Medicine, Patients and The Law, Fifth Edition, 2011 Commissioned Book Review on Medical Law and Bioethics

A BOOK REVIEW COMMISSIONED BY

THE OXFORD UNIVERSITY PRESS


  MEDICINE, PATIENTS AND THE LAW

Fifth Edition

BY MARGARET BRAZIER AND EMMA CAVE

PENGUIN BOOKS, 2011, Paperback, 604 pp., £22.00.

          1.    Mark Fernando

Book Review Author Affiliations

          1.     Associate Tutor & Mentor, University of Oxford, UK,

                  Fellow, Rutherford College, University of Kent, UK and               
                  Guest Faculty Researcher, Harvard University, USA.

Medicine, Patients and The Law (2011), is a fully revised fifth edition, that draws upon the themes of earlier editions, whilst projecting new topics for analytical discourse.  

The main objectives of MPL are to present very cohesive, cogent and dynamic analyses, regarding the medical laws and bioethics of selected countries.   There is an emphasis upon the legal case laws and the medical ethics of the United  Kingdom, in comparison to the laws of the United States of America.  However, there are also brief comparative examples given from Germany, The Netherlands, New Zealand and Sweden.  

The main subject areas that are covered in the fifth edition of MPL are primarily regarding the most recent developments in Britain, in fields such as embryo research, assisted conception, tissue and organ transplants, fertility treatments, patient consent, euthanasia, the definition of death, malpractice and the breach of confidence.  These subject areas have been categorised into three parts of the book.

Part One covers:  Medicine, Law and Society, with topics ranging from, the practice of medicine today, doctors’ responsibilities: patients’ rights, moral dilemmas and the law, to trust and confidence in the medical profession.  Part Two covers:  Medical Malpractice, with topics surrounding, agreeing to treatment; competence, consent and compulsion; clinical negligence, malpractice litigation, complaints and redress, and medical products liability.  Part Three covers:  Matters of Life and Death, with the topics focusing upon, contraception, pregnancy and childbirth; assisted conception; abortion and embryo research; doctors and children; healthcare research; defining death; organ and tissue transplantation; the human body and it’s parts; to end of life issues.   The detailed coverage of these subjects provides an in-depth understanding for the reader.

The context within which this new edition of the book has emerged is as a response to the developments that have taken place in medical laws and medical ethics, since the previous editions of the book, first published in 1987.  A second edition was published in 1992.  Professor Margaret Brazier begins the 2003 MPL Preface by saying that:  "Writing a book about medicine and law these days is rather like chasing a moving target.  No sooner is one chapter completed than some novel development throws the process into disarray."  (Preface, MPL, p.vii, 2003).   The third and fourth editions of this text also  provided valuable additions to comparative studies in medical law and comparative bioethics.  In the fifth edition, the authors say:  “The pace of change in the National Health Service (NHS), Parliament and the law courts has not slowed down at all since our last edition in 2007.” (Preface, MPL, p.v, 2011). 

The authors use both a comparative and a historical legal analytical methodology,   that is also known to be used from within the classical Harvard tradition of comparative historical  research methods. [1]  The authors apply the comparative historical methodology, to  medical ethics laws with academic rigour and make a particularly significant contribution that can be of much inspirational value to influencing the work of scholars conducting legal and medical ethics research. Indeed, this comparative historical methodology can also be usedby others as a research heuristic, a methodological tool for medical law and bioethics analyses.   The authors say:

“Conventions, statutes and statutory regulations alone, be they

British 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 defines the rights and duties of

doctors and patients in areas untouched by statute.”

(Introduction, MPL, p.ix, 2011).

Margaret Brazier has been a Professor of Law since 1990 and the founder Director of the Centre for Social Ethics and Policy and the Institute of Medicine, Law and  Bioethics, at the University of Manchester, England.  Professor Brazier's research  and teaching interests focus upon the law of torts, medical law and bioethics.  She has written widely on medical law and ethics, chaired a review of laws relating to surrogacy from 1996 – 1998 and chaired the Retained Organs Commission from 2001 – 2004.  MPL (2011)  is co-authored by Dr Emma Cave, who is a lecturer in tort and medical law at the University of Leeds. Her research interests include legal and ethical issues in reproductive medicine and she is also author of  The Mother of  all Crimes (2004).

