fails to act to protect patients at risk, and the surgeon accidentally cuts into an artery could the injured patient sue the GP? Might the patient argue that the failure to protect him was itself a breach of his Article 8 rights?¹²⁹ Courts in England are reluctant to make any defendant liable for a wrong committed by an adult and independent third party, unless he either had a special responsibility to exercise control over that third party or a special relationship with the claimant to safeguard him from harm at the hands of that third party.¹³⁰

Data Protection Act 1998

4.17 The Data Protection Act 1998 implemented the 1995 Data Protection Directive.¹³¹ The Act offers additional statutory protection to control the use and processing of all forms of ‘personal data’.¹³² This includes all medical and health records whether the records are manual or computerised. The individual about whom information is held is designated the ‘data subject’, and the person or organisation responsible for holding that information is styled the ‘data controller’. The 1998 Act applies to all kinds of information held about us, not just health records. We are, however, concerned here only with its application to health records. ‘Health records’ are defined as:

any record which consists of information relating to the physical or mental health or condition of an individual, and has been made by or on behalf of a health professional in connection with the care of an individual.¹³³

‘Health professional’¹³⁴ is broadly defined to include doctors, dentists and nurses. The Act is lengthy, complex and not compelling reading. The fundamental points to emphasise are these. Any processing¹³⁵ of data including alteration of health records, retrieval of or use of records, disclosure or erasure of records must be done in conformity with the Act. Any ‘personal data’ from a health record that is information relating to a living and identifiable patient are subject to stringent controls. Whenever such data are processed one at least of the conditions of Schedule 2 of the Act must be met. These include that the patient gave consent to processing, or that processing is necessary to protect the ‘vital interests’ of the patient, or necessary in the administration of justice, or for the purpose of legitimate interests of the data controller. Consent need not be explicit. Notices in GP surgeries and clinics about possible uses of information may suffice. A broader range of justifications for disclosure than the common law allows is sanctioned by Schedule 2.

However health records fall within the category of ‘sensitive personal data’ granted additional protection by the Act. ‘Sensitive personal data’ is defined to include any information about a person’s physical or mental health or condition. ‘Sensitive personal data’ may only be processed, and therefore only disclosed, either with the explicit consent of the patient or in the following circumstances. (Specific provision is made in relation to research and we address this later in Chapter 15). What follows is not an exhaustive list but includes:

(1)  to protect the vital interests of a patient who cannot consent on his own behalf, or where the data controller cannot reasonably be expected to obtain consent, or to protect the vital interests of another person where the patient has unreasonably withheld consent to disclosure;

(2)  in connection with the administration of justice, or disclosure is required by law;

(3)  for medical purposes by a health professional which involves only disclosure to another person bound by a similar duty of confidentiality.

The Secretary of State is empowered to add further conditions allowing the lawful processing of ‘sensitive personal data’. He has done so inter alia to allow the disclosure of health records in professional disciplinary proceedings involving health professionals, and to allow various NHS authorities to investigate mismanagement or malpractice. A wide all-embracing provision allows processing without consent where it is in the substantial public interest and necessary for the discharge of any function designed to protect the public against dishonesty, malpractice or service failure and must necessarily be carried out without the explicit consent of the patient ‘so as not to prejudice the discharge of that function’.

The range of exceptions to the duty of non-disclosure under the Data Protection Act mean that its scope is little greater than the obligation of confidentiality imposed by common law. The force of the 1998 Act lies in its remedies. A patient suspecting misuse of his health records can apply to the data controller to cease processing records when what is being done is or is likely to cause him substantial and unwarranted damage or distress.¹³⁶ Most crucially section 14 of the Act allows a patient to apply to the court to correct inaccurate health records. He can act to ensure that misinformation about his health is not perpetuated for all time. A person who has suffered damage or distress as a consequence of violation of the Act has a right to compensation. He does not need to prove financial loss. However, the data controller may in defence of such a claim establish that he had taken all reasonable care to comply with the Act.¹³⁷

The Information Commissioner’s Office (ICO) can prosecute those in breach of the Act or issue monetary penalty notices of up to £500,000. One health board was fined £70,000 after a letter containing sensitive information about a person’s health was sent to a person with a similar name to the intended recipient.¹³⁸ In 2012 the ICO fined a trust £325,000 when an individual tasked with destroying around 1,000 hard drives containing confidential patient data sold some of them into the public domain.¹³⁹ The ICO responds to complaints and can assess good practice by entering with consent under section 51(7) of the Data Protection Act. The ICO’s powers were enhanced in 2015 when its compulsory audit powers – until that point reserved for government departments – were extended to NHS organisations.¹⁴⁰

An EU Data Protection Regulation

4.18 The Data Protection Directive was formed when the Internet was in its infancy. Interpreted by each Member State in national legislation, it has resulted in inconsistency between nations. Efforts to reform the regulatory regime began in 2010 and the first version of a draft regulation was released by the European Commission in 2012.¹⁴¹ The Regulation, expected to be in force by 2018, will replace Directive 95/46/EC. The Regulation will form a pan-European law, harmonising the legal regime. A draft text was agreed in 2015 following lengthy negotiations between the European Commission, the European Parliament and the Council of the European Union.¹⁴² At the time of writing, the draft awaits approval before it is passed into law.

The scope of the proposed Regulation will be wider than that of the Directive, applying to data subjects in the EU, even if the data controller is established outside the EU. The definition of ‘personal data’ is also widened, incorporating in Article 4(1) any information relating to an identified or identifiable natural person. Articles 15–17 will protect rights to access, rectification and erasure and Article 30 will protect data security. Personal data breaches must be communicated both to the authority (Article 31) and (where there is high risk to the rights and freedoms of individuals) to the data subject (Article 32).

The agreed 2015 draft made a number of compromises, particularly around the need for explicit consent. Consent is defined in Article 4(8) as: ‘freely given, specific, informed and unambiguous indication of his or her wishes by which the data subject, either by a statement or by a clear affirmative action, signifies agreement to personal data relating to them being processed’. The onus will be on the data controller to prove that consent is in place. A right to withdraw consent will be safeguarded by Article 7(3). Consent of a parent will be required where the child is under 16 years old (or, if the Member State sets a lower age, it should not be below 13 years of age). Article 20 contains (subject to narrow exceptions) a right ‘not to be subject to a decision based solely on automated processing, including profiling’. These measures will require significant changes in the way consent is obtained and recorded.

The right to be forgotten

4.19 Article 14 of Directive 95/46/EC incorporates a right to object to the processing of personal data. Article 17 of the draft Regulation proposes to strengthen this right to form a ‘right to be forgotten’; a right recently acknowledged in a landmark ruling of the European Court of Justice which held in 2014 that links from Google search results to irrelevant and outdated data should be erased on request.¹⁴³ Mario Costeja González, a Spanish national, sought the removal of links by Google Spain to a 1998 auction notice of his repossessed home on the website of La Vanguardia, a national newspaper. The judges regarded Google Spain as a data controller, responsible for the content of its links and required that the links be removed.

The ruling has implications for doctors who were once subject to an online complaint, disciplinary proceeding or investigation by the GMC which is revealed in a search of their names. Doctors might rely on the right to be forgotten in requesting that links to webpages which ‘appear to be inadequate, irrelevant or no longer relevant or excessive … in the light of the time that had elapsed’ be removed. Each case will be considered on its facts, balancing privacy and the public interest and it should be noted that removal of the link does not affect the webpage itself. The right to be forgotten will not, however, apply to data processed for health services. Retention of health records is important for both individual and public health.

Anonymised data

4.20 Most of what has been said so far relates to information from which the identity of the patient can be ascertained. For many purposes however anonymised data about patients and their diseases is needed or wanted by diverse organisations. The government is putting increasing amounts of information in the public domain. The ICO has responded to the ‘big data revolution’ with a code of practice on anonymisation.¹⁴⁴ Anonymised information may be necessary to carry out clinical audits, or to compile statistics about health needs, or for epidemiological purposes. Many of us might applaud such purposes. Commercial organisations such as drug companies may also seek access to such information to help them with marketing or product development. The GMC gives extensive advice on anonymising data and its disclosure.¹⁴⁵ It urges doctors to explain to their patients how such data are used and what benefits flow from exchange of information. Does the duty of confidentiality apply to anonymised information?

In R v Department of Health ex p Source Informatics Ltd¹⁴⁶ the applicants were a data collection company. They persuaded GPs and pharmacists to supply them with anonymised information about prescribing habits. They then sold this information to drug companies. The Department of Health issued a document ruling that to disclose such information without patient consent constituted a breach of confidence. The company challenged the ruling. The trial judge found that anonymisation did not remove the obligation of confidence. Transfer of anonymised data might in certain cases be justifiable, for example, to ensure clinical audit, but information about patients was in all cases confidential, whether the patient was identifiable or not. The Court of Appeal disagreed. Disclosure of anonymised information, the appeal court ruled, did not violate the interests which obligations of confidentiality protect. The patient’s privacy is not violated. He is not vulnerable to any harm. Patients have no property in information about them. Ethical safeguards now surround anonymised data. The law restricts itself to controlling information about us only where we can be identified. GPs, pharmacists and drug companies may still profit from information derived from us.¹⁴⁷

The Health and Social Care Information Centre

4.21 The Health and Social Care Act 2012 created a new non-departmental public body: the Health and Social Care Information Centre (HSCIC).¹⁴⁸ Based in Leeds, it is England’s central source of health and social care information for secondary use. The data released are designed to benefit the community by providing measurements for research, planning, commissioning, performance and success.¹⁴⁹ The HSCIC can require providers to send certain data, including confidential data,¹⁵⁰ to the Centre, which it then processes and publishes in the form of statistics, health indicators, reports and audits.¹⁵¹ Confidential information can only be released where there is a legal basis for doing so. In all other cases, the data are processed in the secure environment of the Centre, and published in a form which reduces or eradicates the risk of the patient being identified. The HSCIC issues a Code of Practice on confidential information,¹⁵² setting out five rules:

1.  Confidential information about service users or patients should be treated confidentially and respectfully.

2.  Members of a care team should share confidential information when it is needed for the safe and effective care of an individual.

3.  Information that is shared for the benefit of the community should be anonymised.

4.  An individual’s right to object to the sharing of confidential information about them should be respected.

5.  Organisations should put policies, procedures and systems in place to ensure the confidentiality rules are followed.¹⁵³

Interestingly, Rule 4 goes beyond the requirements of the Health and Social Care Act 2012, which attracted criticism for its failure to require consultation with patients (where practicable) where disclosure is not designed to benefit them directly.¹⁵⁴ The rules make an admirable attempt to restate the complex and sometimes ambiguous legal provisions discussed in this chapter in a simple and applicable format. Naturally there are caveats explored in the Code. For example, Rules 1 and 4 are subject to any legal requirements to provide information. And Rule 3 is dependent on the level of anonymisation deemed necessary given the value of the data, the likelihood of reidentification and the risks posed by the environment into which the data are released. The Code differentiates between anonymised and de-identified information. In the latter case, the individual may be identifiable if controls are not put in place. The Code also recognises that there may be ‘exceptional circumstances’ where confidential information must be used, but requires that there must be a legal basis for doing so (informed consent, legal obligation or disclosure in the public interest).

Care.data

4.22 Since the 1980s, information on hospital admission has been collated. In a move to establish a more comprehensive central database of patient information, NHS England commissioned the care.data programme. The programme aims to extend the database to primary care data. The data collected would then be used to improve patient care, for research and possibly (and controversially) for sale to pharmaceutical companies. NHS England confirmed phased roll-out from 2015.

GP practices are required to send confidential data to the Health and Social Care Information Centre – they cannot opt out. It is up to patients to opt out if they wish to do so.¹⁵⁵ This has resulted in criticism on two grounds. First, some argue that patients should opt in before their data is extracted. This is because it is not (at the time of writing) clear that data will be anonymised at source and because data will not be used for the direct benefit of patients. Recall, however, that the HSCIC is considered a secure environment for the processing of confidential data. The Data Protection Act is satisfied, provided the data are processed fairly. This brings us to the second criticism: the Department of Health considers fairness to be assured provided that patients are properly informed and have the opportunity to opt out.¹⁵⁶ A leaflet campaign did not prove sufficient in this regard. Care.data was twice delayed. A Select Committee Inquiry was launched in 2014.¹⁵⁷ The HSCIC is, at the time of writing, developing a new secure data platform to reassure the public.¹⁵⁸ New and improved methods of communication and education have been instigated.¹⁵⁹

Patients’ access to records¹⁶⁰

4.23 We turn now to the opposite side of the coin. Patients expect their doctors to keep their secrets. Can doctors have secrets from their patients? The law relating to confidentiality prevents doctors from improperly disclosing information from or about their patients. What if the patient seeks information about herself? When can a patient demand to see her records?

An attempt to assert a common law right of access to all health records failed in 1995.¹⁶¹ Until 1998 the statutory picture was confusing. Access is now governed by the Data Protection Act 1998.¹⁶² Section 7 of the 1998 Act establishes a right for data subjects to have access to all personal data relating to them held by the data controller. For our purposes this means that patients have a prima facie right to access of all their health records whether manual or computerised. However, the 1998 Act, like its predecessors, allows the Secretary of State to exempt or modify rights of patient access to health records.¹⁶³

Access is not unlimited. Certain sorts of information held for research, historical or statistical purposes are exempted from access. Special rules are laid down where information about a patient also discloses information about some third party. A host of other exemptions and limitations apply. Most crucially, access to health records may be refused where release of information would be likely to cause serious harm to the physical or mental health or condition of the patient¹⁶⁴ or any other person.¹⁶⁵ In deciding whether to refuse access, NHS authorities are required to consult the health professionals currently responsible for the patient’s care.¹⁶⁶

On the face of it such exclusions from rights of access seem reasonable. A patient whose mental health is fragile and who may be devastated by a full account of his diagnosis and prognosis may be thought to be ‘better off’ not knowing the true state of affairs. Of course, when he is refused access he may imagine an even worse scenario. The crux of the problem though is the way in which relevant NHS authorities and doctors, in particular, will use the exclusions. Suppose a patient is diagnosed as having terminal cancer. His doctor decides not to tell him, and advises the health authority to refuse access to records because he judges that the patient could not cope with the truth. What can the patient do? Section 7 of the Data Protection Act allows him to apply to the court, so a judge can decide if access has been improperly refused.

Finally, the access provisions of the Data Protection Act 1998 apply only to living patients. Consequently a small part of the Access to Health Records Act 1990¹⁶⁷ is preserved to enable executors of a deceased person’s estate or members of his family to gain access to his records in an appropriate case.

One of the aims of the draft Data EU Protection Regulation is to improve access to data, for patients, researchers and carers alike. Hopes for the draft Regulation are high. By creating a new ‘digital single market’, the Regulation aims to establish confidence in e-services, improve enforcement of data protection and facilitate economic growth. It will harmonise conditions for health data processing so as to reduce fragmentation and bring in a new era of cross-border health services and eHealth applications. But four years on from the publication of the draft EU Regulation, we can safely assert that progress is slow. The law is several steps behind the brave new big data world.

¹  GMC, Confidentiality (2009), accessible at www.gmc-uk.org/guidance/ethical_guidance/confidentiality.asp. At the time of writing, the 2009 guidance is under review.

²  The Children Act 2004, s 11 places a duty on NHS trusts (and others) to make arrangements to ensure that ‘their functions are discharged having regard to the need to safeguard and promote the welfare of children’.

³  See, generally, R Pattenden, The Law of Professional–Client Confidentiality: Regulating the Disclosure of Confidential Personal Information (2003) Oxford University Press.

⁴  See Law Commission Report No 110, Breach of Confidence, Cmnd 8388, para 3.1.

⁵  F Gurry, Breach of Confidence (1984) Clarendon Press, chs 8 and 9.

⁶  Argyll v Argyll [1967] 1 Ch 302.

⁷  Stephens v Avery [1988] 2 All ER 477.

⁸  Attorney-General v Jonathan Cape Ltd [1976] 1 QB 752.

⁹  Wyatt v Wilson (1820), unreported but referred to in Prince Albert v Strange (1849) 41 ER 1171, at 1179.

¹⁰  Hunter v Mann [1974] 1 QB 767, at 772.

¹¹  Z v Finland [1997] 25 EHRR 371.

¹²  MS v Sweden [1997] 45 BMLR 133.

¹³  [1997] 25 EHRR 371, [95].

¹⁴  Wainwright v Home Office [2003] 3 WLR 1137. And see Douglas v Hello! Ltd [2007] UKHL 21, [272].

¹⁵  Campbell v Mirror Group Newspapers [2004] UKHL 22, [14]. The term has since been adopted in a number of cases, such as Hutcheson (formerly KGM) v News Group Newspapers Ltd [2011] EWCA Civ 808, [22] and Vidal-Hall v Google Inc [2015] EWCA Civ 311.

¹⁶  [2004] UKHL 22, [157].

¹⁷  [2004] UKHL 22, [86].

¹⁸  W v Egdell [1990] 1 All ER 835, at 846, CA; Campbell v Mirror Group Newspapers [2004] UKHL 22.

¹⁹  Campbell v Mirror Group Newspapers [2004] UKHL 22.

²⁰  Cornelius v De Taranto (2001) 68 BMLR 62.

²¹  [1990] 1 AC 109.

²²  Ibid, at 281.

²³  Campbell v Mirror Group Newspapers [2004] UKHL 22.

²⁴  Ibid, [21] per Lord Nicholls.

²⁵  GMC, Confidentiality, paras 71–2.

²⁶  [2008] EWHC 2196.

²⁷  Lewis v Secretary of State [2008] EWHC 2196, [24]; and see Bluck v The Information Commissioner and Epsom and St Helier University NHS Trust (2007) 98 BMLR 1; T Pitt-Payne, ‘Mother, I Sue Dead People’ (2007) 157 NLJ 1532.

²⁸  [2014] EWCOP 6. And see 4.13.

²⁹  Ibid, [41].

³⁰  Public Health (Control of Diseases) Act 1984 (as amended); see 6.21.

³¹  R v Department of Health ex p Source Informatics Ltd [2000] 1 All ER 786; Campbell v Mirror Group Newspapers [2004] UKHL 22.

³²  Gartside v Outram (1856) 26 LJ Ch 113, at 114.

³³  Lion Laboratories Ltd v Evans [1984] 2 All ER 417, at 433.

³⁴  [1988] 2 All ER 648.

³⁵  X v Y [1988] 2 All ER 648, at 653.

³⁶  [1990] 1 All ER 835; applied in R v Crozier [1991] Criminal Law Review 138, CA.

³⁷  On the issues raised in relation to confidentiality and mental health see MA Fisher, The Ethics of Conditional Confidentiality: A Practice Model for Mental Health Professionals (2013) Oxford University Press.

³⁸  [2004] UKHL 22.

³⁹  Ibid, [145].

⁴⁰  [2014] EWCA Civ 362.

⁴¹  Mental Health Act 1983, s 11(4).

⁴²  See also R (on the application of TB) v CPS and South Staffordshire Healthcare NHS Trust [2006] EWHC 1645 (Admin), discussed at 4.9.

⁴³  [2004] UKHL 22, [145].

⁴⁴  [2009] ECHR 36936/05.

⁴⁵  And see British Medical Association, Confidentiality and Disclosure of Health Information Toolkit (2009).

⁴⁶  Lewis v Secretary of State for Health [2008] EWHC 2196 (QB), at 19; W v Egdell [1990] 1 All ER 835, at 843 and 850.

⁴⁷  (2001) 68 BMLR 62. In 1981, the Law Commission had recommended the award of damages for distress. And see the Scottish decisions AB v CD (1851) 14 D 177; AB v CD (1904) 7 F 72; see JK Mason, GT Laurie, Mason and McCall Smith’s Law and Medical Ethics (9th edn, 2013) Oxford University Press, 6.65, 6.73.

⁴⁸  Though see Mosley v News Group Newspapers [2008] EWHC 1777.

⁴⁹  GMC, Good Medical Practice (2013), paras 50, 69.

⁵⁰  GMC, Confidentiality (2009), para 12.

⁵¹  R Gilbar, ‘Family Involvement, Independence, and Patient Autonomy in Practice’ (2011) 19(2) Medical Law Review 192.

⁵²  GMC, Confidentiality (2009), para 7.

⁵³  Ibid, para 25.

⁵⁴  I v Finland (2008) 48 EHRR 740.

⁵⁵  ‘NHS Breaching Citizens’ Human Rights over Levels of Access’ (2010) 10(5) Privacy and Data Protection 1.

⁵⁶  NHS England, Confidentiality Policy (June 2014).

⁵⁷  NHS staff are bound by the Department of Health, Confidentiality: NHS Code of Practice (2003).

⁵⁸  Note that all doctors in clinical practice should participate in clinical audit. Provided it is undertaken by the team providing the care, or their support staff, personal information may be disclosed if the patient is aware that personal information may be disclosed for audit purposes has been informed and has not objected. GMC, Confidentiality, paras 30–32.

⁵⁹  The Health and Social Care (Safety and Quality) Act 2015 inserts a new s 251B duty to share information for the purposes of the provision of health services or social care into the 2012 Act. Section 251C sets out how to interpret ss 251A and B so as to facilitate the continuity of information. The Health and Social Care Act 2012 (Consistent Identifier) Regulations 2015, SI 2015/1439 implements the reform.

⁶⁰  Mental Capacity Act 2005 s 2(1). On the 2005 Act generally, see Chapter 6.

⁶¹  Ibid, s 3.

⁶²  Ibid, s 4.

⁶³  GMC, Confidentiality, paras 57–62.

⁶⁴  See R (on the application of S) v Plymouth City Council [2002] EWCA Civ 388.

⁶⁵  GMC, Confidentiality (2009), para 61.

⁶⁶  Ibid, para 63.

⁶⁷  Ibid, paras 64–66.

⁶⁸  See further at 6.20.

⁶⁹  Social Services and Well-being (Wales) Act 2014, s 106(1): ‘If a relevant partner of a local authority has reasonable cause to suspect that a person is an adult at risk and appears to be within the authority’s area, it must inform the local authority of that fact’.

⁷⁰  Adult Support and Protection (Scotland) Act 2007, s 5(3): ‘Where a public body or office-holder to which this section applies knows or believes – (a) that a person is an adult at risk, and (b) that action needs to be taken (under this Part or otherwise) in order to protect that person from harm, the public body or office-holder must report the facts and circumstances of the case to the council for the area in which it considers the person to be’.

⁷¹  See E Cave, ‘Disclosure of Confidential Information to Protect the Patient: The Role of Legal Capacity’ (2015) 3(1–2) Journal of Medical Law and Ethics 7.

⁷²  DH, Clinical Governance and Adult Safeguarding – An Integrated Process (2009). And see the Safeguarding Vulnerable Adults Act 2006. See also reporting requirements under the Serious Crimes Act 2015: DH, Female Genital Mutilation: Guidance for Heathcare Staff (2015).

⁷³  See, for example, General Dental Council v Savery and others [2011] EWHC 3011 (Admin), where medical records were lawfully obtained by the GDC without consent for the purposes of disciplinary functions. Sales J said (obiter) at [64] that it is good practice to inform patients.

⁷⁴  See JV McHale, Medical Confidentiality and Legal Privilege (1993) Routledge.

⁷⁵  [1977] 1 All ER 589.

⁷⁶  1993 SLT 36.

⁷⁷  [2006] EWHC 1645 (Admin).

⁷⁸  Hunter v Mann [1974] 1 QB 767.

⁷⁹  Police and Criminal Evidence Act 1984, ss 8–14 and Sched 1.

⁸⁰  The NHS (Venereal Diseases) Regulations 1974, SI 1974/29 make provision for the tracing of sexual contacts, but also seek to ensure that the identity of patients and contacts remains confidential. Note, however, that in the view of the GMC: ‘the Regulations and Directions do not preclude disclosure if it would otherwise be lawful at common law, for example with the patient’s consent or in the public interest without consent’. GMC, Supplementary Guidance: Confidentiality: Disclosing Information about Serious Communicable Diseases (2009, updated 2013).

⁸¹  See the Health Protection (Notification) Regulations 2010, SI 2010/659; and at 6.21.

⁸²  Though provisions for detention in the Public Health (Control of Disease) Act extend to people with AIDS; see at 6.21.

⁸³  But powers must be used with proper regard for the patient’s right to privacy under Article 8 of the Human Rights Convention; see A Health Authority v X [2001] EWCA Civ 2014.

⁸⁴  SI 2002/1438, as amended by the Care Act 2014, s 117. See discussion in M Taylor, ‘Legal Bases for Disclosing Confidential Patient Information for Public Health’ (2015) 23(3) Medical Law Review 348.

⁸⁵  In line with the Health Research Authority Directions 2013.

⁸⁶  See in particular X v Y [1988] 2 All ER 648 and W v Egdell [1990] 1 All ER 835, CA.

⁸⁷  GMC, Confidentiality (2009), para 36.

⁸⁸  Criminal Law Act 1967, s 5(5).

⁸⁹  Ibid, s 5(1).

⁹⁰  The Counter-Terrorism and Security Act 2015, s 26 places a duty on specified authorities (including NHS trusts and NHS foundation trusts – see Sched 6) ‘to have due regard to the need to prevent people from being drawn into terrorism’.

⁹¹  For example, the Road Traffic Act 1988, s 172 (information identifying the driver of a car involved in a road accident).

⁹²  GMC, Confidentiality, paras 54–56.

⁹³  GMC, Supplementary Guidance, Confidentiality; Reporting Gunshot and Knife Wounds (2009).

⁹⁴  Kitson v Playfair (1896) The Times, 28 March.

⁹⁵  Birmingham Assizes (1914) 78 JP 604.

⁹⁶  Initial Services Ltd v Putterill [1968] 1 QB 396, at 405.

⁹⁷  GMC, Confidentiality, para 54.

⁹⁸  W v Egdell [1990] 1 All ER 845, at 849, CA.

⁹⁹  GMC, Supplementary Guidance, Confidentiality: Disclosing Information about Serious Communicable Diseases (2009), para 10.

¹⁰⁰  Law Commission Report No 110, Breach of Confidence Cmnd 8388, paras 6-94–6-96.

¹⁰¹  For example, that a parent might want to know if an adult daughter was HIV-positive in order to offer her support, but that interest, however caring it might be, will not suffice.

¹⁰²  For guidance on managing the risk of transmission from worker to patient, see Public Health England, HIV-Infected Healthcare Workers and Exposure Prone Procedures (January 2014).

¹⁰³  M Brazier, J Harris, ‘Public Health and Private Lives’ (1996) 4 Medical Law Review 171.

¹⁰⁴  GMC, Supplementary Guidance, Confidentiality: Disclosing Information about Serious Communicable Diseases (2009).

¹⁰⁵  GMC, Good Medical Practice (2013), paras 28–29.

¹⁰⁶  Ibid, para 25.

¹⁰⁷  GMC, Supplementary Guidance, Confidentiality: Disclosing Information about Serious Communicable Diseases (2009), paras 4–6.

¹⁰⁸  [2002] Lloyd’s Rep Med 210, CA.

¹⁰⁹  [2014] EWCOP 6. See at 4.3.

¹¹⁰  [2011] EWHC 1197 (COP).

¹¹¹  See, generally, GT Laurie, Genetic Privacy: A Challenge to Medico-Legal Norms (2002) Cambridge University Press.

¹¹²  See further at 15.18. And see E Jackson, Medical Law: Text Cases and Materials (3rd edn, 2013) Oxford University Press, ch 8.

¹¹³  Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, Oviedo, 4.IV.1997.

¹¹⁴  See Mason, Laurie, Mason and McCall Smith’s Law and Medical Ethics, 7.35; R Chadwick, M Levitt, D Shickle (eds) The Right to Know and the Right Not to Know: Genetic Privacy and Responsibility (2014) Cambridge University Press and special issue ‘Symposium: The Right Not to Know’ (2014) 42(1) Journal of Law, Medicine & Ethics.

¹¹⁵  Fully and eloquently discussed in Mason, Laurie, Mason and McCall Smith’s Law and Medical Ethics, 7.28–7.34. And see Nuffield Council on Bioethics, Genetic Screening: The Ethical Issues (1993); Genetic Screening: Ethical Issues (2006) supplement (www.nuffieldbioethics.org); R Gilbar, The Status of the Family in Law and Bioethics: The Genetic Context (2005) Ashgate.

¹¹⁶  See D Bell, B Bennett, ‘Genetic Secrets and the Family’ (2001) 9 Medical Law Review 130; L Skene, ‘Genetic Secrets and the Family: A Response to Bell and Bennett’ (2001) 9 Medical Law Review 162.

¹¹⁷  GMC, Confidentiality (2009), paras 67–69.

¹¹⁸  See Laurie, Genetic Privacy: A Challenge to Medico-Legal Norms.

¹¹⁹  See K O’Donovan, R Gilbar, ‘The Loved Ones: Families Intimates and Patient Autonomy’ (2003) Legal Studies 353.

¹²⁰  H Widdows, Connected Self: The Ethics and Governance of the Genetic Individual (2013) Cambridge University Press.

¹²¹  A Lucassen, M Parker, ‘Genetic Information: A Joint Account? (2004) 329 BMJ 165.

¹²²  C Foster, J Herring, M Boyd, ‘Testing the Limits of the “Joint Account” Model of Genetic Information: A Legal Thought Experiment’ (2015) 41(5) Journal of Medical Ethics 379.

¹²³  See 15.18.

¹²⁴  See Gilbar, The Status of the Family in Law and Bioethics; R Gilbar, ‘Medical Confidentiality within the Family: The Doctor’s Duty Reconsidered’ (2004) 18 International Journal of Law and Policy and the Family 195.

¹²⁵  Association of British Insurers, ‘Insurance Genetics Moratorium Extended to 2017’ (2011) April 5.

¹²⁶  Draft Article 4(10) as agreed by Council of the European Union, Proposal for a Regulation of the European Parliament and of the Council on the protection of individuals with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation) 15039/15 (2015) 15 December: ‘“Genetic data” means all personal data relating to the genetic characteristics of an individual that have been inherited or acquired, which give unique information about the physiology or the health of that individual, resulting in particular from an analysis of a biological sample from the individual in question’.

¹²⁷  Tarasoff v Regents of University of California (1976) 551 P 2d 334; see Mason, Laurie, Mason and McCall Smith’s Law and Medical Ethics, 6.36, 13.72.

¹²⁸  Palmer v Tees Health Authority [1999] Lloyd’s Rep Med 351, CA.

¹²⁹  See Colak v Germany [2009] ECHR 77144/01.

¹³⁰  See Smith v Littlewoods Organisation Ltd [1987] 1 All ER 710, HL; Mitchell v Glasgow County Council [2009] UKHL 11, HL. And see Selwood v Durham CC, Tees, Esk and Wear Valleys NHS FT and Northumberland, Tyne and Wear NHS FT [2012] EWCA Civ 972, discussed at 7.5, where it was held that a working protocol signed by NHS trusts could establish a duty of care with respect to a social worker. Threats by Mr B – who suffered paranoid delusions – against Ms Selwood were communicated to NHS staff. Ms Selwood was subsequently attacked by Mr B and suffered serious injury. The claim was struck out at first instance but the Court of Appeal held it would be open to a trial judge to conclude that the NHS trusts had assumed responsibility to avoid the foreseeable risk of harm to a co-signatory employee to the working protocol.

¹³¹  Directive 95/46/EC on the Protection of Individuals with Regard to the Processing of Personal Data and on the Free Movement of Such Data.

¹³²  Defined in Durant v Financial Services Authority [2003] EWCA Civ 1746 (which did not concern health records) as information focusing on the individual rather than a third party, incident or event in which the individual participated.

¹³³  Data Protection Act 1998, s 68(2).

¹³⁴  Ibid, s 69.

¹³⁵  See Johnson v Medical Defence Union (2007) 96 BMLR 99.

¹³⁶  Data Protection Act 1998, s 10.

¹³⁷  Ibid, s 13.

¹³⁸  ICO, ‘Press Release: ICO Issues First Penalty to the NHS Following Serious Data Breach’ (2012) 30 April. By 2015 the ICO had issued £1.3m in fines to NHS organisations.

¹³⁹  ICO, ‘Press Release: NHS Trust Fined £325,000 Following Data Breach Affecting Thousands of Patients and Staff’ (2012) 1 June.

¹⁴⁰  Data Protection (Assessment Notices) (Designation of National Health Service Bodies) Order 2014, SI 2014/3282.

¹⁴¹  Proposal for a regulation of the European Parliament and of the Council on the protection of individuals with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation), COM(2012)11.

¹⁴²  Council of the European Union, Proposal for a Regulation of the European Parliament and of the Council on the protection of individuals with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation) 15039/15 (2015) 15 December, accessible at www.statewatch.org/news/2015/dec/eu-council-dp-reg-draft-final-compromise-15039-15.pdf

¹⁴³  Google Spain SL, Google Inc v Agencia Española de Protección de Datos, Mario Costeja González, Case C-131/12 (13 May 2014).

¹⁴⁴  ICO, Anonymisation: Managing Data Protection Risk, Code of Practice (November 2012).

¹⁴⁵  See GMC, Confidentiality (2009).

¹⁴⁶  [2000] 1 All ER 786, CA.

¹⁴⁷  See further discussion of Department of Health v Information Commissioner [2011] EWHC 1430 (Admin), at 15.17.

¹⁴⁸  Health and Social Care Act 2012, s 252; the National Institute for Health and Care Excellence (Constitution and Functions) and the Health and Social Care Information Centre (Functions) Regulations 2013, SI 2013/259. The HSCIC replaces the NHS Information Centre for Health and Social Care (which was a Special Health Authority).

¹⁴⁹  See HSCIC, Information and Technology for Better Care: HSCIC Strategy 2015–2020 (March 2015).

¹⁵⁰  Health and Social Care Act 2012, s 256.

¹⁵¹  Ibid, s 260.

¹⁵²  Required by virtue of the Health and Social Care Act 2012, s 263: HSCIC, A Guide to Confidentiality in Health and Social Care (version 1.1 2013); Code of Practice on Confidential Information (version 1.0 2014).

¹⁵³  HSCIC, A Guide to Confidentiality in Health and Social Care (version 1.1 2013).

¹⁵⁴  See J Grace, M J Taylor, ‘Disclosure of Confidential Patient Information and the Duty to Consult: The Role of the Health and Social Care Information Centre’ 21 (2013) Medical Law Review 415.

¹⁵⁵  But see ‘NHS Details Released Against Patients’ Wishes, Admits Data Body’ (2015) Guardian, 6 June, where it is claimed that, due to technical issues, the HSCIC shared data despite patients opting out.

¹⁵⁶  NHS Constitution (2015) part 3(a).

¹⁵⁷  Select Committee, Handling of NHS Patient Data (2014).

¹⁵⁸  See HSCIC, Information and Technology for Better Care: HSCIC Strategy 2015–2020 (HSCIC, 2015).

¹⁵⁹  The HSCIC endorsed General Practice Extraction Service Independent Advisory Group recommendation for the care.data updated addendum on 2 October 2014.

¹⁶⁰  See generally on the implications of record keeping for medical confidentiality, DH Caldicott Review: Information Governance in the Health and Care System (April 2013); DH, Information: To Share or Not to Share: Government Response to the Caldicott Review (September 2013); ICO, Subject Access Code of Practice: Dealing with Requests from Individuals for Personal Information (February 2014).

¹⁶¹  R v Mid-Glamorgan Family Health Services ex p Martin [1995] 1WLR 110.

¹⁶²  Note that the Data Protection Act 1998, rather than the Freedom of Information Act 2000, governs access to personal data.

¹⁶³  Data Protection Act 1998, s 30(1).

¹⁶⁴  See Clive Roberts v Nottinghamshire Healthcare NHS Trust [2008] EWHC 1934.

¹⁶⁵  Data Protection (Subject Access Modification) (Health) Order 2000, SI 2000/413, Article 5(1).

¹⁶⁶  Data Protection Act 1998, s 7.

¹⁶⁷  Access to Health Records Act 1990, s 3(1)(f).

Part II

MEDICAL MALPRACTICE

Chapter 5

AGREEING TO TREATMENT

5.1 There would be little support today, even from the most paternalistic doctor,¹ for the proposition that a sick adult should be compelled to accept whatever treatment his doctor thought best. No one suggests that adults who stay away from dentists out of childlike fear and to the detriment of their dental and general health should be rounded up and marched to the nearest dental surgery for forcible treatment. Few would deny the right of the adult Jehovah’s Witness to refuse a blood transfusion,² even if in doing so she forfeits her life. Medical treatment normally requires the agreement of the patient. The right of the patient, who is sufficiently rational and mature to understand what is entailed in treatment, to decide for herself whether to agree to that treatment is a basic human right. The right to autonomy, to self-rule rather than rule by others, is endorsed by ethicists as a right to patient autonomy.³ Two of their Lordships in Chester v Afshar⁴ signalled that a patient’s right to autonomy and dignity should today be accorded the highest priority by English law. Lord Steyn declared that in ‘modern law, paternalism no longer rules’.⁵ In 2015, the United Kingdom Supreme Court swept away the last vestiges of legal endorsement of medical paternalism in Montgomery v Lanarkshire Health Board.⁶ Patients consenting to treatment must as a general rule be given all the information about the risks and benefits of that treatment that a reasonable person in the patient’s position would want to know. No longer are patients only entitled to be told what doctors think it is appropriate to tell them. The much criticised decision of the House of Lords in Sidaway v Royal Bethlem Hospital⁷ is consigned to history. Lord Kerr and Lord Reed declared that:

[P]atients are now widely regarded as persons holding rights, rather than as the passive recipients of the care of the medical profession. They are also widely treated as consumers exercising choices.⁸

This chapter considers the relatively easy case of adults with mental capacity. Such an adult has a right to determine what is done to his or her body. In Chapters 6 and 14, we look at the law in relation to patients lacking capacity and to children, and also address circumstances where legislation may endorse compulsory medical treatment. A person who intentionally touches another against that other’s will commits a trespass to that person just as much as coming uninvited onto the person’s land is a trespass to his land. The tort of battery is committed. Where a person consents to a contact no battery is committed. So a boxer entering the ring cannot complain of battery when he is hit on the chin by his opponent. Battery is any non-consensual contact. Conduct which constitutes the tort of battery may also amount to the crime of assault. We should also note that contacts resulting in serious bodily harm may still constitute a criminal assault, even when such contacts are wholly consensual. English law does not allow you to consent to, for example, sado-masochistic practices that cause actual injury to you.⁹ Any such ‘injury’ must be justified by some good purpose. Medical treatment and surgery are acknowledged to be such purposes.¹⁰ So, more controversially, are ‘manly sports’, thus justifying the boxers’ mutual exchange of blows.¹¹ There remains a question of whether any kind of maverick or extreme ‘surgery’ might be beyond the privilege usually accorded to medicine and surgery.¹²

How do the rules relate to doctors? Any doctor examining a patient, or injecting or operating on a patient makes contact with that patient’s body. Normally he commits no wrong because he does so with the patient’s agreement. Should he fail to obtain a patient’s agreement, should a doctor force himself on a patient, he commits the tort of battery, and the crime of assault. Not only does he infringe on his patient’s autonomy, he also violates her bodily integrity.¹³ That crude scenario is unlikely, but not unknown. In Border v Lewisham and Greenwich NHS Trust¹⁴ the claimant had a suspected broken arm and the doctor treating her in the accident and emergency department proposed to insert a cannula in her other arm. The claimant objected forcefully, worried that as she had recently had lymph nodes removed she might develop oedema. The doctor considered other options unviable and went ahead with the insertion of the cannula. The Court of Appeal held that in the absence of consent the insertion of the cannula inexorably led to a finding of breach of duty. What of the surgeon who correctly decides to treat cancer of the bone in the right leg by amputating that leg, but by error amputates the wrong leg, the left leg? Once the error is discovered the poor patient has to endure a further operation to remove the right leg. Or a patient’s notes are mixed up and a woman who was scheduled for and consented to an appendectomy is given a hysterectomy. Both unfortunate victims can sue the surgeon in battery. They did not consent to the operation performed. In a Canadian case, a woman who expressed her wish to be injected in her right arm was injected by the doctor in her left. She sued in battery and succeeded.¹⁵

In all the above examples, the surgeon or some other member of the hospital staff has been careless. So the patient could normally sue in negligence too. However, there are differences between the two torts. In battery, a patient need not establish any tangible injury. The actionable injury is the uninvited invasion of his body. This is important. A doctor may, on medically unchallengeable grounds, decide that an operation is in the patient’s best interests. He goes ahead. The patient’s health improves. Yet if the operation was done without consent, a battery has still been committed. A doctor who discovered that his patient’s womb was ruptured while performing minor gynaecological surgery was held liable to her for going ahead and sterilising her there and then. She had not agreed to sterilisation.¹⁶ A woman whose ovaries were removed without her express consent similarly recovered for battery.¹⁷ The essence of the wrong of battery is the unpermitted contact. There is no requirement that the patient prove that if he had been asked to consent to the relevant treatment he would have refused.

These cases can be contrasted with Connolly v Croydon Health Service NHS Trust.¹⁸ Mrs Connolly claimed a battery had occurred when treatment was continued despite her withdrawal of consent. She consented to an angiography to investigate angina and was informed of the risk of complications. During the procedure it became apparent that there was a potentially life-threatening problem and an angioplasty was performed. This caused significant pain and Mrs Connolly demanded that the procedure cease. Judge Collender QC held that she lacked capacity to withdraw consent at the relevant time and had not in fact done so. Had she maintained capacity she could in theory have made a valid withdrawal of consent to the procedure. As it was, her initial consent protected the doctors from an action in battery.

Two further points should be noted. Battery may be alleged by a patient who says he did not consent. First, on whom does the onus of proof lie? It has been held in England that the onus of proof lies on the patient. He must establish that he did not agree.¹⁹ Second, for what will the patient be compensated? In negligence, we shall see that a defendant is only liable for the kind of damage which he reasonably ought to foresee. In battery, the test may be more stringent. The defendant may be liable for all the damage which can factually be shown to flow from his wrongdoing. A doctor who injected a patient in the ‘wrong’ arm would be liable in battery and negligence for any unwanted stiffness in that arm, and for any adverse reaction which he ought to have contemplated in view of the patient’s history. He would not be liable in negligence for a ‘freak’ reaction. In battery he might be so liable. Nonetheless judges in England have sought to limit the scope of battery when it overlaps with negligence. They strive to avoid subjecting a surgeon to liability in battery.

A significant disadvantage with the tort of battery as a means of vindicating patients’ rights was that for a claim to lie in battery traditionally there had to be direct physical contact between doctor and patient. A patient who agreed to take a drug orally, having been totally misled as to the nature of the drug, could not sue in battery. Had the doctor injected him with that self-same drug, a claim in battery would lie. Recently the courts have developed the criminal law to allow prosecution for causing grievous bodily harm where no direct physical contact took place.²⁰ So it is possible that if a doctor deceived a patient into taking a dangerous drug that made her seriously ill, the doctor could face criminal charges.²¹

Emergencies

5.2 What of the patient not in a fit state to give or communicate consent himself? When the patient is unconscious,²² treatment may have to be given immediately, before the patient can be revived and consulted. She may have been wheeled into Casualty after an accident. She may have agreed to operation X, in the course of which the surgeon discovers a rampaging tumour needing immediate excision. Where there is no available evidence of the patient’s own wishes in such circumstances, section 5 of the Mental Capacity Act 2005 grants to doctors a general authority to act in the best interests of the patient and do whatever is immediately necessary to preserve the life and prevent any deterioration in her health.²³ The doctor can invoke the defence of necessity. Such a defence is not exclusive to doctors. The bystanders who rush to the aid of the unconscious accident victim and administer first aid, the ambulance crew who bring him into Casualty, are equally protected from any claim in battery. This is the case even if the patient has attempted suicide, provided there is doubt as to his intentions or capacity.²⁴ Adults of sound mind have a right to refuse life-sustaining treatment,²⁵ and it should not be assumed that a patient who attempts suicide lacks capacity.²⁶

Once the immediate threat to a patient’s life has passed, other decisions may have to be taken before he regains consciousness. In practice, when a patient is unconscious or otherwise incapable of consenting to treatment himself, the response of the hospital staff is to consult, when possible, with the patient’s relatives or friends. What legal validity has a consent given by the relatives of an adult? The answer is none. Consulting relatives is courteous, but is legally significant solely in that as a matter of evidence it establishes that the doctor’s consideration of the patient’s best interests has been adequately informed as required by the Mental Capacity Act 2005.²⁷

One difficult problem arises when some (but inconclusive) evidence is forthcoming about the unconscious patient’s own wishes. A patient is wheeled into hospital unconscious and needs an immediate blood transfusion. His wife says, truthfully, that he is a Jehovah’s Witness and would refuse a transfusion. Can the doctor lawfully give a transfusion? The procedure is necessary, but the doctor knows the patient would be likely to refuse it. In Malette v Shulman,²⁸ a Canadian case, a young woman was brought unconscious into Casualty. She carried with her a card clearly stating that she was a Jehovah’s Witness and that she would in no circumstances consent to a blood transfusion even if her life were in danger. The Canadian court held that the doctor who administered a transfusion committed a battery. There was in that case no room for doubt that the patient had taken pains to ensure that no doctor should be in doubt of her refusal of blood in any contingency. Attempts to argue that a refusal of treatment must be ‘informed’ by knowledge of the actual circumstances of treatment were rejected.²⁹ In the next section we will look at Re T,³⁰ where the English Court of Appeal overruled an apparent objection by T to transfusion. The facts of the cases are markedly different. The evidence T truly and independently objected to transfusion was shaky. Mrs Malette’s convictions were beyond doubt. Sections 24 and 25 of the Mental Capacity Act 2005 now provide for a formal means of making an advance directive (described in the Act as an advance decision) refusing treatment. The Act requires that such an advance decision must be both in writing and witnessed.³¹ However, in Newcastle upon Tyne Hospitals Foundation Trust v LM³² the judge was satisfied that the informal, unwritten evidence that LM would never have agreed to a transfusion sufficed to require that her wishes be respected.

A right to say no?

5.3 Will the law ever set limits to a competent person’s right to refuse treatment? Are we free to reject life-saving treatment which others might consider it ‘wicked folly’³³ to refuse? The theory is clear. In Re T (Adult: Refusal of Medical Treatment),³⁴ Lord Donaldson declared that an adult patient ‘has an absolute right to choose whether to consent to medical treatment, to refuse it or to choose one rather than another of the treatments being offered’.³⁵ Such an absolute right to autonomy ‘exists notwithstanding that the reasons for making the choice are rational, or irrational, unknown or even non-existent’. In Re T, a young woman of 20 had suffered serious injuries in a road accident. She was thirty-four weeks pregnant and consented to a caesarean section on the following day. Later that evening she was visited by her mother, a devout Jehovah’s Witness. T was not herself a baptised Witness. After her mother’s visit, T told doctors that she would not agree to any blood transfusion before or during surgery. She first enquired whether alternatives to whole blood were available, and was assured that such alternatives exist. She was given a form to sign evidencing her refusal of transfusion and absolving the hospital from liability for failing to administer blood should she haemorrhage. After delivery of a stillborn child, T lapsed into a coma and suffered life-threatening internal bleeding. The hospital argued that they could not lawfully give her a blood transfusion. Her boyfriend and father sought a court-order authorising a life-saving transfusion. Notwithstanding his ringing endorsement of patient autonomy, Lord Donaldson and his brethren in the Court of Appeal granted that order.

The Court of Appeal held that on the facts of the case T’s refusal of treatment was not an autonomous judgement. Her decision was ‘flawed’:

(1)  The combination of the effect of her injuries and the medication she was taking impaired her mental capacity to decide whether or not to agree to blood transfusions.

(2)  T lacked sufficient information to make a decision to refuse transfusion. While she was told there were alternatives to whole blood, she was not advised about their limited utility or warned that there were circumstances where, without transfusion, her life would be at risk. Lord Donaldson³⁶ criticised the doctors, whom he suggested were more anxious to disclaim any possible legal liability than to ensure that T was given comprehensible and comprehensive information.

(3)  Pressure from T’s mother may have constituted undue influence rendering her purported refusal of blood transfusion less than independent and voluntary.

These factors that were felt to cloud the nature of T’s decision caused the Court of Appeal to conclude that T’s rejection of blood could be disregarded. The right of the individual to decide whether to accept medical treatment was paramount but in ‘cases of doubt, that doubt falls to be resolved in favour of preservation of life, for if the individual is to override the public interest, he must do so in clear terms’.

It may be tempting to regard Re T as judges saying one thing (upholding the rhetoric of autonomy) and doing another (rejecting an unusual belief which caused a young woman to risk sacrificing her life). Re T requires careful scrutiny. Do the facts in Re T support judicial doubts whether T ever made a truly voluntary and sufficiently informed choice to reject life-saving treatment?³⁷ In the next chapter we explore further whether some vulnerable patients who may not clearly fail the test for mental capacity may nonetheless, like T, be unable to make a real choice because of their circumstances or pressure from those close to them.³⁸

Two recent judgments indicate something of a change in judicial attitudes to adult Jehovah’s Witnesses refusing blood, suggesting a greater willingness to accept the authenticity of the patient’s wish to refuse blood even in marginally questionable cases. In Newcastle upon Tyne Hospitals Foundation Trust v LM³⁹ the hospital sought a declaration that it would be lawful not to administer a blood transfusion to LM. LM, a very sick woman aged 63, ‘needed’ a transfusion if she were to survive and even with the transfusion might still die. She had been a Jehovah’s Witness for over forty years. In hospital, while still able to communicate, LM stressed that she would not want treatment with blood products even if that decision resulted in her death. At the time of the application to court, LM was sedated and in intensive care, and by that time lacked capacity to make or communicate any contemporaneous decision. LM had a long history of mental illness and had not executed a formal advance decision refusing blood. Nonetheless Jackson J held that LM, despite her mental illness, had enjoyed the capacity to decide whether to accept or refuse blood before she was admitted to intensive care and that her longstanding and consistent opposition to transfusions remained effective.⁴⁰ Nottinghamshire Healthcare NHS Trust v RC⁴¹ concerned a young man of 23 with a long history of serious mental illness and self-harming. He slashed his brachial artery in prison and was admitted to hospital where he made a number of attempts to reopen the wound. While in prison RC ‘embraced the religion of the Jehovah’s Witnesses’ although (like Miss T) he was not yet a baptised Witness. In hospital RC signed an advance decision refusing blood products in any circumstances. The hospital sought guidance from the court about the validity of the advance decision⁴² and the legality of doctors’ decisions not to impose a transfusion on RC should he need one. The crucial issue for us here is did RC have capacity to execute that advance decision? Mostyn J was clear that despite his illness RC fully understood the decision he was making and freely chose to abide by the tenets of his faith. The judge declared that ‘to impose a blood transfusion would be a denial of a most basic freedom’.⁴³ In both cases the judges avoid any temptation to question the patients’ capacity and apparently accord greater weight to the beliefs of the patients than might seem to be the case in Re T. Two points might be noted. In both cases the treating clinicians had made a decision that they did not consider it appropriate to force the transfusion on the patient, and in both cases the success of transfusion in preserving the life of the patient was far from certain.

In contexts far different from the very particular issue of blood products and Jehovah’s Witnesses the principle of autonomy has been firmly endorsed by English courts. In Airedale NHS Trust v Bland,⁴⁴ Lord Goff reiterated that the:

principle of self-determination requires that respect must be given to the wishes of the patient, so that if an adult of sound mind refuses, however unreasonably, to consent to treatment or care by which his life would or might be prolonged, the doctors responsible for his care must give effect to his wishes, even though they do not consider it to be in his best interests to do so.

In B v An NHS Trust,⁴⁵ Butler-Sloss P ruled that it was unlawful for doctors to refuse to switch off a ventilator keeping Ms B alive. Ms B suffered a haemorrhage in her spinal cord which left her paralysed from the neck down and wholly dependent on a ventilator to breathe. She asked her doctors to switch the ventilator off. She considered that death was preferable to survival in such a state. Her doctors disagreed. They thought that she could enjoy a reasonable quality of life living in a spinal rehabilitation unit. They expressed strong conscientious objections to ‘killing’ Ms B. When she first indicated her wish to have the ventilator switched off, psychiatrists questioned Ms B’s mental capacity. However, she was ultimately adjudged competent to make her own decisions. The judge ruled that continuing to ventilate Ms B against her will constituted an assault on her and awarded her nominal damages of £100. She ordered that arrangements be made to transfer Ms B to a unit where doctors would be prepared to comply with her request. Butler-Sloss P unequivocally endorsed the value of patient autonomy. The crux of the matter will always turn on the capacity of the individual to make a valid choice – a subject explored further in the next chapter.

In Re T, Lord Donaldson’s recognition of an unqualified right to refuse treatment as long as the adult patient was competent to make that decision was subject to a controversial caveat. He contended that an exception to that right might exist in ‘a case in which the choice may lead to the death of a viable foetus’.⁴⁶ Pregnant women, and women in labour, might be excluded from the normal right to self-determination. A series of controversial cases followed Re T in which judges ordered women to submit to caesarean sections. In Re S,⁴⁷ Sir Stephen Brown P invoked Lord Donaldson’s dictum to authorise caesarean surgery to save the life of the woman’s unborn child. Other judgments⁴⁸ tended to rely more heavily on the judge’s ruling that at the time she refused ‘necessary’ surgery, the woman’s capacity to make decisions was impaired. Ultimately the Court of Appeal clarified the law. A pregnant woman ‘of sound mind’ retains exactly the same right to accept or refuse treatment as any other adult. The unborn child enjoyed no legal personality entitling the court to force its mother to submit to any form of intervention she elects to decline.⁴⁹ The mother’s right to autonomy is not diminished or reduced merely because her decision may ‘appear morally repugnant’.⁵⁰ Adults can say no to treatment as long as their mental capacity is unimpaired. Identifying when a person lacks capacity may be tricky, and judges may be naturally reluctant to stand by and watch a pregnant woman and her child both die.⁵¹

What is meant by consent?

5.4 Consent is mandatory but what is meant by consent? It need not usually be written.⁵² Consent may be implied from the circumstances. If a patient visits his general practitioner complaining of a sore throat and opens his mouth so that the doctor can examine his throat, he cannot complain that he never expressly said to the doctor: ‘You may put a spatula on my tongue and look down my throat’. A patient visiting Casualty with a bleeding wound implicitly agrees to doctors or nurses cleaning and bandaging the wound. In an American case an immigrant to the USA complained that he had not consented to vaccination. It was found that he had bared his arm and held it out to the doctor. His action precluded the need for any verbal consent.⁵³

A patient for whom surgery or any form of invasive investigation is proposed will normally be asked to sign a consent form. The Department of Health issues guidance⁵⁴ on consent to treatment advising that it ‘is good practice to obtain written consent for any significant procedure’. The 2009 Guidance does not contain model consent forms. The Department’s aim is to ensure that healthcare professionals appreciate the need to give patients the information to which they are entitled. Consent forms should ensure that patients appreciate that they are entitled to ask questions and to demand explanations about what is to be done to them. They should cover anaesthetic procedures as well as surgery. As the Supreme Court in Montgomery has now made abundantly clear, patients are not passive recipients of what the doctor thinks best.However, a form is no more than some evidence of what the patient has agreed to. What is important is the substance of what the patient is entitled to be told and has been told, and what is then done to him. Clearly any action expressly prohibited by the patient, that is, additional procedures which on the form he states ‘I do not wish to be carried out without further discussion’ would constitute a battery if imposed on the patient.

In many cases supplementary procedures will require additional consent. However, the consent form might provide for additional procedures necessary to save life or serious injury. What sort of authority does this confer on the doctor? This would not affect liability in the cases discussed earlier of the doctor who sterilised a patient in the course of minor gynaecological surgery, or the surgeon who removed a woman’s ovaries without her consent (see 5.1). Neither measure was immediately necessary to preserve the woman’s health. The doctor is only authorised to carry out further surgery without which the patient’s life or health is immediately at risk. A surgeon discovering advanced cancer of the womb while performing curettage may be justified in performing an immediate hysterectomy. Delay might threaten the woman’s life. A doctor discovering some malformation, or other non-life-threatening condition, must delay further surgery until his patient has the opportunity to offer her opinion. A current issue is whether patients should be asked to give express advance consent to any blood transfusions that may be thought likely to be needed.⁵⁵ Some patients opt ‘not to know’ information, perhaps because they fear the psychological consequences. The Department of Health advises doctors to always provide basic information and, while respecting the patient’s wishes, to stress the importance of knowing and understanding the available options, and check periodically that the patient has not changed her mind.⁵⁶ What would be the effect of a form within which a patient consented to any procedure that the surgeon saw fit to embark on? In the absence of the clearest evidence that the patient fully understood the ‘blank cheque’ which he handed to his doctor, such a form will be virtually irrelevant.⁵⁷ If the patient can show that despite the form he did not give any real consent to the procedure carried out, the surgeon will be liable in battery.

Does it matter who operates?

5.5 As important to many patients as what the operation entails may be the question of who operates. If a patient agrees to surgery believing eminent consultant X will operate on him, is his consent invalidated if registrar Y operates? When a private patient contracts with consultant X that he (X) will operate, the consultant is in breach of contract if he substitutes someone else. Within the NHS, the patient would have to show that his consent was conditional on X operating. He would not have agreed to the surgery if anyone else proposed it. In practice, consent forms used within the NHS usually expressly provide that no assurance is given that any particular doctor will operate. A patient cannot complain if the registrar operates. If the registrar lacked the experience to perform a particular operation, he will be able to sue him and the consultant if harm ensues. He can sue the registrar for his lack of competence. He can sue the consultant (and the NHS trust) for failure to provide proper supervision and for allowing an inadequately qualified member of the team to operate.

In 1984, it was reported that a vet was allowed by a surgeon friend to remove a patient’s gall bladder. A patient operated on by a vet will have a claim in battery against the vet, however competent he may have proved to be. He agreed to a qualified doctor operating on him.⁵⁸ He no more agreed to surgery by a vet than to surgery by the authors of this book. An operation performed by a medical student will give rise to a claim in negligence if the student is not competent. A claim in battery may also lie if the patient was not expressly informed about the proposal to allow a student to operate. He consented to an operation and accepted, if he signed the standard form, that no particular practitioner undertook to operate. He consented to surgery performed by a practitioner, not an ‘apprentice’. Teaching hospitals play a vital role. The public interest requires that medical students train on real people. Nevertheless, any contact with a patient on the part of a medical student requires the patient’s consent.

How much must the doctor tell the patient: informed consent?

5.6 For consent to mean anything the patient must be told what operation is to be performed and why it is to be done. Consent forms will usually certify that doctors have explained the proposed operation, investigation or treatment to the patient. What exactly must the doctor explain? All surgery under general anaesthetic entails some risk. Many forms of surgery and medical treatment carry further risk of harm, even if they are carried out with the greatest skill and competence. Patients have unsuccessfully sought to argue that if an operation entails an inherent risk, then they cannot be said to have given a real consent to that operation if they were not told of the risk. They had inadequate information on which to make a proper decision. They could not give an ‘informed consent’ and therefore a claim in battery should lie. Alternatively, they have contended with some greater success that if a claim in battery does not lie, they ought to be able to sue for negligence. The doctor’s duty of care encompasses giving adequate information and advice. If he has given the patient inadequate information and the patient agreed to a risky procedure from which injury did ensue, the doctor, it is argued, is responsible for that damage.

Let us look first at the argument that if risks or side effects inherent in an operation are not disclosed, then the patient has not really consented at all, and the surgeon is liable for battery. In Chatterton v Gerson,⁵⁹ Miss Chatterton pursued such a claim. She suffered excruciating pain in a post-operative scar. Dr Gerson proposed an operation. The operation failed to relieve her symptoms. A second operation was carried out. Miss Chatterton was no better and subsequently lost all sensation in her right leg and foot with a consequent loss of mobility. She claimed that while Dr Gerson was in no way negligent in his conduct of the surgery, he failed to tell her enough for her to give her ‘informed consent’. Her claim in battery failed. The judge said that a consent to surgery was valid providing that the patient was ‘informed in broad terms of the nature of the procedure which is intended’. Any claim in relation to inadequacy of information about the risks or side effects of treatment, or availability of alternative treatment, should be brought in negligence.

By contrast, a patient who agreed to an injection which she understood to be a routine post-natal vaccination, but which was in fact a long-acting contraceptive, Depo-Provera, succeeded in battery. Her doctor failed the test set in Chatterton v Gerson. He obtained her agreement to the injection leaving her totally unaware of, and misleading her, albeit in good faith, as to the nature of what was being done to her.⁶⁰ A dentist who deliberately misled patients to persuade them to agree to unnecessary dental treatment was also liable in battery. His fraud vitiated the apparent consent given to him by his unfortunate patients.⁶¹ A bogus doctor, who persuaded several women to allow him to examine their breasts, claiming that he was conducting research into breast cancer, was convicted of indecent assault.⁶² The women’s ‘consent’ depended on their belief that he had medical qualifications and that the contact to which they agreed had a proper medical purpose.

Other attempts to claim in battery, where the nature of what was to be done was honestly explained but the risks of the procedure were not fully explained, have failed just as Miss Chatterton’s claim failed.⁶³ In Sidaway v Royal Bethlem Hospital in the Court of Appeal, Lord Donaldson said: ‘It is only if the consent is obtained by fraud or misrepresentation of the nature of what is to be done that it can be said that an apparent consent is not a true consent’ (our emphasis).⁶⁴ The House of Lords unanimously endorsed his views.⁶⁵ Lord Scarman, giving the most patient-oriented opinion on the information that patients should be given about treatment, nonetheless rejected battery as the legal mechanism to attain that end, and declared: ‘it would be deplorable to base the law in medical cases of this kind on the torts of assault and battery’.⁶⁶ The Canadian courts also view battery as an inappropriate remedy for inadequate counselling. The Canadian Chief Justice has said:⁶⁷

I do not understand how it can be said that the consent was vitiated by failure of disclosure of risks as to make the surgery or other treatment an unprivileged, unconsented to and intentional invasion of the patient’s bodily integrity … unless there has been misrepresentation or fraud to secure consent to the treatment, a failure to disclose the attendant risks, however serious, should go to negligence rather than battery.

It is easy to understand why courts shy away from finding doctors liable in battery. The word itself is emotive. Doctors resent being accused of ‘battering’ their patients, being equated with ‘the mugger who assaults his victim’.⁶⁸ However, distinguishing between battery and no battery on the Chatterton v Gerson test is not easy. Consider the example of a patient tested for HIV without his consent.⁶⁹ He agrees to a blood test preparatory to surgery. He is never told that among the tests to be carried out on his blood is a test for HIV. Did he understand the nature and purpose of the test? He understood what would be done to him and that several tests would be carried out on his blood. Opinion about whether such a practice constitutes battery is divided.⁷⁰ Normally, express and detailed information about exactly what tests are proposed when blood is given is rarely sought or offered. Patients agree to tests so that doctors can find out what problems they may encounter and treat them safely. It is difficult to say that such patients, including the patient tested for HIV, do not understand in broad terms what is going on. Were some ruse employed to obtain consent the picture might be different. Imagine that a doctor suspects a patient is HIV positive and wants a test for that sole purpose. Fearing that the patient would refuse consent if asked outright, the doctor uses a pretext, for example, a suspicion of anaemia. Would you argue that the patient falls within the Chatterton v Gerson test, that his consent was obtained by fraud or misrepresentation? The difficulty is that what constitutes fraud is complex.

In the context of criminal law, the courts have tended to say that the fraud must deceive the victim about the very nature of what is being done to her.⁷¹ The patient agreeing to the blood test, albeit believing the test is designed to check his red blood count, still understands what is being done. It may be that civil and criminal law adopts different tests of fraud. In a case where a dentist was prosecuted for assault because, unbeknown to her patients, she continued to practise when suspended from the dental register, the Court of Appeal quashed her conviction for criminal assault.⁷² The patients were not misled about what was being done to them, or as to the identity of the accused. Nonetheless, Otton LJ condemned the accused’s conduct as reprehensible and suggested that a civil claim for damages might well succeed.

Negligence and a duty to inform

5.7 Where no question of misrepresentation arises, a claim based on failure to give a patient adequate information about proposed treatment lies in negligence. The doctor’s duty of care to his patient includes a duty to give him careful advice and sufficient information upon which to reach a rational decision whether to accept or reject treatment. Lord Steyn emphasised in Chester v Afshar that ‘a patient’s right to an appropriate warning from a surgeon when faced with surgery ought normatively to be regarded as an important right which must be given effective protection whenever possible’.⁷³

In the landmark decision in Montgomery v Lanarkshire Health Board⁷⁴ (hereafter Montgomery) the Supreme Court gave substance to that protection overruling the earlier decision of the House of Lords in Sidaway v Royal Bethlem Hospital⁷⁵ (hereafter Sidaway) and establishing that patients are entitled to make their own choices about what risks to incur and thus doctors must provide the information that the patient needs to make that choice. Put briefly, the ‘reasonable professional’ test in Sidaway is replaced by a nuanced ‘reasonable patient’ test. We might note that the GMC beat the courts to this final rejection of Sidaway, emphasising in 2008 that partnership between doctors and patients requires that doctors must ‘share with patients the information they [the patients] want or need in order to make decisions’.⁷⁶

Bye bye Bolam

5.8 We noted at the start of this chapter that the decision of the Supreme Court in Montgomery ended decades of judicial deference to medical paternalism. The Supreme Court has forthrightly rejected any role for the Bolam test in information disclosure. As will be seen in Chapter 7, the Bolam test remains a crucial part of determining negligence in what might be styled ‘ordinary’ clinical negligence claims concerned with such matters as errors in treatment or diagnosis. The famous (or infamous) case of Bolam v Friern Hospital Management Committee,⁷⁷ however, also raised questions of consent and information disclosure. Mr Bolam agreed to electro-convulsive therapy to help improve his depression. He suffered fractures in the course of the treatment. The risk was known to his doctor. He did not tell Mr Bolam. Mr Bolam alleged that the failure to warn him of the risk was negligent. The judge found that the amount of information given to Mr Bolam accorded with accepted medical practice in such cases and dismissed his claim. He added that even if Mr Bolam had proved that the doctor’s advice was inadequate, he would only have succeeded if he could have further proved that, had he been that given that information, he would have refused consent to the treatment. The test of negligence according to McNair J was the test of responsible medical opinion.

Across the Atlantic, courts took a different approach and the doctrine of ‘informed consent’ was born. In Canterbury v Spence⁷⁸ a US court said that the ‘prudent patient’ test should prevail. Doctors must disclose to their patients any material risk inherent in a proposed line of treatment:

A risk is material when a reasonable person, in what the physician knows or should know to be the patient’s position, would be likely to attach significance to the risk or cluster of risks in deciding whether or not to forgo the proposed therapy.

The Canadian Supreme Court also rejected the ‘professional medical standard’ for determining how much the doctor must disclose. Emphasis was laid upon ‘the patient’s right to know what risks are involved in undergoing or forgoing surgery or other treatment’.⁷⁹ The Canadian court did allow that a particular patient might waive his right to know, might put himself entirely in the hands of the doctors. And they said that cases might arise where ‘a particular patient may, because of emotional factors, be unable to cope with facts relevant to the recommended surgery or treatment and the doctor may, in such a case, be justified in withholding or generalising information as to which he would otherwise be required to be more specific’. The doctor could rely on a defence of therapeutic privilege. The High Court of Australia followed Canada in rejecting the Bolam test of professional opinion. In Rogers v Whittaker,⁸⁰ failure to disclose a 1:14,000 chance of blindness in both eyes inherent in surgery was held negligent. The patient had made clear her concerns about risks of losing her sight altogether.⁸¹

Such a patient-oriented approach initially found little judicial support in England. Miss Chatterton, who lost in battery,⁸² also failed in negligence. The doctor, the judge said, did owe her a duty to counsel her as to any real risks inherent in the surgery proposed. He did not have to canvass every risk and in deciding what to tell the patient he could take into account ‘the personality of the patient, the likelihood of misfortune and what in the way of warning is for the particular patient’s welfare’. This standard Dr Gerson had met.

Sidaway

5.9 What amounts to a ‘real risk of misfortune inherent in the procedure’? For thirty years the decision of the Law Lords in Sidaway entrenched in theory a test based prima facie⁸³ on professional opinion, applying the Bolam test. Following an accident at work, Mrs Sidaway had endured persistent pain in her right arm and shoulder. Later the pain spread to her left arm. In 1960 she became the patient of Mr Falconer, an eminent neurosurgeon at the Maudsley Hospital. An operation relieved the pain for a while. By 1973, Mrs Sidaway was again in pain. She was admitted to the Maudsley Hospital and Mr Falconer diagnosed pressure on a nerve root as the cause of her pain. He decided to operate to relieve the pressure. Mrs Sidaway gave her consent to surgery. As a result of that operation Mrs Sidaway became severely disabled by partial paralysis.

Mrs Sidaway sued both Mr Falconer and the Maudsley Hospital. She did not suggest that the operation had been performed otherwise than skilfully and carefully. Her complaint was this. The operation to which she agreed involved two specific risks over and above the risk inherent in any surgery under general anaesthesia. These were: (1) damage to a nerve root, assessed as about a 2 per cent risk; and (2) damage to the spinal cord, assessed as less than a 1 per cent risk. Alas for Mrs Sidaway, that second risk materialised and she suffered partial paralysis. She maintained that Mr Falconer never warned her of the risk of injury to the spinal cord. Mr Falconer died before the action came to trial. In the absence of evidence as to exactly what the patient was told by her surgeon, the trial judge inferred that Mr Falconer would have followed his customary practice and would have warned Mrs Sidaway in general terms of the possibility of injury to a nerve root, but would have said nothing about any risk of damage to the spinal cord.

Ten years after the operation which left Mrs Sidaway paralysed, and seven years after Mr Falconer’s death, the case reached the House of Lords.⁸⁴ The paucity of evidence about what actually happened when Mrs Sidaway and Mr Falconer discussed the proposed surgery rendered the case, as Lord Diplock put it, ‘a naked question of legal principle’. What principle governed the doctor’s obligation to advise patients and to warn of any risks inherent in surgery or treatment recommended by the doctor? The majority of their Lordships largely endorsed the traditional test enunciated in the case of Mr Bolam nearly thirty years before. The doctor’s obligation to advise and warn his patient was part and parcel of his general duty of care owed to each individual patient. Prima facie, providing he conformed to a responsible body of medical opinion in deciding what to tell and what not to tell his patient, he discharged his duty properly. There being evidence that, while some neurosurgeons might warn some patients of the risk to the spinal cord, many chose not to, Mrs Sidaway’s case was lost.

The Law Lords sought to emphasise that Sidaway should not be seen as endorsing the view that providing a doctor follows current medical practice in deciding what information to give his patients he will be immune from legal attack. The courts retain ultimate control of the scope of the doctor’s obligation. First, for Lord Bridge and Lord Templeman, a crucial issue in Mrs Sidaway’s case was that the risk of which she was not advised was a less than 1 per cent risk, and all the medical expert witnesses were agreed that it was a risk which many responsible neurosurgeons elected not to warn patients of. Had the risk been of greater statistical significance, their Lordships might have held in Mrs Sidaway’s favour, even if expert medical witnesses supported non-disclosure. Lord Bridge gave as an example ‘an operation involving a substantial risk of grave adverse consequences, for example [a] 10 per cent risk of a stroke from the operation’.⁸⁵ He went on to acknowledge that there might be cases where ‘disclosure of a particular risk was so obviously necessary to an informed choice on the part of the patient that no reasonably prudent medical man would fail to make it’. Second, for Lord Diplock and Lord Templeman a vital question in the case was that Mrs Sidaway had not expressly inquired of Mr Falconer what risks the surgery entailed. For Lord Diplock the case concerned solely what information the doctor must volunteer. Lord Templeman said that Mr Falconer could not be faulted for failing to give Mrs Sidaway information for which she did not ask.

Nonetheless four out of five of the Law Lords in Sidaway rejected the transatlantic test that what the patient should be told should be judged by what the reasonable patient would want to know and demonstrated little enthusiasm for ‘informed consent’.⁸⁶ Lord Scarman alone rejected current medical practice as the test of what a patient needed to be told. In a powerful dissent he asserted the patient’s right to know. The patient’s right of self determination, his right to choose what happened to his body, was the factor which to Lord Scarman made the issue of advice given to the patient distinct from other aspects of medical care. The doctor should be liable ‘where the risk is such that in the court’s view a prudent person in the patient’s situation would have regarded it as significant’.⁸⁷ But, albeit the patient’s right of self-determination distinguishes advice given from other stages in medical care, advice before treatment cannot be totally separated from the doctor’s general duty to offer proper professional and competent service. Doctors, in Lord Scarman’s view, should be to a certain extent protected by ‘therapeutic privilege’, permitting a doctor to withhold information if it can be shown that ‘a reasonable medical assessment of the patient would have indicated to the doctor that disclosure would have posed a serious threat of psychological detriment to the patient’.⁸⁸

The road from Sidaway

5.10 While in the immediate aftermath of Sidaway, the Court of Appeal⁸⁹ appeared to entrench an unmodified Bolam test and endorse the professional standard as the touchstone for information disclosure, the courts gradually began to chip away at the professional standard and the role of Bolam culminating in the Supreme Court decision in Montgomery. Eleven years before Montgomery, in Chester v Afshar⁹⁰ Lord Steyn said simply: ‘Surgery performed without the informed consent of the patient is unlawful. The court is the final arbiter of what constitutes informed consent’.⁹¹

The trigger for change towards a more patient-oriented test came initially from the doctors themselves.⁹² Professional practice changed markedly. Doctors now endorse more open disclosure of risks. Guidance from the GMC⁹³ gave detailed instructions about the information that patients should be offered covering risks, benefits and burdens, uncertainties and other options. Advice should be tailored to the needs, wishes and priorities of the patient, focusing on the ‘individual situation and the risk to them’.

Judicial change came slowly. In Smith v Tunbridge Wells Health Authority⁹⁴ a claim was brought by a 28-year-old man who was not warned of the risk of impotence inherent in rectal surgery. His claim succeeded despite expert evidence that a body of surgeons did not warn patients of that risk. The judge, citing Lord Bridge in Sidaway, found that failure to warn such a patient of a risk of such importance to him was ‘neither reasonable nor responsible’. Mere evidence of a medical practice did not counter allegations of negligence. That practice must be reasonable in the context of providing patients with an informed choice. In Bolitho v City Hackney Health Authority⁹⁵ the House of Lords stressed that, in relation to all claims of negligence against doctors, expert evidence advanced to support the defendant’s case that he acted without negligence must be shown to be responsible. To rebut negligence a practice must have a ‘logical and defensible’ basis. In Bolitho, Lord Browne-Wilkinson seemed at one stage to suggest that in his clarification of the Bolam test he was not concerned with cases about informed consent.⁹⁶ That statement was not designed to exempt consent claims from judicial scrutiny, but simply to acknowledge that case law stretching back to Lord Bridge in Sidaway already allowed scrutiny of information disclosure practice.⁹⁷

The most fundamental change came in Pearce v United Bristol Healthcare NHS Trust.⁹⁸ Mrs Pearce, who was expecting her sixth child, was two weeks past her due date of delivery. She discussed the possibility of induction with her obstetrician who warned her of the risks of induction and caesarean surgery, but did not tell her that there was a 0.1–0.2 per cent risk of stillbirth associated with non-intervention. Mrs Pearce’s child was stillborn and she alleged that failure to warn her of the risk of stillbirth was negligent. The Court of Appeal held that she had not established negligence. The very slight risk of stillbirth arising from non-intervention, compared to the risks of intervention, was not a risk which the defendants were negligent in failing to disclose, especially in the light of Mrs Pearce’s distressed condition at the time of the consultation. What is of interest in Pearce is that Lord Woolf’s judgment in the doctors’ favour departed radically from a simple test of whether the information offered to Mrs Pearce conformed to a reasonable body of expert opinion. Lord Woolf declared that ‘if there is a significant risk which would affect the judgement of a reasonable patient, then in the normal course it is the responsibility of a doctor to inform the patient of that significant risk, if the information is needed so that the patient can determine for him or herself as to what course she should adopt’ (our emphasis). Lord Woolf seemed to suggest that the reasonable doctor must tell the patient what the reasonable patient would want to know,⁹⁹ and sought to replace the ‘reasonable professional’ test advanced by the majority in Sidaway with a ‘prudent patient’ test.

The impact of Pearce

5.11 Lord Woolf’s formulation of a patient-focused test in Pearce appeared to be endorsed by both the Court of Appeal¹⁰⁰ and the House of Lords.¹⁰¹ It seemed, notwithstanding Sidaway, to have become the ‘standard formulation of the duty to disclose information to patients’.¹⁰² In Montgomery before the Court of Session (sub nom NM v Lanarkshire Health Board), the Scottish Court of Appeal disagreed and with something close to scorn the court dismissed submissions that Pearce replaced the reasonable doctor test with a reasonable patient test. Sidaway, the Scottish judges said, was binding on the English Court of Appeal, as it was on them. Lord Woolf’s judgment in Pearce had been ex tempore. Had it been his intent to refine or qualify Sidaway the Scottish appeal court said that it was unlikely that he would have done so other than in a reserved judgment. The judgment in Pearce did nothing other ‘than follow and endeavour to apply the majority view of the House of Lords’ in Sidaway.¹⁰³ In response to submissions that the House of Lords in Chester v Afshar had endorsed the judgment in Pearce as modifying Sidaway, the Court of Session first dismissed any such remarks as obiter¹⁰⁴ and later rejected any argument that anything said in Chester v Afshar could be so interpreted. The case was appealed to the Supreme Court and the stage was set for the ‘death of Sidaway’.

Montgomery: autonomy reigns?

5.12 Nadine Montgomery sued on behalf of her son born with cerebral palsy and other disabilities caused when he was starved of oxygen during his birth. Mrs Montgomery was small (just over 5 feet in height) and suffered from diabetes; both factors that might result in difficulties in labour including 9–10 per cent risk of shoulder dystocia described by an expert witness as ‘a major obstetric emergency’¹⁰⁵ carrying risks to mother and child. In particular, there was a 0.2 per cent risk of a brachial plexus injury to the child leaving him with a useless arm and a very small (less than 0.1 per cent) risk of hypoxia in labour resulting in cerebral palsy. Sadly for Mrs Montgomery’s son both risks materialised. His mother argued that had she been given advice about the possible problems of vaginal delivery she would have opted for an elective caesarean section. The Supreme Court unanimously upheld her appeal. The decision of the Court was delivered by Lord Kerr and Lord Reed with whom the other Justices agreed. Lady Hale added some additional observations, focused in particular on the very specific context of childbirth, and discussed later in Chapter 11.

The Court held that while assessment of the risks and benefits of treatment was properly regarded as part of medical expertise, the decision about whether those risks, benefits and alternative options should be discussed with the patient was not purely a matter of professional judgement. Such an approach ignored ‘the patient’s entitlement to decide on the risks to her health that she is willing to run (a decision which may be influenced by non-medical considerations)’.¹⁰⁶ Bolam has no role to play in determining what patients should be told.¹⁰⁷ The correct test is in essence that embodied in Lord Scarman’s minority opinion in Sidaway. Save for rare cases where non-disclosure is justified by the ‘therapeutic exception’ (discussed at 5.15) the doctor has a duty to ensure that the patient:

[I]s aware of any material risks involved in any recommended medical treatment, and of any reasonable alternative or variant treatments. The test of materiality is whether, in the circumstances of the particular case, a reasonable person in the patient’s position would be likely to attach significance to the risk, or the doctor is or should be reasonably aware that the particular patient would be likely to attach significance to it.¹⁰⁸

Applying that test to Mrs Montgomery’s case the Court held that, given the substantial risk of shoulder dystocia, itself a major obstetric problem requiring at best traumatic interventions that affect the mother, plus the very serious risks to the child compared to the very small risks of caesarean delivery, the risk of shoulder dystocia was (as the defendant doctor knew) likely to affect a patient in Mrs Montgomery’s position. Indeed Mrs Montgomery had expressed her anxieties about vaginal delivery. In her own evidence the defendant very honestly said that she considered that, if the risk of shoulder dystocia was disclosed to patients such as Nadine Montgomery, they would simply then seek caesarean delivery.

Note the importance placed by the judges on the entitlement of the patient to receive information on which to make her own choices. That choice may be to decline information, to ‘delegate’ her right to choose to her doctor.¹⁰⁹ That is in itself an autonomous choice.

Montgomery concerned information given to a patient in order that he could decide whether or not to undergo the proposed treatment. Must doctors also conform to the reasonable patient standard in disclosing post-operative risks? In Spencer v Hillingdon Hospital NHS Trust¹¹⁰ the High Court held that the Hospital Trust breached their duty of care in failing to warn Mr Spencer of the risk and symptoms of post-operative deep-vein thrombosis. The NICE guidelines were not entirely clear as to which groups of patients should be so warned. The ‘ordinary sensible patient’, however, would expect the warning and Montgomery makes this the focus of the duty to disclosure information.

Alternative treatments

5.13 Montgomery makes it clear that doctors must do more than simply discuss risks of treatment. To enable patients to exercise their right to make their own choices, the patient must be made aware of alternatives to treatment proposed by the doctor. What may this entail? In Birch v University College London Hospital NHS Foundation Trust¹¹¹ (decided before Montgomery and applying Lord Woolf’s formulation in Pearce) Mrs Birch agreed to a cerebral catheter angiogram to test for a possible aneurysm in her brain. She suffered a stroke caused by the procedure and she had been fully warned of the risk of a stroke caused by the angiogram but she had not been informed that there was an alternative and non-invasive procedure, magnetic resonance imaging (MRI). Her counsel argued that information about other options and their comparative risks was essential to discharge the doctors’ duty to give Mrs Birch adequate advice on which to found her decision about whether or not to consent to the angiogram. The judge agreed. Albeit the issue of comparative risk was not addressed by Lord Woolf in Pearce, Cranston J held that:

the duty to inform a patient of the significant risks will not be discharged unless she is made aware that fewer, or no, risks are associated with another procedure. In other words, unless the patient is informed of the comparative risks of different procedures she will not be in a position to give her fully informed consent to one procedure rather than another.¹¹²

In Nicholas v Imperial College NHS Trust¹¹³ the defendant vascular surgeon operated on the claimant’s carotid artery. A follow-up scan showed a residual flap on the artery. The surgeon explained the presence of the flap to Mrs Nicholas but decided not to operate again unless untoward symptoms developed. He did not discuss with her the option of operating again or inserting a stent before any adverse symptoms manifested themselves. After Mrs Nicholas suffered loss of vision in one eye, a further operation was performed and she suffered a stroke. The judge held that while his judgement that further surgery should not be carried out immediately on discovering the flap was not negligent, the defendant was in breach of his duty to make Mrs Nicholas aware of her options. Her claim nonetheless failed because the judge found that had she been fully informed of the pros and cons of immediate surgery, Mrs Nicholas would have accepted the defendant’s advice and thus she failed to prove causation.

What about understanding?

5.14 Imparting information does not of itself assist the recipient to make an informed decision. If a patient is simply deluged with complex technical details and an array of statistics, she may be in no better position to make the choice right for her than if she had simply accepted the recommendation of her doctors. The GMC emphasises the importance of sharing information in a way that the patient can understand, seeking to check that he has understood and making available additional time and support where needed. The courts have held that poor communication of risks by the medical team that led to the claimant being understandably confused did amount to breach of the duty to inform.¹¹⁴ Is there a legal duty to seek to ensure that the patient does understand information properly communicated? In Al Hamwi v Johnson¹¹⁵ the claimant misunderstood what she had been told of the risks of amniocentesis and radically overestimated the risk of miscarriage believing it to be 75 per cent and not less than 2 per cent. On the basis of this misapprehension she refused amniocentesis and went on to give birth to a disabled baby. The judge held that Mrs Al Hamwi had been presented with factually accurate information and the doctor had acted correctly in giving all the relevant information. The doctor should and did take steps to satisfy herself that the patient understood the information but this ‘obligation does not extend to ensuring that the patient has understood’.¹¹⁶ In Montgomery the Supreme Court appears to indicate that the doctor has at least ‘a duty to take reasonable care to ensure the patient is aware of any material risks’.¹¹⁷

The therapeutic exception

5.15 For so long as the professional standard governed what information about treatment doctors must disclose, the question of ‘therapeutic privilege’ exceptionally allowing a doctor to withhold information when disclosure might risk damage to the patient’s health was fairly muted in the UK. For if doctors only had to tell patients what fellow doctors thought they should know then in most cases the professional standard factored in such ‘therapeutic privilege’. The Supreme Court in Montgomery, in departing from the professional standard, expressly acknowledges a role for what they call ‘the therapeutic exception’. Doctors are entitled to withhold information reasonably considered detrimental to the patient’s health¹¹⁸ or in ‘circumstances of necessity’.¹¹⁹ The scope of any ‘therapeutic exception’ remains undefined. Would a surgeon be able to justify withholding from a very elderly patient the frightening information about the risk of impotence in an operation the surgeon judged to be essential to maintain the patient’s independent living? The Court warns that the therapeutic privilege must not be abused to allow doctors to prevent patients making decisions that the doctor might see as contrary to the patient’s best interests.¹²⁰ It is clear that any such defence must be based on cogent reasons relating to the welfare of that particular patient, and so not just based on the patient’s age or the surgeon’s view of the minimal risk. In AB v Leeds Teaching Hospital NHS Trust,¹²¹ the defendants argued that giving families information about the retention of organs from their dead children would cause unnecessary distress, and might result in psychiatric harm. Gage J rejected a blanket plea of therapeutic privilege saying of the defence: ‘In so far as it involved the exercise of a therapeutic privilege it was one that does not appear to have been exercised on a case by case basis’.

Where the ‘therapeutic exception’ is invoked, the GMC advises that the reasons be recorded in the patient’s notes and discussed with the medical team.¹²² Before Montgomery, Maclean warned of the ambiguity of therapeutic privilege and the lack of research into its use and effect.¹²³

Causation

5.16 Proving that the doctor failed to give the patient a sufficient warning of some possible adverse risk or side effect is not enough to ensure that a claim in negligence succeeds. The patient must also establish that, had she received such a warning, she would not have consented to the treatment in question.¹²⁴ She must show that the doctor’s negligent failure caused the injury of which she complains. Despite grand statements about principles of informed consent, it was a narrow question of causation that directly concerned the Law Lords in Chester v Afshar.¹²⁵

Miss Chester, a former journalist, had suffered from lower back pain for many years. She was referred to Mr Afshar, a consultant neurosurgeon, who recommended surgery. Miss Chester, a private patient, consented to the operation. Unfortunately, the operation resulted in cauda equina syndrome. Miss Chester suffered significant nerve damage, and became partially paralysed. Miss Chester’s claim that Mr Afshar had not warned her of the 1–2 per cent risk of cauda equina syndrome was accepted by the trial judge. He held that the defendant was negligent in failing to give Miss Chester such a warning.¹²⁶ The question before the House of Lords was did Mr Afshar’s negligence cause Miss Chester’s paralysis? Miss Chester did not argue that, had she received such a warning, she would probably never have gone ahead with the operation. She did not say that a risk of paralysis was just too great and she would put up with the pain. Nor did she try to claim that she would have sought out a different surgeon, or a different form of operation.¹²⁷ She said only that, had she been properly warned, she would not have gone ahead with surgery on that day. She would have taken time to reflect, to seek a second opinion and consult her friends. The House of Lords found in her favour by a majority of 3:2.

The dissenting judges, Lord Bingham and Lord Hoffmann, applied the conventional principles of causation. Miss Chester had failed to show that, properly warned, she would have been likely to have refused to have surgery. She would most likely have had the operation, albeit some time later. She would have been subject to just the same risk. Her ‘injury would have been as liable to occur whenever the surgery was performed and whoever performed it’.¹²⁸ The majority considered that the patient’s right to autonomy and dignity, the right to make an informed choice, justified ‘a narrow and modest departure from traditional causation principles’.¹²⁹ Should Miss Chester lose her claim, in conformity with the normal rules on causation, Lord Hope argued that the duty on doctors to warn patients of risks of surgery would be rendered ‘useless in the cases where it may be needed most’.¹³⁰ Lord Hope stressed that many patients might find a decision about whether to go ahead with risky treatment difficult. They could not with hindsight say definitively ‘I would have said yes or no’. Many people might share Miss Chester’s ambivalence. Patients who would find such a decision difficult should not be deprived of a remedy. Hence he agreed with the majority to modify the rules of causation, as he saw it ‘modestly’. Lord Bingham saw any departure from those usual rules as ‘substantial and unjustified’.¹³¹

At a practical level we may wonder in how many cases the modified rules of causation in Chester v Afshar will apply. Mrs Montgomery (as we have seen) lost her case on breach of duty in the Scottish Court of Session in NM v Lanarkshire Health Board, but nonetheless the Court offered their views on the issue of causation had breach of duty been established. The Court accepted without question the finding of the judge at first instance that even had Nadine Montgomery been warned of the risk of shoulder dystocia, resulting in such an adverse outcome as in fact ensued, she would have followed the obstetrician’s advice and agreed to attempt a vaginal delivery. Thus applying the traditional rules of causation Mrs Montgomery failed the ‘but for’ test. Her counsel also however sought to argue that Chester v Afshar should be interpreted to mean that if a grave risk of which the doctor should have warned the patient materialised, that sufficed to establish a causal link. The Scottish appeal court was unconvinced. In Chester v Afshar the proposed surgery was elective and so in the unusual circumstances of her case Miss Chester could argue that had she been warned she would have taken some time to deliberate and the outcome might have differed, ‘The birth of a baby cannot simply be put off or postponed’.¹³²

In the Supreme Court, the Scottish court’s decision on causation was also overturned, but by application of the traditional test of causation. The Justices first held that most exceptionally they might reject the usual assumption that the trial judge had fully considered all the evidence on causation. In the light of the defendant obstetrician’s own evidence that Mrs Montgomery’s likely reaction, and that of other women in her predicament, to information about the risks of shoulder dystocia would have been to ask for a caesarean, the case on causation, on the simple ‘but for’ test was amply made out. There was thus no need to address any possible application or extension of Chester v Afshar.¹³³ The full extent to which Chester v Afshar will modify traditional rules of causation remains to be seen.

Rights, partnership and informed consent

5.17 Doctors’ fears of litigation¹³⁴ surrounding ‘consent’ are understandable. The sheer difficulty for both parties of recalling, reviewing and interpreting conversations which took place years ago in a context a million miles from a courtroom should not be underestimated. The possibility that departing from the Bolam test will increase the unpredictability of the outcome of litigation¹³⁵ is acknowledged in Montgomery. The Justices however say expressly that:

[A] degree of unpredictability can be tolerated as the consequence of protecting patients from exposure to risks of injury which they would otherwise have chosen to avoid. The more fundamental response to such points, however, is that respect for the dignity of patients requires no less.¹³⁶

The Supreme Court welcomed informed consent with enthusiasm.¹³⁷ The Court rejected a number of the practical objections once seen as obstacles to a patient-centred approach to information disclosure, notably by Lord Diplock in Sidaway. It may be doubted if those objections were ever supported by adequate evidence,¹³⁸ but the immense changes in society and medical practice led the Supreme Court to dismiss the view that patients do not want more information, and could not understand that information if they were offered it. In the age of the Internet and easy access to multiple sources of information ‘it would be a mistake to view patients as uninformed, incapable of understanding information, or wholly dependent upon a flow of information from doctors’.¹³⁹ As to the argument that more information would lead to patients ‘irrationally’ refusing much-needed treatment, the Supreme Court offers a dual response. First the central principle in Montgomery embodies the tenet that patients have the right to take responsibility for risks affecting their own health and thus must be entrusted with their own choices.¹⁴⁰ Second in the focus on the particular patient, the concept of irrational choice largely evaporates: the circumstances of individuals differ, so that what is rational to us may seem irrational to you or our doctors. Non-medical factors may outweigh a wholly scientific approach. Consider this scenario. A woman is told that radical mastectomy will very significantly maximise her prospects of recovery from breast cancer. She knows that if she loses a breast her husband will leave her and that psychologically she is unable to cope with the necessary mutilation. Who can say she is ‘irrational’ if she opts for the statistically less ‘safe’ option of lumpectomy? Or, envisage an elderly man facing rectal surgery of the same sort as the operation involved in Smith v Tunbridge Wells Health Authority. The younger reader might consider that such a man would contemplate a small risk of impotence with greater equanimity than the 28-year-old Mr Smith. Who but the gentleman in question can judge that risk to his own remaining hopes in life?

The judgment in Montgomery lauds informed consent. The Justices perceive positive benefits as much as an absence of negative factors agreeing with the GMC that partnership can ‘have therapeutic benefits and is regarded as an integral aspect of professionalism in treatment’.¹⁴¹ The ‘death of Sidaway’ will attract few mourners. Yet perhaps Montgomery has still broader implications for medical law and not all are wholly welcome. The judgement notes the change in provision of healthcare and the move away from old fashioned doctor–patient relationships to a world of multiple health providers and the ever encroaching role of managerialism. Responsibility for a range of decisions may become institutional rather than individual and the Court sees an evolving role for public law.¹⁴² Patients may be ‘widely treated as consumers’.¹⁴³ An image of the NHS as a ‘health supermarket’ is created where relationships become at best minimally important and the notion of partnership peripheral. The fiduciary nature of the doctor–patient relationship given legal shape in Canada,¹⁴⁴ where courts have sought to reclassify doctor–patient relationships by adapting the equitable concept of the fiduciary relationship to embrace the doctor and her patient¹⁴⁵ is not considered. Within such a relationship of trust the doctor’s duty would equally be to make available to the patient that information which it seems likely that individual patients would need to make an informed choice on treatment. Such a change would not just endorse patients’ rights but also enhance patient care¹⁴⁶ by fully recognising the alliance between patient and doctor, improving the quality of health-care.¹⁴⁷

It is somewhat ironic that just as the English courts endorse a patient-centred approach to consent, a number of philosophers begin to express doubts about the dominance of ‘informed consent’.¹⁴⁸ Doubts are cast on how far legal rules truly represent the ethical value of autonomy.¹⁴⁹ It is argued that an unduly libertarian view of autonomy has prevented an adequate emphasis on responsibility and that obtaining informed consent has become a mechanistic process detrimental to good communication.¹⁵⁰ O’Neill argues that the goal of full or complete understanding is illusory. Therefore the focus of informed consent should be on preventing coercion and allowing patients to control the amount and form of information they receive.¹⁵¹ The Supreme Court does recognise the danger ‘of bombarding the patient with technical information’,¹⁵² and stresses the importance of skilled communication. The emphasis again must be on the informational needs of the patient in the clinic or the hospital bed.

Those needs may not always fit neatly with a consumer-based ‘supermarket’ ethos, and finally as we will see in the next chapter, the health and social needs of capacitous but vulnerable patients challenge a wholly autonomybased model of decision-making.

¹  And certainly not from the General Medical Council (GMC). See its guidance to doctors: GMC Consent; Patients and Doctors Making Decisions Together (2008).

²  See Jehovah’s Witnesses of Moscow v Russia (2011) 53 EHRR 4.

³  For an elegant analysis of the relationship between autonomy and consent, see A Maclean, Autonomy, Informed Consent and Medical Law (2009) Cambridge University Press.

⁴  [2004] UKHL 4, [17] and [24].

⁵  [2004] UKHL, [16].

⁶  [2015] UKSC 11 (Montgomery).

⁷  [1985] 1 All ER 643.

⁸  Montgomery, [75].

⁹  R v Brown [1993] 2 All ER 75, HL.

¹⁰  See Attorney General’s Reference (No 6 of 1980) [1981] 2 All ER 1057; Law Commission Consultation Paper No 139, Consent in the Criminal Law (1995) HMSO.

¹¹  See R v Coney (1882) 8 QBD 534.

¹²  For example, extreme ‘cosmetic’ surgery involving amputation or gross facial disfigurement. See D Griffiths, A Mullock, ‘The Medical Exception and Cosmetic Surgery: Culpable Doctors and Harmful Enhancement?’ in S Fovargue, A Mullock (eds) Transforming Wrong(s) into Right(s): The Power of ‘Proper Medical Treatment’ (2015) Routledge.

¹³  And so breaches Article 8 of the Human Rights Convention: see Glass v United Kingdom [2004] 1 FLR 1019, ECtHR; Juhnke v Turkey (2009) 49 EHRR 24 ECtHR.

¹⁴  [2015] EWCA Civ 8.

¹⁵  Allan v New Mount Sinai Hospital (1980) 109 DLR (3d) 536.

¹⁶  Devi v West Midlands AHA [1980] 7 CL 44. And see Williamson v East London and City Health Authority [1998] Lloyd’s Rep Med 6 (woman consented to removal of breast implants but not to a mastectomy).

¹⁷  Bartley v Studd (1995) 2(8) Medical Law Monitor 1 (the surgeon was disciplined by the GMC).

¹⁸  [2015] EWHC 1339 (QB).

¹⁹  Freeman v Home Office [1984] 2 WLR 130.

²⁰  R v Ireland and Burstow [1998] AC 147, HL; R v Dica [2004] 3 A11 ER 593, CA.

²¹  See Law Commission, Reform of Offences against the Person: A Scoping Consultation Paper, Consultation Paper 217 (2014), para 2.13.

²²  Or otherwise unable to give or withdraw consent due to a lack of capacity. See discussion of Connolly v Croydon Health Service NHS Trust [2015] EWHC 1339 (QB) at 5.1.

²³  See Chapter 6.

²⁴  DH, Reference Guide to Consent for Examination or Treatment (2009), para 53.

²⁵  Re T (Adult: Refusal of Medical Treatment) [1992] 4 A11 ER 649, CA. See 6.14.

²⁶  For example, Kerrie Wooltorton attempted suicide by drinking antifreeze and then called an ambulance. She left a letter with instructions to keep her comfortable but not to treat or resuscitate her. The hospital complied and she died. See BBC News, ‘Doctors “Forced” to Allow Suicide’ (2009) 1 October. But contrast the situation regarding psychiatric patients at risk of suicide who are admitted into a mental health unit. They are entitled to protection from self-harm and are assumed to lack capacity in this regard. See Rabone and another v Pennine Care NHS Foundation Trust [2012] UKSC 2, [30], per Lord Dyson: ‘In the case of the suicide of a psychiatric patient, the likelihood is that, given the patient’s mental disorder, her capacity to make a rational decision to end her life will be to some degree impaired. She needs to be protected from the risk of death by those means’; and see 2.7.

²⁷  See Mental Capacity Act 2005, s 4(7).

²⁸  (1988) 63 OR (2d) 243 (Ontario High Court).

²⁹  Discussed in (1990) 5 Professional Negligence 118.

³⁰  [1992] 4 All ER 649, CA.

³¹  Mental Capacity Act 2005, s 2(5) and (6).

³²  [2014] EWCOP 454.

³³  See, for example, the judgment of Lord Alverstone in Leigh v Gladstone (1909) 26 TLR 139 authorising forcible feeding of a suffragette prisoner.

³⁴  [1992] 4 All ER 645, CA.

³⁵  [1992] 4 All ER 649, at 652–653, CA.

³⁶  [1992] 4 All ER 649, at 663, CA.

³⁷  It may always be especially difficult to judge capacity retrospectively; see NHS Trust v T [2005] 1 All ER 387.

³⁸  See Local Authority v A [2010] EWHC 1549 (Fam) and see 6.4.

³⁹  [2014] EWHC 454 (COP).

⁴⁰  Alternatively he held that if LM did lack capacity, given her faith, blood transfusions were not in her best interests: see 6.14.

⁴¹  [2014] EWHC 1317 (COP). See 2.7.

⁴²  See Mental Capacity Act 2005, ss 24–25, at 6.14.

⁴³  [2014] EWHC 1317 (COP), [42].

⁴⁴  [1993] 1 All ER 821, at 866; and see Lord Mustill at 889. See also Secretary of State for the Home Department v Robb [1995] 1 All ER 677.

⁴⁵  [2002] EWHC 429 (Fam); discussed at 6.4.

⁴⁶  [1992] 4 All ER 645, at 653, CA.

⁴⁷  [1992] 4 All ER 671.

⁴⁸  For example, Rochdale Healthcare (NHS) Trust v C [1997] 1 FCR 274.

⁴⁹  Re MB (Caesarean Section) [1997] 8 Med LR 217, CA; St George’s Healthcare NHS Trust v S [1998] 3 All ER 673, CA.

⁵⁰  St George’s Healthcare NHS Trust v S [1998] 3 All ER 673, at 692.

⁵¹  See, for example, Bolton Hospitals NHS Trust v O [2003] 1 FLR 824 and Re AA [2012] EWHC 4378 (COP). The rights of pregnant women are dealt with more fully at 11.21.

⁵²  Sometimes legislation such as the Human Fertilisation and Embryology Act 1990 requires written consent; see R v Human Fertilisation and Embryology Authority ex p Blood [1997] 2 A11 ER 687, CA, discussed at 12.15. And see ss 2(5) and 3(5) of the Human Tissue Act 2004.

⁵³  O’Brien v Cunard SS Co (Mass 1891) 28 NC 266.

⁵⁴  DH, Reference Guide to Consent for Examination or Treatment (2nd edn, 2009).

⁵⁵  See SaBTO Consultation, Patient Consent for Blood Transfusion (March 2010); and AM Farrell, M Brazier ‘Consent for Blood Transfusion’ (2010) 341 BMJ 4336.

⁵⁶  Reference Guide to Consent for Examination or Treatment, para 21.

⁵⁷  See Chatterton v Gerson [1981] 1 All ER 257.

⁵⁸  See R v Tabassum [2000] Lloyds Rep Med 404 CA; see 5.6.

⁵⁹  [1981] 1 All ER 457. The nature and purpose test for battery is cogently criticised by TK Feng, ‘Failure of Medical Advice: Trespass or Negligence?’ (1987) 7 Legal Studies 149. And see A Maclean, ‘The Doctrine of Informed Consent: Does It Exist and Has It Crossed the Atlantic?’ (2004) 24 Legal Studies 386, at 398–401 and Autonomy, Informed Consent and Medical Law (2009) Cambridge University Press, pp 191–196.

⁶⁰  See Potts v North West Regional Health Authority (1983) Guardian, 23 July. See 11.2.

⁶¹  Appleton v Garrett [1996] PIQR P1. Contrast with R v Richardson (Diana) (1998) 43 BMLR 21, CA (dentist acquitted of criminal assault even though she failed to inform her patients that she had been struck off the dental register).

⁶²  R v Tabassum [2000] Lloyd’s Rep Med 404, CA.

⁶³  Hills v Potter (note) [1984] 1 WLR 641, at 653.

⁶⁴  [1984] 1 All ER 1018, at 1026 and Freeman v Home Office [1984] 1 All ER 1036.

⁶⁵  Sidaway v Board of Governors of the Bethlem Royal and the Maudsley Hospital [1985] 1 All ER 643.

⁶⁶  [1985] 1 All ER 643, at 650.

⁶⁷  Reibl v Hughes (1980) 114 DLR (3d) 1.

⁶⁸  See Maclean, ‘The Doctrine of Informed Consent’, at 399.

⁶⁹  See JK Mason, GT Laurie, Mason and McCall Smith’s Law and Medical Ethics (9th edn, 2013) Oxford University Press, pp 106–110.

⁷⁰  Discussed elegantly in J Keown, ‘The Ashes of AIDS and the Phoenix of Informed Consent’ (1989) 52 Modern Law Review 790.

⁷¹  R v Clarence (1888) 22 QBD 23.

⁷²  R v Richardson (Diana) (1998) 43 BMLR 21, CA.

⁷³  [2004] UKHL 41, [17].

⁷⁴  [2015] UKSC 11.

⁷⁵  [1985] 1 All ER 643.

⁷⁶  GMC, Consent: Patients and Doctors Making Decisions Together (2008), para 2 (c).

⁷⁷  [1957] 2 All ER 118. Earlier in 1954, Lord Denning held it to be entirely for the individual doctor to decide what to tell his patient, even if the doctor went so far as to resort to what his Lordship termed ‘a therapeutic lie’; Hatcher v Black (1954) The Times, 2 July; and see O’Malley-Williams v Board of Governors of the National Hospital for Nervous Diseases [1975] BMJ 635.

⁷⁸  (1972) 464 f 2D 772, at 780.

⁷⁹  Reibl v Hughes (1980) 114 DLR (3d) 1.

⁸⁰  [1993] 4 Med LR 79: discussed in D Chalmers, R Schwartz, ‘A Fair Dinkum Duty of Disclosure’ (1993) 1 Medical Law Review 189.

⁸¹  For an insightful comparative analysis of the different legal responses to information disclosure in the UK and the Antipodes, see J Miola, ‘On the Materiality of Risk: Paper Tigers and Panaceas’ (2009) 17 Medical Law Review 76. And for a further comparative law review, see Montgomery, [70]–[73].

⁸²  See 5.6.

⁸³  The speeches on the Law Lords in the majority indicate a measure of disagreement as to the exact role to be allocated to Bolam, a matter well addressed by the Supreme Court in Montgomery. See 5.12.

⁸⁴  Sidaway v Board of Governors of the Bethlem Royal and the Maudsley Hospital [1985] 1 All ER 643.

⁸⁵  Ibid, at 663.

⁸⁶  In the Court of Appeal, Dunn LJ declared that, ‘The concept of informed consent forms no part of English law’; Sidaway v Board of Governors of the Royal Bethlem and Maudsley Hospital [1984] 1 A11 ER 1018, at 1030.

⁸⁷  [1985] 1 All ER 643, at 654.

⁸⁸  [1985] 1 All ER 643, at 654. Lord Scarman recognised the right of a patient of sound understanding to be warned of material risks save in exceptional circumstances, yet he too found against Mrs Sidaway on the facts of the case. He held that she failed to establish on the evidence put forward by her counsel that the less than 1 per cent risk was such that a prudent patient would have considered it significant.

⁸⁹  Blyth v Bloomsbury Health Authority [1993] 4 Med LR 151; Gold v Haringey Health Authority [1987] 2 All ER 884, CA. And see Moyes v Lothian Health Board [1990] 1 Med LR 471.

⁹⁰  [2004] UKHL 41.

⁹¹  Ibid, [14].

⁹²  ‘A fair criticism of the law may well be that, up until now, it has lagged behind developments and changing attitudes from within the medical profession’ (R Heywood, ‘RIP Sidaway, Patient-Oriented Disclosure – A Standard Worth Waiting For? Montgomery v Lanarkshire Health Board’ (2015) 23(3) Medical Law Review 455, at 466).

⁹³  GMC, Consent: Patients and Doctors Making Decisions Together (GMC 2008).

⁹⁴  [1994] 5 Med LR 334; and see McAllister v Lewisham and North Southwark Health Authority [1994] 5 Med LR 343; Newall and Newall v Goldenberg [1995] 6 Med LR 371; Williamson v East London & City Health Authority (1997) 41 BMLR 85; Lybert v Warrington Health Authority [1996] 7 Med LR 71, CA.

⁹⁵  [1998] AC 232.

⁹⁶  [1998] AC 232, at 243.

⁹⁷  See M Brazier, J Miola ‘Bye-Bye Bolam: A Medical Litigation Revolution?’ (2000) 8 Medical Law Review 85, at 107–110.

⁹⁸  [1998] 48 BMLR 118, CA. And see AB v Leeds Teaching Hospital NHS Trust [2004] EWHC 644 (QB); Wyatt v Curtis [2003] EWCA Civ 1779.

⁹⁹  Brazier, Miola, ‘Bye-Bye Bolam’, at 110.

¹⁰⁰  Wyatt v Curtis [2003] EWCA Civ 1779, [16].

¹⁰¹  Chester v Afshar [2004] UKHL 41, [15] per Lord Steyn.

¹⁰²  See Montgomery, [69].

¹⁰³  NM v Lanarkshire Health Board [2013] CSIH 3 [26].

¹⁰⁴  Ibid, [19]. Chester v Afshar being strictly speaking a case relating to causation only and not breach of duty.

¹⁰⁵  Ibid, [8].

¹⁰⁶  Ibid, [83].

¹⁰⁷  Ibid, [84].

¹⁰⁸  Ibid, [87].

¹⁰⁹  Ibid, [85].

¹¹⁰  [2015] EWHC 1058 (QB).

¹¹¹  [2008] EWHC 2237. Cranston J’s judgment was criticised by the Court of Appeal in Meiklejohn v St George’s Healthcare NHS Trust [2014] EWCA Civ 120. But Meiklejohn was decided before Montgomery (see at 5.12) and the major criticisms of Birch in the judgments are no longer pertinent.

¹¹²  [2008] EWHC 2237, [74].

¹¹³  [2012] EWHC 591.

¹¹⁴  Cooper v Royal United Hospital Bath NHS Trust [2005] EWHC 3381.

¹¹⁵  [2005] EWHC 206; and see J Miola ‘Autonomy Rued OK?’ (2006) 14 Medical Law Review 108. And note Nathanson v Barnet and Chase Hospitals NHS Trust [2008] EWHC 460.

¹¹⁶  [2005] EWHC 206, [69].

¹¹⁷  Montgomery, [87].

¹¹⁸  Ibid, [88].

¹¹⁹  Ibid.

¹²⁰  Ibid, [91].

¹²¹  [2004] EWHC 644.

¹²²  GMC, Consent: Patient and Doctors Making Decisions Together (2008).

¹²³  Maclean, Autonomy, Informed Consent and Medical Law (2009), pp 205–208. And see re: vulnerable patients and the inherent jurisdiction, at 6.20.

¹²⁴  So in Jones v North West Strategic Health Authority [2010] EWHC 178, Mrs Jones’s claim failed because as she was a Jehovah’s Witness the judge ruled that she would have been unlikely to have consented to a caesarean section with its increased risk of the need for a blood transfusion. And see Nicholas v Imperial College Healthcare NHS Trust [2012] EWHC 591.

¹²⁵  [2004] UKHL 41.

¹²⁶  The Court of Appeal refused leave to challenge the trial judge’s findings of fact.

¹²⁷  See Chappel v Hart [1999] 2 LRC 341.

¹²⁸  [2004] UKHL 41, [8].

¹²⁹  Ibid, [24] per Lord Steyn.

¹³⁰  Ibid, [86] per Lord Hope.

¹³¹  Ibid, [9]; and see S Green, ‘Coherence of Medical Negligence Cases: A Game of Doctors and Purses’ (2006) 14 Medical Law Review 1; T Clark, D Nolan ‘A Critique of Chester v Afshar’ (2014) Oxford Journal of Legal Studies 659.

¹³²  [2013] CSIH 3, [52].

¹³³  Montgomery, [105].

¹³⁴  It has been argued that informed consent claims are the thin end of the wedge, opening the door for no fault liability; see A Meisel, ‘The Expansion of Liability for Medical Accidents: From Negligence to Strict Liability by Way of Informed Consent’ (1977) 56 Nebraska Law Review 51.

¹³⁵  Though not necessarily increase the incidence of litigation; Montgomery, [93].

¹³⁶  Ibid.

¹³⁷  But what exactly does informed consent entail? For an impressive analysis of the varied and variable meaning of ‘informed consent’, see Maclean ‘The Doctrine of Informed Consent’ 386.

¹³⁸  Montgomery, [76].

¹³⁹  Montgomery, [76]; and see R Heywood, ‘Informed Consent in Hospital Practice: Health Professionals’ Perspectives and Legal Reflections’ (2010) 18 Medical Law Review 152 and ‘Medical Disclosure of Alternative Treatments’ (2009) 68 Cambridge Law Journal 30.

¹⁴⁰  Montgomery, [81].

¹⁴¹  Ibid, [78].

¹⁴²  Ibid, [75].

¹⁴³  Ibid.

¹⁴⁴  McInerney v MacDonald (1992) 92 DLR (4th) 415; Norberg v Wynrib (1992) 92 DLR (4th) 449.

¹⁴⁵  Alas, such a proposition was rejected by both the Court of Appeal, and the Law Lords in Sidaway and by the Australian High Court in Breen v Williams (1996) 70 AJLC 772. See M Brazier (1987) 7 Legal Studies 169, at 189–191.

¹⁴⁶  See A Grubb, ‘The Doctor as Fiduciary’ [1994] Current Legal Problems 112; P Bartlett, ‘Doctors as Fiduciaries’ [1997] 5 Medical Law Review 193; M Brazier, M Lobjoit, ‘Fiduciary Relationship: An Ethical Approach and a Legal Concept’ in R Bennett, C Erin (eds) HIV and AIDS Testing, Screening and Confidentiality (1999) Oxford University Press, p 170.

¹⁴⁷  See H Teff, ‘Consent to Medical Procedures, Paternalism, Self-Determination or Therapeutic Alliance’ (1985) 101 Law Quarterly Review 432.

¹⁴⁸  Maclean, Autonomy, Informed Consent and Medical Law, ch 7.

¹⁴⁹  See, in particular, K Veitch, The Jurisdiction of Medical Law (2007) Ashgate.

¹⁵⁰  See N Manson, O O’Neill, Rethinking Informed Consent in Bioethics (2007) Cambridge University Press.

¹⁵¹  O O’Neill, ‘Some Limits of Informed Consent’ (2003) 29 Journal of Medical Ethics 4.

¹⁵²  Montgomery, [90].

Chapter 6

CAPACITY, CONSENT AND COMPULSION

6.1 In Chapter 5, the principles relating to consent to treatment by competent adults were examined. This chapter looks at two other dimensions of consent to medical treatment. When an adult is incapable of deciding for herself whether or not to agree to treatment, how can treatment be lawfully authorised on her behalf? If an adult refuses to agree to treatment, can that refusal be overruled, either on the grounds that the patient ‘irrationally’ refused treatment which was in her interests, or because, untreated, her physical or mental condition threatens the safety of other people? As we shall see, the law is complex and raises fundamental questions of human rights, requiring examination of the European Convention on Human Rights and the United Nations Convention on the Rights of Persons with Disabilities.¹ Health professionals and health providers face challenging questions in ensuring that they both respect the rights of patients with mental disorders and also protect vulnerable patients from harm, including self-harm.² The law relating to decision-making on behalf of people who lack mental capacity is now largely but not exclusively to be found in the Mental Capacity Act 2005. The Act is accompanied by a Code of Practice³ addressing the health and other needs of people who lack capacity. If an elderly person develops dementia, decisions have to be made about where he should live, does he need to move to a nursing home, what happens to his own house, just as much as what medical treatment he receives. Social care and medical care cannot be divorced from each other. Central to the Act was the creation of the new Court of Protection which determines a rising number of cases relating to disputed or controversial treatment of mentally incapacitated adults. The workload of the Court has become close to impossible.⁴

Doctors and nurses caring for a patient who lacks capacity to consent to treatment on her own behalf confront an awkward dilemma. What does the law allow and require them to do when a patient is chronologically 30, but has such severe learning disabilities that she is unable to make decisions about her medical care? Once a person reaches 18, the age of majority, no one else, be he next of kin or a professional carer such as a social worker, can consent to treatment on his behalf. The doctor is faced with a patient who cannot himself give the consent required to make treatment lawful, and so not a battery, and there may be no one else who can lawfully act as the patient’s proxy. Not to treat the patient at all would be inhumane and a breach of the duty of care owed to every patient. If a patient’s physical condition threatens her life, or grave injury to her health, necessary treatment is justified under section 5 of the Mental Capacity Act, just as it is when an otherwise competent patient is wheeled unconscious into Accident and Emergency. What if there is no immediate emergency? An elderly lady with dementia suffers from cataracts. A middle-aged patient with severe learning disabilities has a hernia. A 19-year-old girl with severe autism is found to be pregnant. None of these cases are life-threatening emergencies, yet the patients’ families and their doctors may agree that the patients would be ‘better off’ for treatment. It is these kinds of questions that the Mental Capacity Act addresses.

In considering how English law should address the dilemmas posed by those who are unable to make their own decisions about healthcare, proper account must be taken of human rights law. However well intentioned, non-consensual treatment is in a sense still compulsory treatment. In order to treat a patient, especially if she is actively objecting to treatment, some element of restraint or detention may also be necessary.⁵ Could such treatment violate Article 3 of the Human Rights Convention?⁶ The European Court of Human Rights (ECtHR) set out some ground rules in Herczegfalvy v Austria.⁷ The Court emphasised the vulnerability and powerlessness of patients lacking mental capacity. Treatment could lawfully be imposed on a patient where he is entirely incapable of deciding for himself and where such treatment was a ‘therapeutic necessity’. Where therapeutic necessity was conclusively established, the ‘compulsory’ treatment should not be regarded as inhuman or degrading.

Article 5 of the Convention protects the right to liberty. While Article 5(1)(e) allows for the detention of ‘persons of unsound mind’, English law was found wanting in the legal protection offered to patients lacking mental capacity who are hospitalised without either their own consent or any appropriate independent authorisation.⁸ This meant that the Mental Capacity Act 2005 had to be amended by section 50 of the Mental Health Act 2007 which inserted new provisions into the 2005 Act establishing the Deprivation of Liberty Safeguards (DoLS).⁹

The Mental Capacity Act needs to be distinguished from the Mental Health Acts of 1983 and 2007.¹⁰ The Mental Health Acts regulate treatment for mental illness allowing (inter alia) for compulsory treatment and detention. Many people who may be mentally ill do not lack mental capacity. Few of those who lack mental capacity are eligible for compulsory treatment under the Mental Health Act. Problems of overlap and the ‘eligibility gap’ between the Mental Capacity and Mental Health Acts continue to plague the law.¹¹ Nor are the statutes alone enough to meet the legal questions arising from society’s obligation to meet the needs of vulnerable adults. The inherent jurisdiction of the High Court endures and a series of cases suggest that in exceptional cases when someone is classified as a ‘vulnerable adult’¹² the courts can intervene to protect that person from neglect or abuse.¹³

Not just about healthcare

6.2 The Mental Capacity Act addresses the whole range of decisions that need to be made once there is doubt that the individual can make her own choices about how she lives her life. The Act has generated an avalanche of case law coming close to overwhelming the new Court of Protection set up to ‘preside’ over the Act.¹⁴ Many of the cases arising from the Act are not directly about healthcare decisions. They address questions as diverse as marriage, where a person should reside, and whether family members should remain in contact with him. Nonetheless such cases may have relevance to us in three senses. First, the cases may clarify how we should apply the mental capacity test or understand the concept of best interests. Second, health is about much more than decisions about medical treatment. A safe and comfortable home may do more to advance the person’s well-being than pills or potions. Finally, a number of cases address a mix of issues such as both where and with whom the person should live and, for example, what treatment he should receive for his epilepsy.¹⁵ The diligent reader will need to explore the whole range of judicial decisions applying the 2005 Act and the courts’ inherent jurisdiction. This chapter does not attempt comprehensive coverage and simply introduces the basic principles of English law in this area.

Not altogether new

6.3 In many respects the Mental Capacity Act codifies earlier case law. There are few radical changes in legal principle. The test of mental capacity remains much the same. ‘Best interests’ continues to be the benchmark against which lawful treatment of a patient lacking capacity is normally to be judged. Earlier case law remains relevant to illustrate how the Act will work. There are important changes in practice. A person can now, via a lasting power of attorney, appoint a proxy to make medical and personal decisions for him should he lose mental capacity. A court can exceptionally appoint a deputy (a kind of guardian) to act for a patient. The Court of Protection oversees the framework of the Act. Above all, what the Act should do is offer a uniform and comprehensive framework to help decision-making on behalf of people lacking mental capacity in all the aspects of their lives. Further guidance on the interpretation and application of the Act is found in the Code of Practice.¹⁶ The Code does not add any new legal requirements, but provides guidance on the Act. Some, including (among others) court-appointed deputies, donees of a lasting power of attorney, and people working in a professional capacity, such as doctors and social workers, come under a legal duty to have regard to its provisions.¹⁷ Failure to comply with the Code is taken into account in any relevant legal proceedings.

The threshold of capacity

6.4 The first question that needs to be addressed is how the law decides whether or not a person has the mental capacity to make his own decisions about medical treatment. Three different sorts of test could be used. A status test could assess intelligence, and determine that all who fell below the requisite ‘score’ were incapable, and all above capable. A status test would designate a person as competent or incompetent for all legal purposes. An outcome test would judge the capacity of the decision-maker by the rationality or wisdom of the decision made. Neither test found favour with English law which applies a functional test. The functional test, endorsed in case law, is retained in the Mental Capacity Act. The relevant question becomes whether X enjoys the necessary understanding to embark on the particular enterprise in question – be it entering a contract, making a will, marriage, or consent to medical treatment. Consider the illuminating case of In the Estate of Park.¹⁸ Mr Park, an elderly man who had previously suffered a severe stroke, married his second wife one morning and that afternoon he executed a new will. He died soon afterwards. His family challenged the validity of the marriage. His widow challenged the will. He was found to be mentally competent to marry, but to lack the necessary mental capacity to make a will. His impaired understanding and reasoning power remained sufficient for him to grasp what was entailed in marriage, but his confusion and loss of memory disabled him from having the necessary recollection of his properties and his obligations to make a will.

The application of the functional test to consent to medical treatment is well illustrated in Re C.¹⁹ C was detained in a special hospital. He had been diagnosed as suffering from chronic paranoid schizophrenia. In 1993, he developed severe problems with a grossly infected leg. Doctors judged his life might be at risk if they did not amputate the leg below the knee. Conservative treatment had no better than a 15 per cent prospect of success. C refused to consent to surgery. He sought an injunction preventing doctors amputating the leg without his express consent. There was no doubt C was mentally ill. He suffered from delusions, including a fixed belief that he himself had had a glittering career in medicine. Nonetheless, Thorpe J found that C was competent to make his own decision on the surgery in question, and granted the injunction C sought. The test set out by Thorpe J for mental capacity in medical treatment involved three stages:

(1)  Can the patient take in and retain treatment information?

(2)  Does he believe it?

(3)  Can he weigh that information and make a decision?

Despite his delusions, C remained capable of understanding what he was told about the proposed treatment and, in particular, he comprehended the risk of death consequent on refusing surgery.

Re C indicates that bizarre beliefs or behaviour should not necessarily result in a finding that a person lacks capacity. However, what others perceive as irrational delusions may influence a judge. Contrast NHS Trust v T (Adult Patient: Refusal of Medical Treatment).²⁰ T suffered from borderline personality disorder and frequently self-harmed. She tended to become severely anaemic. T sought to execute an advance directive prohibiting the administration of blood transfusions. She spoke of her blood as evil, contaminating any new blood transfused into her. The judge said that irrational decisions should not be equated with lack of capacity. Nonetheless he found that Miss T’s view of blood as evil constituted such a ‘misconception of reality’ as to indicate incapacity.

The Re C test formed the basis of the test defining the threshold of capacity within the 2005 Act. Section 1 provides that a person must be presumed to have capacity unless proven otherwise.²¹ No one is to be treated as unable to make a decision unless all practical steps have been attempted to help him to do so. A person is not to be treated as lacking capacity because he makes an unwise decision.²² Inability to make a decision must relate to an impairment of, or a disturbance in the functioning of, the mind or brain, which may be permanent or temporary.²³ Inability to make a decision depends on establishing that the person is unable:²⁴

(a)  to understand the information relevant to the decision,²⁵

(b)  to retain that information,

(c)  to use or weigh that information as part of the process of making the decision,²⁶ or

(d)  to communicate his decision (whether by talking, using sign language, or any other means).²⁷

The Act directs that what must be assessed is essentially the patient’s capacity to understand²⁸ what is at stake and act on that information.²⁹ The rationality of the decision should not determine the capacity of the decision-maker. However, when doctors profoundly disagree with a patient’s decision, they may be tempted to suggest that the patient lacks capacity. Butler-Sloss P warned against the dangers of succumbing to such temptation in B v An NHS Trust.³⁰ Ms B was a tetraplegic patient who sought to have the ventilator keeping her alive switched off. Her doctors challenged her capacity to make such a decision, citing alleged ambivalence in her views, her lack of understanding of other options proposed to her, and supposed depression. Butler-Sloss P found that Ms B retained full mental capacity despite her desperate plight. She warned that:

It is most important that those considering the issue should not confuse the question of mental capacity with the nature of the decision made by the patient, however grave the consequences. The view of the patient may reflect a difference in values rather than an absence of competence.³¹

It would be foolish to suggest that outcome plays no role in determining mental capacity. Capacity is unlikely to be disputed unless others disagree with the outcome. Perhaps we should be more concerned about patients of borderline mental capacity who simply acquiesce in the wishes of their doctors or relatives? And the judges themselves do not wholly ignore outcomes. Butler Sloss P herself said in another case, Re MB (An Adult: Refusal of Medical Treatment):

The graver the consequences of a decision, the commensurately greater the level of competence is required to take the decision.³²

The importance of effective communication between patients and professionals cannot be underestimated. When a patient is known to be affected by some degree of learning disability or dementia, it may be too easy to assume a lack of capacity.³³ Consider this example. An elderly patient with moderate dementia needs dental treatment for an abscessed tooth. He has little concept of time, sometimes does not recognise his wife, and engages in bizarre behaviour. Is he incompetent to consent to dental treatment? What does he need to be told and to understand? His tooth hurts. The tooth can be removed so the hurt will be ‘cured’. Despite his dementia, is the presumption of capacity in section 3 of the Mental Capacity Act rebutted for such a simple procedure?

In a number of recent cases, judges have struggled with the problem of how far an ability to appreciate the consequences of refusing treatment, to use or weigh the information given to them, may be seen as impairing capacity under the Act. Connolly v Croydon Health Service NHS Trust³⁴ is an unusual case in which the claimant withdrew consent part way through a procedure. During a routine angiogram, complications arose necessitating an emergency angioplasty. It was held that, at the crucial time, she lacked the capacity to withdraw her consent. In A Local Authority v A³⁵ Mrs A suffered from significant learning disabilities, atypical autism, communication difficulties and problems with empathy. On two occasions her children had been removed from her at birth. For a time she acceded to contraceptive treatment by depot injection but when she married Mr A, he was fiercely opposed to her continuing contraceptive treatment and antagonistic to social and health workers’ interference. Experts disagreed about Mrs A’s capacity to make a decision. The first question was did she understand the issue at stake. Experts agreed that she showed understanding of the medical aspects of contraception and the advantages and disadvantages of different types of contraception,³⁶ but that she did not appreciate the implication of having and rearing a child or that any future child might well be removed from her care. The court held that appreciation of such consequences did not mean that she lacked the understanding required by section 3(1)(a) of the Act. But more is needed and section 3(1)(c) requires the ability to weigh the information offered and make a decision. The court found that Mr A was domineering and Mrs A was scared of him. There was a ‘completely unequal dynamic in the relationship’ and given Mrs A’s disability and vulnerability a decision to reject contraception was not the ‘product of her own free will’.³⁷

In A Local Authority v E,³⁸ E, who had been sexually abused as a child, had suffered for several years from severe anorexia and alcoholism. Her initial treatment in her teens appeared for a time to have succeeded and she studied medicine at university. But in 2006 she relapsed and was compulsorily detained under the Mental Health Act on at least ten occasions. At the age of 32, E, with the concurrence of her parents and the doctors treating her, decided that she wished to refuse all further treatment and receive palliative care only while she died of starvation. She signed an advance decision to that effect. Some months later as E’s condition deteriorated the local authority applied to the court for guidance. The Court of Protection ruled that E lacked capacity at the time of the hearing as her obsessive fear of weight gain meant that she could not weigh the case for and against further treatment and the strong sedative medicine that she was receiving as part of her palliative care clouded her judgement. In relation to the earlier advance decision, evidence for her capacity at that point was equivocal and therefore it was not appropriate to apply that advance decision. E’s case may be contrasted with two decisions³⁹ discussed in Chapter 5 where the wishes of two patients with long histories of mental illness to refuse blood in accordance with the tenets of Jehovah’s Witness⁴⁰ beliefs were held to be capacitous. Perhaps the distinction is that for these patients, unlike E, any impediment to their ability to weigh and process information about proposed treatments derived from a factor (faith) that was independent of their mental illness.

Note that section 3(2) of the Act indicates that lack of capacity may be due to temporary as much as permanent factors affecting the patient’s mind or brain.⁴¹ What of the patient whose understanding and reasoning powers fluctuate? At times he comprehends what is asked of him and can act on information given to him. Days or even hours later his competence deserts him, albeit to return at some later point. Fluctuating competence may be a result of psychotic disorder, or commonly, a consequence of dementia. Prior to the 2005 Act, the courts tended to find that patients with fluctuating capacity lacked capacity.⁴² The Act continues to require an ability to understand and retain information, but section 3(2) states:

The fact that a person is able to retain the information relevant to a decision for a short period only does not prevent him from being regarded as able to make the decision.

In theory, the functional test of capacity endorsed in the 2005 Act enables many patients with some degree of learning disability to retain capacity to authorise their own treatment. It also entails the risk that, although the patient understands enough to authorise their own treatment, he may refuse to do so. The elderly patient with toothache may allow fear of the dentist to overrule his desire to be rid of the toothache. That outcome will be seen by others as undesirable. Those others will be tempted to say the patients are unable to make a decision. Care should be taken before rushing to enforce treatment in the patient’s best interests. Several thousand indubitably competent people damage their dental health by staying away from the dentist. Just because a patient is labelled demented or mentally disabled, should we enforce his visit to the dentist? The courts make laudable efforts to preserve what others perceive to be valuable lives. But are they on occasion requiring that the patient proves her capacity rather than, as the Act requires, operating on a strong presumption of capacity?⁴³

Treating adults who lack mental capacity

6.5 When an adult patient lacks capacity to consent to treatment on her own behalf, two closely related questions next have to be answered. On what basis is proposed treatment lawful, and, who authorises such treatment? Two principal tests are canvassed, ‘best interests’ and ‘substituted judgement’. A ‘best interests’ test requires that decision-makers consider what the overall welfare of the patient demands. It is, in theory at least, an objective test. ‘Substituted judgement’ demands an attempt to discern what the patient would want were she able to decide for herself. It is illustrated in a famous US case, Re Quinlan.⁴⁴ Karen Quinlan was a young woman who succumbed to sudden illness and lay in a coma supported on a ventilator. Her father applied to the court to be appointed her guardian and sought court approval to switch off the ventilator. The court authorised his decision on the basis of evidence that this was what Karen would have wished. The US court: (1) endorsed a test of substituted judgement; and (2) granted Karen’s father, her next of kin, powers to act on her behalf. In many civil law jurisdictions, as well as some states in the USA, the law allows next of kin to make decisions on behalf of adults who lack mental capacity,⁴⁵ just as English law empowers parents to consent to treatment on behalf of their young children. The Mental Capacity Act adopts a modified version of a best interests test and rejects any notion that next of kin should automatically enjoy proxy powers of consent.

Prior to the 2005 Act, the law left patients lacking mental capacity and their doctors in a legal limbo.⁴⁶ No one had legal authority to act as proxy and consent on behalf of the patient. Even if a patient was compulsorily detained under the Mental Health Act 1983, section 63 of that Act allowing doctors to dispense with the patient’s consent applied only to treatment for mental disorder.⁴⁷ And, as we noted earlier, most patients who lack mental capacity are not detained under the Mental Health Act.⁴⁸ Nor could an adult lacking mental capacity be made a ward of court so that the court could authorise treatment.⁴⁹ One of the extraordinary features of the history of this area of law is that not until 1987 did this question trouble the courts.⁵⁰ In earlier times, perhaps no one gave much thought to the legality of treating patients lacking mental capacity? Doctors and families simply went ahead on the basis that ‘doctor knows best’? The rise in medical litigation and increased concern for patients’ rights began to worry doctors. Health professionals feared litigation both if they went ahead with treatment without consent, and if a patient suffered harm because they did nothing.

F v West Berkshire Health Authority⁵¹

6.6 The trigger for judicial action to clarify the legality of treatment of mentally disabled patients came about in the context of the sterilisation of adult women with learning disabilities. If the girl was under 18, she could be made a ward of court, and the court, if sterilisation was in her best interests, could authorise that radical surgery.⁵² The first fully reported case relating to an adult, T v T⁵³ came to court in 1987 and the following year F v West Berkshire Health Authority reached the House of Lords. F was a 36-year-old woman, said to have a mental age of 5 to 6. She was a voluntary patient in a psychiatric unit and had entered into a sexual relationship with a male fellow patient. The House of Lords granted a declaration stating that F might lawfully be sterilised. Lord Brandon declared:

a doctor can lawfully operate on, or give other treatment to, adult patients who are incapable, for one reason or another, of consenting to his doing so, provided that the operation or other treatment concerned is in the best interests of the patient.⁵⁴

Their Lordships made it clear that mentally disabled adults could lawfully receive medical care and treatment. The elderly confused lady with cataracts can have those cataracts removed. But F empowered doctors to decide on what treatment a patient received with no formal restrictions imposed on the exercise of that power. Operating on an old lady with cataracts is one thing, sterilising a mentally disabled woman is an intervention of a different order of magnitude.⁵⁵ Disquiet about the decision in F v West Berkshire Health Authority arose from a suspicion that the judgment benefited doctors rather more than patients. A declaration from a High Court judge protected doctors from subsequent litigation.⁵⁶ Particularly if there was some dispute between the patient’s relatives, or relatives and carers, the doctor benefited from the court’s intervention.

Defining best interests

6.7 The most fundamental problem with F was the way their Lordships defined best interests ruling that courts should apply the Bolam test. Treatment would be lawful if it conformed with a reasonable and competent body of professional opinion, albeit there might be another reasonable and competent body of professional opinion to the contrary.⁵⁷ The Law Commission criticised the use of Bolam in this context. Their report recommended that it ‘should be made clear beyond any shadow of a doubt that acting in a person’s best interests amounts to more than not treating a person in a negligent manner’.⁵⁸

After a decade of rubber-stamping medical opinion, the courts adopted a much more proactive approach to best interests, well before the enactment of the 2005 Act. Refusing to authorise a vasectomy on a mentally disabled man, Thorpe LJ⁵⁹ emphasised that the decision about the patient’s interests was one which the judge must make. It encompasses ‘medical, emotional and other issues’.⁶⁰ In Re S (Adult Patient: Sterilisation)⁶¹ concerned an application to carry out a hysterectomy on a 29-year-old woman with severe learning difficulties. Doctors and her mother were concerned about the risk of pregnancy and the woman also suffered from severe menstrual problems. She had a phobia about hospitals. Overturning the trial judge’s decision that hysterectomy would be lawful, the Court of Appeal held that other less invasive alternatives should be tried first. Butler-Sloss P said this: ‘The Bolam test [is] irrelevant to the judicial decision, once the judge [is] satisfied that the range of options was within the range of acceptable opinion among competent and reasonable practitioners’.⁶²

Thorpe LJ emphasised that what the medical expert witnesses offered was expert advice on the options for treatment. The court must exercise the choice the patient was unable to make. The patient’s welfare in its broadest sense must be the paramount consideration.⁶³

‘Best interests’ survives: the Mental Capacity Act

6.8 The Mental Capacity Act retained but reformed the best interests test to determine how a patient lacking capacity should be treated. Section 5 provides a statutory basis, the general authority, for any act done in relation to the care or treatment of a person lacking mental capacity. It provides that:

1. If a person (‘D’) does an act in connection with the care of treatment or another person (‘P’), the act is one to which this section applies if –

(a) before doing the act, D takes reasonable steps to establish whether P lacks capacity in relation to the matter in question, and

(b) when doing the act, D reasonably believes –

(i) that P lacks capacity in relation to the matter, and

(ii) that it will be in P’s best interests for the act to be done.

[emphasis added]

2. D does not incur any liability in relation to the act that he would not have incurred if P –

(a) had capacity to consent in relation to the matter, and

(b) had consented to D’s doing the act.⁶⁴

Section 5 has a broad application extending beyond medical treatment. Anyone who intervenes to assist a person lacking mental capacity is protected from liability in battery⁶⁵ if he acts in that person’s best interests. The passer-by who pulls a distressed elderly person with dementia out of the way of oncoming traffic falls within section 5. The paramedics who lift her into an ambulance, and all the doctors and nurses who tend her in hospital, act lawfully by virtue of section 5. In ZH v Commissioner of Police for the Metropolis⁶⁶ a severely autistic and epileptic young man who could not speak was on a trip to the swimming baths with carers. He froze at the poolside and after some time the manager called the police. The claimant jumped into the pool and police then forcibly restrained him with handcuffs and leg restraints detaining him in a police van for forty minutes before releasing him to a carer. The man sued for false imprisonment and breaches of Articles 3 and 5 of the Human Rights Convention. The Court of Appeal accepted that the officers acted in good faith believing that they were acting in the claimant’s interests but they failed to consult the carer present at the scene and their actions were ‘hasty and ill informed’ and thus not in the best interests of the claimant and outside the protection given by section 5.

Should Parliament have seized the opportunity to junk the best interests test? Would ‘substituted judgement’ be a preferable test? The Law Commission rejected a simplistic substitution of ‘substituted judgement’ for best interests. The difficulty is this. Where a patient once enjoyed mental capacity, his known preferences, and even idiosyncrasies, the views which he has expressed to family and friends of what he would hope for were he ever to lack mental capacity, are useful and crucial factors on which to base treatment decisions. In the majority of cases where a patient has lacked mental capacity all his life, ‘substituted judgement’ is a myth. The Mental Capacity Act seeks to give force where appropriate to the prior preferences of someone who later in life loses mental capacity. As we shall see:

(1)  Some statutory force is given to advance directives,⁶⁷ often called ‘living wills’, whereby a person gives directions about treatment which he should, and should not receive, if he becomes unable to decide such matters for himself. Thus we could today set out our decisions about continuing treatment in circumstances where for us death would become preferable to life. As we shall see, the Act only gives force to advance refusals of treatment and not to demands for future care.

(2)  In section 9, the Act further empowers us to nominate our chosen proxy (attorney) by executing a lasting power of attorney to act for us should we lose capacity to act for ourselves. However, both advance refusals and lasting powers of attorney will work to reflect the wishes of the individual herself only in limited circumstances. First, the patient must at some point in her life have enjoyed the necessary mental capacity to execute such an instrument. Second, she must actually have done so, contemplated a future loss of capacity and acted to attempt to extend her autonomous choices beyond that sad event. The numbers of patients making advance decisions, or creating lasting powers of attorney may well be small.

(3)  Most importantly, the Act follows the Law Commission’s recommendation that any evaluation of best interests should take into account evidence of what the patient herself might want were she able to articulate her own views. Section 4 of the Mental Capacity Act adopts (with some additions) the Law Commission’s notion of a modified best interests test, a test incorporating elements of substituted judgement.

Modified best interests

6.9 Section 4 of the Mental Capacity Act sets out the test to be applied. The volume of cases addressing the best interests of incapacitated adults is immense and to do justice to even one-quarter of the case law would take a book of its own. Many questions of best interests relate either to matters concerning contraception and pregnancy, or end of life. Such cases are more fully dealt with in Chapters 11 and 19. In this chapter we seek to introduce the broad principles relating to the best interests test. In determining best interests, decision-makers are first instructed that in making their decision they should not act merely on the basis of:

(a) the person’s age or appearance, or

(b) a condition of his, or an aspect of his behaviour, which might lead other to make unjustified assumptions about what might be in his best interests.⁶⁸

Simply because a patient is 94 does not justify assuming that she would be better off dead in some life-threatening emergency.

Next, when considering best interests, the decision-maker must consider if the patient is ever likely to recover the capacity to make her own decisions, and if so, when this may be.⁶⁹ Wherever possible, the patient must be allowed and assisted to participate in decisions as far as she is able.⁷⁰ So if X has suffered serious brain injuries in a road accident, only immediately necessary decisions should be taken by others while there remains the possibility that X will recover at least some of his reasoning powers. As X slowly recovers, where feasible, he should at least be consulted. In determining best interests, a decision-maker must consider as far as reasonably possible:

–  the person’s past and present wishes and feelings (and in particular any relevant written statement made by him when he had capacity);

–  the beliefs and values that would be likely to influence his decision if he had capacity; and

–  the other factors he would be likely to consider if he were able to do so.⁷¹

In considering these matters, the Act further requires that a decision-maker seek the views of those people who may be best placed both to offer the views of the patient herself and judge her welfare.⁷² So where possible the decision-maker must consult:

(a)  anyone named by the person as someone to be consulted on the matter in question or on a matter of that kind;

(b)  anyone engaged in caring for the person or interested in his welfare;

(c)  any donee of a lasting power of attorney granted by the person; and

(d)  any deputy appointed for the person by the court.⁷³

This modified best interests test requires decision-makers to focus on the individual patient and make a judgement to promote her welfare, a judgement which takes proper account of any prior views that she may have expressed and involves the people most likely to know about her views. Substituted judgement becomes a part of best interests where such judgement can practically be discerned.⁷⁴ The dignity of every patient, including those who never enjoyed mental capacity, is given due regard. A patient may never have had the capacity to make judgements. Nonetheless she would have preferences and feelings, displayed particular aversions,⁷⁵ or especial pleasures. Treatment which transgressed those aversions or removed those pleasures could only be in her interests if strong evidence supported its continuation, despite the distress occasioned to the individual. Note though that the requirement to take into account the patient’s own views and feelings, what Mary Donnelly⁷⁶ has called the consultative model, is not without problems in practice. The patient may be unable to communicate save via his family or be heavily dependent on them to the extent that it becomes hard to discern which are the real views of the patient and which are the wishes of the family member.⁷⁷

The statutory best interests test no longer conflates best interests with non-negligent care. In case after case the courts emphasise that doctors and courts assessing best interests must consider the question holistically looking at all the effects of a decision to adopt a particular treatment.⁷⁸

Such an approach allows weight to be given to social as much as medical factors. In A NHS Trust v DE⁷⁹ it was held that a vasectomy would be in the best interests of DE, an adult man with significant learning disabilities. For a number of years he was in a relationship with PQ, a woman who also had learning difficulties and she became pregnant and gave birth to a child. Sometime later PQ ended the relationship but the couple were later reunited. To prevent the prospect of a further pregnancy, DE was subjected to much increased supervision. Evidence suggested that the relationship with PQ and his previous (if limited) independence were hugely important to DE, that he had capacity to consent to sexual intercourse, but that he lacked capacity to consent to vasectomy and alternative means of contraception were simply not practical for the couple. Evidence also indicated that DE did not want another child and very much wished to continue living at home. Eleanor King J authorised the vasectomy, albeit there was no medical benefit to DE and some slight medical risk.

In A NHS Trust v DE the judge’s view of best interests accorded with the views of DE (as far as he was able to express them) and his family, however, there are occasions when a court rightly concludes that there is no alternative to treatment that the patient or family seeks to reject. A patient with learning disabilities and cancer of the womb initially agreed to a hysterectomy, but failed to (and then refused to) keep further appointments. The Court of Protection agreed that surgery was in her best interests, and that doctors could take any measures needed to detain her in hospital and sedate her.⁸⁰

More difficult problems arise when family members who care for, or are close to the patient, vehemently reject treatment that a court would conclude is in the patient’s medical interests. The patient may need to be removed from his family to residential care if the family will not comply with recommended treatment and that will itself harm the patient. The courts are charged with the task of weighing competing harms.⁸¹

In many of the cases above the courts become involved with one aspect of the patient’s care, often when some form of crisis occurs. There are however an increasing number of complex cases where the long-term care of a mentally incapacitated patient results in several applications to the Court of Protection. An example of such a case may be found in the sad story of DD. We offer here only a brief summary of this distressing case. DD was a 36-year-old woman with autistic spectrum disorder and mild to borderline learning disability. She had given birth to five children, all of whom were taken into care and with whom she had no contact. Six separate applications to court were made to address DD’s capacity and best interests, triggered by her sixth pregnancy. DD had a history of concealing her pregnancies and resisting all medical treatment. She made great efforts to deliver at home and had done so twice in grossly unhygienic conditions. Four of her deliveries within a short space of time were by caesarean section. The sixth application concerned the administration of long-term contraception to DD or authorisation of sterilisation.⁸² The previous five court hearings were as follows.⁸³

(1)  A judge authorised an ultrasound scan and antenatal assessment granting authority to use reasonable force and detention to achieve that aim if necessary.⁸⁴

(2)  The court authorised delivery by caesarean section in hospital again with powers to require the woman’s compliance.⁸⁵

(3)  Short-term contraception was authorised at delivery via a Depo-Provera injection.⁸⁶

(4)  Further injections of Depo-Provera were authorised post delivery.⁸⁷

(5)  Further injections of Depo-Provera were authorised pending the hearing to consider whether the court should authorise long-term contraception or sterilisation.⁸⁸

Cobb J first considered with great care both DD’s capacity to participate in the litigation and her capacity to make decisions on contraception and/or sterilisation, concluding that DD lacked capacity in relation to both matters. In determining DD’s best interests, the judge held that a further pregnancy would pose a real risk to DD’s life, exacerbated by her refusal to accept help and determination to deliver at home without professional help. The options presented to the judge were the fitting of a coil or laparoscopic sterilisation. The former would of course offer DD the option to have further children via removal of the coil. The judge held that in this exceptional case the risk of pregnancy to DD was so high, plus the risk that if the coil were expelled DD would conceal this event, that sterilisation as the statistically safest option should be chosen.

Serious medical treatment

6.10 Within the constraints of the modified best interests test, in the majority of cases relating to mentally incapacitated patients, doctors remain proxy decision-makers for their patients. The Law Commission’s initial proposals recommended that the general authority to make decisions in a patient’s best interests should be subject to statutory restrictions.⁸⁹ Certain controversial radical and/or irreversible treatments would normally demand authorisation by the Court of Protection.

The government rejected statutory restrictions on the general authority,⁹⁰ and the Act contains some more limited safeguards.⁹¹ Sections 30–34 of the Act set out special rules relating to the inclusion of people lacking mental capacity in medical research.⁹² Section 37 obliges NHS authorities to seek advice from an independent mental capacity advocate (IMCA):

(1)  If it is proposed to provide serious medical treatment for a patient lacking mental capacity, and;

(2)  if there is no-one (other than professional carers or advisers) who can be consulted about the patient’s best interests.⁹³

Serious medical treatment is defined as:

treatment which involves providing, withdrawing or withholding treatment in circumstances where –

(a)  in a case where a single treatment is being proposed, there is a fine balance between its benefits to the patient and the burdens and risks it is likely to entail for him,

(b)  in a case where there is choice of treatments, a decision as to which one to use is finely balanced, or

(c)  what is proposed would be likely to involve serious consequences for the patient.⁹⁴

As law and practice have evolved since the Mental Capacity Act came into force, the views of the Law Commission on the need for independent scrutiny of any intervention that are significant and/or life changing have been given force by the Mental Capacity Act Code of Practice and the jurisprudence of the Court of Protection. The Code of Practice strongly advises that any proposal to withdraw artificial nutrition or hydration, or to use a person lacking mental capacity as an organ or tissue donor, or to carry out a non-therapeutic sterilisation, should be brought before a court. So should some cases involving termination of pregnancy and other ‘cases where there is a dispute about whether a particular treatment will be in a person’s best interests’.⁹⁵

Use of restraint and detention⁹⁶

6.11 Many patients who lack mental capacity will simply acquiesce in treatment. What of the patient who forcefully objects – the dentist moves towards him and the patient jumps out of the chair? Section 6 of the 2005 Act authorises the use of force and restraint, if such measures are necessary, and a proportional response to: (1) the likelihood of the patient suffering harm if he is not treated; and (2) the seriousness of that harm.⁹⁷ Sometimes, continuing treatment may require more than brief restraint. An elderly patient with dementia may need to be confined in her care home. An anorexic patient who is to be fed forcibly will also need to be detained in hospital. Prior to the 2005 Act, judges were prepared to use common law powers to authorise detention in the patient’s best interests.⁹⁸ Patients were deprived of their liberty without any of the safeguards that would apply to detention under the Mental Health Acts.

The inadequacy of the common law was highlighted in R v Bournewood Community and Mental Health Trust ex p L.⁹⁹ The House of Lords ruled that the common law powers derived from F could be invoked to authorise the detention of patients lacking mental capacity. L was 48 years old, autistic and severely mentally disabled. He could not speak and had very limited understanding. L was incapable of making any of his own decisions about his health or personal care. From 1994, after nearly thirty years in mental hospitals, L lived with paid carers. One day, in 1997, he became extremely agitated at his day centre. His carers could not be contacted. L was taken by ambulance to Bournewood hospital and ultimately admitted as a ‘voluntary’ informal patient. He was not formally detained under the Mental Health Act 1983. He remained in hospital for several months despite his carers’ wish for him to return to their home. An action was brought on L’s behalf, accusing the hospital of false imprisonment. The essence of the case was whether or not L had been unlawfully detained. The Court of Appeal ruled in L’s favour. He had been detained against his will and no lawful grounds for his detention justified his treatment. The Law Lords by a bare majority held that L was not imprisoned in the hospital. He was kept in an unlocked ward and not actually restrained from leaving. The majority considered that evidence that had he attempted to leave he would have been restrained, did not establish that he was detained against his will. All their Lordships agreed however, that L was ‘imprisoned’ in the ambulance, but his detention was in any event lawful. Given his inability to consent to admission to hospital himself, any necessary removal and detention in hospital, plus whatever consequent treatment was called for, was lawful in his best interests.

L’s carers took his case to the ECtHR and won. L’s detention violated Article 5¹⁰⁰ of the Human Rights Convention:

Everyone has the right to liberty and security of person. No one shall be deprived of his liberty, save in the following cases and in accordance with a procedure prescribed by law.

Article 5(1)(e) permits the lawful detention of ‘persons of unsound mind’, but Article 5(4) requires that anyone so deprived of his liberty must have the lawfulness of his detention decided speedily by a court. In HL v United Kingdom,¹⁰¹ the ECtHR ruled that L had been deprived of his freedom solely on the basis of clinical judgements and denied the opportunity for a speedy judicial review of his detention contravening his rights under Article 5. The lack of procedural safeguards breached the Convention. The government was obliged to legislate to close the ‘Bournewood gap’, a gap that the unamended Mental Capacity Act failed to close.

Deprivation of Liberty Safeguards

6.12 The Mental Health Act 2007 was used to amend the Mental Capacity Act by inserting into the 2005 Act new sections 4A 4B and Schedules A1 and 1A and so introducing the Deprivation of Liberty Safeguards (DoLS). We do no more here than seek to give a broad picture of the many complex issues. DoLS do not apply to every instance of restraint imposed to ensure that a patient lacking mental capacity receives proper care and/or medical treatment,¹⁰² but only to levels of restraint that deprive the person of his liberty.¹⁰³ Deprivation of liberty is not permitted under the Act¹⁰⁴ unless:

(a)  authorised under the administrative procedures in Schedule A1 which apply only deprivations of liberty in hospitals and care homes;¹⁰⁵ or

(b)  authorised by the Court of Protection under section 16 (2)(a);¹⁰⁶ or

(c)  deprivation is necessary in order to give life-sustaining treatment or prevent serious deterioration in health pending an application to court.¹⁰⁷

Schedule A1 alone runs to 188 paragraphs and DoLS have been described by Lady Hale DP as having ‘the appearance of bewildering complexity, much greater than that in the comparable provisions for detaining patients in hospital under the Mental Health Act’.¹⁰⁸

Despite the lengthy debates that preceded their enactment, DoLS proved controversial. Post-legislative scrutiny of the Mental Health Act 2007 by the Commons Select Committee in August 2013 suggests that ‘despite fine words in legislation’¹⁰⁹ DoLS are ‘woefully inadequate’.¹¹⁰ In 2014, the House of Lords Select Committee¹¹¹ noted that there had been fewer applications than expected¹¹² and concluded DoLS were overly complex, ‘not fit for purpose’ and should be replaced.

The government rejected the call to scrap DoLS¹¹³ and that decision was swiftly followed by the landmark decision of the Supreme Court in P v Cheshire West and Chester Council.¹¹⁴ The question at the heart of the case is what constitutes deprivation of liberty. The three applicants, who all suffered from learning difficulties, lived in the one case with a foster mother, and in the other two in supported living accommodation. In all three cases their living arrangements were comfortable and benevolent and in no case were the applicants physically confined or locked into their accommodation. All made trips outside to such activities as clubs and swimming but always accompanied by a carer. None of them had sought to leave or objected to their care. The restrictions placed on them were said by the Court of Appeal to be ‘relatively normal’ in the context of people with similar disabilities and needs.¹¹⁵ They were however subject to continuous monitoring and control and had they ever sought to leave would have been prevented from doing so. The majority of the Supreme Court held that they were deprived of their liberty. The Court rejected the concept of ‘relative normality’. Lady Hale said that being deprived of liberty ‘must be the same for everyone, whether or not they have physical or mental disabilities’.¹¹⁶ She went on to say that to be ‘obliged to live in a certain place, subject to continuous monitoring and control, only allowed out with supervision and unable to move away without permission’¹¹⁷ would be a deprivation of her liberty and thus also a deprivation of the liberty of a disabled person. The comfort and even enjoyment of the living arrangements were irrelevant to the question of whether those arrangements deprived the applicants of liberty. As she noted: ‘A gilded cage is still a cage’.¹¹⁸

The Supreme Court in Cheshire West did not rule that the particular arrangements for the care of the applicants and similar people with disabilities were necessarily wrong or not made in their best interests but rather that the vulnerability of such people required that there be a ‘periodic independent check on whether the arrangements made for them are in their best interests’.¹¹⁹

The decision resulted in an unprecedented increase in applications.¹²⁰ Local authorities petitioned Norman Lamb MP for urgently needed additional funding.¹²¹ The Court of Protection struggled under the weight of new applications. One judge, Mostyn J, in Rochdale Metropolitan Borough Council v KW¹²² questioned whether the application of Article 5 in Cheshire West was correct.¹²³ An appeal of his decision was allowed by consent. The President of the Family Division, Sir James Munby looked for a practical solution in Re X and Others (Deprivation of Liberty),¹²⁴ formulating a ‘streamlined’ process for Court of Protection applications which resulted in new forms and processes.¹²⁵ On appeal, the court was critical of Sir James Munby’s unorthodox approach but concluded that it lacked the jurisdiction to overturn the case.¹²⁶ An application for judicial review of the procedures may follow.

The rules governing DoLS are exceedingly complex even in those cases that do not have to go to the Court of Protection. Deprivation of liberty under Schedule A1 relating to patients in hospitals or care homes is lawful only if (inter alia) the patient is 18 or over,¹²⁷ is suffering from a mental disorder within the meaning of the Mental Health Act 1983, is not detained under the Mental Health Acts,¹²⁸ lacks capacity, has no advance decision, LPA or deputy refusing the accommodation, and the deprivation of liberty is in his best interests, and necessary to protect him from harm. The deprivation of liberty must be authorised by a ‘supervisory body’ (the Clinical Commissioning Group where a patient is in hospital, or the local authority where the person is in a care home). In defining mental disorder for the purposes of DoLS, the provisions of the Mental Health Act excluding learning disability from the definition of mental disorder should be disregarded. Authorisations may be challenged in the Court of Protection.

In 2015 the Law Commission reviewed the DoLS scheme and found it wanting.¹²⁹ A consultation document proposes a new ‘protective care’ scheme, to cut bureaucracy and enhance protection of human rights. A new two-tiered system would apply. The first tier – ‘supportive care’ – would cover care homes, supported living and other community social care placements. The second tier – ‘restrictive care and treatment’ – would apply when restrictions on liberty are required to protect the individual. Separate arrangements will apply in hospitals (including palliative care) and mental health settings. Amendment of the Mental Health Act 1983 would be necessary if the proposals are accepted. The aim is to establish draft legislation by 2017–18.

The role of the family?

6.13 Reflecting on the complexity of the law so far, and the immensely difficult process of assessing the welfare of mentally incapacitated adults, why not remove decision-making about patients lacking mental capacity from doctors and ‘supervisory bodies’ and in the first instance entrust decisions to an appropriate ‘guardian’, often a family member?¹³⁰ Intuitively, many people may feel that if a person cannot make decisions for himself, his family are the best substitute decision-makers. The Law Commission and the government rejected both granting automatic proxy powers to families and a system whereby people lacking mental capacity are routinely subjected to guardianship. Family views are one component of the process for establishing best interests.

Laws granting automatic decision-making powers to ‘next of kin’ would be fraught with difficulty and danger. Identifying who the decision-maker should be is not straightforward, though not impossible; the hierarchy of ‘qualifying relatives’ in the Human Tissue Act 2004 offers one model. But genetic relationships of themselves may not qualify the person to be the best substitute decision-maker. Imagine X, a retired schoolteacher who is suffering from dementia at 84 has lived for twenty years with Y, a longstanding friend. Y is better placed to act as X’s ‘guardian’ than X’s only niece Z who may in the strict sense be her next of kin. Envisage A, a widow with three children. The ‘next of kin’ do not agree how their mother should be treated. Perhaps A has just one son, but he has visited her no more than once or twice a year in the past five decades. He will not be the ideal ‘guardian’ of his mother’s interests. Her interests and his may conflict. He stands to inherit a substantial sum of money if she dies. If she recovers and enters a nursing home his inheritance may wither away.¹³¹

Such difficulties might be overcome if laws allowed the express appointment of a guardian. In the case of X, Y (her friend) could be appointed her guardian. Wholesale appointment of guardians for every person unable to make decisions for themselves is simply impracticable. The courts would sink under a flood of applications. Nor is guardianship necessarily beneficial to patients. It imposes a childlike status on an adult. Given that English law endorses a ‘functional’ test of capacity, the law’s aim is that the person herself should take as many decisions as she is capable of making. And so as we will see the Mental Capacity Act seeks to find means whereby as far as possible the individual now lacking capacity is enabled to contribute to decisions about her future care in advance of the onset of incapacity.

Advance directives¹³²

6.14 An advance directive enables a person to set out his own instructions about any future treatment which he should, or should not, receive, were he to lose mental capacity to make such decisions for himself. Such decisions need not be restricted to instructions about the continuation of life-sustaining treatment. A woman might, for example, want to give instructions about the management of her pregnancy in advance. A person in the early stages of a neuro-degenerative disease might wish to set out his own care plan. Prior to the 2005 Act, the courts had made it clear that advance refusals of treatment were legally binding as long as there was unequivocal evidence that the patient’s decision was voluntary, competent, and directly relevant to the factual circumstances in question.¹³³ So, as we have seen, the instructions given by Ms T not to administer blood transfusions were found to be defective. The threshold for finding an advance refusal to be binding was set high. Advance requests (or demands) were not legally binding. The Court of Appeal in R (on the application of Burke) v GMC¹³⁴ made it crystal clear that any advance demand (or request) for treatment has no legal force:

a patient cannot demand that a doctor administer a treatment which the doctor considers is adverse to his clinical needs.

So, at common law, advance refusals were binding in theory, but exceptionally difficult to execute in practice in order to ensure that the individual’s wishes prevailed.¹³⁵ The 2005 Act makes the exercise little easier. ‘Advance decisions’¹³⁶ operate to prohibit specified treatment being carried out. Only advance refusals have legal force.¹³⁷ Save for refusals of life-sustaining treatment,¹³⁸ there is no formal requirement that the advance decision be in writing, or witnessed. Evidence that such a decision was made when the patient had capacity to make such a decision, and has not been withdrawn, must still be forthcoming.¹³⁹ If there is no written document, this may be hard to establish; anecdotal evidence from family and friends may not suffice.¹⁴⁰ And the decision will not have effect if:¹⁴¹

–  the treatment in question ‘is not the treatment specified in the advance decision’; or

–  ‘any circumstances specified in the advance decision are absent’; or

–  ‘there are reasonable grounds for believing that circumstances exist which [the patient] did not anticipate at the time of his advance decision and which would have affected his decision had he anticipated them’.

These stringent conditions set by the 2005 Act illustrate the difficulty of transforming theory into practice. Imagine this scenario. A is successfully treated for a brain tumour, but warned that there is a 20 per cent risk of recurrence and poor prospects of long-term survival if the cancer recurs. Should the tumour return, it will gradually rob her of her reasoning powers, memory and capacity for independent living. So she sets out an advance decision that, should the cancer recur, and she is unable to articulate her own wishes, she should not be resuscitated if she suffers a cardiac arrest, and should not be given antibiotics if she develops an infection. The cancer recurs and advances rapidly. A suffers a cerebral haemorrhage. Her advance decision does not cover the treatment in question and so has no force. Or, the cancer does not recur, but A suffers traumatic brain injuries in a road accident. Her advance decision does not apply because it does not relate to the circumstances that materialise. In an attempt to tackle this dilemma, section 24(2) does provide that the ‘decision may be regarded as specifying a treatment or circumstance even though expressed in layman’s terms’. Perhaps, then, the best advice is to express any advance decision in as general terms as possible? But then you may fall foul of section 25(3) because of failure to anticipate circumstances that might have affected your decision. Yet section 25(3) in itself is an important safeguard for patients. Consider A again. She executes her advance decision in 2011 refusing all treatment should her cancer recur. It recurs in 2016 by which time a new highly effective treatment has been developed.

However some of the rigours of the statutory conditions for a valid advance decision seem to have been abated in a couple of recent decisions of the Court of Protection. In both Nottinghamshire Healthcare NHS Trust v RC¹⁴² and Newcastle upon Tyne Hospitals Foundation Trust v LM¹⁴³ statements by Jehovah’s Witness patients that they would never consent to blood transfusions were in effect treated as advance decisions even though not meeting the exact requirements of the Mental Capacity Act.

Next we must consider withdrawal of any advance decision. People must be free to change their minds. What seemed intolerable at 40 may be acceptable at 70. Changes in personal circumstances will alter one’s perspective of quality of life. Section 24(4) provides that a withdrawal (or partial withdrawal) need not be in writing. HE v NHS Trust¹⁴⁴ (decided prior to the Mental Capacity Act) demonstrates the difficulty of establishing informed withdrawal of an advance directive. When HE was a practising Jehovah’s Witness, she executed (in writing) an advance directive prohibiting any blood transfusion. Later she renounced the Witness faith and reverted back to her original Muslim faith, becoming engaged to a fellow Muslim. Her advance directive stated that it could only be revoked in writing. She had taken no formal steps to revoke her original directive. Nonetheless, Munby J found that her conduct offered sufficient evidence that her directive no longer represented her wishes. It was implicitly revoked. He went on to say that ‘once there is some real reason for doubt, then it is for those who assert the continuing validity and applicability of the advance directive to prove that it is still operative’. In effect, the facts of each case must be assessed. As Munby J goes on to say, ‘the longer the time which has elapsed since an advance directive was made, and the greater the apparent change in circumstance since then, the more doubt there is likely to be as to its continuing validity and applicability’.

Lasting powers of attorney

6.15 An inevitable difficulty in any form of advance directive is defining in exactly what sorts of circumstances one might lose capacity, and what sorts of diseases lie in wait. Appointing a chosen proxy to act for you may be an option welcome to many people. Before the 2005 Act, it was possible to execute an enduring power of attorney¹⁴⁵ and appoint a proxy to take decisions in relation to property and financial affairs. An elderly person, who feared that his mental faculties were declining, could appoint a relative or friend to act as his agent in managing his property and finance. If he subsequently lost mental capacity, the agent could continue to act on his behalf. It was not possible to execute such a power appointing a proxy decision-maker for healthcare, or personal welfare decisions.

Section 9 of the Mental Capacity Act introduced the lasting power of attorney (LPA) whereby a person nominates the chosen donee (or donees) of the power to make decisions for him both in relation to personal welfare (including decisions about medical treatment), and in relation to his property and financial affairs. One person can be selected to manage all your affairs for you. An elderly parent can now authorise a daughter to make any necessary decisions about her intimate welfare and medical care, as much as about her property. The proxy (the donee) may only make decisions about life-sustaining treatment if the donor of the power expressly authorised her to do so. In making any decision on behalf of the donor, the proxy must act in the best interests of the donor and conform fully to the principles underlying the 2005 Act. The proxy’s powers are limited by any advance decision made earlier by the donor. A number of formalities are prescribed.¹⁴⁶

Some people may choose to grant an LPA to a professional adviser. More may prefer to choose a close friend or relative. So is there a risk of conflict of interest again? We think not. LPAs overcome many of the difficulties inherent in automatically entrusting decisions about healthcare to ‘next of kin’. The patient actively chooses her preferred ‘agent’. If, in thirty (or fifty) years, we are estranged from our daughters, we will not grant them power of attorney. If we suspect that they are over-anxious to receive their inheritance, we will not give them power over our life and death. As long as the requisite rules about the execution and registration of LPAs ensure that the grant of a LPA is a free and informed decision of the patient, LPAs are an attractive option to people who want to entrust their decisions about future health to relatives, friends or professional advisers chosen by them.

Deputies

6.16 Although guardianship of adults is generally eschewed in the 2005 Act, sections 15–21 make provision for exceptional cases when the Court of Protection may see fit to appoint a deputy authorised to make personal welfare decisions on behalf of the patient. More and more deputies seem to be being appointed sometimes creating serious problems for the Court of Protection. The appointment of a deputy must be shown to be in the patient’s best interests and the court has a wide discretion to determine the scope of the powers conferred on the deputy. Where serious questions arise about the continuing treatment and welfare of a patient lacking mental capacity, a deputy may be appointed who will be authorised within strict limits, and for as short a time as possible, to act on the patient’s behalf generally. Their powers would not be limited to medical care, but extend to all questions of personal welfare, healthcare, property and finance.

The need for a deputy can be illustrated by the highly exceptional case of Re P (Vulnerable Adult) (Capacity: Appointment of Deputies).¹⁴⁷ P was 30 years old. He is blind and suffers from severe autism and yet he is a musical genius and noted performer. Lacking mental capacity to make his own decisions, he needs one-to-one care. In addition to making decisions about his care, his finances have to be dealt with and travel arranged. The Court of Protection agreed to appoint his parents and sister as joint deputies. Concerns were raised that as family members they lacked independence. But Hedley J was satisfied that the appointed deputies would manage P’s affairs skilfully and in his interests and suggested that where trustworthy and capable family members were available and the need for a deputy was proven, those family members would be strong candidates for appointment. But family members do not always make ideal deputies as was made clear by Baker J in G v E and others:

If Hedley J’s comments in … Re P were intended to indicate that family members should as a matter of course be appointed deputies irrespective of the circumstances, I would respectfully disagree … a person who lacks capacity should wherever possible be cared for by members of his natural family, provided that such a course is in his best interests and assuming that they are able and willing to take on what is often an enormous and challenging task. That does not, however, justify the appointment of family members as deputies simply because they are able and willing to serve in that capacity. The words of section 16(4) are clear.¹⁴⁸

In Re BM¹⁴⁹ Senior Judge Lush set out further guidance. While a family member or friend¹⁵⁰ is generally preferred, due to their familiarity with the incapacitated person’s affairs and wishes, it will not be appropriate to appoint such as person as deputy where there is evidence of abuse; poor management of the person’s own financial affairs; friction between family members; or other conflicts of interest. A distressing example of abuse of power by deputies may be seen in Re GM.¹⁵¹ Two nieces by marriage made gifts to themselves and close family members of well over £200,000. The Court revoked their appointment and indicated that the person’s best interests required that a new deputy be appointed with experience of handling unjust enrichment and restitution claims, presumably so that the new deputy could recover the miscreants’ ill-gotten gains.

Court of Protection¹⁵²

6.17 Central to the Act is the Court of Protection which enjoys a wide-ranging jurisdiction to oversee the care of adults lacking mental capacity, in both healthcare and welfare matters. It adjudicates on disputes about what form such care should take, and can issue declarations about the legality of proposed treatment. The powers of the Court of Protection were considered in In the Matter of MN (Adult).¹⁵³ Upholding Eleanor King J’s ruling, ¹⁵⁴ Sir James Munby held that the Court of Protection’s powers with respect to an incapacitated person were limited to the powers that person would have if they retained capacity. In this case this meant that the best interests declaration was dependent to some extent on practical issues, such as the availability of funding from the local authority. The Court could not compel the authority to allocate additional resources for the care of the person. Any challenge to the legality of resource decisions should be by way of an application for judicial review.

