Autonomy, the Law, and Ante-Mortem Interventions to Facilitate Organ Donation A thesis submitted to the University of Manchester for the degree of Doctor of Philosophy in the Faculty of Humanities 2017 Sarah-Jane R. Brown School of Law 2 Contents Abstract .................................................................................................................................... 5 Declaration ............................................................................................................................... 6 Copyright Statement ................................................................................................................ 6 Dedication ................................................................................................................................ 7 Acknowledgements .................................................................................................................. 7 Preface ...................................................................................................................................... 8 1. The Legal and Policy Framework for Donor Optimisation Procedures ............................... 9 Introduction.............................................................................................................................. 9 The Organ Donation System in the UK ................................................................................... 13 Human Tissue Legislation ....................................................................................................... 17 Legal Framework Governing Ante-Mortem Donor Optimisation Procedures ....................... 22 The Legal Regulation of Death ............................................................................................... 28 Identification and Referral of the Potential Organ Donor ..................................................... 34 The Assessment of Best Interests .......................................................................................... 40 Ante-Mortem Interventions to Facilitate Organ Donation .................................................... 44 The Human Rights of the Potential Organ Donor .................................................................. 50 Autonomy and Specific Advance Consent .............................................................................. 52 2. Autonomy, Trust, and the Supply of Organs ................................................................... 54 Introduction............................................................................................................................ 54 Autonomy as Self-determination ........................................................................................... 57 The Value of Self-determination ............................................................................................ 64 Self-Determination, Dignity, and Integrity ............................................................................. 67 The Concept of Trust .............................................................................................................. 71 Types of Trust, Distrust, and the Supply of Organs ................................................................ 81 3. Autonomy, Informed Consent, and Advance Decision-Making........................................ 90 Introduction............................................................................................................................ 90 The Concept of Informed Consent ......................................................................................... 92 The Prospective Nature of Informed Consent ....................................................................... 95 Real Consent and Battery ....................................................................................................... 98 3 The Tort of Negligence and the Duty of Care ....................................................................... 101 Legal Standards of Informed Consent .................................................................................. 109 Damage and Causation......................................................................................................... 115 The Law on Advance Decision-Making ................................................................................. 124 Realising the Autonomy of Organ Donor Registrants .......................................................... 130 4. The Best Interests of the Potential Organ Donor .......................................................... 137 Introduction.......................................................................................................................... 137 Medical Interests .................................................................................................................. 141 Centrality of the Individual ................................................................................................... 148 Social and Psychological Interests ........................................................................................ 156 The Balance of Best Interests ............................................................................................... 162 Evidence of Specific Wishes ................................................................................................. 170 A System for Determining Best Interests ............................................................................. 176 5. The Public Interest in Donor Optimisation Procedures ................................................. 179 Introduction.......................................................................................................................... 179 The Concept of the Public Interest ....................................................................................... 180 Medical Law and the Public Interest .................................................................................... 190 Human Rights Law and the Public Interest .......................................................................... 201 The Public Interest in Donor Optimisation Procedures ....................................................... 211 6. Incorporating Autonomy into Donor Optimisation Policy ............................................. 223 Introduction.......................................................................................................................... 223 Trust, Knowledge, and Willingness to Donate ..................................................................... 225 Democratic Presumption ..................................................................................................... 233 The Impact of Policy Change ................................................................................................ 235 Conclusion ............................................................................................................................ 238 Bibliography ................................................................................................................ 243 UK Cases ............................................................................................................................... 243 ECtHR Cases .......................................................................................................................... 246 US Cases ............................................................................................................................... 249 Statutes ................................................................................................................................ 249 4 Statutory Instruments .......................................................................................................... 