Medicine, Patients and  The Law, emanates from both the medical ethics and the legal schools of analyses, whilst taking medical law discussions into many difficult moral and philosophical areas, that are particularly  problematic to codify into legal statutes, such as regarding morality and the general sanctity of life.   MPL  being structured into three distinct sections is particularly helpful.   

“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 for over a century and a half has regulated the medical profession, meet patients’ needs? What rights do we enjoy in the context of health care and how has the Human Rights Act 1998 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.”

(Introduction, MPL, p.ix, 2011).

Woven into the central fabric of the book are highly significant contemporary issues within medical law and bioethics discourse. Firstly, regarding the medical profession being properly regulated   and controlled.  Where possible, to obtain a clear definition of the rights and obligations of patients, doctors and other healthcare professionals. Secondly, an adequate and rational  system of compensation for patients suffering injury. Thirdly, an effective means of investigating medical accidents and errors, whilst making adequate provision for doctors and patients to be given comprehensive guidance, on those areas of medical practice, with moral and ethical sensitivity. There is a strong focus upon the United Kingdom’s National Health Service and discussions such as, the entitlement to practise, self-regulation, the roles of the General Medical Council, revalidation, the disciplining of doctors in the fitness to practise, governance, including Healthcare Regulatory Excellence and specialist regulators are considered in some detail. In Doctors’ Responsibilities and Patients’ Rights, the effects of  The Human Rights Act 1998 and The European Human Rights Convention are outlined. 

This is combined with the complexities of the United Kingdom not currently being a signatory within the European Convention on Human Rights and Biomedicine 1997.  Access to health care by patients, the right to health care, The National Institute for Clinical Excellence (NICE), NHS resource-allocation decisions and possible treatments abroad, are  also further discussed.  The work of  Ian Kennedy and Andrew Grubb,  in  Medical Law, (3rd edition, 2000) [2]  is cited as two of  England's most influential experts, declaring that medical law is, "essentially ...  a sub-set of human rights law." (p.31, MPL, 2011).  

There is an exploration regarding the European Convention on Human Rights and Biomedicine 1997, the United Kingdom Human Rights Act 1998 and the possible effects of these combined with other legal instruments such as, the Human Fertilisation and Embryology Act 2008. The comparative discussion here is regarding the biomedical laws and regulations that are applicable in mainland Europe and in the United Kingdom, within the context of the European Biomedical Convention.   

There is also a consideration of key concepts such as:  1. respect for autonomy,  as self-determination;  2. beneficence, as the doing of good;  3. non-maleficence, as the doing of no harm;  4. justice, in the context of,  to do justly and within judicial frameworks; with,  5. sanctity of life issues and the medical profession.  These are sub-themes that emerge throughout the entire book. [3]  

However, unlike the more theoretical approaches of previous editions, many more highly detailed case law examples are provided in the fifth edition of MPL (2011). Issues of autonomy and patients’ responsibilities, the virtue of ethics and the ethics of care, sanctity of life and legal frameworks,  are juxtaposed  with concepts regarding a breach of confidence  in medical privacy and issues surrounding disclosures.  Serious crimes and the highly topical  issues of the freedom of the press, are combined with privacy issues and the Data Protection Act 1998.  

In MPL (2011), Part Two:  Medical Malpractice, examines topics such as,  aging and agreement to treatment; competence, consent and compulsion; clinical negligence;  malpractice litigation; medical products liability; hospital complaints procedures; and no fault compensations are discussed in some considerable detail.   The ideas surrounding the concept of agreement to treatment are explored:  “Battery is any non-consensual contact. Conduct which constitutes the crime of  battery may also amount to the crime of assault.” (p.116, MPL, 2011).   

There are exceptions to this, such as children and mentally incapacitated patients, who can be granted consent for medical treatment by a responsible third party,  such as by a child's parents or by a medical institution able to grant such a legal agreement to treatment, in the case of mentally incapacitated patients.   The scope of battery overlapping with negligence is discussed. [4]     

A comparative analysis of malpractice litigation in the United States of America  and in the United Kingdom further explores the medico-judicial similarities and differences between these two countries in particular. [5] 

Discussions surrounding the case of  Sidaway [1984] and  the impact of Pearce [1998], are examined.  Concepts of causation, informed consent, therapeutic privilege and fiduciary obligations are also discussed.  In terms of competence, consent and compulsion, the West Berkshire Health Authority case,  defining best interests, The Mental Capacity Act 2005, The Mental Health Act 1983, the use of restraint and detention, combined with issues regarding the protection of the public and vulnerable patients are also explored in some detail.  In considering clinical negligence, there is a duty of care and quality standards of care that are expected from the medical profession and healthcare institutions.  Regarding standards of  care, the Bolam test case [1957] is cited.  In the idiom of Glover, Bolam in The House of Lords, is also explored.  [6]   