The Court of Protection has extensive powers of enforcement. Like the High Court, it can grant injunctions, summon witnesses and commit those in contempt to prison. Penal notices can be attached to orders making clear the consequences of breach. There has long been uncertainty, however, surrounding the binding nature of a best interests declaration where no injunctive order is made.¹⁵⁵ Will deliberate defiance constitute contempt of court? Hayden J made clear in the case of In re M that it will not: ‘There cannot be “defiance” of a “declaration” nor can there be an “enforcement” of one. A declaration is ultimately no more than a formal, explicit statement or announcement’.¹⁵⁶ The court can appoint deputies where appropriate and register and supervise LPAs. But, as we have noted, resort to the court to oversee especially controversial or problematic medical procedures is not mandatory. Does this matter? Can we not trust the good sense of doctors and families to seek judicial oversight of what they propose to do in cases when, and only when, such oversight is truly needed? Doctors and carers are guided by the Code of Practice, which, as we have seen, requires that certain cases are brought before the court. A failure on the part of a health professional to comply with this guidance will be taken into account in any relevant proceedings in any court or tribunal. It would, for example, be relevant to an assessment of a doctor’s fitness to practise before the General Medical Council. One difficulty remains. When doctors and families disagree either with each other or among themselves, an application to court is likely to be made. Where there is either consensus among the several people involved with the patient, or perhaps an absence of involved family or friends, resort to court is less likely. The patient, lacking an advocate, is deprived of any voice to speak on his behalf. Two limited safeguards operate. First, we have seen that under section 37, an independent mental capacity advocate (IMCA) should be appointed where doctors propose serious medical treatment of a patient lacks capacity and does not have a family member or friend to advise as to his best interests. Second, the jurisdiction of the Court of Protection does extend to claims arising from alleged breach of the Human Rights Act 1998 and can award damages accordingly.¹⁵⁷

Mental health legislation¹⁵⁸

6.18 This book does not deal in any detail with the provisions of the Mental Health Acts. Brief reference needs to be made here to the Mental Health Acts 1983 and 2007. The 2007 Act makes significant amendments to the earlier statute. For the purposes of this chapter, one of the most crucial provisions of the mental health legislation is that section 63 of the 1983 Act grants statutory authority to dispense with detained patients’ consent to treatment for mental disorder. A patient’s refusal of treatment can thus be overridden, even if he meets the test of mental capacity under the 2005 Act. As we shall see, the courts have on occasion interpreted section 63 to sanction treatments that might primarily be seen as treatment for physical illness.

Part II of the 1983 Act (as amended) makes provision for the detention in hospital of certain mentally disordered patients. Only a minority of patients with mental disorder are detained in hospital under the Act. Application for admission for assessment (observation and tests) must be based on the written recommendations of two medical practitioners who testify that the patient: (1) is suffering from mental disorder of a nature or degree which warrants his detention in hospital for assessment or assessment followed by medical treatment for at least a limited period; and (2) he ought to be so detained in the interests of his own health or safety, or to protect others.¹⁵⁹ Admission for the assessment authorises the patient’s detention for up to twenty-eight days. If he is to be detained longer, an application for admission for treatment must be made.¹⁶⁰ Such an application made under section 3 of the Act must be founded on grounds that the patient:

(a)  is suffering from mental disorder of a nature or degree which makes it appropriate for him to receive treatment in a mental hospital; and

(b)  it is necessary for the health and safety of the patient or for the protection of other persons that he should receive such treatment and it cannot be provided unless he is detained under this section; and

(c)  appropriate medical treatment is available for him.

The crucial question becomes: how is mental disorder defined? Section 1(2) of the 1983 Act (as amended) adopts a very broad definition; mental disorder means ‘any disorder or disability of the mind’. ‘Learning disability’¹⁶¹ will not however as such be said to constitute mental disorder. A person with learning disability will be able to be detained under section 3 of the 1983 Act only if his ‘disability is associated with abnormally aggressive or seriously irresponsible conduct’.¹⁶²

Note too the condition that there should be appropriate medical treatment available for any patient who is to be detained for treatment. Some mental disorders, notably personality disorders, rarely respond to drug therapy as disorders such as schizophrenia may. But section 145 of the Mental Health Act 1983 now defines treatability broadly as ‘medical treatment the purpose of which is to alleviate or prevent a worsening of the disorder or one or more of its symptoms or manifestation’.

The effect of sections 2 and 3 of the 1983 Act means that the number of people lacking capacity liable to be detained under the 1983 Act is small:

(1)  The many patients who lack capacity as a result of learning disability can be detained only if they become aggressive or seriously irresponsible.

(2)  In many cases their disability will not meet the ‘treatability’ condition. Being shut up in hospital will not do them any good.¹⁶³

(3)  A person lacking mental capacity can usually be protected from herself by means other than detention, so condition (b) may not be met.

(4)  Government policy for several years was to promote care in the community, and numerous long-stay mental hospitals were closed down.

(5)  Psychiatrists maintain that there are insufficient beds in mental hospitals even for patients who indubitably meet the criteria set out in the 1983 Act. Only the most dangerously disordered or profoundly disabled patients are detained in hospital under the 1983 Act. When it is deemed necessary to confine a patient lacking capacity with learning or other disabilities for his own safety, the usual route now will be to resort to the much criticised Deprivation of Liberty Safeguards introduced into the Mental Capacity Act 2005,¹⁶⁴ though we must reiterate that the two systems for care and detention have in practice both significant overlap and gaps through which some patients may fall.¹⁶⁵

Compulsory treatment under the 1983 Act

6.19 Part IV of the Mental Health Act provides for the compulsory treatment of that minority of patients detained under the Act. Section 63 provides that:

The consent of a patient shall not be required for any medical treatment given to him for the mental disorder from which he is suffering, not being treatment given within section 57, 58 or 58A [of the Act].

Section 63 applies to detained patients only. It cannot be used on voluntary patients, or on an out-patient basis. But that poses a dilemma. A patient may recover in hospital on appropriate medication and be fit to return home if he continues to comply with treatment, but the risk is that when he is out of hospital, he will stop taking his medicine. So at one hospital doctors admitted patients under section 3, gave them long-term medication, then released them on licence until their next dose of medication was due. That practice was found to be unlawful.¹⁶⁶ Section 63 could be used to dispense with a patient’s consent to treatment only where that patient actually needed to be detained, the conditions laid down in section 3 for admission for treatment were not met, and the use of section 3 to enforce treatment was an unlawful fiction. The Court of Appeal however later held that as long as some element of hospital treatment was required, ‘extended leave’ could be used to ‘enforce’ medicating in the community.¹⁶⁷ Amendments inserting section 17A–G in the 1983 Act now provide for community treatment orders enabling doctors to ensure treatment in the community via the sanction of recall to hospital.

Section 63 on its face authorises psychiatric treatment, not treatment for physical illness. It has been interpreted by judges to extend to allow the forcible feeding of anorexic patients and to justify non-consensual caesarean surgery on a detained patient. The first example is perhaps the less curious. In B v Croydon District Health Authority¹⁶⁸ the Court of Appeal authorised the naso-gastric feeding of a woman of 24. She suffered from a borderline personality disorder, including among its symptoms a compulsion to self-harm. She was dangerously anorexic and was detained in hospital under the 1983 Act. The appeal court held that feeding constituted treatment for her mental disorder because such treatment included treatment to alleviate the symptoms of her disorder. Refusing food was such a symptom. Forcible feeding thus constituted a ‘cure’.¹⁶⁹ Tameside and Glossop Acute Services Trust v CH¹⁷⁰ requires an even more imaginative approach to section 63. CH suffered from paranoid schizophrenia and was detained in a mental hospital. On admission to hospital she was discovered to be pregnant. At 37 weeks, the retarded growth of the fetus caused doctors to suspect placental failure and they wanted to deliver the child swiftly by caesarean section. Wall J held that such surgery was justified under section 63 as treatment for CH’s mental disorder. CH maintained a belief that medical staff were malicious and out to harm her child. She could not be given the medication most appropriate to treat her mental illness while still pregnant. The judge ruled ‘a successful outcome of her pregnancy is a necessary part of the overall treatment of her mental disorder’. Whether B or CH should have been compelled to submit to treatment is something reasonable people might disagree on. More recently in A NHS Trust v A¹⁷¹ Baker J expressed concerns about any extended use of section 63 as a device to compel detained patients to accept treatment for essentially physical disorders. Dr A is an Iranian doctor suffering from delusional disorder and detained under the Mental Health Act. He had sought asylum in the UK and been refused on three occasions. His passport was confiscated by the UK Borders Agency and he commenced a hunger strike in protest. The judge held that Dr A lacked capacity both to litigate and in relation to eating and drinking and that it would be in his best interests to be ‘force-fed’. But he also held that forcible feeding did not constitute treatment for A’s mental disorder, being rather treatment for the physical ills consequent on the hunger strike. Were A detained under the DoLS, then treatment for such physical ills could be imposed but as he was now detained under the Mental Health Act, he was ineligible to be deprived of his liberty under DoLS. The judge fell back on the inherent jurisdiction to protect vulnerable people (discussed at 6.20).

In those cases where section 63 may be applicable, it should be noted that sections 57, 58 and 58A provide important safeguards both for patients’ welfare and autonomy. Section 57 is unusual in that it applies to all patients and not just those detained in hospital. Any form of psychosurgery,¹⁷² such as lobotomy, and any surgical implantation of hormones to reduce male sexual drive will be unlawful¹⁷³ unless: (1) the patient consents: and (2) a specially appointed and independent doctor certifies that (a) the patient is capable of understanding the nature and purpose of the treatment proposed and its likely effects; and (b) the treatment is likely to benefit the patient.

Sections 58 and 58A apply to detained patients only. Any long-term medication (administered for longer than three months)¹⁷⁴ is authorised only if either: (a) the patient consents and a doctor certifies that he is competent to do so; or (b) an independent doctor certifies that the patient is incapable of giving consent or has refused to do so but that none the less ‘it is appropriate for the treatment to be given’. Section 58 used to include electro-convulsive therapy (ECT) too, but section 58A now provides that ECT cannot be given without consent (except in emergencies covered by section 62) unless the patient lacks capacity and has not refused ECT via an advance directive.

Vulnerable patients: the inherent jurisdiction

6.20 Should compulsory treatment of a competent patient ever be legally justifiable, outwith any Mental Health Act? Can an elderly, confused, yet still arguably capacitous, patient be required to submit to dental treatment in his own ‘interests’? Should a patient who refuses to bathe, yet retains mental capacity, be compelled to do so in the interests of those who share a ward with him? What of the elderly widow with bedsores and severe arthritis who says she is managing well but whose overbearing daughter is determined that her mother should not move to a nursing home as the daughter does not want to see her inheritance evaporate? You may well see the last example as rather different from the first two. The arthritic mother is vulnerable: are the other two simply misguided and/or pig-headed?¹⁷⁵

Before the Mental Capacity Act came into force the courts had begun to invoke the inherent jurisdiction to protect adults whose health and circumstances made them vulnerable but who may not lack mental capacity. Munby J defined such a vulnerable adult as a person who ‘even if not incapacitated, is either under constraint, or subject to coercion or undue influence, or for some other reason deprived of the capacity to make free choice, or disabled from making a free choice, or incapacitated or disabled from giving or expressing a real and genuine consent’.¹⁷⁶ The Court of Appeal has made it clear that such a protective jurisdiction survives the Mental Capacity Act allowing the courts to intervene to protect the vulnerable individual from abuse or coercion by carers or family members.¹⁷⁷ An injunction could order the ‘abusive’ relative to cease interfering in the vulnerable person’s affairs and even to ban contact altogether. Consider the third example above of a person whose daughter is actively blocking attempts to obtain proper care for her mother. An order restraining her from so behaving might seem acceptable. And such an order could enhance, not diminish the patient’s autonomy. The other two examples are harder. Both patients actively object to the measures proposed, the visit to the dentist and the bath. If they retain mental capacity, invoking the inherent jurisdiction to protect them from themselves seems to undermine the safeguards put in place by the Mental Capacity Act and DoLS. Nor is the third example problem free. What if the mother says to social services that she is well aware that her daughter is bullying her and is after her money, but she accepts that as she loves her daughter and does not want any intervention?¹⁷⁸ The majority of cases involving such vulnerable adults have involved social care rather than medical treatments. One example that did touch on medical care was A Local Authority v A.¹⁷⁹ A local authority feared that a husband was pressuring his wife, who has learning difficulties, to stop contraceptive treatment. The court in the end concluded that for the present no order was needed.

The inherent jurisdiction may also be used in relation to patients who lack capacity where, as in A NHS Trust v A,¹⁸⁰ interventions clearly in the best interests of the incapacitated patient fall into the gap between the Mental Capacity Act and the Mental Health Acts.¹⁸¹ In Re L (Vulnerable Adults with Capacity: Court’s Jurisdiction) (No 2), Davis LJ explained that where cases fell clearly within the ambit of the Mental Capacity Act there is no room or need for the inherent jurisdiction but ‘even in the case of an adult who lacks capacity within the meaning of the 2005 Act, it appears that the inherent jurisdiction survives, albeit now reinforced by the provisions of the Mental Capacity Act 2005’.¹⁸²

Protecting the public

6.21 May treatment ever be enforced on an adult with capacity for the benefit of others? In the United Kingdom, unlike the USA,¹⁸³ legislation has never enforced sterilisation on those seen as mentally or physically unfit to reproduce. In England, unlike many countries in Europe, childhood vaccination has never been compulsory.¹⁸⁴ Compulsory treatment has focused on the control of infectious disease, but now extends to broader risks of contamination and threats to the health of the community. The outbreak of Ebola in 2014 and the transmission of the disease across national boundaries illustrates that devastating infectious diseases remain a potent threat to health. The relentless growth of antibiotic resistance raises the spectre that quite common diseases may again become fatal. The Chief Medical Officer for England has said that antibiotic resistance is set to become the greatest threat to human health.¹⁸⁵

The Public Health (Control of Disease) Act 1984 was heavily amended by Part 3 of the Health and Social Care Act 2008 which inserted a new Part 2A in the Public Health (Control of Disease) Act. The Act seeks to implement extensive measures to protect the public from the spread of infection or contamination (including radiation and artificial biological artefacts) which poses or could pose a significant harm to human health. Sections 45B–D confer extensive powers on ministers to make regulations to protect public health from infection or contamination. The scope of such powers is extensive and coercive, enabling government to restrain people, seize property and impose quarantines.

The Health Protection (Notification) Regulations 2010¹⁸⁶ require doctors to notify the proper authority if they have reasonable grounds to suspect that the patient has a ‘notifiable disease’, or has some other infection that could present a significant harm to human health, or is contaminated.¹⁸⁷ The list of notifiable diseases includes most major communicable diseases such as tuberculosis, cholera, food poisoning, whooping cough and rubella. But note the doctor must also notify authorities of any other potentially dangerous infection such as a virulent new strain of flu. Such patients lose not only their right to confidential treatment, but may also lose their liberty. Magistrates may order such a patient to submit to testing, be subject to restriction on their movements, and in an extreme case be detained in hospital.¹⁸⁸ However, there is no power to compel the patient to submit to medical treatment.¹⁸⁹

HIV is not expressly listed as a notifiable disease, but a person with HIV may still be subject to the powers of a magistrate under section 45G of the Act should she pose a threat to others. Under the previous Public Health (Infectious Diseases) Regulations 1985, similar powers were to the best of our knowledge invoked only once in the case of a patient with AIDS.

Draconian powers to address infectious diseases allowing the detention of the infected person have a long history and many of the original notifiable diseases, such as plague or cholera, carried a high risk of potentially deadly infection to others with little possibility of the patient herself, whatever she did, of protecting others from infection. Diseases such as HIV, Hepatitis B (and even tuberculosis) do not fit that pattern. A person may be seropositive for HIV or Hepatitis B, but not ill, and certainly not suffering from any mental impairment of confusion. If he amends his lifestyle in conformity with medical advice, the risk he poses to others is minimal. Using public health powers to force his compliance with ‘safe living’ necessarily involves an invasion of his liberty. For how long could society justifiably detain a person with Hepatitis B? She may never cease to be a carrier of that disease.

The legality of the powers to detain people to prevent the spread of infectious diseases was tested in the ECtHR in 2005. In Enhorn v Sweden,¹⁹⁰ an HIV-positive man who had unknowingly infected a 19-year-old girl, was required under Sweden’s Infectious Diseases Act 1988 to attend regular medical appointments. When he failed to do so, he was compulsorily isolated in hospital. Over a period of six years, he spent around eighteen months in compulsory isolation. Did the Swedish courts unlawfully deprive Mr Enhorn of his liberty, protected by Article 5, or was the deprivation justified under Article 5(1)(e) for ‘the lawful detention of persons for the prevention of spreading of infectious diseases, of persons of unsound mind, alcoholics or drug addicts, or vagrants’? The Court held that the isolation was a disproportionate response to the threat to the public. Mr Enhorn’s Article 5 right to liberty had been breached.¹⁹¹ Compulsory isolation must be used only as a last resort.

Criminal liability¹⁹²

6.22 Does/should a ‘patient’ who fails to protect other people from herself and recklessly disregards the welfare of others, commit a criminal offence?¹⁹³ A midwife knows that she is infected by Hepatitis B, conceals her condition and infects several patients; is her conduct significantly different from the train driver who, knowing that he is over the alcohol limit, still takes the controls and endangers his passengers? Identifying a pigeonhole in which to fit criminal liability for spreading diseases used to be tricky. If our hypothetical midwife’s patients have consented to her ministrations, their consent is unlikely to be vitiated by lack of information about her infection, so no assault is committed.¹⁹⁴ In one case, a surgeon continued to operate, fraudulently concealing that he had Hepatitis B. Several of his patients contracted Hepatitis. The surgeon was ultimately convicted of the antiquated common law offence of causing a public nuisance.¹⁹⁵

In R v Dica,¹⁹⁶ the Court of Appeal held that reckless transmission of serious disease constituted a criminal offence in English law.¹⁹⁷ Dica was convicted on two counts of inflicting grievous bodily harm, contrary to section 20 of the Offences Against the Person Act 1861, on lovers whom he infected with HIV. The trial judge ruled (inter alia) that any consent on the part of the victims to the risk of contracting HIV, thus their knowledge or otherwise of the accused’s seropositive status, was irrelevant and provided no defence because the women had no capacity to consent to such serious harm.¹⁹⁸ Following the judge’s ruling, the accused chose not to give evidence and the question of whether his lovers knew of his HIV-positive condition was not left to the jury. The Court of Appeal quashed the conviction and ordered a retrial. Consensual acts of sexual intercourse do not become unlawful ‘merely because there may be a known risk to the health of one or other participant’.¹⁹⁹ As Judge LJ said²⁰⁰ ‘interference of this kind with personal autonomy, and its level and extent, may only be made by Parliament’. The key question was had the victims consented to the risk of contracting HIV? To consent, they must first be aware of the accused’s condition, though knowledge alone would not normally establish consent. Absence of consent to such a risk did not vitiate consent to intercourse. Dica was not guilty of rape. Inflicting serious bodily harm is no longer an offence parasitic on assault.²⁰¹ No assault needs to be proven, simply the imposition on the victim of serious harm to which she has not consented.

The decision in Dica has met with much criticism.²⁰² Critics maintain that criminalisation will reinforce stigmatisation of people living with HIV, will deter patients from seeking testing and counselling, and, in its operation, discriminate against minority groups such as gay men and drug users.²⁰³ John Spencer lends his voice to a powerful defence of Dica:

To infect an unsuspecting person with a grave disease you know you have, or may have, by behaviour you know involves a risk of transmission, and that you know you could easily modify to reduce or eliminate the risk, is to harm another in a way that is both needless and callous. For that reason criminal liability is justified unless there are strong countervailing reasons.²⁰⁴

That Dica remains good law is signalled by the Court of Appeal in R v Golding.²⁰⁵ The appellant was convicted of inflicting grievous bodily harm under section 20 of the Offences Against the Person Act after he infected his girlfriend with genital herpes. He never warned her about his diagnosis. The appeal court rejected the appeal. One of the grounds of appeal was that genital herpes did not constitute grievous bodily harm. The court held that such harm did not need to be permanent or at the level of danger to life of HIV. The matter was for the jury applying contemporary social standards.

There are circumstances where private interests should rightly be subordinated to the public good. This reasoning lies at the heart of public health laws. The basis of enforced treatment under public health legislation is the protection of the public. A person can be removed to hospital if precautions to prevent the infection spreading can be taken, are not being taken, and a ‘serious risk of infection is thereby caused to other people’. There is no pretence that the compulsory powers are exercised solely in the ‘best interests’ of the patient. Where someone, albeit through no fault of his own, poses a threat to the health of others, his interest in autonomy cedes to others’ interest in health and safety. Where someone has the capacity to protect others from contracting disease from him and fails to do so, the criminal law is properly engaged.

The uncooperative patient

6.23 What of the patient whose condition or conduct poses a risk of some harm or serious nuisance to others but who refuses to cooperate in measures to minimise that harm or nuisance? We have suggested that it is not appropriate to use the inherent jurisdiction protecting vulnerable patients when the patient retains capacity. And, in this example, what is in issue is not protecting the individual herself but protecting others from nuisance or harm she has created. At common law an individual enjoys a right to self-defence. This is a common law right which almost certainly survives the enactment of a public right to use force to prevent crime in section 3 of the Criminal Law Act 1967. If you are attacked by a person so mentally disordered that he could not be found guilty of any crime, you are still lawfully entitled to fend off your attacker using whatever degree of force is necessary. Might there then be circumstances in which treatment of a competent but confused or disturbed patient could be justified because of the harm his untreated condition poses to others? Can a patient who refuses to bathe be washed to prevent him becoming a hazard to hygiene? Such a suggestion sounds like heresy. Apart from the provisions in the Public Health Acts, the Mental Health and Mental Capacity Acts (discussed earlier), treatment of adult patients whose mental capacity is disputed is in theory lawful only if in the patient’s ‘best interests’. The anomalous provisions of the National Assistance Act 1948²⁰⁶ that empowered community health doctors to seek to remove from their homes and place in a suitable hospital a person ‘suffering form chronic disease, or being aged, infirm or physically incapacitated’ and unable to care for themselves either in his own interests or ‘to prevent injury to the health of, or serious nuisances to, other persons’ (our emphasis) have at long last been repealed.²⁰⁷

In practice there can be little doubt that healthcare professionals are imposing ‘treatment’ on patients which cannot be shown to be exclusively in the patients’ interests. We are not suggesting that gynaecologists are sterilising women for eugenic reasons, or that surgeons are experimenting on unfortunate patients. Patients are washed against their will. Patients are sometimes given medication they would rather not have, perhaps disguised in their food. Without such stratagems, nurses struggling to care for wards catering for confused geriatric patients, or working in long-stay institutions for voluntary mental patients, might give up the struggle. Should such miscreants be tracked down and prosecuted for assault?

It is dubious whether it is ever possible to divorce the interests of the individual entirely from the interests of the carer. The example that follows is unpleasant but is an instance of a dilemma that doctors have to face, and parents may have to live with. A young woman lives at home with her father. She is physically adult and normal but has the mind of a 2-year-old. She is sexually provocative and fertile. She is incontinent and it is her father who every month has to cope with her periods. None of this distresses her any more than it would a 2-year-old child. Sterilisation by hysterectomy could never be said to be in her best interests, even if sterilisation per se could. Yet her father may find that he cannot cope much longer. Dealing with menstruation is the straw that breaks the camel’s back. Is that young woman better off without a uterus but with her father, or with her uterus intact but in an institution? Her interests and her father’s are inextricably intertwined.

The interests of the patient must be the predominant interest to be considered. Perhaps other interests should also be taken into account? Individuals live as part of society. Society has obligations to the individual, especially the vulnerable individual. Individuals, though, have reciprocal obligations to society. Moreover, a careful review of all the decided cases on non-consensual treatment may suggest that courts do in fact take note of interests other than the patient’s. If 19-year-old T would never have been properly aware of her pregnancy, or the birth and removal of a child, that experience may at any rate not have harmed her. Her mother and the child would certainly suffer. Would it be wrong to consider their interests? If the interests of others will inevitably be considered, would it not be better to do so openly?

¹  See P Bartlett ‘The United Nations Convention on the Rights of Persons with Disabilities and Mental Health Law’ (2012) 75 Modern Law Review 752.

²  Rabone v Pennine Care NHS Foundation Trust [2012] UKSC 2.

³  Department of Constitutional Affairs, Mental Capacity Act: Code of Practice (2007), revised (July 2013), updated (November 2014).

⁴  Select Committee on the Mental Capacity Act 2005, Mental Capacity Act 2005: Post-Legislative Scrutiny (February 2014), ch 6, paras 205–206. And see 6.12.

⁵  Extending in some instances to the use of restraint and ‘reasonable force’; see Norfolk and Norwich NHS Trust v W [1996] 2 FLR 613.

⁶  See ZH (A Protected Party) v Commissioner of Police for the Metropolis [2013] EWCA Civ 69.

⁷  (1993) 15 EHRR 437 (ECtHR).

⁸  See HL v United Kingdom (2004) 40 EHRR 761, discussed at 6.11.

⁹  Discussed at 6.12.

¹⁰  See P Bartlett, R Sandland, Mental Health Law: Policy and Practice (4th edn, 2013); JK Mason, GT Laurie, Mason and McCall Smith’s Law and Medical Ethics (2013) Oxford University Press, ch 13.

¹¹  See Special Edition, ‘A Model Law Fusing Incapacity and Mental Health Legislation – Is It Viable; Is It Advisable?’ Journal of Mental Health Law (2010).

¹²  See DL v A Local Authority & Ors [2012] EWCA Civ 253 and see 6.20.

¹³  See J Herring, ‘Protecting Vulnerable Adults: A Critical Review of Current Case Law’ [2009] Child and Family Law Quarterly 498.

¹⁴  G v E and others [2010] EWHC 621 (Fam), [4].

¹⁵  Re P (Adult Patient: Consent to Medical Treatment) [2008] EWHC 1403 (Fam).

¹⁶  Department of Constitutional Affairs, Mental Capacity Act: Code of Practice (2007), revised (July 2013), updated (November 2014).

¹⁷  See the Mental Capacity Act 2005, ss 42(4) and (5).

¹⁸  [1954] P 112.

¹⁹  [1994] 1 All ER 819; and see the similar case of Heart of England NHS Foundation Trust v JB [2014] EWHC 342 (COP). Compare the decisions that C and JB retained capacity with that of Kay J in R v Collins and Ashworth Hospital Authority ex p Brady [2000] Lloyds Rep Med 355; and see Surrey and Sussex Healthcare NHS Trust v MSAB [2015] EWCOP 50.

²⁰  [2004] EWHC 1279.

²¹  In Re F (case No 11649371) (2009, unreported) it was held that a reasonable belief that the patient may have capacity is sufficient to ground an application to the court to enable a full examination of the issue of capacity to be made without delay.

²²  See s 1(4).

²³  See s 2(1).

²⁴  See s 3.

²⁵  See Mental Health Trust v DD [2014] EWCOP 13 (inability to understand (inter alia) significant risks of pregnancy to the woman’s life).

²⁶  And this includes a requirement to believe that information; Local Authority X v MM [2007] EWHC 2003 (Fam).

²⁷  See Re AK (Adult Patient) (Medical Treatment: Consent) [2001] 1 FLR 129, CA. AK was in the terminal stages of motor neurone disease. He could communicate only by barely blinking an eye to answer yes or no to questions. He indicated that he wished doctors to switch off the ventilator keeping him alive. The court granted a declaration that it was lawful to act on his instructions. AK retained mental capacity and extraordinary means made communication possible.

²⁸  It is not necessary to show that the patient understands every detail of proposed treatment simply the salient features: Mental Health Trust v DD [2014] EWCOP 13, [15].

²⁹  See Re LT (Vulnerable Adult) (Decision Making: Capacity) [2010] EWHC 1910 (Fam).

³⁰  [2002] 2 All ER 449; see also 5.3 and 19.4.

³¹  [2002] 2 All ER 449, [100].

³²  [1997] 8 Med LR 217, at 224, CA.

³³  Select Committee on the Mental Capacity Act 2005, Mental Capacity Act 2005: Post-Legislative Scrutiny, HL Paper 139 (March 2014) points to problems implementing the Mental Capacity Act and gaps between theory and practice. See also government response: Valuing Every Voice, Respecting Every Right: Making the Case for the Mental Capacity Act, Cm 8884 (June 2014).

³⁴  [2015] EWHC 1339 (QB). See 5.1.

³⁵  [2010] EWHC 1549 (Fam).

³⁶  And see Sheffield City Council v E [2005] 2 WLR 953.

³⁷  [2010] EWHC 1549 (Fam), [73]; and see A Local Authority v MA, NA and SA [2005] EWHC 2942 (Fam).

³⁸  [2012] EWHC (COP) 1639.

³⁹  Newcastle upon Tyne Hospitals Foundation Trust v LM [2014] EWHC 454; Nottinghamshire Healthcare NHS Trust v RC [2014] EWCOP 1317; see 5.3.

⁴⁰  Even though RC was not a baptised Witness.

⁴¹  See discussion of Re MB (An Adult: Refusal of Medical Treatment): [1997] 8 Med LR 217, at 224, CA; see 11.21.

⁴²  See Re R (A Minor) (Wardship: Medical Treatment) [1991] 4 All ER 177, at 187; Re D (Medical Treatment: Mentally Disabled Person) [1998] 2 FLR 22, at 24.

⁴³  See Select Committee on the Mental Capacity Act 2005, Mental Capacity Act 2005: Post-Legislative Scrutiny, HL Paper 139 (March 2014), ch 3.

⁴⁴  Re Quinlan 355 A 2d 664 (NJ, 1976). Discussed at 19.14.

⁴⁵  A test controversially employed in extensive litigation in the USA surrounding the proposed withdrawal of artificial hydration and nutrition from Terri Schiavo. The application was supported by her husband and opposed by her parents. See Respondent Michael Schiavo’s Opposition to Application for Injunction Case No: 04A-825, 25 March 2005 (Supreme Court, USA). See 19.14.

⁴⁶  See T v T [1988] 1 A11 ER 613; and see the third edition of this work, pp 115–117.

⁴⁷  So under the 1983 Act, doctors may require a detained patient to accept medication for schizophrenia but have no power to authorise surgery for a hernia. But it should be noted that judges tend to give mental disorder a wide meaning. In R v Collins and Ashworth Health Authority ex p Brady [2000] Lloyds Rep Med 355, forcible feeding to prevent Ian Brady starving himself to death was held to constitute treatment for his mental disorder. And see 6.19.

⁴⁸  Or are eligible to be so detained. Patients with severe learning disabilities who are treated in hospital are usually voluntary (or informal) patients.

⁴⁹  See BM Hoggett, ‘The Royal Prerogative in Relation to the Mentally Disordered: Resurrection, Resuscitation or Rejection’ in MDA Freeman (ed), Medicine, Ethics and the Law (1988) Stevens.

⁵⁰  See Re T (14 May 1987, unreported); Re V (1987) The Times 4 June; T v T [1988] 1 All ER 613.

⁵¹  See 11.4.

⁵²  See Re B (A Minor) (Wardship: Sterilisation) [1987] 2 All ER 206, HL, discussed further in Chapters 11 and 14.

⁵³  T v T [1988] 1 All ER 613.

⁵⁴  [1989] 2 All ER 545, at 551.

⁵⁵  Lord Griffiths dissented. He argued that a grave decision such as sterilisation with all its implications should not be left to doctors alone. He believed that it was open to the House of Lords to develop a common law rule that prior judicial approval was required before an operation as radical as sterilisation could be performed (at 561–562).

⁵⁶  See J Bridgeman, ‘Declared Innocent?’ (1995) 3 Medical Law Review 117.

⁵⁷  Bolam v Friern Hospital Management Committee [1957] 1 WLR 582 discussed fully in Chapter 7 and see MA Jones, ‘Justifying Medical Treatment without Consent’ (1989) 5 Professional Negligence 178.

⁵⁸  Law Commission Report No 231 Mental Incapacity, para 3.27.

⁵⁹  See in Re A (Medical Treatment: Male Sterilisation) [2000] 1 FCR 193, CA.

⁶⁰  [2001] 1 FCR 193, at 200.

⁶¹  [2000] 3 WLR 1288.

⁶²  Ibid, at 1299; and see R (on the application of N v Doctor M) [2003] 1 FLR 667.

⁶³  See also Simms v Simms [2003] 1 A11 ER 669; A v A Health Authority [2002] 1 FCR 481.

⁶⁴  See further Mental Capacity Act 2005: Code of Practice, para 6.20.

⁶⁵  Note, however, that section 5 grants only immunity from battery. Should the patient’s care be negligent, she retains her rights to redress.

⁶⁶  [2013] EWCA Civ 69.

⁶⁷  See Law Commission, Report No 231 Mental Incapacity, Part V.

⁶⁸  See s 4(1).

⁶⁹  See s 4(3).

⁷⁰  See s 4(4).

⁷¹  Section 4(6). See Ashan v University Hospitals Leicester NHS Trust [2006] EWHC 2624 (importance of religious faith).

⁷²  The importance of such evidence is beautifully illustrated in Sheffield Teaching Hospitals NHS Foundation Trust v TH [2014] EWCOP 4.

⁷³  Section 4(7).

⁷⁴  See Aintree University Hospitals Foundation Trust v James [2013] UKSC 67, [24] per Lady Hale.

⁷⁵  ‘To take a simple example, it cannot be in the best interests to give the patient food which he does not like when other equally nutritious food is available’ (ibid, [24] per Lady Hale).

⁷⁶  M Donnelly, ‘Best Interests, Patient Participation and the Mental Capacity Act’ (2009) 17 Medical Law Review 1.

⁷⁷  See Re P (Adult Patient: Consent to Medical Treatment) [2008] EWHC 1403 (Fam), [19]; A NHS Trust v DE [2013] EWHC 2562 (Fam).

⁷⁸  See Aintree University Hospitals NHS Foundation Trust v James [2013] UKSC 67, [26] per Lady Hale and Sheffield Teaching Hospitals NHS Foundation Trust v TH & Anor [2014] EWCOP 4, [53–56] per Jayden J.

⁷⁹  [2013] EWHC 2562 (Fam). Discussed further at 11.4.

⁸⁰  DH NHS Foundation Trust v PS (by her Litigation Friend the Official Solicitor) [2010] EWHC 1217 (Fam).

⁸¹  See Re P (Adult Patient: Consent to Medical Treatment) [2008] EWHC 1403 (Fam); in A Local Authority v WMA [2013] EWHC 2580 (COP) it was held to be in WMA’s best interests to move out of his mother’s house and into a residential unit. WMA lacked capacity but wished to remain with his mother. His mother also opposed the move. But there was a history of neglect and WMA’s lifestyle at his mother’s house was isolated. HHJ Cardinal made the necessary authorisation of the associated Deprivation of Liberty.

⁸²  Re DD (No 4) (Sterilisation) [2015] EWCOP 4.

⁸³  See ibid, where the previous judgments are concisely summed up.

⁸⁴  [2014] EWCOP 8.

⁸⁵  [2014] EWCOP 11.

⁸⁶  [2014] EWCOP 13.

⁸⁷  [2014] EWCOP 44.

⁸⁸  December 2014.

⁸⁹  See Law Commission Report No 231, Mental Incapacity, Part VI.

⁹⁰  Making Decisions (1999) Cm 3803, para 12.

⁹¹  See also s 4(5) relating to the withdrawal of life-sustaining treatment; and see at 19.18.

⁹²  See 15.11.

⁹³  And see the Mental Capacity Act 2005 Code of Practice, para 6.9.

⁹⁴  Mental Capacity Act 2005 (Independent Mental Capacity Advocate) (General) Regulations 2006, SI 2006/1832, reg 4.

⁹⁵  Mental Capacity Act 2005 Code of Practice, para 6.18; and see paras 8.18–8.24. See also Court of Protection Practice Direction 9E.

⁹⁶  For fuller advice, see Code of Practice, paras 6.40–6.53.

⁹⁷  See the discussion of Re DD at 6.9.

⁹⁸  See Re C (Detention: Medical Treatment) [1997] 2 FLR 180.

⁹⁹  [1998] 3 All ER 299, HL.

¹⁰⁰  See Winterwerp v Netherlands (1979) 2 EHRR 387; Herczegfalvy v Austria (1992) 15 EHRR 437.

¹⁰¹  (2004) 40 EHRR 761.

¹⁰²  See JE v DE [2006] EWHC 3459 (Fam).

¹⁰³  But see An NHS Trust v A [2013] EWHC 2442, [56–57].

¹⁰⁴  See s 4(A).

¹⁰⁵  As provided for in the Care Standards Act 2000.

¹⁰⁶  For example, this route is used if the person is in supported living accommodation.

¹⁰⁷  See s 4(B).

¹⁰⁸  P (by his litigation friend, the Official Solicitor) v Cheshire West and Chester Council and another: P and Q (by their litigation friend, the Official Solicitor) v Surrey County Council [2014] UKSC 19. (Cheshire West)

¹⁰⁹  House of Commons Health Committee, Post-legislative Scrutiny of the Mental Health Act 2007, HC 584 (2013), para 105.

¹¹⁰  Ibid, para 106.

¹¹¹  Select Committee on the Mental Capacity Act 2005, Mental Capacity Act 2005: Post-Legislative Scrutiny, HL Paper 139 (March 2014).

¹¹²  Cheshire West [10], per Lady Hale DP.

¹¹³  The government rejected this advice in HM Government, Valuing Every Voice, Respecting Every Right: Making the Case for the Mental Capacity Act Cm 8884 (June 2014).

¹¹⁴  Cheshire West.

¹¹⁵  [2011] EWCA Civ 1257.

¹¹⁶  Cheshire West, [46].

¹¹⁷  Ibid.

¹¹⁸  Ibid.

¹¹⁹  Ibid, [57].

¹²⁰  HSCIC, Mental Capacity Act 2005, Deprivation of Liberty Safeguards (England) Quarter 3 Return, 2014–15 (February 2015): in 2014 to 2015 ‘Overall there was a 56 per cent increase in the number of applications (11,700) between quarter 1 and quarter 3’ (p 8).

¹²¹  ADASS and Local Government Association, Letter to Secretary of State re: Impact of Supreme Court Decision re Deprivation of Liberty Safeguards (July 2014).

¹²²  [2014] EWCOP 45.

¹²³  [2014] EWCOP 45, [14], [26–27].

¹²⁴  Re X and Ors (Deprivation of Liberty) [2014] EWCOP 25 and Re X and Ors (Deprivation of Liberty) (Number 2) [2014] EWCOP 37.

¹²⁵  Practice Direction – Deprivation of Liberty COPDOL10 (November 2014); the Court of Protection (Amendment) Rules 2015, SI 2015/548. In light of Re X (Court of Protection Practice) (2015) EWCA Civ 599, they may be revised.

¹²⁶  Re X (Court of Protection Practice) (2015) EWCA Civ 599.

¹²⁷  Children of 16 or 17 years old can be detained on the authority of the court under the Children Act 1989 or the Mental Health Act 1983 (as amended). Note that the Law Commission, Mental Capacity and Deprivation of Liberty Consultation Paper 222 (July 2015) proposes extending the scheme to 16-/17-year-olds. See 14.22.

¹²⁸  A NHS Trust v A [2013] EWHC 2442 (Fam).

¹²⁹  Law Commission, Mental Capacity and Deprivation of Liberty Consultation Paper 222 (July 2015).

¹³⁰  See A Grubb, ‘Treatment Decisions, Keeping it in the Family’ in A Grubb (ed), Choices and Decisions in Health Care (1993) Wiley.

¹³¹  For an example of financial self-interest driving a family’s defiance of declarations by the Court of Protection, see MASM v MMAM and others [2015] EWCOP 3.

¹³²  Discussed further at 19.19 and see A Maclean, ‘Advance Directives, Future Selves and Decision Making’ (2006) 14 Medical Law Review 291.

¹³³  See Re T (Adult: Refusal of Medical Treatment) [1992] 4 A11 ER 649, CA.

¹³⁴  [2005] EWCA Civ 1003, [35].

¹³⁵  See, for example, T Thompson, R Barbour, L Schwartz, ‘Adherence to Advance Directives in Critical Care Decision Making: Vignette Study’ (2003) 327 British Medical Journal 1011, demonstrating the divergent attitudes of healthcare professionals when faced with a patient’s mock advance directive.

¹³⁶  See Mental Capacity Act 2005, ss 24–26.

¹³⁷  Under s 26(1) if P has made an advance decision which is: (a) valid; and (b) applicable to a treatment, the decision has effect as if he had made it, and had had capacity to make it, at the time when the question arises whether the treatment should be carried out or continued.

¹³⁸  Which must meet stringent conditions set out in s 25(6) and discussed at 19.19.

¹³⁹  See s 25(1).

¹⁴⁰  Well illustrated in a pre-2005 Act case; see W Health Care Trust v H [2004] EWCA 1324.

¹⁴¹  See s 25(4).

¹⁴²  [2014] EWCOP 1317.

¹⁴³  [2014] EWCOP 454.

¹⁴⁴  [2003] 2 FLR 408.

¹⁴⁵  See the Enduring Powers of Attorney Act 1985.

¹⁴⁶  See the Office of the Public Guardian, which lists recent cases in a regular newsletter ‘OPG In Touch’; accessible at www.publicguardian.gov.uk

¹⁴⁷  [2010] EWHC 1592 (Fam). The case aroused great media interest; on which see Independent News and Media v A [2010] EWCA Civ 343.

¹⁴⁸  [2010] EWHC 2512, [60–61] per Baker J.

¹⁴⁹  [2014] EWCOP B20. And see LB Haringey v CM [2014] EWCOP B23 on the importance of ensuring that the appointed deputy does not subject the incapacitated person to undue influence.

¹⁵⁰  For the appointment of a longstanding friend in preference to a nephew; see DB v DW [2015] EWCOP 16.

¹⁵¹  [2013] EWHC 2966 (COP).

¹⁵²  See ss 45–61.

¹⁵³  [2015] EWCA Civ 411.

¹⁵⁴  ACCG v MN [2013] EWHC 3859 (COP).

¹⁵⁵  A question answered in part in A v A Health Authority [2002] EWHC 18 (Fam).

¹⁵⁶  In Re M (Incapacitated Adult) (Best Interests Declaration: Potential Contempt) [2015] EWCOP 3 Hayden J at [49].

¹⁵⁷  YA (F) v A Local Authority [2010] EWHC 2770.

¹⁵⁸  See Mason, Laurie, Mason and McCall Smith’s Law and Medical Ethics, ch 13; E Jackson, Medical Law, ch 6; Bartlett, Sandland, Mental Health Law; Policy and Practice (4th edn, 2013) Oxford University Press.

¹⁵⁹  See Mental Health Act 1983, s 2. An emergency application founded on the recommendation of one doctor may be made under s 4 and authorises detention for up to seventy-two hours.

¹⁶⁰  A successful application for admission for treatment authorises detention for an initial period of six months.

¹⁶¹  Defined as a ‘state of arrested or incomplete development of the mind which includes significant impairment of intelligence and social functioning’; see s 1(4).

¹⁶²  Section 1(2A), but he could be admitted for assessment under s 2 without establishing such an association.

¹⁶³  Even though the Court of Appeal has developed a fairly broad definition of treatment to include group therapy and nursing care in a structured environment; see R v Canon Park Mental Review Tribunal ex p A [1994] 2 All ER 659, CA; R v Mental Health Review Tribunal ex p Macdonald (1998) Crown Office Digest 205.

¹⁶⁴  See 6.12.

¹⁶⁵  See A NHS Trust v A [2013] EWHC 2442 (Fam): and see G Richardson, ‘Mental Capacity at the Margin. The Interface between Two Acts’ (2010) 18 Medical Law Review 56.

¹⁶⁶  R v Hallstrom ex p W (No 2) [1986] QB 824.

¹⁶⁷  B v Barking, Havering and Brentwood Community NHS Trust [1999] 1 FLR 106.

¹⁶⁸  [1995] 1 All ER 683 CA; Re KB (Adult) (Mental Patient: Medical Treatment) [1994] 2 FLR 1051. And see R v Collins and Ashworth Hospital Authority ex p Brady [2000] Lloyds Rep Med 355.

¹⁶⁹  See K Keywood, ‘Rethinking the Anorexic Body; How English Law and Psychiatry “Think”’ (2003) 26 International Journal of Law and Psychiatry 599; P Lewis, ‘Feeding Anorexic Patients Who Refuse Food’ (1999) 7 Medical Law Review 21.

¹⁷⁰  [1996] 1 FCR 753.

¹⁷¹  [2013] EWHC 2442 (Fam).

¹⁷²  See s 57(1).

¹⁷³  See s 57(2). Section 57(2) empowers the Secretary of State to bring other treatments within the ambit of s 57(2). See also the Mental Health (Hospital, Guardianship and Treatment) (England) Regulations 2008, SI 2008/1184 (amended SIs 2008/2560; 2012/1118), reg 27(1).

¹⁷⁴  See s 58(2).

¹⁷⁵  See J Herring, ‘Protecting Vulnerable Adults: A Critical Review of Recent Case Law’ [2009] Child and Family Law Quarterly 498.

¹⁷⁶  A Local Authority v MA, NA and SA [2005] EWHC 2942 (Fam), [77].

¹⁷⁷  DL v A Local Authority and others [2012] EWCA Civ 253.

¹⁷⁸  For an analogous scenario see DL ibid.

¹⁷⁹  [2010] EWHC 1549 (Fam); see 6.4 and 11.4.

¹⁸⁰  [2013] EWHC 2442 (Fam); see 6.12.

¹⁸¹  XCC v A [2013] 2 All ER 988.

¹⁸²  [2013] Fam 1.

¹⁸³  For discussion of compulsory sterilisation laws in the USA, see MDA Freeman, ‘Sterilising the Mentally Handicapped’, in MDA Freeman (ed), Medicine, Ethics and Law (1988) Stevens.

¹⁸⁴  For discussion, see N Glover-Thomas, S Holm, ‘Compulsory Vaccination: Going Beyond a Civic Duty?’ in C Stanton, S Devaney, A-M Farrell, A Mullock (eds), Pioneering Healthcare Law: Essays in Honour of Margaret Brazier (2016) Routledge, ch 3.

¹⁸⁵  DH, Antibiotic Resistance – A Threat to Global Health Security and the Case for Action (May 2013).

¹⁸⁶  SI 2010/659.

¹⁸⁷  SI 2010/659, reg 2.

¹⁸⁸  See Public Health (Control of Disease) Act 1984, s 45G.

¹⁸⁹  See s 45E.

¹⁹⁰  [2005] EHHR 34. See R Martin, ‘The Exercise of Public Health Powers in Cases of Infectious Disease: Human Rights Implications’ (2006) 14(1) Medical Law Review 132.

¹⁹¹  See A Mowbray, ‘Compulsory Detention to Prevent the Spreading of Infectious Diseases’ (2005) 5 Human Rights Review 387.

¹⁹²  See H Quirk, C Stanton (eds) The Criminal Law and Contagion (2016) Cambridge University Press; Law Commission Consultation Paper No 217 Reform of Offences Against the Person: A Scoping Consultation Paper (2014) ch 6.

¹⁹³  See SH Bronitt, ‘Spreading Disease and the Criminal Law’ [1994] Criminal Law Review 21; KM Smith, ‘Sexual Etiquette, Public Interest and the Criminal Law’ (1991) 42 Northern Ireland Legal Quarterly 309.

¹⁹⁴  R v Clarence (1888) 22 QBD 23; Hegarty v Shine (1878) 14 Cox CC 124.

¹⁹⁵  R v Gaud (unreported); analysed in M Mulholland, ‘Public Nuisance – A New Use for an Old Tool’ (1995) 42 Professional Negligence 70.

¹⁹⁶  [2004] 3 A11 ER 593; see M Brazier, ‘Do No Harm – Do Patients Have Responsibilities Too?’ (2006) 65(2) Cambridge Law Journal 397.

¹⁹⁷  In HM Advocate v Kelly (2001) High Court of Judiciary, Glasgow, a Scottish court convicted a man who infected his lover with HIV of culpably and recklessly endangering her health; see J Chalmers, ‘The Criminalisation of HIV Transmission’ (2002) 28 Journal of Medical Ethics 160. And see R v Konzani (2005) 2 Cr App R 13; discussed in M Weait, ‘Knowledge, Autonomy and Consent: R v Konzani’ [2005] Criminal Law Review 673.

¹⁹⁸  Relying on R v Brown [1994] 1 AC 212, HL.

¹⁹⁹  [2004] 3 All ER 593, at 605.

²⁰⁰  Ibid, at 606.

²⁰¹  See R v Ireland, R v Burstow [1998] AC 147, HL.

²⁰²  See M Weait, ‘Criminal Law and Sexual Transmission of HIV: R v Dica’ (2005) 68 Modern Law Review 121.

²⁰³  Ibid, at 134.

²⁰⁴  JR Spencer, ‘Liability for Reckless Infection – Part 2’ (2004) 154 New Law Journal 448, at 448.

²⁰⁵  [2014] EWCA (Crim) 899.

²⁰⁶  Section 47 of the National Assistance Act 1948, as amended by the National Assistance (Amendment) Act 1951.

²⁰⁷  Care Standards Act 2014.

Chapter 7

CLINICAL NEGLIGENCE

¹

7.1 The civil law of negligence is designed to provide compensation for one individual injured by another’s negligence. Gross negligence resulting in death and wilful neglect of patients may be punished by the criminal courts. We consider possible criminal liability incurred by doctors at the end of this chapter. A person seeking compensation for negligence has to establish: (1) that the defendant owed him a duty to take care; (2) that he was in breach of that duty, that he was careless; and (3) that the harm of which the victim complains was caused by that carelessness. He must satisfy all these tests to succeed. A widow succeeded in establishing that a hospital doctor was careless in not coming down to Accident and Emergency to examine her husband. He was admitted to hospital in an appalling state which eventually proved to be caused by arsenical poisoning. He died within hours. She failed to recover any compensation from the hospital in respect of her husband’s death because the evidence was that, even had he been properly attended, he would still have died.²

The bare bones of the law of negligence outlined above are general to everyone, in the conduct of their everyday activities and in carrying out their job. They are not special to doctors or health professionals more generally. Certain special factors about clinical negligence claims need to be noted. Proving negligence where there is a clash of medical opinion remains difficult. The need to prove ‘fault’ with its implications of wrongdoing affects the medical profession’s reaction to claims against them prompting claims that doctors have become defensive. Patients used to be deferential. For a long time, English judges were unwilling to find against a ‘medical man’. A brotherly solidarity bound the ancient professions of law and medicine together. Judicial attitudes have changed.³ Claims against doctors and damages awarded against NHS hospitals have risen dramatically. The medical profession is haunted by the spectre of a malpractice crisis. In the next chapter, we explore whether it is a spectre of any substance.

Duty of care

7.2 A patient claiming against his doctor, or a hospital, generally has little difficulty in establishing that the defendant owes him a duty of care. A general practitioner accepting a patient on to her list undertakes a duty to him. A hospital and its entire staff owe a duty to patients admitted for treatment. If the patient is an NHS patient, the duty derives from the law of tort, which imposes a duty wherever one person can reasonably foresee that his conduct may cause harm to another. Where the patient is a private patient, in addition to the duty in tort, a duty arises from his contract with the doctor or the hospital. It is the same duty regardless of its origins. We look later at the circumstances in which the private patient is owed duties other than that of care. Difficulty arises where a person has not been accepted as a patient. English law does not oblige anyone to be a Good Samaritan. If someone has a coronary attack on an Inter-City express, and a doctor fails to respond to the guard’s call, ‘Is there a doctor on the train?’ the doctor incurs no liability to the victim who dies for lack of medical treatment.⁴ Does the law discourage the Good Samaritan? If the doctor comes to the sick man’s aid, she undertakes a duty to him and in theory may be liable if her skill fails her, but any court ascertaining the standard of care that the Samaritan must attain will take into account the circumstance in which the doctor volunteers her help.

A practical problem arises from the increasing practice of centralising casualty facilities in the larger hospitals. More and more hospitals have notices on their gates stating that they do not accept emergencies and accident victims. The notice refers the injured person to another named hospital. An accident victim whose injuries worsened because of the delay in reaching a casualty department is unlikely to succeed in a claim against the hospital which refused him admission. It never assumed any duty to him. A hospital which operates a casualty department by contrast, is responsible for the patients who come within its doors regardless of whether they have been formally admitted to hospital. By running a casualty department, an NHS hospital undertakes to treat those who present themselves and will be liable in negligence if any failure on the part of their staff causes the patient to be sent away untreated.⁵ Similarly, a GP currently owes a duty to emergency patients as well as to those on his own list. His contract with the NHS provides that he will treat visitors to his practice area falling suddenly ill. Like the hospital with the casualty ward he undertakes to treat the genuine emergency as much as his regular patients.

In Kent v Griffiths,⁶ the duties owed to patients by the ambulance services came before the courts. The claimant was asthmatic. She was also pregnant. She had been exceptionally wheezy on the day in question and called her GP who telephoned for an ambulance using the 999 service. The ambulance took forty minutes to arrive despite two further anxious phone calls from the claimant’s husband. On the journey to the hospital, the claimant was given oxygen. Shortly before arrival at the hospital she suffered a respiratory arrest resulting in serious brain damage and a miscarriage. The ambulance service denied negligence. They contended that their only duty to the claimant was not by their own actions to cause her any additional injury. They had no duty to come to her aid, to ‘rescue’ her from the danger her illness placed her in. Earlier cases⁷ involving police and fire services had found that (generally) simply failing to respond to, or respond sufficiently promptly to, a 999 call did not render those services liable in negligence. The Court of Appeal was adamant that the ambulance service was different. It is an NHS service owing equivalent responsibility to patients in need of that service to doctors and nurses. Where an identifiable patient needed and summoned the ambulance service, there was a duty to respond. Due care on the part of an ambulance service demands a reasonably prompt response. There might be cases of conflicting priorities. For example, two major road accidents take place in the same city at the same time as a winter ‘flu’ epidemic. The elderly ‘flu’ patient, whose call is given lower priority than the crash victims, is still owed a duty by the ambulance service. In the circumstances, there may be no breach of duty because, confronted by competing demands, the ambulance service responded reasonably.

Would delay by a hospital in arranging treatment breach the duty of care? If a patient is seen at an out-patients clinic and then waits so long for surgery that her cancer cannot be successfully treated, does she have a claim against the hospital? What if she could show that NHS guidelines on timely treatment had been breached? Her principal problem may well be to prove that had she been treated sooner the cancer would have been treatable. Another possible avenue of redress for patients whose health deteriorates because treatment is delayed might be to sue the authority responsible for arranging their secondary care. Clinical Commissioning Groups (CCGs) generally now have that responsibility for all NHS patients within their jurisdiction.⁸ If a CCG fails to arrange, sufficiently promptly, a cardiac bypass for a patient with clogged arteries, and he dies, could his family bring a claim in negligence? We would argue that CCGs, like the ambulance service, owe a duty to all their patients to arrange reasonably prompt and adequate secondary care for patients in need of such care.⁹ That does not mean they will be liable to compensate every patient who does not obtain the treatment he needs. The demand for secondary care may outstrip what can be supplied. The CCG must act reasonably. If the unfortunate cardiac patient did not get his operation quickly enough because the notes are lost, or arrangements are bungled, his family should succeed. If difficult decisions about priorities for treatment have to be made, resulting in other sick patients having first call on the budget, proving negligence will be harder.

Psychiatric harm

7.3 Patients may seek to sue, not just in respect of physical harm, such as a perforated bowel in the course of surgery, but also in cases of psychiatric injury. Where additional psychiatric harm ensues directly from bungled treatment of the claimant herself, such claims have a fair chance of success.¹⁰ In Farrell v Merton, Sutton and Wandsworth Health Authority,¹¹ the claimant suffered a horrific childbirth. She remained aware during an emergency caesarean section; she contracted a post-operative infection and her child was born with serious brain damage. News of her child’s condition was communicated inadequately and totally insensitively. She recovered compensation to include the adverse effects on her mental health of all that had happened to her.

Claims where one person alleges that negligent treatment of someone else, a close relative, caused them to suffer mental illness are harder to sustain. The law regards such people as secondary victims of psychiatric injury, akin to those who witness some horrific disaster, such as the events at Hillsborough Football Stadium when fans were crushed to death as a result of negligence on the part of the police.¹² Just because a relative suffers injury from inadequate treatment and the effect of distress and grief make you ill, does not suffice to create a duty owed by the defendant hospital to you. Only if you actually suffer psychiatric injury from the trauma and shock of witnessing or discovering what has happened to your relative, are you likely to be owed any duty.¹³ A husband who was present and watched his wife screaming in agony because she remained awake during caesarean surgery and saw her haemorrhaging might well succeed.¹⁴ A mother, coming to visit her daughter who had had routine surgery, and who, with no warning, is simply and abruptly told that her child is dead and directed to the mortuary might be owed a duty.¹⁵ If, in either example, husband or mother were not in any sense at the scene of the ‘accident’ to their beloved, but simply learned of their fate, or were told of the tragedy insensitively, they will not recover compensation, even if, not unnaturally, the original injury to wife or daughter drives them into clinical depression.¹⁶

Medical examinations

7.4 A number of cases consider how far doctors examining patients not for the patient’s benefit, but on the instruction of a third party, owe a duty to the patient being examined. For example, you have to have a medical examination before a job offer will be confirmed. Two different scenarios must be addressed.

(1)  The doctor, had he carried out the examination with due care, would have discovered that you had early signs of cancer. Delay in diagnosis means that your cancer is now inoperable. Did the doctor who performed your ‘medical’ owe you a duty to alert you to your dangerous condition? There is no case directly in point but such a duty may well be found.¹⁷

(2)  The doctor carries out the ‘medical’ negligently and wrongly concludes that you are unfit for the job. You lose a chance of the job. Does the doctor owe you a duty to protect you from the financial (economic) loss of not getting the job? One case suggests such a duty is owed.¹⁸ A later judgment of the Court of Appeal is to the contrary.¹⁹ The examining doctor owed no duty to the job applicant to protect him from economic loss. He was not responsible for looking after his job prospects.²⁰

Responsibility for harm inflicted by ‘dangerous’ patients

7.5 Patients being treated for some types of mental disorder – in particular personality disorders – are sometimes a danger to themselves. A trust that fails to take reasonable steps to protect such a patient from harm may be held negligent.²¹ What if the patient causes harm to another? As we explained in Chapter 4,²² English courts are wary of imposing a duty of care in relation to the acts of a third party. It will not be enough to show that an individual doctor or mental health trust was aware their patient posed a risk of harm to the claimant.²³ In Selwood v Durham County Council²⁴ the Court of Appeal upheld an appeal against a trial judge’s decision to strike out a claim against two NHS trusts treating a patient, G, who stabbed and injured the claimant, a social worker working with G and his family in proceedings involving G’s children. On a number of occasions G made threats against the claimant at one stage threatening to ‘kill her on the spot’. The claimant was employed by Durham County Council. The Council and the NHS trusts had signed a protocol on working together that focused in part on protection of staff and sharing information. The Court of Appeal ruled that there was thus sufficient evidence for there to be an arguable case that the defendant trusts had assumed responsibility for protecting employees of co-signatories, as well as their own employees, from harm by clients where explicit threats had been made.²⁵

The medical standard of care

7.6 The second matter that any claimant in negligence has to prove is that the defendant was careless. A warning is called for. The diligent student who searches legal databases for cases on proving clinical negligence will be overwhelmed with hundreds of cases each year. Few will offer more clarity by way of legal principle. What is in dispute will be disagreement about the facts, what happened and how reliable is memory, and/or just how to apply the current law. Brief mention of a recent case turning on issues of fact may illustrate some of the difficulties. In Oliver v Williams²⁶ a principal issue was whether the GP told the claimant that he had sent an urgent referral letter to the hospital. The letter got lost and the claimant, who alleged that she had not been told about the letter, did not question the absence of a hospital appointment. At the trial of her claim over six years later, the judge accepted that both parties gave honest recollections of a meeting years ago. He found however that it was unlikely that the claimant would have ignored or forgotten information that would have alerted her to the seriousness of her condition.

The fundamental principles of law are as follows. The onus of proof is on the claimant. He must show that the defendant fell below the required standard of care. The basic standard is that of the reasonable man in the circumstances of the defendant. A professional person must meet the standard of competence of the reasonable professional doing his job. A woman who went to a jeweller’s to have her ear pierced developed an abscess because the jeweller’s instruments were not aseptically sterile. The jeweller had taken all the precautions that any jeweller could be expected to take. The woman’s claim failed. The defendant had done all a jeweller could reasonably be expected to do.²⁷ If she wanted the standard of care a surgeon could offer, she should have consulted a surgeon.

Before examining the case law in clinical negligence, we should note briefly section 1 of the Compensation Act 2006. The Act was passed as a knee-jerk reaction to much publicised claims of a ‘compensation culture’. Supposedly schools were refusing to take children on school trips and local authorities were closing playgrounds to avoid any risk of liability for injury. Section 1 provides:

A court considering a claim in negligence or breach of statutory duty may, in determining whether the defendant should have taken particular steps to meet a standard of care (whether by taking precautions against a risk or otherwise), have regard to whether a requirement to take those steps might –

(a)  prevent a desirable activity from being undertaken at all, to a particular extent or in a particular way, or

(b)  discourage persons from undertaking functions in connection with a desirable activity.

The Act has had little effect on clinical negligence claims.²⁸ Unless judges were to decide to accept the wildest claims about defensive medicine, and determine that allowing doctors to be sued damages healthcare, the Compensation Act need not be treated as a matter of great concern. However, politicians continue to believe that gold-digging compensation claims incited by greedy lawyers are damaging public services including the NHS. The principles of law may not be affected by such rhetoric but as we shall see in the next chapter, the process of bringing a claim has become more difficult.

The standard of care demanded of the doctor is the standard of the reasonably skilled and experienced doctor. In Bolam v Friern Hospital Management Committee,²⁹ McNair J said:

The test is the standard of the ordinary skilled man exercising and professing to have that special skill. A man need not possess the highest expert skill, it is well established law that it is sufficient if he exercises the ordinary skill of an ordinary competent man exercising that particular art.

The defendant doctor will be tested against the standard of the doctor in his particular field of medicine. The general practitioner must meet the standard of the competent general practitioner; the consultant gynaecologist the standard of the competent consultant in that specialty. As Lord Scarman put it: ‘a doctor who professes to exercise a special skill must exercise the ordinary skill of his specialty’.³⁰ A patient who attends her general practitioner complaining of an eye disorder cannot require him to have the skill of a consultant ophthalmologist. She can complain if the GP fails to refer her to a consultant in a timely fashion³¹ when her condition should have alerted a reasonable GP to the need for further advice or treatment. In Meiklejohn v St George’s Health-care NHS Trust³² the claimant sought to argue that the defendant should be judged against a higher standard than that of the post she held as a tertiary specialist in aplastic anaemia to take account of her ‘international renown’. The claim was rejected by the Court of Appeal.

Junior doctors

7.7 No allowance is made for inexperience. The Court of Appeal has consistently rejected arguments that standards of care should vary to allow for the degree of experience possessed by the defendant. They held an L-driver liable where, although she had done the best that could be expected of a learner, she fell short of the standard of the reasonably competent and experienced motorist.³³ In Wilsher v Essex Area Health Authority,³⁴ the appeal court considered the liability of junior hospital staff. Martin Wilsher was born nearly three months prematurely. He was admitted to a neonatal unit managed by the defendants where skilled treatment probably saved his life. He needed extra oxygen to survive. Sadly, junior doctors made an error in monitoring the oxygen levels in Martin’s blood, and on two occasions, he received an excess of oxygen. It was argued by Martin’s lawyers that excess oxygen caused him to develop retrolental fibroplasia (RLF), a retinal condition which left Martin nearly blind. Ultimately, the House of Lords held that the plaintiff had failed to prove that excess oxygen caused RLF in Martin and ordered a retrial.³⁵ The importance of the Court of Appeal’s judgment lies in its exposition of the rules on negligence by junior staff. Argument by the defendants that staff concerned did their best in view of their inexperience was rejected. The law requires all medical staff in such a unit to meet the standard of competence and experience society expects from those filling such demanding posts. Their Lordships recognised the need for medical staff to train ‘on the job’. They stressed that a finding of negligence on one occasion did not imply incompetence or any degree of moral culpability. Legal and moral tests of negligence may differ. Doctors may find the distinction hard to understand. One point must be made clear here. A junior doctor, who, recognising his inexperience, calls in his consultant will have discharged his duty. Responsibility in law will move to the consultant.³⁶

Ascertaining the standard of care: Bolam

7.8 How does a court ascertain the standard of skill which the doctor should have met? Let us consider the case of Mr Bolam again. He was given electro-convulsive therapy and sustained fractures. He argued that the doctor was negligent: (1) in not giving him relaxant drugs; (2) as drugs were not given, in failing to provide adequate physical restraints; (3) in not warning him of the risks involved in the treatment. We have seen that he failed in his argument that he should have been warned, but that today after the decision of the Supreme Court in Montgomery v Lanarkshire Health Board³⁷ he might well have succeeded in this ‘informed consent’ claim.³⁸ Indeed, the Supreme Court in Montgomery made it clear that the Bolam test has no application to the question of what information the doctor must disclose to the patient. As to the absence of relaxant drugs or restraints, the evidence was that while some doctors would have thought them necessary, many did not. The judge found the doctor not guilty of negligence for he acted:³⁹

in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular area … a man is not negligent, if he is acting in accordance with such a practice, merely because there is a body of opinion who would take a contrary view.

The Bolam test became (in)famous. At first sight, it is unexceptionable. Courts cannot decide whether a doctor was negligent without expert evidence of ‘accepted medical practice’.⁴⁰ Within any profession, genuine differences of opinion may surface. In obstetrics, doctors have different views about how best to deliver a premature breech baby. Some doctors consider that, in every case, the woman should be strongly advised to agree to an elective caesarean section. Others believe that a trial of labour should be permitted and, only if complications ensue in labour, should surgery be advised as the best ‘medical’ option. Both sides of the debate advance logical reasons for their respective judgements. Judges are not well placed to resolve such questions. Note however in the light of the decision in Montgomery (above), the doctor must warn the patients of the risks and pros and cons of both options. The Bolam test (responsible professional opinion) will apply to the question whether the doctor has correctly identified the options and the risks and benefits of each, but then she must disclose all the information that a reasonable patient in the circumstances of the claimant would wish to have to make an informed choice.

The Bolam test focusing on ‘accepted practice’ came to be applied to all claims for professional negligence. ‘Responsible professional opinion’ is the litmus test of liability for solicitors, accountants and architects, just as much as for doctors. There was a crucial difference. In claims against other professionals, the courts rigorously scrutinised expert evidence to ensure that evidence of professional opinion could be demonstrated to be responsible and reasonable.⁴¹ In claims against doctors, it appeared that as long as suitably qualified expert witnesses endorsed the defendant’s conduct, English judges simply deferred to the doctors. Providing expert testimony was seen to be truthful, the courts assumed that it must be responsible.⁴² The key to successfully defending a claim in negligence was to find expert witnesses who would be impressive in the witness box.⁴³

Trial judges who took it upon themselves to scrutinise and evaluate medical evidence faced reprimands from above. In Maynard v West Midlands Regional Health Authority,⁴⁴ the plaintiff had consulted a consultant physician and a surgeon with symptoms indicating tuberculosis, but she also displayed symptoms which might indicate Hodgkin’s disease. The doctors decided on a diagnostic operation, mediastinoscopy. It carried a risk of damage to the vocal cords and Mrs Maynard’s vocal cords were in fact damaged. She proved to have tuberculosis. She alleged that the defendants were negligent in subjecting her to the operation. Her expert witness argued that the operation should never have been done. He would have regarded her condition as almost certainly a case of tuberculosis. The defendants called a formidable number of experts who testified that the fatality rate for Hodgkin’s disease if treatment was delayed justified the defendants in exposing Mrs Maynard to the risk of the mediastinoscopy. The original judge preferred Dr Hugh-Jones’s evidence. The Court of Appeal and the House of Lords overruled him. Lord Scarman said:

a judge’s ‘preference’ for one body of distinguished professional opinion to another also professionally distinguished is not sufficient to establish negligence in a practitioner.⁴⁵

In Maynard, the defendants had numbers on their side. In De Freitas v O’Brien,⁴⁶ the expert evidence established that only a tiny minority of neurosurgeons endorsed the defendant’s practice, just four or five out of 250 doctors in that specialty. The Court of Appeal ruled that the body of opinion supporting the defendant need not be large. The perception arose that English judges would not cross swords with the doctors, however thin the evidence advanced in defence of a claim.⁴⁷

Individual judges did on occasion attempt to assert judicial authority over medical evidence. Sir John Donaldson MR⁴⁸ emphasised that professional opinion must be ‘rightly accepted as proper by a body of skilled and experienced medical men’. In 1968, the Court of Appeal in Hucks v Cole⁴⁹ rejected expert evidence in the defendant’s favour. Evidence that other doctors would have followed the same practice as the defendant was ‘a very weighty matter’, but not conclusive. Such challenges to the supremacy of medical evidence tended to be ephemeral, apparently forgotten in the next flurry of cases.

Bolitho: a new dawn?

7.9 In Bolitho v City & Hackney Health Authority,⁵⁰ Lord Browne-Wilkinson reasserted the proper authority of the courts. Bolitho involved questions of causation as much as breach of duty. The facts, briefly, were these. Patrick Bolitho, aged 2, was admitted to the defendant’s hospital suffering from respiratory difficulties. On the second afternoon of this hospital stay, Patrick was in respiratory distress. A nurse summoned the paediatric registrar. She promised to attend as soon as possible, but did not do so. Patrick appeared to recover. At 2.00 pm, Patrick was once again having breathing problems. The registrar was called a second time, but again failed to attend. At 2.30 pm, the boy collapsed; he stopped breathing and suffered a cardiac arrest causing catastrophic brain damage. The hospital admitted negligence on the part of the paediatric registrar. She should have come to examine the child, or arranged for a suitable deputy to do so. They denied liability, however, arguing that, even if the doctor had attended Patrick prior to 2.30 pm, she would not have intubated him. Intubation offered the only prospect of averting the respiratory distress and cardiac arrest which Patrick suffered at 2.30 pm.

The trial judge accepted the doctor’s evidence of fact that she would not have intubated Patrick. The question then became whether or not a competent doctor who had attended Patrick should have intubated the child. The Bolam question became the key to resolving causation. The experts were sharply divided. The plaintiff’s five experts testified that Patrick’s history of breathing problems was such that responsible practice required that he be intubated to prevent just the sort of catastrophe which materialised. The defendants’ three experts argued that, apart from the two episodes of respiratory difficulty, Patrick seemed generally well. Intubation was distressing and not risk free for so young a child. A responsible doctor would not have intubated Patrick prior to 2.30pm. The judge ruled that, as both sets of experts represented a body of professional opinion espoused by distinguished and truthful experts, he was bound to conclude that Patrick’s injury did not result from the defendants’ admitted negligence. In effect, the judge asserted that he was disqualified from any form of scrutiny of expert medical evidence.

The Court of Appeal upheld the trial judge. The case proceeded to the House of Lords. Two issues fell to be resolved by their Lordships. The first, whether the Bolam test applies to causation, will be addressed later. The second is our present concern. Does the Bolam test require a judge to accept without question truthful evidence from eminent experts? Their Lordships, speaking with one voice through Lord Browne-Wilkinson, answered that question with a firm and forceful no. Reviewing precedents relating to claims of negligence against other professionals, his Lordship declared that:

the court has to be satisfied that the exponents of the body of opinion relied on can demonstrate that such opinion has a logical basis. In particular, in cases involving as they so often do, the weighing up of risks against benefits, the judge before accepting a body of opinion as being reasonable, responsible or respectable, will need to be satisfied that, in forming their views, the experts have directed their minds to the questions of comparative risks and benefits and have reached a defensible conclusion on the matter.⁵¹

Expert evidence after Bolitho remains of the highest importance to the success or failure of clinical negligence claims. Lord Browne-Wilkinson acknowledged that in ‘the vast majority of cases the fact that distinguished experts in the field are of a particular opinion will demonstrate the reasonableness of that opinion’. Nonetheless, he went on to say ‘if in a rare case, it can be demonstrated that the professional opinion is not capable of withstanding logical analysis, the judge is entitled to hold that the body of opinion is not reasonable or responsible’.⁵²

Bolitho returns Bolam to its proper limits.⁵³ Doctors, like solicitors and all other professionals, are subject to legal scrutiny. The courts, not the medical profession, are the ultimate arbiters of the standard of care in clinical negligence claims. Bolitho has generated a plethora of academic commentary.⁵⁴ How influential has Bolitho been? Pessimistic commentators pointed out that Lord Browne-Wilkinson spoke of ‘rare’ cases and later noted that it will be ‘very seldom’ that it would be right to conclude that views genuinely held by competent experts were unreasonable. Bolitho, they fear, does little to aid patients.⁵⁵ Concerns are also expressed that Bolitho might stifle innovation and that doctors will be wary of resorting to innovative drugs or techniques even when such measures may offer the last chance of a cure for the patient. So great was this concern for Lord Saatchi whose wife had died of untreated cancer that in 2014 he introduced his Medical Innovation Bill. The Bill was vetoed by the Liberal Democrats and a similar Bill, Chris Heaton-Harris’s Access to Medical Treatments (Innovation) Bill, was introduced in 2015. The Bill would provide that it is not negligent to depart from accepted treatments in accordance with a prescribed process, a process that falls well short of the strict regulation of medical research discussed in Chapter 15. The Bill has been criticised by doctors and lawyers⁵⁶ as opening the doors to allow unregulated research. Such legislation is unnecessary to achieve Lord Saatchi’s aim that in the last resort doctors should be able to offer the patient any treatment that they justifiably consider may offer benefit to that patient, even if the treatment is not accepted practice and/or has not yet been through rigorous research trials. Nothing in Bolitho militates against a judicial approach that would allow a well-reasoned and balanced judgement⁵⁷ to be held non-negligent in such cases of last-ditch choices.⁵⁸

But did Bolitho truly did herald a new dawn? We would agree with Mulheron that it did, even if the day that followed was somewhat cloudy!⁵⁹ The proclamation of judicial authority over medical practice came at last from the highest court in the UK and came at a time when several other developments in the manner medical practice is regulated and audited were placing limits on unfettered clinical autonomy.⁶⁰ Simply asserting that a medical expert considers that there was no negligence is no longer a ‘trump card’ for defendants. As Mason and Laurie put it ‘Bolam can no longer be regarded as impregnable’.⁶¹

What of the case law post Bolitho? In Marriott v West Midlands Health Authority,⁶² the plaintiff had suffered head injuries. He was discharged from hospital but remained unwell. Eight days after the fall he was visited by the defendant general practitioner. The GP carried out some basic neurological tests, prescribed painkillers and told the plaintiff’s wife to telephone him again if her husband’s condition got worse. Four days later the plaintiff collapsed and was readmitted to hospital. A large extradural haematoma was operated on and surgery revealed a skull fracture and internal bleeding. The plaintiff was left paralysed and afflicted by a speech disorder. In the claim against the GP, the crucial question was whether a responsible GP would have judged that a full neurological examination was called for and readmitted the plaintiff to hospital. The defendant’s expert acknowledged that the defendant should have recognised that there was a risk that the plaintiff had a clot on the brain, but contended that the risk was so small that it was not negligent to fail to refer the plaintiff for further tests. The trial judge evaluating that evidence held that albeit the risk was small, ‘the consequences, if things go wrong are disastrous to the patient. In such circumstances, it is my view that the only reasonable prudent course … is to re-admit for further testing and observation’. The Court of Appeal upheld the judgment. Beldam LJ endorsed the judge’s exercise in risk assessment. Whatever the expert witnesses might say, the devastating nature of the consequences of a clot on the brain were such that no responsible doctor would have subjected the plaintiff to that risk.⁶³ In Burne v A,⁶⁴ Sedley LJ stressed that:

judges are there to exercise judgment, and their judgment cannot be entirely dictated by expert evidence, even where the evidence is unopposed. The question always remains (provided a party raises it) whether the expert evidence makes sense.

Extrajudicially both the then Lord Chancellor⁶⁵ and Lord Chief Justice⁶⁶ indicated many years ago that judges should no longer blindly defer to medical opinion. Alasdair MacLean took a less optimistic view.⁶⁷ His research into clinical negligence claims showed that out of sixty four cases post-Bolitho, but before 2001, Bolitho was only even mentioned in twenty-nine. It has been made clear that Bolitho in no sense reverses the burden of proof,⁶⁸ but nor was it ever designed to do so. Judges have re-enforced the view that it will seldom be right to reject expert opinion as unreasonable.⁶⁹ The Court of Appeal has warned that a judge is ‘not entitled to impose his own opinion regardless of the practice of the medical profession’.⁷⁰ And a tendency to presume that eminent experts will necessarily give logical evidence can be discerned in Wisniewski v Central Manchester Health Authority.⁷¹

If Bolitho offers some assistance to patient-claimants, does it risk damaging medical care? Will doctors simply retreat into defensive practice? Will guidelines and protocols (a tick-box approach) replace a sensitive and imaginative approach to the needs of particular patients? This should not happen. Bolitho does not seek to usurp judgements which properly rest with doctors. Judges are not empowered to decide what constitutes good medical practice.⁷² What Bolitho does is to require expert witnesses to justify and explain the basis of their judgements.⁷³ It may be noted that expert evidence today is much more based on evidence and literature⁷⁴ than simple opinion.

‘Responsible practice’ means current practice

7.10 It has never been a defence for a doctor to say that a practice was widely accepted when he was at medical school and is therefore accepted practice, once informed medical opinion has rejected the practice.⁷⁵ A doctor clearly cannot ‘obstinately and pig-headedly carry on with some old technique if it has been proved contrary to what is substantially the whole of informed medical opinion’.⁷⁶ Doctors must keep up to date with new developments. But there is an inevitable ‘time lag’ between the making of new findings by researchers and the percolation of ideas through to doctors in the field. The doctor will be judged by the standard of awareness and sophistication to be expected of a doctor in his sort of practice. Great emphasis is placed on the professional position and the specialty of the defendant.⁷⁷ A patient who suffered from brachial palsy as a result of his arm being extended in a certain position while he was given a blood transfusion in the course of a bladder operation brought a claim against the anaesthetist. Six months before the operation, an article had appeared in the Lancet condemning this practice because of the risk of brachial palsy. The claim failed. Failure to read one recent article was not negligent.⁷⁸ In 2016 the greater ease of access to medical journals via the Internet may affect judgements about how far doctors must be up to date within their specialty.

The relevant date to judge current practice must be the date of the operation or treatment, not the date the claim comes to trial. In Roe v Ministry of Health, a patient had become permanently paralysed after an injection of the spinal anaesthetic Nupercaine, administered in 1947. His claim against the doctors and the hospital came to trial in 1954. Before the operation, the drug had been kept in glass ampoules in a solution of phenol. The accident to the patient occurred because phenol percolated through invisible cracks in the ampoules and contaminated the Nupercaine. No one had ever known this to happen. The claim in negligence failed. Lord Denning said: ‘We must not look at the 1947 accident with 1954 spectacles’.⁷⁹

Once a tragic incident of this nature has occurred and has been attended by publicity then of course a further incident would easily be proved to be negligence. Current practice would have been shown to be wanting.

Protocols and guidelines⁸⁰

7.11 Buzzwords in medicine today are evidence-based medicine and clinical governance. Within the NHS, the government has sought to ensure that treatment provided to patients is soundly based on good practice derived from concrete evidence. The National Institute of Clinical Excellence (NICE) is expressly instructed to investigate medical practice and provide authoritative guidelines on good practice. The Royal Colleges of Medicine, and other doctors’ organisations, increasingly draw up protocols for treatment and issue guidelines on good practice.

Evidence of good practice as defined by protocol and guidelines will play a role in any claim for clinical negligence. The considered judgement of NICE, or the profession itself, will be evidence of what constitutes responsible practice. Does this mean any doctor departing from official guidelines will be proven negligent? Some doctors fear guidelines enforced by the courts will lead to a ‘tick-box’ approach to patient care.⁸¹ Doctors will cease to exercise professional judgement based on the needs and circumstances of the individual patient. This should not happen. Where departure from the guidelines can be justified in the interests of the patient, the doctor discharges his duty of care. Blind adherence to guidelines or protocols would itself be negligent.⁸² Bolitho requires that responsible practice be demonstrably logical and defensible. Guidelines will offer some evidence of what constitutes proper treatment for the patient’s condition. Evidence that the patient requires a different mode of care should not be excluded by the presence of such general guidance.⁸³ NICE itself put it thus:

(H)ealth professionals, when exercising their clinical judgment, should take its guidance fully into account, but … it does not override their responsibility for making appropriate decisions in the circumstances of the individual patient.⁸⁴

Diagnosis

7.12 A wrong diagnosis is by itself no evidence of negligence on the part of the doctor. As a Scottish judge said:

In the realm of diagnosis and treatment there is ample scope for a genuine difference of opinion and one man is clearly not negligent merely because his conclusion differs from that of other professional men.⁸⁵

A patient alleging that a wrong diagnosis was negligent must establish either that the doctor failed to carry out an examination or a test which the patient’s symptoms called for, or that his eventual conclusion⁸⁶ was one that no competent doctor would have arrived at (the Bolam test), or was not ‘capable of withstanding logical analysis’ (the Bolitho test).⁸⁷ Not surprisingly, a doctor who failed to diagnose a broken kneecap in a man who had fallen 12 ft onto a concrete floor was found to be negligent.⁸⁸

The courts are readier to find negligence when a patient and his experts can point to a specific failure on the part of the doctor. A casualty doctor, who failed to examine or X-ray a drunken patient admitted with the information that he had been seen under a moving lorry, was found to be negligent when after his death next day he was discovered to have eighteen fractured ribs and extensive damage to his lungs. It was no defence that the patient never complained of pain. The doctor should have known that alcohol would dull the patient’s reaction to pain.⁸⁹ The doctor must be alert to the patient’s background. A GP who failed to test for, and diagnose, malaria in a patient who had recently returned from East Africa was held liable for the patient’s death. The doctor was consulted nine days after the patient’s return to this country, a relative suggested malaria, but the doctor diagnosed flu. Six days later malaria was diagnosed in hospital, where the patient died that day.⁹⁰ Failure to diagnose diabetes where the symptoms complained of by the patient should have alerted the doctor to this possibility may lead to liability.⁹¹ Too hasty a diagnosis of hysteria or depression will often be negligent.⁹²

In all the above examples, the doctor was negligent because he failed to act on information available to him and/or to perform routine tests. Where a diagnostic procedure is not routine, is costly, or painful, or risky, an additional factor has to be considered. Do the symptoms displayed by the patient justify subjecting him to the procedure? The doctor faces a legal as well as a medical dilemma. If he does not arrange for the test and the patient does suffer from some condition which the test would have revealed, the doctor may be sued for that failure. If he does arrange the test and an inherent risk of the test harms the patient, the patient may sue if the test reveals that the doctor’s suspicions were groundless. We saw that that is what happened with Staff Nurse Maynard.⁹³ The defendants were not liable to her because they had followed accepted practice in going ahead with the test, despite its dangers. Doctors argue that alacrity to pin liability on them for every diagnostic error may cause patients to be submitted to more expensive and potentially risky procedures than may be strictly medically desirable.

Interpreting screening and diagnostic tests is a difficult skill, but failure to act on information that should have alerted the laboratory or the doctor to undertake further investigations may give rise to liability. So in Penney v East Kent Health Authority,⁹⁴ the claimants developed cervical cancer after an erroneous negative report from a screening test. The false negative result itself was no evidence of negligence. It was admitted that abnormalities were present on the patients’ slides and that any competent screener would thus have been unable to rule out that the cells were pre-cancerous. Reporting the tests as negative was therefore found by the Court of Appeal to be illogical. Although the defendants’ experts sought to argue that the screeners were not negligent in their interpretation of the slides as both set of experts agreed that the standard for a negative report was ‘absolute confidence’, a negative report in the face of admitted abnormalities failed the Bolitho test.⁹⁵

Treatment

7.13 A claim in respect of negligent treatment may be based on an allegation that the treatment chosen was inappropriate, or that while the treatment embarked on was correct, it was negligently carried out. Doctors must ensure that they act on adequate information and supply each other with adequate information. A GP prescribing drugs must check what other medication the patient is on. Doctors must be alert to common drug reactions and actively seek relevant information from patients. A clinic which injected a woman with penicillin was held liable for her death an hour later.⁹⁶ Had they inquired of her, or examined her records, they would have been aware of her allergy to penicillin. A GP arranging for the admission of a pregnant patient to hospital, while he was treating her for a septic finger, was found negligent in not so informing the hospital. She contracted septicaemia. Had the hospital known of the state of her finger, they would have put her on antibiotics straight away.⁹⁷ Doctors must be wary of relying entirely on information supplied by their colleagues. A patient was admitted for a gynaecological operation. The gynaecologist asked a general surgeon to remove what he said was a ganglion from the patient’s wrist. Thus the patient would be spared two separate operations. It was not a ganglion. Surgery of that sort was inappropriate and the patient’s hand was permanently paralysed. The Medical Defence Union (MDU) settled because the general surgeon should have made his own pre-operative assessment, and not relied on a colleague from another specialty.⁹⁸

Once the doctor is properly informed and has selected his course of treatment, he must ensure that he carries it out properly. He must check the dosage of any drug. Prescribing an overdose will readily be found to be negligent.⁹⁹ He must be sure that his handwriting is legible.¹⁰⁰ Care must also be taken always to read drug labelling properly. In a tragic case,¹⁰¹ a senior house officer misread a label and administered potassium chloride instead of saline to a newborn infant. The baby died.

Where surgery is called for, the risk of injury is increased. Especially risky is the administration of the anaesthetic. The anaesthetist will be found to be negligent if he failed to make a proper pre-operative assessment of the patient, failed to check his equipment, failed to monitor the patient’s blood pressure and/or heartbeat in the course of surgery or if, an inevitable accident having occurred, the anaesthetist fails to invoke adequate resuscitation measures. Some specific failure on the defendant’s part must be pinpointed. A disturbing number of claims arose from failure to intubate the patient properly (putting the tube in the wrong place) or attaching tubes to the wrong gas so that the patient fails to receive essential oxygen.¹⁰² Several claims have arisen from failure to anaesthetise the patient completely. Patients are paralysed and unable to communicate, but remain awake and feel pain throughout surgery.¹⁰³

An anaesthetic tragedy of itself is generally not evidence of negligence. An anaesthetist who injected cocaine instead of procaine was found negligent,¹⁰⁴ as was the junior doctor who injected pentothal into an anaesthetised patient, causing his death.¹⁰⁵ If the wrong drug, or the wrong dosage, or a contaminated drug, is used, the patient’s claim will generally be made good. The exception will be where the error cannot be laid at the anaesthetist’s door. So, as we saw in Roe v Ministry of Health,¹⁰⁶ a patient who was paralysed because a then unknown risk of phenol percolating into the ampoules of local anaesthetic materialised, recovered no compensation.

Surgery must be performed with the utmost care. One judge has suggested that the more skilled the surgeon, the higher the standard of care.¹⁰⁷ Some errors advertise their negligence. Leaving swabs and equipment inside the patient is a good example. And the surgeon must accept responsibility for such matters and not rely on nursing staff.¹⁰⁸ Nor does the surgeon’s responsibility end with the careful completion of surgery. He must give his patient proper post-operative care and advice. A surgeon performed a cosmetic operation just below the eye. He told his patient to inform him if bleeding occurred within forty-eight hours. It did and the patient tried to telephone the surgeon and got no reply. The surgeon was held to be negligent.¹⁰⁹

An especially important issue today concerns the need to protect patients against hospital-acquired (nosocomial) infections such as Methicillin Resistant Staphyloccus Aureus (MRSA) and Clostridium Difficile (C Diff). In a Scottish case, Miller v Greater Glasgow NHS Board,¹¹⁰ the defendants applied to strike out a claim by a patient who alleged that she had contracted MRSA because staff had not followed an adequate hand hygiene practice. The court refused the application holding that protection from hospital acquired infection was an integral part of the duty owed to patients by both individual professionals and the hospital trust.¹¹¹

Overtired, overworked doctors

7.14 If a doctor makes a mistake because she is intolerably weary, or just having a bad day, will the patient’s rights be in any way affected? No, the courts rightly will not accept any argument that the doctor’s duty is fulfilled if he provides an adequate service generally and only occasionally falls below the required standard of competence.¹¹² Judges sympathise with hard-pressed doctors. A doctor who carries on beyond the point when fatigue and overwork impair her judgement remains liable to an injured patient. The fact that the doctor was required by his employer to work such hours will not affect the patient.

The patient might, though, more appropriately proceed against the doctor’s employers, the hospital. He would allege that the hospital undertook to provide him with adequate care.¹¹³ Requiring their doctors to work to the point of utter exhaustion, or organising shifts in such a way as to prevent continuity of care, is a breach of that duty. The essence of the patient’s claim would become, not that the hospital was vicariously liable for an individual doctor’s negligence, but that there was a breach of a primary duty to ensure an adequate and competent service. In Wilsher v Essex Area Health Authority,¹¹⁴ Browne-Wilkinson VC suggested that in many cases this was a more appropriate analysis of clinical negligence claims, avoiding stigmatising overworked doctors for understandable errors. But there is a risk that even fewer patients may obtain compensation if this analysis were accepted. The defendant hospital might plead in its defence the problems it faces arising from lack of resources. If patient A suffers an injury because the surgeon who operated on him was too tired to perform the surgery properly and no other surgeon was available, the hospital may argue that it could not afford to employ more, or more senior, surgeons. It will be contended that, although far from ideal, the level of service was reasonable in the light of the defendants’ limited budget. In one judgment, a judge expressly said that lack of resources should be taken into account in medical negligence claims.¹¹⁵ But in a later case any such argument was vigorously rejected.¹¹⁶ And it has been made clear that any argument that the conditions of work and need to balance the claims of competing patients for urgent care affects the standard of care owed by the hospital must at the least be supported by cogent evidence. The defendant cannot simply ask the court to assume that an accident and emergency department is so busy that account must be taken of the unusual level of demand.¹¹⁷

Relating the injury to medical negligence: problems of causation¹¹⁸

7.15 So far, the majority of the cases examined involved something going wrong as a result of a medical mistake. The patient’s problem has been to prove that what was done, or not done, amounted to actionable negligence. Proving negligence by the doctor does not conclude the case in the patient’s favour. He must also show that his injury, his worsened or unimproved condition, was caused by the doctor’s negligence. He must prove causation. In practice, proving causation is often the most problematic aspect of a patient’s claim. The difficulties of causation in medical malpractice cases fall into two main categories. (1) Can the patient convince the court that it was the relevant negligence which caused his injury, rather than the progress of his original disease or condition? (2) How should the courts proceed when the essence of a claim is, not that clinical negligence caused any fresh or additional injury to the patient, but that that negligence deprived him of a chance of full recovery from his original disease or condition? In each and every case the patient must advance evidence showing that it is more likely than not that the defendant’s negligence caused the injury of which he complains.

In Kay v Ayrshire and Arran Health Board,¹¹⁹ a 2-year-old boy, Andrew Kay, was suffering from pneumococcal meningitis. He was negligently given a massive overdose of penicillin and nearly died as a result. Intensive efforts by hospital staff saved Andrew’s life and he recovered from both the toxic overdose and from meningitis. But he was found to be profoundly deaf. His parents, on his behalf, sued the Scottish health board responsible for the hospital where Andrew had been treated. The board admitted negligence, but denied that Andrew’s deafness resulted from that negligence. Deafness is often a complication of meningitis even where the disease has been correctly treated. Massive overdoses of the sort that Andrew was given are mercifully rare. So there was little available evidence of whether such an overdose materially increased the risk that Andrew would become deaf as a result of his disease. The trial judge found in Andrew’s favour, but his decision was overruled in the appeal courts. In the House of Lords, Lord Keith commented that the lack of recorded cases demonstrating the effect of overdose of penicillin ‘cannot in itself make good the lack of appropriate evidence’.¹²⁰

As we have seen, in Wilsher v Essex Area Health Authority¹²¹ junior doctors were found to be negligent in administering excess oxygen to a very premature baby, Martin Wilsher. Martin succumbed to retrolental fibroplasia (RLF), an incurable condition of the retina causing gradual blindness. The question that went to the House of Lords was whether Martin’s lawyers could prove that RLF resulted from that negligent administration of excess oxygen. The scientific evidence suggested that RLF may result from excess oxygen, but there were five other possible causes of RLF in very sick, very premature infants.

The trial judge had held that, as negligence had been proved, the burden of disproving that that negligence caused Martin’s injuries, moved to the defendants. He said that as the evidence showed that the doctors were in breach of their duty to Martin and failed to take a precaution expressly designed to safeguard Martin from RLF, it was then up to them to prove that Martin’s condition resulted from one of the other possible causes. The House of Lords roundly condemned such an approach, and ordered a retrial. The burden of proving causation rests on the claimant alone, and does not move to the defendant even though negligence has been proved or admitted. What is crucial for the claimant is the quality of the expert scientific evidence presented on his behalf. That evidence must, at the very least, demonstrate that it is more likely than not that the defendant’s negligence materially contributed to the claimant’s condition, or materially increased the risk that the claimant would succumb to such a condition.¹²² Where the scientific evidence is ambivalent or suggests a variety of competing causes for the claimant’s state, the action for negligence will normally fail.

Uncertainty about causation is likely to be common in many claims that essentially relate to whether the defendant’s negligence caused or exacerbated disease. In Fairchild v Glenhaven Funeral Services Ltd,¹²³ claims were brought by workers who had been exposed to asbestos dust or fibres during their working lives and developed the fatal lung disease mesothelioma. The men had worked for several different employers, so pinpointing which defendant employer was responsible for the onset of the disease was nigh on impossible. Mesothelioma can result from a single asbestos fibre entering the lung. The greater your exposure to asbestos fibres, the more likely it is that this will occur. The Law Lords allowed the claim, holding all the defendant employers liable, as each of them had materially increased the risk of harm to their employees. The judges overtly invoked policy considerations to support their modified approach to, and departure from, the usual strict rules of causation.¹²⁴ Might the harsh decision in Wilsher thus be reconsidered? It seems unlikely. Lord Hoffmann not only declares Wilsher to be correctly decided in principle, but also suggests that policy reasons to protect NHS budgets could play a part in denying patient-claimants a more favourable approach to causation. He says:

The political and economic arguments involved in the massive increase in the liability of the National Health Service which would have been a consequence of the broad rule favoured by the Court of Appeal in Wilsher’s case are far more complicated than the reasons … for imposing liability upon an employer who has failed to take simple precautions.¹²⁵

However, in Bailey v Ministry of Defence¹²⁶ the Court of Appeal held that in particular circumstances and in relation to cumulative causes a ‘material contribution’ to the claimant’s injury was sufficient to establish causation in a clinical negligence claim. In such cases the ‘but for’ test could be modified. The claimant was a patient at a hospital managed by the Ministry of Defence. She underwent an unsuccessful procedure to remove a gallstone. The defendants admitted that following the procedure her post-operative care was inadequate, in particular a failure to resuscitate. She became progressively more ill, she was subjected to a battery of major medical interventions, and was also diagnosed as suffering from pancreatitis. Her condition deteriorated and she was eventually transferred to the renal unit of an NHS hospital where she aspirated her vomit and suffered a cardiac arrest resulting in brain damage. The issue in dispute was whether the negligent post-operative care caused the cardiac arrest and consequential brain damage. The claimant could not establish that ‘but for’ that negligence she would not have suffered the arrest. She was a very sick woman and her pancreatitis also contributed to her weakness. The trial judge found that the post-operative negligence contributed to her weakened state and that, but for her weakened state, she would have undergone a further intervention that would have alleviated her condition and spared her some of the later traumatic interventions to which she was subjected. The negligent care thus made a material contribution to her injury. The Court of Appeal upheld his finding. It was sufficient to show that the contribution made by inadequate care was more than negligible. Waller LJ said:

In a case where medical science cannot establish the probability that ‘but for’ an act of negligence the injury would not have happened but can establish that the contribution of the negligence was more than negligible, the ‘but for’ test is modified, and the claimant will succeed.¹²⁷

No distinction was to be drawn between clinical negligence claims and others. Wilsher was distinguished on the grounds that it was never established that the excess oxygen, rather than one of the five alternative causes, caused or contributed to the plaintiff developing RLF. Unlike Ms Bailey, Martin Wilsher could not meet the first condition of showing some causal link between the relevant negligence and his injury.

Modifying the ‘strict rules’

7.16 In Chester v Afshar,¹²⁸ an earlier patient-claimant also benefited from judicial willingness to modify strict application of the rules of causation. As we have seen, Mr Afshar failed to warn Miss Chester of the 1–2 per cent risk of nerve damage in the course of spinal surgery. Miss Chester did not contend that, had she been properly warned, she would never have consented to surgery, or that she would have sought a second opinion. All she claimed was that, had she been warned, she would not have gone ahead with surgery that day. The risk of damage on any later occasion would have been just the same. Miss Chester faced the utmost difficulty in proving that, but for Mr Afshar’s negligence, she would have avoided injury. The majority (3:2) in the House of Lords invoked policy grounds to assist her. Giving proper legal force to patients’ rights to autonomy and dignity justified ‘a narrow and modest departure from traditional causation principles’.¹²⁹

Bolitho v City & Hackney Health Authority¹³⁰ raised a rather different question of causation. You will recall that Patrick Bolitho stopped breathing and suffered a cardiac arrest resulting in serious brain damage. The hospital admitted negligence in relation to the failure of the paediatric registrar to attend Patrick when she had been summoned to do so earlier. They denied liability because, they said, the registrar would not have intubated Patrick, had she attended him prior to his collapse. Intubation was the only means by which Patrick’s respiratory failure and cardiac arrest might have been averted. The plaintiffs argued that, had Patrick been intubated, he would not have suffered injury. The defendants responded that attendance would have made no difference; medical opinion would support not intubating the child. The key question became does the Bolam test play a role in causation?

Lord Browne-Wilkinson agreed with counsel for the plaintiff that ‘in the generality of cases’ Bolam plays no role in causation. Bolitho exemplifies an unusual problem. How do the courts address causation when the essence of the matter is whether something should have been done which has not been done? The factual inquiry proceeds into the ‘realms of hypotheses’.¹³¹ The court has to ask:¹³²

(1)  What would the defendant have done if she had attended the boy? This is a purely factual question to which Bolam has no relevance.

(2)  If the answer to that first question is that she would not have intubated, would that have been negligent?

In addressing that question, Bolam is central. The court had to decide if non-intubation conformed to responsible professional practice, applying their Lordships’ caveat that responsible practice must be demonstrated to be ‘logical and defensible’. In the event, the evidence of the defendants’ experts that intubation of a child of Patrick’s age in his circumstances was itself far from risk-free, convinced their Lordships.

Loss of a chance

7.17 When the unfortunate claimant complains not of some new injury inflicted by the defendants, but of a lost chance of recovery, his claim is even more difficult to prove. In Hotson v East Berkshire Health Authority,¹³³ the plaintiff, a schoolboy of 13, fell heavily, from a rope on which he had been swinging, to the ground 12 ft below. He was taken to hospital. His knee was X-rayed and revealed no injury. No further examination was made and the plaintiff was sent home. Five days later, the boy was taken back to the same hospital and an injury to his hip joint was diagnosed and subsequently swiftly and correctly treated. The injury had traumatic consequences. The boy suffered a condition known as avascular necrosis. This condition, caused by a restriction of the blood supply in the region of the original injury, leads to misshapenness of the joint, disability and pain, and later in life almost certainly brings on osteoarthritis in the joint. The plaintiff’s disability might have ensued from the accident in any case. But there was a 25 per cent chance that given the correct treatment immediately the plaintiff might have avoided disability and made a nearly full recovery.

The defendant hospital admitted negligence in failing to diagnose and treat the plaintiff’s injury on his first visit. Both parties agreed that prompt treatment would have offered a 25 per cent chance of avoiding permanent disability. The trial judge awarded the boy 25 per cent of full compensation for his condition: a sum of money to compensate him for a 25 per cent lost chance of full recovery.¹³⁴ The House of Lords quashed his judgment.¹³⁵ Their Lordships held that the plaintiff had failed to prove that it was more likely than not that avascular necrosis resulted from the negligent delay in treatment, because there was a 75 per cent chance he would have suffered from avascular necrosis, even if the treatment had been given promptly. To recover damages for the avascular necrosis, the plaintiff needed to establish at least a 51:49 likelihood that ‘but for’ the negligent delay in treatment, he would have made an uncomplicated recovery from his original injury. Had he succeeded in so doing, he would have been entitled to 100 per cent compensation for his disability. Their Lordships declined to say that loss of a less than 50 per cent chance of full recovery was never recoverable in a medical negligence claim. They left that question open.

The claimant in Gregg v Scott¹³⁶ may have hoped that his case for loss of a chance was stronger. In November 1994, his GP (the defendant) wrongly diagnosed a lump under Mr Gregg’s arm as a benign lipoma. The following August, a different doctor referred him to a consultant, and, in November 1995, a biopsy revealed a malignant lymphoma. The delay in diagnosis reduced Mr Gregg’s chance of a ‘cure’ (defined as ten years in remission) from 42 to 25 per cent. Mr Gregg (unlike the young plaintiff in Hotson) could therefore argue that, as a consequence of the defendant’ negligence, he had lost a 17 per cent chance of a ‘cure’. But, alas, he could not establish that had the defendant done his job properly, he would have had a better than 50 per cent chance of a ‘cure’. He was still more likely than not to face an early death even had his cancer been more promptly diagnosed. The majority of the House of Lords (3:2) applied the rules in causation strictly and found against Mr Gregg. Lord Hoffmann declared:

[A] wholesale adoption of possible rather than probable causation as the criterion of liability would be so radical a change in our law as to amount to a legislative act. It would have enormous consequences for insurance companies and the National Health Service.¹³⁷

One of the dissenting judges, Lord Nicholls retorted:

It cannot be right to adopt a procedure having the effect that, in law, a patient’s prospects of recovery are treated as non-existent whenever they exist but fall short of 50 per cent. If the law were to proceed in this way it would deserve to be likened to the proverbial ass.¹³⁸

How may Gregg v Scott be distinguished from Chester v Afshar and Fairchild? Baroness Hale seeks to contend that the latter two decisions were confined to ‘problems which could be remedied without altering the principles applicable to the great majority of personal injury cases which give rise to no real injustice or particular problems’.¹³⁹ Their Lordships seem deeply divided on causation. Sarah Green argues cogently that distinguishing Chester and Gregg on grounds of principle cannot be done. Both are hard cases. In her view, it is Chester that made bad law.¹⁴⁰ In Wright v Cambridge Medical Group¹⁴¹ the Court of Appeal suggested that while the decision in Gregg does not rule out all variations of a loss of chance claim, only the Supreme Court could realistically expand case law on loss of a chance in the context of clinical negligence claims.

General practice

7.18 Most patients visit their GP on average four or five times a year and make one or two hospital visits in a lifetime. While clinical negligence claims against GPs are becoming more common, they are still rare when compared to the number of claims against NHS surgeons and obstetricians. From 1995 to 2015, 42,381 claims were brought against surgeons, 19,918 against obstetricians and just 550 against GPs.¹⁴² Changes in general practice which alter the more personal relationship between GP and patient may increase the GP’s vulnerability to claims for clinical negligence. A claim against a GP may face some particular obstacles. Many common complaints about general practice do not tend to be the kind of grievances that make litigation with its expense, pomp and ceremony worthwhile. Patients object to unhelpful receptionists, difficulty in getting home visits, and often simply sense a lack of sympathy. Rarely do these irritations cause injury serious enough to merit litigation.

Proving negligence, and that the patient’s injury resulted from that negligence, is always difficult. Against a GP the problems multiply. How do you prove that a child’s sudden deterioration resulted from the GP not seeing the child swiftly? Would immediate referral to hospital have arrested the condition? In Wright v Cambridge Medical Group¹⁴³ a two-day delay by GPs in referring a baby with a serious bacterial infection back to hospital resulted in permanent damage to the infant’s hip, affecting her gait and mobility. Further delays in initiating correct treatment in the hospital contributed to the permanent damage to the hip joint. The hospital was not made a party to the proceedings. The trial judge held that the defendant GP practice was negligent in delaying referral, but that even if the child had been promptly referred to the hospital, it was more likely than not that she would not have been treated properly and would still have suffered the damage to her hip. Thus the GP practice while negligent did not cause the permanent injury of which the infant claimant complained. The Court of Appeal reversed the decision. The subsequent negligence of the hospital was not so significant as to destroy any causative contribution to the child’s injury on the part of the GP.¹⁴⁴ Nor was the judge right to assume that had she been referred to hospital in a timely manner, the hospital would not have treated her properly. The GP practice as a joint tortfeasor remained liable for the whole of the damage suffered by the claimant, albeit that had the hospital been joined in the proceedings, the practice would have been able to claim a contribution to the damages from the hospital and it was likely that a court would hold that the hospital should bear a greater share of the blame and thus pay a greater share of the damages awarded. Stripping out the complexity of the case, what is clear is that GPs who are negligent in referring a patient to hospital in due time, cannot argue that subsequent failures on the part of the hospital wipes out any liability on their part. They deprive the claimant of the opportunity to receive adequate treatment.

Every GP must attain that standard of skill and competence to be expected of the reasonably skilled and experienced GP. It is no defence that she has just entered practice, or that she is elderly and infirm. Nor, as we have seen, can he be expected to have the skills or qualifications of a consultant specialist. He must exercise his judgement about when to refer a patient to a specialist, or admit him to hospital, with due care.¹⁴⁵ Should a GP offer additional services to his patients, for example, if he is on the obstetric list and is prepared to attend home confinements, then he must show the skill that he holds himself out as possessing. He must attain the standard, not of the consultant obstetrician, but of the specially qualified and experienced GP.

In reported cases where negligence has been proved against GPs, certain danger areas stand out. The maintenance of proper records and ensuring adequate communication with patients,¹⁴⁶ and with hospitals and other doctors sharing the care of a patient is one. A failure to record and pass on to a hospital, information on a patient’s allergy to certain drugs, is a clear case of negligence.¹⁴⁷ Similarly, a failure to check exactly what treatment has been given by the hospital may result in liability. A GP was found liable for a young man’s death in this case.¹⁴⁸ The man had gone to a cottage hospital after a lump of coal had fallen on him and crushed his finger. A nurse dressed the wound and instructed him to go to another larger hospital. Either because this was not properly explained to him or because he was in shock he did not go. He went later to his own doctor, who did not inquire as to his earlier treatment and simply put on a new dressing. At no stage did the patient receive an anti-tetanus injection and he died of toxaemia. The cottage hospital and the GP were both found to be negligent and responsible for the youth’s death. The judge made his views emphatically clear:

the National Health Service had been developed on the basis that a patient might well be transferred for treatment from one person to another so that the responsibility for the patient shifted … Any system which failed to provide for effective communication was wrong and negligently wrong.

Prescription errors

7.19 Prescribing medicines is another area where GPs must be ultra-cautious, not just out of professional concern for the patient, but also in order to safeguard themselves. In 1982, a GP prescribed Migril for a Mrs Dwyer. Carelessly he wrote out a prescription for a massive overdose of the drug. A pharmacist dispensed the drug as prescribed. Mrs Dwyer became ill. A partner in the same practice attended her at home. The Migril was on a table in her bedroom, but the second doctor did not notice the bottle. Mrs Dwyer suffered gangrene as a result of the overdose. She sued both doctors and the pharmacist. All were originally found liable.¹⁴⁹ Mrs Dwyer received £100,000 in damages. Eventually the second doctor was exculpated on appeal. At the end of the day, the GP whose slip caused the over-prescription paid 45 per cent of the damages, and the pharmacists 55 per cent. In Prendergast v Sam and Dee Ltd,¹⁵⁰ a general practitioner prescribed Amoxil, a common antibiotic, for the plaintiff who was suffering from a chest infection. The doctor’s handwriting was so atrocious that the pharmacist read the prescription as an instruction to dispense Daonil, an anti-diabetic drug. The plaintiff succumbed to hypoglycaemia and brain damage. The Court of Appeal upheld Auld J’s finding that both the doctor and the pharmacist were negligent. The doctor was liable because he should have foreseen that his careless writing of the prescription might mislead the pharmacist into a dangerous error. The pharmacist was liable because the dosage prescribed and other indications on the prescription should have alerted him to the fact that the doctor did not intend to prescribe Daonil. Both judgments operate as timely warnings against sloppy practice. Doctors must exercise great care in writing out prescriptions. Pharmacists must exercise even greater care in checking on the doctors.

Contributory negligence¹⁵¹

7.20 The Law Reform (Contributory Negligence) Act 1945 provides where a claimant suffers injury partly as a result of his own fault his damages may be reduced to take account of his own responsibility for the damage. How might such a defence apply in a clinical negligence claim? Such a case might arise if a doctor negligently prescribed a moderate overdose of a drug and the claimant exacerbated the injury from the drug by taking twice what the doctor prescribed, or drinking alcohol when he had been correctly instructed to abstain. In one reported case the claimant was wrongly told that her cervical smear test was negative but then over several years failed to attend for further tests which would have identified the cancer more swiftly. She was judged to be two-thirds responsible for her injury.¹⁵² But what of patients whose abuse of drink or drugs, or grossly unhealthy lifestyle, made them need treatment in the first place? So that if they had not neglected their own health they would never have needed treatment and not been at risk of inadequate treatment?

Trevor Horsley was not injured by medical treatment, but by his employers’ negligence in exposing him to asbestos. He was found to have contributed to his respiratory disability by having smoked heavily for thirty-five years, having received multiple warnings of the adverse effects it was having on his health.¹⁵³ Compare this case with St George v Home Office,¹⁵⁴ where the claimant was addicted to drink and drugs. On admission to prison he refused to see a doctor and was assigned to a ward in the hospital wing. He was allocated a top bunk and fell out of the bunk when he suffered a withdrawal seizure. He continued to fit for some time developing a highly dangerous status epilepticus (status). He was transferred to an NHS hospital. As a result of his seizures he suffered permanent brain damage. The judge found that the fall triggered status, the cause of his brain damage. The defendants argued that the claimant’s substance abuse contributed to his injury and damages should be proportionately reduced. Noting that this was a case on which there was no direct previous authority the Court of Appeal agreed that the claimant was at fault. But both the judge and the appeal court held that the claimant’s conduct in becoming an addict in his teens was too remote from the events in the prison that led to his fall and withdrawal seizures. It could not be said to be a cause of his negligent treatment by prison hospital staff. Counsel for the defendants had conceded that within the NHS a patient’s smoking or drinking could not be invoked to hold him contributorily negligent if he suffered injury in the course of treatment related to those conditions. And it would be an odd result if doctors treating, say, smokers, could argue that their responsibility was less because the patient should never have needed their services. However, if a patient were to develop an illness as a result of medical negligence which is unrelated to the treatment – for example a patient with kidney disease is negligently given an overdose which damages his heart – and the injury is indivisible from that caused by, for example, poor weight management which the patient has been warned to address to avoid damage to his heart, it is possible that the claimant might be viewed contributorily negligent.

Private patients

7.21 A patient who pays for treatment enters into a contract with his doctor. They are free to set the terms of that contract, save that the doctor cannot exempt himself from liability for any injury to his patient arising from his negligence.¹⁵⁵ There is rarely a written contract between them. The terms will be implied from their relationship. This usually means that the doctor undertakes a duty of care to the patient. His duty of care to his private patient is usually indistinguishable from his duty in tort to his NHS patient.¹⁵⁶ The possibility remains of doctors agreeing to undertake a higher standard of care.

In private practice, could a doctor be found to have contracted to guarantee the desired result of treatment? This can never happen in the NHS. The doctor can only be liable in tort for a failure in care. Only rarely will a private doctor be found to have guaranteed a result in contract.¹⁵⁷ Where a patient is ill and seeks a cure, unless the doctor foolishly and expressly promises success in his treatment, no court will infer any term other than that the doctor will exercise skill and care. And, so far, claims by patients who have undergone private sterilisation have ultimately failed in attempts to argue that the surgeon guaranteed permanent sterility.¹⁵⁸

Criminal liability

7.22 Negligence is normally a matter for the civil, not the criminal, law. However gross or culpable an act of negligence may be, negligence will not generally be a criminal offence in England, unless made so by an Act of Parliament, as in the case of careless driving. The picture changes if the victim dies. Gross negligence causing death can lead to a conviction for gross negligence manslaughter (GNM). Much more than ordinary negligence, of the sort which would found a civil action for negligence, must be proved. In older cases, the negligence will be seen to derive from morally disgraceful conduct – a doctor operating while drunk or under the influence of drugs. In R v Bateman,¹⁵⁹ the Court of Appeal overruled a conviction for manslaughter of a doctor whose ignorance and failure to send a woman to hospital resulted in his patient’s death. The judge at the trial had failed to direct the jury properly. Criminal liability required more than the degree of negligence needed to establish civil liability. The doctor must be proved to have shown ‘such disregard for the life and safety of others as to amount to a crime against the State and conduct deserving of punishment’. The language of disregard of the life and safety of the patient might suggest that only recklessness on the part of the doctor would engage liability for GNM. Not so – the Court of Appeal and the House of Lords have made it clear that the test of gross negligence is objective.

In R v Prentice, R v Adomako and R v Holloway,¹⁶⁰ the Court of Appeal considered two¹⁶¹ appeals by doctors against conviction for manslaughter. In the first case, two junior doctors, Drs Prentice and Sulman were convicted of manslaughter after they had wrongly injected a potent chemotherapeutic drug (vincristine) into the patient’s spine, when it should have been administered intravenously. Their 16-year-old patient was suffering from leukaemia. Every month he received an intravenous injection of vincristine. Every other month he received a spinal injection of another powerful drug, methotextrate. The drug came down to the ward on the same trolley. Neither Dr Prentice nor Dr Sulman had ever administered such drugs before, and they were left unsupervised.

The second case involved a Dr Adomako. He was an anaesthetist. During surgery to reattach a detached retina, Dr Adomako failed to notice, for over four minutes, that the tube administering oxygen to his patient had become disconnected. He neither noted the evidence before his eyes that the tube was no longer in place, nor did he respond to the alarm raised by the operating theatre’s monitoring system. One prosecution expert described his standard of care as abysmal. The appeal court quashed the convictions of Drs Prentice and Sulman, but upheld Dr Adomako’s conviction.

The Court of Appeal set the following test for gross negligence manslaughter:

(1)  Did the doctor show obvious indifference to the risk of injury to his patient?

(2)  Was he aware of the risk but nonetheless (for no good reason) decided to run the risk?

(3)  Was an attempt to avoid a known risk so grossly negligent to deserve punishment?

(4)  Was there a degree of inattention or failure to have regard to risk, going beyond mere inadvertence?

Only if at least one of these questions could be answered affirmatively should a doctor be convicted of manslaughter. In the case of Dr Prentice and Dr Sulman, there was insufficient evidence of gross negligence deserving punishment. Dr Adomako, the Court of Appeal declared failed to perform:

his essential and in effect sole duty to see that his patient was breathing satisfactorily and to cope with the breathing emergency … his failure was more than mere inadvertence and constituted gross negligence of the degree necessary for manslaughter.

Dr Adomako appealed to the House of Lords without success. His conviction was upheld.¹⁶² The Law Lords offered no precise definition of ‘medical manslaughter’. Lord Mackay endorsed the trial judge’s warning to the jury:

You should only convict a doctor of causing death by negligence if you think he did something which no reasonably skilled doctor would have done.¹⁶³

The lack of clarity about what degree of negligence constitutes ‘gross’ medical negligence was challenged in the Court of Appeal in R v Misra and Srivistava.¹⁶⁴ Drs Misra and Srivistava were convicted of manslaughter after a patient died because of a failure to treat a post-operative infection. The evidence established that, over a period of forty-eight hours, the doctors failed to act on information that their patient was critically ill. They did not chase up blood tests, and ignored warnings from nurses and another doctor. Part of the grounds for their appeal was that the ill-defined boundaries of gross negligence manslaughter contravened Article 7 of the Human Rights Convention. Article 7 requires that criminal offences must be defined in clear enough terms so that people are aware what constitutes criminal conduct. The appeal failed.¹⁶⁵ The Court of Appeal said that to be convicted of gross negligence manslaughter, the doctor must have failed to avert a risk of death. Other risks of lesser harm were not sufficient. Once a risk of death was established, it was for the jury to determine if the relevant negligence was gross. The citizen seeking to understand his potential criminal liability should be advised that, if he negligently breaches a duty of care, so as to endanger life, he may be convicted of manslaughter if a jury is satisfied that his negligence is gross. The appeal court judges acknowledged an element of circularity in their own arguments. The definition of what constitutes gross negligence remains vague and vulnerable to the subjective interpretations of juries.

Doctors are unsurprisingly concerned about the prospect of criminal charges arising out of a professional error. They fear that the Crown Prosecution Service (CPS) is too ready to prosecute doctors; a fear re-enforced by Ferner and McDowell who reported rising rates of prosecution and suggested that the CPS saw prosecuting doctors for GNM as ‘an emotionally satisfying way of exacting retribution’.¹⁶⁶ A study by Griffiths and Sanders, which surveyed CPS files from 2004 to 2009, took a very different view. There was, they found, no evidence of a rise in the number of prosecutions, rather the contrary might be the case and the CPS were too reluctant to prosecute ‘without – to put it crudely – evidence of “badness” on the part of the suspect’.¹⁶⁷ But Griffiths and Sanders also report an increase in police investigations and inquests into medical deaths.¹⁶⁸

When should doctors face criminal prosecution?¹⁶⁹ The increasingly common demand that doctors be punished for tragic mistakes causes anxiety within the profession. Some argue that only if there is evidence of indifference or total disregard for the patient’s welfare should a doctor face criminal liability.¹⁷⁰ The civil law should compensate victims of mistakes. Incompetent doctors should be dealt with by the General Medical Council (GMC). Patients may lack trust in the GMC and perceive monetary compensation which comes from the NHS, not the doctor’s pocket, as inadequate redress for the death of a relative. Doctors are not the only workers who risk prosecution for negligence doing their job. Train drivers and electricians, for example, meet the same fate.¹⁷¹ In 2003, a teacher was jailed when his inadequate supervision of a school trip led to a child’s death by drowning.¹⁷² In all these cases, the crux of the difficulty is to determine when a fatal mistake is so bad that an otherwise law-abiding citizen deserves to be branded a criminal.

In considering the role of the criminal law in relation to medical error, it is important to reflect on the proper functions of the criminal law and its impact on doctors. If deterrence should be the primary concern, then we would need to be convinced that prosecuting doctor reduces levels of error. Or is there a risk that, fearing criminal liability, doctors might be less willing to acknowledge error?¹⁷³ Merry and McCall Smith argue cogently that preventing error is preferable to retrospective punishment and that more thought needs to be given to learning from error, and the impact of blame.¹⁷⁴

One final point should be noted. While the evidence that doctors are more likely to face criminal charges for GNM is thin, and there is no evidence that the threshold for prosecution has been lowered, a doctor convicted of GNM is today more likely to face jail, rather than a suspended sentence as a result of change in the general law relating to sentencing. Section 143(1) of the Criminal Justice Act 2003 expressly directs judges to take account of the harm caused as well as the culpability of the defendant.¹⁷⁵

Wilful neglect

7.23 One of the longstanding anomalies of the operation of the criminal law in relation to medical malpractice was that a doctor or nurse normally only faced criminal liability if the patient died. A doctor who was reckless as to his patient’s welfare and caused serious injury short of death normally faced no risk of criminal redress. You may have read reports of investigations¹⁷⁶ into appalling care at some hospitals recounting how patients were left to lie in filthy beds, dressings were not changed and patients not fed. The conduct of some staff would appear to be more morally culpable than that of some doctors convicted of manslaughter. Under the Mental Health¹⁷⁷ and Mental Capacity Acts¹⁷⁸ wilful neglect of a mentally ill or mentally incapacitated patient has long been a crime. Sections 20–25 of the Criminal Justice and Courts Act 2015 extends the offence of ill treatment or wilful neglect to cover such conduct by all paid care workers, which includes doctors and nurses. Care providers too are made subject to the Act. The offence, unlike GNM, focuses on the culpability of the health professional’s conduct not on the chance of outcome.¹⁷⁹

Corporate manslaughter

7.24 Finally, how far should responsibility for a dreadful medical mistake focus on institutions rather than individuals? Careful reading of virtually all the cases of accusations of medical manslaughter reveal a series of errors, many committed by people other than the doctors in the dock and compounded by inadequate systems to minimise opportunities for errors.¹⁸⁰ One response to such systems errors may be that health and safety legislation will be invoked more often.¹⁸¹ But if a patient has died, could a trust be prosecuted for manslaughter? In R v Prentice, the two young doctors should have been supervised. The packaging of the two drugs should have given much clearer warnings about the consequences of wrongly administering vincristine. Should the hospital, rather than the doctor have been on trial for corporate manslaughter?¹⁸² Some of the difficulties in bringing such a prosecution may be eased by the Corporate Manslaughter and Homicide Act 2007. Section 1 of that Act provides that an NHS trust may face prosecution for corporate manslaughter if a patient dies as a result of a gross breach of a duty of care owed to the deceased, and ‘the way in which its activities are managed or organised by its senior management is a substantial element in the breach’. Section 8 outlines some of factors that should be taken into account by the jury in determining whether a breach of duty was gross. The jury must consider whether the evidence shows that the trust failed to comply with health and safety legislation. The jury may consider compliance with health and safety guidance and take into account ‘attitudes, policies, systems or accepted practices’ that were likely to have encouraged non-compliance with health and safety legislation. A trust convicted under the Act faces an unlimited fine, may be ordered to remedy the relevant breach and/or be subjected to a publicity order.¹⁸³ Any prosecution requires the consent of the DPP. It will not be a panacea for all ills. Individual doctors may still face prosecution and a study of the cases shows that there may often be more than one organisation whose poor management contributes to a patient’s death.¹⁸⁴ In 2015 owners of a care home in Nottingham pleaded guilty to corporate manslaughter for failing to provide food and drink to an elderly resident who died in 2012.

¹⁸⁵

¹  See generally, MA Jones, Medical Negligence (4th edn, 2008) Sweet & Maxwell; A Buchan Lewis and Buchan: Clinical Negligence – A Practical Guide (7th edn, 2012) Tottel.

²  Barnett v Chelsea and Kensington Hospital Management Committee [1969] 1 QB 428. And see Davies v Countess of Chester Hospital [2014] EWHC 4294 (QB).

³  See Lord Woolf, ‘Are the Courts Excessively Deferential to the Medical Profession?’ (2001) 9 Medical Law Review 1.

⁴  Though she may be in breach of her professional code of conduct and face professional disciplinary proceedings; see GMC, Good Medical Practice (2013), para 26.

⁵  Barnett v Chelsea and Kensington Hospital Management Committee [1969] 1 QB 428.

⁶  [2000] 2 All ER 74, CA; and see Taaffe v East of England Ambulance Service NHS Trust [2012] EWHC 1335 (QB). See K Williams, ‘Litigation against NHS Ambulance Services and the Rule in Kent v Griffiths’ (2007) 15(2) Medical Law Review 153.

⁷  See, for example, Capital & Counties plc v Hampshire County Council [1997] QB 1004, CA; and, more recently, Michael and others v The Chief Constable of South Wales Police and another [2015] UKSC 2.

⁸  See 1.3.

⁹  National Health Service Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) Regulations 2012, SI 2012/2996, Part 9, s 45(2) (as amended by SI 2015/1430). And see M Brazier, J Beswick, ‘Who’s Caring for Me?’ (2006) 7 Medical Law International 183. But see also at 8.6.

¹⁰  As long as the claimant can prove that the mental illness is related to the defendant’s breach of duty; see Oliver v Williams [2013] EWHC 600 (QB); P Case, ‘Secondary Iatrogenic Harm: Claims for Psychiatric Damage Following a Death Caused by Medical Error’ (2004) 67 Modern Law Review 501.

¹¹  (2001) 57 BMLR 158; and see North Glamorgan NHS Trust v Walters [2002] EWCA Civ 1792.

¹²  Alcock v Chief Constable of South Yorkshire [1991] 4 All ER 907, HL.

¹³  See Sion v Hampstead Health Authority (1994) 5 Med LR 170, CA.

¹⁴  Though consider Wild v Southend University Hospital NHS Trust [2014] EWHC 4053. A father was not able to recover for the psychiatric harm he suffered on discovering that his child had died in utero as a result of the trust’s negligent antenatal care.

¹⁵  Though see Taylor v Somerset Health Authority (1993) 16 BMLR 63.

¹⁶  For an exceptionally generous interpretation of what may constitute trauma and shock of witnessing injury to a wife, see Frogatt v Chesterfield and North Derbyshire Royal Hospital NHS Trust [2002] All ER (D) 218. Contrast this with the much harsher interpretation of the ‘control mechanisms’ in Shorter v Surrey & Sussex NHS Healthcare Trust [2015] EWHC 614 (QB).

¹⁷  See DM Kloss, ‘Pre-Employment Health Screening’ in M Freeman, A Lewis (eds), Law and Medicine: Current Legal Issues (2000) Oxford University Press, vol 3.

¹⁸  Baker v Kaye (1996) 39 BMLR 12.

¹⁹  Kapfunde v Abbey National plc (1998) 46 BMLR 176, CA.

²⁰  For discussion of other circumstances where a medical examination is carried out on the instructions of a third party, see E Jackson, Medical Law: Text, Cases and Materials (3rd edn, 2013) Oxford University Press, pp 104–112.

²¹  See for example Webley v St George’s NHS Trust and the Metropolitan Police [2014] EWHC 299 (QB) where the police and hospital to prevent a patient with mental disorder suffering serious injury. And see at 2.7 on claims under Article 2 of the European Convention on Human Rights.

²²  See 4.16.

²³  Palmer v Tees Health Authority [1998] 45 BMLR 88 (CA).

²⁴  [2012] EWCA Civ 979.

²⁵  But see Buck v Norfolk and Waveney Mental Health NHS Foundation Trust [2012] Med LR 266.

²⁶  [2013] EWHC 600 (QB).

²⁷  Phillips v William Whiteley Ltd [1938] 1 All ER 566.

²⁸  See Uren v Corporate Leisure and Others [2010] All ER (D) 132 (Jan).

²⁹  [1957] 1 WLR 582, at 586.

³⁰  Maynard v West Midlands Regional Health Authority [1984] 1 WLR 634, at 638, HL.

³¹  Wright (A Child) v Cambridge Medical Group [2011] EWCA Civ 669.

³²  [2014] EWCA Civ 120.

³³  Nettleship v Weston [1971] 2 QB 691, CA.

³⁴  [1986] 3 All ER 801, CA.

³⁵  [1988] 1 All ER 891; see 7.15.

³⁶  See Jones v Manchester Corporation [1952] 2 QB 852, at 871. Note that in Wilsher v Essex Area Health Authority [1986] 3 All ER 801, CA, Dr Wiles, the house officer, was found not negligent.

³⁷  [2015] UKSC 11.

³⁸  See at 5.7.

³⁹  Bolam v Friern HMC [1957] 1 WLR 582, at 587–588.

⁴⁰  See Burne v A [2006] EWCA Civ 24, [10].

⁴¹  See, for example, Edward Wong Finance Co Ltd v Johnson, Stokes & Master [1984] AC 296, PC.

⁴²  See the account of the first instance decision in Bolitho v City & Hackney Health Authority [1998] AC 232, HL.

⁴³  Graphically illustrated in Whitehouse v Jordan [1981] 1 All ER 246, HL.

⁴⁴  [1984] 1 WLR 634, HL.

⁴⁵  [1984] 1 WLR 634, at 639, HL.

⁴⁶  [1993] 4 Med LR 281, CA.

⁴⁷  Michael Jones expressed the state of play as a football score. In six medical negligence claims before the House of Lords between 1980 and 1999, the score stood at Plaintiffs 0, Defendants 6. See MA Jones, ‘The Bolam Test and the Responsible Expert’ (1999) Tort Law Review 226.

⁴⁸  Sidaway v Royal Bethlem Hospital [1984] 2 WLR 778, at 752, CA. And see Lord Bridge [1985] 1 All ER 643, at 663, HL.

⁴⁹  Reported [1993] 4 Med LR 393, CA.

⁵⁰  [1998] AC 232, HL.

⁵¹  [1998] AC 232, at 242, HL.

⁵²  Ibid, at 243.

⁵³  As Andrew Grubb so nicely put it “Eureka!’ The courts have got it at last. Expert evidence, whether of professional practice or otherwise is not conclusive in a medical negligence case that the defendant has not been careless!’ (‘Negligence, Causation and Bolam’ (1998) 6 Medical Law Review 378, at 380); MA Jones, ‘The Illogical Expert’ (1999) 15 Professional Negligence 117. And see J Miola, Bolam v Friern Hospital Management Committee [1957]: Medical Law’s Accordion’ in J Herring, J Wall, Landmark Cases in Medical Law (2015) Hart, pp 21–39, analysing the judicial expansion and contraction of the Bolam concept.

⁵⁴  See H Teff, ‘The Standard of Care in Medical Negligence – Moving on from Bolam’ (1998) 18 Oxford Journal of Legal Studies 473; J Keown, ‘Reining in the Bolam Test’ (1998) 57 Cambridge Law Journal 248; J Badenoch, ‘Brushes with Bolam: Where Will It Lead?’ (2005) 72 Medico-Legal Journal 127.

⁵⁵  See N Glover, ‘Bolam in the House of Lords’ (1999) 15 Professional Negligence 42.

⁵⁶  N Hoppe, J Miola ‘Innovation in Medicine through Degeneration in Law? A Critical Perspective on the Medical Innovation Bill’ (2015) 14 Medical Law International 266.

⁵⁷  Duffy v Lanarkshire Health Board 1998 SCLR 1142: discussed in JK Mason, GT Laurie Mason and McCall Smith’s Law and Medical Ethics (9th edn, 2013), at 5.51.

⁵⁸  And see Walker-Smith v GMC [2012] EWHC 503: P Case ‘Treading the Line between Clinical Research and Therapy’ (2012) 28 Professional Negligence 224.

⁵⁹  R Mulheron argues claims that there are now recognisable categories which flesh out the requirement that professional peer opinion must be ‘logical’, ‘responsible’ and ‘defensible’. She further articulates these categories in the hope that the law further clarifies the ambits of Bolitho (‘Trumping Bolam: A Critical Legal Analysis of “Bolitho’s” Gloss’ (2010) 69(3) Cambridge Law Journal 609).

⁶⁰  See M Brazier, J Miola, ‘Bye-Bye Bolam: A Medical Litigation Revolution’ (2000) 8 Medical Law Review 85.

⁶¹  Mason, Laurie, Mason and McCall Smith’s Law and Medical Ethics, at 5.49.

⁶²  [1999] Lloyd’s Rep Med 23.

⁶³  Penney v East Kent Area Health Authority [2000] Lloyds Rep Med 41; Reynolds v North Tyneside Health Authority [2002] Lloyd’s Rep Med 453; Lillywhite v University College London Hospital NHS Trust [2005] EWCA Civ 1466; Manning v King’s College Hospital NHS Trust [2008] EWHC 1838.

⁶⁴  [2006] EWCA Civ 24, [10].

⁶⁵  Lord Irvine of Lairg, ‘The Patient, the Doctor Their Lawyers and the Judge: Rights and Duties’ (1999) 7 Medical Law Review 255.

⁶⁶  See Lord Woolf, ‘Are the Courts Excessively Deferential to the Medical Profession?’ (2001) 9 Medical Law Review 1.

⁶⁷  A MacLean, ‘Beyond Bolam and Bolitho’ (2002) 5 Medical Law International 205.

⁶⁸  Smith v West Yorkshire Health Authority [2004] EWHC 1592 (QB).

⁶⁹  Morris v Blackpool Victoria NHS Trust [2003] EWHC 1744; Dunn v South Tyneside Health Care NHS Trust [2003] EWCA Civ 870.

⁷⁰  Ministry of Justice v Carter [2010] EWCA Civ 694.

⁷¹  [1998] Lloyd’s Rep Med 85; and see Davies v University Hospital of North Staffordshire NHS Trust [2014] EWHC 4004 (QB).

⁷²  Ministry of Justice v Carter [2010] EWCA Civ 694.

⁷³  Brazier and Miola (2008) 8 Medical Law Review 85, at 106.

⁷⁴  See Newman v Maurice [2010] EWHC 171.

⁷⁵  Hunter v Hanley (1955) SC 200.

⁷⁶  Bolam v Friern HMC [1957] 1 WLR 582, at 587.

⁷⁷  See Gascoine v Ian Sheridan & Co [1994] 5 Med LR 437.

⁷⁸  Crawford v Board of Governors of Charing Cross Hospital, 8 December (1953) The Times, 8 December, CA. And see Whiteford v Hunter (1950) 94 Solicitors’ Journal 758, HL.

⁷⁹  Roe v Ministry of Health [1954] 2 KB 66, at 84; and see L (A Child) v West Midlands Strategic Health Authority [2009] EWHC 259; Oliver v Williams [2013] EWHC 600 (QB), [3].

⁸⁰  See V Harpwood, ‘NHS Reform: Audit Protocols and the Standard of Care in Medical Negligence’ (1994) 1 Medical Law International 1; V Harpwood, ‘The Manipulation of Medical Practice in Law and Medicine’; H Teff, ‘Clinical Guidelines, Negligence and Medical Practice’ both in M Freeman and A Lewis (eds), Law and Medicine: Current Legal Issues; A Samanta et al, ‘The Role of Clinical Guidelines in Medical Negligence Litigation: A Shift from the Bolam Standard’ (2006) 14 Medical Law Review 321.

⁸¹  See J Warden, ‘NICE to Sort out Clinical Wheat from Chaff’ (1999) 318 BMJ 416.

⁸²  Or for example to textbooks; see Shortall v Mid Essex Hospital Services NHS Trust [2014] EWHC 246 (QB).

⁸³  See Brazier and Miola (2000) 8 Medical Law Review 85; but see B Hurwitz, ‘How Does Evidence Based Guidance Influence Determinations of Medical Negligence?’ (2004) 329 BMJ 1024.

⁸⁴  National Institute for Clinical Excellence, Response to the Report of the Bristol Royal Infirmary Inquiry (2001).

⁸⁵  Hunter v Hanley 1955 SLT 213, at 217.

⁸⁶  See Lillywhite v University College London Hospitals NHS Trust [2005] EWCA Civ 1466.

⁸⁷  See for example Penney v East Kent Health Authority [2000] Lloyd’s Rep Med 23.

⁸⁸  Newton v Newton’s New Model Laundry (1951) The Times, 3 November.

⁸⁹  Wood v Thurston (1951) The Times, 25 May.

⁹⁰  Langley v Campbell (1975) The Times, 6 November; and see Tuffil v East Surrey Area Health Authority (1978) The Times, 15 March (failure to diagnose amoebic dysentery in a patient who had spent many years in the tropics).

⁹¹  MDU, Annual Report (1990) pp 26–27.

⁹²  Serre v De Filly (1975) OR (2d) 490; and see MDU Annual Report (1982), pp 22–23; and (1983) p 24.

⁹³  Maynard v West Midlands Regional Health Authority [1984] 1 WLR 634; see 7.8.

⁹⁴  [2000] Lloyd’s Rep Med 41. Note too the discussion as to the applicability of Bolam to such screening tests. And see Farraj v King’s Healthcare NHS Trust [2009] EWCA 1203, CA.

⁹⁵  See also Manning v King’s College Hospital NHS Trust [2008] EWHC 1838 (failure to diagnose rare tongue cancer).

⁹⁶  Chin Keow v Govt of Malaysia [1967] 1 WLR 813.

⁹⁷  Hucks v Cole (1968) 12 Sol J 483.

⁹⁸  MDU, Annual Report (1984), p 18.

⁹⁹  Dwyer v Roderick (1983) 127 SJ 806; and see J Finch, ‘A Costly Oversight for Pharmacists’ (1982) 132 New Law Journal 176.

¹⁰⁰  Prendergast v Sam and Dee [1989] 1 Med LR 36.

¹⁰¹  MDU, Annual Report (1989), p 32.

¹⁰²  Ibid, pp 28–29: (1989), pp 20–21.

¹⁰³  For example, Taylor v Worcester and District Health Authority (1997) 2 Med LR 215.

¹⁰⁴  Collins v Hertfordshire Corporation [1947] 1 KB 598.

¹⁰⁵  Jones v Manchester Corporation [1952] 2 QB 852.

¹⁰⁶  [1954] 2 QB 66, CA.

¹⁰⁷  Ashcroft v Mersey Area Health Authority [1983] 2 All ER 245, 247. And see Lillywhite v University College London Hospitals NHS Trust [2005] EWCA Civ 1466.

¹⁰⁸  Urry v Biere (1955) The Times, 19 July.

¹⁰⁹  Corder v Banks (1960) The Times, 9 April.

¹¹⁰  [2010] CSIH 40.

¹¹¹  On the direct liability of hospital trusts, see further Chapter 8.

¹¹²  Wilsher v Essex Area Health Authority [1986] 3 All ER 801, CA.

¹¹³  See Cassidy v Ministry of Health [1951] 2 KB 14; see 8.14.

¹¹⁴  [1986] 3 All ER 801, at 833–834.

¹¹⁵  Knight v Home Office [1990] 3 All ER 237.

¹¹⁶  Brooks v Home Office (1999) 48 BMLR 109.

¹¹⁷  Gardner v Northampton General Hospital NHS Trust [2014] EWHC 4217 (QB), [32].

¹¹⁸  See generally J Stapleton ‘Unnecessary Causes’ (2013) 129 Law Quarterly Review 39.

¹¹⁹  [1987] 2 All ER 417. And see Loveday v Renton [1990] 1 Med L Rep 117.

¹²⁰  [1987] 2 All ER 417, at 421.

¹²¹  [1988] 1 All ER 871, HL.

¹²²  [1988] 1 All ER 871, at 882–823, per Lord Bridge.

¹²³  [2002] UKHL 22; and see Gardner v Northampton General Hospital Trust [2014] EWHC 4217 (QB).

¹²⁴  Subsequently, in Barker v Corus UK Ltd [2006] UKHL 22, the Law Lords ruled that each defendant should be liable only to the extent of their relevant contribution to the claimant’s exposure to asbestos dust. In the specific context of claims for mesothelioma, section 3 of the Compensation Act 2006 nullified that decision; discussed fully in C Witting, Street on Torts (14th edn, 2015) Oxford University Press, pp 158–165.

¹²⁵  [2002] UKHL 22, [69].

¹²⁶  [2008] EWCA Civ 883. And see Coakley v Rosie [2014] EWHC 1790 (QB), [118]. The claimant was able to establish ‘but for’ causation, but would otherwise have succeeded on the basis of Bailey.

¹²⁷  Ibid, [46].

¹²⁸  [2004] UKHL 41, discussed fully at 5.16.

¹²⁹  Ibid, [24] per Lord Steyn; but see to the contrary, Lord Bingham at [9].

¹³⁰  [1998] AC 232, HL; see Jones, ‘The Bolam Test and the Responsible Expert’ 226; Grubb, Negligence, Causation and Bolam’ 378. And see L (A Child) v West Midlands Strategic Health Authority [2009] EWHC 259.

¹³¹  See Gardner v Northampton General Hospital Trust [2014] EWHC 4217 (QB) where the judge draws a ‘hypothetical time line’ to assess what should have happened had there been no breach of duty and thus to assess whether that breach caused the damage complained of [31–41].

¹³²  [1998] AC 232, at 240.

¹³³  [1987] 2 All ER 909, HL. See T Hill, ‘A Lost Chance for Compensation in the Tort of Negligence in the House of Lords’ (1991) 54 Modern Law Review 111.

¹³⁴  [1985] 3 All ER 167.

¹³⁵  [1987] 2 All ER 909, HL.

¹³⁶  [2005] UKHL 2. Contrast the facts of Gregg v Scott with Manning v King’s College Hospital NHS Trust [2008] EWHC 1838.

¹³⁷  [2005] UKHL 2, [90].

¹³⁸  Ibid, [43].

¹³⁹  Ibid, [192].

¹⁴⁰  S Green, ‘Coherence of Medical Negligence Cases: A Game of Doctors and Purses’ (2006) 14 Medical Law Review 1.

¹⁴¹  [2011] EWHC Civ 669, [82] discussed more fully at 7.18.

¹⁴²  National Health Service Litigation Authority, Factsheet 3 (2015).

¹⁴³  [2011] EWCA Civ 669.

¹⁴⁴  Ibid, [37].

¹⁴⁵  Marriott v West Midlands Area Health Authority [1999] Lloyd’s Rep Med 23.

¹⁴⁶  See Langley v Campbell (1975) The Times, 6 November.

¹⁴⁷  Chin Keow v Government of Malaysia [1967] 1 WLR 813.

¹⁴⁸  Coles v Reading and District Hospital Management Committee (1963) The Times, 30 January.

¹⁴⁹  Dwyer v Roderick (1983) 127 SJ 806. Recounted in ‘A Costly Oversight for Pharmacists’ (1982) 132 New Law Journal 176.

¹⁵⁰  [1990] 1 Med LR 36.

¹⁵¹  See J Herring, C Foster, ‘Blaming the Patient: Contributory Negligence and Medical Malpractice litigation’ (2009) Professional Negligence 76.

¹⁵²  Pidgeon v Doncaster Health Authority [2002] Lloyd’s Rep Med 130. Contrast with Re P [2011] EWHC 1266 where the appointment letter was sent to the wrong address.

¹⁵³  Horsley v Cascade Insulation Services & Others [2009] EWHC 2945 (QB), applying Badger v The Ministry of Defence [2005] EWHC 2941.

¹⁵⁴  [2008] EWCA Civ 1068.

¹⁵⁵  Unfair Contract Terms Act 1977, s 2.

¹⁵⁶  Mary McGill v Royal Group of Hospitals [2010] NIQB 10.

¹⁵⁷  See Thompson v Sheffield Fertility Clinic [2001] unreported, Westlaw.

¹⁵⁸  Eyre v Measday [1986] 1 All ER 488; Thake v Maurice [1986] 1 All ER 497, CA.

¹⁵⁹  (1925) 41 TLR 557.

¹⁶⁰  [1993] 4 All ER 935, CA.

¹⁶¹  The third appeal, R v Holloway, involved an electrician whose faulty wiring caused a death.

¹⁶²  R v Adomako [1995] 1 AC 171, HL.

¹⁶³  Ibid, at 188.

¹⁶⁴  [2004] EWCA Crim 2375; note that subsequently the trust employing the two doctors was convicted of offences contravening health and safety legislation in respect of the same events: R v Southampton University Hospitals NHS Trust [2006] EWCA Crim 341.

¹⁶⁵  Leave to appeal to the House of Lords was refused; R v Misra [2004] All ER (D).

¹⁶⁶  See R Ferner, S McDowell, ‘Doctors Charged with Manslaughter in the Courts of Medical Practice’ (2006) 99 Journal of RSM 309; O Quick, ‘Prosecuting “Gross” Medical Negligence: Manslaughter, Discretion and the Crown Prosecution Service’ (2006) 33 Journal of Law and Society 421.

¹⁶⁷  D Griffiths, A Sanders, ‘The Road to the Dock; Prosecution Decision-Making in Medical Manslaughter Cases’ in D Griffiths, A Sanders (eds) Medicine, Crime and Society (2013) Cambridge University Press, p 117.

¹⁶⁸  Ibid, p 118.

¹⁶⁹  See M Brazier, N Allen, ‘Criminalising Medical Malpractice’ in C Erin, S Ost (eds), The Criminal Justice System and Health Care (2007) Oxford University Press, p 15; M Brazier, A Alghrani, ‘Fatal Medical Malpractice and Criminal Liability’ (2009) 25 Professional Negligence 49.

¹⁷⁰  See A McCall Smith, ‘Criminal Negligence and the Incompetent Doctor’ (1993) 1 Medical Law Review 336.

¹⁷¹  The fourth appellant in R v Prentice, R v Adomako, R v Holloway [1993] 4 All ER 935, CA was an electrician whose faulty rewiring of a house resulted in the death of one of the residents.

¹⁷²  (2003) The Times, 24 September.

¹⁷³  But see now the statutory duty of candour: Care Act 2014, s 81 discussed at 1.6.

¹⁷⁴  See A Merry, A McCall Smith, Errors, Medicine and the Law (2001) Cambridge University Press.

¹⁷⁵  See H Quirk ‘Sentencing White Coat Crime: The Need for Guidance in Medical Manslaughter Cases’ [2013] Criminal Law Review 871: R v Bala Subrahmanyam Kovvali [2013] EWCA Crim 1056. And see S Boseley, ‘Doctors Sign Letter Expressing Worry over Criminalisation of Surgeon’ (2015) Guardian, 6 August.

¹⁷⁶  A shocking example is the Independent Inquiry into Care Provided by Mid Staffordshire NHS Foundation Trust January 2005–March 2009, HC375–1.

¹⁷⁷  See Mental Health Act 1983, s 127.

¹⁷⁸  See Mental Capacity Act 2005, s 44.

¹⁷⁹  See A Alghrani, M Brazier, AM Farrell, D Griffiths, N Allen, ‘Healthcare Scandals in the NHS’ (2011) 37 Journal of Medical Ethics 230.

¹⁸⁰  See in particular Professor B Toft, External Inquiry into the Adverse Incident that Occurred at Queen’s Medical Centre Nottingham (2001) Department of Health.

¹⁸¹  See R v Southampton University Hospitals NHS Trust [2006] EWCA Crim 341.

¹⁸²  See M Childs, ‘Medical Manslaughter and Corporate Liability’ (1999) Legal Studies 316; N Allen, ‘Medical or Managerial Manslaughter’ in Erin and Ost, Criminal Justice System and Health Care, p 49.

¹⁸³  Corporate Manslaughter and Homicide Act 2007, ss 8 and 9.

¹⁸⁴  See P Gooderham, ‘No-one Fully Responsible: A “Collusion of Anonymity” Protecting Health-care Bodies from Manslaughter Charges’ 6 (2011) Clinical Ethics 68.

¹⁸⁵  BBC News, ‘Nottingham Care Home Boss Admits Manslaughter Charge’ (2015) 3 December.

Chapter 8

MALPRACTICE LITIGATION

¹

8.1 In 2014/15, the National Health Service Litigation Authority (NHSLA)² received 11,497 new claims for clinical negligence, 448 fewer than in 2013/14 but nearly double the number of claims in 2009/10.³ We have addressed the principles governing liability for clinical negligence. Formidable practical problems confront the patient bringing a claim. How can she fund a lawsuit? Whom should she sue? How quickly must she act? How do you prove negligence? What level of compensation is available? Is it worth it? There have been radical changes in the process of litigation. Legal aid has been withdrawn for most clinical negligence claims. In response to changes implemented after a review of the systems for costs in civil litigation undertaken by Lord Justice Jackson,⁴ it may become more difficult to fund a claim by way of a conditional fee agreement. We cannot predict the effect of cumulative reform on clinical negligence claims. It may be that as funding becomes harder to obtain, seeking compensation for clinical negligence will become more difficult and numbers of claims will fall. The minor reduction in claims for 2014/15 offers little by way of evidence. The reduction in the cost of claims to the NHS may be welcomed. Patients denied a civil remedy may look elsewhere even to the criminal process for redress,⁵ and we must question how far limitations on access to funding for those who cannot self-fund a claim meet the needs of justice and accountability.⁶

We begin this chapter by offering an overview of the litigation process. Then we consider claims that lawsuits against doctors are damaging medicine. The spectre of the malpractice crisis is often invoked but is it a spectre with any substance? Or is the real spectre not the threat to doctors and the NHS of too many claims, but the denial of redress to patients who cannot fund a legitimate claim for compensation and thus a reduction in accountability for medical errors?

Funding a lawsuit: public funding⁷

8.2 Few people are rich enough to meet the costs of clinical negligence claims out of their own income and savings. The majority of clinical negligence claims in the past were funded by legal aid. The success rate of such claims was low. The cost to the public purse of legal aid in personal injury claims rose rapidly. Unsurprisingly the government sought to find ways to reduce the legal aid bill. The Access to Justice Act 1999 removed legal aid from most personal injury claims but retained legal aid for clinical negligence claims. The Legal Aid, Sentencing and Punishment of Offenders Act 2012 – hereafter LASPO – abolishes legal aid for clinical negligence claims save for ‘exceptional cases’ where the Director of Legal Aid⁸ determines that the claimant qualifies for such services. In the context of clinical negligence ‘exceptional cases’ are claims where it is necessary to provide legal aid because not to do so would be a breach of the individual’s ECHR rights⁹ and claims for severe neurological damage to babies injured during pregnancy, labour or the first eight weeks of life.¹⁰

In the consultation process leading to the enactment of LASPO, the Ministry of Justice took the view that most patient-claimants should be able to access alternative funding primarily via conditional fee agreements (CFAs) and so ‘legal aid funding is not justified’.¹¹ But as we shall see the same Act (LASPO) made it less likely that solicitors will take on claims that are not both highly likely to succeed and of high value.¹²

In those rare cases where public funding is available, obtaining legal aid ‘is no easy task’.¹³ Eligible claimants must meet a stringent means test; only adults with a very low income and minimal capital will qualify. Even if the potential claimant passes the means test, her case must be strong on its merits. However children under 18¹⁴ are assessed on their own, not their parents’ income, so child-patients claiming in respect of birth or neonatal injury still qualify for legal aid.

Conditional fee agreements

8.3 The virtual abolition of legal aid for most clinical negligence claims took place in the wake of a major review of the costs of the civil justice system as a whole by Lord Justice Jackson.¹⁵ The government made it clear that it saw a radically reformed system for CFAs as the primary source of future funding for clinical negligence claims.¹⁶ Under CFAs in their original form the solicitor agreed to provide legal services on the basis that unless the claim was successful the client paid nothing for her services. If the case succeeded, the solicitor could charge up to twice the normal fee (a success fee), up to a limit of 25 per cent of any damages recovered. Unsuccessful defendants might be required to meet that ‘success fee’. But the ‘no-win no-fee’ provision only covered the patient’s own solicitors’ costs. If the case failed, he became liable for the defendant hospital, or doctor’s, costs. In most personal injury claims, claimants could buy insurance, after-the-event insurance (ATE), to cover them against the risk of liability for the defendants’ costs, about £60,000 at least for anything other than a modest claim. The complexity and expense of clinical negligence claims is such that insurers were wary about entering this field. However, if the claimant won, she could recover the cost of ATE insurance premiums from the defendant, the losing party, providing the premium was set at a reasonable rate.¹⁷

Implementing reforms proposed by Lord Justice Jackson, LASPO radically alters CFAs. Section 44 amends the Courts and Legal Services Act 1990 so that claimants will no longer be able to recover the success fee from defendants but will have to pay the success fee and any insurance ATE premium¹⁸ from their own damages. Moreover, the success fee cannot exceed 25 per cent of the claimant’s damages, excluding damages for future care and loss. CFAs become a less attractive option to both solicitors and clients. To meet some of the concerns that claimants would be under-compensated once success fees and ATE premiums were deducted from damages, the Court of Appeal in Simmons v Castle¹⁹ announced that there should be a 10 per cent rise in general damages (for pain, suffering and loss of amenity) to compensate successful claimants for loss of the right to recover the success fee from the defendants. The appeal court later clarified its guidance to make it clear that the 10 per cent uplift in damages applies only where the claimant entered into a CFA after April 1 2013 when the relevant provisions of LASPO came into force.²⁰ Clients who entered into CFAs before that date cannot claim both the success fee from defendants and benefit from a rise in damages designed expressly to compensate for the loss of the right to recover that fee.

Conditional fees must be distinguished from contingency fees, the system used to fund most claims in the USA. A contingency fee allows the claimant’s lawyers to take a proportion of the damages awarded (in some cases up to 50 per cent), but he can claim nothing if the action fails. Until the Jackson Report, contingency fees met with little favour in England. The Jackson Report expressed particular concern about the impact of CFAs on the NHS in a chapter dedicated to clinical negligence.²¹ Lord Justice Jackson stressed the importance of ensuring that ‘the resources of the health service are not being squandered unnecessarily on litigation costs’.²² As we have seen his proposals relating to CFAs have been implemented in LASPO. But Lord Justice Jackson’s most radical proposal was that contingency fees should be allowed, renamed damages-based agreements (DBAs), and this proposal is implemented by section 45 of LASPO. So far few solicitors in personal injury or clinical negligence claims have taken up the option of DBAs.²³

The Jackson Report also proposed that far more people should be encouraged to take out legal expenses insurance also styled before-the-event (BTE) insurance, to cover them against the costs of claims in the future. Many household insurance policies offer this option. It seems unlikely that many clinical negligence claimants will benefit from BTE. Few people who live lives with little risk of resort to litigation are likely to consider that a medical accident might create the need for funds to sue their doctor. Moreover, BTE insurance may well be an unaffordable luxury for many families who might before LASPO have qualified for legal aid. It is too early to evaluate the impact of LASPO.²⁴ The evidence generally so far suggests that risky and lower-value claims are not being taken on by solicitors and that there seems to be little enthusiasm for DBAs.²⁵ One consequence of the increased difficulty in obtaining funding for professional legal services is a marked rise in people representing themselves; litigants in person.²⁶

Defending claims²⁷

8.4 Until 1990, the medical defence organisations, principally the Medical Defence Union and the Medical Protection Society, indemnified individual doctors against personal liability for clinical negligence. Each hospital, health authority or other NHS organisation met its own costs. NHS Indemnity, introduced in 1990,²⁸ provides that hospital trusts indemnify hospital doctors against liability; trusts have taken over the cost of defending all claims and the management of claims. The medical defence organisations continue to meet claims against GPs and claims arising in the private sector.

In 1995, the Clinical Negligence Scheme for Trusts (CNST) was established.²⁹ NHS trusts may choose to join the CNST and a pooling arrangement meets liabilities arising out of patient claims. ‘Premiums’ for trusts are worked out depending on the types of trust, the specialities offered and their scale of operations. Membership of the CNST is voluntary, but as of March 2014, all foundation trusts, NHS trusts and Clinical Commissioning Groups (CCGs) were members. Independent sector providers of NHS care were also able to join the CNST from 2013 and over fifty such independent sector organisations had joined CNST by April 2014.³⁰ Membership is conditional on trusts complying with risk management procedures prescribed by the CNST. It offers a mutual assurance system so that no individual trust risks devastation of its service because of a clutch of unfortunate losses in the courts.

The NHSLA³¹ now administers the CNST.³² Since April 2002, the NHSLA has dealt with all CNST claims regardless of value. The NHSLA, a Special Health Authority, is the driving force behind defence of claims against the NHS today. It exercises significant control over all claims seeking to ensure swift resolution of indefensible claims and to minimise the cost to the NHS. Greater efficiency and uniformity should benefit patients as much as hospitals. The NHSLA plays an active role, not just in advising on defence of individual claims, but also in seeking to ensure that the whole litigation system is regularly kept under review. The medical defence organisations and NHS trusts were often accused of persisting in defending ‘indefensible’ cases. The NHSLA claims that it seeks to avoid litigation, encourage apologies and explanations, and settle appropriate claims swiftly, offering members concrete advice on how to say sorry.³³ Lawyers who act for claimants take a less rosy view of the NHSLA and Lord Justice Jackson was critical of some of their practices.

Whom should the patient sue?

8.5 If funding can be accessed, one of the first practical matters which the patient and his legal advisers must consider is whom they should sue. The legal doctrine of vicarious liability provides that when a person who is an employee commits a tort in the course of his employment, his employer is also responsible to the victim. The employer will often be better able to pay compensation than an individual employee. Let us look first at a claim by a patient who alleges that he suffered injury in the course of treatment as an NHS patient in an NHS trust or foundation hospital. If he can identify a particular individual as negligent he may, of course, proceed against him, be he consultant, anaesthetist, junior doctor, nurse, physiotherapist or hospital porter. However, he may also sue the person’s employer, in the case of an NHS trust, or foundation hospital, the hospital itself. Where a hospital doctor is a defendant in the action, payment of any award of compensation made against her is guaranteed. NHS Indemnity ensures that any liability incurred by an NHS hospital doctor will be met by her employer. NHS trusts indemnify doctors directly, just as they have always done for nurses and other hospital employees. There is no practical need to bring a claim against the doctor personally. Patients who bring a claim based on the alleged negligence of a nurse rarely name the nurse personally as a defendant.³⁴ Patients and their lawyers should ponder the wisdom of suing a doctor personally. As her employer will meet any award of compensation in full, there is little to gain from naming the doctor in the claim. However, suing a doctor individually may be designed not to obtain compensation, but to ensure accountability. As long as complaints procedures are perceived by patients as inadequate, patients able to fund claims may still seek to use clinical negligence claims naming individuals as a means to ensure accountability.³⁵

The employer to sue, as vicariously liable, in the case of NHS hospital treatment, will normally be the NHS trust, or foundation hospital. As privatisation creeps into the health service, this must be examined carefully. Take this example: an elderly, confused patient slips and falls on a highly polished floor. Who, if anyone, is responsible? The relevant negligence may be that a nurse failed to supervise the patient, or it may be that cleaners were careless. The nurse may be employed by the hospital or may be an agency nurse. The cleaner may be the employee of a private contractor. If the patient can rely only on the doctrine of vicarious liability to make someone other than the individual nurse or cleaner liable, he may have difficulty in selecting the correct defendant. Hospital and contractor may each blame the other’s employee. What we now need to examine is the direct liability of the hospital to an NHS patient, what is often described as a non-delegable duty. First, the hospital will be liable for any failure of its own. A patient may suffer injury not because any particular doctor or nurse is careless, but because the system provided by the authority is inadequate. There may be insufficient medical staff to cope swiftly enough with injured patients admitted to the casualty ward. Lack of experienced staff on night duty may cause injury to a patient whose condition deteriorates rapidly, and whom the staff on duty cannot, with the best will in the world, treat sufficiently promptly. For such ‘systems errors’ an action will lie directly against the hospital.³⁶ The Court of Appeal has confirmed that hospitals have an ‘organisational duty’. An NHS hospital must ‘ensure that the hospital staff, facilities and organisation provided are those appropriate to provide a safe and satisfactory service for the patient’.³⁷

Extending direct liability

8.6 May direct responsibility to NHS patients go further? When a patient is admitted for hospital treatment under the NHS, the NHS trust undertakes to provide him with reasonably careful, competent and skilled care. Should his treatment fall below that standard, the hospital is directly, not just vicariously, responsible to the patient.³⁸ So if an elderly patient falls on a slippery floor, and had proper care been taken that would not have happened, the hospital is liable. It matters not whether a nurse employed by the hospital, an agency nurse or a cleaner employed by a contractor was the individual personally at fault. The hospital undertook to care for the patient. It failed and is directly liable. In X (Minors) v Bedfordshire County Council, Lord Browne-Wilkinson said this: ‘It is established that those conducting a hospital are under a direct duty of care to those admitted as patients to the hospital’.³⁹ In Woodland v Essex County Council⁴⁰ the Supreme Court confirmed that the principle stated obiter by Lord Browne-Wilkinson represented the current law.

What of a patient offered a hip replacement on the NHS whose operation is contracted out to a private hospital, or independent treatment centre? This may happen when the NHS hospital trust to which she is referred contracts with a private sector hospital to carry out surgery on its behalf, often to deal with a backlog of operations, or her CCG arranges her care in the private sector. If her treatment is carried out negligently, one option is to sue the private provider. But can she sue the NHS trust which despatched her to the private sector, or her CCG where the CCG contracted her care with a private hospital? This could be important if, say, the private clinic goes bankrupt.

The legal position is unclear. In M v Calderdale Health Authority,⁴¹ M became pregnant and consulted an NHS doctor at an NHS Community Health Centre. He arranged an abortion at a private hospital, but it was negligently performed and the woman went on to give birth to a baby boy. The health authority was found liable in negligence to M. Albeit no NHS employee was negligent, nor was the health authority negligent in selecting the private clinic to which they contracted out abortions, they were in breach of a direct non-delegable duty to their patient. The judge summed up the position.

[M] never left the care of the first defendant. She was its patient. She never had an opportunity to divert from the route of treatment arranged on her behalf. In these circumstances she is entitled in my view to remain in the same position as a patient who remains in house relying upon the expectation of an effective provision of services.⁴²

The judgment in M suggested that an NHS patient suffering injury in the private sector could sue an NHS hospital or CCG which contracted out her care, but it is only a decision of the county court and in Child A v Ministry of Defence⁴³ the Court of Appeal was dismissive of M, stating that the decision does ‘not represent the current state of English law’.⁴⁴ Very briefly, Child A was born in 1998, in a German hospital while his father was serving with the British Army. Until 1996, the Ministry of Defence had run its own military hospitals in Germany. From 1996, the Ministry (via a complicated set of contracts) contracted out healthcare for service personnel and their families to German hospitals. Child A suffered brain damage in the course of his delivery. It was not disputed that his injuries were as a result of negligence. A could claim damages in Germany under German law, but his lawyers sought to sue in England and make the Ministry of Defence liable for A’s injury, just as Calderdale Health Authority had been liable to M. The Court of Appeal found against him. The Ministry owed a duty to use reasonable care to provide access to suitable hospital care for service personnel and their families.⁴⁵ They had a responsibility (an organisational duty) to act reasonably to ensure care provided was on the basis of an adequate system, ie properly equipped hospitals were selected to provide care.⁴⁶ There was no ‘duty to ensure that the treatment administered … is administered with reasonable care and skill’. There was no duty ‘broken if one of the hospital staff, however competent, commits an isolated act of negligence in the treatment of the patient’. Such a duty (described in A as a non-delegable duty) would generally only lie ‘in an environment over which the defendant is in control’.⁴⁷ An NHS trust hospital might well owe such a duty to all patients being treated in their hospital. The Ministry of Defence had no control over its German contractors.

Does that mean that NHS hospitals and CCGs can similarly never be liable for treatment contracted out to the private sector? Not necessarily. One of us sought to argue elsewhere that PCTs (now CCGs) did owe a direct non-delegable duty to those patients for whose care they are responsible.⁴⁸ Lord Phillips says that, even if Primary Care Trusts (PCTs) (the predecessors of CCGs) did owe such a duty, it would not follow that a similar duty was incumbent on the Ministry of Defence.⁴⁹

The judgment of the Court of Appeal in Farraj v King’s Healthcare NHS Trust⁵⁰ indicated an unwillingness to extend the limits of direct liability. Mrs Farraj knew that she and her husband carried the gene that can cause beta thalassaemia major (BTM), a serious blood disorder. The couple were in the care of an obstetrician in Jordan and a chorionic villus sample was taken from Mrs Farraj and sent for testing at the defendant hospital to determine whether the fetus was affected by BTM. The hospital found that the sample was not suitable for DNA testing in its own laboratory and sent it on to an independent specialist cytogenetics laboratory, CSL. CSL were held negligent in wrongly stating that the fetus was not affected by BTM. The issue that concerns us here is could King’s Healthcare NHS Trust be held liable for the negligence of CSL on the grounds that they owed a non-delegable duty to the claimants? The appeal court decided no to that question. Dyson LJ was prepared to assume that hospitals owe such a duty to the patient it treats regardless of the employment status of the staff delivering treatment.⁵¹ But he could see no reason in this case to depart from the usual rule that a defendant can discharge his duty of care by delegating a task to a suitably competent independent contractor. Mrs Farraj was not being treated by King’s, but by a hospital in Jordan. King’s Healthcare NHS Trust undertook no special duty to her. Farraj leaves open the question of whether an NHS patient who undergoes tests organised by the NHS hospital treating her, or by her CCG, could argue that the hospital or CCG owed her a non-delegable duty in respect of tests contracted out to independent laboratories and/or any other form of negligence on the part of the private contractor.

The decision of the Supreme Court in Woodland v Essex County Council⁵² leaves that possibility open. A pupil at a school for which Essex County Council was responsible suffered serious injuries at a swimming lesson run by a private organisation whose staff were responsible for the negligence that caused the child’s injury. The individuals responsible were not employed by the County Council and the Council argued that there was no non-delegable duty owed to the pupils. Lord Sumption reviewed the case law and crucially ‘respectfully’ disagreed with Lord Phillips in Child A v Ministry of Defence who had stated that for a non-delegable duty to lie, the defendant must have control of the environment in which the injury occurred.⁵³ The crucial question is whether the defendant has control over the claimant ‘for the purpose of performing a function for which the Defendant has assumed responsibility’. The injured child was attending a swimming lesson, an integral part of the education for which the defendant assumed responsibility. The parents entrusted the child to the school with no knowledge or influence over when and how the school might contract out some of its functions. The school remained responsible for the child.

Woodland differs markedly from both Child A and Farraj. Child A’s parents had no sound basis for thinking that it was the Ministry of Defence providing healthcare for Mrs A. Mrs Farraj was not a patient of the defendant hospital. Woodland may well be applicable to the NHS hospital that contracts out a backlog of operations, or certain sorts of treatments, to private sector organisations. The claimant may well argue that just as the injured child’s parents in Woodland entrusted their child to the school and had no control over who the school arranged to carry out educational services, so if we are referred to Muncaster NHS Trust for a hip replacement, we have no control or choice as to how the hospital discharges the health service provided for us.

What of CCGs? In 2013/14, the NHSLA acknowledged that as a result of Woodland the NHS is likely to receive more claims alleging a non-delegable duty of care.⁵⁴ It flatly denied that CCGs fall within the criteria of the Supreme Court decision,⁵⁵ but offers no reasons for this firm assertion. We would argue that the CCG in exercising its function of arranging secondary care for the patients for whom it is responsible undertakes responsibility for the service provided even if it delegates that responsibility to an organisation outside the NHS. However, one point made by the NHSLA should be noted. Independent sector providers are now able to join CNST and many have done so.⁵⁶ The risk for the patient whose care is delegated by the NHS to the private sector in England is that the private provider might go bankrupt, be under-insured or otherwise unable to meet the claim for compensation. Membership of CNST ensures that the private provider via the NHSLA will be ‘insured’ to meet all claims. We might then ask whether commissioning care from a private provider not a member of the NHSLA would itself be a breach of the trust of CCG’s ‘organisational duty’ to arrange adequate care for the patient.⁵⁷

What about treatment abroad funded by the NHS? Some patients go abroad to reduce waiting time, for example. There are two possible funding routes: one requiring prior permission from NHS England and another facilitating reimbursement in certain circumstances.⁵⁸ If something goes wrong, must the patient bring an action in negligence in the country where the treatment took place? Litigating abroad dealing with a different legal system and a foreign language will be difficult. In such circumstances NHS trusts advise patients to take out appropriate insurance. The treatment is funded by the NHS but controlled by the patient.

Private patients

8.7 A private patient, who engages a private bed in an NHS hospital, contracts individually with the surgeon and anaesthetist for the surgery and the administration of the anaesthetic, and he contracts separately with the hospital trust for nursing and ancillary care. Even if the surgeon and the anaesthetist are employed by the trust when caring for NHS patients, when they act for a private patient they are acting on their own behalf, and not in the course of their NHS employment. If an error by surgeon or anaesthetist causes the patient injury, he can sue only the responsible individual. If the carelessness is that of nursing or other medical staff employed by the trust, he may sue the trust. As we shall see, this may cause problems of proof of negligence. Identifying who was the responsible individual may be nigh on impossible, leaving surgeon and hospital to blame each other, and the patient to go uncompensated.

A patient entering a private hospital needs to consider the nature and scope of his contract. The usual arrangement is similar to that entered into by a private patient taking a private bed within the NHS. The patient engages his own surgeon and anaesthetist, who will not be employees of the private hospital. The hospital contracts to provide other medical and nursing care. Like the private patient within the NHS, the patient must proceed against the surgeon for any error of his, and against the hospital for any error by their staff. Some private hospitals and clinics will contract to provide a whole ‘package’ of care and treatment. When the hospital undertakes to provide total care, the operation, anaesthetic, post-operative care, etc., then it is liable for any failure to meet the required standard of care. They are in breach of contract.⁵⁹ It is irrelevant that the surgeon, anaesthetist, or anyone else is not an employee of the hospital. The hospital is not vicariously liable for any fault of a particular person. It is directly responsible for its own breach of contract.

General practitioners

8.8 What of claims against GPs? First of all, most general practitioners are not employees of the NHS. A claim relating to negligence by a GP operating a single-doctor practice lies usually against that GP alone.⁶⁰ Where a GP is a member of a partnership, his partners may be sued as jointly responsible for any negligence. If it is not the doctor himself who is at fault, but a receptionist or nurse employed by the practice, the GP and his partners are vicariously liable as employers. If a receptionist refuses to allow a home visit, or refuses to allow the patient to speak to a doctor, or fails to pass any information onto the doctor with the result that a seriously ill patient becomes sicker or even dies, the doctor, while she may be personally blameless, will be vicariously at fault and liable to the patient or his family.

When must proceedings be started?

8.9 A patient contemplating an action for clinical negligence must act relatively promptly. The general rule is that all actions for personal injuries must be brought within three years of the infliction of the relevant injury. This is known as the limitation period and is laid down in the Limitation Act 1980. A claim form must be served no later than three years from the date of the alleged negligence. But sections 11 and 14 of the 1980 Act provide that where the patient originally either: (1) was unaware that he had suffered significant injury;⁶¹ or (2) did not know about the negligence which could have caused his injury, the three-year period begins to run only from the time when he did discover, or reasonably should have discovered, the relevant facts. Where the patient knew all the relevant facts, but was ignorant of his legal remedy, the three-year limitation period runs from the time when he was, or should have been, aware of the facts.

All is not quite lost for the patient who delays beyond three years, or who is ignorant of the law. Section 33⁶² of the 1980 Act gives the judge discretion to override the three-year limitation period where, in all the circumstances, it is fair to all parties to do so. The courts will examine the effect of allowing the action to go forward on both parties, taking into account, among other things, the effect of delay on the cogency of the evidence, the conduct of the parties, and the advice sought by, and given to, the patient by his lawyers and medical advisers.⁶³

One further aspect of the rules on limitation must be noted. Where the injured patient is under a legal disability at the time he suffers injury, that is to say, he is underage (under 18) or lacks mental capacity, the limitation period does not begin to run until he reaches the age of majority, or ceases to lack mental capacity. This means that, for example, a baby might be injured at birth and the obstetrician could face an action in respect of the injury up to twenty-one years after the event.

Civil justice reform: the Woolf and Jackson Reports

8.10 Cost, complexity and delay bedevilled, not just clinical negligence claims, but all actions for compensation in the latter part of the twentieth century. The civil justice system was perceived as inadequate. One of England’s most senior judges, Lord Woolf, was commissioned to conduct a comprehensive review of the civil justice system and to recommend radical reform. He issued his Final Report in 1996.⁶⁴ Lord Woolf set out a number of admirable objectives for the civil justice system. It should be just in its results, and the operation of the system should be fair to all parties. Costs should be proportionate to the nature of the case. Claims must be dealt with reasonably swiftly. The process should be understandable to everyone using it, including any litigant who chooses not to engage a lawyer, but to sue in person. The system should be responsive to the needs of litigants. There should be certainty in the way the process works. Civil justice should be adequately resourced and reasonably funded.

Four features of the Woolf reforms are central to malpractice litigation.

(1)  The Pre-Action Protocol for the Resolution of Clinical Disputes (the Clinical Negligence Protocol) sought to find less adversarial and more cost-effective ways of resolving disputes about healthcare.

(2)  New Civil Procedure Rules⁶⁵ came into force in 1999 introducing a unified set of procedures for claims regardless of whether a claim is heard in the County Court or the High Court.

(3)  Integral to the Rules is the concept of case management. Judges are given infinitely greater powers to manage cases.

(4)  The rules governing expert witnesses were altered, seeking to limit the misuse of expert evidence

But by 2009 it was clear that the Woolf reforms had not resulted in total success. Research commissioned by the Ministry of Justice suggested that delay was less of a problem with cases taking less time between issuing a claim and trial or settlement.⁶⁶ But costs had risen⁶⁷ and thus as we have seen Lord Justice Jackson was asked to conduct a further review of civil litigation costs, resulting in radical change to the funding of claims.

The Clinical Negligence Protocol and case management

8.11 As a result of the Jackson Report and other reviews commissioned by the Ministry of Justice, substantial changes have been made both to the Clinical Negligence Protocol and the Civil Procedure Rules that govern the management of claims that fail to settle. Substantial changes to the Protocol came into force on 6 April 2015.⁶⁸ The complexity and detail of the Protocol and the Rules would add several further chapters to this book. Thus we simply outline some of the key points here. The Protocol sets out ‘ground rules’ for handling disputes at their ‘early stages’, seeking to encourage a greater climate of openness, to provide guidance how this more open culture can be achieved, and recommend a timed sequence of events when disputes do arise.

The Protocol aims to maintain or restore the relationship between the aggrieved patient and healthcare professionals and providers, and to resolve as many disputes as possible without litigation. Communication between the parties lies at the heart of the Protocol. Cases should be investigated swiftly, and records volunteered to the claimant for a reasonable period of time. Full consideration needs to be given to early settlement and, whether, if agreement between the parties cannot be reached, resort might be had to mediation or some other form of alternative dispute resolution.⁶⁹ The Protocol promotes a ‘cards on the table’ approach. Ideally, when a patient believes that she has a case in clinical negligence, in a matter of months she will be able to judge whether her belief is well founded. The defendant doctor or hospital will be in a position to settle any sustainable claim quickly. Means other than litigation of resolving genuine disputes will be reviewed. Only the truly intractable case should go to court, but more cases still seem to end in court and settlements take too long. Unfortunately the Jackson Report found that it was not working well to ensure early settlement in appropriate cases and this was contributing to an escalation of costs.

If attempts to resolve the claim fail, and the patient starts formal proceedings, the conduct of the case will be strictly controlled with an emphasis on enforcing time-limits and keeping costs down. The claim will be allocated to a track. A clinical negligence claim worth less than £1,000 would theoretically be allocated to the small claims track. Most such claims ought never to result in proceedings, but rather be resolved within complaints procedures. Claims worth between £1,000 and £15,000 are allocated to the fast track. This means that the case should be resolved within thirty weeks. The actual hearing should take one day or less and oral expert evidence is limited. Claims worth more than £15,000, or where the issues are especially complex, go onto the multi-track. Judges control the allocation process. Most clinical negligence claims will be multi-track. At every point, opportunities to resolve the case without further proceedings must be seized. Time-wasting and unnecessary manoeuvres by lawyers will be penalised.

The aims of the Protocol and case management are laudable, to settle cases where possible and ensure that cases are handled efficiently. However, the system remains complex and if claimants have no access to funding for legal services and are forced to act as litigants in person they will struggle, and Lord Dyson has argued that much more needs to be done to simplify procedures.

Openness, candour and obtaining health records

8.12 Where attempts to settle lead to naught, the Protocol aims to ensure that proper disclosure of information facilitates fairness and keeps the costs down. As we shall see in Chapter 9, efforts to engender an NHS culture of openness and learning face significant hurdles. In Chapter 1⁷⁰ we considered the duty of candour. A new, statutory duty was introduced in section 81 of the Care Act 2014.⁷¹ When a safety incident occurs, the healthcare provider must inform and support the relevant person and ‘provide an account of the incident which, to the best of the health service body’s knowledge, is true of all the facts the body knows about the incident as at the date of the notification’.⁷²

One of the principal features of the Clinical Negligence Protocol is the provision for voluntary disclosure of records which should normally be provided within forty days. The claimant too in setting out her letter of claim must ensure sufficient information is given to enable the defendants to investigate the claim and determine how to proceed. Litigation should not resemble a game of poker.If the Protocol works, there should be no need for compulsory disclosure of records. Alas this is not always the case. The patient seeking to compel disclosure of records will rely on section 33⁷³ of the Senior Courts Act 1981. The court can impose costs and sanctions for unreasonable delay.⁷⁴ The patient can apply for a court order for pre-action disclosure requiring the doctor or hospital whom she plans to sue to disclose any records or notes likely to be relevant in forthcoming proceedings. Section 34⁷⁵ goes further. The court may order a person not a party to proceedings to produce relevant documents. So if the patient has started proceedings against a GP, or a private medical practitioner, but believes that the hospital or clinic holds notes of value to his claim, the hospital or clinic can be made to hand over the notes. This will help the private patient in a dilemma of whether he should properly proceed against doctor or hospital. It may also lead to the clinic being brought into the proceedings.

Three important matters on disclosure need a mention. First, the intention to bring proceedings and the likelihood that they will go ahead must be real before the court will order disclosure. The patient must have some solid ground for thinking he has a claim. He cannot use an application for disclosure as a ‘fishing expedition’ on the off-chance that some evidence of negligence will come to light.⁷⁶ Resort to compulsory disclosure ought to be rare.

Relevant documents should have been volunteered under the Protocol. Other avenues to discover records and information may also be pursued. A patient may always apply to see his records under the Data Protection Act 1998.⁷⁷ Or he may use the complaints procedure to explore whether he has any legal entitlement to pursue a compensation claim.⁷⁸

Second, will the patient be able to see notes of any inquiry ordered by the hospital into his misadventure? The Care Quality Commission sets out the information that should be communicated to a relevant person in the event of a ‘notifiable safety incident’ as part of the statutory duty of candour imposed on healthcare providers.⁷⁹ Beyond this, the position is complex. If the inquiry was held mainly to provide the basis of information on which legal advice about the authority’s legal liability is based, the records are protected by legal professional privilege. If the dominant purpose of the inquiry was otherwise, for example, to improve hospital procedures or to provide the basis of disciplinary proceedings against staff, then the patient may be allowed access to the notes of the inquiry.⁸⁰ That is the legal position. The Court of Appeal long ago expressed its disquiet about the effect such claims of legal professional privilege might have on the patient’s claim. Claims of privilege were used to frustrate the patient’s attempt to find out what happened, what went wrong, and judges called for a duty of candour.⁸¹ The introduction so many years later of a duty of candour, discussed above, will require the hospital or other heath service provider to prepare a report for the family and married to the emphasis on openness in the Clinical Negligence Protocol ought to mean that this unsatisfactory state of affairs will not be repeated.

Third, the court retains the power to refuse to order disclosure where to do so would be injurious to the public interest.⁸² This is unlikely to be the case where what is asked for is the patient’s own medical notes. An attempt by the Secretary of State for Health to plead public interest immunity to avoid disclosure of records in the actions brought by several haemophiliac patients who had contracted HIV from contaminated blood products failed.⁸³

Proving negligence: the role of the expert

8.13 We come now to the heart of the problem. How does the patient prove negligence?

How does the claimant discharge the onus of proof laid on him?⁸⁴ He will be heavily reliant on expert testimony. He will need to put forward medical evidence to demonstrate: (1) that there was negligence on the part of the defendant, or a person for whom the defendant was responsible; and (2) that the relevant negligence caused the harm of which he complains. Obtaining expert evidence used to be a nightmare for patients. Doctors were unhappy about voicing public criticism of a colleague. Doctors in the same hospital may remain unwilling to testify against each other. However, greater openness does mean that today most patients should be able to obtain medical expert advice fairly locally. Before looking further at the rules governing medical expert witnesses, we should distinguish between ‘expert’ and ‘professional’ witnesses. The expert witness testifies as to his expert opinion on the facts of the case referred to him, a case that he will not have been involved in personally. The professional witness gives evidence about what occurred in the series of events that led to harm to the claimant on the basis of what he saw and heard.⁸⁵

Until the Civil Procedure Rules came into force, unrestricted freedom for each side to call its own experts sometimes made a mockery of justice.⁸⁶ The Civil Procedure Rules are explicit and emphatic, the expert’s primary duty is owed to the court to assist the court in matters involving his expertise, and this duty to the court ‘overrides any obligation to the person from whom instructions were received or by whom the expert is paid’.⁸⁷ The Civil Procedure Rules also impose limits on the use of expert evidence. Expert testimony must be restricted to what is reasonably required to resolve the case.⁸⁸ The court has power to direct the appointment of a single joint expert rather than each party choosing their own experts.⁸⁹ Obviously if a single expert is to be appointed, it makes sense for the parties themselves to agree on such an expert. Lord Woolf saw no reason why, in a straightforward clinical negligence claim up to a value of £10,000, parties should not be able to agree on a single expert. Such cases may necessarily not be all that common. They are likely to be limited to cases where there is no substantial medical dispute about causation or prognosis, and perhaps all that is in issue is the appropriate measure of compensation. Many clinical negligence cases will involve disputes about whether there was negligence at all, whether the negligence caused the injuries of which the claimant complains, and what the likely prognosis for the claimant will be. Such issues may well require separate experts. Imagine a claim that a child was brain-damaged allegedly because of a mismanaged delivery. Obstetric evidence will be needed to establish if the obstetrician was negligent. Neurologists may have to be called to testify to the likely cause of the brain damage. Paediatricians and rehabilitation experts will be required to assess how the child can best be cared for into adulthood. Multiple experts may be unavoidable. Nonetheless, control of proliferation of expert evidence will be asserted by the court. Where practical, a single joint expert must be agreed in relation to any particular issue. So if there is a real and substantive dispute about whether the obstetrician was negligent, each party will probably be allowed to call its own obstetric expert, but, save in the most exceptional case, not more than one expert each. If there is no especial complexity about causation, a single expert should be agreed to address that issue. As much of the expert evidence as possible should be in writing. Oral testimony is allowable only with the permission of the court.

Where there are multiple experts, all letters, documents and instructions must be disclosed to the experts and there must be mutual disclosure of all experts’ reports. Experts’ meetings are encouraged. The hope may be that at such a meeting, the experts will resolve the differences between them and promote resolution of the case without proceeding to a hearing. Initially it was envisaged that experts would meet alone and conduct a quasi-scientific seminar. Lawyers and their clients were uncomfortable with such a process which could be seen as surrendering the judicial process to the doctors. Additionally the objective of resolving proceedings more speedily might well be frustrated. The parties would not accept the experts’ conclusions as binding. Consequently it was agreed that the parties’ lawyers may be present at experts’ meetings.

How expert are the experts? In a number of criminal and family law cases the accuracy and even integrity of some experts were challenged. The GMC brought disciplinary proceedings against a very senior paediatrician, Sir Roy Meadow, and found him guilty of serious professional misconduct. He challenged the finding and his erasure from the register. The Court of Appeal ultimately struck down the finding of serious misconduct, but held that expert witnesses have no immunity from disciplinary proceeding when giving expert testimony.⁹⁰ This and other cases have caused great controversy.⁹¹ In Jones v Kaney,⁹² the Supreme Court ruled that the historical immunity from litigation long enjoyed by expert witnesses should be abolished. The need for better training and accreditation of experts is widely agreed on. The GMC now offers doctors guidance on giving expert evidence.⁹³

May the burden of proof shift to the doctor?

8.14 While in the majority of cases the patient must prove negligence and the doctor is not called on to prove her ‘innocence’, are there ever occasions when that burden shifts to the doctor? There is a general rule of the law of negligence that where the defendant is in complete control of the relevant events, and an accident happens which does not ordinarily happen if proper care is taken, then the accident itself affords reasonable evidence of negligence. The defendant will be held liable unless he can advance an explanation of the accident consistent with the exercise of proper care. This rule is known as res ipsa loquitur (the thing speaks for itself). Res ipsa loquitur can be applied in clinical negligence cases, but the courts have sometimes seemed reluctant to do so. At first, it was argued that res ipsa loquitur applied only where everyone of reasonable intelligence would know that that sort of accident did not ordinarily happen without negligence. As most people are not medically qualified, how could they know whether the accident to the patient was one which could, or could not, happen, if proper care was taken? The Court of Appeal said that expert medical evidence was admissible to establish what should and should not occur if ordinary care was exercised.⁹⁴ Res ipsa proved to be a boon in the following kind of case. Sometimes after an abdominal operation, a swab, or even a pair of forceps, is discovered in the patient’s body. Without evidence of a quite exceptional nature, it is clear someone has been careless. Res ipsa may also help the NHS patient who has undoubtedly suffered because someone was negligent, either in the theatre, or in the course of post-operative care, but she cannot identify that someone. If every member of the staff who might be responsible is employed by the hospital, then an inference of negligence is raised against the hospital, who are necessarily vicariously liable for whoever may be the culprit.⁹⁵ So in Cassidy v Ministry of Health,⁹⁶ a patient was operated on for Dupuytren’s contraction affecting two of his fingers. After the operation, the patient’s hand and lower arm had to be kept rigid in a splint for up to fourteen days. When the splints were removed, the plaintiff’s whole hand was paralysed. Upon finding that all the staff involved in Mr Cassidy’s care were NHS employees, the court held that there was evidence of negligence against their common employer. The onus shifted to the hospital to explain how this disaster might have struck without any of its employees being negligent.

Beyond this kind of obvious bungling, res ipsa has limited use in clinical negligence claims. In many operations, the source of greatest danger for the patient lies not in the surgery itself, but in the anaesthetic. An anaesthetic mishap will not usually be of itself evidence of negligence, although res ipsa was applied in Saunders v Leeds Western Health Authority.⁹⁷ The patient was a 4-year-old girl in otherwise perfect health who was undergoing surgery to correct a congenitally displaced hip. She suffered a cardiac arrest and consequent brain damage. Mann J said: ‘It is plain from evidence called on her [the child’s] behalf that the heart of a fit child does not arrest under anaesthesia if proper care is taken in the anaesthetic and surgical processes’.

The Court of Appeal⁹⁸ has however made it clear that res ipsa will rarely be applicable in such cases and criticises the phrase itself. It can arise only when either what happened simply cannot normally happen with negligence (for example, the patient went into theatre for surgery on his left foot and comes out with surgery having been performed on the right foot) or where expert evidence agrees, that without negligence, such an adverse outcome is highly unlikely. An unexpected outcome in itself will not raise any inference of negligence. More recent cases seek to avoid the very language of res ipsa with judges preferring to take a common sense view of the facts and how far the facts call for an explanation from the defendants as to any apparent failure in the patient’s care. So in Richards v Swansea NHS Trust⁹⁹ the court held that the length of the delay in moving to carry out a caesarean section required some explanation as to why the surgery was not performed more expeditiously and when no such evidence was forthcoming, the judge held that the claimant had established the breach of a duty of care. In Thomas v Curley,¹⁰⁰ the Court of Appeal held that even if res ipsa did not apply, the occurrence of injury in an uncomplicated operation and at a site other than where the operation took place called for an explanation and in the absence of a satisfactory explanation negligence could be proven. Mason and Laurie¹⁰¹ suggest that res ipsa as a phrase should be consigned to history and we should rather refer to a prima facie case.

Even in cases of obvious negligence, such as the forceps left in the abdomen, where the facts give rise to an inference of negligence, problems surface if one of the staff caring for the patient is not an employee of the hospital. For example, the theatre sister may be an agency nurse. Can the hospital say, ‘No inference of negligence is raised against us because the negligent actor may well have been that nurse for whom we are not responsible’? It now seems established that the hospital will be directly liable for any failure to measure up to the required standard of skill and care.¹⁰² If the hospital is directly liable, it matters not to the patient who actually employs the negligent individual. The private patient may be less fortunate. Whether he enters an NHS, or a private hospital, he will usually contract separately with the surgeon and the anaesthetist for surgery and anaesthetic. The surgeon and the anaesthetist will not be acting as employees of the hospital. If something goes wrong in the operating theatre or post-operatively and it is not clear who is to blame, res ipsa probably cannot be invoked. The hospital is not liable for any negligence on the part of the surgeon or anaesthetist. He can raise an inference of negligence against the hospital only if he can trace the relevant negligence to one of their staff. He can raise an inference of negligence against the surgeon or anaesthetist only if he can pin the relevant act on one of them personally.

If the surgeon, anaesthetist and hospital are all sued, none of them can be compelled to testify against each other. The patient will not be able to identify who was negligent. However, hope lies in the following statement made long ago by Lord Denning:

I do not think that the hospital and [the doctor] can both avoid giving an explanation by the simple expedient of throwing responsibility on to the other. If an injured person shows that one or other or both of two persons injured him, but cannot say which of them it was, then he is not defeated altogether. He can call on each of them for an explanation.¹⁰³

Thus robust common sense would force open any ‘conspiracy of silence’.

Awards of compensation¹⁰⁴

8.15 Once a patient has established that there has been negligence by the defendant as a result of which he suffered harm, what damages will he receive? There are no special rules governing clinical negligence awards. The patient’s damages will be assessed to compensate her for any actual, or prospective, loss of earnings, and for the pain, suffering and disability which she has endured, and will endure. Her compensation for loss of earnings will include a sum representing any period in which she would have expected to be alive and earning but because of her injuries she will be prematurely dead.¹⁰⁵ Additionally, for these sums to represent what she has lost, the patient will be awarded an amount to cover extra expenses which she and her family will incur. If she requires intensive nursing care, or her house needs adapting to her invalid needs, or she requires constant attendance so that her husband gives up his job, all these expenses will be reflected in the award of damages.¹⁰⁶ It is important to note that the amount of compensation will be tailored to the claimant’s actual circumstances and losses. So in Miller v Imperial College Healthcare NHS Trust¹⁰⁷ a 63-year-old claimant lost her leg as a result of clinical negligence but she continued to work at least two days a week and so her future loss of earnings still fell to be assessed. If the patient is dead, the damages awarded to her family will reflect the loss to them of the moneys she regularly expended on them. They recover for their loss of dependency.¹⁰⁸ It takes little imagination to see that if the patient dies, the burden of compensation may be reduced. Dead he suffers no pain. Dead he incurs no expenses.

Returning to the living patient, thorny problems bedevil the question of damages. The first is this. The patient must usually sue within three years. At that stage, a prognosis about future health is speculative. All his medical advisers may be able to say is something like this. The patient has a degree of brain damage. He is mildly disabled now. There is a 20 per cent chance he may deteriorate to become paralysed, and totally unable to do anything for himself, in ten years’ time. The court can make an award of provisional damages based on the assumption that the prospect of further damage or deterioration will not materialise. Should it do so at some later date, the patient may return to court to ask for a further award to compensate him for the consequences of that damage or deterioration.¹⁰⁹

Until recently, courts had to struggle to assess damages on a once and forever basis. The exercise was particularly difficult when estimating claims for future expenses, especially where the patient is so badly injured as to be unable to manage his own affairs. Large sums of money can be claimed to cover the cost of future care in expensive nursing homes. But there is no guarantee that that money will be so spent. The patient may be consigned to the NHS and the money deposited to grow with interest and eventually, when the patient dies, to form a windfall for relatives. The courts are alert to this danger. They will seek to ensure that the sum awarded is such as will be wholly exhausted by care of the patient, aiming at no surplus as a bonus for relatives. Plans for care must be realistic, and section 5 of the Administration of Justice Act 1982 provides that ‘any saving to the injured person which is attributable to his maintenance at public expense … in a hospital … or other institution shall be set off against any income lost’. A further anomaly in the law is that the claimant may be able to claim for the full cost of any private medical care regardless of whether such facilities are available free on the NHS.¹¹⁰ Even where exactly identical surgery to alleviate the patient’s condition could have been performed without charge, the claimant may demand the full cost of private care.

Once the patient’s monetary losses have been quantified, consideration must then be given to how to compensate pain and suffering. Levels of compensation for those non-monetary losses have traditionally been much lower in this country than in the USA. The sum to be awarded is based on a ‘tariff’ system with guidance as to what sum each category of injury should attract.¹¹¹ In 1986, the Court of Appeal ruled that £75,000 was the ‘tariff’ to compensate the suffering of a young woman left tetraplegic (paralysed from the neck down).¹¹² Incrementally that sum crept up to about £100,000. Claimants felt that £100,000 for a lifetime of suffering was ludicrously low. The Law Commission conducted a review of compensation for pain and suffering and recommended that compensation for pain and suffering should be increased dramatically, in some instances of catastrophic injury, by as much as 100 per cent.¹¹³ In Heil v Rankin,¹¹⁴ the Court of Appeal considered the Law Commission’s proposals. An especially enlarged court agreed that more generous compensation for suffering and disability was justified. They settled on a lesser increase than that envisaged by the Law Commission. No increase should be offered in claims of less than £10,000. Graduated increases would be allowed thereafter to a maximum of about 50 per cent above prior levels of awards. Their Lordships acknowledged that the impact on the NHS of increased levels of damages played a role in motivating their caution.¹¹⁵

Other changes in the law relating to damages have also contributed to the increase in compensation payable in negligence claims against the NHS.¹¹⁶ Medical skills means patients who suffer injury as a consequence of medical mistakes live much longer. Greater opportunities exist to improve their quality of life. Such benefits escalate costs. The concern generated by spiralling awards of damages is exacerbated by the fact that compensating people for injury can never be an exact science.

Claimants and defendants are often unhappy with the level of compensation awarded. For example, when negligence results in a patient’s death, compensation for bereavement is only available to parents of children under 18, or to spouses. The level of compensation is set at £12,890. The child left desolate at the loss of her father receives no compensation for her emotional loss. The parent losing a child is told her child is worth £12,890. This amount can be seen as an insulting assessment, but can any sum compensate bereavement? Was the old rule that bereavement damages were never available preferable? When a patient survives paralysed from the waist down, will £150,000 heal her pain? Defendants also feel badly done to. Who the patient is may be crucial to the extent of their liability. Should one of us be left paralysed by an anaesthetist’s mistake, the defendant hospital will have to cover the cost of future care and of equipment we will need, such as wheelchairs and alterations to our home. Providing that we can still go on lecturing, even if seated, our loss of income will be minimal. Should England’s football captain suffer an identical mishap at the height of his career, his claim for loss of income could easily exceed £20m.¹¹⁷ The lottery element in compensation awards was graphically illustrated by the case of Hollie Calladine.¹¹⁸ Nine-year-old Hollie was awarded £700,000 in respect of brain damage caused by negligence during her birth. Much of this sum was to cover the expense of her future care. Days after the award was made, Hollie died. The hospital tried unsuccessfully to recover their damages.

This sad case must suggest lump sum payments are not accurate or fair. The only equity of the system is that both sides suffer. For every case like Hollie Calladine’s, there is another where claimants go grossly under-compensated by any lump sum payment. A young man of 23 is injured in the course of surgery. Doctors estimate he will live a further ten years. He survives for twenty-five years. His compensation will be less than half of what he required.

Periodical payments – structured settlements¹¹⁹

8.16 Some of the uncertainties generated by having to assess compensation as a lump sum are avoidable by resort to reviewable periodical payments or, as they used to be described, structured settlements. The claimant receives an initial capital sum to cover actual losses already quantifiable and such matters as compensation for pain and suffering. The remainder of the money is used by the defendant to purchase an annuity for the claimant’s benefit. The annuity will be flexible to adapt to the changing circumstances of the patient.¹²⁰ The income received by the patient is not taxable. The money paid out will be what he requires and no more. Should he die earlier than anticipated, payments will cease. Periodical payments avoid cases like that of Hollie Calladine. In certain cases, the periodical payments agreed or ordered can be reviewed at a later date. In ordinary personal injury claims, the defendant’s insurer arranges the settlement and negotiates the purchase of annuities. As we have seen, the NHS does not insure against liability for clinical negligence on the commercial market. NHS structured settlements are usually self-financed.¹²¹ The NHS uses its own income to arrange periodical payments, building the settlement into budgets. Tax concessions aid this process. Periodical payments in large claims may save the NHS some money. Since 2005 the courts have been able to impose a Periodical Payments Order (PPO).¹²² Until 2005, structured settlements could only be established with the agreement of both parties. Periodical payments may be efficient and fairer. The overall size of some awards for catastrophic injury is unlikely to drop. In 2012 there was a record personal injury claim pay-out of £23m,¹²³ compared to a maximum claim of £16,500 in the mid 1970s.¹²⁴ In 2015 the NHSLA had around 1,500 ongoing periodical payment cases ‘on its books’.¹²⁵

Malpractice crisis: reality or illusion?

8.17 Bringing a claim for compensation, in any but the most straightforward of cases, is rarely easy. Yet despite the obvious difficulties associated with funding a claim and proving negligence, critics of the civil justice system have long argued that England has succumbed to a ‘compensation culture’. Personal injury claims, it has been said, are stifling ordinary life. ‘Gold-diggers’ make spurious claims. Schools are afraid to let children engage in any sort of risky activity. Children are barred from conker fights without wearing goggles.¹²⁶ Lord Hobhouse suggested:

The pursuit of an unrestrained culture of blame and compensation has many evil consequences and one is certain interference with the liberty of the citizen.¹²⁷

In May 2010 Lord Young was asked to review the effect of health and safety legislation in particular. While Lord Young acknowledged¹²⁸ that there is great deal of exaggeration in the media about a compensation culture, he aroused the wrath of lawyers acting for claimants in personal injury claims by attacking the advertising of lawyers’ services and saying that they should be ashamed.¹²⁹ In the context of clinical negligence claims, this alleged compensation culture, it is argued, results in a malpractice crisis. The NHSLA contends that the rise in claims over recent years is due to a number of factors including more patients being treated, more incidents being reported and more patients claiming compensation when incidents are reported.¹³⁰ It has been argued that increased litigation means that doctors practise ‘defensive medicine’. A doctor will choose the treatment for the patient most likely to be ‘legally safe’ to ensure that he will not be sued by the patient. That treatment may not necessarily be medically best for the patient, and may be unnecessarily expensive and time-consuming. A common example of alleged defensive medicine is a decision to carry out a caesarean section as soon as there is any sign of difficulty in the course of labour, rather than to run the legal risk of continuing to attempt a natural delivery. And, it is contended that the NHS is drained of resources because so many people sue.

Defensive medicine

8.18 The prospect that doctors will base decisions concerning treatment, not on their professional judgement of what is best for the patient, but on what is ‘legally safest’ for the doctor, does sound appalling. But is there hard evidence that doctors are being forced to practise defensive medicine?¹³¹ The classic example often given of defensive medicine – the rise in the rate of caesarean sections – has often been found to be explicable by many other factors. Caesarean rates rose in several countries, not all of which experienced rising litigation rates. Nonetheless, obstetricians have voiced a subjective belief that fear of litigation makes them more ready to move swiftly to surgery rather than allow a difficult labour to proceed.¹³² Then there is the question of what is meant by defensive medicine. In the House of Lords nearly thirty years ago, Lord Pitt argued that the rising tide of litigation meant that doctors ordered unnecessary and sometimes painful tests, and he predicted ‘an increase in defensive medicine with an alarming waste of resources’.¹³³ The difficulty is to decide when further tests and cross-checks cease to be a sensible precaution in the interests of the patient and become a waste of resources.¹³⁴

Some of the concerns felt by doctors about defensive medicine may stem from anxiety that this country will see the excesses of malpractice litigation in the USA cross the Atlantic.¹³⁵ But we should note first that in the USA, most medical care is provided by the private sector. If your treatment goes wrong and you suffer a medical accident, you will have to pay out more money for corrective treatment. Naturally an aggrieved patient is going to be looking to the doctor whom she perceives as responsible for the accident for the money to pay for any necessary corrective treatment. Most patients will carry private health insurance. Their insurers will be as keen as the patient to ensure that any costs, arising from medical negligence, are recovered from the doctor and his insurers. In a private health system such as that of the USA, healthcare is charged on a fee-for-service basis. The more tests a doctor carries out, the more money he makes. Perhaps some of the apparent evidence for ‘defensive medicine’ is better explained as ‘expensive medicine’?

Note too that awards of damages in the USA are decided not by a judge, as is the case in England, but by a jury. Even though the Court of Appeal in Heil v Rankin¹³⁶ and later Simmons v Castle¹³⁷ have raised the tariff for compensation to pain and suffering in this country, levels of compensation remain infinitely more generous in the USA. Moreover, currently damages in this country are awarded solely for the purpose of compensating the patient for what he has lost as a result of the defendant doctor’s negligence. A US jury is empowered in certain circumstances to double, or even treble, compensatory damages by making a further award of punitive damages, to punish the defendant for negligence.¹³⁸ Combining these factors, the CMO found that while malpractice litigation consumed 0.2 per cent of gross domestic product in the USA, that figure was only 0.04 per cent in the UK.¹³⁹

Finally, lawyers acting for clients in the USA act on a contingency fee basis. If the case fails, the client pays nothing; if the claim succeeds the lawyer takes a percentage of the damages, normally about one-third. Such a system gives lawyers a direct interest in the level of damages awarded. With the introduction of a form of contingency fee arrangements ‘damages based agreements’ in LASPO¹⁴⁰ we will have to see what effect this may have in England.

Financial costs to the NHS

8.19 However, the financial effects of litigation on the NHS have generated serious concern for many years now. A study of medical litigation¹⁴¹ published in 1988 first raised alarm, demonstrating that numbers of claims against doctors doubled between 1983 and 1987. In 1999 to 2000, the National Audit Office¹⁴² reported that 10,000 new claims were initiated against the NHS. The cost to the NHS had escalated. Between 1983 and 1987, the average cost of compensation doubled. And overall, litigation cost the NHS £300m.¹⁴³ In March 2000, £2.6bn was set aside to meet the cost of claims, and an estimated £1.3bn was estimated as needed to meet claims not yet reported. Since 1995 to 1956, the cost of litigation to the NHS had increased sevenfold. In claims worth less than £50,000 in 1999 to 2000, costs exceeded compensation in 65 per cent of cases. One health minister was provoked to declare:¹⁴⁴ ‘The only place for a lawyer in the NHS is on the operating table’.

The steep rise in claims appeared to stall in 2004/5, when the number of claims fell from 6,251 in 2003/4 to 5,609. By 2013/14 claims and the cost to the NHS were rising again, to fall marginally in 2014/15. In 2013/14 the NHSLA received 11,945 new claims up by 1,816 from the previous year. It may be that 2013/14 was an aberrant year and the dramatic rise in claims is in part explicable by the fact that the ‘vast majority’ of claims reported to the NHSLA in 2013/14 were conducted under the pre-LASPO arrangements, ie with the support of legal aid or the more client-friendly CFA rules that applied before LASPO.¹⁴⁵ In 2014/15 the number of claims fell a little to 11,497.

In 2014/15 the NHS paid out nearly £1.4bn in relation to legal claims for clinical negligence.¹⁴⁶ In some (particularly low to mid-value) claims the costs claimed by their solicitors exceeded compensation paid to the client. Once such case involved a claim settled for £2,000. The claimant’s solicitors presented a bill for £53,529.60. This was disputed by the NHSLA and costs were assessed at £12,146.59,¹⁴⁷ but the NHSLA has little control on costs incurred before the claim is reported to them. In 2014/15 the NHSLA paid £109.9m to their defence lawyers but received claims for costs from claimants’ solicitors for successful claims of over £326m. The NHSLA expresses great concern about disparity in costs, stating:

We are seeing an increasing number of plainly excessive and disproportionate costs bills, the presentation of which coincides with the banning of success fees and the reduction of the recoverability of the full cost of after the event (ATE) insurance against the defendant. We have successfully challenged a substantial number of these bills and in many cases achieved significant savings.¹⁴⁸

The NHSLA estimates that its total liability in relation to clinical negligence (the ‘theoretical cost’ of paying all outstanding claims including the incidents not yet reported to the NHSLA) amounts to £26.1 billion.¹⁴⁹ How efficiently are claims dealt with? In claims of above £10,000 which were closed in 1999 to 2000, the time from making the claim to settlement or an award of damages was on average five and a half years.¹⁵⁰ Claims are now dealt with much more swiftly. The average time to deal with a claim is now just under 1.31 years and fewer than 12 months in relation to claims of less than £25,000.¹⁵¹ How do claims fare? In relation to claims handled by the NHSLA from 1 April 2014 to 31 March 2015, over 4,000 clinical negligence claims were resolved without payment of damages.¹⁵² The major remaining problem seems to lie in legal costs, especially in relation to low-value claims. Worryingly, for both patients and the NHS, the NHSLA reports evidence that a number of solicitors’ firms with no expertise in clinical negligence are taking on claims ratcheting up costs with little hope of success for their clients.¹⁵³

Any judgement about whether the number of clinical negligence claims brought is excessive must be made in the context of estimates of the numbers of medical errors causing harm to patients. In one survey in 2005, 2,081 deaths were attributed to error.¹⁵⁴ It has been estimated that 10 per cent of ‘in patient episodes’ result in some injury to patients and that half of these ‘adverse events’ may be preventable.¹⁵⁵ The figure of 11,497 claims for clinical negligence suggests that many patients or families who could sue do not do so.

Nevertheless, where a claim is made by an NHS patient, money to compensate an injured patient, and money to defend claims brought in respect of alleged negligence must come out of NHS funds which might otherwise have been used to employ an extra surgeon, or pay for a new neonatal unit, or support a programme of preventive medicine.¹⁵⁶ When NHS money is used to compensate an injured patient, some benefit to society can be discerned. The disproportion between costs and compensation remains disturbing. John Harris¹⁵⁷ has argued that claimants in clinical negligence should compete for scarce resources with patients in urgent need of treatment. If resources for treatment are rationed, so compensation for medical accidents should be too. Costs arguments too must be kept in proportion. In 2003, the CMO found that just under 1 per cent of the NHS budget was expended on malpractice litigation.¹⁵⁸ The Daily Telegraph has claimed that the bill to the NHS for clinical negligence may soon reach 20 per cent of the NHS budget.¹⁵⁹

The Department of Health warns that further action is needed to address increasing claims and costs: ‘Any action will need political will and public understanding to dispassionately take action to bring to a halt the steep rise in claimant costs, the level of damages and the rates charged for legal representation of claimants’.¹⁶⁰ Four options are tabled for further discussion:

•  mandatory fixed costs for clinical negligence claims (with damages up to £100,000);

•  increase in the court discount rate;

•  removing recovery of any reimbursement for ATE insurance from clinical negligence claims; and

•  changing the assessment and cost of long-term care.¹⁶¹

LASPO is a stark reminder of the hefty price tag on access to justice and the sacrifices required in an era of austerity.

Wider ‘costs’ to the NHS

8.20 Financial costs to the NHS are not the only cause for concern. Critics of the medical litigation process argue that it is unfair to doctors and damaging to the doctor–patient relationship. Are doctors unfairly treated? The evidence does not substantiate such a claim: 46 per cent of claims fail,¹⁶² and of claims settled out of court, many will result in limited compensation to the claimant. Claimants do not seem to be ‘winning’ disproportionate numbers of cases, and bringing a claim after 2013 is ever more difficult. Nor does an argument that doctors are unjustly judged by lawyers, stand up to scrutiny. For, in deciding whether a doctor is negligent, in the majority of cases the court relies on expert professional opinion.¹⁶³ A doctor can normally only be found to be negligent if his peers testify to his negligence. The House of Lords in Bolitho v City & Hackney Health Authority¹⁶⁴ has endorsed judicial power to disregard expert testimony in exceptional cases. Evidence of adequate practice to rebut a claim of negligence must be shown to be ‘logical and defensible’. Doctors cannot really complain if courts refuse to accept evidence of ‘illogical or indefensible’ practice.

What is true is that many doctors have become so frightened by the spectre of a malpractice crisis that doctor–patient relationships may be damaged.¹⁶⁵ Evidence of defensive medicine may be disputable; defensiveness in medicine is a sad fact.¹⁶⁶ Doctors in ‘high-risk’ specialties such as obstetrics and anaesthetics are the worst affected among the profession. Doctors who are sued are concerned about: ‘the damage to their professional reputation, whether they were found negligent or not: the fact of the case was sufficient for the damage to reputation and morale’.¹⁶⁷ The CMO noted: ‘Legal proceedings for medical injury frequently progress in an atmosphere of confrontation, acrimony, misunderstanding and bitterness’.

¹⁶⁸

Clinical negligence litigation is often traumatic for all the parties, but unless complaints procedures and other avenues for redress can be seen to be fair and transparent, little is likely to change, save for growing resentment on the part of the patient-claimant priced out of the civil litigation system.

¹  For practical advice, see A Buchan, Buchan and Lewis Clinical Negligence: A Practical Guide (7th edn, 2012) Tottel. An extremely helpful, but not wholly impartial, account of the impact of malpractice litigation can be found in Chief Medical Officer (CMO), Making Amends: A Consultation Paper Setting out Proposals for Reforming the Approach to Clinical negligence in the NHS (2003) DH (hereafter CMO, Making Amends).

²  See NHSLA, Factsheets 1–5 (2015). The NHSLA website is a rich source of information on clinical negligence claims against the NHS. See www.nhsla.com

³  NHSLA, Factsheet 3 (2015), p 2.

⁴  Lord Justice Jackson, Review of Civil Litigation Costs: Final Report (2009), accessible at www.judiciary.gov.uk/publications-and-reports/reports/review-of-civil-litigation-costs/civil-litigation-costs-review-intro

⁵  See 7.22.

⁶  See the comments from Lord Dyson in Gudanaviciene v Director of Legal Aid [2014] EWCA 1622.

⁷  See Legal Aid Handbook 2013/14, accessible at http:/legalaidhandbook.com; and see C Klage, S Trask, J Wheeler, ‘Legal Aid – But Not as We Know It: A Guide to the New Legal Aid Scheme for Personal Injury Following LASPO’ [2014] Journal of Personal Injury Law 29.

⁸  A civil servant appointed by the Lord Chancellor; LASPO, s 4.

⁹  LASPO, s 10(3); though see also Sched 1, Part 1, para 22.

¹⁰  Sched 1, Part 1, para 23.

¹¹  Ministry of Justice, Proposals for the Reform of Legal Aid in England and Wales (2010), para 4.165.

¹²  See M Taddia, ‘Medical Negligence: Unkindest Cut’ (2013) Law Society Gazette 14.

¹³  Guidance is available at www.gov.uk/legal-aid

¹⁴  LASPO, s 21. There is evidence that the reforms breach children’s rights under the UN Convention on the Rights of the Child. See Office of the Children’s Commissioner, The Impact of Legal Aid Changes on Children Since April 2013 (September 2014).

¹⁵  Review of Civil Litigation Costs: Final Report (2009) (hereafter the Jackson Report).

¹⁶  Ministry of Justice, Proposals for Reform of Civil Litigation Funding and Costs in England and Wales (2010).

¹⁷  Callery v Gray [2001] EWCA Civ 1246; [2002] UKHL 28.

¹⁸  Save for insurance premiums to cover expert witness fees.

¹⁹  [2012] EWCA Civ 1039.

²⁰  Simmons v Castle; Note [2012] EWCA Civ 1288.

²¹  Jackson Report (2009), ch 23.

²²  Ibid, para 1.4.

²³  See D Greene ‘A Civil Sea Change’ (2015) 165 New Law Journal 10.

²⁴  See the Law Society ‘Access to Justice’ campaign, accessible at www.lawsociety.org.uk/policy-campaigns/campaigns/access-to-justice

²⁵  M Taddia, ‘Medical Negligence: Unkindest Cut’ [2013] Law Society Gazette 14. But see 8.19 for the view of the NHSLA.

²⁶  ‘Lord Dyson Calls for Simpler Rules’ [2015] Law Society Gazette 2(1).

²⁷  See generally L Mulcahy, ‘The Market for Precedent: Shifting Visions of Clinical negligence Claims and Trials’ (2014) 22 Medical Law Review 274.

²⁸  HC(89)34 ‘Claims of Medical Negligence Against NHS Hospitals and Community Doctors and Dentists’; as amended by HGG(96)48; see M Brazier, ‘NHS Indemnity: The Implications for Medical Litigation’ (1990) 6 Professional Negligence 88; CMO, Making Amends, pp 53–55.

²⁹  See CMO, Making Amends, p 55. National Health Service (Clinical Negligence Scheme) Regulations 1996, SI 1996/251 (amended SI 2014/933).

³⁰  DH, Triennial Review of the NHSLA (July 2015), 6.14.

³¹  See CMO, Making Amends, pp 55–57.

³²  For the first three years of its life, the CNST was administered by the Medical Protection Society. The NHSLA also runs the Existing Liabilities Scheme dealing with claims prior to April 1999.

³³  See NHSLA, Reports and Accounts 2014–15 (2015) HC 293, pp 19, 23–24. And see the Compensation Act 2006, s 2.

³⁴  Though see C v Cumbria University Hospitals NHS Trust [2014] EWHC 61, where a claim was made against a midwife.

³⁵  Membership of a defence organisation is no longer required of hospital doctors. Most doctors retain membership of such a body to ensure access to individual legal advice, which could be crucial if a doctor faced disciplinary or criminal proceedings.

³⁶  See Bull v Devon Area Health Authority [1993] 4 Med LR 117, CA; Robertson v East Kent Health Authority [1999] Lloyd’s Rep Med 123.

³⁷  Child A v Ministry of Defence [2004] EWCA Civ 641, [32].

³⁸  See Cassidy v Ministry of Health [1951] 2 KB 343, per Lord Denning at 359–360; and Roe v Ministry of Health [1954] 2 QB 66, at 82.

³⁹  [1995] 2 AC 633, at 740. And see Miller v Greater Glasgow NHS Board [2010] CSIH 40.

⁴⁰  [2013] UKSC 66, [16], [23], [37].

⁴¹  [1998] Lloyd’s Rep Med 157.

⁴²  [1998] Lloyd’s Rep Med 161.

⁴³  [2004] EWCA Civ 641, CA.

⁴⁴  Ibid, [52].

⁴⁵  Ibid, [32].

⁴⁶  Ibid.

⁴⁷  [2004] EWCA Civ 641, [47].

⁴⁸  M Brazier, J Beswick, ‘Who’s Caring for Me?’ (2006) 7 Medical Law International 183.

⁴⁹  [2004] EWCA Civ 641, [54].

⁵⁰  [2009] EWCA Civ 1203. See also 11.12.

⁵¹  Ibid, [88].

⁵²  [2013] UKSC 66.

⁵³  Ibid, [24].

⁵⁴  NHSLA Report 2013/14 (2014) p 29.

⁵⁵  Ibid.

⁵⁶  Ibid.

⁵⁷  See Child A v Ministry of Defence, see 8.5.

⁵⁸  The routes to treatment abroad are discussed at 2.22.

⁵⁹  Consumer Rights Act 2015, s 49 (service to be performed with reasonable care and skill).

⁶⁰  But a CCG might be liable if they should have known and acted on information that a GP was not providing appropriate care; see Godden v Kent & Medway Strategic Health Authority [2004] Lloyd’s Rep Med 521.

⁶¹  For example, he did not know for some years that he had been given blood infected by CJD; N v UK Medical Research Council [1996] BMLR 83.

⁶²  See Godfrey v Gloucestershire Royal Infirmary NHS Trust [2003] EWHC 549.

⁶³  See, for example, Smith v Leicestershire Health Authority (1996) 36 BMLR 23.

⁶⁴  Access to Justice: Final Report to the Lord Chancellor on the Civil Justice System in England and Wales (1996) HMSO. See CMO, Making Amends, pp 86–87.

⁶⁵  Civil Procedure Rules, SI 1998/3132.

⁶⁶  Constitutional Affairs, Civil Justice Reform Evaluation: Further Findings: A Continuing Evaluation of the Civil Justice Reforms (2002).

⁶⁷  J Peysner, M Severatne, The Management of Civil Cases: The Court and the Post-Woolf Landscape (2005) Department for Constitutional Affairs.

⁶⁸  See Ministry of Justice Pre-Action Protocol for the Resolution of Clinical Disputes Clinical Disputes Forum (2015).

⁶⁹  See CMO, Making Amends, pp 95–96.

⁷⁰  See 1.6.

⁷¹  Brought into force by Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, SI 2014/2936, reg 20: ‘(1) A health service body must act in an open and transparent way with relevant persons in relation to care and treatment provided to service users in carrying on a regulated activity’.

⁷²  CQC, Regulation 5 and Regulation 20: Guidance for NHS Bodies (November 2014), p 16.

⁷³  And see Civil Procedure Rules1998, SI 1998/3132, Rule 31.16.

⁷⁴  Pre-Action Protocol for the Resolution of Clinical Disputes Clinical Disputes Forum (2015), para 3.7.

⁷⁵  And see Civil Procedure Rules, 1998 SI 1998 /3132, Rule 31.7 ss (1).

⁷⁶  Dunning v Liverpool Hospitals’ Board of Governors [1973] 2 All ER 454.

⁷⁷  See 4.17.

⁷⁸  See Chapter 9.

⁷⁹  CQC, Regulation 5 and Regulation 20: Guidance for NHS Bodies (November 2014).

⁸⁰  Waugh v BRB [1980] AC 521.

⁸¹  See Lee v South West Thames Regional Health Authority [1985] 2 All ER 385 CA; Naylor v Preston Area Health Authority 1987] 2 All ER 353 CA.

⁸²  Senior Courts Act 1981, s 35.

⁸³  Re HIV Haemophilia Litigation (1990) 41 BMLR 171, CA.

⁸⁴  In Laughton v Shalaby [2014] EWCA Civ 1450, the Court of Appeal ruled that claimants could not invoke bad character evidence about the defendant in order to bolster the case to prove negligence.

⁸⁵  The line may sometimes be blurred. See ES v Chesterfield North Derbyshire Royal Hospital NHS Trust [2003] EWCA Civ 1284, [10].

⁸⁶  See, for example, Whitehouse v Jordan [1981] 1 All ER 287, HL.

⁸⁷  Civil Procedure Rules 1998, SI 1998/3132, Rule 35(3): (1)It is the duty of an expert to help the court on the matters within his expertise. (2)This duty overrides any obligation to the person from whom he has received instructions or by whom he is paid.

⁸⁸  Ibid, Rule 35(1).

⁸⁹  Ibid, Rule 35(7).

⁹⁰  GMC v Meadow [2006] EWCA 1390. And see S Devaney ‘The Loneliness of the Expert Witness’ (2007) 15 Medical Law Review 116.

⁹¹  See C Williams, ‘The Trouble with Paediatricians’ (2010) 18 Medical Law Review 389.

⁹²  [2011] UKSC 13; and see S Devaney, ‘Balancing Duties to the Court and Client; The Removal of Immunity from Suit of Expert Witnesses’ (2012) 20 Medical Law Review 450.

⁹³  GMC, Acting As a Witness in Legal Proceedings (2013).

⁹⁴  Mahon v Osborne [1939] 2 KB 14.

⁹⁵  Roe v Ministry of Health [1954] 2 QB 66.

⁹⁶  [1951] 2 KB 343.

⁹⁷  (1985) 82 Law Society Gazette 1491.

⁹⁸  Ratcliffe v Plymouth & Torbay Health Authority [1998] Lloyd’s Rep Med 162, CA. And see Lillywhite v University College London Hospitals NHS Trust [2006] EWCA Civ 1466.

⁹⁹  [2007] EWHC 487.

¹⁰⁰  [2013] EWCA Civ 117.

¹⁰¹  JK Mason, GT Laurie, Mason and McCall Smith’s Law and Medical Ethics (9th edn, 2013) Oxford University Press, p 168.

¹⁰²  Woodland v Essex County Council [2013] UKSC 66: see 8.6.

¹⁰³  Roe v Ministry of Health [1954] 2 QB 66, at 82.

¹⁰⁴  See CMO, Making Amends, pp 65–76.

¹⁰⁵  This is known as compensation for the ‘lost years’; see Pickett v BRB [1980] AC 136, HL. And see the Damages Act 1996, s 3.

¹⁰⁶  The complexity of this exercise is well illustrated in A (A Child) v University Hospitals of Morecambe Bay NHS Foundation Trust [2015] EWHC 366 (QB).

¹⁰⁷  [2014] EWHC 3772 (QB).

¹⁰⁸  Fatal Accidents Act 1976, as amended by the Administration of Justice Act 1982.

¹⁰⁹  See Senior Courts Act 1981, s 32A and Chewings v Williams [2009] EWHC 2490.

¹¹⁰  Law Reform (Personal Injuries) Act 1948, s 2(4).

¹¹¹  See Judicial Studies Board, Guidelines for the Assessment of General Damages in Personal Injuries Cases (10th edn, 2010) Oxford University Press.

¹¹²  Housecroft v Burnett [1986] 1 All ER 332, CA.

¹¹³  Law Commission Report No 257, Damages for Personal Injury: Non-Pecuniary Loss (1999).

¹¹⁴  [2000] 3 All ER 138.

¹¹⁵  Ibid, at 150.

¹¹⁶  See Wells v Wells [1999] 1 AC 345, HL; Damages Act 1996.

¹¹⁷  See the compensation claim in 2010 for former Commonwealth Games cyclist Manny Helmot, who was awarded £13.7 million following a road traffic accident which left him with brain injuries, mental health problems and requiring twenty-four-hour care. See www.claimscouncil.org

¹¹⁸  See ‘Legal Moves’ (2001) 138 Liability Risk and Insurance 19.

¹¹⁹  See C Witting, Street on Torts (14th edn, 2015) Oxford University Press, pp 703–704. And see A Sands, ‘Periodical Payments – The Development of a Pragmatic Approach’ (2006) 74 Medico-Legal Journal 69.

¹²⁰  A key issue is indexation to allow for inflation. See Thompstone v Tameside and Glossop Acute Services NHS Trust [2008] EWCA Civ 5. And see R Lewis, ‘The Indexation of Periodical Payments of Damages in Tort: The Future Assured?’ (2010) 30 Legal Studies 391.

¹²¹  See CMO, Making Amends, p 74.

¹²²  See the Damages Act 1996, ss 2–2B (as substituted by the Courts Act 2003) and the Damages (Variation of Periodical Payments) Order 2005, SI 2005/841.

¹²³  See ‘Girl, 17, Wins Record £23 Million Payout for Car Crash Injuries’ (2012) Daily Telegraph, 19 November.

¹²⁴  See CMO, Making Amends, p 65.

¹²⁵  NHSLA, Reports and Accounts 2014–15 (2015) HC 293, p 32.

¹²⁶  See (2006) The Times, September 18.

¹²⁷  Tomlinson v Congleton Borough Council [2003] UKHL 47, [81].

¹²⁸  Lord Young, Common Sense; Common Safety (2010) HM Government.

¹²⁹  See ‘News: Lord Young Attacks Personal Injury “Lottery”’ (2010) Law Society Gazette 7 October 3(1).

¹³⁰  See NHSLA, Reports and Accounts 2014–15 (2015) HC 293, p 8.

¹³¹  See MA Jones, AE Morris, ‘Defensive Medicine: Myths and Facts’ (1989) 5 Journal of the Medical Defence Union 40, and in relation to defensive medicine in the USA, see DM Studdert, MM Mello, TA Brennan, ‘Medical Malpractice’ (2004) 350 New England Journal of Medicine 283.

¹³²  National Sentinel Caesarean Section Audit (RCOG, 2001) (www.rcog.org.uk).

¹³³  HL Official Report, 10 November 1987, cols 1350–1351.

¹³⁴  See generally, P Danzon, Medical Malpractice (1985) Harvard University Press.

¹³⁵  See CMO, Making Amends, pp 26–27.

¹³⁶  Heil v Rankin [2000] 2 WLR 1173, CA. See 8.15.

¹³⁷  [2012] EWCA Civ 1288; see 8.3.

¹³⁸  Although Law Commission Report No 247, Aggravated, Exemplary and Restitutionary Damages (1997) did propose that, in exceptional cases, punitive damages should be awarded in England.

¹³⁹  See CMO, Making Amends, p 26.

¹⁴⁰  See 8.3.

¹⁴¹  Ham et al, Medical Negligence: Compensation and Accountability (1988) King’s Fund.

¹⁴²  NAO, Handling Clinical Negligence Claims in England (2001). But see the criticism of the NAO Report in P Fenn, A Gray, N Rickman, ‘The Economics of Clinical negligence Reform in England’ (2004) 114 Economic Journal 272.

¹⁴³  Ham et al, Medical Negligence, p 26.

¹⁴⁴  See (1998) Guardian, 30 April.

¹⁴⁵  NHSLA, Report and Accounts 2014–15 (2015), HC 293, p 19.

¹⁴⁶  Ibid, p 4.

¹⁴⁷  Ibid, p 21.

¹⁴⁸  Ibid.

¹⁴⁹  DH, Triennial Review of the NHSLA (July 2015), 8.10.

¹⁵⁰  House of Commons Public Accounts Committee, Handling Clinical Negligence Claims in England, HC 280 (2002) PAC, p 6.

¹⁵¹  NHSLA, Report and Accounts 2014–15 (2015), p 19.

¹⁵²  Ibid, p 9.

¹⁵³  Ibid, p 21.

¹⁵⁴  See NAO, A Safer Place for Patients: Learning to Improve Patient Safety (2005).

¹⁵⁵  See CMO, Making Amends, pp 31–41.

¹⁵⁶  See A Merry, A McCall Smith, Errors, Medicine and the Law (2001) Cambridge University Press, p 212.

¹⁵⁷  J Harris, ‘The Injustice of Compensation for Medical Accidents’ (1997) 314 British Medical Journal 182.

¹⁵⁸  See CMO, Making Amends, p 26.

¹⁵⁹  L Donnelly, ‘NHS Negligence Claims Rise by 20 per cent in Just One Year’ The Telegraph (2013) 2 June.

¹⁶⁰  DH, Triennial Review of the NHSLA (2015), 6.3.

¹⁶¹  Ibid, 6.4; and see Chapter 9.

¹⁶²  NHSLA, Report and Accounts 2014/15 (2015), p 19.

¹⁶³  Bolam v Friern HMC [1957] 1 WLR 582. See 7.6.

¹⁶⁴  [1998] AC 232, HL. See 7.9.

¹⁶⁵  See CMO, Making Amends, p 76.

¹⁶⁶  Hence Ian Kennedy argued many years ago that what is required to defuse any ‘crisis’ is better information about the law for doctors so that they will not feel constrained to practise ‘defensive medicine’: see ‘Review of the Year 2: Confidentiality, Competence and Malpractice’ in P Byrne (ed) Medicine in Contemporary Society (1987) King’s Fund.

¹⁶⁷  See CMO, Making Amends, p 76. And note his estimate that 38 per cent of doctors who have been sued suffer clinical depression (ibid, p 43).

¹⁶⁸  CMO, Making Amends, p 7.

Chapter 9

COMPLAINTS AND REDRESS

9.1 When injury results from medical treatment, patients or their relatives seek accountability. Such cases are not limited to the kinds of injury that would give rise to a claim for clinical negligence, but may include poor care, rudeness and a failure to have real regard for the welfare of the patient. In these and other instances patients may seek redress when they feel that health professionals have let them down. This can take a number of forms. Some may wish the responsible health professionals to be disciplined, and we examined in Chapter 1 ways in which that might be achieved. When there is an injury to health, some seek financial compensation, and bring a clinical negligence claim (examined in Chapters 7 and 8). Many others simply want an explanation and an assurance that the same mistake will not be repeated. One case example published by the Parliamentary and Health Service Ombudsman¹ tells of Mrs F who had a blood test that revealed post-operative infection. Her deteriorating condition was monitored, but the consultant who operated on her did not review the case and the severity of her condition was not spotted for two days. She did not respond to treatment and died the next day. The son complained and received an apology. He did not seek financial compensation. An action plan was put into place to address the failings.²

In particularly serious cases of repeated error or bad practice, patients and families may demand a formal public inquiry. In other cases, the individual affected may make a formal complaint. Complaints are an important route to redress for patients and their families and also identify deficiencies in the care of patients. Robert Francis QC’s Report of the Mid Staffordshire NHS FT Public Inquiry 2013 (the Francis Report) lamented the lack of effective reaction to the persistently appalling standards of care:

In the end, the truth was uncovered in part by attention being paid to the true implications of its mortality rates, but mainly because of the persistent complaints made by a very determined group of patients and those close to them. This group wanted to know why they and their loved ones had been failed so badly.³

But, as we shall see, the NHS complaints procedure has come under fire for many years. Several attempts to reform the system have met with failure, especially in terms of providing explanations for mistakes. In New Zealand, where patients are compensated without proving fault through the Accident Compensation Corporation, adverse events are usually admitted.⁴ Here, doctors may fear that the complaints process will lead to patients seeking compensation in the courts. And so they may be reluctant to admit errors. An inadequate complaints system causes patients to lose confidence in it and choose to bring proceedings in court.⁵ Some patients sue simply to find out what really happened.⁶ An effective complaints system might both improve care and cut the litigation costs to the NHS.⁷

The NHS Constitution,⁸ which came into force in 2009, incorporates the right to make a complaint: but what is the substance of that right? The complaints system has been ‘reformed’ several times, in 1996, 2003, 2006 and 2009. Additional changes followed the enactment of the Health and Social Care Act 2012, in the form of a new independent consumer body called ‘Health-Watch England’; and from the Francis Inquiries,⁹ which include changes to the second of the two-stage complaints process: the Parliamentary and Health Service Ombudsman (PHSO).

Not only does the NHS Constitution incorporate a right to complain, it also reiterates the right to seek financial compensation.¹⁰ This is currently achieved through expensive clinical negligence litigation, examined in the last chapter. Acting on some of the CMO’s recommendations in Making Amends,¹¹ the NHS Redress Act 2006 is enabling legislation through which a fast-track process for small claims could have been developed. While the devolved government in Wales has developed secondary legislation to bring the scheme into effect,¹² England stalled and delayed and now seems unlikely to develop a scheme based on the Act. As we have seen in Chapter 8, other mechanisms to tackle the rising costs associated with negligence claims against the NHS were taken forward. The much criticised Legal Aid, Sentencing and Punishment of Offenders (LASPO) Act 2012 has impacted greatly on clinical negligence litigation. Yet costs keep rising, requiring the Department of Health to find new ways to reduce claims.¹³

We will consider complaints mechanisms having first outlined the ways in which services or individuals may be made the subject of a health service public inquiry in order that the NHS as a whole can benefit from the outcome of the investigation. In the second half of the chapter we will consider criticisms of the tort system and alternative proposals such as no-fault liability.

Health Service public inquiries¹⁴

9.2 Dissatisfaction with the outcome of complaints procedures in a number of high-profile cases fuelled a growing demand for public inquiries. Such inquiries colour popular perceptions of the NHS as a whole, even if they address the exceptional, rather than the routine grievance. Patients and patients’ organisations want a comprehensive and independent review, either of an inadequate service in general, or of the misconduct of particular individuals. They want to see the whole picture and receive assurance that action is being taken to remedy the shortcomings of the NHS and/or call to account staff whose wrongdoing caused serious harm.

A number of different procedures within the NHS provide for further investigation of such NHS ‘scandals’. An NHS inquiry may be established under section 2 of the National Health Service Act 2006,¹⁵ whereby the health minister has a general power to do anything calculated to facilitate the discharge of his duty. In serious cases, an independent team will be drafted in to conduct the investigation. Such an inquiry will be conducted by a small committee, usually consisting of a legally qualified chairman and two medical practitioners, one from the same specialty as the person whose competence is in issue. All inquiry members will be unconnected with the hospital where the complaint originated. Copies of all documents are circulated to all parties. The complainant and the subjects of the complaint may be legally represented, and cross-examination of witnesses is allowed. The committee’s findings of fact are then submitted to the staff concerned for further comment. Finally, the committee reports its findings and recommendations. The inquiry procedure can be effective, but if hospital staff refuse cooperation the procedure may break down altogether. No one can be compelled to attend the inquiry. NHS inquiries of this kind are relatively informal and lack coercive powers. The Morecambe Bay Investigation, chaired by Dr Bill Kirkup, looked at maternity and neonatal services between 2004 and 2013. It made forty-four recommendations for the trust and NHS.¹⁶

At the other end of the spectrum, the Department of Health may set up a formal, independent inquiry under the Inquiries Act 2005,¹⁷ where the matter is of sufficient public concern. When monitoring revealed poor progress in putting things right in Mid Staffordshire,¹⁸ the government ordered a formal, independent inquiry under the Inquiries Act 2005. The report was published in 2010.¹⁹ A further public inquiry report into the regulatory failures at Mid Staffordshire (the 2013 Francis Inquiry), referred to at 9.1, made 290 recommendations designed to effect culture change.²⁰

The Inquiries Act gives ministers the power to convert other types of inquiry, both statutory and non-statutory, into an Inquiry Act inquiry²¹ at which point the minister can change the terms of reference. The findings of an inquiry are not determinative of liability.²² Instead the aim is to restore public confidence and ensure that mistakes are not repeated. Under section 19(4)(d) of the Inquiries Act, wide-ranging restrictions on public access may be applied according to the requirements of the particular inquiry.

Where the inquiry is held in private people might be more willing to speak openly and honestly, but lack of openness can evoke hostile reactions. Patients involved in the many grievances caused by the conduct of Drs Neale and Ayling pressed the Secretary of State for Health for public inquiries. Richard Neale had been struck off the register in Canada in 1985, but continued to practise in Yorkshire long after that event. He was arrogant, overly optimistic about patients’ prognoses and undertook clinical procedures beyond his expertise. Clifford Ayling was convicted on twelve counts of indecent assaults on former patients in 2000. The Secretary of State refused a public inquiry in both cases. His decisions were unsuccessfully challenged in the courts. The resulting inquiries were private.²³ The Bristol Report²⁴ points out that private inquiries may be counterproductive. Holding the Inquiry in private may be ‘more likely to inflame than protect the feelings of those affected by the Inquiry’. And, the Report emphasises the need for transparent clear criteria determining when a public inquiry should be established. These warnings fell on deaf ears. In 2000, the Secretary of State announced a private inquiry into the murders committed by Harold Shipman. There was uproar from patients and media. A public inquiry was duly ordered in September 2000 under the Tribunals of Inquiry (Evidence) Act 1921. Patients will have less confidence in inquiries held behind closed doors. Government fears the cost of public inquiries both in terms of cash and to the reputation of the NHS.

Aligning complaints and redress

9.3 If an individual wants a swifter, more personalised investigation of his particular case, for example to find out why he lay on a trolley in a corridor for hours with no pain relief, he may make a complaint or, if he seeks financial redress (maybe because he fell off the trolley and broke a rib), he may initiate legal proceedings. Clinical negligence litigation has come under sustained attack in recent years. In particular, the blame culture has been perceived as adverse to the promotion of patient safety and proper accountability for error.²⁵ The Bristol Inquiry²⁶ called for the ‘abolition of clinical negligence litigation, taking clinical error out of the courts and the tort system’. Litigation should be replaced by effective systems for identifying and addressing errors and new no-fault-based provisions for compensation. Complaints and redress, including financial redress should be aligned.

Responding to such criticisms in 2003, the Chief Medical Officer (CMO) circulated a consultation paper, Making Amends,²⁷ setting out proposals to unify complaints and redress within the NHS. Making a complaint would no longer disqualify the individual from making a claim for compensation. The report focused on changing the culture of the NHS to one of openness and learning and restoring public trust. The report rejected the possibility of a comprehensive no-fault compensation scheme for medical accidents²⁸ in favour of a limited NHS redress scheme but one which, for the most part, remained wedded to the law of tort.

The NHS Redress Act 2006 gave the Secretary of State power to introduce a new scheme for certain claims for compensation relating to NHS hospital services. In theory it applies in England and Wales, but as yet no action has been taken to bring the Act into force in England. Promises in 2009 that the government would implement an NHS redress scheme once new complaints procedures were embedded,²⁹ have not been delivered. The future of the scheme in England is uncertain. Wales introduced an NHS redress scheme in 2011³⁰ which combines investigation and, where appropriate, explanation, apology and financial redress. Scotland, where the NHS Redress Act 2006 does not apply, proposes a more radical no-fault scheme.³¹ We explore all these proposals later in the chapter.³² We now turn to the complaints process.

Complaints procedures – a troubled history

9.4 A formal NHS complaints system was introduced in 1966. There were three separate schemes relating to primary care, clinical care and non-clinical care respectively. In 1996,³³ new procedures were introduced. One single complaints procedure became applicable throughout the NHS. Hospital doctors, GPs and other community-based health professionals were dealt with within a unified complaints system. A three-step process was established so that complaints were first subject to ‘local resolution’ which could be followed by an ‘independent review’ of the case, with an ultimate right to resort to the Health Service Commissioner, popularly known as the NHS ombudsman. The NHS ombudsman was finally empowered to investigate complaints about clinical judgement and his jurisdiction was extended to cover GPs. But patients complained that the second stage was not truly independent and that the process was complex, time-consuming and inefficient. Doctors were perceived as defensive and mistakes were repeated.

Revisions were made in 2004,³⁴ entrusting independent review to the Healthcare Commission, now the Care Quality Commission. A number of major inquiries necessitated further reform. The Shipman Inquiry and two private inquiries, the Neale and the Ayling Inquiries, considered the adequacy of the NHS complaints process. The Fifth Report of the Shipman Inquiry³⁵ made recommendations for improvements to the system, especially in relation to GPs. The National Health Service (Complaints) Amendment Regulations 2006³⁶ were duly enacted to improve local resolution and to align the NHS and social care complaints systems. Problems endured.³⁷ There were at least seven different routes for complaints about health services and many were poorly signposted.³⁸ Only 27 per cent of people making a complaint were satisfied in the way it had been handled.³⁹ The demand for independent review was seriously underestimated and timeliness and quality suffered.⁴⁰

The current Regulations, introduced in 2009,⁴¹ launched a single complaints system across health and social care. Applicants now have the right to local resolution, while simultaneously pursuing a legal claim.⁴² The second stage of a three-tier complaints system was abandoned. Where previously a complainant would start with local resolution and potentially progress to the independent Healthcare Commission and finally the Health Service ombudsman, those dissatisfied with local resolution now go straight to the ombudsman.

Raising a concern

9.5 A distinction is drawn between concerns and complaints. A concerned individual can talk informally to the designated complaints manager, or Patient Advice and Liaison Service (PALS) staff in each trust. PALS are concerned with wider patient safety issues. They will attempt to resolve the situation without the need for a formal complaint. Otherwise they can provide details of how to complain formally and refer complainants to the NHS Complaints Advocacy Service.⁴³ A new consumer body, HealthWatch England,⁴⁴ sits within the Care Quality Commission and supports a network of local HealthWatches.⁴⁵ The aim is to make it easier to feed back concerns to the Care Quality Commission, but there is evidence of inconsistent quality and inadequate advertising means that some people do not know where to go for help.⁴⁶ In 2015, proposed Standards for Complaints Advocacy were published, encouraging hospitals to make clear how to raise concerns or complain with linked independent support from HealthWatch or alternative organisations.⁴⁷

In the majority of cases the complaint is resolved informally, but if the individual wishes to proceed with a formal complaint there are potentially two stages to the process.

Local resolution

9.6 The first stage of the formal complaints process is to make a complaint at a local level. According to the 2009 Regulations,⁴⁸ a complaint may be made to any relevant NHS organisation. Each organisation must have a complaints manager, publicise complaints arrangements, and keep records of complaints which they must publish in an annual report and make available on request. A complaint can be made orally or in writing, by a patient or any person affected by actions, omissions or decisions made by an NHS organisation. Complaints can be made on behalf of a person where that person so requests, or has died, or is a child, or cannot make a complaint himself due to a lack of mental capacity.

At local resolution, the complaint must be investigated ‘speedily and efficiently’ and a response made ‘as soon as reasonably practicable’ including an explanation, conclusions and, where relevant, action to be taken.⁴⁹ What constitutes ‘as soon as reasonably practicable’ is open to conjecture. In 2006 a twenty-day target was extended to twenty-five days.⁵⁰ The 2009 Regulations removed the target altogether and the Health and Social Care Information Centre no longer publishes data on the time taken to resolve complaints at local level. The aim is to give local resolution every opportunity of success, so reducing the burden on the second stage of the complaints process.

The local NHS complaints process introduced in 2009 is streamlined and more user-friendly.⁵¹ Importantly, the 2009 Regulations remove an exclusion preventing complaints being considered where the complainant intends to take legal proceedings.⁵² But the beleaguered system faced criticism from a number of sources.⁵³ A year after the reforms were enacted, the ombudsman stated that ‘The NHS needs to listen harder and learn more from complaints’.⁵⁴ The implications of not doing so were made all too clear in the course of the Mid Staffordshire inquiries. Robert Francis QC’s 2010 report found that poor complaints procedures were a contributory factor in the failings of the trust.⁵⁵ The Health Select Committee proposed changes to the system in 2011.⁵⁶ And the Francis Report in 2013 made further recommendations for reform.⁵⁷ The government produced an initial response in 2013⁵⁸ and a subsequent response (following the Clwyd/Hart review)⁵⁹ eight months later.⁶⁰ The quality of complaints handling is, since October 2014, part of the Care Quality Commission inspections. And the PHSO, the Local Government ombudsman and HealthWatch England set out clear and universal expectations for local resolution in November 2014.⁶¹ But enduring problems were highlighted by the Health Select Committee in 2015:

The current system for complaints handling … remains variable. Too many complaints are mishandled with people encountering poor communication or at worst, a defensive and complicated system which results in a complete breakdown in trust and a failure to improve patient safety.⁶²

The Select Committee recommends a single gateway for complaints and concerns, better integration of complaints about health and social care and better treatment of whistle-blowers.⁶³ Meanwhile, the number of complaints continues to rise. In 2014 to 2015 the total number of hospital and community health service written complaints was 205,000, equivalent to 562 a day.⁶⁴

The Parliamentary and Health Service Ombudsman (PHSO)

9.7 Those dissatisfied with local attempts at resolution may, once local remedies to resolve the complaint have been exhausted, take their complaint to the Health Service Commissioner, better known as the NHS ombudsman. The post was established in 1973.⁶⁵ The ombudsman is independent of both the NHS and government, and unaffected by the 2009 Regulations. For complex or unresolved cases, she is the ‘Court of last resort’. The ombudsman is empowered to investigate any complaint where it is alleged that a failure in the health service or maladministration in the service resulted in injustice or hardship. She still may not pursue a complaint where the person concerned may have a remedy in the courts unless she is satisfied that it is not reasonable to expect the complainant to invoke that remedy.⁶⁶ The ombudsman only investigates complaints where the patient can show that he has ‘sustained injustice or hardship’⁶⁷ as a result of maladministration or a failure in the service, except in the case of complaints about clinical judgement where this restriction does not apply.

The ombudsman has been empowered to investigate action taken as a result of the exercise of the professional, clinical judgement of doctors or nurses since 1996.⁶⁸ By 2000 to 2001, 77 per cent of completed investigations concerned clinical judgement.⁶⁹ The nature of these complaints is varied. Traditionally, quite a number have dealt with the level of care provided by junior doctors, and the adequacy of supervision and support provided for junior staff. Dealing with complaints about clinical matters is not easy. Identifying whether a complaint has substance is time-consuming. Records must be obtained with the complainant’s consent. Clinical advice is required and often has to be sought from specialists outside the ombudsman’s office.

What then is the extent of the ombudsman’s power and influence today? Complaints to the ombudsman must be made in writing,⁷⁰ usually within twelve months of the event, by a patient or by some responsible person acting on his behalf. Health service organisations may also refer written complaints to the ombudsman.⁷¹ Her powers of inquiry are extensive. She and her staff investigate in private. They will contact all hospital, or primary care staff, involved in the complaint and seek their comments. The ombudsman has complete control of the investigation. If cooperation from hospital staff or administrators is not forthcoming, the production of records and documents may be ordered and staff may be compelled to testify to the ombudsman.⁷²

Investigations take considerable time and resources. The ombudsman has to select the most pressing complaints to follow up – many aggrieved patients will be turned away. On completion of an investigation, the ombudsman reports to the complainant, the relevant NHS organisation, and any individual against whom allegations were made. The report will contain a decision about whether the complaint was justified and recommend a remedy. The ombudsman might recommend action, or an apology, or systemic change – such as staff training or changes to policy – in which case the ombudsman will send copies to relevant regulators, such as the Care Quality Commission and Monitor, so that they can check progress. Sometimes compensation will be recommended for financial loss, or distress.⁷³ For example, when Mrs T was put on the wrong consultant’s list and endured a long journey and time off work to no avail, the ombudsman decided that it would be reasonable for the trust to pay not only travel costs (which the trust had reimbursed) but loss of earnings. The trust agreed to do so.⁷⁴ In 2013 to 2014 the ombudsman asked for 752 apologies, 628 compensation payments, made 631 recommendations for management action and 197 recommendations for other action to put things right.⁷⁵

Each year the ombudsman makes an annual report to Parliament published by HMSO and available to the public. The ombudsman’s activities are monitored by a Select Committee of MPs which encourage her in her work and spur her onto greater efforts on behalf of NHS patients. The Health Service Commissioner for England (Complaint Handling) Act 2015 amends the Health Service Commissioners Act 1993 to require that data on the time taken to conclude investigations is incorporated into the annual report. Furthermore, it requires the Commissioner to notify a complainant of the reason for the delay if the investigation of the complaint is not concluded within a twelve-month period.

The PHSO is one of a number of ombudsmen, whose functions may overlap. This can make the second stage of review particularly difficult to navigate. Take, for example, a patient in a care home. She might complain to the ombudsmen in relation to health matters; the Local Government ombudsman if her care is funded by the local authority; and would have no access to an ombudsman if her care was privately funded. We have seen that the Select Committee suggests a single entry point for complaints. Calls for reform extend beyond health and social care.⁷⁶ The government published a draft Public Services Ombudsman Bill in the 2015–16 parliamentary session. Designed to modernise the sector, it may create a single Public Service ombudsman.⁷⁷ Meanwhile, in light of the Francis Report⁷⁸ and amid continued criticism,⁷⁹ the ombudsman’s caseload increased from April 2013, with the Service investigating six times more complaints in 2013 to 2014 than the previous year. A reduction was made in the time taken to investigate a complaint, and the publication of anonymous case summaries increased transparency.⁸⁰ The ombudsman will produce a Service Charter in 2016 and consider extending its remit to serious cases that happened more than twelve months ago and allegedly led to avoidable death.

Private treatment

9.8 The Health and Social Care Act 2008 established the Care Quality Commission which, in April 2009, took over the regulation of health and social care, in NHS, private and voluntary organisations. All registered health-care providers are required to publish and operate complaints procedures.⁸¹ However, there is some variation in their format because private hospitals are not required to follow the NHS Complaints Regulations.⁸² Some but not all private hospitals are represented by the Independent Healthcare Advisory Service. Furthermore, the NHS ombudsman cannot look at complaints about privately funded healthcare services.

What of the patients receiving NHS care in an independent hospital? The patient can complain either to the provider under their complaints procedures, or to the Clinical Commissioning Group which commissioned the service, under the NHS complaints procedure. Where NHS-funded care takes place in a private hospital or NHS-funded care is provided to a privately funded patient, the NHS ombudsman can consider the complaint.

The power of apology

9.9 A significant problem endemic in the complaints procedure is the guardedness of doctors. The ombudsman notes, ‘When things do go wrong, an apology can be a powerful remedy; simple to deliver and costing nothing’.⁸³ The blame culture engendered by the medical litigation system can make doctors unwilling to apologise, lest it be seen as an admission of guilt. Attempts have been made to remedy this problem. New measures to enhance institutional responsibility (considered at 1.6) include new contractual⁸⁴ and statutory duties of candour.⁸⁵ In Scotland, proposals for an Apologies (Scotland) Bill were made in 2012, 2014 and 2015.⁸⁶ If passed into law, apologies could not be used as evidence of liability in certain Scottish civil proceedings. This has potential to result in earlier settlement and lower costs.⁸⁷

Section 2 of the Compensation Act 2006 states that: ‘An apology, or offer of treatment or other redress, shall not of itself amount to an admission of negligence or breach of statutory duty’.⁸⁸ This position is endorsed by the GMC,⁸⁹ NHS Litigation Authority⁹⁰ and Care Quality Commission.⁹¹ But Vines questions the value of an apology that is not accompanied by an admission of guilt. First, it is difficult to frame an apology stripped of factual statements or admissions of guilt which might later be used as evidence of negligence. Second, the apology might seem guarded, partial and disingenuous, and make things worse. Vines extols the virtues of the systems in parts of Australia and America whereby legislation protects even those apologies accompanied by an admission of guilt.⁹² Meaningful apologies may offer a means by which to turn some patients away from litigation, but only as part of broader measures to reform NHS redress.

Redress

9.10 Lack of patient confidence in the complaints system as well as a requirement for financial compensation, leads some patients to litigate. Julie Bailey, founder of Cure the NHS which was set up to represent those harmed at Mid Staffordshire hospital said:

In Mid Staffordshire the majority of people that came forward to me for advice didn’t want to take the litigation route. It is the same throughout the country. All people want a lot of the time is answers as to what happened to their relative and why. It is a torture not knowing ...⁹³

The Bristol Inquiry Report⁹⁴ eloquently implored the government to abolish clinical negligence litigation and introduce no-fault compensation.

The system or clinical negligence litigation is now ripe to review … [W]e take the view that it will not be possible to achieve an environment of full, open reporting within the NHS when, outside it, there exists a litigation system the incentives of which press in the opposite direction. We believe that the way forward lies in the abolition of clinical negligence litigation, taking clinical error out of the courts and the tort system. It should be replaced by effective systems for identifying, analysing, learning from and preventing errors, along with all other sentinel events. There must also be a new approach to compensating those patients harmed through such events … [W]e recognise that such a radical change is likely to have wide implications not least in terms of any new system of compensation.

So in September 2001, the CMO⁹⁵ initiated a comprehensive consultation process to explore potential options for reform of clinical negligence claims. Two years later the Department of Health’s consultation paper Making Amends rejected a comprehensive no-fault system of compensation on the grounds of the financial costs, problems of causation, and the scheme’s perceived inability to deal with wider learning issues. So the NHS Redress Act received royal assent in 2006. While the intention was to take ‘clinical error out of the courts’, as suggested in the Bristol Inquiry Report, it did not remove it from the tort system. Arguably the NHS Redress Act was not ambitious enough, but, as noted above, it is in any event, unlikely to be taken forward in England now. But before we look at some of the detail of the scheme, let us address the debate on a no-fault compensation scheme for medical injuries.

An attack on tort

9.11 Does the tort system work? Criticism of the tort of negligence as a means of compensating for personal injury, however caused, whether by medical error or in a road accident or any other area of human activity, is far from new.⁹⁶ The tort system has been condemned as unpredictable, expensive and unfair.⁹⁷ The nature of the tort system is unpredictable. The injured claimant, on whom the burden of proving negligence falls, cannot know in advance whether he will receive any monetary compensation. He cannot plan his personal finances and put his life in order. For example, a person rendered paraplegic in an accident cannot know whether he will be able to afford to convert his house to meet the limitations imposed by his new disability. Uncertainty and delay may even impede his recovery.

The tort system remains expensive because of the cost of litigation, much of which used to fall on the state where the claimant was publicly funded by legal aid. Very few claimants will now receive legal aid but the NHS still bears the cost of defending the claim and any costs or damages payable. Recall that new clinical claims rose by 17.9 per cent from 2012/13 to 2013/14.⁹⁸ And in 2014/15, the NHSLA paid out nearly £1.4bn in connection with clinical negligence claims, – a substantial rise from £911m in 2010/11; £650m in 2007/8; and £450m in 2002.⁹⁹ The level of compensation has reached record highs. In 2014 the media reported a pay-out amounting to an estimated £24m over the course of a girl’s life after glue was accidently injected into her brain in place of dye.¹⁰⁰

Patients suffer in equal measure. The prohibitive price of litigation may deter claimants with a genuine case from pursuing a claim if their claim is not a good enough gamble for a conditional fee arrangement (CFA), noting of course that CFAs have become harder to obtain.¹⁰¹

Most of all, is the tort system fair? First, the difficulties and cost of litigation place enormous pressure on a claimant to settle for less than full compensation. Second, the dividing line between negligence and no-negligence is paper thin. In Ashcroft v Mersey Area Health Authority,¹⁰² Kilner Brown J reluctantly dismissed the plaintiff’s claim for compensation after an operation on her ear left her with a degree of facial paralysis. He found the expert evidence on whether such damage could occur without negligence equally balanced and so the plaintiff failed to discharge the burden of proof. He commented:

Where an injury is caused which never should have been caused common sense and natural justice indicate that some degree of compensation ought to be paid by someone. ¹⁰³

Finally, the tort system has been attacked as unfair on the grounds that it lacks any proper moral basis. What is the justification for giving X, who can attribute his injury to human error, full compensation, and leaving Y, whose injury has some other cause, to struggle on state benefits?

The litigation system has generated blame, distrust and dissatisfaction on the part of patients and defensiveness, concealment and low morale on the part of doctors. Solicitors and claims management companies tout for business inviting claims with advertising campaigns. The Constitutional Affairs Committee reported in 2006 that the compensation culture is a myth, but that the cost of the belief, in terms of risk aversion, is real.¹⁰⁴ In 2010 Lord Young reiterated the misconceptions and called for a common-sense approach, levelling criticism primarily at health and safety legislation, but also appealing for reform to reduce and lower the costs of claims at common law.¹⁰⁵ Although the media has exaggerated the rise in the number of clinical negligence claims, the size of clinical negligence awards is increasing. Unsurprisingly, there have been several proposals for reform.¹⁰⁶

Alternatives to tort

9.12 So should we abolish clinical negligence litigation?¹⁰⁷ Tort is not the only means of providing compensation to victims of misadventure. Private insurance is one option.¹⁰⁸ Another is no-fault liability. In the UK, there are various no-fault schemes including the Industrial Injuries Scheme, the Criminal Injuries Compensation Scheme and the Vaccine Damage Payment Scheme. But they are piecemeal and incomprehensive. The case for a no-fault scheme is made out in part by the manifest deficiencies of the present system. It is beyond the scope of this book to consider whether a comprehensive no-fault scheme for all types of accidents should be introduced. In a perfect society, any person suffering from disability from whatever cause would receive appropriate financial support. The person paralysed by a stroke has identical needs to the person paralysed by a fall from a ladder or a bungled operation. That ideal would require not an accident compensation scheme, but provision of a general disability income.¹⁰⁹ Radical reform can never be expected to happen instantly. It must be approached incrementally. Previous editions of this book have put forward a scheme of no-fault compensation embracing two categories of medical injury:

(1)  Injury or illness arising from an absence of, or delay in, appropriate medical treatment¹¹⁰ provided that

(i)  treatment would have prevented that injury or illness, and

(ii)  a reasonable request for medical care from a person or authority under an obligation to provide care has been made by the patient or some other person acting on his behalf.

(2)  Injury or illness resulting from medical treatment provided that

(i)  the injury or illness is not caused by the natural progression of disease or the ageing process, and

(ii)  the injury or illness in not the consequence of an unavoidable risk inherent in the treatment, of which the patient has received proper warning.

Category 1 would cover injury arising from failure to treat both in circumstances where the present tort of negligence would operate, and where it would not. For example, a request for treatment might be made and not acted on by the GP because at the time he acted reasonably in thinking an immediate appointment was not necessary. Events prove him wrong. They do not render him negligent. Under this proposed no-fault scheme, the patient would recover because he did in fact suffer as a result of lack of treatment, albeit no one was to blame.

Category 2 is more difficult to define. The intention of category 2 is that it should extend to any damage to the patient, which is neither the result of the natural progression of his original disease or condition nor a consequence inherent in that treatment and unavoidable if that treatment is to be successful. Under that last limitation, the side effects of certain surgery and therapy would be excluded. At one level, the patient could obviously not recover compensation for pain and suffering ordinarily attendant on surgery. At another level, unpleasant and dangerous side effects, for example, the patient’s hair falling out during chemotherapy, or the risk of a stroke in some forms of brain surgery, would have to be excluded if they were inescapable in the pursuit of proper treatment. One important proviso is attached to the exclusion of unavoidable side effects from compensation. The patient must have been properly warned. Failure to give proper warning, which results in injury unexpected and unconsidered by the patient, would remain a ground for compensation.

Avoiding definitions and drafting points may well be criticised as cowardice. The scheme above operates in a presumption of entitlement when injury follows medical treatment and ensues from lack of treatment. It seeks to avoid the linguistic complications of concepts of error or mishap. Ken Oliphant¹¹¹ has argued that experience from New Zealand should make us cautious. Initially at least, a compensation scheme should be based on evidence of ‘medical error’. Where investigation and hindsight indicate that the patient receives less than the optimum treatment and with such treatment her injury could have been avoided, she would receive compensation. Simple evidence of an unexpected outcome of treatment would not suffice however serious that outcome. If a previously healthy patient suffers a cardiac arrest in the course of minor surgery, he will recover compensation if, for example, a defect is found in the anaesthetic equipment or some error was made by the anaesthetist. He will not have to show blameworthiness. If no reason for the sudden heart failure can be discovered, he has no claim in relation to that mishap.

The ‘Oliphant solution’ would, as he says, provide ‘consistency and ease of application’. It might provoke awkward questions of causation and make it difficult to cast off the shackles of negligence. It is a notable attempt to put substance into the defining of ‘medical misadventure’.

No-fault compensation abroad¹¹²

9.13 A growing number of no-fault compensation schemes operate abroad. We briefly outline only two,¹¹³ the New Zealand accident compensation scheme, which covers medical injury within comprehensive provision for compensation for personal injury from all causes, and the Swedish Patients’ Insurance Scheme, designed specifically for medical injuries. Review of New Zealand’s and Sweden’s experience will highlight certain problems of no-fault liability. They are problems which should be treated as an education in mistakes to avoid, rather than an indication that the concept of no-fault liability should necessarily be abandoned. In this brief review of both schemes, we concentrate on how the basic principle of no-fault liability works. Space does not allow consideration in detail of the funding and administration of either scheme. It will swiftly become apparent that defining the criteria governing eligibility to compensation is the litmus test of whether no-fault compensation can be made to work.

The New Zealand scheme was first set up in 1974 to award compensation to anyone who suffered ‘personal injury by accident’. It was reformed in 2002, but links to fault-based compensation were retained. Concepts of ‘medical error’ and ‘medical mishap’ were introduced.¹¹⁴ Further reform in 2005 finally broke those links.¹¹⁵ In 2005, eligibility for compensation was significantly expanded to cover all ‘treatment injuries’.¹¹⁶ The scheme now covers most personal injuries suffered while receiving treatment from health professionals. It is a true no-fault compensation system. Claims have risen. Performance of the fund deteriorated between 2005 and 2009 but have since stabilised.¹¹⁷

While the scheme has been commended for providing timely compensation and effective complaints resolution, there remain concerns surrounding patient safety.¹¹⁸ But the provision of a no-fault scheme does not necessarily render doctors unaccountable. A new patient safety team was introduced in order to address systemic problems and an independent health ombudsman, the Health and Disability Commissioner¹¹⁹ mediates, resolves complaints and promulgates lessons for the health service.

The Swedish Patients’ Insurance Scheme¹²⁰ is expressly designed to provide compensation for medical injuries. Compensation is payable in respect of any injury or illness resulting from any procedure related to healthcare. Injury arising from any diagnostic procedure, inappropriate medication, medical treatment or surgery falls within the ambit of the Swedish scheme. But compensation for such injury is subject to three important provisos. First, the injury must be proved to result from the procedure in issue, and not from the original disease. Second, injury resulting from a risk taken by the doctor to save life or prevent permanent disability is excluded. Third, and most crucially, the claimant has to show that the procedure causing his injury was not medically justified. The test of whether the procedure was medically justified often reintroduces the question of negligence. Nevertheless, certain claimants who lose in England will obtain compensation in Sweden. Mrs Ashcroft, who suffered injury to a facial nerve when the surgeon accidentally cut the nerve, would recover in Sweden. The surgeon was not to blame, but cutting the nerve was not medically indicated.¹²¹

Examination of the problems encountered in New Zealand and Sweden must not obscure the benefits of no-fault schemes. Patients uncompensated by a tort-based system benefit in those countries. In Sweden the investigation of the cause of a medical injury may still involve questions akin to negligence. It is an investigation. The patient will discover what happened. The opportunities for scoring points and the advantages to be gained from having the best advocate rather than the best case, do not exist.

The rejection of no-fault compensation in England

9.14 As long ago as 1978, the Pearson Commission¹²² advised against abolition of tort as a means of compensating personal injuries. The Commission made a number of specific proposals for more limited reforms. We concentrate on the proposals which relate to medical injuries. The Commission decided against recommending a no-fault scheme for all medical injuries.¹²³ Following its recommendations, the Vaccine Damage Payment Scheme was introduced. Strict liability for defective drugs was introduced by the Consumer Protection Act 1987.¹²⁴ That reform came not as a result of the Pearson Report, but because of pressure from Europe. The Commission’s Report gathered dust. Many of their proposals went unheeded.

The Bristol Inquiry Report¹²⁵ renewed the attack on tort and in Making Amends, the CMO also condemned the torts system in terms of both its financial and emotional ramifications, especially in relation to low value claims.

Legal proceedings for medical injury progress in an atmosphere of confrontational acrimony, misunderstanding and bitterness. The process is anathema to the spirit of openness, trust, and partnership which should characterise the modern relationship between doctor and patient. Moreover, the whole nature of a legal dispute between two parties works against the wider interests of patients. The emphasis is on revealing as little as possible about what went wrong, defending clinical decisions that were taken and only reluctantly releasing information.¹²⁶

Yet, once again, the problems associated with causation, deterrence and accountability, and the financial implications of a no-fault scheme led to the rejection of a comprehensive no-fault system. Let us examine these criticisms more carefully.

Causation

9.15 The CMO, like the Pearson Commission before him, felt that distinguishing between an injury arising from treatment given and the natural progression of disease or inescapable side effects of treatment was too difficult. This is a valid concern. But is it enough to rule out a change to no-fault compensation? Causation presents just as much of a problem within the present system. Reform of the law introducing a no-fault principle would have the following benefits. A greater number of claimants would obtain compensation to help them adapt their lives to their disabilities, or to meet financial loss resulting from the death of a breadwinner. The damage done to relations between the medical profession and the public by bitter and protracted litigation would be removed. The patient would obtain compensation because he suffered injury as a result of treatment going wrong. The issue of why it went wrong and the doctor’s competence would be for completely separate investigatory procedures. The problem of causation would still be present. Distinguishing between injury and the progression of disease (or whatever) would be made easier. The issue of causation would be investigated. It would not be part of a battle between the patient and the NHS, with the NHS having a vested interest in finding experts to deny that the patient’s condition was caused by the treatment. Consideration could be given to whether the burden of proof of causation might be alleviated by requiring only proof of a reasonable possibility of causation.

Deterrence and accountability

9.16 Arguably, tort serves a valuable purpose in emphasising the accountability and responsibility of individual medical staff. It may be costly and inefficient, may be inequitable in whom it compensates, but if it deters medical malpractice, can we afford to abandon it? We remain unconvinced that the tort system has much systematic deterrent effect in healthcare in so far as individual doctors are concerned. Moreover, the alleged deterrent impact of tort often obscures the crucial question of accountability.

(1)  The tort system is capricious in its operation. Obstetricians are at high risk of a lawsuit. It is not unheard of for compensation to exceed £10m where allegedly negligent treatment during birth leads to cerebral palsy in infants. Geriatricians are hardly ever sued. This is not because obstetricians are more likely to be negligent than their colleagues in geriatrics. It is because if granny dies as a result of a negligent overdose, so little could be claimed by way of damages that it is not worth suing the responsible doctor.

(2)  Even where NHS doctors are sued, the deterrent effect of tort is not direct. The damages will not come out of the doctor’s pocket nor will his ‘premiums’ be increased. The deterrent function of tort normally operates via the insurance system. Poor drivers are deterred from carelessness and encouraged to improve because ‘carelessness costs money’. NHS Indemnity means that NHS doctors do not pay any sort of insurance or indemnity. There is the emotional impact of litigation. Does the worry of being sued deter the incompetent doctor? We doubt it. Where negligence is gross and obvious, claims are settled swiftly to avoid adverse publicity. It is the cases where there truly is doubt about whether an error is negligent that drag on in the public eye. We suspect ‘good’ doctors worry about litigation and ‘bad’ doctors rarely give the possibility much thought.

(3)  Finally, there are a number of cases where, albeit there was actionable negligence, there is no moral culpability. Doctors who make mistakes after hours without sleep in under-resourced hospitals should not be blamed for their error. The tort system could operate to deter such ‘negligence’ only by encouraging such a doctor to refuse to treat patients at all, once he suspected he could not do so entirely competently. Such an outcome would prompt more, not less, patient suffering.

One caveat must be issued before dismissing the impact of deterrence via the tort system. Health providers are encouraged to be cost-conscious. Is there a risk that an NHS trust anxious to offer and a CCG to ‘buy’ the lowestcost appendectomy will cut corners and offer less than safe appendectomies? The fear of litigation might operate on the collective mind of the trust to deter economy measures that prejudice patients’ safety. The impact of tort on providers must not be overlooked in the no-fault debate. Evaluating the extent to which providers may be influenced by the deterrent function of tort is difficult. Risk management has a high profile within the NHS now. That is good. Hospitals review their practice and investigate adverse outcomes to try to prevent medical accidents.

Currently a key player in risk management is the Clinical Negligence Scheme for Trusts (CNST), which is run by the NHS Litigation Authority (NHSLA). The NHSLA indemnifies providers of NHS care in England, including NHS and NHS foundation trusts and, since 2013, Clinical Commissioning Groups (CCGs) and independent sector providers of NHS care. Membership of the CNST is voluntary, but currently all CCGs and trusts are members. Pricing is risk-dependent: in 2014, the NHSLA rolled out a ‘Sign up to Safety’ campaign to give incentives to member organisations whose robust safety plans reduce their claims.¹²⁷ CNST is the enforcer of risk management. It operates a strategy embedded in the tort system. Put simply, NHS hospitals and other bodies are obliged to comply with risk management or face financial disaster. Risk management could and should survive a no-fault compensation scheme. But what would replace CNST and will it have the same ‘teeth’?

Returning to accountability, does the tort system ensure that health professionals and providers are made to account for their conduct? Tort’s role in ensuring accountability is minimal. The nature of adversarial litigation militates against such an outcome. If an operation goes wrong and a patient is injured, what went wrong and why it went wrong needs investigation. The professional or professionals involved should be required to explain all they can to the patient and their conduct should be evaluated to discover whether it fell below a standard of good practice and to consider what measures might be taken to avoid such an accident in future. It may well be that even though there is no negligence in the tort sense, doctors and nurses can learn from the accident and amend standard procedures in the light of that knowledge.

Adversarial litigation does not encourage such an investigation of the incident. Doctors and nurses in the shadow of litigation clam up; they are naturally wary of admitting any doubts they may have as to what they did or did not do. If the patient fails to prove negligence, within the tort system that is the end of the matter. Accountability is crucial. The tort system provides only token accountability. It is organisations such as the Care Quality Commission which should help ensure the NHS learns from its mistakes.

Cost

9.17 For Mason and Laurie, cost is a major reason for the government’s rejection of no-fault compensation in England.¹²⁸ The overall cost of a no-fault scheme is difficult to judge. It is not a cheap option. They estimate a total cost of £4bn annually. One article suggests that the operation of a no-fault scheme in England along the lines of the Swedish system would cost several times the cost of the current system due largely to the increase in claimants.¹²⁹

In Scotland, a review group led by Sheila McLean recommended in 2011 that a no-fault scheme based on the Swedish model should be introduced.¹³⁰ Early estimates considered that the increase in expenditure would be relatively modest when compared with the costs of instituting such a scheme in England.¹³¹ But a consultation in 2014 was more cautious about the projected costs and recommended further work.¹³²

No fault can however be cost-effective in some respects. The ultimate cost of a no-fault scheme will depend on the level of payments made to victims. Several hard questions need to be addressed. It would seem obvious that the payment of compensation for loss of income and cost of care should generally be by way of periodical payments rather than as a lump sum. Payments can then be adjusted to meet the claimant’s current needs. Should there be a ceiling on payments? Under the tort system, a high-earning solicitor rendered unable to work obtains money to make up her actual loss of income. Should no-fault compensation be limited to sufficient to provide for the claimant’s needs arising from her disability up to the ‘average’ standard of living?¹³³ What about compensation for pain and suffering? The harder a no-fault scheme tries to offer generous compensation, the harder it is to fund a scheme to meet the needs of the widest possible range of claimants. An affordable no-fault scheme will necessarily have to limit compensation payments. Typically, no-fault compensation schemes do not compensate non-pecuniary loss. Previously wealthy victims of medical accidents will not receive full compensation for their monetary loss. Their loss of income will be capped. Medical and rehabilitation costs which could be met from other sources will not be included in compensation payments.

Consider this scenario. X and Y are both paralysed in a medical accident, X, a PE teacher, who might have got nothing from the tort system because he could not prove negligence will benefit from no-fault whatever his prior circumstances. He will gain a reasonable income (shall we say £700 a week) if he can no longer work. He will obtain money to pay for care at home over and above what the social security system may provide, and money to adapt his house to the demands of his disability. Y who could win damages under the tort system may lose. Assume that prior to his accident, Y was a wealthy young football star. Now he is paralysed. The £700 a week could be about 5 per cent of his previous income. He will get nothing for pain and suffering. A no-fault scheme will not pay for him to have costly private care in the USA.

Proponents of social justice will argue then it is better to offer some recompense to more people than award a lottery-type damages to winners in the tort system. The problem is this. If a no-fault compensation scheme exists side by side with access to the tort system, patients such as Y will still opt for the tort system. Two options could be explored.

(1)  Claimants who opt to sue in tort do so at their peril. If their claim fails, they are excluded from the no-fault scheme. That might radically lower the cost of tort claims because only the most clear cut claims will be brought and they should be swiftly settled.

(2)  Or, as in New Zealand, where a claimant is entitled to claim under the no-fault scheme a tort claim is barred altogether. No-fault becomes the exclusive route to compensation for medical accidents. Financially, and to achieve the objective of a no-fault scheme the second option makes pre-eminent sense. But, in barring access to the courts, would it violate Article 6 of the European Convention on Human Rights entitling everyone to a fair trial in determination of his civil rights and obligations?

Reforming the torts system

9.18 In Making Amends, the CMO rejected a no-fault medical injury scheme. Instead the report proposed reform of the existing negligence system, incorporating four main elements:

• an investigation of the incident which is alleged to have caused harm and of the harm that has resulted;

•  provision of an explanation to the patient and of the action proposed to prevent repetition;

•  development and delivery of a package of care providing remedial treatment, therapy and arrangements for continuing care where needed;

•  payments for pain and suffering, out-of-pocket expenses and care or treatment which the NHS could provide.¹³⁴

The report provided the basis for the NHS Redress Act 2006. The Act provided an alternative to litigation in the form of a broad structure for a new fast-track scheme for claims under £20,000. But it requires secondary legislation which, in England, now seems unlikely. One reason for this is the poor reception of the scheme. It did not satisfy the proponents of no-fault compensation, because, while the scheme was non-adversarial, it was tort-based – that is, the claimant must still be able to prove fault. The proposed scheme authority, the NHS Litigation Authority, raised issues of impartiality and independence – the NHSLA is traditionally the defender of NHS interests. There was no statutory duty of candour to enhance openness and accountability.¹³⁵ The Act did not satisfy economists because although it would reduce delay, it would be costly to set up and would bring in new claims. It was estimated that it would, in the first year result in anything between a £7m saving and a cost of £48m. After ten years, it was predicted that the scheme would range between a saving of £15m and a cost of £80m.¹³⁶ Farrell and Devaney opined that, far from ‘making amends’, the NHS Redress Act might ‘make things worse’.¹³⁷

Section 17 of the Act gave the National Assembly for Wales power to introduce an NHS redress scheme. Wales has been operating a successful¹³⁸ optional Speedy Resolution Scheme for low-value claims since 2005. The NHS Redress (Wales) Measure 2008 is designed to align complaints and redress. The National Health Service (Concerns, Complaints and redress Arrangements) (Wales) Regulations,¹³⁹ introduce a single portal for ‘concerns’ which include ‘a complaint, a notification of an incident concerning patient safety or, save in respect of concerns notified in respect of primary care providers or independent providers, a claim for compensation [under £25,000]’.¹⁴⁰

When a concern is raised, a responsible body generally has thirty days to investigate the issue and make a written response. This might incorporate an apology or action taken, and include a right to take the case to the NHS ombudsman or request further information. The relevant body considers whether there is a ‘qualifying liability in tort’ in which case the redress process is activated. The scheme shares a number of potential flaws with the proposed English scheme, but unlike the English scheme it attempts to bring together a fragmented system of redress. It constitutes a credible attempt to offer a just and unified approach to redress.¹⁴¹

In 2013, the NHSLA ran a pilot fixed costs scheme for certain clinical negligence claims up to £25,000¹⁴² and in 2015 the Department of Health promised to explore ways of fixing claimant legal costs.¹⁴³ Until this or an alternative scheme is rolled out, much reliance is placed on pre-action dispute resolution, which emphasises the benefits of openness and the need to reduce delay and avoid unnecessary litigation.¹⁴⁴ The NHSLA launched a mediation pilot in 2014¹⁴⁵ and the Department of Health recommends its roll-out ‘as a less adversarial, mainstream model of redress’.¹⁴⁶ One of us has written elsewhere of the importance of ensuring that NHS redress is ‘joined up’.¹⁴⁷ While the focus on cutting costs to the NHS has merit, barring the way to effective litigation will put increased pressure on a struggling complaints system and may result in more patients and families looking to the law for redress.

¹  The ombudsman makes final decisions on complaints that have not been resolved by the NHS. See 9.7.

²  Parliamentary and Health Service Ombudsman (hereafter PHSO), Selected Summaries of Investigations by the Parliamentary and Health Service Ombudsman, Volume 1, Report 1 (HC 566) (July 2014), at 32.

³  Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry, chaired by Robert Francis QC (February 2013) HC947, para 1. See 1.1.

⁴  P Davis et al, ‘Acknowledgement of “No-Fault” Medical Injury: Review of Patients’ Hospital Records in New Zealand’ (2003) 326 BMJ 79.

⁵  See L Mulcahy, Mediating Medical Negligence Claims: An Option for the Future (2000), HMSO. Only 30 to 39 per cent of aggrieved patients initially wanted monetary compensation. And see C Vincent et al, ‘Why Do People Sue Doctors? A Study of Patients and Relatives Taking Legal Action’ (1994) 343 Lancet 1609.

⁶  See M Bismark, EA Dauer, ‘Motivations for Medico-Legal Action’ (2006) 27 Journal of Legal Medicine 55.

⁷  E Cave, ‘Redress in the NHS’ (2011) 27(3) Journal of Professional Negligence 139.

⁸  NHS Constitution (updated 2015). Provided for under the Health Act 2009, s 1.

⁹  See DH, Culture Change in the NHS: Applying the Lessons of the Francis Inquiries Cm 9009 (February 2015).

¹⁰  Ibid, pp 9–10.

¹¹  Chief Medical Officer, Making Amends – Clinical Negligence Reform (2003) (hereafter CMO, Making Amends).

¹²  NHS Redress (Wales) Measure 2008; NHS (Concerns, Complaints and redress Arrangements) (Wales) Regulations SI 2011/704; (amended SI 2011/1706).

¹³  See 8.19.

¹⁴  See K Walshe, ‘The Use and Impact of Inquiries in the NHS’ (2002) 325 BMJ 895.

¹⁵  Formerly NHS Act 1977, s 2.

¹⁶  DH, Morecombe Bay Investigation Report (March 2015). See 1.1 and 1.18.

¹⁷  Previously, formal statutory NHS inquiries of this kind were conducted (publicly or privately) under the National Health Service Act 1977, s 84. One famous example is the public inquiry into children’s heart surgery at the Bristol Royal Infirmary. See Learning from Bristol – The Report of the Public Inquiry into Children’s Heart Surgery at the Bristol Royal Infirmary 1984–95, CM 5207 (1) (2001) (hereafter the Bristol Inquiry).

¹⁸  Healthcare Commission, Investigation into Mid Staffordshire NHS Foundation Trust (March 2009).

¹⁹  Independent Inquiry into Care Provided by Mid Staffordshire NHS Foundation Trust, chaired by Robert Francis QC (February 2010).

²⁰  Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry.

²¹  See s 15.

²²  Inquiries Act 2005, s 2.

²³  Department of Health (hereafter DH), Report of the Committee of Inquiry into How the NHS Handled Allegations about the Conduct of Richard Neale, Cm 6315 (2004). DH, Committee of Inquiry – Independent Investigation into How the NHS Handled Allegations about the Conduct of Clifford Ayling, Cm 6298 (2004).

²⁴  At p 31.

²⁵  See A Merry, A McCall Smith, Errors, Medicine and the Law (2001) Cambridge University Press, p 217.

²⁶  The Bristol Inquiry, ch 26; and see DH Expert Group, An Organisation with a Memory (2000).

²⁷  CMO, Making Amends.

²⁸  The option of a no-fault scheme had been canvassed in the CMO’s initial position paper; see Clinical Negligence: What Are the Issues and Options for Reform (2001), DH.

²⁹  Lord Darzi, Hansard, 18 Mar 2009: col WA49.

³⁰  NHS Redress (Wales) Measure 2008; NHS (Concerns, Complaints and redress Arrangements) (Wales) Regulations, SI 2011/704 (amended SI 2011/1706).

³¹  Scottish Government, Consultation Report – Consultation on Recommendations for No-Fault Compensation in Scotland for Injuries Resulting from Clinical Treatment (April 2014).

³²  See at 9.13, 9.17 and 9.18.

³³  See NHSE, Complaints – Listening – Acting – Improving: Guidance on Implementation of the NHS Complaints Procedures (1996), DH.

³⁴  National Health Service (Complaints) Regulations 2004, SI 2004/1768.

³⁵  Safeguarding Patients: Lessons from the Past – Proposals for the Future, Cm 6394 (2004) DH. And see Citizens Advice Bureau, The Pain of Complaining (2005), CAB, recommending measures to raise standards, improve access, ensure timeliness and learn from complaints.

³⁶  SI 2006/2084.

³⁷  DH, Making Experiences Count: A New Approach to Responding to Complaints (2007) London; National Audit Office, Feeding Back? Learning From Complaints Handling in Health and Social Care (2008) Stationery Office.

³⁸  National Audit Office Report, Feeding Back? Learning from Complaints Handling in Health and Social Care (HC 853 2007–8) opens in new window, 7.

³⁹  Ibid, 8.

⁴⁰  NAO, Feeding Back? Learning from Complaints Handling in Health and Social Care (2008), 7–8 and see Healthcare Commission, Spotlight on Complaints: A Report on Second-stage Complaints about the NHS in England (2007).

⁴¹  Local Authority Social Services and National Health Service Complaints (England) Regulations 2009, SI 2009/309 (amended SI 2009/1768). And see NHS England, Guide to Good Handling of Complaints for CCGs (May 2013).

⁴²  DH, Clarification of Complaints Regulations 2009, Gateway Reference Number: 13508 (2010), p 2. The complaint may be put on hold if it might prejudice a legal claim.

⁴³  NHS Complaints Advocacy Service replaced the Independent Complaints Advocacy Service (ICAS) in 2013 when advocacy commissioning moved from the NHS to local authorities.

⁴⁴  Health and Social Care Act 2012, s 181.

⁴⁵  Health and Social Care Act 2012, s 182, amending the Local Government and Public Involvement in Health Act 2007, s 221.

⁴⁶  HealthWatch, Improving Independent Complaints and Advocacy in Health and Social Care (November 2013).

⁴⁷  HealthWatch, Proposed Standards for Complaints Advocacy (February 2015); and see DH, Hard Truths: The Journey to Putting Patients First, Cm 8777 (January 2014).

⁴⁸  Local Authority Social Services and National Health Service Complaints (England) Regulations 2009, SI 2009/309 (amended SI 2009/1786).

⁴⁹  SI 2009/309, reg 14.

⁵⁰  NHS Information Centre press release, ‘Latest Statistics on NHS Written Complaints’ (2006).

⁵¹  There are a number of special routes for complaints eg about mental health treatment which we do not cover here.

⁵²  Confusion as to when a complaint should be put on hold for compelling legal reasons (eg formal request by the police or a judge), has resulted in clarification notices in 2010 and 2014.

⁵³  See T Powell, NHS Complaints Procedures in England (SN/SP/5401) (January 2014).

⁵⁴  PHSO, Listening and Learning: The Ombudsman’s View of Complaint Handling by the NHS in England 2009–10 (2010), p 4.

⁵⁵  Robert Francis QC (Chair) The Independent Inquiry into care provided by Mid Staffordshire NHS Foundation Trust (February 2010).

⁵⁶  Health Select Committee, Complaints and Litigation, HC 786–I 2010–12 (June 2011).

⁵⁷  Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry (February 2013); and see Sir Robert Francis QC, Report on the ‘Freedom to Speak up?’ Review into Creating an Open & Honest Reporting Culture in the NHS (February 2015).

⁵⁸  DH, Patients First and Foremost: The Initial Government Response to the Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry (Cm 8576) (March 2013), 53.

⁵⁹  Rt Hon Ann Clwyd MP and Professor Tricia Hart, A Review of the NHS Hospitals Complaints System: Putting Patients Back in the Picture (October 2013).

⁶⁰  DH, Hard Truths, the Journey to Putting Patients First (2013), paras 1.35–1.37.

⁶¹  My Expectations for Raising Concerns and Complaints (November 2014).

⁶²  Commons Select Committee, Complaints and Raising Concerns, HC 350 (January 2015). See also PHSO press release, ‘PHSO Responds to HSCIC Data on Written Complaints in the NHS 2014–15’ (2015) 26 August: ‘We investigate more than 3,000 complaints a year about the NHS in England that haven’t been resolved locally. In almost two-thirds of those, people have felt let down by the complaints process’.

⁶³  See Government Response to the House of Commons Health Select Committee Fourth Report of Session 2014–15 Complaints and Raising Concerns, Cm 9050 (March 2015).

⁶⁴  HSCIC, Data on Written Complaints in the NHS – 2014–15 (August 2015), p 5.

⁶⁵  National Health Service Reorganisation Act 1973. The ombudsman’s powers are set out in the Health Commissioners Act 1993, as amended by the Health Service Commissioners (Amendment) Act 1996, National Health Service (Primary Care) Act 1997, the Health Act 1999, and the Health Services Commissioners (Amendment) Act 2000. In theory there are three separate NHS ombudsmen. In practice to date the post has been held by one person who is also the Parliamentary Commissioner for Administration (the general national ombudsman). She is supported in her NHS post by a Deputy Commissioner with experience of NHS management.

⁶⁶  Health Service Commissioners Act 1993, s 4(1)(b).

⁶⁷  Ibid, s 3(1).

⁶⁸  Health Service Commissioners (Amendment) Act 1996.

⁶⁹  Annual Report, 2000–1, p 1.

⁷⁰  Health Service Commissioners Act 1993, s 3. The ombudsman has discretion to extend this time limit.

⁷¹  Ibid, s 10.

⁷²  Ibid, ss 11, 12.

⁷³  PHSO, Listening and Learning, p 16.

⁷⁴  Ibid.

⁷⁵  PHSO, press release: ‘Ombudsman Service to “Radically” Change in Modernisation Drive’ (October 2014).

⁷⁶  Public Administration Committee, Third Special Report: More Complaints Please! and Time for a People’s Ombudsman Service (September 2014); Robert Gordon, Better to Serve the Public: Proposals to Restructure, Reform, Renew and Reinvigorate Public Services Ombudsmen (October 2014)

⁷⁷  Queen’s Speech (May 2015).

⁷⁸  DH, Hard Truths: The Journey to Putting Patients First, Cm 8777 (January 2014).

⁷⁹  See for example, BBC News, ‘Death of Sam Morrish “Absolutely Shocking”’ (2014) 2 July.

⁸⁰  Reportedly halving the time it takes to perform an investigation. PHSO, ‘Ombudsman Service to “Radically” Change in Modernisation Drive’.

⁸¹  Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (amended SI 2015/64), reg 16.

⁸²  Members of the Independent Healthcare Advisory Service must follow their guidance: Independent Healthcare Advisory Services, Making a Complaint in the Independent Sector: A Guide for Patients (2007).

⁸³  PHSO, Listening and Learning, p 4.

⁸⁴  NHS Standard Contract (2013), Condition 35.

⁸⁵  Care Act 2014, s 81, which inserts a new s 5A into the Health and Social Care Act 2008; Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, SI 2014/2936 (amended SI 2015/64), reg 20.

⁸⁶  See A Evans, SPICe Briefing: Apologies (Scotland) Bill 15/29 (June 2015); C Irvine, ‘The Proposed Apologies Act for Scotland: Good Intentions with Unforeseeable Consequences’ (2013) 17(1) Edinburgh Law Review 84.

⁸⁷  P Vines, Justice Committee Apologies (Scotland) Bill Written submission (2015). Available at: www.scottish.parliament.uk/S4_JusticeCommittee/Inquiries/A16._Professor_Prue_Vines.pdf

⁸⁸  But see P Vines, ‘Apologies and Civil Liability in the UK: A View from Elsewhere’ (2008) 12(2) Edinburgh Law Review 200 commenting on the brevity of the provision which does not define ‘apology’ and seems to add little to existing law.

⁸⁹  GMC, Good Clinical Practice (2013): ‘You must be open and honest with patients if things go wrong. If a patient under your care has suffered harm or distress, you should: a put matters right (if that is possible); b offer an apology; c explain fully and promptly what has happened and the likely short-term and long-term effects’ (para 55). See also paras 24–25. And see GMC Openness and Honesty When Things Go Wrong: The Professional Duty of Candour (July 2015) discussed at 1.6.

⁹⁰  National Health Service Litigation Authority, Apologies and Explanations: Letter to Chief Executives and Finance Directors (2009); Saying Sorry leaflet (December 2013).

⁹¹  Care Quality Commission, A Quality Service, A Quality Experience (2009).

⁹²  Vines, ‘Apologies and Civil Liability in the UK’ 222.

⁹³  Health Committee, Complaints and Litigation – Oral Evidence (2011) HC786-i, Q36.

⁹⁴  See The Bristol Inquiry, p 367.

⁹⁵  DH, Clinical Negligence: What Are the Issues and Options for Reform (2001).

⁹⁶  See in particular, P Cane, PS Atiyah, Atiyah’s Accidents, Compensation and the Law (8th edn, 2013), Cambridge University Press.

⁹⁷  Pearson Report (Report of the Royal Commission on Civil Liability and Compensation for Personal Injury), Cmnd 7054 vol 1 (1978), paras 246–263.

⁹⁸  NHSLA, Annual Review: Supporting the NHS (July 2014), p 18.

⁹⁹  NHSLA, Factsheet 2: Financial Information (2015).

¹⁰⁰  D Campbell, ‘NHS Faces £24m Bill after Glue Injected into Girl’s Brain at Great Ormond Street’ Guardian (2014) 27 January.

¹⁰¹  See 8.3.

¹⁰²  [1983] 2 All ER 245. And see Nash v Richmond Health Authority (1996) 36 BMLR 123.

¹⁰³  [1983] 2 All ER 245, at 246. See also Wilsher v Essex AHA (1986) 3 All ER 801, at 810 per Mustill LJ.

¹⁰⁴  House of Commons, Constitutional Affairs Committee (HC(CAC)), Compensation Culture Third Report of Session 2005–6, HC 754–1, para 111. And see J Hyde, ‘Compensation Culture Is “Media-Created” Myth – Dyson’ (2013) Law Society Gazette 25 March referring to a lecture on the topic by Lord Dyson MR.

¹⁰⁵  Lord Young, Common Sense, Common Safety (2010). See 8.17.

¹⁰⁶  See, for example, the Pearson Report 1978; the Kennedy Report, The Report of the Inquiry into the Care and Management of Children Receiving Complex Heart Treatment Between 1984 and 1995 (2001) HMSO; NAO, Handling Clinical Negligence Claims in England, HC 403 (2001); House of Commons Public Accounts Committee, Handling Clinical Negligence Claims in England; CMO Making Amends; Lord Justice Jackson, Review of Civil Litigation Costs, Final Report (2010); Lord Young, Common Sense, Common Safety (2010).

¹⁰⁷  See C Dyer, ‘Fault Lines: Resolving Clinical Negligence Claims’ (2013) 347 BMJ f4996.

¹⁰⁸  See Cane, Atiyah, Atiyah’s Accidents, Compensation and the Law.

¹⁰⁹  See C Ham et al, Medical Negligence: Compensation and Accountability (1988) King’s Fund Institute/Centre for Socio-Legal Studies.

¹¹⁰  Treatment would be defined to include treatment given to the mother and injuring the child. Consideration of the implications of antenatal treatment would be required, for example: (1) would treatment necessary for the mother but injuring the child be excluded? (2) What about pre-conception injury to either parent?

¹¹¹  K Oliphant, ‘Defining “Medical Misadventure”: Lessons from New Zealand’ (1996) 1 Medical Law Review 1, 30–31.

¹¹²  In Scotland the No Fault Compensation Review Group, set up in 2009, considered in depth a range of no-fault compensation schemes. See A-M Farrell, S Devaney, A Dar, No Fault Compensation Schemes for Medical Injury – A Review (2010), accessible at: www.scotland.gov.uk/Resource/Doc/924/0099427.pdf

¹¹³  See J Dute (ed) et al, ‘No Fault Compensation in the Health Care Sector’ (2004) 8 Tort and Insurance Law, covering schemes in a range of countries. And for analysis of the French administrative system of compensation, see J Barbot et al, ‘“No-fault” Compensation for Victims of Medical Injuries. Ten Years of Implementing the French Model’ (2014) 114 Health Policy 236.

¹¹⁴  J Manning, ‘Informed Consent to Medical Treatment: The Common Law and New Zealand’s Code of Patients’ Rights’ (2004) 12(2) Medical Law Review 181.

¹¹⁵  Injury Prevention, Rehabilitation, and Compensation Act 2001, s 32 (as amended by Injury Prevention, Rehabilitation, and Compensation Amendment Act [No 2] 2005).

¹¹⁶  See K Oliphant, ‘Beyond Misadventure: Compensation for Medical Injuries in New Zealand’ (2007) 15(3) Medical Law Review 357.

¹¹⁷  ACC, Financial Condition Report 2013, p 6. Overall ACC’s net assets have increased from −$7.2bn to −$2.3bn; the Scheme achieved surplus in 2013/14.

¹¹⁸  See M Bismark, R Paterson, ‘No-fault Compensation in New Zealand: Harmonizing Injury Compensation, Provider Accountability and Patient Safety’ (2006) 25(1) Health Affairs 278.

¹¹⁹  Created by the Health and Disability Commissioner Act 1994 (NZ). The Act was passed to implement the recommendations of Judge Cartwright: The Report of the Committee of Inquiry into Allegations Concerning the Treatment of Cervical Cancer at National Women’s Hospital and into Other Related Matters (1988) Government Printing Office.

¹²⁰  Patient Injury Act 1996 (Sweden). LH Fallberg, B Borgenhammar, ‘The Swedish No Fault Patient Insurance Scheme’ (1997) 4 European Journal of Health Law 279; Patient Claims Panel (Sweden), Patient Injury Compensation for Healthcare-Related Injuries (2007), accessible at www.patientforsakring.se

¹²¹  Ashcroft v Mersey Regional Health Authority [1983] 2 All ER 245.

¹²²  The Pearson Report, vols 1–3.

¹²³  Ibid, paras 1304–1371.

¹²⁴  See 10.1.

¹²⁵  See The Bristol Inquiry, p 367.

¹²⁶  CMO, Making Amends, p 7.

¹²⁷  NHSLA, Reports and Accounts 2014–15 (2015) HC 293, p 44. And see p 43: NHSLA uses score cards for each member organisation to capture and learn from claims information.

¹²⁸  Mason, Laurie, Mason and McCall Smith’s Law and Medical Ethics, 5.06. And see CMO, Making Amends, p 15. And see T Douglas, ‘Medical Injury Compensation: Beyond No Fault’ (2009) 17 Medical Law Review 30, who argues that, given the limited resources available, a fairer scheme might require abandoning medical injury compensation altogether, in favour of better social security and public healthcare systems and a safer NHS.

¹²⁹  P Fenn, A Gray, N Rickman, ‘The Economics of Clinical Negligence Reform in England’ (2005) 114 Economic Journal 272, 290.

¹³⁰  No Fault Compensation Review Group, Report and Recommendations: Volume 1 (February 2011).

¹³¹  Discussed in Mason, Laurie, Mason and McCall Smith’s Law and Medical Ethics, 5.05.

¹³²  Scottish Government, Consultation Report – Consultation on Recommendations for No-Fault Compensation in Scotland for Injuries Resulting from Clinical Treatment (April 2014).

¹³³  In New Zealand, a maximum limit of 80 per cent of actual earnings. CMO, Making Amends, p 98.

¹³⁴  CMO, Making Amends, p 16.

¹³⁵  A statutory duty of candour was, however, subsequently introduced by the Care Act 2014, s 81; Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, SI 2014/2936 (amended SI 2015/64), reg 20. See 1.6.

¹³⁶  NHS Redress Bill Explanatory Notes, Bill 137-EN, para 52.

¹³⁷  A-M Farrell, S Devaney, ‘Making Amends or Making Things Worse? Clinical Negligence Reform and Patient Redress in England’ (2007) 27(4) Legal Studies 630.

¹³⁸  See M Rosser, ‘The Changing Face of Clinical Negligence in Wales’ (2010) 3 Journal of Personal Injury Law 162, at 169.

¹³⁹  NHS (Concerns, Complaints and redress Arrangements) (Wales) Regulations, SI 2011/704 (amended SI 2011/1706).

¹⁴⁰  SI 2011/704 – Explanatory note.

¹⁴¹  An alternative timely resolution scheme was proposed by Lord Young, Common Sense, Common Safety (2010) based on extension of the Road Traffic Accident Personal Injury Scheme. But though the fast-track web portal was extended to cover public and employers’ liability personal injury claims in 2013, clinical negligence was excluded due to its complex nature.

¹⁴²  NHSLA, A Pilot Scheme for Managing Defined Categories of Clinical Negligence Claims (February 2013).

¹⁴³  DH, Triennial Review of the NHSLA (July 2015), 4.17 cautiously supporting a fixed cost recovery scheme for claims between £1,000 and £100,000. And see rec 4.

¹⁴⁴  Ministry of Justice, Pre-Action Protocol for the Resolution of Clinical Disputes Clinical Disputes Forum, accessible at www.justice.gov.uk/courts/procedure-rules/civil/protocol/prot_rcd

¹⁴⁵  NHSLA, Annual Review: Supporting the NHS (HC 302) (July 2014) p 23.

¹⁴⁶  DH, Triennial Review of the NHSLA (July 2015), 2.4; and 9.21–9.24.

¹⁴⁷  E Cave, ‘Redress in the NHS’ (2011) 27(3) Journal of Professional Negligence 139.

Chapter 10

MEDICAL PRODUCTS LIABILITY

¹

10.1 The pharmaceutical industry once basked in the warm glow of public acclaim. The development of antibiotics, of drugs to combat high blood pressure and heart disease, of medicines to alleviate the pain of rheumatism, and later the invention of the contraceptive pill, brought benefits to many and life itself for some.² Events were to change the drug companies’ image. Starting with the thalidomide tragedy, a series of disasters taught us the painful lesson that drugs can be dangerous and their use must be paid for. The list of drugs enthusiastically promoted in the first place and withdrawn from the market a few years later, amid bitter allegations that the drug in question caused injury and even death, is long. Opren,³ the benzodiazepine tranquillisers such as Valium,⁴ human growth hormone,⁵ the pill itself,⁶ the painkiller Vioxx⁷ and most recently, the type-2 diabetes drug Avandia⁸ are but a random sample of the better-known cases. Allegations of gross profit-making by multinational drug companies have proliferated.⁹ Pharmaceutical companies have been criticised for testing products destined for the West on patients in developing countries.¹⁰ Concern about the safety of drugs has extended today to anxiety about the safety of vaccinations,¹¹ medical devices¹² (such as breast implants)¹³ and the risks posed by contaminated blood supplies¹⁴ and other body parts.¹⁵

Thalidomide was developed originally by West German manufacturers, Chemie Grünenthal. A British company, Distillers, bought the formula and manufactured and marketed the drug here under licence from Chemie Grünenthal. The drug was promoted as a safer alternative to existing sedatives and was expressly claimed to be suitable for pregnant and nursing mothers. Thalidomide was alleged to be the cause of gross fetal deformity. All over Europe, wherever thalidomide had been available, babies began to be born suffering from startlingly similar deformities, notably phocomelia (deformities of the limbs). After a bitter campaign, Distillers and the children’s parents reached a settlement to provide compensation for children recognised as damaged by thalidomide.¹⁶ But as they got older and their needs changed, the compensation proved inadequate. In 2010 the UK government issued a formal apology and set up a £20m support package.¹⁷ But some victims, now in their fifties, seek more comprehensive compensation. An Australian class action against Grünenthal and Diageo (which now owns Distillers) reportedly settled in 2013 for the sum of AUD89 million (£52m).¹⁸ And in June 2014 eight victims of thalidomide filed a claim in the High Court.¹⁹

The anti-rheumatic drug Opren, withdrawn from the UK in 1982, is alleged to have caused kidney and liver damage, and even death, in some of its elderly users. Patients who suffered injury took legal action on both sides of the Atlantic. In the USA, Opren sufferers secured substantial compensation payments. British victims found themselves entangled in lengthy and complex litigation. They won some preliminary skirmishes,²⁰ but ultimately the cost of litigation forced many of them to accept an out-of-court settlement offering only meagre compensation.²¹ Other Opren victims fought on in the courts. The defendant drug company successfully contended that they took legal action too late and were barred from either benefiting from the settlement or pursuing their case further in the courts.²² Costly litigation ending in minimal compensation payments was for decades the pattern for virtually all claims for drug-induced injury in England.²³

In 1987, Parliament enacted the Consumer Protection Act. Part 1 imposed on all producers of goods strict liability for unsafe products. This Act was based on a European Community directive²⁴ which required all Member States to introduce strict liability for products. In part the intention of the Directive was to ensure fair competition between businesses in the Community. If France required French producers to meet more stringent safety laws than other Member States, French businesses competed at a disadvantage to their rivals. However, much of the impetus for strict liability for unsafe goods in Europe²⁵ and the UK arose from a desire to give more effective protection and remedies to people who suffered injury as a result of defects in goods.

The Consumer Protection Act might be thought to make the law on drug-induced injury straightforward.²⁶ The drawn out legal battle which culminated in a Supreme Court ruling in O’Byrne v Aventis Pasteur²⁷ demonstrates that this is far from the truth. O’Byrne received a meningitis vaccination which, he alleged, caused him brain damage. He mistakenly brought an action against the supplier of the vaccine, believing it to be the producer. By the time the mistake was realised, he had fallen foul of the rule that the claim must be brought within ten years of the product being put into circulation. As the supplier was a wholly owned subsidiary of the producer, O’Byrne sought to substitute the supplier defendant for the producer. The European Court of Justice held this would be permissible, provided a domestic court is satisfied that the producer controlled the supplier. The Court of Appeal was so satisfied but its decision was overturned in the Supreme Court.

A drug which causes kidney damage or fetal abnormality would be perceived by most lay observers as ‘unsafe’. Defining ‘defective’ under the Act will be seen to be more problematical. The damage caused by some drugs takes years to manifest itself. No action under the Act is allowed more than ten years after the drug in question was put on the market.²⁸ Nor is a drug company’s liability under the Act wholly strict, for the Act permits producers to plead a ‘development risks’ defence and so escape liability. Victims of drug-induced injury may still resort to prior common law remedies in contract and the tort of negligence. And negligence liability for drug-induced injury needs to be understood to evaluate how far strict liability under the Act is a real advance on the bad old rules under which thalidomide and Opren victims had to play.²⁹

Product liability and drugs

10.2 Whatever scheme for compensation is in operation there are problems relating to drug-induced injury which will not go away. English law purports to treat drugs (and body products such as blood) as just another product. For legal purposes a defective drug is (in theory) little different from a defective electric blanket or kettle. In practice there are vital distinctions affecting both user and manufacturer if litigation is started. Defects in products can be of two sorts; in design, which means that every example of the product will prove defective, or in construction, which means that some but not all of the eventual products will be faulty simply because they have not been put together properly.³⁰ Faults in electric blankets, kettles or even aircraft are usually construction faults.

Defects in drugs are mostly design defects. That means that a drug company facing a claim alleging their product to be defective is facing a disaster. There are going to be not just one or two claimants but a host of embittered and injured users. The cost to the company may put it out of business. The company fights back with equal vigour.

From the user’s viewpoint, changes to legal aid eligibility in the Legal Aid, Sentencing and Punishment of Offenders Act 2012 makes it increasingly difficult to claim against pharmaceutical companies, especially given the poor record of success which makes ‘no win no fee’ arrangements unattractive.³¹ The greatest difficulty in any claim against the drug company is proving that the drug caused her injury. Should a new brand of electric blanket suffer a design defect, and within a week of purchase 5 per cent of users suffer an electric shock, the link between cause and effect is clear. With a new drug the process will be nothing like so swift or sure. Consider the case of diethylstilboestrol, a drug prescribed over fifty years ago to women threatening to miscarry. Evidence has emerged that women, in utero when their mothers took the drug, were affected in disproportionate numbers by vaginal and cervical cancer.³² Delay in effect is only one of the problems. There may be uncertainty whether injury resulted from the drug taken, the original disease, or some other natural cause. When a drug is alleged to cause fetal deformity this is a particular difficulty. Was the child’s disability the result of the drug, or of some inherited disorder or disease in the mother, or one of a number of other possible causes? Then in all claims there is the problem of proving that the drug was taken by the patient in the proper dosage, and as often the same drug is manufactured under different brand names, it must be shown which brand the patient actually used.³³ Medical records are often far from perfect; memory is fallible. Finally, there is the intractable difficulty of personal idiosyncrasy. A drug beneficial to 99.9 per cent of us may be lethal to 0.1 per cent. Is that drug defective? Should the company, or anyone else, compensate the 0.1 per cent who suffers injury?

The pharmaceutical industry argues that laws which weigh too onerously on it may inhibit research.³⁴ Medicine would be held back and British companies would suffer loss of competitiveness. Some view this claim sceptically. Much of the competition appears aimed at producing new brands of the same basic drugs. The pace of innovation has slowed down.³⁵ Doctors are moving away from prescribing as freely as in the past. Any decline in the pharmaceutical industry is as likely to be due to these factors as it is to be the result of law reform to help drug-injured patients.

Consumer-buyers: most favoured claimants

10.3 A victim of drug-induced injury who bought the offending drug himself, or acquired the drug in the course of a contract, has a more effective remedy than any of his fellow sufferers. Despite the Consumer Protection Act, consumer-buyers remain the most favoured claimants in England.

The Consumer Rights Act 2015 was enacted to simplify the law.³⁶ It sets out a number of conditions implied in every contract for the sale of goods.³⁷ The goods must be of satisfactory quality.³⁸ This means they must meet the standard that a reasonable person would regard as satisfactory. The goods must be reasonably fit for the purpose for which they are sold.³⁹ And the good must match the description.⁴⁰ When drugs are bought over the counter they must meet these conditions just like any other goods. To take a simple example, a patient buying a bottle of cough mixture suffers internal injury because the medicine is contaminated by powdered glass. That patient recovers full compensation for his injuries from the pharmacist who sold him the medicine. The pharmacist may be entirely without fault. The medicine may have been supplied by the manufacturer in a sealed, opaque container. That does not matter; the medicine is neither of satisfactory quality nor fit to be sold, and the pharmacist is in breach of contract. This simple and effective remedy has a defect, however. It is normally available only when the person suffering injury from the defective drug bought it himself. Had the contaminated medicine in our example been purchased by a husband and taken by his wife, she may well have had no remedy in contract.⁴¹ She cannot benefit from a contract to which she is not a party.

How useful is the contractual remedy in practice? A growing range of medicines are no longer available by prescription only. They have been reclassified to allow sale in pharmacies, or in many cases just in ordinary shops.⁴² Antihistamines to alleviate hay fever, similar drugs to aid sleep, antibiotic eye drops and a host of medicines to help digestive problems can now be bought over the counter. These ‘deregulated’ drugs are more likely to carry inherent risks of harm than the sort of cough and cold remedies available over the counter not long ago. More patients may look to their pharmacist or local supermarket for redress. Patients prescribed their medicines on the NHS remain less favoured. Such medicines will not attract conditions of satisfactory quality and fitness for purpose because there is no contract between the pharmacist and the patient into which such conditions can be implied, even though the patient will often pay for his prescription.⁴³ The pharmacist dispenses the drug as part of his obligation under his contract with the local Clinical Commissioning Group to provide pharmaceutical services in the area. The patient pays a statutory charge. He does not buy the drug; he pays a tax for NHS services.

By contrast, when drugs are dispensed under a private prescription, a contract does exist between the pharmacist and the patient. The patient pays the full cost of the drug directly to the pharmacist. It matters not whether the contract is one of simple sale or a contract of service under which the pharmacist provides a skilled service and incidentally supplies the drug. Quality conditions are imposed in identical terms regardless of whether goods are supplied in the course of a service or in an ordinary sale transaction.⁴⁴ The number of private prescriptions is rising. The pharmacist is exposed on the front line of liability for defective drugs. When more potent drugs become the subject of conditions of fitness for purpose, whether by private prescription or an over-the-counter sale, problems of applying those conditions are likely. The question may arise as to whether a drug perfectly safe for all but pregnant women is fit to be supplied. If it is specifically aimed at pregnant women, for example, a morning sickness preparation, clearly if it damages the woman or her baby it is not fit for the purpose for which it is supplied. If it is a general medicine, such as a hay-fever remedy, it could be argued that if it carries risk to a substantial section of the community, pregnant women, then it is not of satisfactory quality, nor fit to be on general sale. This immediately raises further questions. Did the manufacturer warn of the risk to pregnant women? Is such a warning sufficient? Should the woman herself be aware of the dangers of taking drugs and avoid drugs while pregnant?

These sorts of problems inevitably plague questions of liability for defective drugs. Where a remedy lies in contract, once a court finds the drug unsafe, the claim for compensation is established. It is no defence for the retailer of the drug, or the pharmacist dispensing the drug, to argue that he personally was blameless. Nor is it any answer to the patient’s claim that the state of scientific and technical knowledge at the time when the drug was produced was such that the defect could not have been discovered. There is no ‘development risks’ defence against a claim in contract. The liability imposed on the retailer or supplier is truly strict.

The remedy in negligence

10.4 Patients who suffer injury as a result of drugs prescribed within the NHS must look outside contract for a remedy. Prior to the Consumer Protection Act 1987 that remedy would have to be found in the tort of negligence. Gaps in the Consumer Protection Act mean that victims of drug-induced injury cannot ignore the tort of negligence.

An action in negligence arises where one person suffers injury as a result of the breach of a duty of care owed him by another. His doctor may be the first person to whom the patient turns for a remedy when he believes a drug prescribed by that doctor has harmed him. The doctor will be liable for drug-induced injury if the drug caused damage because she prescribed an incorrect dosage, or because she ought to have appreciated that that drug posed a risk to a particular patient in the light of his medical history, or where drugs have been prescribed in inappropriate and harmful combination. Similarly if the injury to the patient results from a negligent error by the pharmacist in, for example, dispensing the wrong drug, or indicating the wrong dosage, an action in negligence lies against the pharmacist. In a number of cases, it is the cumulative negligence of both doctor and pharmacist which causes injury, as where a doctor’s atrocious handwriting misled the pharmacist into dispensing entirely the wrong drug.⁴⁵ The problem for the patient is that all he knows is that he is ill and he believes the drug to be the cause. He will have no means of knowing whether an inherently ‘safe’ drug was prescribed for him in an unsafe and careless fashion, or whether the drug is inherently defective and harmful, however careful his doctor may be. Hence patients contemplating litigation for drug-induced injury often have to start by considering suing the doctor, the pharmacist and the manufacturer, and hope that evidence of who was actually to blame will emerge in the course of the litigation.

Turning now to the liability in negligence of drug companies manufacturing drugs, the manufacturer of any product:

which he sells in such a form as to show that he intends them to reach the ultimate consumer in the form in which they left him with no reasonable possibility of intermediate examination, and with the knowledge that the absence of care in the preparation or putting up of the products will result in injury to the consumer’s life or property, owes a duty to the consumer to take that reasonable care.⁴⁶

There is no doubt that this duty to take care attaches as much to the manufacturer of drugs as to the manufacturer of ginger beer or any other product. The duty covers the design and formulation of the drug as well as its construction. Nor is the duty limited to the original manufacturer. Thalidomide was initially developed by a West German company and manufactured under licence here by Distillers. Distillers still owed a duty to British patients to take steps to check on the safety of the drug by testing and monitoring the formula before putting the product on the UK market.⁴⁷

Establishing a duty to avoid negligence is not the problem. Determining what amounts to negligence is a formidable task. The potential harm caused by a defective drug is such that a very high standard of care will be imposed on the manufacturer. This is generally acknowledged. However, in England no action for personal injuries against a drug company has yet resulted in an award of damages by a court although a claim against the National Blood Authority has, as we shall see, succeeded. What are the obstacles confronting claimants? First, the drug company must be judged by the standards for drug safety pertaining at the date when the drug was put on the market, not at the date proceedings are taken against them. Drug companies, like doctors, must not be judged negligent on hindsight alone. Today the risk to the developing fetus of drugs taken by the mother is well known to all laywomen. When thalidomide was first on the market it is far from clear that the dangers of drugs to the fetus were widely appreciated even by gynaecologists and scientists.

Consideration of the history of the thalidomide claim⁴⁸ leads us into the second difficulty for litigants. How does a claimant obtain the evidence he will need to prove the company careless? The thalidomide story is instructive, albeit depressing. The charge against Distillers was that they should have foreseen that the drug might harm the fetus and therefore should have conducted adequate tests before promoting it as safe for use in pregnancy and/or that once adverse reports on the drug reached them they should have withdrawn it at once. In retrospect, the available evidence that Distillers was negligent falls into three categories. First, there was material available from 1934 onwards to suggest that drugs could pass through the placenta and damage the fetus. Second, in the 1950s a number of drug companies marketing new products had carried out tests to check the effect on the fetus mainly by way of animal experiments. Such evidence would need to have been given by experts and might not have been conclusive. The burden of proof lies on the claimant. The defendant’s experts would have argued that when thalidomide was developed it was by no means universally accepted that drugs could damage the fetus, the efficacy of animal tests would have been disputed, and it would have been strongly submitted that in any case such tests were not then current general practice.

The third and final category of evidence might have been more damning if the claimants could have got hold of it. Reports of the original testing of thalidomide in West Germany by Chemie Grünenthal suggest that it may have been a pretty hit-and-miss affair. Fairly early on, adverse reports on the drug and concern over risk to fetus were in the hands of Chemie Grünenthal. Some considerable time elapsed before they withdrew the drug there. Distillers acted faster, taking the drug out of circulation soon after adverse reactions were reported to them. The contents of adverse reports on a drug, the sequence and exact dates on which those reports are received, are of crucial importance to a claimant. No drug company is going to hand the reports over voluntarily. The process of discovery, of compelling a defendant to hand over documents, was seen to be complex enough in a malpractice claim against an individual doctor. In claims against a drug company the process often became an insuperable obstacle race.

One general point on the law of negligence as it affects drug claims can be made by way of illustration from the thalidomide case. It may ultimately prove to be the case that there is insufficient evidence that the company were negligent when they originally marketed the drug. There may be evidence, however hard to come by, that they were negligent in failing to act on adverse reports and recall the drug. Is that a breach of the manufacturer’s duty? Two separate situations must be examined. Had it been proved that a child was injured by thalidomide when the drug taken was put on the market by Distillers after a date by which they should have known it to be dangerous, there is no problem. The drug that injured that child was negligently put into circulation. Difficulty would arise where the drug taken by the mother had been put into circulation before Distillers should have known it was dangerous but was actually prescribed to her and taken by her after that date. There is a strong case that a manufacturer owes a further duty to monitor his product and to take reasonable steps to withdraw it if it proves unsafe.⁴⁹ Proving breach of the duty could be a nightmare. Stories of doctors continuing to prescribe, and pharmacists retaining stocks of, withdrawn drugs recur. The patient bringing such a claim may falter and sink in a sea of allegation and counter-allegation between drug company, doctor and pharmacist.

The inadequacy of negligence as an effective means of compensating victims of drug-induced injury has been demonstrated time and time again. Successive reviews of negligence as a means of remedying personal injuries resulting from any unsafe product concluded that the reform of product liability laws was essential.⁵⁰ What must now be evaluated is how effective reform by way of the Consumer Protection Act 1987 has proved to be.

Strict liability: the Consumer Protection Act⁵¹

10.5 The concept of strict liability is simple. A claimant seeking compensation from the manufacturer of a product need prove only (1) that the product was defective and (2) that the defect in the product caused his injury. Strict liability is fairer to claimants because it establishes that responsibility for an injury caused by a defective product is borne by the person creating the risk and benefiting financially from the product; that is the manufacturer. The manufacturer is in the best position to exercise control over the safety and quality of the product, and can more conveniently insure against the risk of injury posed by the product. Prolonged, expensive and complex litigation should be less common with a strict liability regime.

The Act imposes liability for personal injury arising from defective products on all producers of goods. ‘Producers’ embraces a wider category of businesses involved in the marketing of drugs than simply the companies manufacturing the finished products.⁵² Manufacturers of components are liable for any defect in the components. Companies importing drugs into the EU are liable under the Act as if they manufactured the drug in England. If the drug in question was manufactured in Japan, the aggrieved patient need not concern himself with the potential difficulties of suing the Japanese company abroad; he can bring his claim in England⁵³ against the EU company who brought the drug into the EU. A company that brand-names a drug is a producer within the Act. Companies cannot use their name to claim the credit and the profit for a drug and when something goes badly wrong, disclaim any responsibility for that drug. Finally, any supplier⁵⁴ of a drug will be deemed to be a producer unless he identifies the source of his supply. This provision is crucial for patients. The patient may well receive his prescription or injection in a form such that he cannot possibly identify the original producer of the drug. The community pharmacist or hospital pharmacy supplying the drug must identify the producer or bear liability for the patient’s injuries themselves.⁵⁵ The intention of the European Directive,⁵⁶ on which the Act is based, and of the Act itself is that there should, as far as humanly possible, always be an identifiable producer on whom liability must rest. No company should be able to hide behind a smokescreen.

However, if a claim is brought against the supplier in error, the claimant cannot then sue the producer unless he still falls within the ten-year time-limit which starts to run when the drug is first put into circulation. An HiB vaccine produced by a French company, Aventis Pasteur SA (AP) was sold to an English subsidiary company, Aventis Pasteur MSD Ltd (MSD), who supplied it to the Department of Health, who provided it to a medical centre which then vaccinated 1-year-old O’Byrne. O’Byrne suffered brain damage and alleged that the vaccine had caused it. Instead of claiming against the producer, O’Byrne mistakenly brought his claim against MSD, the supplier of the vaccine. AP successfully defended the claim on the ground that it had not produced the vaccine. By the time the mistake became apparent, O’Byrne could no longer bring a claim against the producer due to a time-limit imposed by the Act – claims must be brought within ten years of the product being put into circulation.⁵⁷ The first of two preliminary rulings from the European Court of Justice confirmed that the test is objective – the fact that the reason for not bringing a claim against the producer within the time-limit was a mistake as to who produced the vaccine, was irrelevant.⁵⁸ So O’Byrne sought instead to substitute his existing claim against the supplier, MSD (which was brought within the time-limit) for a claim against the producer, AP. To do so, under Article 3(1) of the Directive, it was necessary to prove both that the supplier put the vaccine into circulation, and that the producer (the parent company) determined when it was put into circulation, by transferring the vaccine to MSD.⁵⁹ The argument was that the vaccine was put into circulation not when SA supplied it to MSD (in which case the case was time-barred), but when MSD supplied it to the Department of Health under AP’s control. The UK Supreme Court reached a verdict on this matter in O’Byrne v Aventis Pasteur.⁶⁰ Overruling the Court of Appeal, the Supreme Court held that the relationship between the two companies precluded substitution. AP could not be said to have controlled supply by MSD. The product was therefore put into circulation when AP supplied it to MSD, and consequently the action fell outside the ten-year time-limit and was barred. After extensive litigation, O’Byrne’s case came to nothing.

Assuming the claimant has identified the right defendant, how do you establish that the drug is defective?⁶¹ Section 3(1) provides that:

there is a defect in a product … if the safety of the product is not such as persons generally are entitled to expect.

Section 3(2) goes on to direct the judge to take into account all relevant circumstances pertaining to the safety of a product including:

(a)  the manner in which, and purposes for which, the product has been marketed, its get-up, the use of any mark in relation to the product and any instructions for, or warnings with respect to, the doing of anything with or in relation to the product;

(b)  what might reasonably be expected to be done with or in relation to the product; and

(c)  the time when the product was supplied by its producer to another; and nothing in this section shall require a defect to be inferred from the fact alone that the safety of a product which is supplied after that time is greater than the safety of the product in question.

Determining when a drug falls within the definition is far from easy.⁶² Drugs are by their nature dangerous. They are designed to do damage to the bacteria or diseased cell or whatever caused the original disease. How much safety are persons generally entitled to expect? Side effects are often unavoidable. The court has to try to balance the potential benefit against the risk when deciding if an unwanted side effect renders a drug defective. Distinctions may be drawn based on the condition that the drug was designed to combat. A minor tranquilliser which carried an unforeseen 5 per cent risk of liver damage could be deemed defective when an anti-cancer drug carrying identical risk would not. Relief of moderate anxiety may be seen as insufficient to warrant the risk, whereas the battle against cancer may justify that degree of inherent danger.

Anticipated risks raise different issues. An anticipated risk must be warned against. Of course there must be some determination as to the seriousness of the anticipated risk. Consider a drug used to treat schizophrenia which may cause weight gain. Must the pharmaceutical company warn of this relatively benign potential side effect? Class actions in the USA were brought against AstraZeneca on the ground that they should have warned that weight gain might occur in patients using Seroquel, particularly in view of the links between weight gain and type-2 diabetes.⁶³

What if the risk is acknowledged? Will the tranquilliser be deemed not defective if its potential danger is outlined to doctors and patients, leaving the choice to them? Clearly the warning must be taken into account. An antibiotic harmful only to the fetus will almost certainly not be defective if a warning of its risk is clearly given. Less essential drugs may remain defective even if risks are detailed in the literature supplied to doctors. The patient may never have the warning passed on to him. In such a case, though, a heavy share of liability would rest with the doctor prescribing the drug, in contravention or ignorance of warnings from the producer.

Other problems in applying this definition of ‘defective’ beset the patient. What of the patient who suffers injury because of an allergic reaction to the drug? The drug is perfectly safe and effective for you, but lethal to us. So might it be argued that the drug is safe for ‘persons generally’? Such an argument will fail. Society, ‘persons generally’, demands that regard be had to the safety of all of us where, as in the case of drugs, allergic and idiosyncratic reactions are a well-known risk of the product. If risk to an individual or group is foreseeable and not warned of in the presentation of the product, it is defective. An individual is entitled to expect that the manufacturer will not simply ignore an identified danger to however small a group. When the risk is not foreseeable, the size and predictability of the affected group will be crucial. A sedative which causes damage to the fetus or liver damage in 10 per cent of the overseventies will be defective. Pregnant women and the elderly are large groups of potential consumers known to be vulnerable to drug-induced injury. But what if the sedative injured only a handful of users out of millions?

Guidance on defining ‘defective’ is to be found in a series of judgments. In Abouzaid v Mothercare Ltd⁶⁴ a 12-year-old boy was trying to attach a fleece-lined sleeping bag to his baby brother’s pushchair. The sleeping bag had to be clipped onto the pushchair by passing elasticated straps round the back of the chair joined by a metal buckle. There were no instructions provided. As the boy struggled to fasten the sleeping bag to the chair, one of the straps slipped from his grasp and the metal buckle flew up and hit him in his left eye. The injury caused him to lose significant vision in that eye. The Court of Appeal found that the product was defective. There was a failure to provide instructions and the design of the product was unsafe because it could not be secured without risk. Consumers would properly expect that such a product could be used without that degree of risk. Relatively minor alterations in design would eliminate that risk.

The Mothercare judgment can be applied to make two key points about liability for drugs. (1) Instructions about the use of and warnings concerning possible adverse effects of drugs are crucial. Failure to warn of a known risk will, as argued earlier, render a drug defective. (2) Common sense will play its part in determining what ‘people generally’ may expect from a product.⁶⁵ That latter point is reinforced in Richardson v LRC Products Ltd.⁶⁶ The plaintiff became pregnant after a condom split. She sued the manufacturers arguing that the condom failure demonstrated that the product was defective. She was unable to identify any particular construction defect in the condom or point to a risk of damage which the manufacturers should have avoided. The judge found no evidence of unsatisfactory testing of the product. The evidence was simply that, in actual use, an inexplicable number of condoms fail. Dismissing the plaintiff’s claim, the judge held that the manufacturers made no claims that their (or any method) of contraception was 100 per cent safe. The fallibility of contraception is well known.

Returning to drug-induced harm, consider the following examples in the light of the above cases. You purchase ibuprofen in a supermarket. The packet clearly warns you not to take the medicine if you suffer from asthma. You ignore that warning and despite your asthma, take several tablets. An acute attack of asthma lands you in hospital. Is that pack of ibuprofen defective? You are prescribed a cream to cure acne. No warning accompanies the product. The cream causes the eruption of a rash all over your body. Evidence emerges that that product will produce just such an allergic reaction in about 2 per cent of female users if they use the cream during pregnancy. Neither you nor your GP was aware you were pregnant at the time. Is the product defective?

A v National Blood Authority⁶⁷

10.6 The judgment in A v National Blood Authority is by far the most important case yet to interpret the Consumer Protection Act. It breathed new life into strict liability. The case addressed claims by patients infected with hepatitis C from blood and blood products through blood transfusions after March 1 1988. Two important points must be made. First, the defendants (rightly) conceded that blood and body parts fell within the regime of strict liability imposed by the Consumer Protection Act. Second, the judge ruled that the provisions of the UK legislation (the 1987 Act) must be interpreted in the light of the European Product Liability Directive. Where there were apparent inconsistencies between the two, the Directive should be preferred. The importance of this will be highlighted later.

Moving to the substance of the claims, the judge held that in determining whether the contaminated blood products were defective what must be decided is what the legitimate expectations of the public were in relation to that product. People expected blood to be 100 per cent clean. Whether the relevant ‘defect’ in the product was avoidable was not the issue. The defendants had tried to argue that the public could only expect they would have done what was possible to screen blood and avoid contamination. In more diplomatic language, the judge effectively declared this to be nonsense. He said:

it is as inappropriate to propose that the public should not ‘expect the unattainable’ – in the sense of tests and precautions which are impossible – at least unless it is informed as to what is unattainable or impossible as it is to reformulate the expectation as one that the producer will not have been negligent or will have taken all reasonable steps.⁶⁸

The judge marked a clear boundary between negligence and strict liability. He went on to say a distinction needs to be made between standard and non-standard products, a distinction analogous to design and construction defects. Establishing that a standard product was defective would continue to be difficult. The infected batches of blood were non-standard. They could only not be defective if it could be shown the public were made aware of the risks. In this instance, this was not the case. Unlike condoms, which most people know do and can split for no apparent reason, most of us assume that blood will not cause us to succumb to serious, even fatal, disease.

Development risks⁶⁹

10.7 In A v National Blood Authority,⁷⁰ the Blood Authority had another weapon. If the contaminated blood was defective, they argued they were not liable because they could invoke the development risks defence.⁷¹ A ‘development risks’ defence amounts to this. The manufacturer will not be liable if he can prove that the state of scientific and technical knowledge at the time when he put the product into circulation was not such as to enable the existence of the defect to be discovered.⁷²

The scope of the development risks defence in the United Kingdom looked broad. The European Directive on Products Liability framed the defence in terms of the scientific and technical knowledge generally available. Section 4(1)(e) of the Consumer Protection Act provides:

the state of scientific and technical knowledge was not such that a producer of products of the same description as the product in question might be expected to have discovered the defect.

The test in the Act appears to be what was the knowledge and practice of the pharmaceutical industry at the time. The European Commission challenged the British Act alleging that the UK had improperly sought to broaden the defence allowed by the Directive. The challenge failed.⁷³ The European Court of Justice allowed the UK interpretation of the Directive. The result might have been depressing.⁷⁴ Academic research may reveal significant concerns about the safety of a novel drug. If that research has not permeated industry, the ‘development risks’ defence could still avail the drug companies creating a test little different from ‘old’ negligence rules. So, in A v National Blood Authority the defendants argued: (1) that as at the relevant time there was no effective test to screen blood for Hepatitis C the development risks defence applied: and (2) that the 1987 Act provided that producers of analogous products must at the relevant time have been aware of and able to eliminate the relevant risk. Construing the Act in the light of the Directive, the judge dismissed both arguments. The defence applies only where the very existence of the defect was unknown and undiscoverable.⁷⁵ Authorities responsible for blood supplies at the relevant time were aware of the risks of contamination. That no method of screening for Hepatitis C had yet been developed was irrelevant. The wording of section 4(1)(e) of the 1987 Act was inappropriate. The Directive made it clear that once knowledge of a risk was accessible to manufacturers, the risk was known. A single article in an obscure Chinese journal (‘the Manchurian exception’) might not suffice.⁷⁶ General knowledge accessible to the academic and commercial communities would.⁷⁷

If A v National Blood Authority is followed in the higher courts, the Consumer Protection Act may make a difference.⁷⁸ A producer invoking the development risks defence will have to establish that the defect in the drug, or device, or bodily product, was undiscoverable and the onus will lie on him to prove this.

Until 2010 it seemed likely that Burton J’s decision in A v National Blood Authority would come under review in a group litigation on anti-epileptic drugs. The claimants were children whose mothers took the anti-epileptic drug, Epilim, in pregnancy. Some mothers were warned of potential adverse effects to their fetuses but were reliant on the drug to control their epilepsy. They took the drug out of necessity. Is the drug ‘defective’ within the meaning of the Act? Preliminary hearings were unable to reach a conclusion on the matter.⁷⁹ The case was expected to come to trial in November 2010, but after a six-year battle, legal aid was withdrawn weeks before the case was due to come to trial.⁸⁰

Collective actions

10.8 Class or ‘collective’ actions where members of a larger faction sue on behalf of the whole group, are common in the USA, but rarer and more limited⁸¹ in the UK. The most common procedural method for a collective action is the Group Litigation Order (GLO),⁸² but this is more a method of case management rather than a representative action.⁸³ Two current GLOs relate to medical devices. The High Court approved a GLO in 2014 for potential claimants implanted with the DePuy Pinnacle metal on metal hip prosthesis which had a higher than normal failure rate for patients.⁸⁴ And in 2012 a GLO was approved when Poly Implant Prothese (PIP) silicone breast implants were found to contain industrial-grade silicone.⁸⁵ The group litigation by around 1,000 women against the owners of private clinics⁸⁶ is based on the alleged substandard nature of the product under the Sale of Goods Act 1979 and the Supply of Goods and Services Act 1982.⁸⁷

As we shall see, actions which have been successful abroad have stalled or failed in the UK, for both legal and financial reasons. In 2008 the Civil Justice Council (CJC) sought to make it easier to bring a collective action in any type of civil case.⁸⁸ Access to justice might be enhanced by allowing individuals to opt out of group litigation rather than requiring then to opt in. But the government rejected the proposals, insisting that it was preferable to develop rules that are specific to each sector.⁸⁹ Pressure for change mounted in Europe, but the European Commission’s 2013 Recommendations for national collective redress mechanisms are non-binding.⁹⁰ Reform, if it ever comes, is likely to stop short of a US-style class action, both in deference to opposition from industry and due to the perception that it would contribute to a compensation culture.

vCJD-contaminated blood products

10.9 When bovine spongiform encephalopathy (BSE) was linked to new variant Creutzfeldt–Jakob disease (vCJD), a class action was mounted against the government.⁹¹ It petered out when a no-fault compensation scheme, run by the national CJD Surveillance Unit, was put in place in 2001 in the wake of the BSE Inquiry. The scheme has been criticised for its complexity and the extensive discretion given to trustees, but an application for judicial review of the Department of Health’s decision to reject radical amendment failed.⁹² In 2004, the Secretary of State announced a similar ex gratia compensation scheme for people infected with Hepatitis C from NHS blood or blood products.⁹³ In R (Moore) v Skipton Fund Ltd⁹⁴ M applied for judicial review of the terms of the scheme. During the course of medical treatment, M was infected with Hepatitis C in 1987. Very occasionally, the immune system clears the body of the disease. In the vast majority of this small number of cases, this occurs in the early, acute stage of the disease, in which case, no compensation is payable. M’s body was clear of the disease and, according to the scheme, she bore the burden of proving, with ‘robust medical evidence’, that this occurred in the later chronic stage of the disease if she were to be paid compensation. M could not prove this and complained that such proof was, in her case, scientifically impossible. Her application failed. Parker J held that, given the statistical improbability of the disease clearing after six months, and the low risks of long-term problems if it cleared before that time, it was right that M must demonstrate that she had suffered the chronic stage of the disease.

More recently fears have arisen surrounding the contamination of blood products with variant Creutzfeldt–Jakob disease (vCJD). The disease, which has a long incubation period, is carried by as many as 1:2000 people in the UK.⁹⁵ In 2003, it was found that a blood donor may have transmitted vCJD to a patient who underwent a blood transfusion.⁹⁶ The National Blood Service⁹⁷ now asks anyone who has received blood products since 1980 not to donate blood. A donor history is taken from potential or definite vCJD cases, and their blood products recalled. Plasma is imported from countries with few or no cases of BSE. All children born after 1996 receive this plasma.⁹⁸ Since 2005, donors and donees who are identified as being ‘at risk’ for public health purposes, are informed of the public health precautions they and their healthcare staff should take. Around 6,000 patients, many of them haemophiliacs, have been told they are ‘at risk’. For them the uncertainly has the potential to blight their lives. There is no test and no cure for this fatal disease. Researchers are developing a test which will diagnose vCJD earlier and potentially allow blood screening.⁹⁹ But if the result is positive, should donors be made aware of the results? Will anyone consent to giving blood any more?¹⁰⁰ A number of attempts have been made to introduce a Private Member’s Bill, the Contaminated Blood (Support for Infected and Bereaved Persons) Bill, to provide additional support for families and patients infected by contaminated blood products and to establish a committee on contaminated blood.¹⁰¹ In the meantime, for those who go on to develop vCJD, the compensation fund will provide for those victims who on the balance of probabilities:

contracted vCJD as a result of (i) exposure to bovine product(s) purchased in the UK which came from cattle reared and slaughtered in the UK or (ii) otherwise as a result of exposure in the UK to BSE or vCJD.¹⁰²

Acceptance of compensation does not preclude legal action.¹⁰³ For those infected, group litigation is conceivable if it can be demonstrated that the government was aware of the potential risk but took no action because of the cost of alternative synthetic products.¹⁰⁴

The UK also sold blood products abroad.¹⁰⁵ The wording of the trust deed clearly encompasses cases where infected meat products are exported, but it seems that transmission of vCJD from blood products contaminated in the UK will not result in ex gratia compensation unless exposure occurred ‘in the UK’. While the compensation fund may deter UK citizens from pursuing legal action, there is no such luxury for someone infected by exported blood products.

Causation

10.10 The claimants in A v National Blood Authority were lucky in one respect. They knew who had supplied the ‘defective’ blood. Where a claim relates to a drug, a potential claimant may well have taken the drug over several years and not be able to trace which of several drug companies manufactured the drug that caused his injury. An analogous problem arose in Fairchild v Glenhaven Funeral Services Ltd¹⁰⁶ facing workers who contracted the industrial disease, mesothelioma. They could show that their illness was caused by exposure to asbestos dust or fibres. They established that their employers were negligent in exposing them to asbestos. However, as they had worked for several companies during their working life, they could not pinpoint which employer was actually responsible for their disease, which can be caused by a single fibre entering the lung. The Law Lords ruled that as each defendant employer had increased the risk to the affected workers, causation was established against all of them. In the USA, in Sindell v Abbott Laboratories,¹⁰⁷ it has been held that where patients are exposed to risk from a defective drug manufactured by several different companies, each company is held liable in proportion to its market share. Lord Hoffmann in Fairchild did not consider that the industrial disease claims before the Law Lords and claims against drug companies were the same. He said that the risk from consuming a drug bought in one shop is not increased by the fact it can be bought in another shop. With respect, he overlooks the possibility of drug-induced injury caused by prolonged or incremental use of a medicine. However, more importantly, he signalled that, even if Fairchild does not conclusively determine that the Sindell rule prevails in England, he looked at the possibility with some favour.¹⁰⁸

Lord Hoffmann implemented this approach in Barker v Corus,¹⁰⁹ which also involved a mesothelioma victim employed by a number of employers who had breached their duty of care and exposed the employee to asbestos. Lord Hoffmann stated:

In my opinion, the attribution of liability according to the relative degree of contribution to the chance of the disease being contracted would smooth the roughness of the justice which a rule of joint and several liability creates. The defendant was a wrongdoer, it is true, and should not be allowed to escape liability altogether, but he should not be liable for more than the damage which he caused and, since this is a case in which science can deal only in probabilities, the law should accept that position and attribute liability according to probabilities.¹¹⁰

Consequently Corus was liable according to the probability of risk it created. Corus was not liable for the probability of risk created by the first, insolvent employer. This meant that Mr Barker went under-compensated. Those employed by a single solvent employer, however, could be assured of 100 per cent compensation. The government responded with the Compensation Act 2006, section 3 of which reverses the effect of Barker for mesothelioma victims and provides that compensation will be joint and several. Victims of mesothelioma can seek full compensation from any solvent negligent employer. The negligent employer will then be able to claim back contributions from other responsible persons under the Civil Liability (Contribution) Act 1978. Barker remains an authoritative decision in non-mesothelioma cases.¹¹¹ The case was applied in the High Court decision of Heneghan v Manchester Dry Docks Limited and others¹¹² in a case of asbestos lung cancer, though this may be subject to appeal.

Problems proving causation are not confined to those cases where there are multiple defendants. The toxicity of medicinal products and the health of patients render a causal link between the product and the alleged harm particularly hard to prove.¹¹³ Does the Fairchild exception to the normal causation principles extend to cases involving a single defendant? The Supreme Court in Sienkiewicz v Greif¹¹⁴ held that it can. Enid Costello died of mesothelioma in 2006 having been exposed to asbestos in the course of her employment as well as low levels of asbestos in the environment. Overturning the Court of Appeal decision, the claim succeeded on the basis of the Fairchild exception.

Sienkiewicz raises another issue in relation to causation in product liability cases. The claim failed in the Court of Appeal on the basis that the employers had not doubled the relative risk of the claimant contracting mesothelioma.¹¹⁵ The ‘doubles the risk’ approach involves a statistical risk analysis based on epidemiological evidence. In other words, it looks at the effect of the drug on the population as a whole. If the analysis reveals more than double the chances of injury, it is considered on the balance of probabilities to have caused the injury. This approach has proved problematic in the USA, but has found favour in some cases in the UK.¹¹⁶ In Sienkiewicz, the Supreme Court, however, deemed the ‘doubles the risk’ approach unsuited to mesothelioma cases, because science cannot pinpoint the precise origin of the disease. For non-mesothelioma cases, on the other hand, it seems that the ‘doubles the risk’ approach survives Sienkiewicz, at least where there are competing alternative (rather than cumulative) causes of disease.¹¹⁷ Could the ‘doubles the risk’ approach be used in product liability litigation? While possible, it seems unlikely. In Australia, a claim that the painkiller Vioxx¹¹⁸ doubled the risk of heart attack across the population and thus materially contributed to the claimant’s heart attack was accepted at first instance but rejected on appeal.¹¹⁹ While a relative doubled risk shows an association in the general population, other factors, such as the individual’s obesity and history of smoking, indicated a lack of causality in the individual case.

In Chapter 5, we examined a causation case which has potentially wider implications for product liability. In Chester v Afshar¹²⁰ Miss Chester underwent surgery on the advice of Mr Afshar, her surgeon, during which she suffered nerve damage to her legs. The operation was performed with due care, but, even so, there was a 1 to 2 per cent risk of nerve damage. Miss Chester was not warned of the risk. Had she been so warned, she would have deferred the operation, but on the balance of probabilities, it could not be said that she would have withheld consent. Did the lack of causation defeat her claim? The majority held that it did not. Lord Hope stated:

To leave the patient who would find the decision difficult without a remedy, as the normal approach to causation would indicate, would render the duty useless in the cases where it may be needed most. This would discriminate against those who cannot honestly say that they would have declined the operation once and for all if they had been warned. I would find that result unacceptable. The function of the law is to enable rights to be vindicated and to provide remedies when duties have been breached.¹²¹

Once again, it remains to be seen whether this approach will be applied in wider contexts.¹²² If the same practical justice is applied to product liability, could a failure by the manufacturer or supplier to warn a patient of side effects or adverse reactions result in liability, even if the claimant cannot prove that he would not have used the product if he had been properly warned?¹²³

Prevention better than cure?¹²⁴

10.11 The thalidomide tragedy prompted new laws to vet drugs before they could be marketed in the UK. The Medicines Act 1968 provided for the licensing and monitoring of drugs. In 1998 a similar system was set up to regulate medical devices (for example diagnostic tests or intra-uterine devices) and in 2003 both systems were brought under a single agency: the Medicines and Healthcare Products Regulatory Agency (MHRA). UK laws (including over 200 statutory instruments) are consolidated in the Human Medicines Regulations 2012.¹²⁵ The licensing process (described below) has evolved to take into consideration the increasing relevance of European regulations. The 2012 Regulations implement EU Directive 2001/83/EC relating to medicinal products for human use,¹²⁶ and also EC Regulation 726/2004 on the authorisation of medicinal products and EU Directive 2010/84/EU on pharmacovigilance (safety-monitoring) in the EU market.

No medicine¹²⁷ may be manufactured, imported or marketed without a licence. The Clinical Trials Directive¹²⁸ (Chapter 15) requires three different types of licence in the development of an investigational medicinal product. First, the companies manufacturing and distributing the medicines are required to have ‘manufacturer’s and wholesale dealer’s licences’; second, ‘clinical trial authorisations’ are required in order to develop new products; and third a ‘marketing authorisation’ is required before the product can be marketed.

There are various routes to marketing authorisation; the Medicines and Healthcare Products Regulatory Agency oversees UK marketing authorisation and the European Medicines Agency gives ‘centralised’ authorisation valid in all EU and EEA states. In addition, there are systems by which marketing authorisation can be obtained in several EU countries concurrently.