Debates regarding overtired and overworked doctors that could lead to medical negligence, wilful neglect, corporate manslaughter and defending claims are also considered in some depth.  Civil justice reform: the Woolf Report and the Clinical Negligence Protocol, are examined to give a quintessential overview regarding the financial costs to the NHS and the wider costs to the NHS, in addressing the compensation culture, that could have highly damaging effects upon the NHS, at a time of large scale organisational reforms and refocused budgetary allocations. In considering problems about complaints and redress, health service public inquiries, complaints procedures, the  role of  the NHS Ombudsman, clinical judgment and the courts, are analysed and articulated in some depth.  As are issues of wider redress and legal remedy strategies,  as some possibilities are viewed as an attack on tort and therefore alternatives to  tort are considered.  The NHS Redress Act 2006 and the reducing of public funding costs is  also a highly topical issue that is considered.

In Part Three of the book, Matters of Life and Death, considers in detail topics regarding family planning; assisted conception; abortion and embryo research;  doctors and children; pregnancy and childbirth; medical research; organ and tissue transplantation;  dying and the medical practitioner;  whilst also analysing  the issues surrounding the retention of body parts.  The focus in the third section of this book is primarily upon reproduction, reproductive technology and the ethics surrounding medical research.  There are several topics that are addressed.  Beginning with how to prevent unwanted conceptions, moving to assisted conceptions, in its many possible formulations,  including test tube babies, egg donation, embryo transplants, to the freezing of  gametes and embryos,  embryo research, cloning issues with allied debates surrounding pregnancy and childbirth. 

Within this third section of the text, there are discussions regarding medical research, the work and functions of research ethics committees, combined with the monitoring of clinical research.  There are also further discussions about organ and tissue transplantation, including some debates regarding child donors, types of possible transplantation and live donor transplantations. Some significantly important aspects of assisted conception are discussed with a detailed consideration of topics within regulating human fertilisation and embryology, the licensing of fertility treatment,  In vitro fertilisation ( IVF ) with access to fertility treatments, gamete donation and parental status, artificial insemination, the storing gametes and embryos, pre-implantation genetic diagnosis, reproductive cloning and surrogacy.

The human rights to reproduce are also discussed in some eloquent detail. Aspects of criminal abortion, The Abortion Act 1967 and abortions on demand, are also analysed.   There is a significant emphasis upon the status of the embryo and embryo research,  combined with the legal effects of the Human Fertilisation and Embryology Act 1990,  upon embryo research, ‘cloning’, human admixed embryos, and artificial gametes.  There is an interesting discussion regarding replacing the British Human Fertilisation and Embryology Authority (HFEA).  It is the embryo to foetus and foetus to baby subject topics that are of much sustained interest to the authors, combined with the moral and philosophical aspects of prenatal and neonatal medical law and bioethics.

Regarding doctors and children, there is an interesting discussion about the threshold of viability, the proposals for reform of law and practice, the courts and deliberate killing, the withholding and the withdrawing of treatment, ‘best interests’ procedures to protect children, the Family Law Reform Act 1969 and the Gillick [1985] case: 

“For instance, may a mother, learning that her four-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. Gillick 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.”

( MPL, p.417, 2011).

The authors also ask several very pertinent questions throughout the book, such as:

“If legislation allowing active neonatal euthanasia were to be enacted in the UK , 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 1967 may have altered perceptions of the sanctity of life. Debate has ebbed and flowed for centuries as to the status

and humanity 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?”  ( MPL, p.421, 2011).

The authors further elaborate when they discuss:

“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. Should the child die, the parents may be convicted of manslaughter. 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.”  ( MPL, p.426, 2011).

Whilst considering healthcare research, research governance, the role of research ethics committees (RECs), the consent of patients to participation in trials, innovative therapy, children in medical research programmes, compensation for mishaps, research misconduct and genetic privacy are also themes that are explored:

“Genetic research generates significant public concern. 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. ... 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. Genetic profiling is playing an ever increasing role in research.  Much controversy has been created by the UK Biobank project.  It is funded by the Department of Health, Scottish Executive, Medical Research  Council and Wellcome Trust and aims to collect both data and samples on the

health of 500,000 volunteers and analyse it over a period of thirty years.  ( MPL, p.489, 2011).