The European Medicines Agency (EMA) was established in 1995¹²⁹ to harmonise and streamline licensing across Europe. It has a staff of around 800 and is based in London. One of its committees is called the Committee for Medicinal Products for Human Use (CHMP)¹³⁰ which licenses human medicinal products for distribution across the EU. Some drugs must be authorised by this route.¹³¹ In other cases, a product can be licensed in the UK only, via the Medicines and Healthcare products Regulatory Agency, an executive agency of the Department of Health based in London. With a staff of around 900, the MHRA supports expert advisory bodies, such as the Devices Expert Advisory Committee¹³² and the Commission on Human Medicines (CHM).¹³³ The CHM reviews licensing applications and produces an independent assessment. It will review the safety, quality and efficacy of the healthcare product but will not consider its efficacy in comparison with any existing product. The CHM does not exist to prevent copies, sometimes referred to as ‘me-too’ drugs.

Once marketing authorisation is obtained, the product manufacturer must show that the product is cost-effective before the NHS will make it available.¹³⁴ The MHRA then subject the product to a lifetime of checks and inspections, operating systems to control product information, advertising,¹³⁵ pharmacovigilance and potentially reclassification (for example, if a prescription drug is made available in pharmacies or ordinary shops). Marketing authorisations are granted for periods of up to five years after which they must be renewed.

The CHM ‘promote the collection and investigation of information relating to adverse reactions for human medicines’.¹³⁶ The EMA promulgates guidance to enhance consistency and transparency.¹³⁷ Post-marketing surveillance systems include the ‘yellow card scheme’ which concerns adverse reactions to medicines and Adverse Incidence Reports regarding devices. On the basis of these systems, the CHM makes recommendations regarding safety issues and the minimisation of risk and less urgent issues are communicated via a regular bulletin.

Section 28 of the Medicines Act 1968 empowers the minister to revoke an existing licence. Several grounds for revocation are established, of which the most important is where:

medicinal products of any description to which the licence relates can no longer be regarded as products which can safely be administered for the purposes indicated in the licence, or can no longer be regarded as efficacious for those purposes.

The decision to withdraw a drug from the market is no longer solely a matter for the manufacturer. A manufacturer aggrieved by the refusal or revocation of a product licence may seek a review by the CHM. No product licence can be refused or revoked without consultation with the CHM. A manufacturer whose product has been approved by the CHM, but who is refused a licence by the minister has a right to a further hearing. If he chooses, as he may, to reject their advice, he must set up an independent inquiry before which the manufacturer may state his case.¹³⁸

Off-label drug use

10.12 Drugs are sometimes used ‘off-label’ – that is, in an unapproved form or dosage. For example, a drug licensed for use in adults might be used ‘off-label’ to treat a child with a related illness when no licensed treatment exists.¹³⁹ The alternative would be to refuse the child treatment until a clinical trial can be carried out and marketing authorisation received.¹⁴⁰ Clearly this would be too late for the patient. In other cases, a patient might suffer a rare disease and a trial would not be financially viable. As a result, some ‘off-label’ drug use is sanctioned, but the lack of regulation and limited recourse to redress can expose (sometimes vulnerable) patients, to risk.¹⁴¹

The drug company should not actively market the drug for this use. However, it has been alleged that the profits attainable by marketing a drug for unlicensed use might justify the fines imposed upon the company if they are caught.¹⁴² A lacuna in the law relating to off-label drug use was revealed in 2008. The anti-depressant drug, Seroxat, was licensed for use in adults, but frequently used off-label to treat teenagers. GlaxoSmithKline were alleged to have withheld clinical trial data showing that Seroxat was ineffective and potentially unsafe for those under the age of 18.¹⁴³ However, the regulations controlling safety information did not extend to off-label drug use and as a result the case against the drug company was weak. Nevertheless, the MHRA was much criticised for its decision not to prosecute, especially as other countries responded far more harshly.¹⁴⁴ In 2009 the Medicines for Human Use (Marketing Authorisations Etc) Amendment Regulations 2009¹⁴⁵ extended the requirement to provide safety information to encompass off-label drug use.

Holding regulators to account

10.13 The MHRA authorises, inspects, surveys and enforces the use of medicines and devices, aiming to protect, promote and improve public health. But does the system adequately represent patient’s interests? Critics fear that drug regulators lack transparency and favour efficacy over patient safety. As long as drug companies evaluate their own products the public interest will not be served. The MHRA, they complain, is ‘unaccountable, slow, and lacking the necessary expertise’.¹⁴⁶ The 2005 House of Commons Select Report on the Pharmaceutical Industry¹⁴⁷ was critical of the MHRA’s close proximity to industry, its over-reliance on trust and its failure to properly scrutinise licensing data,¹⁴⁸ concluding:

In view of the failings of the MHRA, we recommend a fundamental review of the organisation in order to ensure that safe and effective medicines, with necessary prescribing constraints, are licensed.¹⁴⁹

Can aggrieved patients sue the regulators? The possibility of governmental liability for drug-induced injury was aired even in the thalidomide days. The Health Minister, Sir Keith Joseph, dismissed suggestions that the government could be liable. He argued further that, even when the elaborate licensing provisions of the 1968 Act were in force, the legal liability for any defect in the drug rested on the manufacturers alone.¹⁵⁰ The patients injured by the antiarthritic drug, Opren, sought compensation from the health minister and the former Committee on Safety in Medicines as well as from the drug company.¹⁵¹ They contended that the government and the CSM had been negligent both in originally licensing the drug and for continuing to allow it to be marketed after its dangers should have become apparent to the ministry and the CSM. The Opren case against the government was ultimately abandoned.

Another claim against the CSM was mounted in Smith v Secretary of State for Health (on behalf of the Committee for Safety of Medicines).¹⁵² In May 1986, 7-year-old Amanda Smith caught chickenpox and was given one aspirin tablet on two consecutive days by her mother, who followed the advice on the label. Amanda’s condition worsened. She developed spastic tetraplegia and was eventually diagnosed with Reye’s syndrome. In June 1986, the CSM issued a warning that aspirin should not be given to children under the age of 12 except on medical advice because it could trigger Reye’s syndrome. They had met in March 1986, but delayed the warning so as to cooperate with the drug companies. No interim warning was made. Was the CSM negligent? Morland J held that it was not. There was no breach of statutory duty or common law duty of care. The decision by the CSM was a discretionary policy decision which is not, Morland J held, justiciable in private law, even if there was fault in the timetabling of the warning.¹⁵³

In XYZ and others v Schering Health Care Ltd,¹⁵⁴ the CSM was once again under fire, but this time from the drug companies. The case involved a group action by claimants alleged to have suffered cardiovascular injuries as a result of taking certain brands of the combined oral contraceptive (‘the pill’). In 1995, the CSM circulated a warning to prescribers of ‘the pill’ that three as yet unpublished articles indicated a twofold increase in risk of venous-thromboembolism. The defendants argued that the letter was ill-considered and that the ensuing ‘pill scare’ was a public health disaster. Mackay J held that there was not in fact a twofold increase in risk and on that basis the claimants lost their case. Nor was the advisability of the CSM’s letter under review in this case. Regulators have the unenviable task of deciding when it is appropriate to ‘act as though a given association were causal rather than to continue to assume that it is not’.¹⁵⁵

In R (Roche Registration Limited) v Secretary of State for Heath,¹⁵⁶ the MHRA supplied a re-inspection report on Roche’s pharmacovigilance systems (monitoring the effects of licensed drugs) to the EMA, which then used it for penalty proceedings. It was not clear that the EMA had the requisite power to request the report. Had the MHRA acted unfairly in collating the information and passing it on? Carr J held that the MHRA acted appropriately. Roche was not misled about the purpose of the inspection or the use of the report.

Could a claim against the Commission on Human Medicines, in effect for negligently monitoring drugs and/or blood products, succeed? In Smith, Morland J did not rule out the possibility. Neither the Secretary of State nor the CHM enjoys blanket immunity from a common law suit.¹⁵⁷ Improper exercise of duty such as the postponing of a meeting ‘because it clashed with the Epsom Derby meeting’¹⁵⁸ would clearly be considered negligent. Beyond that, claimants would have to persuade the court that it was ‘just, fair and reasonable’ for the CHM to be subjected to a duty of care to individual patients and that the decision was not discretionary or policy-based. Two particular questions will pose problems for claimants. The court will seek to ask whether the scheme of regulation established by the Medicines Act and now heavily influenced by European legislation, was designed to provide a right to compensation to those injured by unsafe drugs. And given that the primary responsibility for the medicine still rests with the drug company, should the government be liable for their wrongdoing?

Claims brought abroad

10.14 The majority of drug companies are multinationals. Drugs are not confined within national borders. British women who suffered injury as a result of suing the Dalkon Shield IUD sued the manufacturers in the USA and recovered compensation from a settlement fund set up when the company went bankrupt.¹⁵⁹ When can an injured patient resort to a foreign court and why should he want to?

When a claim has a foreign element a set of rules known as private international law, or conflict of laws, comes into play. These are excessively complex and we give only the barest outline of the relevant law. Essentially, when a claim for negligence is brought the claimant can sue in any country where a relevant act of negligence occurred, or in the country where the drug company is based.¹⁶⁰ There may be more than one such country. So in the case of a defective drug, negligence may have occurred both in the country where it was carelessly manufactured and in the country where it was carelessly marketed as safe¹⁶¹ and injured the claimant. It is on the basis of the careless manufacture of the device in the USA that the women suing over the Dalkon Shield were able to go to court in USA. Where there is a dispute over whether an action should be allowed to go ahead, the law of the country where the claimant is trying to sue determines whether it should do so.

Why should anyone want to sue abroad? After all, if they took the drug here and were injured here they can bring their claim in their homeland on the basis that it was here the drug caused them harm. There are three reasons why claimants in England and Wales may opt for the hassle of a foreign lawsuit. First, the procedural rules in the foreign courts may be more favourable to claimants. They may be able to conduct a ‘collective (or class) action’ more effectively than in England and Wales. Second, there remain financial incentives to sue in the USA if you can. Not only is liability for drugs strict, but awards of damages are made by juries, and are generally much higher than domestic judge-made awards. The contingency fee system may offer more favourable access to the courts than conditional fees do here. And finally a threat to sue in the USA may prompt the defendants into offering a more generous settlement than would otherwise have been the case.

However, legal action abroad is fraught with difficulties. When the pharmaceutical giant, Merck, withdrew the drug Vioxx from the market because of links to cardiovascular problems such as heart attacks,¹⁶² successful claims were brought in Australia and the USA. However, legal aid was refused in England and Wales,¹⁶³ and law firms were unwilling to risk action based on a conditional fee arrangement.¹⁶⁴ As a result, UK citizens took their case to the American courts, but this too was unsuccessful.¹⁶⁵

Vaccine damage: a special case?

10.15 Vaccine damage has received special treatment because of the distinction in social effect between vaccines and other drugs.¹⁶⁶ Generally the benefit and risk of taking a drug rests with the individual patient alone. No one else suffers directly if he does not take the drug. No one else benefits directly if he does. With a vaccine the position is different. If a child is immunised, the child himself benefits from the immunity conferred and his friends and schoolfellows benefit from the elimination of the risk that he will pass that disease on to them. Consequently vaccination of young children against diseases such as tetanus, diphtheria, polio, measles, meningitis C and whooping cough is actively promoted by the Department of Health. The whooping cough vaccine caused outcry and distress, and concerns about the MMR vaccine generated similar controversy. A number of children healthy before vaccination have, their parents claim, suffered severe and lasting brain damage as a consequence of receiving the vaccine. More recently, however, the scientific claims that MMR vaccine had such an effect have been largely discredited and the doctor who led the research was found guilty of serious professional misconduct by the General Medical Council (GMC).¹⁶⁷

What remedies have the parents of a vaccine-damaged child? First they may, as a number of parents of children allegedly damaged by whooping cough vaccine have done, seek to use the tort of negligence to obtain compensation. The advantage of this course is that, if the claim was successful, their children would receive full compensation for any disability caused by the vaccine. One problem is whom to sue. The crux of the question is often whether the risk of the vaccine to a child is greater than the risks posed by contracting the disease itself. An action against a doctor for negligently using a reputable vaccine is likely to fail because, even if some doctors and experts condemn its use, a substantial body of informed opinion still backs the vaccine. A negligence action is usually only viable if some special feature of the child’s history should have ruled out routine vaccination, or if symptoms at a first vaccination, indicating that further vaccination was unwise, were missed. Suing the manufacturers will run into the problem of the risk–benefit ratio of the product. The manufacturers dispute the level of risk from the vaccine and will argue that the overwhelming benefit to the community of vaccination outweighs any risk to a very few. They will contend that, properly used, the vaccine is not defective. In relation to the whooping cough vaccine the companies deny that the vaccine does indeed cause brain damage. In Loveday v Renton¹⁶⁸ a judge held that the claimants failed to prove that the pertussis (whooping cough) vaccine caused the child’s brain damage. Attempts to recover compensation for vaccine injuries through claims in negligence have generally proved unsuccessful in England.¹⁶⁹ The MMR litigation cost in the region of £15m. In 2004, the High Court rejected an application for a judicial review of an earlier decision to withdraw legal aid on the basis that the claims were unlikely to succeed and would cost the public a further £10m.¹⁷⁰ Today legal aid would not be accessible for such a claim. Unless there is a very good chance that the case will succeed and unless the claim is based on solid research, group actions such as the MMR Vaccine Group Litigation and Gulf War syndrome are unlikely to attract funding via a conditional fee or damages based agreement.¹⁷¹

The problems of litigation deter many parents from going to court. Successive reviews of the issue of compensation for vaccine damage recognised that it is an example of injury where compensation via the tort of negligence, or the Consumer Protection Act, may be inappropriate. There may prove to be no negligence on anyone’s part because the benefit to the majority is held to justify the risk to a small minority. Yet it is scarcely fair that those who suffer damage should bear the whole burden of disability alone. On the recommendation of the Pearson Commission, Parliament enacted the Vaccine Damage Payments Act 1979 to provide for a no-fault compensation scheme for vaccine-damaged individuals. The current amount payable is £120,000.¹⁷² The making of a payment under the 1979 Act does not debar a claimant from also suing for negligence in respect of the vaccination.

The Act remains a target of criticism.¹⁷³ Successful cases are rare.¹⁷⁴ The sum of £120,000 may sound substantial. If a child is so damaged that he will never be able to care for himself and earn his own living, it falls far short of his needs. A successful tort claim would result in a multimillion pound award.¹⁷⁵ The Act remains a compromise. It has not replaced tort with an adequate compensation mechanism. Critics complain that the ever-present problem of causation of drug-induced injury is simply ignored in the Act. The claimant must establish on the balance of probability that his disablement resulted from the vaccine.

¹  See generally S Whittaker (ed), The Development of Product Liability (2009) Cambridge University Press; E Jackson, Law and the Regulation of Medicines (2012) Hart; R Goldberg, Medicinal Product Liability and Regulation (2013) Hart.

²  Though J Blech, GW Hajjer, Inventing Disease and Pushing Pills (2006) Routledge, suggest that the pharmaceutical industry is guilty of medicalising normal life processes such as birth, unhappiness and sexuality to create new markets with costly results; see P Conrad et al, ‘Estimating the Costs of Medicalization’ (2010) 70(12) Social Science and Medicine 1943.

³  Discussed later in 10.1.

⁴  See AB v Wyeth (1996) 7 Med LR 267.

⁵  The CJD Litigation, Newman v Secretary of State for Health (1997) 54 BMLR 85.

⁶  See XYZ v Schering Health Care Limited and Ors [2002] EWHC 1420 (QB). See 10.13.

⁷  See 10.14.

⁸  ‘GlaxoSmithKline: £2.2bn Charge over Avandia and Legal Case’ BBC News (2011) 17 January.

⁹  M Goozner, The $800 Million Pill: The Truth Behind the Cost of New Drugs (2004) University of California Press; R Anderson, ‘Pharmaceutical Industry gets High on Fat Profits’ BBC News (2014) 6 November.

¹⁰  See S Shah, The Body Hunters: How the Drug Industry Tests Its Products on the World’s Poorest Patients (2006) New Press.

¹¹  See 10.15.

¹²  We do not look at the regulation of medical devices in any detail. Medical devices are regulated by the Medical Devices Regulations 2002, SI 2002/618 (amended SI 2007/400), which implement Directives 90/385/EEC; 93/42/EEC and 98/79/EC. In September 2012, the European Commission released a proposal for new European medical device regulations expected to be implemented by 2020: European Commission, Regulation of the European Parliament and of the Council on Medical Devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 COM(2012) 542 final. The Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010, SI 2010/1882 (since consolidated in SI 2012/1916), implemented EU Regulation 1394/2007 governing advanced therapy medicinal products covering certain types of ‘regenerative medicine’ which bridge devices and medicines.

¹³  See 10.8.

¹⁴  See 10.6–10.9.

¹⁵  See JK Mason, GT Laurie, Mason and McCall Smith’s Law and Medical Ethics (9th edn, 2013), 5.68–5.74.

¹⁶  For a full and lively history of the events surrounding the thalidomide tragedy, see H Teff, C Munro, Thalidomide: The Legal Aftermath (1976) Saxon House.

¹⁷  See parliamentary statement, ‘Government Money for Thalidomide Survivors’ (2010) 15 January.

¹⁸  S Wilson, ‘Australian Thalidomide Victims Settle Class Action’ (2013) The Telegraph, 2 December.

¹⁹  C Dyer, ‘Eight More People in UK Sue Grünenthal and Diageo over Thalidomide’ (2014) 348 BMJ 3806.

²⁰  See, for example, Davies v Eli Lilly and Co [1987] 1 All ER 801, CA.

²¹  In Davies v Eli Lilly and Co ibid, it was held that the costs of litigation must be borne proportionately by all claimants. Legally aided claims could not be used to provide ‘lead’ cases so that the costs would be borne by the legal aid fund.

²²  Nash v Eli Lilly and Co [1993] 4 All ER 383. For a full analysis of the Opren litigation, see PR Ferguson, Drug Injuries and the Pursuit of Compensation (1996) Sweet & Maxwell, p 14.

²³  H Teff, ‘Regulation under Medicines Act 1968’ (1984) 47 Modern Law Review 303, at 320–322.

²⁴  EU Product Liability Directive 85/374/EEC. See P Shears, ‘The EU Product Liability Directive – Twenty Years On’ (2007) November Journal of Business Law 884.

²⁵  For a disparaging view of the impact of the Directive, see J Stapleton ‘Products Liability in the United Kingdom: The Myths of Reform’ (1999) 34 Texas International Law Journal 45.

²⁶  But see M Mildred, ‘Pitfalls of Product Liability’ (2007) 2 Journal of Personal Injury Law 141.

²⁷  [2010] UKSC 23. Discussed at 10.5.

²⁸  For definition of ‘put into circulation’ see O’Byrne v Sanofi Pasteur MSD Ltd (formerly Aventis Pasteur MSD Ltd) [2006] Case C127/0, ECJ. See H Preston, ‘Liable to Change’ 156 (2006) New Law Journal 538.

²⁹  Richardson v LRC Products Ltd [2000] Lloyd’s Law Reports; Abouzaid v Mothercare (UK) Ltd, [2000] EWCA Civ 348; A v National Blood Authority [2001] Lloyd’s Rep Med 187.

³⁰  In A v National Blood Authority [2001] Lloyd’s Rep Med 187, Burton J prefers the terminology standard and non-standard products.

³¹  E Jackson, Law and the Regulation of Medicines (2012) Hart, p 119; Goldberg, Medicinal Product Liability and Regulation, p 9. And see 8.2.

³²  A particular difficulty here has been establishing which manufacturer made the actual drug taken by the mother. There were several brands of the same drug on the market; see Sindell v Abbott Laboratories (1980) 26 Cal 3d 588, Mindy Hymowitz v Eli Lilly & Co (1989) 541 NYS 2d 941 (NY, CA). See discussion of Fairchild v Glenhaven Funeral Services Ltd [2002] UKHL 22, Barker v Corus [2006] UKHL 20 and the Compensation Act 2006, at 10.10.

³³  See Sindell v Abbott Laboratories (1980) 26 Cal 3d 588.

³⁴  See, for example, RA Epstein, Overdose: How Excessive Government Regulation Stifles Pharmaceutical Innovation (2006) Yale University Press.

³⁵  Though some claim the ‘innovation crisis’ is a myth. See DW Light, JR Lexchin, ‘Pharmaceutical Research and Development: What Do We Get for All that Money? (2012) 345 BMJ e4348: ‘More relevant than the absolute number of new drugs brought to the market is the number that represent a therapeutic advance’.

³⁶  And, together with the Consumer Contracts (Information, Cancellation and Additional Charges) Regulations 2013, SI 2013/3134, to implement provisions of Directive 2011/83/EU of the European Parliament and of the Council on consumer rights.

³⁷  Consumer Rights Act 2015, ss 9–18.

³⁸  Ibid, s 9. For contracts made before 1 October 2015, see Sale of Goods Act 1979, s 14(2) (as amended by the Sale and Supply of Goods Act 1999); WCH Ervine, ‘Satisfactory Quality: What Does It Mean?’ (2004) Journal of Business Law 684.

³⁹  Ibid, s 10. For contracts made before 1 October 2015 see Sale of Goods Act 1979 s 14(3); C Twigg-Flesner, ‘The Relationship between Satisfactory Quality and Fitness for Purpose’ (2004) 63 Cambridge Law Journal 22.

⁴⁰  Ibid, s 11.

⁴¹  Unless she can show that her husband bought the medicine for her as her agent.

⁴²  See RR Fenichel, ‘Which Drugs Should Be Available over the Counter?’ (2004) 329 BMJ 182.

⁴³  Pfizer v Ministry of Health [1965] AC 512; Appleby v Sleep [1968] 1 WLR 948.

⁴⁴  See Consumer Rights Act 2015 and, for contracts made before 1 October 2015, the Supply of Goods and Service Act 1982; AP Bell, ‘The Doctor and the Supply of Goods and Service Act’ [1984] Legal Studies 175.

⁴⁵  Prendergast v Sam and Dee [1985] 1 Med LR 36. And see Dwyer v Roderick (1988) 127 Solicitors’ Journal 805.

⁴⁶  Donoghue v Stevenson [1932] AC 562, at 599, HL.

⁴⁷  Watson v Buckley and Osborne, Garrett & Co Ltd [1940] 1 All ER 174 (duty imposed on distributors of hair dye).

⁴⁸  Teff and Munro, Thalidomide: The Legal Aftermath (1976) Saxon House, chs 1–2.

⁴⁹  Wright v Dunlop Rubber Co. Ltd [1972] 13 KIR 255; Hollis v Dow Corning Corporation (1995) 129 DLR (4th) 609 (Canada).

⁵⁰  Notably the Law Commission in their report Liability for Defective Products (1977) Law Com No 82, Cmnd 6831, and the Royal Commission on Civil Liability and Compensation for Personal Injury (1978) Cmnd 7054 (the Pearson Report).

⁵¹  The pharmaceutical industry repeatedly argued that drugs should remain exempt from any regime of strict liability, mainly on the grounds that: (1) scientific research and innovation would be adversely affected; (2) the nature of drug disasters meant that strict liability could have catastrophic results for the industry; (3) the difficulty of defining defect in a drug: these arguments have been consistently rejected; see Law Com, pp 19–21; Pearson Report, para 1274.

⁵²  Consumer Protection Act 1987, ss 1–2.

⁵³  Even if the importer is not an English company, but a company based in another EU or EFTA state, the victim will usually be able to sue here in England if he suffered injury here; see the Civil Jurisdiction and Judgments Acts 1982 and 1991 and the Civil Jurisdiction and Judgments Order 2001, SI 2001/3929 which gave Courts jurisdiction under Council Regulation (EC) 44/2001.

⁵⁴  This includes pharmacists dispensing NHS drugs even though they do not sell NHS drugs to patients.

⁵⁵  See, for example, C Langley, ‘Pharmacy Legislation: Public Protector or Professional Hindrance?’ (2014) 22(1) Medical Law Review 87.

⁵⁶  Council Directive of 25 July 1985 Products Liability 85/374/EC.

⁵⁷  Consumer Protection Act 1987, s 22A.

⁵⁸  O’Byrne v Sanofi Pasteur MSD Ltd (formerly Aventis Pasteur MSD Ltd (Case C-127/04) [2006] 1 WLR 1606.

⁵⁹  See the ECJ’s second preliminary ruling: Aventis Pasteur SA v OB (2009) C-358/08 ECJ (Grand Chamber).

⁶⁰  [2010] UKSC 23. See H Preston, ‘The End of the Decade’ (2010) 33 Commercial Litigation Journal 5.

⁶¹  See D Fairgrieve, G Howells, ‘Rethinking Product Liability: A Missing Element in the European Commission’s Third Review of European Product Liability Directive’ (2007) 70(6) Modern Law Review 962, which suggests that there is a lack of consistency in Europe on the concept of defectiveness.

⁶²  See the thorough and excellent discussion of this problem in C Newdick, ‘Strict Liability for Defective Drugs in the Pharmaceutical Industry’ (1985) 101 Law Quarterly Review 405, at 409–420.

⁶³  ‘AstraZeneca in $198m Claim Payout’ BBC News (2010) 9 August.

⁶⁴  [2000] EWCA Civ 348, CA.

⁶⁵  See also Tesco Stores v Pollard (A Minor) [2006] EWCA 393, where the child-resistant top on a bottle of dishwasher powder was more difficult to open than an ordinary top and therefore fell in line with reasonable expectations.

⁶⁶  [2000] Lloyd’s Law Report 280. And see Worsely v Tambrands [2000] PIQR P 95; Foster v Biosil (2000) 59 BMLR 178.

⁶⁷  [2001] Lloyd’s Rep Med 187. See R Goldberg ‘Paying for Bad Blood: Strict Product Liability after the Hepatitis C Litigation’ (2002) 10 Medical Law Review 165.

⁶⁸  [2001] Lloyds Rep Med 167, at 216.

⁶⁹  Consumer Protection Act, s 4 outlines a number of defences that will only rarely be relevant in claims for drug-related injuries. For example, in Piper v JRI (Manufacturing) [2006] EWCA Civ 1344 a replacement hip sheared into two but the manufacturer was not liable because ‘the defect did not exist in the product at the relevant time’.

⁷⁰  [2001] Lloyd’s Rep Med 187.

⁷¹  See s 4(1)(e).

⁷²  European Directive Article 7(e) permitted states to incorporate a development risks defence.

⁷³  Commission v UK (Case C-300/95) [1997] All ER (EC) 481.

⁷⁴  Discussed in C Hodges, ‘Developing Risks: Unanswered Questions’ (1998) 61 Modern Law Review 560; M Mildred and G Howells, ‘Comment on Development Risks: “Unanswered Questions”’ (1998) 61 Modern Law Review 570.

⁷⁵  And see Richardson v LRC Products Ltd [2000] Lloyd’s Rep Med 280.

⁷⁶  [2001] Lloyd’s Rep Med 187, at 220–221.

⁷⁷  See G Howells, M Mildred, ‘Infected Blood: Defect and Discoverability: A First Exposition of the EC Product Liability Directive’ (2002) 65 Modern Law Review 95.

⁷⁸  For a contrary view, see J Stapleton (1999) 34 Texas International Law Journal 45 and ‘Bugs in the Anglo-American Products Liability’ (2002) 53 South Carolina Law Review 1225.

⁷⁹  [2007] EWHC 1860 (QB); [2009] EWHC 95 (QB).

⁸⁰  See 11.8. New evidence of developmental problems in children whose mothers took Epilim in pregnancy was revealed in 2013. See RL Bromley et al, ‘The Prevalence of Neurodevelopmental Disorders in Children Prenatally Exposed to Anti-Epileptic Drugs’ (2013) 84 Journal of Neurology, Neurosurgery and Psychiatry 637. The European Medicines Agency issued strengthened warnings in 2014: EMA, CMDh Agrees to Strengthen Warnings on the Use of Valproate Medicines in Women and Girls (November 2014).

⁸¹  See, for example, Emerald Supplies Ltd v British Airways Plc [2010] EWCA Civ 1284.

⁸²  Civil Procedure Rules, 19.10: A Group Litigation Order (GLO) means an order made under rule 19.11 to provide for the case management of claims which give rise to common or related issues of fact or law (the ‘GLO issues’).

⁸³  Civil Justice Council, Improving Access to Justice through Collective Actions (2008), p 24.

⁸⁴  Ministry of Justice, ‘The DePuy Pinnacle Metal on Metal Hip Litigation’ Gov.uk (2014) 31 July.

⁸⁵  Ministry of Justice, ‘The PIP Breast Implant Litigation’ No 88 Gov.uk (2012) 17 November.

⁸⁶  See initial case management cases XYZ v Various Companies [2013] EWHC 3643 (QB); [2014] EWHC 4056 (QB); and refusal of permission to join the register of claims after the cut off date in Holloway v Transform Medical Group (CS) Ltd [2014] EWHC 1641 (QB).

⁸⁷  Sale of Goods Act 1979 and the Supply of Goods and Services Act 1982 have been replaced by the Consumer Rights Act 2015.

⁸⁸  Civil Justice Council, Improving Access to Justice through Collective Actions (2008).

⁸⁹  Ministry of Justice, The Government’s Response to the CJC’s Improving Access to Justice through Collective Actions (2009). And see White Paper, A Better Deal for Consumers: Delivering Real Help Now and Change for the Future Cm 7669 (2009). An ‘opt out’ measure is introduced in the Consumer Rights Act 2015 Act for cases of anti-competitive behaviour brought before the Competition Appeal Tribunal.

⁹⁰  See European Commission, Recommendation on Common Principles for Injunctive and Compensatory Collective Redress Mechanisms in the Member States Concerning Violations of Rights Granted under Union Law (2013/396/EU); European Commission, Communication: Towards a European Horizontal Framework for Collective Redress COM(2013) 401.

⁹¹  See, for example, ‘Families of CJD Victims Will Sue for Millions’ (2001) Daily Telegraph, 19 June.

⁹²  See R (McVey) v Secretary of State for Health [2010] EWHC 437 (Admin).

⁹³  DH, ‘Details of Hepatitis C Ex-Gratia Payment Scheme Announced’ 2004/0025.

⁹⁴  [2010] EWHC 3070 (Admin).

⁹⁵  ON Gill et al, ‘Prevalent Abnormal Prion Protein in Human Appendixes after Bovine Spongiform Encephalopathy Epizootic: Large Scale Survey’ (2013) 347 BMJ f5675. For evidence of the continued risk, see House of Commons Science and Technology Committee, After the Storm? UK Blood Safety and the Risk of cCJD HC 327 (incorporating HC 990) (2014) July.

⁹⁶  See, for example, CA Llewelyn et al, ‘Possible Transmission of Variant Creutzfeldt–Jakob Disease by Blood Transfusion’ (2004) 363 The Lancet 417.

⁹⁷  Part of NHS Blood and Transplant, a Special Health Authority established by the NHS Blood and Transplant Order, SI 2005/2529.

⁹⁸  UK Blood Services Joint Statement on Blood Safety, August 2011.

⁹⁹  JE Edgeworth et al, ‘Detection of Prion Infection in Variant Creutzfeldt–Jakob Disease: A Blood-Based Assay’ (2011) 377(9764) The Lancet 487; GS Jackson et al, ‘A Highly Specific Blood Test for vCJD’ (2014) 123(3) Blood Journal.

¹⁰⁰  ‘Blood Test for vCJD Unrealistic’ BBC News (2008) 20 October. But see After the Storm? UK Blood Safety and the Risk of cCJD (2014), pp 29–35, available at: www.publications.parliament.uk/pa/cm201415/cmselect/cmsctech/327/327.pdf

¹⁰¹  First proposed in 2009/10. The most recent version: 2013/14, Bill 187, HC Deb, 24 March 2014, c45 ran out of time.

¹⁰²  vCJD Main Trust Deed (2002), para. 1.12.2.

¹⁰³  Ibid, para B.

¹⁰⁴  For an examination of products liability for pathogenically infected products, see J Stapleton (2002) 53 South Carolina Law Review 1225. For tortious liability arising from public health initiatives, see R Martin, ‘Public Health and the Scope of Potential Liability in Tort’ (2005) 21 Professional Negligence 39.

¹⁰⁵  J Meikle, R Evans, ‘British Blood Products May Pose vCJD Risk in 14 Countries’ (2006) Guardian, 14 May.

¹⁰⁶  [2002] UKHL 22. See also Gregg v Scott [2005] UKHL 2. These cases were discussed in Chapter 7.

¹⁰⁷  (1980) 607 P 2d 924.

¹⁰⁸  [2006] UKHL 20, [74].

¹⁰⁹  [2006] UKHL 20. Examined in 7.15.

¹¹⁰  Ibid, [43].

¹¹¹  The Court of Appeal in IEG Ltd v Zurich Insurance Plc [2013] EWCA Civ 39 held that the common law decision of Barker was effectively overruled by the Compensation Act 2006. However, the Supreme Court allowed the appeal: neither the 2006 Act nor Durham v BAI (Run-Off) Ltd [2012] UKSC 14 (Trigger litigation) undermines the decision in Barker. See Zurich Insurance Plc v IEG Ltd [2015] UKSC 33.

¹¹²  [2014] EWHC 4190.

¹¹³  R Goldberg, ‘Epidemiological Uncertainty, Causation and Drug Product Liability’ (2014) 59(4) McGill Law Journal 777.

¹¹⁴  [2011] UKSC 10I.

¹¹⁵  [2009] EWCA Civ 1159.

¹¹⁶  See XYZ v Schering Health Care Ltd [2002] EWHC 1420 (QB) discussed at 10.13 and see Goldberg, Medical Product Liability and Regulation, pp 90–95.

¹¹⁷  Jones v Secretary of State for Energy and Climate Change [2012] EWHC 2936 (QB), [42], [53]. See E O’Leary ‘Double or Nothing’ (2013) 163(7553) New Law Journal 22 March.

¹¹⁸  See further at 10.14.

¹¹⁹  Merck Sharp & Dohme (Australia) Pty Ltd v Peterson [2011] FCAFC 128, [2012] HCATrans 105, discussed in Goldberg, Medical Product Liability and Regulation, pp 94–95.

¹²⁰  [2004] UKHL 41. For a critique, see T Clark, D Nolan, ‘A Critique of Chester v Afshar’ (2014) 34 Oxford Journal Legal Studies 659, exploring an alternative position taken in the High Court of Australia in Wallace v Kam [2013] HCA 19 (2013) 87 ALJR 648.

¹²¹  [2004] UKHL 41, [87].

¹²²  See J Stapleton, ‘Occam’s Razor Reveals an Orthodox Basis for Chester v Afshar’ (2006) 122 Law Quarterly Review 426; Goldberg, Medical Product Libaility and Regulation, pp 80–83.

¹²³  See L Jones, ‘Chester v Afshar: Effect of Product Liability’ (2005) 5(1) Health and Safety Law 12.

¹²⁴  We deal predominantly with medicines here. For the regulatory regime surrounding medical devices and tissue-engineered products, see S Pattinson, Medical Law and Ethics (2014) Sweet & Maxwell, pp 13–012. For a fuller account, see G Appelbe, J Wingfield, Dale and Appelbe’s Pharmacy and Medicine Law (10th edn, 2013) Pharmaceutical Press; S Shorthose, Guide to EU Pharmaceutical Regulatory Law: Annual Manual (4th edn, 2013) Wolters Kluwer.

¹²⁵  SI 2012/1916 (amended SIs 2013/1855; 2013 2593; 2014/323; 2014/324; 2014/490; 2014/1878; 2015/178; 2015/259; 2015/323; 2015/903; 2015/1503).

¹²⁶  Directive 2001/83/EC, as amended by Directives 2002/98/EC, 2003/63/EC, 2004/24/EC, 2004/27/EC, 2006/1901/EC, 2007/1394/EC, 2008/29/EC 2009/53/EC, 2009/120/EC, 2010/84/EU, 2011/62/EU and 2012/26/EU.

¹²⁷  As to what constitutes a medicine, see MHRA, A Guide to What Is a Medicinal Product (2012) MHRA Guidance Note 8.

¹²⁸  2001/20/EC, implemented in the UK by the Medicines for Human Use (Clinical Trials) Regulations 2004.

¹²⁹  The original European Medicines Evaluation Agency was renamed in 2004.

¹³⁰  Established by Regulation 726/2004, replacing the Committee for Proprietary Medicinal Products (CPMP).

¹³¹  This route is compulsory for: medicines for the treatment of HIV, AIDS, cancer, diabetes, neurodegenerative diseases, immune dysfunctions, and viral diseases; medicines derived from biotechnology processes; gene-therapy, somatic cell-therapy or tissue-engineered medicines; medicines used for rare human diseases: see www.ema.europa.eu

¹³²  Which replaced the Committee on the Safety of Devices in 2015 following recommendations in Professor T Stephenson’s report: Expert Clinical Advice – MHRA Medical Devices (April 2014).

¹³³  Established under the Medicines Act 1968, s 2. The terms of reference are set out in s 3 as amended by the Medicines (Advisory Bodies) Regulations 2005, SI 2005/1094.

¹³⁴  A proposal for a new European Directive to improve transparency in the regulation of prices of medicinal products was set out in 2012: Proposed Directive of the European Parliament and of the Council relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of public health insurance systems, repealing Council Directive 89/105/EEC. COM(2013)168.

¹³⁵  Prescription drugs cannot be advertised directly to the public. Human Medicines Regulations 2012, SI 2012/1916, Part 14, implementing European Directive 2001/83/ EC as amended.

¹³⁶  As do the Advisory Board on the Registration of Homeopathic Products and Herbal Medicines Advisory Committee.

¹³⁷  European Commission, Detailed Guidance on the Collection, Verification and Presentation of Adverse Reaction Reports Arising from Clinical Trials on Medicinal Products for Human Use (2011).

¹³⁸  Medicines Act 1968, s 21(5).

¹³⁹  See Royal College of Paediatrics and Child Health, The Use of Unlicensed Medicines or Licensed Medicines for Unlicensed Applications in Paediatric Practice (2010).

¹⁴⁰  See 7.9 for discussion of the Access to Medical Treatments (Innovation) Bill 2015–16. And see DH, Accelerated Access Review (June 2015).

¹⁴¹  See for example R Harding, E Peel, ‘“He was Like a Zombie”: Off-Label Prescription of Antipsychotic Drugs in Dementia’ (2013) 21(2) Medical Law Review 243.

¹⁴²  D Evans, ‘When Drug Makers’ Profits Outweigh Penalties’ (2010) Washington Post, 21 March. Though see report of ‘unprecedented’ $3bn (£1.9bn) settlement in 2012: ‘GlaxoSmithKline to Pay $3bn in US Drug Fraud Scandal’ BBC News (2012) 2 July.

¹⁴³  L McGoey, E Jackson, ‘Seroxat and the Suppression of Clinical Trial Data: Regulatory Failure and the Uses of Legal Ambiguity’ (2009) 35 Journal of Medical Ethics 107. For a comparable US case, see allegations that AstraZeneca illegally marketed Seroquel for uses not approved by the FDA between 2001 and 2006: US Dept of Justice, accessible at www.justice.gov/opa/pr/2010/April/10–civ-487.html

¹⁴⁴  D Batty, ‘Seroxat’ (2008) The Times, 6 March: ‘Critics of the MHRA and the pharmaceutical industry point to the tougher penalties faced by firms overseas. In the US, GSK was sued by the New York state attorney general, Eliot Spitzer, and settled for $2.5m (£1.25m) and an agreement to publish all its trial results – negative or positive – on a publicly available database’.

¹⁴⁵  SI 2009/2820, consolidated with minor amendments in the Human Medicines Regulations 2012, SI 2012/1916.

¹⁴⁶  F Godlee, ‘Can We Tame the Monster?’ (2006) 333 BMJ 0.

¹⁴⁷  HC 42-I, 2005.

¹⁴⁸  HC 41-I (2005), p 4.

¹⁴⁹  Ibid, p 5.

¹⁵⁰  HC Deb Vol 847 cols 440–441, 29 November 1972.

¹⁵¹  The claim against the CSM was dropped.

¹⁵²  [2002] EWHC 200 (QB).

¹⁵³  [2002] EWHC 200 (QB), [93], per Morland J.

¹⁵⁴  [2002] EWHC 1420 (QB).

¹⁵⁵  [2002] EWHC 200 (QB), [19], per Mackay J.

¹⁵⁶  [2014] EWHC 2256.

¹⁵⁷  Stovin v Wise [1996] AC 923, HL, at 937–941, per Lord Nicholls.

¹⁵⁸  Smith v Secretary of State for Health [2002] EWHC 200 (QB), [95].

¹⁵⁹  See Ferguson, Drug Injuries and the Pursuit of Compensation, pp 6–8.

¹⁶⁰  These complex rules are neatly summarised in A Saggerson, ‘PI Litigation across Jurisdictions: Summary of Service Regimes’ (2002) 6 Personal Injury 3.

¹⁶¹  Distillers Co (Biochemicals) Ltd v Thompson [1971] AC 458. Where a New Zealand mother was allowed to sue the British company Distillers in New Zealand over thalidomide manufactured here; the essence of the negligence alleged was failure to warn her, in New Zealand, of the danger to her baby.

¹⁶²  See, for example, T Nesi, Poison Pills: The Untold Story of the Vioxx Drug Scandal (2008) Thomas Dunne Books: USA; HM Krumholz et al, ‘What Have We Learnt from Vioxx?’ (2007) 334 BMJ 120.

¹⁶³  But not in Scotland: Cooper v Merck Sharp & Dohme [2012] CSOH 48; Hamilton and Others v Merck Sharp & Dohme Ltd [2012] CSOH 144, discussed in Goldberg, Medical Product Liability and Regulation, p 8.

¹⁶⁴  J Dreaper, ‘UK Vioxx Cases Await Court Hearing’ BBC News (2006) 11 April.

¹⁶⁵  In re Vioxx Litigation, 395 NJ Super 358, 373–374 (Sup Ct NJ, App Div, 2007): see J Robins ‘Stars and Gripes’ (2006) 46 Litigation Funding 4–6, discussing New Jersey Court decision to reject UK class action for alleged injuries suffered as a result of using Vioxx.

¹⁶⁶  See in particular, the Pearson Report, ch 25.

¹⁶⁷  GMC, Dr Andrew Wakefield: Determination on Serious Professional Misconduct and Sanction, May 2010. Accessible at www.gmc-uk.org. A finding of serious professional misconduct against Professor John Walker-Smith, who had carried out tests on children later used by Dr Wakefield, was quashed in Walker-Smith v General Medical Council [2012] EWHC 503 (Admin).

¹⁶⁸  [1990] 1 Med LR 117.

¹⁶⁹  Though parents in Ireland succeeded: see Best v Wellcome Foundation [1993] 2 IR 421.

¹⁷⁰  See C Dyer, ‘Commission Withdraws Legal Aid for Parents Suing over MMR Vaccine’ (2003) 327 BMJ 641. And see ‘MMR Vaccine: Lawyers Sued for Pursuing Claim Based on Link to Autism’ BBC News (2014) 26 June, detailing legal action against lawyer for pursuing ‘hopeless claim’.

¹⁷¹  See 8.2.

¹⁷²  Vaccine Damage Payments Act 1979 Statutory Sum Order 2007, SI 2007/1931.

¹⁷³  See S Pywell, ‘The Vaccine Damage Payment Scheme – A Proposal for Radical Reform’ (2002) 9 Journal of Social Security Law 73.

¹⁷⁴  See ‘Vaccine Damage Payments’ 27 (2004) Consumer Law Today 4(5)(1).

¹⁷⁵  See for example L Rogers, ‘Victims of Swine Flu Jab to Get £60m Payout’ (2014) Sunday Times, 2 March. According to the report, GlaxoSmithKline insisted on government indemnification as a condition for supplying Pandemrix vaccine.

Part III

MATTERS OF LIFE AND DEATH

Chapter 11

CONTRACEPTION, PREGNANCY AND CHILDBIRTH

Reproductive autonomy and reproductive health

11.1

Gone are the days when it was thought that, on becoming pregnant, a woman lost, not only her capacity, but also her right to act as a genuinely autonomous human being.

So concluded Lady Hale in the 2015 Supreme Court decision of Montgomery v Lanarkshire Health Board.¹ Reproductive autonomy spans choices in conception, pregnancy and childbirth. In Rees v Darlington Memorial Hospital NHS Trust² a woman who gave birth to a child after a failed sterilisation was said to have suffered a legal wrong – ‘the denial of an important aspect of their personal autonomy, viz the right to limit the size of their family’.³ The majority of the House of Lords concurred with Lord Millett in McFarlane v Tayside Health Board⁴ in his endorsement of a legal right of reproductive autonomy. English law today leaves such matters to personal choice.⁵

In 2002, Munby J resoundingly declared that contraception was a matter for personal choice and conscience, and no business of the law.⁶ The judge declared that it was:

not any part of the responsibilities of public authorities – let alone of the criminal law – to be telling adult people whether they can or cannot use contraceptive devices of the kind which I have been considering.

This chapter will examine several aspects of how the law implements or fails to implement broad notions of reproductive autonomy, embracing choices about whether or not to conceive or beget a child, and choices that may face women in the course of pregnancy. We also look at a number of practical legal questions relating to contraception, pregnancy and childbirth.

Contraceptives: patients’ rights

11.2 An infallible contraceptive has yet to be invented.⁷ Contraceptives, such as the pill and the IUD (intrauterine device), carry a price tag. They pose some risk to women’s health. Contraception is a medical as well as a social issue. And it largely concerns women, since except for the still experimental male ‘pill’, men must choose between the condom and vasectomy. The more sophisticated contraceptives which pose medical risk are used by women. A doctor advising a woman on contraception owes her the same duties as in any other area of medicine. He must offer her competent and careful advice. He must perform any technical procedure, for example, inserting an IUD, skilfully.⁸ He must obtain her consent to any invasive procedure and ensure that she is competent to give it.⁹

Modern contraceptive treatments have not just generated moral controversy. They have resulted in litigation where use of contraceptive methods has resulted in adverse effects for women. Several million dollars in compensation were paid out to women who suffered injury through use of the Dalkon shield, an IUD which caused substantial pelvic injuries to patients.¹⁰ And the injectable contraceptive Depo-Provera led to a number of lawsuits in the United Kingdom. The use of Depo-Provera in its early years offers a classic example of how not to approach contraceptive advice and treatment.

Depo-Provera is a synthetic form of a natural hormone, which acts like most brands of the Pill to prevent eggs developing and makes the womb hostile to any fertilised embryo. One injection is effective for at least three months. Depo-Provera can produce unpredictable and unpleasant side effects, including severe and irregular bleeding. Complaints were made that: (1) some women were injected with the drug without ever being told of its nature; and (2) even where Depo-Provera was expressly prescribed and described as a contraceptive, inadequate explanation of its potential side effects was given. Fears were voiced that Depo-Provera might be ‘forced’ on inarticulate, or not particularly intelligent, woman.¹¹

A Salford woman, Mrs Potts, won £3,000 damages¹² after she was injected with Depo-Provera concurrently with a vaccination against rubella. She suffered severe bleeding. The injection was given days after the delivery of her third child, and she thought that it was a routine post-natal ‘jab’. The aim of her doctor was laudable, to protect her from pregnancy while the vaccine might harm any unborn child. He had no right to deprive her of her choice of whether or not to accept or decline a controversial drug. Women must be told the nature of the drug offered to them, and if their right to choose is to be effective they must have its advantages and disadvantages explained to them. The judge awarding Mrs Potts’s compensation said: ‘She should have been given the choice, and she was entitled to know beforehand what the decision entailed’. The same holds true of any contraceptive treatment.¹³

A doctor prescribing contraception must be properly informed about the current stage of research and knowledge about different types and brands and their risks to particular patients. What information is the user entitled to? We would argue that in the light of Bolitho v City & Hackney Health Authority,¹⁴ Pearce v United Bristol Healthcare NHS Trust¹⁵ and Montgomery v Lanarkshire Health Board,¹⁶ women must be advised of any risk that the contraception poses to them which a woman of sound mind would consider material to a reasonable decision about what sort of contraception to use.¹⁷

What about contraceptives which simply fail? We shall see later that parents cannot recover compensation for the cost of bringing up a normal, healthy child.¹⁸ Might a failed contraceptive method be viewed as ‘defective’ under the Consumer Protection Act 1987? In Richardson v LRC Products Ltd¹⁹ it was held that evidence a condom split was not by itself sufficient to prove that product defective. The fallibility of condoms was well known. The manufacturer never guaranteed 100 per cent success.

Sterilisation

11.3 When a further pregnancy or the burden of caring for more children may endanger a woman’s health, therapeutic sterilisation may be advised. Non-therapeutic sterilisation is increasingly sought as a method of permanent birth control,²⁰ both by older couples who feel that their family is complete and by younger people adamant that they never wish to reproduce.²¹

A doctor undertaking sterilisation must ensure that the patient understands and agrees to what is to be done. Operating without any consent is obviously a battery. Nor should sterilisation be automatically performed concurrently with some other gynaecological operation to which the patient has consented. The doctor may correctly judge, in the course of some other form of surgery, that a woman should not risk pregnancy again. He cannot act ‘in her best interests’ without her agreement. In Devi v West Midlands Area Health Authority,²² a married woman of 33 who already had four children, entered hospital for a minor gynaecological operation. Her religion outlawed sterilisation or contraception. In the course of the operation the surgeon discovered her womb to be ruptured and sterilised her there and then. She received £4,000 damages for the loss of her ability to conceive again and £2,700 damages for the ‘neurosis’ caused by the knowledge of what had been done to her. The choice whether to accept sterilisation is the patient’s. It may be more convenient to sterilise the patient on the spot. It is unlikely to be so immediately necessary as to justify acting in an emergency without consent.

A doctor who has obtained consent may still be liable for negligence if he fails to discuss properly with the patient the implications of the operation in a manner consistent with good medical practice. The doctor must not only give the patient sufficient information on which to make up her mind, but do so at a time when she is in a fit state to make a reasoned decision.²³ In Thake v Maurice, Mr Thake decided to have a vasectomy and paid £20 for the operation. The judge found that the defendant never warned Mr and Mrs Thake of the small but real risk that nature would reverse the surgery. She did not discover her pregnancy until it was nearly five months advanced. The couple sought compensation from the defendant surgeon. As Mr Thake had paid for his vasectomy, unlike an NHS patient he had a contract with the surgeon. The trial judge held²⁴ that Mr Thake had agreed to an operation that he understood would render him irreversibly infertile. That is what he contracted for.

The defendant was in breach of contract if he failed to achieve that aim. By failing to warn Mr Thake of the risk of natural reversal of the vasectomy, he guaranteed to make him sterile. He was responsible for the financial loss to the family occasioned by the birth of the unplanned infant. The Court of Appeal²⁵ held by a majority that the surgeon never guaranteed to make Mr Thake sterile. Neill LJ found that no reasonable person would have understood the defendant as giving a binding promise that the operation would achieve its purpose. They nevertheless unanimously found for Mr Thake on grounds enabling NHS patients as well as private patients to sue if they are not warned of the risk of nature reversing sterilisation of either sex. They held that failure to warn of this risk was negligent.

If sterilisation is proposed on therapeutic grounds the patient’s consent must necessarily be based on adequate and careful advice as to the medical need for sterilisation. In Biles v Barking Health Authority²⁶ a woman was advised to undergo sterilisation on the grounds that she was suffering from a severe and probably fatal kidney complaint. That diagnosis was proved later to be mistaken and negligent. Mrs Biles recovered damages of £45,000, which included the cost of a failed attempt to reverse the sterilisation and the cost of IVF treatment to try to enable her to have a child of her own, despite her surgically blocked fallopian tubes.

Involuntary sterilisation²⁷

11.4 No statute in England ever provided for the compulsory sterilisation of patients with physical or mental disability. In Chapter 14 we discuss a number of cases of involuntary sterilisation of minors. In 1989, in F v West Berkshire Health Authority,²⁸ their Lordships ruled that sterilisation of an adult woman with mental disability was not unlawful if that operation was in her ‘best interests’. In theory, a woman may not be sterilised in the interests of society, of her potential children, or on eugenic grounds²⁹.³⁰ She may be sterilised only where she lacks the capacity to make decisions on childbearing for herself, and to protect her health and welfare.

The Mental Capacity Act 2005 governs the law surrounding adults and young persons³¹ who lack mental capacity. It is examined in detail in Chapter 6.

Much of the Act and the accompanying Code of Practice³² enshrine principles developed by the common law. In F v West Berkshire HA³³ protection from liability to carers and health professionals was granted through the application of the doctrine of necessity. Section 5 of the Mental Capacity Act 2005 performs a similar role, granting a ‘general authority’ to act in the best interests of the patient lacking mental capacity and setting conditions that must be satisfied before liability can be avoided. The Act defines what constitutes a lack of capacity in section 2(1):

[A] person lacks capacity in relation to a matter if at the material time he is unable to make a decision for himself in relation to the matter because of an impairment of, or a disturbance in the functioning of, the mind or brain.

The Code of Practice gives guidance on how to make that judgement. The requirement of an ‘impairment or disturbance’ sets the ‘diagnostic threshold’ for lack of capacity. In addition to this, it must be demonstrated that the person is ‘unable to make a decision’;³⁴ the test is decision-specific. The protection of the incapacitated person’s health or welfare is more complex. The Act endorses the common law position that the ‘act done, or decision made … must be done, or made, in his best interests’.³⁵ In DH NHS Foundation Trust v PS,³⁶ for example, a patient suffering from a learning disability did not have the capacity to consent to a hysterectomy necessary to treat cancer of her uterus. The High Court was able to sanction the operation on the basis that it was in her best interests. In Re DD (No 4) (Sterilisation)³⁷ sterilisation was authorised in the best interests of a 36–year-old woman with autistic spectrum disorder who lacked capacity. DD was the mother of six children, all permanently cared for by others. The decision was based on the stark expert evidence that: ‘The risk to [DD] of a future pregnancy, especially if concealed, is highly likely to lead to her death’.³⁸

PS and DD were exceptional cases on their facts. As Cobb J summarised in DD:

Any proposal for significant, life-changing surgery in respect of a person who lacks capacity will inevitably be (as it has been in this case) extremely carefully scrutinised, and only authorised where it is clearly demonstrated to be necessary, proportionate and ‘best’ for the individual involved. In this exercise, the views of the person concerned, of those close to them, and of the professionals will be considered with care; steps will be taken to assist the vulnerable person to make the decision for themselves. The court should (as I have in this case) always have regard to the less restrictive way of achieving the ultimate objective.³⁹

The Mental Capacity Act requirement that consideration is given to the least restrictive means by which the best interests of an individual lacking capacity can be met⁴⁰ was relevant in the case of A Local Authority v K.⁴¹ K had learning difficulties associated with Down’s syndrome. Having received medical advice about contraception for their daughter, K’s parents sought sterilisation. The Court of Protection held that sterilisation would not achieve a proportionate balance between K’s protection and empowerment.⁴²

For men, the choice of contraceptive methods are limited. In An NHS Trust v DE,⁴³ a 37–year-old man with learning difficulties had capacity to consent to sexual relations but lacked capacity to make decisions about contraception. He already had one child and did not want another. His female partner was thought to be unreliable in using the contraceptive pill and had a needle phobia which ruled out contraceptive injections. In light of the limited options, Eleanor King J authorised a vasectomy.

Contraception is less restrictive than sterilisation, but the courts are rightfully reluctant to compel its use. In A Local Authority v A⁴⁴ Bodey J refused to make an order requiring Mrs A to have contraception. Mrs A had learning difficulties and had previously had two children taken away at birth. Her refusal of contraception was involuntary on account of pressure brought to bear by her husband. Bodey J held that efforts should be made to achieve a capacitated decision from Mrs A, ‘through “ability-appropriate” help and discussion without undue contrary pressure from Mr A’.⁴⁵

Must all sterilisation cases come before the court? The Code of Practice on the Mental Capacity Act 2005 advises that a court order be sought in cases of non-therapeutic sterilisation.⁴⁶ The Act also gives authority to the decision-maker to act when there is a therapeutic necessity. Thus, the Code of Practice acknowledges that there may be situations when treatment should be given without delay⁴⁷ and the duties incumbent on the decision-maker under sections 4(6) and 4(7) to consult others when determining whether treatment is in the best interests of the person lacking capacity exist only ‘if it is practicable and appropriate’. Where the procedure is therapeutic but not urgent, the waters remain murky. The definition of best interests under the Act is not synonymous with non-negligent care. The decision-maker is required to look beyond the clinical need of the person lacking capacity, to her wider welfare issues. Consequently it is likely doctors and carers will seek reassurance from the Court of Protection that any therapeutic (but not urgent) sterilisation they propose for an adult lacking capacity is in her best interests.

Conception to birth

11.5 Medical care begins long before a baby is born. Research into the growth of the fetus in the womb has established the crucial importance of good antenatal care.⁴⁸ In the next sections we explore whether a parent or child can claim for injury sustained before birth.

Can parents sue?

11.6 The parents of a child injured before birth may be able to recover for their loss at common law. The doctor caring for the mother in pregnancy owes her a duty in relation to her own health and in respect of the health of the developing fetus. The damage which she will suffer if she bears a disabled child, the emotional trauma⁴⁹ and the financial burden of the extra expense such a child entails are readily foreseeable and recoverable. But will she be able (1) to prove negligence, and (2) to prove that the child’s disability resulted from that negligence? One rare success occurred in a 2009 group litigation,⁵⁰ where Akenhead J found a local authority to have been negligent in allowing harmful dust to contaminate the environment during their reclamation of a British Steel complex. The dust contained heavy metals and dioxins and was found to be teratogenic – exposed to pregnant women, it caused some babies to suffer birth defects.⁵¹

Proving negligence is no easy task in any malpractice claim. A claim in relation to the birth of a disabled child has two special problems. First, if the claim lies against the doctor, it has to be established that he should have been aware of the risk posed to the fetus by drugs he prescribed or treatment he gave. Second, where a mother becomes ill in pregnancy, or the pregnancy itself is complicated, the interests of mother and child may conflict. A pregnant woman may need treatment known to carry risk to the child. For example, a woman injured in an accident may need surgery which can only be carried out under general anaesthetic. The anaesthetic may harm the baby.⁵² The doctor’s duty to the mother is to give her sufficient information about her needs and the risk to her baby. If she chooses to reject treatment for the sake of the baby he cannot impose it. He must in any case aim at a course of action which will benefit the mother with minimum risk to the child. Even if it can be shown that the doctor has failed in his duty to the mother, that he was negligent, establishing that the infant’s disability resulted from that negligence is likely to be even more difficult.⁵³ Despite immense advances in knowledge concerning the development of the fetus, pinpointing the exact cause of the birth defect remains extremely difficult. Success in a claim for negligence depends on proof that it is more likely than not that the relevant negligence caused the injury. All a claimant with a damaged child is likely to be able to prove is that a drug she took or treatment she received may have caused the defect in the baby. However, the cause may be inherited disease, a problem that the mother suffered in pregnancy, or some unknown cause. The parents may well fail to satisfy the burden of proof.

Congenital Disabilities (Civil Liability) Act 1976

11.7 This Act, passed to give rights and a remedy to children born disabled as a result of human fault, is ambitious, complex and largely irrelevant. It is ambitious in that it sought to provide a scheme to protect children, not just against injury in the womb, but against any act at any stage of either parent’s life which might ultimately result in a disability affecting a child. Its complexity we outline in succeeding sections. It is irrelevant because it fails to address the central problem in this type of claim. How do you prove that the disability resulted from an identified act of negligence? Just as his mother’s claim is likely to founder for lack of proof of the cause of the disability, so is the child’s. If Parliament intends and desires to give children disabled by human act a remedy, it must consider whether retaining the normal burden of proof in actions by mother and child is practical.

The Act applies to all births after 1976 and purports to provide a comprehensive code of liability for disabled children in respect of damage caused to them before birth. Under the Act the child’s mother⁵⁴ is generally exempt from any liability to her child. The father is offered no such immunity. The Act entirely replaces the common law and it would not be possible for a child unable to recover under the Act to argue that liability exists at common law. So, for example, a child seeking to sue his mother, exempt under the Act, must fail, however reckless her conduct in pregnancy and however clear it might be that she caused him to be born disabled.

The scheme of the Act is this. The child must be born alive.⁵⁵ He must establish that his disabilities resulted from an ‘occurrence’ which either: (1) affected the mother or father in her or his ability to have a normal healthy child (pre-conception event): or (2) affected the mother during her pregnancy: or (3) affected mother or child in the course of its birth. At this first hurdle, proving the cause of the disability, many claims will fail. Where proof of cause is forthcoming the child faces further obstacles. It is not enough to show that the person responsible for the occurrence was negligent. The child must prove that the person responsible for the occurrence was liable to the affected parent. The child’s rights are derivative only. The likelihood is that the occurrence at the time caused the parent no harm. The Act provides that it is no answer that the parent affected suffered no visible injury at the time of the occurrence providing there was ‘a breach of legal duty which, accompanied by injury, would have given rise to the liability’. The breach of duty is the negligence of the defendant in relation to the affected parent’s reproductive capacity. Sandra Roberts recovered £334,769 in compensation for catastrophic damage she suffered during her mother’s pregnancy.⁵⁶ A blood transfusion administered to her mother seven years before her birth rendered her parents rhesus incompatible, creating danger for any child of theirs. The hospital knew of Mrs Roberts’s condition. They failed to act to prevent or minimise the risk to Sandra. This was negligent care for the mother and thus created a right to compensation for mother and via her for Sandra. Other cases are less straightforward.

Drugs and damage to the fetus

11.8 Let us take first what appears to be a simple case. A pregnant woman takes a drug prescribed for her by her GP that damages her baby so that he is born disabled.

The child can prove that his disability results from the effect of the drug on the fetus. He will have to show that the doctor was negligent towards his mother. It must be proven that: (1) the doctor knew or ought to have known that she was pregnant, and therefore was in breach of duty to her in prescribing a drug which might damage her baby; and (2) that he ought to have been aware of the risk posed by the drug. It will be no defence for the doctor to answer that, far from injuring the mother, the primary effect of the drug benefited her by ameliorating the symptoms of some common ailment, or helping her to relax or sleep. The doctor’s responsibility to her embraces taking care to avoid harm to the child she carries. Two difficulties arise. First, a GP is judged by the standard of the reasonable, average GP. He is not expected to be an expert on embryology or drug-related damage. Proving that he ought to have been aware of the risk of the drug may be awkward. Second, the doctor may be aware of the risk to the baby, but argue that the risk to mother and child of not prescribing the drug is greater. Perhaps the mother might argue that, given the uncertainty surrounding the effect of medicines on fetal development, only exceptionally should any drug be prescribed to a pregnant woman by her GP. Advice should be sought from the specialist obstetrician. However, is it reasonable to deny pregnant women basic medicine for minor ailments and is the cost to the NHS of multiple referrals to obstetricians justifiable? The focus ought to lie on ensuring that all doctors give women adequate advice about the potential risks of drugs in pregnancy.

Doctors are not the only potential source of compensation for a drug-damaged child. Could the child sue the drug company? The company’s liability is governed by the Consumer Protection Act 1987 which we examined in Chapter 10. The crucial questions will be is the drug defective, and did it cause the relevant injury to the fetus? There can be little doubt that if the company can be shown to be aware of a risk of fetal damage, yet still marketed the drug with no warning of that risk, the drug is defective. The unborn baby is most vulnerable to harm in the earliest stages of pregnancy. The mother may not know that she is pregnant. Warnings about the use of many non-prescription medicines in pregnancy are routine, but futile if a woman is unaware of her pregnancy. Might a drug be defective simply because it poses a risk of fetal harm? Clearly that cannot generally be the case with many prescription drugs. The benefit such drugs offer when properly prescribed outweigh the remote chance of unwitting fetal harm. Over-the-counter, non-prescription medicines might be looked at differently. If a cough remedy poses a substantial risk of harm, greater than other similar products, for relatively small benefit, that product might be found to be defective.⁵⁷

In Multiple Claimants v Sanifo-Synthelabo⁵⁸ pregnant women took the anti-epileptic drug, Epilim, despite warnings that it could cause fetal abnormalities. Some of their children mounted a class action to test whether the product is defective within the meaning of section 3 of the Consumer Protection Act 1987 and also whether their disabilities result from an ‘occurrence’ within the meaning of sections 1(2)(a) or 1(2)(b) of the Congenital Disabilities (Civil Liability) Act 1976. The children argued that their disabilities result from the drug. Sanifo-Synthelabo argued that the ‘occurrence’ is the epilepsy itself. The case foundered when legal aid was withdrawn in November 2010.

Suing a doctor

11.9 We have already mentioned the potential liability of the mother’s GP in prescribing drugs for her. She will meet other doctors during antenatal visits. One special feature of suing a doctor under the Act needs note: section 1(5) of the 1976 Act, ‘the doctors’ defence’. Section 1(5) of the Act provides:

The defendant is not answerable to the child, for anything he did or omitted to do when responsible in a professional capacity for treating or advising the parent, if he took reasonable care having due regard to the then received professional opinion applicable to the particular class of case; but this does not mean that he is answerable only because he departed from received opinion.

The aims of those who sought the inclusion of those words ‘then received professional opinion’ were probably twofold. First, they quite reasonably wanted it made clear that hindsight as to the effect of a drug or course of treatment should not prejudice a doctor, and second, less reasonably, they did not want the courts to adjudicate on the adequacy of received opinion. As the defendant’s standard of care will always be tested by what was expected of the competent practitioner at the time of the alleged breach of duty, that first objective was met at common law. Second, perhaps doctors sought to ensure courts would not seek to evaluate ‘received professional opinion’. In 1976, it is likely that no court would have done so. The judgment of the House of Lords in Bolitho v City & Hackney Health Authority⁵⁹ now requires that responsible professional opinion, be demonstrably ‘logical and defensible’. We see no reason why section 1(5) should not be susceptible to similar judicial scrutiny.

Antenatal screening⁶⁰

11.10 Antenatal screening to diagnose fetal abnormalities has become routine. Just some of the more common procedures are looked at here.⁶¹ In amniocentesis, a needle is inserted through the mother’s abdomen and the uterine wall, into the sac surrounding the fetus. A small amount of the amniotic fluid surrounding the baby is removed. Tests on the fluid will indicate whether a number of abnormalities are present, including spina bifida and Down’s syndrome. Cultures from the fluid may be grown which will disclose the child’s sex. A mother who underwent amniocentesis and was told that she carried a spina bifida or Down’s syndrome baby could then opt for an abortion. A mother who knew she was a carrier of haemophilia and learned that she carried a male child might similarly seek a termination. There are medical problems with amniocentesis. It is usually performed between fifteen and twenty weeks of pregnancy. It carries about a 1 per cent risk of causing a miscarriage. It sometimes causes the mother acute discomfort. It is expensive, reserved largely for mothers at special risk of producing a disabled infant, in particular those over 35 or where blood tests suggest some abnormality in the baby.

Chorionic villus testing, whereby early placental cells are removed and analysed, is possible earlier in pregnancy, at about the eleventh to fourteenth weeks. But there is a slightly greater risk of miscarriage and chorionic villus testing does not detect neural tube defects (such as spina bifida). Increasingly doctors are seeking to limit the number of women who need to undergo invasive tests of this sort by using simple blood tests to identify high-risk pregnancies. Blood tests can identify infectious disease and inherited genetic conditions. A blood test to discover raised alpha-protein levels, an indication of possible spina bifida, has been available for several years. A blood test identifying increased risk of Down’s syndrome is available. Only women whose blood tests indicate possible fetal abnormalities will then have to undergo the invasive procedures of amniocentesis or chorionic villus testing. Finally, ultrasound scans are now routinely used to check on the growth and development of the fetus and will in certain cases reveal the presence of such deformities as spina bifida without the need to submit the pregnant woman to risky or invasive tests.⁶²

What are the legal implications of amniocentesis and chorionic villus testing? First, they involve an invasion of the mother’s body. Her consent is essential and should be obtained expressly and in writing. Second, the risk that a healthy baby may be lost should be communicated to the parents. The duty of the obstetrician caring for the mother must embrace offering her the information on which to make such a crucial decision.⁶³ Tests should be carried out and analysed with due care. Negligence in offering or carrying out antenatal screening may result in claims by both mother and child. In AK v Latvia⁶⁴ the European Court of Human Rights found that the antenatal care offered to Ms AK was not compatible with her rights under Article 8. Ms AK had a right to information in the form of antenatal screening. She was denied the information that she carried a child with Down’s syndrome. The Court limited its judgment to the procedural aspects of Article 8 and thus avoided the thorny issues inherent in a negligence claim. An action in negligence involves the contention that had adequate care been provided for the mother in pregnancy, she would have elected to terminate the pregnancy. The mother would have avoided the burden of a disabled child.⁶⁵ The child would have avoided the harm of her disabled existence. In neither case is the essence of the claim a claim for wrongful disability. Unlike the examples discussed earlier in this chapter, the defendants’ negligence is not responsible for causing disability to a fetus normal at conception. The defendants’ negligence is responsible for the birth of a child who, but for his negligence, would not have been born. The mother seeks compensation for a wrongful birth, a birth which if properly advised she would have chosen to avoid. The child sues in respect of wrongful life, a life, her counsel argues, she would have chosen not to endure. Both claims face major obstacles.

Wrongful life

11.11 A classic claim for wrongful life is recounted in McKay v Essex AHA.⁶⁶ The plaintiffs in McKay were a little girl, born disabled as a result of the effect of rubella suffered by her mother early in pregnancy, and her mother. When Mrs McKay suspected that she had contracted rubella in the early weeks of her pregnancy, her doctor arranged for blood tests to establish whether she had been infected. As a result of negligence by either her doctor or by laboratory staff, Mrs McKay was wrongly informed that she had not been infected by rubella. She continued with the pregnancy. Had she known the truth she would, as her doctor was well aware, have requested an abortion under the Abortion Act 1967. The little girl was born in 1975, before the Congenital Disabilities Act was passed. The Court of Appeal had to decide the position at common law. They said that no action lay where the essence of the child’s claim was that, but for the negligence of the defendant, she would never have been born at all. The child’s claim was thrown out, although her mother’s claim was allowed to proceed. The case is not solely of historical interest. The judges further said that under the Act no child born after its passing could pursue such a claim.

In the view of the Court of Appeal, the Act⁶⁷ can never give rise to a claim for ‘wrongful life’. Ackner LJ considering section 1(2)(b) of the Act, said that the relevant ‘occurrence’ has to be one that affected the mother in pregnancy ‘so that the child is born with disabilities which would not otherwise have been present’. Clearly under the Act, then, where the breach of duty consists of carelessness in the conduct of the pregnancy or the birth, the claim must relate to disabilities inflicted as a result of the breach of duty by the defendants. Where the essence of the claim is that the child should never have been born at all, it lies outside the scope of section 1(2)(b). A claim by the child that amniocentesis should have been performed, or that subsequent tests were negligently conducted so that the pregnancy continued, and he was born disabled, will fail.

The effect of the judgment in McKay is that in England a child injured before birth may claim only compensation for wrongful disability that is against a defendant whose conduct actually caused his disability. He cannot sue for wrongful life. The Court of Appeal gave three main reasons for ruling out such claims. (1) It was not possible to arrive at a proper measure of damages representing the difference between the child’s disabled existence and non-existence.⁶⁸ (2) The law should not impose a duty on doctors to abort, to terminate life in utero.⁶⁹ (3) To impose any duty to abort would be to violate the sanctity of life and to devalue the life of handicapped persons.⁷⁰ The second and third reasons are difficult to sustain in the light of the fact that the court did allow Mrs McKay to pursue her wrongful birth action. Thirty years on, Rosamund Scott⁷¹ points out the anomalous legal position whereby a parent whose child’s Tay–Sachs condition (for example) is negligently undetected in utero has no claim against the health professional under McKay. And yet, a child born with the same condition because of negligent embryo selection prior to IVF could claim under the Congenital Disabilities (Civil Liability) Act 1976.

Wrongful birth⁷²

11.12 In Udale v Bloomsbury Health Authority⁷³ Jupp J held that the birth of a healthy child could not be allowed to create a claim in damages. He argued that the child, when he came to know of the award, might feel unwanted and the family’s relationship to be disrupted. Doctors might put pressure on women to have abortions. Children were a blessing, and any financial loss was offset by the joy of their birth.

A series of judgments from the Court of Appeal firmly rejected Jupp J’s invocation of policy to refuse parents compensation in such a case.⁷⁴ Damages amounting to the cost to the family of raising an unplanned child appeared to be readily endorsed in claims for wrongful conception. Two decisions of the House of Lords restored English and Scottish law to the position declared by Jupp J in Udale, albeit on different grounds. It was held in McFarlane v Tayside Health Board⁷⁵ that compensation for the cost of bringing up a healthy child will not be awarded. Such a loss is categorised now as irrecoverable economic loss. McFarlane is difficult to analyse.⁷⁶ Five Law Lords rejected the parents’ claim. Five sets of very different reasons are advanced by their Lordships.

The facts of the case are straightforward. Mr and Mrs McFarlane had four children. Mr McFarlane had a vasectomy. Six months after his operation, the surgeon told him that his sperm count was negative and he and his wife could dispense with contraception. The couple relied on that advice. Mrs McFarlane became pregnant. They alleged that the surgeon was negligent and sought compensation (1) for Mrs McFarlane’s pain and distress in pregnancy and labour and (2) for the costs of bringing up their healthy daughter, Catherine.

Four out of the five Law Lords⁷⁷ held that Mrs McFarlane could recover damages for the pain and discomfort of pregnancy and any immediately consequential financial loss to her. All agreed that the more substantial claim for the cost of raising Catherine should fail. All tried to avoid Jupp J’s forthright reliance on policy to categorise such claims as repugnant to the public interest.⁷⁸ Lord Slynn appeared to accept that the blessings conferred by healthy children come in tandem with substantial burdens. He rejected the argument that courts should regard the financial costs of raising a child as offset by the joys of parenting. He claimed not to be concerned by possible psychological consequences to a child of learning that she is unwanted because her parents received damages for her wrongful conception. His speech focused on his finding that doctors are not responsible for the economic loss entailed in child-rearing. Doctors owe a duty of care to prevent pregnancy and the consequential physical effects on the mother. It is not fair, just or reasonable to extend that responsibility to the costs of rearing the child.⁷⁹ Lord Hope took a somewhat similar approach. He appeared exercised by the potential scale of claims for wrongful conception. If such a claim is allowable, it would relate to the actual costs to particular parents of raising that child. Thus a claim by wealthy aristocrats might extend to the cost of nannies, ponies, public school and so on. The extent of liability would be disproportionate to the negligence.⁸⁰

Lord Hope and Lord Steyn both, unlike Lord Slynn, adverted to the benefits of parenthood, Lord Hope declared:

it would not be fair, just or reasonable, in any assessment of the loss caused by the birth of a child, to leave these benefits out of account. Otherwise the [claimant] would be paid far too much. They would be relieved of the costs of rearing the child. They would not be giving anything back to the wrongdoer for the benefits. But the value attached to their benefits is incalculable. The costs can be calculated but the benefit, which must in fairness be set against them, cannot. The logical conclusion, as a matter of law, is that the cost to the [claimant] of meeting their obligations to their child during her childhood are not recoverable as damages.⁸¹

Lord Steyn contended that his rejection of the parents’ claim was not on policy grounds. He ‘would avoid those quicksands’.⁸² He saw the question as one of distributive justice. He stated that he was ‘firmly of the view that an over-whelming number of ordinary men and women’ would reject claims such as the McFarlanes. He argued that if claims by a child for wrongful life should be rejected as repugnant to the value of human life, so should a claim by parents for its wrongful conception.⁸³ Lord Steyn may have sought to avoid the quicksands of public policy but became immersed in them none the less.

Lord Clyde treated the claim as one of quantum of damages. Like Lord Hope, he was exercised by questions of proportionality. There could be significant differences in the level of awards depending on parental lifestyle. The expense of bringing up the child would be disproportionate to any wrongdoing and go beyond reasonable restitution.⁸⁴ Lord Millett, uniquely, sought to reject both claims by the parents, the claim for the mother’s pain and suffering in pregnancy, as well as the claim for the cost of raising Catherine. Lord Millett was forthright in his views:

In my opinion, the law must take the birth of a normal healthy baby to be a blessing, not a detriment. In truth it is a mixed blessing. It brings joy and sorrow, blessing and responsibility. The advantages and disadvantages are inseparable. Individuals may choose to regard the balance as unfavourable and take steps to forego the pleasures as well as the responsibilities of parenthood. They are entitled to decide for themselves where their own interests lie. But society itself must regard the balance as beneficial. It would be repugnant to its own sense of values to do otherwise. It is morally offensive to regard a normal, healthy baby as more trouble and expense than it is worth.⁸⁵

The only damages Lord Millett would allow was a nominal sum to represent the loss of the parental freedom to limit the size of their family. He proposed £5,000. Lord Millett stands alone in the openness of his opinion that it is just unacceptable to society to compensate parents for having a child, however hard they had tried to avoid further pregnancies. His honesty should be commended. The reasons advanced by his colleagues are not convincing.

Will McFarlane affect a claim by parents of a disabled child who can establish that, had the child’s disability been diagnosed in utero, the mother would have terminated the pregnancy?⁸⁶ The Law Lords in McFarlane expressly restricted their decision to claims concerning healthy infants. Yet consider the approval Lord Steyn bestows on the following statement from an Australian textbook:

it might seem inconsistent to allow a claim by the parents, while that of the child, whether healthy or disabled, is rejected. Surely the parents’ claim is equally repugnant to ideas of the sanctity and value of human life and rests, like that of the child, on a comparison between a situation where a human being exists and one where it does not. [our emphasis]⁸⁷

Lord Steyn comments:⁸⁸ ‘the reasoning is sound. Coherence and rationality demand that the claim by the parents should also be rejected’.

So can a distinction between a claim for wrongful birth of a healthy child, and wrongful birth of a disabled child be sustained?⁸⁹ The Court of Appeal endorsed such a distinction in Parkinson v St James and Seacroft NHS Hospital Trust⁹⁰ ruling that where a disabled child is born as a consequence of clinical negligence his parents may recover the additional costs occasioned by his disability. The relevant negligence in Parkinson ensued from a bungled operation to sterilise the mother. The surgeon failed to secure a clip effectively to Mrs Parkinson’s left fallopian tube. She conceived again ten months after the operation. The case for compensation covering the costs resulting from a child’s disability when the alleged ‘wrong’ is a failure to prevent the birth of a disabled infant looks stronger. Doctors expressly advising potential parents about the risks of conception, and screening women in pregnancy, undertake that responsibility expressly to avoid the birth of a disabled child. The ‘harm’ to the parents of the birth of a child with spina bifida, or damaged by rubella,⁹¹ is just what the doctors seek to prevent. Only a limited group of people (parents whose children were unfortunately born disabled) could bring a claim and Brooke LJ saw no difficulty with the proposition that the doctor assumed responsibility for the disastrous economic consequences of the birth of such a child. ‘[O] rdinary people would consider that it would be fair for the law to make an award in such a case provided that it is limited to the extra expenses associated with the child’s disability’.⁹² Both Brooke LJ and Hale LJ⁹³ constructed elegant examples to distinguish the case of the disabled child from McFarlane. Hale LJ proposed a model of ‘deemed equilibrium’ whereby the costs and benefits of a healthy child balance each other out. The reader may ponder whether the appeal court did not in reality simply regard McFarlane as wrongly decided.⁹⁴ Unable to say so forthrightly, the judges sought to mitigate its worst effects. The parents’ damages however will be limited to the additional costs of raising a child with his particular disability.⁹⁵ Before McFarlane, English courts awarded such parents the whole cost of child-rearing.⁹⁶ Compensation in such cases of wrongful birth will now relate only to the additional cost of caring for the disabled child.⁹⁷ Compensation may still be considerable. There were 164 successful wrongful birth claims against the NHS between 2003 and 2013, amounting to a total payout of £95,208,477.⁹⁸ Compensation can and should include cost of care beyond the child’s minority.⁹⁹ ‘Good’ parents will seek to provide for their disabled children into adulthood.

The tangled web of case law following McFarlane may be morally disturbing to some people. Refusing to compensate parents for the unplanned birth of a healthy child Lord Millett said in McFarlane: ‘There is something distasteful, if not morally offensive, in treating the birth of a normal healthy child as a matter of compensation’.¹⁰⁰

He regarded childbirth as akin to a balance sheet. The joys of parenthood offset financial costs. Mutual support of parent and child, the support perhaps of the parent in old age offset the burdens of parenting. Distinguishing the healthy and disabled child might seem to suggest the latter is a ‘curse’ not a ‘blessing’. In Parkinson, Hale LJ took a pragmatic approach. She said of the disabled child that: ‘This analysis treats a disabled child as having exactly the same worth as a non-disabled child. It affords him to same dignity and status. It simply acknowledges that he costs more’.¹⁰¹

If cost is key, then what of the wrongful birth of a healthy baby to a disabled parent? In Rees v Darlington Memorial Hospital NHS Trust the Court of Appeal¹⁰² allowed the claim of a visually impaired woman whose negligent sterilisation led to the birth of a healthy child. The claimant suffered from retinitis pigmentosa. She had only very limited vision in one eye. She elected to be sterilised because she did not want children and judged that her virtual blindness would prevent her looking after a child. Hale LJ¹⁰³ distinguished McFarlane on a number of grounds, relying on the pragmatic ‘deemed equilibrium’ model she first set down in Parkinson. Unlike the healthy parent of a healthy child, but like the parent of any disabled child, the claimant incurred extra costs in bringing up a child. The compensation awarded to her was not compensation for the cost of the child per se, but the costs occasioned by her own disability. McFarlane, it was held, applied only to healthy parents.

The case proceeded to the House of Lords,¹⁰⁴ where the Law Lords had an opportunity to revisit their judgment in McFarlane. They refused to do so. By a 4:3 majority, they overturned the decision of the Court of Appeal. Though, for reasons of public policy it is unacceptable to view a healthy child as a financial liability, the Law Lords put a ‘gloss’ on the McFarlane ruling. As we noted at the start of this chapter, the Law Lords in Rees belatedly endorsed Lord Millett’s proposal in McFarlane that an award of general damages was appropriate to mark the injury to the claimant. Lord Bingham proposed that, in addition to the award for pregnancy and birth, a conventional figure of £15,000 should be awarded to reflect that the defendant’s negligence constituted a legal wrong causing the parents to suffer a loss of autonomy.¹⁰⁵ The majority agreed. Elevated costs of rearing a healthy child as a result of parental disability are not recoverable. ‘General damages’ are all that such parents can hope for.¹⁰⁶

Hale LJ’s ‘deemed equilibrium’ was rejected on the basis that the costs and benefits associated with the birth of a child were unquantifiable and consequently impossible to balance. Alasdair Maclean argues that, though correct, this leaves no legal basis for the ‘gloss’ on McFarlane.¹⁰⁷ Whilst there may be public policy grounds for the avoidance of general negligence principles in wrongful birth cases, even after two House of Lords decisions, sound legal reasoning remains elusive. Perhaps, as Emily Jackson suggests,¹⁰⁸ the Law Lords in Rees were simply creating their own novel scheme of compensation to acknowledge the legal wrong whilst limiting the pay out. On the other hand the ‘gloss’ may be viewed, as Lord Steyn suggested in his dissenting judgment, as ‘a radical and most important development which should only be embarked on after rigorous examination of competing arguments’.¹⁰⁹ On this view, the majority in Rees overstepped the limits of judicial discretion.¹¹⁰

Rees has implications for the status of Parkinson. Though Lord Hutton approved of the decision,¹¹¹ Lord Bingham was critical of it.¹¹² The refusal of the majority to make a calculation of costs based on benefits and detriments in the case of a healthy child is arguably equally applicable to the disabled child.¹¹³ Parkinson was applied in Farraj v King’s Healthcare Trust and Cytogenetic Data Services.¹¹⁴ Mrs Farraj, who was pregnant with her third child, was the carrier of recessive gene which can cause beta thalassaemia major. Her husband was also a carrier creating a strong chance that any child of theirs would suffer from the disease. Mrs Farraj thus underwent chorionic villus testing. Their second child had the blood disorder and they intended to terminate the pregnancy if the fetus was a carrier. The test result was negative, but proved to be a false negative. Sadly, baby Abdullah inherited the disorder. The laboratory had failed to identify that the sample was poor quality, or ask for a second sample. They were held liable and the couple were able to claim expenses related to the child’s disability.

Children damaged by pre-conception events

11.13 The Congenital Disabilities (Civil Liability) Act 1976 purports to protect children against pre-conception injury,¹¹⁵ not just injury in utero. This could happen where the father or mother is affected by radiation or drugs so that the sperm or egg carries a serious defect. Or the child may be damaged if doctors mismanage a previous pregnancy, for example if they fail to take note of and treat rhesus incompatibility in the mother and the second child is born brain damaged.¹¹⁶ The Act intended to cover such cases, providing as it does that the relevant occurrence may be one which affected either parent in his or her ability to have a healthy child. But it may be argued that, if the claim is that the child was born disabled because one of his parents is incapable of creating a healthy infant, his claim is essentially that he should never have been born at all, and that it is an action for ‘wrongful life’ and is barred under the Act. We think this is a mistaken view of the Act. The child’s claim in the case of a pre-conception occurrence rests on the hypothesis that but for that occurrence he would have been born normal and healthy, and that his actionable injury is therefore the difference between the life he might have had and the life he must now perforce endure. In McKay,¹¹⁷ the child sought to maintain that her actionable injury was life itself, and as such her claim was not and would not be sustainable. What McKay does clarify in cases of pre-conception injury is that a doctor who is not responsible for that original injury, cannot be liable under the Act if he fails to diagnose the child’s disabilities in pregnancy, and fails to perform an abortion in such circumstances.

Pre-pregnancy advice and genetic counselling

11.14 Women planning a child often seek advice before conception. For a healthy woman, this may be simply a check that she is immune from rubella. Another may seek reassurance that pregnancy will not damage her own health, for example, if she has a history of cardiac disease. Couples in whose family genetic disease is prevalent, or couples who already have a child with a genetic disease, may need specialised genetic counselling.

In all these cases, those counselling the woman undertake a duty to her in relation not only to her own health and welfare, but also in relation to the birth of a healthy child. If she is given the green light to go ahead with a pregnancy and suffers at the end of it the trauma and additional financial burden of a damaged child, she may have a claim in negligence.¹¹⁸ She and the child’s father will be able to claim the additional cost to them of caring for a disabled child. Proving negligence may not be easy. Not only must she show that the doctor failed to take into account factors relating to her medical history or genetic background, or failed to conduct tests that would have alerted him to the danger, she must show that a reasonably competent doctor would have discovered the risk.¹¹⁹ If a woman requests a test for immunity from rubella, is brushed aside, and subsequently contracts the disease in pregnancy, her claim should succeed. The enormous publicity given to the Department of Health campaign to eradicate the risk to the unborn child posed by rubella is such that any GP must be aware of and guard against the risk. If the sister of a haemophiliac consults her doctor and explains her brother’s condition, and he fails to refer her for counselling with the result that she bears a haemophiliac son, she too should succeed.¹²⁰ Beyond these obvious examples of want of competence the medical profession is much divided on the value of pre-conception advice. Finally, the claimant must also establish that had she received proper advice she would not have allowed herself to become pregnant when she did.

Has the disabled child a remedy? We must distinguish three types of cases where negligent pre-pregnancy advice results in the birth of a disabled child. In the first case, the relevant negligence may be that the woman was encouraged to become pregnant when, had proper care been taken, she could have been advised never to contemplate pregnancy because of the risk to any child she might bear. The child’s action in such a case will fail because the essence of his claim is that he should never have been born at all. It is a claim for ‘wrongful life’.

In the second instance, the negligence may have been in failing to counsel the mother properly on precautions to take, or the timing of pregnancy. Such a claim raises an awkward problem. For example, a woman is not tested for immunity to rubella, or the test is negligently conducted. She is wrongly told that she has immunity. She becomes pregnant, contracts the disease and the child is born disabled. Had she been properly advised, she would have been vaccinated against the disease and advised in the strongest of terms to delay pregnancy for three months after the vaccination. The actual child born would never have been born. The particular set of genes in the egg and sperm that went to create him would never have met. A literal interpretation of McKay would deny the child a remedy on the ground that that unique individual would never have been born had his mother had proper advice. It would seem a harsh result, but the conclusion that it follows from the interpretation of the Act by the Court of Appeal in McKay is difficult to resist. Examples of this sort could be multiplied endlessly. A parent might be undergoing treatment for venereal disease. He or she is carelessly advised that pregnancy is now safe. It is not. Treatment was not complete. The particular child born disabled would not have been born, had proper advice been given. A woman knows a little of a family history of genetic disease affecting the males in her family. She seeks counselling. She should have been advised of the risks to male children and been offered pre-implantation genetic diagnosis (PGD) so that she could if she wished have ensured she did not give birth to a male child. A disabled male child cannot sue under the Act, for, had PGD or amniocentesis been offered and accepted, that boy would not exist.

Finally, there is one limited class of case where the child’s action based on allegedly careless pre-pregnancy advice may succeed. That is where adequate counselling advice would have enabled that very child to be born hale and hearty. Realistic examples are difficult to think of. Perhaps one example concerns the relationship between maternal diet before conception and spina bifida. There is evidence that folic acid supplements may reduce the likelihood of spina bifida. The child could contend that, had his mother been advised to follow that regime, his disability would not have developed. He would have been born, but not born disabled. Such a child claims for his disabilities, not wrongful life. He overcomes the first problem in his claim against medical staff, but will he be able to prove that the treatment if given would have prevented his disability?

What if a parent realises the risk?

11.15 Alas, further problems confront the child whose claim is based on pre-conception injury. Section 1(4) of the 1976 Act provides that in such cases if the affected parent is aware of the risk of the child being born disabled the defendant is not liable to that child. Responsibility for knowingly running the risk of creating a disabled baby rests with his parents, and whatever the degree of fault, the original creator of the risk is relieved of liability to the child. There is one exception to this rule. Where the child sues his father, the fact that the father is aware of the risk of begetting an abnormal child will not defeat the child’s claim as long as his mother is ignorant of the danger. This raises a nice question. A young man suffers contamination by toxic chemicals at work through the negligence of his employers. He is warned that his reproductive capacity has been damaged, that he is likely to beget abnormal offspring and is advised never to have children. He ignores the warning, marries and tells his wife nothing. A disabled child is born. The child cannot sue his father’s original employers. Even if they were in breach of duty to his father, ‘the affected parent’, the father’s knowledge of the risk is a defence. Can the child sue her father? The answer has to be no. This child, like the plaintiff in McKay¹²¹ can only claim against her father that she should never have been born at all. His father’s condition at the time of the relevant ‘negligence’, begetting the child, was such that he could not beget a normal child. The father’s ‘negligence’ was in creating him, not in inflicting a disability which but for some act or omission on his part would not have been present.

Must a mother consider abortion?

11.16 Section 1(7) of the 1976 Act offers a partial defence whereby if the affected parent shared responsibility for the child being born disabled, the child’s damages may be reduced. For example, the child’s disabilities may be diagnosed when the mother has an ultrasound scan, or amniocentesis, before his birth. Once the mother knows of the potential damage to her child, she will under the 1967 Abortion Act be entitled to an abortion on the grounds that there is substantial risk that the child if born would be seriously handicapped. Assuming that it is the mother who is the affected parent, does she share responsibility for the child being born disabled, if she refuses an abortion? In McKay v Essex Area Health Authority, refusing to allow child’s claim that she should have been aborted, Ackner LJ said that he could not accept:

that the common law duty of care to a person can involve, without specific legislation to achieve this end, the legal obligation to that person, whether or not in utero, to terminate his existence. Such a proportion runs wholly contrary to the concept of the sanctity of human life.¹²²

Applying Ackner LJ’s proportion to a submission that a mother should have accepted abortion advanced by the defendant responsible for inflicting the disabilities suffered by the child, such a submission must fail. To impose an obligation on a mother to undergo an abortion is more repugnant to the concept of the sanctity of human life than to impose an obligation to abort on a doctor.

In Emeh v Kensington, Chelsea and Fulham Area Health Authority,¹²³ the plaintiff brought a wrongful conception claim, long before McFarlane.¹²⁴ An operation to sterilise her was carried out negligently by the first defendant and she became pregnant again. She was offered, but refused an abortion. The trial judge held that once she elected to continue the pregnancy, the pregnancy ceased to be unwanted, and that the birth of the child was the result of her own actions and not a consequence of the defendant’s negligence. Her refusal to consider an abortion was so unreasonable as to eclipse the defendant’s wrongdoing. The Court of Appeal overruled him.¹²⁵ Mrs Emeh did not become aware of her pregnancy until it was about seventeen to eighteen weeks advanced. Refusing an abortion at that stage in pregnancy could not be considered unreasonable. Whether the Court would have taken a different view had the pregnancy been less advanced remains open to question. Waller LJ laid great stress on the increased risk, discomfort and hospitalisation entailed in abortion at twelve weeks plus.¹²⁶ Slade LJ was emphatic that abortion should generally never be forced upon a woman. He said:

Save in the most exceptional circumstances, I cannot think it right that the court should ever declare it unreasonable for a woman to decline to have an abortion in a case where there is no evidence that there were any medical or psychiatric grounds for terminating the particular pregnancy.¹²⁷

Slade LJ’s condemnation of judicially enforced abortion is endorsed in McFarlane by Lords Slynn¹²⁸ Steyn¹²⁹ and Millett. Lord Millett declares¹³⁰ that it is morally repugnant to suggest that it is unreasonable not to have an abortion.

Some slight doubt however, lurks in the kind of cases we are currently considering. If a fetal abnormality is diagnosed in pregnancy, and caused by the defendants’ prior negligence, does this constitute medical grounds to terminate the pregnancy, and constitute the sort of exceptional circumstances Slade LJ refers to? Certainly the fetal injury would entitle the mother to choose to abort the child. We cannot see that it could require her to do so or risk a reduction to her child’s compensation for the disability he suffers. Section 1(7) of the 1976 Act envisages the sort of case where a pregnant woman ignores medical advice and exacerbates her child’s disability by drinking, smoking or failing to take precautions advised by her doctors. The mother actively contributes to the disability. That is very different from refusing abortion. Assume a court was prepared to entertain this defence, how will they assess the mother’s decision? Is it some totally objective test? Or must the woman’s own moral views and religious affiliation be considered? Given that the Court of Appeal has finally confirmed that no women can be forced to undergo a caesarean section to protect the life or health of the fetus, to ‘force’ a woman to ‘kill’ her fetus would be illogical.¹³¹ Maternal autonomy demands that pregnant women’s choices in this delicate arena of moral controversy should be respected.

Maternal immunity: discriminating against fathers?

11.17 We noted earlier that, save in respect of road accidents on public roads, mothers remain immune from claims under the 1976 Act.¹³² Fathers enjoy no such formal immunity. A pregnant woman who drinks so heavily that her child is born with fetal alcohol syndrome or whose drug habit is such that her baby is born addicted to crack cannot be sued by her child. The Law Commission,¹³³ recommending that mothers be exempted from claims for prenatal injury, offered a number of reasons for maternal privilege. They considered that a claim against the mother would have little practical utility. She, unlike the father, was unlikely to have funds to meet an award of damages. Suing ‘mum’ would disturb the parental bond and in practice would only happen where a father used his child’s claim as a weapon in parental dispute. The first of these two reasons looks rather outdated now when many more women have independent means. The second applies equally to fathers. Other reasons remain more compelling.¹³⁴

How could an equitable standard of reasonable pregnancy conduct be set? Women are beset by contradictory advice about what they should and should not eat, drink or do. Though, objectively one might agree that the reasonable mother-to-be should give up smoking, for example, achieving that standard is more difficult for some than others. The harassed mother of four struggling alone in poverty may know that she ought to quit smoking but struggles to do so. Most importantly, potential liability for fetal injury would in practice constitute a significant invasion of pregnant women’s liberty and privacy. The threat of possible redress by the child could be used by partners and doctors to impose their judgement of fetal welfare. Given evidence of the fetus’s vulnerability in early pregnancy, when a woman may not know she is pregnant, as Sheila McLean has said, the law would in effect demand that ‘fertile, sexually active women of childbearing age should act at all times as if they were pregnant’.¹³⁵ Finally, pragmatically, we should remind ourselves that a claim under the 1976 Act can only arise if a child is born alive. Maternal liability under the 1976 Act could simply provide an incentive to abort. A woman fearing, perhaps for little reason, that she has harmed her child could ensure that he was never born at all.

If there remains a case for maternal immunity, consideration must at least be given to paternal immunity. In 1976, the kind of harms men might do their unborn children were perceived as crude and obvious wrongdoing. A father who beats his partner up so badly that he injures both her and the child in the womb elicits little sympathy. What science can now tell us about how lifestyle from an early age may affect human gametes is cause for concern. Studies have shown that heavy smoking in teenage years could increase the risk of a man’s child born years later succumbing to certain cancers. Whether fathers ought to be constrained by law in their pre-conception conduct must be questionable. Paternal liability unearths a further quirk of the 1976 Act. Even absent maternal immunity, in what sort of circumstances could either parent be liable for pre-conception injury? Liability under the Act is derivative only. The defendant must be liable in tort to the affected parent. Consider this example. A man is a heavy drug user in his youth in an era when such drug use is known to damage sperm. Later he begets a child born disabled because of his damaged gametes. To be liable to the child, he must be liable to her mother. To be liable to the mother, the courts would have to find that men have a duty of care to their future partners to ensure that they protect those partners’ reproductive health. Imagine the outcry if the law declared that women must order their lives to safeguard their husbands’ right to have healthy children.

Criminal liability¹³⁶

11.18 Before concluding that pregnancy conduct can never be subjected to legal redress, the decision of the House of Lords in Attorney General’s Reference (No 3 of 1994)¹³⁷ must be considered. A father attacked his pregnant girlfriend and injured his child in the womb. The baby was born alive but subsequently died of her prenatal injuries. The father was charged with his daughter’s murder. Following his acquittal, the Attorney-General referred the case to the Court of Appeal to determine whether murder or manslaughter can be committed where a fetus is injured in utero, but is subsequently born alive only to die later of prenatal injuries. In a convoluted judgment, the Court of Appeal answered yes to both questions.¹³⁸ The House of Lords partially upheld their judgment on very different grounds. The Law Lords endorsed earlier judgments¹³⁹ that a charge of murder or manslaughter can be sustained where a fetus is injured in utero is born alive and later dies as a consequence of those injuries. On the facts of this case, their Lordships held that a charge of murder could not be sustained, but that a charge of manslaughter could. Murder could not be committed in this case because there was no express design to harm the fetus ‘or the human person which it would become’.¹⁴⁰ However, manslaughter could be established in this instance. In his assault on the mother, the father committed an unlawful and dangerous act likely to cause harm to the child and to the event resulting in her death. Such conduct constituted unlawful act type manslaughter. The implications of Attorney-General’s Reference (No 3 of 1994) are that:

(a)  a person whose unlawful and dangerous conduct results in fetal injury followed by the birth of a child ‘doomed to die’ commits manslaughter;

(b)  gross and culpable negligence in relation to the fetus may similarly, where the child is born alive and subsequently dies, constitute manslaughter;

(c)  a deliberate attempt to harm or kill the fetus directly could in such cases amount to murder.

Finally Lord Mustill¹⁴¹ suggested that any violence against the fetus resulting in harm short of death may engage criminal responsibility.

At no point, did any of the Law Lords consider maternal criminal responsibility. Their reasoning left pregnant women open to such liability in a range of scenarios. Could the pregnant woman who continues to abuse illegal drugs so that her child is born damaged by those substances and dies of their effect be said to commit unlawful act-type manslaughter? Could the woman whose heavy abuse of alcohol results in a child so dreadfully harmed by fetal alcohol syndrome that he lives only a short while, be seen as criminally negligent? And even if her child does not die, might the mother be charged with causing him grievous bodily harm?¹⁴²

In 2014, the Court of Appeal in CP (A Child) v Criminal Injuries Compensation Authority tackled the latter question.¹⁴³ CP was a 7-year-old girl with fetal alcohol spectrum disorder whose mother had drunk excessive amounts of alcohol during pregnancy. She appealed against a decision of the Administrative Upper Tribunal that she was not entitled to compensation from the Criminal Injuries Compensation Scheme. CP needed to show that there had been a ‘crime of violence’ to claim under the Scheme. But the Court of Appeal held that there was no offence under section 23 of the Offences Against the Persons Act 1861, which criminalises ‘maliciously administering poison so as to endanger life or inflict grievous bodily harm’. The judges reasoned that CP was harmed in utero, and the fetus is not recognised in law as a person. This position can be contrasted with the Attorney General’s Reference, where the harm started in utero and continued after the child’s birth.

Had CP succeeded in her appeal it would have created a precedent that would lead inexorably to criminalisation for acts in pregnancy that harm the fetus born alive. The moral obligation to have due regard for the welfare of a child whom a mother elects to bring to term is incontrovertible.¹⁴⁴ Whether the invocation of the criminal law would in practice enhance fetal welfare or simply offer means of coercing pregnant women and stigmatising unfortunate mothers is to be doubted.¹⁴⁵ The decision in CP brings a measure of clarity but leaves open the possibility raised by the Attorney-General’s Reference, that a woman could be prosecuted for an unlawful act in pregnancy which causes the subsequent death of her child.

Once the baby is born alive, a mother who deliberately kills her baby will not necessarily have committed murder or manslaughter if ‘the balance of her mind was disturbed by reason of her not having fully recovered from the effect of giving birth to the child’. Section 1(1) of the Infanticide Act 1938 provides a partial defence. In R v Gore¹⁴⁶ G hid her pregnancy and abandoned her baby which sadly died due to lack of medical attention. At the time, section 1 stipulated that ‘notwithstanding that the circumstances were such that but for this Act the offence would have amounted to murder, she shall be guilty of felony, to wit of infanticide’ (our emphasis).¹⁴⁷ Her parents argued¹⁴⁸ that the elements of murder (including the requisite mens rea) must be proved, but the Court of Appeal held not. There is no requirement in the Act of proof of intention to kill. In 2006 the Law Commission expressed concern that a negligent act which falls short of gross negligence manslaughter might lead to prosecution.¹⁴⁹ Section 57 of the Coroners and Justice Act 2009¹⁵⁰ made minor amendments to section 1 of the Infanticide Act.¹⁵¹ Now no one can be convicted of infanticide unless a homicide is committed.

Childbirth: how much choice?¹⁵²

11.19 In future, ectogenesis may allow the fetus to be gestated in an artificial womb.¹⁵³ Today medical technology offers a whole range of sophisticated devices to monitor mother and baby and ensure safe delivery. Some women reject the panoply of machinery found in many hospital labour wards. Accepting the necessity of ‘high-tech’ birth for a minority of difficult cases, the natural childbirth movement has campaigned for the medical profession to be more willing to let nature take its course. For a number of women the ideal is delivery at home in the comfort of familiar surroundings. Others seek delivery by caesarean section for a variety of reasons including the safety of the baby, fear of natural delivery or simple convenience.

The Supreme Court decision of Montgomery v Lanarkshire Health Board¹⁵⁴ is a powerful assertion of reproductive autonomy. Nadine Montgomery was awarded £5.25m in damages when her son sustained catastrophic injuries during childbirth. She was not advised of the possibility of an elective caesarean section, despite her small stature and the fact that her baby would be bigger than average. Nor was the operation offered during the difficult labour. The Supreme Court affirmed that doctors have a duty to ensure patients are aware of any material risk of injury, whether or not they question the doctor about the risk.

And yet, childbirth remains a professional monopoly. The law denies a woman, unable to persuade a doctor or midwife to attend her at home or a hospital to comply with her wishes concerning the birth, the choice of seeking alternative help.¹⁵⁵ For it is a criminal offence for a person, other than a registered midwife or a registered medical practitioner, to attend a woman in childbirth. And any person means any person. In 1982, a husband was convicted of delivering his own wife and fined £100.¹⁵⁶ Nor is the unqualified attendant the only potential ‘criminal’. The mother herself, if she procures the other’s services – in ordinary English, if she asks for help – may be guilty of counselling and procuring a criminal offence. So her choice is to accept the medical help available or give birth alone. Giving birth alone is not an attractive option and one not free of legal hazard, not to speak of medical risk, for, if the baby dies, the mother may face prosecution for manslaughter.¹⁵⁷ Gross negligence by attendants in the delivery of a baby has resulted in criminal conviction where the baby died.¹⁵⁸ The issue where an unattended mother was on trial would be whether refusing medical attendance was sufficiently culpable negligence in relation to the safety of her child.

The rationale for legislation which makes professional attendance at childbirth compulsory may appear self-evident. If a person refuses to seek medical help for any other life-threatening condition he physically harms himself alone. A woman refusing medical attention in childbirth puts her baby at risk. The legislation originally enacted to require professional attendance at childbirth was intended to outlaw the ‘Sarah Gamps’, elderly and often dirty local women who made their living as unqualified midwives.¹⁵⁹ Today’s legislation has moved a long way from that point. It may by chance be correct, but it needs proper consideration whether a husband delivering his wife, or a mother her daughter, should be branded as criminal when all goes well and mother and baby thrive.

Hospital birth

11.20 How far does a woman retain control of her labour? Save in an emergency, explicit consent is required for any invasive examination or procedure in labour.¹⁶⁰ That does not mean that the midwife must obtain a written consent for every vaginal examination, or that explicit consent to wiping the woman’s brow is called for. Any significant procedure must where possible proceed with the woman’s agreement.

Childbirth can be an unpredictable process. Midwives and obstetricians sometimes have to respond swiftly to an unforeseen emergency. The woman may be in acute pain, perhaps a little panicky, or significantly affected by doses of painkilling drugs which cause some mental confusion. Doubts may surface about her decision-making capability, and/or time to seek consent may truly be limited. The Court of Appeal¹⁶¹ has suggested that if the woman is temporarily incompetent to make decisions for herself, health professionals may do whatever is required in her best interests. Defining the borderline between capacity and mental incapacity in such cases is tricky. It is too easy to assume women are incompetent. ‘Birth plans’ offer a partial solution to such dilemmas. Women, ideally in consultation with their midwives outline how they wish to be treated if certain emergencies materialise. ‘Advance decisions’¹⁶² should have just as great force and authority at childbirth as in the life-threatening circumstances in which they are more usually invoked. The controversy over whether the law should compel medical attendance in childbirth would be much less substantial if the woman’s rights in hospital were fully protected.

It goes without saying that a mother suffering injury as a result of carelessness in the management of childbirth is entitled to compensation for negligence. She will recover compensation for her pain and suffering and for the shock and grief consequent on the death of a baby, or the birth of a disabled child. Her damages may also include any effect of the mismanaged delivery on her prospects of future childbearing.¹⁶³ Where obstetric negligence results in the birth of a disabled infant, the child too has a claim. The most common case centres on allegations that the baby suffered brain damage as a consequence of oxygen starvation during delivery. The parents argue that the obstetric team failed to act on signs of fetal distress and perform a caesarean section as swiftly as the circumstances required. The child is born with cerebral palsy. Very often the core of the dispute is not whether clinical negligence can be proven, but whether causation can be established. Such cases are expensive, slow and worryingly common. The NHS Litigation Authority reports the value of claims made against each medical speciality. The highest value claims by far (totalling £7,995,414 since 1995) are in obstetrics and gynaecology.¹⁶⁴ Little wonder the Chief Medical Officer gave serious thought to a special no-fault scheme to compensate birth injuries.¹⁶⁵

Maternal autonomy/fetal welfare

11.21 The child injured by obstetric negligence will have a claim against doctors and midwives who failed him. What are his rights if his mother refuses a course of action that will benefit him and thus causes him injury? In theory the child’s rights are governed by the Congenital Disabilities (Civil Liability) Act 1976, albeit the Act appears to go unnoticed in the relevant case law. The 1976 Act covers not just injury to the child in the womb but also any occurrence which affected mother or child in the course of its birth. It has been argued that the 1976 Act reduced the child’s rights.¹⁶⁶ Liability under the Act arises only where the defendant would have been liable in tort to the affected parent. Where a failure by the defendant caring for the mother, eg failure to proceed quickly enough to caesarean section, is in no way the responsibility of the mother, no problem is caused to the child. The duty to the mother embraces care of her child. A breach of duty to her which injures the child creates rights for both her and her child.

The thrust of the argument that the Act reduced the child’s rights lies in these sorts of circumstances. The child is believed to be at risk. Doctors recommended caesarean section. The mother refuses and the child is born suffering brain damage. The child will not be able to sue the doctor. The doctor is not liable to the mother. The child cannot sue his mother, for the Act grants immunity to mothers.¹⁶⁷ If there is no duty directly to the child, a doctor cannot after the 1976 Act, advance his duty to the child as a defence to acts done to the mother.¹⁶⁸ Where there is still a direct duty to the child, the doctor might contend that in exceptional circumstances, he could, for example, proceed to caesarean section without consent in order to save the baby. That begs the fundamental question of whether doctors ought ever to be allowed to prioritise the child’s welfare above his mother’s right to autonomy, to make her own choices about her childbirth.

In 1998, the Court of Appeal in St George’s Healthcare NHS Trust v S¹⁶⁹ finally ruled that in English law no mentally competent woman could be required to submit to a caesarean section or any other form of obstetric intervention to which she objected. Neither pregnancy nor labour diminished the woman’s rights of self-determination. Judge LJ put the position succinctly: ‘while pregnancy increases the personal responsibilities of the pregnant woman it does not diminish her entitlement to decide whether or not to undergo medical treatment’.¹⁷⁰

Six years of uncertainty were ended. In 1992, in Re S,¹⁷¹ the then President of the Family Division, had ruled doctors could carry out a caesarean on a woman whose own life and that of her child were imminently imperilled by an obstructed labour. Several other cases¹⁷² followed where courts, often in hurried hearings in circumstances of dire emergency, ordered caesarean surgery despite maternal objections. In a number, but not all, of these cases the mother’s mental capacity was questionable. In 1997, in Re MB (Adult: Medical Treatment)¹⁷³ the Court of Appeal said that if a woman retained mental capacity she retained the right to make decisions about surgery for herself but found on the facts that MB’s needle phobia rendered her temporarily incompetent.

The theory of the law is this. Unless a woman lacks the mental capacity to make her own decisions about labour, her freedom to determine what is and is not done to her is unimpaired. This is confirmed in Department of Health guidance which states:

If an adult with capacity makes a voluntary and appropriately informed decision to refuse treatment (whether contemporaneously or in advance), this decision must be respected, except in certain circumstances as defined by the Mental Health Act 1983. This is the case even where this may result in the death of the person (and/or the death of an unborn child, whatever the stage of the pregnancy).¹⁷⁴

In practice, the temptation to seek grounds to find her capacity to be impaired is great.¹⁷⁵ Judge LJ in St George’s is emphatic in his endorsement of maternal autonomy. The mother’s wishes should be respected even if her thinking process is ‘apparently bizarre and irrational and contrary to the views of the overwhelming majority of the community at large’. Yet in Re MB, Butler-Sloss LJ suggested a woman might suffer temporary incapacity induced by confusion, shock, pain or drugs. Or fear might paralyse the will.¹⁷⁶ Finding any of these factors in childbirth will not be hard.

The situation is altered little by the Mental Capacity Act 2005.¹⁷⁷ The Act codifies the test for capacity in section 2. Capacity is judged at the ‘relevant time’. Its temporary nature is irrelevant. However neither a condition (such as pregnancy) nor an aspect of the person’s behaviour (such as irrationality) can establish a lack of capacity under the Act.¹⁷⁸

In the case of a pregnant woman, it must be demonstrated that she is unable to make the particular decision as a result of an impairment or disturbance of the mind. The Code of Practice on the Mental Capacity Act recognises a wide range of factors which can lead to such impairment, including drugs and delirium.¹⁷⁹ Consequently, it will remain the case that doctors may have little difficulty in demonstrating a temporary lack of capacity during labour.

Where it is established that a patient lacks capacity, an assessment of her best interests must be undertaken. This too can be highly controversial.¹⁸⁰ Mostyn J’s judgment in Re AA¹⁸¹ was initially private, but a transcript was released in light of significant media interest. A 35-year-old woman, Ms Pacchieri, had travelled here from Italy for a short work trip. She was detained under the Mental Health Act 1983 when she stopped taking medication for bipolar disorder following a panic attack. At 39 weeks gestation, Mostyn J in the Court of Protection held that Ms Pacchieri lacked capacity to litigate and to make decisions about the birth of her child. On the basis of risks to her health posed by vaginal delivery, a planned caesarean section (including reasonable restraint) took place the following day. The judgment raises issues around judicial transparency; the (poor) participation of Ms Pacchieri in decisions about her care; and the potential to manipulate the best interests test to ensure maternal compliance.¹⁸²

Is the theory right? Or ought the fetus at the point of birth to be more highly valued? The difficulty of using law to enforce a duty to the fetus is well illustrated in Re F (In Utero),¹⁸³ where a local authority unsuccessfully tried to make a fetus a ward of court. The mother was a 36-year-old woman who suffered from severe mental disturbance, but she was not ‘sectionable’ under the Mental Health Act 1983. She refused antenatal care and had disappeared by the time the local authority started proceedings to make the fetus a ward of court. There was concern for the child’s welfare. Refusing to extend the wardship jurisdiction to unborn children, the court advanced the following reasons for their decision.

(1)  In English law the fetus has no legal personality until it is born, and has an existence independent of the mother.

(2)  To extend the wardship jurisdiction to the fetus with its predominant principle that the interests of the ward are paramount would create inevitable conflict between the existing legal interests of the mother and her child. Is the mother to be ‘sacrificed’ for the child?

(3)  There are immense practical difficulties in enforcing any order against the mother. If she is, for example, refusing to consent to an elective caesarean and is not already in hospital, will the police be called on to go and arrest her?

(4)  There would be problems with the limit of such a jurisdiction. Mothers can do most harm to their unborn children early in pregnancy by, for example, alcohol and drug abuse. Yet up to twenty-four weeks in pregnancy a mother may well be able to obtain a legal abortion. Would a woman who wants her baby be subject to coercive measures in the baby’s interests, yet free to destroy it should she change her mind? May LJ concluded that in the light of these problems any such radical extension of the wardship jurisdiction was a matter for Parliament and not for the courts themselves. In the event, and unbeknownst to the court, while they were hearing the action the mother had already safely given birth to a healthy child.

Parliament should reject any proposal to extend the wardship jurisdiction to unborn children or to endorse non-consensual obstetric interventions.¹⁸⁴ Over and above the reasons given by the Court of Appeal, such a proposal should be thrown out on the grounds of the damage it would do to antenatal care generally. Obstetricians, knowing that they could in the end coerce their patients, would become less willing to inform and persuade, to rely on patience rather than compulsion. Women, knowing that they could be forced against their will to submit to blood transfusion or surgery may opt out of formal obstetric care and far more babies could be born damaged as a result. The law must continue to recognise the pregnant woman’s autonomy and her sovereignty over her own body. In no other circumstances can one person be required to submit to any medical procedure to benefit another’s welfare. Once a child is born, neither of his parents could be forced to donate even a drop of blood to him however trivial the discomfort to them or great the child’s need. Caesarean surgery remains major invasive surgery with significant risks and pain for the patient.¹⁸⁵

¹  [2015] UKSC 11.

²  [2003] UKHL 52.

³  Ibid, [123].

⁴  [1999] 4 All ER 961, HL. Discussed at 11.12.

⁵  For attitudes in days gone by see Lord Denning in Bravery v Bravery [1954] 3 All ER 59, pp 67–8.

⁶  R (on the application of SPUC) v Secretary of State for Health [2002] 2 FLR 146.

⁷  For an overview of the efficacy of contraceptives, see: J-J Amy, V Tripathi, ‘Contraceptives for Women – An Evidence Based Overview’ (2009) 339 BMJ 1136. A list of contraceptive methods is available at Faculty of Sexual and Reproductive Healthcare for Royal College of Obstetricians & Gynaecologists – Clinical Guidance. Accessible at: www.fsrh.org/pages/Clinical_Guidance_2.asp

⁸  For example, making a 20 cm incision to perform a hysterectomy when a 15 cm incision was appropriate constituted negligence: Brown v Scarborough and North East Yorkshire Healthcare NHS Trust [2009] EWHC 3103 (QB).

⁹  See NICE, Guideline PH51: Contraceptive Services with a Focus on Young People up to the Age of 25 (2014).

¹⁰  See at 10.14.

¹¹  When Depo-Provera and Norplant (a slow release capsule injected into the arm) were first licensed in the USA, they were used as sentencing alternatives as a pregnancy restriction for drug and alcohol addicts and child abusers, though most cases were overturned on appeal. See J Mertus, S Heller, ‘Norplant Meets the New Eugenicists: The Impermissibility of Coerced Contraception’ (1992) 11 St Louis University Public Law Review 359.

¹²  See the (1983) Guardian, 23 July, p 4.

¹³  See for example A Local Authority v A [2010] EWHC 1549 (Fam), discussed at 6.4.

¹⁴  [1997] 4 All ER 771.

¹⁵  [1999] PIQR P 53; see 5.10.

¹⁶  [2015] UKSC 11, at [87] per Lord Kerr and Lord Reed: ‘An adult person of sound mind is entitled to decide which, if any, of the available forms of treatment to undergo, and her consent must be obtained before treatment interfering with her bodily integrity is undertaken. The doctor is therefore under a duty to take reasonable care to ensure that the patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments. The test of materiality is whether, in the circumstances of the particular case, a reasonable person in the patient’s position would be likely to attach significance to the risk, or the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it’.

¹⁷  But see Vadera v Shaw ((1999) 45 BMLR 172, CA. Discussed in R Goldberg, ‘The Contraceptive Pill Negligence and Causation: Views on Vadera v Shaw’ (2001) 8(3) Medical Law Review 316.

¹⁸  See McFarlane v Tayside Health Board [1999] 4 All ER 961, HL.

¹⁹  [2000] Lloyd’s Law Reports 280. See 10.5.

²⁰  See also NICE, Guideline CG30: Long-Acting Reversible Contraception (2005, updated 2014).

²¹  Amid fierce criticism, Barbara Harris reportedly attempted to extend her ‘Project Prevention’ (see www.projectprevention.org) to English cities. The project (inter alia) offers money to drug addicts willing to undergo sterilisation, in the hope of reducing the number of babies born with drug withdrawal symptoms. See J Doward, ‘Anti-Drugs Campaigner Barbara Harris Brings Crusade to Sterilise Addicts to UK’ (2010) The Observer 30 May.

²²  [1980] 7 Current Law 44.

²³  Wells v Surrey Area Health Authority (1978) The Times, 29 July.

²⁴  [1984] 2 All ER 513.

²⁵  [1986] 1 All ER 497, and see Eyre v Measday [1986] 1 All ER 488.

²⁶  See M Puxon, A Buchan, ‘Damages for Sterility’ (1988) 138 New Law Journal 80.

²⁷  See further 6.6–6.7.

²⁸  [1989] 2 All ER 545, HL.

²⁹  See Re DD (No 4) (Sterilisation) [2015] EWCOP 4, [8] per Cobb J: ‘This case is not about eugenics. This outcome has been driven by the bleak yet undisputed evidence that a further pregnancy would be a significantly life-threatening event for DD’. And see [114].

³⁰  To do so may breach Articles 3 and 8 of the ECHR: see VC v Slovakia (2014) 59 EHRR 29 on forced sterilisation of a Roma woman.

³¹  The Mental Capacity Act 2005 applies largely to persons of age 16 and over who lack capacity (see s 2(5)). For those aged under 16 who lack competence, persons with parental responsibility can consent on their behalf in their best interests. Disputes are resolved under the Children Act 1989; the Mental Health Act 1983 or under the jurisdiction of the High Court. In the case of young persons between the ages of 16 and 18, there is overlap between the Mental Capacity Act 2005 and the Children Act 1989.

³²  Mental Capacity Act 2005 Code of Practice, updated 2014.

³³  [1989] 2 All ER 545, HL.

³⁴  Mental Capacity Act 2005, s 2(1).

³⁵  Section 1(5). See also section 4 which lists factors relevant to the determination of an individual’s best interests. See 6.9.

³⁶  [2010] EWHC 1217 (Fam).

³⁷  [2015] EWCOP 4, discussed at 6.9.

³⁸  Ibid, [8], per Cobb J. This was the 5th COP judgment concerning DD. See [2014] EWCOP 8; [2014] EWCOP 11; [2014] EWCOP 13; [2014] EWCOP 44; the administration of short-term contraception pending the 2015 hearing (December 2014).

³⁹  Ibid, [6].

⁴⁰  Mental Capacity Act 2005, s 1(6). There is evidence that, even before the Act came into force, judges were already endorsing this principle: Re S (Medical Treatment: Adult Sterilisation) [1998] 1 FLR 944.

⁴¹  [2013] EWCOP 242.

⁴²  Ibid, [33] per Cobb J.

⁴³  [2013] EWHC 2562 (Fam).

⁴⁴  [2010] EWHC 1549 (Fam).

⁴⁵  Ibid, [75].

⁴⁶  Mental Capacity Act 2005 Code of Practice, 2014, para 8.18.

⁴⁷  Ibid, para 6.35.

⁴⁸  The thalidomide tragedy highlighted the vulnerability of the developing fetus. See above 10.1.

⁴⁹  S v Distillers Co [1970] 1 WLR 114.

⁵⁰  Corby Group Litigation v Corby DC [2009] EWHC 1944 (TCC). The contamination was also found to constitute a public nuisance.

⁵¹  An out-of-court settlement was reached in 2010: S Adams, ‘Council to Pay out Millions to Birth Defect Children’ (2010) The Telegraph 17 April.

⁵²  Another example is Multiple Claimants v Sanifo-Synthelabo [2007] EWHC 1860 (QB); [2009] EWHC 95 (QB), discussed at 11.8.

⁵³  On the difficulties in proving causation of birth defects, see the Report of the Royal Commission on Civil Liability and Personal Injury (Pearson Report) Cmnd 7054 (1978), paras 1441–1452.

⁵⁴  Under s 2, she is liable for injuries caused through negligent driving of a vehicle on the road.

⁵⁵  Where the child is not born alive, the mother may be able to claim for the pain and suffering of miscarriage or stillbirth.

⁵⁶  (1986) The Times, 26 July. The hospital conceded liability.

⁵⁷  See 10.3.

⁵⁸  Preliminary hearings include [2007] EWHC 1860 (QB); [2009] EWHC 95 (QB).

⁵⁹  [1997] 4 All ER 771.

⁶⁰  For a more comprehensive account of antenatal screening and genetic counselling, see JK Mason, GT Laurie, Mason and McCall Smith’s Law and Medical Ethics (9th edn, 2013) Oxford University Press, ch 7.

⁶¹  See Royal College of Obstetricians and Gynaecologists, Amniocentesis and Chorionic Villus Sampling, 2010.

⁶²  For example, in P v Leeds Teaching Hospital NHS Trust [2004] EWHC 1392, a routine scan revealed a fetal bladder anomaly. P was referred for a specialist scan and was told that the fetus had a minor, correctable condition. On birth, P’s son had a major bladder and bowel deformity. P was awarded damages due to the high standard owed by the specialist on the basis that P would, on the balance of probabilities, have opted for a termination has she known the real extent of her son’s condition.

⁶³  Though the duty does not necessarily extend to ensuring that the patient understands the advice: see Al Hamwi v Johnston [2005] EWHC 206. The decision is criticised, in J Miola, ‘Autonomy Rued OK’ (2006) 14(1) Medical Law Review 108.

⁶⁴  No 33011/08 ECHR (2014).

⁶⁵  See, for example, Farraj v King’s Healthcare NHS Trust [2006] EWHC 1228 [2008] EWHC 2468, discussed at 11.12.

⁶⁶  [1982] 2 All ER 771.

⁶⁷  It has been argued that the Act does not apply to a ‘wrongful life’ claim. The Act provides a scheme to compensate for disability inflicted by human error, not to a claim for allowing a disabled fetus to be born at all. See J Fortin ‘Is the “Wrongful Life” Action Really Dead?’ [1987] Journal of Social Welfare Law 306.

⁶⁸  [1982] 2 All ER 771, at 782, 787 and 790.

⁶⁹  Ibid, at 787.

⁷⁰  Ibid, at 781.

⁷¹  R Scott, ‘Reconsidering “Wrongful Life” in England after Thirty Years: Legislative Mistakes and Unjustifiable Anomalies’ (2013) 72(1) Cambridge Law Journal 115.

⁷²  See JK Mason, The Troubled Pregnancy: Legal Rights and Wrongs in Reproduction (2007) Cambridge University Press.

⁷³  [1983] 2 All ER 522.

⁷⁴  See Emeh v Kensington & Chelsea Health Authority [1984] 3 All ER 1044, CA; Thake v Maurice [1986] 1 All ER 479, CA.

⁷⁵  [1999] 4 All ER 961, HL. See also Greenfield v Irwin (A Firm) [2001] 1 FLR 899.

⁷⁶  Se JK Mason, ‘Unwanted Pregnancy: A Case of Retroversion?’ (2000) 4 Edinburgh Law Journal 191; J Weir ‘The Unwanted Child’ (2000) 59 Cambridge Law Journal 238; L Hogano, ‘Misconceptions about Wrongful Conception’ (2002) 65 Modern Law Review 883; Mason, The Troubled Pregnancy, ch 4; N Priaulx, The Harm Paradox: Tort Law and the Unwanted Child in an Era of Choice (2007) Routledge-Cavendish.

⁷⁷  Lord Millett dissented on this point.

⁷⁸  And for commentary on a related Irish High Court case: see C Craven, ‘Recoverability of Damages for Pregnancy and Children: Variations on the Theme of Byrne v Ryan’ (2008) 3(1) Quarterly Review of Tort Law 8.

⁷⁹  [1999] 4 All ER 961, at 978, HL.

⁸⁰  Ibid.

⁸¹  Ibid.

⁸²  Ibid, at 998.

⁸³  Ibid.

⁸⁴  Ibid.

⁸⁵  Ibid, at 1005.

⁸⁶  In Mrs A v East Kent Hospitals University NHS Foundation Trust [2015] EWHC 1038 (QB), Mrs A sought damages for costs suffered when her baby was born with a chromosomal abnormality. She alleged that she would, if aware of the risk, have had amniocentesis and terminated the pregnancy. Dingemans J recognised a ‘background risk’ that Mrs A’s baby would be born with a chromosomal abnormality but this was not ‘a risk to which a reasonable patient … would have attached any significance’ [101]. Furthermore, Dingemans J did not accept that awareness of the risk would have led to Mrs A having amniocentesis which is itself a risky procedure that can lead to disability. Nor did the judge accept that amniocentesis would have led her to terminate the pregnancy.

⁸⁷  F Trindade, P Cane, The Law of Torts in Australia (2nd edn, 1993) Oxford University Press, p 434.

⁸⁸  [1999] 4 All ER 961, at 978.

⁸⁹  On the potential relevance of Article 8 in wrongful birth claims, see Costa and Pavan v Italy No 54270/10, ECHR (28 August 2012); and MP and others v Romania No 39974/10, ECHR (15 April 2014).

⁹⁰  [2001] Lloyds Rep Med 309, CA.

⁹¹  As in Hardman v Amin [2000] Lloyds Rep Med 498.

⁹²  [2001] EWCA Civ 530, [50]; and see Hale LJ, [82].

⁹³  Note Hale LJ’s analysis of the nature of the loss and injury. Are the costs consequent on the birth of an unplanned child, disabled or not, truly pure economic loss?

⁹⁴  The Australian High Court rejected McFarlane in Cattanach v Melchior [2003] HCA 38. Queensland and New South Wales have legislated to counteract the effects of this case. For analysis, see Mason, The Troubled Pregnancy, p 125.

⁹⁵  For guidance on what constitutes ‘disability’, see [2001] EWCA Civ 530, [91], per Hale LJ.

⁹⁶  Salih v Enfield Health Authority [1991] All ER 400 (though note that, if the parents would in any case have gone on to have a healthy child, the damage would be restricted to the costs incurred by the child’s disability).

⁹⁷  Rand v East Dorset HA [2000] Lloyd’s Rep Med 181; and see Anderson v Forth Valley Health Board (1997) 44 BMLR 108 (Scotland).

⁹⁸  Parliament, NHS: Negligence: Written question – 208750 (9 September 2014). There were a further 83 unsuccessful claims. And see NHSLA, Ten Years of Maternity Claims: An Analysis of NHS Litigation Authority Data (2012), including an analysis of wrongful life claims made on the basis of alleged negligence in antenatal screening.

⁹⁹  Nunnerley v Warrington Health Authority [2000] Lloyd’s Rep Med 170; and see R Glancy, ‘Damages for Wrongful Birth: Where Do They End?’ (2006) 3 Journal of Personal Injury Law 271–279.

¹⁰⁰  [1999] 4 All ER 961, at 1003, HL.

¹⁰¹  Parkinson v St James and Seacroft NHS Hospital Trust [2001] Lloyd’s Rep Med 309, at 325, CA. It should be noted Hale LJ seems less than convinced of Lord Millett’s general reasoning that the joys of a healthy child outweigh the costs. And see Hardman v Amin [2000] Lloyds Rep Med 498. Mason and Laurie, Law and Medical Ethics (9th edn, 2013) OUP, 10.27 argue that Lady Hale’s opinion, which is based on bodily integrity, can be applied equally to the disabled and healthy child. ‘The feeling remains that one or other decision [McFarlane or Parkinson] must be wrong’.

¹⁰²  [2002] 2 All ER 177.

¹⁰³  Note the difference in reasoning between Hale and Robert Walker LJJ. Consider whether poverty is a ‘disability’ deserving at least some compensation for an un-planned child. Waller LJ dissented, comparing a hypothetical woman driven to ‘crisis in health terms’ by the birth of a fifth child following a negligent sterilisation, with a similar crisis on the part of a disabled parent. For both, the recovery of the costs of caring for the healthy child might alleviate the crisis. Why should the law treat the two differently?

¹⁰⁴  [2003] UKHL 53.

¹⁰⁵  Note that no damages for loss of autonomy are awarded under Rees if the child is not born alive: See Less and Carter v Hussain [2012] EWHC 3513.

¹⁰⁶  But see V Chico, ‘Wrongful Conception: Policy, Inconsistency and the Conventional Award’ (2007) 8 Medical Law International 139.

¹⁰⁷  A Maclean, ‘An Alexandrian Approach to the Knotty Problem of Wrongful Pregnancy: Rees v Darlington Memorial Trust in the House of Lords’ [2004] 3 Web Journal of Current Legal Issues. And see P Cane, ‘Another Failed Sterilisation’ (2004) 120 Law Quarterly Review 181.

¹⁰⁸  E Jackson, Medical Law: Text, Cases and Materials, p 747.

¹⁰⁹  Per Lord Steyn (dissenting) Rees v Darlington Memorial Hospital NHS Trust [2003] UKHL 52, [43]. See also Lord Hope’s Judgment. Note that the decision in Rees is referred to in the landmark decision Montgomery v Lanarkshire [2015] UKSC 11, [108], per Lady Hale who went on to say: ‘[T]he interest which the law of negligence protects is a person’s interest in their own physical and psychiatric integrity, an important feature of which is their autonomy, their freedom to decide what shall and shall not be done with their body’.

¹¹⁰  Note that the Rees decision has since been cited by the Supreme Court to justify a conventional award of damages serving a vindicatory purpose: see Lumba (WL) v Secretary of State for the Home Department [2011] UKSC 12, [179–180], [216–217], [236–237].

¹¹¹  [2003] UKHL 53, [96].

¹¹²  Ibid, [9].

¹¹³  See A Maclean, [2004] 3 Web Journal of Current Legal Issues: ‘Unless one is prepared to argue that having a disabled child is not – as a matter of policy – a blessing, which might be interpreted as devaluing the disabled, then the calculation is no more possible for the birth of a disabled child than it is for the birth of a healthy child … [I]f x cannot be balanced against y then nor can x be balanced against y + x’.

¹¹⁴  [2008] EWHC 2468 (QB) Cross-appeal dismissal: see 8.6. See also Scottish case: JS v Lothian Health Board [2009] CSOH 97.

¹¹⁵  Including injury caused by infertility treatment: see Congenital Diasbilities (Civil Liability) Act 1976, s 1A, as amended by the Human Fertilisation and Emrbyology Act 1990, s 44(1).

¹¹⁶  See American cases: Yeager v Bloomington Obstetrics and Gynaecology, Inc 585 NW2d 696 (Ind, 1992); Lazenvnick v General Hospital of Munro City Inc F Supp 146 (Md, 1980).

¹¹⁷  McKay v Essex Area Health Authority [1982] 2 All ER 771.

¹¹⁸  See Parkinson v St James and Seacroft University Hospital NHS Trust [2001] EWCA Civ 530, CA; Hardman v Amin [2000] Lloyd’s Rep Med 458; Enright v Blackpool Victoria Hospital NHS Trust [2003] EWHC 100 (QB); Farraj v King’s Healthcare NHS Trust [2006] EWHC 1228; FP v Taunton and Somerset NHS Trust [2009] EWHC 1965 (QB) (interim payment) with an additional award in [2011] EWHC 3380 (QB).

¹¹⁹  See for example Constable v Salford and Trafford HA and Kerr [2005] EWHC 2967 (QB) where a failure to retest a women for Chlamydia which allegedly caused her son to be born prematurely, was not shown to have caused or materially contributed to his prematurity.

¹²⁰  See Anderson v Forth Valley Health Board (1998) 44 BMLR 108.

¹²¹  McKay v Essex Area Health Authority [1982] 2 All ER 771.

¹²²  [1982] 2 All ER 771, at 787.

¹²³  (1983) The Times, 3 January.

¹²⁴  McFarlane v Tayside Health Board [1999] 4 All ER 961, HL.

¹²⁵  [1984] 3 All ER 1044.

¹²⁶  Ibid, at 1048.

¹²⁷  Ibid, at 1053.

¹²⁸  [1999] 4 All ER 961, at 970, HL.

¹²⁹  Ibid, at 976.

¹³⁰  Ibid, at 1004.

¹³¹  St George’s Healthcare NHS Trust v S [1998] 3 All ER 673, CA.

¹³²  See at 11.7.

¹³³  Discussed fully in P Pace, ‘Civil Liability for Pre-Natal Injuries’ (1977) 40 Modern Law Review 193.

¹³⁴  See M Brazier, ‘Parental Responsibilities, Foetal Welfare and Children’s Health’ in C Bridge (ed) Family Law: Towards the Millennium (1997) Butterworths, p 263.

¹³⁵  See SAM McLean, Old Law, New Medicine (1999) Pandora Press, p 66.

¹³⁶  See E Cave, The Mother of All Crimes (2004) Ashgate.

¹³⁷  [1997] 3 All ER 936. See S Fovargue, J Miola, ‘Policing Pregnancy: Implications of the Attorney-General’s Reference (No 3 of 1994) (1998) 6 Medical Law Review 265 and Cave, The Mother of All Crimes.

¹³⁸  [1996] 2 All ER 10, CA; discussed in M Seneviratne, ‘Pre-Natal Injury and Transferred Malice: The Invented Other’ (1996) 59 Modern Law Review 884.

¹³⁹  R v West (1848) 175 ER 329; R v Senior (1832) 168 ER 1298.

¹⁴⁰  [1997] 3 All ER 936, at 949 per Lord Mustill.

¹⁴¹  Ibid, at 942.

¹⁴²  And see C Stanton, ‘Maternal Transmission of HIV Infection: A Crime against My Child?’ (2015) 41(5) Journal of Medical Ethics 375.

¹⁴³  [2014] EWCA Civ 1554. Permission to appeal to the Supreme Court was refused. For commentary, see E Cave, C Stanton, ‘Maternal Responsibility to the Child Not Yet Born’ in C Stanton, S Devaney, A-M Farrell, A Mullock (eds) Pioneering Healthcare Law: Essays in Honour of Margaret Brazier (Routledge, forthcoming, 2016); N Priaulx, ‘Pre(natal) Crime: Pregnant Women, Substance Abuse and the Law’ (2015) 83(1) Medico-Legal Journal 43.

¹⁴⁴  M Brazier, ‘Liberty, Responsibility, Maternity’ (1999) 52(1) Current Legal Problems 359.

¹⁴⁵  See Fovargue and Miola [1998] 6 Medical Law Review 265; M Brazier ‘Parental Responsibilities, Foetal Welfare and Children’s Health’ in C Bridge (ed) Family Law: Towards the Millennium (1997) Butterworths; Cave, The Mother of All Crimes (2004) Ashgate; M Brazier ‘Liberty Responsibility and Maternity’ (1999) 52 Current Legal Problems 359.

¹⁴⁶  [2007] EWCA Crim 2789. See A Ashworth, ‘Infanticide’ (2008) Criminal Law Review 388.

¹⁴⁷  Infanticide Act 1938, s 1(1) prior to amendment.

¹⁴⁸  G was deceased and her parents appealed on her behalf.

¹⁴⁹  See Law Commission, Murder, Manslaughter and Infanticide No 304 (2006); and Ministry of Justice, Murder, Manslaughter and Infanticide: Proposals for Reform of the Law (2008).

¹⁵⁰  Which came into force October 2010. See A Samuels, ‘The Coroners and Justice Act 2009’ (2010) 174(17) Criminal Law and Justice Weekly 250.

¹⁵¹  Infanticide Act 1938, s 1(1), as amended: Where a woman by any willful act or omission causes the death of her child being a child under the age of twelve months, but at the time of the act or omission the balance of her mind was disturbed by reason of her not having fully recovered from the effect of giving birth to the child or by reason of the effect of lactation consequent upon the birth of the child, then, if the circumstances were such that but for this Act the offence would have amounted to murder or manslaughter, she shall be guilty of felony, to wit of infanticide, and may for such offence be dealt with and punished as if she had been guilty of the offence of manslaughter of the child.

¹⁵²  See J Jomeen, ‘Choice in Childbirth – A Realistic Expectation?’ (2007) 15(8) BMJ 485 and see guidance from Royal College of Obstetrics and Gynaecology, Obtaining Valid Consent (2015).

¹⁵³  A Alghrani, ‘Regulating the Reproductive Revolution: Ectogenesis – A Regulatory Minefield’ in M Freeman (ed) Law and Bioethics: Current Legal Issues (2008), vol 11, Oxford University Press, pp 303–329; A Smajdor, ‘In Defense of Ectogenesis’ (2012) 21(1) Cambridge Quarterly of Healthcare Ethics 90.

¹⁵⁴  [2015] UKSC 11. See 5.12.

¹⁵⁵  Nurses, Midwives and Health Visitors Act 1997, s16. An exception is made for emergencies to protect family, policemen and ambulance crew from liability for helping in emergencies.

¹⁵⁶  For further discussion of this case, see Finch (1982) 132 New Law Journal 995.

¹⁵⁷  See Attorney-General’s Reference (No3 of 1994) [1997] 3 All ER 936 discussed at 11.18 above.

¹⁵⁸  R v Senior (1832) 1 Mood CC 346; and see R v Bateman (1925) 19 Cr App R 8.

¹⁵⁹  See Finch (1982) 132 New Law Journal 995, at 995–996.

¹⁶⁰  Though see the contrary view expressed by Eekelaar and Dingwall (1984) Journal of Social Welfare Law 258.

¹⁶¹  Re MB (An Adult) (Medical Treatment) [1997] 2 FCR 541, CA.

¹⁶²  See 6.14.

¹⁶³  Kralj v McGrath [1986] 1 All ER 54.

¹⁶⁴  NHSLA, Factsheet 3: Information on Claims (2014). And see NHSLA, Ten Years of Maternity Claims: An Analysis of NHS Litigation Authority Data (2012).

¹⁶⁵  CMO, Making Amends – Clinical Negligence Reform, 2003, rec 2. However, there are, at present, no plans to take this recommendation forward.

¹⁶⁶  Eekelaar and Dingwall (1984) Journal of Social Welfare Law 258, p 265.

¹⁶⁷  Congenital Disabilities (Civil Liability) Act 1976, s 1(2).

¹⁶⁸  Eekelaar and Dingwall (1984), p 265.

¹⁶⁹  [1998] 3 All ER 673.

¹⁷⁰  Ibid, at 692.

¹⁷¹  [1992] 4 All ER 671.

¹⁷²  Rochdale Healthcare NHS Trust v C [1997] 1 FCC 274; Norfolk and Norwich (NHS) Trust v W [1996] 2 FLR 613; Re L (An Adult: Non Consensual Treatment) [1997] 1 FCR 609; Tameside & Glossop Acute Services Trust v CS [1996] 1 FLRC 762.

¹⁷³  [1997] 2 FLR 426.

¹⁷⁴  DH, Reference Guide to Consent for Examination or Treatment (2nd edn, 2009), ch 1, para 44.

¹⁷⁵  See Bolton Hospitals NHS Trust v O [2003] 1 FLR 824.

¹⁷⁶  Note that the DH, Reference Guide to Consent for Examination or Treatment (2009), ch 1, para 46 which recognises that withdrawal of consent during a procedure may be non-capacitous (and therefore not valid) if brought on by ‘pain, panic and shock’. And see Connolly v Croydon Health Service NHS Trust [2015] EWHC 1339 (QB), discussed at 5.1, where a claimant consented to angiogram which, due to complications, led to a (probably life-sustaining) angioplasty. C’s claim to have withdrawn consent during the procedure was rejected on the basis that she lacked capacity.

¹⁷⁷  See Chapter 6.

¹⁷⁸  Mental Capacity Act 2005, s 2(3)(b).

¹⁷⁹  Mental Capacity Act 2005 Code of Practice, updated 2014, para 4.12.

¹⁸⁰  There have been a number of recent cases where the Court of Protection has authorised caesarean sections operations and use of proportionate force for women with mental disorders. See, for example, In the Matter of P [2013] EWCOP 4581; Great Western Hospitals NHS Foundation Trust v AA & Ors [2014] EWHC 132 (Fam); Royal Free NHS Foundation Trust v AB [2014] EWCOP 50; The Mental Health Trust & Anor v DD [2014] EWCOP 11. And see discussion: S Fovargue, J Miola, ‘Are We Still “Policing Pregnancy”?’ in Stanton et al, Pioneering Healthcare Law, ch 21.

¹⁸¹  [2012] EWHC 4378 (COP).

¹⁸²  See E Walmsley, ‘Mamma Mia! Serious Shortcomings with Another “(En)forced” Caesarean Section Case: Re AA [2012] EWHC 4378 (COP) (2014)’ 23(1) Medical Law Review 135, at 140: ‘Re AA gives the impression that since the patient’s best interests were supposedly crucial whilst the fetus was in utero, but not after the birth, the “best interests” framework is a tool for maternal compliance with recommended medical treatment’.

¹⁸³  [1989] 2 All ER 193.

¹⁸⁴  As the Royal College of Obstetricians and Gynaecologists itself has done; see RCOG, Law and Ethics in Relation to Court-Ordered Obstetric Intervention (2006). And see RCOG, Obtaining Valid Consent (2015).

¹⁸⁵  See L Miller, ‘Two Patients or One? A Problem of Consent in Obstetrics’ (1993) Medical Law International 97.

Chapter 12

ASSISTED CONCEPTION

¹

12.1 About one in seven couples have difficulty conceiving naturally.² The birth of the first ‘test-tube’ baby, Louise Brown,³ in 1978 gave hope to many childless couples. Since then, the pace of development in the reproductive technologies has been relentless. Reproductive medicine no longer focuses exclusively on the management of infertility. Single women can be assisted to have a child without resort to sexual intercourse. Same sex couples can be helped to have a child. Couples, who are fertile, but know that they, or one of them, is a carrier of a genetic disease can be helped to have a healthy child, by way of preimplantation genetic diagnosis (PGD) whereby embryos are screened to avoid implanting any embryos with the defective gene. Couples who already have one sick child can seek PGD together with tissue typing, to attempt to create a ‘saviour sibling’ for their sick child. Each and every development in the reproductive technologies attracts controversy. For everyone who rejoices at what doctors can now do, there are those who condemn the advances in medicine as unnatural, contrary to the will of God, or destructive of ‘normal family life’.

Louise Brown’s birth did not only generate moral controversy. Concerns arose about the safety of the ‘new’ technologies. Fears grew about the competence of practitioners and basic issues, such as hygienic storage of human gametes.⁴ In response, the government established a committee under Dame Mary Warnock (now Baroness Warnock) which reported in 1984 and recommended legislation to regulate these emerging reproductive technologies.⁵ Parliament eventually enacted the Human Fertilisation and Embryology Act 1990.⁶ That Act entrusted the primary responsibility for regulating the reproductive technologies in the United Kingdom to the Human Fertilisation and Embryology Authority (HFEA).

The 1990 Act and the HFEA were once seen as the model for effective regulation of assisted conception and embryo research but the 1990 Act, and the HFEA became the subject of increasingly intense criticism.⁷ It is scarcely surprising that a statute enacted in 1990 no longer met the needs of scientific developments, undreamed of twenty years before. The Act generated prolific litigation.⁸ The paternalist structure of regulation was perceived as outdated and incompatible with a human rights culture, especially section 13(5) of the Act requiring that consideration be given to a child’s ‘need for a father’. Liberal critics of the 1990 Act attacked it as insufficiently responsive to reproductive autonomy.⁹ Conservative critics charged that the Act permitted the degradation of human embryos and children, reducing them to mere means to an end.¹⁰ In 2005, the Department of Health launched a review of the 1990 Act¹¹ and a White Paper¹² proposing substantial reforms was published in December 2006. Some fertility specialists had argued that there was no longer any need for special regulation of reproductive medicine. This argument for deregulation was rejected by the government. Instead the 1990 Act was heavily amended by the Human Fertilisation and Embryology Act 2008 and that Act also introduced new rules relating to parenthood, allowing female same sex couples to achieve the status of legal parents when they seek fertility treatment together. The amended 1990 Act and the self-standing parts of the 2008 Act continue to generate a flood of case law especially in the context of surrogacy, parental status and contact with children born as a result of assisted conception.

Regulating human fertilisation and embryology

12.2 The primary responsibility for regulating the reproductive technologies in the United Kingdom is vested in the Human Fertilisation and Embryology Authority (HFEA), operating as a statutory licensing authority, and established by section 5 of the Human Fertilisation and Embryology Act 1990. Schedule I of the Act prescribes the authority’s membership with a strong emphasis on a partnership between lay representation and expert input. Neither the chairman nor the deputy chairman may be a medical practitioner, or professionally involved in embryo research or assisted conception. At least one-third, but fewer than half, of the members must be persons so involved in research or infertility treatment.

The HFEA is granted impressive powers many focusing on the power to license clinics to undertake fertility treatments. Section 3 of the Act makes it a criminal offence to bring about the creation of an embryo outside the human body, or keep or use such an embryo,¹³ except in pursuance of a licence granted by the HFEA. Any infertility treatment requiring the creation of an embryo by means of in vitro fertilisation (IVF), that is, the creation of a ‘test-tube’ embryo, must be licensed. An embryo in vitro is defined to include embryos where the process of fertilisation started outside the woman’s body.¹⁴

Section 4 prohibits storage of gametes (sperm or eggs), and the use of donor sperm or eggs, without a licence from the HFEA. Any infertility treatment involving artificial insemination by donor (DI) or egg donation is unlawful unless licensed by the HFEA. There is a limited exception to the rule relating to sperm. DI can be undertaken outside a licensed clinic if the sperm is ‘partner-donated sperm which has neither been processed nor stored’.¹⁵ The amendments to the 1990 Act introduced much stricter controls on DI designed to control the growing number of ‘businesses’ offering both access to fresh donated sperm and ‘sperm sorting’, a crude form of primary sex selection. Often based on Internet sites, sperm was advertised to women who wanted a child but no relationship with a man. Given that the sperm was fresh and the sites were not based in any form of medical environment, health risks were high, as are the risks of later disputes about parentage of a resulting child.¹⁶ Any such enterprise must now be licensed in the new category of ‘non-medical fertility services’. In 2010 two men were convicted of supplying sperm from an unlicensed site.¹⁷ One question that arises is: does the new law effectively ban self-insemination in such cases as a lesbian woman asking a friend to donate sperm to her with which she inseminates herself, or a commissioning father providing sperm for self-insemination by a surrogate mother? A literal reading of the Act might suggest that it does, for in such cases the sperm is not partner donated. Mason and Laurie¹⁸ argue that the man providing sperm on the basis of a private agreement with a woman who is a friend or a potential surrogate falls outside the ban in section 4 as he is not ‘providing treatment services’. We tend to agree but wonder about the case of a man who widely advertises his own services as a sperm donor.¹⁹

Sections 3 and 4 outlaw a number of specific procedures, for example, keeping an embryo after the appearance of the primitive streak (fourteen days), placing an embryo in an animal and the use of embryos for reproductive cloning. One of the fiercest debates around the 2008 Act centred on the creation of human/animal hybrids. The Act permits a number of techniques in relation to research only and within strict limits. Those issues are dealt with further in the next chapter. One point must be made here. Only ‘permitted’ embryos and gametes may be placed in a woman in the course of fertility treatment.²⁰ Permitted gametes must have been produced or extracted from a human male or female and the nuclear or mitochondrial DNA of the gamete must not have been altered.²¹ Permitted embryos must be created from permitted gametes. No embryo created from the mixing of human and animal material may be used in fertility treatment. The Act however provided for Parliament to make regulations to amend the definitions of permitted embryos and eggs to allow for the licensing of treatment to prevent the transmission of serious mitochondrial disease,²² and this Parliament has now done.²³ We discuss this controversial development in the next chapter.

Licensing fertility treatment

12.3 Any clinic that offers IVF or artificial insemination (AI) is subject to the control of the HFEA. A clinic cannot operate lawfully without a licence and its staff and procedures are strictly monitored and controlled. Failure to comply with HFEA guidelines about, for example, safety procedures, numbers of embryos to be implanted,²⁴ selection of donors or assessment of patients may lead to forfeiture of that licence.

The 1990 Act only provided a basic framework of rules governing assisted conception in the UK. The Act entrusted to the HFEA extensive powers to fill in the details of those rules and to regulate both the ethical and practical problems of assisted conception. The HFEA has to operate within the framework set by Parliament, but many crucial decisions were left to them. So, the HFEA has had to consider – should ovarian tissue be harvested from fetuses, should sister-to-sister egg donation be banned, should egg sharing be permitted? And these were examples of the HFEA’s less contentious business. Developments in techniques of assisted conception continually posed novel problems for the HFEA. The controversy relating to PGD exposed the HFEA to attack on several fronts. Other ethical dilemmas facing the HFEA fade almost into insignificance in comparison with the debate surrounding human cloning. The HFEA found itself making policy in relation to deeply divisive social questions generated by the rapid developments in reproductive medicine. The rewards for its efforts were charges that the unelected Authority has usurped the role of Parliament.²⁵

Crucial to the role played by the HFEA is its Code of Practice setting out the general ‘rules’ within which clinics must work. Clinics that violate the Code may lose their licence.²⁶ The 8th edition of the Code was published in 2009 but is subject to a continuous process of revision and updating. Grand ethical issues have faced the HFEA. Their everyday difficulties are apparently more mundane. How often should gametes from one donor be used? The more often sperm from one donor is used, the higher the risk of unwitting incest. No single donor is to be used for more than ten inseminations.²⁷ The HFEA has long sought to reduce the number of multiple births resulting from IVF.²⁸ The more embryos replaced in the woman, the greater the risk of multiple pregnancies. Such pregnancies increase the risk of premature labour with adverse consequences for mother, babies and over stretched neonatal units within the NHS. The current guidance requires all clinics to aim to reduce any multiple births and to consider when it might be appropriate to move to Single Embryo Transplants. Some fertility specialists vehemently opposed what they saw as paternalistic interference with clinical freedom. If the woman considers that increased chances of pregnancy outweigh the risk of multiple pregnancy, those doctors argued that the number of embryos replaced is none of the HFEA’s business. An attempt to strike down this policy by way of judicial review failed.²⁹ In 2011 an emboldened HFEA made it a condition of clinics’ treatment and storage licences not to exceed the 10 per cent multiple birth rate target. This time judicial review sought by disgruntled clinics was successful.³⁰ They argued that the decision about how many embryos to implant is a medical one in which the individual circumstances of each patient should be considered.³¹ Patterson J held that the HFEA did not have the power to impose a licence condition before the appeals process initiated by the clinics had been completed. In 2014, the HFEA withdrew the maximum multiple birth rate condition from licences, but the target rate and policy stand.

Another dilemma for the HFEA relates to clinics with poor success rates. In 2013, live birth rates per cycle using fresh eggs averaged 37.1 per cent, an increase on the rate seen in 2011 (32.8 per cent).³² Small, less well-equipped centres achieve much less success. All clinics are regularly inspected. The HFEA publishes information enabling patients to know about the track record of each clinic. Ensuring patients receive information designed to help them to determine whether and where to seek treatment might seem uncontroversial. Alas for the HFEA, this is not the case. Clinics complain about the criteria used to grade them. It is claimed that some clinics turn away older women, or couples with complex fertility problems, to inflate their success rates.³³

The HFEA became a target for attack. The ethical decisions entrusted to it go to the heart of differences in our society and those who disagree with the HFEA may incline to perceive the Authority as remote and undemocratic. The role of the HFEA as an everyday regulator of fertility practice is sometimes overlooked. The HFEA received little credit for the job it did in ensuring ‘quality control’ of reproductive medicine at a time when in some other European countries assisted conception was wholly unregulated. British patients could be reasonably assured that they would be treated by competent practitioners and protected by standards enforced by the HFEA.³⁴ Some serious errors contributed to the HFEA coming under attack for incompetence. In one incident, evidence emerged that the sole embryologist who was working for two clinics had engaged in a range of malpractice. A number of frozen embryos had been allowed to thaw. The embryologist knew this, but did not disclose this disaster to his colleagues. Several women underwent procedures which they believed involved implanting ‘their’ embryos. In fact, no embryo was within the substances inserted in the women. The embryologist was convicted of assault as well as several charges of fraud.³⁵ Another mistake came to light in Leeds Teaching Hospital NHS Trust v A.³⁶ A white couple, Mr and Mrs A, were receiving IVF treatment. Mrs A gave birth to mixed-race twins. It emerged that failure to monitor the sperm used to create the embryos implanted in Mrs A led to the use of sperm from Mr B who was black. Mr and Mrs B were also undergoing treatment at the same clinic. Media reports suggest that implanting the wrong embryos after a ‘mix-up’ in the laboratory is not uncommon.³⁷ Failures in procedures have led to confusion over parental status.³⁸ Such errors are not directly attributable to the HFEA but in detracting from its reputation for quality control render the Authority more vulnerable to attack from those who dislike its ethical decisions.

In vitro fertilisation: opening Pandora’s box?

12.4 Before the birth of Louise Brown, doctors were limited in what they could offer couples who could not have a child. Women might be offered drugs to help them ovulate or undergo surgical investigations and procedures. Where the man was infertile, donor insemination (DI) had been practised for decades. IVF created a whole new range of possibilities for those who seek to have a child. IVF of itself provokes relatively few ethical³⁹ or legal dilemmas. The original context for resort to IVF related to women who ovulate normally, but whose fallopian tubes are absent or damaged, and so cannot conceive naturally because the eggs they produce cannot travel to meet sperm and be fertilised. Eggs are removed from the woman and fertilised in the laboratory with sperm taken from her husband, or partner or a donor. The embryo, or embryos, are carefully tested and implanted in the mother’s womb. IVF is now used in a number of other instances including cases of ‘unexplained infertility’. The woman ovulates, her fallopian tubes are clear and her partner provides healthy sperm, yet no pregnancy results. Male infertility may be addressed via IVF in that if the male partner produces very few, or poor quality sperm a single spermatozoon can be injected directly into an egg taken from the woman, embryos created and then implanted in the woman womb. Intra-cytoplasmic sperm injection (ICSI) now accounts for 52 per cent of IVF treatment despite concerns about safety.⁴⁰ No questions of family law normally arise from IVF where a couple use their own gametes. That child has the same relationship to her parents as if she were naturally conceived. The ability to fertilise eggs outside the woman opened Pandora’s box. No longer was it only sperm that could be donated, eggs could be too. As reproductive medicine developed, social attitudes changed. Individuals who were not infertile, single women and same sex couples sought treatment as did women past the normal age of childbearing. The difficult questions posed by IVF relate to whom should have access to ‘fertility’ treatment, how to define parenthood once donor gametes are used, to IVF and the many issues that arise from developments in IVF that allow selection of embryos.

Before looking at access to treatment we ask what happens even in a straightforward IVF if a mistake is made, and the woman’s eggs are inseminated by the ‘wrong’ sperm from someone else’s husband or partner, as occurred in Leeds Teaching Hospital NHS Trust v A.⁴¹ As we noted earlier, sperm from Mr B (intended for treatment of his wife, Mrs B) was in error used to fertilise eggs from Mrs A (who was undergoing treatment with her husband Mr A). The mistake became apparent only when Mrs A gave birth to mixed-race twins.⁴² Who was the twins’ father? Which couple should bring up the children? Section 28(2) of the 1990 Act deemed a husband to be the legal father of his wife’s child born as a result of sperm donation if he consented to her undergoing donor insemination. This was of no help to Mr A as he patently did not consent to donor insemination of his wife. Nothing in the 1990 Act assisted Mr A in his claim to become the legal father of his wife’s children. Mr B was their genetic father. Dame Elizabeth Butler-Sloss P held that, although he had not consented to the use of his sperm to fertilise Mrs A’s eggs, Mr B as the genetic father, should be treated as the legal father of the twins. Nonetheless, she ruled that Mr and Mrs A should retain ‘custody’ of the children. The twins should stay with the ‘parents’ who had settled them in a loving home. Mr A could apply for a parental responsibility order or the couple could apply to adopt the twins. At some point when they were older, their origins should be explained to them and contact with Mr B arranged. In this case and in many others where the complexity of the law and the actions of others leave a child’s status unclear, judges focus on the child⁴³ and its needs, sometimes resorting to imaginative interpretations of the law.

Access to fertility treatment: the welfare of the child

12.5 Women who have no male partner may want to have a child. They plan to raise the child alone or be part of a same sex couple wanting a family. During the passage of the first Human Fertilisation and Embryology Act, attempts were made in Parliament to outlaw fertility treatment, IVF or DI, for women without a male partner. A compromise was embodied in section 13(5) of the Act, which provided, apparently innocuously, that a licence holder treating a woman must take into account the welfare of any child who may be born as a result of treatment, including the need of that child for a father.⁴⁴ Section 13(5) was viewed by many commentators as outdated and unnecessary.⁴⁵ The House of Commons Select Committee on Science and Technology concluded that the requirement to consider the need for a father was ‘offensive to many’ and constituted ‘unjustified discrimination against unconventional families’.⁴⁶ The Select Committee went further and recommended abolition of the welfare principle. In the event the welfare principle survives in an amended form now requiring that clinics must still take account of the ‘welfare of any child who may be born as a result of the treatment (including the need of that child for supportive parenting) and of any other child who may be affected by its birth’. Section 13(5) as amended would seem to look more favourably on any couple seeking treatment, heterosexual or not, than a single woman. The HFEA Code of Practice that had long sought to attenuate the effect of the provision when it focused on the need for a father, now seeks to limit the impact of the current wording. Clinics must assess each patient individually and gauge whether ‘there is a risk of significant harm or neglect to any child’.⁴⁷ Clinics should operate on a presumption of providing treatment to those seeking help to conceive whether they be heterosexual couples, lesbian couples or single women. Only if there is evidence of risk of serious harm to a future child should treatment be refused. In considering the statutory need for supportive parenting, clinics should regard this as a commitment to the health and well-being of the child that all prospective parents may be presumed to have. The HFEA has de facto virtually eliminated the need to demonstrate any specific family structure before being granted access to fertility treatment. Lacking a partner is of itself no bar.

Access to fertility treatment: post-menopausal mothers

12.6 In the lead-up to the passage of the 2008 Act much of the debate on the welfare principle focused on its application to single and gay women. Another area of controversy concerns older women seeking treatment. Egg donation offers women the opportunity to extend their reproductive lives. The menopause no longer marks the end of a woman’s chance to bear a child. Eggs are collected from a donor and implanted in the post-menopausal woman whose womb has been restored to a pre-menopausal state by hormone treatment. Success rates are low, nonetheless, it is reported that an Indian woman has given birth at 70. In 2006, a British woman of 62 gave birth as a result of such treatment in Russia, and in Germany a woman of 65 had quadruplets.⁴⁸ The crux of the question should not be the post-menopausal state of the woman. Some women suffer a premature menopause in their twenties. Few argue that they should be denied help. The question is whether women over 50, or even 60 should be assisted to have a child. France prohibits treatment of women past the normal age of childbearing. Those opposed to treating older women focus on the child. If a woman gives birth at 62, she will be 80 before her child is legally an adult. It is more likely that her health may decline, or the child faces the death of his mother, than if she were 40. Given the HFEA Guidance, the crux of the question becomes, does the age of the mother pose ‘a risk of serious harm or neglect to the child’? Others point out that men fairly often beget children in their fifties and later. Is it discriminatory to prohibit helping women to do what nature permits men to do? Perhaps what we should ask is whether to create a child at an age when the chances are your ability to care for that child are diminishing is morally responsible for either men or women? Then we need to consider if it is ethical to assist another person to do something irresponsible.⁴⁹ The age of the partner may be a key factor. Many older fathers have younger wives. So would the risk assessment to the child be different if the prospective mother of 62 had a partner aged 45? And if the age of the mother is relevant to the welfare of the child, should it follow that treatment would be refused if the man’s age was such that he may well not be alive to nurture his child to adulthood? In R and S v T,⁵⁰ a British couple (both in their early sixties) sought a parental order in respect of twins born to a Ukrainian surrogate. Addressing briefly the welfare of the children, who by this stage were born and living with the couple, the judge noted that both parents seemed to be in good health and that the father’s niece had agreed to be the guardian of the children should the couple either die or become incapacitated. Given the reality of two infants settled in their home, the judge had little choice but to ensure that the legal status of the twins was secured, but should a couple who will both be over 80 before the children come of age embark on parenthood however much they may desire a child?

Access to treatment on the NHS

12.7 The liberal guidance from the HFEA, and in particular their advice that only a risk of significant harm or neglect to a potential child should ‘disqualify’ patients from receiving treatment, grants clinics a broad discretion about whom to treat. Private treatment costs a great deal of money and many prospective parents are unable to pay such sums, or nearly bankrupt themselves to do so. For them the real problem is not access to any clinic but access to treatment funded by the NHS. It has been argued that section 13(5) never made much difference in practice to the range of patients private clinics will treat.⁵¹ IVF treatment is largely provided in the private sector, with limited NHS facilities for those who cannot pay for treatment. NHS clinics had to make hard choices, choices that today fall to Clinical Commissioning Groups (CCGs). Practice in the past varied. Many clinics operated upper age limits as low as 35 for women. Courts were reluctant to interfere. Mrs Harriott was refused IVF because of a criminal record for prostitution offences and because she and her husband had been rejected as prospective adoptive or foster parents by Manchester social services department. The judge found that the grounds for regarding her to be an unsuitable parent were reasonable.⁵² Mrs Seale and her husband were refused NHS treatment because at 37 she was ‘too old’. The authority argued that 35 was a sensible cut-off point because the older the woman, the less the chances of establishing a successful pregnancy. Given a tight budget, the NHS should concentrate on treating women most likely to benefit from treatment. The judge agreed.⁵³

Decisions about who gets access to treatment on the NHS rest with those who fund NHS care, to CCGs. NICE currently recommends that women aged under 40 years who have not conceived after two years of regular unprotected intercourse or twelve cycles of artificial insemination are offered three full cycles of IVF.⁵⁴ Women aged 40–42 should generally be offered one cycle. CCGs may set additional conditions, such as childlessness or smoking cessation. By no means all CCGs comply with NICE guidance and some do not fund IVF at all. Waiting lists can be lengthy. Private fertility treatment remains the only viable option for many.

A right to reproduce?

12.8 Issues surrounding access to fertility treatment go beyond questions of funding. At the heart of the matter lies the intractable problem of whether individuals enjoy a right to reproduce, and just what such a right entails. Articles, 8, 12 and 14 all touch on this problem. The ECtHR in Evans⁵⁵ (discussed at 12.18) and Dickson⁵⁶ (discussed at 12.9) has acknowledged that Article 8 rights to private life are engaged in laws regulating reproductive medicine, and access to treatment. Article 12 speaks of a ‘right to marry and found a family’.⁵⁷ Article 14 prohibits unjustifiable discrimination, so a woman denied fertility treatment might argue that barriers to treatment discriminate against her just because she is infertile. The first difficulty of a rights-based argument in the context of fertility treatment is this. As Wall J noted in his first instance judgment in Evans:

The right to found a family through IVF can only, put at its highest, amount to a right to have IVF treatment. Self-evidently it cannot be a right to be treated successfully.⁵⁸

What would a right to procreate entail? Does it manifest a right to reproductive autonomy ie to reproductive choice? Would that include a right to abortion?⁵⁹ Is it a positive as well as a negative obligation?⁶⁰ The ECtHR seems at present to go little further than this. Article 8 is engaged in claims touching on reproduction and the right to respect for decisions ‘to become and not become a parent’.⁶¹ But any such claim must be weighed against the countervailing public interests in Article 8(2) and in the stormy waters of debates on reproduction the Court will allow states a more than generous margin of appreciation.⁶²

Access and prisoners

12.9 A particular issue of access arises in the context of couples where the man is serving a prison sentence. English law does not permit conjugal visits. If a couple wish to have a child while the male partner remains in prison, he has to be able to access the facilities to ‘donate’ sperm to his wife or partner. The Home Office placed substantial restrictions on any attempt to facilitate artificial insemination (AI) by prisoners and two prisoners refused permission to access AI challenged the Secretary of State contending that this violated their rights to family life (Article 8) and to found a family (Article 12). The first case failed in the Court of Appeal, the court holding that such restrictions were justifiable in the public interest under Article 8(2). The Court noted that the wife would in this case still be of childbearing age when her husband was eligible for parole.⁶³ Founding a family was merely delayed and not prevented. In the second case, Mrs Dickson would be past childbearing age before her husband would be free. Her husband’s challenge to the refusal of AI succeeded before the Grand Chamber of the ECtHR.⁶⁴ The UK government argued that as Mr and Mrs Dickson had married while he was in prison and had never lived together, the relationship had never been tested in a normal environment and there were concerns about the welfare of any child. Moreover, the public had a legitimate concern that the punitive element in the prison sentence would be circumvented by allowing him to father a child. The ECtHR was unimpressed. Mr Dickson’s conviction deprived him of some of his rights to private life, but rules made by the minister and not sanctioned by Parliament that effectively denied him and his wife any prospect of conception did not represent a fair balance between the public and private interests involved.

Gamete donation and parental status: meaning of ‘father’

12.10 The capacity to fertilise eggs outside the womb and the expansion of those who can access treatment has generated a host of legal questions many relating to gamete donation when IVF involves the use of donated gametes, for example where the woman cannot ovulate and/or her partner produces no sperm. If a woman is treated with donated eggs, who is the child’s legal mother? If a woman is treated with donated sperm who is the father? Where the man is infertile, couples have long had the opportunity to have a child using sperm from another man, by artificial insemination by donor (DI). In its most basic form, DI is so simple that it can be, and often is, performed without medical assistance. There are many instances when donor sperm will now be used in conjunction with IVF. In any such a case, who is the child’s legal father? Two sets of rules now operate. If the woman was treated using donor sperm before April 2009, section 28 of the 1990 Act still applies. If the couple were married, were treated in a licensed clinic and the husband fully and freely consented, section 28(2) deems the child to be the husband’s child⁶⁵ and gives the husband all the usual privileges of fatherhood, including an entitlement to contact with his child should the marriage break down.⁶⁶

Section 28(3) of the 1990 Act related to unmarried heterosexual couples who sought DI together because the male partner was infertile. Whenever donor sperm were used in the treatment of a woman and a man together by a person to whom a licence applies, the man was to be treated as the father of the child.⁶⁷ The intent of sections 28(2) and (3) was to bestow the legal rights and responsibilities of fatherhood on the social father, the man who seeks a child with his wife or partner. The apparent simplicity of these provisions about legal paternity is misleading. The notion of the couple treated together posed endless points of tricky interpretation. Evidence that at the time the mother received DI she was living with a male partner was not sufficient. The social father himself was unlikely to receive any treatment, though he would have undergone fertility tests at an earlier date.⁶⁸ Several legal cases ensued that are dealt with fully in the fourth edition of this work.⁶⁹ What was clear was the law was not satisfactory.⁷⁰

Sections 35 to 41 of the 2008 Act provide new rules on the meaning of ‘father’ whenever a woman is treated with donor sperm after April 2009. The position of a married couple has changed little. Section 35 provides that if a married woman is treated with donor sperm as part of IVF or simple DI, her husband will be the legal father of the child unless he did not consent to the use of donor sperm or DI. The section applies regardless of whether fresh or frozen sperm is used, whether the woman is treated in a licensed clinic or elsewhere or simply self-inseminates,⁷¹ and whether the woman is treated in the UK or abroad. The position is more complicated when a couple are unmarried. The ‘agreed fatherhood conditions’ in sections 36 and 37 apply. If the woman is treated in licensed clinic in the UK and no man is deemed to be the father by virtue of section 35, nor any female civil partner deemed to be parent by virtue of section 42, fatherhood is conferred by agreement. A man will be deemed to be the legal father of the child if he has given notice in writing to the clinic that he consents to be treated as the father and the woman has given notice in writing that she agrees that he shall be the father of her child, and neither party has withdrawn such consent.⁷² There does not seem to be any requirement as such that the man and the woman must be living together or be partners. So a single woman planning to bring her child up largely alone could, if she so wished and he agreed, nominate a friend to act as the child’s legal father. When sections 35 and 36 apply, the sperm donor need fear no parental responsibility to his genetic offspring for the husband or the agreed father and no other man is to be treated as the father. But we should note that if DI is conducted outside the UK, or outside a licensed clinic within the UK, and the woman is not married or a civil partner, the donor will remain the legal father of the child. So if X agrees to help out a friend and gives her sperm for her to self-inseminate, he remains as much the legal father of the child as if the child were conceived naturally.

Gamete donation: the meaning of ‘mother’⁷³

12.11 IVF created the possibility to treat women who do not ovulate, with donated eggs. A woman could have eggs implanted that were donated by another and fertilised with her husband or partner’s sperm enabling her to bear a child. Who is the child’s legal mother – the donor or the woman who gives birth? Section 27 of the 1990 Act applying to a woman treated before April 2009 and section 33 applying to women treated after that date both set out a simple rule, the woman who carries the child ‘as the result of the placing in her of an embryo or sperm and eggs; and no other woman’ is the legal mother. If a woman is treated with donor eggs the donor has no claim on or responsibility to the child. That also means that if a surrogate carries a child, even using eggs provided from the commissioning mother, it is the surrogate and not the woman who seeks to have the child via surrogacy who is in law the mother. Finally we must note that in the case of embryo transplant or ‘adoption’ the child may have no genetic link with either parent. If both are infertile an embryo may be created from donated sperm and eggs or a surplus embryo may be donated by another couple. The woman who carries the child will be the mother and the rules above will determine if her husband or partner is the legal father.

Gamete donation: same sex couples

12.12 The 1990 Act made no express provision for the growing number of cases where a same sex couple sought fertility treatment to have a child together.

One partner in a lesbian couple might seek DI or IVF with donated sperm with a view to bringing up the child with her partner. The partner would have no legal status in relation to the child unless she later sought to adopt her. The 2008 Act makes express provision for such couples. The provisions are modelled as closely as possible on those applying to heterosexual couples. Section 42 provides that when two women are in a civil partnership or marriage⁷⁴ and one becomes pregnant via IVF or DI, the other partner will be treated as parent of the child unless she did not consent to the treatment of her partner. Section 42 applies whether in the UK or abroad, and to self-insemination, as much as treatment in a licensed clinic. Sections 43 and 44 deal with lesbian couples not party to a civil partnership and provide that a second woman can be treated as a parent of the child by virtue of ‘agreed female parenthood conditions’. The prospective ‘second’ parent and the woman being treated must both give notice in writing that they consent to the second woman being treated as a parent of the child. The parenthood provisions only apply if the woman is treated in a licensed clinic in the UK.⁷⁵ As with heterosexual couples, when a second woman is treated as the other parent by virtue of the Act, the sperm donor has no legal relationship with his genetic child. If the couple are not in a civil partnership and perhaps ask a gay male friend to provide sperm for self-insemination, once again the ‘partner’ obtains no parental status and the sperm donor is in law the father of the child.

A number of problems have beset the provisions for female same sex parents. The complexity of the legislation and conditions which must be met in relation to consents, information, counselling and record keeping may mean that if the ‘parental relationship’ breaks down, the second parent may find herself deprived of the parental status that she thought that she had secured. In Re E and F (Children) (Assisted conception)⁷⁶ AB was a lesbian woman in a relationship with CD. They sought to have children together and CD underwent three cycles of donor insemination with CD becoming pregnant with twins as a result of the final cycle. The third cycle took place after the provisions of the Human Fertilisation and Embryology Act 2008 came into force allowing same sex couples to share legal parenthood. CD as the woman who gave birth to the twins was the legal mother. AB believed that she had the status of second female parent. The couple’s relationship broke down, CD acquired a new partner and when AB sought a contact order in relation to the twins, CD opposed the contact order and applied for an order under section 55A of the Family Law Act 1986 that AB was not a parent. Cobb J found with great reluctance that a series of errors on the part of the clinic meant that treatment was not provided within the terms of the clinic’s licence and the consents given by the parties were not effective. He granted the order that AB was not a legal parent while seeking to assure her that this did not mean she had no parental role to play in the boys’ lives and listed her application for contact to be heard later.

Re G (Children) (Shared Residence Order: Biological Mother of Donor Egg Children)⁷⁷ addresses another permutation of the perils of fertility treatment. The appellant and the respondent lived together as couple for some time, albeit the respondent argued that the relationship became purely one of friendship before the twins at the centre of the dispute were born. The respondent had undergone a number of unsuccessful attempts using her own eggs to have a child by DI. The appellant agreed to donate her eggs which were fertilised using sperm from an anonymous donor. The respondent gave birth to twins. The couple and the twins lived together for some time sharing parenting duties, though their accounts of ‘family life’ differed considerably. The couple parted and the respondent later formed a civil partnership with another woman and entered into a parental responsibility agreement to confer parental responsibility on her new partner. The appellant, although she was the genetic mother of the twins, had no legal relationship with them. Her former partner was the gestational mother and thus the legal mother. The couple had not sought to confer the status of second parent on the appellant. The appellant applied for a joint residence order as a means of acquiring parental responsibility for children she saw as ‘hers’. Her application was rejected by HH Judge Black as not being in the best interests of the children. The judge placed great weight on the fact that the couple had not taken advantage of the provisions of the 2008 Act that would have enabled the appellant to be named as the second legal parent and on concerns that the appellant might seek to undermine the parental role of the respondent and her new partner. The Court of Appeal, while confirming that the appellant had no claim to be the legal mother of the children, was more sympathetic to her plight and sent the case back for rehearing, saying that the judge had failed to consider all the factors pertinent to the children’s interests and the role that the appellant might play in their lives.

Finally, we should consider Re G (A Child) (Sperm Donor: Contact Order): Re Z (A Child) (Sperm Donor: Contact Order).⁷⁸ A lesbian couple D and E wanted children. They preferred a known donor so that the child would know something of its background and ultimately approached a gay male friend S. S had a longstanding relationship with T. E was to be the biological mother of the child. Attempts at self-insemination began in January 2008 and a child, F, was born in December 2008, shortly after D and E had entered into a civil partnership in the September. At this time the Human Fertilisation and Embryology Act 2008 had not come into force to allow for two female parents and thus E was the biological and legal mother of F, and S was her biological and legal father. In 2009, D and E decided they wanted a sibling for F and wanted the children to have the same biological father (ie S). Self-insemination resulted in the birth of G in 2010. The 2008 Act was now in force and thus E was the biological and legal mother of G, but D (E’s civil partner) was the second legal parent and S, the biological father, was not in law the father of his second child, G. In the meantime, T had entered into a similar arrangement with another lesbian couple, X and Y, friends of D and E. Following self-insemination with T’s sperm X gave birth to a child, Z, in April 2010. As X and Y were civil partners, Y became the second legal parent of Z, and T, the biological father, had no claim to be the legal father of Z. The once friendly relationship between all three couples broke down in acrimony and disagreement about the role (if any) that S and T should play in the lives of their biological children, G and Z. S and T applied for leave to seek contact orders under section 8 of the Children Act 1989. Both female couples opposed the applications on a number of grounds. The argument most pertinent to us was that the 2008 Act in vesting legal parenthood in the civil partners and excluding the biological fathers, providing as it does that the sperm donor should not be treated as the father of the child ‘for any purpose’,⁷⁹ excluded biological fathers, even if known donors, from any ‘parental’ role in the life of those children. Granting S and T leave to seek contact would frustrate the intention of Parliament to protect same sex couples from any claim by the biological fathers to play a role in the child’s life, save by the consent of the legal parents. Baker J dismissed this claim arguing that same sex parents were in just the same position as other parents who created a family via gamete donation. The biological fathers had no claim to legal fatherhood and so in one sense were ‘strangers’ to G and Z. But given the circumstances of the children’s birth, the choice of known donor, the involvement of the men with the children in earlier times, the judge allowed the application for leave while stressing that it did not follow that contact would be granted. Baker J recalled the speech of Baroness Hale in Re G (Children)⁸⁰ in which she classified parenthood as genetic, gestational, and social and psychological. The latter might have no genetic or gestational relationship to the child but nonetheless contribute to the well-being and raising of a child. The 2008 Act excluded biological fathers from legal parenthood, but did not wholly strip the fathers from any claim to involvement in the child’s life. Each case would be fact specific and heavily dependent on the father’s involvement with the life of the child and the best interests of that child.

On the horizon?

12.13 Despite the breadth of the provisions in the 2008 Act, they do not cover all the permutations of parenthood that modern medicine can or may soon facilitate.⁸¹ They address only female same sex couples and make no provision for transsexuals.⁸² Male couples have to navigate the murky waters of the law governing surrogacy. If two men agree with a surrogate that she will bear a child for them created by the fertilisation of her eggs with sperm from one of them, the latter will be the father of the child and the surrogate the mother. The other partner will, as we shall see later, have to seek an adoption or parental order. If it becomes possible to transplant a womb into a man so he could gestate his own child, or if ectogenesis (artificial) wombs become reality, then the very notion of ‘mother’ and ‘father’ will be turned on its head.⁸³

Artificial insemination by husband (AIH) or partner (AIP)

12.14 There are cases where, although a woman’s husband or partner is fertile, he cannot beget a child because he is incapable of normal intercourse. His sperm may be used to impregnate his wife or partner by artificial means.⁸⁴ Or the man may produce some sperm, but not sufficient healthy and mobile sperm to achieve fertilisation in the usual way. Such a couple may be helped by ICSI. A single sperm is injected into the cytoplasm (outer casing) of the woman’s egg. IVF is combined with AIH. Concerns have been expressed about the safety of ICSI.⁸⁵ The child’s legal status will be just the same as if she were conceived naturally. Where normal intercourse was not possible so that a marriage has never been consummated, AIH will not prevent the wife from petitioning the court to annul the marriage,⁸⁶ although on policy grounds, the court may refuse a decree if they consider that in having the child the wife approbated the marriage.

AIH or AIP may also be resorted to when a man has banked sperm for example in advance of chemotherapy for cancer. If he survives and the couple agree to treatment using the stored sperm no problems arise, but what if he dies and the woman seeks treatment with his sperm? Or she asks a doctor to take sperm from a dying or just dead partner?

Posthumous gamete donation

12.15 The issue of posthumous donation made headlines in the case of Diane Blood. Diane and Stephen Blood had been married for four years before Mr Blood was struck down with meningitis. He lapsed into a coma and died. Shortly before his death, at Mrs Blood’s request, doctors used electro-ejaculation to take sperm from her dying husband which was then stored at a licensed fertility clinic. The HFEA instructed the clinic not to treat Mrs Blood, nor to release her husband’s sperm to her so that she could seek treatment abroad. The HFEA ruled that the recovery and storage of Stephen Blood’s sperm was unlawful under the 1990 Act. The taking of sperm did not comply with Schedule 3 of the 1990 Act which imposed a mandatory requirement for written ‘effective’ consent. No such written consent had ever been given by Mr Blood, although his widow argued that they had planned to start a family, and that Stephen had told her that in the kind of tragic circumstances which ultimately overtook him she should do just as she did.

Mrs Blood challenged the HFEA by way of an application for judicial review, alleging that it was the HFEA who was acting unlawfully. The High Court upheld the HFEA, but Mrs Blood succeeded in the Court of Appeal.⁸⁷ The appeal court agreed that the taking of sperm without Mr Blood’s written consent was unlawful. It contravened the 1990 Act, and constituted a common law assault.⁸⁸ The court expressed sympathy with Mrs Blood. She had acted in good faith. There should be no question of prosecution. Nonetheless, treatment in the UK would be unlawful. However, the Court of Appeal held that the HFEA had failed to give sufficient consideration to EU law.⁸⁹ Section 24 (4) of the 1990 Act permitted the HFEA to issue directions authorising the export of sperm. Articles 59 and 60 of the Treaty of Rome guarantee fundamental freedoms, which include a right to receive services. Such a right is not absolute, but any limitations on that right must be justified. Given that the Court’s ruling that taking sperm without written consent was unlawful, the court said that the circumstances of Mrs Blood’s case would not be repeated. The Court of Appeal directed the HFEA to reconsider Mrs Blood’s request to export sperm. They did so and granted her permission to take her husband’s sperm to Belgium where she finally received treatment and gave birth to a healthy son, Liam, followed some years later by a second son. The narrow grounds of the appeal court’s ruling in Mrs Blood’s favour left domestic law unchanged. No woman in a similar position would benefit. Unless the deceased then had given formal written consent to storing and use of his sperm,⁹⁰ no British clinic could treat his widow or former partner. Judicial optimism that there would be no repeat of the Blood case proved ill founded. In L v Human Fertilisation and Embryology Authority,⁹¹ L’s husband died suddenly in the course of minor operation. L obtained an order that it was lawful to retrieve sperm from his body and the sperm was then stored at a licensed clinic. L sought to argue that the absolute rule that prevented her using the sperm contravened both EU law and Article 8 of the ECHR. She failed.

The judge found that while the retrieval of the sperm fell outside the Act and indeed immediate use of the sperm might have done so too, he had no power to declare that continued storage of the sperm was lawful. The power vested in the HFEA to allow the sperm to be exported meant that EU treaty rights were not violated and later the HFEA authorised the export of the sperm retrieved from L’s husband so that she like Mrs Blood could seek treatment abroad.

After the Blood case, Professor Sheila McLean conducted an extensive review of the law on consent and removal of gametes, but recommended only limited changes in the law.⁹² One change did however result from the review and Mrs Blood’s campaign to have her dead husband recognised as her sons’ father. The Human Fertilisation and Embryology (Deceased Father) Act 2003 amended section 28(6) of the 1990 Act to allow the name of the deceased (genetic) father to be entered on the child’s birth certificate. That Act has now been repealed and sections 28(5) A–I of the 1990 Act as amended by the 2008 Act address questions of post-mortem fatherhood in relation to women treated before April 2009 and sections 39–41 address children born as a result of treatment after that date. Under both Acts the written consent of the husband or partner remains an essential precondition to lawful treatment. Assuming that such consent is present and the woman is successfully treated and bears a child, she has fortytwo days to elect to have her deceased husband or partner treated as the father of the child in the sense that his name will be entered into the Register of Births. However the child born in such circumstances remains ineligible to inherit from his genetic father’s estate.

The 2008 Act has not substantially changed the law and the Blood case leaves more questions unanswered that it resolves. If Stephen Blood’s sperm had been lawfully stored, could Diane Blood have demanded treatment? It seems unlikely; the ultimate decision remains with the clinician. In the context of private treatment a widow might seek to argue that she has a contractual right to AIH. The possibility remains of attempts to contend that the frozen sperm form part of the deceased husband’s estate. Should a court accept that sperm can be classified as ‘property’ and ‘inherited’ by the wife, it would logically follow that she could demand ‘her’ sperm, but she could still not require a licensed clinic to inseminate her. In the light of the underlying philosophy of the 1990 and 2008 Acts, it seems at first sight unlikely that such a ‘property’ argument would succeed. But consider the judgment of the Court of Appeal in Yearworth v North Bristol NHS Trust.⁹³ The claimants sued in negligence after sperm banked in advance of treatment for cancer was negligently allowed to thaw. The appeal court held that for the purposes of a claim in negligence the men enjoyed property rights in that sperm and could be awarded damages for the damage to their property.

Might anyone other than a spouse or partner seek access to stored gametes? In R (on the application of IM and another) v Human Fertilisation and Embryology Authority⁹⁴ a mother (IM) sought access to her deceased daughter’s eggs stored before the young woman (AM) underwent chemotherapy for the bowel cancer that killed her. The mother wanted her daughter’s eggs to be fertilised by an anonymous sperm donor and implanted in her. She and her husband would bring up their ‘grandchild’. The couple advanced evidence of their daughter’s passionate desire to have a child, that she had asked her mother to carry ‘my babies’ and ‘wanted her genes to be carried forward after her death’.⁹⁵ The deceased daughter had never executed the necessary effective consents under the 1990 Act. The applicants therefore sought special directions from the Authority authorising the export of the eggs to New York where IM would receive the fertility treatment that would allow her to give birth to AM’s child. The Authority’s Special Approvals Committee considered all the evidence and finally rejected the application. The Committee expressly stated that IM’s age and her relationship to AM and any child of AM’s whom she might bear were not a factor in their decision-making. The Committee was not satisfied that prior to her death AM was fully informed of the process that would be needed to allow her mother to bear ‘her’ child, that she would have agreed to the use of an anonymous donor, or that she explicitly expressed a wish for her mother to carry her child after her death. IM and her husband unsuccessfully sought judicial review of the Authority’s decision.⁹⁶ Note that both the HFEA Committee and the court based their decisions wholly on the scope and validity of any consent given by AM to posthumous use of her eggs and avoided any moral judgements as to whether ‘grandparents’ should be allowed to bring to birth a dead child’s child and eschewed any consideration of IM and her husband’s ages.

Gamete donation: supply and demand

12.16 For many prospective parents seeking fertility treatment, access to suitable donated gametes is crucial to their treatment. Both eggs and sperm are in short supply and so there have been several proposals to increase supply. Eggs donors are especially hard to recruit. Unlike sperm donation, egg donation is attended by some risk to the donor. Egg donation requires a surgical procedure, an invasion of the donor’s body. The woman will be given drugs to induce her to supra-ovulate, to produce several eggs at once. Supra-ovulation carries risks to the health and in a very, very few cases to the life of the woman. A woman undergoing IVF runs identical risks. She does so to have ‘her’ baby. Egg donors are asked to risk harm with no prospect of benefit to themselves.

Payments for eggs, sperm or embryos are currently unlawful in the UK unless authorised by directions from the HFEA.⁹⁷ After an extensive consultation,⁹⁸ in 2012 the HFEA introduced new limits for what is described as ‘donor compensation’ allowing payments of £35 per clinic visit for sperm donors and a fixed sum of £750 per cycle for egg donors. Payments for eggs still fall well short of offering significant incentives to young women to sell their eggs. In the USA, payments of $50,000 are not unknown to attract tall, healthy, highly intelligent college students to sell their eggs.⁹⁹ The HFEA still uses cautious language speaking only of expenses, compensation and benefits in kind.

One such benefit in kind is ‘egg sharing’. If an open ‘egg market’ is not allowed in the UK, does ‘egg sharing’ operate as a covert market? Women who are undergoing egg collection as part of their own IVF treatment agree to donate a proportion of their eggs to others. In return, they receive reduced cost or even free IVF (which might otherwise cost them about £5,000 per cycle). ‘Egg sharing’ avoids subjecting the donor to risks unrelated to her own treatment.¹⁰⁰ But does the invitation to ‘egg sharing’ operate as a questionable inducement to women who could never afford private fertility treatment? Unless they agree to ‘egg sharing’ some women have no chance of treatment by IVF. How might a donor feel if she learns that the recipient of her eggs had a successful pregnancy, when she did not?¹⁰¹

Women who have to undergo medical treatment that may compromise her fertility or women who simply want to preserve and freeze eggs to allow them to delay motherhood, can store their own eggs (or a portion of ovarian tissue) for future use. Freezing eggs proved more difficult than freezing sperm.¹⁰² More damage is caused when the eggs are thawed. Freezing sections of ovarian tissue may be more successful in the long term. When the woman wishes to contemplate pregnancy, the ovarian tissue (with eggs intact) is simply reimplanted.

Most of the problems surrounding storing eggs and ovarian tissue taken from the intending mother herself are generated by questions about the safety of the procedure. For example, if ovarian tissue is taken from a woman about to undergo chemotherapy for cancer, is there a risk of reimplanting cancer cells in her? However, storing eggs avoids some of the practical and moral problems that arise if embryos are stored.¹⁰³

Legal and ethical dilemmas are not absent. If a child of 7 is about to undergo chemotherapy, can her parents authorise surgical removal of ovarian tissue in case their daughter, once she is an adult, wants to have children?¹⁰⁴ Is such a procedure in the child’s interests? Perhaps that will depend on the extent of the immediate risk and distress posed to the child by additional surgery balanced against the long-term benefit of preserving some hope of fertility. Storing eggs when a woman or girl faces the loss of fertility as a result of medical treatment is coming to be seen as fairly routine medical care. Egg storage may be simply a matter of choice. Women may seek to delay child bearing or simply not have found a suitable partner and so wish to ‘bank’ eggs for future use.

It is technically possible to collect immature eggs from fetuses.¹⁰⁵ Aborted female fetuses could be collected, ‘their’ eggs harvested and subjected to a process of maturation. A plentiful supply of eggs would be secured. Controversy over such a possibility led to amendment of the 1990 Act. Section 3A now bans treatment using eggs derived from fetuses. Research can still lawfully continue. Ovarian tissue might be taken from dead women, just as kidneys and other organs are taken from cadaver donors. Such a process would need to meet the legal conditions currently provided for by both the Human Tissue Act 2004 and Schedule 3 of the 1990 Act.

Storing gametes and embryos

12.17 The capacity to freeze and store gametes and embryos has been crucial to the improvement of success rates in fertility treatment. Storage of gametes and embryos is lawful only if licensed by the HFEA.¹⁰⁶ Storage has generated its own ethical and legal conundrums. The 1990 Act (as amended) now prescribes a maximum statutory storage period of ten years for both gametes and embryos,¹⁰⁷ subject as we shall see to regulations that can in certain circumstances alter the storage periods prescribed in the Act.¹⁰⁸ Freezing inevitably means that at the end of the storage period there will be embryos left unused. The Act requires that such embryos be ‘allowed to perish’.¹⁰⁹ In 1996, the first storage period for embryos (then set at five years) came to an end, and thousands of embryos were to be disposed of. In many cases, clinics had lost all contact with the gamete donors (or parents). A public outcry greeted the fate of what the media styled the ‘orphan embryos’. The government used its powers under the 1990 Act to extend the storage period for embryos from five to ten years in certain cases.¹¹⁰ The furore around ‘orphan embryos’ remains instructive. If embryos can be equated to orphan children, they should not be created doomed to die. If they are children, these ‘orphans’ should have been offered to other infertile couples for adoption. If embryos are morally insignificant, they should be put to some good use, whether that use was to help other infertile couples or forward research.

The rules governing storage periods were addressed in Warren v Care Fertility (Northampton) Ltd.¹¹¹ In 2005, prior to having radiotherapy for cancer, the deceased arranged to store sperm for the ‘statutory period’ to enable him to have children should treatment render him infertile. He also gave consent to the use of his sperm after his death and in such a case also being named as the father of the child. He died in February 2012. The usual statutory period for storage of ten years would end in 2015. His widow, Elizabeth Warren, sought to have that period extended as she was not yet ready to make a decision about having a child. The Human Fertilisation and Embryology (Statutory Storage Period for Embryos and Gametes) Regulations 2009¹¹² allowed for the extension of that ten-year period in the event of the death of the donor. The clinic failed to comply with the necessary requirements of Regulations 4 and 7, and the consents given by the deceased failed to specify that his sperm should in the event of his death be stored beyond the ten-year period. The clinic had failed to inform the man of the additional requirements to extend the storage period. The widow sought a declaration that notwithstanding the non-compliance with the 2009 Regulations, it was lawful for her husband’s sperm to be stored beyond 2015 to enable her to conceive his child. The declaration was granted on the grounds that the Regulations failed to address what should happen if a clinic did not inform a patient of the requirements of the Regulations and deprived him of the opportunity to extend the storage period. The claimant widow had a right under Article 8 of the ECHR to become a parent. Parliament had provided and intended that a deceased man’s sperm could be used by a named person as long as his consent was in writing. Interpreting the Regulations strictly would violate the claimant’s right to have a child. The decision in Warren indicates the willingness of the judges to seek where possible to give effect to the wishes of prospective parents and to adopt a much more ‘rights based’ approach to the law governing assisted conception.

Disputes and stored embryos

12.18 What about embryos in storage prior to their expiry date? The Act requires anyone storing gametes or embryos to decide what may or may not be done with those embryos before any treatment begins. The donors of the genetic material jointly decide its fate in foreseeable circumstances. In Evans v Amicus Healthcare Ltd,¹¹³ Natalie Evans wanted to be able to have ‘her’ frozen embryos implanted to establish a pregnancy. Her former partner, Howard Johnson, refused to agree and sought to have the embryos destroyed. Some years earlier, Ms Evans had been diagnosed with pre-cancerous tumours in both ovaries. She was advised to have her ovaries removed. As the cancer was growing slowly, there was time for her and her partner to undergo IVF and freeze embryos for future use. Ms Evans enquired about the possibility of freezing her eggs and was told that success rates using frozen eggs were much lower than where frozen embryos were used. Her partner reassured her that they would not split up, but would go on to have children together when she was recovered and clear of cancer. Both partners signed the necessary forms consenting to storage of the embryos. A year later, the relationship broke down and Mr Johnson notified the clinic that he withdrew his consent to storage of the embryos and asked that they be destroyed. Ms Evans was prepared to undertake that she would never make a financial claim for child support and argued that the stored embryos offered her her only chance to have a child genetically related to her.

The obstacle confronting Ms Evans, when persuasion failed to change her former partner’s mind, lay in Schedule 3 of the 1990 Act. To summarise, any continuing storage of the embryos and any use (ie implantation) of the embryos required the ‘effective consent’ of both the parties who had contributed the gametes creating the embryos. ‘Effective consent’ means a consent ‘which has not been withdrawn’. Mr Johnson had withdrawn his consent to continued storage of the embryos and never gave any consent to Ms Evans to use the embryos on her own. Wall J held that Schedule 3 made it clear that the continuing consent of both parties was required and that either party was free to withdraw that consent.¹¹⁴ The Court of Appeal upheld his judgment.¹¹⁵ Throughout the litigation in England, Ms Evans argued that if Schedule 3 was interpreted to require Mr Johnson’s continuing consent, the 1990 Act was incompatible with Ms Evans’s rights under Articles 8, 12 and 14 of the European Convention on Human Rights. Her rights to family life and to found a family were violated by an absolute rule that denied her her only chance to have a genetically related child. The Court of Appeal held (inter alia) that any interference with Ms Evans’s right to private and family life under Article 8(1) was justifiable within the terms of Article 8(2). Permitting implantation without Mr Johnson’s consent would violate his Article 8 rights. Justification for violating the father’s right to self-determination and autonomy could not be based on any claim that violation was necessary to protect Ms Evans’s right.

The need, as perceived by Parliament, is for bilateral consent to implantation … To dilute this requirement in the interests of proportionality, in order to meet Ms Evans’ otherwise intractable biological handicap, would create new and even more intractable difficulties of arbitrariness and inconsistency.¹¹⁶

Ms Evans took her case to the ECtHR. She lost again in both the European court of first instance¹¹⁷ and the Grand Chamber.¹¹⁸ The Court noted that there is no consensus among Convention states, or internationally, as to how to regulate consent to implantation of embryos. A number of states conform to the UK model allowing consent to be withdrawn up to the time of implantation. Others limit the male partner’s right of veto. Ms Evans sought to argue that her circumstances were exceptional and precluded the Court from deciding that this vexed question of consent fell within the margin of appreciation allowed to Member States. Destruction of the embryos destroyed her right to reproduce. Permitting the consent regime in the 1990 Act to stand was not necessary or proportionate. The position of women and men could not be equated. Mr Johnson might suffer some violation of his right to determine his reproductive fate. Ms Evans’s right was obliterated. Despite sympathy from the European judges, the Court held that the UK regime was based on a clear and principled rule and fell within the margin of appreciation. The Grand Chamber concurred.

The 2008 Act made one small change to help anyone finding themselves in the same position as Natalie Evans, amending Schedule 3 of the 1990 Act to provide that if one party withdraws consent to storage of embryos, a one year ‘cooling off’ period should be introduced before the embryos have to be destroyed.¹¹⁹ Within that year, the hope is that the parties can reach some agreement about the future of the embryos.

Preimplantation genetic diagnosis

12.19 Advances in reproductive medicine have helped not only infertile couples, but also couples who risked transmitting a genetic disease to their children. Initially a woman who was a haemophilia carrier could avoid giving birth to an affected son by opting for egg donation. PGD offers such a woman the chance to have her own genetic child. Embryos are created by IVF, and PGD is used to screen out embryos affected by the relevant genetic disease. Only healthy embryos are selected for implantation. In some cases, PGD involves sex selection for medical reasons, for example, screening out male embryos potentially susceptible to haemophilia. As PGD develops, doctors become more able to refine the screening process and identify affected, and unaffected, embryos.

The 1990 Act made no express provision for PGD and it was the HFEA that developed the framework within which PGD could lawfully be offered to couples at risk of transmitting a genetic disease. Not everybody applauded this development and PGD has been criticised both on the grounds that it involves deliberate destruction of embryos and that in screening out disabled embryos it discriminates against disabled people and reinforces negative images of disability.¹²⁰ Pro-life groups challenged the legality of PGD arguing that the HFEA had no power to license a treatment for couples who could have children without assistance. The Court of Appeal¹²¹ confirmed that HFEA policy permitting PGD was lawful under the Act in that for couples affected by a risk of transmitting such disease PGD constituted treatment ‘for the purpose of assisting women to carry children’. A process that enabled the woman to become pregnant free from the fear that her child would be affected by a serous genetic disease was one that assisted her to carry a child. Amendments to the 1990 Act now set out a statutory framework for PGD modelled on HFEA policy. The provisions are lengthy and complex and we do no more than set out the basics here. Schedule 2 1ZA of the Act now provides that PGD may be licensed to establish whether the embryo has a defect affecting its capacity to result in live birth, in any case where there is a particular risk that the embryo may have a gene, chromosomal or mitochondrion abnormality, or to establish gender where there is a particular risk of a serious gender related condition. In cases where PGD is licensed in relation to an abnormality in the embryo it must further be shown that there is significant risk that if born the person would have or develop a serious disability or illness. Not every genetic anomaly will qualify as ‘serious’. The ends of the spectrum are easy to discern. You could not license PGD to screen out red hair. Dreadful diseases, for example, Tay–Sachs, where the child born is condemned to early disability and death while little more than an infant, clearly meet the test. Other conditions will provoke debate, and prospective parents may have different perceptions about both risk and seriousness. The HFEA Code of Practice places a great deal of emphasis on consultation with the couple and their subjective judgement of the condition that they seek to avoid for their child.¹²² Whether this approach meets the conditions now laid down in the Act remains to be seen.

What about late onset diseases where a child is born healthy but carries a gene that results in serious illness later in life? For example if BRAC1, the gene predisposing family members to breast cancer, is present in the prospective mother, can she seek PGD to ensure that any child she bears is free of that gene? The amended Act once again endorses the prior policy of the HFEA in permitting PGD for late onset disease¹²³ in including not just persons who will be born with a genetic disease but also those who may develop such a disease.¹²⁴

PGD and ‘saviour siblings’

12.20 It was the development of the ability to use PGD as the first step to offering treatment to a sick child that provoked especial controversy, what is popularly described as the creation of ‘saviour siblings’. Parents who have a child already afflicted by a potentially fatal genetic disorder can seek to have another baby whose stem cells, taken from her umbilical cord, could ‘cure’ her brother or sister. PGD is combined with human leukocyte antigen (HLA) typing the embryos. By this means, a baby is created who is both unaffected by the genetic disorder in question, and an exact tissue match for the sick sibling. Opponents of PGD/HLA argued that it was wrong to create a baby purely as a means to an end. But desperate parents often make several attempts to have a baby naturally to achieve just that end – a tissue match for a sick child. Nothing in the original 1990 Act addressed this question. The HFEA struggled to deal with the dilemma. The Authority gave a clinic permission to treat Zain Hashmi. Zain suffered from beta thallasaemia (BT), a genetic disease. His family could provide no compatible stem cell donor. So his parents sought PGD with HLA. Charlie Whitaker suffered from Diamond Blackfan Anaemia (DBA). His parents also wanted to use PGD with HLA to create a ‘saviour sibling’ for Charlie. The HFEA said no. The Hashmi embryo was itself at risk of BT. DBA is not thought to be a genetic disease, so the HFEA initially argued that Whitaker embryos could not be screened as they would obtain no benefit. The distinction between the two cases met vigorous criticism.¹²⁵ The HFEA changed its mind.

Meanwhile pro-life groups challenged the legality of the HFEA decision to allow PGD with HLA in the Hashmi case. Ultimately, the House of Lords¹²⁶ ruled in favour of the HFEA, confining themselves to an exercise in statutory interpretation and seeking to sidestep moral controversy. Amendments to the 1990 Act give statutory backing to the use of PGD/HLA to create saviour siblings. Schedule 2, paragraph 1ZA expressly allows testing on the embryo to ascertain whether the tissue of the embryo would be compatible with an existing sibling who suffers from a serious illness that could be treated by umbilical cord cells, bone marrow or other tissue from the child to be born. Other tissue is expressly defined to exclude solid organs. But while this prohibition would mean that tissue-typing could not go ahead were there an intent to resort to organ donation at the time of the creation of the savour embryo, it would not of itself make it unlawful to authorise organ donation later if all other measures had failed. A living transplant from a minor would however require approval under the Human Tissue Act 2004 and that would be unlikely to be forthcoming.¹²⁷

PGD: selecting for ‘disability’

12.21 As the 2008 Act made its way through Parliament a new controversy erupted. PGD is normally used to screen out certain sorts of serious disease or disability. What if a couple wanted to screen in a particular condition, for example a deaf couple wanted to ensure that their child was also deaf?¹²⁸ They want their child to be part of their community and challenge society’s notion of deafness as disability. Sections 13(8)–(10) of the 1990 Act as amended now provide that embryos known to have a serious abnormality ‘must not be preferred to those not known to have such an abnormality’. Nor must a gamete donor known to carry such an abnormality be preferred to one who is not. Note the limits of the statute. First, is it clear that deafness would qualify as sufficiently serious under the Act? If it did, note that the Act does not ban implantation of the ‘deaf embryo’, just that it cannot be selected if there are unaffected embryos created at the same treatment.

PGD: social sex selection

12.22 It may be that at the root of concerns about PGD lies discomfort with the notion of parents having a free choice of what kind of children they have, the prospect of ‘designer babies’. The UK legislation as it relates to PGD is heavily based on a medical model so testing an embryo to establish its gender is allowed to avoid the birth of a child with a sex-linked genetic disease. Should the law allow sex selection for non-medical reasons? A couple with three sons want a daughter to ‘balance’ their family.¹²⁹ A single woman wants only female children. Despite strong support for lifting any ban on social sex selection, the law is now clear. It is unlawful to use PGD to test for gender save in the context of gender linked disease.¹³⁰ Nor can techniques based on sperm sorting, that is, separating X and Y sperm and using only Y sperm to inseminate the woman wanting a son and vice versa. The legislation now prohibits any use of sperm without a licence, save as we have seen for partner-donated sperm that has not been processed. Sorting will constitute processing. The debate will continue.

What should the child be told?

12.23 Does a child born after the use of donor gametes have a right to know the identity of his genetic parents? An adopted child has, at 18, a right of access to his original birth certificate and so has the opportunity to trace his natural parents.¹³¹ If an adopted child may trace his birth mother and genetic father, should children born from gamete donation be afforded a similar right? Until August 2005, anonymity protected all gamete donors, while affording some limited rights to children born as a result of donation. Section 31 of the 1990 Act required the HFEA to keep a register detailing the provision of treatment services and the use of gametes. At the age of 18 a person could, after proper counselling, request information from that register. Section 31(4)(b) provided that information must include information about whether or not the applicant and a person whom he proposes to marry are related. Section 31(4)(a) provided that such other information relating to the applicant ‘as the Authority is required by regulations to give’ shall be made available to him. The wording of section 31(4)(a) was such that HFEA would be free to decide that the information should include the identity of the child’s genetic parents, the gamete donors. Section 31(5), however, ensured that any removal of anonymity could not be retrospective. If anonymity prevailed when sperm was donated, a later change in the rules will not give children access to the identity of the donor. Regulations removing anonymity from gamete donors were brought into force in April 2005,¹³² and are now consolidated in the heavily amended section 31 of the 1990 Act. The ‘new’ section 31 provides that a person will, at the age of 18, acquire the right to information about the identity of donor parents.¹³³ An offer of counselling must be made to the applicant before any information is released. The new rules cannot apply retrospectively, so no pre-existing donor risks losing his or her anonymity. Anyone donating now is aware that his or her offspring may be able to trace them and make contact and the HFEA has a power to warn donors when requests for information are made.

Clinics fear that loss of prospective anonymity will exacerbate the acute shortage of gamete donors. Some children will acquire the right to know the identity of a genetic parent at the expense of couples who remain childless for lack of donors. The removal of anonymity to donors was prompted by powerful arguments that the child’s interests in private and family life require that she has access to such information. A person’s psychological well-being is, it is claimed, intimately connected to a sense of identity and heritage. If donation is seen as an ethical, altruistic act why must it be kept secret? If adopted children need to know the identity of their genetic parents, why are the needs of children born from gamete or embryo donation less pressing?¹³⁴ Granting a young man who had spent a miserable childhood in care access to all the files held on him, the ECtHR declared¹³⁵ that ‘everyone should be able to establish details of their identity as individual human beings’. And in R (on the application of Rose) v Secretary of State for Health,¹³⁶ Scott Baker J held that Article 8 of the Human Rights Convention was relevant to the question of what access to information children born via assisted conception should enjoy.

Liability for disability

12.24 What if fertility treatment results in the birth of a disabled infant? This could happen for several reasons. In DI, the donor may turn out to be the carrier of some disease or genetic disorder. Babies have been born abroad suffering from HIV contracted from donor sperm. An error may be made in the laboratory, damaging an IVF embryo. Or treatment, such as ICSI, might in years to come be shown to produce abnormalities manifesting themselves only when the children reach maturity.

Parents will be able to maintain an action against the doctors and the clinic if mother or child is injured by negligence. Clearly, if the mother herself suffers any injury, for example, in the course of collecting eggs, she may recover compensation for that injury. The woman accepted for treatment expects care, not only in relation to herself, but also in the ‘production’ of a healthy infant. If, by negligence, the child is born disabled, damage to the parents is readily foreseeable. Both mother and father will suffer emotional trauma and face the added expense of bringing up a disabled child.¹³⁷ Is there a problem if the parents cannot pinpoint exactly who was negligent? It may be impossible for them to know if the embryo was damaged by the gynaecologist removing the eggs and implanting the embryo, or by the scientists in the laboratory. In NHS clinics, the NHS trust owes a direct duty to the parents and is responsible for negligently failing to discharge that duty. In the private sector, patients should ensure that the clinic similarly undertakes a contractual duty to provide and underwrite the whole course of treatment. One final point relating to actions by parents is that, while they may have legal redress if a damaged baby is born, there will be no legal remedy if no baby is born. Neither NHS nor private clinics undertake more than to attempt to assist conception using all due skill and care.

What of an action by the child? He will need to rely on the right of action in respect of pre-natal injuries enacted in the Congenital Disabilities (Civil Liability) Act 1976.¹³⁸ The Human Fertilisation and Embryology Act 1990 amended the 1976 Act to allow for an action arising out of negligence in the process of assisted conception. Section 44 inserts into the 1976 Act section 1A which provides for an action if a child carried by a woman as a result of the placing in her of an embryo, or sperm and eggs, or DI, is born disabled, and the disability results from negligence in the selection, or keeping or use outside the body, of the relevant embryo or gametes. Providing the defendant is answerable in tort to one or both parents, he is liable to the child. The sorts of cases envisaged by section 1A are just the sort of examples mentioned earlier – the child born HIV-positive because doctors failed to screen donors adequately, the child born damaged by some technical error in his creation, and the child born disabled because a defective embryo was negligently implanted in the mother. A further extension to the rights of the child is made in section 35(4) of the 1990 Act, again amending the 1976 Act, to provide that injury to the reproductive capacity of the genetic parent gives rise to a derivative action under the 1976 Act for the child. Sections 34 and 35 of the 1990 Act make extensive provision for disclosure of information necessary to any action by parent or child for damages occasioned by assisted conception.

One difficulty facing an action by the child remains. Is the essence of his action for ‘wrongful life’, or ‘wrongful disability’? If the former, no action can lie.¹³⁹ Much will then turn on how it is alleged the child came to suffer injury. If it is claimed that gametes and embryo were originally healthy, but damaged by some act of the doctors or scientists treating the mother, the claim is for ‘wrongful disability’. It is on a par with a claim that a healthy fetus was damaged in utero by drugs given to the mother. But what if the alleged negligence is that infected sperm was used to inseminate the mother or a defective embryo implanted in her? Such a claim must logically be classified as a ‘wrongful life’ claim. Assume these facts. A clinic negligently fails to check donors for HIV. Baby X is born with HIV from contaminated sperm. Had the clinic exercised due care in the collection of sperm, that individual, Baby X, would never had been born at all. Similarly, if a defective embryo is not screened and discarded in the laboratory, any action the child brings is for ‘wrongful life’. His parents could, ‘but for’ the relevant negligence, have had a healthy child. He would not have been that child.

Both parents and children seeking compensation for disability will face problems proving negligence where it is difficult to isolate the cause of the damage to the child. A baby resulting from DI born HIV-positive, or afflicted by a genetic disease carried by the father, poses no legal problem in a claim by his parents. Competent screening should have discovered the disease or defect and that sperm should never have been used to inseminate the mother. Linking a defect to an error in the laboratory will be less easy. An action based on abnormalities manifesting themselves later in life is almost bound to fail. If in 2025 it is shown that freezing embryos produces cancer in the late teens and early twenties, the defence to any claim in negligence will be that responsible professional opinion, endorsed by countless official reports, believed freezing to be safe in 2005 when the child was born.

Finally, if parent or child has a right to sue and proves negligence, are there defences open to the doctor based on the parents having agreed to run the risk of a damaged child? Section 44(3) provides that an action by the child shall fail if either or both parents knew of the risk of their child being born disabled ‘that is to say, the particular risk created by the act of omission’. So if the mother is known to carry a genetic disease herself and is counselled that it would be better to use donor eggs for an IVF pregnancy, yet insists on a child who is genetically hers, she cannot turn round and sue the doctors who carried out her wishes, if her genetic problem is inherited by her child. However, it would be no defence for a defendant simply to say, ‘Well, parents know that this is a relatively new and risky process, so I am not liable’. The parents must be aware of the particular risk of harming their child. Often the risk of harm arises from the increased danger of a multiple pregnancy. A parent who was not fully counselled on this risk might argue that not warning of that particular risk was negligent. To succeed in an action she would then have to prove that had she been warned she would not have gone ahead with the treatment.

Reproductive cloning

12.25 Human reproductive cloning is illegal in the UK. It does not matter how the ‘clone’ is created. When Parliament enacted the Human Fertilisation and Embryology Act 1990, the intent was to ban any form of reproductive cloning and the assumption was that section 3(1)(d) outlawed any form of human cloning. Replacing the nucleus of an embryo with the nucleus of a cell taken from any other person or embryo was prohibited. The development of cell nuclear replacement (CNR), heralded by the birth of Dolly the Sheep, highlighted the inadequacy of section 3(1)(d). Placing the donated nucleus into an emptied egg still fell outside the prohibition. As we shall see in the next chapter, the government sought to permit the HFEA to license the use of CNR in developing stem cell therapies, often referred to as therapeutic cloning.¹⁴⁰ Reproductive cloning was condemned.¹⁴¹ Pro-life groups, however, challenged the regulations arguing that CNR embryos fell outside the 1990 Act altogether because the embryos were not created by fertilisation. Their victory at first instance¹⁴² led to the Human Reproductive Cloning Act 2001 prohibiting the implantation in a woman of an embryo ‘created otherwise than by fertilisation’.¹⁴³ That Act has now been repealed. The amendments to the 1990 Act made by the 2008 Act make it clear that embryo is defined to include embryos created by fertilisation or ‘any other process capable of resulting in an embryo’.¹⁴⁴ Only ‘permitted embryos’ may be implanted in a woman and that excludes any cloned embryo.¹⁴⁵

Several arguments are advanced for,¹⁴⁶ and against, reproductive cloning.¹⁴⁷ Safety is a concern that all parties in the debate share. Mammalian cloning has shown a high rate of birth defects and miscarriage. Research might overcome this hurdle to permitting cloning. Other arguments centre on the impact on the cloned child of her means of production. She will (it is said) lack a unique genetic identity, but so does any identical twin. If she is a clone of her mother, she will see her genetic future mapped out from birth. Moreover, she may be condemned to live more generally in her creator’s shadow – a copy, not a daughter. If she is a clone of a dead sibling, her parent(s) may not value her, but rather the ghost of her sister. Yet environment shapes us as much as our DNA. A clone of either of the authors would grow up in different times and with different parents. Confusion about relationships is another problem for a clone. A clone of Emma Cave would have Emma for her mother? Or would Emma’s mother be mother to the clone? The Emma clone would be truly fatherless. The debate goes on. Yet Mason and Laurie¹⁴⁸ ‘suspect that the days of the outright prohibition on reproductive cloning are numbered’.

Surrogacy

12.26 Where a woman is unable to carry a child herself, perhaps because she has undergone a hysterectomy or has endured several miscarriages, surrogacy may be her and her partner’s only hope for a child. Increasingly surrogacy is also used to enable a male couple or indeed a single man to found a family. In B v C and others¹⁴⁹ B’s mother acted a surrogate bearing his child (her grandchild) created from a donor egg fertilised with B’s sperm.

Surrogacy can take a number of forms. In partial surrogacy, a surrogate agrees with the commissioning couple or individual to undergo artificial insemination with the man’s sperm. She agrees to carry any resulting child, and to hand the child over to the genetic father and where there is such a person his wife or partner, immediately she is born. In the past, many surrogates practised self-insemination privately,¹⁵⁰ and although amendments to the 1990 Act have imposed stricter controls on the use of fresh sperm self-insemination (sometimes described as home-insemination) persists. It would appear that a purely private arrangement between the commissioning father and the surrogate still falls outside the need for a licence and note that, even if that were not the case, a pregnancy could still be established via normal sexual relations.¹⁵¹ As we shall see, partial surrogacy is not wholly unregulated. The ban on commercial surrogacy arrangements applies and couples who seek to acquire parental status for both partners are subject to the regulations governing parental orders. The attraction of partial surrogacy using self-insemination however may be that its initiation is private. There is no need to seek treatment at a licensed fertility clinic and thus no intrusive questions to answer about the welfare of the child. Alas a plethora of cases now demonstrate how easily such private arrangements entered into without advice on the law and parental status can go wrong. Eleanor King J warned of:

[T]he real dangers that can arise as a consequence of private ‘partial’ surrogacy arrangements where assistance is not sought at a licensed fertility clinic (or indeed of full surrogacy arrangements where the child is born abroad). At a licensed clinic consideration will be given to the welfare of a child born as a result of a surrogacy arrangement and counselling services will be provided to the parties which will include the provision of information about the likely repercussions of a surrogacy arrangement and the importance of obtaining a parental order.¹⁵²

IVF offers a couple where the woman ovulates, but cannot safely carry a child to term, the chance of a baby who is genetically theirs. Eggs are taken from the woman, fertilised in the laboratory with sperm from the man, and the embryo implanted in the surrogate. The surrogate once again carries the child and agrees to hand her over at birth. The surrogate is literally a ‘hostess’ for the couple’s embryo. This practice may be styled full or complete surrogacy. The term gestational surrogacy is also used and in the USA surrogates are often now described as ‘gestational carriers’. Mason and Laurie prefer the term womb leasing.¹⁵³ Language is instructive. A surrogate mother may be seen as a person with a relationship with and interest in the child born. A gestational carrier is more easily perceived as simply a service provider. In a growing number of cases, male couples seeking a surrogacy arrangement will obtain eggs from a chosen donor and arrange for the embryos to be implanted in a second woman, the gestational carrier, avoiding the surrogate being both genetic and gestational mother.

Who are the parents?

12.27 The first legal question is: who in English law are the mother and father of a child born as result of a surrogacy arrangement? As will become clear, in both partial and full surrogacy the couple will need to seek a parental order or adopt the child if they are both to become the legal parents of the child, and moreover to obtain a parental order the couple will need to establish that both legal parents consent to the granting of the order. In relation to both partial and full surrogacy, the surrogate who carries the child is the legal mother¹⁵⁴ and the wife or female partner in the commissioning couple has no legal relationship with the child,¹⁵⁵ even if her eggs are used and she is the genetic mother of that child. If the surrogate is married and her husband consented¹⁵⁶ to her participation in the surrogacy arrangement, the surrogate’s husband will be the legal father of the child whenever and wherever the surrogate was inseminated or the embryo implanted in her body.¹⁵⁷ If the surrogate is not married and practised self-insemination using donor sperm from the commissioning father, he will be the legal as well as the biological father of the child. If the surrogate was treated in a licensed clinic before April 2009, then it may be that her partner, if she has one, will be the legal father or the child will be legally fatherless.¹⁵⁸ After April 2009, theoretically the agreed fatherhood conditions could apply and the surrogate could nominate her partner as the ‘father’.¹⁵⁹ Note that the surrogate cannot give notice that the commissioning father be the legal father of the child as the agreed fatherhood conditions exclude the donor of the sperm.¹⁶⁰

The complexity of the provisions on parenthood and the mistaken belief by many commissioning couples that biological parenthood will confer legal status on them has resulted in a raft of cases before the Family Division, many (but by no means all) relating to surrogacy arrangements entered into abroad. Obtaining a parental order is crucial not simply to confer parental status on both the commissioning couple but also to ensure that the surrogate ceases to be the legal mother of the child. All too often couples who access surrogacy outside licensed clinics have little or poor advice on the need to and how to obtain an order. In JP v LP and others (Surrogacy Arrangement: Wardship)¹⁶¹ the problems are well illustrated and we give only a brief overview of a most complicated case. A couple arranged with a friend of the woman that she would carry a child for them as part of a partial surrogacy arrangement. The friend became pregnant after self-insemination with the father’s sperm. The baby was born and handed over to the couple. A few months later, the marriage broke down and the woman (JP) left the marital home with the child. A whole series of legal applications followed but were changed or abandoned and this case came before Eleanor King J when the child was 3 years and 8 months old. The judge found, as she had to, that the legal mother remained the surrogate and the legal father the husband. JP, who had cared for the child all his life, had no legal relationship with ‘her’ son, though interestingly the judge chose to refer to JP as the mother. She found that, given the six-month time limit to apply for a parental order and the fact that the couple were no longer living together, no such order could be granted. Granting an adoption order to JP was inappropriate, as that would extinguish the father’s parental responsibility, and, as the couple were no longer together, they could not adopt together. A shared residence order granted JP parental responsibility but not legal motherhood and the surrogate remained the legal mother with parental responsibility for the child. In the end the parties agreed to a complex solution. The child became a ward of court. The couple were granted a joint residence order and the surrogate prohibited from exercising any parental responsibility without leave of the court.¹⁶² The couple had sought legal advice and a probably illegal and wholly inadequate agreement had been drawn up by a firm of Birmingham solicitors. Perhaps more worrying than this case, where in the end the couple did agree a way forward to care for the child well, is the evidence that a number of surrogacy arrangements are effected without any attempt by the ‘parents’ to seek a parental order or other legal means to assure the parental status of both parties.

Parental orders and adoption

12.28 Prior to the 1990 Act the only way that a commissioning couple could both acquire parental responsibility for ‘their’ child was to adopt the child, going through exactly the same process of assessment and scrutiny as any other couple seeking to adopt a child not genetically related to them. As we will see, section 95 of the Adoption Act 2002 bans payments in relation to adoptions and normally the legal parents of the child must both consent to the adoption but the courts have the power to dispense with parental consent in adoption proceedings if it is unreasonably withheld and adoption applications are not subject to the same time limits as parental orders. Commissioning couples, especially in full surrogacy arrangements, were unhappy at being obliged to adopt their own genetic child and so section 30 introducing ‘parental orders’ was inserted in the 1990 Act to help some commissioning couples in surrogacy cases.¹⁶³ It provided for a simpler and faster procedure, other than adoption,¹⁶⁴ by which some couples could acquire parental rights over ‘their’ child. Parental orders are now governed by section 54 of the Human Fertilisation and Embryology Act 2008 which empowers the court to order that the commissioning couple be treated in law as the parents of the child, but only in a limited number of circumstances. In the past few years virtually every condition for the grant of a parental order has proved problematic and judges have engaged in some imaginative interpretations of the law to secure the legal status of a child living with the commissioning couple whose legal parents may have no interest, no capacity to raise, or are untraceable. To obtain an order:

(1)  The couple must be married, or civil partners, or ‘living as partners in an enduring family relationship’. Single people cannot apply for a parental order and so to achieve sole parental responsibility for the child and relieve the surrogate of her status as the legal mother, a single man establishing a family via surrogacy must adopt his child.¹⁶⁵ A divorced or separated couple cannot obtain an order if their relationship breaks down during the pregnancy or soon after the child’s birth.¹⁶⁶

(2)  The child must have been conceived from either the placing of the embryo, or sperm and eggs in the woman, or by DI. And the eggs or sperm or both must come from the couple. There must be a genetic link with at least one partner in the commissioning couple. Children conceived by natural intercourse between the surrogate and the husband are not within the ambit of section 54.¹⁶⁷

(3)  Normally the application must be made within six months of the birth of the child. Exceptionally an application may be made beyond the time-limit where there were grounds to explain the delay and the welfare of the child or children required that an order be made.¹⁶⁸

(4)  At the time of the making of the order, the child must be living with the couple, one or both of whom are domiciled¹⁶⁹ in the United Kingdom.

(5)  The surrogate (and the ‘legal father’ if not the commissioning ‘father’)¹⁷⁰ must have given full and free consent not less than six weeks after the birth.¹⁷¹ Section 54 is of no relevance if the surrogate changes her mind and is not willing to hand over the child. Nor is it a backdoor route to enforcing a surrogacy contract. Unlike adoption, the court cannot dispense with the consent of a legal parent on the grounds that it is unreasonably withheld, but section 54(7) does provide that consent is not required from a legal parent who cannot be found or is incapable of giving consent. In several cases relating to foreign surrogacy arrangements the courts have found themselves in effect ‘forced’ to conclude that either the surrogate or her husband cannot be located and that the applicants had taken all reasonable measures to locate them and seek consent.¹⁷²

(6)  No payments (other than for expenses reasonably incurred)¹⁷³ must have been made to the surrogate unless authorised by the court. As we shall see, the ban on overt payments and the interpretation of expenses has become a challenging part of many applications for parental orders.

Until the passing of the 2008 Act, only married couples could apply for parental orders and section 54(11) allowed partners who were unable to apply under the 1990 Act but qualified under the 2008 Act six months’ grace to make a retrospective application for a parental order.

Prohibiting ‘commercial’ surrogacy

12.29 Surrogacy where no money changes hands is lawful in the sense that no crime is committed. The Surrogacy Arrangements Act 1985 made it a criminal offence for anyone to play any part in setting up a surrogacy arrangement on a commercial basis and advertising or compiling information to promote or assist surrogacy arrangements was also made criminal. The ban applied equally to partial and full surrogacy. Section 59 of the 2008 Act amended the Surrogacy Arrangements Act to allow reasonable payments to be made to non-profitmaking bodies and for such non-profit agencies to place advertisements. Under the Act, no offence is committed by a woman herself seeking to become, or becoming, a surrogate, nor is any offence committed by the man or the couple who persuade her to carry a child. The 1985 Act (as amended) is limited to banning the activities of any commercial agencies or individuals aiming to make a profit out of arranging surrogacy. A fertility specialist who helps in establishing a full surrogacy even in the private sector incurs no criminal liability, so long as he does not involve himself in arranging the introduction of couple and surrogate. Lawyers however who draw up agreements for profit may contravene the law and this of itself contributes to the problems of surrogacy, acting as a disincentive to firms to provide advice.¹⁷⁴

Although the surrogate and the couple engaging her services do not commit any offence under the 1985 Act even if she is paid for what she does, the law still seeks to prevent any payment suggesting that the child has been bought. As we have seen, the commissioning couple need either to adopt the child or obtain a parental order, and it is a criminal offence to give or receive any payment in relation to the adoption of a child, the grant of consent to adoption, or the handing over of a child with a view to its adoption, unless that payment is authorised by a court.¹⁷⁵ Any payment beyond ‘reasonable expenses’ (again unless authorised by the court) will debar the couple from obtaining a parental order.¹⁷⁶ And if barred from obtaining a parental order the couple’s only option is to adopt but if they try to adopt the child and money paid to the surrogate is found to include a sum in payment for her agreement to the adoption and handing over the child, the surrogate and the couple may all face prosecution. Moreover, the Adoption Act further provides that the court may order the infant to be removed to a place of safety ‘until he can be restored to his parents or guardians or until other arrangements can be made for him’.

Judicial responses to ‘commercial surrogacy’ have been pragmatic and focused on the needs of the child. In 1985, Kim Cotton had agreed to carry a child for a childless couple from abroad. She was artificially inseminated with the husband’s sperm. The arrangements were made through an agency paid £13,000 by the father, of which the surrogate received £6,500. At the relevant time, the Surrogacy Arrangements Act had not yet been enacted. The baby was born and the mother prepared to hand her over. Barnet social services stepped in. The child was made a ward of court. Latey J¹⁷⁷ set the precedent for pragmatic compassion that his judicial colleagues have followed since. He said that the crucial issue before him was what was best for this baby. The methods used to create the child and the commercial aspects of the case raised delicate problems of ethics, morality and social desirability. They were not for him to decide. Careful inquiries showed that the father and his wife were eminently suitable parents. The judge granted them custody of the baby and permission to take her abroad with them to their home. The question of adoption, and the illegality of any payment under the Adoption Act 1976, did not arise in that case.

Two years later, Latey J adjudicated on the consequences of another surrogacy arrangement where all the parties desired to abide by that arrangement.¹⁷⁸ Mr and Mrs A arranged for Mrs B to carry a child for them. The child was conceived by natural sexual intercourse between Mr A and Mrs B. Mrs B was to be paid £10,000.¹⁷⁹ A baby was born and handed over to Mr and Mrs A after birth. They sought to adopt the child, as they then had to do to acquire parental rights. Were they in breach of the Adoption Act and so at risk of losing their child? Latey J found they were not. He held that the payments were not to procure Mrs B’s consent to adoption. At the time of the agreement this was not in the parties’ minds. The payments were in the nature of expenses for Mrs B, recompense for her time and inconvenience. Furthermore, the judge held that, even if he were wrong and the payments were illegal payments, he had power to ratify those payments retrospectively. Payments authorised by the court are not unlawful. As a matter of pure legal reasoning, Latey J’s grounds for finding the payments made by Mr and Mrs A to Mrs B were lawful may well be faulty. What is clear is that the judge saw no reason to upset an arrangement which had worked, or to remove the child, now 2 years old, from the only parents it had known.

The problem of payments to the surrogate remains a source of difficulty. In Re X and Y (Foreign Surrogacy),¹⁸⁰ the commissioning couple entered into an agreement with a married woman in the Ukraine. She gave birth to twins after being implanted with a donor egg fertilised by the commissioning father’s sperm. The couple were able to bring the children back with them to the UK by special leave of the immigration authorities. Under Ukrainian law, the surrogate and her husband had no legal relationship with the twins but under UK law, they were the legal parents and both had to consent before the grant of any parental order. Hedley J managed to find that there was such as consent from the Ukrainian husband. But the surrogate has been paid substantial sums of money; €235 a month during pregnancy and a lump sum of €25,000 on the live birth, 80 per cent of which was paid on the delivery of her consent to hand over the twins. Such payments were lawful in the Ukraine. The couple conceded that the sums paid exceeded reasonable expenses. Hedley J first prioritised the welfare of the twins as requiring that they be considered to be lifelong members of the applicants’ family. Then he considered if the money paid was so disproportionate to reasonable expenses that for him to grant the parental order would be an affront to public policy. Noting that the couple had always acted in good faith and had made no attempt to defraud the authorities he felt able to grant the order.

Later in Re S (Parental Order),¹⁸¹ the same judge granted an order despite a payment of $23,000 to a Californian surrogate, identifying three issues relating to public policy. The court must ensure that a surrogacy arrangement is not used to circumvent the childcare laws in the UK to allow an order in favour of people who would not be approved as parents in England. The court should be astute not to be involved in anything that looks like a simple payment to buy a child abroad and to ensure that the sums of money offered are not such that they overbear the will of the surrogate.¹⁸² In Re L (A Minor)¹⁸³ Hedley J faced a case where there could be no doubt that the payments made exceeded even the most generous interpretation of reasonable expenses. The commercial surrogacy arrangement entered into by British couple in Illinois was lawful under the law of Illinois and unlawful under the 2008 Act in the UK. Nonetheless the judge used his powers under section 54(8) of the 2008 Act to authorise the payment retrospectively and grant the parental order. He was careful to stress that the couple acted in good faith, unaware of the law here. He described the authorised payment as ‘compensation’ and stressed that each case must be scrutinised on its own facts. But when the welfare of the child was at stake, Hedley J stressed that good of the child must be accorded priority and that ‘if it is desired to control commercial surrogacy arrangements, those controls need to operate before the court process is initiated’.¹⁸⁴ In J v G¹⁸⁵ payments to a surrogate in California of £35,650 plus expenses were authorised.

Reading the case law it may seem that the courts are rewriting the law, but what can a judge do, especially given that the Human Fertilisation and Embryology (Parental Orders) Regulations (2010)¹⁸⁶ require that the child’s welfare be the paramount consideration? More worrying perhaps than payments to the surrogate may be the payments made to agencies overseas. In P-M (Parental Order; Payments to Surrogacy Agency)¹⁸⁷ a couple paid $17,700 to the surrogate and $48,000 to the agency, including sums described as a ‘gift’ to jump the queue.

‘Custody’ of the baby

12.30 If the surrogate is content to hand the baby over, the courts will help the commissioning couple to become the legal parents of the baby. What if she changes her mind? First, it is absolutely clear in England that surrogacy agreements are not enforceable as contracts. The commissioning couple cannot sue the surrogate for breach of contract, or ask a court to order performance of a contract. Nor can the surrogate sue if she does not receive any agreed payments. Section 1A of the Surrogacy Arrangements Act 1985, provides quite simply that: ‘No surrogacy arrangement is enforceable by or against any of the persons making it’. It does not matter by what means the child was created, be it sexual intercourse, DI or IVF, the arrangement is not an enforceable contract.

That still leaves open the question of what happens if the surrogate wants to keep the baby. In England, if the surrogate changes her mind and refuses to surrender the child, she will usually be allowed to keep the child. In A v C¹⁸⁸ as long ago as 1978, a young woman agreed to have a baby by DI and hand over the child to the wealthy father and his partner. She was to be paid £3,000. When the child was born she refused to give him up. The father sought care and control. The trial judge found that the mother should be allowed to keep the child, but granted the father limited access. The Court of Appeal removed his rights of access, condemning the whole arrangement as ‘irresponsible, bizarre and unnatural’. Nor does it seem that greater tolerance of surrogacy has altered judicial policy where surrogates change their minds. In Re P (Minors) (Ward-ship: Surrogacy),¹⁸⁹ Sir John Arnold P refused to order a surrogate mother to hand over twins born as a result of her artificial insemination by the father. It would seem that in England, a surrogate would be deprived of her baby only if she were an unfit mother who would not be allowed to keep the child however it had come to be conceived. Surrogacy is an arrangement couples enter into at their peril. If all goes to plan, they will get ‘their’ baby. If the arrangement breaks down, the law will not in most cases assist them in a battle with the surrogate. More recently in Re T (A Child) (Surrogacy: Residence Order)¹⁹⁰ Baker J refused to make a residence order in favour of the commissioning father after a surrogacy agreement broke down in acrimony.

But there are exceptions. If the surrogate hands over the child, who is settled into the couple’s home, but later changes her mind about consent to adoption or a parental order, the court has on two occasions at least overruled the surrogate’s refusal of consent.¹⁹¹ The welfare of the child once he or she is established in a ‘new’ family will override any claims of the surrogate.

Re N (A Child)¹⁹² is another exceptional case and a cautionary tale of the perils of surrogacy. We do no more than summarise this complex case. Mrs P agreed to carry a child for Mr SJ and his wife TR. Mrs P underwent artificial insemination with SJ’s sperm and became pregnant but deceived SJ, telling him she had miscarried so that she could keep the child, N. She had perpetrated just the same fraud on another couple some years earlier, giving birth to a child, C. The Court of Appeal upheld the judgment by Coleridge J that N now aged 18 months should live with the biological father and his wife.¹⁹³ A residence order in favour of SJ with contact for Mr and Mrs P was most likely to give N a happy home into which to mature as a happy balanced adult. Mrs P’s fraud was relevant to her suitability as a parent but the judgment in favour of SJ must not be seen as a penalty for breaking the surrogacy agreement. In relation to the older child, C, an agreement was reached before the court hearing that C who was nearly 6, should remain with Mr and Mrs P and at an appropriate time be told of her biological paternity and contact with her genetic father arranged. Both children were made wards of court.

The case of H v S (Surrogacy Agreement)¹⁹⁴ was presented in the media as a judge enforcing a surrogacy agreement against the surrogate in favour of a gay couple. Russell J was however explicit stating that she was not enforcing the agreement but acting in the best interests of the child when she granted a shared residence order in favour of the couple. The facts (as in Re N above) were extraordinary. The surrogate agreed with the two men (H and B) that she would carry a child and was inseminated with H’s sperm. She later denied any such agreement and claimed that in effect H agreed to act as sperm donor. She did all she could to keep H out of the child’s life. She had the child baptised in breach of a prohibited steps order, adopted a highly possessive parenting style and was obstructive and untruthful in court proceedings. The mother was unable to put the child’s needs first or to meet her emotional needs. The judge decided that despite the fact the child had lived with her mother for over a year, her interests were better served by moving her to live with her father and his partner.

Foreign surrogacy arrangements

12.31 Many cases reaching the courts relate to couples who go abroad to find a surrogate in a jurisdiction where more young women may be prepared to act as surrogates, or the rules on parenthood may be more favourable to the couple and controls on payment less rigorous. Re X and Y (Foreign Surrogacy)¹⁹⁵ (discussed above) has shown that it is UK rules on legal parenthood that will apply and the problems that may cause. In particular, the rule that makes a surrogate’s husband the legal father has proved problematic. The couple may be told that the surrogate is single (perhaps divorced) only to discover later that she probably remained married.¹⁹⁶

When couples seek to gain the requisite consent there may even be uncertainty about the literacy¹⁹⁷ or even the identity of the surrogate.¹⁹⁸ We have also seen that judges will take a fairly lenient view of payments so as not to disrupt an established relationship between the commissioning couple and the child.¹⁹⁹ Other couples have faced more serious problems. If the child is born abroad and the commissioning couple are not in law her parents how can they lawfully bring her home to the UK? Can they only apply for such an order when the child has a home with them in this country? The immigration authorities will grant exceptional leave to allow the child into the UK if at least one partner has a genetic link to the child and it is likely that a parental order will be granted. In Re K (Minors)²⁰⁰ twins were born as a result of a commercial surrogacy arrangement in India entered into by a British couple. The children were handed over to the couple, but remained for most of the time with their Indian grandparents while the couple sought to bring them home to the UK. An application for a parental order was listed before Hedley J who ruled that as the children were not in this country he could not progress the applications and declined to issue any directions to the immigration authorities. He noted that without the children’s presence in the UK, no welfare assessment could be made and expressed concern about the issues that might arise in relation to the monies paid to the surrogate and her husband. He also questioned whether the payments would be at a level that the court would be unable to accept as reasonable expenses or exercise their powers to authorise.

Problems also arise when couples come from abroad to seek a surrogacy arrangement in the UK. A Turkish couple made such an arrangement and the child was handed over to them but they were not domiciled in the UK and so ineligible to apply for a parental order. The judge was able to exercise a power under the Adoption and Children Act 2002 to confer parental responsibility on the couple to permit them to take the child home to Turkey and adopt the child there.²⁰¹

Surrogacy in need of reform

²⁰²

12.32 The cases discussed, a small sample of the many decisions on surrogacy, demonstrate that the law is sorely in need of reform. Many couples are unaware of the law governing surrogacy arrangements and the potential exists for exploitation of all parties by an unscrupulous agencies or individuals.

How serious is the problem? The number of surrogacy arrangements is impossible to ascertain accurately. Media reports suggested up to 1,000 births to British couples in India alone.²⁰³ Crawshaw, analysing parental orders, found evidence of 149 in 2012.²⁰⁴ In 1996 the government set up a review of the law relating to surrogacy and in its report in 1998,²⁰⁵ it was estimated that there were about 50 to 80 births in the UK arising from surrogacy arrangements.

The Surrogacy Review made a number of recommendations which included maintaining the prohibition on paying surrogates for their services. A new Surrogacy Act should define expenses to exclude covert payments. Any agency which introduced couples and surrogates or offered advice on surrogacy would have to be registered with the Department of Health. A Code of Practice would be developed which agencies must abide by, setting out a model of good practice for couples and surrogates. The Code would seek to ensure frank exchanges of information and offer independent counselling to all involved. Prohibition on payments was vigorously opposed by the major surrogacy agency COTS (Childlessness Overcome Through Surrogacy) and a number of eminent scholars. The most telling criticism of the Surrogacy Review came from Michael Freeman²⁰⁶ who argued, first, that surrogates are entitled to payment and, second, that a ban on payment will drive surrogacy underground, increasing risks of exploitation and harm the children. In the event, the report of the Surrogacy Review has simply mouldered on the shelves of the Department of Health.

In 2016 the pressing need for more effective regulation of surrogacy is patent. The form of regulation will never be settled, however, unless the vexed question of payment is resolved. The arguments are finely balanced. We expect and receive payment for the use of our brains. Why should a surrogate not be paid for the use of her uterus? But should bodily services or body parts be traded? Can you buy children?²⁰⁷ Proponents of payment argue that paying a surrogate for reproductive labour is not buying a child. Yet what couple would pay if the child is not surrendered? Most pro-payment campaigners argue that surrogacy contracts should remain unenforceable.²⁰⁸ Is that logical? If the use of the uterus is no different from manual or intellectual labour, why should the surrogate not be obliged to honour her contract?

Given the growth of surrogacy here and abroad a ban on payments no longer looks feasible even to those who, like the first named author, might wish to affirm a gift relationship. If there is to be a market, it needs to be overt and regulated. The provision for parenthood must be revisited and the option of prenatal approvals considered. The task will be immense, as surrogacy is now an international business. Moylan J put it thus:

This case provides a clear example of the difficulties created as a result of surrogacy arrangements being subject to varying degrees of domestic regulation, from significant regulation to none at all … There is in my view a compelling need for a uniform system of regulation to be created by an international instrument in order to make available an appropriate structure in respect of what can only be described as the surrogacy market.²⁰⁹

¹  E Jackson, Regulating Reproduction: Law Technology and Autonomy (2001) Hart.

²  Human Fertilisation and Embryology Authority: Fertility Treatment: Trends and Figures 2013 (2014).

³  Who gave birth to her own first child without fertility treatment in 2006.

⁴  There is a (possibly apocryphal) story about one clinic storing sperm in the same fridge as milk for staff coffee breaks.

⁵  Report of the Committee of Inquiry into Human Fertilisation and Embryology (1984) Cm 9314 (the Warnock Report).

⁶  The Act reached the statute book only after vitriolic debate in Parliament and the publication of two further reports by the government, a general consultation document early in 1987 and a White Paper later that year. See Legislation on Human Infertility Services and Embryology (1987) Cm 46; Human Fertilisation and Embryology: A Framework for Legislation (1987) Cm 259.

⁷  See in particular, the House of Commons Science and Technology Committee Fifth Report of Session 2004–5 Human Reproductive Technologies and the Law HC-7-1, Vol 1.

⁸  See, for example, R (Quintavalle) v Human Fertilisation and Embryology Authority [2003] 2 All ER 105; R (Quintavalle) v Human Fertilisation and Embryology Authority [2005] 2 All ER 555, HL.

⁹  See Jackson, Regulating Reproduction.

¹⁰  See J Laing, DA Oderberg ‘Artificial Reproduction, the “Welfare Principle” and the Common Good’ (2005) 13 Medical Law Review 328.

¹¹  DH, Review of the Human Fertilisation and Embryology Act – A Public Consultation (2005) Ref 269640; Report on the Consultation on the Review of the Human Fertilisation and Embryology Act 1990 (2006).

¹²  Review of the Human Fertilisation and Embryology Act – Proposals for Revised Legislation (including the Establishment of the Regulatory Authority for Tissue and Embryos) (2006) Cm 6989.

¹³  See Attorney-General’s Reference (No 2 of 2003) [2004] EWCA Crim 785.

¹⁴  Section 1(2). But gamete intra-fallopian transfer (GIFT) where eggs and sperm are mixed in the laboratory and then placed in the woman’s body would seem to remain outside the Act unless donor gametes are used as fertilisation does not begin until the sperm and eggs unite within the body.

¹⁵  See s 4(1)(b)(ii). And see s 1(5) sperm to be treated as partner donated if the donor and the recipient declare that they have an ‘intimate physical relationship’.

¹⁶  See M v F [2013] EWHC 1901 (Fam).

¹⁷  HFEA press release (2010) 17 September.

¹⁸  JK Mason, GT Laurie, Mason and McCall Smith’s Law and Medical Ethics (9th edn, 2013) Oxford University Press, 8.27.

¹⁹  See for example the activities of Mr F in M v F (above n 16).

²⁰  Section 3(2).

²¹  Section 3ZA.

²²  Section 3ZA(5).

²³  Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015, SI 2015/572.

²⁴  See R (on the application of the Assisted Reproduction and Gynaecology Centre) v Human Fertilisation and Embryology Authority [2002] EWCA Civ 20; but see The Assisted Reproduction and Gynaecology Centre and the Reproductive Genetics Institute v HFEA [2013] EWHC 3087 (Admin).

²⁵  See in particular, the Report of the House of Commons Science and Technology Committee.

²⁶  X v St Bartholomew’s Hospital Centre for Reproductive Medicine [2015] EWFC 13.

²⁷  See Human Fertilisation and Embryology Authority, Code of Practice (8th edn, 2009), version 8.0, paras 11.46–11.52.

²⁸  Ibid, paras 7.1–7.9.

²⁹  R (on the application of the Assisted Reproduction and Gynaecology Centre) v HFEA [2002] EWCA Civ 20.

³⁰  The Assisted Reproduction and Gynaecology Centre and the Reproductive Genetics Institute v HFEA [2013] EWHC 3087 (Admin).

³¹  S-K Templeton, ‘Fertility Clinic Defeats Legal Limit on Number of Twins and Triplets’ The Times (2013) 10 November.

³²  HFEA, Fertility Treatment: Trends and Figures 2013 (2014), 35.

³³  See Understanding Clinic Success Rates (2009) HFEA, accessible at www.hfea.gov.uk/fertility-clinics-success-rates.html

³⁴  See M Brazier, ‘Regulating the Reproduction Business?’ (1999) 7 Medical Law Review 166.

³⁵  See (2003) Guardian 16 January. And see Attorney General’s Reference (No 2 of 2003) [2004] EWCA Crim 785.

³⁶  [2003] 1 FLR 1091.

³⁷  www.dailymail.co.uk/health/article-144788/IVF-embryo-mix-up.html

³⁸  Re E and F [2013] EWHC 1418.

³⁹  IVF is still opposed by the Roman Catholic Church on the grounds that it separates the conjugal act and the creation of a child: see E. Jackson, Medical Law: Text, Cases and Materials (2013) Oxford University Press, p 773.

⁴⁰  Mason, Laurie, Mason and McCall Smith’s Law and Medical Ethics, 8.13.

⁴¹  [2003] 1 FLR 1091. And see A Bainham, ‘Whose Sperm Is It Anyway?’ [2003] Cambridge Law Journal 566.

⁴²  It was suggested at the time that this was not a unique error, but one which became apparent because the couples involved had different racial origins; see (2002) Guardian 8 July.

⁴³  M v F [2013] EWHC 1901 (Fam), [9].

⁴⁴  A number of MPs and peers (in 1990) hoped that the HFEA would ban DI, and other forms of assisted conception, for all single women, save in the most exceptional circumstances.

⁴⁵  See, for example, E Jackson, ‘Conception and the Irrelevance of the Welfare Principle’ (2002) 65 Modern Law Review 176.

⁴⁶  See House of Commons Science and Technology Committee, Human Reproductive Technologies and the Law, para 101.

⁴⁷  HFEA, Code of Practice (8th edn, 2009), version 8.0, para 8.3.

⁴⁸  ‘German Woman Aged 65 Gives Birth to Quadruplets after IVF Treatment’ Guardian (2015) 23 May.

⁴⁹  See M Brazier, ‘Liberty, Responsibility Maternity’ (1999) 52 Current Legal Problems 359.

⁵⁰  [2015] EWFC 22.

⁵¹  G Douglas, ‘Assisted Reproduction and the Welfare of the Child’ (1993) Current Legal Problems 46.

⁵²  R v Ethical Advisory Committee of St Mary’s Hospital ex p Harriott [1998] 1 FLR 512.

⁵³  R v Sheffield Area Health Authority ex p Seale [1994] 25 BMLR 1.

⁵⁴  NICE, Fertility Assessment and Treatment for People with Fertility Problems CG156 (2013), 1.11.1.3. The 2013 guidance also extends funded treatment to lesbian couples.

⁵⁵  Evans v United Kingdom (2008) 46 EHRR 34.

⁵⁶  Dickson v United Kingdom (2007) 46 EHRR 41; and see SH and others v Austria (Application No 55813/00) November 15 2007.

⁵⁷  But Article 12 has seemingly been relegated to the sidelines by the ECtHR: see M Eijkholt, ‘The Right to Found a Family as a Stillborn Right to Procreate?’ (2010) 18 Medical Law Review 127.

⁵⁸  [2003] EWHC 2161 (Fam), [263].

⁵⁹  See A, B and C v Ireland [2010] ECHR 25579/05.

⁶⁰  A question skilfully ducked in Dickson v United Kingdom [2008] 46 EHRR 41.

⁶¹  Dickson v United Kingdom (2008) 46 EHRR 41, para 71.

⁶²  See A, B and C v Ireland [2010] ECHR 25579/05.

⁶³  R v Secretary of State for the Home Department ex p Mellor [2001] EWCA Civ 472.

⁶⁴  Dickson v United Kingdom (2007) 46 EHRR 41.

⁶⁵  In cases where the husband’s consent is disputed, it would be for him to prove that he did not consent.

⁶⁶  Re CH (Contact: Parentage) [1996] 1FCR 768.

⁶⁷  This means that if he and the mother register the birth of the child together, they share parental responsibility for the child. Should they not do so, to gain parental responsibility for the child, the ‘social’ father must either enter into a formal agreement with the mother to do so, or seek a court order to share parental responsibility with the mother; see section 4 of the Children Act 1989 as amended by the Adoption and Children Act 2002.

⁶⁸  Re B (Parentage) [1996] FLR 15; In Re Q (Parental Order) [1996] 1 FLR 369.

⁶⁹  See for example U v W (Attorney General Intervening) [1998] Fam 29: Re R (A Child) (IVF: Paternity of a Child) [2003] 2 AC 621, HL.

⁷⁰  See C Lind, ‘In Re R (Paternity of IVF Baby) – Unmarried Paternity under the Human Fertilisation and Embryology Act 1990’ (2003) 15 Child and Family Law Quarterly 327.

⁷¹  But not to any case where the pregnancy is established by sexual intercourse even if the man and the woman perceive the man as acting merely as a ‘sperm donor’. In such a case the biological father will be the legal father of the child. See the strange and troubling case of M v F [2015] EWFC 22.

⁷²  Substantial problems have arisen when clinics have failed to use /record the requisite information demanded by the legislation. Such failure runs the risk of invalidating the clinic’s licence and thus threatening to deprive the ‘agreed father’ of his status as the legal father. Judges seek to avoid such an out come where possible: see X v Y (St Bartholomew’s Hospital Centre for Reproductive Medicine (CRM) intervening) [2015] EWFC 13; but contrast with the sad outcome in Re E and F (Children) (Assisted Reproduction) [2015] EWHC 1418 (Fam).

⁷³  See R D’Alton-Harrison, ‘Mater Semper Incertus Est: Who’s Your Mummy’ (2014) 22 Medical Law Review 357.

⁷⁴  See Marriage (Same Sex Couples) Act 2013, Sched 7, para 40.

⁷⁵  On problems of record keeping and process; see AB v CD [2013] EWHC 1418 (Fam).

⁷⁶  [2013] EWHC 1418 (Fam).

⁷⁷  [2014] EWCA Civ 336. See C Bridge, ‘Parental Responsibility’ (2014) 44(Jul) Family Law 970. And see JB v KS [2015] EWHC 180 (Fam).

⁷⁸  [2013] EWHC 134 (Fam). See A Brown, ‘Re G; Re Z (Children: Sperm Donors: Leave to Apply for Children Act Orders): Essential “Biological Fathers” and Invisible “Legal Parents”’ (2014) 26(2) Child and Family Law Quarterly 237.

⁷⁹  Section 48(2).

⁸⁰  [2006] UKHL 629, [32–37].

⁸¹  See S McGuinness, A Alghrani, ‘Gender and Parenthood: The Case for Realignment’ (2008) 16 Medical Law Review 261.

⁸²  See R (on the application of JK) v Registrar General for England and Wales [2015] EWHC 990 (Admin). J, a transgender woman who was born male, objected to being recorded as the father on her children’s birth certificates. Her application for judicial review was refused. Hickinbottom J held there was no breach of articles 8 or 14 of the ECHR.

⁸³  See 13.20.

⁸⁴  And see Dickson v United Kingdom [2008] 46 EHRR 41 (at 12.9) where a prisoner challenged the refusal by the prison authorities to allow him to arrange to provide sperm to enable his wife to become pregnant.

⁸⁵  Do resulting children face a greater risk of genetic disease? Will some born via ICSI be themselves infertile? See S Mayor, ‘Technique for Treating Infertility May Be Risky’ (1996) 313 BMJ 248.

⁸⁶  L v L [1949] P 211.

⁸⁷  [1997] 2 All ER 687, CA. See D Morgan and R Lee, ‘In the Name of the Father? Ex parte Blood Dealing with Novelty and Anomaly’ (1997) 60 Modern Law Review 84.

⁸⁸  But note R (AB) v HFEA [2014] EWHC 1528 (Admin), where a woman seeking recovery of sperm from her partner who was said to be in a permanent vegetative state after a cardiac arrest sought to argue that the recovery of sperm was in his best interests and thus would be lawful by virtue of s 4 of the Mental Capacity Act 2005. Even were that argument to succeed and the process of recovery itself was deemed not to be an assault, further storage and use of the gametes would contravene the Human Fertilisation and Embryology Act in the absence of the requisite effective consents in writing.

⁸⁹  See T Hervey, ‘Buy Baby: The European Union and Regulation of Human Reproduction’ (1998) 18 Oxford Journal of Legal Studies 207.

⁹⁰  A number of children have been born after posthumous AIH where the requisite written consent had been given.

⁹¹  [2008] EWHC 2149.

⁹²  Review of Common Law Provision Relating to the Removal of Gametes and of the Consent Provision in the Human Fertilisation and Embryology Act 1990 (1998).

⁹³  [2009] EWCA Civ 37; discussed at 18.1 and 18.10.

⁹⁴  [2015] EWHC 1706 (Admin).

⁹⁵  Ibid, [33].

⁹⁶  See also the discussion in the judgment of IM’s Article 8 rights.

⁹⁷  See Human Fertilisation and Embryology Act 1990, s 12(e). And see Directive on Setting Standards of Quality and Safety for the Donation, Testing, Processing, Preservation, Storage and Distribution of Human Tissues and Cells (Directive 2004/23/ EC).

⁹⁸  HFEA, Egg and Sperm Donation UK 2012–13.

⁹⁹  See Jackson, Medical Law, pp 800–805.

¹⁰⁰  See HFEA, Code of Practice (8th edn, 2009), version 8.0, paras 12.1–12.32.

¹⁰¹  Another benefit in kind might be to offer sterilisation in the private sector to a woman who agrees to donate her eggs prior for surgery.

¹⁰²  Though note that children have been born using frozen eggs.

¹⁰³  No question of destroying embryos arises if a woman decides later that she does not wish to have children. And a woman who stores her eggs avoids the fate that overtook Natalie Evans. See Evans v United Kingdom [2006] ECHR discussed at 12.18.

¹⁰⁴  See BBC News, ‘Baby Born from Ovary Frozen in Mother’s Childhood’ (2015) 10 June.

¹⁰⁵  See HFEA, Donated Ovarian Tissue in Embryo Research and Assisted conception (1994).

¹⁰⁶  Section 4.

¹⁰⁷  See s 14(3)–(4).

¹⁰⁸  See s 14 (5).

¹⁰⁹  Section 14 (1)(c).

¹¹⁰  Human Fertilisation and Embryology (Statutory Storage Period for Embryos) Regulations 1996, SI 1996/375.

¹¹¹  [2014] EWHC 602 (Fam).

¹¹²  SI 2009/1582 (amended SI 2009/2581).

¹¹³  [2004] EWCA Civ 727.

¹¹⁴  [2003] EWHC 2161 (Fam).

¹¹⁵  [2004] EWCA Civ 727; see A Alghrani, ‘Deciding the Fate of Frozen Embryos’ (2005) 15 Medical Law Review 244.

¹¹⁶  [2004] EWCA Civ 227, [69] per Thorpe LJ.

¹¹⁷  [2006] 1 FCR 585 (ECtHR). The House of Lords declined to hear Ms Evans’s appeal. See T Annett, ‘Balancing Competing Interests over Frozen Embryos: The Judgment of Solomon’ (2006) 14 Medical Law Review 425; C Lind, ‘Evans v United Kingdom – Judgments of Solomon: Power, Gender and Procreation’ (2006) 18 Child and Family Law Quarterly 576.

¹¹⁸  [2008] 46 EHRR 34.

¹¹⁹  See Schedule 3 para 4A(4).

¹²⁰  See R Scott, ‘Choosing Between Possible Lives: Legal and Ethical Issues in Pre-Implantation Genetic Diagnosis’ (2006) Oxford Journal of Legal Studies 153.

¹²¹  R (on the application of Quintavalle) v Human Fertilisation and Embryology Authority [2003] 3 All ER 257, CA.

¹²²  HFEA Code of Practice (8th edn), version 8.0, paras 10.11–10.12; and see R Scott, C Williams, K Ehrich, B Farsides, ‘The Appropriate Extent of Pre-implantation Genetic Diagnosis: Health Professionals’ and Scientists’ View on the Requirement for a Significant Risk of a Serious Genetic Condition’ (2007) 15 Medical Law Review 320.

¹²³  HFEA, Choices and Boundaries (2006).

¹²⁴  Note that PGD to establish if a person is a carrier of a genetic abnormality is not permitted as such by the amended Schedule 2 but tests for a recessive condition may disclose that there are embryos which are not affected by the disease themselves but are carriers and could lawfully then not be selected for implantation.

¹²⁵  See S Sheldon, S Wilkinson, ‘Hashmi and Whitaker: An Unjustifiable and Misguided Distinction’ (2004) 12 Medical Law Review 137.

¹²⁶  R (on the application of Quintavalle v Human Fertilisation and Embryology Authority [2005] 2 All ER 555, HL.

¹²⁷  See 17.5.

¹²⁸  See J Savulescu, ‘Deaf Lesbians, “Designer Disability” and the Future of Medicine’ (2002) 325 BMJ 771.

¹²⁹  S Wilkinson, ‘Racism and Sexism in Medically Assisted conception’ (1998) 12 Bioethics 25.

¹³⁰  Sch 2, para 1ZB.

¹³¹  Adoption Act 1976, s 51(2).

¹³²  HFEA (Disclosure of Donor Information) Regulations 2004, SI 2004/1511.

¹³³  And about possible half siblings.

¹³⁴  K O’Donovan, ‘What Shall We Tell the Children? Reflections on Children’s Perspectives and the Reproduction Revolution’ in R Lee and D Morgan (eds) Birthrights: Law and Ethics and the Beginning of Life (1989) Routledge.

¹³⁵  Gaskin v United Kingdom [1990] 1 FLR 167.

¹³⁶  [2002] EWHC 1593.

¹³⁷  See Parkinson v St James and Seacroft University Hospital NHS Trust [2001] 3 All ER 97, CA. See 11.12.

¹³⁸  See 11.7.

¹³⁹  See McKay v Essex Area Authority [1982] 2 All ER 771, CA, discussed at 11.11.

¹⁴⁰  See Human Fertilisation and Embryology (Research Purposes) Regulations 2001, SI 2001/188.

¹⁴¹  HFEA/HGAC Cloning Issues in Reproduction, Science and Medicine (1998).

¹⁴²  R (on the application of Quintavalle) v Secretary of State for Health [2001] 4 All ER 1019.

¹⁴³  And see R (on the application of Quintavalle) v Secretary of State for Health [2003] 2 All ER 113, HL.

¹⁴⁴  Section 1(1).

¹⁴⁵  Section 3(2).

¹⁴⁶  See, notably, J Harris, On Cloning (2004) Routledge.

¹⁴⁷  Summed up in Jackson, Medical Law, pp 831–835.

¹⁴⁸  Mason, Laurie, Mason and McCall Smith’s Law and Medical Ethics, 7.103.

¹⁴⁹  [2015] EWFC 17.

¹⁵⁰  See M Brazier, A Campbell, S Golombok, Surrogacy: Review for Health Ministers of Current Arrangements for Payments and Regulation (1998) Cm 4068 (hereafter referred to as Surrogacy Review).

¹⁵¹  As was the case in M v F and another [2013] EWHC 1901 (Fam).

¹⁵²  JP v LP and others (Surrogacy Arrangements: Wardship) [2014] EWHC 595, [39].

¹⁵³  Mason, Laurie, Mason and McCall Smith’s Law and Medical Ethics, 8.89.

¹⁵⁴  See Human Fertilisation and Embryology Act 1990 (as amended), s 27; and Human Fertilisation and Embryology 2008, s 33. See R D’Alton-Harrison (above n 73).

¹⁵⁵  And so if her relationship with the biological father breaks down before a parental order is obtained she may have no legal claim in relation to the child even if she has been since the birth the ‘social’ and ‘psychological’ mother; see JP v LP and others (Surrogacy Arrangement: Wardship) [2014] EWHC 595 (Fam).

¹⁵⁶  So it may be that the commissioning couple will want to try and show that the husband did not consent; see Re G (Surrogacy: Foreign Domicile) [2007] EWHC 2814.

¹⁵⁷  See Human Fertilisation and Embryology Act 1990 (as amended), s 28; and Human Fertilisation and Embryology Act 2008, s 35.

¹⁵⁸  Ibid, s 28.

¹⁵⁹  See Human Fertilisation and Embryology Act 2008, ss 36–38.

¹⁶⁰  Ibid, s 36(d).

¹⁶¹  [2014] EWHC 595 (Fam).

¹⁶²  And see Re D (A Child) [2014] EWHC 2121 (Fam).

¹⁶³  See Re W (Minors Surrogacy) [1991] 1 FLR 385.

¹⁶⁴  See AB v CD (Surrogacy: Time Limit and Consent) [2015] EWFC 12, [71] for the view that a parental order is much to be preferred to adoption in that the former recognises the reality of the child’s identity and biological relationship to at least one of the commissioning couple.

¹⁶⁵  B v C and others [2015] EWFC 17.

¹⁶⁶  JP v LP and others (Surrogacy Arrangement: Wardship) [2015] EWHC 595 (Fam).

¹⁶⁷  As was the case in Re an Adoption Application (Surrogacy) [1987] 2 All ER 826; and see M v F [2013] EWHC 1901 (Fam).

¹⁶⁸  X (A Child) (Surrogacy: Time Limit) [2014] EWHC 3135: AB v CD (Surrogacy: Time Limit and Consent) [2015] EWFC 12.

¹⁶⁹  See A and B (Parental Order: Domicile) [2013] EWHC 426 (Fam); JV and OV v AR [2014] EWHC 4756 (Fam).

¹⁷⁰  On which see Re Q (Parental Order) [1996] 2 FCR 345.

¹⁷¹  In AB v CD (Surrogacy: Time Limit and Consent) [2015] EWFC 12 the couple set out to seek a single surrogate in India so that AB would be the legal father but in the event it appeared that the surrogate was still married. The judge however held that the husband would not have consented to his ‘wife’s’ treatment and so was not the legal father.

¹⁷²  See again AB v CD, ibid.

¹⁷³  But note payments of £12,000 and more have been deemed reasonable expenses; Re C (Application by Mr and Mrs X under s 30 of the Human Fertilisation and Embryology Act) [2002] EWHC 157.

¹⁷⁴  JP v LP and others (Surrogacy Arrangement: Wardship) [2015] EWHC 595 (Fam), [41].

¹⁷⁵  See Adoption Act 2002, s 95.

¹⁷⁶  Section 54(8).

¹⁷⁷  Re C (A Minor) [1985] FLR 846.

¹⁷⁸  Re an Adoption Application (Surrogacy) [1987] 2 All ER 826. And see Re Q (Parental Order) [1996] 1 FLR 369.

¹⁷⁹  In the event, Mrs B accepted only £5,000 of the agreed fee, having co-authored a book on her experience of surrogacy.

¹⁸⁰  [2008] EWHC 3030 (Fam).

¹⁸¹  [2009] EWHC 2977 (Fam).

¹⁸²  See also JV, OV v AR [2015] EWHC 4756 (Fam).

¹⁸³  [2010] EWHC 3146 (Fam).

¹⁸⁴  [2010] EWHC 3146 (Fam), [10].

¹⁸⁵  [2013] EWHC 1432 (Fam).

¹⁸⁶  SI 2010/985 and the Human Fertilisation and Embryology (Parental Orders) (Consequential, Transitional and Saving Provisions) Order 2010, SI 2010/986.

¹⁸⁷  [2013] EWHC 1561 (Fam).

¹⁸⁸  [1985] FLR 445 (FD and CA).

¹⁸⁹  Re P (Minors) (Wardship: Surrogacy) [1987] 2 FLR 421.

¹⁹⁰  [2011] EWHC 33 (Fam).

¹⁹¹  Re MW (Adoption: Surrogacy) [1995] 2 FLR 759; C v S (1996) SLT 1387.

¹⁹²  [2007] EWCA Civ 1053.

¹⁹³  Re P (Surrogacy: Residence) [2008] 1 FLR 177.

¹⁹⁴  [2015] EWHC 36 (Fam).

¹⁹⁵  [2008] EWHC 3030 (Fam); and see Re S (Parental Order) [2009] 2977 (Fam).

¹⁹⁶  Re D (A Child) [2014] EWHC 2121 (Fam).

¹⁹⁷  Re WT (Foreign Surrogacy) [2014] EWHC 1303 (Fam).

¹⁹⁸  Re D (A Child) [2014] EWHC 2121 (Fam). And see R v T [2015] EWFC 22.

¹⁹⁹  As in Re L (A Minor) [2010] EWHC 3146 (Fam). On the issue of judicial leniency in relation to a host of reproduction services abroad, see B van Beers, ‘Is Europe “Giving in to Baby Markets”? Reproductive Tourism in Europe and the Gradual Erosion of Existing Legal Limits to Reproductive Markets’ (2015) 23(1) Medical Law Review 103.

²⁰⁰  [2010] EWHC 1180 (Fam).

²⁰¹  Re G (Surrogacy: Foreign Domicile) [2007] EWHC 844.

²⁰²  A Alghrani, D Griffiths, M Brazier, ‘Surrogacy Law: From Piecemeal Tweaks to Sustained Review and Reform’ in A Diduck, N Peleg, H Reece (eds) Law In Society: Reflections on Children, Family, Culture and Philosophy – Essays in Honour of Michael Freeman (2014) Brill, at 425–453.

²⁰³  S Bhatia, ‘Indian Surrogacy Industry: We Could Never Have Imagined We’d Be Parents’ Daily Telegraph (2012) 26 May.

²⁰⁴  M Crawshaw, E Blyth, O Akker, ‘The Changing Profile of Surrogacy in the UK – Implications for National and International Policy and Practice’ (2012) 34 Journal of Social Welfare and Family Law 265.

²⁰⁵  Surrogacy: Review for Health Ministers of Current Arrangements for Payments and Regulation (CM 4068).

²⁰⁶  M Freeman, ‘Does Surrogacy Have a Future after Brazier?’ (1999) 7 Medical Law Review 1.

²⁰⁷  See M Brazier, ‘Can You Buy Children?’ (1999) 11 Child and Family Law Quarterly 345.

²⁰⁸  With the honourable exceptions of COTS and Mason, Laurie, Mason and McCall Smith’s Law and Medical Ethics, 8.116. And see Jackson, Medical Law, pp 866–869.

²⁰⁹  Re D (A Child) [2014] EWHC 2121 (Fam), [1].

Chapter 13

ABORTION AND EMBRYO RESEARCH

13.1 The legal and moral status of the human embryo continues to attract controversy. For the devout Roman Catholic and many others, life is given by God and begins at conception, thus the deliberate destruction of an embryo, be it in the course of embryo research, or by abortion, is the equivalent of killing you or us. The destruction of the embryo can only be justifiable, if at all, where the mother’s life is at risk. Even in such a case, abortion is still not lawful in some countries.¹ In 2010, three women went to the European Court of Human Rights (ECtHR) to challenge Irish laws that failed to provide access to safe and lawful abortion for women whose health was imperilled by pregnancy. The ECtHR, as we shall see, allowed one of the three claims but stopped well short of ruling that draconian restrictions on abortion in Ireland violated Article 8 of the Convention.²

Others contend that the human embryo has no greater moral status than a mouse embryo, and so neither research nor abortion is morally wrong. ‘Gradualists’ argue that the embryo acquires increasing moral claims as it develops in the womb. For many feminists, a right to abortion is part and parcel of a woman’s rights over her own body. While the central question of the claims of the embryo and the rights of the pregnant woman continues to be a source of vehement, even violent debate, in England, attention has tended to focus on narrower issues including the legality of sex selective abortion and the limits of the fetal disability ground in the Abortion Act 1967. Other problems relating to the embryo in the laboratory not the womb also command public attention. Should the creation of animal/human hybrids be allowed? What about mitochondrial treatment involving in the eyes of the media the creation of three parent families?

The present English laws³ on abortion and embryo research represent an attempt to reach a compromise in a debate in which there is no consensus. In 1990, Parliament, in the first Human Fertilisation and Embryology Act, sanctioned embryo research up to fourteen days, and permitted abortion in certain cases up to the moment of birth. ‘Pro-life’ campaigners continued to fight to ban research and restrict abortion. In recent years, the principal thrust of the campaign to restrict abortion in the United Kingdom has centred on attempts to reduce the time-limit for legal abortions. In parliamentary debates on the Human Fertilisation and Embryology Act 2008, further attempts were made by ‘pro-life’ groups to reduce time-limits while ‘pro-choice’ groups sought to remove the requirement that two doctors approve any termination of pregnancy. Both attempts to hijack the Bill to change the law on abortion failed. The 2008 Act in its amendments to the 1990 Act does make some substantial changes to the law governing embryo research principally to address the development of stem cell therapies and the vexed question of human/animal hybrid embryos.

Criminal abortion⁴

13.2 The law relating to criminal abortion is still to be found in sections 58 and 59 of the Offences Against the Person Act 1861.⁵ Strictly speaking, all that the Abortion Act 1967 does is create defences to charges under the 1861 Act. Section 58 of that Act makes it a criminal offence punishable by a maximum of life imprisonment: (1) for any woman, being with child, unlawfully to do any act with intent to procure a miscarriage;⁶ and (2) for any other person unlawfully to do an act with intent to procure the miscarriage of any woman.⁷ Self-induced abortion by the woman herself is criminal only if the woman is in fact pregnant. Any act by a third party is criminal regardless of whether or not the woman can be proved to be pregnant. This limited protection afforded to the woman extends only to cases where she acts entirely alone. If she seeks help from a doctor, or any other person, she may be charged with aiding and abetting that person to commit the offence of criminal abortion⁸ or of conspiracy with him to commit that offence.⁹ Section 59 makes it an offence to ‘unlawfully supply or procure any poison or other noxious thing, or any instrument or thing whatsoever, knowing that the same is intended to be unlawfully used or employed with intent to procure the miscarriage of any woman’.

A possible lacuna in the law is to be seen in the extraordinary case of Regina v A.¹⁰ Mr A set up a deliberate scheme of deception to seek to ensure that his young wife (to whom he was unhappily married) underwent an abortion without her consent or even her knowledge. Mrs A spoke no English and he took her to two clinics attempting to deceive doctors into believing that his wife wanted a termination. Both attempts failed and the wife was very upset when she discovered on the second occasion that she was booked into an abortion clinic. She finally managed to escape from her husband who was convicted under section 59 of the Offences Against the Person Act. His conviction was however overturned in the Court of Appeal. The appeal court rejected the argument that A had sought to procure a ‘thing’ ie surgery contrary to section 59 and found many of the grounds for the prosecution to be unsustainable. Additionally the court noted that on the information available to them the doctors, had the deception succeeded, might have acted lawfully in terminating the pregnancy. So A walked free after trying to terminate his wife’s pregnancy against her will.

The rigour of the law has always been tempered by a defence to a charge of criminal abortion by a doctor that he acted to preserve the life or health of the mother.¹¹ At no time in England was abortion absolutely prohibited so as to require the mother to be sacrificed for her unborn child.¹² In the 1939 case of R v Bourne,¹³ acquitting a doctor of a charge of criminal abortion, the judge suggested that there might be a duty to abort to save the ‘yet more precious’ life of the mother. The extent of the defence available to doctors was unclear. Some doctors interpreted this defence liberally to include the mother’s mental health and even happiness. Others would intervene only to prevent a life-threatening complication of pregnancy endangering the woman. Abortion on the ground that the fetus suffered from some serious disability was not lawful. Illegal abortion flourished. Several thousand women were admitted to hospital for treatment after back-street abortions. The Abortion Act 1967 was introduced to bring uniformity into the law, to clarify the law for the doctors, and to stem the misery and injury resulting from unhygienic, risky, illegal abortions.

The Abortion Act 1967

13.3 The Abortion Act 1967 provides that abortion may be lawfully performed under certain conditions.¹⁴ A pregnancy may be terminated by a registered medical practitioner if two registered medical practitioners¹⁵ are of the opinion, formed in good faith, that one of four grounds specified in the Act are met. They are:

(1)  The pregnancy has not exceeded its twenty-fourth week and the continuance of the pregnancy would involve risk to the life of the pregnant woman, or of injury to her physical or mental health, or that of the existing children of her family, greater than if the pregnancy were terminated. This is sometimes described as the ‘social’ ground for abortion.

(2)  The termination is necessary to prevent grave permanent injury to the physical or mental health of the woman.

(3)  The continuance of the pregnancy would involve risk to the life of the pregnant woman, greater than if the pregnancy were terminated.

(4)  There is a substantial risk that if the child were born it would suffer such physical or mental abnormalities as to be seriously handicapped.

No time-limit restricts termination of pregnancy on any of these latter three grounds. In assessing any risk to the health of the woman or her children, account may be taken of the woman’s actual or reasonably foreseeable environment. Exceptionally, one registered medical practitioner may act alone when he is of the opinion that an abortion is immediately necessary to save the life of the woman, or to prevent grave permanent injury to her physical or mental health. Save in an emergency any termination of pregnancy must be carried out in a National Health Service (NHS) hospital or a place (clinic) approved by the Department of Health.¹⁶ Section 4 of the Act provides that no person shall be under any duty to participate in the performance of an abortion if he has a conscientious objection to abortion, save where immediate treatment is necessary to save the life of the woman or to prevent grave permanent damage to her health.¹⁷

Abortion on demand or request?

13.4 The total number of abortions carried out in England and Wales in 2014 was 184,571; a slight decrease on the previous year. Of these, 98 per cent were funded by the NHS; 92 per cent were carried out before 13 weeks, and 80 per cent at under 10 weeks.¹⁸ Critics claim that abortion is available on demand, and that the Act is not being properly applied. Gynaecologists prepared to perform an abortion on the request of the pregnant woman rely on statistics which appear to show that statistically the risk of abortion in the first twelve weeks of pregnancy is less than the risk of childbirth. Therefore any abortion performed in that period meets the requirement of the Act that the continuance of the pregnancy poses a greater risk to the health of the woman than does termination. Such statistics include women for whom pregnancy poses exceptional risk, such as very young girls, or older women. The individual patient’s risk will often be much less than any statistical ‘average’. The issue has never been tested in court.

A successful prosecution against a doctor performing an abortion on demand would have to establish: (a) that the statistics indicating that abortion posed less risk than childbirth were invalid: and (b) that the doctor on trial did not believe them to be valid and so failed to act in good faith. In view of the fact that only one successful prosecution has ever been brought against a doctor for performing an abortion purportedly under the 1967 Act in bad faith,¹⁹ such a course would appear a clumsy means of regulating or eliminating abortion on demand or request. However, the Abortion Act confers on women no right to abortion. By making doctors the ‘gatekeepers’ for the Act, abortion in England is a privilege granted or withheld at the doctors’ discretion.²⁰

Many doctors however will comply with the woman’s request at least before the twenty-four-week limit for so-called ‘social abortions’. They do not question the woman’s reasons for ending her pregnancy. One reason however that generates huge controversy is sex selective abortion, ending a pregnancy because the fetus is not of the preferred sex. In 2012 media reports alleged that two doctors were offering tests to determine fetal sex and agreeing to abort female fetuses.²¹ Outcry followed and investigation into the conduct of the doctors is ongoing. Claims were made that sex selective abortion are illegal under the Abortion Act. That is not so. Such abortion might well not be carried out until after twenty-four weeks and in such cases must meet one of the grounds for late termination. But even then there might be a case where a woman is under such pressure to have a son that her mental health is at risk. We loathe the notion that one would abort a fetus for not being the ‘right’ sex, but sex selective abortion of itself is not at present illegal. Fiona Bruce MP unsuccessfully sought to introduce a Bill to make it so, and section 84 of the Serious Crime Act 2015 commits the government to investigate and report on the incidence of sex selective abortion. The issue is challenging. If abortions should be refused for one reason however good, should a more rigorous test of motivation for all abortions be carried out?

Post-coital birth control

13.5 The Abortion Act 1967 envisaged that once a diagnosis of pregnancy had been made, the doctor faced with a request for an abortion would consider and weigh any risk to the woman or the child. Post-coital contraceptive drugs (emergency hormonal contraception) if taken by a woman within seventy-two hours of intercourse, ensure that any fertilised egg will not implant in the womb. This, inaptly named, ‘morning-after’ pill is not the only means by which a fertilised egg may be disposed of at a stage before pregnancy can be confirmed. An intrauterine device (IUD) fitted within a similar time after intercourse will have the same effect.²²

Post-coital contraception raised the question of where the line is drawn between contraception and abortion. Post-coital contraception works before the fertilised egg can implant in the womb. The crucial legal issue, in relation to the use of the post-coital contraception, is whether a drug or a procedure which prevents implantation is an act done to procure a miscarriage.²³ Is there a carriage of a child by a woman before implantation takes place? If not, to prevent that event occurring cannot be an act done to procure a miscarriage. Many fertilised eggs fail to implant naturally and no one suggests that a miscarriage has occurred. The opponents of post-coital birth control responded that the fertilised egg is present within the body of the woman; thus she carries it within her. Therefore, there is a carriage of a child, and any act removing that child from her womb is an act done to procure a miscarriage.²⁴ As at least 40 per cent of implanted embryos abort spontaneously; the arguments based on spontaneous loss of fertilised eggs are irrelevant.

In 2000, a version of the ‘morning-after’ pill (Levonelle) was deregulated to allow sale over the counter in pharmacies. Women no longer need a prescription to obtain post-coital birth control.²⁵ The Pro-Life Alliance unsuccessfully sought judicial review, arguing that the free availability of such a drug contravened the 1861 Act because the drug procures miscarriage. Munby J poured scorn on their case, and forcefully held that no pregnancy is established until the fertilised egg implanted in the uterus.²⁶ ‘Miscarriage’ today means the termination of an established pregnancy, whatever it may have meant in 1861.

Emergency hormonal contraception must not be confused with ‘medical abortion’²⁷ and the ‘abortion pill’. Mifepristone (RU-486) and misoprostol (prostaglandin) are drugs which are administered orally in the first nine weeks of pregnancy, and will, in most women, induce a complete miscarriage. A small percentage of women require a surgical abortion to complete the evacuation of the uterus.²⁸ The use of mifepristone is lawful only within the conditions laid down in the 1967 Act. The development of the drug does not liberalise the law on abortion. Section 37(3) of the Human Fertilisation and Embryology Act permitted its routine use in England by authorising the Secretary of State for Health to approve clinics prescribing the drug. The woman will need to attend an approved clinic to take mifepristone, which blocks the hormones necessary to maintain pregnancy. She must return two days later to receive misoprostol, which causes the uterus to contract. The practice of many clinics is to allow women to take the misoprostol and return home so they can ‘miscarry’ in privacy. This usually occurs four to six hours later. Some women fear that contractions will start on the journey home, whilst others object to the inconvenience and stress of having to attend the clinic twice and lose control over the timing of their miscarriage. The British Pregnancy Advisory Service (BPAS) challenged the Department of Health’s interpretation of section 1(3) of the Abortion Act 1967 which requires that ‘any treatment for the termination of pregnancy’ is carried out in an approved clinic or hospital. BPAS branded the rule ‘medically unnecessary’ and called for women to be allowed to take the second part of the treatment, the misoprostol, at home. They made an application for judicial review of the Department of Health’s refusal to sanction such a change in practice arguing that clinics would comply with section 1(3) were they to administer the mifepristone and prescribe and issue the misoprostol at the same visit. The Abortion Act, they claim, was designed to make abortion safe, and there was evidence from other countries that their proposed method is both safe and convenient. The application failed.²⁹

Mason and Laurie, who for the most part support lawful abortion, express concerns that link emergency hormonal contraception and the ‘abortion pill’. They fear both ‘will inevitably come to be regarded as a safe form of contraceptive back-up’ blurring the distinction between preventing new life and taking life.³⁰ We are less pessimistic. What mifepristone does do is to place responsibility for ending her pregnancy on the woman taking the drug. She cannot evade responsibility by seeing the abortion as something done to her. The procedure involves experiencing the pain and distress of a miscarriage. The loss of the embryo will be very evident to her. It is no more likely to be used lightly than recourse to surgical abortion.

The status of the embryo and embryo research: the debate³¹

13.6 The development of in vitro fertilisation (IVF) offered not just new means to overcome infertility, but also the capacity to develop medicine in several directions via research on embryos in the laboratory. The process of IVF generates far more embryos than will ever be implanted in a maternal womb, especially as the Human Fertilisation and Embryology Authority (HFEA) seeks to limit implantation of embryos in women under the age of 40 to a maximum of two;³² what should happen to the ‘spare embryos’? The possibilities opened up by embryo research prompted renewed controversy about the nature and status of early human embryos, whether the embryo is located in a Petrie dish or a woman’s uterus. John Harris argued that it cannot ‘be morally preferable to end the life of an embryo in vivo than it is to do in vitro’.³³

The law regulating abortion in England sanctioned the destruction of 184,571 fetuses in 2014.³⁴ Advocates of embryo research asked how society can logically accept abortion yet ban research. If the fetus can be destroyed at its mother’s request, how can it be unethical to destroy the embryo in the course of beneficial scientific research? Both camps in the debate on embryo experiments link the questions of abortion and research.³⁵

At the heart of the debate lies the question of the moral status of the developing embryo. When does it acquire the same right to protection as we enjoy? We will for the moment assume that the embryo is created the ‘old fashioned’ way via fertilisation (even if fertilisation takes place in a Petrie dish) rather than cell nuclear replacement (CNR). Is it at fertilisation, when a new unique genetic entity comes into being?³⁶ Or, is it at some later stage in embryonic development? This might be at fourteen days, when the primitive streak forms,³⁷ or when brain activity, brain life, is first discernible at eight to ten weeks.³⁸ Or, is it much, much later, after birth? One school of philosophy argues thus.³⁹ Humanity is just another species of animal and as such has no greater moral status than any other animal. What gives rise to moral rights is not being a human animal, but being a person. It is the capacity to value your own existence which gives a person rights, including the right to life. Embryos, and newborn infants, lack that capacity and so are not persons. So at no stage of embryonic or fetal development, inside or outside the womb, does the embryo or fetus have moral status.

Each ethical school of thought marshals impressive arguments in support of its thesis. Argument that the embryo enjoys full human status from fertilisation is an argument often resting on theological grounds. If you believe that human life is divinely created in the image of God, and that human beings possess an immortal immaterial soul, you are unlikely to find any argument based on personhood acceptable. The crucial moment when the embryo acquires humanity becomes ensoulment. Traditionally that moment might be seen as fertilisation, but a number of eminent Christian theologians argued for a later date – either the appearance of the primitive streak as marking clear individuality, as this is the latest date that twinning can occur and when it is possible to distinguish embryonic and placental cells, or the beginning of brain life.⁴⁰ Any concept of human life as special per se is irrelevant to those who support the personhood thesis. Mason advances a rather different argument, one which allows a clearer demarcation between abortion and embryo research. Mason argues that the embryo in the Petrie dish can be viewed as either a human being or as no more than a ‘laboratory artefact’. Arguably, the crucial factor that brings an embryo within the moral community of humankind, and so entitles it to protection, is implantation.⁴¹ Implantation in the womb connects the embryo to its mother and grants it capacity for meaningful development.⁴²

How should the law respond to such a divergence of moral opinion? Consensus is impossible to attain. Proponents of embryo research argued that no one is compelled to participate in research. A liberal democracy should respect divergent moral views. But that is anathema to ‘pro-life’ groups. It is rather like saying that if a sufficient number of people decide redheads are not human and have no moral claim on society, anyone who holds that belief may kill off any redhead he meets. Of course, no ‘pro-redhead’ will be required to join in the slaughter! So what is the difference between redheaded adults and embryos? On any analysis, the redhead enjoys moral and legal rights. She is without doubt a person. The embryo’s true nature is unprovable. One of the authors of this work happens to believe that from fertilisation the embryo is very probably of the same moral value as herself. It is a unique being created in the image of God, in whom she believes. She cannot prove that belief. But then nor can those who maintain that humanity is just another animal species prove their contention. The verdict on the nature of the embryo must be ‘not proven’.

What consequences should the ‘not-proven’ nature of the embryo have for its legal status? It must be accorded recognition and respect. If its claims to rights conflict with the claims of an entity whose status is beyond doubt, its claims may be subordinated to that entity’s. Thus if there is a conflict between the claims of the embryo and the rights of the mother, indubitably a legal person, the mother’s rights take precedence. A belief that the embryo must be respected as fully human from fertilisation requires that a woman rejects abortion as an option for herself. As that belief is unprovable, she cannot legitimately enforce it on other women.⁴³ Embryo research, by contrast, gives rise to no such direct conflict of rights. The question becomes whether society can legitimately destroy an entity which may be fully human in nature and status. The embryo should be given the benefit of the doubt. Justifications have always been advanced for permitting the killing of indubitably human persons in certain cases. It might be argued that the public ‘good’ expected from embryo research justifies destruction of these ‘maybe’ human persons. The onus of proof lies on those who advocate research.

What are the goods which may flow from research? They include developments in medicine for which we already have evidence of proven effect, such as improvement in fertility treatments,⁴⁴ particularly IVF, the development of more effective means of contraception, the detection and ‘cure’ of genetic defects and disease.⁴⁵ Most notably at present we should note the potential for the development of stem cell therapies, ‘therapeutic cloning’, the use of pluripotent stem cells retrieved from early embryonic tissue to transplant into sick adults and children.⁴⁶ Embryonic stem cells extracted from the blastocyst have the potential both to multiply endlessly and can be manipulated to form different cells within the body: they are pluripotent at that stage of development and not confined to becoming say a brain cell or a kidney cell. Stem cell therapies offer the hope that regenerative medicine will produce radical new ways of treating a range of diseases, in particular neurodegenerative conditions such as Parkinson’s and injuries to the spinal cord. The benefit of such therapies is not disputed. How much could be achieved without research on human embryos is. At the heart of the dispute lies evidence derived from research on induced pluripotent stem (iPS) cells. It is suggested that the need for stem cells harvested from embryos could be eliminated by retrieving adult stem cells and manipulating those cells to operate like embryonic stem cells. There would then be no need for embryonic stem cells.⁴⁷ It is difficult for a layperson to evaluate the scientific debate, partly because scientific opinion on the merits of research seems to depend on what stance the scientist takes on the ethics of research. However, if the ‘pro-research’ camp confronts some difficulty establishing that the manifest benefit of research justifies the destruction of arguably human embryos, the ‘anti-research’ camp has a fundamental problem of its own. If an embryo is arguably human, it is wrong to destroy it, to experiment on it for a purpose not designed to benefit it, so that it must ultimately perish. If it is wrong to destroy embryos for research purposes, it must also be wrong to destroy them in the course of infertility treatments using IVF. As long as ‘spare’ embryos are created, surplus embryos are doomed to die. To return to a practice of harvesting only one egg from the woman, and so creating and implanting just one embryo, was thought to be a fatal blow to IVF.⁴⁸

It is difficult to argue that it is ethical to destroy embryos to alleviate infertility and yet unethical to destroy embryos in order to improve our knowledge and treatment of genetic disease. Opponents of research should logically also have opposed the creation of multiple embryos for IVF.⁴⁹

Embryo research: the Human Fertilisation and Embryology Act 1990 (as amended)

13.7 At this point the reader is advised to apply a cold flannel to his or her head! To begin to understand the regulation of embryo research in the UK, we need to examine the Human Fertilisation and Embryology Act 1990 as amended by the later 2008 Act. We can do little more than introduce the legislation. One initial point should be made. The UK legislation now distinguishes sharply between those ‘permitted’ embryos, eggs and sperm that can be used in fertility treatment and those embryos and gametes which must not be implanted in a human but may be used in research and the development of stem cell therapies.

The 1990 Act was, and even as amended remains, based on a compromise advanced in the Warnock report of 1984.⁵⁰ The human embryo should be accorded special status and treated with respect⁵¹ but that ‘status’ is far short of the status to be accorded to any born human. Legislation permits research on embryos but only if licensed by the HFEA,⁵² subject to a strict limit of fourteen days (‘not counting any time during which the embryo was stored’),⁵³ and a number of other prohibitions.

The 1990 Act expressly prohibited certain activities, seeking to ban both reproductive cloning and attempts to create human/animal hybrids. Amendments in the 2008 Act provide for both stem cell therapies (‘therapeutic cloning’) and for what are now called ‘human admixed embryos’. But while the HFEA may now license research in these fields, the Act in its rules on permitted embryos ensures that no cloned or hybrid embryo may be implanted in a woman.⁵⁴ Other restrictions apply. Human embryos or gametes may not be implanted in animals, nor may animal embryos be inserted in humans.⁵⁵ A non-human primate could not be used as a surrogate to gestate a human embryo. The genetic structure of an embryo may not be altered ‘except in such circumstances (if any) as may be specified in’ regulations to be made by the HFEA.⁵⁶ Such regulations have now been made to allow for mitochondrial treatment, discussed below.

The original rules governing embryo research in the Act centred on two principles. We suggest that the 2008 amendments changed the application but not the premise of those principles:

(1)  The Act implicitly accords respect to the embryo from fertilisation, but up until the development of the primitive streak, the ‘goods’ to be expected from research outweigh the interests of the embryo.

(2)  The Act sought to allay fears of a science-fiction nightmare in which scientists freely create all sorts of clones, hybrids and other monsters. It should be noted that until the enactment of the Human Fertilisation and Embryology Act 1990 embryos in vitro enjoyed no legal protection at all. The wording of abortion legislation prohibiting ‘procurement of miscarriage’ meant that in theory ‘test-tube’ embryos could then be grown and destroyed at will.

Subject to the express prohibitions above, the HFEA was given a remarkably free hand by the Act. Legislation allows embryos to be created solely for research purposes. Schedule 2 outlines what a research licence may authorise.

First the HFEA must be satisfied that the proposed research is necessary and desirable for an authorised purpose. Five specific purposes were originally set out in 1990:

(1)  promoting advances in the treatment of infertility;

(2)  increasing knowledge about the causes of congenital disease;

(3)  increasing knowledge about the causes of miscarriage;

(4)  developing more effective techniques of contraception;

(5)  developing methods for detecting the presence of gene or chromosomal abnormalities in embryos before implantation.

Those five specific purposes may be regarded as justification for the destruction of embryos, aimed at improving medicine and increasing human happiness, designed to reassure those who were doubtful about, but not adamantly opposed to, research. To those named purposes was added an apparently innocuous phrase ‘or for such other purposes as may be specified in regulations’.

Embryo research and ‘cloning’

13.8 For a short while from 1990 to about 1998 the fury of the embryo research debate abated. The birth of Dolly, the cloned sheep, changed all that. Dolly was created by a process of cell nucleus replacement (CNR). The nucleus of an unfertilised egg was removed (‘enucleated’) and a stem cell introduced to the empty cell and fused by applying an electrical impulse. The egg cell then began to divide and develop as an embryo. The embryo was implanted in a surrogate ‘mother’. CNR replacement has been successful in creating (cloning) many other species of mammals albeit with a high failure rate and incidence of abnormalities.⁵⁷ There is no scientific reason why this process could not (in theory) be replicated in humans. Two principal and very different purposes could drive the development of CNR in humans.

(1)  Obviously attempts could be made to create a child, a copy of its lone parent sharing most of his or her DNA. Many British scientists abhor the notion of ‘reproductive cloning’. A number of eminent ethicists argue no case has been made out sufficient to justify banning ‘reproductive cloning’.⁵⁸ As we saw in the last chapter reproductive cloning is prohibited in the UK.

(2)  Stem cells could be collected from the cloned embryo. As we have noted above, embryonic stem cells retain their pluripotency and can be cultured to develop into different sorts of tissue, or even potentially grown into organs. ‘Therapeutic cloning’, or stem cell therapy as it is more usually styled today, offers a tantalising range of scientific benefits. In the case of a patient with a neurodegenerative disease, an embryo could be created by CNR using DNA from one of the patient’s own cells and stem cells taken from the resulting embryo could be used to create tissue to repair her damaged brain. As the cells used were ‘hers’ there would be no risk of rejection.

In 1998, the HFEA joined the Human Genetic Advisory Commission (HGAC) to consider the ethics of cloning in both its guises. Their report⁵⁹ recommended that regulations under the 1990 Act should be extended to allow the HFEA to authorise procedures:

(a)  to extract embryonic stem cells for research on the possible treatment benefits in a wide range of disorders by replacing cells which have become damaged or diseased: and

(b)  to conduct research into the treatment of some rare but serious inherited disorders carried in maternal mitochondria.

A further consultation led by the Chief Medical Officer⁶⁰ endorsed the recommendations of the HFEA and HGAC. Both ruled out reproductive cloning. ‘Good’ cloning would be allowed. ‘Bad’ cloning would be banned. Regulations to permit stem cell therapy were approved by Parliament in January 2001.⁶¹ These regulations purported to authorise the following additional research purposes:

–  increasing knowledge about development of embryos;

–  increasing knowledge about serious disease;

–  enabling such knowledge to be applied in developing treatment for serious disease.

The Regulations were made on an assumption that CNR fell within the 1990 Act. Pro life groups challenged the regulations arguing that embryos created by CNR fell wholly outside the 1990 Act and were not covered by section 3(3)(d) which had been intended to ban cloning. Section 3(3)(d) only barred replacing a nucleus of a cell taken from an embryo with a nucleus taken from any person or an embryo. CNR removes the nucleus from an egg cell, not an embryo. The government argued that nonetheless reproductive cloning was effectively outlawed because the HFEA would never license any attempt at reproductive cloning. So to do so would be a crime, because creating an embryo without an HFEA licence is a crime. But ‘embryo’, for the purpose of the unamended 1990 Act, was defined as follows: ‘embryo means a live human embryo where fertilisation is complete’ (our emphasis).⁶²

If CNR is used to create the embryo, fertilisation never takes place.⁶³ CNR involves propagation not fertilisation. Did it fall outside the 1990 Act and so CNR ‘cloning’ (for either therapeutic or reproductive purposes) could take place without a licence?

The All-Party Pro-Life Alliance challenged the regulations allowing stem cell therapy. They argued that the regulations were ultra vires because an embryo created by CNR was not an embryo within the definition provided in the 1990 Act. Crane J agreed that an embryo created otherwise than by fertilisation fell outside the Act.⁶⁴ The government rushed through the Human Reproductive Cloning Act 2001. That Act made implanting a CNR embryo in a woman a criminal offence. The status of the regulations governing stem cell therapy remained in limbo. The Court of Appeal came to the government’s rescue.⁶⁵ The House of Lords upheld the Court of Appeal.⁶⁶ In both courts, moral controversy was translated into an exercise in statutory interpretation. Lord Bingham declared⁶⁷ that the ‘basic task of the court is to ascertain and give effect to the true meaning of what Parliament has said in the enactment to be construed’. The 1990 Act must ‘be read in the historical context of the situation which led to its enactment’. Parliament, their Lordships concluded, never intended to distinguish between live embryos produced by fertilisation, and embryos produced without fertilisation. Parliament, in 1990, would have been unaware that the latter process was possible. The fundamental purpose of section 3(1)(a) of the Act was to provide protection for embryos created outside the human body: ‘The protective purpose was plainly not intended to be tied to the particular way in which an embryo might be created’.⁶⁸

Amendments made by the 2008 Act, give statutory endorsement to the earlier regulations allowing and controlling stem cell therapies. What of the moral arguments? Does it follow that anyone who in 1990 was sceptical about the legitimacy of embryo research should be outraged by developments allowing stem cell therapies, ‘therapeutic cloning’? It is no more than a logical outcome of permitting research at all. If the ‘goods’ of more successful fertility treatments justified destroying embryos, it is difficult to say that the ‘good’ of helping seriously ill patients does not. The argument may be raised that use of embryos is not essential to achieve that end. We have seen that adult stem cells could be treated to recover pluripotency. It might just take longer to do the research. But CNR forces some reconsideration of the basis of opposition for embryo research. Embryos created from fertilisation of egg by sperm result (normally) in the creation of a unique new genetic entity. What is the nature of an embryo created by CNR using our nuclei, our DNA? If used solely for stem cell therapy, is it different from taking a skin graft from a leg to treat burns on an arm.

Amendments to the 1990 Act clarify the status of CNR embryos and give statutory endorsement to the development of stem cell therapies. First, section 1(b) redefines embryo as ‘an egg that is in the process of fertilisation or is undergoing any other process capable of resulting in an embryo’ (our emphasis). Thus CNR embryos are ‘captured’ by the Act and so would be embryos created by any other process as yet unknown. Schedule 2, paragraph 3A of the 1990 Act (as amended) formally extends the list of purposes for which the HFEA may grant a research licence adding to the original five:

(a)  increasing knowledge about serious disease or other serious medical conditions,⁶⁹

(b)  developing treatments for serious disease or other serious medical condition

(c)  increasing knowledge about the cause of any congenital disease or other congenital condition that does not fall within paragraph (a).

But it is crucial to remember that for a licence to be granted for any of these purposes (and/or for the use of human admixed embryos), the applicant must establish that the use of embryos is necessary.⁷⁰ Those opposed to embryo research will no doubt seek to argue that it is not necessary, as the objectives above could be met by using adult stem cells (iPS).

Hybrid (‘human admixed’) embryos

13.9 Before the amendments to the 1990 Act, once the regulations to permit stem cell therapies had been declared lawful by the courts under the unamended Act, the HFEA granted licences to allow the use of embryos to develop stem cell therapies, but scientists immediately faced a resource problem. Developing CNR embryos needs a plentiful supply of eggs to ‘empty’ and into which the nucleus cell can be inserted to create embryos, from which embryonic stem cells can then be cultured. Human eggs for the purposes of egg donation in fertility treatment are in short supply, never mind human eggs for research such as this. However, human eggs are not necessary for the purpose. A cow or rabbit egg will do just as well; sometimes referred to as cytoplasmic hybrid embryos, the resulting embryo remains more than 99.9 per cent ‘human’. Only the mitochondrial DNA from the animal egg remains and any stem cells retrieved are 100 per cent human.⁷¹

The possibility of creating human/animal hybrids sparked new controversy and initially the government indicated that it would use new legislation to ban any research entailing any element of hybridisation stating in its White Paper that the ‘Government will propose that the creation of hybrid or chimera embryos in vitro should not be allowed’.⁷² Scientists criticised the government’s proposal to ban the procedure, arguing it was based solely on unreasoned expressions of pubic revulsion and the opinions of certain religious groups.⁷³ The use of rabbit eggs to develop human embryonic cells will not create a creature half-rabbit/half-human. The cloned embryo will never develop into a living animal of any species. The HFEA launched a consultation on the matter and the government changed its mind.⁷⁴ Thus the 2008 Act amended the 1990 Act to permit the HFEA to license research on what the Act now terms human admixed embryos. It is worth repeating that the Act still prohibits implanting any such embryo in a woman (because they are not permitted embryos) and equally bans implanting a human admixed embryo in any animal.⁷⁵ Section 4A defines human admixed embryos to include not only the cytoplasmic hybrids described above but a range of other embryos created by mixing animal and human gametes. So human/animal hybrids mixing human and animal gametes are allowed as are transgenic embryos in which animal DNA has been introduced, and chimeras where a human embryo has been altered by the addition of animal cells. And finally provision is made for other hybrid/chimeras subject to the condition that the animal DNA is not predominant.⁷⁶

Artificial gametes

13.10 Developments in stem cell research open up the possibility that scientists may be able to manipulate stem cells to create artificial gametes. That is to say that stem cells taken from an infertile man or woman could be used to create functioning sperm and eggs, even that stem cells from a male could be used to create artificial eggs and vice versa. Research into the development of artificial gametes remains lawful in the UK but section 3ZA of the Act prohibits the use of any artificial gametes in treatment by providing that only permitted sperm and eggs may be so used and defining such gametes as extracted from the testes of a man or ovaries of a woman with no alteration of the nuclear or mitochondrial DNA of sperm or eggs.

Mitochondrial treatment⁷⁷

13.11 As we have noted above, only permitted eggs and embryos may be implanted in a woman and used for fertility treatment. All forms of animal/ human hybrids fall outside the definition of permitted eggs or embryos as does any egg or embryo where the genetic structure of the egg or embryo has been altered unless Parliament makes regulations to confer permitted status on such eggs or embryos. The germ line should not be tampered with. In the face of much controversy Parliament approved regulations⁷⁸ to allow alteration of the genetic structure of eggs and embryos and confer on them the status of ‘permitted’ in the case of treatment for mitochondrial disease. Of our DNA, 99 per cent is to be found in the nuclei of our cells and in the case of an egg or embryo the same holds good. The remainder lies in the mitochondria from the outer layer of the egg (rather like the ‘egg shell’) and inherited from the mother and acting so to speak as the battery for the egg, embryo or cells of the born individual. In a few women, defects in the mitochondria can result in serious disease affecting any children they may bear sometimes resulting in early death and/or terrible suffering. Mitochondrial donation involves taking an egg from woman A (the woman affected by mitochondrial disease), or an embryo created from one of her eggs, and removing the nucleus of the egg or embryo. An egg or embryo is also taken from woman B, a woman unaffected by mitochondrial disease, and the nucleus removed. The nucleus from A is then inserted in the egg or embryo from B and the resultant embryo implanted in A. A will carry a child free of the curse of mitochondrial disease and sharing 99 per cent of its genetic heritage with her and its father. The defective mitochondria will have been eliminated from the matrilineal line. Some of the media and opponents of such treatment (that inevitably does alter the genetic structure of the egg or embryo) argued first that this was creating ‘three parent’ families and second that it opened the doors to wholesale genetic manipulation of embryos. The notion of ‘three parent’ families is somewhat exaggerated and we would argue that the donor of the egg (or egg shell) is much more akin to the donor of bone marrow than either a biological mother or indeed a conventional egg donor.⁷⁹

Embryo to fetus: fetus to baby

13.12 An embryo in vitro will not be allowed to develop beyond fourteen days from fertilisation. What of the embryo in vivo, growing and developing in his mother’s womb? By twelve weeks, the embryo will, if seen on an ultrasound scan, bear a distinct resemblance to a baby⁸⁰ and from then on will usually be termed a fetus. In many legal systems, the protection given to the embryo/fetus is extended as the pregnancy progresses, and the fetus develops. Thus, in France, abortion is allowed on demand up to ten weeks’ gestation, and from then is permissible only on the ground of risk to the mother’s health. In the USA, the Supreme Court in Roe v Wade⁸¹ declared that any restriction on abortion in the first twelve weeks of pregnancy was unconstitutional, as a violation of the pregnant woman’s right to privacy. States may regulate abortion to protect maternal health from twelve to twenty-four weeks, and from viability (between twenty-four and twenty-eight weeks) the interests of the fetus take precedence over the interests of the mother. Roe v Wade adopts an openly gradualist approach to the conflict of rights between the mother and her unborn child.

In England, the Abortion Act 1967 originally set no limit to the time when an abortion might lawfully be performed. Section 5(1) provided instead that nothing in the Act should affect the provisions of the Infant Life (Preservation) Act 1929 protecting the viable fetus. Under that Act any person who with intent to destroy the life of a child capable of being born alive causes the child to die before it has an existence independent of the mother is guilty of child destruction. The fetus was deemed to be capable of being born alive at twenty-eight weeks.⁸² The objective of the 1929 law was to protect the fetus in the course of delivery,⁸³ and to safeguard any fetus who, but for improper intervention, could have been born alive.

But what was meant by ‘capable of being born alive’? In C v S,⁸⁴ a young man, seeking to stop his girlfriend aborting their child at eighteen weeks, argued that at eighteen weeks a fetus was ‘capable of being born alive’. It is fully formed and its heart may beat for a second or so after expulsion from the mother. At eighteen weeks there is no prospect of a baby breathing independently of its mother even with the aid of a ventilator. The Court of Appeal found that to be ‘capable of being born alive’ a fetus must be able, on delivery, to breathe either naturally or with mechanical aid. The fight to limit late abortions returned to Parliament. Anti-abortion campaigners persuaded the government to agree to the introduction of an amendment to what was to become the Human Fertilisation and Embryology Act 1990, an amendment designed to reduce the time-limit for abortions. Their attempt misfired, and after a night of confusion, section 37 of the Human Fertilisation and Embryology Act emerged. Section 37 produced a liberalisation, rather than restriction, of abortion laws in England.

Section 37 amended the Abortion Act 1967 to provide that the time-limit for lawful abortions carried out on grounds of risk to the physical or mental health of the woman of her existing children (so called ‘social abortions’) is twenty-four weeks. In the other three cases, there is no time-limit, ie an abortion may be performed right up to the end of the pregnancy. Abortion up to birth is lawful when: (1) termination is necessary to prevent grave permanent injury to the physical or mental health of the mother; or (2) continuance of the pregnancy threatens the life of the mother; or (3) there is a substantial risk that if the child is born it would suffer from such physical or mental abnormalities as to be seriously handicapped.

It is the third of these cases which has proved most controversial. The Infant Life (Preservation) Act permitted action necessary to save the life of the mother, even if doing so inevitably entailed the destruction of the child; preventing grave permanent injury to her health was also almost certainly permissible.⁸⁵ Such cases of a stark choice between mother and child are few and far between in modern medicine. Permitting abortion up to forty weeks on grounds of fetal handicap was novel. In debate in Parliament, that provision seemed to be regarded as covering only the most grave of disabilities, perhaps where a woman was found late in pregnancy to be carrying an anencephalic child incapable of surviving more than a few hours after birth. However, the wording of section 37 is identical to the general fetal handicap ground provided for in the 1967 Act. So, if Down’s syndrome or spina bifida is diagnosed, however late into pregnancy, may the fetus lawfully be destroyed? The wording of the Act is vague.⁸⁶ The Royal College of Obstetricians and Gynaecologists (RCOG) offer doctors further guidance.⁸⁷ They shy away from prescription, considering that ‘it would be unrealistic to produce a definitive list of conditions that constitute serous handicap’. The RCOG emphasises the need for the parents and the doctor to weigh the potential suffering of the child, the suffering of the mother, the burden on the family, and the severity of the handicap affecting the fetus. The 2010 report does set a minimum threshold advising that the child must have a physical or mental disability which would cause ‘significant suffering or long term impairment of their ability to function in society’. The RCOG acknowledges that in applying these criteria to actual cases, fetal medicine specialists take different moral views.⁸⁸

In 2004, the Reverend Joanna Jepson challenged the decision by West Mercia Police not to investigate a complaint that doctors had authorised the termination of a pregnancy at 28 weeks of a fetus with bilateral cleft lip and palate. She obtained leave to apply for judicial review.⁸⁹ The hearing was postponed while police conducted further investigations. The Crown Prosecution Service (CPS) reviewed the evidence and decided not to pursue a prosecution.

Reverend Jepson took no further action.⁹⁰ The CPS found that doctors acted in good faith on the basis of appropriate expert opinion. Much was made of the importance of consultation in the absence of a precise definition of serious fetal handicap.⁹¹ It seems that in effect, serious handicap may come to be defined subjectively – do the parents and the doctors consider the relevant handicap to be serious? The impact of section 37 of the Human Fertilisation and Embryology Act is that in England children capable of being born alive may be killed, providing they are disabled.⁹² The protection afforded to the viable fetus by the Infant Life (Preservation) Act is withdrawn from the disabled fetus. A medical practitioner acting within the provisions of the amended and extended Abortion Act cannot be convicted of child destruction. The 1929 Act remains in force, but applicable only to unlawful late abortions, and those cases where a violent attack on a pregnant woman kills the child within her.

Late abortions on grounds of fetal handicap are not the only source of controversy in relation to time-limits to termination of pregnancy. As we shall see in the next chapter, developments in the care of extremely premature babies mean that a small number of babies born before twenty-four weeks’ gestation survive. The twenty-four-week limit for ‘social abortions’ is under attack. It is argued that it is not ethically justifiable to destroy a fetus which may have the capacity to survive independently outside its mother’s womb. A ‘viable’ fetus should acquire a right to survive.⁹³

The issue of feticide brings the debate on late abortions into a sharp focus. Doctors aborting a fetus late on in pregnancy will seek to ensure that they use means that will destroy the fetus before it emerges from the mother. For, if a child is born alive, nothing in the Abortion Act authorises her destruction. Accounts are given of premature infants left to die in the sluice room adjacent to the operating theatre where an abortion was attempted.⁹⁴ What are the legal rules applicable when an attempted abortion results not in a dead fetus, but a living, albeit sick infant? The child once born alive is protected by the law. Any positive act to destroy it is murder. Failure to offer the child proper care with the intention that it shall die on the part of persons with an obligation to care for the child is equally murder.⁹⁵ Failure to offer the child proper care out of incompetence or carelessness is manslaughter. The theory is clear. Reality is more problematical. A doctor who embarks on an abortion undertakes the care of the mother, and to relieve her of her unwanted child. Yet the criminal law imposes on him an obligation to the child. His position nonetheless is clearly distinct from that of the doctor undertaking safely to deliver a mother of a desired child. And what of the child born disabled? The doctor sets out to abort on the grounds of the substantial disability affecting the child, but if the child survives, must he then use all his efforts to save her? This leads us into the question of medical care of the disabled newborn baby, his rights and those of his parents, a minefield we enter in Chapter 14.

Unsurprisingly, obstetricians try to avoid entering that minefield. Advice from the RCOG recommends feticide in all terminations of pregnancy at a gestational age of more than 21 weeks and 6 days, unless the fetal abnormality is such that early neonatal death is inevitable.⁹⁶ In practice, this means that fetal medicine specialists administer a fatal injection of potassium chloride into the fetal heart before beginning the process of terminating the pregnancy. Feticide has become a routine part of late termination of pregnancy. It is performed not only to ensure that the fetus is born dead, but also to ensure that the fetus suffers no pain in the course of the termination.⁹⁷ Not all women agreeing to termination of pregnancy for a serious abnormality want also to agree to feticide. The RCOG recognises that in cases where a lethal abnormality is present, feticide may not be appropriate.

Selective reduction: selective feticide

13.13 So far, discussion of the legality of abortion has proceeded on the basis that the procedure used terminates the woman’s pregnancy completely. There are cases where only selected fetuses in a multiple pregnancy are destroyed, and the pregnancy continues to term when the woman delivers her surviving children. Selective reduction, or selective feticide, may be advised either when the woman has a multiple pregnancy and is unlikely to carry all the fetuses safely to term, or when one of two or more fetuses is disabled. The ‘surplus’ or disabled fetuses will, using fetoscopically directed procedures, be killed. The dead fetuses are not expelled from the uterus, but become ‘fetus papyraceous’, and emerge on delivery of its healthy brothers and sisters. Selective reduction to destroy a disabled twin was quietly practised for years. The development of IVF and consequent increase in multiple pregnancies brought the procedure to public attention. Until recently, in a number of fertility clinics, to maximise the woman’s chances of pregnancy, several embryos were implanted. If she conceived quadruplets or more, the risk was that the babies would be delivered prematurely and in the worst-case scenario all might fail to survive. Selective reduction offered the prospect of one or two healthy children being born safely.

The deliberate destruction of selected fetuses raised ethical and legal problems. Legal debate focused on whether selective reduction was lawful.⁹⁸ Section 37(5) of the Human Fertilisation and Embryology Act legalises selective reduction, if performed for one of the grounds on which termination of the whole pregnancy is lawful. Thus, if fetuses are destroyed on grounds of fetal handicap, or because a multiple pregnancy poses a risk to the mother’s health, selective reduction is as lawful as ending the pregnancy altogether would be. The anomalous situation is this. Where multiple pregnancy occurs the underlying reason for wanting to destroy fetus A and B is to maximise the prospects of a healthy birth for fetuses C and D. The ground that would need to be invoked is that permitting abortion to safeguard the health of any ‘existing children’ of the pregnant woman. Can fetuses C and D be regarded as ‘existing children’? The whole philosophy of English law relating to the status of the fetus is that a fetus is not for legal purposes a child.

Section 37(5) grants legal recognition to a much disputed procedure.⁹⁹ If fetuses can be selected and destroyed in effect as part and parcel of infertility treatment, the message from Parliament seems to be that unborn life is little more than a means to an end. The fetus itself counts for little. The parents’ desire for children justifies its destruction. Does selective killing of disabled fetuses with legal blessing reinforce the second-class status of the disabled fetus?

Nurses and abortion

13.14 Nurses are increasingly involved in the process of termination of pregnancy as surgical procedures are increasingly replaced by medically induced abortion at all stages in pregnancy.¹⁰⁰ The Abortion Act provides for circumstances when a pregnancy may lawfully be terminated by a registered medical practitioner, a doctor. In 1967, all lawful abortions were carried out by surgical means. The surgeon removed the fetus and ended the pregnancy. By 1972, medical induction of abortion was introduced as the standard method of terminating pregnancies in the second trimester. A doctor inserts a catheter into the woman’s womb. Later, a nurse attaches the catheter via a flexible tube to a pump, which feeds the hormone prostaglandin through the catheter and induces premature labour. The nurse administers another drug via a drip in the woman’s arm to stimulate her contractions. The immature fetus is born dead. The substances that cause the abortion are administered by the nurse. The nurse in effect terminates the pregnancy.

The Royal College of Nursing was doubtful whether a pregnancy terminated by a nurse was lawfully terminated. Might nurses face prosecution for conducting criminal abortions? The Department of Health and Social Security issued a circular upholding the legality of medical inductions of abortion. The Royal College of Nursing went to court for a declaration that the circular was wrong in law. The College lost in the High Court, won in the Court of Appeal and finally lost by 3:2 in the House of Lords.¹⁰¹ The majority of their Lordships held that the Act must be construed in the light of its social purposes, first, to broaden the ground on which abortions may lawfully be obtained, and, second, to secure safe and hygienic conditions for women undergoing abortion. The Act contemplated the participation of a team of hospital staff involved in the overall treatment of the woman, and exonerated them all from criminal liability if the abortion was carried out within the terms of the Act. It was not necessary for a doctor to perform every physical act leading to the termination of the pregnancy. Provided a doctor accepts full responsibility for every stage in the treatment, a nurse acting under his instructions and in conformity with accepted medical practice does not act unlawfully when she administers the drugs which terminate the pregnancy in an induced abortion.

Conscientious objection¹⁰²

13.15 A vital component of the compromise on which the Abortion Act 1967 was based was the right of conscientious objection.¹⁰³ Section 4 provides that no person shall be under any duty ‘to participate in any treatment authorised by this Act to which he has a conscientious objection’.¹⁰⁴ It is for the person objecting to prove that their objection rests on grounds of conscience. The professional’s conscience does not relieve him of any duty to intervene to save the life of the mother or to prevent grave permanent injury to her health.

In Janaway v Salford Area Health Authority,¹⁰⁵ the House of Lords was asked to determine who was entitled to rely on the right of conscientious objection. Mrs Janaway was a devout Roman Catholic employed as a secretary. She refused to type abortion referral letters and the authority dismissed her. She challenged her dismissal as unlawful because, she argued, she was entitled to rely on the right of conscientious objection provided for by section 4. Her action failed. The Law Lords ruled that the term ‘participate’ in section 4 meant actually taking part in treatment designed to terminate a pregnancy. Mrs Janaway was not asked to do anything that involved her personally in the process of abortion. Yet she was an essential cog in the wheel. Abortion was as repugnant to her as murder. For Mrs Janaway, however irrational others might perceive her views to be, her employers were asking her to type out a death warrant.

The scope of section 4 and conscientious objection was revisited by the Supreme Court in Greater Glasgow and Clyde Health Board v Doogan.¹⁰⁶ Two Roman Catholic midwives working as ward managers in the labour ward sought to avoid any involvement with women who were admitted to the labour ward for medically induced abortions. They were not asked to take any direct part in the process of terminating pregnancies. But they sought to argue that they were entitled to refuse to undertake a number of administrative tasks too such as booking patients in, allocating staff to duties, briefing staff coming on shift. The Supreme Court held that the question was one of simple statutory construction and took a narrow view of section 4. Section 4 in effect allowed an objector to refuse to take part in any ‘hands on’ role in terminating a pregnancy, to refuse to undertake any task that but for the defences provided by the Abortion Act would have been unlawful. Thus administrative duties such as booking patients in, allocating staff to duties in the ward, ensuring staff took breaks fell beyond section 4, whereas supporting any medical intervention or fetching the drugs came within the scope of conscientious objection.¹⁰⁷ However, a key point in the judgment that must not be overlooked is this. Lady Hale made it clear even if the midwives were not protected by section 4, they could still claim that under the Human Rights Act or the Equality Act their employers should have made reasonable adjustments to accommodate the objectors’ religious beliefs.¹⁰⁸

The right to conscientious objection is thus limited in scope and in practice difficult to exercise.¹⁰⁹ Hospitals are wary of staff who will not participate in what has become a fairly common operation. It is said that nurses face greater risk to their career prospects if they declare their conscientious objection to abortion.¹¹⁰ Paradoxically, there remain areas of England where abortion within the NHS is difficult to obtain. Is that a violation of women’s rights caused by giving undue precedence to the professional’s right to his conscience? The irony is that consultants and general practitioners can avoid involvement in abortion without having to invoke the right to conscientious objection. The doctor simply refuses to certify that a ground specified in the Act is made out. The woman can then only try to find another more sympathetically inclined doctor. Her only remedy against the first practitioner would lie if she could prove that to refuse her an abortion was a breach of the duty of care owed to her. If the doctor is a consultant or a GP, no one can order him to participate in an abortion.¹¹¹

Fathers and abortion¹¹²

13.16 Has the father of the unborn child any say in whether or not the child be aborted? In 1978, in Paton v British Pregnancy Advisory Service,¹¹³ a husband tried to prevent his wife having an abortion. She had been concerned about her pregnancy and consulted her doctor, but did not consult her husband. She obtained a certificate from two registered medical practitioners that the continuance of the pregnancy would involve risk to her health. So an abortion could lawfully proceed. Her husband intervened. He went to court to ask for an injunction (an order) to prevent the abortion from being carried out without his consent. The court refused an injunction. The judge said that the 1967 Act gave no right to the husband to be consulted. In the absence of such a right under the Act, the husband had ‘no legal right enforceable at law or in equity to stop his wife having this abortion or to stop the doctors from carrying out the abortion’.

The abortion went ahead. The husband went to the European Commission of Human Rights, arguing that the Act and the judge’s decision infringed the European Convention on Human Rights. He argued that his right to family life and the unborn child’s right to life had been infringed. The Commission dismissed his claim.¹¹⁴ They said that where an abortion was carried out on medical grounds, the husband’s right to family life must necessarily be subordinated to the need to protect the rights and health of the mother. The unborn child’s right to life was similarly subordinate to the rights of its mother, at least in the initial months of pregnancy. In C v S,¹¹⁵ the Court of Appeal, having held that the abortion of a fetus at eighteen weeks did not contravene the Infant Life (Prevention) Act 1929, refused the father any right qua father or a guardian of the unborn child to challenge the proposed abortion. In England, husbands have no standing to oppose an abortion agreed to by the wife, nor has a father any right to intervene to ‘save’ the fetus, nor can anyone argue that the fetus itself has legal personality so enabling him to act as its ‘guardian’ and stop an abortion.

One issue remains open. The father in Paton reluctantly accepted that the doctors’ certificate as to the need for the abortion was issued in good faith. Had he challenged the certificate, could he have asked for an injunction to prevent an unlawful abortion taking place? The judge in Paton did not have to decide this point. He expressed the view that an injunction would not be granted. The supervision of abortion and the issue of the doctors’ good faith is left to the criminal law and a jury. The Court of Appeal in C v S¹¹⁶ endorsed that opinion.

Girls under 16

13.17 The Abortion Act made no special provision for abortion involving girls under 16. In 1981, a 15-year-old girl who already had one child became pregnant again while in local authority care. She wanted an abortion. Her doctors believed that the birth of a second child would damage her mental health and endanger her existing child. The girl’s father objected. Abortion was contrary to his religion. The local authority applied to have the girl made a ward of court and thereby seek the consent of the court to the operation. Butler-Sloss J authorised the abortion.¹¹⁷ She said that while she took into account the feelings of the parents she was satisfied that the girl’s best interests required that her pregnancy be ended. Her decision was approved by the House of Lords in Gillick v West Norfolk and Wisbeck Area Health Authority.¹¹⁸ Gillick would suggest that as long as the girl is mature enough to understand what abortion entails physically and emotionally, the doctor may go ahead on the basis of her consent alone.¹¹⁹ Nor are doctors under any obligation to inform her parents. The Gillick competent girl is as entitled to confidential treatment as the adult woman.¹²⁰ If the girl is insufficiently mature to make a decision for herself, the doctor must act in her best interests. Should her parents refuse consent to abortion, doctors and social workers may seek to go to court¹²¹ and ask a judge to decide on the conflict between medical and parental opinion. Her wishes will be considered, but not treated as decisive.¹²² A doctor who ignores parental views will not be guilty of an offence of criminal abortion. He may face legal action by the girl’s parents in the civil courts, or, in an extreme case, prosecution for an assault on her.

What of a case where parents want their daughter to have an abortion but she refuses? The Court of Appeal in Re W (A Minor) (Medical Treatment)¹²³ ruled that a doctor may lawfully proceed with treatment of any young person under 18 with parental consent. He simply needs a valid consent either from his young patient herself, or from her parents. Gillick competent children and minors under 18 can authorise their own treatment, but not veto treatment. In theory, a gynaecologist could elect to override his patient’s refusal to terminate her pregnancy as long as her parents endorsed the abortion. In Re W, Lord Donaldson, considering the implications of his judgment, said:

Hair-raising possibilities were canvassed of abortions being carried out by doctors in reliance upon the consent of parents and despite the refusal of consent by 16- and 17-year-olds. Whilst this may be possible as a matter of law, I do not see any likelihood taking account of medical ethics, unless the abortion was truly in the best interests of the child. This is not to say that it could not happen.¹²⁴

To force an abortion on a girl must question whether either doctor or parents act in her interests. Lord Donaldson considered it unthinkable that doctors would use the law to coerce young girls into abortion.¹²⁵

In An NHS Trust v A, B, C and a Local Authority¹²⁶ a grandmother noticed a change in her 13-year-old granddaughter, A, and took her to the GP. A was uncommunicative and there was some doubt as to her competence. She was found to be at least 21 weeks pregnant. Mostyn J held that she had ‘sufficient understanding and intelligence’¹²⁷ and was therefore Gillick competent to decide whether to continue or terminate her pregnancy.

The courts are loath to force termination of pregnancy on a young person, even if they lack competence. In Re X (A Child),¹²⁸ 13-year-old X had an IQ of 54 and 14 weeks pregnant to a 14-year-old boy. X lacked Gillick competence and so could not consent. Moreover, she initially objected to the termination. Sir James Munby concluded that termination was in her best interests, but that she should not be subjected to termination unless she was ‘accepting’. By the end of the proceedings she was compliant and the order was made.

Mentally incapacitated women

13.18 In T v T,¹²⁹ a woman of 19 became pregnant. She was said to have a mental age of 2, was doubly incontinent and incapable of any comprehensible speech. The problem for her mother and her doctors was that T was quite incapable of giving her consent to the proposed abortion and, as she was an adult, no one else could authorise treatment on her behalf. Wood J granted a declaration that performing an abortion on T was not unlawful if that operation was considered to be in her best interests and in conformity with good medical practice. Termination of pregnancy in such a case will now be governed by the Mental Capacity Act 2005, discussed earlier in Chapter 6. The fundamental test will continue to be whether, in all the circumstances, abortion is in the best interests of the woman. In determining her best interests, regard must be had for any views of feelings the woman herself expresses, or has expressed, in the past. The impact on her must be fully evaluated. The timing of the proposed abortion may be crucial. In 2002, a judge refused to authorise an abortion close to the twenty-four-week limit for ‘social abortions’.¹³⁰

Fetal status: Vo v France and A, B and C v Ireland

13.19 The vexed question of fetal status, and whether the unborn child can assert a right to life, came before the ECtHR once again in Vo v France.¹³¹ The applicant, Mme Vo, attended hospital in France for an antenatal appointment in the sixth month of her pregnancy. Mme Vo was originally from Vietnam and spoke little French. A terrible error led to a doctor mistakenly supposing her to be another woman with a similar name. This other patient was scheduled to have a contraceptive coil removed. The doctor then proceeded to attempt to remove a non-existent coil from the pregnant Mme Vo. He pierced the amniotic sac and a week or so later the pregnancy had to be terminated on health grounds. The fetus was found to be between twenty and twenty-one weeks’ gestation.

Mme Vo began a number of civil and criminal proceedings against the doctor and the hospital. For our purposes, the crucial process was an attempt to bring a criminal prosecution against the doctor for involuntary homicide, what in this country would be styled gross negligence manslaughter. The French courts held a non-viable fetus could not be the subject of homicide. Mme Vo argued that French law violated Article 2 of the Human Rights Convention by failing to protect the life of her unborn child.

The majority of the ECtHR dodged the central question of fetal status.¹³² They held that the question of when a right of life accrued fell within the margin of appreciation allowed to contracting states. This was a question unresolved among European countries, and there was no European consensus on scientific and legal definitions of the beginning of life. Additionally, even if the fetus in Vo was entitled to such protection under Article 2, its rights were sufficiently protected by the rights the mother enjoyed to protection from assault and injury. It was not desirable to address the question of whether an unborn child was a person for the purposes of Article 2 in the abstract. Reading the dissenting opinions within the Court demonstrates that the human rights judges in Strasbourg are as divided in their judgments on fetal status as society in general.

In Vo, the margin of appreciation operated to deny any specific protection for the fetus under the ECHR. In A, B and C v Ireland¹³³ it was invoked to accept laws in Ireland to protect the unborn. The three applicants challenged Irish laws that only permit a lawful abortion in Ireland when the mother’s life is at risk, and even in that case while a termination of pregnancy is permissible in theory, in practice the lack of clear legislative guidance on the criteria for a lawful abortion means that it is impossible to access abortion even in such a case. Applicants A and B advanced evidence that the absence of legal abortion in Ireland forcing them to travel to the UK damaged their health and thus violated their rights under Article 8 of the ECHR. C contended that the absence of lawful abortion in Ireland endangered her life.¹³⁴ C’s claim succeeded on the narrow grounds that, as Irish law permitted abortion to save the mother’s life, the state’s failure to implement that right granted her by Irish law breached C’s right to respect for her private life.¹³⁵ A and B’s claims failed. While the prohibition on abortion even on health grounds amounted to an interference with their private rights, the interference was justified under Article 8(2). It fell within the margin of appreciation within which Ireland should be permitted to judge the value to be attached to unborn life.

Fetal status: research and ectogenesis¹³⁶

13.20 Both in England and in the ECtHR, the question of the status of the fetus is fudged whenever possible. Most (though not all decisions) about the fate of the fetus are entrusted to the mother and her doctors to the exclusion of the father. The reason for such a state of affairs is simple. For so long as the fetus is within the woman, her claims to bodily integrity conflict with any claim of the fetus to survive or of the father to intervene on his putative child’s behalf. Biology grants women control over access to the fetus in her womb.¹³⁷ As we have seen too, she cannot be compelled to undergo a caesarean section or other intervention to which she objects however great the potential benefit to the fetus.¹³⁸

But does this mean that the woman has untrammelled rights to do as she wishes to the fetus? Consider this scenario. Sue is twenty weeks pregnant when doctors advise her that the fetus has a minor cardiac defect. Research on animals has resulted in a procedure that in 80 per cent of cases cures the defect but with a 20 per cent risk of severe brain damage which will not be apparent until sometime after birth. Sue is happy to consent and take the risk. Her husband and putative father of the child, Tom, is not. Does it follow from the case law denying Tom any say about whether his wife can terminate a pregnancy or deliver by caesarean section that he equally has no say about a decision to intervene that may affect the child-to-be adversely?

What though if the fetus were not located in a female womb but rather in an artificial chamber, ectogenesis? Evading the question of fetal status would no longer be an option and maternal priority would be hard to defend. Ectogenesis could in theory be complete in that the embryo is fertilised in a Petrie dish and immediately transferred to an ectogenic chamber. At present, such a course of action would be unlawful under the Human Fertilisation and Embryology Act 1990 which prohibits the keeping of an embryo beyond the fourteen-day limit.¹³⁹ Were that ban to be lifted and a fetus could be gestated for the whole term of ‘pregnancy’ in the artificial chamber, what then of fetal status? Is the fetus ‘capable of being born alive’ from its insertion in the artificial womb? How does such a machine differ from the apparatus that now keeps very premature babies alive in neonatal intensive care? If the law is to allow the fetus to be destroyed and disconnected from the ectogenic chamber, must both gamete donors (parents) agree? Paradoxically it is perhaps the case that as the law stands today, the embryo in the ectogenetic chamber has no protection at all. Remember that sections 58 and 59 of the Offences Against the Person Act prohibit the procuring of a miscarriage in a woman. The embryo in the artificial womb is never carried in a woman.

Complete ectogenesis may be many decades away. Partial ectogenesis may be closer to reality whereby a fetus could be transferred part way through pregnancy from the uterus to an ectogenic chamber. In those cases where pregnancy threatens a woman’s health, forcing her to choose between her own health and the birth of a wanted child, partial ectogenesis may be welcomed. Some commentators have gone further, presenting partial ectogenesis as the solution to the battles over abortion. Sheila McLean¹⁴⁰ has argued that women have the right to be free of pregnancy but it does not follow that they have the right to kill the fetus. Thus if partial ectogenesis becomes feasible after, say, eighteen weeks of gestation a woman wishing to end her pregnancy would be obliged to agree to the fetal transfer. Alas, such a possibility is more likely to ignite than calm the ‘abortion wars’. The argument rests on an assumption that a woman seeking to abort seeks only to be free of pregnancy rather than to avoid becoming a mother even if the law were to free her of any legal parental responsibility.¹⁴¹ Surgery to remove the fetus from the human womb would be complex and probably more intrusive than a caesarean section and so a woman could not be compelled to consent. Finally, in removing the fetus, might doctors contravene section 58 of the Offences Against the Person Act 1861 in that they are procuring a miscarriage?

If medical progress comes close to making ectogenesis in any form feasible, the compromise on which abortion laws rest in England will be severely challenged, and evading the thorny question of fetal status and father’s rights will become impossible.

¹  See R Sifris, ‘Restrictive Regulation of Abortion and the Right to Health’ (2010) 18 Medical Law Review 185.

²  A, B and C v Ireland [2010] ECHR 2032. See 13.19 below.

³  On the history of abortion law in England, see J Keown, Abortion, Doctors and the Law (1988) Cambridge University Press.

⁴  See, generally, S Sheldon, Beyond Control: Medical Power and Abortion Law (1997) Pluto; E Lee (ed), Abortion: Whose Right? (2002) Hodder & Stoughton.

⁵  The Law Commission is currently reviewing the 1861 Act but that review does not encompass ss 58 and 59. See Law Commission Consultation Paper No 217 Reform of Offences Against the Person: A Scoping Consultation Paper (2014). The report is scheduled for publication in autumn 2015.

⁶  Sarah Catt was convicted under s 58 after she took poison to abort her own chid at close to full term. Her original prison sentence of eight years was reduced to three and a half years on appeal; R v Catt (Sarah Louise) [2013] EWCA (Crim) 1187.

⁷  See R v Matthew Fletcher [2014] EWCA (Crim) 1876: a man obtained pills on the Internet to induce his girlfriend to miscarry despite her settled wish to keep the child.

⁸  R v Sockett (1908) 72 JP 428. In 1927, a girl of 13 was prosecuted for attempting to induce an abortion on herself by taking laxative tablets and sitting in a hot bath.

⁹  R v Whitchurch (1890) 24 QBD 420.

¹⁰  [2010] EWCA Crim 1949.

¹¹  R v Bourne [1939] 1 KB 687.

¹²  See M Brazier ‘Can the Common Law Accommodate Moral Controversy in Medicine: The Case of Abortion’ in A Alghrani, R Bennett, S Ost, The Criminal Law and Bioethical Conflict: Walking the Tightrope (2012) Cambridge University Press, 191.

¹³  R v Bourne [1939] 1 KB 687, at 693.

¹⁴  See section 1 as amended by Human Fertilisation and Embryology Act 1990, s 37.

¹⁵  An attempt to amend the Abortion Act 1967 to require only one medical practitioner to certify that one of the grounds specified in the Act was met failed; see Abortion Act 1967 (Amendment) Bill 2014 HL Bill 26.

¹⁶  Abortion Act 1967, s 1(3).

¹⁷  See Greater Glasgow and Clyde Health Board v Doogan [2014] UKSC 68 discussed at 13.15.

¹⁸  DH, Abortion Statistics, England and Wales 2014 (2015).

¹⁹  R v Smith (John) [1974] 1 WLR 1510, CA. In 2013 the CPS decided not to prosecute two doctors investigated for certifying abortions based on the gender of the fetus. In response, the DH produced Guidance in Relation to Requirements of the Abortion Act 1967 (May 2014).

²⁰  The history of abortion in England from well before the 1967 Act is marked by ‘medicalisation’; see Keown, Abortion, Doctors and the Law.

²¹  See CPS, Statement from Director of Public Prosecutions on Abortion Related Cases (2013) 7 October. And more recently, see BBC News, ‘Sex-selection Abortion Case “Not in Public Interest”’ (2015) 13 March.

²²  In R v Price [1969] 1 QB 541, a prosecution for criminal abortion was brought against a doctor who inserted an IUD into a woman who was some months pregnant. The prosecution failed because it was not proved that he knew her to be pregnant.

²³  As long ago as 1983, the Attorney-General expressed his opinion that prior to implantation there is no pregnancy and so means used to prevent implantation do not constitute procuring miscarriage. HC Official Report, 10 May 1983, Cols 238–239. In 1991, a judge dismissed a prosecution for criminal abortion based on the insertion of an IUD agreeing with the Attorney-General that until implantation there is no pregnancy; R v Dhingra (1991) unreported.

²⁴  See J Keown, ‘Miscarriage: A Medico Legal Analysis’ [1984] Criminal Law Review 604.

²⁵  See Prescription Only Medicines (Human Use) Amendment (No 3) Order 2000; SI 2000/3231.

²⁶  R (on the application of Smeaton v Secretary of State for Health and Others [2002] 2 FLR 146. See J Keown, ‘Morning after Pills, Miscarriage and Muddle’ (2005) 25 Legal Studies 302.

²⁷  Of abortions in England and Wales, 51 per cent are now ‘medical abortions’; see DH, Abortion Statistics, England and Wales 2014 (2015).

²⁸  The woman will be asked to agree to undergo surgical abortion should the drug fail to work before being given mifepristone. She cannot be forced to go through with the surgical procedure should she later change her mind. But, providing she has been properly warned of the risk of failure and possible adverse effect on the embryo, neither she nor any child damaged by the drug could sue in respect of their injuries. See RP Jansen, ‘Unfinished Feticide’ (1990) 16 Journal of Medical Ethics 61.

²⁹  British Pregnancy Advisory Service v Secretary of State for Health [2011] 3 All ER 1012; and see K Greasley, ‘Medical Abortion and the “Golden Rule” of Statutory Interpretation’ (2011) 19 Medical Law Review 314.

³⁰  JK Mason, GT Laurie, Mason and McCall Smith’s Law and Medical Ethics (9th edn, 2013) Oxford University Press, at 9.90.

³¹  See, generally, A Dyson, J Harris (eds), Experiments on Embryos (1999) Routledge.

³²  HFEA, Code of Practice (8th edn, 2015), paras 7.4–7.6.

³³  JM Harris, The Value of Life (1985) Routledge & Kegan Paul, p 117.

³⁴  DH, Abortion Statistics, England and Wales: 2014 (2015).

³⁵  See M Brazier, ‘Embryos’ “Rights”: Abortion and Research’, in MDA Freeman (ed), Medicine, Ethics and Law (1988) Stevens, pp 9–23.

³⁶  See O O’Donovan, Begotten Not Made (1984) Oxford University Press; A Holland ‘A Fortnight of My Life is Missing: A Discussion of the Status of the Pre-embryo’ (1990) 7 Journal of Applied Philosophy 25.

³⁷  As the Warnock Report concluded, see Report of the Committee of Inquiry into Human Fertilisation and Embryology, pp 63–64.

³⁸  See in particular, M Lockwood, ‘When Does a Life Begin?’ in M Lockwood (ed) Moral Dilemmas in Medicine (1988) Oxford University Press.

³⁹  See Harris, The Value of Life, pp 18–25; and ‘Embryos and Hedgehogs: on the Moral Status of the Embryo’, in Dyson and Harris, Experiments on Embryos, p 65; and see J Glover, Causing Death and Saving Lives (1977) Penguin.

⁴⁰  See K Ward, ‘An Irresolvable Debate?’ in Dyson and Harris, Experiments on Embryos, p 106.

⁴¹  JK Mason, Medico-Legal Aspects of Reproduction and Parenthood (2nd edn, 1998), p 234; Mason and McCall Smith’s Law and Medical Ethics, at 8.74.

⁴²  JK Mason, Human Life and Medical Practice (1988) Edinburgh University Press, p 94.

⁴³  For a powerful argument that even if the embryo is presumed to enjoy full human status, abortion remains defensible, see J Jarvis Thompson, ‘A Defence of Abortion’, in RM Dworkin (ed) The Philosophy of Law (1977), p 112. But note the response by JM Finnis, ‘The Rights and Wrongs of Abortion’, ibid, p 129.

⁴⁴  See Chapter 12.

⁴⁵  Notably the development of Pre-Implantation Genetic Diagnosis: see 12.19.

⁴⁶  The science and the ethical issues are lucidly explained in JK Mason, GT Laurie, Mason and McCall Smith’s Law and Medical Ethics (2013), Oxford University Press, 20.42–20.60.

⁴⁷  See Jackson, Medical Law: Text, Cases and Material (3rd edn, 2013) Oxford University Press, pp 651–652.

⁴⁸  Clinicians are now suggesting that modern treatment may achieve much greater success with single embryo transplant (SET) at less risk to the woman. However even with SET multiple embryos will be created and stored and so the issue of the fate of the ‘spare’ embryo remains moot.