The authors discuss The Human Tissue Act 2004, live donor transplantations, mentally incapacitated ‘donors’, cadaver transplantation, conditional donations, xenotransplantation, foetal tissue and neonatal transplants.  Regulation and the ownership of body parts are also analysed.  The authors discuss regarding the ownership of bodies:

“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 dictates 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’. Our bodies were too valuable to be ‘things’,  to be mere property. Would classifying bodies as property devalue  them or endorse that value?”    ( MPL, p.546, 2011).

Regarding end of life issues, the topics discussed include, murder, suicide and assisting  suicide; whether patients are competent and whether there is a ‘right’ to die, including the debates surrounding assisted dying and the UK Director of Public Prosecutions’ Policy for Prosecutors. The ethical consequences of Bland [1993] and the ‘right’ to artificial nutrition and hydration (ANH) are discussed with much erudite eloquence, whilst considering The Mental Capacity Act 2005, and the role of  the courts:

“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). He now enjoys limited communication via a computer.”  ( MPL, p.570, 2011).

The euthanasia debate, physician-assisted suicide (PAS) and active euthanasia, is also discussed, as the book concludes: 

“In the wake of the decision in Bland , the House of Lords set up a Select Committee on Medical Ethics 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 no change and 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.   ( MPL, p.587, 2011).

In a clinical research and practice arena, that is without any doubt moving so very fast,  due to scientific and technological innovations and change, those who are regularly involved with these subjects need to keep pace with weekly developments by being on clinical practice electronic mailing lists, to be prompted as to the current trends and the medical law and ethics regulations in specific countries.  [7]    Therefore, any medical law and bioethics reference book such as this, can only outline some of the most  recent developments.

As medical technology and clinical progress advances apace, particularly regarding genomic technologies,  the use of stem cells to create and transplant organs in the future,  combined with the vast possibilities for medical science, in the use of nanotechnology,   Medicine, Patients and The Law,  is a very accessible and a particularly absorbing  text,  that is able to provide  researchers,  doctors, lawyers and general readers,  with an exceptionally valuable reference tool,  a research heuristic,  that is able to lead the readers to a much more detailed  and to a better  understanding of the topics under discussion.  The accuracy and completeness of the details given in the book are particularly helpful for researchers, clinicians and ethics committee members to reflect  upon.  The content is eloquently well argued and organised in a manner that can be used for reference by legal and medical professionals and researchers.  The recently fully revised  MPL (2011) text is highly valuable for use by many Healthcare Ethics and Research Ethics Committees.  Medicine, Patients and The Law (2011), can assist towards a deeper knowledge and understanding of comparative medical law,  healthcare ethics  and  international  medical  jurisprudence.

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Notes

1. Skocpol T, Sommers M. The uses of comparative history in macrosocial
    inquiry. Comparative Studies in Society and History 1980; 22(2):174-97.

    This gives further methodological details regarding historical comparative analyses.

2.  Kennedy I, Grubb A. Medical Law. 3rd ed. London: Butterworths; 2000.

3.  cf.  Beauchamp TL, Childress JF. Principles of Biomedical Ethics. 5th ed. New York: Oxford University Press; 2001.

4.  Jones MA, Morris AE. Statutes on Medical Law. London: Blackstone Press; 1992.

5.  For further details regarding comparative medical jurisprudence in Australia,      

     Canada,  Germany, United Kingdom and United States of America, see: Mason, JK, 

     McCall-Smith, RA and Laurie, GT, Law and Medical Ethics. London: Butterworths;

     2002. 

6.  Glover N, Bolam in the House of Lords. Professional Negligence 1999; 42(15).

7.  There are regular clinical ethics electronic mail alerts that can be obtained,

     including  from:    http://www.thelancet.com/  and   http://www.bmj.com/             

     regarding current medical profession perspectives, healthcare ethics

     and clinical practice regulation developments in several countries.

__________________________________________________________________

Dr. Mark Fernando  B.Sc., Dip. Psych., Ph.D., MBAC Psych.,

is an Associate Tutor & Mentor, University of Oxford, England,
a Fellow of Rutherford College, University of Kent, Canterbury, UK 
and a Guest Faculty Researcher, with Harvard University, USA.
This book review has been commissioned by Oxford University Press
Editors, in 2011.

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