⁴⁹  See M Brazier, ‘The Challenge for Parliament: A Critique of the White Paper on Human Fertilisation and Embryology’, in Dyson, Harris, Experiments on Embryos, p 142.

⁵⁰  Report of the Committee of Inquiry into Human Fertilisation and Embryology (1984) Cmnd 9314 (the Warnock Report) and see 12.1.

⁵¹  Baroness Warnock has since regretted that her committee endorsed any notion of respect for the embryo; see Jackson, Medical Law, p 637.

⁵²  See s 3(1). Breach is a criminal offence, punishable by up to ten years imprisonment. Any prosecution under the Act will require the consent of the DPP; s 42.

⁵³  Section 3(3)(a).

⁵⁴  See ss 3 and 3ZA.

⁵⁵  See s 3(2) and s 3(3)(b).

⁵⁶  Sched 2 para 3(4).

⁵⁷  Department of Environment, Food and Rural Affairs, Commission Report on Animal Cloning for Food Production (2010) COM(10) 585, para 1.2: ‘The overall success rate for cloning procedures is less than 10% in bovine animals and between 5 and 17% in pigs’.

⁵⁸  See, for example, J Harris, ‘Goodbye Dolly? – The Ethics of Human Cloning’ (1997) 23 Journal of Medical Ethics 353.

⁵⁹  HFEA/HGAC, Cloning Issues in Reproduction, Science and Medicine (1998). And see J Harris, Clones, Genes and Immortality (1998) Oxford University Press.

⁶⁰  Expert Group of the CMO, Stem Cell Research: Medical Progress and Responsibility (2000) DH. See also House of Lords, Stem Cell Research (2002) HL 83(i); Nuffield Council on Bioethics, Stem Cell Therapy: A Discussion (2000).

⁶¹  Human Fertilisation and Embryology (Research Purposes) Regulations 2001, SI 2001/188. Such was the public concern about their regulations that they were immediately reviewed (and in the event approved) by a Select Committee of the House of Lords; see ibid House of Lords Stem Cell Research.

⁶²  Section 1(1)(a).

⁶³  See M Brazier, ‘Regulating the Reproduction Business?’ (1999) 8 Medical Law Review 166.

⁶⁴  R (Quintavalle) v Secretary of State for Health [2001] 4 All ER 1019.

⁶⁵  R (Quintaville) v Secretary of State for Health [2002] 2 All ER 625, CA.

⁶⁶  [2003] 2 All ER 113. The House of Lords however, did also confirm that section 3(3) (a) of the Act did not impose an absolute prohibition on CNR.

⁶⁷  Ibid, at 118.

⁶⁸  Ibid, at 126 per Lord Steyn.

⁶⁹  The addition of serious conditions to serious diseases in the Act is to cover research into treatment for such conditions as spinal injury.

⁷⁰  Human Fertilisation and Embryology Act, Sched 3A.

⁷¹  See Jackson, Medical Law, pp 643–645.

⁷²  Review of the Human Fertilisation and Embryology Act (2006) Cm 6989, para 2.85.

⁷³  See (2007) The Times, January 5.

⁷⁴  When the 2008 Act had been passed but was not yet in force the HFEA granted two licences to permit research using cytoplasmic hybrid embryos. An application for judicial review to strike down the licences failed; see R (On the application of Quintavalle and the CLC) v HFEA [2008] EWHC 3395 (Admin).

⁷⁵  Section 4A(4).

⁷⁶  See Mason, Laurie, Mason and McCall Smith’s Law and Medical Ethics, at 8.05–8.07.

⁷⁷  Ibid, 7.09–7.13.

⁷⁸  Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015, SI 2015/572.

⁷⁹  See Nuffield Council on Bioethics, Novel Technologies for the Prevention of Mitochondrial Disorders: An Ethical Review (2012).

⁸⁰  D Kirklin, ‘The Role of Medical Imaging in the Abortion Debate’ (2004) 30 Journal of Medical Ethics 426.

⁸¹  (1973) 93 S Ct 705. Though since Roe v Wade, anti-abortion campaigners have ceaselessly sought to reverse the decision or limit its impact; see Mason, Laurie, Mason and McCall Smith’s Law and Medical Ethics, 341–343.

⁸²  Albeit at 28 weeks the fetus was deemed to be capable of being born alive, that did not mean an earlier abortion was necessarily lawful. It would be for the prosecution to prove that fetus was capable of being born alive.

⁸³  Closing a lacuna in the abortion laws.

⁸⁴  [1987] 1 All ER 1230. A somewhat different interpretation was offered in Rance v Mid-Downs Health Authority [1991] 1 All ER 801.

⁸⁵  See R v Bourne [1939] 1 KB 687.

⁸⁶  See E Wicks, M Wyldes and M Kilby, ‘Late Termination of Pregnancy for Fetal Abnormality: Medical and Legal Perspectives’ (2004) 12 Medical Law Review 285; S Sheldon and S Wilkinson, ‘Termination of Pregnancy for Reasons of Foetal Disability: Are there Grounds for a Special Exception in Law?’ (2001) 9 Medical Law Review 85.

⁸⁷  Royal College of Obstetricians and Gynaecologists, Termination of Pregnancy for Fetal Abnormality in England, Scotland and Wales (2010).

⁸⁸  Evidence of under-reporting of abortions on grounds of fetal disability resulted in guidance from the DH: Matching Department of Health Abortion Notifications and Data from the National Down’s Syndrome Cytogenetic Register and Recommendations for Improving Notification Compliance (May 2014).

⁸⁹  Jepson v The Chief Constable of West Mercia Police Constabulary [2003] EWHC 3318.

⁹⁰  C Dyer, ‘Doctor Who Performed Late Abortion will Not be Prosecuted’ (2005) 330 BMJ 668.

⁹¹  See R Scott, ‘The Uncertain Scope of Reproductive Autonomy in Pre-implantation Genetic Diagnosis and Selective Abortion’ (2005) 13 Medical Law Review 291; R Scott, ‘Interpreting the Disability Ground of the Abortion Act’ (2005) 64 Cambridge Law Journal 388.

⁹²  See S McGuinness, ‘Law, Reproduction and Disability: Fatally Handicapped’ (2013) 21 Medical Law Review 213.

⁹³  See M Brazier, J Harris, ‘Fetal Infants: At the Edge of Life’ in P Ferguson and G Laurie, Inspiring a Medico-Legal Revolution: Essays in Honour of Sheila McLean (2015) Ashgate, ch 4.

⁹⁴  See SK Templeton, L Rogers, ‘Babies that Live after Abortions Are Left to Die’ (2004) Sunday Times, 20 June.

⁹⁵  R v Hamilton (1983) Times 16 September. In 1983, a consultant gynaecologist was charged with attempted murder. Police had been informed that a baby had been left on a slab to die for some time before being transferred to a paediatric unit. The allegation against the doctor was that he performed an abortion on the basis of an estimate of twenty-three weeks’ pregnancy and, when the baby proved to be of thirty-four weeks’ gestation, left it without attention intending it to die. The prosecution was dismissed by magistrates for lack of evidence.

⁹⁶  RCOG, Termination of Pregnancy for Fetal Abnormality (2010), pp 29–31.

⁹⁷  See RCOG, Fetal Awareness: Review of Research and Recommendations for Practice (2010).

⁹⁸  See J Keown, ‘Selective Reduction of Multiple Pregnancy’ (1987) 137 New Law Journal 1165; DPT Price, ‘Selective Reduction and Feticide: The Parameters of Abortion’ [1988] Criminal Law Review 199.

⁹⁹  R Lee and D Morgan, Human Fertilisation and Embryology: Regulating the Reproductive Revolution (2000) Blackstone, pp 252–256.

¹⁰⁰  Greater Glasgow and Clyde Health Board v Doogan [2014] UKSC 68, [8].

¹⁰¹  Royal College of Nursing v DHSS [1981] AC 800.

¹⁰²  See S McGuinness and M Thomson, ‘Medicine and Abortion: Complicating the Reforming Profession’ (2015) 23 Medical Law Review 177.

¹⁰³  Greater Glasgow and Clyde Health Board v Doogan [2014] UKSC 68, [27] per Lady Hale.

¹⁰⁴  The Human Fertilisation and Embryology Act, s 38 confers a similar right to refuse to participate in embryo research or any of the infertility treatments regulated by that Act.

¹⁰⁵  [1988] 3 All ER 1051, HL.

¹⁰⁶  [2014] UKSC 68.

¹⁰⁷  See Lady Hale’s helpful list of examples: ibid, [39].

¹⁰⁸  Ibid, [24]. See J Montgomery, ‘Conscientious Objection: Personal and Professional Objections in the Public Square’ (2015) 23 Medical Law Review 200, 219–220.

¹⁰⁹  Note that the Conscientious Objection (Medical Activities) Bill 2015–16 (HL Bill 26), a Private Members Bill introduced by B O’Loan, seeks to extend conscious objection to incorporate supervision, delegation, planning and supporting staff.

¹¹⁰  See Greater Glasgow and Clyde Health Board v Doogan [2014] UKSC 68, [25–27].

¹¹¹  Montgomery (2015) 23 Medical Law Review 200, 206.

¹¹²  See M Fox, ‘Abortion Decision-Making – Taking Men’s Needs Seriously’ in E Lee (ed), Abortion Law and Politics Today (1998) Macmillan, 198; S Sheldon, ‘Unwilling Fathers and Abortion: Terminating Men’s Child Support Obligations’ (2003) 66 Modern Law Review 175.

¹¹³  [1979] QB 276.

¹¹⁴  [1980] 3 EHRR 408.

¹¹⁵  [1987] 1 All ER 1230. And see Kelly v Kelly 1997 SLT 896 (Scotland).

¹¹⁶  [1987] 1 All ER 1230, at 1243.

¹¹⁷  Re P (A Minor) (1981) 80 LGR 301.

¹¹⁸  [1985] 3 All ER 402, HL.

¹¹⁹  See An NHS Trust v ABC and a Local Authority [2014] EWHC 1445 Fam, where Mostyn J held that a girl aged 13 was Gillick competent and could consent to an abortion; but see KL Moreton, ‘Gillick Reinstated: Judging Mid-Childhood Competence in Healthcare Law’ (2015) 23 Medical Law Review 303.

¹²⁰  Axon v Secretary of State for Health [2006] EWHC 37.

¹²¹  See Re B (A Minor) (Wardship: Abortion) [1991] 2 FLR 226 (Hollis J authorised abortion for 12-year-old-girl).

¹²²  Though may be given considerable weight; see X (A Child) (Capacity to Consent to Termination) [2014] EWHC 1871 (Fam).

¹²³  [1992] 4 All ER 627, discussed at 14.21.

¹²⁴  [1992] 4 All ER 627, at 635.

¹²⁵  Ibid.

¹²⁶  [2014] EWHC 1445 (Fam). See K Moreton (2015) 23(2) Medical Law Review 303. And see 14.21.

¹²⁷  [2014] EWHC 1445 (Fam), [15].

¹²⁸  [2014] EWHC 1871.

¹²⁹  [1988] 1 All ER 613.

¹³⁰  Re SS (Medical Treatment: Late Termination) [2002] 1 FLR 445. Contrast with D v NHS Trust (Medical Treatment: Consent: Termination) [2003] EWHC 2793.

¹³¹  [2004] 2 FLR 577; see JK Mason, ‘What’s in a Name?: The Vagaries of Vo v France’ [2005] Child and Family Law Quarterly 97. And see Evans v United Kingdom (2008) 46 EHRR 34.

¹³²  See K O’Donovan, ‘Taking a Neutral Stance on the Legal Protection of the Fetus’ (2006) 14 Medical Law Review 115.

¹³³  [2010] ECHR 25579/05.

¹³⁴  Attorney General v X [1992] 2 CMLR. And see Tysiac v Poland (2007) 45 EHRR 42.

¹³⁵  And see Tysiac v Poland (2007) 45 EHRR 42. Note Ireland’s Protection of Life During Pregnancy Act 2013 makes concessions within the confines of the eighth amendment of the Irish constitution. A Private Members’ Bill to repeal the eighth amendment (the Protection of Life in Pregnancy Amendment (Fatal Foetal Abnormalities) Bill) was rejected in May 2015.

¹³⁶  A Alghrani, M Brazier, ‘What Is It? Whose Is It? Re-Positioning the Fetus in the Context of Research’ (2011) 70 Cambridge Law Journal 51.

¹³⁷  R Scott ‘The English Fetus and the Right to Life’ (2004) 11 European Journal of Health Law 347.

¹³⁸  See 6.9 and 11.21.

¹³⁹  A Alghrani, ‘Regulating the Reproductive Revolution: Ectogenesis – A Regulatory Minefield’ in M Freeman (ed), Law and Bioethics (2008) Oxford University Press, p 303.

¹⁴⁰  S McLean, ‘Abortion Law; Is Consensual Reform Possible?’ (1990) 17 Journal of Law and Society 106.

¹⁴¹  See Brazier, Harris, ‘Fetal Infants’.

Chapter 14

DOCTORS AND CHILDREN

14.1 In this chapter, we examine the law governing doctors’ relationships with child patients. The courts are often asked to determine the fate of sick children when doctors and parents disagree about how best to care for the child. Several cases have attracted much publicity. In two recent cases parents sought to protect their children, who suffered from malignant brain tumours, from the adverse effects of radiotherapy. The parents of 5-year-old Ashya King removed him from hospital and sought alternative treatment abroad. The hospital feared for Ashya’s safety and the parents were arrested in Spain before treatment in Prague was held to be in his best interests.¹ And a mother disappeared for four days when the court ruled that her 7-year-old son, Neon Roberts, should receive radiotherapy to help prevent the return of his medulloblastoma.²

The courts continue to struggle with the question of blood transfusions for the children of Jehovah’s Witnesses.³ May a doctor insist on administering a transfusion against the parents’ wishes? Some cases involve, not disagreement between doctors and parents, but disputes between parents themselves. Should a little boy be circumcised as his Muslim father wishes, when his mother vehemently opposes circumcision? On the opposite side of the coin, are there limits to treatment to which a parent may agree on behalf of the child? For instance, may a mother, learning that her 4-year-old daughter is a likely carrier of haemophilia, have the child subjected to genetic testing for carrier status, or even sterilised? As a child matures, common sense dictates that she be allowed to take more decisions for herself. Gillick⁴ appeared to establish a right to adolescent autonomy. It proved to be an odd sort of ‘right’, a right to say yes but not to say no.⁵

We begin by looking at the legal position where everyone would agree that the child is too young to make any sort of decision about medical treatment for herself. Then we explore the vexed issues surrounding adolescents.

At the threshold of viability⁶

14.2 The birth of such a very sick baby is a tragedy. The joy of normal childbirth is replaced by fear for the baby’s and the family’s future. Until relatively recently, two factors, to some extent, mitigated the parents’ dilemma. Little could be done for the baby. Most extremely premature babies died at birth. Many severely disabled infants survived only a few weeks or months after birth. Their parents suffered the pain of bereavement, but were spared anxiety about the child’s future. In any case, whether the child lived or died, the decision was made by ‘God or nature’. The parents could do nothing about it. Developments in neonatal intensive care enable doctors to prolong the lives of babies born at ever earlier stages in gestation. And babies born later in pregnancy, but affected by severe abnormalities, can also be ‘saved’. The evidence, however, suggests that although these babies’ lives are prolonged, many babies will not survive to leave the neonatal intensive care unit and go home. A proportion of those who do survive will be affected by severe impairments. In a recent study, survival of babies born at twenty-two to twenty-four weeks was 53 per cent compared with 90 per cent for those born at twenty-five to twenty-seven weeks.⁷ An earlier study⁸ showed that of those babies born at twenty-three weeks who survived to their sixth birthday, 25 per cent or so were affected by severe disability. At twenty-two weeks, just two babies survived at all. Babies born nearer to the usual term of pregnancy, or at term, may also suffer from severe abnormalities, for example, the baby’s brain may not have developed properly or she may be born with virtually no bowel. Some congenital conditions such as Edwards syndrome mean that a baby can survive only with intensive care, and are unlikely, whatever is done for them, to live for more than a short time. Parents may be faced with agonising decisions about the treatment of their baby within minutes of her birth.

The dilemma about how to care for a very sick person, whether prolonging life is always the right course of action, is not exclusive to babies. Nonetheless, there are special features surrounding any discussion of the care of sick babies. The conscious adult patient can speak for himself. The decision about any continuation of treatment may be his. Even if unconscious, he may earlier have expressed his wishes should the question arise. The baby cannot express any preference. Her parents may give their views. Should parental wishes be decisive? Parents’ views are crucial, but children have interests too. The baby’s plight is different from that of a newly disabled adult. She does not move from full health to disability. A life of disability is all that she can know. Nor will her parents be as able to speak for her as for an older child. The older child (even at 2 or 3 years old) will have indicated what gives her pleasure and what causes her pain. Questions about how to treat newborn babies raise somewhat different issues to the more general questions about when to give priority to prolonging life.

For doctors, one critical factor has been the evidence that certain kinds of intervention have poor long-term results. While some parents will want doctors to do everything possible to keep their baby alive, others who discover at birth that their baby is severely disabled may be perplexed by suggestions that their newborn baby must now be subjected to aggressive measures to keep him alive. The Abortion Act permits the termination of pregnancy when there is a substantial risk that the child, if born, will be severely disabled. Some people ask why a child who could have been actively destroyed if his disability had been diagnosed in pregnancy, must be the subject of intensive life-saving measures if his disability goes unnoticed until birth. Some philosophers argue that it is irrational that the law should allow the killing of a fetus at 38 weeks into pregnancy, but insist on saving the baby prematurely delivered at 24 weeks. What moral difference does the journey through the birth canal make?

The concept of the sanctity of each and every human life is under attack. Forceful arguments are advanced,⁹ that the value of life lies in its quality and its contribution to society, rather than in any intrinsic merit in life itself. The newborn baby is no more a ‘person’ than the embryo or the fetus.¹⁰ Such arguments are equally forcefully rebutted.¹¹

Proposals for reforms of law and practice

14.3 Debate about whether the law should make special provision in relation to newborn babies is not new. The prosecution of Dr Leonard Arthur for murder prompted calls for new legislation as long ago as 1981.¹² Broadly similar proposals were made by Mason and McCall Smith in the first edition of Law and Medical Ethics,¹³ and survived with amendments to the sixth edition of that work.¹⁴ Legislation aimed solely at clarifying the law concerning withholding and withdrawing treatment may be of limited utility. What is meant by ‘worthwhile quality of life’? What degree of pain and suffering renders life unbearable?

Another question in relation to changing the law to try to clarify when doctors may lawfully withhold or withdraw treatment is this. If it is lawful to withhold life support from a baby, ‘allowing her to die’, should it also be lawful to take active steps to end her life swiftly and painlessly? Is there any moral difference between the two? What of the baby whose condition is agonising and likely to be fatal who hangs on to life? In 2007 it was reported that Dr Michael Munro had administered a muscle relaxant, pancuronium, to two babies who were suffering agonal gasping, a type of paroxysmal distress which often precedes death. Both babies were born prematurely and as a result of the health problems they endured, the decision was taken to withdraw treatment. Because Dr Munro’s primary motivation was a desire to relieve suffering, the GMC found him not guilty in a fitness-to-practise hearing.¹⁵ Dr Munro had the full support of both sets of parents.

In the Netherlands,¹⁶ the Groeningen Protocol¹⁷ permits doctors to act to end the life of a baby in the most exceptional circumstances. To put it crudely, the Protocol allows neonatal euthanasia. It is not formally part of Dutch law. A team of physicians, including a doctor who is not directly involved in the care of the baby, must confirm that the baby’s condition is such that he is subjected to unbearable suffering, and that his condition is untreatable. If the parents consent,¹⁸ high doses of opiates such as morphine are used to induce the death of the baby gently over one to two days. After the baby’s death, a report should be¹⁹ made to the coroner, and a committee of five members, including an ethicist and a lawyer, scrutinise the decision to check that the treatment of the baby meets the conditions set out in the Protocol. The ‘killing’ of the baby remains a criminal offence, but if the Protocol is followed, doctors will not be prosecuted.

If legislation allowing active neonatal euthanasia were to be enacted in the UK,²⁰ a series of difficult decisions would need to be taken. Do we accept some distinction in the value of the life of the newborn baby, and the older child or adult? If so, where is the line to be drawn? Is it seventy-two hours, or twenty-eight days, or later? The Abortion Act may have altered perceptions of the sanctity of life. Debate has ebbed and flowed for centuries as to the moral status of the unborn. Abortion, although severely punished, was never equated with murder in England. Birth is a relatively clear dividing line. No other distinction can be as clear. So how (if at all) could legislation, expressly and exclusively designed to allow ending the lives of newborn babies, be justified? Do we regard the parents as standing proxy for their child in any decision as to treatment? If so, why draw the line at twenty-eight days? Older children develop chronic disease, are disabled in accidents, or are discovered to suffer from severe disabilities later in childhood.

One other possibility to be considered is whether, without changing the law, clearer guidelines relating to the resuscitation of extremely premature babies would be helpful.²¹ In light of increasingly consistent case law, this is the approach recommended by Mason and Laurie in the 2013 edition of their book.²² Societies and professional bodies in many countries produce such guidance.²³ Practice in the UK varies considerably. Some neonatal units will try to discuss what to do with the parents before the birth where this is possible. Others resuscitate all babies born after twenty-three weeks, admit the baby to neonatal intensive care, and then review his prospects. A few units will seek to resuscitate a baby born at twenty-two weeks, or even below. The extent of parents’ involvement in such decisions also varies.²⁴ Resuscitation of such a very premature baby raises questions of the ethics of attempting to resuscitate a baby who is highly likely to die whatever is done for her. And when a baby does survive on a ventilator, but the long-term prognosis is dire, decisions to withdraw intensive care may be even more painful than decisions to institute care.

Finally, the question of use of resources raises its ugly head.

(1)  Should money spent on intensive care of babies unlikely to survive be spent elsewhere, say, on treatment for early breast cancer?

(2)  Would money spent on Baby A born at twenty-two weeks be better spent on B, born a little later? The limited number of places in neonatal units means that doctors sometimes have to arrange for a baby to be transported hundreds of miles to a neonatal unit far away because there is no capacity to care for him nearer the family home.

In the Netherlands,²⁵ professional guidelines issued in the 1990s advise against the resuscitation of a baby born before twenty-five weeks unless the parents press very strongly for resuscitation and doctors have grounds to judge that the particular baby has an exceptional chance of survival. The Nuffield Council on Bioethics²⁶ examined ethical, social and legal issues arising in relation to critical care decisions in neonatal medicine. Among a number of recommendations, the report proposed guidelines for deciding whether to institute neonatal intensive care. The guidelines suggest that below twenty-two weeks no baby should be resuscitated, except within an approved clinical research study. Between twenty-two and twenty-three weeks, the general practice would be not to institute intensive care unless the parents, fully informed, reiterate requests for resuscitation. Between twenty-three and twenty-four weeks, precedence should be given to parental wishes, and from twenty-four weeks, the presumption should be that full intensive care for the baby should be instituted.²⁷

The courts and sick infants

14.4 For the present, legal principles governing the medical care of newborn babies and small children must be discerned from the judgments of the courts. Professional guidelines seek to translate them²⁸ and the GMC requires that these are taken into account and that doctors seek a second opinion where doubts or uncertainties arise.²⁹ The focus in any case referred to court is the individual baby.³⁰ Flexibility has advantages, but may result in some parents feeling that judgments are too subjective and governed by the moral and personal viewpoints of the chosen judge. Doctors worry about lack of certainty. They are concerned that decisions to withhold or withdraw treatment (even when agreed with parents) could subject them to possible criminal liability for murder or manslaughter.

The fundamental principle governing withholding life saving treatment from young children was settled in Re B in 1981. An infant girl, Alexandra, was born suffering from Down’s syndrome and an intestinal obstruction. In a normal child, simple surgery would have been carried out swiftly with minimal risk to the baby. Without surgery, the baby would die within a few days. Her parents refused to authorise the operation. They argued that God or nature had given their child a way out. The doctors contacted the local authority and the child was made a ward of court. A judge was asked to authorise the operation. He refused to do so. The authority appealed, and the Court of Appeal³¹ ordered that the operation go ahead. Counsel for the parents submitted that in this kind of decision, the views of responsible and caring parents must be respected and that their decision should decide the issue. The Court of Appeal rejected the submission, holding that the decision must be made in the best interests of the child.

In the same year that the Court of Appeal held that Alexandra must be treated and live, Dr Arthur faced trial for murder.³² A baby was born in the hospital where Dr Arthur was consultant paediatrician. The baby suffered from Down’s syndrome. His parents did not wish him to survive. He died sixty-nine hours after his birth. The prosecution alleged that Dr Arthur ordered nursing care only and prescribed a drug to suppress the baby’s appetite and so starve him to death. They claimed that, apart from Down’s syndrome, the baby was otherwise healthy, and that his death resulted from starvation and the effect of the drug causing him to succumb to bronchopneumonia. Defence evidence established that: (1) the baby suffered from severe brain and lung damage; (2) Dr Arthur followed established practice in the management of such an infant; (3) that in the first three days of life, normal babies take in little or no sustenance and usually lose weight (which the dead baby had not done). The baby patently did not starve to death. The judge directed that the charge be altered to attempted murder. Summing up, the judge stressed that there is ‘no special law in this country that places doctors in a separate category and gives them special protection over the rest of us’. He emphasised that, however severely disabled a child may be, if the doctor gives it drugs in an excessive amount so that the drugs will cause death, then the doctor commits murder.

He highlighted the distinction between doing something active to kill the child and electing not to follow a particular course of treatment which might have saved the infant. Considering the ethical arguments on terminating newborn life, the judge reminded the jury that if ethics and the law conflict, the law must prevail. Nonetheless his Lordship concluded:

I imagine that you [the jury] will think long and hard before deciding that doctors of the eminence we have heard in representing to you what medical ethics are and apparently have been over a period of time, you would think long and hard before concluding that they in that great profession have evolved standards which amount to committing crime.

The jury acquitted Dr Arthur.

A confused picture emerges. A baby with Down’s syndrome was ordered to be saved, yet Dr Arthur was not guilty of a crime in relation to his treatment of a severely damaged Down’s infant. The acquittal of Dr Arthur tells us little about the law. The confusion over the pathological evidence may have irretrievably prejudiced the jury against the prosecution’s case. The baby’s multiple abnormalities should have been irrelevant to the reduced charge of attempted murder. When Dr Arthur ordered nursing care only, he thought that he was dealing with a Down’s baby as entitled to survive as Alexandra. Did the jury see it that way? As Mason puts it: ‘Murder, in the popular sense of the word, was the one thing of which Dr Arthur was certainly innocent’.³³

Deliberate killing

14.5 In all but one exceptional instance illustrated by the case of the Manchester conjoined twins, it is indisputable that neither doctor, nor parents, nor anyone else may do any act intended solely to hasten the death of the disabled baby. The deliberate killing of any human being is murder. The moment that the child has an existence separate from his mother,³⁴ the moment he has independent circulation, even though the afterbirth may not yet fully have been expelled from the mother’s body, he is protected by the law of homicide. It has on occasion been faintly argued that a grossly malformed child, ‘a monstrous birth’, should not be regarded in law as human. We shall see that this argument was advanced unsuccessfully in the conjoined twins’ case.³⁵ Defining humanity, other than by virtue of human parentage, is an impossible and unacceptable task. Does ‘monstrous’ refer to appearance, in which case an intelligent infant of appalling mien could legitimately be destroyed? Does it cover lack of intelligence, or lack of a brain?³⁶ Both are almost impossible to measure at birth.

In Re A (Minors) (Conjoined Twins: Separation),³⁷ the Court of Appeal authorised the killing of the weaker of two conjoined twins. Jodie and Mary were born in Manchester after a scan in their native Malta revealed their condition. Their parents came to this country in the hope of surgery to separate and save both children. The girls were joined at the pelvis. Each had her own arms and legs as well as a brain, heart and lungs. Mary’s brain was said to be ‘primitive’, her heart was defective, and she had no functioning lung tissue. Mary remained alive only because a common artery allowed Jodie’s heart to circulate oxygenated blood to both infants. Left conjoined, the strain on Jodie’s organs would result in the death of both children within three to six months. Surgery to separate the girls would result in Mary’s death within minutes of separation. Surgery would kill Mary.³⁸ Doing nothing would result in the death of both girls. The parents were devout Roman Catholics. They refused to consent to surgery because they believe that it would be a sin to ‘murder’ Mary and that their children’s fate must be subject to God’s will. The hospital applied to the court for authority to overrule the parents’ objections.

The Court of Appeal ruled that surgery should go ahead. What follows can only be a summary of their Lordships’ complex, and not always unanimous, reasoning. Let us deal first with the question of how it could be said to be lawful to kill Mary. Mary, the judges agreed, was in law a person whose right to life was entitled to respect. She was not to be regarded as non-human, a monster or, as some had suggested, a ‘tumour’ attached to Jodie’s body.³⁹ Ward and Brooke LJJ⁴⁰ accepted that surgery to separate the twins constituted killing Mary. However much their doctors wished the case to be different, in cutting off Mary’s blood supply by clamping the common artery, they ‘intended’ Mary’s death. Unless some lawful excuse justified their conduct, the doctors were exposed to liability for murder. The Court found such excuse. They found that excuse in the doctrine of necessity.⁴¹ Brooke LJ cited the analogy of the captain of a ship about to capsize. He had to choose who entered the lifeboats. The judge continued:

He would not be guilty even though he kept some of the passengers back from the boat at revolver-point and he would not be guilty even though he had to fire the revolver.⁴²

Doctors caring for the conjoined twins had duties to both girls. Surgery would involve an assault, a fatal assault on Mary. To save Jodie, it was justifiable.

It was necessary to avoid an inevitable and irreparable evil. It was no more than what was necessary to preserve Jodie’s life. Given Mary too would die without surgery, the evil of her inevitable death was not disproportionate. A finding that surgery did not constitute murder did not conclude the question of the twins’ fate. The more important question revolved around who had the right to make the crucial decision. Doctors wanted to operate. The parents objected. Before going on to look at the question of who decides, we must first consider the more common case, where what is at stake is not actively killing a child, but withholding treatment from her.

Withholding and withdrawing treatment

14.6 To what extent does the law require parents and doctors to provide treatment to prolong the baby’s life? Before any failure to treat a child can engage criminal liability, it must be established that a duty to act was imposed on the accused. Parents are under a duty to care and provide for their dependent children. Failing to provide proper care, including medical aid where necessary, will result in a conviction for wilful neglect of the child, provided that the parent was aware of the risk to the child’s health.⁴³ Should the child die, the parents may be convicted of manslaughter.⁴⁴ Parents who are aware of the danger to a child’s health, but who do not seek medical aid because of religious or other conscientious objection to conventional medicine, have no defence to criminal prosecutions for neglect or manslaughter.⁴⁵ Parents who deliberately withhold sustenance and care from a child intending him to die may be guilty of murder.⁴⁶ Finally, a range of other legal remedies is available to local authority social services departments. Failure to provide medical aid, risking significant harm to the child, is a ground for taking a child into care.⁴⁷

What of the doctor? If he is under a duty to treat a baby, then, like the parent, should the child die, he could be prosecuted for manslaughter if his omission resulted from neglect, or for murder if he intended the infant to die. Once the doctor accepts the baby as a patient, he assumes a duty to that baby to give him proper medical care. Nor is it likely that a paediatrician could, should anyone ever want to, evade responsibility by refusing to accept a child as a patient after his birth. His contract with the NHS imposes on him an obligation towards the children born in his hospital, giving rise to a duty to the individual infant.⁴⁸

Parents and doctors have a duty to provide medical aid, but what is the scope of that duty? Where a child is suffering from severe abnormalities, may proper medical care be defined as keeping her comfortable, but withholding life-prolonging treatment? Two factors play a vital role in the decision as to whether to treat an acutely ill child. What do her parents desire? What is the practice of the medical profession in the management of her kind of illness or disability?⁴⁹ The answer to the second question is that in many instances, doctors will explain the treatment available, give a prognosis as to the child’s future, and accept the decision taken by the parents. Yet, as we have seen, the Court of Appeal in the case of Alexandra, ordered surgery to remove an intestinal blockage against her parents’ wishes. The baby would be affected by the mental and physical disabilities attendant on Down’s syndrome. If treated, she could expect the same quality of life as any one of the many other Down’s babies born each year. She would suffer no pain from her disability, and the evidence suggests that properly cared for Down’s children lead happy lives. The surgery needed to save Alexandra was simple and without risk. Her proposed treatment had a purpose, the baby was not inevitably dying, and the treatment was in no way unduly burdensome. Re B⁵⁰ signalled that the legality of withholding treatment is dependent on the degree of a child’s disability and the degree of suffering continued life may cause her. Some sort of balance between the pain of prolonged life and the finality of death has to be struck.⁵¹ In striking that balance, the law, in appropriate cases, allows doctors and parents to conclude that it is not in the interests of the baby to intervene to prolong her life.

What, though, of withdrawing treatment already instituted? A baby may be resuscitated at birth, or an older child put on a ventilator after a traumatic injury, but tests later show that the child is never likely to leave hospital, or even to survive off the ventilator. It is thought his best interests are best served by allowing him to die peacefully in his parents’ arms. Can doctors lawfully switch off the ventilator? Or is that an act hastening death and so murder? We shall see later that the House of Lords⁵² has ruled that switching off a ventilator, or withdrawing life-sustaining treatment from a patient of any age, does not constitute an act hastening death. Discontinuing life support is ‘no different from not initiating it in the first place’. In a case directly concerned with the care of a baby in intensive care, the judge stressed that⁵³ ‘there is no legal distinction between withholding or withdrawing life support … the best interests test applies equally to both situations’.⁵⁴ Where withdrawal of treatment includes the withdrawal of artificial nutrition and hydration, the GMC advises that a second medical opinion be sought.⁵⁵ The Royal College of Paediatrics and Child Health advises that treatment limitation be considered where it cannot provide overall benefit, either because it is unlikely to prolong life significantly (for example in cases of brain stem death and imminent or inevitable death) or due to the unlikelihood that treatment will alleviate burdens associated with illness or treatment.⁵⁶

‘Best interests’: a balancing exercise⁵⁷

14.7 The decision must be made in the ‘best interests’ of the child and case law has evolved to give a fuller picture of the balancing exercise required. In 2006 Holman J produced a tenfold summation in An NHS Trust v MB.⁵⁸ An abridged version is repeated here:

i) It is the role and duty of the court to ... exercise its own independent and objective judgment. ii) The right and power of the court ... only arises because the ... child lacks the capacity to make a decision for himself … iv) The matter must be decided by the application of an objective approach or test. v) That test is the best interests of the patient. Best interests ... include, non-exhaustively, medical, emotional, sensory (pleasure, pain and suffering) and instinctive (the human instinct to survive) considerations … vii) Considerable weight ... must be attached to the prolongation of life … But it is not absolute, nor necessarily decisive … ix) All these cases ... depend entirely on the facts of the individual case.

x) The views and opinions of both the doctors and the parents must be carefully considered … [parental] ... views may have particular value because they know the patient and how he reacts so well … [parental] wishes, however understandable in human terms, are wholly irrelevant to consideration of the objective best interests of the child save to the extent in any given case that they may illuminate the quality and value to the child of the child/parent relationship.⁵⁹

Let us review some of the case law. In Re C (A Minor) (Wardship: Medical Treatment),⁶⁰ a baby had been made a ward of court shortly after birth on grounds of her parents’ inability to care for her. C suffered from an exceptionally severe degree of hydrocephalus, and the brain itself was poorly formed. She appeared to be blind and virtually deaf. At sixteen weeks she was, apart from her enlarged head, the size of a four-week baby. It was said to be inevitable that she would die in a matter of months at most. The judge made an order that leave be given to ‘treat the ward to die’. This infelicitous phrase caused an outcry, being wrongly interpreted by some of the media as sanction for active euthanasia. The Court of Appeal affirmed his judgment, deleting the unfortunate phrase. Lord Donaldson MR saw C’s case as very different from that of in Re B. C was inevitably dying. Her life appeared to offer her no pleasures.

Re J (A Minor) (Wardship: Medical Treatment)⁶¹ is a more difficult case. J was born thirteen weeks prematurely at a birth weight of 1.1 kg. He nearly died several times, but was saved by medical skill. He was found to have severe brain damage: ‘A large area of fluid filled cavities where there ought to have been brain tissue’. J was said to be likely to develop paralysis, blindness and probable deafness. Unlike baby C, his life expectancy might extend to his late teens. If he developed an infection, must he be treated? If he suffered a further episode of cyanosis and collapse, must he be resuscitated? The Court of Appeal found that he need not. Lord Donaldson regarded Re B as near to binding authority that a balancing exercise should be performed in assessing the course to be adopted in the best interests of the child. The exercise must seek to reflect the ‘assumed’ view of the child. In deciding whether the prolonged life of the child will be ‘demonstrably awful’,⁶² the child’s perspective on life is the crucial test. He will know no other life, and the amazing adaptability and courage of disabled people must be considered.

But in the end there will be cases in which the answer must be that it is not in the interests of the child to subject it to treatment which will cause increased suffering and produce no commensurate benefit, giving the fullest possible weight to the child’s, and mankind’s, desire to survive.⁶³

Note that in Re J there was no disagreement between J’s parents and doctors. The application to court was undertaken to ensure that any decision to withhold treatment was lawful so neither parents nor doctors would risk prosecution.

English judges have shown themselves prepared to accept that appropriate care for a terribly sick child is not always to prolong his life. Does the Human Rights Act 1998 make any difference, enforcing as it does the right to life enshrined in Article 2 of the Human Rights Convention? In A National Health Service Trust v D,⁶⁴ a baby was born with irreversible lung disease and multiorgan failure. D was in the process of dying and the trust sought a declaration that it would be lawful not to resuscitate him if he stopped breathing. The judge held that as long as any decision not to resuscitate D was made in his best interests, there was no violation of Article 2. Article 3 which prohibits cruel or inhuman treatment entails a right to be allowed to die with dignity.

Disputing best interests

14.8 The most difficult cases arise when parents and doctors disagree about the best interests of a baby or child.⁶⁵ Professional guidelines place great emphasis on working in partnership with parents.⁶⁶ In many cases the decision can be postponed until consensus between doctors and parents is reached.⁶⁷

In other cases the court is called upon to determine the child’s best interests. The GMC hails this a ‘constructive way of thoroughly exploring the issues and providing reassurance for the child and parents that the child’s interests have been properly considered in the decision’,⁶⁸ though sadly the court’s involvement sometimes signifies a breakdown in the relationship between parents and doctors. Some parents seek continued treatment against the advice of doctors. In Kings College Hospital NHS Foundation Trust v Y and MH⁶⁹ the trust was granted a declaration that it would be lawful to withhold life-sustaining treatment from a severely ill 7-year-old girl with spinal muscular atrophy type 1. In accordance with their religion, Y’s father and family sought preservation of life. But Y’s medical quality of life was poor. The strong presumption in favour of life was rebutted.

Disagreement was also present in the case of the conjoined twins, Re A.⁷⁰ Having decided that ending Mary’s life was not unlawful, the court had to address whose judgement on the interests of the two little girls should determine their fate. Their Lordships stressed that while the decisions of devoted and responsible parents should be treated with respect, the court retained power to intervene to protect the paramount welfare of the child. The conjoined twins’ case was unique because Jodie’s welfare depended on Mary’s demise. The parents, however, had other separate concerns about Jodie. They feared⁷¹ that she would be profoundly disabled, unable to walk, likely to have to undergo several more operations during her infancy and possibly doubly incontinent. Their view was that it was not in the interests of either child to operate. The Court of Appeal disagreed. There was a reasonable prospect that Jodie could lead a relatively normal life. Mary, Ward LJ said, was ‘beyond help’. Surgery might shorten her brief life. Without surgery she would still die. The ‘least detrimental choice, balancing the interests of Mary against Jodie and Jodie against Mary permit the operation to be performed’.⁷²

Jodie’s prospects, it might be said, were not ‘demonstrably awful’. Will the courts always rule in favour of continuing a child’s life unless it is either likely to involve unbearable suffering, or will be such that the child will have virtually no ability to enjoy any of the senses, or use any of her abilities? In Re T⁷³ (1997), T was born with biliary atresia, a life-threatening liver disease. Without a liver transplant, he would die at about two and a half years of age. Earlier surgery when he was three and a half weeks old had failed, and the baby suffered great pain and distress. His parents, both health professionals, adamantly opposed transplant surgery. Fearing intervention by social services, the parents fled abroad. The local authority intervened seeking a court order requiring the family’s return to England and that the transplant go ahead. The parents argued that if their son had the transplant, even if the operation was successful, he would be subjected to further pain and distress, he would have to take anti-rejection drugs for the rest of his life and might face repeated surgery. They thought that his best interests were better served by a short, happy life and a peaceful death. The Court of Appeal ruled that the parental views should prevail. The parents in Re T were entitled to withhold life-saving treatment from their child. The essence of the court’s ruling in Re T was that on the ‘unusual facts’ of the case, any presumption that the best interests of the child are to prolong his life was rebutted. The trial judge, ordering the transplant, had given insufficient weight to the mother’s views. Best interests are not limited to clinical considerations.⁷⁴ If the operation was ordered against her will, her son’s welfare would be compromised. Her commitment to his care was an integral part of any successful recovery post-transplant. Deprived of her care (ie taken into care) he would suffer. If she reluctantly complied with the court order, family problems would beset child and parents. The mother would have to return to, and remain in, England reluctantly. It was not clear whether the father would give up his job and return with her. If not, problems would arise in terms of financial and emotional support for mother and son. Butler-Sloss LJ, finding that the mother’s view could not be considered unreasonable, said this:

The mother and child are one for the purposes of this unusual case and the decision of the court to consent to the operation jointly affects the mother and it also affects the father. The welfare of the child depends on his mother. The practical considerations of her ability to cope with supporting the child in the face of her belief that this course is not right for him, the requirement to return probably for a long time to this country, either to leave the father behind and lose his support or to require him to give up his present job and seek one in England were not put by the judge into the balance when he made his decision.⁷⁵

Is Re T an aberration? Consider Butler-Sloss’s LJ’s language. She says ‘mother and child are one’ and that the child’s welfare depends on his mother. Where the child remains with loving parents, is this not usual rather than unusual? A sick child always requires extra parental commitment. Why, you might ask, did a similar analysis not apply to Jodie, the stronger of the conjoined twins? Are there other singular features of Re T? All the judges emphasise that the parents were themselves health professionals. Did this give their views extra weight? More importantly, and what is truly unusual about Re T, is that any court order would also have needed to drag the family back from the other side of the world. Would Re T have had the same outcome if the parents had never left England?⁷⁶

Re T was affirmed in LA v SB, AB and MB.⁷⁷ Doctors argued that surgery was the optimal treatment for 6-year-old MB, who was suffering around 100 epileptic seizures a day. The seizures were thought to be causing permanent developmental problems and posed a risk to his life, but his parents objected to surgery in preference for drug treatment. Sir Nicholas Wall P refused the local authority’s application⁷⁸ on procedural grounds. The matter was between the hospital and the parents and when the hospital was invited by the court to intervene, it declined to do so. Though surgery remained the optimal treatment, it was not the only treatment and talks between the hospital and the parents could be resumed. Were MB’s best interests served by this judgement? Surgery had an 85 per cent chance of stopping the seizures and MRI scans had already demonstrated irreversible harm.

Scruple or dogma?⁷⁹

14.9 Re T and LA are unusual cases where parents refuse to consent to treatment for their child because of their judgements about the medical outcome. As parents turn increasingly to the Internet for information, such cases may grow in number. At present, more common are cases where parents who are Jehovah’s Witnesses refuse to consent to blood transfusions. Transfusions violate a fundamental tenet of Witnesses’ faith.⁸⁰ The kinds of case which reach the courts are well illustrated by Re S (1993).⁸¹ S was four and a half and suffering from T-cell leukaemia. His parents agreed to intensive chemotherapy. Doctors argued that transfusion of blood products was essential to maximise the prospects of successful treatment and saving S’s life. Without resort to blood, the chances of successful treatment were significantly reduced. His parents objected not just on religious grounds. They raised concerns about the safety of blood products. Their lawyers argued that S’s relationship with his family might suffer, for his parents would believe that his life had been prolonged by an ‘ungodly act’. Thorpe J dismissed the parental objection. The child’s welfare required he be given the best chance of prolonged life. He was unimpressed by talk of problems in the family later in life. Reconciling Re S and Re T is nigh on impossible. In a series of cases, while judges now show some understanding of the dilemma confronting Jehovah’s Witness parents, in the end the courts endorse the child’s interest in survival and overrule parental objections.⁸²

Perhaps part of the key to apparently contradictory decisions about parents’ rights to determine the treatment of their young children can be found in the judgment of Waite LJ in Re T (1997).⁸³ He contrasts cases where parental opposition to treatment is ‘prompted by scruple or dogma of a kind which is patently irreconcilable with principles of health and welfare widely accepted by the generality of mankind’ and ‘highly problematic cases where there is a genuine scope for a difference of opinion’. Ward LJ, in the conjoined twins’ case, says⁸⁴ that that was not a case where the parents’ opposition to surgery to separate the girls was ‘prompted by scruple or dogma’. How much weight should parents’ religious beliefs carry? Parents will argue that Article 8 of the Human Rights Convention (endorsing their right to family life) and Article 9 (guaranteeing religious freedom) mean that their views should be conclusive. Both Articles are qualified. The parents’ ‘rights’ must be balanced against the children’s interests. Caroline Bridge has argued that in delaying treatment, so prolonging a child’s suffering, in attempts to meet parents’ convictions, the child’s interests are undervalued.⁸⁵

Responsibilities not rights?

14.10 One consistent message can be elicited from English case law about the medical treatment of young children. The common law only confers on parents those rights they need to fulfil their responsibilities to provide adequate medical care for their children. Lord Templeman summed up the position in Gillick v West Norfolk and Wisbeck Area Health Authority:

Where the patient is an infant, the medical profession accepts that a parent having custody and being responsible for the infant is entitled on behalf of the infant to consent or to reject treatment if the parent considers that the best interests of the infant so require. Where doctor and parent disagree, the court can decide and is not slow to act. I accept that if there is no time to obtain a decision from the court, a doctor may safely carry out treatment in an emergency if the doctor believes the treatment to be vital to the survival or health of the infant and notwithstanding the opposition of a parent or the impossibility of alerting the parent before the treatment is carried out.⁸⁶

In Birmingham Children’s NHS Trust v B & C⁸⁷ the High Court authorised the administration of blood products to a baby against the wishes of his Jehovah’s Witness parents. Keehan J was satisfied that the low-risk operation was in the best interests of the baby. And in An NHS Trust v SR,⁸⁸ doctors recommended chemotherapy and radiotherapy for a 7-year-old suffering from a medulloblastoma; a cancer affecting the brain and spinal cord. The father consented but the mother did not. Radiotherapy in particular had lasting effects on quality of life. Authorising the treatment, Bodey J concluded:

The balance of advantage and disadvantage tilts well in favour of radiotherapy and chemotherapy, notwithstanding the detrimental side-effects. One cannot enjoy even a diminished quality of life if one is not alive.⁸⁹

In a genuine emergency,⁹⁰ doctors may proceed without parental consent or court authority. So if a child is brought into casualty bleeding to death after a road accident and his Jehovah’s Witness parents refuse to agree to a blood transfusion, the hospital can overrule them if delay threatens the child’s life. Dire necessity justifies their action.

The decision of the European Court of Human Rights in Glass v United Kingdom⁹¹ issues a warning to doctors not to stretch the definition of emergency, and places a strong emphasis on a presumption of the parents’ right to make decisions about the treatment of their young children. David Glass suffered from multiple disabilities. In 1998, he suffered a series of infections after a tonsillectomy. Doctors believed that David had little awareness of, or pleasure in, his surroundings, and that he was dying. They decided that if David stopped breathing he would not be resuscitated, and administered diamorphine to relieve any distress. His mother vehemently objected both to the administration of diamorphine, and the doctors’ decision not to resuscitate David. On one occasion she successfully resuscitated David herself. The relationship between David’s family and doctors deteriorated into acrimony and violence. Mrs Glass unsuccessfully challenged her son’s treatment in the English courts.⁹² She eventually took his case to the Human Rights Court in Strasbourg, and won. The Court ruled that administering diamorphine to David against the wishes of his mother violated Article 8 of the Human Rights Convention. Doctors violated David’s right to respect for his privacy, notably his bodily integrity. Where children are too young, or otherwise unable, to make their own decisions about medical treatment, doctors must normally seek consent from the parents who speak on their child’s behalf. Where doctors considered that parents were not acting in the child’s interests, they must seek authority from a court before overruling the parents, except where intervention was immediately necessary to save the child’s life.

The court can respond quickly where an emergency application is made. However this gives little time to parents to prepare their case. In Re OT (A Baby),⁹³ which we examine further in the next section, OT’s parents argued that an emergency application was procedurally unfair. They claimed it breached baby OT’s rights under Article 8. This submission was not accepted by the court. Parker J held that the parents had had adequate time to prepare their case and given the serious nature of OT’s condition it was ‘imperative now to reach a conclusion’.⁹⁴ The parents were refused permission to appeal.⁹⁵

Disputing best interests: parental demands

14.11 Glass v United Kingdom⁹⁶ reiterated that doctors may not unilaterally override the wishes of a child’s parents. Courts retain the authority to do so. We have seen that courts will rarely endorse a parental refusal of treatment offering to a child a realistic prospect of continued life. Other cases present the reverse scenario. Parents want doctors to continue treating a child for whom the doctors judge there is little (if any) hope of meaningful survival.

In Re C (A Minor) (Medical Treatment),⁹⁷ Orthodox Jewish parents argued that their 16-month-old daughter with spinal muscular atrophy should continue to be ventilated. Doctors argued that continued ventilation was futile. The child was dying. Ventilation would only prolong her life by a few days. The parents’ faith dictated that every effort be made to preserve the spark of life. The court declined to interfere with the doctors’ clinical judgement. Re C can be explained in several ways. English courts have on several occasions refused to order doctors to carry out treatment which in their clinical judgement they consider inappropriate.⁹⁸ It can persuasively be argued that prolonging a child’s suffering cannot be in her interests.⁹⁹ Is Re C, however, another case where judges may have been tempted to dismiss the parents’ case as ‘scruple and dogma’?

In Re OT (A Baby),¹⁰⁰ 9-month-old OT suffered from mitochondria, a progressive neuro-metabolic genetic condition. He was unable to swallow and dependent on a ventilator. He had suffered irreversible brain damage. Doctors felt that continued treatment was futile and would cause him distress. Both parents felt strongly that treatment of their son should be continued. They argued that he was aware of them and still enjoyed pain-free periods. The court accepted the expert evidence and made the declarations sought by the hospital trust. Sadly, this led to OT’s immediate death in March 2009.

Charlotte Wyatt’s parents’ received a sympathetic hearing from Hedley J. Their religious faith and determination to prolong their daughter’s life were given careful consideration. Charlotte was born at twenty-six weeks’ gestation. She needed to be ventilated for most of her first three months of life. She suffered severe infections and both her breathing and brain functions had steadily deteriorated. The damage was probably irreparable. She was believed at the first hearing to be blind and deaf and incapable of voluntary movement. On five occasions, Hedley J was asked to adjudicate in disputes between her parents and her doctors,¹⁰¹ and on one occasion, the case went to the Court of Appeal.¹⁰² The dispute concerned not the current care of the child, but a contingency that might arise. Should Charlotte stop breathing, must she be re-ventilated? Her fundamentalist Christian parents were adamant that everything be done to prolong her life. They sought a miracle. Her doctors considered that the pain and distress likely to ensue from ventilation would only prolong the process of her dying. The trust sought a declaration that doctors were not obliged to re-ventilate Charlotte. At the original hearing in 2004, experts suggested that Charlotte had no more than a 5 per cent chance of surviving the winter of 2004–5. Charlotte defied the odds. Her parents’ and her doctors’ perception of what sort of life Charlotte could enjoy differed radically. The doctors saw a baby with severe brain damage, unable to respond to stimulation other than pain. Her parents believed (and believe) that she responds to them, that she feels pleasure.

Hedley J emphasised the presumption in favour of prolonging life, but acknowledged that, in assessing the best interests of a sick child, there is this balancing exercise to be performed. He quoted Taylor LJ in Re J (A Minor) (Wardship: Medical Treatment),¹⁰³ asking would ‘the child in question, if capable of exercising sound judgment … consider the life to be intolerable’? Hedley J expressly declined to utilise ‘intolerability’ as a supplementary test, or a replacement test, for best interests. Examining the nature of her current existence and the risks and distress entailed in a tracheotomy, the judge concluded (in October 2004) that further aggressive treatment, even if necessary to prolong Charlotte’s life, was not in her best interests.¹⁰⁴ Rejecting her parents’ views, Hedley J acknowledged that her parents knew her best. He had to regard their ‘intuitive feelings’, but he reminded himself ‘they may project those on Charlotte’. So, in three hearings, the judge granted and continued the declaration sought by the trust.

Charlotte survived, and in October 2005, the judge lifted his declaration.¹⁰⁵ The judge found that given her improved condition, it could no longer be said that ventilation would inevitably be futile or wholly inappropriate. Whether ventilation was in Charlotte’s best interests would depend on her condition at the relevant time when a decision must be made. Charlotte’s improved condition was such that one would expect that decisions about her care would fall to be determined by normal principles of law and clinical practice. However, the relationship between her parents and the hospital had been, at times, openly hostile. Professionals feared retribution if they made a decision opposed by the Wyatts. The trust sought a declaration that in the event of irreconcilable disagreement, the professionals’ decision would be lawful and final. This wide declaration, Hedley J refused to grant. Instead he sought to reinforce that the usual principles relating to the medical care of infants must apply. If a decision whether or not to intubate (or provide other treatment) arose, her parents and doctors must seek to agree on what constitutes her best interests. They must seek to work in partnership. No doctor was compelled to administer treatment he considered not to be in the child’s best interests or an affront to his conscience; though he should not prevent other clinicians from so doing. Hedley J concluded by urging the parties to work together. In 2006, the case returned to court. Charlotte developed an infection and her condition had worsened again. The judge reaffirmed that doctors have no obligation to intubate or ventilate her, should she stop breathing.

The protracted litigation relating to Charlotte Wyatt, highlighted three rather different issues about the role of the law. (1) Hedley J declined to replace the best interests test with any test of ‘intolerability’ or ‘significant harm’ that might give more force to parental judgements. He preferred to retain the traditional ‘balancing exercise’ of best interests. (2) The length and bitterness of the litigation spelled out a cruel lesson concerning the consequences of a breakdown in trust between families and professionals. (3) Medical prognosis is not always accurate. Charlotte defied medical expectations and improved, but the converse can also happen. Court declarations sought by hospital trusts may vary in their specificity and may need to be revisited.

In Re B (A Minor),¹⁰⁶ the court issued a declaration concerning the future treatment of 22-month-old B who had a deteriorating illness and was not expected to reach the age of 5. If, in future, she deteriorated considerably, she should not be given intensive resuscitation. Obiter dicta, Coleridge J suggested that a short joint experts’ report might be attached to broader declarations made in similar circumstances, so that new and existing doctors might have much needed guidance and elaboration.

In An NHS Trust v MB¹⁰⁷ Holman J refused to authorise doctors to withdraw life support from baby MB, against the strongly voiced objections of his parents. MB was eighteen months old; he had the most severe form of spinal muscular atrophy and breathed only with the aid of a ventilator. He would inevitably die within the next twelve months or so. His parents refused to consent to switching off the ventilator except as a test to see if he could breathe independently. They also wanted MB to have a tracheotomy to allow the baby to be ventilated outside hospital. The doctors sought to withdraw the endotracheal tube and, with the aid of sedatives, allow MB a pain-free dignified death. The medical evidence unanimously supported this course of action, as did the guardian appointed by the court to represent the baby. His parents gave evidence that MB responded to them, that he enjoyed stories, songs and his favourite TV programmes. The Muslim father believed that the decision about when, or if, his son dies, must be left to God. The judge refused the parents’ request for an order for further invasive treatment to prolong MB’s life. He refused the doctors’ request to withdraw ventilation. He attempted a balancing exercise in which the crucial feature was that MB retained some significant cognitive function. MB was (or might be) still able to function at some level like any other infant, recognising his mother and taking simple pleasures from touch, light and sound. The suffering he might endure as a consequence of all the invasive, intrusive treatments keeping him alive was in the judge’s view balanced by these benefits.

The judgment in An NHS Trust v MB poses difficult questions. If MB’s cognitive function is the key factor tipping the balance in favour of continuing to ventilate him, those questions include the following. MB’s parents fought to keep him alive. What of a baby whose medical condition is identical to MB, but whose parents want him to be allowed to die – does that tip the balancing exercise the other way?¹⁰⁸ If MB does have the cognitive function to distinguish him from earlier cases where ventilation was withdrawn, is his suffering maybe all the greater? What weight do we put on cognitive function? Does mental disability make a life less worth living than even grave physical abnormalities? Why was this case decided differently from Baby C who was also dying of spinal muscular atrophy?¹⁰⁹

Not just life or death

14.12 Difficult decisions about the medical care of young children are not exclusively confined to decisions relating to life-sustaining treatment. In Re C (HIV test),¹¹⁰ a baby was born to an HIV-positive mother. She had declined conventional treatment for HIV, rejected treatment in pregnancy which might have diminished the risk of transmitting HIV to the child, and intended to breastfeed. Both parents refused to agree to an HIV test for their baby. They argued that any possible treatment for the child (were she HIV-positive) could be more toxic than beneficial, and that sero-positive status would stigmatise the child. The local authority, applying for an order to test the child, relied on medical opinion that the child was at a 25 per cent risk of having contracted HIV and that effective medical care of the child required knowledge of her HIV status. The Court of Appeal upheld the trial judge’s view that it was in the child’s best interests to allow the HIV test. The parents sought to assert their right to respect for family life enshrined in Article 8 of the European Convention on Human Rights. As the trial judge noted, such a claim is swiftly countered by consideration of the child’s own rights and the needs of his health and welfare expressly recognised in Article 8(2).¹¹¹

Portsmouth City Council v King¹¹² was one of a number of cases concerning a 5-year-old boy, Ashya King, who suffered from medulloblastoma. The parents agreed that both radiotherapy and chemotherapy were required, but disagreed with the hospital’s plan for conventional radiotherapy to target the head and neck. They sought more targeted, proton therapy, not generally available in the UK, but available in Prague. Relations broke down and Mr and Mrs King took Ashya from the hospital without informing the staff and began their journey. The hospital, concerned about Ashya’s health, successfully applied for Ashya to be made a ward of court, following which a European Arrest Warrant was issued and the parents were arrested in Spain. In Portsmouth City Council v King, Baker J considered evidence that the travel arrangements and treatment options favoured by the parents were satisfactory. The hospital’s fears that the parents would not be able to feed and care for Ashya were not substantiated and it was thus in Ashya’s best interests to follow the course of treatment chosen by his parents.

Resolving ‘conflicts of rights’ is not easy. Disputes between parents can be just as complex as disagreements between doctors and parents. In Re J (Child’s Religious Upbringing and Circumcision),¹¹³ a devout Muslim father sought a court order to circumcise his 5-year-old son. The child’s non-Muslim mother objected. The couple were estranged. The father argued that circumcision would identify child with father and establish the boy within the Muslim community. He invoked his right under Article 9 of the European Convention on Human Rights to freedom of religion. The mother’s religious adherence to Christianity was said to be notional only. There were no medical grounds for circumcision. The courts found for the mother, influenced by the pain and distress circumcision might cause the boy.¹¹⁴

The balance is more complex when the dispute concerns preventive action. In Re C (Welfare of the Child: Immunisation),¹¹⁵ two fathers applied for court orders that their daughters should receive the MMR vaccine. Both girls lived with their mothers who considered the MMR vaccine to be unsafe. The Court of Appeal upheld the trial judge’s ruling that vaccination was in the girls’ best interests. The judges considered that the medical evidence of both the efficacy and safety of the MMR vaccine was overwhelming. They dismissed the contrary evidence out of hand. In F (Mother) v F (Father),¹¹⁶ Theis J considered the differing perspectives of a father who wanted his 15- and 11-year-olds to receive the MMR and the mother and children who disagreed. Despite the opposition of the children and the fact that the older child had already had the first of two MMR vaccines (and thus heightened immunity) the vaccinations were considered to be in the girls’ best interests.¹¹⁷

The limits of parental consent

14.13 As parental rights to determine medical treatment of their child derive from the parental duty to obtain adequate medical care for them, those rights cannot be unfettered. In Skegg’s words, a parent may give ‘a legally effective consent to a procedure which is likely to be for the benefit of the child, in the sense of being in the child’s best interests’.¹¹⁸ Routine treatment or surgery for an existing physical condition, diagnostic procedures or preventive measures such as vaccination, pose no problem. The benefit is there for all to see. More intricate and even risky procedures cause little difficulty. Not all parents might agree to complex heart surgery on a baby, but if doctors and parents weigh risk and benefit, and conclude in favour of going ahead, they have exercised their respective duties properly. Problems surface in relation to medical or surgical procedures not immediately called for to treat or prevent ill-health. Two classic issues are dealt with later – whether a child can donate organs or tissue (in Chapter 17), and when children can be used for medical research purposes (in Chapter 15). Sterilising minors raises interesting questions about the limits of parental and judicial authority.

Re D¹¹⁹ concerned a girl aged 11. She suffered from Soto’s syndrome and was afflicted by epilepsy and a number of other physical problems. The girl also had some degree of learning disability. Her mother was anxious about her future and considered that she would never be capable of caring for a child, that having a child would damage her, that she might all too easily be seduced and would be incapable of practising any form of contraception. Accordingly she sought to have her sterilised before these risks should materialise. The girl’s paediatrician agreed, and a gynaecologist was found who was ready to perform the operation. An educational psychologist involved with the child disagreed and applied to have the child made a ward of court. Heilbron J ordered that proposals for the operation be abandoned. Her function, she said, was to act as the ‘judicial reasonable parent’, with the welfare of the child as her paramount consideration. She found that medical opinion was overwhelmingly against sterilisation of such a child at 11. The irrevocable nature of sterilisation, the emotional impact on the girl when she discovered what had been done to her, her present inability to understand what was proposed, coupled with evidence that her mental development was such that she would one day be able to make an informed choice for herself on childbearing, all led the judge to conclude that the operation was ‘neither medically indicated nor necessary. And that it would not be in [the girl’s] best interests for it to be performed’.¹²⁰

Nonetheless, in Re B¹²¹ (1987), the House of Lords sanctioned the sterilisation of 17-year-old Jeanette. Jeanette was more profoundly disabled than D. She was said to have a mental age of 5 or 6, with a more limited capacity to communicate. She had no understanding of the link between sexual intercourse and pregnancy. Those caring for her testified that, apart from sterilisation, no means of reliable contraception would be suitable for Jeanette. If she became pregnant, delivery might well have to be by caesarean section, and the girl had an unbreakable habit of picking and tearing at any wounds. Despite her profound disability, Jeanette was sexually mature. The Law Lords held that the legality of the proposal to sterilise Jeanette must depend only on whether sterilisation would ‘promote the welfare and serve the best interests of the ward’.¹²² Consideration of eugenics and whether sterilising Jeanette would ease the burden on those caring for her were irrelevant.¹²³ Their Lordships concluded that as Jeanette: (1) would never be capable of making any choice for herself on whether to have a child; (2) would never even appreciate what was happening to her; and (3) would suffer damage to her health if she ever became pregnant, she could lawfully be sterilised by occlusion of her fallopian tubes (not hysterectomy). Lord Templeman, however, suggested that the radical nature of sterilisation was such that a girl of 18 should never be sterilised without the consent of a High Court judge.

A doctor performing a sterilisation operation with the consent of the parents might still be liable to criminal, civil or professional proceedings. A court exercising the wardship jurisdiction emanating from the Crown is the only authority which is empowered to authorise such a drastic step as sterilisation after a full and informed investigation. ¹²⁴

Following Re B a number of subsequent cases appeared to evidence judicial willingness to authorise sterilisation of young girls fairly readily. In 2007 doctors sought legal advice regarding the proposed hysterectomy of 15-year-old Katie Thorpe, who had a mental age of 18 months. Her mother feared that menstrual bleeding would frighten and confuse her, and adversely affect her dignity.¹²⁵ There is no record of the case reaching the courts. Parallels were drawn between the request to treat Katie and the controversial¹²⁶ treatment of Ashley X in America. Ashley had the mental age of a 3-month-old baby and could not walk, talk or swallow. Her breast buds and uterus were removed and she was treated with hormones designed to keep her small. The intention was to enhance her quality of life – to improve her care by making her more mobile. The media reported that a hospital ethics committee supported the decision.¹²⁷

Decisions relating to the proposed sterilisation of adult women indicate that: (a) judges are more ready to scrutinise any proposal to sterilise a woman more rigorously; and (b) that where other surgery, such as hysterectomy, will result in infertility, cases where reasonable people might disagree on what was best for the patient ought to go before a judge.¹²⁸

What Re B reaffirms in the context of children’s treatment generally is that parental powers are limited. Albeit parents honestly believe they are acting in their child’s interests, if they propose to authorise some irreversible or drastic measure, their authorisation alone will not make that measure lawful. It must be shown to be in the child’s interests. No mother could authorise the sterilisation of her 4-year-old daughter because that daughter was a haemophilia carrier. She has no right to deprive her child of the right to make that decision herself. The child’s best interests include her potential right to autonomy. It seems unlikely that parents could authorise a vasectomy on even the most severely mentally disabled son.¹²⁹ For such an operation would not be in his interests, albeit it benefited society. Similarly, no parent, however strong or genuine his commitment to medical research might be, could lawfully authorise the entry of his healthy child into a research trial posing real and substantial risk to that child’s health.

Procedures to protect children

14.14 We do not examine in any detail the procedural means by which disputes about the care or treatment of a child come before the courts. One or two brief points about parental responsibility and family law procedures are noted here.¹³⁰ When a child’s parents are married, both parents share parental responsibility for her. When the parents are unmarried, they share parental responsibility if either they jointly register the child’s birth, or they subsequently enter into a formal agreement to share parental responsibility. Or a father may seek a court order conferring parental responsibility on him where the mother is not voluntarily prepared to share legal responsibility for the child.¹³¹ Normally, in relation to medical treatment, the consent of one parent to the treatment of their young child suffices.¹³² If a mother takes her 5-year-old for a booster vaccination, the doctor does not need to delay matters by ensuring that the father also agrees to vaccination. The courts have, however, made it clear that where some major or irreversible decision needs to be made about a child’s treatment, or where there is disagreement between the parents sharing parental responsibility, both parents’ consent is required and/or the case must be referred to the court.¹³³

Should a father without parental responsibility, or other relatives, such as grandparents, local social services, or any other third party have concerns about a child’s medical treatment, a number of means exist by which a dispute concerning the child’s welfare can be adjudicated by a court. The child could be taken into care or made a ward of court,¹³⁴ but that is rare these days. The inherent jurisdiction of the Court can be invoked, or an order sought under section 8 of the Children Act 1989. Section 8 orders are diverse in kind. Of particular relevance here are ‘specific issue orders’ and ‘prohibited steps orders’. If an unmarried father (who does not have parental responsibility) strongly believes that surgery to correct a hideous birthmark is in his child’s interests and her mother opposes surgery solely because she believes that her child’s deformity was ‘God’s will – a punishment for being born out of wedlock’, he may seek a ‘specific issue order’.¹³⁵ Should he seek to prevent the performance of purely cosmetic surgery which his child’s mother wants because she wants the child to be a model, he could apply for a ‘prohibited steps order’ to prevent surgery.

The Children and Families Act 2014 has reformed processes in an attempt to reduce delay and make the experience of going to court less damaging for families. But sometimes the machinery to protect children from inappropriate ‘treatment’ operates fairly randomly. In the course of the judgment in Re D (above), it emerged that two similar sterilisation operations on mentally disabled girls had already been performed in Sheffield. D was lucky. Her psychologist was persistent and chance took D’s dilemma to the High Court. Despite judicial pronouncements that sterilisation of girls under 18 must always be a matter for the courts, girls have been sterilised by hysterectomy for ‘hygienic’ reasons, without judicial approval. These cases involve girls who cannot in any sense cope with menstruation. They may refuse to wear sanitary protection. It is not clear beyond doubt that such an operation is in the girl’s interests, though it is certainly in her carers’ interests. The Court of Appeal considers such ‘borderline’ cases should always go before a judge.¹³⁶ However, the problem in protecting such girls is: who will know what happened? Only if some interested third party intervenes will the matter reach the light of day in time to prevent the procedure going ahead.¹³⁷

The views of the child

14.15 What of a child’s own wishes? Once a child can communicate, she will in many cases have an opinion of her own. Most 4-year-olds object robustly to injections, dental treatment and anything likely to cause them discomfort. At 4, the case that the child cannot form any sensible judgement about the pros and cons of treatment may well be made out. At 8, 10 and 12 the child acquires greater maturity, albeit most doctors and parents would be reluctant to bow to the child’s judgement. What must be remembered, however, is that the balance of the child’s best interests will be (radically) affected by his willingness or otherwise to participate in treatment. Obtaining assent even from very young children is good practice.¹³⁸ Forcible treatment which may involve restraining, even detaining the child, requires strong justification. And as the child reaches her teens, becomes what is rather pompously called a ‘mature minor’, the legal picture changes. GMC guidance states that: ‘Parents are usually the best judges of their children’s best interests and should make important decisions up until children are able to make their own decisions’.¹³⁹

Family Law Reform Act 1969

14.16 The Family Law Reform Act 1969 reduced the age of majority from 21 to 18. When the 1969 Act was before Parliament it was unclear what effect, if any, consent to medical treatment given by a minor might have. Many 16- and 17-year-olds live, or spend considerable periods of time, away from their parents. Some are married and parents themselves. Section 8 of the 1969 Act clarified the law concerning 16- to 18-year-olds and empowered them to consent to their own medical treatment. Subsections (1) and (2) of section 8 provide:

(1)  The consent of a minor who has attained the age of 16 years to any surgical, medical or dental treatment which, in the absence of consent, would constitute a trespass to his person shall be as effective as it would be if he were of full age: and where a minor has by virtue of this section given an effective consent it shall not be necessary to obtain any consent for it from his parent or guardian.

(3)  In this section ‘surgical, medical or dental treatment’ includes any procedure undertaken for the purposes of diagnosis, and this section applies to any procedure (including, in particular, the administration of an anaesthetic) which is ancillary to any treatment as it applies to that treatment.

So far, so good; once a person is 16 he can consent to treatment himself. That does not mean that any parental consent relating to their children under 18 is always ineffective. If the child of 16 or 17 is incapable of giving consent, for example, because he lacks mental capacity, his parents may still act on his behalf until he comes of age. Section 8 went on in subsection (3) to provide:

(3)  Nothing in this section shall be construed as making ineffective any consent which would have been effective if this section had not been enacted.

The majority of lawyers and doctors interpreted section 8(3) in this way. The common law had never directly determined when, if at all, a child could give effective consent to medical treatment. The assumption was that the law gave effect to consent by a minor provided she or he was sufficiently mature to understand the proposed treatment or surgery.¹⁴⁰ Sixteen was the average age at which doctors judged patients to be old enough to give consent without consulting parents on every occasion. Many doctors also regarded themselves as free to treat children under 16 without parental approval, if the individual child appeared sufficiently intelligent and grown up to take the decision on treatment alone. Before 1969, every case turned on the doctor’s assessment of the particular minor in her surgery. The 1969 Act freed the doctor from doubt and risk where the patient was over 16. She no longer had to consider the maturity of a patient over 16. She could assume adult status and capability. Subsection (3), it was argued, simply preserved the status quo for the under-16s. Doctors could continue to treat a child under 16 as long as that child was mature enough to make his own judgement. This assumption, that there had always been a limited freedom to treat children under 16 without parental consent, and that what subsection (3) did was preserve that freedom, was at the heart of the Gillick saga and its sequels in Re R and Re W.

The Gillick case

14.17 The Gillick saga has its origins in a circular issued by the DHSS in 1974, outlining arrangements for a comprehensive family planning service within the NHS. Statistics on the number of births and induced abortions among girls under 16 led the DHSS to conclude that contraceptive services should be made more readily available to that age group. The essence of their advice was that the decision to provide contraception to a girl under 16 was one for the doctor. He might lawfully treat, and prescribe for, the girl without contacting her parents. He should not contact parents without the girl’s agreement. In 1980, the DHSS revised its advice. The revised version stressed that every effort should be made to involve parents. If the girl was adamant that her parents should not know of her request for contraception, the principle of confidentiality between doctor and patient should be preserved. This amended advice from the DHSS did not satisfy critics. Victoria Gillick sought assurances that none of her daughters would be given contraceptive, or abortion advice, or treatment without her prior knowledge and consent until they were 16. Those assurances were refused, and Mrs Gillick went to court seeking declarations: (1) against her health authority and the DHSS to the effect that their advice that children under 16 could be treated without parental consent was unlawful and wrong; and (2) against her health authority to the effect that medical personnel employed by them should not give contraceptive and/ or abortion advice and/or treatment to any child of Mrs Gillick’s under 16 without her prior knowledge and consent. Mrs Gillick’s concern was with contraception and abortion for under-16s. She had no axe to grind in respect of other forms of medical treatment. The trouble is that contraception cannot be isolated from more general questions. Mrs Gillick’s counsel challenged the assumption that the common law permitted medical treatment of children under 16 in the absence of parental consent.

Children under 16 and consent to treatment: Gillick competence

14.18 At first instance, Woolf J¹⁴¹ endorsed the view that once a child was able to understand what was entailed in proposed treatment, he or she could consent to such treatment. Any physical contact involved in treatment would not constitute battery. Mrs Gillick appealed and, in a complex judgment, the Court of Appeal¹⁴² found for her. Not only was any treatment of a child under 16 potentially battery unless authorised by a parent, but giving children advice or information about contraception without parental knowledge could constitute an infringement of parental rights. After the Court of Appeal decision, no doctor could (save in emergency) safely see a child under 16 in her clinic or surgery without parental knowledge. The DHSS appealed to the House of Lords. By a majority, the House of Lords held that the original advice circulated by the DHSS was not unlawful and that a child under 16 can in certain circumstances give a valid consent to medical treatment, including contraception or abortion treatment, without parental knowledge or agreement.¹⁴³

The general problem of consent

14.19 The majority of their Lordships rejected the Court of Appeal’s finding that consent given by a child under 16 was of no effect. Like Woolf J, they accepted the view that the Family Law Reform Act had left that question open. The matter was for the common law to determine. The common law was not static, fossilised in eighteenth-century notions of the inviolable rights of the paterfamilias. Judge-made law must meet the needs of the times. Parental rights derived from parental duties to protect the person and property of the child. Modern legislation qualified and limited parental rights by placing the welfare of the child as its first priority. Parental rights being dependent on the duty of care for – and maintenance of – the child, they endured only so long as necessary to achieve their end. As Lord Scarman put it:

the parental right yields to the child’s right to make his own decisions when he reaches a sufficient understanding and intelligence to be capable of making up his own mind on the matter requiring decision.¹⁴⁴

Their Lordships argued that the common law had never regarded the consent of a child as a complete nullity. Were that the case, intercourse with a girl aged under 16 would inevitably be rape. That is not so. Provided the girl is old enough to understand what she is agreeing to, intercourse with her consent will not be rape. Parliament, to protect girls under 16 from the consequences of their own folly, enacted a separate offence of unlawful sexual intercourse with girls under 16 in the commission of which the girl’s consent is irrelevant. If the girl validly consented, that is the only offence committed, and not the more serious crime of rape.¹⁴⁵

Moving from the general issue of consent by children to the problem of consent to medical treatment, the House of Lords saw no reason to depart from the general rule. Lord Fraser thought it would be ludicrous to say that a boy or girl of 15 could not agree to examination or treatment for a trivial injury. Importantly, Lord Templeman, who dissented on the specific issue of contraceptive treatment, agreed that there were circumstances where a doctor could properly treat a child under 16 without parental agreement. He concurred that the effect of the consent of the child depended on the nature of the treatment and the age and understanding of the child. A doctor, he thought, could safely remove tonsils or a troublesome appendix from a boy or girl of 15 without express parental agreement. Gillick establishes that a child below 16 may lawfully be given general medical advice and treatment without parental agreement, provided that child has achieved sufficient maturity to understand fully what is proposed. The doctor treating such a child on the basis of her consent alone will not be at risk of either a civil action for battery or criminal prosecution.

The special problem of contraception¹⁴⁶

14.20 Lord Templeman, however, dissented on the specific issue of contraception. He did not accept that a girl under 16 has sufficient maturity and understanding of the emotional and physical consequences of sexual intercourse to consent to contraceptive treatment. His Lordship put it thus: ¹⁴⁷

I doubt whether a girl under the age of 16 is capable of a balanced judgement to embark on frequent, regular or casual sexual intercourse fortified by the illusion that medical science can protect her in mind and body and ignoring the danger of leaping from childhood to adulthood without the difficult formative transitional experiences of adolescence. There are many things a girl under 16 needs to practise but sex is not one of them.

The majority of his colleagues disagreed. They conceded that a request by a girl under 16 for contraception, coupled with an insistence that her parents not be told, posed a problem for the doctor. Assessing whether she is mature enough to consider the emotional and physical consequences of the course she has embarked on is not easy. But that question should be left to the clinical judgement of the doctor. Lord Fraser set out five matters the doctor should satisfy himself on before giving contraceptive treatment to a girl below 16 without parental agreement. They are:

(1)  that the girl … will understand his advice;

(2)  that he cannot persuade her to inform her parents;

(3)  that she is very likely to begin or continue having sexual intercourse with or without contraceptive treatment;

(4)  that unless she receives contraceptive advice or treatment her physical or mental health or both are likely to suffer;

(5)  that her best interests require him to give her contraceptive advice or treatment or both without the parental consent.¹⁴⁸

Lord Fraser’s formula failed to satisfy Mrs Gillick. She regarded it as inadequate in two respects. First, in a busy surgery or clinic has any doctor sufficient time to embark on the investigation and counselling of the girl necessary to fulfil the criteria laid down? Second, underlying the judgments of the majority is acceptance of the view that, as significant numbers of young girls under 16 are going to continue having sexual intercourse regardless of whether they have lawful access to contraception, it may be in their best interests to protect them from pregnancy by contraceptive treatment. Mrs Gillick disagreed. She contended that if access to contraception without parental agreement were stopped, at least the majority of young girls would: (a) be deterred from starting to have intercourse so young by fear of pregnancy and/or parental disapproval; and (b) would have a defence against pressure from their peers to ‘grow up’ and sleep with someone. Both sides in the debate on ‘under-age’ contraception agree that early sexual intercourse increases the danger of disease to the child, be it cervical cancer or venereal disease. Most agree about the emotional damage the child risks. They are no nearer agreement how girls under 16 may best be protected than on the day Mrs Gillick first went to court. The decision to allow emergency contraception (morning-after pill)¹⁴⁹ to be sold over the counter in local pharmacies reignited controversy.

Mrs Gillick had, however, a second line of attack. The Sexual Offences Act 1956 made it a criminal offence ‘to cause or encourage … the commission of unlawful sexual intercourse with … a girl for whom [the] accused is responsible’. So Mrs Gillick argued that providing contraception for a girl under 16 amounted to ‘encouraging’ that crime. The Law Lords dismissed this second claim too. The Sexual Offences Act 2003 replaces the 1956 Act. It creates a raft of new criminal offences and toughens up the law relating to unlawful sexual relations with people under 16. But sections 14 and 73 of the Act provide express protection for doctors and nurses providing contraceptive advice or treatment, abortions, or indeed any healthcare relating to the young person’s sexual health. No offence of facilitating a child sex offence of aiding and abetting unlawful sexual intercourse is committed if the person acts either: (1) to protect the child from sexually transmitted diseases; (2) to protect the child’s physical safety; (3) to prevent a girl becoming pregnant or to promote the child’s emotional well-being.

A right to say no?

14.21 For several years, Gillick was assumed to have established that once young people acquired the necessary maturity to consent to treatment, what Lord Donaldson was later to style Gillick competence,¹⁵⁰ they acquired a right to determine what medical treatment they received. This was borne out in the recent case of An NHS Trust v A, B, C and a Local Authority,¹⁵¹ examined at 13.17. Mostyn J held that a 13-year-old girl had ‘sufficient understanding and intelligence’¹⁵² and was therefore Gillick competent to decide whether to continue or terminate her pregnancy. Mostyn J was not concerned with the outcome of his decision and whether it would be in A’s best interests. Having found A competent, the decision was for A to make:

It is implicit in [Gillick] that provided the child, under the age of 16, has sufficient understanding and intelligence, she can then be lawfully prescribed with contraception even if the result of that would lead her to take steps which are wholly contrary to her best interests. So, the question of best interests does not really inform the primary decision I have to make which is whether she has the necessary capacity.¹⁵³

The best interests of the consenting minor were irrelevant in light of A’s Gillick competence. In the context of decisions to limit treatment in children, the Royal College of Paediatrics and Child Health recognises that one of the three sets of circumstances when treatment limitation can be considered is where there is an informed competent refusal of treatment:

[A]n older child with extensive experience of illness may repeatedly and competently consent to the withdrawal or withholding of life sustaining treatment (LST). In these circumstances and where the child is supported by his or her parents and by the clinical team there is no ethical obligation to provide LST.¹⁵⁴

What happens if the competent young person is not supported by her parents? One might assume that competent minors would have a right to say no, as much as a right to say yes. Recall Lord Scarman’s words in Gillick,¹⁵⁵ ‘the parental right yields to the child’s right to make his own decision when he reaches a sufficient understanding and intelligence to be capable of making up his own mind on the matter requiring a decision’. Subsequent judgments of the Court of Appeal rejected that apparently logical conclusion. Adolescent autonomy is little more than myth, for no young person under 18 – no minor – has a right to refuse treatment.¹⁵⁶ Parental powers to authorise treatment against their offsprings’ will endure, concurrently with extensive judicial powers to order minors to submit to treatment others deem necessary for their welfare.

In Re R, R¹⁵⁷ was a 15-year-old girl suffering from acute psychiatric problems. Her condition fluctuated. At times she appeared rational and lucid. However, she lacked insight into her illness. During her lucid phases she refused medication and became psychotic once again. R was in care, and the local authority responsible for her sought judicial guidance seeking authority to administer anti-psychotic drugs without R’s consent. The Court of Appeal agreed with the trial judge that R was not Gillick competent. Her illness prevented her from fully understanding the need for drugs to control her condition. R could lawfully be treated against her will. In this particular case, the court authorised her treatment via its wardship jurisdiction. But the local authority as her legal guardian could equally have provided a proxy consent on R’s behalf. The interest of Re R lies in Lord Donaldson’s dicta. He went on to say that even were R Gillick competent, she would still have no power to veto treatment. A Gillick competent minor could consent to, but not refuse, treatment. Consent was akin to a key which ‘unlocked the door to treatment’ making the doctor’s action lawful, but not obligatory. Once a young person became Gillick competent she became a keyholder. Her parents remained keyholders until she reached 18. They could still authorise treatment on her behalf. Doctors faced with willing parents but unwilling children were not obliged to treat the child, indeed might choose not to. They could lawfully elect to act on the basis of the parents’ consent alone. The problem was one of ethical and clinical judgement for the physician.¹⁵⁸

Re R was not well received.¹⁵⁹ In Re W,¹⁶⁰ Lord Donaldson was unfazed by his critics. W was a 16-year-old girl. She was critically ill with anorexia nervosa and had had a tragic childhood. The local authority sought guidance whether W could, if it proved necessary, be moved to a specialist unit and force-fed. As W was 16, she was empowered to consent to treatment by virtue of section 8 of the Family Law Reform Act 1969. The Court of Appeal ruled that section 8 on its wording solely empowered a minor over 16 to give an ‘effective consent’ to treatment. Section 8(3)¹⁶¹ preserved the concurrent parental power to authorise treatment and the inherent powers of the courts to act to protect a minor’s welfare. Lord Donaldson regretted only one part of his dicta in Re R, his use of the keyholder metaphor. For as he acknowledged keys can lock as readily as unlock. In Re W he preferred to compare consent to a flak jacket saying pithily:

I now prefer the analogy of the legal ‘flak jacket’ which protects from claims by the litigious whether [the doctor] acquires it from his patient who may be a minor over the age of 16, or a ‘Gillick competent’ child under that age or from another person having parental responsibilities which include a right to consent to treatment of the minor. Anyone who gives him a flak jacket (ie consent) may take it back, but the doctor only needs one and so long as he continues to have one he has the legal right to proceed.¹⁶²

Re R and Re W make a nonsense of Gillick. They are explicable on their facts. There are powerful grounds to argue that both R and W lacked mental capacity regardless of their age.¹⁶³ Their illness deprived them of the understanding and capacity to make a decision about treatment. Were they adults, they would be found to lack capacity applying sections 2 and 3 of the Mental Capacity Act. The same is true of the young people involved in a number of similar cases where judges ruled that an adolescent could not veto treatment.¹⁶⁴

Consider Re E.¹⁶⁵ E was 15 and shared his parents’ Jehovah’s Witness faith. He was seriously ill with leukaemia. Doctors advised that to maximise the prospects of successful chemotherapy, E should receive transfusions of blood products. E, like his parents, refused to agree to transfusions. The boy was made a ward of court. The judge authorised transfusion. He acknowledged that E was highly intelligent, mature for his age and well informed about his illness. Nonetheless, he held that E was not Gillick competent. He lacked insight into the process of dying. He could not turn his mind to the effect of the manner of his death or its effect on his family. How many adults enjoy such insight? Understandably, courts seek to protect young people from decisions that may endanger their life. In E’s case, the outcome is tragic. Treatment at 15 resulted in a temporary remission. At 18 he relapsed, refused treatment and died, believing that he had participated in an ungodly act. Then in Re M (Child: Refusal of Medical Treatment),¹⁶⁶ a girl of 15 and a half refused to consent to a heart transplant. Her refusal was overridden by Johnson J, whereupon M complied with the treatment. One of M’s reasons for refusing surgery was said to be the prospect of lifelong medication. Were her reasons for refusing a transplant much different from those of T’s parents in Re T (A Minor) (Wardship: Medical Treatment)?¹⁶⁷

More recently, in An NHS Foundation Hospital v P,¹⁶⁸ Baker J, in an emergency hearing, authorised treatment of a non-consenting 17-year-old who had a history of self-harming behaviour and had taken an overdose of paracetamol. Non-treatment within around eight hours would result in death or serious injury. P was thought to have capacity under the Mental Capacity Act, so Baker J authorised the treatment (and any necessary restraint and sedation) regardless of P’s refusal, on the basis of Re W.¹⁶⁹ The wishes and feelings of P were considered but were not decisive. Her Article 8 rights to privacy were trumped by the positive obligation to protect life under Article 2. Once again, the outcome of the case is understandable. But is this the right way to bring about the result? Did this suicidal 17-year-old P truly have capacity to make this decision under sections 2 and 3 of the Mental Capacity Act?

Without further information it is impossible to judge. A wish to commit suicide does not necessarily constitute a lack of capacity. But P was known to the child and adolescent mental health services and a week before the overdose she had been detained under section 2 of the Mental Health Act 1983. This does not mean that P lacked capacity then or at the time of the hearing, but does suggest ‘an impairment of, or a disturbance in the functioning of, the mind or brain’ so as to satisfy section 2 of the Mental Capacity Act. Did it render her unable to make a decision, as per section 3 of the Act? If P’s desire to end her life resulted from a mental disorder, then a parallel can be drawn with the case of Re E (Medical Treatment: Anorexia).¹⁷⁰ E was an intelligent and articulate 32-year-old woman with anorexia nervosa. She had a settled wish to die. Despite expert opinion to the contrary, Jackson J held that by virtue of her anorexia she lacked capacity to accept or refuse treatment in relation to interventions relating to forcible feeding. Returning to the case of P, had Baker J more time to explore evidence of capacity, it might have presented an alternative means of authorising the treatment. He did not have that luxury and Re W offered an immediate solution, albeit one that is unfortunate in its wider implications.

An interesting attribute of An NHS Foundation Hospital v P was Baker J’s reference to P’s human rights. This is a feature that is markedly absent in the two previous post-Human Rights Act cases on adolescent treatment refusals.¹⁷¹ Article 12 of the United Nations Convention on the Rights of the Child¹⁷² and Article 8 of the European Convention on Human Rights, both protect the right to decisional autonomy,¹⁷³ but both are subject to limitations. In Axon, Silber J reflected that children’s rights are being given increased significance in the European Court of Human Right jurisprudence.¹⁷⁴ Silber J relied on Article 8 to show that the mature minor’s right to a private and family life not only outweighed the parental right, but extinguished it.¹⁷⁵

Re R and Re W leave the law in a contradictory and unsatisfactory state and are subject to challenge.¹⁷⁶ Indeed, guidance from the Department of Health recognises that a test case is needed on treatment refusals by mature minors.¹⁷⁷ The challenge is likely to focus on the ability of parents to provide the consent their competent child withholds. The courts’ inherent jurisdiction to authorise coercive treatment in the best interests of the child is more readily justifiable. Though Article 8(1) is engaged, the breach is likely to be permissible if the child’s life depends on it, both under Article 8(2) and Article 2, which protects the right to life.¹⁷⁸

The courts have distorted common sense and ethics in attempts to avoid the implications of Gillick.¹⁷⁹ Judges have even gone so far as authorising restraint and detention of young people to ensure that they comply with treatment.¹⁸⁰ All this can be done without resort to the Mental Health Act 1983 (as amended by the Mental Health Act 2007), or the amended provisions of the Mental Capacity Act 2005 which at least build in some safeguards for adult patients.

Authorising a deprivation of liberty

14.22 At 6.12 we discussed safeguards that apply to adults with mental disorder who are informally detained but lack capacity to consent to the detention and treatment. We saw that a lacuna in the law breached Article 5 of the European Convention. Adults were deprived of their liberty without lawful justification. The ‘Bournewood gap’ was filled by an amendment to the Mental Capacity Act 2005 in the form of new Deprivation of Liberty Safeguards (DoLS). The situation with regard to under 18-year-olds is less certain. Where formal admission under the Mental Health Act 1983 is not appropriate, how are the liberty rights of minors who lack capacity to consent safeguarded?

Consider D (A Child) (Deprivation of Liberty).¹⁸¹ D, a 15-year-old, had Asperger’s syndrome and Tourette’s syndrome. He had been lovingly cared for at home for a long time, but his parents were no longer able to cope. In 2012, with the agreement of his parents, D was informally admitted for assessment and treatment to a specialist hospital providing mental health services. D lacked Gillick competence. He did not object and indeed did not want to leave. The hospital trust sought a declaration that the deprivation of D’s liberty was lawful and in his best interests. Following the Supreme Court decision P v Cheshire West and Chester Council,¹⁸² the prima facie position was that D was deprived of his liberty within the meaning of Article 5. D was under constant supervision and control and the definition of a ‘deprivation of liberty’ is the same regardless of disability. But Keehan J held that it is not the same for adult and child. D was not deprived of his liberty because his parents provided the necessary consent. The result is that a minor can be confined for a considerable length of time without independent scrutiny, purely on the basis of parental consent. Is it time for DoLS for under 18-year-olds? The considerable criticism levelled at the DoLS framework caused the Law Commission to recommend its replacement with a new ‘protective care’ scheme. The Law Commission proposes that this scheme applies from the age of 16.¹⁸³

Confidentiality and children under 16

14.23 Do young people seeking treatment independently of their parents have any right to confidentiality? A young girl, embarking on a sexual relationship and considering seeking contraception, probably does not think so much about her capacity to give consent to treatment, as ‘Will the doctor tell my mum?’. The thought that a doctor may be free to give contraceptive advice to a child without the parents even knowing of what is proposed was perhaps at the heart of Mrs Gillick’s concern. The disruption of family life, and the danger that the girl might omit to give the doctor information on other drugs she might be taking, worried many caring parents. The Law Lords’ decision in Gillick did not expressly address confidentiality. The assumption on which most doctors¹⁸⁴ and lawyers proceeded was that a Gillick competent minor had as much of a claim to a right of confidentiality, as he had a right to grant an independent consent to any treatment proposed by his doctor. Twenty years after Gillick, Mrs Axon challenged this assumption.¹⁸⁵ She argued that the parent of a child under 16 had a right to be notified if a health professional proposed to offer advice or treatment relating to abortion or contraception to a child under 16. The parents’ responsibility for the welfare of their children justified a limited exception to the usual duty of confidentiality to patients. The parents’ right to respect for their privacy and family life under Article 8 of the European Convention on Human Rights granted them a right to such information about their child. Silber J¹⁸⁶ rejected Mrs Axon’s case: a Gillick competent minor has the same right to confidentiality as any adult patient. This is reflected in recent guidance from the Department of Health.¹⁸⁷ Nevertheless it remains good practice to involve parents, ‘unless the young person specifically wishes to exclude them’.¹⁸⁸ If the doctor considers that his young patient is not Gillick competent, the GMC advises that he first seek to persuade her to involve her family, but ultimately he may disclose information to an appropriate person (usually the girl’s parents). Could a doctor justify disclosure without consent in relation to a Gillick competent young patient? A difficult dilemma arises if the doctor suspects that the girl is being subjected to sexual abuse. Might public interest justify his action, especially if he suspected that other children might also be at risk from abuse?

Gillick champions the right of competent minors to make decisions for themselves and in confidence, but aligning minors’ decisions with the obligation to protect their best interests has resulted in a complex body of law, fraught with inconsistencies.

¹  Portsmouth City Council v King [2014] EWHC 2964 (Fam). See 14.12.

²  An NHS Trust v SR [2012] EWHC 3842 (Fam). See 14.10.

³  For example, An NHS Trust v Child B and others [2014] EWHC 3486 (Fam): where, in relation to a young child with severe burns, Moylan J said: ‘Accordingly, and despite the deeply held views of B’s parents, I am entirely satisfied that it is in B’s best interests both for him to receive skin grafts and for him to receive blood transfusions if they are clinically indicated’ (at [21]). See also Birmingham Children’s NHS Trust v B & C [2014] EWHC 531 (Fam), discussed at 14.10.

⁴  Gillick v West Norfolk and Wisbech Area Health Authority [1985] 3 All ER 402, HL.

⁵  See Re R (A Minor) [1991] 4 All ER 177, CA; Re W (A Minor) [1992] 4 All ER 627, CA.

⁶  See generally, Nuffield Council on Bioethics, Critical Care Decisions in Fetal and Neonatal Medicine (2006) (hereafter NCOB Report).

⁷  BE Stephens et al, ‘Special Health Care Needs of Infants Born at the Limits of Viability’ (2010) 125(6) Pediatrics 1152. See also T Markestad et al, ‘Early Death, Morbidity, and Need of Treatment Among Extremely Premature Infants’ (2005) 115 Pediatrics 1289 indicating that just 16 per cent of babies born at 23 weeks survive, and only 44 per cent of those born at 24 weeks.

⁸  See the discussion of the EPICure 1 study in the NCOB Report. EPICure 1 looked at babies born at 22–25 weeks’ gestation in 1995. EPICure 2 looked at babies born in 2006 and sought to determine how effective advances in neonatal care have been. Accessible at www.epicure.ac.uk

⁹  See J Glover, Causing Death and Saving Lives (1977) Penguin, ch 12. And see 3.10–3.13.

¹⁰  A Giubilini, F Minerva, ‘After-birth Abortion: Why Should the Baby Live?’ (2013) 29 Journal of Medical Ethics 261.

¹¹  A McGee, ‘The Moral Status of Babies’ (2013) 39 Journal of Medical Ethics 345.

¹²  See, for example draft ‘Limitation of Treatment Bill’ discussed by D Brahams (1981) 78 Law Society Gazette 1342.

¹³  JK Mason, RA McCall Smith, Law and Medical Ethics (1985) Butterworths, p 89.

¹⁴  At 390.

¹⁵  See O Dyer, ‘Doctor Cleared of Act “Tantamount to Euthanasia”’ (2007) 335 BMJ 67. And see J Goodman, ‘The Case of Dr Munro: Are there Lessons to the Learnt?’ (2010) 18(4) Medical Law Review 564 supporting the outcome of the case but pointing out potential ‘slippery slope’ concerns.

¹⁶  See S Moratti, ‘End of Life Decisions in Dutch Neonatology’ (2010) 18(4) Medical Law Review 471.

¹⁷  See E Verhagen, PJ Saver, ‘The Groeningen Protocol – Euthanasia in Severely Ill Newborns’ (2005) 352 New England Journal of Medicine 959; AAE Verhagen, ‘The Groningen Protocol for Newborn Euthanasia; Which Way Did the Slippery Slope Tilt?’ (2013) 39 Journal of Medical Ethics 293.

¹⁸  Though the ethical validity of this requirement is questioned by JM Appel, ‘Neonatal Euthanasia: Why Require Parental Consent’ (2009) 6(4) Journal of Bioethical Inquiry 477.

¹⁹  The committee was set up in 2007. It expected to deal with around 15 to 20 cases a year. By 2010 there had been only one case, raising questions about the extent to which cases are reported. See S Buiting et al, ‘Dutch Experience of Monitoring Active Ending of Life for Newborns’ (2010) 36 Journal of Medical Ethics 234.

²⁰  As we shall see in Chapter 19, there have been a number of proposals for legislation governing assisted dying in adults. See 19.12.

²¹  See the NCOB Report; British Association of Perinatal Medicine, Palliative Care: A Framework for Clinical Practice in Perinatal Medicine (2010); and RCPCH, Practical Guidance for the Management of Palliative Care on Neonatal Units (2014).

²²  JK Mason and GT Laurie, Mason and McCall Smith’s Law and Medical Ethics (2013) Oxford University Press, at 15.53.

²³  MS Pignotti et al, ‘Perinatal Care at the Threshold of Viability: An International Comparison of Practical Guidelines for the Treatment of Extremely Preterm Births’ (2008) 121(1) Pediatrics 193.

²⁴  See KJ Griswold et al, ‘An Evidence-Based Overview of Prenatal Consultation with a Focus on Infants Born at the Limits of Viability’ (2010) 125(4) Pediatrics 931.

²⁵  See Dutch Pediatric Association, To Treat or Not to Treat? Limits for Life-Sustaining Treatment in Neonatology (1992) Utrecht, Netherlands; FJ Walther, ‘Withholding Treatment: Withdrawing Treatment and Palliative Care in the Neonatal Intensive Care Unit’ (2005) 81 Early Human Development 905; NCOB Report, p 135; and J Dorscheidt, ‘End of Life Decisions in Neonatology and the Right to Life of the Disabled Newborn Child: Impressions from the Netherlands’ in L Clements, J Read (eds) ‘Disabled People and the Right to Life: The Protection and Violation of Disabled People’s Most Basic Human Right’ (2007) Routledge-Cavendish, ch 9.

²⁶  NCOB Report. For commentary, see A Morris, ‘Selective Treatment of Irreversible Impaired Infants: Decision-Making at the Threshold’ (2009) 17(3) Medical Law Review 347 and G Birchley, R Juxtable, ‘Critical Decisions for Critically Ill Infants’ in C Stanton, S Devaney, A-M Farrell, A Mullock (eds) Pioneering Healthcare Law: Essays in Honour of Margaret Brazier (2016) Routledge, ch 10.

²⁷  Similar recommendations are in place internationally. See Pignotti et al, ‘Perinatal Care at the Threshold of Viability’ at 193.

²⁸  For example, Royal College of Paediatrics and Child Health, Making Decisions to Limit Treatment in Life-limiting and Life-threatening Conditions in Children: a Framework for Practice (March 2015); BMA, Withholding and Withdrawing Life-Prolonging Medical Treatment: Guidance for Decision Making (2007). The courts refer to professional guidelines with increasing. See for example Kings College Hospital NHS Foundation Trust v Y and MH [2015] EWHC 1966 (Fam), [28] per MacDonald J.

²⁹  GMC, Treatment and Care towards the End of Life: Good Practice in Decision Making (2010), para 94.

³⁰  Ibid, para 90: ‘You must also consider the role and responsibilities of parents and others close to them, but your primary duty is to the child or young person who is your patient’.

³¹  Re B (A Minor) (Wardship: Medical Treatment) [1981] 1 WLR 1421, CA.

³²  (1981) 12 BMLR 1. See also ‘Dr Leonard Arthur: His Trial and Its Implications’ (1981) 283 BMJ 1340; H Benyon, ‘Doctors as Murderers’ [1982] Criminal Law Review 17; M Gunn and JC Smith, ‘Arthur’s Case and the Right to Life of a Down’s Syndrome Child’ [1985] Criminal Law Review 705.

³³  JK Mason, Human Life and Medical Practice (1988) Edinburgh University Press, p 63.

³⁴  Some dispute exists as to the moment in childbirth when this occurs. The child need not have breathed apparently. See R v Poulton (1832) 5 C & P 329, and R v Brain (1834) 6 C & P 349; Attorney General’s Reference (No3 of 1994) [1997] 3 All ER 936, HL. And see NCOB Report 5.

³⁵  Re A (Minors) (Conjoined Twins: Separation) [2000] Lloyd’s Rep Med 425, at 464–465.

³⁶  How would you classify the status of a baby born with anencephaly?

³⁷  [2000] Lloyd’s Rep Med 425. The names given to the girls to preserve their anonymity, but the ban on identifying the family was later lifted.

³⁸  For an eloquent discussion of the issues raised by surgery to separate conjoined twins prior to Re A, see S Sheldon, S Wilkinson, ‘Conjoined Twins: The Legality and Ethics of Sacrifice’ (1997) 2 Medical Law Review 149.

³⁹  Though note Mason’s interesting argument that as Mary had no independent lung function she should have been classified as stillborn; JK Mason ‘Conjoined Twins: A Diagnostic Conundrum’ (2001) 5 Edinburgh Law Review 226.

⁴⁰  [2000] Lloyd’s Rep Med 425, at 456, 466–467. Robert Walker LJ sought to argue that Mary’s death resulted not from surgery but her own inability to sustain life (at 510).

⁴¹  Ward LJ advanced, and preferred, a doctrine of quasi-self defence.

⁴²  [2000] Lloyd’s Rep Med, at 474.

⁴³  Children and Young Persons Act 1933, s 1(1).

⁴⁴  R v Lowe [1973] QB 702.

⁴⁵  R v Senior [1899] 1 QB, 823.

⁴⁶  R v Gibbons and Proctor (1918) 13 Cr App Rep 134.

⁴⁷  Children Act 1989, s 31(2).

⁴⁸  See Beynon, [1982] Criminal Law Review 17, at 27–28.

⁴⁹  See GMC, Treatment and Care towards the End of Life, para 106.

⁵⁰  Re B (A Minor) (Wardship: Medical Treatment) [1981] 1 WLR 1421, CA.

⁵¹  In GMC, Treatment and Care towards the End of Life, para 93.

⁵²  Airedale NHS Trust v Bland [1993] AC 789, HL. See 19.4 and 19.15.

⁵³  Ibid at 866, per Lord Goff.

⁵⁴  An NHS Trust v MB [2006] EWHC 507 (Fam), [20].

⁵⁵  See GMC, Treatment and Care towards the End of Life, para 106.

⁵⁶  Royal College of Paediatrics and Child Health, Making Decisions to Limit Treatment in Life-limiting and Life-threatening Conditions in Children: A Framework for Practice (March 2015) (RCPCH (2015)), exec summary.

⁵⁷  See S Elliston, The Best Interests of the Child in Healthcare (2007) Routledge-Cavendish.

⁵⁸  [2006] EWHC 507 (Fam), [106–107].

⁵⁹  [2006] EWHC 507 (Fam), [16], based on Wyatt v Portsmouth Hospital NHS Trust [2005] EWCA Civ 1181, [87].

⁶⁰  [1989] 2 All ER 782, CA.

⁶¹  [1990] 3 All ER 930, CA.

⁶²  See J Read, L Clements, ‘Demonstrably Awful: The Right to Life and the Selective Non-Treatment of Disabled Babies and Young Children’ in L Clements, J Read (eds) Disabled People and the Right to Life: The Protection and Violation of Disabled People’s Most Basic Human Right (2007) Routledge-Cavendish, ch 8.

⁶³  [1990] 3 All ER 930, at 938, CA.

⁶⁴  (2000) 2 FLR 677.

⁶⁵  For a review of the different ethical approaches see R McDougall, L Notini, ‘Overriding Parents’ Medical Decisions for their Children: A Systematic Review of Normative Literature’ (2014) 40 Journal of Medical Ethics 448.

⁶⁶  GMC, Treatment and Care towards the End of Life, paras 95, 107; RCPCH (2015), para 2.4.3.

⁶⁷  See for example A Verhagen et al, ‘Conflicts about End-of-Life Decisions in NICUs in the Netherlands’ (2009) 124 Pediatrics 112.

⁶⁸  GMC, Treatment and Care towards the End of Life, para 108.

⁶⁹  [2015] EWHC 1966 (Fam); [2015] EWHC 1920 (Fam).

⁷⁰  [2000] Lloyd’s Rep Med 425, discussed at 14.5.

⁷¹  These fears have not materialised. Surgeons expected ‘Jodie’ to be able to walk, to avoid incontinency and even to be able to bear children. S Laville, ‘Siamese Twin Jodie is Making Progress’ (2000) The Telegraph, 9 November.

⁷²  [2000] Lloyd’s Rep Med 425, at 455.

⁷³  Re T (A Minor) (Wardship: Medical Treatment) [1997] 1 All ER 906, CA, discussed in M Fox and J McHale, ‘In Whose Best Interests?’ (1997) 60 Modern Law Review 600.

⁷⁴  See GMC, Treatment and Care towards the End of Life, para 90.

⁷⁵  [1997] 1 All ER 906, at 914–915.

⁷⁶  This seems to be the tenor of Roch LJ’s judgment.

⁷⁷  [2010] EWCA Civ 1744, per Wall P at 2: ‘As the most recent case cited to me was the decision of the Court of Appeal in Re T (Wardship: Medical Treatment) [1997] 1 FLR 502 (and in particular the judgment of Butler-Sloss LJ (as she then was)) I thought it sensible to revisit the point to see if the law needed to be moved on. In my judgment, it does not’.

⁷⁸  Made under section 100 of the Children Act 1989 for leave to invoke the court’s inherent jurisdiction or alternatively for permission to apply for a specific issue order.

⁷⁹  See C Bridge, ‘Religion, Culture and Conviction – the Medical Treatment of Young Children’ (1999) 11 Child and Family Law Quarterly 1, and ‘Religion, Culture and the Body of the Child’ in A Bainham, SD Sclater, M Richards, Body Lore and Laws (2002) Oxford University Press, p 265; J McHale, ‘Health and Health Care Law, Faith(s) and Beliefs: New Perspectives and Dilemmas’ 9(4) (2009) Medical law International 279; M Fox, M Thomson, ‘Older Minors and Circumcision: Questioning the Limits of Religious Actions’ 9(4) (2009) Medical law International 283.

⁸⁰  Although the Council of Elders does seem to have softened slightly its opposition to transfusions, leaving the matter more to the conscience of the believer.

⁸¹  Re S (A Minor) (Medical Treatment) [1993] 1 FLR 376.

⁸²  Re E (A Minor) (1990) 9 BMLR 1; Re O (A Minor) (Medical Treatment) (1993) 4 Med LR 272; Re R (A Minor) [1993] 2 FLR 757. Though note that not all such cases reach the courts. See, for example, L Roberts, ‘Teenage Jehovah’s Witness Refuses Blood Transfusion and Dies’ The Telegraph (2000) 18 May.

⁸³  Re T (A Minor) (Wardship: Medical Treatment) [1997] 1 All ER 906.

⁸⁴  Re A [2000] Lloyds Rep Med 425, at 454; and see Re C (A Minor) (Medical Treatment) [1998] 1 FLR 384.

⁸⁵  See C Bridge, ‘Parental Powers and the Medical Treatment of Children’ in C Bridge (ed) Family Law: Towards the Millennium (1997) Butterworths, p 321. Note that in An NHS Trust v MB (discussed at 14.11), Holman J accords some weight to the parents’ Muslim beliefs.

⁸⁶  [1985] 3 All ER 402, at 432.

⁸⁷  [2014] EWHC 531 (Fam).

⁸⁸  An NHS Trust v SR [2012] EWHC 3842 (Fam).

⁸⁹  Ibid, [23].

⁹⁰  As Lord Scarman put it in Gillick v West Norfolk and Wisbech Area Health Authority [1985] 3 All ER 402 at 410, HL: ‘Emergency, parental neglect, abandonment of the child, or inability to find the parent are examples of exceptional situations justifying the doctor proceedings to treat the child without parental knowledge or consent’.

⁹¹  [2004] 1 FLR 1019, ECtHR.

⁹²  R v Portsmouth NHS Trust v Glass (1999) 50 BMLR 269, CA.

⁹³  [2009] EWHC 635 (Fam).

⁹⁴  Ibid, at 7.

⁹⁵  [2009] EWCA Civ 409.

⁹⁶  [2004] 1 FLR 1019, ECtHR.

⁹⁷  [1998] 1 FLR 384. And see Royal Wolverhampton Hospitals NHS Trusts v B [2000] 2 FLR 953; A National Health Service Trust v B [2000] 2 FCR 577; Re MM (Medical Treatment) [2000] 1 FLR 224.

⁹⁸  R (Burke) v General Medical Council [2005] EWCA Civ 1003.

⁹⁹  See Superintendent of Family and Child Services and Dawson (1983) DLR (3d) 610.

¹⁰⁰  [2009] EWHC 635 (Fam). See S Burns, ‘The Right to be Kept Alive’ (2009) 153(17) Solicitors Journal 11. See also Re K (A Minor) [2006] EWHC 1007 (Fam).

¹⁰¹  Re Wyatt [2004] EWHC 2247; [2005] EWHC 117; [2005] EWHC 693; [2005] EWHC 1181; [2005] EWHC 2902; [2006] EWHC 319.

¹⁰²  Wyatt v Portsmouth NHS Trust [2005] EWCA Civ 1181.

¹⁰³  [1990] 3 A11 ER 930, at 945.

¹⁰⁴  See M Brazier, ‘Letting Charlotte Die’ (2004) 30 Journal of Medical Ethics 519.

¹⁰⁵  Portsmouth NHS Trust v Wyatt [2005] EWHC 2293 (Fam).

¹⁰⁶  [2008] EWHC 1998 (Fam).

¹⁰⁷  [2006] EWHC 507 (Fam). See M Jonas, ‘The Baby MB Case: Medical Decision Making in the Context of Uncertain Infant Suffering’ (2007) 33(9) Journal of Medical Ethics 541.

¹⁰⁸  Consider Re RB (A Child [2009] EWHC 3269 (Fam). After a six-day hearing RB’s father accepted the views of the medical team that withdrawal of treatment was in his son’s best interests. The ten-paragraph judgment endorses the parental decision. See further G Douglas, ‘Medical Treatment’ (2010) 40(Feb) Family Law 139.

¹⁰⁹  [1998] 1 FLR 384.

¹¹⁰  [2000] Fam 48, CA.

¹¹¹  See L Haggar, ‘Some Implications of the Human Rights Act 1998 for the Medical Treatment of Children’ (2003) 6 Medical Law International 25.

¹¹²  [2014] EWHC 2964 (Fam). See J Bridgeman, ‘Misunderstanding, Threats, and Fear, of the Law in Conflicts over Children’s Healthcare: In the Matter of Ashya King [2014] EWHC 2964 (2015) 23(3) Medical Law Review 477.

¹¹³  [2000] 1 FRC 307.

¹¹⁴  But see SS (Malaysia) v Secretary of State for the Home Department [2013] EWCA Civ 888 where an asylum seeker challenged expulsion on the ground that the son was likely to be circumcised in Malaysia. MooBlick LJ (at [14]) found it ‘difficult to see how C’s circumcision would involve any infringement of the appellant’s Convention rights’.

¹¹⁵  [2003] 2 FLR 1095, CA.

¹¹⁶  [2013] EWHC 2683.

¹¹⁷  E Cave, ‘Adolescent refusal of MMR inoculation: F (Mother) v F (Father) [2013] EWHC 2683 (Fam)’ (2014) 77(4) Modern Law Review 630.

¹¹⁸  See PDG Skegg, ‘Consent to Medical Procedures on Minors’ (1973) 36 Modern Law Review 370, at 377.

¹¹⁹  [1986] 1 All ER 326.

¹²⁰  [1986] 1 All ER 326, at 335.

¹²¹  [1987] 2 All ER 206.

¹²²  Ibid at 213, per Lord Bridge.

¹²³  Ibid at 219, per Lord Oliver.

¹²⁴  [1987] 2 All ER 206, at 214.

¹²⁵  C Dyer, ‘Mother Asks Surgeons to Perform Hysterectomy on Daughter with Cerebral Palsy’ (2007) 335 BMJ 743.

¹²⁶  Some of the ethical debates are recited in DS Diekema, N Fost, ‘Ashley Revisited: A Response to the Critics’ (2010) 10(1) American Journal of Bioethics 30, which supports the treatment.

¹²⁷  C Ayres, ‘Parents Defend Decision to Keep Girl a Child’ (2007) Sunday Times, 4 January.

¹²⁸  Mental Capacity Act 2005 Code of Practice, 2014, para 8.18. See 11.4.

¹²⁹  See Re A (Medical Treatment: Male Sterilisation) [2000] 1 FCR 193 CA, discussed at 6.7.

¹³⁰  See J Bridgeman, Parental Responsibility, Young Children and Healthcare Law (2007) Cambridge University Press.

¹³¹  See section 4 of the Children Act 1989 as amended by the Adoption and Children Act 2002.

¹³²  GMC, Treatment and Care towards the End of Life, para 104.

¹³³  See Re J (Child’s Religious Upbringing and Circumcision) [1999] 2 FLR 1004 CA, discussed at 14.12.

¹³⁴  In which case the court will acquire control over all aspects of the child’s life and upbringing.

¹³⁵  As the fathers did in Re C (Welfare of the Child: Immunisation) [2003] EWCA Civ 1148.

¹³⁶  Re S (Adult Patient: Sterilisation) [2000] 3 WLR 1288, CA.

¹³⁷  And consider female circumcision regulated by the Female Genital Mutilation Act 2003 and see the Serious Crimes Act 2015, ss 70–75 which mandates reporting of female genital mutilation in girls under 18 that they come across in their work.

¹³⁸  See United Nations Convention on the Rights of the Child Article 1989, Art 12(1): ‘States Parties shall assure to the child who is capable of forming his or her own views the right to express those views freely in all matters affecting the child, the views of the child being given due weight in accordance with the age and maturity of the child’. And see RCPCH (2015), para 2.4.5.

¹³⁹  GMC, 0-18 Guidance for all Doctors (2007), para 21.

¹⁴⁰  See Skegg (1973) 36 Modern Law Review 370, at 370–375.

¹⁴¹  [1984] 1 All ER 365.

¹⁴²  [1985] 1 All ER 533.

¹⁴³  [1985] 3 All ER 402.

¹⁴⁴  Ibid, at 422.

¹⁴⁵  See Sexual Offences Act 2003 s 5 (rape of a child under 13) and s 9 (sexual activity with a child). In another context, just a year before the Gillick hearing, the House of Lords had considered the crime of kidnapping as it related to children under 16. They held that the central issue was the agreement of the child, not either parent, to being taken away by the accused. In the case of a young child absence of consent could be presumed. With an older child the question was whether he or she had sufficient understanding and intelligence to give consent. See R v D [1984] 2 All ER 449.

¹⁴⁶  And see further 13.17 on the related issue of abortion.

¹⁴⁷  [1985] 3 All ER 402, at 432, HL.

¹⁴⁸  Ibid, at 413.

¹⁴⁹  And, from April 2015, the five-day emergency contraceptive pill.

¹⁵⁰  See Re R (A Minor) [1991] 4 All ER 177, CA.

¹⁵¹  [2014] EWHC 1445 (Fam). See K Moreton, ‘Gillick Reinstated: Judging Mid-Childhood Competence in Healthcare Law: An NHS Trust v ABC and A Local Authority’ (2014) 22(3) Medical Law Review 452.

¹⁵²  [2014] EWHC 1445 (Fam), [15].

¹⁵³  Ibid, [10].

¹⁵⁴  RCPCH, Executive Summary (2015).

¹⁵⁵  [1985] 3 All ER 402, at 422, HL.

¹⁵⁶  See C Bridge, M Brazier, ‘Coercion or Caring: Analysing Adolescent Autonomy’ (1996) 15 Legal Studies 84.

¹⁵⁷  Re R (A Minor) [1991] 4 All ER 177, CA.

¹⁵⁸  See Re R (A Minor) [1991] 4 All ER 177, at 184.

¹⁵⁹  See, for example, A Bainham, ‘The Judge and the Competent Minor’ (1992) 108 Law Quarterly Review 104.

¹⁶⁰  [1992] 4 All ER 627.

¹⁶¹  See Balcombe LJ, at 639.

¹⁶²  [1992] 4 All ER 627, at 635.

¹⁶³  And see Re JA (Medical Treatment: Child Diagnosed with HIV) [2014] EWHC 1135 (Fam) where Baker J held that a 14-year-old boy who refused to accept the diagnosis of HIV lacked competence and acknowledged: ‘to an extent, however, there is an element of unreality about this analysis. It could be argued, that if J were to give his consent, his parents having indicated that they would not oppose the treatment, the Trust would in reality provide the treatment without delay. In those circumstances, it could be argued that J falls into the category of patients identified in Re W, above, namely someone capable of giving consent but whose refusal to give consent is capable of being overridden by the court’ (at [75]).

¹⁶⁴  For example, South Glamorgan County Council v B & W [1998] 1 FLR 574; Re S (A Minor) (Consent to Medical Treatment) [1994] 2 FLR 1065; and see Bridge, Brazier (1996) 15 Legal Studies 84.

¹⁶⁵  Re E (A Minor) (1990) 9 BMLR 1.

¹⁶⁶  [1999] 2 FLR 1097.

¹⁶⁷  [1997] 1 All ER 906, CA.

¹⁶⁸  [2014] EWHC 165. Discussed in S Pattinson, Medical Law and Ethics (4th edn, 2014) Sweet & Maxwell, 5-029. Note that some jurisdictions have shown willing to confine and coerce young people for extended periods of time. See for example In Cassandra C, No 19426, Supreme Court of Connecticut (January 2015). ‘Cassandra C’, a 17-year-old, was confined and treated with chemotherapy for Hodgkin’s lymphoma. She was judged to be under a strong influence from her mother who distrusted the doctors’ diagnosis and treatment, and was not considered a ‘mature minor’.

¹⁶⁹  [2014] EWHC 165, [12].

¹⁷⁰  [2012] EWHC 1639 (COP).

¹⁷¹  Re P (Medical Treatment: Best Interests) [2003] EWHC 2327 (Fam); F (Mother) v F (Father) [2013] EWHC 2683.

¹⁷²  Article 12(1) ‘States Parties shall assure to the child who is capable of forming his or her own views the right to express those views freely in all matters affecting the child, the views of the child being given due weight in accordance with the age and maturity of the child’. See A MacDonald, ‘Bringing Rights Home for Children: Arguing the UNCRC’ (2009) Family Law 1073. Note that in 2010 the National Assembly of Wales proposed a ‘Rights of Children and Young Persons (Wales) Measure’ to increase regard to the UN Convention on the Rights of the Child 1989 (UNCRC).

¹⁷³  As reflected in RCPCH (2015), para 2.3.

¹⁷⁴  See Yousef v The Netherlands (2003) 36 EHRR 345. See also Johansen v Norway (1996) 23 EHRR 33 and Hoppe v Germany [2003] 1 FCR 176.

¹⁷⁵  R (on the application of Axon) v Secretary of State for Health [2006] EWHC 37 (Admin), [132]. See critique: See A Hall, ‘Children’s Rights, Parents’ Wishes and the State: The Medical Treatment of Children’ (2006) 36 Family Law 317; J Fortin, ‘Children’s Rights – Substance or Spin?’ (2006) 36 Family Law 36, 757.

¹⁷⁶  See R Taylor, ‘Reversing the retreat from Gillick? R (Axon) v Secretary of State for Health’ Child and Family Law Quarterly, 19 (1) (2007), 81 and E Cave, ‘Adolescent Consent and Confidentiality in the UK’ (2009) 16(4) European Journal of Health Law 309. And see 13.17.

¹⁷⁷  DH, Reference Guide to Consent to Examination of Treatment (August 2009), para 8.1.

¹⁷⁸  An NHS Foundation Hospital v P [2014] EWHC 165, [15] per Baker J.

¹⁷⁹  Resulting in an incoherent set of children’s rights and liberties. See for example S Fovargue, S Ost, ‘Does the Theoretical Framework Change the Legal End Result for Mature Minors Refusing Medical Treatment or Creating Self-generated Pornography? (2013) 13(1) Medical Law International 6; E Cave, ‘Competence and Authority: Adolescent Treatment Refusals for Physical and Mental Health Conditions’ (2013) 8(2) Contemporary Social Science 92; B Lyons, ‘Dying to be Responsible: Adolescence, Autonomy and Responsibility’ (2010) 20(2) Legal Studies 257. And see E Cave, ‘Goodbye Gillick? Identifying and Resolving Problems with the Concept of Child Competence’ (2014) 34(1) Legal Studies 103.

¹⁸⁰  See Re C (Detention: Medical Treatment) [1997] 2 FLR 180.

¹⁸¹  [2015] EWHC 922 (Fam).

¹⁸²  P v Cheshire West and Chester Council and another; P and Q v Surrey County Council [2014] UKSC 19 (Cheshire West).

¹⁸³  Law Commission, Mental Capacity and Deprivation of Liberty, Consultation Paper 222 (July 2015), 15.11.

¹⁸⁴  GMC, Confidentiality: Protecting and Providing Information (2000), para 38. Superseded by GMC, 0-18 (2007), para 51, which states that disclosures when a child lacks capacity to consent should only be made if they are in the best interests of the child.

¹⁸⁵  Mrs Axon sought judicial review of Department of Health Guidance, Best Practice Guidance for Doctors and Other Health Professionals on the Provision of Advice and Treatment to Young People under Sixteen on Contraception, Sexual and Reproductive Health (2004).

¹⁸⁶  R (on the application of Axon) v Secretary of State for Health [2006] EWHC 37 (Admin). See J Loughrey, ‘Can You Keep a Secret?’ 20(3) (2008) Child and Family Law Quarterly 312.

¹⁸⁷  DH, Reference Guide to Consent for Examination of Treatment (2nd edn, 2009), ch 3, paras 2–11.

¹⁸⁸  Ibid, ch 3, para 5.

Chapter 15

HEALTHCARE RESEARCH

¹

15.1 In 2006, six healthy volunteers at Northwick Park Hospital were rushed to Critical Care after suffering an adverse reaction in a phase 1 clinical trial.² At least four of them suffered multiple organ failure, and it was feared that they may have suffered permanent damage to their immune systems. The drug, TGN1412, was a monoclonal antibody designed to treat leukaemia and rheumatoid arthritis. Volunteers were paid £2,000.³ The Medicines and Healthcare Products Regulatory Agency (MHRA) concluded that the reaction resulted from an ‘unpredicted biological action’ of the drug in humans. It found no deficiencies in the manufacturers’ work, the formulation of the drug or its administration to the participants.⁴ An independent Expert Scientific Review, chaired by Professor Duff, was less sympathetic:

Our conclusion is that the pre-clinical development studies that were performed with TGN1412 did not predict a safe dose for use in humans, even though current regulatory requirements were met.⁵

The system was at fault. The expert group made twenty-two recommendations to improve the safety of first-in-man clinical trials.

The shocking incident at Northwick Park continued a trend of diminishing confidence in the regulation of research. In 2000, inquiries were held into allegations that research was carried out on newborn babies without parental consent in a hospital in North Staffordshire.⁶ Scandals surrounding retention of body parts originated in Bristol and Liverpool with evidence of children’s body parts being retained for research without their parents’ consent or knowledge.⁷ And in 2010 Andrew Wakefield was struck off the medical register for serious professional misconduct relating to research into the alleged link between autism and the triple MMR vaccine.

Medical research was acquiring a bad reputation. Yet every time any one of us receives a prescription for antibiotics we benefit from research performed on others in the past. It is becoming a human guinea pig oneself, or letting one’s child be so used, that may be an unattractive prospect. However, if medicine is to progress to combat cancer and continue the battle against diseases such as diabetes and multiple sclerosis, new drugs and procedures must be subject to trials.

In this chapter, we examine the role the law does and should play in the control of medical research involving human participants. Two European directives, the Clinical Trials Directive 2001⁸ and Good Clinical Practice (GCP) Directive 2005⁹ instigated change across Europe. They enabled clinical trials to take place in more than one country, with a single permission, and enhanced the safety of research participants. Some felt they went too far and stifled research. States were inconsistent in their interpretation of the Clinical Trials Directive 2001. Its remit was arguably too wide, leading to disproportionate regulation of some research. Research generates not only medical advances but also increased revenue. It became apparent that the regulation and governance of research was ‘discouraging academic and commercial health research sponsors from conducting their studies in the UK’.¹⁰ The emphasis shifted and reforms focused on facilitating research and making Europe and the UK attractive to big pharma.

In 2014 this culminated in a new EU Clinical Trials Regulation 536/2014.¹¹ The Regulation is likely to become operational in 2016 at which time Directive 2001/20/EC will be repealed. We will attempt to deal with both regimes in this chapter, not least because the Directive will continue for three years to apply to trials applications submitted before the Regulations becomes applicable; and for a year after the new system becomes operational, sponsors will be able to opt for the older system.

Unlike the Directive, a Regulation is directly applicable in full, in all Member States. Regulation 536/2014 harmonises authorisation procedures, reduces delays, adopts a more proportionate review system and introduces simplified reporting mechanisms. But will the reformed system achieve an appropriate balance between the facilitation of good research and the protection of the rights and interests of research participants?¹² In this chapter we consider in particular:

(1)  The authority to carry out research on the human adult derives from that person’s consent. How satisfactory are the principles governing consent to participation in clinical research?

(2)  The law on medical treatment demands that the physician respects the confidences of his patient. How does this translate into medical research?

(3)  And, finally, what provision does the law make for an individual suffering injury in the course of her participation in such clinical research?

What is clinical research?

15.2 Health research ranges from clinical trials to qualitative projects such as surveys or interviews. This chapter focuses on clinical research,¹³ which may be classified in a number of ways. Non-intrusive research involves no direct interference with participants, for example, research into medical records and epidemiological research. Intrusive research may be non-invasive, for example, psychological inquiries, or invasive, involving actual contact with the patient’s body, for example, taking blood, administering drugs and testing new surgical techniques. Some research is combined with medical care, sometimes referred to as ‘therapeutic research’. Some utilises volunteers who agree to participate in a research project not likely to confer any personal benefit to them. In previous versions of the Declaration of Helsinki¹⁴ such research was categorised as ‘non-therapeutic’, and special restrictions recommended, but the distinction was abandoned in 2000.¹⁵ It is not always logical to be more permissive of ‘therapeutic’ than ‘non-therapeutic’ research. Some research (such as pathogenesis and pathophysiology, or where a patient is at risk but currently healthy) does not fit neatly into either category.¹⁶ Consequently, the category of ‘non-therapeutic research’ was removed and a new category of ‘research combined with medical care’ was introduced. The concepts remain broadly the same. The boundaries are still difficult to draw. Generally, the more invasive the research and the smaller the potential benefit to the participant, the greater are the ethical problems.

Research governance

15.3 Health research governance is the responsibility of the Health Research Authority (HRA). Originally established as a Special Health Authority in 2011¹⁷ in response to a review by the Academy of Medical Sciences,¹⁸ the HRA is responsible for coordinating and standardising the regulation of research¹⁹ and overseeing the ethical review system. To facilitate the HRA’s UK-wide responsibility for research governance, it was re-established in the Care Act 2014 as a Non-Departmental Public Body.²⁰

At the time of writing, two HRA plans in particular are worthy of note. First, the HRA plans to replace the current Research Governance Framework²¹ with updated guidance that will form a single policy framework for research across the UK. The current Framework, which covers all health and social care research within the remit of the Secretary of State for Health, has improved patient safety. But because trusts implemented the Framework on an individual basis, inconsistencies, delays and duplication in the permissions process emerged. The new UK Policy Framework for Health and Social Care Research will set out high-level principles that will be applied through operational frameworks set out by the HRA. It aims to engender consistent and proportionate standards for ethical conduct across health and social care research.

Second, phased roll-out of a single ‘HRA Approval’ of NHS research proposals began in May 2015. It will replace the current system of shared regulation by local NHS research and development (R&D) management and NHS research ethics committees (RECs). In future, local NHS decisions will be confined to issues of local capacity and capability. The HRA will employ NHS staff to assess the research proposal in conjunction with independent REC approval.

Clinical trials

15.4 Special rules apply to clinical trials which investigate in humans the effects of one or more investigational medicinal products (IMPs).²² IMPs constitute around 15 per cent of research applications. They cannot commence without the authorisation of both an ethics committee (see 15.5) and the UK licensing authority,²³ the MHRA. The MHRA²⁴ provides the relevant assessment for clinical trials of medicines and devices. It must make its assessment within sixty days of receiving the application. If the MHRA gives approval and the clinical trial commences, then the MHRA takes on a monitoring role. As we saw in Chapter 10, the MHRA goes on to provide marketing authorisation (licences), inspect the marketing processes and is also responsible for surveillance and enforcement. The MHRA subjects proposals to a scientific assessment to ensure that participants are safe. These are followed up with routine and triggered Good Clinical Practice Inspections. The Academy of Medical Sciences recommended that the MHRA make efforts to improve the consistency and proportionality of their clinical trials regulations,²⁵ but ultimately much will depend on the EU Clinical Trials Regulation (see 15.7).

Research ethics committees

15.5 A number of ethics committees exist outside the NHS. These include ethical review committees set up by universities, private hospitals and pharmaceutical companies. The Economic and Social Research Council’s Framework for Research Ethics²⁶ and other subject-specific frameworks provide guidance.

Within the NHS, the HRA is responsible for the National Research Ethics Service (NRES) and has powers to establish and abolish RECs in England.²⁷ The NRES has about 90 members of staff and 1,200 volunteer ethics committee members. There are specialist ethics committees including the Gene Therapy Advisory Committee and the Confidentiality Advisory Group, and around 70 NHS RECs – independent committees which review applications for research in (and occasionally outside) the NHS.

Both the 2001 Clinical Trials Directive and 2014 EU Regulation require that IMPs have prior regulatory and ethical approval. Embarking on a trial without the prior sanction of a relevant ethics committee is a criminal offence.²⁸ Not all NHS RECs have the authority to review IMPs. To do so, the Committee must be given statutory authority by the UK Ethics Committee Authority.²⁹ Consequently there are a number of different types of NHS REC. These include:

•  RECs authorised to review non-IMP proposals;

•  RECs with authority to review non-IMPs and also statutory authority to review IMPs;

•  RECs specialising in early phase IMPs involving healthy volunteers;

•  specialist RECs (eg specialising in children, incapacity, gene therapy).³⁰

We will say more about the constitution of ethics committees under the UK Clinical Trials Regulations shortly. First, it is important to note that outside the remit of the UK Clinical Trials Regulations a researcher contravenes no law in carrying out research without ethical approval. However, other sanctions and ethical guidance³¹ deter any such practice. An NHS employee failing to seek approval from the relevant REC is likely to be disciplined by his employing trust. Outside the NHS, researchers may face disciplinary action by professional regulatory authorities. Conducting research without ethical review may constitute impaired ‘fitness to practice’. In 2007, the General Medical Council (GMC) instigated disciplinary action against Andrew Wakefield, the author of a 1998 Lancet paper linking autism and the MMR vaccine. Among ten counts of serious professional misconduct, was the claim that children underwent research procedures without prior approval from an ethics committee. Dr Wakefield was struck off the medical register in 2010.³²

Section 112(3) of the Care Act 2014 requires that the HRA publish an REC policy document (currently the Governance Arrangements for Research Ethics Committees)³³ specifying requirements with which RECs must comply. According to this document, RECs comprise lay and medical individuals who advise as to the ethics of any NHS healthcare research and ‘protect the dignity, rights, safety and well-being of people who take part in research’.³⁴ They can also consider private sector research if requested to do so. RECs include up to eighteen members from a balanced age and gender distribution. There should be a mixture of expert and lay members, the latter constituting at least one-third of the membership.³⁵

A troubled history

15.6 The Department of Health first recommended that district health authorities establish local research ethics committees (LRECs) in 1975. More detailed formal guidance was issued in 1991.³⁶ Each local health authority was required to set up at least one, and there were over 200 LRECs in all. Multi-centre research ethics committees (MRECs) were introduced in 1997,³⁷ performing a single ethical review of research taking place in more than one research site. The process remained unwieldy. The Central Office for NHS Research Ethics Committees (COREC) was established in 2000, to coordinate the system.³⁸ In 2001, the Department of Health issued Governance Arrangements for NHS RECs (GAfREC) (updated in 2011)³⁹ to harmonise the committees’ constitutions and remit. Researchers stepped up political pressure, aimed at reducing the level of bureaucracy and facilitating research, and as a result, the National Patient Safety Agency (NPSA) took over responsibility for COREC in 2005.

The implementation of the Clinical Trials Directive 2001,⁴⁰ in the Medicines for Human Use (Clinical Trials) Regulations 2004 wrought further changes on the system. In each Member State, the decision of one REC became valid for the whole of that country, thereby enabling research to cross borders within Europe. The Directive also brought in new standards of good clinical practice.⁴¹ The remit of RECs was tightened.⁴² In summary, the committee can consider the relevance of the trial and its design; the balance of risks and benefits; the protocol; the suitability of the investigator and the facilities; the information sheet and procedure for obtaining informed consent; indemnity, insurance and compensation arrangements and payments to the participant and investigator. Ethics committees should not concern themselves with legal and scientific evaluations.⁴³

Efforts to streamline the process continued. A reformed ‘National Research Ethics Service’ (NRES), launched in 2007, took over from COREC and introduced a ‘Proportionate Review Service’ to fast-track research proposals that raise no material ethical issues. And much more radical simplification followed the Academy of Medical Science’s 2011 recommendations for reform.⁴⁴ Subsuming the NPSA, a single regulator called the HRA (see 15.3) took on governance and ethical review of all NHS research. A new, integrated version of GAfREC⁴⁵ harmonised the requirements of ethical review in England, Scotland and Wales and new Standard Operating Procedures (running to 200 pages) were published in 2015.⁴⁶

The future: EU Clinical Trials Regulation 536/2014

15.7 The potential for medical research to reinvigorate the economy has spurred the streamlining of the review process. Researchers want a proportionate review system and they do not want to duplicate their applications. But national efforts can only go so far. In Europe, the Clinical Trials Directive 2001 has been labelled ‘arguably the most criticised piece of legislation in the Union acquis on medicines’.⁴⁷ In 2011 the Academy of Medical Sciences urged the government to exert their influence on the European Commission for speedy revision.

The days of the Clinical Trials Directive are numbered. EU Clinical Trials Regulation 536/2014⁴⁸ is likely to become operational in 2016. Unlike the 2001 Directive (which it repeals), it does not need to be transposed into national laws, so avoiding some of the pitfalls of unharmonised translation. Regulation 536/2014 will be underpinned by a new EU online portal and database which will harmonise the submission, authorisation and reporting of IMPs. The sponsor of the research will submit a single application via the EU portal. Member States in which the research will be conducted will participate in the review to the extent that national or local ethical issues arise. An expedited review process will apply to low-risk IMPs – especially where the medicine is already authorised or there is an evidence-base for off-label (unlicensed) use. Reporting will be largely the responsibility of a ‘reporting’ Member State, avoiding the duplication of near-identical reports from each country involved in the trial.

The Clinical Trials Regulation includes a legal duty to register clinical trials. This will enhance transparency of results – whether or not they indicate that the trial product is effective. The HRA sought to implement an ethical duty to register trials ahead of the Regulation coming into force. Though widely supported, an action for judicial review by Richmond Pharmacology imposes serious limits on the initiative. Richmond Pharmacology complained that the HRA’s rules undermined the attraction of the UK as a centre for research. The lack of clarity about the requirements and sanctions were found to fail the public law test of certainty and transparency.⁴⁹

The EU Regulation will achieve greater consistency, but it will also render the system less flexible. And its remit is confined to IMPs. It will not address the wider issues associated with disharmony in European research governance. Across Europe, each country has its own specific regulations which may or may not go beyond the regulation of IMPs.⁵⁰ The number, purpose and remit of ethics committees is similarly inconsistent.⁵¹

The ongoing reform of the ethical review process, both in the UK and Europe, focus on the facilitation of good research; efficiency, effectiveness and proportionality are of key importance. Article 8 of the Declaration of Helsinki (2013) states that: ‘while the primary purpose of medical research is to generate new knowledge, this goal can never take precedence over the rights and interests of individual research subjects’; sentiments echoed in Article 2 of the European Convention on Human Rights and Biomedicine.⁵² This begs the question: how well does the law protect research participants? We attempt to answer that question in the next sections.

Consent to participation in trials⁵³

15.8 In 2000, allegations were made, albeit later largely not proven,⁵⁴ surrounding research carried out a decade before on premature babies at North Staffordshire Hospital. It was claimed the research was conducted without parents’ consent.⁵⁵ Since 1964 the Declaration of Helsinki has sought to protect research participants’ rights by demanding rigorous consent procedures. Special rules apply to IMPs under the UK Clinical Trials Regulations 2004. Schedule 1, Part 2, paragraph 9 requires that ‘subject to the other provisions of this Schedule relating to consent, freely given informed consent shall be obtained from every subject prior to clinical trial participation’. The UK Regulations go on to require that informed consent:

(a)  is given freely after that person is informed of the nature, significance, implications and risks of the trial; and

(b)  either:

(i)  is evidenced in writing, dated and signed, or otherwise marked, by that person so as to indicate his consent, or

(ii)  if the person is unable to sign or to mark a document so as to indicate his consent, is given orally in the presence of at least one witness and recorded in writing.⁵⁶

EU Regulation 536/2014 will also require that an interview is conducted by an appropriately qualified member of the investigating team who explains the information and answers questions (Art 29(2)(c)). The interviewer should sign the consent form alongside the participant or representative (Art 29(1)). At the end of the trial, a summary of the results must be placed on the EU database which participants will be free to access (Art 29(6)).

Article 30 introduces a simplified consent process in ‘cluster trials’ where allocation to different arms of the trial is determined by group rather than on an individual basis. This will only apply when patients receive standard treatments whether or not they consent to participate. And participants will be able, in some circumstances, to consent to future uses of their data, though they will retain a right to withdraw their consent (Art 28(2)).

Though informed consent of the participant is a prerequisite for ethical approval in most types of medical research, the UK Clinical Trials Regulations, EU Regulation 536/2014 and, outside their remit, ethical codes of conduct, accept limited circumstances where alternative safeguards are acceptable. Self-evidently someone may be unable to consent by virtue of being a child or suffering from mental incapacity. In such circumstances, we shall see that other safeguards are put in place to protect the research participant.⁵⁷ Even in relation to competent adult participants, there may be trials where low risks justify research without consent. Thus, in some cases of epidemiological research (such as the collection of statistics on measles, for example) where the individual participant cannot be identified, an ethics committee might decide that obtaining consent is unnecessary.⁵⁸ Even in epidemiological trials, however, if data are not fully anonymised, consent should usually be obtained.⁵⁹ Article 26 of the Declaration of Helsinki outlines the importance of adequate information and Article 25 stresses the importance of voluntariness. What does this mean in practice?

In any research on human beings, each potential participant must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail. The participant should be informed of the right to abstain from the study or to withdraw consent to participate at any time without reprisal. After ensuring that the participant has understood the information, the researcher should then obtain the participant’s freely given informed consent, preferably in writing. If the consent cannot be obtained in writing, the non-written consent must be formally documented and witnessed.

The requirement of adequate information for consent to treatment has been addressed in Chapter 5 and we have seen that the decision of the Supreme Court in Montgomery v Lanarkshire Health Board⁶⁰ at long last abandoned the professional standard of information disclosure in favour of the ‘reasonable patient’ test. In the context of research, we would assume that a ‘reasonable subject’ test now governs what researchers must disclose to research participants.⁶¹ A House of Commons Review led to new guidance on the framing of information sheets.⁶² The formal guidance offered to researchers is overtly patient-centred.

The volunteer is not free to accept any risk whatsoever. RECs will carefully assess the risk involved before sanctioning a research project. Special measures were put in place to protect volunteers in first-in-man phase 1 drug trial in response to the Northwick Park disaster in 2006.⁶³

Ethics committees will consider whether the volunteers are truly volunteers. Do medical students feel under compulsion to assist in trials mounted by their teachers? Do patients feel obliged to ‘help’ their doctor if he asks them to participate in research that is not related to their medical care?⁶⁴

Where resort is had to volunteers outside the medical schools and hospital patients, payments are often made in this country. Amounts paid are usually relatively modest but may still constitute an inducement to impoverished students and the unemployed.⁶⁵ The principles of law are clear. Any degree of compulsion renders any written consent given invalid.⁶⁶ Proving compulsion might be the difficulty for a medical student. And for an unemployed ‘volunteer’, economic compulsion arising from his circumstances rather than any misconduct by the research team is as yet unrecognised in English law. Article 27 of the Declaration of Helsinki provides that where any suspicion of duress might arise, an independent physician unconnected with the research project should seek the participant’s consent. The issue of free and full consent⁶⁷ is central to the propriety and legality of clinical trials.⁶⁸ The definition of what constitutes a proper consent is, as we have seen, far from easy.

Innovative therapy

15.9 The obvious benefits of speedy access to innovative healthcare⁶⁹ must be balanced with the risks it presents.⁷⁰ Problems arise when the experimental treatment is offered to patients who have exhausted standard treatment options and have no other hope. Such patients (and their families) may be desperate and vulnerable.⁷¹ The line between experimenting on a patient and doing your utmost for him is blurred.⁷² For example, if a doctor caring for patients with AIDS attempts a novel treatment as a last resort, knowing that there is no conventional treatment which will prolong the patient’s life, has she crossed that line and made her patient a research-participant? One hurdle is to secure funding for such treatment. In general, the NHS will not routinely fund treatments which are considered to be experimental, but commissioners may make exceptions, for example when a disease is very rare and unlikely to attract clinical trials.⁷³

In Simms v Simms and An NHS Trust⁷⁴ it was held to be lawful to administer experimental treatment that had never been tested on humans to two patients suffering from new variant Creutzfeldt–Jacob disease. Both lacked the mental capacity to give consent themselves. Both faced a dismal prognosis given their degenerative and terminal condition. The risks of treatment were unknown but as some benefit was possible, Butler-Sloss P held that administration of the drug, pentosan polysulphate by intracerebral infusion was in the best interests of the patients. Simms establishes that the use of innovative therapies in the best interests of the patient is not necessarily unlawful.

Jonathan Simms’s father fought for the treatment which might effect an improvement in his son’s terrible condition. In An NHS Trust v J, the patient’s family opposed the administration of innovative therapy.⁷⁵ J was in a persistent vegetative state (PVS) after suffering a brain haemorrhage three years earlier. Against the wishes of her family, withdrawal of artificial hydration and nutrition was postponed so that an innovative therapy could be administered. Two research papers had indicated that the insomnia drug Zolpidem sometimes enhanced neural responses in PVS patients. Experts held out little hope that it would work in J’s case, but saw no harm in trying. The family disagreed. J had extensive neurological damage. Heightened awareness, if it could be brought about, would bring to her only distress. Sir Mark Potter P accepted the expert opinion that the therapy was in J’s best interests and ordered it to proceed.⁷⁶

In Europe regulations have been introduced to enhance consistency and transparency in the compassionate use of unauthorised medicinal products. Under Article 83 of Regulation 726/2004,⁷⁷ the European Medicines Agency’s Committee on Human Medicinal Products (CHMP) can provide an opinion on the compassionate use of medicines. It did so for the first time in 2010 where two applications concerned the compassionate use of new medicines to treat influenza.⁷⁸ The CHMP issued guidance as to when Zanamivir and Tamiflu IV should be given, and at what dosage.

Young people in medical research programmes⁷⁹

15.10 When can a young person give her own consent to participation in a trial? When can she withhold that consent? If the young person is incapable of giving an effective consent, may a parent give consent on her behalf?⁸⁰ Once again, the answers depend on whether or not the study is governed by the Medicines for Human Use (Clinical Trials) Regulations 2004⁸¹ (and in future, the EU Clinical Trials Regulation 536/2014).

For studies that fall outside the ambit of the Regulations, the House of Lords’ ruling in Gillick⁸² empowers a minor to consent to medical treatment when he or she has reached an age and individual maturity to judge what the treatment entails and assess its benefit and disadvantages. In the case of research combined with medical care, the test might be the same, though professional guidelines encourage the involvement of parents.⁸³ If the child is over 16, the Family Law Reform Act 1969 statutorily empowering minors over 16 to consent to medical treatment, will offer protection to the medical team.

What of research that confers no direct benefit on the child? There is no apparent reason why the Gillick ruling should not apply. The basis of the judgment is not limited to medical treatment alone but concerns the general capacity of older children to make decisions for themselves. Whenever researchers wish to include in such research a research participant under 18, only the Gillick test can grant the minor herself authority to consent to participate in the trial. Section 8 of the Family Law Reform Act 1969, empowering young people between 16 and 18 to consent to medical treatment, is strictly limited to therapeutic and diagnostic interventions.⁸⁴ Lord Donaldson considered it to be ‘highly improbable’⁸⁵ that a Gillick competent minor could consent to a procedure of no benefit to himself. Nevertheless, recent Department of Health guidance encourages parental involvement, but recognises that young people and children may provide a valid consent to research which is of no direct benefit to them, provided they are Gillick competent.⁸⁶

What about younger children?⁸⁷ The law is unclear as to whether parental consent to research of no benefit to the child is of any effect.⁸⁸ Paediatricians emphasise the need for carefully controlled research on children.⁸⁹ Children respond differently to drugs, they suffer from illnesses not afflicting adults and, above all, their suffering when afflicted is particularly poignant. The GMC (2007) states that children can be involved in research that has either ‘potential benefits for children or young people generally, as long as the research does not go against their best interests or involves only minimal or low risk of harm … or potential therapeutic benefits for them that outweigh any foreseeable risks’,⁹⁰ a position endorsed in guidance issued by the Department of Health in 2009.⁹¹

In law, research can only be carried out on children if it is in their best interests. How can research of no benefit to the child ever be in his best interests? Do best interests include the interests of the community?⁹² The House of Lords in S v S⁹³ were asked to authorise a blood test on a child to determine his paternity. Lord Reid described the parental power to authorise such a test in this way:

Surely a reasonable parent would have some regard for the general public interest and would not refuse a blood test unless he thought that would clearly be against the interests of the child. [our italics]

Arguably where any risk to the child is minimal, parents may authorise any procedure which is not perceived as against the interests of the child. However, the UK Clinical Trials Regulations 2004, which, at the time of writing, will cover most research projects on healthy children, take a different, altogether more restrictive, stance.

The Gillick ruling does not apply to clinical trials of medicinal products (IMPs). The UK Clinical Trials Regulations 2004⁹⁴ require that in IMPs, the written consent of the person with legal responsibility⁹⁵ for the child is obtained. In addition the child should be ‘given information according to his capacity of understanding’ whereupon his refusal to participate or request to withdraw from the trial must be ‘considered’. Thus the Regulations do not require the child’s informed consent even if he is capable of giving it. The weight given to his refusal or request to withdraw will depend on his capacity and possibly on the effect withdrawal will have on his health. As we saw in Chapter 14, competent children are not always entitled to decline treatment that might save them from death or serious injury. But research is by nature experimental – it is difficult to predict the outcome for an individual patient, especially in a randomised controlled trial (RCT).⁹⁶ Should competent children have a stronger right to withdraw or object? The Council of Europe’s draft guidelines for ethics committees⁹⁷ recommend that in addition to parental consent, competent children’s should assent to their inclusion in research and their objections should be respected.

Article 32(3) of the EU Regulation 536/2014 (which replaces the Directive) will, when it becomes operational, resolve the situation. It leaves Member States to determine both the age of legal competence and whether a minor’s assent is required in addition to the consent of a legal representative.⁹⁸

However, it makes very clear (in Article 32(1)(c)) that when a minor ‘who is capable of forming an opinion’ and assessing the relevant information refuses to participate or wants to withdraw, that wish must be respected.

Research poses a more awkward problem where is it is not combined with medical care. The Clinical Trials Regulations 2004 state that children should only be enrolled in research where it ‘can only be carried out on minors’ and, more prohibitively, that ‘some direct benefit for the group of patients involved in the clinical trial is to be obtained from that trial’.⁹⁹ Research of no direct benefit to the group of trial participants cannot be sanctioned, notwithstanding the consent of both child and legal representative; that the research poses minimal risk to the child; and that it will benefit children in the future.

The EU Regulation takes a different approach. Rather than demanding that direct group benefit is obtained from the trial, Article 32(1)(g) requires that there are ‘scientific grounds for expecting’ the trial to produce direct benefit for the minor outweighing risks and burden. Furthermore, the Regulation poses an alternative position should direct benefit prove unlikely, namely:

some benefit for the population represented by the minor concerned and such a clinical trial will pose only minimal risk to, and will impose minimal burden on, the minor concerned in comparison with the standard treatment of the minor’s condition.

This is a boon for children suffering rare diseases. The requirement of direct benefit under the UK 2004 Regulations was particularly restrictive of phase 1 trials (which test very small doses of the treatment) designed to combat diseases which affect only children.¹⁰⁰

And there is another, perhaps bigger, problem in paediatric medicine. Too many drugs that are licensed for use in adults are not licensed for use in children.¹⁰¹ This frequently results in drugs being prescribed for children ‘offlabel’.¹⁰² More good quality paediatric clinical trials are needed. In an attempt to tackle this problem, the EU Regulation on Paediatric Medicines 2006¹⁰³ requires that new medicines (and some existing drugs) are tested on children in accordance with an agreed Paediatric Investigation Plan (PIP) in order to produce information for the drug label.¹⁰⁴ In addition, new networks have been established to facilitate paediatric trials.¹⁰⁵ But are the new rules and incentives sufficient? Too frequently ethics committees and insurers automatically perceive paediatric clinical trials as high risk. In addition there are practical problems ‘such as the transfer of children from specialist hospitals to other, non-specialised, hospitals, the need to adapt pill sizes to children, and training in GCP for nurses’¹⁰⁶ which make paediatric clinical trials burdensome.

Adults who lack mental capacity

15.11 As problematic as the question of research involving children is the question of research involving mentally ill, mentally disabled or unconscious patients. The UK Clinical Trials Regulations 2004 deal with clinical trials and the Mental Capacity Act 2005 with other research.¹⁰⁷ Consistency between the two was inevitably too much to ask and there is evidence of confused interpretation of the law by RECs.¹⁰⁸ In 2010 the NRES released an online toolkit offering practical advice on the confusing legal requirements.¹⁰⁹

According to the Mental Capacity Act (discussed fully in Chapter 6), capacity is now assessed in a decision-specific test made at the relevant time. Where a person lacks capacity, her best interests, determined by reference to her previous wishes and the views of family and carers, will dictate the appropriate course of action. There is a notable exception to this rule: according to section 32(8) the duty to consult is waived if treatment is urgent or consultation is impracticable.

Special rules are put in place to govern research. Section 30 states that intrusive research¹¹⁰ is lawful if an ‘appropriate body’¹¹¹ (normally an REC) agrees that the research is safe and relates to the person’s impairing condition and that it cannot be done as effectively using people who have the requisite mental capacity to consent. In addition, the research must produce a benefit to the person that outweighs any risk or burden, or it will derive new scientific knowledge¹¹² and it is of minimal risk to the person and can be carried out with minimal intrusion or interference with their privacy.¹¹³

Let us compare this with the arrangements for clinical trials under the Clinical Trials Regulations 2004. According to these Regulations, a clinical trial can only recruit adults lacking mental capacity if it relates ‘directly to a life-threatening or debilitating clinical condition from which the subject suffers’¹¹⁴ and ‘[t]here are grounds for expecting that administering the medicinal product to be tested in the trial will produce a benefit to the subject outweighing the risks or produce no risk at all’.¹¹⁵ Note that this test is stricter than the test applied under the Clinical Trials Regulations to children; there the benefit need only apply to the group as a whole, rather than to the individual participant. This is probably due to the necessity to prioritise research on children whose physiology is quite different to adults. It is also somewhat more restrictive than the equivalent section dealing with adults lacking capacity in the Mental Capacity Act 2005. Under the MCA, the benefits do not necessarily have to outweigh the risks provided the study derives new scientific knowledge and is of ‘minimal risk’. Under the Clinical Trial Regulations the research must either benefit the participant or produce ‘no risk at all’.¹¹⁶

Article 31 of the EU Regulation more closely aligns the requirements vis-àvis incapacitated and minor participants and, importantly, will lead to more consistent regulation with respect to clinical trials and other research, covered by the Mental Capacity Act. Article 31 only allows trials that are both ‘essential with respect to incapacitated subjects’¹¹⁷ and relate ‘directly to a medical condition from which the subject suffers’.¹¹⁸ As is the case with minors, Art 31(1)(g) requires either direct benefit to the participant outweighing the risk and burdens or, where the trial poses only minimal risks and burdens in comparison with standard treatment, that it will benefit the population represented by the incapacitated subject. However, there is an important caveat. The second option applies only if the trial relates to ‘the life-threatening or debilitating medical condition from which the subject suffers’. In the majority of cases, then, there will need to be grounds to suppose that the trial will directly benefit the incapacitated participant.

Emergency research

15.12 As regards emergency research, EU Regulation 536/2014 requires more radical reform of UK law. We will turn to this in due course, but first let us consider the law that applies to research other than clinical trials.

Section 32(9) of the Mental Capacity Act 2005 provides an exception to the requirement to obtain consent where there is either ‘prior agreement of a registered medical practitioner not involved in the trial or the researcher acts in accordance with a procedure approved by the appropriate body at the time the research project was approved’.¹¹⁹ An ethics committee will be unlikely to sanction research without the prior agreement of a medical practitioner, save in one situation: emergency research. Emergency research involves participants with life-threatening conditions who cannot give consent. It might, for example compare two methods of treatment of stroke on admission to hospital. Were it not for section 32(9), emergency research would be severely restricted.

No such exception was to be found in the original UK Clinical Trials Regulations 2004. Schedule 1, Part 4, para 4 (relating to minors) and Schedule 1, Part 5, para 4 (relating to adults lacking capacity) required that the prior consent of a legal representative must always be obtained where the proposed research participant lacks the capacity to give consent. Ideally, the legal representative will be a ‘personal’ one; a carer or family member. Otherwise a professional legal representative might be sought: ‘A person not connected with the conduct of the trial who is (a) the doctor primarily responsible for the adult’s medical treatment, or (b) a person nominated by the relevant health-care provider (eg an acute NHS Trust or Health Board)’. While this posed few problems in most cases, it presented insurmountable difficulties for some types of emergency research.

This was highlighted in the international TROICA trial¹²⁰ comparing two types of emergency treatment given when patients suffering cardiac arrest were brought into hospital by ambulance. In many cases a personal representative could not be immediately located and, given that treatment often had to be administered within minutes by ambulance personnel, it was impracticable to utilise an independent professional representative. Yet the research was clearly valuable. Other countries across Europe had interpreted Article 5(a) of the Clinical Trials Directive more flexibly and the TROICA trial had been sanctioned. In England, the MHRA, concerned at the potential ill-effects on emergency medicine, or perhaps at missing out on lucrative research, proposed an amendment in August 2005 sanctioning deferred consent. Accordingly, it was proposed that consent could be obtained within twenty-four hours of commencing the research treatment. The Medical Research Council thought this was not enough time and suggested seventy-two hours. But would this constitute a contravention of the Clinical Trials Directive? Beyleveld and Pattinson¹²¹ argue that the provisions in the Directive ‘unequivocally rule out both … no consent and deferred consent approaches to emergency research on medicinal products’; that the position taken in the original Clinical Trials Regulations was correct. They argue that the duty to put the research participant before the interests of science prevents a purposive interpretation of the Directive.

Nevertheless, the UK Medicines for Human Use (Clinical Trials) Amendment (No 2) Regulations 2006¹²² promulgates a new interpretation of Article 5(a) of the Directive. The ‘deferred consent’ model proposed by the MHRA was abandoned for a ‘no consent’ model. Accordingly, an exception to the requirement that a legal representative gives consent on behalf of an adult who lacks capacity is created when:

(i)  treatment is required urgently;

(ii)  the nature of the trial also requires urgent action;

(iii)  it is not reasonably practicable to meet the conditions in paragraphs 1 to 5 of Part 5 (obtaining consent etc); and

(iv)  an ethics committee has given approval to the procedure under which the action is taken.

The Clinical Trials Directive received vehement criticism for the restrictions it placed on emergency research on participants unable to consent.¹²³ EU Regulation 536/2014 deals specifically with emergency research. It will effect change, but it will adopt a ‘deferred consent’ model rather than the ‘no consent’ model currently utilised in the UK.

Article 35 allows derogation from the consent requirements in Articles 31(1) and 32(1) relating to minors and incapacitated participants where a number of conditions are fulfilled. Namely:

•  the participant is unable to give consent;

•  it is not possible within the time-frame to obtain the consent of a legal representative;

•  the investigator is not aware of any prior objection expressed by the participant;

•  the trial relates directly to the participant’s condition; and

•  the trial poses minimal risk and burden in comparison to standard treatment.

Provided these conditions are satisfied, the intervention can proceed and consent should then be sought in order for the participant’s involvement in the trial to continue.

Researchers remain concerned about possible delays. Will emergency research be feasible if the patient comes into hospital with her legal representative (let us say an unconscious woman is accompanied by her husband)? Decisions in emergency research must be taken very quickly and explaining information to a representative will cause delay.¹²⁴ But the Regulation does not necessarily require the consent of the representative, provided there is insufficient time to supply information and to obtain consent. Will family members deliberately be kept in the dark? It is unlikely. If the representative withholds consent after the initial intervention, the participant must be withdrawn from the trial. Where the patient is accompanied, investigators are likely to seek initial assent based on partial information and follow this up with post-intervention informed consent.

Randomised controlled trials¹²⁵

15.13 At the heart of much modern medical research lies the RCT. Patients suffering from the same illness are divided into two groups and subjected to different treatments. Most commonly, either: (a) one group will receive the conventional treatment, and another be given the experimental and hopefully more effective treatment; or (b) one group will be given a new drug, and the other a placebo.¹²⁶ For an outsider there are a number of worrying features to RCTs. First, there is again the question of consent. Second, there is concern that the control group is denied a chance of superior treatment.¹²⁷ In particular, public anxiety was highlighted by a trial involving 3,000 women at risk of conceiving a spina bifida baby. Studies had shown that similar women appeared to suffer a reduced incidence of carrying a spina bifida baby if treated with special vitamin supplements. The trial involved randomising the women into four groups. One group received the full treatment under trial, another part only of the supplement, a third the other element of the supplement, and the fourth a placebo. Why should any women at risk be denied a treatment which might help her to avoid a spina bifida conception? Further criticism of randomised trials includes this point, that while the control group in a test may be denied a benefit, people are also concerned at the risk to the experimental group. And, finally, who controls and monitors RCTs?

There are doctors and researchers who believe that the RCT is most effective if conducted ‘blind’, that is, the patient is told nothing at all.¹²⁸ The issue then is whether consent to treatment given generally is negated by unwitting participation in the RCT. The law will decide the issue on how closely related the RCT is to the condition under treatment and whether consent to treatment impliedly includes consent to what was done in the trial. At best, a patient asked to take part in an RCT will be told just that. The nature of the trial and the purpose of random allocation may be explained. Exactly what will be done to the patient cannot be explained, by virtue of the very nature of a RCT. Consent on the strength of a proper explanation of the trial and free acceptance by the patient of its random basis would appear both sufficient and necessary. Entering the patient in a random test with no explanation and no consent places the doctor at risk of an action for battery if the patient finds out. Fears that patients, if properly informed, will refuse to participate are natural. The erosion of personal freedom resulting from allowing ‘blind’ trials is not justified by those fears. A patient who will not agree to, or cannot understand the implications of, a trial should not be entered in that trial.¹²⁹

The RCT is particularly hard on participants in research to test a new therapy, where existing treatments have failed. In those circumstances the Royal College of Physicians suggested that Zelen’s design might be appropriate.¹³⁰ Instead of randomising participants after consent has been taken, randomisation occurs before (and thus without) consent. At this point patients are told which treatment they have been assigned and can choose whether to remain in the trial or seek alternative (including possibly the experimental) treatment. Alternatively, only those patients who are offered the experimental treatment might be told that there is an alternative, existing treatment which they can take if they prefer to opt out of the trial.

Apart from the questions of consent, the other means by which the courts may be invoked to consider the RCT arise when something goes wrong, and a participant suffers injury. Will the law enable him to obtain compensation?

Compensation for mishap

15.14 Article 76 of the EU Regulation requires there to be a compensation system in place should a participant suffer injury resulting from the clinical trial.¹³¹ Under the research governance framework, the sponsor of research is responsible for ensuring that appropriate insurance and indemnity arrangements are in place. RECs do not scrutinise the arrangements but are required to ensure that they at least exist.¹³²

Unlike salaried employees of the NHS, many GPs and other independent practitioners must make their own indemnity or insurance arrangements with their professional bodies or the Medical Defence Union to protect themselves and their staff. In both cases, however, the HRA advises¹³³ that RECs leave the matter of indemnity and insurance in NHS research to the research governance process. They should, however, concern themselves with the adequacy of indemnity and insurance in research on private patients where the NHS governance research governance arrangements do not apply.

At present, compensation for personal injury suffered as a participant in a clinical trial is available only either to a participant who can prove negligence on the part of the operator of the trial, or on an ex gratia basis. Indemnity for non-negligent harm (caused through no discernible fault of an individual or institution involved) cannot be purchased by NHS bodies, and universities are finding the costs of such arrangements increasingly prohibitive.¹³⁴ A claim in negligence may arise in two contexts in an RCT. First, a participant from the control group may complain that he was denied an improved prospect of cure. Second, participants from the experimental group may allege that unjustifiable risks were taken. Neither is likely to succeed. As long as conventional treatment of the control group remains proper medical practice, the control has no claim in negligence. As long as the novel procedure was a properly conducted piece of research, carried out in conformity with a well-founded and responsible body of medical opinion, the subject of that procedure is likely to fail.

Next, what about the case where something goes disastrously and unexpectedly wrong? The participant will not know why. It may be an inherent risk in the trial; it may be that the staff conducting the trial were negligent. The patients in the Northwick Park debacle¹³⁵ quickly ran into difficulties in their legal action. Not only did the MHRA conclude that the reaction was an ‘unpredicted biological action’, but TeGenro, the German manufacturer, offered an interim payment but then filed for bankruptcy with only limited insurance. While the NHS will meet their immediate medical needs, the injured participants went under-compensated. Guidance, issued in 2012, provides detailed recommendations on sponsor’s responsibilities and the appropriate level of cover.¹³⁶

In principle, carelessness by the research team, be it in selecting participants on the basis of their previous medical history, or in the conduct of the trial or in monitoring of the effects of the trial, creates a remedy for the patient. Moreover, he also may have in theory a possible remedy against the ethics committee which approved the trial. It has been held that ethics committees can be subject to judicial review.¹³⁷ Arguably committees recognised by the UKECA have sufficient legal personality to be a defendant in a civil lawsuit. However, for those which lack statutory recognition, both the appointing authority and each individual ethics committee member of the committee have direct legal responsibilities to research participants. The Governance Arrangements for RECs require the appointing authorities to indemnify RECs members ‘to relieve them of personal liability in respect of their opinions of the ethics of research’.¹³⁸

No-fault compensation

15.15 Is the present law adequate as a means to provide compensation for injury suffered as a participant of medical research? Thirty-eight years ago the Pearson Commission¹³⁹ recommended that:

Any volunteer for medical research or clinical trials who suffers severe damage as a result should have a cause of action, on the basis of strict liability, against the authority to whom he has consented to make himself available.¹⁴⁰

To date, the Department of Health and the pharmaceutical industry have operated ex gratia compensation schemes. The injured participant’s legal rights remain, in general, dependent on the vagaries of the law of negligence. When a research participant suffers injury in a drug trial he may, of course, gain some slight advantage from the regime of strict liability imposed on drug companies by the Consumer Protection Act 1987. He still has to prove that his injury resulted from a defect in the drug, and that it was that defect which caused his injury. If the drug company chooses to dispute liability, once again the matter is clumsily resolved by adversarial proceedings.¹⁴¹ An individual, volunteer or patient, who agrees to subject himself to risk in the cause of medical science and the better health of the community deserves better than this.

Extra-legally, drug companies in the United Kingdom recognise the research participants’ moral right to compensation independent of proof of fault. The Association of British Pharmaceutical Companies (ABPI) operates an ex gratia scheme whereby any healthy volunteer in a drug trial mounted by an ABPI member will receive compensation for any injury arising from that trial. However, many drug trials relate to drugs manufactured by foreign companies. Such companies may not be ready to accept the ABPI guidelines. HRA guidance provides that ethics committees should be adequately reassured ‘that the sponsor and investigators will have appropriate insurance or indemnity cover for the potential legal liability arising from the research, and consider provision in proportion to the risk for compensation or treatment in the event of injury, disability or death attributable to participation’.¹⁴² Further, the Royal College of Physicians advises RECs that ‘sponsors and investigators must have insurance or indemnity cover to meet their potential liabilities arising from research’.¹⁴³

Patients agreeing to participate in research, and volunteers involved in nondrug trials, remain outside this informal no-fault provision. And the ex gratia nature of the ABPI scheme means that compensation remains dependent on the drug companies’ generosity and is in no sense a right enjoyed by research participants.

The case for no-fault compensation of persons injured in the course of research has long received wide support among doctors.¹⁴⁴ The burden of compensating those injured in the course of research to benefit us all should have a wide base. A fund could be financed from all bodies promoting research, from the profession, the pharmaceutical industry and the Department of Health. The prospects for introduction of a scheme to compensate medical research victims along these lines may be brighter than prospects for a general no-fault scheme for all victims of medical accidents.

A scheme limited to injury suffered as a research participant will confront one very real problem. Exactly who would be entitled to benefit under the scheme? Would eligibility be confined to healthy volunteers, such as those in the Northwick Park hospital disaster? The moral case for automatic compensation for that group is overwhelming. Volunteers put their health on the line with no hope of personal benefit. But what of patients used as participants in research into conditions unrelated to their illness? Should eligibility depend on the lack of any conferral of benefits from the research? Or should it extend to all research participants? If it did, the problem of deciding eligibility moves to determining when a patient suffers injury as a result of a research enterprise, as opposed to in the course of general healthcare which may include resorting to some novel procedure. These potential problems are not insuperable. A second problem occurs where the threat of litigation is removed without the introduction of stringent measures to ensure accountability. Abolishing legal liability in clinical research may provoke a scandal if existing controls are not seen to operate effectively.

Research misconduct

15.16 Monitoring guards against research misconduct, which has been the subject of public outcry in recent years.¹⁴⁵ Career promotions are dependent on research publications and competition is fierce. In 1995, a high-ranking obstetrician and gynaecologist made headline news when it was discovered that he had forged a number of papers.¹⁴⁶ Two years later a former secretary of the Royal College of Physicians in Edinburgh was struck off the medical register for research misconduct.¹⁴⁷ In 2002, a GP falsified research data.¹⁴⁸ And in 2014 a Japanese research institute alleged that one of its star stem cell scientists had fabricated evidence.¹⁴⁹

Professional groups are subject to disciplinary action by the relevant regulatory bodies, such as the GMC and the Nursing and Midwifery Council. The Medical Research Council promulgates Good Research Practice guidance¹⁵⁰ and issues a policy and procedure for investigating allegations of research misconduct.¹⁵¹ In relation to clinical trials it is an offence to provide false or misleading information when requesting authorisation of an opinion from an REC.¹⁵² We have seen that the MHRA perform routine and triggered Good Clinical Practice Inspections during which they will be alert to potential research misconduct. In addition, an NHS Counter Fraud and Security Management Service operate to combat fraud in the NHS. Fraud, however, is only one species of research misconduct. The Committee on Publication Ethics promulgates guidelines and a code of conduct for journals¹⁵³ but not all misconduct comes to the attention of journal editors. A panel for Research Integrity in Health and Biomedical Sciences was set up in 2006,¹⁵⁴ but its role is promotional and advisory. Investigations of research misconduct remain in the hands of employers or sponsors. Overall there remains a substantial imbalance between the monitoring of clinical trials and the monitoring of other research.¹⁵⁵

Confidentiality and medical research¹⁵⁶

15.17 As we collect ever-increasing amounts of health data from a widening range of sources, the opportunities for commercialisation and economic growth are matched by fears for our privacy. In 2015 a Nuffield Council on Bioethics report into the ethics of data use called for greater participation, accountability and governance, including criminal penalties for the misuse of data.¹⁵⁷ How does current law protect our research data?

The Data Protection Act 1998 (implementing the European Directive 95/46/ EC on the processing of personal data into UK law) came into effect in March 2000. The Directive has been criticised as outdated, unclear and overly burdensome¹⁵⁸ and in 2012 the European Commission proposed major reform in the form of a new European Regulation, expected in 2016.¹⁵⁹

Under the 1998 Act, an Information Commissioner registers the names of data controllers and a description of the processing of data by each. Medical researchers are among those who must in most cases register with the Commissioner. In addition to registration, researchers must also comply with the complex provisions of the Act which demand special conditions to be attached to the processing of ‘sensitive data’ (including all personal health data). The Act requires that explicit consent is obtained before personal health data is processed, but an exception is made in the case of medical research. However, the Act demands that ‘personal data shall be processed fairly and lawfully’. This arguably places a duty on the researcher to apply the principles enshrined in the common law duty of confidentiality. Arguably it goes further still.

The common law duty of confidentiality, which applies independently of the Act, is equally open to misinterpretation in relation to medical research. To advance the development of medicine and to enable research when completed to benefit other patients, the results of research must be published. Does publication of research findings amount to a breach of confidence to the patient? First, the patient, if he has given full and free consent to his participation in a trial may at the same time agree to information about him being disclosed once the trial is completed and a report is prepared. This must be the preferable course of action. Whether in law disclosure in the course of a research project of confidential information about a patient without his consent amounts to an actionable breach of confidence depends yet again on the nebulous test of whether that disclosure can be justified by the public interest in the advancement of the relevant research.

The GMC¹⁶⁰ requires that where practicable, researchers seek consent and anonymise data, and always keep disclosures to a minimum.¹⁶¹ It provides special requirements for researchers dealing with medical records and advises on the reporting of research data. Prior to 1999 it was generally assumed that it was not necessary to obtain the participant’s consent to release data, provided that data was fully anonymised. In such a case neither the researcher nor any other individual can trace the data to a given research participant. The Data Protection Act 1998 does not apply when data is fully anonymised because the data is not considered ‘personal’. The matter was put to the test in R v Department of Health, ex parte Source Informatics Ltd¹⁶² which involved pharmacists who sold fully anonymised data to industry. Latham J held at first instance that such disclosure might breach confidentiality on the basis that consent could not be implied because the data were used for commercial purposes and were therefore not in the public interest. However, researchers breathed a sigh of relief when the decision was overturned in the Court of Appeal where it was held that confidence would not be breached where the confider’s identity was not disclosed.

What is clear is that disclosure should be limited to information strictly necessary to the project and that the anonymity of the patient must be protected. The NHS ombudsman upheld a complaint from a young man who discovered in a medical textbook a full-face frontal picture of his naked body. There are various means of achieving ‘anonymity’; a much abused term. Full anonymisation offers greatest protection to research participants’ confidentiality; however the research cannot then be linked to either the individual’s past medical history or his future treatment. In most research projects a system of data coding is preferred. The codes can be broken in the event of adverse reaction and results can be linked to the individual’s past medical history. A significant problem lies in aggregating data so they can be coded or anonymised. Who should perform this task?¹⁶³ The Health and Social Care Information Centre, a non-departmental public body created in the Health and Social Care Act 2012, has published extensive guidance, including advice on implementing systems for handling confidential information for research and other purposes.¹⁶⁴ Linkage of data should only be undertaken in a ‘trusted environment’ (for example, where there are signed contracts and demonstrated compliance with the Information Governance Toolkit)¹⁶⁵ and subject to strict controls.

There is one limited exception to the rule that identifiable data cannot be used in research without consent. As we saw in Chapter 4, the controversial sections 251–252 of the National Health Service Act 2006¹⁶⁶ enable the Secretary of State to support the use of confidential patient information to improve the patient’s medical care or in the public interest without the patient’s consent provided there is no reasonably practicable alternative. The approvals process is carried out by the HRA, advised by the Confidentiality Advisory Group. The application can only be granted if (inter alia) the activity:

•  has a medical purpose. (Access to identifiable medical data to make decisions about education, for example, would not be sanctioned);¹⁶⁷

•  is in the public interest;

•  is compliant with the Data Protection Act 1998;

•  is subject to annual review to ensure it is necessary.¹⁶⁸

Where these requirements are fulfilled, an application may be made under sections 251–252 for approval of the research.

The Freedom of Information Act 2000 heralded a new age of transparency. The interface between this and the Data Protection Act was put to the test in a Scottish case in 2008.¹⁶⁹ Mr Collie asked the Scottish Common Services Agency to release details of the incidence of childhood leukaemia between the years 1990 and 2003, for the Dumfries and Galloway postal area, so that he might undertake epidemiological research. The Agency replied that some of the data were incomplete and that other data were sensitive and subject to the common law duty of confidentiality. Because the low incidence of childhood leukaemia and small geographic area might lead to identification, the information could not be released. Mr Collie took his case to the Scottish Information Commissioner, who issued a decision in 2005.¹⁷⁰ He was satisfied that individual children might be identified and that disclosure would breach the Data Protection Act. The Commissioner asked that the Agency provide the information to Mr Collie in an alternative form. The First Division of the Court of Session refused the Agency’s subsequent appeal and the case proceeded to the House of Lords where the appeal was allowed. The case was remitted back to the Commissioner to determine whether or not the data could be sufficiently anonymised and thus released to Mr Collie. The data must be presented in a form that either was not personal data, or did not contravene the principles of the Data Protection Act. In 2010, the Commissioner decided that this was achievable and directed the Agency accordingly.¹⁷¹

What if the anonymised data is based on personal data and there is a risk of identification? In 2008, the Department of Health turned down a request for statistical information on late-term abortions conducted under section 1(1) (d) of the Abortion Act 1967, on the basis that there was a risk of reidentification and can therefore be considered personal data.¹⁷² On appeal, the tribunal held that it did not constitute personal data about third parties and that the restriction therefore constituted a breach of the Freedom of Information Act 2000. Cranston J disagreed. In Department of Health v Information Commissioner,¹⁷³ the High Court held that, provided individuals cannot be identified by cross-referencing the data with publicly available data, it does not constitute personal data, despite the fact that the data constituted personal data when in the hands of the Department of Health. Article 8 is not engaged where likelihood of identification is remote.¹⁷⁴

Genetic privacy¹⁷⁵

15.18 Genetic research generates significant public concern.¹⁷⁶ Some deem it ‘unnatural’ or unethical. Others worry about the implications for their right to privacy under Article 8 of the European Convention on Human Rights. Public databases containing genetic information have vastly increased in number.¹⁷⁷ As we saw in Chapter 4, Article 8 is transforming the law of confidentiality.

Tighter controls on medical data were ushered in by the Data Protection Act 1998. It became harder for researchers to access the data they desire. They are required to protect the identity of participants and to prove that any non-consensual use of confidential data is in the public interest. A draft EU Data Protection Regulation was published in 2012.¹⁷⁸ It was agreed in 2015 and is likely to be in force by 2018. Unlike the Directive it will replace (Directive 95/46/ EC), it will specifically address the processing of genetic data,¹⁷⁹ though it is unclear at the time of writing whether the prohibitory stance will relate to all genetic data or just personal genetic data.

Genetic profiling is playing an ever-increasing role in research. Much controversy was created by the UK Biobank project,¹⁸⁰ which aims to collect both data and samples on the health of 500,000 volunteers¹⁸¹ and analyse them over a period of thirty years. It is guided by an Ethics and Governance Framework and overseen by an independent Ethics and Governance Council. Consent of participants was sought, but because it is not possible to predict all future research uses, the consent was general rather than specific.¹⁸²

In Chapter 18, we examine the law relating to the human body and its parts and the effects of the Human Tissue Act 2004. The doctrine of consent is central to the legislation. An exception exists for health-related research on living people where the tissue is unidentifiable and the project has received ethical approval¹⁸³ in accordance with the Human Tissue Act 2004 (Ethical Approval, Exceptions and Licensing and Supply of Information about Transplants) Regulations 2006. The REC must consider how tissue is to be disposed of and the means by which relatives are informed of results.¹⁸⁴ Another exception exists by virtue of section 7(4) of the 2004 Act which confers on the Secretary of State a power to deem consent to be in place, though it is envisaged that this will only be used where there is an overwhelming public interest in doing so.¹⁸⁵

The Genetic Interest Group¹⁸⁶ (renamed Genetics Alliance UK in 2010) expressed concern that insignificant weight is attached to the public interest in research. Concessions to research in the Human Tissue Act, it claimed, are ‘piecemeal, diffident and on occasion, virtually secret’. Could we be heading for a policy of ‘ask or anonymise’ that applies to both human tissue and data? Might the public interest threshold be set so high as to inhibit valuable research? It is unlikely. As we demonstrated in Chapter 4, the right to privacy under Article 8(1) is not absolute. It can be limited under Article 8(2):

in the interests of national security, public safety or the economic well-being of the country, for the prevention of disorder or crime, for the protection of health or morals, or for the protection of the rights and freedoms of others.

Though there has been little case law on Article 8(2) in the context of medical confidentiality,¹⁸⁷ the House of Lords in R (S & Marper) v Chief Constable of South Yorkshire Police¹⁸⁸ indicated how readily the judiciary put the public interest before that of the individual. The UK National DNA Database holds DNA profiles of select individuals. Since 1998 it has been instrumental in the detection of more than 300,000 crimes.¹⁸⁹ It was held in Marper that the retention and use of DNA and fingerprints by the police, after a suspect had been cleared of the offence, did not offend Article 8. Four of the Law Lords held that Article 8(1) was not invoked. Baroness Hale held that, though there was an interference with privacy within the meaning of Article 8(1), it was justified as proportionate under Article 8(2). The information would not be made public and individuals were not identifiable to the ‘untutored eye’. The retention of the samples to be used as comparators was appropriate.

The European Court of Human Rights disagreed and in S and Marper v UK¹⁹⁰ ruled the UK’s policy incompatible with the European Convention on Human Rights. The Protection of Freedoms Act 2012 resulted in the deletion of more than a million DNA profiles and fingerprint records and the destruction of DNA samples.¹⁹¹ What are the implications for the storage and retention of genetic data for healthcare research? Mason and Laurie argue that the decision does not necessarily prevent long-term retention of genetic data, but makes it imperative that it is justified as both necessary and proportionate. Strong governance is essential.¹⁹²

The government will not shackle researchers. Research is lucrative. Let us not forget that it also advances medicine and saves lives. In England and Wales, regulation and review of research is going through a period of unprecedented change. The Health and Social Care Act 2012 introduced new duties incumbent on the Secretary of State¹⁹³ and Clinical Commissioning Groups¹⁹⁴ to promote research and use the evidence obtained. Efforts to facilitate good research have been matched by significant improvements in the level of participant safety. Provided this equilibrium is maintained, (and as domestic reform proposals and reforms of the Clinical Trials and Data Protection Directives unravel this cannot yet be assumed), the changes are to be celebrated.

¹  For an international perspective on medical research, see A Plomer, The Law and Ethics of Medical Research: International Bioethics and Human Rights (2005) Cavendish. And for an excellent practical guide, see H Biggs, Healthcare research Ethics and Law: Regulation, Review and Responsibility (2009) Routledge-Cavendish.

²  Department of Health (hereafter DH), Expert Scientific Group on Phase One Clinical Trials Final Report (2006) HMSO.

³  And see (at the time of going to press) BBC News, ‘France Clinical Trial: 90 Given Drug, One Man Brain-Dead’ (2016) 15 January.

⁴  MHRA, Investigations into Adverse Incidents during Clinical Trials of TGN1412 Final Report (May 2006), para 6.

⁵  Expert Scientific Group on Phase One Clinical Trials Final Report, p 2.

⁶  See 15.8.

⁷  See 18.2.

⁸  EC 2001/20.

⁹  (EC) 2005/28 implemented in Medicines for Human Use (Clinical Trials) Amendment Regulations, SI 2006/1928.

¹⁰  AcMedSci, A New Pathway for the Regulation and Governance of Health Research (January 2011).

¹¹  Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC.

¹²  See J McHale, ‘Reforming the Clinical Trials Directive: Streamlining Processes or a Radical New Agenda?’ (2013) 20(4) European Journal of Health Law 363.

¹³  Wider aspects of healthcare research (including sociological research) are not covered here. See P Liamputtong, Research Methods in Health (2nd edn, 2013) Oxford University Press.

¹⁴  The Declaration is an international ethical guideline. The 1996 version is endorsed in the Medicines for Human Use (Clinical Trials) Regulations 2004, SI 2004/1031, Sch 1, Part 2, para 1; and the 2008 version is referred to in the preamble of EU Regulation 536/2014.

¹⁵  World Medical Association, The Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects, WMA General Assembly, Edinburgh, October 2000. Clarifications were added in 2002, 2004 and the Declaration was amended in 2008 and 2013.

¹⁶  See, for example, RJ Levine, ‘The Need to Revise the Declaration of Helsinki’ (1999) 341 New England Journal of Medicine 531.

¹⁷  Health Research Authority (Establishment and Constitution) Order 2011, SI 2011/2323 (since revoked).

¹⁸  AcMedSci, A New Pathway for the Regulation and Governance of Health Research (2011). And see J McHale, ‘Reforming the Regulation of Health Research in England and Wales: New Challenges: New Pitfalls’ (2013) Journal of Medical Law and Ethics 23.

¹⁹  The HRA’s remit goes beyond legal standards to also incorporate ethical standards and responsibilities: R (Richmond Pharmacology Ltd) v HRA and Sense about Science [2015] EWHC 2238 (Admin), [71] per Jay J.

²⁰  Care Act 2014, s 109; The Care Act 2014 (Health Education England and the Health Research Authority) (Consequential Amendments and Revocations) Order 2015, SI 2015/137 and see also SI 2014/3090.

²¹  2nd edn (2005); annex updated (2008). A draft UK Policy Framework for Health and Social Care Research was released for comment in February 2015.

²²  ‘These are substances or combinations of substances which either prevent or treat disease in human beings or are administered to human beings with a view to making a medical diagnosis or to restore, correct or modify physiological functions in humans’ (mhra.gov.uk).

²³  Medicines for Human Use (Clinical Trials) Regulations 2004, reg 11(3).

²⁴  The MHRA subsumed the old Medicines Control Agency.

²⁵  A New Pathway for the Regulation and Governance of Health Research (2011), rec 6.

²⁶  Economic and Social Research Council, Framework for Research Ethics 2010 (revised 2012).

²⁷  Care Act 2014, s 115.

²⁸  Medicines for Human Use (Clinical Trials) Regulations 2004, reg 49.

²⁹  Ibid, reg 5. Care Act 2014, s 116.

³⁰  HRA Summary of Role, Structure and Functionality of RECs within the HRA in England (2013) Version 0.9, para 3.

³¹  See Declaration of Helsinki (2013), art 23; Council of Europe, Additional Protocol to the Convention on Human Rights and Biomedicine, Concerning Biomedical Research (2005), art 9 (the UK is not a signatory).

³²  GMC, Wakefield: Determination on Serious Professional Misconduct and Sanction, 24 May 2010. See DJ Opel et al, ‘Assuring Research integrity in the Wake of Wakefield’ (2011) 342 BMJ d2. Note that in Walker-Smith v General Medical Council [2012] EWHC 503 (Admin) where finding of serious professional misconduct against Professor John Walker-Smith, who had carried out tests on children later used by Dr Andrew Dr Wakefield, was quashed.

³³  DH Governance Arrangements for Research Ethics Committees (2011).

³⁴  Ibid, para 3.1.1.

³⁵  Ibid, para 4.2.7.

³⁶  DH, Local Research Ethics Committees HSG (91) 5. Replaced by the Governance Arrangements for NHS Research Ethics Committees (2001) (updated 2011).

³⁷  DH, Multi-centre Research Ethics Committees, HSG (97) 23. Replaced by the Governance Arrangements for NHS Research Ethics Committees (2001) (updated 2011).

³⁸  The National Research Ethics Service took over from COREC in 2007.

³⁹  DH, Governance Arrangements for RECs: A Harmonised Edition (2011).

⁴⁰  (EC) 2001/20.

⁴¹  Medicines for Human Use (Clinical Trials) Regulations 2004, Part 4. See also Commission Directive (EC) 2005/28.

⁴²  Medicines for Human Use (Clinical Trials) Regulations, reg 15.

⁴³  Governance Arrangements for NHS Research Ethics Committees (2011).

⁴⁴  AcMedSci, A New Pathway for the Regulation and Governance of Health Research (2011).

⁴⁵  DH, Governance Arrangements for Research Ethics Committees: A Harmonised Edition (2011).

⁴⁶  Standard Operating Procedures for Research Ethics Committees in the United Kingdom v 6.1 (2015).

⁴⁷  European Commission, Roadmap: Legislative Proposal on a Regulation/Directive Amending the Clinical Trials Directive 2001/20/EC (2010), 1.

⁴⁸  Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC.

⁴⁹  R (Richmond Pharmacology Ltd) v HRA and Sense about Science [2015] EWHC 2238 (Admin).

⁵⁰  P Veerus, J Lexchin, E Hemminki, ‘Legislative Regulation and Ethical Governance of Medical Research in Different European Union Countries’ (2014) 40 Journal of Medical Ethics 409.

⁵¹  Ibid, reporting that the number of ethics committees in each country varies from 1 to 264.

⁵²  Art 2: ‘The interests and welfare of the human being shall prevail over the sole interest of society or science’.

⁵³  See GMC, Good Practice in Research and Consent to Research (2010) (updated 2013).

⁵⁴  See Editorial, ‘Babies and Consent: Yet Another NHS Scandal’ (2000) 320 BMJ 1285.

⁵⁵  MP Samuals, DP Southall, ‘Negative Extrathoracic Pressure in Treatment of Respiratory Failure in Infants and Young Children’ (1989) 299 BMJ 1253. There was a sub-sequent NHS review: NHS Executive, West Midlands Regional Office Report of a Review of the Research Framework in North Staffordshire Hospital NHS Trust (2000).

⁵⁶  Schedule 1, Part 1, para 3(1) implementing Article 2(j) of Directive (EC) 2001/20. See also Schedule 1, Part 3 which sets out conditions of informed consent.

⁵⁷  See 15.10 and 15.11.

⁵⁸  GMC, Confidentiality (2009), paras 40–44.

⁵⁹  But see National Health Service Act 2006, ss 251–252; formerly Health and Social Care Act 2001, s 60, discussed at 15.17.

⁶⁰  [2015] UKSC 11.

⁶¹  Governance Arrangements for NHS Research Ethics Committees (2001) paras 9.17 and 10.6.

⁶²  See House of Commons Health Committee, The Influence of the Pharmaceutical Industry, Fourth Report of Session 2004–5, HC 42–I (2005). See also HRA, Consent and Participant Information Sheet Preparation Guidance (online version: accessible at www.hra-decisiontools.org.uk/consent).

⁶³  See P Ferguson, ‘Clinical Trials and Healthy Volunteers’ (2008) Medical Law Review 23 and see 15.1.

⁶⁴  On the other hand, routine exclusion of groups from participating in research is also problematic. See A Charles, A Rid, H Davies, H Draper, ‘Prisoners as Research Participants: Current Practice and Attitudes in the UK’ Journal of Medical Ethics, advance online publication, April 2014.

⁶⁵  See M Wilkinson and A Moore, ‘Inducements in Research’ (1997) 11 Bioethics, 373 who argue that inducements are acceptable and promote individual autonomy; A Wertheimer, F Miller, ‘Payment for Research Participants – A Coercive Offer?’ (2008) 34 Journal of Medical Ethics 389; and J McMillan, ‘Coercive Offers and Research Participants – A Comment on Wertheimer and Miller’ (2010) 36 Journal of Medical Ethics 383.

⁶⁶  Re T (Adult: Refusal of Medical Treatment) [1992] 4 All ER 649.

⁶⁷  V Sanchini et al, ‘Informed Consent as an Ethical Requirement in Clinical Trials: An Old, but still Unresolved Issue’ (2014) 40 Journal of Medical Ethics 269.

⁶⁸  See L Doyal, JS Tobias (eds) Informed Consent in Medical Research (2000) BMJ Publishing.

⁶⁹  See DH, Accelerated Access Review (2015).

⁷⁰  See discussion of Medical Innovation Bills 2014–15 and 2015–16 at 7.9.

⁷¹  See S Fovargue, ‘The (Ab)use of Those with No Other Hope? – Ethical and Legal Safeguards for Recipients of Experimental Procedures’ (2013) 22(2) Cambridge Quarterly of Healthcare Ethics, 181.

⁷²  See JK Mason, GT Laurie, Mason and McCall Smith’s Law and Medical Ethics (2013) Oxford University Press, 19.05.

⁷³  NHS Commissioning Board, Commissioning Policy – Experimental Treatments NHSCB/CP/06 (2013). And see Libraries of the House of Commons, Debate Pack: Access to Drugs for Ultra-Rare Diseases, Number 2015/0011, 15 June 2015.

⁷⁴  [2002] EWHC 2734 (Fam). See J Harrington, ‘Deciding Best Interests’ [2003] 3 Web Journal of Current Legal Issues.

⁷⁵  [2006] All ER (D) 290.

⁷⁶  See DH, Reference Guide to Consent for Examination of Treatment (2nd edn, 2009), ch 1, para 41.

⁷⁷  In accordance with EC Regulation 726/2004, Art 83.

⁷⁸  EMA45566/2010; EMA110920/2010.

⁷⁹  For an examination of the ethical issues see Nuffield Council on Bioethics, Children and Clinical Research (May 2015).

⁸⁰  This will be particularly difficult if the parent is himself a minor: S Fovargue, ‘Doctrinal Incoherence or Practical Problem? Minor Parents Consenting to their Offspring’s Medical Treatment and Involvement in Research in England and Wales’ 2013 25(1) Child and Family Law Quarterly 1.

⁸¹  See E Cave, ‘Seen But Not Heard? Children in Clinical Trials’ (2010) 18 Medical Law Review 1.

⁸²  Gillick v West Norfolk and Wisbech Area Health Authority [1984] QB 581.

⁸³  Medical Research Council, Medical Research Involving Children (2004), at para 5.1.3.a; GMC, 0–18 (2007), para 38: ‘If they are able to consent for themselves, you should still consider involving their parents, depending on the nature of the research’.

⁸⁴  Re W (A Minor) (Medical Treatment) [1992] 4 All ER 177, at 635 and 647, CA.

⁸⁵  [1992] 4 All ER 177 at 635, CA.

⁸⁶  DH, Reference Guide to Consent for Examination of Treatment (2nd edn, 2009), ch 3 paras 3–5.

⁸⁷  Neonatal research poses particular problems: see A Alghrani, M Brazier, ‘What Is It? Whose It? Re-Positioning the Fetus in the Context of Research?’ (2011) 70(1) Cambridge Law Journal 51; A Alghrani, ‘Womb Transplantation and the Interplay of Islam and the West’ (2013) 48(3) Journal of Religion and Science 618.

⁸⁸  See, for example, the American case Grimes v Kennedy Krieger Institute, Nos 128, 129, Sept Term, 2000, cert den 2001, in which the Appeal court in Maryland ruled that parents cannot consent to their child’s participation in non-therapeutic research.

⁸⁹  See S Conroy, J McIntyre, I Choonara, TJ Stephenson, ‘Drug Trials in Children: Problems and the Way Forward,’ (2000) 49 British Journal of Clinical Pharmacology 93.

⁹⁰  GMC, 0–18 (2007), para 37.

⁹¹  DH, Reference Guide to Consent for Examination of Treatment (2nd edn, 2009), chapter 3 para 28.

⁹²  P Lewis, ‘Procedures that are Against the Medical Interests of Incompetent Adults’ (2002) 22(4) Oxford Journal of Legal Studies 575 asks whether we should we be more honest and accept a utilitarian calculus that sometimes the incompetent person’s interests are not paramount.

⁹³  [1972] AC 24, HL.

⁹⁴  See Schedule 1, Part 4.

⁹⁵  The ‘person with legal responsibility’ will usually be a parent, guardian, or the court.

⁹⁶  Cave, ‘Seen But Not Heard?’ 1.

⁹⁷  Council of Europe, Draft Guide for Research Ethics Committee Members CDBI/ INF(2009)6, fig 6.2.

⁹⁸  The definition of which will be left to each member state – usually a parent or guardian.

⁹⁹  Medicines for Human Use (Clinical Trials) Regulations, Part 4, paras 9, 10.

¹⁰⁰  See Cave, ‘Seen But Not Heard?’ 1.

¹⁰¹  A Svobodník et al, ‘How to Improve Children’s Research’ Applied Clinical Trials, February (2010), 0: ‘Children and adolescents represent about 25% of the European population, however, most medicines given to children are used off-label. In hospital pediatric wards this is around 45% and in the neonatal intensive care setting this can be as high as 90%’.

¹⁰²  See Royal College of Paediatrics and Child Health, The Use of Unlicensed Medicines or Licensed Medicines for Unlicensed Applications in Paediatric Practice (2010).

¹⁰³  EU Regulation on Medicinal Products for Paediatric Use Regulation (EC) No 1901/2006. See also European Commission, Better Medicines for Children from Concept to Reality: Progress Report on the Paediatric Regulation 1901/2006 (2013).

¹⁰⁴  There are exceptions, for example if the illness does not affect children or the drug may be unsafe for them.

¹⁰⁵  See European Medicines Agency, European Paediatric Research Network Ready to Start EMA/273427/2010 (2010).

¹⁰⁶  European Commission, Assessment of the Functioning of the Clinical Trials Directive 2001/20/EC: Summary of Responses to the Public Consultation Paper (2010), p 14.

¹⁰⁷  Also see Mental Capacity Act 2005 (Loss of Capacity During Research Project) (England) Regulations 2007, SI 2007/679. And see guidance in DH, Reference Guide to Consent for Examination of Treatment (2nd edn, 2009), ch 2, paras 31–33.

¹⁰⁸  See M Dixon-Woods, E Angell, ‘Research Involving Adults who Lack Capacity: How have Research Ethics Committees Interpreted the Requirements?’ (2009) 35 Journal of Medical Ethics 377.

¹⁰⁹  Available at https://connect.le.ac.uk/alctoolkit

¹¹⁰  In essence, intrusive research is research that would normally require consent. The Mental Capacity Act 2005, s 30(2) states; ‘Research is intrusive if it is of a kind that would be unlawful if it was carried out – (a) on or in relation to a person who had capacity to consent to it, but (b) without his consent’.

¹¹¹  Mental Capacity Act 2005, s 30(4). Defined in Mental Capacity Act 2005 (Appropriate Body) (England) Regulations 2006, SI 2006/2810, reg 2.

¹¹²  Mental Capacity Act 2005, s 31(5).

¹¹³  Ibid, s 31(6).

¹¹⁴  Medicines for Human Use (Clinical Trials) Regulations 2004, Part 5, para 11.

¹¹⁵  Ibid, para 9.

¹¹⁶  See Medical Research Council, Medical Research Involving Adults who Cannot Consent (2007) which gives guidance on assessing risk and other decisions relevant to research on adults lacking capacity; Royal College of Physicians, Guidelines on the Practice of Ethics Committees in Medical Research with Human Participants (2007) paras 4.32–4.36; GMC, Consent to Research (2010, updated 2013), p 13.

¹¹⁷  EU Regulation No 536/2014, Art 31(1)(e).

¹¹⁸  Ibid, Art 31(1)(f).

¹¹⁹  See GMC, Consent to Research (2010, updated 2013) paras 33–35.

¹²⁰  Thrombolysis in Cardiac Arrest: A prospective, randomised, double-blind, placebo-controlled, multicentre, parallel-group comparison trial led by Boehringer Ingelheim GmbH to evaluate the efficacy of tenecteplase during CPR as compared with standard treatment in patients suffering from out-of-hospital cardiac arrest.

¹²¹  See D Beyleveld, S Pattinson, ‘Medical Research into Emergency Treatment: Regulatory Tensions in England and Wales’ [2006] 5 Web Journal of Current Legal Issues.

¹²²  SI 2006/2984.

¹²³  European Commission, Assessment of the Functioning of the Clinical Trials Directive 2001/20/EC: Summary of Responses to the Public Consultation Paper (2010), p 14 recognises that: ‘Most respondents agreed that the situation as established by the CTD [in relation to emergency research] was unsatisfactory’. And see S Pattinson, ‘Emergency Research and the Interests of Participants’ (2012) 12(2) Medical Law International 121.

¹²⁴  EJO Kompanje et al, ‘Medical Research in Emergency Research in the European Union Member States: Tensions between Theory and Practice Intensive Care Medicine’ (2014) 40(4) Intensive Care Medicine 496.

¹²⁵  For trenchant criticism of randomised clinical trials, see J Penston, Fiction and Fantasy in Medical Research: The Large Scale Randomised Trial (2003) London Press.

¹²⁶  Note that the Declaration of Helsinki (2013) states: ‘The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best proven intervention(s), except in the following circumstances: Where no proven intervention exists, the use of placebo, or no intervention, is acceptable; or Where for compelling and scientifically sound methodological reasons the use of any intervention less effective than the best proven one, the use of placebo, or no intervention is necessary to determine the efficacy or safety of an intervention and the patients who receive any intervention less effective than the best proven one, placebo, or no intervention will not be subject to additional risks of serious or irreversible harm as a result of not receiving the best proven intervention. Extreme care must be taken to avoid abuse of this option’ (art 33). See also Additional Protocol to the Convention on Human Rights and Biomedicine, Concerning Biomedical Research (2005), Art 23(3).

¹²⁷  The ethical acceptability of placebo-controlled research is usually based on either the concept of ‘equipoise’ or minimal risk. See Royal College of Physicians, Guidelines on the Practice of Ethics Committees in Medical Research with Human Participants (2007), at 5.17; 5.20 and ch 6.

¹²⁸  And see Mason, Laurie, Mason and McCall Smith’s Law and Medical Ethics, at 19.39 on the ethical implications of a blind, randomised controlled trial on the treatment of Parkinsonism.

¹²⁹  See the useful discussion in SJ Edwards et al, ‘Ethical Issues in the Design and Conduct of Randomised Controlled Trials’ (1998) 2 Health Technology Assessment 1.

¹³⁰  Royal College of Physicians, Guidelines on the Practice of Ethics Committees in Medical Research with Human Participants (2007); M Zelen, ‘A New Design for Randomised Clinical Trials’ (1979) 300 New England Journal of Medicine 1242.

¹³¹  Note that under Article 76(3) ‘Member States shall not require any additional use of the system referred to in paragraph 1 from the sponsor for low-intervention clinical trials, if any possible damage that could be suffered by a subject resulting from the use of the investigational medicinal product in accordance with the protocol of that specific clinical trial on the territory of that Member State is covered by the applicable compensation system already in place’.

¹³²  HRA, SOPs (2015), para 3.48. And see Annex G.

¹³³  Ibid, Annex G, p 226.

¹³⁴  In the European Commission Assessment of the Functioning of the Clinical Trials Directive 2001/20/EC: Summary of Responses to the Public Consultation Paper (2010), at para 10.3 ‘an EU-wide insurance was suggested and advocated as a ‘silver bullet’ for academic research’.

¹³⁵  See 15.1.

¹³⁶  ABPI, NRES et al, Insurance and Compensation in the Event of Injury in Phase I Clinical Trials (2012).

¹³⁷  R v Ethical Committee of St. Mary’s Hospital (Manchester) ex parte H. [1988] 1 FLR 512.

¹³⁸  DH, Governance Arrangements for RECs (2011) Annex D(g).

¹³⁹  See 9.14.

¹⁴⁰  Royal Commission on Civil Liability and Compensation for Personal Injury, Cmnd 7054 (HMSO, 1978), paras 1340–1341.

¹⁴¹  For the problems of establishing strict liability under the 1987 Act, see Chapter 10.

¹⁴²  HRA, SOPs for RECs (version 6.1 2015), para 3.48. And see Annex G.

¹⁴³  Royal College of Physicians, Guidelines on the Practice of Ethics Committees in Medical Research with Human Participants (2007), para 4.10.

¹⁴⁴  See JM Barton et al, ‘The Compensation of Patients Injured in Clinical Trials’ (1995) 21 Journal of Medical Ethics 166.

¹⁴⁵  See M Farthing, R Horton, R Smith, ‘Research Misconduct: Britain’s Failure to Act’ (2000) 321 BMJ 1485.

¹⁴⁶  S Lock, ‘Lessons from the Pearce Affair: Handling Scientific Fraud’ (1995) 310 BMJ 1547.

¹⁴⁷  C Dyer, ‘Consultant Struck off over Research Fraud’ (1997) 315 BMJ 205.

¹⁴⁸  C Dyer, ‘GP who Falsified Research Data Found Guilty of Professional Misconduct’ (2001) 323 BMJ 1388. More recently see BBC News, ‘South Korea Clone Scientist Convicted’ (2009) 26 October; C Dyer, ‘Surgeon Is Suspended for Misleading His Supervisor over His Research’ (2010) 341 BMJ 4969.

¹⁴⁹  J Gallagher, ‘Stem Cell Scientist Haruko Obokata Resigns’ BBC News (2014) 19 December.

¹⁵⁰  Medical Research Council, Good Research Practice (2000, updated 2012).

¹⁵¹  Medical Research Council, Policy and Procedure for Investigating Allegations of Research Misconduct v 1.4 (2014).

¹⁵²  Medicines for Human Use (Clinical Trials) Regulations 2004, reg 50. Penalties are set out in reg 52.

¹⁵³  COPE, Code of Conduct and Best Practice Guidelines for Journal Editors (2011).

¹⁵⁴  See UK Research Integrity Office, Code of Practice for Research: Promoting Good Practice and Preventing Misconduct (2009).

¹⁵⁵  R Smith, ‘It’s Time to Criminalise Serious Scientific Misconduct’ (2014) New Scientist, 15 September.

¹⁵⁶  The common law duty of confidentiality and the Data Protection Act 1998 are explored in more detail in Chapter 4.

¹⁵⁷  Nuffield Council on Bioethics, The Collection, Linking and Use of Data in Biomedical Research and Health Care: Ethical Issues (February 2015).

¹⁵⁸  Rand Europe, Review of the European Data Protection Directive (2009).

¹⁵⁹  Proposal for a Regulation of the European Parliament and of the Council on the Protection of Individuals with Regard to the Processing of Personal Data and on the Free Movement of Such Data (General Data Protection Regulation) COM(2012)0011 – C7-0025/2012 – 2012/0011(COD). See 4.18.

¹⁶⁰  GMC, Confidentiality (2009), paras 40–50; GMC, Good Practice in Research (2010, updated 2013), para 42.

¹⁶¹  See discussion of care.data at 4.22. Patients were able to opt out of incorporating their health data in this central database of patient information. But see ‘NHS Details Released Against Patients’ Wishes, Admits Data Body’ (2015) Guardian, 6 June where it is claimed that due to technical issues, the Health and Social Care Information Centre shared data despite patients opting out.

¹⁶²  [1999] 4 All ER 185; [2000] 1 All ER 786, CA.

¹⁶³  See J Strobl, E Cave, T Walley, ‘Data Protection Legislation: Interpretation and Barriers to Research’ (2000) 321 BMJ 890.

¹⁶⁴  HSCIC, A Guide to Confidentiality in Health and Social Care (version 1.1 2013); Code of Practice on Confidential Information (version 1.0 2014). See further 4.21.

¹⁶⁵  An online system allowing NHS organisations to self-assess their compliance with policies and standards. See www.igt.hscic.gov.uk

¹⁶⁶  Previously Health and Social Care Act 2001, s 60. Enabled by the Health Service (Control of Patient Information) Regulations 2002 SI 2002/1438 (as amended by s 117 of the Care Act 2014).

¹⁶⁷  NHS Act 2006, s 251(12).

¹⁶⁸  HRA, Section 251 and the Confidentiality Advisory Group – online guidance: see www.hra.nhs.uk/about-the-hra/our-committees/section-251/#sthash.iSw12dOa.dpuf

¹⁶⁹  Common Services Agency v Scottish Information Commissioner [2008] UKHL 47.

¹⁷⁰  Scottish Information Commissioner, Mr Michael Collie and the Common Services Agency (CSA), Decision 021/2005.

¹⁷¹  Scottish Information Commissioner, Mr Michael Collie and the Common Services Agency (CSA), Reference No: 200500298 (2010).

¹⁷²  Department of Health v Information Commissioner, Case Ref EA/2008/0074.

¹⁷³  [2011] EWHC 1430 (Admin). See 14.20.

¹⁷⁴  For critique, see E Jackson, Medical Law: Text, Cases and Materials (2013) Oxford University Press, p 364.

¹⁷⁵  See 4.14. And see G Laurie, Genetic Privacy: A Challenge to Medico-Legal Norms (2002) Cambridge University Press; H Widdows, C Mullen, The Governance of Genetic Information: Who Decides? (2009) Cambridge University Press.

¹⁷⁶  Medical Research Council, Public Perceptions of the Collection of Human Biological Samples (2000); H Widdows, Connected Self: The Ethics and Governance of the Genetic Individual (2013) Cambridge University Press.

¹⁷⁷  Editorial, ‘Genetic Privacy’ Nature 493, 451 (2013) 24 January.

¹⁷⁸  Proposal for a regulation of the European Parliament and of the Council on the protection of individuals with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation), COM(2012)11.

¹⁷⁹  D Hallinana, M Friedewalda, P De Hertb, ‘Genetic Data and the Data Protection Regulation: Anonymity, Multiple Subjects, Sensitivity and a Prohibitionary Logic Regarding Genetic Data?’ (2013) 29(4) Computer Law and Security Review 317.

¹⁸⁰  See Mason, Laurie, Mason and McCall Smith’s Law and Medical Ethics, at 7.81; SMC Gibbons, ‘Regulating Biobanks: A Twelve-Point Typological Tool’ (2009) 17(3) Medical Law Review 313.

¹⁸¹  UK Biobank announced that it had reached the goal of recruiting 500,000 participants in July 2010. See www.ukbiobank.ac.uk

¹⁸²  See UK Biobank Ethics Governance Framework (version 3.0, 2007), para B1.

¹⁸³  By an authorised REC: see the Human Tissue Act 2004 (Ethical Approval, Exceptions from Licensing and Supply of Information about Transplants) Regulations 2006, SI 2006/1260, reg 2.

¹⁸⁴  See Human Tissue Authority, Code of Practice 9: Research (2014) (subject to parliamentary approval in 2015).

¹⁸⁵  For additional guidance on research involving human tissues, see GMC, Consent to Research (2010, updated 2013), paras 36–39 and Royal College of Physicians Guidelines on the Practice of Ethics Committees in Medical Research with Human Participants (2007) paras 4.37–4.41, and ch 7.

¹⁸⁶  Genetics Interest Group, Human Rights, Privacy and Medical Research (2006), at 3.

¹⁸⁷  Though see Strasbourg cases MS v Sweden (1997) 28 EHRR 313 and Z v Finland (1997) 25 EHRR 371 protecting children’s medical confidentiality.

¹⁸⁸  [2004] UKHL 39.

¹⁸⁹  Home Office, Helping the Police Fight Crime More Effectively (2013).

¹⁹⁰  (2009) 48 EHRR 50.

¹⁹¹  Protection of Freedoms Act 2012, s 1, inserting a new 63D into the Police and Criminal Evidence Act 1984.

¹⁹²  Mason, Laurie, Mason and McCall Smith’s Law and Medical Ethics, 7.86.

¹⁹³  NHS Act 2006, s 1E (as amended).

¹⁹⁴  Ibid, s 14Y (as amended).

Chapter 16

DEFINING DEATH

16.1 The single certainty in human life is that we shall die. Death cannot be evaded, albeit it may be delayed. Until the mid-twentieth-century, there would have been little debate about how to define death. Nonetheless there is ample evidence that our ancestors feared that their physicians and their families might mistakenly anticipate their demise and one might find oneself buried alive.¹ Today, as we shall see, medical technology has created real questions about just how we identify the threshold between dying but alive, and death itself. The development of transplantation played a major role in prompting doctors to rethink definitions of death. It would be wrong to conclude that a desire to maximise the number of viable organs suitable for transplant is the only or the most important factor in the imperative need to define the moment of death.² The question is far from straightforward and a legal definition of death is required for several purposes.

Defining death³

16.2 Defining death is difficult because biologically, death is a process and not an event. Different organs and systems supporting the continuation of life cease to function successively, and at different times. The need to determine an exact or, at best, approximate time of death is important for many reasons. The law often requires such a finding. Establishing the date of death may be important for property purposes. Until death is established, steps cannot be taken to obtain probate or letters of administration to that person’s estate, and the interest of a beneficiary under a will is usually dependent upon the beneficiary surviving the testator. In some cases, when the testator and the beneficiary die at around the same time, it is important to know when each death took place. When two relatives die in a common accident, there may be a legal presumption that the elder died before the younger, unless evidence can be established as to the precise time of death of either; and the property consequences of this decision are significant.⁴ There may also be tax factors. If a person gives away property before his death, that property may be free from inheritance tax, or be subject to less tax, only if he survives the gift for a specified period. There have been many stories written involving relatives of such donors going to great lengths to postpone or conceal the ‘true moment’ of death so that the donor ‘survives’ beyond the relevant statutory period for tax purposes. If the victim has a claim for damages for the injuries sustained, the amount of damages will differ substantially between cases where the victim is comatose yet living, or dead.⁵ And, self-evidently, doctors cannot remove organs for transplant under the rules governing cadaver donations unless the donor is legally dead.

Determining whether a person was dead, once posed little difficulty. Historically, the key factors in the process used to determine whether death had occurred were the cessation of breathing and the cessation of heartbeat. Thus, the irreversible cessation of heartbeat and respiration implied death of a patient as a whole, although that did not necessarily imply the immediate death of every cell in the body. Doctors accepted and used traditional methods of establishing death. When someone’s heart stopped beating and he stopped breathing, he was dead. Advances in medicine gradually demonstrated that this was not a valid test for all purposes: elective cardiac arrest during openheart surgery, for example, or cases of spontaneous cardiac arrest followed by successful resuscitation. The heart stops but the patient is not dead. Machines such as mechanical ventilators or respirators have effected major improvements in techniques of resuscitation and life support for those who are desperately ill or injured. Where these efforts are successful and the patients recover, one may praise the advances in medical techniques. Sometimes such measures do not provide any satisfactory outcome, for example, where the person’s heart continues to beat on the machine long after breathing has stopped but his brain is irreversibly damaged. In such circumstances, keeping a body ‘alive’ on a machine can be as undesirable as it is pointless. It is distressing to relatives. It can have an adverse effect on nursing staff morale; the cost of maintaining the patient in such intensive care is high, and the use of machines in these cases can mean that other patients better able to benefit from them, may be denied access to them. Developments in life support made rethinking death inevitable.

Nonetheless, a significant trigger to rethinking our definition of death was the development of transplantation which highlighted the need for speed in diagnosing death and removing organs from the body. Thus, pressures developed to consider a redefinition of death based upon a new concept of ‘irreversible brain damage’ or ‘brain death’. This concept can be illustrated dramatically by considering a guillotine victim. Nobody would consider the body, after the head has been severed, to represent an individual living being; yet the decapitated body could be resuscitated and the organs kept ‘alive’ for a considerable period. In most cases, brain death follows the cessation of breathing and heartbeat in the dying process, but occasionally that order of events is reversed. This occurs as a result of severe damage to the brain itself, from perhaps, a head injury or a spontaneous intracranial haemorrhage. In such cases, instead of failure of such vital functions as heartbeat and respiration eventually resulting in brain death, brain death results in the cessation of spontaneous respiration; normally followed within minutes by cardiac arrest. If, however, the patient is supported by artificial ventilation, the heartbeat can continue for some days and this will, for a time, enable the function in other organs, such as the liver and kidneys, to be maintained.

This condition of what was then described as a ‘state beyond coma’ or ‘irreversible coma’ or ‘brain death’ was first advanced as a new criterion of death in 1968 in an influential report of an ad hoc Committee of the Harvard Medical School.⁶ In such cases (it was said) a doctor could pronounce as dead a ‘comatose’ individual who had no discernible central nervous system activity; and then the ventilator could be switched off. The Harvard doctors stated that judgement of the existence of the various criteria of death was solely a medical issue. Using words such as coma or comatose was unhelpful and raised suspicion that concepts of death were being manipulated to make it easier to declare a patient ‘dead’.⁷

Public opinion was unwilling to surrender control of such matters lightly to the medical profession. Unease was expressed about the relationship between attempts to redefine death and the needs of transplant surgeons to ensure that organs taken from a deceased person should be taken as soon as possible after death. In 1975, the British Transplantation Society expressed concern at the poor quality of cadaver kidneys being transplanted, mainly because of delay between the determination of death and the removal of the kidneys from the body. It was also important, for transplantation, that a ventilator should not be switched off permanently, but rather that the donor’s body be kept on the machine to preserve the quality of the organs until they were required. Two major fears were voiced. First, was the pressure to redefine death being made simply to enable transplant surgeons to obtain better results? Could it be said, for example, that potential transplant donors might be designated ‘dead’ at a point of time earlier than if they were not potential donors? Second, was it ethically or legally permissible to remove organs from a donor before the ventilator had been turned off? Because of doubts such as these, the British Transplantation Society recommended that the death of a potential organ donor should be certified by two doctors; neither of whom were a member of the transplant team and, most important, that the decision to stop a ventilator should be made quite independently of transplant considerations.

From the late 1970s the medical establishment in Britain⁸ agreed that ‘brain death’⁹ or, preferably, ‘brain stem death’ (which is the ‘irreversible loss of brain stem function’) could be diagnosed with certainty; and in these circumstances, the patient is dead whether or not the function of some organs, such as a heartbeat, is still maintained by artificial means.

Some commentators continued to reject the notion that ‘death’ could be equated with ‘irreversible loss of brain stem function’.¹⁰ They argued that only the cessation of the heartbeat truly indicated the end of life. Claims were made of ‘mistakes’. Were patients being diagnosed as brain dead who were not ‘really’ dead? Or were, the few reported examples of such mistakes simply cases where the appropriate criteria for determining brain death had not been properly implemented? Was it possible that organs were being taken for transplant before a patient had died? The validity of procedures to establish ‘brain-death’ had never, some argued, been rigorously tested. Shortcuts in procedures were too often prompted by pressure from the transplant team anxious to ‘get at’ organs swiftly.¹¹ In January 2011, the Chief Rabbi, Lord Sachs, reignited controversy relating to brain death. He issued a rabbinical ruling that only ‘cardiac death’ was acceptable as the definition of death in Orthodox Jewry.¹² The consequences for organ donation are discussed in the next chapter.¹³ Others have argued that we should be less ‘precious’ about the technical moment of death and be ready to retrieve organs from the nearly dead whose prior wishes were to be an organ donor.¹⁴ Such arguments in turn fuel the fears of those suspicious that brain stem death is simply a device to hasten the removal of organs. Hence we note repeated calls for a more general acceptance of the concept of ‘brain death’.¹⁵

Official endorsement of ‘brain stem death’ in the UK is now to be found in a comprehensive Code of Practice issued by the Academy of Medical Royal Colleges.¹⁶ The Code notes that ‘[D]eath involves the irreversible loss of those essential characteristics which are necessary to the existence of living human person and thus the definition of death should be regarded as the irreversible loss of consciousness combined with the irreversible loss of the capacity to breathe’. Brain-stem death is defined as follows:

2.1 Death following the irreversible cessation of brain-stem function

The irreversible cessation of brain stem function (brain stem death) whether induced by intra-cranial events or the result of extra-cranial phenomena, such as hypoxia, will produce this clinical state and therefore irreversible cessation of the integrative function of the brain stem equates with the death of the individual and allows the medical practitioner to diagnose death.

Importantly, the Code of Practice also sets out detailed and careful instructions for rigorous criteria for tests to confirm death.¹⁷

The law

16.3 There is still no statutory definition of death in the UK. There is, however, sufficient judicial authority in England to support a definition of death based on ‘brain stem death’. The question first arose where persons accused of murder claimed that it was not they who killed the victim, but the hospital team who disconnected the life-support machine. The courts did not react favourably, even though they sidestepped the issue as to what, in law, constitutes death. In R v Malcherek; R v Steel,¹⁸ the Court of Appeal dealt with two such cases. The first defendant had stabbed his wife, who was taken to hospital and put on a life-support machine. When it was found she had irreversible brain damage, the ventilator was disconnected and shortly after that all her bodily functions ceased. The second defendant attacked a girl, causing her multiple skull fractures and severe brain damage. She too was taken to hospital and put on a life-support machine, which was disconnected when the doctors concluded that her brain had ceased to function. The Court of Appeal upheld the trial judges’ decisions in each case not to leave the issue of causation to the jury, pointing out rather tartly that it was not the doctors, but the accused who were on trial. The Court took the crucial evidence to be that the original criminal acts by the defendants were continuing, operating and substantial causes of the death of their victims. In the ordinary case where treatment is given bona fide by competent and careful medical practitioners, evidence is not admissible to show that the treatment would not have been administered in the same way by other medical practitioners. Without exploring the definition of death, the Court was not prepared to allow assailants to shelter behind technical arguments challenging standard medical procedures. Lord Lane CJ did go slightly further saying:

whatever the strict logic of the matter may be, it is perhaps somewhat bizarre to suggest … that where a doctor tries his conscientious best to save the life of a patient brought to hospital in extremis, skilfully using sophisticated methods, drugs and machinery to do so, but fails in his attempt and therefore discontinues treatment he can be said to have caused the death of the patient.¹⁹

Re A²⁰ settles the matter. A 2-year-old boy suffered a serious head injury. Doctors struggled to save his life and he was put on a ventilator. His condition deteriorated and tests established that he was, undoubtedly, brain stem dead. His parents vehemently opposed the decision to switch off the ventilator. The hospital sought a declaration that doctors in disconnecting the child from the ventilator did not act unlawfully. Endorsing the definition of brain stem death then encapsulated in a Department of Health Code of Practice, the judge declared that the child was for all purposes legally dead. The House of Lords in Airedale NHS Trust v Bland²¹ lent further authority to a legal definition of death dependent on proof of ‘brain stem death’.

In 2015 the Code of Practice criteria for death were once again affirmed in Re A (a Child).²² The case concerned a 19-month-old boy who, having tragically choked on food, was brought to hospital and ventilated. There he was declared clinically dead on the basis of two brain stem tests. Extubation was opposed by A’s parents. Forty-eight hours later, the coroner assumed jurisdiction over the body and asked that ventilation be withdrawn. Such a move is unprecedented. While the coroner has legal jurisdiction to remove a body²³ so too does the High Court which is clearly better placed to deal with the sensitive question of withdrawal of treatment from a clinically dead child. Hayden J stated:

I cannot conceive of any circumstances in which the Coroner should seek to intervene, where a body remains ventilated, beyond those circumstances concerning the removal of organs where the family are consenting. Any other approach I regard as likely to generate immense distress and contribute to an atmosphere where sound judgment may be jeopardised.²⁴

Should there be a statutory definition of death?

16.4 The case for a statutory definition of death is less compelling than when such arguments were first advanced,²⁵ as the courts have introduced a degree of certainty into the debate. Had there been a statutory definition of death in 1976, a definition based upon the longstanding medical criteria of irreversible cessation of breathing and heartbeat, then the medical redefinition of death to take into account irreversible cessation of brain function would have no legal effect in those cases where there was a difference in time between the two definitions, until the existing definition had itself been changed by statute. As long as the matter is treated as a question of medical fact, changes in medical approach can be accommodated within the law without any requirement for further legislation.

Those in favour of legislation regard the ease with which, without legislation, definitions of death can, and have altered as a source of disquiet. Doctors, supported by judges, changed the goalposts. Visceral fears that doctors continue to be eager to declare A dead to give B her organs have not gone away.²⁶ A debate on a statutory definition of death would allow wide public involvement in that debate, and an opportunity for public education. Such a debate could also encompass other difficult issues surrounding defining death. There are those who argue that patients in a persistent vegetative state (PVS), such as Tony Bland²⁷ are not dying but dead. The destruction of the cortex and consequent loss of all cognitive function rendered Tony Bland, in that ghastly phrase, a ‘human vegetable’. He had irreversibly lost personhood, and those capacities which made him distinctively human. Should we modify the definition of death so that patients in this state are also regarded as dead? Some argue that this is the most sensible and most compassionate way of dealing with these persons. Criteria based on ‘brain stem death’ would be replaced by a concept of ‘cognitive death’. But is this a decision that unelected judges should take by choosing to endorse flexible and developing definitions of death as valid if they accord with medical practice? Would a definition of death based on ‘cortical or cognitive death’ be comprehensible or acceptable to the public?

Formulating a statutory definition of death is not straightforward.²⁸ Early attempts provided for alternative definitions; the long-established traditional definition and the new definition. This, it was said, would lead the public to believe that there are two separate phenomena of death, one being primarily for transplantation purposes. The American Uniform Brain Death Act (1978) served as a model for a number of states in the USA. It provides simply that ‘for legal and medical purposes, an individual who has sustained irreversible cessation of all functioning of the brain, including the brain stem, is dead. A determination under this section must be made in accordance with reasonable medical standards’. It is difficult to see what this would add to English law, were it to be enacted. Such a statute would simply repeat and reinforce the Academy of Medical Royal Colleges’ Code currently operated voluntarily by the medical profession. Any doctor violating that Code today by acting on a concept of ‘cognitive death’ in relation to his patients would have difficulty in justifying his action in any subsequent legal or disciplinary proceedings. Section 26(2)(d) of the Human Tissue Act 2004 empowered the Human Tissue Authority (HTA) to prepare a Code of Practice in relation to the definition of death, but for the purposes of that Act only. No such Code has been developed by the HTA. While the HTA may be well placed to consult widely in relation to its preparation of such a Code, it is regrettable that their Code of Practice would be narrowly focused within the 2004 Act. This could re-enforce fears that a different standard applies where the primary question is removal of organs and tissue from the body.²⁹

Open debate about how we define death would allow two other questions to be explored, those relating to anencephalic infants and pregnant women. In anencephalic babies, the conventional criteria for ‘brain stem death’ are unworkable. An anencephalic baby is born lacking a higher brain. He is bound to die, usually in a matter of days and, were his interests alone to be considered, such an infant would not be ventilated. Other babies are born with intact brains, but defective hearts or kidneys. Doctors may want to use organs from the anencephalic baby to save the life of a baby with other defective organs. In 2015, the parents of Teddy Houlston learned during the pregnancy that their son was anencephalic but elected to continue the pregnancy so that Teddy could be an organ donor. He lived for about a 100 minutes and died in his mother’s arms. Once his heart stopped, surgeons removed the kidneys which were then transplanted into an adult.³⁰ Teddy was thus a non-heart-beating (DCD) donor. If newborn infants are to be used more often as organ donors, brain death in newborns and anencephalic infants needs to be clarified to allow the baby to be ventilated while arrangements for a transplant are made. That poses a problem in defining when he dies. Tests for ‘brain stem death’ are not applicable to newborn babies,³¹ and there is some evidence that, if ventilated, an anencephalic infant’s brain stem may remain active, ‘alive’, for some considerable period of time. The Royal College of Paediatrics and Child Health³² has now issued a report providing recommendations of diagnosis of brain death in infants under 2 months old. The guidance may enable doctors to diagnose death in newborns without waiting for the heart to stop and so increase the numbers of organs available for transplant especially into child recipients.

One objection, regardless of how we define death in such cases, is that in ventilating an anencephalic baby to retrieve her organs we use her solely as a means to an end. A similar problem surrounds ventilating brain dead pregnant women.³³ We do no more than pose a series of questions. If a pregnant woman suffers head injuries during pregnancy and brain stem death is diagnosed, should her corpse be ventilated to allow the fetus the opportunity to be delivered alive? Who should make such decisions? Where a woman has herself contemplated such a possibility and in an advance directive expressed her wish that her body be sustained so her child can live, the outcome might seem clearer. She has authorised the use of her body for that purpose but such a use of a dead body is not contemplated in the Human Tissue Act 2004. The temptation for doctors wishing to comply with the ‘dead’ woman’s instructions might be to fall back on earlier definitions of death based on cessation of heartbeat and declare that this woman is not dead. What of instructions not to ventilate her ‘corpse’ from a woman in the later stages of pregnancy when a few further days in the womb might give the fetus a fighting chance of survival? Can her wishes be ignored? Absent any instruction from the woman herself, does her husband, partner or parent have a right to determine whether or not the fetus survives? Or is this a case where an independent fetal interest can be asserted? The Irish case of PP v Health Service Executive³⁴ illustrates the complexity and poignancy of the dilemma of the brain dead pregnant woman. NP was fifteen weeks pregnant when she was diagnosed as brain stem dead. Her father and her partner sought to have the ventilator switched off. Doctors sought to maintain NP on life support to allow the fetus to survive. Note that in Ireland Article 40(3) of the Constitution expressly acknowledges the ‘right to life of the unborn and, with due regard to the equal right to life of the mother, guarantees in it laws to respect, and, as far as practicable, by its laws to defend and vindicate those rights’. The Irish High Court heard medical evidence that indicated that the fetus was highly unlikely to survive. The judges concluded that thus it was not in the interests of the fetus for its mother to be maintained on life support. They noted too the terrible distress caused to her family if this largely ‘futile’ exercise were to continue and that NP herself would be deprived of ‘dignity in death’. Whatever your conclusion as to the continued ventilation of brain dead pregnant women, the notion of ‘brain dead incubators’³⁵ challenges our understanding of death, and could undermine confidence in definitions of brain stem death.

The brutal reality may be that, however death is defined, and whether such a definition is enshrined in statute or not, diagnosing death will always be a matter of concern. Few people wish their final moments to be cut short by others. Accepting the death of someone close to you is more than an exercise in logic.

¹  See J Bondeson, Buried Alive: The Terrifying History of our Most Primal Fear (2001) Norton.

²  See C Machado, J Korein, Y Ferrer et al, ‘The Concept of Brain Death Did Not Evolve to Benefit Organ Transplants’ (2007) 33 Journal of Medical Ethics 197.

³  For an excellent analysis of all the medical and ethical conundrums surrounding a definition of death, see JK Mason, GT Laurie, Mason and McCall Smith’s Law and Medical Ethics (9th edn, 2013) Oxford University Press, ch 16.

⁴  See Law of Property Act 1925, s 184.

⁵  See Lim Poh Choo v Camden and Islington Area Health Authority [1980] AC 174.

⁶  ‘A Definition of Irreversible Coma’ (1968) 205 Journal of the American Medical Association 337.

⁷  See Mason, Laurie, Mason and McCall Smith’s Law and Medical Ethics, 16.16–16.21.

⁸  See Conference of Medical Royal Colleges and their Faculties in the UK, ‘Diagnosis of Brain Death’ (1976) 2 BMJ 1187; and ‘Memorandum on the Diagnosis of Death’ (1979) 1 BMJ 332; C Pallis, DH Harley, ABC of Brainstem Death (2nd edn, 1996) BMJ Books.

⁹  For an analysis of the confusing terms in debates on ‘brain death’, see Mason, Laurie, Mason and McCall Smith’s Law and Medical Ethics, pp 557–559.

¹⁰  See M Evans, ‘A Plea for the Heart’ (1990) 3 Bioethics 227; and note that in Japan ‘brain stem death’ was only accepted as a lawful definition of death in the late 1990s; see J Wise, ‘Japan to Allow Organ Transplants’ (1997) 314 BMJ 1298.

¹¹  See A Joffe ‘Are the Recent Defences of the Brain Death Concept Adequate?’ (2010) 24 Bioethics 47.

¹²  And see A Bedir, S Aksoy, ‘Brain Death Revisited: It Is Not “Complete Death” According to Islamic Sources’ (2011) 37(5) Journal of Medical Ethics 290.

¹³  (2011) Guardian 14 January.

¹⁴  RD Truog, FG Miller, SD Halpern ‘The Dead-Donor Rule and the Future of Organ Donation’ (2013) 369 New England Journal of Medicine 1287–1289.

¹⁵  DC Magnus, BS Wilford, A Caplan ‘Accepting Brain Death’ (2014) 370 New England Journal of Medicine 891–894.

¹⁶  Academy of Medical Royal Colleges, A Code of Practice for the Diagnosis and Confirmation of Death (2008).

¹⁷  Ibid, chs 4–6.

¹⁸  [1981] 2 All ER 422. And see Finlayson v HM Advocate 1978 SLT 60.

¹⁹  [1981] 2 All ER 422, at 429.

²⁰  [1992] 3 Med LR 303; and see Mail Newspapers plc v Express Newspapers plc [1987] FSR 90; Re TC (A Minor) (1993) 2 Medical Law Review 376.

²¹  [1993] 1 All ER 821, HL. See 19.15.

²²  [2015] EWHC 443 (Fam).

²³  Under the Coroners Act 2009, s 15.

²⁴  [2015] EWHC 443 (Fam), [22].

²⁵  For example, see 14th Report of the Criminal Law Reform Committee, Offences Against the Person (Cmnd 7844, 1980).

²⁶  See JM Appel, ‘Defining Death: When Physicians and Family Disagree’ (2005) 31 Journal of Medical Ethics 641.

²⁷  Airedale NHS Trust v Bland [1993] 2 All ER 821, HL. See 19.15.

²⁸  For an argument against a statutory definition, see DN Banyubala, ‘Death in Ghana: Socio-cultural Implications for Organ Transplant Legislation’ (2014) 14 Medical Law International 52.

²⁹  See C Machado et al, ‘A Definition of Human Death Should Not Be Related to Organ Transplants’ (2003) 29 Journal of Medical Ethics 201.

³⁰  BBC News, ‘Newborn Baby Teddy Was UK’s Youngest Ever Organ Donor’ (2015) 23 April.

³¹  See Working Party of the British Paediatric Association, Diagnosis of Brain-Stem Death in Infants and Children (1991) endorsed in the Academy of Medical Royal Colleges, Code of Practice for the Diagnosis and Confirmation of Death (2008) see para 6.2 and Appendix 4.

³²  Royal College of Paediatrics and Child Health, The Diagnosis of Death by Neurological Criteria in Infants Less than Two Months Old (2015).

³³  See Mason, Laurie, Mason and McCall Smith’s Law and Medical Ethics, at 16.28–16.31; D Sperling, Management of Post Mortem Pregnancy: Legal and Philosophical Aspects (2000) Ashgate.

³⁴  [2014] IEHC 622.

³⁵  See NS Peart, AV Campbell, AR Manara, ‘Maintaining a Pregnancy Following Loss of Capacity’ (2000) 8 Medical Law Review 275.

Chapter 17

ORGAN AND TISSUE TRANSPLANTATION

17.1 This chapter explores legal questions surrounding organ and tissue transplantation. It focuses solely on transplantation. Closely related questions relating to organ retention for the purposes of education and research are dealt with in Chapter 18.¹ The Human Tissue Act 2004 regulates transplantation in England and Northern Ireland. Scotland has its own statute, the Human Tissue (Scotland) Act 2006 and as we shall see Wales has made a substantial change to the law relating to cadaver transplantation in the Human Transplantation (Wales) Act 2013.² The origins of the 2004 Act owe more to the controversy surrounding revelations about practice of organ retention than the needs of transplant medicine itself.³ The Act is complex and difficult to understand.⁴ In the context of transplantation a fundamental principle embodied in the Act is that all donations, including cadaver donations, must be based on ‘appropriate consent’.

Certain sorts of tissue transplantation, such as blood donation and skin grafts, have been routine for many decades. Tens of thousands of lives have been saved by bone marrow transplants. Despite the number of lives saved, solid organ donation has had a stormy history. Debates involving clinical, ethical, scientific, financial and resource considerations continue to rage. The 2004 Act has not stilled controversy. Public response to transplantation has often been erratic, influenced by publicity given to dramatic successes and failures. For example, in the early days of heart transplants stories which described transplant surgeons as ‘human vultures’, and claims of organs allegedly removed from bodies before ‘real death’ had occurred, excited concern and hostility. On the other hand, the media can be effective in publicising the benefit of transplantation and creating favourable public awareness about transplant medicine.

Scientific developments in transplantation continue to be amazing. The principal problem remains the discrepancy between supply and demand.⁵ Until 2014/15 it had seemed that in the UK the number of donors was steadily rising.⁶ In 2013/14 deceased organ donation rose by 9 per cent to 1,320 donors, the highest number of cadaver donors recorded in the UK and the number of living donors increased by 4 per cent to 1,146. However, that promising trend stalled in 2014/15. The number of deceased donors fell by 3 per cent to 1,282 and the number of living donors fell to 1,092. On the active waiting list, there were 6,943 patients registered as needing a transplant, and 3,375 more people are on the ‘suspended’ list, that is to say, that they need a transplant but are currently too ill for surgery. In the UK in 2014/15, 429 people died for want of a transplant,⁷ surprisingly a fall on the death rate of 456 in the previous year despite the decline in donor numbers. The percentage of families consenting to/authorising donation also fell slightly from 59 per cent to 58 per cent. In its 2015 report on transplant activity, NHS Blood and Transplant (NHSBT) can as yet offer no explanation for the slight fall in donor numbers⁸ and perhaps we should not read too much into one year’s outcomes. What is clear is that compared to countries such as Spain the UK falls well short of the optimum number of cadaver transplants.⁹

When considering the supply of organs, four factors must be noted:

(1)  Living donors play a central role in organ donation.

(2)  One single cadaveric donor is often the source of multiple transplants.

(3)  The criteria for selecting cadaver donors are becoming less stringent.¹⁰

(4)  The demand for organs steadily increases with ever higher rates of renal and liver disease.

Additionally, the very success of transplant medicine increases demand as many people who are restored to health by a transplant will later in life need a second or third transplant. Such was the degree of concern about rates of organ donation that the government convened the Organ Donation Taskforce (ODT) which issued its first report in 2008 setting out a strategy designed to achieve an increase of 50 per cent in cadaver donation within five years.¹¹ The ODT was then asked by government to reconvene specifically to look again at the case for amending the Human Tissue Act 2004 to introduce a system of presumed consent (sometimes styled an ‘opt-out’ system) for cadaver donations. Perhaps to the surprise of the government, the ODT’s second report recommended against moving to presumed consent at present.¹² Proponents of presumed consent argue that doctors should be allowed to remove organs from the dead unless the deceased had registered an objection to organ donation. Attempts to introduce presumed consent during the passage of the Human Tissue Act had also failed. Those who press its case are unlikely to give up easily and will watch with interest the progress of the Welsh Act (the Human Transplantation (Wales) Act 2013) which for Wales introduces a system of presumed consent, styled ‘deemed consent’.

Another strategy to increase the supply of organs focuses on living donors with many ethicists advocating a ‘market’ in organs. In future it may become possible to ‘grow’ new organs from stem cells,¹³ and the possibility of xenotransplantation, using genetically modified organs harvested from non-human animals, remains on the agenda, but looks less likely to materialise than some years ago. At present there remains a pressing need for organs donated by human donors. The focus is on developing better systems of identifying and recruiting potential organ donors and improving ways of maintaining the quality of organs removed from deceased donors.¹⁴

Before examining the law in more detail, three points need to be understood about the mechanics of transplantation. First, the organ must be suitable for transplant – that means it should be ‘healthy enough’ and retain a reasonable ‘shelf life’. That does not mean that the donor must have enjoyed perfect health but controversy has arisen over what we might call risky transplants. Reports of a coroner’s inquest in Wales raised a nice question of consent and the condition of donor organs. Two patients died as a result of the kidneys they received having been infected by a parasitic worm. The organs came from a homeless alcoholic and had been rejected by other transplant teams. The families of the dead recipients argued that while their relative might have been prepared to take a risk to receive an organ they should have received much more information about the risk of the kidney on offer.¹⁵

Most deaths occur in the elderly: age alone is no barrier to donation. Organs are now taken from an increasingly older range of cadaver donors, but those who die of progressive organ failure, common in the very old, are unsuitable donors. Second, the organ must remain viable – in good condition. Either the transplant must take place a very short time after its removal from the donor, or means must be found to preserve it while it is transported to the potential recipient. Finally, there should be a tissue match between donor and recipient. Improvements in drugs used to prevent rejection of ‘alien’ organs have made it possible to use a wider range of donors with less emphasis on the perfect tissue match but a live transplant from a close relative is still an optimal choice. A healthy sibling may be able to provide a matched organ that can be transplanted within minutes of its removal from the donor.

The Human Tissue Act – an overview

17.2 In England and Northern Ireland, the Human Tissue Act 2004 regulates most of the issues relating to the removal, retention, and use of human body parts and tissue.¹⁶ It repeals all previous legislation including the Human Tissue Act 1961 and the Human Organ Transplants Act 1989.¹⁷ The 2004 Act regulates all aspects of human transplantation, whether the organs (or tissue) are removed from the living or the dead. Scanning the Act, the reader will find surprisingly few express references to transplantation. The Act sets out rules for twelve scheduled purposes involving the use of human organs and tissue. Transplantation is just one of the twelve.¹⁸ For the most part, the broad rules which the Act imposes apply generally to transplantation. Only a few sections of the Act apply exclusively to transplants. The Act itself offers no more than a framework to regulate transplantation. The details are supplied by regulations made by the Department of Health, and Codes of Practice promulgated by the Human Tissue Authority (HTA).

The HTA is central to the Act,¹⁹ established to regulate all matters concerning the removal, storage, use and disposal of human tissue (except for gametes and embryos).²⁰ The HTA is also the competent authority in the UK for the implementation of the EU Tissue and Cells Directive,²¹ and the EU Directive on standards of quality and safety of human organs intended for transplant.²² We shall see that the Authority has a number of special responsibilities in relation to transplants. The HTA must have a majority of lay members. Its remit in the context of this chapter is principally to regulate transplantation. Another authority, the NHSBT, is charged with operational matters relating to transplantation, and required to encourage donation and ensure the quality of the transplant service. The HTA has however also played a role in working to increase the number of organs made available for transplant as for example when in 2006, it promulgated a policy designed to increase the numbers of living donors by allowing new kinds of altruistic donation.²³

The 2004 Act, ‘policed’ by the HTA, rests on a number of central tenets. Explicit consent to most forms of the use of organs and tissue is required. Criminal penalties attach to certain breaches of the Act. A number of activities relating to the removal and use of tissue, and the conduct of post-mortem examinations have to be licensed. Transplants do not require a licence, but certain kinds of transplant activities will require special approval from the HTA.

Live donor transplantation

17.3 For one person to subject himself to an unnecessary procedure for the benefit of another requires courage and altruism. A distinction must be made between donation of regenerative and non-regenerative organs. The blood donor undergoes temporary discomfort. His body replaces the blood he has lost. Blood and bone marrow are regenerative tissue. Some non-regenerative organs, such as the heart, are impossible for a living donor to donate in normal circumstances. However, what are possible are domino transplants, involving organ ‘swaps’. For example, a cystic fibrosis patient may need a lung transplant. The success rate is higher and the operation easier if a heart and lung transplant is performed. The recipient may receive a heart and lungs from a cadaver donor and opt to donate her own healthy heart to another patient.²⁴

The most common non-regenerative organ donated by a living person remains the kidney. There were 1,052 living kidney donors in 2014/15.²⁵ Techniques allowing transplants of lobes of the lung and segments of liver have increased the utility of live donations, but at a cost. The risk of death in a live kidney donation is about 1:3,000 but rises to 1:100 for living liver donations.²⁶ The donor agrees to major surgery and accepts a significant risk to his own health. In 2014/15 there were twenty-eight living liver donors.²⁷ The ODT commented that the acceptance of such risks to healthy people demonstrated ‘the critical shortage of deceased donors’.²⁸ But it is not clear that living donation should be seen as second best and a mark of failure to recruit enough cadaver donors given that the live donations achieve better results in terms of the length of time that the transplanted organ continues to function.

The law needs to be designed to ensure that living donation is informed, truly voluntary, and not the result of coercion. The British tradition has been that the donation of body products should be just that, a gift, not a sale. So it has been argued that no part of a person’s body should be treated as a commodity subject to the pressures of the market.²⁹ Section 32 of the Human Tissue Act 2004 continues the prohibition on sale of organs (or other bodily material) for transplantation, a ban initially imposed by the Human Organs Transplant Act 1989.³⁰ Markets remain illegal in the UK. Whether this should be so, we discuss later.

Adult donors

17.4 In the early days of transplantation, doubts were cast about whether it was lawful for a person to agree to donate a solid organ, such as a kidney, to another during his lifetime. As we have seen, inflicting actual bodily harm on another person can constitute a crime regardless of consent.³¹ By 1995, the Law Commission³² could say with confidence that ‘once a valid consent has been forthcoming, English law now treats as lawful donation of regenerative tissue and also non-regenerative tissue not essential to life’.³³ The Human Tissue Act 2004 provides a statutory basis for live donation of organs and tissue for transplantation.

Sections 1 and 3 of the Act provide in effect that it is lawful to remove organs from a living adult for transplant with, but only with, his appropriate consent. The law empowers a person to choose to give a kidney, or a lobe of her lung, or segment of liver, to another in need of a transplant. But what is an appropriate consent? Living donors are often closely related to the potential recipient. The potential donor may be the best match as a person whose compatibility is such that a relative’s life can be saved.³⁴ In such circumstances, the psychological pressure can be enormous. It becomes crucially important to establish that the donor did give a genuinely free and informed consent. The Act itself does not define what appropriate means. That task is left to the HTA, which has set out guidance on consent in two key Codes of Practice.³⁵ Both Codes emphasise the need for good communication. The potential donor must be given information about what will be done to her and the risks to her. She must be given reliable information about the chances of success. She must be warned about some of the risks of tissue typing. Tests might reveal that apparent siblings are not full siblings. A donor could discover that her supposed father is not after all her biological parent. Donors should be offered counselling, given time to make a decision and reassured that they are free to withdraw consent at any time up to the operation.

Nor is the donor’s consent alone sufficient to make a live organ donation lawful. Under the Human Organs Transplant Act 1989, where the donor and recipient were not closely genetically related, it was a criminal offence to remove an organ for transplant without the authorisation of the Unrelated Live Transplant Authority (ULTRA). This rule was primarily designed to prevent covert sales of organs. The 1989 Act banned such sales, but the legislators suspected that organ vendors and purchasers might seek to bypass the ban. ULTRA had the task of ensuring that all apparently altruistic donations between strangers were truly altruistic. The law would be enforced, and potential unrelated donors could be protected from coercion or exploitation.

Section 33 of the 2004 Act extends the powers of the new HTA to oversee all live donations, including those between family members. The HTA must be satisfied that no money has changed hands and that other conditions prescribed by regulations are met.³⁶ All potential donations, whether by a stranger, a friend, or a sister, will be scrutinised. Is this right? The need to ensure a tissue match between donors and recipients means doctors will normally prefer a living donor closely related to the potential recipient. Close genetic relationships maximise the chances of a successful transplant. It might be argued that if we (as adults) choose to give a kidney, or a segment of liver, to a dying sibling, this is nobody else’s business. Within the family, emotional pressure may be as potent a threat to our free will as poverty could be were sales of organs allowed. Questions must also be asked about donors’ understanding of risk. As we have seen, the risk to a donor giving a kidney is small, but the donor of a liver segment faces a 1:100 risk of death.

The regulations made under section 33 of the 2004 Act need to be read together with the HTA Code of Practice Donation of Solid Organs for Transplantation.³⁷ Doctors responsible for any potential live donor of a solid organ, or part of an organ, or bone marrow,³⁸ must refer the case to the HTA. The HTA must satisfy itself that the organ or bone marrow is not being sold. All live donations must be scrutinised to ensure a genuinely free consent has been given by the donor. The HTA appoints Independent Assessors (IAs) who interview potential donors and recipients, satisfy themselves that the conditions set out by the HTA are fully met, and report to the HTA. The IAs will be specially trained and senior health professionals. The Regulations and the Code of Practice distinguish between different kinds of live donation and set different levels of decision-making.³⁹ When the donor and the recipient are genetically related or are partners or closely known to each other (what the HTA describes as ‘genetically related donation’ or ‘emotionally related organ donation’),⁴⁰ the IA simply reports to the HTA transplant approvals team and on the basis of the team’s approval, the donation may lawfully go ahead. Four⁴¹ other sorts of live donation involving competent adults are then identified, and more closely regulated. The first two involve an ‘exchange’ of donated organs.⁴²

(1)  In a ‘paired donation’ a kidney will be removed from donor A and given to someone who is a stranger to him. In return, a kidney removed from donor B will be given to a relative or close friend of donor A. Assume your husband needs a kidney transplant but you are not a suitable tissue match. If you agree to donate your kidney to B, a relative of B will provide a kidney for your spouse.

(2)  ‘Pooled donations’ involve a linked series of ‘paired donations’. For example, donor A gives a kidney to the son of donor B. Donor B gives a kidney to the husband of donor C. Donor C’s kidney is given to the wife of donor A. These ‘exchange’ donations increase the likelihood of live donations. Should a brother be dying of renal failure and none of his relatives are a tissue match, his family could volunteer to give an organ to someone else for whom one of them is a match. And then, in exchange, directly or indirectly, a relative of the recipient will donate an organ to the brother.

(3)  Directed altruistic donation where the donor specifies a recipient but has no pre-existing relationship with her. For example the two may have been ‘introduced’ via a social network site.

(4)  Altruistic non-directed donation where the donor donates an organ to a person in every sense unknown to her, wholly altruistic donations, where the donor gives an organ with no conditions, and no expectation of any exchange benefiting those close to her.

In all of the above kinds of donation, the case must be considered by a panel of at least three members of the HTA. The panel will decide whether or not to approve the donation.⁴³

Child donors

17.5 More difficult questions arise where organs or tissue are to be taken from children. Should children ever be used as organ donors?⁴⁴ In the USA, the courts sanctioned such a course of action over fifty years ago. The cases involved three sets of minor twins aged 19, 14 and 14 respectively. In each case, the healthy twin was willing to donate a kidney to his dying brother, but it was not clear whether the law permitted this. Applications were made to the court for guidance. The court focused on the psychiatric evidence given to show that each donor had been fully informed about the nature of the procedure and also that, if it were not possible to perform the operation and the sick twin were to die, there would be a resulting grave emotional impact on the surviving twin. This enabled the court to be satisfied in each case that the operation was for the benefit not only of the recipient but also of the donor, and that accordingly a parent was capable of giving consent to such a ‘therapeutic’ procedure, just as he could to any other medical treatment needed by his child.⁴⁵

In England, until the Human Tissue Act 2004, this was a ‘grey’ area of law. It became routine practice for parents to authorise bone marrow donations (and skin grafts) from a healthy child to a sick sibling. Solid organ donations from one living child to another appear to have been ruled out by the transplant community itself. Bone marrow donations⁴⁶ proceeded on the basis that the harvesting of bone marrow involves some discomfort, but minimal risk, for the donor child. The psychological benefit of a sibling’s survival or well-being was said to outweigh any distress to the donors. The balance of burdens and benefits made the ‘donation’ a procedure in the best interests of the child and so an intervention parents could properly authorise. But how does a parent make an impartial evaluation of the interests of one child when the life of another of her children is at risk?

The Human Tissue Act 2004 clarifies the law, and the HTA has ensured that any donation by a person under 18 is scrutinised by both the HTA and the courts. In the ‘rare’ case where it is proposed to use a child (defined by the HTA as anyone under 18) as a living donor, such a donation will require appropriate consent from a person with parental responsibility for the child.⁴⁷ That means in most cases consent from his parents.⁴⁸ It will not be strictly necessary for both parents to consent, even when they share parental responsibility for the child, but we submit that the nature of the procedure is such that a court would be likely to wish to ensure that both parents agreed to the donation.⁴⁹ Parental authorisation alone will not suffice to make a donation by a minor lawful, even to a sibling. First the approval of a court must be obtained and then just as with adult donors, the donation will need to be scrutinised by the HTA. Regulations made under the Act require that any proposal to use a child⁵⁰ as a solid organ donor must be referred to the HTA for advice, and considered by a panel of three members of the Authority.⁵¹ And the HTA states that ‘Children can be considered as living organ donors only in extremely rare circumstances’.⁵²

What of older children? The younger American twins were 14. Even if legally not of an age to give independent consent, at 14 the child can be a party to the decision. Many 14-year-olds would be considered Gillick competent in this country if what was in issue was therapeutic treatment.⁵³ Section 2(2) of the Human Tissue Act empowers the Gillick competent minor to donate organs and tissue. If a minor of 15 or 17 is considered sufficiently mature and intelligent to weigh up the benefits or risks of donating an organ, her consent will authorise the donation. As with younger children the approval of a court must first be sought and then the proposed donation will be further scrutinised by the HTA. Doctors and the HTA will be anxious to ensure that any such decision is fully understood by the young person and not subject to undue pressure from the family. So, as is the case with younger children, all proposed live donations of organs⁵⁴ involving Gillick competent minors will be examined by a panel of three from the HTA. The more mature teenager, not her parents, can decide to offer a kidney to her brother. The HTA will exert a more intense scrutiny of her decision than if she were 18. Should a minor be allowed to donate a kidney? If a beloved twin needed such a transplant, it is not difficult to suggest that the physical risk to a willing donor is outweighed by the emotional benefit.

Mentally incapacitated ‘donors’

17.6 In the USA, in Strunk v Strunk⁵⁵ a 28-year-old married man who was dying of a fatal kidney disease sought the permission of the court for a kidney donation from his 27-year-old brother, who was said to have a mental age of 6 and who was detained in a mental institution. The Kentucky court emphasised the emotional and psychological dependence of the mentally disabled sibling on his brother, and that his well-being would be jeopardised more severely by the loss of his brother than by the removal of a kidney. Accordingly, it applied a doctrine of ‘substituted judgement’, to allow the court to act as they believed the mentally disabled brother would have acted had he possessed all his faculties, and gave consent on behalf of the donor. Subsequent cases in the USA stressed that in authorising organ donation on behalf of a mentally disabled adult the court must be fully satisfied that the interests of the donor will be served by the transplant. The benefits to him of his sibling’s, or relative’s, survival must be real, not speculative.⁵⁶

Before the Human Tissue Act 2004 came into force, in Re Y,⁵⁷ Connell J granted a declaration that bone marrow donation from a severely learning disabled woman of 25 to her 36-year-old sister, who was dying of leukaemia, was lawful. Of the elder sister’s relations, only her learning disabled sister proved to be a compatible donor. She was, it was agreed, incapable of giving consent to the procedure. The relationship between the sisters themselves was not especially close. The elder sister’s illness had meant that visits had become fewer. The relationship between the younger sister and her mother was close, as was the relationship between mother and her elder, sick daughter. The judge found that if the elder daughter died, her death would have an adverse impact on the mother. She would be less able to visit Y and much occupied in caring for her grandchild if the child’s mother died. If the transplant went ahead the ‘positive relationship’ between Y and her mother would be enhanced, as would the relationship between the sisters. The risk and discomfort to Y would be minimal. Accordingly it was in Y’s best interests to allow the bone marrow transplant to go ahead. Connell J made it clear that he was not setting a precedent for kidney ‘donation’ by a learning disabled person. He said:

It is doubtful that this case would act as a useful precedent where the surgery involved is more intrusive than in this case.

Should he have sanctioned a transplant which amounts to enforced donation?

The ‘benefit’ to Y seems somewhat remote on the facts of the case.

Regulations⁵⁸ made under section 6 of the Human Tissue Act 2004 provide that organs or tissue can be removed from a person lacking mental capacity for transplant if, but only if, such a procedure is in that patient’s best interests.

Any such proposal must first receive approval from the Court of Protection⁵⁹ and must then be referred to an HTA panel. It is difficult to see how the discomfort and surgery needed to remove a solid organ could be justified by a supposed emotional benefit. If the proposed donor cannot comprehend what is done to her, the balancing exercise becomes somewhat mythical.

Cadaver transplantation

17.7 Although the number of live donations is rising, the need for much greater numbers of cadaver donors remains acute. As we shall see later⁶⁰ a person has no legal right at common law to determine what shall happen to his body after his death. A body, or part of it, cannot ordinarily be the subject matter of ownership, and normally it is the legal duty of the close relatives of a deceased or those who are in ‘lawful possession’ of the body to arrange for its disposal at the earliest opportunity. So it is not legally possible for a person to impose a duty upon others that she be cremated after death. All she can do is to indicate that she desires to be cremated, and her executors or family are free to comply with or ignore such a wish as they see fit. At common law, a person had no legal power to donate organs from his body after his death; equally nobody has any right to interfere with a corpse, and any such interference would be a criminal act.⁶¹ It was feared that cadaver transplantation might be illegal. Legislation was needed.

In 1952, the Corneal Grafting Act, later amended by the Corneal Tissue Act 1986, authorised the removal and use of eyes for therapeutic purposes in some circumstances. This statute attracted little publicity, nor was there much more public interest when, in 1961, the Human Tissue Act 1961 widened the law to cover any other parts of the body. Although the 1961 Act served as a model for similar legislation in many other countries, it was unsatisfactory in almost every respect. It is repealed and replaced by the Human Tissue Act 2004.

Before examining the provisions of the 2004 Act in more detail, we need to address the problems with which the Act engages. What should be the basis on which organs can lawfully be removed from a dead body for transplant into another person? How can the law maximise the numbers of organs made available for transplant and ensure that organs can be removed and transplanted in a state likely to be ‘fit for purpose’? The philosopher John Harris⁶² proposed a radical and simple solution. Organ retrieval from the bodies of the dead should be lawful without any need for either the authorisation of the deceased or any consent from her family. The dead person has no interests sufficient to outweigh the needs of patient whose life depends on a transplant. Organ conscription would replace organ donation. Harris⁶³ himself recognises that such a radical proposal would be highly unlikely to gain parliamentary support and so has also endorsed a doctrine of ‘presumed consent’ as second best.

Presumed consent

17.8 ‘Presumed consent’, sometimes referred to as ‘opt-out’ or ‘contracting out’, means in effect that the law should allow organs to be removed for transplant unless the deceased had expressly put on record, for example, on a public register, that he had objected to such use. Relatives would lose any right of veto. Such a law, which now exists in a number of European countries and from December 2015 has applied in Wales, should, in theory, enable surgeons to acquire all the organs they need, unless there happened to be a dramatic change in public attitude so that large numbers of people go to the trouble of registering their objections.

‘Presumed consent’ is a much more complex issue than first appears and what we can say here is merely introductory.⁶⁴ Regimes of ‘presumed consent’ differ, with the majority whatever the letter of the law operating a system of ‘soft’ presumed consent. Relatives are still consulted and if they object their objections are normally respected. Difficulties can arise when quick decisions are needed. In Petrova v Latvia⁶⁵ the European Court of Human Rights found that there was a violation of a mother’s Article 8 rights when organs were removed from her 23-year-old son, a victim of a road traffic accident, shortly before he died. The Latvian law was insufficiently clear on the arrangements for consulting relatives.

Very few countries implement ‘hard’ presumed consent and simply remove organs unless the deceased’s name is entered on a register of objectors.⁶⁶ A transnational comparison suggested that donation rates improved by 25 to 30 per cent if the law of the country allowed presumed consent. In Belgium, law reforms introducing ‘presumed consent’ rules for organ donation were implemented in one part of the country, but not universally.⁶⁷ Spain has the most successful cadaver donation programme in Europe and the law endorses presumed consent.⁶⁸ But in Spain the system is markedly ‘soft’ with the family still permitted to refuse to allow the donation to go ahead. And study of the Spanish model suggests that only many years after the introduction of laws on presumed consent did donation rates rise. The major factor in the Spanish success is a well-resourced and highly organised system for identifying potential donors and obtaining the family’s agreement.⁶⁹

Wales will be the first jurisdiction in the UK to introduce a system of presumed consent. Enacted in 2013, section 2 of the Human Transplantation (Wales) Act⁷⁰ imposes on Welsh ministers a duty to ‘promote transplantation as a means of improving the health of the people of Wales’. This duty incorporates a requirement to inform residents of Wales about the potential to opt out. The coming into force of the Act in December 2015 was consequently preceded by a two-year public information campaign. The Act follows the broad structure of the Human Tissue Act 2004, requiring authorisation of transplantation activities by consent. Crucially, consent may be either express or ‘deemed’: adults who live and die in Wales⁷¹ will be able to opt out, opt in (setting limits on donation) or do nothing, in which case they will be deemed (presumed) to consent. Where a deceased patient has not opted out, there are possible exceptions to the application of deemed consent, including the objections of a friend or relative. Such objections are relevant only where:

a reasonable person would conclude that the relative or friend knows that the most recent view of the deceased before death on consent for transplantation activities was that the deceased was opposed to consent being given.⁷²

Organs donated in Wales may be given to patients in the rest of the UK. Public support and a reduction in the waiting list for transplants would provide strong incentives to roll out a similar scheme elsewhere in the UK.

Two other options should be noted, ‘mandated choice’ and ‘required request’. In the first, the law requires that each citizen places on record whether he consents or objects to the removal of his organs after death. ‘Required request’ focuses on the role of doctors rather than the deceased and the family. It is suggested that one of the main reasons for the shortfall in donor organs is the failure by doctors to ask relatives to agree cadaver organ donations. A number of American states⁷³ enacted legislation requiring hospital staff to request permission from the deceased’s family to remove suitable organs. The King’s Fund report⁷⁴ suggested it was unlikely to work and might result in undue pressure being placed on families. The GMC recognises that such discussions ‘may be appropriate’ depending on the patient’s circumstances and that doctors ‘should be prepared to explore with those close to [the patient]’ the patient’s views on donation.⁷⁵

The enactment of the Human Tissue Act 2004 ruled out reforms based on ‘conscription’, ‘presumed consent’, ‘mandated choice’ or ‘required request’, and the two reports of the ODT also rejected reform of the Act relating to consent to donation. The controversy generated by revelations that organs had been retained for research, education and diagnosis without consent, created a climate in which new laws even appearing to endorse an element of coercion would not command support. Explicit consent thus becomes the fundamental condition for all cadaver donations as much as donations by living donors.

Beating- and non-beating-heart donors

17.9 Whatever the legal rules governing consent to donation, any principled basis for donation must also take account of the practical need for the shortest possible period between removal of an organ and its transplantation into the intended recipient. We noted earlier that a successful transplant requires that the organ to be transplanted remains viable – so it has not, to put it brutally, begun to decay in the time between removal from the dead donor and implantation in the recipient. When a beating-heart donor is used, the donor will usually have been on a ventilator and diagnosed as brain stem dead. Oxygen will have continued to perfuse his organs up to the time that the heart or kidney is removed. However, the number of potential donors who are diagnosed as brain stem dead while on a ventilator remains small.⁷⁶

In 2014 to 2015 deceased donors comprised 772 donors after brain death and 510 donors after circulatory death.⁷⁷ DBD (donors after brain death) donors, or ‘beating-heart donors’, are patients whose initial condition resulted in their being placed on a ventilator in the hope that treatment could be instituted to prolong their lives. Once they are diagnosed as brain stem dead, but with the heart still beating, arrangements may be made for organ donation. In the 1990s, elective ventilation was seen as a possible solution to the problem and implemented at a hospital in Exeter. Elective ventilation would involve patients dying from strokes or similar conditions being transferred to the intensive care unit and ventilated until brain stem death occurs. In this way, their organs are maintained in optimum condition for organ retrieval. Patients would be brain stem dead when organs are removed, but not legally dead when ventilated. Ventilation would be performed solely to enable the patient to become a potential organ donor and confer no benefit on him. Is elective ventilation lawful? The practice was abandoned well before the enactment of the Human Tissue Act 2004 on the grounds that the ventilation of the dying patient constituted an assault on her. There is nothing in the Human Tissue Act 2004 expressly authorising or prohibiting elective ventilation. But is such a procedure an assault in all cases? At the time a decision is made to transfer the patient to intensive care he is unlikely to be able to consent to such a procedure himself. And so it is argued that the transfer to benefit the potential organ recipient is unlikely to be judged to be in his interests⁷⁸ and might fall foul of section 4 of the Mental Capacity Act 2005.⁷⁹

Should elective ventilation be lawful?⁸⁰ The Law Commission’s original report on the treatment of adults lacking mental capacity suggests that with proper safeguards, such a procedure could be ethical and lawful. The Mental Capacity Act 2005 does not expressly implement this proposal. Perhaps two cases should be differentiated. If I choose, not just to carry a donor card, but to indicate that were I to suffer a stroke or other cerebral incident and recovery of consciousness was possible, I should be ventilated to maximise my utility as an organ donor, that advance directive is as entitled to respect as any other. If I have expressed no such wish, should I, while still alive, be used as means to other ends even with my family’s concurrence? The Mental Capacity Act 2005 gives statutory force to advance refusals of treatment but not alas in this context, advance requests. Could one argue nonetheless that if we have expressly requested elective ventilation to bolster our wish to be organ donors, then that procedure does, paradoxically, become something done in our best interests? We would agree with Price that the time has come to revisit the troubled topic of elective ventilation.⁸¹

Efforts to improve the rate of organ donation in the UK now involve the use of DCD donors, donors after cardiac death (non-heart-beating donors).⁸² The donors’ hearts would have stopped and death would be diagnosed by the traditional cardio-respiratory criteria. The statement by the Chief Rabbi for England in January 2011 that Jewish law only recognised a definition of death based on traditional cardio-respiratory criteria may limit the numbers of organs that may be donated from within the Orthodox Jewish community.⁸³

Organs removed from a DCD donor need to be rushed to the recipients, as lack of oxygenation will swiftly trigger the start of decay. Cold perfusion of the organ (or the whole body) will extend the time in which organs remain viable. Such a procedure needs to be done as soon as the heart stops beating, at a time when it cannot be ascertained if the deceased had consented to donation and relatives are not at the scene. Section 43 of the 2004 Act allows hospitals, or other relevant authorities, to take whatever steps are immediately necessary to preserve parts of the body for transplantation. What is done must be the minimal and least invasive steps possible. It means this. A young man is brought into hospital after suffering inevitably fatal brain injuries in a road accident. His heart stops before his family can be contacted or even his identity ascertained. Doctors may lawfully use cold perfusion to preserve his organs until, either it can be shown he had consented in advance to organ donation, or his family can be contacted.⁸⁴

But could other steps (short of elective ventilation) be taken earlier, prior to the patient’s death to increase the potential that the dying patient could become an organ donor? Such steps could include delaying for short time the withdrawal of treatment, and measures such as administering drugs close to the point of death to protect the viability of the organs destined for donation.⁸⁵ The steps taken would be in the interests of the potential organ recipient and not in the clinical interests of the dying patient. Thus some doctors argue that doing anything to the patient before his death is unethical and unlawful given that patients unable to consent for themselves must be treated in their best interests. But best interests embrace more than narrow clinical considerations and for the many dying patients who wish to be organ donors, interventions to assist in the realisation of that wish once there is no hope of recovery are part and parcel of their best interests.⁸⁶ Such a view is gaining increasing official sanction.⁸⁷

The Human Tissue Act 2004

17.10 As we have reiterated, the 2004 Act adopts a principle of explicit consent for cadaver donation; Parliament expressly rejected calls to introduce a system of presumed consent for transplant purposes. Removal of organs and tissue after death for the purposes of transplantation, are governed by rules identical to those applying to removal of tissue after death for those other purposes, such as medical research or education. When the proposed donor died over the age of 18, removal of organs for transplantation will be lawful if:

(1)  the deceased himself gave appropriate consent before he died; or if he gave no consent, but nor did he veto organ donation;

(2)  consent is given by the deceased’s nominated representative – that is a person expressly nominated by the deceased to make decisions about the use of his body parts before his death; or if the deceased neither made his own decision about donation, nor did he nominate a representative;

(3)  consent is given by a close family member or friend – what is described as ‘a person who stood in a qualifying relationship with the deceased before his death’.⁸⁸

Let us take each case in turn. When the deceased has made his own decision about donation of organs after his death, the 2004 Act provides that his consent alone is sufficient to authorise the transplant team to take his organs.⁸⁹ In theory, the objections of his family carry no weight. There are two difficulties. First, the 2004 Act prescribes no formalities to govern post-mortem donations for transplant.⁹⁰ There is no requirement that directions be given in writing. So, extra-legal measures to ensure easy access to information about donors are crucial. The first-named author carried a donor card for decades. It resided in her handbag. Should she have been killed in a road accident, the handbag would not necessarily accompany her to the casualty unit where she was declared brain stem dead. A 1992 survey showed only 27 per cent of people had donor cards and only one in five carried their card with them at any time.⁹¹ The NHS Organ Donor Register (ODR) is of paramount importance. Around 21.1 million potential donors (33 per cent of the population) were registered on the ODR as of March 2015.⁹² Where no wishes are recorded, 50 per cent of families refuse donation.⁹³ The GMC encourages doctors to discuss with patients who have not made their wishes known and are close to death, the potential for tissue donation.⁹⁴ Where donation is a possibility, the first job for staff at the hospital where the potential donor dies is to check the register. When evidence of the deceased’s wishes is available, her wishes should not be subject to any family veto. The objections of a grieving widower do not in law override his wife’s authorisation. Implementing such a policy in practice will be harder. The HTA urges doctors to discuss this dilemma sensitively with the family. They should be encouraged to accept the deceased’s wishes. Their last sentence of advice on this matter is telling. ‘There may nevertheless be cases in which donation is inappropriate and each case should be assessed individually’.⁹⁵ We hope that this compassionate sentiment will not routinely be allowed to override the gift of life offered by the deceased.⁹⁶

The second means of authorising organ donation is by way of a nominated representative. The Act requires any such nomination to be in writing and witnessed. It may be asked why one should delegate such a task to someone else.⁹⁷ If a person has given the thought to donation required to make a nomination, you might expect her to express her own wishes directly. One reason for nominating a proxy may be a case where the potential donor is aware of divisions in his family about organ donation. The family might belong to a faith where more orthodox adherents rule out organ donation. The deceased may wish to ensure that authority to decide about uses of his body rest with a relative who shares his own views. The HTA stresses that in such a case it is the nominated representative whose decision is crucial and he cannot be overruled by other family members but advises that doctors should ensure that the representative and the family have discussed the question of donation.⁹⁸

In this absence of express authorisation by the deceased or a proxy chosen by him, the power to donate organs falls to the family. The Act sets out a hierarchy of relatives.⁹⁹ The 2004 Act requires the consent of a relative (or exceptionally, a friend) if no directions have been given by the deceased, or his chosen proxy. Staff seeking consent should first approach the deceased’s spouse or partner.¹⁰⁰ If he or she declines to make a decision, or the deceased had no spouse or partner those seeking consent then work their way through the following list:¹⁰¹ (1) parent or child; (2) siblings; (3) grandparent or grand-child; (4) nephews or nieces; (5) stepparents; (6) half siblings; (7) friend of longstanding. In what will often be the case, where more than one individual falls into any of these categories, the consent of one person alone will suffice to make removal of organs for transplant lawful.¹⁰² Both authors are married, so our cases would be easy; our surviving husbands would decide whether our organs could be used for transplant. Should, alas, those same husbands not survive us, the decision would fall to Margot Brazier’s adult daughter, and one of Emma Cave’s surviving parents. Authorisation from one parent alone would suffice. If there is no one standing in a qualifying relationship to the deceased organs cannot be taken for donation.¹⁰³

Section 2 of the 2004 Act addresses cadaver donations from minors. It provides that where a person under 18 has given advance consent to organ donation at a point in her life when she was sufficiently mature and intelligent to make such a decision for herself, her consent authorises cadaver transplantation. The Gillick competent minor can determine what happens to her body after her death too. In theory, her parents have no say in the matter. Establishing Gillick competence retrospectively will be hard. Overriding grieving parents will be painful. Where a child has expressed no wishes of her own, the decision falls to a person with parental responsibility¹⁰⁴ immediately prior to her death. This will normally be her parents. Again, in theory, the consent of one parent alone will be enough.

Violating the Human Tissue Act 2004

17.11 One of the principal causes of the failure of the Human Tissue Act 1961 was that no provision was made for a criminal penalty or civil redress for breach of the Act.¹⁰⁵ The 2004 Act¹⁰⁶ imposes criminal sanctions for any failure to comply with the Act’s rules requiring consent for removal of organs for transplant. Any removal of cadaver organs without appropriate consent is a criminal offence unless the person removing the organs reasonably believes that he acts on the basis of such an appropriate consent. Any false representation that such a consent has been obtained is equally a criminal offence. Both offences carry the possibility of a prison sentence of up to three years. Any prosecution requires the consent of the Director of Public Prosecutions.

Some practical problems: the coroner

17.12 The kinds of death likely to yield organs for transplant may often be the kinds of death likely to involve referral to the coroner, for example a fit healthy adult suffers massive brain injuries in a road traffic collision. Where there is reason to believe that an inquest may have to be held on a body, or a post-mortem examination may be required by the coroner, it will also be necessary to obtain the consent of the coroner to the removal of any part of the body and so risks delaying the opportunity to remove organs. This may be the case particularly where a coroner regards his duty to act as coroner as being of greater importance than the secondary power which he has to authorise the use of organs before his coroner’s duties are complete. In a controversial case in Leicester in 1980, the father of a girl who had died in a road accident had given surgeons permission to use any of her organs, including her heart, which had been removed by surgeons. At a subsequent inquest, the coroner complained that he had not given permission for the heart to be removed since permission had been sought from him only for the removal of a kidney. He therefore directed that in future written permission would have to be obtained from him and countersigned by a pathologist. This incident highlighted the problem that coroners, acting in pursuance of what they regarded as their legal duties, could adversely restrict the use of organs even where parents or other relatives had consented. It was for such reasons that the Home Secretary issued guidance to coroners, stressing that it was not part of a coroner’s function to place obstacles in the way of the development of medical science or to take moral or ethical decisions in this matter, and that the coroners should assist rather than hinder the procedure for organ removal. A coroner should refuse his consent only where there might be later criminal proceedings in which the organ might be required as evidence, or if the organ itself might be the cause or partial cause of death, or where its removal might impede further inquiries.¹⁰⁷ The HTA gives complementary advice to doctors and donor coordinators about how to proceed in case of potential organ donation that may properly involve the coroner.¹⁰⁸

Some practical problems: establishing death

17.13 In Chapter 16, we noted that heart-beating donors were not under traditional definitions of death strictly ‘dead’. The needs of transplant medicine provided part but not all of the impetus to reformulate that traditional view of death as the irreversible cessation of heartbeat and respiration. The difficulty in persuading the public that ‘brain stem death’ truly constitutes the death of a person has beset organ transplantation for decades. And, as we have seen in 2011, both Jewish and Islamic scholars and leaders voiced the judgement that within their religious laws ‘brain stem death’ could not be accepted, the person was only dead when the heart stopped beating.¹⁰⁹ Even among those who rationally accept the concept of brain stem death, fears have been voiced that doctors might have conflicting interests in that, on the one hand, their duty would be to act in the best interests of the ill or dying patient to keep him alive and yet, on the other, there might be pressures to certify a potential donor’s death at the earliest possible moment to enable organs to be removed for the benefit of potential recipients.

In 1975, the British Transplantation Society sought to allay public fears by recommending a Code of Practice for Organ Transplantation Surgery (finally agreed in 1979) to provide safeguards for those who needed reassurance about possible abuses of practice by overzealous transplant teams.¹¹⁰ Extensive guidance to ensure that adequate steps to confirm a diagnosis of brain stem death are now to be found in the Code of Practice for the Diagnosis and Confirmation of Death published by the Academy of Medical Royal Colleges.¹¹¹ The Code sets out detailed rules governing the process of diagnosing brain stem death including that before organs are removed from a body for transplant, death should be certified by two doctors, one of whom has been qualified for at least five years; neither of these doctors should be members of a transplantation team and at least one of them should be a consultant.

A market in organs

17.14 The thrust of current policy in relation to transplantation (endorsed and expanded by the ODT) is to seek to improve the systems for identifying potential cadaver donors and to use public education to encourage voluntary altruistic donations. Whether that strategy will suffice to make up the shortfall in organs needed for transplant, remains to be seen. Those who doubt its efficacy attack a tradition that has long held sway in the UK – the tradition that bodily products should be freely given and not traded.¹¹² Section 32 of the Human Tissue Act 2004 bans payments for live or cadaver organs, although allowing payment of expenses (including loss of earnings) within conditions prescribed by the HTA.¹¹³ The European Convention on Human Rights and Biomedicine states forcefully: ‘The human body and Its parts shall not, as such, give rise to financial gain’.¹¹⁴

And yet organs are frequently shipped across borders.¹¹⁵ And paid donation abroad is not uncommon.¹¹⁶ In support of maintaining a prohibition of a market in organs are a cluster of arguments. They centre on four questions. (1) Would financial incentives to sell your own, or your deceased relative’s organs, risk endangering the safety of organ transplants? In their anxiety to obtain payment might people conceal medical conditions which could endanger the recipient?¹¹⁷ (2) Is there a risk that financial pressure on potential vendors is such that they would give a less than voluntary and informed consent. There is evidence from the developing world that economic duress operates to pressure the poor into selling organs to the rich. (3) Is it intrinsically wrong that, even if properly informed, poorer people should ‘have’ to ‘earn’ part of their living by selling off body parts? (4) In sum, do markets degrade?¹¹⁸

Those proposing markets do so cautiously. They stress the vulnerability of the person needing the transplant. Her life is at risk. Harris and Erin argue that a regulated market,¹¹⁹ where the NHS is the only permitted ‘purchaser’, would ensure: (1) the quality of organs ‘sold’; and (2) rigorously monitor the consent process. Provision would be made to ensure that the vendor was adequately informed and acted freely. Fears of exploitation could be met in a regulated market. As to the distastefulness of the poor becoming organ banks, it is contended that worldwide the rich have benefits denied the poor. Mason and Laurie¹²⁰ question whether commercialism and altruism are irreconcilable values. They ask why one poor and needy person is allowed to risk his brain in the boxing ring, when another is barred from selling his kidney. They remind us that illegal markets across the world already exploit the poor. Janet Radcliffe Richards,¹²¹ leading the advocates for markets, sums up the debate:

The weakness of the familiar arguments suggests that they are attempts to justify the deep feelings of repugnance which are the real driving force of the prohibition, and feelings of repugnance among the rich and healthy, no matter how strongly felt cannot justify removing the only hope of the destitute and dying. This is why we conclude that the issue should be considered again, with scrupulous impartiality.

For the most part, advocates for markets focus on living vendors. But why not allow payments for cadaver organs? The risk of harming the donor’s health is nil. ‘Donors’ might see the promise of an organ for payment as an alternative, or a supplement, to life insurance. Relatives auctioning off grandma’s kidneys might be distasteful, unless your child was dying for want of a kidney. Mason and Laurie¹²² find ‘payment for organs of the dead far less easy to justify than payment to a living donor’. But they somewhat reluctantly suggest that this may come to pass. The justification for banning payments needs more careful thought. Exploitation arguments are less compelling and the ‘safety’ arguments advanced by Titmuss¹²³ have proved fallible in the context of blood donation.¹²⁴

Other inducements¹²⁵

17.15 In debating the ethics of payments for organs, other forms of inducement to donate need to be considered. Is there an issue about any form of inducement or incentive to donate or is it simply money that is seen as ‘evil’? In permitting ‘paired’ and ‘pooled’ donations, inducements are sanctioned. The potential ‘reward’ of a kidney for your husband or child may be a much more powerful inducement than money. What of the promise of priority for registered donors or families who have agreed to donation should they later require an organ? Such a scheme is now embodied in Israeli law. Registered donors of at least three years’ standing are granted priority should they themselves need an organ transplant. A similar priority is given to close relatives of registered and deceased donors.¹²⁶ Then, if non-monetary inducements are considered acceptable, we return to the issues of cash payments and must consider whether a moderate financial ‘reward’ short of a sale might be considered. In many countries the state will at least meet the funeral expenses of the deceased donor.¹²⁷

Conditional donations

17.16 Conditional donation, whereby families seek to direct to whom a cadaver organ might go or to place some restrictions on who may benefit from a cadaver donation, was initially banned when a family sought to restrict the use of a relative’s organs to white recipients only. Such an attempt to restrict donation to persons of one’s own racial group, or religious persuasion, appears fairly odious at first sight, and after an investigation the Department of Health ruled out acceptance of conditional donations.¹²⁸ But should any form of conditional directed donation be banned? We allow living donors to direct to whom their gift should be donated. Consider this example. A young man dies in a road accident. His twin sister has end-stage renal failure. His parents are prepared to donate all his organs if one of his kidneys is made available to his sister. In 2008, something not dissimilar occurred. A young woman, Laura Ashworth, died suddenly after an acute asthma attack. Before her death she has discussed donating a kidney to her mother but had not taken any formal steps to become a living donor. The family asked that one of her kidneys be given to Laura’s mother but that wish was overruled and both kidneys went to strangers. The Department of Health¹²⁹ has now diluted the ban on conditional donations to allow account to be taken of wishes to donate to a person related to the deceased ‘genetically socially or by way of friendship’ who is in urgent need of a transplant.

Xenotransplantation

17.17 A once much vaunted development in the field of organ transplantation involves the use of non-human animals. Non-human animal to human transplant attempts are not new. Early efforts resulted in disastrous rejection episodes. Scientists responded by seeking to develop procedures to modify the genetic make-up of pigs to provide tailor-made organs suitable to transplant into humans. The technical progress with xenotransplantation has been slow.

The range of problems associated with it is vast.¹³⁰ Is it right to use non-human animals in this way?¹³¹ What about infection risks? How would the first human volunteers be recruited?¹³² The UK government initially responded cautiously, setting up an interim regulatory body, the United Kingdom Xenotransplantation Interim Regulation Authority (UKXIRA).¹³³ For those that are satisfied that breeding animals for transplant is ethical, the major problem becomes the risk to humans. Zoonoses are diseases that cross the species barrier, as it would appear swine flu has done. Genetically engineered pigs may carry viruses harmless to pigs, but lethal to humans. In the light of this risk, it is argued xenograft recipients would have to consent to lifelong monitoring, sterilisation and abstention from unprotected sexual intercourse. How would such draconian rules be policed? Should recipients be allowed to create risks for us all?¹³⁴ Yet in 2006 the government announced its decision to abolish UKXIRA, and the Medical and Healthcare Products Regulatory Authority (MHRA) and research ethics committees are now charged with making any necessary decisions about clinical trials of xenografts in humans.¹³⁵

Liability for mishaps¹³⁶

17.18 A number of questions about potential liability arise if organ transplantation goes awry. In February 2011 a living donor whose life was wrecked when the operation to remove his kidney was botched was awarded £6.75 million in damages. Massive blood loss destroyed his remaining kidney and the donor had himself to receive a kidney from his sister.¹³⁷A failed transplant will not of itself give rise to any legal claim by the recipient. The renal surgeon does not guarantee success any more than any other medical practitioner. But what if, for example, donated blood or kidneys prove to be infected, perhaps with HIV? Might the donor, or the transplant team, be liable in tort? It would seem unchallengeable that donors owe a duty of care to recipients which is breached by a donor knowingly donating organs or tissue when he is aware that he is infected by, say, hepatitis or HIV.¹³⁸ The recipient’s problem may be tracing the donor. Public policy grounds for protecting the anonymity of donors may be found to outweigh the recipient’s individual right of action.¹³⁹

Realistically, any claim in respect of contaminated body products will be brought against the hospital supplying those products. The Pearson Commission recommended that strict liability should be imposed on authorities responsible for the supply of human blood and organs. It is now clear that the Consumer Protection Act 1987, imposing strict liability for defective products, includes human tissue in its definition of a product.¹⁴⁰

Fetal tissue and neonatal transplants

17.19 The potential for the use of fetal tissue for transplantation initially aroused much ethical debate. Fetal brain cells can be taken from aborted fetuses and transplanted into the brains of patients with Parkinson’s disease, and perhaps other neurodegenerative conditions in the hope of improving the recipient’s condition. Currently, further trials of such fetal transplants are on hold and many doctors see stem cell therapies as a much better potential line of treatment.¹⁴¹ Fetal tissue is governed by the Human Tissue Act, and the HTA¹⁴² has issued guidance that makes it clear that fetal tissue is to be treated as the mother’s tissue and that, as with any other human tissue, her informed consent is needed for any use of issue that she elects to donate and she must be told of the proposed purposes to which the tissue will be put.

A rather different question arises in relation to anencephalic neonates. Could a baby born without a brain be used as a donor of organs for a baby born with a defective heart? As we have seen, the usual criteria for brain stem death are not applicable to newborn babies¹⁴³ Nonetheless the removal of organs for donation (with parental consent) was endorsed in a report from the medical Royal Colleges in 1998 when ‘two doctors, who are not members of the transplant team, agree that spontaneous respiration has ceased’.¹⁴⁴

Transplantation: the future

17.20 Developments in transplant medicine create the potential for transplant of an ever-greater range of organs and tissue. Face transplants have excited popular attention, but it is doubtful that they pose any new ethical or legal questions.¹⁴⁵ Womb transplants may create more dilemmas.¹⁴⁶ Four women have successfully given birth in Sweden after receiving a donated womb from a living donor.¹⁴⁷ In England a woman-to-woman transplant might face regulatory hurdles. If the womb is donated by a living donor, then, as with other organs, the donation would have to be approved by the HTA. To become pregnant, the recipient would then need to undergo IVF at a licensed clinic where questions might be raised about the welfare of the child. But no insuperable problems seem to confront woman-to-woman transplants, save for resource issues. The ethical problems lie in what else such a development might make possible. If it is possible to transplant a womb into a woman born without one, then it may also become possible to transplant a womb into a male-to-female transsexual, and unlawful under the Gender Recognition Act 2004 to refuse on grounds that relate to the person’s status as a woman. Finally, if a womb can be transplanted into a male-to-female transsexual, it may become possible to transplant a womb into a man. Male pregnancy, once the stuff of tawdry drama and cheap jokes, may become reality. One legal problem stands in the way of the pregnant man. He would need IVF to create embryos for implantation into his donated womb. At present the Human Fertilisation and Embryology Act only allows licensed clinics to provide treatment services ‘for the purposes of assisting women to carry children’.

Advances in transplantation, gene therapy, stem cell research and medical devices together bring new potential to replace or repair damaged organs, tissues and cells. The emerging field of ‘regenerative medicine’¹⁴⁸ has potential to exactly match tissue and to create potentially inexhaustible supply. The ethical and regulatory issues,¹⁴⁹ particularly those surrounding patents, have yet to be resolved, but in an increasingly ageing population regenerative medicine – focusing on repair rather than cure – is set to have an ever-increasing role.

¹  For a masterly analysis of legal and ethical issues relating to all uses of human tissue, see D Price, Human Tissue in Transplantation and Research (2010) Cambridge University Press. And for a range of proposals addressing strategies to increase the supply of donor organs, see A-M Farrell, D Price, M Quigley (eds) Organ Shortage: Ethics Law and Pragmatism (2011) Cambridge University Press.

²  The Act came into force in December 2015. See 17.8.

³  See 18.2. As Mason and Laurie rightly say ‘the 2004 Act was born under the wrong star’. JK Mason, GT Laurie, Mason and McCall Smith’s Law and Medical Ethics (9th edn, 2013) Oxford University Press, 17.36.

⁴  For an overview of the Act, see D Price, ‘The Human Tissue Act 2004’ (2005) 68 Modern Law Review 798; M Brazier, S Fovargue, ‘A Brief Guide to the Human Tissue Act 2004’ (2006) 1 Clinical Ethics 26.

⁵  See the analysis in B New, M Solomon, R Dingwall, J McHale, A Question of Give and Take? Improving the Supply of Donor Organs for Transplantation (King’s Fund Institute, 1994). But note that far more people are considered eligible to receive a transplant than used to be the case.

⁶  NHSBT, Taking Organ Transplantation to 2020, A Detailed Strategy (2013), 9: ‘[T] he number of people donating their organs after death increased by 50% between 2007/08 and 2012/13 … Consequently in 2012/13, transplant rates had increased by 30.5% and more people in the UK received an organ transplant than ever before’.

⁷  NHS Blood and Transplant, Organ Donation and Transplantation – Activity Figures for the UK as at 10 April 2015 (2015) p 2.

⁸  Ibid, Foreword.

⁹  See Price, Human Tissue in Transplantation and Research (2010), p 15.

¹⁰  See A Cronin, ‘Making the Margins Mainstream: Strategies to Maximise the Donor Pool’ in Farrell et al, Organ Shortage, p 104.

¹¹  Organs for Transplant: A Report from the Organ Donation Taskforce (2008), hereafter ODT Report 1.

¹²  The Potential Impact of an Opt Out System for Organ Donation in the UK: An Independent Report from the Organ Donation Taskforce (2008) (hereafter ODT Report 2).

¹³  See Price, Human Tissue in Transplantation and Research, pp 7–8.

¹⁴  See, for example, Cabinet Office, Organ Donor Registrations: Trialling Different Approaches (December 2014).

¹⁵  BBC News, ‘Patients Given Kidneys Rejected “Unfit” by Other Hospitals’ (2014) 18 November.

¹⁶  Section 53 of the Act adopts the term ‘relevant material’ and defines such material as ‘material other than gametes, which consists of or includes human cells’. Embryos outside the human body, hair and nail clippings are expressly excluded from the Act. This very broad definition covers more than organs, such as kidneys, and tissue, such as bone marrow, but does not mean that every section of the Act applies to every speck of ‘human material’; see Price, ‘The Human Tissue Act 2004’ (2005), p 800.

¹⁷  The Act also repeals the Human Tissue Act (Northern Ireland) 1962; the Corneal Tissue Act 1986 and the Anatomy Act 1984.

¹⁸  See Sch 1 Part 1(7).

¹⁹  See ss 13–15 and Sch 2. Note that although different legislation (the Human Tissue (Scotland) Act) applies in Scotland and will also do so in Wales from December 2015, the HTA performs various roles in Scotland and Wales.

²⁰  Already regulated by the Human Fertilisation and Embryology Authority; see 12.2.

²¹  See the Human Tissue (Quality and Safety for Human Application) Regulations 2007, SI 2007/1253 (amended SI 2014/2883).

²²  See the Quality and Safety of Organs Intended for Transplantation Regulations 2012, SI 2012/1501 (amended SI 2014/1459) laying down information procedures for the exchange, between Member States, of human organs intended for transplantation.

²³  HTA, press release (2006) April 26.

²⁴  As a domino transplant involves treatment of both patients, such procedures are not as such regulated by the HTA, but the HTA nonetheless gives guidance on good practice; see Human Tissue Authority, Code of Practice: Donation of Solid Organs for Transplantation, Code 2 (2014), paras 19 and 30.

²⁵  See NHSBT, Transplant Activity in the UK 2014/15 (2015), p 7.

²⁶  See ODT Report 1, para 1.7.

²⁷  See NHSBT, Transplant Activity in the UK 2014/15 (2015), p 7.

²⁸  See ODT Report 1, para 1.7.

²⁹  See RM Titmuss, The Gift Relationship: From Human Blood to Social Policy (1971) Allen & Unwin.

³⁰  This Act was rushed through Parliament as a hasty response to a scandal involving the sale of human kidneys by four impoverished Turkish citizens in circumstances where it seemed highly likely that the ‘vendors’ were cruelly exploited.

³¹  See R v Brown [1993] 2 All ER 75, HL.

³²  Law Commission Consultation Paper No 139 Consent in the Criminal Law (1995) HMSO, para 8.32.

³³  For ethical analysis, see G den Hartough, ‘Is Consent of the Donor Enough to Justify the Removal of Living Organs? (2013) 22(1) Cambridge Quarterly of Healthcare Ethics 45.

³⁴  In one American case a court, not surprisingly, refused to order the only possible donor to submit to a bone marrow transplant; McFall v Shimp (1978) 10 Pa D & C 3d.

³⁵  See Human Tissue Authority, Donation of Solid Organs for Transplantation Code 2 (2014); and Code of Practice: Consent Code 1 (2014). The Codes of Practice were amended in 2014 and await final parliamentary approval likely to be forthcoming in 2016.

³⁶  Human Tissue Act 2004 (Persons Who Lack Capacity to Consent and Transplants) Regulations 2006, SI 2006/1659.

³⁷  HTA, Code of Practice, Code 2.

³⁸  See HTA Code of Practice, Code 6 Donation of Allogeneic Bone Marrow and Peripheral Blood Stem Cells for Transplantation (2014).

³⁹  Code 2, paras 29–30.

⁴⁰  The IA must seek evidence to prove the relevant relationship.

⁴¹  And note domino transplants; see Code 2, paras 19 and 30.

⁴²  See SI 2006/1659, reg 1.12, and HTA Code of Practice, Code 2, p 36.

⁴³  As must all adult-to-adult liver donations and economic dependence cases.

⁴⁴  See D Price, A Garwood-Gowers, ‘Transplantation from Minors: Are Children Other People’s Medicine?’ (1995) 1 Contemporary Issues in Law 1. And see 16.4 for discussion of organ donation in anencephalic infants and see BBC News, ‘Newborn Baby Teddy Was UK’s Youngest Ever Organ Donor’ (2015) 23 April.

⁴⁵  WJ Curran, ‘A Problem of Consent: Kidney Transplantation in Minors’ (1959) 34 New York University Law Review 891.

⁴⁶  See now HTA, Code of Practice 6, Donation of Allogeneic Bone Marrow and Peripheral Blood Stem Cells for Transplantation (2014). We do not address this Code in detail but note that the level of scrutiny of bone marrow donations by young children has been increased.

⁴⁷  Human Tissue Act 2004, s 2(3).

⁴⁸  Where parents are married or register the birth of the child together they automatically share parental responsibility. In other cases, the unmarried father will need either to seek an order granting him such parental responsibility or enter into a formal agreement with the mother.

⁴⁹  See 14.14.

⁵⁰  SI 2006/1659, reg 12(2)(a).

⁵¹  See HTA, Code of Practice, Code 2, paras 69–70 and Appendix A, A8–13.

⁵²  HTA, Code of Practice, Code 2, para 49.

⁵³  Prior to the Human Tissue Act 2004, it was doubtful whether any minor was legally competent to consent to organ donation. See Re W (A Minor) (Medical Treatment) [1992] 4 A11 ER 627, at 635 and 647.

⁵⁴  For regulation of bone marrow donations, see HTA, Code of Practice, Code 6.

⁵⁵  (1969) 35 ALR (3d) 683.

⁵⁶  See Re Peslinski 226 NW 2d 180 at 181 (Wisconsin); Re Richardson (1973) 284 So 2d 185.

⁵⁷  Re Y (Mental Incapacity: Bone Marrow Transplant) [1997] Fam 110.

⁵⁸  See SI 2006/1659 and HTA, Code of Practice, Code 2, paras 32, 40, 52–59.

⁵⁹  HTA, Code of Practice, Code 2, para 52 and see the Mental Capacity Act Code of Practice (updated 2014), para 8.18.

⁶⁰  See 18.5.

⁶¹  In R v Lennox-Wright [1973] Crim LR 529. An unqualified person removed eyes from a cadaver for further use in another hospital. He was successfully prosecuted for contravening Human Tissue Act 1961, s 1(4) which prohibited removal save ‘by a fully registered medical practitioner’.

⁶²  J Harris, ‘The Survival Lottery’ (1975) 50 Philosophy 81.

⁶³  J Harris, ‘Law and Regulation of Retained Organs: The Ethical Issues’ (2002) 22 Legal Studies 527.

⁶⁴  For a full discussion of the issue, see Price, Human Tissue and Transplantation and Research, ch 5. And see ODT Report 2.

⁶⁵  (Application no 4605/05) (2014).

⁶⁶  Austria has a system of ‘hard’ presumed consent: See E Jackson, Medical Law: Text, Cases and Materials (3rd edn, 2013) Oxford University Press, p 594. The positive effects on the transplant waiting lists have been dramatic.

⁶⁷  See I Kennedy et al, ‘The Case for “Presumed Consent” in Organ Donation’ (1998) 351 The Lancet 1650.

⁶⁸  A Abadie, S Guy, ‘The Impact of Presumed Consent Legislation on Cadaveric Organ Donation: A Cross Country Study’ (2006) 25 Journal of Health Economics 599.

⁶⁹  M Quigley, M Brazier, R Chadwick et al, ‘The Organs Crisis and the Spanish Model: Theoretical Versus Practical Consideration’ (2008) 34 Journal of Medical Ethics 223.

⁷⁰  Which amends the Human Tissue Act 2004 so that some parts no longer apply in Wales. See the Human Transplantation (Wales) Act 2013 (Consequential Provision) Order 2015, SI 2015/865.

⁷¹  The Act applies to those over 18 who has lived in Wales for the past twelve months and who have had capacity sufficient to enable them to opt out. See Human Transplantation (Wales) Act 2013, s 5(3).

⁷²  Human Transplantation (Wales) Act 2013, s 4(4)(b).

⁷³  I Kennedy, A Grubb, Medical Law (3rd edn, 2000) Butterworths, pp 1048–1057.

⁷⁴  New et al, A Question of Give and Take?, pp 60–63.

⁷⁵  GMC, Treatment and Care towards the End of Life: Good Practice in Decision Making (2010), paras 54–55 and 81.

⁷⁶  Although the NHSBT reported a 12 per cent rise in such donors in 2013/14: see Transplant Activity in the UK 2013/14 (2014).

⁷⁷  NHS Blood and Transplant, Organ Donation and Transplantation – Activity Figures for the UK as at 10 April 2015 (2015) p 5.

⁷⁸  See JV McHale, ‘Elective Ventilation – Pragmatic Solution or Ethical Minefield?’ (1995) 11 Professional Negligence 23.

⁷⁹  See 6.10.

⁸⁰  See J Coggon, ‘Elective Ventilation for Organ Donation: Law, Policy and Public Ethics’ (2013) 39 Journal of Medical Ethics 130.

⁸¹  D Price, ‘End of Life Treatment of Potential Organ Donors: Paradigm Shifts in Intensive and Emergency Care (2011) 19(1) Medical Law Review 86.

⁸²  For discussion of the ethical issues raised, see D Price, J Samanta, ‘Supporting Controlled Non-Heart-Beating Donation – An Ethical Justification’ (2013) 22(1) Cambridge Quarterly of Healthcare Ethics 22.

⁸³  See 16.2. And see NHSBT, Organ Donation and Religious Beliefs (2012).

⁸⁴  HTA, Code of Practice, Code 2, paras 125–134.

⁸⁵  Fully discussed in Price, ‘End of Life Treatment of Potential Organ Donors’.

⁸⁶  See J Coggon, M Brazier, P Murphy, D Price, M Quigley, ‘Best Interests and Potential Organ Donors’ (2008) 336 BMJ 1346.

⁸⁷  DH, Legal Issues Relevant to Non-Heartbeating Organ Donation (2009); ODT Report 1, paras 4.13–4.15; Price, ‘End of Life Treatment of Potential Organ Donors’.

⁸⁸  Section 3(6).

⁸⁹  And equally his veto will prohibit any removal of organs for transplant.

⁹⁰  Unlike donation for anatomical examination or public display, see 18.6.

⁹¹  New et al, A Question of Give and Take?

⁹²  NHS Blood and Transplant, Organ Donation and Transplantation – Activity Figures for the UK as at 10 April 2015 (2015).

⁹³  NHSBT, Taking Organ Transplantation to 2020: A Detailed Strategy (2013), 10.

⁹⁴  GMC, Good Medical Practice (2013), paras 81–82.

⁹⁵  HTA, Code of Practice, Code 2, para 102.

⁹⁶  NHS Blood and Transplant, Taking Organ Transplantation to 2020: A Detailed Strategy (2013) p 10: ‘Just over 30% of the population – nearly 20 million people – have recorded their consent for organ donation on the NHS Organ Donor Register (ODR) and although most families will support their relative’s wish, in 2012/13 115 families overruled their relative’s consent’.

⁹⁷  Section 4.

⁹⁸  HTA, Code of Practice, Code 2, para 109.

⁹⁹  Section 27(4).

¹⁰⁰  ‘[A] person is another’s partner if the two of them (whether of different sexes or the same sex) live as partners in an enduring family relationship’ (s 54(8)).

¹⁰¹  See s 27(8).

¹⁰²  See s 27(6).

¹⁰³  CM v The Executor of the Estate of EJ (deceased) [2013] EWHC 1680 (Fam). See 18.6.

¹⁰⁴  Or if there is no such person, if for example, parents and child died together in a road traffic collision, consent must be sought from the nearest qualifying relative, usually a grandparent.

¹⁰⁵  See PDG Skegg, ‘Liability for the Unauthorised Removal of Cadavers Transplantation Material’ (1974) 14 Medicine, Science and the Law 153.

¹⁰⁶  See s 5.

¹⁰⁷  HC (65) 1977. And more recently, see DH, Organ & Tissue Donation: An Aide Memoire for Coroners (2010).

¹⁰⁸  HTA, Code of Practice, Code 2, paras 135–136 and Appendix B.

¹⁰⁹  See 16.2.

¹¹⁰  For an argument that it should be permissible to remove organs before brain stem death is established, see J Savelescu, ‘Death, Us and Our Bodies: Personal Reflections’ (2003) 29 Journal of Medical Ethics 127.

¹¹¹  Academy of Medical Royal Colleges, Code of Practice for the Diagnosis and Confirmation of Death (2008), discussed at 16.2.

¹¹²  Radcliffe-Richards et al, ‘The Case for Allowing Kidney Sales’ (1998) 351 The Lancet 1950.

¹¹³  See HTA, Code of Practice, Code 2, paras 44–48.

¹¹⁴  Article 21.

¹¹⁵  See 2012 EU Directive 2012/25/EU to facilitate EU cross-border exchange of information about organs and their donors.

¹¹⁶  On the legal and ethical issues of paid donations abroad (that would be prohibited in the UK under the Human Tissue Act 2004), see J McHale, ‘Organ Transplantation, the Criminal Law, and the Health Tourist: A Case for Extraterritorial Jurisdiction? (2013) 22(1) Cambridge Quarterly of Healthcare Ethics 64. For an international perspective, see I Cohen, ‘Transplant Tourism: The Ethics and Regulation of International Markets for Organs’ 41(1) (2013) Journal of Law, Medicine and Ethics 269.

¹¹⁷  At the heart of Titmuss’s argument in The Gift Relationship.

¹¹⁸  See M Radin, ‘Market – Inalienability’ (1987) 100 Harvard Law Review 1849; N Duxbury, ‘Do Markets Degrade?’ [1996] 59 Modern Law Review 331.

¹¹⁹  See C Erin, J Harris, ‘An Ethical Market in Human Organs’ (2003) 29 Journal of Medical Ethics 137.

¹²⁰  Mason, Laurie, Mason and McCall Smith’s Law and Medical Ethics, 17.26–17.33.

¹²¹  Radcliffe-Richards et al, ‘The Case for Allowing Kidney Sales’.

¹²²  Mason, Laurie, Mason and McCall Smith’s Law and Medical Ethics, 17.62–17.68.

¹²³  Titmuss, The Gift Relationship and Social Policy.

¹²⁴  See A-M Farrell, ‘Is the Gift Still Good? Examining the Politics and Regulation of Blood Safety in the European Union’ (2006) 14 Medical Law Review 155.

¹²⁵  See M Brazier, J Harris, ‘Does Ethical Controversy Cost Lives?’ in Farrell et al, Organ Shortage, pp 15–34.

¹²⁶  See J Lavee, T Asheknazi, D Steinberg, ‘A New Law for the Allocation of Donor Organs in Israel’ (2010) 375 The Lancet 1131–1133; M Quigley, ‘Incentivising Organ Donation’ in Farrell et al, Organ Shortage, pp 89–103.

¹²⁷  See ‘Patients May be Asked about Organ Donation on Hospital Admission, Guardian (2012) 12 October, recounting possible incentives such as payment of funeral expenses.

¹²⁸  See DH, An Investigation into Conditional Organ Donation (2000).

¹²⁹  DH, Requested Allocation of a Deceased Donor Organ (2010).

¹³⁰  See M Fox, J McHale, ‘Xenotransplantation: The Ethical and Legal Ramifications’ (1998) 6 Medical Law Review 42; Nuffield Council on Bioethics, Animal to Human Transplants (1996); S Fovargue, Xenotransplantation and Risk: Regulating a Developing Biotechnology (2011) Cambridge University Press.

¹³¹  See W Cartwright, ‘The Pig, the Transplant Surgeon and the Nuffield Council’ (1996) 4 Medical Law Review 250.

¹³²  See S Fovargue, ‘Oh Pick Me, Pick Me – Selecting Participants for Xenotransplant Clinical Trials’ (2007) 15 Medical Law Review 176.

¹³³  See HSC 1998/126.

¹³⁴  See S Fovargue, ‘Consenting to Bio-Risk: Xenotransplantation and the Law’ (2005) 25 Legal Studies 405.

¹³⁵  See L Williamson, M Fox, S Mclean, ‘The Regulation of Xenotransplantation after UKXIRA: Legal and Ethical Issues’ (2007) 34 Journal of Law and Society 441. And for scientific developments and guidance, see WHO, Report of the Second WHO Global Consultation on Regulatory Requirements for Xenotransplantation Clinical Trials (2011).

¹³⁶  In Urbanski v Patel (1978) 84 DLR (3d) 850, the donor claimed that the defendant’s negligence in removing his daughter’s only kidney caused injury (the loss of his kidney) to him.

¹³⁷  (2011) The Times, 15 February, p16.

¹³⁸  And might be criminally liable for causing grievous bodily harm? See R v Dica [2004] 3 A11 ER 593, CA.

¹³⁹  A Scottish court so found in relation to a claim against a blood donor; see AB v Scottish Blood Transfusion Service [1990] SL 203.

¹⁴⁰  See A v The National Blood Authority [2001] Lloyds Med Rep 187 discussed at 10.7. And see also 10.9 discussing vCJD Contaminated Blood Products.

¹⁴¹  See Mason, Laurie, Mason and McCall Smith’s Law and Medical Ethics, 17.79.

¹⁴²  HTA, Code of Practice: Consent, Code 1, paras 171–175. Pre-Human Tissue Act, the matter was governed by the Polkinghorne Code of Practice: see Review of the Guidance on the Research Use of Fetuses and Fetal Material Cm 762 (1989) HMSO.

¹⁴³  See Academy of Medical Royal Colleges, Code of Practice for the Diagnosis and Confirmation of Death, Appendix 4.

¹⁴⁴  Report of the Working Party of the Conference of Medical Royal Colleges and their Faculties in the United Kingdom on Organ Transplantation in Neonates (1988) discussed in Mason, Laurie, Mason and McCall Smith’s Law and Medical Ethics, 17.74.

¹⁴⁵  See RS Hartman, ‘Face Values: Challenges of Transplant Technology’ (2005) 31 American Journal of Law and Medicine 7. Though see BBC News, ‘Face Transplant Patient Meets Donor’s Sister’ (2015) 29 May.

¹⁴⁶  J Foley, ‘Uterine Transplantation: A Step too Far?’ (2012) 7 Clinical Ethics 153.

¹⁴⁷  See Daily Telegraph (2014) 26 January. In the first case the donor was the woman’s mother.

¹⁴⁸  Medical Research Council, A Strategy for UK Regenerative Medicine (2012).

¹⁴⁹  See S Devaney, Stem Cell Research and the Collaborative Regulation of Innovation (2014) Routledge.

Chapter 18

THE HUMAN BODY AND ITS PARTS

¹

18.1 We take our bodies for granted most of the time. The purpose of our organs and tissue is to sustain us, the people who live in those bodies. We refer without reflection to ‘our’ hands, ‘our’ hearts. Whether that language of ownership is reflected in the law may be doubted, although the decision of the Court of Appeal in Yearworth v North Bristol NHS Trust² issued in a new era in debates about owning at least some parts of ‘ourselves’. What is beyond doubt is that our human body parts have value to others.³ ‘My’ kidney may save ‘your’ life. That kidney could become ‘yours’ while I remain alive. ‘My’ heart could also save your ‘life’, but only when my ‘life’ has ended. The development of transplantation highlighted the usefulness of human body parts, taken from both the living and the dead. However, doctors and scientists have been learning from the bodies, and body parts, of the dead for centuries. Medicine has developed from the knowledge gathered from the dissection of corpses. Dissection, however good its ends, has a murky history.⁴ Bodies were stolen in the seventeenth and eighteenth centuries. The Anatomy Act 1832 conscripted the bodies of the poor to help to train medical students in anatomy and provide material for early medical research. In the twentieth century, the public knew little about practices whereby doctors retained organs and tissue for both research and education. Post-mortem examinations were rarely discussed. Only when the controversy surrounding organ retention erupted at the end of that century was public attention drawn to the uses of bodies and their parts. That controversy obscured the fact that donation of tissue for research and education, and donation of bodies to train doctors has an even greater role in saving lives and preserving health than the better known practice of organ transplantation.

In this chapter, we examine how (outwith the context of transplantation) English law regulates the removal, retention and uses of human body parts and we consider briefly how far (if at all) we own our own bodies. We examine the relevant provisions of the Human Tissue Act 2004 and the role of the Human Tissue Authority (HTA). In addition we address some aspects of the role of the coroner; a key actor in the regulation of the use of bodies and body parts post-mortem. The Coroners and Justice Act 2009 was enacted to reform both the substantive law on the investigation of deaths in England and Wales and to reform the operation of the coroners’ service, a central part of the latter being the creation of the office of Chief Coroner.⁵ We noted in the previous chapter that Scotland enacted its own legislation in relation to the removal and uses of human tissue from the dead in the form of the Human Tissue (Scotland) Act 2006. It must also be noted that the system for investigation of deaths in Scotland is wholly different to the coronial system applying south of the border.⁶ While Wales has enacted separate legislation (the Human Transplantation (Wales) Act 2013)⁷ to introduce an opt-out system for cadaver organ transplants, the Human Tissue Act 2004 continues to regulate other matters relating to organ retention and use in Wales and the law relating to the role of the coroner is the same in both England and Wales.

Removal of body parts from the dead

18.2 It was organ retention from the bodies of the dead that resulted in the enactment of the Human Tissue Act 2004. For this reason we reverse the natural order, and consider first the questions relating to the use of corpses before addressing retention of organs and tissue from the living. In the course of the inquiry⁸ established in 1998 to investigate the paediatric cardiac service at Bristol Royal Infirmary, evidence emerged of a widespread practice of organ and tissue retention. Over a long period of time, organs and tissue had been taken at, or after, post-mortem examinations from children’s bodies and used ‘for a variety of purposes, including audit, medical education and research, or had simply been stored’. The Bristol Inquiry Team, led by Professor Ian Kennedy issued an Interim Report Removal and Retention of Human Material,⁹ in May 2000. The report noted that this had become an ‘issue of great and grave concern’ generating an outcry not confined to the Bristol parents. One of the witnesses to the Bristol Inquiry, Professor R H Anderson, in explaining the benefits of retaining hearts for educational purposes, noted the existence of many collections of children’s hearts elsewhere. The largest collection, he commented, was at the Royal Liverpool Children’s Hospital (Alder Hey). His evidence prompted the Department of Health to set up an Independent Confidential Inquiry under section 2 of the National Health Service Act 1977 chaired by Michael Redfern QC. The inquiry was instructed to investigate the removal and disposal of human organs and tissue following post-mortem examinations at Alder Hey.

The Redfern Report¹⁰ published in January 2001 proved to be political dynamite. It revealed longstanding practices of removing and retaining children’s organs without the consent or even knowledge of their grieving parents. In some cases, infants were literally stripped of all their organs and what was returned to their families was an ‘empty shell’. In a horrifying number of cases, organs and tissue retained were simply stored. They were put to no good use. In some instances, the whole of a fetus or stillborn infant was kept and stored in pots. The report addressed not only the retention of organs without consent, but also the subsequent mishandling of organ return and a range of other appalling practices and mismanagement. In this chapter, we focus on the legal issues arising out of organ retention.

Simultaneously with the publication of the Redfern Report, the Chief Medical Officer published a census carried out to ascertain the extent of organ retention since 1970 across the NHS in England and Wales.¹¹ What became apparent was that practices whereby pathologists simply took and retained human material after post-mortem examination were routine. The extent to which the deceased’s family was involved at all in such decisions varied radically. Adequate and free consent was rarely obtained, or even thought necessary. Nor was this a practice limited to children. Many families were to learn about organs stripped from adult relatives.¹²

The value of taking and retaining organs after post-mortem examination in certain cases should not be doubted. Ascertaining the cause of death is self-evidently important. And often, especially with infants, tests on organs and tissue may have crucial value to the child’s family. Investigations which reveal genetic disease may be the key to helping that family have further healthy children. In the wider public interest, medical research is dependent on access to human organs and tissue. Medical education requires such material. One simple example illustrates the educational use of human organs. If a child dies tragically and is found to have a grossly abnormal heart, retaining that heart so that paediatric surgeons can examine it before attempting to operate on and save the life of a child with a similar abnormality makes sense. It can only be ethical to do so with the family’s consent. For the devout Jew or Muslim, it is a religious imperative to bury the body intact. For other families, the pain of not laying their relative to rest complete is overwhelming. However, for many families involved in the organ retention controversy, what motivated their anger was the loss of control over their relative’s burial or cremation. Many relatives said publicly that had they been consulted they would have agreed to doctors retaining the organs of the dead child or other relatives. They would have been content to ‘gift’ some parts of the body to achieve good ends, ends fully explained to them. What they abominated was the lack of respect shown to them and their relative. They felt that someone whom they loved dearly had been treated as a mere convenience, treated with contempt.¹³

Post-mortem examinations¹⁴

18.3 Before looking at the law relating to retention of dead bodies, organs and tissue, we need to say a little about post-mortem examinations, sometimes referred to as autopsies. A post-mortem examination is conducted by a pathologist to investigate (inter alia) the cause of a death, and to understand more fully the nature of the patient’s disease, including an evaluation of any medical or surgical treatment given to him. Such examinations are a key tool of modern scientific medicine. One distinguished doctor and philosopher has said: ‘Of all the clinical disciplines, pathology is the one that most directly reflects the demystification of the human body that has made scientific medicine so effective and so humane’.¹⁵ To the lay person, what is done to the body in a full post-mortem examination may seem grisly. The body is opened and organs removed, weighed and sometimes dissected. In some cases, organs must be retained for a period of time to be treated before they can be fully examined, or organs and tissue may be sent away for tests elsewhere. Cultural issues cannot be ignored in deciding how to regulate the use of the bodies of the dead.¹⁶ Some religious faiths, including Orthodox Judaism and Islam, mandate the swift burial of the intact body. Post-mortem examinations (save in exceptional circumstances)¹⁷ thus offend those faiths.¹⁸

Post-mortem examinations in England and Wales can either be compulsory on the orders of the coroner, or voluntary, conducted with the consent of the deceased or his family. This latter form of post-mortem examination, we shall refer to as a hospital autopsy.

Post-mortem examinations must be distinguished from anatomical examinations. Anatomical examinations involve what is more commonly known as dissection. People donate their whole bodies to medical schools to assist in medical education, primarily to educate students in human anatomy and train them in dissection.

The law before 2004: complex and obscure¹⁹

18.4 Doctors, especially pathologists, endured odium in the wake of revelations in the Bristol Interim and Redfern Reports. Some of the blame lay with the unsatisfactory state of the law prior to the Human Tissue Act 2004. The Bristol Interim Report said simply but tellingly:

we have no doubt that the complexity and obscurity of the current law will be manifest to all. Equally we have no doubt that there will be general agreement that this state of affairs is regrettable and in need of attention.²⁰

Prior to the 2004 Act, a complicated mixture of ancient common law principles and statutes governed the retention and use of body parts taken from the dead. The common law asserted that there was ‘no property in a corpse’.²¹ This principle remains untouched by the 2004 Act. When a family member dies his family have no claim by which they can assert ‘this is now our body and we have unfettered rights to dispose of it or its parts’. However, the executors or administrators of the deceased’s estate are subject, ultimately, to a common law duty to dispose of the body decently. This duty confers on them a right to possession of the body to fulfil that duty of decent disposal of the body.²² Several Acts of Parliament touched on the lawful use of dead bodies.

The three key statutes were the Anatomy Act 1984, the Human Tissue Act 1961 and the Coroners Act 1988. All have now been replaced by new legislation.

The Anatomy Act enabled people to donate their bodies or their parts for use for anatomical examination. The details of the 1984 Act were in some ways as fuzzy as the Human Tissue Act 1961. The framework for the use of donated bodies was, however, closely regulated, and subject to the supervision of HM Inspector of Anatomy. Violation of the Anatomy Act resulted in criminal liability. The Anatomy Act worked well, within a culture of respect for the donors of the bodies given to medical schools. However, it was that vast majority of cases not regulated by the Anatomy Act which provoked the controversy around organ retention. First, a distinction must be made between removal of organs and tissue after a hospital autopsy, and removal of body parts subsequent to a coroner’s post-mortem examination. The Human Tissue Act 1961 governed removal and retention of organs after a hospital autopsy. It provided that where no coroner’s inquiry was likely, the person lawfully in possession of the body (the hospital) could authorise an autopsy where, after:

such reasonable enquiry as may be practicable, there is no reason to believe: (a) that the deceased had expressed an objection to his body being so used after his death … or (b) that the surviving spouse or any surviving relative objects to his body being so dealt with.²³

Under the 1961 Act, a person was not empowered to authorise an autopsy on himself in advance of his death. If body parts were to be retained after completion of the autopsy, a further enquiry was supposed to establish that there was no objection to retention and use of those parts. ‘Consent’ to an autopsy should not have been judged to presume consent (or no objection) to organ retention.

In relation to transplants, doctors were reluctant to exercise the powers granted by the 1961 Act. They sought positive and explicit consent from families before removing organs for transplant, even if the deceased carried a donor card. In the context of organ retention, the opposite ethos seems to have prevailed. The 1961 Act was obscure. It did not require explicit consent. Rather it set up a ‘no objection’ rule. Put crudely, hospitals thought that they could take organs and tissue for purposes of education and research if no family member voiced dissent. The Bristol Interim Report suggests that even where families were asked their views and expressed no objection, ‘agreement’ both to hospital autopsies and subsequent removal of body parts was often given with little understanding of what was entailed. It might be an ‘agreement’ given at a time of great personal trauma, for example, shortly after the death of a child. In some cases, families, knowing nothing of the distinction between hospital autopsies and coroners’ post-mortem examinations, did not realise that they had a right to object. The use of the word ‘tissue’ confused people. Understandably, laypeople assumed that in agreeing to the removal of tissue, they agreed to doctors taking small specimens from organs, not whole organs. The Redfern Report revealed a bleaker picture. Organs had been taken and stored without even any pretence of seeking the family’s views. The flaws in the Human Tissue Act 1961 became patent. Even if it could be shown to have been flouted, the lack of sanctions punishing violation of the Act rendered it toothless.

The position in relation to coroners’ post-mortem examinations was no better. The overwhelming majority of post-mortems were and are performed on the orders of the coroner. Rules made under the Coroners Act 1988 placed a duty on the pathologist to remove and preserve ‘materials’ which in his opinion bore on the cause of death. If a baby died in the course of cardiac surgery, the pathologist might lawfully remove and retain his heart until it was possible to ascertain why the infant died. However, there was no power to retain organs for research or teaching purposes. Once the cause of death was established, neither the coroner nor the pathologist had any further legal power to retain body parts. Such ‘material’ should have been disposed of, unless the relatives of the deceased authorised retention for research or teaching purposes. In practice, coroners simply allowed pathologists to do what they wished with human material no longer required for the purposes of verifying cause of death. Pathologists, in ignorance of the law in many cases, retained organs and tissue over long periods of time and for a multiplicity of purposes. By 2001, NHS hospitals were in possession of literally tens of thousands of organs and vast collections of blocks and tissue slides. Leading teaching hospitals and medical museums such as the Royal College of Surgeons had extensive archival material of body parts, some including collections long predating the NHS. Families had no say either in the decision to order a post-mortem or in the subsequent retention of parts of the body of their dead relative.

The Coroners and Justice Act 2009

18.5 Section 1 of the Coroners and Justice Act 2009 now provides that a senior coroner who is made aware that the body of a deceased person is within that coroner’s area must conduct an investigation into that person’s death if the coroner has reason to suspect that the deceased:

(a)  died a violent or unnatural death;

(b)  the cause of death is unknown; or

(c)  the deceased died in custody or otherwise in state detention.²⁴

The coroner is empowered to make whatever enquiries seem necessary and this includes ordering a post-mortem examination.²⁵ The family of the deceased have no right to object to the conduct of the post-mortem however strong their religious beliefs relating to the burial or cremation of the intact body may be. However, the Act and regulations made under it do provide for notification to next of kin and an emphasis is placed on respect for the needs of bereaved families. Section 40 of the 2009 Act originally provided for an appeal against a coroner’s decision to order a post-mortem but this provision was repealed without ever coming into force. It is the law relating to retention of organs after a coroner’s post-mortem that has been radically changed by the combination of the Coroners and Justice Act and the Human Tissue Act 2004.

The Human Tissue Act 2004: the dead²⁶

18.6 The Human Tissue Act 2004 governs the removal, retention and use of body parts taken from the dead, except where body parts are removed and retained solely for the purpose of investigating a death under the authority of the coroner. The Act also governs the performance of hospital autopsies. The Anatomy Act 1984 and the Human Tissue Act 1961 are wholly repealed. The Act, as we have seen in Chapter 17, makes ‘appropriate’ consent the fundamental principle governing retention and use of whole bodies and body parts. The Act also introduces extensive regulation of hospital autopsies²⁷ and retention and use of both bodies and what is styled ‘relevant material’. It is tortuous to read. It does not apply in Scotland.²⁸ The scope of the Act will surprise many for it covers much more than organs such as hearts or kidneys and encompasses nearly all human bodily products. Defining organs and tissue and attaining a common understanding of what those words meant had been a major source of controversy in the debates surrounding organ retention. Section 53 defines ‘relevant material’ as ‘material, other than gametes, which consists of or includes human cells’, save that embryos outside the human body are excluded,²⁹ as are hair and nails from living subjects. Blood and urine are within the Act. The Academy of Medical Sciences proposed that the definition be amended to exclude plasma, serum, urine, faeces and saliva.³⁰

Let us start with the circumstances in which it is lawful to conduct a post-mortem examination. All post-mortem examinations must now be performed in premises licensed by the HTA. The 2004 Act does not govern when a post-mortem examination can be ordered by the coroner. So if a person dies in hospital and there is suspicion that her death may be as a result of some crime or medical malpractice, the coroner will be informed. If the coroner orders a post-mortem examination, as we have seen, the family have no right to object. The Coroners and Justice Act is supported by guidance to assist families coping with the trauma of the investigation into a relative’s death.³¹

Beyond the jurisdiction of the coroner, there are many other circumstances when doctors might want to conduct a post-mortem examination, to carry out a hospital autopsy. There may be uncertainty about the exact cause of death. There may be a wish to learn more about why treatment failed and the underlying disease or injury. Doctors (and families) may want to explore whether any genetic factors are implicated in the deceased patient’s disease. Any such hospital autopsy will be lawful only if³² the deceased himself gave appropriate consent to the autopsy in advance of his death, or, such consent is given by his nominated representative,³³ or failing any advance consent by the deceased or authorisation by his nominated representative, appropriate consent is obtained from a person who stood in a qualifying relationship to the deceased.³⁴ Whatever the purpose of the hospital autopsy, be it to determine the cause of death, investigate the effect of treatment on him, or examine genetic factors, what is done can only be done with appropriate consent.³⁵

Should doctors wish to retain body parts after the hospital autopsy, explicit consent to both the retention, and the projected use of those parts, must be obtained additionally, and separately, from any consent to the autopsy.³⁶ Imagine that knowing she is dying from ovarian cancer, a woman consents in advance to an autopsy, especially in order to assess any genetic risk to her daughters. In the course of the autopsy, pathologists identify further tumours in her kidneys and liver. They want to retain those organs for further investigation and research. For such retention and use to be lawful, appropriate consent will have to be obtained from the woman’s husband or partner, if she had one, or from one of her daughters. Retention of body parts from the dead must be authorised by appropriate consent, be the purpose of retention, research, audit, education, performance assessment, public health monitoring or surveillance.³⁷

If there is no advance consent from the deceased person or his nominated representative and no one who stands in a qualifying relationship to the deceased and so able to consent, nothing can be done to the body of the deceased that falls within the scope of the Human Tissue Act.³⁸ The consequences of this ‘rule’ are graphically illustrated in the extraordinary case CM v The Executor of the Estate of EJ (Deceased).³⁹ CM, a senior doctor, was driving home off duty when she saw a body lying on the pavement. She stopped and went to help the woman (EJ). EJ was seriously injured and bleeding profusely. She died at the scene. When CM reached her home she noticed abrasions on her hands, hands that had been covered with the deceased’s blood. Concerned that she might have contracted a blood-borne disease, such as HIV or hepatitis, CM commenced a course of antiviral drugs but the drugs made her very unwell and so she wished to know if EJ had suffered from any such disease and have EJ’s blood or tissue tested. Tests need to be done swiftly. The matter came to court. The judge ruled that the coroner, while able to order a post-mortem to investigate EJ’s death, had no power to authorise tests for the benefit of a third party. Unless a person in a qualifying relationship to EJ gave consent, tests to benefit CM were unlawful. EJ proved to be a foreign national. EJ was unmarried and her parents were abroad, as yet unaware of their daughter’s death and tracking them down would take time. They would of course be first in the hierarchy of qualifying relatives. EJ’s mother’s cousin OP was contacted. The judge referred to section 27(8) of the Human Tissue Act that provides that if it is not reasonably practicable in the time available to contact the highest ranking qualifying relative, the next person in the hierarchy may give the necessary consent. He went on to find that although section 27 makes no reference to remoter relatives, such as a mother’s cousin, OP as ‘a reasonably close relative’ was enabled to give appropriate consent as a friend of longstanding. Had OP not lived in England and the judge not been so innovative in his interpretation of the Act, CM, the Good Samaritan, would have been left in limbo, ill and unable to work. A happy postscript to the case is that tests on EJ proved negative and CM has been able to resume her career.

Albeit no consent is required when the coroner orders a post-mortem examination, once that examination is complete should a pathologist wish to retain body parts removed in the course of that investigation, appropriate consent must be sought to make such retention and any projected use of those parts lawful. If our hypothetical patient who died of ovarian cancer died unexpectedly on the operating table, the coroner may well order a post-mortem. Should the examination establish that her death was in no sense caused by any error or lack of care, but pathologists still wish to retain her organs, consent must be sought for the retention and use of those organs even though it was not required for the post-mortem examination itself. The Coroners (Investigations) Regulations 2013⁴⁰ require that a coroner ordering a post-mortem examination and notified about retention of organs⁴¹ and tissue must inform the deceased’s family (inter alia) that organs and tissue will be retained, about the options⁴² once examination of retained material is complete and (if the relatives wish the material to be returned to them) about what arrangements may need to be made.⁴³

Somewhat surprisingly, the Human Tissue Act 2004 prescribes no formalities for consent to a hospital autopsy, or in general to retention and use of organs after post-mortem examination. There is no statutory rule requiring that consent must be given in writing. Greater formality is required for two particular uses of dead bodies, and their parts. A person who wishes to donate his body for anatomical examination or for public display must (normally) do so in writing and in the presence of at least one witness.⁴⁴ Moreover only the individual himself can donate his body to anatomical examination⁴⁵ or public display.⁴⁶ Should the authors of this book die in advance of our respective husbands having given no instruction about the use of our corpses, those husbands could authorise a hospital autopsy and donate our organs and tissue for medical research or education. Only we can donate our whole bodies to the local medical school or gain a strange sort of immortality in exhibitions such as Bodyworlds, where plastinated human bodies are on display as public ‘entertainment’.

Section 2 of the 2004 Act makes express provision in relation to children and young people who die before reaching the age of majority at 18. If a young person was sufficiently mature and intelligent to make an advance direction about the conduct of an autopsy or retention of body parts, her advance direction authorises implementation of her wishes. A Gillick competent minor can in theory determine what happens to her body after death.⁴⁷ Establishing Gillick competence retrospectively after death will not be easy. In relation to younger children, normally his parents will be the designated decision-makers. Autopsy and organ retention are lawful only on the basis of appropriate consent from a person with parental responsibility⁴⁸ for the dead child. Consent from one parent alone will in theory suffice to make the relevant activity lawful. Overriding an objecting bereaved parent will pose ethical and practical difficulties. Consider this dilemma. A child dies of cancer at the age of 4. His Orthodox Jewish father objects to any retention of his organs. His mother desperately wants to know if his disease has any genetic implications for her other children, and so want his organs retained and samples tested.

The Human Tissue Act 2004: the living

18.7 The Human Tissue Act 2004 was enacted in the wake of controversy about the (mis)use of the bodies of the dead. The Act, however, also regulates the retention and use of ‘relevant material’ from living patients. So if a patient undergoes surgery to remove a diseased organ, the Act regulates the conditions in which doctors may retain that organ for teaching or research purposes. The wide definition given to ‘relevant material’⁴⁹ within the Act, means that not only retention of whole organs is regulated, but also the retention of any specimen including cells, however small that may be. The Academy of Medical Sciences sought to amend and restrict the definition of relevant material and pointedly notes that the Scottish legislation is confined to post-mortem tissue.⁵⁰ The original Human Tissue Bill imposed almost the same regime of requirements for explicit consent in relation to such surgical or surplus tissue from living patients, as for body parts removed and retained from the dead. The Bill caused an outcry with senior scientists claiming that such burdensome rules would paralyse medicine.⁵¹ Hence a modified set of rules govern retention of surgical or surplus tissue from living patients.⁵² Many doctors still regard the regulations as unreasonably onerous.

The 2004 Act does not regulate the initial removal of body parts from the living. That continues to be governed by the common law. Any surgery is normally unlawful and a criminal assault unless properly authorised by the patient’s consent. A hysterectomy on a mentally competent woman self-evidently requires her consent. But what if doctors want to retain her diseased uterus, either to help to train medical students or to pursue research⁵³ into the kind of cancer that necessitated the surgery? Must doctors seek the woman’s explicit consent to retain her uterus, or even any specimens of diseased tissue? It depends on their purpose.⁵⁴ If retention is intended for the purposes of audit, education or training, performance assessment, public health monitoring or quality assurance, her consent may be presumed.⁵⁵

Retention to acquire genetic or other information relevant to others will normally require an explicit consent. However, in relation to material taken from the body of living persons, the HTA can exceptionally dispense with the need for consent if (inter alia) the donor cannot be traced or reasonable efforts to obtain consent have been unsuccessful.⁵⁶ Had EJ survived but remained unconscious, the HTA would have been able to authorise tests on her blood to establish whether CM was at risk of contracting a blood-borne disease.⁵⁷

Retention for research will require specific consent if the identity of the patient will be ascertainable. The Act empowered the Secretary of State to make regulations allowing retention of material from the living for research, without an explicit and specific consent, where the research has been approved by an accredited research ethics committee and the ‘source’ of the material has been anonymised.⁵⁸ Research on surgical or surplus tissue taken from us must be explicitly authorised by us if researchers will be able to discover that the source is Brazier or Cave. Very often, researchers will require this information about our identity to be able to, for example, access our medical records, which may be crucial to the research project. Only research, approved by a Research Ethics Committee, where that link is not necessary, and has not been broken, will not require our explicit consent.⁵⁹

The final version of the Act operates on the assumption that more people have little concern about what happens to ‘bits of their living body’ removed at surgery. They would be indifferent to whether such ‘bits’ were incinerated or put to some good use. Two caveats should be stated.

(1)  Some religious faiths attach an almost equal value to parts separated from the living body as from the dead. When an Orthodox Jew has to have a limb amputated, he will make arrangements for that limb to be stored and ultimately interred with him.

(2)  Surplus tissue is not necessarily mere ‘waste’. It can be the source of crucial and sensitive genetic information. It can be the source of medical advances of commercial value.

‘Appropriate consent’

18.8 We have so far indicated when an explicit consent is required by the Act. The Act refers to ‘appropriate consent’. Just what those two words may mean is crucial to how the Act will operate in practice. The HTA was expressly required by the Act to address what constitutes consent and has done so in a number of Codes of Practice (revised in 2014) including a general Code on Consent,⁶⁰ and more specific Codes relating to post-mortem examinations,⁶¹ anatomical examination,⁶² removal, retention and storage of tissue⁶³ and public display.⁶⁴ At the time of writing, changes made to all the Codes of Practice await final parliamentary approval, likely to be forthcoming in 2016.

In Code 1 on Consent the HTA stresses that health professionals seeking consent ‘should tailor the information they provide to each specific situation as some people may insist on in-depth detail, whereas others would prefer to consent having only the basics of the procedure explained to them’.⁶⁵ While written consent is only mandatory for consent to anatomical examination or public display, written consent should be obtained wherever possible for any donation of tissue post-mortem.⁶⁶ A valid consent must be given voluntarily and on the basis of sufficient information. What degree of information is sufficient is difficult. Some families asked to consent to a hospital autopsy and organ retention may not want comprehensive and graphic descriptions of what will be done to their newly dead relative.⁶⁷ Some living patients will be happy simply to ‘give away’ excess tissue or diseased organs uninterested in its fate. Doctors should not however assume either that acute distress in the first case or indifference in the second, justifies failing to offer information. A number of families brought claims against hospitals retaining organs without consent. In AB v Leeds Teaching Hospital NHS Trust,⁶⁸ the judge stressed that (even under the old Human Tissue Act 1961) families were ‘entitled to have their wishes in respect of their deceased (relative’s) body respected and complied with … those wishes cannot be complied with unless it is explained to the (relative) what is involved’. He rejected any blanket view that information would have been distressing to all relatives saying: ‘In so far as it involved the exercise of a therapeutic privilege it was one which does not appear to have been exercised on a case by case basis’.

Doctors should offer to disclose to the person giving consent all the information that any reasonable lay person would need to make a sensible choice about whether or not to give the requested consent.⁶⁹ Especially in the context of sudden bereavement, time and support for the decision-maker will be crucial. Information must neither be withheld nor forced on the unwilling recipient. Evidence of compliance with HTA Codes of Practice will weigh strongly with the courts.

In the context of retention for research, one particularly thorny question surfaced. Must consent be specific to every research use of the relevant material? Or will a general consent suffice? If a woman agrees to consent to retention of her diseased uterus for research into one form of cancer therapy and in the course of that research other more promising lines of research emerge, must she be contacted to give specific consent to this further research? The HTA seems to endorse the applicability of a seeking a general consent, for multiple purposes.⁷⁰ Donors may be asked to make an unconditional gift of their tissue (or that of their deceased relative). The key factor will be to establish what kind of consent was sought and given. Did the patient or relative consent only to the use of the relevant material for Project X, alone, or Project X plus any related research or teaching activities, or did they consent to surrender all control of that material, and ‘gift’ the body parts in question to the hospital or university?

Regulation

18.9 We have focused in this chapter on the legal requirements for consent to removal, retention and use of body parts. The Human Tissue Act 2004 also imposes substantial regulatory requirements on such activities. We touch on these only briefly. As we saw in relation to transplantation, the HTA plays a major role in regulation. Its mandate to prepare Codes of Practice means that the HTA profoundly influences how the Act works in practice.⁷¹ More directly, a number of activities require a licence from the HTA.⁷² These include carrying out anatomical examinations and storing anatomical specimens. Medical schools have to be licensed by the HTA to carry out and train students in dissection.⁷³ Post-mortem examinations must be carried out in licensed premises. Storage of any body or part of a body for any of the purposes covered by the Act must be licensed, as must the use of bodies and their parts for public display. Pathology museums and archives of tissue will also need to be licensed in respect of acquisitions after the Act came into force. It remains lawful to retain existing holdings (even where there is no evidence of consent).⁷⁴ The HTA nonetheless advises that if the views of the deceased person or their relatives are known, those views should be respected,⁷⁵ and it gives extensive advice on the respectful disposal of existing holdings.⁷⁶

The 2004 Act, unlike its predecessor, the Human Tissue Act 1961, has teeth. Proceeding without appropriate consent where consent is required is a criminal offence unless the person reasonably believed that he acted on the basis of an appropriate consent.⁷⁷ In the context of consent to the removal and retention of body parts from the dead, a practical question besets obtaining consent. If, for example, a child dies of leukaemia, it is usually the treating clinicians who will approach the family to seek consent to an autopsy and subsequent retention of material. But it is the pathologist who will carry out the autopsy and retain any material. Pathologists will need to ensure that they have a reasonable basis for a belief in consent and that, in most cases, will mean evidence in writing of consent. To ensure doctors charged with seeking consent do their part, it is also a criminal offence to represent falsely to another that appropriate consent has been obtained.⁷⁸ Carrying out unlicensed activities where such a licence is required equally engages criminal liability.⁷⁹

Ownership of body parts⁸⁰

18.10 The vexed question of whether we own our bodies is only fleetingly addressed in the Human Tissue Act 2004. We noted earlier the ancient common law assumption that there is no property in a corpse. That statement must be qualified. Consider the Egyptian mummies held in the British Museum. Do they belong to the British Museum? Or might we lawfully help ourselves to one or two? R v Kelly⁸¹ confirmed that, once a body or body parts had been changed in nature by work done on them, such parts become capable of being property. A technician was accused of stealing body parts from the Royal College of Surgeons and selling them to an artist who wished to use the parts as moulds for his sculptures. Both were charged with theft. Their defence was that the College did not own the parts and so they could not steal them. Upholding the convictions, the Court of Appeal found that body parts became capable of being property for the purposes of the Theft Act 1968 because they had ‘acquired different attributes by virtue of the application of skills, such as dissection or preservation technology, for exhibition or teaching purposes’. The notion of ‘property’ however is complex in this context. The Court of Appeal in Kelly did not find that the Royal College of Surgeons owned the stolen body parts. A right to lawful possession of property is all that is required for that property to be stolen from you. The English Court of Appeal concurred with their Australian brethren in Doodeward v Spence;⁸² in that case Griffith CJ spoke of a body and its parts becoming the subject of property. He said:

when a person has by the lawful exercise of work or skills so dealt with a human body or part of a human body that it has acquired some attributes differentiating it from a mere corpse awaiting burial he requires a right to retain possession of it, at least as against any person not entitled to have delivered to him for the purpose of burial.

Does it follow from Kelly that whenever organs or tissue have been retained and, for example, have been preserved in formalin or put in blocks, the hospital in possession of the specimen can assert a property right to it? Dobson v North Tyneside Health Authority⁸³ appears to undermine such an argument. The family of a woman who had died of a brain tumour brought a claim in clinical negligence against the health authority alleging failure to diagnose her condition sufficiently swiftly to offer her effective treatment. To succeed in their claim, they needed to ensure that their expert witnesses could examine samples of the brain. The brain had been removed at a coroner’s post-mortem, preserved in paraffin, and later disposed of. The family sued the hospital for conversion, alleging unlawful disposal of the brain. They argued that on completion of the coroner’s investigation the family were entitled to the return of the brain. They enjoyed, either ownership, or, at least, a right of possession of the deceased’s brain. The Court of Appeal dismissed their claim. Fixing the brain in paraffin was not a sufficient exercise of skill or labour to give that brain any different attributes to the organ initially removed from the body in the course of post-mortem. There was:

nothing … to suggest that the actual preservation of the brain after the post mortem was on a par with stuffing or embalming a corpse or preserving an anatomical or pathological specimen for collection or with preserving a human freak such as a double-headed foetus that had some value for exhibition purposes.⁸⁴

Identifying exactly what must be done to transform an organ taken from a body into property is difficult and somewhat artificial, and Dobson may be a decision soon to be consigned to legal history. Nonetheless the ‘no property rule’ received further support in AB v Leeds Hospital NHS Trust.⁸⁵ Parents whose deceased children had been subject to post-mortem examinations and organ retention without their consent brought claims for psychiatric injury to themselves and wrongful interference with the bodies of the children. Gage J, rejecting the latter claim, reasserted the rule of ‘no property in a corpse’. He also confirmed that nonetheless separated parts of the body subjected to the application of work and skill might become property – the property of he who expended that work and skill. So, pathologists who dissected and fixed organs from the body and transformed them into blocks and slides could acquire ownership of that ‘property’. The skill and labour rule creates the odd paradox whereby our bodies and their parts are not our property (or at least do not form part of our estate) but put ‘to the uses of medicine, their body parts become, as if by magic, property, but property owned by persons unknown for purposes unforeseen by the deceased’.⁸⁶

However in R v Kelly⁸⁷ Rose LJ had suggested obiter that the common law could develop to recognise a body part as property even without the acquisition of different attributes if it had acquired ‘a use or significance beyond … mere existence’. He even indicated that in such a case outright ownership may be recognised. The Court of Appeal in Yearworth v North Bristol NHS Trust⁸⁸ took a small further step towards recognising property in separated body parts. Claims were brought by five men and the widow of a sixth in respect of the alleged negligence of the defendant trust in allowing their stored sperm to perish when the temperature in the storage tanks dropped and no attempt was made to ensure the sperm remained safely frozen. All the men had stored sperm for future use before undergoing chemotherapy for cancer. The men’s claim that the loss of their sperm constituted personal injury failed. The appeal court allowed their claims for damage to their property, stating that ‘developments in medical science now require a re-analysis of the common law’s treatment of and approach to the issue of ownership of parts or products of a living body’.⁸⁹ The Court acknowledged that they could have used the ‘skill and labour’ notion to find that the complex process of storing sperm in liquid nitrogen was enough to transform the sperm to property.⁹⁰ Lord Judge CJ and his colleagues in the Court of Appeal were scornful of that principle, saying that its ‘ancestry did not commend it as a solid foundation’.⁹¹ Their Lordships preferred to derive their findings from Rose LJ’s dictum in Kelly. The men had for the purposes of a claim in negligence, ‘ownership of the sperm which they ejaculated’. They alone had generated and ejaculated the sperm and done so solely to ensure that it could later be used for their benefit. The storage of the sperm was governed by the Human Fertilisation and Embryology Act 1990. The 1990 Act restricted how the men could use the sperm, but entrenched the ability of the men to ensure that ‘their’ sperm was not used contrary to their direction; their ‘negative control over its use remains absolute’. Furthermore, as the authority could not continue to store the sperm without the continuing consent of the men, the Act recognised a fundamental feature of ownership in that the men and they only could require destruction of the sperm at any time. Analysis of the rights relating to the use and storage of the men’s sperm led the Court to conclude that no individual or authority had any rights in relation to the sperm.

Yearworth could be seen as a narrow judgment⁹² heavily dependent on the context of the claim relating to storage of gametes under the Human Fertilisation and Embryology Act.⁹³ It is hedged around by qualifications, as will have been noted. The judgement of ownership was for the purposes of a claim in negligence and relates to property in products of the living body. Lord Judge was adamant that the old rules must be revisited and the law must keep up with modern science. Another feature of Yearworth is this. The restrictions on use of the sperm imposed by the Human Fertilisation and Embryology Act did not undermine the men’s ownership claims. It does not follow that by allowing ownership you open the door to wholesale commodification. Policy-based restrictions on sale and use are not incompatible with ownership.

As we have seen, section 32 of the Human Tissue Act 2004 prohibits commercial dealings in body parts for transplant purposes, but the Act exempts from this prohibition ‘material which is the subject of property because of an application of human skill’.⁹⁴ The Bill had originally sought to ban commercial dealings in body parts by anyone for any purposes. Such a broad rule would have been unworkable as human tissue is a fundamental material in medical research and trade among laboratories is well established. What the Act seems to deem objectionable is not for University A to sell human material excess to its requirements to Company B but for the human originator of that material to receive any recompense or property rights in his or her body. Why should that be?

The fundamental question of whether we should own our bodies would constitute a book of its own. We might ask: does it matter? The Human Tissue Act 2004 grants us and our families fairly extensive control of what may be done with our bodies and their component parts. A number of reasons suggest that it might matter. Common law dicta that there was no property in a corpse did not derive from any belief that such bodies were without value. Quite the contrary – the dead should not be seen ‘as other inanimate objects, but were to be treated quite differently, even reverently’.⁹⁵ Our bodies were too valuable to be ‘things’, to be mere property. Would classifying bodies as property devalue them or endorse that value?

There is no avoiding the evidence that in the modern world bodies have certain sorts of tangible value. Sometimes this value is crudely commercial. Consider the famous case of Mr Moore.⁹⁶ Cell lines developed from his excised and diseased spleen made his doctor $15m and much greater profits for the drug company who bought the potential cell line. Yet Mr Moore was held to have no ownership rights in the body part removed. Another value secreted in our body parts is our genetic information. What may seem to be redundant surplus tissue carries within it information about the whole of our health and much about ourselves. We may prefer to retain control of that information.

Until recently proponents of property models and bodies tended to be motivated by a belief in markets in human tissue. We should own our bodies so we can sell them. The debate is much more sophisticated now. Mason and Laurie⁹⁷ have made a powerful case for a modified property model.⁹⁸ Finally, we have not touched on the vexed question of intellectual property and refer you again to Mason and Laurie.⁹⁹

¹  For an analysis of different theoretical and legal approaches, see I Goold, K Greasley, J Herring, L Skene (eds) Persons, Parts and Property: How Should We Regulate Human Tissue in the 21st Century? (2014), Hart. And see D Price, Human Tissue in Transplantation and Research (2009) Cambridge University Press.

²  [2009] EWCA Civ 37. See 18.10.

³  See M Brazier, ‘Human(s) (as) Medicine(s)’ in SAM McLean (ed) Do No Harm (2006) Ashgate, at 187.

⁴  See R Richardson, Death, Dissection and the Destitute (2nd edn, 2000) University of Chicago Press.

⁵  See the Coroners and Justice Act 2009, s 35 and Sched 8.

⁶  The provisions of the Fatal Accidents and Sudden Deaths Inquiry (Scotland) Act 1976 apply to fatal accidents occurring in Scotland.

⁷  See 17.8.

⁸  Learning from Bristol: The Report of the Public Inquiry into Children’s Heart Surgery at the Bristol Royal Infirmary 1984–1995 (2001) Cm 5207 (1).

⁹  Inquiry into the Management of Care of Children Receiving Complex Heart Surgery at the Bristol Royal Infirmary Interim Report, Removal and Retention of Human Material (available at www.bristol-inquiry.org.uk) (hereafter Bristol Interim Report).

¹⁰  Royal Liverpool Children’s Inquiry Report (2001) HC 12-11 (hereafter the Redfern Report). Michael Redfern QC later completed a further inquiry on the retention of tissue from workers in the nuclear industry; see The Redfern Inquiry into Human Tissue Analysis in UK Nuclear Facilities (2010) HC 571-1.

¹¹  DH, Report of a Census of Organs and Tissue Retained by Pathology Services in England (2001).

¹²  See, in particular, DH, The Investigation of Events that Followed the Death of Cyril Mark Isaacs (2003). The Bristol Interim Report, the Alder Hey Report and the Chief Medical Officer all made extensive recommendations about how the NHS should seek to manage and resolve the process of informing families about organ retention and organ return, about support for families and how to resolve past controversies as well as how the law should be reformed. The Secretary of State established a special health authority, the NHS Retained Organs Commission to manage the process by which NHS trusts provided information to families about organ retention, oversee the process of organ return, act as an advocate for families and develop a new regulatory framework for organ and tissue retention.

¹³  For diametrically opposed views about the ethics of organ retention, see J Harris, ‘Law and Regulation of Retained Organs: the Ethical Issues’ (2002) 22 Legal Studies 527; M Brazier, ‘Retained Organs: Ethics and Humanity’ (2002) 22 Legal Studies 550. And see S McGuinness, M Brazier, ‘Respecting the Living Means Respecting the Dead Too?’ (2008) 28 Oxford Journal of Legal Studies 297. And for an analysis of the human rights implications of non-consensual organ retention, see Elberte v Latvia (application no. 61243/08), 13 January 2015. The European Court of Human Rights held that there was a breach of Articles 8 and 3 when the applicant’s deceased husband’s body tissue was removed after his death without her consent. Latvian law was unclear and lacked safeguards.

¹⁴  For comprehensive guidance on the regulation of post-mortem examinations today, see HTA Code of Practice 3, Post-Mortem Examination (2014).

¹⁵  See R Tallis, Hippocratic Oaths: Medicine and Its Discontents (2004) Atlantic Books, p 195.

¹⁶  See DN Banyubala, ‘Posthumous Organ Retention and Use in Ghana; Regulating Individual, Familial and Societal Interests’ (2014) Health Care Analysis, forthcoming.

¹⁷  See, for example, M Lamm, The Jewish Way in Death and Mourning (1998) Jonathan David Publishing, p 100; A Sheikh, AR Gartrad, Caring for Muslim Patients (2000) Radcliffe Medical Press, p 107.

¹⁸  One option may be to carry out a limited post-mortem so restricting the intrusion on the body; see generally, Guidelines on Autopsy Practice (2005) Royal College of Pathologists.

¹⁹  See D Price, ‘From Cosmos and Damian to Van Velzen: The Human Tissue Saga Continues’ (2003) 11 Medical Law Review 1.

²⁰  At 20.

²¹  Doodeward v Spence (1908) 6 CLR 906. And see 18.10.

²²  Williams v Williams (1882) 20 Ch D 659.

²³  See ss 2(2) and 1(2) and see PDG Skegg, ‘The Use of Corpses for Medical Education and Research: The Legal Requirements’ (1991) 31 Medicine, Science and the Law 345.

²⁴  See also ss 2–4 and Schedule 10.

²⁵  See the Coroners and Justice Act 2009, s 14 and the Coroners (Investigation) Regulations, SI 2013/1269.

²⁶  See D Price, ‘The Human Tissue Act 2004’ (2005) 68 Modern Law Review 798; K Liddell, A Hall, ‘Beyond Bristol and Alder Hey: The Future Regulation of Human Tissue’ (2005) 13 Medical Law Review 170.

²⁷  See HTA Code of Practice 3, Post-Mortem Examination.

²⁸  See the Human Tissue (Scotland) Act 2006.

²⁹  Regulated by the Human Fertilisation and Embryology Act 1990; see Chapters 12 and 13.

³⁰  Academy of Medical Sciences, A New Pathway for the Regulation and Governance of Health Research (2011), rec 11.

³¹  Ministry of Justice, Guide to Coroner Services (February 2014) issued under the Coroners and Justice Act 2009, s 42.

³²  Human Tissue Act 2004, ss 1, 3, and Sch 1, paras 2 and 3.

³³  Ibid, s 4.

³⁴  For discussion of who constitutes such a person, see 17.10.

³⁵  The bare rules of the Human Tissue Act 2004 are elaborated in this context by two Codes of Practice: Human Tissue Authority, Code of Practice: Consent – Code 1 (2014) and Human Tissue Authority, Code of Practice: Post Mortem Examination, Code 3 (2014). The HTA Codes of Practice were amended in 2014 and await final Parliamentary approval likely to be forthcoming in 2015.

³⁶  See the Human Tissue Act 2004, s 1 and Sch 1.

³⁷  See also HTA, Code of Practice, Disposal of Human Tissue, Code 5 (2014).

³⁸  HTA Code of Practice 1 Consent, para 93.

³⁹  [2013] EWHC 1680 (Fam).

⁴⁰  SI 2013/1629, reg14.

⁴¹  Reg 13.

⁴²  Disposal of the material by the pathologist, return to the ‘family’ or consent to retention of the materials for research, education or any scheduled purpose within the Human Tissue Act.

⁴³  And see HTA, Code of Practice, Code 3, para 65.

⁴⁴  See ss 3(4) and (5).

⁴⁵  For further information about anatomical examination, see HTA, Code of Practice, Anatomical Examination Code 4 (2014).

⁴⁶  HTA, Code of Practice, Public Display Code 7 (2014).

⁴⁷  See s 2(3). Only such a Gillick competent minor can authorise donation of her body for anatomical examination or public display. Parents cannot donate their children’s bodies for such purposes.

⁴⁸  See ss 1, 2 and Schedule 1. Where there is not such person, the nearest person in a qualifying relationship to the dead child is the designated decision-maker.

⁴⁹  See s 53, at 18.6.

⁵⁰  Academy of Medical Sciences, A New Pathway for the Regulation and Governance of Health Research, p 72.

⁵¹  See P Furness, R Sullivan, ‘The Human Tissue Bill’ (2004) 328 BMJ 533.

⁵²  See Liddell, Hall, ‘Beyond Bristol and Alder Hey’.

⁵³  And see HTA, Code of Practice Research, Code 9 (2014).

⁵⁴  See generally HTA, Code of Practice Code 5.

⁵⁵  See ss 1(d) and (f) and Sch 1.

⁵⁶  See Human Tissue Act 2004, s 7.

⁵⁷  CM v The Executor of the Estate of EJ [2013] EWHC 1680 (Fam), see 18.6.

⁵⁸  See ss 1(7), 1(8) and 1(9); see also Human Tissue Act 2004 (Ethical Approval, Exceptions from Licensing and Supply of Information about Transplants) Regulations 2006, SI 2006/1260.

⁵⁹  Section 6 empowers the Secretary of State to make regulations relating to ‘deemed consent’ by persons who lack the requisite mental capacity to consent on their own behalf. See the Human Tissue Act 2004 (Persons Who Lack Capacity to Consent and Transplants) Regulations 2006, SI 2006/1659 (amended SI 2008/3067), regs 3 and 8.

⁶⁰  HTA, Code of Practice, Code 1.

⁶¹  HTA, Code of Practice, Code 3.

⁶²  HTA, Code of Practice, Code 4.

⁶³  HTA, Code of Practice, Code 5.

⁶⁴  HTA, Code of Practice, Code 7.

⁶⁵  HTA, Code of Practice, Code 1, para 107.

⁶⁶  HTA, Code of Practice, Code 1, para 61.

⁶⁷  See D Knowles, ‘Parental Consent to the Post Mortem Removal and Retention of Organs’ (2001) 18 Journal of Applied Philosophy 215.

⁶⁸  [2004] EWHC 644.

⁶⁹  Modelled on Montgomery v Lanarkshire Health Board [2015] UKSC 11 (discussed at 5.12).

⁷⁰  See HTA, Code of Practice, Code 1, paras 114–116.

⁷¹  See ss 26 and 27.

⁷²  See s 16.

⁷³  Continuing the regulatory regime previously imposed by the Anatomy Act 1984; and see ss 16(2)(a), 17 and 18.

⁷⁴  See s 9. And the licensing requirement does not apply to bodies of people who died before the Act came into force and are at least 100 years old (ie archaeologists are exempt). A topical example is the remains of King Richard III discovered under a car park in Leicester.

⁷⁵  HTA, Code of Practice, Code 5, paras 34–35.

⁷⁶  Ibid, paras 61–98 and Appendix A.

⁷⁷  See s 5(1).

⁷⁸  See s 5(2).

⁷⁹  See s 25.

⁸⁰  For an up-to-date critical analysis of English law, see M Quigley ‘Property in Human Biomaterials-Separating Persons and Things’ (2012) 32 Oxford Journal of Legal Studies 659; and see JW Harris, ‘Who Owns My Body?’ (1996) 16 Oxford Journal of Legal Studies 55. Mason and Laurie devote a whole chapter entitled ‘The Body as Property’ (Mason and McCall Smith’s Law and Medical Ethics, ch 14); and see Price, Human Tissue in Transplantation and Research (2009), ch 8.

⁸¹  [1998] 3 All ER 741.

⁸²  (1908) 6 CLR 406, at 413–444.

⁸³  [1996] 4 All ER 479.

⁸⁴  Ibid (per Peter Gibson LJ).

⁸⁵  [2004] EWHC 644. And see the Scottish decision Stevens v Yorkhill NHS Trust 2007 SCLR 606.

⁸⁶  See Brazier, ‘Retained Organs’, at 563.

⁸⁷  [1998] 3 All ER 741, at 750.

⁸⁸  [2009] EWCA Civ 37.

⁸⁹  [2009] EWCA 37, [45(a)].

⁹⁰  Ibid, [45(c)].

⁹¹  Ibid, [45(d)]. And see discussion in Scottish case Holdich v Lothian Health Board [2013] CSOH 197, per Lord Stewart at [31–34].

⁹²  But see also the latter part of the judgment relating to bailment. And note the extension of the narrow ruling in Yearworth in the decision of the Supreme Court of British Columbia in JCM v ANA 2012 BCSC 584. Also note that the Outer House of the Court of Session in Scotland allowed a claim to proceed to trial where a leak of liquid nitrogen resulted in damage to sperm in a cryogenic storage facility. Lord Stewart in Holdich v Lothian Health Board [2013] CSOH 197 acknowledged that it is not possible to ‘put a kilt on Yearworth’ [15].

⁹³  For an elegant analysis of the judgment and the sort of precedent it might set, see SHE Harmon, GT Laurie ‘Yearworth v North Bristol NHS Trust: Property, Precedents and Paradigms’ (2010) 69 Cambridge Law Journal 476; J Lee, ‘Yearworth v North Bristol NHS Trust: Instrumentalism and Fictions in Property Law’ in E Waring, S Douglas, R Hickey (eds) Landmark Cases in Property Law (2015) Hart.

⁹⁴  See s 32(9)(c).

⁹⁵  See P Matthews, ‘The Man of Property’ (1995) 3 Medical Law Review 237, at 254.

⁹⁶  Moore v Regents of the University of California 793 P 2d 479 (Cal 1950).

⁹⁷  JK Mason, GT Laurie, ‘Consent or Property: Dealing with the Body and Its Parts in the Shadow of Bristol and Alder Hey’ (2001) 64 Modern Law Review 710.

⁹⁸  And see L Skene, ‘Property Rights in Human Bodies, Body Parts and Tissue: Regulatory Contexts and Proposals for New Laws’ (2002) 22 Legal Studies 102.

⁹⁹  Mason, Laurie, Mason and McCall Smith’s Law and Medical Ethics, 14.49–14.72.

Chapter 19

THE END OF LIFE

¹

19.1 Society has never been comfortable with issues surrounding the process of dying; and as healthcare staff are involved with the dying, they inevitably become involved in ethical as well as medical dilemmas.¹ For the last few years the heat of the debate has focused on when the law should permit some sort of assistance for those who help a terminally ill relative or friend end her life, in particular when families have travelled with a relative to the Dignitas clinic in Switzerland where assisted dying is not unlawful. But this is just one of a host of difficult dilemmas. These include whether efforts should always be made to keep a dying person alive in spite of the additional suffering incurred by that person and the cost in terms of human dignity; and when, if ever, attempts may be made to hasten death when there is excessive suffering and when the cause is hopeless.

The practice of, what some regard as ‘striving officiously to keep alive’ has been facilitated by the increase in high-technology equipment capable of postponing inevitable death. The benefits of such equipment may often be great; yet there is a cost, both in human and economic terms. Further treatment may sometimes be said to be futile. A vast literature has developed around the concept of medical futility.² The very word generates controversy. Mason and Laurie³ prefer to talk of non-productive treatment, treatment which cannot offer even a minimal likelihood of benefit to the patient. Part of the difficulty in this debate is the problem of separating human and economic considerations. Refusing to order doctors to continue to ventilate a severely injured infant, Balcombe LJ said openly:

[A]n order which may have the effect at compelling a doctor or health authority to make available scarce resources and to a particular child … might require the health authority to put J on a ventilator in an intensive care unit, and thereby possibly deny the benefit of those limited resources to a child who was much more likely than J to benefit from them.⁴

Language invoking medical futility could be seen as disguising rationing decisions, or even covert euthanasia. Whatever the economic considerations, few would deny the personal cost to the patient and to those close to the patient in terms of human dignity. Do the ‘rights’ of patients include the right to die with dignity? If so does that ‘right’ extend to being ‘helped to die’? In preserving and sustaining the life of a patient with a hopeless prognosis, is it in the interests of the patient, the family, or the doctor, to prolong his suffering? Unlimited access to technology may sometimes be as cruel as the illness itself. Doctors concerned with terminally ill patients must make professional and human decisions to give up treatment which may be merely sustaining the function of the organs, and turn to appropriate care at the terminal stage.

In 1993, the tragic case of Tony Bland thrust this question into the public domain.⁵ Did the law demand that a young man grievously injured in the horrific disaster at Hillsborough Football Stadium should continue to be kept alive by artificial means? The Law Lords concluded that it did not. The Bland judgment rekindled debates on euthanasia, albeit their Lordships and many commentators⁶ vehemently rejected suggestions that the decision to allow Tony Bland to die was in any sense sanctioning euthanasia.⁷

End-of-life decisions relating to adults lacking capacity now fall under the Mental Capacity Act 2005 which came into force in 2007. The Act sets down principles by which the social and medical care of persons lacking the mental capacity to make their own decisions should be conducted. A Code of Practice provides guidance on the interpretation of the Act. We examined the wider effects of the Act in Chapter 6. In this chapter, we will consider the implications of the Act for adults, like Tony Bland, lacking capacity.

But what of patients who retain capacity? Since Bland, the courts have been deluged with cases seeking clearer definition of an individual’s right to determine the manner of her death, or life. The Human Rights Act 1998 focused attention on what exactly is entailed in the right to life embodied in Article 2. Does the prohibition on inhuman and degrading treatment in Article 3 assist those dying in distress? Does a right to privacy in Article 8 encompass autonomy in decisions on the end of life? The case law remains confused and confusing.

The Suicide Act 1961 decriminalised suicide and attempted suicide, but section 2⁸ makes it an offence to encourage or assist the suicide (or attempted suicide) of another. In 2002, the President of the Family Division endorsed a tetraplegic patient’s right to demand that doctors switch off the ventilator keeping her alive,⁹ but when Dianne Pretty argued that she had a right to assisted suicide, the House of Lords found against her.¹⁰ Doctors cannot be forced to administer treatment which they believe to be clinically unnecessary, futile or inappropriate. Does this include artificial nutrition and hydration (ANH)? The Court of Appeal held that it does.¹¹ An appeal to the ECtHR was ruled inadmissible.¹² In 2009 Debbie Purdy¹³ enjoyed partial success when she approached her battle for a right to assisted suicide from a different angle, claiming that the Director for Public Prosecutions¹⁴ (DPP) was required to clarify guidance on the circumstances when a prosecution would be brought under the Suicide Act 1961 in order to comply with Mrs Purdy’s rights under Article 8. In February 2010 the DPP issued new guidance identifying more clearly when prosecution would be deemed in the public interest and controversially placing emphasis on the motive of the suspect.¹⁵ But these changes did not address the potential incompatibility of section 2 of the Suicide Act 1961with Article 8. This matter came before the Supreme Court in 2014 when Tony Nicklinson and others challenged the restrictive nature of the law on assisted suicide before nine Supreme Court justices.¹⁶ Two of the Justices declared the law on assisted suicide to be incompatible with Article 8. Elizabeth Wicks warns that apparent progress is marred by judicial division:

Overall Nicklinson reveals a Supreme Court divided on two of the most fundamental and controversial legal issues facing the UK at present: the appropriate legal response to assisting or encouraging a suicide, and the respective roles of Parliament, domestic courts and the European Court of Human Rights in protecting human rights.¹⁷

Nor are the courts the only forum for debates on the end of life. A series of failed attempts to enshrine a right to assisted suicide in legislation have not dampened the ardour of reformers. The Supreme Court in the Nicklinson litigation signalled a growing willingness to take matters into the hands of the judiciary if legislative reform is not forthcoming. Opponents argue for the sanctity of life and for better palliative care. NHS England consulted on new ways to fund palliative care in 2014,¹⁸ but many hospices are dependent on the voluntary sector.

The Concise Oxford Dictionary defines euthanasia as: ‘Gentle and easy death; bringing about of this, especially in case of incurable and painful disease’. It is a term much used, and misused. It may be popularly invoked to include conduct characterised as ‘mercy killing’, when somebody, usually a relative, deliberately and specifically performs some act, such as administering a drug, to accelerate death and terminate suffering. Prosecutions for mercy killing, while rare, are sometimes reported, and the courts tend to deal with such cases with compassion. Mercy killing, where doctors are not usually directly involved, may also be termed active euthanasia. This can be contrasted with ‘passive euthanasia’ which might describe, for example, withholding of life-support treatment. The terminology of the debate is complex and confusing.¹⁹ Active euthanasia involves an act done deliberately designed to shorten life, by however short a span. Active euthanasia may involve voluntary euthanasia where the act done, the killing of the patient, is done at her specific request. Non-voluntary euthanasia may be the term used to refer to ending the life of someone who cannot express a view on the prolongation of her life at the relevant time. A proxy speaks on her behalf and what is done is done at least purportedly for the patient’s own good. Involuntary euthanasia involves killing a person without her own or any proxy authority. The patient’s life may be ended for what others perceive as her good, or could be terminated because of the burden her continued life places on society. Passive euthanasia can itself be voluntary, non-voluntary or involuntary. As we shall see any boundary between passive and active euthanasia is less clear than it might at first be thought to be.²⁰

In 2009 a postal survey of medical practitioners’ end-of-life decisions found that 0.21 per cent of deaths were attributable to voluntary euthanasia; 21 per cent to non-treatment decisions; 17.1 per cent to ‘double effect’ measures; 16.5 per cent to continuous deep sedation and 0.0 to physician assisted suicide.²¹ Now we must explore the legality of this range of decisions.

Murder, suicide and assisting suicide

19.2 Deliberately taking the life of another person, whether that person is dying or not, constitutes the crime of murder. Accordingly, any doctor who, no matter how compassionately, practised voluntary euthanasia or mercy killing can be charged with murder, if the facts can be clearly established. As Lord Mustill puts it:

‘mercy killing’ by active means is murder … that the doctor’s motives are kindly will for some, although not for all, transform the moral quality of his act, but this makes no difference in law.²²

A doctor convicted of murder faces a mandatory life sentence in prison. Dr Cox was in a sense lucky.²³ He injected his patient Mrs Lilian Boyes with potassium chloride. Mrs Boyes suffered unbearable pain from rheumatoid arthritis and begged Dr Cox to end her suffering. Potassium chloride stops the heart. It kills and has no therapeutic or painkilling properties. Before Dr Cox’s action came to the attention of the police, Mrs Boyes was cremated. It could not therefore be proved beyond reasonable doubt that the injection administered by Dr Cox killed her. Dr Cox was convicted only of attempted murder. The judge imposed a suspended sentence, and the General Medical Council (GMC) allowed him to continue to practise subject to certain conditions. Had the link between his action and Mrs Boyes’s death been clearly established, no such merciful course would have been open to the judge.²⁴ This applies equally to family members and loved ones.

At present, judicial sympathy for a perpetrator of ‘mercy killing’ is limited by the extent of their sentencing discretion. This was demonstrated in two recent cases. In 2010 Francis Inglis killed her 22-year-old son, Tom, with a lethal injection of heroin.²⁵ Tom was in a coma following an accident, but doctors felt there were chances of improvement. Inglis had previously attempted to administer a lethal injection to Tom and been released on bail and banned from seeing him. She entered the hospital under false pretences, injected him with heroin and barricaded herself into the room. Inglis contended that she acted out of compassion and love, but was convicted of murder and sentenced to a minimum of nine years’ imprisonment. The verdict was much criticised.²⁶ On appeal the sentence was reduced to five years:²⁷

[T]he law of murder does not distinguish between murder committed for malevolent reasons and murder motivated by familial love. Subject to well established partial defences, like provocation or diminished responsibility, mercy killing is murder.²⁸

In January 2011 the Court of Appeal allowed an appeal against sentence by 73-year-old George Webb. Mr Webb was sentenced to two years’ imprisonment in 2010 when he was found guilty of manslaughter on grounds of diminished responsibility having suffocated his 75-year-old wife during her suicide attempt.²⁹ Substituting a twelve-month suspended sentence, Lord Judge said:

We recognise, as the judge was at pains to underline, that this is not a case of assisted suicide. It is a case of manslaughter. The facts that we have narrated make that clear. Nevertheless, it seems to us that there are features of this case which bring it close to an assisted suicide.³⁰

In 2010 Tony Nicklinson, who suffered from ‘locked-in syndrome’ and was unable to move, launched a legal bid to allow his wife to kill him. He was paralysed from the neck down after a stroke. He could not commit suicide, did not want to suffer withdrawal of nutrition or hydration and wanted to die in his own home rather than travelling abroad to an assisted suicide clinic. His argument was not that Article 8 requires voluntary euthanasia to be legalised, but that the current law on murder, which imposes a life sentence on anyone found guilty of murder, irrespective of whether or not the killing was consensual, disproportionately affected his Article 8 rights.³¹ Mr Nicklinson died six days after his case was rejected by the High Court.³² His wife and two others – Mr Lamb and an individual known as Martin – appealed to the Court of Appeal³³ and then to the Supreme Court,³⁴ claiming that the current legal position breaches the European Convention on Human Rights and questioning whether the prosecution policy is lawful. As we shall see (at 19.9), by a 5:4 majority it was held that the court has the power to declare the law on assisted suicide incompatible with human rights legislation. However, by a 7:2 majority, the ban on assisted suicide was upheld. The Supreme Court Justices were divided as to whether UK law is compatible with Article 8 of the European Convention on Human Rights. Mrs Nicklinson and Mr Lamb’s subsequent application to the ECtHR was ruled inadmissible in 2015.³⁵

Double effect

19.3 Until the law is changed, or the DPP revises his guidelines to extend beyond assisted suicide,³⁶ active euthanasia, whatever the circumstances, equals murder in English law.³⁷ The only exception to that rule was spelled out by Devlin J in the case R v Adams³⁸ in 1957. Dr Adams was charged with the murder of an 81-year-old patient who had suffered a stroke; it was alleged that he had prescribed and administered such large quantities of drugs, especially heroin and morphine, that he must have known that the drugs would kill her. In his summing-up to the jury, Devlin J first stated:

it does not matter whether her death was inevitable and her days were numbered. If her life was cut short by weeks or months it was just as much murder as if it was cut short by years. There has been much discussion as to when doctors might be justified in administering drugs which would shorten life. Cases of severe pain were suggested and also cases of helpless misery. The law knows no special defence in this category.

However, he went on to say:

but that does not mean that a doctor who was aiding the sick and dying had to calculate in minutes, or even hours, perhaps, not in days or weeks, the effect on a patient’s life of the medicines which he would administer. If the first purpose of medicine – the restoration of health – could no longer be achieved, there was still much for the doctor to do and he was entitled to do all that was proper and necessary to relieve pain and suffering even if the measures he took might incidentally shorten life by hours or perhaps even longer. The doctor who decided whether or not to administer the drug could not do his job, if he were thinking in terms of hours or months of life. Dr Adams’s defence was that the treatment was designed to promote comfort, and if it was the right and proper treatment, the fact that it shortened life did not convict him of murder.

Devlin J introduced into English law a version of the ‘double-effect’ principle, whereby if one act has two inevitable consequences, one good and one evil, the act may be morally acceptable in certain circumstances. His ruling is endorsed in Bland.³⁹ It is not crystal clear in its meaning. In one passage, Devlin J referred to the incidental shortening of life by hours and, in another passage, he referred to the shortening of life by hours or months. It must be a matter of judgement in each case.⁴⁰ Clearly he was dealing with terminally ill patients where, in order to alleviate pain, it is permissible to disregard the fact that the treatment involved may accelerate the patient’s death.

In recent years there is evidence of increased use of continuous deep sedation (CDS) – medically induced unconsciousness at the end of life – as a form of palliative care. Use of CDS is inconsistent and poorly documented but one study claims that it is used in around 18 per cent of medically attended deaths in the UK.⁴¹ Provided death is imminent, Mason and Laurie are of the view that CDS can be ‘accommodated within the acceptable processes of good medical practice – as defined by double effect’.⁴² Charles Douglas is less optimistic, particularly when CDS may be accompanied with removal of artificial life support, which might hasten death: ‘[T]he fact that sedation to unconsciousness is available at all will surely remain a source of tension in the debate about assisted death’.⁴³ The spectre of early terminal sedation is particularly worrying. Where it is used on patients whose death is not imminent we would agree with Mason and Laurie that the practice constitutes ‘euthanasia hiding under emollient terminology’.⁴⁴

The application of laws relating to murder and suicide are central to an understanding of law controlling treatment of the dying. It will be appropriate to consider first the case of the ‘competent’ patient, that is, a person with full legal and mental capacity who is aware of what is happening and who may wish to make decisions himself about his quality of life: the way he will be treated and how he will continue to live or die. Second, the case of the adult ‘incapacitated’ patient will be considered: unconscious patients or persons who do not have the mental or physical capacity to make their own wishes known at the relevant times.⁴⁵

Is there a ‘right’ to die?

19.4 Does a patient have a ‘right’ to die? The answer will depend on the circumstances in which she seeks to exercise such a ‘right’. Where the patient lacks capacity, a strong presumption operates in favour of life. But the presumption is not absolute.⁴⁶ In A Local Authority v E,⁴⁷ examined at 6.4, the Court of Protection decided it would be in the best interests of a 32-year-old anorexic patient to be fed, by force if necessary, for a period of a year or longer in circumstances where there was thought to be between a 20 and 30 per cent chance of success. Conversely, in A NHS Foundation Trust v Ms X⁴⁸ and The NHS Trust v L and others⁴⁹ the chances that re-feeding would lead to meaningful recovery were so slim that it was not considered to be in the patients’ best interests to require re-feeding. Futile coercive treatment is not in the best interests of a patient.

What of the competent patient? The Court of Appeal in Re T⁵⁰ made it clear that an adult patient with mental capacity enjoys an absolute right to refuse further treatment even where refusing treatment means certain death. The patient who is terminally ill, or who, even if not terminally ill, suffers from intractable pain or unbearable disability can refuse further treatment. The only caveat is that the evidence that her refusal of treatment was free and informed must be unequivocal. Her reasons to refuse treatment are not material. A patient dying of cancer has the right to say ‘no more’, however strongly her doctor may argue that more chemotherapy would offer her some additional months of life. A person paralysed by multiple sclerosis can refuse to be ventilated. A patient whose condition is no longer bearable to her can take her own life if she has access to the means to do so, and is still independently capable of such action. There is a right to prevent others forcing you to live.

The first major difficulty is this. A patient who wishes to die may already be receiving life-sustaining treatment. She is hooked up to a ventilator or receiving artificial nutrition via a naso-gastric tube or intravenous drip. She wants her life support withdrawn and to be permitted to die. Intrinsically her position seems indistinguishable from the patient who refuses further chemotherapy, or instructs her doctors not to ventilate her. However, someone will have to intervene in this scenario to switch off the ventilator or remove the feeding tube. Will a doctor who does the relevant act risk prosecution for murder or assisting suicide?

The decision in Airedale NHS Trust v Bland⁵¹ made it clear that if a doctor disconnects a patient from life support at her specific request, that act does not constitute either murder or assisting suicide. Bland exposes the fragility of distinctions made between active and passive euthanasia.⁵² Three principles emerge from Bland. (1) Treatment involving any invasive procedure constitutes a battery, unless authorised by the patient, or if he is unable to authorise his own treatment, it is justified by other lawful authority. (2) Continuing invasive treatment once justification for that treatment is withdrawn becomes a battery and therefore unlawful. (3) ANH constitutes treatment as much as drug therapy or ventilation. If a patient instructs doctors to switch off a ventilator or withdraw a naso-gastric tube, failure to act on those instructions renders continuing treatment unlawful.

In B v An NHS Trust,⁵³ Ms B suffered a haemorrhage in the spinal column in her neck. Her condition deteriorated rapidly. Within two years she was paralysed from the neck down and could breathe only supported by a ventilator. Doctors told her that she was unlikely to recover. Rehabilitation programmes to allow her to live outside hospital on the ventilator were proposed to her. Ms B was adamant that she did not want to survive in such a condition. She instructed doctors to switch off the ventilator. The doctors treating her refused, citing conscientious objections to such a course of action and challenging Ms B’s mental capacity to refuse further treatment. Butler-Sloss P held that Ms B retained mental capacity.⁵⁴ That being the case, continuing to ventilate her against her will was unlawful. She was entitled to demand that the ventilator be switched off, though not to require an individual clinician to act contrary to his conscience. Yet there can be no doubt that switching off a ventilator or removing a naso-gastric tube is an act hastening death. The Law Lords in Bland skirt around the logical implications of their findings. Lord Browne-Wilkinson is honest in his appreciation of the dilemma. He says:

Mr Munby QC … submits that the removal of the naso-gastric tube necessary to provide artificial feeding and the discontinuation of the existing regime of artificial feeding constitute positive acts of commission. I do not accept this. Apart from the act of removing the naso-gastric tube, the mere failure to continue to do what you have previously done is not, in any ordinary sense to do anything positive; on the contrary it is by definition an omission to do what you have previously done.

The positive act of removing the naso-gastric tube presents more difficulty. It is undoubtedly a positive act, similar to switching off a ventilator in the case of a patient whose life is being sustained by artificial ventilation. But in my judgment in neither case should the act be classified as positive, since to do so would be to introduce intolerable fine distinctions. If instead of removing the naso-gastric tube, it was left in place but no further nutrients were provided for the tube to convey to the patients’ stomach, that would not be a positive act … if the switching off of a ventilator were to be classified as a positive act, exactly the same result can be achieved by installing a time-clock which requires to be reset every 12 hours; the failure to reset the machine could not be classified as a positive act. In my judgment, essentially what is being done is to omit to feed or ventilate; the removal of the naso-gastric tube or the switching off a ventilator are merely incidents of that omission.⁵⁵

Eliding acts and omissions enable the Law Lords to achieve the desired result. Consider its implications. Luis is sustained by a ventilator. He asks his wife, Anna to switch it off because his doctor refuses to do so. Luis rejects advice to seek a declaration from the courts to overturn his doctors’ advice. Reluctantly, Anna pulls the switch and Luis dies. Is Anna exempt from a charge of murder, or is a Bland defence exclusive to doctors? In the light of B v An NHS Trust, could Anna argue thus? Continuing to ventilate Luis against his will constitutes the tort of battery and the crime of assault. When Anna switched off the ventilator all she did was use reasonable measures to prevent a crime. Then there is the most awkward question of all. What of the patient whose illness renders their life intolerable, but who are not reliant on treatment or life support to survive? Their condition is such that they cannot take their own life.

Assisted dying

19.5 Since the Suicide Act 1961, it is no longer a criminal offence to commit, or attempt to commit, suicide. However, section 2 of the Act, as amended in 2009⁵⁶ provides that:

A person (D) commits an offence if (a) D does an act capable of encouraging or assisting the suicide or attempted suicide of another person, and (b) D’s act was intended to encourage or assist suicide or an attempt at suicide.

It is a crime that may be committed for diverse reasons, ranging from the avaricious to the compassionate. In R v McShane,⁵⁷ a daughter was found guilty of trying to persuade her 89-year-old mother in a nursing home to kill herself so that she could inherit her estate. A secret camera installed by the police showed the daughter handing her mother drugs concealed in a packet of sweets, and pinning a note on her dress saying ‘Don’t bungle it’.

Clear evidence of aiding and abetting a particular act of suicide is necessary before a prosecution can be successful. In Attorney-General v Able,⁵⁸ the court was asked to declare that it was an offence for the Voluntary Euthanasia Society to sell a booklet to its members aged 25 and over, setting out in some detail various ways in which individuals could commit suicide. The Society neither advocated nor deplored suicide; it had a neutral stance and regarded such decisions as matters of personal belief and judgement. Evidence in the case suggested that over a period of eighteen months after the first distribution of the booklet, there were fifteen cases of suicides linked to the booklet, and nineteen suicides where documents were found which showed that the deceased was a member of, or had corresponded with, the Society. The court concluded that in most cases the supply of the booklet would not constitute an offence. Normally, a member requesting the booklet would not make clear his intentions, and the booklet would be supplied without any knowledge by the supplier of whether it was required for general information, research, or because suicide was contemplated. To establish an offence, it would have to be proved that the Society distributed the booklet to a person who, at the time of the distribution, was known to be contemplating suicide, with the intention of assisting and encouraging that person to commit suicide by means of the booklet’s contents, and, further, that that person was in fact assisted and encouraged by the booklet to commit or attempt to commit suicide.

So too the doctor who knowingly provides someone with sufficient tablets with which to end a life, and advises how best to take them, risks prosecution. In 2010 the CPS decided not to charge Dr Wilson, a member of pro-euthanasia group Friends At The End (Fate), for advising a multiple sclerosis sufferer, Caroline Loder, how to commit suicide. Dr Wilson did not meet Loder, and nor did she encourage her suicide. However the offence encompasses both encouragement and assistance. In a press statement, the CPS said that there was ‘sufficient evidence to lead to a realistic prospect of conviction’ but because Dr Wilson’s input was minimal, it was not in the public interest to prosecute.⁵⁹

The well informed and able may kill themselves. The patient dying of degenerative disease, or in the terminal throes of cancer, may need help to do so. If Fatima can breathe only with the aid of a ventilator, she can require her doctor to switch off the ventilator. If Fatima is slowly choking to death with motor neurone disease, but can still swallow enough lethal sleeping tablets, Fatima can end her misery. If Fatima is so weakened by the disease that she cannot reach for the tablets or swallow, she must endure her suffering.

An increasing number of commentators now advance the case for legalising physician assisted dying.⁶⁰ But what does this mean? The Oregon Death with Dignity Act 1994, Washington State Death with Dignity Act 2009 and Vermont Patient Choice and Control at End of Life Act 2013⁶¹ allow doctors to comply with a patients’ request for medication to end their life. But this does not meet the truly hard cases where the patient, even if supplied with medication, cannot take the dose independently. As we shall see, recent attempts to introduce legislation legalising physician assisted dying in England and Wales have so far proved unsuccessful.

The patient who cannot commit suicide

19.6 Does the patient who cannot, or does not wish to administer the means of suicide himself, have a right to assistance? Articles 2, 3, 8, 9 and 14 of the European Convention on Human Rights have been employed, to date unsuccessfully, in defence of such a right.

This matter first came before the UK courts in the sad case of Dianne Pretty. Mrs Pretty was dying of motor neurone disease. Gradually she had lost all ability to use her muscles. She could barely speak and could not swallow. She was fed by a tube. Mrs Pretty sought an assurance from the Director of Public Prosecutions (DPP) that no charge would be brought against her husband should he help her to die at a time of her choice. The DPP refused to give any such assurance. Mrs Pretty brought an application for judicial review. She argued that the DPP acted unlawfully. The DPP failed to pay due regard to Mrs Pretty’s fundamental human rights. Her application failed before the Divisional Court,⁶² as did her subsequent appeal to the House of Lords.⁶³ She took her case to the ECtHR at Strasbourg, but lost again.⁶⁴ The Law Lords held that the decision not to promise immunity to Mr Pretty should he help his wife to die was not, in the circumstances, amenable to judicial review.⁶⁵

What human rights arguments did Mrs Pretty raise? It was put to the judges that Article 2, endorsing the right to life, carried with it the corollary of a right to die at a time and in a manner of one’s own choosing. The Law Lords were unimpressed. They could read nothing into Article 2 to confer a right to be helped to die. Lord Bingham regarded Article 2 as embodying the traditional doctrine of sanctity of life. He put it thus:

Whatever the benefits which, in the view of many, attach to voluntary euthanasia, physician-assisted suicide and suicide without the intervention of a physician, these are not benefits which derive protection from an article framed to protect the sanctity of life.⁶⁶

Nor did an argument based on Article 3 prohibiting inhuman or degrading treatment find any greater favour. Dignity in sickness and dying should be protected. Nothing in Article 3 conferred a positive obligation to help an individual end her life.⁶⁷ The Divisional Court declared:

far from having the effect contended for by Mr Havers, Article 2 and 3 between them are aimed at the protection and preservation of life and the dignity of life, because of its fundamental value, not only to the individual but also to the community as a whole. It is to stand the whole purpose of these articles on its head to say that they are aimed at protecting a person’s right to procure their own death.

In the House of Lords, Lord Bingham⁶⁸ doubted whether any positive obligation to prevent citizens being subjected to degrading treatment could translate into a duty to ensure a person could seek help to die. Lord Steyn was clear that: ‘article 3 was not engaged’. It was:

singularly inapt to convey the idea that the state must guarantee to individuals a right to die with the deliberate assistance of third parties. So radical a step, infringing the sanctity of life principle, would have required far more explicit wording.⁶⁹

Lord Hope⁷⁰ was not convinced that Mrs Pretty’s condition met the minimum level of severity required in Article 3. Since she could not be compelled to accept treatment and, in his view, palliative treatment was available, Lord Hope doubted that her state was degrading.⁷¹

Arguments centred on Article 8, the right to respect for private and family life, fared a little better. The Divisional Court conceded that Article 8 could extend to embrace a right to bodily integrity, including a right to refuse life-saving treatment. They were even prepared to assume Article 8(1) could extend to a right to be allowed to take one’s own life. In some of their speeches, the Law Lords suggest Article 8 does not even go that far. Lord Steyn puts it bluntly:

article 8 prohibits interference with the way in which an individual leads his life and it does not relate to the manner in which he wishes to die.⁷²

The ECtHR, on the other hand, was ‘not prepared to exclude that this constitutes an interference with [Dianne Pretty’s] right to respect for private life as guaranteed under Article 8(1) of the Convention’.⁷³ However the European Court and House of Lords concurred with the Divisional Court that even if some sort of right to choose one’s manner of dying can be inferred from Articles 8(1), Article 8(2), placing restrictions on privacy rights, justifies the state in criminalising assisted dying. The need to afford protection for vulnerable people, especially the elderly, justifies the provisions of the Suicide Act as they stand. Lord Bingham says:

It is not hard to imagine that an elderly person, in the absence of any pressure, might opt for a premature end to life if that were available, not from a desire to die or a willingness to stop living, but from a desire to stop being a burden to others.⁷⁴

Arguments grounded on Article 9 and 14 of the Convention also failed. Two policy questions perhaps influenced the judges in the Divisional Court and the Lords. First note that Mrs Pretty did not seek physician assisted suicide, but her husband’s help to die. The Divisional Court noted:

We are not being asked to approve physician assisted suicide in carefully defined circumstances with carefully defined safeguards. We are being asked to allow a family member to help a loved one die, in circumstances of which we know nothing, in a way of which we know nothing, and with no continuing scrutiny by any outside person.⁷⁵

Second, the Law Lords were much exercised by the European scope of the Convention. Lord Steyn made this point:

The fact is that among the 41 member states … there are deep cultural and religious differences in regard to euthanasia and assisted suicide. The legalisation of euthanasia and assisted suicide as adopted in the Netherlands would be unacceptable in predominantly Roman Catholic countries in Europe. The idea that the European Convention requires states to render lawful euthanasia and assisted suicide (as opposed to allowing democratically elected legislatures to adopt measures to that effect) must therefore be approached with caution.⁷⁶

Debbie Purdy tried a different approach. She was diagnosed with multiple sclerosis in 1995, after which her condition deteriorated. Like Dianne Pretty she was concerned that she would need the support of her husband to travel abroad to an assisted suicide clinic in which case he might be prosecuted under section 2(1) of the Suicide Act. Her argument was that the lack of specific guidance on assisted suicide in the Code for Crown Prosecutors breached her right under Article 8 of the European Convention on Human Rights. That lack of clarity prevented her from identifying the facts and circumstances relevant to any future prosecution. The House of Lords, in their final decision before moving to the Supreme Court, overruled the Court of Appeal decision. The House of Lords did not rule whether or not it was lawful to assist another in their suicide by travelling abroad to a suicide clinic, but it did require the DPP to clarify his guidance.⁷⁷

R (on the application of Purdy) v DPP⁷⁸ has connotations for public law⁷⁹ but is also significant in its application of Article 8. Purdy argued that the Article was engaged, as was indicated in the ECtHR decision in Pretty. But the lower courts were bound by the House of Lords’ decision, concluding: ‘it is their Lordships who, if they think it appropriate, must release the knot’.⁸⁰ The House of Lords acknowledged not only that Article 8(1) was engaged, but that the level of discretion exercised by the DPP was not justified under Article 8(2).⁸¹

The relevance of Article 8 was considered by the ECtHR again in 2013. Ms Gross was an elderly Swiss national with capacity. She had a settled wish to die and sought physician assisted suicide as an exercise of free will, based on her increasing frailty and not associated with a clinical or psychiatric condition. Because her case did not fall within the requirements laid down in Swiss medical ethics guidelines, she initially found it difficult to locate a doctor willing to prescribe a lethal dose of sodium pentobarbital. Her application was lodged with the court in 2010. She argued that the Swiss law breached her Article 8 right to decide how to end her life. In 2011, she found a doctor willing to prescribe the lethal dose and ended her life. However, the court was only made aware of her death in 2014. In the meantime, her counsel dealt with an intermediary who had agreed with Ms Gross to keep her death quiet. She wanted the case to continue for the sake of others in her position. Assuming Ms Gross to still be alive, the ECtHR in a 4:3 ruling found that Swiss law lacked clarity and therefore violated her Article 8 rights.⁸² The substantive content of the law was not discussed – the court focused on the lack of clear and comprehensible guidance. The decision was not final and was selected to come before the Grand Chamber, whereupon it was discovered by the Swiss government that Ms Gross was deceased. The Grand Chamber was divided. Should the law be clarified, or the case thrown out as an ‘abuse of the right of application’? In a 9:8 ruling, the majority, finding that Ms Gross had deliberately misled the Court, opted for the latter course.⁸³ The 2013 judgment is therefore robbed of any effect. The last (judicial) word on physician assisted suicide may still be to come. In the UK, hopes that the Strasbourg Court or Parliament will take this burden from judges and prosecutors have so far proved unfounded.

Death tourism

19.7 With the development of the freedom of movement in Europe, some patients have travelled abroad to take advantage of laws permissive of assisted dying in a practice labelled ‘death tourism’. In Switzerland, assisted dying is not illegal provided it is not motivated by self-serving ends.⁸⁴ The practice of assisting dying is not limited to doctors and the suicide organisations in Switzerland are some of the few in the world willing to accept foreign patients.⁸⁵ The English courts are powerless to intervene unless someone ‘does an act capable of encouraging or assisting the suicide or attempted suicide of another person’. Many applicants are too ill to make all the arrangements themselves and are helped by a doctor or loved one.

In Re Z (An Adult: Capacity),⁸⁶ Mr Z informed his local authority that he and his wife, Mrs Z would travel to Switzerland where arrangements had been made for her to end her life at the Zurich-based assisted-suicide clinic, Dignitas. Could the court prevent him from assisting his wife? The judge satisfied himself that Mrs Z remained competent and was not subject to any undue influence. The decision to travel to Switzerland was hers. Any question of her husband’s criminal liability was a matter for the Director of Prosecutors who had not authorised any prosecution: ‘[A]lthough an act may be criminal, it is not always in the public interest to prosecute in respect of it’.⁸⁷

Hirst argues that no offence is committed in these circumstances on the basis that, unless statute provides otherwise, the criminal law has no application outside this country.⁸⁸ Nor, Hirst argues, would initial preparations in this country necessarily lead to a prosecution, because arguably⁸⁹ assisted suicide is criminal only when the assisted suicide or attempted assisted suicide actually occurs. These arguments were considered in Purdy but not resolved as they were not central to the case.⁹⁰ Consequently rather than relying on jurisdictional arguments, those travelling abroad to assist a loved one in his suicide should pay heed to the DPP’s guidelines about prosecution.⁹¹

The DPP’s policy for prosecutors

19.8 Following a public consultation exercise, the DPP issued a Code for Crown Prosecutors and the Policy for Prosecutors in respect of Cases of Encouraging or Assisting Suicide, in February 2010. The Code shifts emphasis from the characteristics of the victim, to the motives of the suspect.⁹² It encompasses not only those travelling abroad for assisted dying, but also those who assist or attempt to assist dying in England and Wales.⁹³ It imposes a two-stage test. For the evidential stage to be satisfied, the prosecution must prove that the victim attempted to commit suicide and the suspect has done an act capable of encouraging or assisting the suicide or attempted suicide of another person. At the public interest stage each case is considered on its merits. The Code lists sixteen factors in favour of prosecution (for example where the victim is under 18; the suspect was not motivated purely by compassion; or the suspect acted in his capacity as a healthcare professional)⁹⁴ and six against.

A prosecution is less likely to be required if:

1.  the victim had reached a voluntary, clear, settled and informed decision to commit suicide;

2.  the suspect was wholly motivated by compassion;

3.  the actions of the suspect, although sufficient to come within the definition of the offence, were of only minor encouragement or assistance;

4.  the suspect had sought to dissuade the victim from taking the course of action which resulted in his or her suicide;

5.  the actions of the suspect may be characterised as reluctant encouragement or assistance in the face of a determined wish on the part of the victim to commit suicide;

6.  the suspect reported the victim’s suicide to the police and fully assisted them in their enquiries into the circumstances of the suicide or the attempt and his or her part in providing encouragement or assistance.⁹⁵

To date, the guidelines have resulted in a permissive approach. The CPS had the required evidence to prosecute Michael Bateman who helped his wife to commit suicide. She was in chronic pain and had a settled wish to die. Bateman put a plastic bag over her head and assembled helium gas apparatus, but Mrs Bateman tightened the bag and turned on the helium.⁹⁶ The CPS concluded that it was not in the public interest to prosecute. The first (and, as far as we are aware, only) prosecution since the guidelines were issued was made in 2013. Mr Kevin Howe was found guilty of encouraging or assisting attempted suicide when he intentionally supplied his friend, Mr Walker, with the means by which to set himself on fire. Mr Walker had mental health problems and had previously attempted suicide. The 19-year-old Howe purchased petrol and a lighter which Mr Walker poured over his head and lit. Walker suffered terrible burns, but miraculously survived.⁹⁷

The permissive nature of the DPP’s policy did not receive universal acclamation. Laing questions the constitutionality of the DPP’s Code, suggesting that the lenient approach it endorses will gradually alter criminal law without recourse to Parliament.⁹⁸ On the other hand, campaigners argue that the reformed Code is not permissive enough.

The matter came before the Supreme Court in 2013. The ‘Nicklinson litigation’ was in fact a series of claims by three individuals: Tony Nicklinson, Paul Lamb and an individual known as ‘Martin’. Each wanted his life to end but lacked the ability to bring this about. The Lamb/Nicklinson claim was a bid to change the law so as to sanction assisted suicide. Martin’s claim was an attack on the DPPs guidelines. Let us take them in order.

Challenging the prohibition on assisted suicide in court

19.9 Unlike Martin, Tony Nicklinson and Paul Lamb would be physically unable to undertake assisted suicide.⁹⁹ After his claim failed in the High Court,¹⁰⁰ Mr Nicklinson refused food and contracted pneumonia. He died six days after the decision. His wife Jane Nicklinson and Paul Lamb, who was paralysed in a road accident, took the case to the Court of Appeal arguing (on the grounds of necessity) that voluntary euthanasia would not be unlawful. The claim was dismissed¹⁰¹ and they went on to the Supreme Court.¹⁰²

In the Supreme Court, the Nicklinson/Lamb case centred on the alleged incompatibility of the law with Article 8. The first matter was to determine whether the courts have the authority to declare the prohibition on assisted suicide incompatible with Article 8. Lord Neuberger, Lady Hale, Lord Mance, Lord Kerr and Lord Wilson (a majority of 5:4) held that it does. Lord Neuberger (President) concluded that:

[E]ven under our constitutional settlement, which acknowledges parliamentary supremacy and has no written constitution, it is, in principle, open to a domestic court to consider whether section 2 infringes article 8. The more difficult question, to which I now turn, is whether we should do so.¹⁰³

In answer to his question, Lord Neuberger concluded that the timing was not (yet) right:

In my opinion, before making such a declaration, we should accord Parliament the opportunity of considering whether to amend section 2 so as to enable Applicants, and, quite possibly others, to be assisted in ending their lives.¹⁰⁴

Lord Clarke, Lord Sumption, Lord Reed and Lord Hughes called for Parliament to address the issue. Lady Hale and Lord Kerr, however favoured granting a declaration of incompatibility. Lady Hale (dissenting) said:

Like everyone else, I consider that Parliament is much the preferable forum in which the issue should be decided. Indeed, under our constitutional arrangements, it is the only forum in which a solution can be found which will render our law compatible with the Convention rights. None of us consider that section 2 can be read and given effect, under section 3(1) of the Human Rights Act 1998, in such a way as to remove any incompatibility with the rights of those who seek the assistance of others in order to commit suicide. However, in common with Lord Kerr, I have reached the firm conclusion that our law is not compatible with the Convention rights. Having reached that conclusion, I see little to be gained, and much to be lost, by refraining from making a declaration of incompatibility. Parliament is then free to cure that incompatibility, either by a remedial order under section 10 of the Act or (more probably in a case of this importance and sensitivity) by Act of Parliament, or to do nothing. It may do nothing, either because it does not share our view that the present law is incompatible, or because, as a sovereign Parliament, it considers an incompatible law preferable to any alternative.

By a majority of 7:2 the appeal was dismissed. Lord Neuberger offered Parliament the chance to change the law. Lady Hale and Lord Kerr had run out of patience. The subsequent application to the European Court of Human Rights (ECtHR) in 2015 was ruled inadmissible for non-exhaustion of domestic remedies.¹⁰⁵ As we shall see, proposals for legislative change in 2003, 2004, 2005 and 2009 led to naught. The Assisted Dying Bill 2014–15 progressed further than any other, but ran out of time in 2015. The Assisted Dying Bill (No 2) 2015–16 did not pass its second reading. The Supreme Court waits in the wings.¹⁰⁶

Prosecution policy on physician assisted suicide

19.10 Martin (as he was known for the purpose of the proceedings) suffered a brain stem stroke and had very limited movement. He wanted to travel to Dignitas for assisted suicide, but to do so would require assistance from another. His wife respected his decision to end his life but did not want to play a role in bringing about his death. Like Nicklinson and Lamb, Martin also relied on Article 8, but rather than challenging the compatibility of the Suicide Act with the Convention, his claim focused on the lack of clarity in the DPP’s guidelines. If someone who had no personal connection to him – a healthcare professional or carer, for example – decided out of compassion to help him to die, would they be more likely to face prosecution? The lack of clarity, he claimed, was a disproportionate interference with his rights under Article 8(2) of the European Convention on Human Rights.

The DPP’s Code distinguishes between suicide assisted by loved ones and doctors. One factor in favour of prosecution is:

The suspect was acting in his or her capacity as a medical doctor, nurse, other healthcare professional ... and the victim was in his or her care. [emphasis original]¹⁰⁷

Whether this component of the policy was designed to target doctors who use undue influence to persuade a patient to access assisted suicide or also to incorporate doctors whose involvement in the final stages of illness is entirely motivated by compassion was initially unclear. The GMC attempted to fill the lacuna, issuing guidance in 2013 stating:

Where patients raise the issue of assisting suicide, or ask for information that might encourage or assist them in ending their lives, doctors should be prepared to listen and to discuss the reasons for the patient’s request but they must not actively encourage or assist the patient as this would be a contravention of the law. Any advice or information they give about suicide should be limited to an explanation that it is a criminal offence for them to encourage or assist a person to commit or attempt suicide.¹⁰⁸

The GMC’s approach is highly restrictive. Is this what the DPP intended? Martin’s challenge was unsuccessful in the High Court, but in a 2:1 Court of Appeal judgment, it was held:

In our view, the Policy should give some indication of the weight that the DPP accords to the fact that the helper was acting in his or her capacity as a healthcare professional and the victim was in his or her care.¹⁰⁹

Martin’s success was short-lived. On appeal, the Supreme Court unanimously allowed the DPP’s appeal. It was not, the Court held, for judges to dictate matters of policy.

Nonetheless, in 2014 the DPP amended the policy, emphasising that the factor for prosecution will apply only where the doctor has exerted influence on the ‘victim’.¹¹⁰ Those who act out of compassion are unlikely to face prosecution.

In light of this policy change, Martin launched a bid to require the GMC to follow suit and amend its guidance.¹¹¹ Martin’s application for judicial review sought to ensure that doctors assisting those in his position would not face disciplinary action. In R (AM) v The General Medical Council¹¹² the court found that the GMC’s guidance did not breach Articles 8 or 10 of the Convention and neither was the GMC required to ensure that its guidance is in line with the DPP’s. In 2015 an application for judicial review of the DPP’s policy on the grounds that the DPP has overstepped the mark, making instead of applying the law, was dismissed.¹¹³

Should patients be able to turn to their doctor for help? To have adopted a permissive approach to physician assisted suicide might have been hailed a radical (and unconstitutional) change in law. Doctors are primarily concerned with preserving life. Though in 2005, the British Medical Association (BMA) changed its policy on assisted dying from one of opposition to one of neutrality, the Royal College of General Practitioners and the Royal College of Physicians maintained their opposition to both physician assisted suicide and voluntary euthanasia, and, in a spectacular U-turn, the BMA reverted to opposition in 2006.¹¹⁴ Not all healthcare professionals support this approach. The Royal College of Nurses moved to a position of neutrality in 2009. And in 2010 a body of medical professionals dedicated to changing the law on the right to die launched Healthcare Professionals for Change.¹¹⁵ What are the options for legislative reform?

The assisted dying debate¹¹⁶

19.11 English law is imprecise and uncertain. Doctors cannot always be given clear advice about the legality of various procedures. Is this fair to the medical profession? Is it right that some doctors, even acting with the best of motives, may under a screen of silence do things which they believe may be unlawful? There is some evidence that doctors practise covert euthanasia.¹¹⁷ If what is taking place in medical practice is acceptable to society, it is argued that the law should be changed to set out clearly the parameters within which they should be acting. If society disapproves of certain procedures, how can they be controlled? Is it right, again, for the law to be left obscure, yet that when clear evidence of euthanasia occurs prosecutors may elect not to enforce the law? On the other hand there are those who oppose legislation on the grounds that the current fudge allows for maximum flexibility for a caring medical profession.

Once any proposal to clarify the current fudge surfaces, opinions polarise sharply. As Kennedy and Grubb note ‘whenever the topic of voluntary euthanasia is broached, rational argument becomes an early casualty’.¹¹⁸ The case for voluntary euthanasia is deceptively simple. It rests on the principle of autonomy. The individual is the ‘final determinant of his or her destiny’.¹¹⁹ We enjoy the right to control our death just as we enjoy the right to control our lives. Moreover, dignity and welfare, it is contended, impel us to allow the individual the right to end an intolerable life. A compassionate society should not force people dying, or living, with pain and disability, to continue to live. The patient in the terminal stages of motor neurone disease should not be compelled to suffer all the consequences of a drawn out death. Human rights are invoked in support of the pro-euthanasia case. Article 3 prohibits inhuman and degrading treatment. Does the absence of an assisted dying option in effect impose such degrading treatment? Article 8 protects our private and family lives. Do laws preventing my doctor, or indeed my husband, from helping me to end an intolerable life violate my privacy? We have seen that the Supreme Court decision in Nicklinson may herald renewed interest in the relevance of Article 8.

Those opposed to legislation permitting physician assisted suicide and voluntary euthanasia advance several objections. For many, though not all opponents of euthanasia, central to their opposition to euthanasia is their commitment to the doctrine of sanctity of life.¹²⁰ But other concerns are voiced. Just how voluntary would such euthanasia be? Would the introduction of such laws result in a change of attitude by society towards the sanctity of life generally, towards the elderly, infirm and the mortally sick? Would the existence of such laws impose pressures upon elderly and terminally ill patients to seek euthanasia, rather than remain a burden on relatives or on society? Would the existence of such legislation provide opportunities for fraud and abuse, and undermine the relationship of trust between doctor and patient? How easy would it be to apply such a law?

Let us examine what kind of form legislation might take. It seems increasingly likely that any reform would centre on human rights rather than the criminal law. Two rather different sorts of laws might be envisaged – both of which have models in other jurisdictions. Legislation could sanction physician assisted dying (as is the case in the states of Oregon, Vermont and Washington, USA) or could allow voluntary active euthanasia (as is the case in the Netherlands and Belgium).¹²¹

Legislating to allow physician assisted suicide¹²²

19.12 The Oregon Death with Dignity Act 1994 came into force in 1997. It applies only to adults who have been diagnosed as terminally ill. A prescription for oral medication is the only assistance sanctioned. Direct assistance with suicide is prohibited.¹²³ The Washington State Death with Dignity Act 2009 allows terminally ill adults with less than six months to live to ask their doctors for a life-ending prescription. Vermont’s Patient Choice and Control at End of Life Act 2013 provides criminal, civil and professional protections for doctors who prescribe life-ending medication to capacitous, terminally ill patients.¹²⁴ Lord Joffe’s Patient (Assisted Dying) Bill 2003 was modelled on the Oregon Act, but incorporated voluntary euthanasia for those physically incapable of taking the final steps to end their life. It did not progress beyond a Second Reading. His ill-fated Assisted Dying for the Terminally Ill Bill 2004 ran out of time. It was more restrictive than the 2003 Bill, applying only to terminally ill patients and including a requirement for a discussion of the option of palliative care. The Select Committee on the Assisted Dying for the Terminally Ill Bill reported in April 2005.¹²⁵ Nine recommendations were made for any future bills, including (inter alia):

–  a clearer delineation between euthanasia and physician assisted suicide;

–  a statement of the actions which a doctor may or may not take in providing assisted suicide or administering voluntary euthanasia;

–  a clinical definition of terminal illness (if terminal illness is a qualifying condition);

–  a definition of mental competence so as to differentiate between applicants lacking mental capacity and those suffering a mental disorder.¹²⁶

Lord Joffe accepted four of the nine recommendations when introducing his third Bill in 2005. It was outvoted in the House of Lords by 148 to 100.¹²⁷ And two attempts to amend the Coroners and Justice Bill (now the Coroners and Justice Act 2009) to legalise a limited form of assisted suicide were unsuccessful.

Despite increasing public support,¹²⁸ recent attempts to legislate have also failed. Lord Falconer introduced a Private Member’s Bill in 2013 called the Assisted Dying Bill.¹²⁹ Shaped by the findings of the Commission on Assisted Dying,¹³⁰ it was reintroduced in 2014. It aimed to allow competent terminally ill adults with a life expectancy of up to six months to self-administer (by swallowing medication or activating a syringe driver) medication that will end their lives. The Bill included a conscientious objection clause¹³¹ and legislation would be accompanied by a Code of Practice. It focused on terminal illness and excluded from its remit those in the position of Nicklinson and Lamb. Thus, Alexandra Mullock warned that it would not resolve the tensions between their position and Article 8 of the European Convention.¹³² In any event, the Bill ran out of time in 2015. It was introduced again in 2015¹³³ but did not have government backing and failed to make it to the statute book.

In May 2015 the Scottish Parliament rejected the Assisted Suicide (Scotland) Bill by eighty-two to thirty-six votes.¹³⁴ Margo MacDonald’s first Bill¹³⁵ was defeated in 2010. Her 2013 Bill was closely modelled on the Oregon law and aimed to allow those with terminal illness or deteriorating progressive conditions to seek assisted death. Patrick Harvie took up the cause when Margo MacDonald died in 2014.

Active euthanasia

19.13 Meyers and Mason¹³⁶ envisaged the doctor ‘providing or administering a lethal dose of medication’. But a lethal injection performed by the doctor must be killing, not simply assisting suicide? Do we have to resort to complex mechanical devices whereby the doctor sets up a machine to inject the patient with her lethal dose and somehow (maybe via a computer) she triggers the mechanism delivering the injection? The line between assisted dying and killing becomes as fragile as the artificiality of the current law. In Pretty, Lord Bingham exposed the dilemma:

If article 2 does confer a right of self-determination in relation to life and death, and if a person were so gravely disabled as to be unable to perform any act whatsoever to cause his or her own death, it would necessarily follow in logic that such a person would have a right to be killed at the hands of a third party.¹³⁷

In the Netherlands, an informal agreement between the prosecution authorities and the medical profession allowed active euthanasia for several years. The Postma¹³⁸ case was the first in a series of rulings easing restrictions on euthanasia. Dr Postma gave his disabled mother, who had previously attempted suicide and no longer wanted to live, a fatal dose of morphine. The court imposed a suspended sentence of one week’s imprisonment and indicated that euthanasia might be acceptable, provided that the patient was incurably ill, was suffering unbearably, had requested assisted suicide, and that the act was performed by the patient’s own doctor or in consultation with her. Nine years later, the prosecution authorities agreed not to prosecute any doctor who ended his patient’s life within the parameters set by agreed guidelines.¹³⁹ The patient must have freely requested ‘help in dying’ and the physician must assure himself that that request is truly voluntary and well considered. The patient and his doctor must be satisfied that there are no other means of relieving the patient’s suffering or other incurable condition. A second doctor must be consulted. It is estimated that thousands of patients each year have opted for active euthanasia in the Netherlands, amounting to around 2.8 per cent of all reported deaths in 2010.¹⁴⁰ Nonetheless, until 2000, euthanasia remained formally unlawful in the Netherlands. Legislation to give legal effect to the earlier informal arrangements came into force in 2002.¹⁴¹ Controversially, individuals can make advance requests for euthanasia and children over 12 may request it, though until they are 16, parental assent is required.¹⁴²

The impact of Dutch practice and their new laws is much debated. Opponents argue¹⁴³ (inter alia) that: (1) the incidence of active euthanasia is under-reported; (2) there is evidence of termination of life without an explicit request from the patient (in perhaps as many as one in five cases); (3) withdrawal of treatment with minimal safeguards is common; (4) depressed and mentally disturbed patients are helped to die. The nub of the case is that what is supposed to be a limited provision to allow free and informed choices by competent patients to end their lives has become a convenient means of disposing of the elderly and grievously sick.¹⁴⁴ Supporters¹⁴⁵ equally passionately refute these allegations. Dispassionate analysis of how voluntary euthanasia ‘works’ in the Netherlands is hard to find.

The first Euthanasia Bill in this country was introduced into Parliament in 1936. The Bill was quickly rejected. Another Voluntary Euthanasia Bill, introduced in 1969, was designed to allow a patient or prospective patient to sign in advance a declaration requesting the administration of euthanasia if he was believed to be suffering from a fatal illness or was incapable of rational existence. Again, the Bill failed. The coup de grâce was applied with the following comment:

Such a Bill is medically unnecessary, psychologically dangerous and ethically wrong. Unnecessary, because legal rigidity should not be substituted for medical discretion. Dangerous, because this Bill would diminish the respect for life, blurring the line between crime and medicine. Ethically wrong, because it infringes on the absolute value of life.

Subsequent Bills in the mid-1970s were more modest and attempted to avoid being seen as attempts to legalise euthanasia or ‘mercy killing’. In the wake of the decision in Bland, the House of Lords set up a Select Committee on Medical Ethics¹⁴⁶ to investigate legal, ethical and social issues surrounding treatment decisions at the end of life. The Committee endorsed the judges’ ruling in Bland, commended, but refused to endorse legislation to give effect to advance directives, and in total delivered a report of almost amazing banality. Their recommendations in effect were to change nothing and to leave such difficult questions to the doctors. The report came out firmly against legalising voluntary euthanasia. Their Lordships considered that argument based on autonomy, the right to choose to die constituted ‘insufficient reason to weaken society’s prohibition on intentional killing’. It was not, in their view, possible to set secure limits in voluntary euthanasia, and vulnerable people might be pressured into requesting early death. Moreover, there was good evidence that palliative care could relieve pain and distress in the majority of cases. The debate intensifies. It does not seem to move on.¹⁴⁷

The unconscious patient¹⁴⁸

19.14 The patient who retains mental capacity can thus refuse further treatment to bring an end to her life but active euthanasia is contrary to the law. What of the fate of the patient whose illness or injury has rendered him unconscious and unlikely ever to regain consciousness? What test should be employed to determine the appropriate course of action? Two tests were examined in Chapter 6; the substituted judgement test and the best interests test, and we have seen that in England the Mental Capacity Act 2005 has given statutory force to the best interests test. The substituted judgement test was employed in the seminal American case of Karen Quinlan,¹⁴⁹ a young woman who, suddenly stricken with illness, lay in a coma attached to a life-support machine. Although she was not brain stem dead, her doctors were satisfied that there was no hope that she would ever recover a cognitive state: she was characterised as being in a ‘chronic, persistent, vegetative condition’ kept alive only with the assistance of a ventilator. Karen’s parents decided that it would be best for her to be removed from the life-support machine. Accordingly, her father applied to the court to be appointed her guardian and claimed that, as guardian, he would be entitled to authorise the discontinuance of all ‘extraordinary’ medical procedures sustaining Karen Quinlan’s life. The Supreme Court of New Jersey upheld the father’s claim. First, had Karen Quinlan been conscious and lucid, she would have had a right, just like Ms B, to decide to discontinue life-support treatment in circumstances where it was simply prolonging for a short period a terminal condition. She was not conscious or lucid. Second, because of her condition, her father was appointed guardian and the question then arose whether he could make a decision of that kind on her behalf. He was entitled to go to the court to seek assistance; and the court was prepared to ‘don the mental mantle of Karen Quinlan’ to make a decision for her which she would have made had she been able to do so. Thus, by applying a ‘substituted judgement’ test, the court decided that if, upon the concurrence of the guardian and the family of the patient, the attending physicians should conclude that there was no reasonable possibility of her ever emerging from her comatose condition to a cognitive state and that the life-support apparatus should be discontinued, they should consult with the Hospital Ethics Committee and, if that body agreed, the life-support system might be withdrawn, without any civil or criminal liability on the part of any participant. Following that judgement, a Hospital Ethics Committee was convened and the decision was taken to remove the life-support system machine. It is an interesting reflection on the fallibility of human judgement that withdrawal of the life-support system did not lead to a swift death, and Karen Quinlan survived for ten long years after falling into the coma.

Quinlan illustrates the substituted judgement test working smoothly but where relatives disagree as to the appropriate course of action, the substituted judgement test can result in acrimonious legal action. Difficult decisions remain difficult whether the legal test is best interests or substituted judgement.¹⁵⁰

English law has rejected a test whereby the next of kin should automatically enjoy proxy powers of consent. Instead, both the case law and the Mental Capacity Act 2005 embrace a modified best interests test. The Mental Capacity Act introduces important changes in practice. The Court of Protection can appoint a ‘deputy’ to act for the patient. Alternatively the patient himself can, while competent, appoint a donee of a Lasting Power of Attorney (LPA) to make certain decisions on his behalf if, or when, he loses capacity to make them himself. He may also make an advance directive refusing treatment.¹⁵¹ Decisions of the LPA and the relevance and applicability of advance directives are subject to stringent controls.¹⁵² The best interest test survives the reform, and earlier case law remains relevant. As we shall see, the best interests test involves a careful balancing of the sanctity of life, the quality of life and the individual’s rights and interests in dignity and autonomy.¹⁵³

Bland: crossing the Rubicon?¹⁵⁴

19.15 At the age of 17, Anthony Bland suffered crush injuries at Hillsborough football stadium. He suffered catastrophic and irreversible damage to his brain. The condition from which he suffered was known as a persistent vegetative state (PVS).¹⁵⁵ He had lost all cortical (higher brain) function, but his brain stem continued to function. PVS patients continue to breathe independently and their digestion continues to function. Tony Bland was incapable of voluntary movement and could feel no pain. He could not see or hear, taste or smell.¹⁵⁶ He remained alive, fed through a tube. All his excretory functions were managed mechanically. Doctors were agreed that there was no hope of recovery of any sort. In this condition, the young man existed for two years until, with the concurrence of his family, the hospital applied for a declaration that they might lawfully discontinue ANH. The House of Lords unanimously granted that declaration.

We have seen¹⁵⁷ how their Lordships managed to find that withdrawing the naso-gastric tube was not an act hastening death such as to expose doctors to liability for murder. Tony Bland, however, could not instruct his doctors to cease treatment. Unlike in the Karen Quinlan case in the USA, his family could not seek to be appointed as guardians of their adult son. The Law Lords fell back on F v West Berkshire Health Authority.¹⁵⁸ When a patient was incapable of deciding whether to continue treatment for himself, what could lawfully be done to him depended on what constituted treatment in his best interests and in conformity to responsible medical practice. For Lords Goff, Keith and Lowry, the evidence of medical opinion and professional guidelines on diagnosis and confirmation of PVS assisted them to conclude that, as Tony Bland received no benefit from treatment, it was not in his best interests to continue naso-gastric feeding. They reasoned – the regime of artificial feeding constitutes treatment, an overwhelming body of medical opinion supported withdrawing ANH from patients confirmed in PVS.¹⁵⁹ Therefore withdrawing ‘treatment’ was lawful.

Lord Mustill acknowledged¹⁶⁰ the complexity of best interests in this context. Tony Bland was not suffering; he felt no pain.

By ending his life the doctors will not relieve him of a burden become intolerable, for others carry the burden and he has none. What other considerations could make it better for him to die now rather than later? None that we can measure, for of death we know nothing. The distressing truth which must not be shirked, is that the proposed conduct is not in the best interests of Anthony Bland, for he has no best interests of any kind.

Lord Mustill turned traditional analyses of best interests on their heads. He looked at the justification for what was being done to Tony Bland’s body; the tubes feeding him, the tubes excreting his waste. Absent evidence that such invasive treatments were necessary to promote his best interests, they were themselves unlawful, a trespass on the youth’s unconscious body. Thus treatment not in his interests could and must be withdrawn. Bland is an exceptional, difficult case. No one could fail to sympathise with his family whose child was breathing, but effectively a ‘living corpse’. Yet where does Bland lead?¹⁶¹ Can something as basic as feeding be withheld to bring about death? Would this mean staff caring for a patient in advanced stages of dementia who could swallow, but did not demand food, could stop spoon-feeding?

The Law Lords saw the dangers of their decision. They advised that before treatment was discontinued, a declaration should be sought from the courts. They warned that their ruling covered only patients in PVS. They sought to restrain any slide down slippery slopes. Withdrawal of ANH required evidence that: (1) every effort should have been made to provide rehabilitation for at least six months; (2) diagnosis of irreversible PVS should not be considered confirmed until at least twelve months after the injury; (3) diagnosis should be agreed by two independent doctors; and (4) generally the views of the patient’s immediate family will be given great weight.¹⁶²

Bland is a limited and cautious decision. Even on its own facts it provokes numerous questions. The experts who gave evidence in Bland expressed total confidence in medical ability to judge that a patient was irreversibly in PVS. Others are more dubious, concerned that diagnosis may be mistaken and arguing that in some cases, intensive treatment can result in limited recovery. In 2010, new sophisticated scans revealed that Rom Houben, who was thought to have been in PVS for twenty-three years, was in fact suffering from ‘locked in syndrome’ (or ‘unresponsive wakefulness syndrome’ as his doctors have named it).¹⁶³ He went on to develop limited communication via a computer.

The legerdemain by which their Lordships classified removal of a feeding tube as an omission not an act, provokes charges of covert legalisation of euthanasia.¹⁶⁴ Lord Mustill¹⁶⁵ recognised that it is difficult to find any moral difference between inaction resulting in a slow death and action resulting in a swift one. Can the legal distinction be maintained?¹⁶⁶ If it is a matter of policy rather than legal principle, then should the mantra of sanctity of life be swapped for that of quality of life and euthanasia legalised?¹⁶⁷ If Tony Bland’s life was sacred, for itself, not its quality, how can withholding basic food and water be acceptable?

After Bland: PVS to ‘near PVS’

19.16 Bland has led to radical change in the law governing the ending of life. The carefully constituted limitations built into Bland to keep that decision within bounds were eroded step by step. In Frenchay Healthcare NHS Trust v S,¹⁶⁸ the patient was said to have been in PVS for two and a half years following a drug overdose. His feeding tube was accidentally disconnected.

The hospital immediately sought a declaration that it could lawfully refrain from reinserting the tube. The Court of Appeal granted the declaration in haste and without any independent medical opinion confirming that S was irreversibly in PVS. The court recognised that the evidence as to S’s condition was neither as unanimous nor as emphatic as in Bland. The judges found that in the emergency which had arisen because of the disconnection of the tube, there was no benefit conferred on S by reinserting the tube. Indeed, following Lord Browne-Wilkinson’s reasoning in Bland, it might be construed as an assault on S to do so. In these circumstances, the further inquiry necessary to take an independent medical opinion could be dispensed with. A fortuitous event affected the criteria set out in Bland to protect patients. On the facts of S, some doubt exists whether S was truly in PVS. There was evidence of restlessness and distress for which S was receiving medication.¹⁶⁹ Condition 3 set by Lord Goff in Bland, independent evidence confirming PVS survived barely a year.

Subsequent decisions eroded the Bland limitations yet further. In Re D,¹⁷⁰ the patient had suffered serious brain damage after a road accident. As in Frenchay, her feeding tube became disconnected. Stephen Brown P accepted evidence that D’s condition did not fully conform to guidelines for diagnosis of PVS laid down by the Royal College of Physicians (RCP). He was satisfied that there was ‘no evidence of any meaningful life whatsoever’ and held that it was lawful to refrain from reinserting the tube. In Re H¹⁷¹ a 43-year-old woman had suffered brain injuries in a car crash. She retained some rudimentary awareness and like D, did not fit squarely within the RCP definition of PVS. The President of the Family Division approved cessation of artificial feeding. He was: ‘satisfied that it is in the best interests of this patient that the life sustaining treatment currently being artificially administered should be brought to a conclusion’.¹⁷²

Another lesson which may be drawn from post-Bland cases on PVS, or near PVS, is that PVS cases are no longer ‘special’. Nor is withdrawal of feeding seen as much more of a dilemma than withdrawal of any other form of treatment, such as dialysis.¹⁷³ The Practice Note¹⁷⁴ setting out procedures to obtain court sanction to withdraw treatment from an adult lacking mental capacity embraces PVS within a wider range of medical and welfare disputes leading to litigation. Each case turns on the best interests of the patient. Best interests is a phrase easy to utter and difficult to interpret. It inevitably involves judgements of quality of life. In Re D,¹⁷⁵ a patient who had been hospitalised for much of his life with serious psychiatric illness developed renal failure and required dialysis. D lacked mental capacity to consent to treatment and often would not be cooperative in dialysis treatment. To continue dialysis he might have to be anaesthetised on each occasion. The judge ruled that it was not in the patient’s interest to impose dialysis on him where in the doctors’ opinion ‘it is not reasonably practicable to do so’.

In W Healthcare NHS Trust v H and Another,¹⁷⁶ the feeding tube of a 59-yearold multiple sclerosis sufferer, KH, fell out. KH was conscious, but lacked the capacity to make her own decisions. She recognised nobody, had difficulty swallowing and had required a feeding tube for the past five years. The family opposed the carers’ wish to replace the tube. In the absence of a valid advance directive, the court held that it was in KH’s best interests for the tube to be reinserted: death by starvation would be even less dignified than the death she would face if the feeding tube was reinserted.¹⁷⁷ Whether judges like it or not, the effect of the long series of judicial decisions relating to withdrawal of treatment is that judges are making life-or-death decisions.¹⁷⁸

Minimally conscious state¹⁷⁹

19.17 The law has struggled to keep up with advancing medical understandings of consciousness. The terminology has moved on since Bland. A ‘minimally conscious state’, unlike a ‘vegetative state’, is characterised by evidence of awareness of self or environment. As Baker J has pointed out, ‘there is a spectrum of minimal consciousness extending from patients who are only just above the vegetative state to those who are bordering on full consciousness’.¹⁸⁰

Though some of the cases in the preceding section may well have featured patients in a minimally conscious state, the first application to a court to withhold ANH from a patient diagnosed as being in a minimally conscious state was W v M and others.¹⁸¹ Refusing the application, Baker J in the Court of Protection distinguished vegetative state (in which case, ‘the balance falls in one direction in every case – in favour of withdrawal’)¹⁸² from minimally conscious state. In cases falling into the latter category, best interests are assessed by the ‘balance sheet’ approach.¹⁸³ On the facts before them, the court ruled in favour of preserving life. While the ‘do not attempt CPR’ notice should continue, assisted nutrition and hydration should be maintained.

Rigorous collection of evidence is necessary to establish an accurate diagnosis. In St George’s Healthcare NHS Trust v P and Q¹⁸⁴ family members took video recordings to dispute the hospital’s contention that the patient was in a vegetative state. Newton J, holding that withdrawal of renal replacement therapy would not be in the patient’s best interests cautioned:

[T]hose video recordings provided a watershed insight to the proper conclusion in this case … [B]ut for [the family’s] persistence … I could have so easily concluded on inadequate evidence, as it transpired, a conclusion that would have led to P’s demise.¹⁸⁵

The courts are unwilling, however, to require doctors to administer futile treatment. In An NHS Foundation Trust v VT,¹⁸⁶ VT, who had previously suffered a stroke, was admitted to hospital after suffering a cardiac arrest. He was without oxygen for around seventeen minutes and meaningful recovery was unlikely. The trust sought a declaration that it would be unlawful to resuscitate VT (other than by bag and mask) or to provide intensive care. The family disagreed:

If CPR would, they say, cause further brain damage and distress but, nonetheless, their father survives it, that, they believe, is the will of Allah. Moreover, to deprive their father of the opportunity to suffer is to deprive him of the chance to purify his soul in preparedness for death. These are the strongly held views of this family.¹⁸⁷

Intensive care is intended to be restorative but the evidence was that, at best, such care would preserve VT’s minimally conscious state. Hayden J concluded that ‘these interventions are wholly contrary to the central medical objectives of intensive care’.¹⁸⁸ There was no justifiable medical reason for CPR or intensive care and the declaration was granted.

The question of how to gauge when treatment of a patient in a minimally conscious state is futile was raised in the case of Aintree University Hospitals NHS Foundation Trust v James.¹⁸⁹ In this important case, the Supreme Court considered for the first time the best interests of a patient in a minimally (‘or very limited’)¹⁹⁰ conscious state under the Mental Capacity Act framework. Lady Hale gave the sole judgment with which the other Supreme Court Justices agreed.

David James was admitted to hospital in 2012. Recurring infections led to a gradual deterioration in his condition. He was fed and hydrated through a nasogastric tube. The trust applied for a declaration that three specific treatments (not including assisted ventilation or nutrition and hydration) should be withheld. The treatments included CPR, invasive procedures and renal replacement therapy. The clinical team felt that such treatments were not in Mr James’s best interests. The family disagreed. The declarations were refused at first instance but granted by the Court of Appeal. Lady Hale in the Supreme Court disagreed with the reasoning of the Court of Appeal, but granted the declarations on the basis of a change in facts – Mr James’s condition had deteriorated. Lady Hale upheld the principles applied in the first instance decision. These include recognition that best interests incorporate the patient’s welfare in the widest sense; and the assertion that treatment is not futile if it brings benefit to the patient, even if that benefit does not extend to impacting on the underlying medical problem.¹⁹¹ Pointing out the limited nature of the guidance provided by section 4 of Mental Capacity Act,¹⁹² Lady Hale reiterated the common law presumption that it is in the person’s best interests to stay alive.¹⁹³ We would agree with Shaun Pattinson’s assertion that it is a weakness of section 4 that the presumption is not explicitly stated.¹⁹⁴

A right to ANH?

19.18 The entry into force of the Human Rights Act raised questions about the legality of the reasoning in Bland and the cases which followed Bland. Were decisions to cease feeding, especially to withdraw ANH lawful? Or did they contravene Article 2 of the Human Rights Convention protecting the right to life? In NHS Trust A v M,¹⁹⁵ the President of the Family Division ruled that in the circumstances of cases such as Bland, where a recovery allowing the patient to enjoy any sort of cognitive abilities was nigh on impossible, nothing in Article 2 required measures to ensure prolongation of survival.

The matter recently came before the ECtHR. The French Supreme Court, the Conseil d’État, had authorised the withdrawal of ANH from Vincent Lambert, who had suffered severe brain damage and quadriplegia in a road traffic accident in 2008 when he was 32 years old. Lambert was said to be minimally conscious in 2011 and vegetative in 2014. His wife supported the removal of treatment but his devout Catholic parents sought continued treatment. The parents made an emergency appeal to the ECtHR in June 2014. Lambert’s wishes could not be ascertained. He had made no relevant advance directive. The Court relinquished jurisdiction to the Grand Chamber which upheld the French court’s decision and ruled, by twelve votes to five, that there was no violation of the Article 2 right to life.¹⁹⁶ The dissenting judges feared that depriving a severely disabled person of food and water in circumstances when he could not communicate his views constituted a ‘retrograde step’ in the protection afforded to vulnerable people.¹⁹⁷ The wide margin of appreciation afforded to Member States in matters relating to the beginning and end of life recognises the lack of consensus across Europe but makes for sparse guidance from the Strasbourg court. Provided Member States fulfil their duties under Article 2, they will be left to determine whether or not to allow withdrawal of life-sustaining treatment and the balance between the rights to life and autonomy.¹⁹⁸ On this basis, the Grand Chamber held that there was no need to rule separately on the potential violation of Article 8. Member States must look elsewhere for guidance.

The GMC produced guidance in 2002 indicating that, where a patient’s disease is severe and the prognosis poor, ANH will not always be appropriate, even if death is not imminent.¹⁹⁹ This prompted Leslie Burke, who suffered from a degenerative neurological condition, cerebellar ataxia, to fight for the right to ANH in the event that he is unable to voice his wishes. His condition gradually reduced his coordination while his mental faculties were unimpaired. His condition would cause the loss of the abilities to walk, hear, see and swallow. He could make an advance directive, but his worry was that, after a significant deterioration, the GMC guidance would sanction the discontinuation of ANH in spite of it, and that he would be aware of great pain and suffering caused by malnutrition and dehydration. His argument was that, in his personal view, knowing as he did the likely progression of his disease, ANH would never be futile.

Mr Burke argued that the GMC guidance offended his human rights in four ways. First, the right to life in Article 2(1) contains both a negative obligation not to unlawfully take life and a positive obligation to protect it. The guidance failed to adequately protect his life. Second, by failing to protect him from death by malnutrition and dehydration, it offended Article 3 which protects him from inhuman and degrading treatment. Third, by failing to give his advance directive legal force, the guidance offended Article 8 which protects his right to a private and family life. Finally, it discriminated against those incapable of making a competent decision and therefore offended Article 14. At first instance, it was held that the GMC guidance was incompatible with Articles 3 and 8 of the Human Rights Act 1998.²⁰⁰ Munby J’s decision was controversial because it suggested a positive right to demand treatment that was not, in the doctors’ views, in his medical best interests.²⁰¹ Could the principle be extended beyond the provision of ANH, to other forms of treatment? The GMC feared that it might and took the case to the Court of Appeal where Munby J’s decision was overturned.²⁰² Mr Burke’s concerns, the Court held, were already addressed by the law. Where a competent patient indicates his wish to be kept alive through ANH, a doctor who deliberately brings that life to an end by removing ANH may be guilty of murder. Mr Burke was more concerned about what should happen in the event that he loses capacity. The Court is clear. Doctors cannot be forced to administer treatment which they believe to be clinically unnecessary, futile or inappropriate. There is no discrimination, as the law applies equally to both a competent patient demanding treatment and an incompetent patient whose demands are expressed through an advance directive. Doctors are guided by the indistinct and complex concepts of futility and best interests. The Court of Appeal decision (on the facts of this case) is a setback to patient autonomy and a victory for medical paternalism.

In 2006, Leslie Burke lodged an appeal with the ECtHR. His application was ruled inadmissible.²⁰³ There was no imminent risk that ANH would be withdrawn in circumstances that would lead to death by malnutrition and dehydration. In many ways, Mr Burke made his case too early: the emphasis on ‘imminent’ risk and the court’s view that no issue arose under Articles 2, 3 and 8 on the basis that ‘the applicant cannot pre-determine the administration of specific treatment in future unknown circumstances’²⁰⁴ must come as a blow given that by the time the issues are ‘imminent’, Mr Burke is unlikely to be competent to bring the proceedings himself. Nevertheless, the Court affirms the position taken in the Court of Appeal that the GMC guidelines do not have legal status and make no recommendations contrary to the law. Nor is there any discrimination within the meaning of Article 14: neither competent nor incompetent patients can require a doctor to provide treatment that he does not believe is clinically justified.²⁰⁵

As we shall see, section 4(5) of the Mental Capacity Act 2005 offers further guidance. It provides that decisions relating to life-sustaining treatment must not be motivated by a desire to bring about the patient’s death. Does this mean that there is a positive obligation on doctors to provide life-sustaining treatment? This is unlikely. The Code of Practice provides that:

Where a person has made a written statement in advance that requests particular medical treatments, such as artificial nutrition and hydration (ANH), these requests should be taken into account by the treating doctor in the same way as requests made by a patient who has the capacity to make such decisions. Like anyone else involved in making this decision, the doctor must weigh written statements alongside all other relevant factors to decide whether it is in the best interests of the patient to provide or continue life-sustaining treatment.²⁰⁶

This guidance is reiterated in more recent direction from the Department of Health.²⁰⁷ Those in Mr Burke’s position can make an advance directive refusing treatment, or appoint an LPA.

In 2013 Baroness Julia Neuberger chaired a review of the Liverpool Care Pathway – a clinical model of care designed to standardise care in the last days and weeks of life. The review was critical of the lack of individualised care, in particular, care surrounding nutrition and hydration.²⁰⁸ Reiterating the GMC’s advice that there can be no moral or legal obligation to administer assisted hydration or nutrition if they will have no beneficial effect, the report makes clear that there is no justification for denying a drink to a dying patient who wants one or for sedating a patient when it is not necessary to do so, so that the patient is unable to ask for a drink.²⁰⁹ A new approach based on five priorities for care was presented in 2014.²¹⁰ It emphasises the importance of clear and sensitive communication and an individual plan of care, which includes food and drink: until the time when assisted nutrition and hydration is considered futile, ‘refusing food and drink is a decision for the patient, not clinical staff, to make’.²¹¹ The Liverpool Care Pathway was phased out and NICE released guidance in 2015.²¹²

The Mental Capacity Act 2005²¹³

19.19 As we have noted, the Mental Capacity Act 2005 now governs decision-making on behalf of adults who temporarily or permanently lack mental capacity and thus affects decision-making concerning incapacitated patients at the end of life.

How does the Act affect end-of-life decisions? As we have seen, the test of lawfulness remains the best interests of the patient, but an element of substituted judgement is incorporated into the statutory checklist for best interests. Decision-makers must give due consideration to the patient’s previous wishes, beliefs and values.²¹⁴ In the Supreme Court decision of Aintree University Hospitals NHS Foundation Trust²¹⁵ (examined at 19.17), the Court of Appeal’s objective test was rejected in favour of the subjective assessment of what the patient would want, as adopted by the trial judge.²¹⁶ There is no clinical obligation to provide futile treatment, but treatment is not necessarily futile just because it will not return the patient to good health. The patient’s past and present views as to what constitutes an adequate quality of life are a relevant consideration.

Particular attention must be paid to any written statement made by the patient when he had capacity.²¹⁷ An advance directive purporting to demand treatment may be persuasive – it is not binding.²¹⁸ Many patients in Mr Burke’s condition might prefer to ensure that life-sustaining treatment was not prolonged. The Act gives force only to advance refusals and as we saw in Chapter 6 under section 25 of the Act, advance decisions to refuse treatment are not valid if:²¹⁹

–  the treatment in question ‘is not the treatment specified in the advance decision’; or

–  ‘any circumstances specified in the advance decision are absent’ or

–  ‘there are reasonable grounds for believing that circumstances exist which [the patient] did not anticipate at the time of his advance decision and which would have affected his decision had he anticipated them’.

In addition, where the advance decision to refuse treatment relates to life-sustaining treatment, special conditions apply. It must incorporate a statement that the decision stands, even if life is at risk. It must be in writing, signed, witnessed and verified by the author.²²⁰ If so it is as binding as a statement refusing life-sustaining treatment made by a competent patient such as Ms B.

Yet there is no requirement that the patient discuss the content or implications of the statement with a health professional or that they be fully informed.

The legal requirement for a witness is not necessarily obvious to patients and their families. In An NHS Trust v D,²²¹ D fell into a vegetative state following surgery. He had made an advance refusal of treatment in the form of a signed letter but did not get it witnessed. As a result, it did not satisfy section 25 of the Mental Capacity Act. Though his decision was upheld on the basis that it was in his best interests to do so, the failure to comply with section 25 resulted in court proceedings and delay, with consequent distress to his family.

Rather than making an advance decision, a competent patient may appoint a proxy to act for her via an LPA and make decisions on her behalf in the event that she loses capacity.²²² Again, special conditions apply if the LPA is to make decisions regarding life-sustaining treatment. The LPA may only make such decisions if the donor of the LPA expressly enabled him to do so.²²³ Even then, the decision of an LPA is subject to the conditions of the Act. If the LPA and the doctors or carers disagree about what is in the best interests of the patient, the court will usually be called upon to make a decision or declaration.²²⁴ The court as ‘decision-maker’ will be guided, but not bound by the views of the LPA.

Whoever is making the crucial decision, doctors, or any attorney, or the Court, section 4(5) of the Mental Capacity Act contains special considerations relating to life-sustaining treatment, which is defined as ‘treatment which in the view of a person providing healthcare for the person concerned is necessary to sustain life’:

Where the determination relates to life-sustaining treatment [the person making the decision] must not, in considering whether the treatment is in the best interests of the person concerned, be motivated by a desire to bring about his death.²²⁵

This peculiar statement was framed to appease those who feared that the Mental Capacity Act would sanction covert euthanasia. It forbids the decision-maker from being ‘motivated by a desire to bring about the person’s death’.²²⁶ We are at a loss to define ‘desire’ in this context. The Code of Practice states:

There will be a limited number of cases where treatment is futile, overly burdensome to the patient or where there is no prospect of recovery. In circumstances such as these, it may be that an assessment of best interests leads to the conclusion that it would be in the best interests of the patient to withdraw or withhold life-sustaining treatment, even if this may result in the person’s death.²²⁷

The Code recognises that those making the treatment decision might wish the patient dead (either to ease his suffering or for other reasons) but insists that this is not the motivation for the discontinuation of treatment.

The role of the courts

19.20 It is good practice to seek prior judicial sanction in cases of dispute or uncertainty as to the patient’s capacity or his best interests, but is there a legal requirement to do so? We saw in Chapter 6 that there is not. In Burke, Lord Phillips MR stated:

Good practice may require medical practitioners to seek such a declaration where the legality of proposed treatment is in doubt. This is not, however, something that they are required to do as a matter of law.²²⁸

Nor does the Mental Capacity Act 2005 mandate resort to the court. The Court of Protection Rules, however, direct practitioners to bring to court certain decisions concerning serious medical treatment. This includes proposals to withdraw artificial nutrition or hydration.²²⁹ Most controversial cases therefore appear before the Court of Protection. However, as we noted in Chapter 6, where there is consensus regarding a course of action, there may be no one to enforce recourse to the court. The patient will lack an advocate.

Where there is disagreement as to the proposed course of action and an application to the Court of Protection is made, how do the courts determine what is in the patients’ best interests? What weight is given to the views of carers and family members?

DNACPR notices²³⁰

19.21 DNACPR (do not attempt cardio-pulmonary resuscitation) notices are not expressly referred to in the Mental Capacity Act 2005. What is in issue is not withdrawing treatment, but whether or not the patient should be given cardio-pulmonary resuscitation (CPR) if he suffers a cardiac arrest.

The validity of DNACPR orders came before the English courts in Re R (Adult: Medical Treatment).²³¹ R was 23. He was born with a severe malformation of the brain. He developed epilepsy in infancy. He suffered from multiple disabilities and had no real means of communicating with others. He had severe and debilitating intestinal troubles including ulcers ‘all the way through his guts’. His only real response to others seems to have been to being cuddled. He appeared to experience quite acute pain. He was not in PVS or anything akin to ‘near PVS’. Since he was 19, he had lived in a nursing home, attending a day centre and going home to his devoted family most weekends. In the year before the court proceedings, R had been hospitalised five times. His doctors, with the full agreement of R’s parents, issued a DNACPR notice. Should R suffer from a life-threatening condition involving a cardiac arrest he should not be resuscitated. Staff at R’s day centre were concerned about the use of DNACPR notices in R’s case, and made an application for judicial review of the order. Sir Stephen Brown P upheld the DNACPR notice. He was persuaded that the evidence established that in cases such as R, CPR was unlikely to succeed. R had never been able to articulate his wishes. Nonetheless, the judge concluded that it was permissible to consider the patient’s quality of life in assessing his best interests. DNACPR notices do not involve measures to terminate life or accelerate death. Where continued existence involved a life ‘so afflicted as to be intolerable’,²³² policies designed to limit life-saving intervention could be approved. In the absence of consent from the patient, the decision to institute a DNACPR notice should usually be made by the physicians, family and carers.

Whose decision should determine whether or not a DNACPR notice is made? In some cases, the patient can be consulted. Where she lacks capacity, the Mental Capacity Act 2005 will apply. An advance refusal of treatment may be effective, or where the donor expressly authorises it, the LPA may ‘authorise the giving or refusing of consent to the carrying out or continuation of life-sustaining treatment’.²³³ In other cases, guidelines on DNACPR notices make it clear that decision-making is not an exclusively medical role.²³⁴ The patient’s wishes if known must be respected.

In R (Tracey) v Cambridge University Hospitals NHS Foundation Trust & Ors R²³⁵ the Court of Appeal held that a DNACPR notice that was applied without consultation of or notice to Mrs Tracey (who retained capacity) and her family breached Article 8 of the European Convention on Human Rights. The DNACPR notice was withdrawn when her family complained and a second notice imposed when Mrs Tracey lost capacity to decide for herself. Mrs Tracey died shortly afterwards. The claim focused on the first DNACPR notice. The Court of Appeal stopped short of requiring that (capacitous or otherwise) patients are consulted. There must, however, be a convincing reason for not involving a patient, such as the likelihood of causing harm (which is more than mere distress).²³⁶ ‘Particularly convincing justification’ is needed to justify not telling a patient that the clinicians consider CPR to be futile in a particular case. A failure to inform the patient in these circumstances robs them of the opportunity to seek a second opinion. And even if the patient cannot demand CPR that the clinician considers futile, he is prima facie, entitled to know that the decision has been taken.²³⁷

In Tracey, the claim against the trust was upheld in part. A second claim against the Secretary of State focusing on the lack of clear national guidance on DNACPR notices was dismissed. The government’s policy is to encourage local decision-making and this policy does not necessitate breach of Article 8.²³⁸ Guidelines developed jointly between the BMA, the Resuscitation Council (UK) and the Royal College of Nursing were revised in light of Tracey.²³⁹ The guideline reiterates the presumption in favour of involvement of the patient in the decision-making process; encourages advance care planning (which gives people the opportunity to say ‘no’ to treatment they do not want) and reiterates the importance of making decisions on an individual basis; not simply on the basis of the person’s age or condition.²⁴⁰ Decisions should be made after appropriate consultation with other staff and the patient’s family. Once a DNACPR notice is in place, the guidelines state that: ‘A DNACPR decision does not override clinical judgement in the unlikely event of a reversible cause of the person’s respiratory or cardiac arrest that does not match the circumstances envisaged’.²⁴¹ Where a DNACPR notice has not been made and the wishes of the patient are unknown, CPR should generally be attempted if cardiac or pulmonary arrest occurs, though there may be cases where this is not appropriate, for example, if the patient is in the final stages of terminal illness and has not requested CPR.

Fears about DNACPR decisions focus on who makes the decision about life or death, whether such decisions may be made arbitrarily or in a discriminatory fashion, and whether the patient will be treated well once a DNACPR notice is in place.²⁴² DNACPR notices are made more often in relation to elderly patients. That of itself may not be surprising. It is the quality of decision-making which counts and how prospects of successful resuscitation and future quality of life are assessed. A greater number of very elderly patients who are also gravely ill may be more unlikely to recover than their grandchildren in their twenties and thirties. Junior doctors in particular require training to understand the needs of their elderly patients.²⁴³ The criteria governing the assessment of the patient and the weight given to his or her family’s wishes should not vary with age. Recourse to the courts is rare indeed and should be reserved for cases of serious disagreement.

Conclusion

19.22 The debate around assistance in dying arises out of tragic facts and raises ethically and socially intractable issues. The courts have begun to tackle medical advances which facilitate, with increasing accuracy, differentiation between vegetative and minimally conscious states. Judicial interference with assisted suicide is, in principle, open to domestic courts but should the courts so intervene? In Nicklinson Lady Hale and Lord Kerr’s minority judgments proposed a declaration of incompatibility of section 2(1) of the Suicide Act 1961 with the appellants’ rights under article 8 of the ECHR. Lady Hale opined:

[W]e have no jurisdiction to impose anything: that is a matter for Parliament alone. We do have jurisdiction, and in some circumstances an obligation, to form a professional opinion, as judges, as to the content of the Convention rights and the compatibility of the present law with them.²⁴⁴

Legislative reform proposals have, so far, led to naught. Principles of justice, autonomy and non-discrimination vie with slippery slope arguments, resulting in pragmatic reform proposals to assist the terminally ill, that fail to fully satisfy either camp. We have seen that the Assisted Dying Bill introduced by Lord Falconer made historic progress in 2015 but ran out of time. Support for reform is mounting.

¹  Note that, at the time of writing, a Private Member’s Bill, the Conscientious Objection (Medical Activities) Bill [HL] 2015–16, has been introduced by Baroness O’Loan. It would establish that medical practitioners are under no duty to participate in the withdrawal of life-sustaining treatment (and certain other activities). The proposed definition of ‘participation’ (s1(2)((b)) is wide, incorporating supervision, delegation, planning and supporting staff.

²  JK Mason, GT Laurie, Mason and McCall Smith’s Law and Medical Ethics (9th edn, 2013) Oxford University Press, ch 15.

³  Ibid, at 15.06.

⁴  Re J (A Minor) (Wardship: Medical Treatment) [1992] 4 All ER 614 at 625, CA. And see GMC, Treatment and Care towards the End of Life: Good Practice in Decision Making (2010), paras 38 and 39.

⁵  Airedale NHS Trust v Bland [1993] 1 All ER 821, HL.

⁶  Mason, Laurie, Mason and McCall Smith’s Law and Medical Ethics, 15.79.

⁷  See in particular Airedale NHS Trust v Bland [1993] 1 All ER 821 at 856, CA, per Hoffmann LJ.

⁸  As amended by the Coroners and Justice Act 2009, s 59(2).

⁹  B v An NHS Trust [2002] EWHC 425.

¹⁰  R (Pretty) v DPP [2002] 1 All ER 1, HL. Mrs Pretty’s appeal to the European Court of Human Rights also failed: Pretty v United Kingdom (2002) 35 EHHR 1.

¹¹  R (on the application of Burke) v GMC [2005] EWCA Civ 1003.

¹²  Burke v United Kingdom [2006] App 19807/06. And see discussion of Lambert and Others v France (application No 46043/14) (Grand Chamber), 5 June 2015, at 19.18.

¹³  R (on the application of Purdy) v DPP [2009] UKHL 45.

¹⁴  Prosecution requires the consent of the DPP. Suicide Act 1961, s 2(4).

¹⁵  DPP, Code for Crown Prosecutors and the Policy for Prosecutors in respect of Cases of Encouraging or Assisting Suicide (2010, updated October 2014).

¹⁶  R (on the application of Nicklinson and another) v Ministry of Justice; R (on the application of AM) v The Director of Public Prosecutions [2014] UKSC 38.

¹⁷  E Wicks, ‘The Supreme Court Judgment in Nicklinson: One Step Forward on Assisted Dying: Two Steps Back on Human Rights: A Commentary on the Supreme Court Judgment of R (Nicklinson) v Ministry of Justice; R (AM) v Director of Public Prosecutions [2014] UKSC 38’ (2015) 23(1) Medical Law Review 144.

¹⁸  NHS England, Developing a New Approach to Palliative Care Funding (March 2015).

¹⁹  See Mason, Laurie, Mason and McCall Smith’s Law and Medical Ethics, 18.01; but see also E Jackson, Medical Law: Text, Cases and Materials (3rd edn, 2013) Oxford University Press, pp 874–875.

²⁰  See D Shaw ‘The Body as Unwarranted Life Support’ (2007) 33 Journal of Medical Ethics 519 arguing that if a competent person wishes to die this is ‘unwarranted life support’ which arguably can be ended in the same way that a competent person can refuse medical life support.

²¹  C Seale, ‘End of Life Decisions in the UK Involving Medical Practitioners’ 23 (2009) Palliative Medicine 198.

²²  Airedale NHS Trust v Bland [1993] 1 All ER 821 at 850, HL.

²³  R v Cox (1992) 12 BMLR 38. See E Jackson, ‘Whose Death Is It Anyway? Euthanasia and the Medical Profession’ (2004) 57 Current Legal Problems 415.

²⁴  Though the judge might reduce the sentence: see for example R Ford, ‘Life May Mean Just 3 Years for Mercy Killing Husband’ (2007) The Times, 25 May, involving the case of Frank Lund who was found guilty of murder having suffocated his wife, who suffered a chronic bowel condition, on her request.

²⁵  Unreported. See S Burns, ‘Showing Mercy’ (2010) 154(1) Solicitor’s Journal 6, 8, also commenting on R v Gilderdale Unreported, January 25 2010 (Crown Ct (Lewes)). Kay Gilderdale helped her 31-year-old daughter, who suffered from ME, to die. Gilderdale admitted assisting suicide (for which she received a conditional discharge) and was acquitted of attempted murder.

²⁶  L Bannerman, ‘Jury Heckled over Murder Verdict for Mother Francis Inglis Who “Acted out of Love”’ (2010) The Times, 21 January.

²⁷  R v Inglis [2010] EWCA Crim 2637.

²⁸  Per Judge LCJ, [37].

²⁹  See ‘Pensioner Cleared of Murdering Wife in Mercy Killing’ (2010) Guardian, 9 December.

³⁰  R v Webb [2011] EWCA Crim 152, [19–20].

³¹  S Chahal, Tony Nicklinson’s Case: Submission to Commission on Assisted Dying (December 2010), para 7.

³²  R (Nicklinson) v Ministry of Justice [2012] EWHC 2381.

³³  [2013] EWCA Civ 961. The argument focused on the availability of the defence of necessity to a murder charge in certain cases of euthanasia where a carer complies with the settled with of a competent person to end his life.

³⁴  [2014] UKSC 38. The final appeal refocused on the blanket ban on assisted suicide rather than on necessity as a defence to murder.

³⁵  Nicklinson and Lamb v UK (application nos 2478/15 and 1787/15), ECtHR 16 July 2015.

³⁶  DPP, Code for Crown Prosecutors and the Policy for Prosecutors in respect of Cases of Encouraging or Assisting Suicide (2010, updated 2014), para 33: ‘It is murder or manslaughter for a person to do an act that ends the life of another, even if he or she does so on the basis that he or she is simply complying with the wishes of the other person concerned’.

³⁷  See Jackson, Medical Law, pp 876–879.

³⁸  R v Adams [1957] Crim LR 773.

³⁹  Airedale NHS Trust v Bland [1993] 1 All ER 821at 868, HL. But consider the impact of R v Woollin [1999] AC 82, HL (jury may infer intent to kill even if causing death is not the accused’s primary purpose); see Jackson Medical Law, p 894.

⁴⁰  See, for example, the investigation surrounding forty-three cases of patient deaths under GP Howard Martin. In 2005 Martin was cleared of murdering three patients by injecting them with morphine. See ‘Morphine Doctor Cleared of Murder’ (2005) The Times, 14 December. Further investigation followed and Dr Martin was struck off by the GMC in 2010 on the basis that he had hastened the death of eighteen patients.

⁴¹  C Seale, ‘Continuous Deep Sedation in Medical Practice: A Descriptive Study’ (2010) 29(1) Journal of Pain and Symptom Management 44.

⁴²  Mason, Laurie, Mason and McCall Smith’s Law and Medical Ethics, 18.41.

⁴³  C Douglas ‘Commentary: Moral Concerns with Sedation at the End of Life’ (2014) 40 Journal of Medical Ethics 241.

⁴⁴  Mason, Laurie, Mason and McCall Smith’s Law and Medical Ethics, 18.41.

⁴⁵  It should be noted, of course, that it may not always be an easy issue to determine whether a person is clinically or legally competent; see Chapter 6. Children and infants are considered in Chapter 14.

⁴⁶  Aintree University Hospital NHS Foundation Trust v James [2013] UKSC 67, [35] per Lade Hale. The case is discussed further at 19.17.

⁴⁷  [2012] EWCOP 1639.

⁴⁸  [2014] EWCOP 35.

⁴⁹  [2012] EWCOP 2741.

⁵⁰  Re T (Adult: Refusal of Treatment) [1992] 4 All ER 465, CA; discussed at 5.3.

⁵¹  [1993] 1 All ER 821, HL; and see Nancy B v Hôtel Dieu de Quebec (1992) 86 DLR (4th) 385 (Canada); Auckland Area Health Board v A-S [1993] 1 NZLR 235 (New Zealand); Bouvia v Superior Court (1986) 225 Cal Reptr 297 (USA).

⁵²  But see A McGee, ‘Finding a Way through the Ethical and Legal Maze: Withdrawal of Medical Treatment and Euthanasia’ (2005) 13 Medical Law Review 357 and J Keown, ‘A Futile Defence of Bland: A Reply to Andrew McGee’ (2005) 13 Medical Law Review 393.

⁵³  [2002] EWHC 429.

⁵⁴  Discussed more fully at 6.4.

⁵⁵  [1993] 1 All ER 821, at 881.

⁵⁶  The Coroners and Justice Act 2009, s 59 reframes the offence, modernising the wording and combining the offence of assisting in a suicide and the offence of attempting to assist in a suicide into one single offence. The scope of the law is unchanged.

⁵⁷  (1977) 66 Cr App R 97.

⁵⁸  [1984] QB 795.

⁵⁹  CPS, Press Statement: No Charges Following Death of Caroline Loder (16 August 2010).

⁶⁰  Notably and eloquently, DW Meyers, JK Mason, ‘Physician Assisted Suicide: A Second View from Mid-Atlantic’ (1999) 29 Anglo-American Law Review 39.

⁶¹  Discussed 19.12.

⁶²  [2001] All ER (D) 251.

⁶³  [2002] 1 All ER 1, HL.

⁶⁴  Pretty v United Kingdom (2002) 35 EHHR 1.

⁶⁵  Although at least some of their Lordships left open the question of whether on different facts such an application might succeed.

⁶⁶  [2002] 1 All ER 1 at 7, HL. The ECtHR concurred that Article 2 ‘could not be interpreted as involving a negative aspect’.

⁶⁷  But see the persuasive arguments of J Coggon, ‘Could the Right to Die with Dignity Represent a New Right to Die in English Law?’ (2006) 12 Medical Law Review 219.

⁶⁸  [2001] EWHC Admin 788, [51].

⁶⁹  [2002] 1 All ER 1, at 11–12, HL.

⁷⁰  Ibid, at 37.

⁷¹  Ibid, at 37.

⁷²  Ibid, at 29.

⁷³  (2002) 35 EHRR 1.

⁷⁴  [2002] 1 All ER 1, at 18. A view endorsed by the ECtHR.

⁷⁵  [2001] EWHC (Admin) 788, [60]. See also [2002] 1 All ER 1, at 21, per Lord Bingham.

⁷⁶  [2002] 1 All ER 1, at 27. In recognition of the lack of consensus in Europe, the European Court of Human Rights accords mamber states a wide margin of appreciation. See Haas v Switzerland [2011] 53 EHRR 33; Koch v Germany [2012] ECHR 1621; Nicklinson and Lamb v UK (application nos 2478/15 and 1787/15), ECtHR 16 July 2015.

⁷⁷  For commentary, see N Cartwright, ‘48 Years On: Is the Suicide Act Fit for Purpose?’ 17 (2009) Medical Law Review 467.

⁷⁸  [2009] UKHL 45.

⁷⁹  R Daw, A Solomon, ‘Assisted Suicide and Identifying the Public Interest in the Decision to Prosecute’ (2010) Criminal Law Review 737.

⁸⁰  R (on the application of Purdy) v DPP [2009] EWCA Civ 92, [54].

⁸¹  [2009] UKHL 45, [106]: ‘Our decision is simply that the article 8 rights of Ms Purdy entitle her to be provided with guidance from the director as to how he proposes to exercise his discretion under section 2(4) of the 1961 Act’ (per Lord Neuberger).

⁸²  Gross v Switzerland [2013] ECHR 429 (2nd Sect), [67]. See I Black, ‘Existential Suffering and the Extent of the Right to Physician-Assisted Suicide in Switzerland: Gross v Switzerland [2013] ECHR 67810/10’ (2014) 22(1) Medical Law Review 109.

⁸³  Gross v Switzerland [2014] ECHR 1008 (Grand Chamber).

⁸⁴  Swiss Criminal Code, Article 115.

⁸⁵  Between 1998 and 2013, 244 Britons have undertaken assisted suicide in Switzerland: S Warnes, ‘How Many People Choose Assisted Suicide Where It Is Legal?’ (2014) Guardian 18 July. And see S Knapton, ‘Nearly a Quarter of Suicide Cases at Dignitas Are Brits’ (2015) The Telegraph, 20 August.

⁸⁶  [2004] EWHC 2817 (Fam). See P De Cruz, ‘The Terminally Ill Adult Seeking Assisted Suicide Abroad’ (2005) 13 Medical Law Review 257.

⁸⁷  Re Z (An Adult: Capacity) ibid, [14], per Hedley J.

⁸⁸  M Hirst, ‘Suicide in Switzerland – Complicity in England?’ (2009) Criminal Law Review 335.

⁸⁹  There is some doubt following Smith (Wallace Duncan) (No 4) [2004] EWCA Crim 631.

⁹⁰  [2009] UKHL 45, [94].

⁹¹  M Hirst, ‘Assisted Suicide after Purdy: The Unresolved Issue’ (2009) Criminal Law Review 872.

⁹²  But will it adequately safeguard the ‘victim’? See A Mullock, ‘Overlooking the Criminally Compassionate: What are the Implications of Prosecutorial Policy on Encouraging or Assisting Suicide?’ (2010) 18(4) Medical Law Review 442.

⁹³  P Lewis argues that this makes the informal changes brought in by the Code more significant than was originally thought would be the case: ‘Informal Legal Change on Assisted Suicide: The Policy for Prosecutors’ (2011) 31(1) Legal Studies 119.

⁹⁴  Regarding the latter factor, see 19.10.

⁹⁵  DPP, Code for Crown Prosecutors and the Policy for Prosecutors in respect of Cases of Encouraging or Assisting Suicide (2010, updated 2014), para 45.

⁹⁶  CPS, Assisted Suicide Charge Not in the Public Interest (2010) 24 May.

⁹⁷  CPS, Kevin Howe Convicted of Assisted Attempted Suicide (2013) 12 September. And see CPS, One Woman Charged with Encouraging or Assisting Suicide 15 September (2014). Howe successfully argued for a reduction in sentence (from twelve years to ten) in R v Howe [2014] EWCA Crim 114.

⁹⁸  J Laing, ‘On the Wrong Track’ (2010) 154(2) Solicitor’s Journal 8. The lack of prosecutions pre-dates the DPP’s Code and indicates that this phenomenon had been going on for some time. See for example A Mullock, ‘Prosecutors Making (Bad) Law?’ (2009) 17(2) Medical Law Review 290, on the DPP’s decision regarding the death of Daniel James.

⁹⁹  An alternative was postulated by the Supreme Court, but this was not the method preferred by Mr Nicklinson: ‘[Mr Nicklinson’s] preference was for someone to kill him by injecting him with a lethal drug, such as a barbiturate, but, if that was not acceptable, he was prepared to kill himself by means of a machine invented by Philip Nitschke, an Australian doctor. This machine, after being loaded with a lethal drug, could be set up so as to be digitally activated by Mr Nicklinson, using a pass phrase, via an eye blink computer’ (R (Nicklinson and another) v Ministry of Justice (CNK Alliance Ltd and another intervening); (R (AM) v Director of Public Prosecutions and another (CNK Alliance Ltd and another intervening) [2014] UKSC 38, [4] per Lord Neuberger).

¹⁰⁰  R (Nicklinson) v Ministry of Justice [2012] EWHC 2381. See J Herring, ‘Escaping the Shackles of Law at the End of Life: R (Nicklinson v Ministry of Justice [2012] EWHC 2381 (Admin)’ (2013) 21(3) Medical Law Review 487; S Michalowski, ‘Relying on Common Law Defences to Legalise Assisted Dying: Problems and Possibilities’ (2013) 21(3) Medical Law Review 337.

¹⁰¹  [2013] EWCA Civ 961.

¹⁰²  [2014] UKSC 38.

¹⁰³  Ibid, [76].

¹⁰⁴  Ibid, [113].

¹⁰⁵  Nicklinson and Lamb v UK (application nos 2478/15 and 1787/15), ECtHR 16 July 2015.

¹⁰⁶  And see Carter v Canada 2015 SCC 5 in which the Supreme Court of Canada in a unanimous decision overturned an absolute ban on assisted dying and gave Parliament a year to create a ‘stringently limited, carefully monitored system of exceptions’ (at [29]).

¹⁰⁷  DPP, Code for Crown Prosecutors and the Policy for Prosecutors in respect of Cases of Encouraging or Assisting Suicide (2010, updated 2014), para 43.14. See 19.8. The BMA have issues guidance advising doctors how to handle patients who make requests relating to assisted suicide: BMA, Responding to Patient Requests Relating to Assisted Suicide: Guidance for Doctors in England, Wales and Northern Ireland (February 2015).

¹⁰⁸  GMC, Guidance for the Investigation Committee and Case Examiners when Considering Allegations about a Doctor’s Involvement in Encouraging or Assisting Suicide (2013), para 10. And see GMC, When a Patient Seeks Advice or Information about Assistance to Die (2013).

¹⁰⁹  R (AM) v Director of Public Prosecutions and another (CNK Alliance Ltd and another intervening) [2013] EWCA Civ 961, [140], per Elias LJ.

¹¹⁰  DPP, Code for Crown Prosecutors and the Policy for Prosecutors in respect of Cases of Encouraging or Assisting Suicide (2010, updated 2014), para 43.14. The 2014 update includes a footnote that reads: ‘For the avoidance of doubt the words “and the victim was in his or her care” qualify all of the preceding parts of this paragraph. This factor does not apply merely because someone was acting in a [professional] capacity described within it: it applies only where there was, in addition, a relationship of care between the suspect and the victims such that it will be necessary to consider whether the suspect may have exerted some influence on the victim’.

¹¹¹  See C Dyer, ‘Man with Locked-in Syndrome Challenges GMC Ruling on Doctors’ Involvement in Ending His Life’ (2015) 350 BMJ h3524.

¹¹²  [2015] EWHC 2096 (Admin).

¹¹³  R (Kenward) v DPP [2015] EWHC 3508.

¹¹⁴  N Hawkes, ‘Doctors Reject Making Euthanasia Legal’ (2006) The Times, 29 June; BMA, End-of-Life Decisions (2006), p 4; BMA End-of-Life Decisions: View of the BMA (2009).

¹¹⁵  Now Health Professionals for Assisted Dying: see www.hpad.org.uk

¹¹⁶  For an excellent examination of pro-euthanasia, anti-euthanasia and compromise positions (respectively), see A Alghrani, R Bennett, S Ost (eds) The Criminal Law and Bioethical Conflict: Walking the Tightrope Volume 1 (2012) Cambridge University Press: J Griffiths ‘Euthanasia and Assisted Suicide Should, When Properly Performed by a Doctor in an Appropriate Case, Be Decriminalised’ pp 15–29; J Keown, ‘Five Flawed Arguments for Decriminalising Euthanasia’ pp 30–48 and R Huxtable, ‘Euthanasia Excused: Between Prohibition and Permission’ pp 49–68. And see E Jackson, J Keown, Debating Euthanasia (2011) Hart: a debate in which Jackson argues for and Keown argues against legalising euthanasia.

¹¹⁷  See RS Magnusson, ‘Above Ground, Below Ground’ (2004) 30 Journal of Medical Ethics 441; S Ost, An Analytical Study of the Legal, Moral and Ethical Aspects of the Living Phenomenon of Euthanasia (2003) Edwin Mellor Press; J Keown, Euthanasia, Ethics and Public Policy (2002) Cambridge University Press.

¹¹⁸  Kennedy, Grubb, Medical Law, p 1997.

¹¹⁹  See Otlowski, Voluntary Euthanasia and the Common Law, p 189.

¹²⁰  See L Gormally (ed) Euthanasia, Clinical Practice and the Law (1994) Linacre Centre. And see 3.10–3.13.

¹²¹  See P Lewis, ‘Euthanasia in Belgium Five Years after Legalisation’ (2009) 16 European Journal of Health Law 125.

¹²²  For comparative assessments of euthanasia and assisted suicide, see P Lewis, Assisted Dying and Legal Change (2007) Oxford University Press, and Griffiths, Weyers, Adams, Euthanasia and the Law in Europe: With Special Reference to the Netherlands and Belgium (2008) Hart.

¹²³  Upheld by the US Supreme Court in Gonzales v Oregon (04-623) 546 US 243 (2006).

¹²⁴  A 5:2 decision in Baxter v Montana No. DA 09-0051 (Montana Supreme Court, 2009), upholds the right to die of competent terminally ill patients in the state of Montana.

¹²⁵  HL Paper 86.

¹²⁶  Ibid, para 269(c).

¹²⁷  See J Keown, ‘Physician-Assisted Suicide: Lord Joffe’s Slippery Bill’ (2007) 15(1) Medical Law Review 126.

¹²⁸  Campaign for Dignity in Dying, ‘Press Release: Largest Ever Poll on Assisted Dying Shows 82% of Public Support Lord Falconer’s Proposed Change in the Law’ (2015) accessible at www.dignityindying.org.uk/press-release/poll-assisted-dying. Populus interviewed 5,018 adults aged 18+ online between 11 and 19 March 2015.

¹²⁹  See A Mullock, ‘The Assisted Dying Bill and the Role of the Physician’ (2015) Journal of Medical Ethics (published online January 9, 10.1136/medethics-2014-102418).

¹³⁰  Commission on Assisted Dying, The Current Legal Status of Assisted Dying is Inadequate and Incoherent… (2012).

¹³¹  For a discussion of conscientious objection in relation to assisted dying, see R Huxtable, A Mullock, ‘Voices of Discontent? Conscience, Compromise and Assisted Dying’ (2015) 23(2) Medical Law Review 242.

¹³²  A Mullock, ‘The Supreme Court Decision in Nicklinson: Human Rights, Criminal Wrongs and the Dilemma of Death’ (2015) 31(1) Professional Negligence 18, at 28.

¹³³  Assisted Dying Bill (No 2) 2015–16, introduced by Rob Marris MP.

¹³⁴  The Welsh Assembly rejected a motion in support of Lord Falconer’s Bill by 21:12 (December 2014) and the Isle of Man’s House of Keys rejected an assisted suicide Bill by 17:5 (February 2015).

¹³⁵  End of Life Assistance (Scotland) Bill.

¹³⁶  Meyers, Mason, ‘Physician Assisted Suicide’.

¹³⁷  R (on the application of Pretty) v DPP [2002] 1 All ER 1, at 6–7, HL.

¹³⁸  Nederlandse Jurisprudentie 1973 No 183 District Court of Leeuwarden, 21 February 1973.

¹³⁹  Wertheim, Nederlandse Jurisprudentie 1982 No 63, Rotterdam Criminal Court.

¹⁴⁰  BD Onwuteaka-Philipsen et al, ‘Trends in End-of-Life Practices Before and After the Enactment of the Euthanasia Law in the Netherlands from 1990 to 2010: A Repeated Cross-Sectional Survey’ (2012) 380(9845) The Lancet, 908.

¹⁴¹  Termination of Life on Request and Assisted Suicide (Review Procedures) Act 2000. Discussed in J de Haan, ‘The New Dutch Law on Euthanasia’ (2002) 10 Medical Law Review 57.

¹⁴²  Discussed by Jackson, Medical Law, p 934.

¹⁴³  See J Keown, ‘The Law and Practice of Euthanasia in the Netherlands’ (1992) 108 Law Quarterly Review 51; H Jochenson, J Keown, ‘Voluntary Euthanasia under Control? Further Empirical Evidence from the Netherlands’ (1999) 25 Journal of Medical Ethics 16.

¹⁴⁴  And see L Clements, J Read (eds) Disabled People and the Right to Life: The Protection and Violation of Disabled People’s Most Basic Human Right (2007), Routledge-Cavendish.

¹⁴⁵  JM Van Delden, ‘Slippery Slopes in Flat Countries – A Response’ (1999) 25 Journal of Medical Ethics 22.

¹⁴⁶  Report of the Select Committee on Medical Ethics, 1993–94, HL-21.

¹⁴⁷  S Holm, ‘The Debate about Physician Assistance in Dying: 40 Years of Unrivalled Progress in Medical Ethics?’ (2015) 41(1) Journal of Medical Ethics 40.

¹⁴⁸  See Parliamentary Office of Science and Technology, Postnote: Vegetative and Minimally Conscious States, No 498 (March 2015).

¹⁴⁹  In re Quinlan (1976) 355 A 2d 647. And see Cruzan v Director Missouri Department of Health (1990) 110 S Ct 2841 (USA Supreme Court).

¹⁵⁰  For other controversial cases, see K Goodman (ed) The Case of Terri Schiavo: Ethics, Politics and Death in the 21st Century (2009), Oxford University Press; S Moratti, ‘The Englaro Case: Withdrawal of Treatment from a Patient in a Permanent Vegetative State in Italy’ (2010) 19 Cambridge Quarterly of Healthcare Ethics 372. And see discussion of Lambert and Others v France (application No 46043/14) (Grand Chamber), 5 June 2015, at 19.18.

¹⁵¹  The Royal College of Physicians sets out clinical guidance: RCP Advance Care Planning: National Guideline (2009, updated 2012).

¹⁵²  See 19.18.

¹⁵³  The law is supplemented with professional guidance. The BMA produced Withholding and Withdrawing Life-Prolonging Medical Treatment: Guidance for Decision Making in 2007, and the GMC issued Treatment and Care towards the End of Life: Good Practice in Decision Making (2010).

¹⁵⁴  Airedale NHS Trust v Bland [1993] 1 All ER 821, HL

¹⁵⁵  Since Bland the terminology has changed. The RCP uses the term ‘prolonged disorders of consciousness’. According to NHS Choices (available at www.nhs.uk): ‘There are several different states of impaired consciousness, depending on how these abilities are affected. These include: coma – when there are no signs of wakefulness or awareness; vegetative state – when a person is awake but showing no signs of awareness; minimally conscious state – when there is clear but minimal evidence of awareness that comes and goes’.

¹⁵⁶  This incontrovertible physical evidence and irreparable damage to the brain distinguishes Bland from some subsequent cases.

¹⁵⁷  At 19.1.

¹⁵⁸  [1989] 2 All ER 545, discussed fully at 6.6.

¹⁵⁹  See the RCP’s clinical guidance: RCP, Oral Feeding Difficulties and Dilemmas (2010).

¹⁶⁰  [1993] 1 All ER 821 at 894, HL.

¹⁶¹  For critical appraisal of Bland, see JM Finnis, ‘Bland: Crossing the Rubicon?’ (1993) 109 Law Quarterly Review 329; J Keown, ‘Restoring Moral and Intellectual Shape to the Law after Bland’ (1997) 113 Law Quarterly Review 481.

¹⁶²  And see BMA, Withholding and Withdrawing Life-Prolonging Medical Treatment: Guidance for Decision-Making (3rd edn, 2007).

¹⁶³  S Laureys et al, ‘Unresponsive Wakefulness Syndrome: A New Name for the Vegetative State or Appalic Syndrome’ (2010) 8 BMC Medicine 68. For legal analysis, see S Burns, ‘Life … But Not as We Know It’ (2010) 160 New Law Journal 121.

¹⁶⁴  See the incisive arguments of Finnis, ‘Bland: Crossing the Rubicon?’ and Keown, ‘Restoring Moral and Intellectual Shape to the Law after Bland’.

¹⁶⁵  [1993] AC 789, para 885 (HL).

¹⁶⁶  See L Doyal, ‘Dignity in Dying Should Include the Legalization of Non-Voluntary Euthanasia’ (2006) 1(2) Clinical Ethics 65.

¹⁶⁷  See P Singer, Rethinking Life and Death (1994) Oxford University Press, p 75.

¹⁶⁸  [1994] 2 All ER 403.

¹⁶⁹  See J Stone, ‘Withholding of Life-Sustaining Treatment’ (1995) New Law Journal 354.

¹⁷⁰  Re D (Medical Treatment) [1998] FLR 411.

¹⁷¹  Re H (A Patient) [1998] 2 FLR 36.

¹⁷²  [1998] 2 FLR 36, at 41.

¹⁷³  For example, Re D (Medical Treatment: Mentally Disabled Patient) [1998] 2 FLR 22.

¹⁷⁴  Practice Note (Official Solicitor: Declaratory Proceedings: Medical and Welfare Decisions for Adults who Lack Capacity) [2001] 2 FLR 569.

¹⁷⁵  Re D (Medical Treatment) [1998] FLR 411.

¹⁷⁶  [2004] EWCA Civ 1324.

¹⁷⁷  Ibid, per Brooke LJ, [22] and [27].

¹⁷⁸  A series of cases involving the withdrawal of treatment from children is examined in Chapter 14, at 14.6–14.12.

¹⁷⁹  See RCP, Prolonged Disorders of Consciousness: National Clinical Guidelines (2013). And see R Heywood, ‘Moving on From Bland: The Evolution of the Law and Minimally Conscious Patients’ (2014) 22(4) Medical Law Review 548 for an excellent discussion of the ethical and legal issues raised in relation to end-of-life decisions concerning patients in a ‘minimally conscious state’.

¹⁸⁰  W v M and others [2011] EWHC 2443, [46].

¹⁸¹  [2011] EWHC 2443, [56] per Baker J.

¹⁸²  Ibid, [35], per Baker J.

¹⁸³  See A Mullock, ‘Deciding the Fate of a Minimally Conscious Patient: An Unsatisfactory Balancing Act?: W v M and Others [2011] EWHC 2443 (Fam)’ (2012) 20(3) Medical Law Review 460 for discussion of the tensions that arise between the balance sheet approach and the Mental Capacity Act requirement to respect to the patient’s previously expressed wishes.

¹⁸⁴  [2015] EWCOP 42.

¹⁸⁵  Ibid, [7].

¹⁸⁶  [2013] EWHC B26 (Fam).

¹⁸⁷  Ibid, [20], per Hayden J.

¹⁸⁸  Ibid, [19].

¹⁸⁹  [2013] UKSC 67.

¹⁹⁰  Aintree University Hospitals NHS Foundation Trust v James [2013] UKSC 67, [6] per Lady Hale.

¹⁹¹  Ibid, [39–40].

¹⁹²  Ibid, [23].

¹⁹³  Ibid, [35].

¹⁹⁴  S Pattinson, Medical Law and Ethics (4th edn, 2014), Sweet & Maxwell, 14-038.

¹⁹⁵  [2001] 1 All ER 801 and see E Wicks, ‘The Right to Refuse Medical Treatment Under the European Convention on Human Rights’ (2001) 9 Medical Law Review 17.

¹⁹⁶  Lambert and Others v France (application No 46043/14) (Grand Chamber), 5 June 2015.

¹⁹⁷  Ibid, dissenting opinion, [1].

¹⁹⁸  Ibid, [148].

¹⁹⁹  General Medical Council, Withholding and Withdrawing Life-Prolonging Treatments: Good Practice in Decision-Making (2002). Para 16 provided: ‘Doctors must take account of patients’ preferences when providing treatment. However, where a patient wishes to have a treatment that – in the doctor’s considered view – is not clinically indicated, there is no ethical or legal obligation on the doctor to provide it’. The 2002 guidelines were replaced by GMC, Treatment and Care towards the End of Life: Good Practice in Decision Making (2010).

²⁰⁰  R (on the application of Burke) v General Medical Council [2004] EWHC 1879 (Admin).

²⁰¹  See R Gillon, ‘Why the GMC is Right to Appeal Over Life-prolonging Treatment’ (2004) 329 BMJ 810. In support of the High Court judgment, see H Biggs, ‘In Whose Best Interests: Who Knows?’ (2006) 1(2) Clinical Ethics 90; D Gurnham, ‘Losing the Wood for the Trees: Burke and the Court of Appeal’ (2006) 14 Medical Law Review 253, Also see J Coggon (2006) 12 Medical Law Review 219, who argues that a right to die with dignity cannot exist in the absence of a right to die.

²⁰²  R (on the application of Burke) v General Medical Council [2005] EWCA Civ 1003.

²⁰³  Burke v United Kingdom [2006] App 19807/06.

²⁰⁴  Ibid, per Casadevall J.

²⁰⁵  Though subsequent case law has indicated that the courts will give weight to previously autonomous requests made by those lacking capacity: see S Pattinson, ‘R (on the Application of Burke) v GMC; Burke v UK: Contemporaneous and Advance Requests: The Fight for Rights at the End of Life’ in J Herring, J Wall, Landmark Cases in Medical Law (2015) Hart, pp 255–269.

²⁰⁶  Department for Constitutional Affairs, Mental Capacity Act 2005 Code of Practice, para 5.34.

²⁰⁷  DH, Reference Guide to Consent for Examination or Treatment (2nd edn, 2009), ch 4, para 14.

²⁰⁸  Independent Review of the LCP, More Care, Less Pathway: A Review of the Liverpool Care Pathway (2013).

²⁰⁹  Ibid, 7.

²¹⁰  Leadership Alliance for the Care of Dying People, One Chance to Get It Right (2014). And see NHS England, Actions for End of Life Care: 2014–16 (November 2014).

²¹¹  More Care, Less Pathway: A Review of the Liverpool Care Pathway, 7.

²¹²  NICE Care of Dying Guideline (December 2015).

²¹³  See also Chapter 6.

²¹⁴  Mental Capacity Act, s 4(6)(b).

²¹⁵  [2013] UKSC 67.

²¹⁶  As we have seen, the deterioration of Mr James’s health led Lady Hale to accept the Court of Appeal’s conclusion that treatment should be withdrawn.

²¹⁷  Mental Capacity Act 2005, s 4(6)(a) and see ss 24–26 on advance decisions to refuse treatment.

²¹⁸  This was also the case in common law: R (on the application of Burke) v GMC [2005] EWCA Civ 1003 CA, [35].

²¹⁹  Section 25(1).

²²⁰  See ss 25(5)–(6).

²²¹  [2012] EWHC 885 (COP).

²²²  Lasting Powers of Attorneys are governed by ss 9–14.

²²³  See s 11(8)(a).

²²⁴  See for example Re AVS v An NHS Trust [2010] EWHC 2746 (COP).

²²⁵  Section 4(10).

²²⁶  Mental Capacity Act 2005 Code of Practice, para 5.29.

²²⁷  Ibid, para 5.31. And see J Coggon, ‘Ignoring the Moral and Intellectual Shape of the Law after Bland: The Unintended Side-effect of a Sorry Compromise’ (2007) 27 Legal Studies 110.

²²⁸  [2005] EWCA Civ 1003, [80].

²²⁹  Court of Protection Rules 2007 Part 9, Direction E, Applications Relating to Serious Medical Treatment para 5(a): ‘[D]ecisions about the proposed withholding or withdrawal of artificial nutrition and hydration from a person in a permanent vegetative state or a minimally conscious state’ should be brought to the court. And see W v M [2011] EWHC 2443 (Fam) [78], per Baker J.

²³⁰  See also discussion of Re Wyatt [2004] EWHC 2247; [2005] EWHC 693 [2005] EWHC 1181; [2005] EWHC 2902 and Re B (A Minor) [2008] EWHC 1996 (Fam), at 14.11.

²³¹  (1996) 31 BMLR 127.

²³²  See Re J (A Minor) (Wardship: Medical Treatment) [1990] 3 All ER 930, CA.

²³³  Section 11(8)(a).

²³⁴  GMC, Treatment and Care towards the End of Life (2010), paras 129–131.

²³⁵  [2014] EWCA Civ 822. See J Samanta, ‘Tracey and Respect for Autonomy: Will the Promise be Delivered?’ (2015) 23(3) Medical Law Review 467.

²³⁶  [2014] EWCA Civ 822, [54] per Dyson MR.

²³⁷  Ibid, [55] per Dyson MR.

²³⁸  Ibid, [84] per Dyson MR: ‘to hold that article 8 requires the formulation of a unified policy at national level, rather than having individual policies at local level, is unwarranted and would represent an unjustified intrusion into government healthcare policy’.

²³⁹  BMA/RC(UK)/RCN, Decisions Relating to Cardiopulmonary Resuscitation (3rd edition) (2014). See also NHS Scotland, Integrated Policy on Do Not Attempt Cardiopulmonary Resuscitation (2010).

²⁴⁰  BMA/RC(UK)/RCN, Decisions Relating to Cardiopulmonary Resuscitation, p 4.

²⁴¹  Ibid, p 5.

²⁴²  See T Shakespeare, B Vernon, ‘Disability Rights and Resuscitation: Do Not Attempt Reconciliation’ in Clements and Read, Disabled People and the Right to Life, ch 5; D Rose, ‘Nurses to Decide If Patients Are Revived’ (2007) The Times, 27 October.

²⁴³  Mason, Laurie, Mason and McCall Smith’s Law and Medical Ethics, 18.32.

²⁴⁴  [2014] UKSC 38, [325].

Index

Abortion

abortion pill 13.5

conscientious objection 13.15

criminal offences 14.20

emergency hormonal contraception 13.5

fathers 13.16

fetal handicap 13.12

fetal status 13.19

girls under 16 13.17

gradualist approach to protection 13.12

Human Fertilisation and Embryology Authority (HFEA) 13.1

intra-uterine devices 10.11

legislative provision 13.6

mentally disabled women 13.18

miscarriage 13.5

nurses 13.14

permitted reasons 13.12

post-coital contraceptives 13.5

risk to women’s health 11.1

selective reduction 13.13

self-induced 13.2

social abortions 13.12

statistical risk 10.10

time limits 12.28

see also Embryo research

Access to health care 2.17

assisted conception see Assisted conception

existence of a right 2.2, 2.17–2.19 passim

NHS resources 2.19

NICE see National Institute for Health and Care Excellence

treatment abroad 2.22

Access to records see Confidentiality; Malpractice litigation

Advance decisions see Capacity to consent

Agreeing to treatment

advisory duty 5.3–5.9 passim

capacity to consent see Capacity to consent

causation 5.16

consent 5.6

effect of informed consent 5.4

emergencies 5.2

fiduciary obligations see Consent to treatment

identity of surgeon 5.5

patient knowledge 5.6

refusal of treatment 5.3

and see Consent to treatment

Amniocentesis see Congenital disabilities; Conscientious objection

Anonymised data see Data protection

Appropriate consent see Organ retention

Artificial gametes see Embryo research

Artificial insemination 12.14

Blood (Diane) decision 12.15

see also Assisted conception

Artificial nutrition and hydration see End of life

Assault and battery 5.1

consent 5.6

patient knowledge 5.6

refusal of treatment 5.3

see also Consent to treatment

Assisted conception

access to services 12.15–12.18 passim

artificial insemination see Artificial insemination

cell nuclear replacement 12.25

cloning 12.25

disabled child 12.24

donor insemination

single mothers 12.5

embryo storage 12.2, 12.14

embryo transplants 12.16

ethics see Ethics

Evans (Natalie) decision 12.18

gamete donation 12.10–12.12

HFEA see Human Fertilisation and Embryology Authority

human rights see Human rights

identification of genetic parents 12.27

in vitro fertilisation 12.4

licensing 12.3

post-menopausal motherhood 12.6

pre-implantation genetic diagnosis 12.19

reproductive cloning 12.25

right to reproduce 12.8

saviour siblings 12.20

storage of embryos and gametes 12.17

surrogacy 12.26

Assisting suicide 19.2

DPP Policy for Prosecutors 19.8

person who cannot act 19.6

Autonomy see Ethics

Babies see Children

Beating-heart donors see Transplantation

Best interests 14.7

children

conjoined twins 14.5

disputing 14.11

parental demands 14.11

parental responsibilities 14.10

scruples and dogma 14.9

end of life see End of life

F v West Berkshire HA 6.6

legislative basis 6.8

modified test 6.9

Bioethics see Ethics

Biomedicine see Human rights

Blood donation see Transplantation

Blood transfusions see Children

Bolam test see Clinical negligence; Consent to treatment, Medical malpractice

Bone marrow donation

child donors 17.5

and see Transplantation

Brain stem death see End of life

Breach of confidence

common law 4.2–4.4

GMC guidance 4.5

and see Confidentiality

Cadaver donation 17.7

explicit consent 17.10

sanctions for breach of law 17.12

and see Transplantation

Capacity to consent

advance decisions 6.14

advance demands 6.14

advance directives 6.14

advance refusals 6.14

background

case law 6.1

legislation 6.1

compulsory treatment

mental health legislation 6.19

Court of Protection 6.17

deputies 6.16

family decision-making 6.13

functional test 6.4

Bournewood 6.9

lasting powers of attorney 6.15

legality of treatment

Bournewood 6.9

F v West Berkshire HA 6.6

legislative reform 6.8–6.10

living wills 6.8

next of kin 6.13

outcome test 6.3

Re C test 6.4

restraint and detention 6.11

right to liberty and security 6.11

status test 6.4

sterilisation cases 11.4

threshold 6.4

see also Best interests; Human rights; Mental health legislation

Care see Ethics

Care Quality Commission 1.18

Case management see Malpractice litigation

Causation see Clinical negligence; Embryo research; Informed consent

Cell nucleus replacement see Assisted conception; Embryo research

Chief Medical Officer (CMO) see Medical education; Revalidation

Child donors see Transplantation

Childbirth

available choices 11.19

fetal welfare 11.21

hospital 11.20

maternal autonomy 11.21

wrongful birth 11.12

wrongful life 11.11

see also Pregnancy

Children

blood transfusions 14.9

conjoined twins 14.5

cosmetic surgery 14.13

deprivation of liberty 14.22

deliberate killing 14.5

disability 14.2

female circumcision 14.16

Glass (David) decision 14.10–14.11

HIV testing 14.12

medical research 15.10

neonatal euthanasia 14.3

non-life or death situations 14.12

parental consent 14.13

parental demands 14.11

parental responsibilities 14.10

sterilisation 14.13

views of child 14.15

Wyatt (Charlotte) decision 14.11

see also Best interests; Family planning; Organ retention; Religious beliefs; Withdrawal and withholding of treatment; Young people

Chimera embryos see Embryo research

Civil Procedure Rules see Malpractice litigation

Clinical Commissioning Groups 1.3, 7.2, 8.4, 12.7

Clinical governance 7.10

Clinical negligence

Bolam test 7.8

causation 7.15–7.16

Clinical Negligence Protocol 8.11

Clinical Negligence Scheme for Trusts 8.4

criminal liability 7.22

current practice 7.10

diagnosis 7.12

duty of care 7.2

evidence based medicine 7.11

GPs see General Practitioners

guidelines 7.11

inexperience 7.7

junior doctors 7.7

loss of a chance 7.17

medical examinations 7.4

misdiagnosis 7.10–7.11

negligent treatment 7.13

overworked doctors 7.14

prescription errors 7.19

private patients 7.21

procedure 7.11

psychiatric harm 7.3

standard of care

Bolitho test 7.9

protocols and guidelines 7.11

responsible practice 7.10

treatment 7.13

and see Malpractice litigation; Redress

Clinical research see Medical research

Clinical trials 15.4

approval 15.5

compensation for mishap 15.14

consent to participation 15.8

ethics committees 15.5

governance 15.3

patient protection 15.8

randomised controlled trials 15.13

see also Medical products liability

Cloning see Assisted conception; Embryo research; Ethics

Cognitive death 16.4

see also End of life

Commencement of proceedings see Malpractice litigation

Compensation

damages 8.15

no-fault schemes 9.13

periodical payments 8.16

see also Malpractice litigation; Medical research

Complaints see Redress

Compulsory disclosure see Confidentiality

Compulsory treatment see Capacity to consent

Conditional fee agreements see Malpractice litigation

Confidentiality

access to records 4.20

anonymised data 4.20

children 14.23

compulsory disclosure 4.9

data protection 4.17

disclosure with consent 4.6

doctors with HIV 4.4

duty of disclosure 5.9

genetics 4.14–4.15

justification for disclosure

patient lacks capacity 4.7

protection of patient 4.8

public interest 4.10

NHS practices 4.21

parents’ rights 4.1

patient access to records 4.23

patient lacks capacity 4.7

protection of patient 4.8

right to respect for private and family life 4.2–4.4 passim

withholding information from patient 4.1

see also Breach of confidence; General Medical Council; Human rights; Public interest

Congenital disabilities

ante-natal screening 11.10

criminal liability 11.18

doctors’ defence 11.9

drugs 11.8

genetic counselling 11.14

legislative provision 11.7

maternal immunity 11.17

pre-conception events 11.13

pre-implantation genetic diagnosis 11.14

pre-pregnancy advice 11.14

proceedings by parents 11.6

refusal of abortion 11.16

understanding of risk by parent 11.15

wrongful life 11.11

Conjoined twins see Best interests; Children

Conscientious objection see Abortion

Consent to participation see Medical research

Consent to treatment

advice 5.7

causation 5.16

effect 5.4

Montgomery decision 5.12

assault and battery 5.1

Bolam test 5.8

capacity 5.14

competence see Capacity to consent

‘consent’ 5.4

emergencies 5.2

extent of information 5.10

fiduciary obligations 5.17

identity of surgeon 5.5

informed consent 5.6

meaning 5.4

patient knowledge 5.6

procedure 5.4

real risk of misfortune inherent in the procedure 5.9

refusal of treatment 5.3

therapeutic exception 5.15

trespass to person 5.1

Contingency fees see Malpractice litigation

Contraception

Gillick competence 14.20

patients’ rights 11.2

product liability 11.2

and see Family planning

Contractual claims see Medical products liability

Contributory negligence 7.20

Corneal grafting see Transplantation

Coroners see Transplantation

Corporate manslaughter 7.24

Cosmetic surgery see Children

Court of Protection see Capacity to consent

Criminal liability see Abortion; Clinical negligence; Congenital disabilities; Transplantation

Damages see Malpractice litigation

Data protection 4.17–4.18

and see Confidentiality

Death see End of life

Declaration of incompatibility see Human rights

Defences see Malpractice litigation

Defendants see Malpractice litigation

Defensive medicine see Malpractice litigation

Degrading treatment see Human rights

Deliberate killing see Children

Deprivation of Liberty Safeguards (DoLS) 6.12

Deputies see Capacity to consent

Diagnosis see Clinical negligence

Direct liability 8.6

Disabled child see Assisted conception; Consent to treatment

Discipline see General Medical Council (GMC)

Disclosure see Malpractice litigation

Do not attempt CPR orders see End of life

Doctor-patient relationship see Malpractice litigation

Doctors

entitlement to practise

see also Congenital disabilities; Fitness to practise; regulation

Doctors’ responsibilities 2.1

see also Confidentiality; Human rights

Donor insemination

single mothers 12.5

see also Assisted conception

Double effect principle see End of life

Drugs see Congenital disabilities; Medical products liability

Duty of care see Clinical negligence

Education see General Medical Council (GMC)

Elective ventilation see Transplantation

Embryo research

artificial gametes 13.10

cell nucleus replacement 13.8

chimera embryos 13.9

cloning 13.8

deregulation;

Human Fertilisation and Embryology Authority (HFEA)

hybrid embryos 13.9

legislative provision 13.7

permitted purposes 13.7

principles 13.7

purpose 13.6

status of embryo 13.6

stem cell therapies 13.9

see also Abortion; Cloning; In vitro fertilisation

Embryo storage see Assisted conception

Embryo transplants see Assisted conception

Emergencies see Confidentiality; Consent to treatment; Medical research

Emergency hormonal contraception see Abortion

End of life

artificial nutrition and hydration 19.18

courts’ role 19.20

death

Bland (Tony) case 19.15

brain stem death 16.2

cognitive death 16.2–16.4 passim

definition legal 16.3–16.4

medical 16.2

establishing date 16.2

Human Tissue Authority (HTA) 16.3–16.4

irreversible brain damage 16.2

life-support 16.2

PVS 16.3–16.4

transplantation 16.2

death tourism 19.7

disagreement between carers 19.20

do not attempt CPR orders 19.21

‘double effect’ principle 19.3

DPP Policy for Prosecutors 19.8

lasting power of attorney 19.19

mental capacity 19.19

mercy killing 19.2

murder 19.2

minimally conscious state 19.17

Nicklinson (Tony) litigation 19.8

person cannot act 19.6

physician-assisted 19.12

Pretty (Dianne) case 19.6

PVS 19.16

right to die 19.4

suicide 19.2

unconscious patient 19.14

see also Best interests; Euthanasia

Ethics

autonomy 3.3, 3.7

beneficence 3.4

care 3.8

distinction from etiquette 3.2

do good 3.4

do no harm 3.5

justice 3.6

non-maleficence 3.5

patients’ responsibilities 3.7

persons entitled to ethical obligations

self-determination 3.3

virtue 3.8

see also Medical research; Sanctity of life

Ethics committees 15.5

clinical trial regulations 15.7

problems 15.6

statutory authority 15.6

Ethics service 15.5–15.6

Etiquette see Ethics

European Medicines Agency see Medical products liability

Euthanasia

active 19.13

physician-assisted 19.10, 19.12

see also Human rights

Evidence-based medicine see Clinical negligence

Expert evidence see Malpractice litigation

Explicit consent 17.2, 17.10

legislative requirement 17.10

and see Transplantation

False imprisonment see Human rights

Family decisions see Capacity to consent

Family planning

children

abortion 14.20

consent to treatment 14.19

contraception 14.20

parental rights 14.13

product liability 11.2

vasectomy 11.1

see also Contraception; Sterilisation cases

Fathers see Abortion

Female circumcision see Children

Fertility treatment see Assisted conception

Fetal handicap see Abortion

Fetal life see Human rights

Fetal status see Abortion

Fetal tissue see Transplantation

Fetal welfare see Childbirth

Fiduciary obligations see Consent to treatment

Fitness to practise

appeals 1.12

effect of reforms 1.14

Foreign proceedings see Medical products liability

Funding see Malpractice litigation

Gamete donation see Assisted conception

Gamete storage see Assisted conception

Gametes intra-fallopian transfer (GIFT) see Assisted conception

General Medical Council (GMC)

composition 1.9

effect of reforms 1.13–1.15

establishment 1.8

functions

advice 1.10

discipline 1.14

education 1.11

maintenance of register 1.12

revalidation 1.13

medical ethics see Ethics

membership 1.9

principal objective 1.8

General Practitioners (GPs) 7.18

clinical negligence

prescription errors 7.19

see also Malpractice litigation

Genetic counselling 11.14

Genetic parents see Assisted conception

Genetic privacy see Medical research

Genetics see Confidentiality

Gillick competence 14.18

effect 14.21

extent of rights and responsibilities 14.10

parental rights 14.18–14.20

see also Abortion; Children; Consent to treatment; Contraception; Transplantation

Girls under 16 see Abortion

Glass decision 14.10–14.12

see also Children

Governance see Medical research; National Health Service

Health Service Commissioner see Redress

HealthWatch England 1.19

Hippocratic Oath see Ethics

HIV testing see Children

Human clone see Children; Ethics

Human Fertilisation and Embryology Authority (HFEA) see Abortion; Assisted conception; Embryo research

Human rights

application 2.3

biomedicine 2.15

claimants 2.6

declarations of incompatibility 2.3

defences 2.1

defendant 2.4

freedom of expression 2.13

freedom of thought; conscience and religion 2.12

inhuman or degrading treatment or punishment 2.8

justification 2.1

margin of appreciation 2.1

necessary in a democratic society 2.1

NHS resources 2.19

NICE 2.18

precedent 2.3

privacy 2.3

proportionality 2.1

public authorities

defendants 2.4

restrictions 2.1

right to fair trial 2.10

right to liberty and security 2.9

right to life 2.7

right to marry and found a family 2.14

right to private and family life 2.11

see also confidentiality

top-up treatment 2.20

treatment abroad 2.22

victims 2.5

see also Access to health care; Assisted conception; capacity to consent; Confidentiality; Young people

Human Tissue Authority (HTA) see End of life; Transplantation

Hybrid embryos see Embryo research

In vitro fertilisation (IVF) 12.4

see also Assisted conception; Embryo research

Inexperience see Clinical negligence

Infanticide see Fetal status

Informed consent

causation 5.16

effect 5.4

meaning 5.4

Montgomery decision 5.12

see also Consent to treatment; Transplantation

Innovative therapy see Medical research

Intra-cytoplasmic sperm injection (ICSI) see Assisted conception

Intra-uterine devices see Abortion

Intrusive research see Medical research

Irreversible brain damage see End of life

Jehovah’s Witnesses see also Children; Human rights

children 14.9

human rights 2.12

Joint Royal Colleges of Physicians Training Board 1.11

Junior doctors see Clinical negligence

Justice see Ethics

Justification see Human rights

Lasting powers of attorney see Capacity to consent; End of life

Legal aid see Malpractice litigation

Letting die see Ethics

Licensing see Assisted conception

Life-support see End of life

Limitation periods see Malpractice litigation

Litigation see Malpractice litigation

Live donation 17.3

adult donors 17.4

child donors 17.5

informed consent 17.4

see also Informed consent

mentally-incapacitated donors 17.6

paired donation 17.4

pooled donation 17.4

and see Transplantation

Living wills see Capacity to consent

Local resolution 9.4–9.7 passim

see also Redress

Loss of a chance see Clinical negligence

Malpractice litigation

access to medical records 4.9

burden of proof 8.14

case management 8.13

Civil Procedure Rules 8.10–8.11

Clinical Negligence Protocol 8.10–8.11

Clinical Negligence Scheme for Trusts 8.4

commencement of proceedings 8.9

compulsory disclosure of records 8.12

conditional fee agreements 8.3

contingency fees 8.3

cost to NHS

doctor-patient relationship 8.20

financial 8.19

current situation 8.17

damages 8.15

defences 8.4

defendants

direct liability 8.6

general practitioners 8.8

private practitioners 8.7

defensive medicine 8.18

disclosure 8.11–8.12

expert evidence 8.13

funding 8.2

legal aid 8.2

limitation periods 8.9

Medical Protection Society 8.4

National Health Service Litigation Authority 8.4

NHS Indemnity 8.4

no-win no-fee 8.3

periodical payments 8.16

pre-action protocol 8.10–8.12

private patients 8.7

proof of claim 8.13

structured settlements 8.16

see also Compensation

Manufacturer’s licences see Medical products liability

Margin of appreciation see Human rights

Marketing authorisations see Medical products liability

Maternal immunity see Congenital disabilities

Medical education see General Medical Council (GMC)

Medical ethics see Ethics

Medical malpractice

Bolam test 7.8

causation 7.15–7.16

corporate manslaughter 7.24

criminal liability 7.22

current practice 7.10

diagnosis 7.12

duty of care 7.2

evidence-based medicine 7.11

GPs 7.18

guidelines 7.11

inexperience 7.7

junior doctors 7.7

loss of a chance 7.17

medical examinations 7.4

misdiagnosis 7.12

negligent treatment 7.13

NICE 7.11

overworked doctors

prescription errors

private patients

protocols 7.11

psychiatric harm 7.3

treatment 7.13

wilful neglect 7.23

and see Clinical negligence; Malpractice litigation; Redress

Medical products liability

causation 10.10

clinical trial authorisations 10.11–10.13 passim

collective actions 10.8

consumer-buyers 10.3

contractual claims 10.3

drugs 10.2

European Medicines Agency 10.11–10.13 passim

foreign proceedings 10.14

manufacturer’s licenses 10.11–10.13 passim

marketing authorisations 10.11–10.13 passim

Medicines and Healthcare Products Regulatory Agency 10.11–10.13 passim

mesothelioma 10.10

most favoured claimants 10.3

negligence 10.4

off-label drug use 10.12

regulators 10.13

remedies

negligence 10.4

sale of goods 10.3

strict liability 10.5

A v National Blood Authority 10.6

contaminated blood products 10.9

defective 10.5

development risks 10.7

vaccine damage 10.15

vCJD contaminated blood products 10.9

wholesale dealer’s licences 10.11–10.13 passim

Medical research

adults lacking capacity 15.11

children 15.10

classification 15.1

clinical trials of investigational medicinal products see Clinical trials

compensation for mishap 15.14

no-fault schemes 15.15

consent to participation 15.8

emergencies 15.12

EU clinical trials regulation 15.7

European law 15.1

genetic privacy 15.18

governance 15.3

innovative therapy 15.9

intrusive research 15.1

mentally disordered persons 15.11

misconduct 15.16

no-fault compensation 15.15

non-intrusive research 15.1

non-therapeutic research 15.1

patient protection 15.8

randomised controlled trials 15.13

regulation 15.3

research ethics service 15.7

TGN1412 case 15.1

therapeutic research 15.1

see also Confidentiality; Ethics; Ethics committees; Ethics service; Research ethics committees (RECs)

Medicines and Healthcare Products Regulatory Agency see Medical products liability; Medical research

Mental capacity see Capacity to consent

Mental Capacity Act 6.8 15.11

substituted judgement 6.8

see also Best interests; Compulsory treatment; Consent to treatment; End of life; Human rights

Mental health legislation see Capacity to consent

Mercy killing see End of life

Mesothelioma see Medical products liability

Minimally-conscious state see End of life

Misconduct see Medical research

Misdiagnosis see Clinical negligence

Murder see End of life

National Health Service (NHS)

budget 1.3

commissioning 1.3

Constitution 2.16

redress 9.1

Foundation Trust status 1.4,1.18

future developments 1.20

regulation

governance 1.18

specialist organisations 1.19

supervision, management and protection of employees 1.17

top-up treatment 2.20

see also Confidentiality; Redress

National Health Service Litigation Authority

collective actions 9.10

malpractice litigation 8.1

National Institute for Health and Care Excellence (NICE)

see Human rights

National Research Ethics Service 15.5–15.6

Necessary in a democratic society see Human rights

Negligence see Clinical negligence

contributory negligence 7.20

corporate manslaughter 7.24

wilful neglect 7.23

Negligent treatment see Clinical negligence

Neonatal organs see Transplantation

Neonate see Children

Next of kin see Capacity to consent

NHS England 1.3

NHS Indemnity see Malpractice litigation

NHS Redress Scheme see Redress

NHS resources see Ethics; Human rights

No-fault compensation

accountability 9.16

causation 9.15

cost 9.17

deterrence 9.16

effect of tort system 9.11–9.12

foreign schemes 9.13

proposals 9.12

reforms to tort system 9.18

rejection in England 9.14

see also Human rights; Medical research

Non-beating-heart donors see Transplantation

Non-consensual treatment see Human rights

Non-human animal to human transplants see Transplantation

Non-intrusive research see Medical research

Non-regenerative organs see Transplantation

Non-therapeutic research see Medical research

No-win no-fee see Malpractice litigation

Nurses see Abortion

Ombudsman

clinical judgement 9.7

courts 9.7

see also Redress

Organ conscription see Transplantation

Organ retention

Alder Hey hospital 18.2

appropriate consent 18.8

children 18.6

Gillick competence 18.6

legislative provision 18.5

pre-HTA 2004 18.4

ownership of body parts 18.10

post-mortem examinations 18.3

regulatory requirements 18.9

removal of body parts from the dead 18.2

removal of body parts from the living 18.7

Organ transplantation see Transplantation

Outcome test see Capacity to consent

Overworked doctors see Clinical negligence

Paired donation see Transplantation

Parental consent see Children

Parental demands see Children

Parental responsibility see Children

Parents’ rights see Confidentiality

Paternalism see Ethics

Patient access to records see Confidentiality

Patient Advice and Liaison Service 19.1

see also Redress

Patient protection see Medical research

Patients’ rights see Human rights

Payment see Transplantation

Periodical payments see Malpractice litigation

Permanent vegetative state (PVS) see End of life

Post-menopausal motherhood see Assisted conception

Post-mortem examinations see Organ retention

Pre-action protocols see Malpractice litigation

Pre-conception events see Congenital disabilities

Pregnancy

ante-natal screening 11.10

criminal liability 11.7–11.8

doctors’ defence 11.9

drugs 11.8

genetic counselling

legislative provision

maternal immunity

pre-conception events

pre-implantation genetic diagnosis see Assisted conception;

Congenital disabilities

pre-pregnancy advice see Congenital disabilities

proceedings by parents 11.5

refusal of abortion 11.16

understanding of risk by parent 11.15

wrongful life 11.11

Pre-implantation genetic diagnosis see Assisted conception; Congenital disabilities

Pre-pregnancy advice see Congenital disabilities

Presumed consent see Transplantation

Privacy see Human rights

Private patients see Clinical negligence; Malpractice litigation

Product liability see Medical products liability

Proof of claim see Malpractice litigation

Proportionality see Human rights

Protection of patient see Confidentiality

Psychiatric harm see Clinical negligence

Public authorities 2.1

defendants 2.4

see also Human rights

Public inquiries 9.2

see also Redress

Public interest

communicable diseases 4.12

prevention or detection of crime 4.10

see also Confidentiality

Publicly funded care see Human rights

Quality adjusted life years (QALYS) 2.18

see also Ethics

Randomised controlled trials see Medical research

Redress

complaints

Complaints Advocacy Service 9.5

local resolution 9.6

private patients 9.8

raising a concern 9.5

see also Ombudsman

Francis inquiry/Mid Staffordshire NHS Foundation Trust Public Inquiry 8.15, 9.1, 9.6

NHS Constitution 9.1

Patient Advice and Liaison Service 9.5

public inquiries 9.2

tort system 9.11–9.12

see also Health Service Commissioner; Ombudsman; No-fault compensation

Refusal of treatment see Consent to treatment; Human rights

Regenerative organs see Transplantation

Register of medical practitioners see General Medical Council (GMC)

Regulation see General Medical Council (GMC); National Health Service

Regulators see Medical products liability

Relatives see Transplantation

Religious beliefs see Children; Jehovah’s Witnesses

Religious practices see Human rights

Removal of body parts see Organ retention

Reproductive cloning see Cloning

Research see Medical research

Research ethics committees (RECs) 15.5

clinical trial regulations 15.6

problems 15.6

statutory authority 15.6

Research ethics service see Medical research

Responsible practice see Clinical negligence

Restraint and detention

Bournewood 6.9

deprivation of liberty safeguards 6.12

see also Capacity to consent

Retention of organs see Organ retention

Revalidation see General Medical Council (GMC)

Sanctity of life

beginning of life 3.14

different perspective 3.12

end of life 3.15

Judaeo-Christian tradition 3.10

killing 3.15

law 3.16

letting die 3.15

medical profession 3.13

secular society 3.11

and see Ethics

Saviour sibling see Assisted conception; Ethics

Selective reduction see Abortion

Self-determination see Ethics

Self-regulation 1.8

Skin grafts 17.1

child donors 17.5

see also Transplantation

Standard of care see Clinical negligence

Status test see Capacity to consent

Stem cells see Embryo research; Ethics

Sterilisation cases

capacity to consent 6.6

children 14.13

involuntary 11.4

non-therapeutic 11.3

therapeutic 11.3

voluntary 11.3

Storage of embryos and gametes see Assisted conception

Strict liability see Medical products liability

Structured settlements see Malpractice litigation

Substituted judgement see Capacity to consent

Suicide see End of life

Surrogacy

commercial prohibition 12.29

custody of baby 12.30

foreign 12.31

parental orders 12.28

parenthood provisions 12.27

reforms 12.32

see also Assisted conception

Test-tube babies see Assisted conception

Therapeutic cloning see Embryo research

Therapeutic research see Medical research

Tissue 17.1

see also Transplantation

Top-up treatment 2.20

Tort system see Redress

Transplantation

adult donors 17.4

beating-heart donors 17.9

blood donation 17.1

breach of law 17.11

child donors 17.5

conditional donation 17.16

corneal grafting 17.7

coroners 17.12

criminal offences 17.10–17.11

elective ventilation 17.9

fetal tissue 17.19

future issues 17.20

informed consent 17.4

legislative provision 17.1–17.2

liability 17.18

mechanics 17.1

mentally-incapacitated donors 17.6

neo-natal organs 17.19

non-beating-heart donors 17.9

non-human animal to human transplants 17.17

non-regenerative organs 17.3

organ conscription 17.7

paired donation 17.4

payment for organs 17.14

pooled donation 17.4

practical problems

coroners 17.12

establishing death 17.13

presumed consent 17.10

legislative prohibition 17.12

regenerative organs 17.3

relatives 17.10

sanctions for breach of law 17.11

trading in organs 17.14

xenotransplantation 17.17

see also Bone marrow donation; Cadaver donation; End of life; Explicit consent; Gillick competency; Human Tissue Authority; Live donation; Skin grafts

Treatment abroad see Human rights

Trespass to person see Consent to treatment

Trust and confidence see Confidentiality

Unborn child see Abortion

Unconscious patient see End of life

Universal Declaration of Human Rights 2.1

see also Human rights

Vaccine damage see Medical products liability

Vasectomy 11.1

see also Family planning

vCJD contaminated blood products see Medical products liability

Victims see Human rights

Views of child 14.16

Virtue see Ethics

Warnock Report 12.1

see also Assisted conception

Wholesale dealer’s licences see Medical products liability

Wilful neglect 7.23

Withdrawal and withholding of treatment

children

best interests 14.7

disputing best interests 14.8

parental demands 14.11

parental responsibilities 14.10

scruples and dogma 14.9

human rights 2.7

Withholding information from patient see Confidentiality

Wrong diagnosis see Clinical negligence

Wrongful birth 11.12

Wrongful life 11.1

Xenotransplantation 17.17

see also Transplantation

Young people

confidentiality 14.23

right to say no 14.21

see also Gillick competence; Human rights