250 Hansard and Parliamentary Reports .................................................................................... 250 Bills ....................................................................................................................................... 250 Codes of Practice .................................................................................................................. 250 Regional and International Conventions, Statements, and Reports .................................... 251 UK Guidelines and Recommendations ................................................................................. 251 Journal Articles ..................................................................................................................... 253 Special Issues ........................................................................................................................ 271 Essays Within Collections ..................................................................................................... 271 Books .................................................................................................................................... 273 PhD Theses ........................................................................................................................... 277 Research Papers, Inquiry Reports, and Miscellaneous Reports and Statements ................ 278 News Releases and E-Sources .............................................................................................. 280 Word Count: 79970 5 Abstract Over the last few years, policies have been introduced in the UK which aim to improve organ transplantation rates by changing the way that potential organ donors are treated before death. Patients incapacitated due to catastrophic brain injury may now undergo ante-mortem donor optimisation procedures to facilitate deceased organ donation. As I identify in this thesis, the most significant ethical and legal problem with these policies is that they are not based on what the patient would have chosen for themselves in the specific circumstances. The policies identify and treat patients meeting certain clinical criteria as a group rather than the individuals, with their own viewpoints, that the law on best interests requires. They equate registration on the Organ Donation Register with ante-mortem donor optimisation procedures being in their best interests, despite registrants having neither been informed about nor given consent to ante-mortem interventions. The overarching claim I make in this thesis is that a system of specific advance consent is needed to provide a clear and unequivocal legal justification for ante-mortem donor optimisation procedures. The ethical foundation for this claim is autonomy, and this is the central theme running through all six chapters. I argue that autonomy should be incorporated into donor optimisation policy to promote the dignity and integrity of potential organ donors and to safeguard trust in the organ donation programme. I argue that a system of specific advance consent is needed as part of the duty of care owed to registrants on the Organ Donor Register and to facilitate the determination of the best interests of the potential organ donor. I argue that the state has not established the necessity of the current policy of non-consensual donor optimisation procedures and that they are under an ethical and legal obligation to introduce an autonomy-based framework for ante-mortem interventions to facilitate organ donation. 6 Declaration No portion of the work referred to in the thesis has been submitted in support of an application for another degree or qualification of this or any other university or other institute of learning. Copyright Statement i. The author of this thesis (including any appendices and/or schedules to this thesis) owns certain copyright or related rights in it (the “Copyright”) and she has given The University of Manchester certain rights to use such Copyright, including for administrative purposes. ii. Copies of this thesis, either in full or in extracts and whether in hard or electronic copy, may be made only in accordance with the Copyright, Designs and Patents Act 1988 (as amended) and regulations issued under it or, where appropriate, in accordance with licensing agreements which the University has from time to time. This page must form part of any such copies made. iii. The ownership of certain Copyright, patents, designs, trademarks and other intellectual property (the “Intellectual Property”) and any reproductions of copyright works in the thesis, for example graphs and tables (“Reproductions”), which may be described in this thesis, may not be owned by the author and may be owned by third parties. Such Intellectual Property and Reproductions cannot and must not be made available for use without the prior written permission of the owner(s) of the relevant Intellectual Property and/or Reproductions. iv. Further information on the conditions under which disclosure, publication and commercialisation of this thesis, the Copyright and any Intellectual Property and/or Reproductions described in it may take place is available in the University IP Policy (see http://documents.manchester.ac.uk/DocuInfo.aspx?DocID=24420 ), in any relevant Thesis restriction declarations deposited in the University Library, The University Library’s regulations 7 (see http://www.library.manchester.ac.uk/about/regulations/ ) and in The University’s policy on Presentation of Theses. Dedication I dedicate this thesis to my mother Valerie Leonard, who instilled in me an appreciation of the value of education and a determination to work hard to achieve my goals. Acknowledgements I acknowledge the support of the many academics working at the Centre of Social Ethics and Policy at the University of Manchester, including but not limited to those named here. I thank Dr Catherine Stanton for her cheerful and optimistic approach to PhD supervision. I appreciate the help of Dr Iain Brassington in developing my skills of argumentation and for his attempts at improving my grammar. I acknowledge the support of Professor Nicola Glover-Thomas in helping me believe that a PhD was the right next step to take in my career and the input of Professor Muireann Quigley in the initial stages of this PhD. I thank Dr Alexandra Mullock for helping me believe in myself as an academic researcher within the field of healthcare law and ethics. I acknowledge the advice of Dr Becki Bennett on how to present my own original ideas within this thesis. I particularly give thanks to Professor Margaret Brazier for her wisdom and for her kindness. This thesis would not have been possible without the support of a Graduate Teaching and Research Assistant Scholarship from the University of Manchester. Parts of this thesis, particularly Chapter 4, have been published in S-J. Brown, ‘The Legal Justification for Donor Optimisation Procedures’ (2016) 11(4) Clinical Ethics 122-129. 8 Preface My background is in hospital medicine and not in law. However, over the last few years I have established a specialist interest in healthcare ethics and law through study, independent research, and teaching law undergraduates. After ten years working as a hospital doctor in dermatology and the acute medical specialties, I developed my interest in healthcare ethics and law by completing a Masters in Law at the University of Liverpool. To pursue this interest further, I then joined the PhD programme in law at the Centre for Social Ethics and Policy at the University of Manchester. I aim in this thesis to use an interdisciplinary approach, encompassing medicine, ethics, and law, to address my concerns relating to the legal justification for ante-mortem donor optimisation procedures. 9 1. The Legal and Policy Framework for Donor Optimisation Procedures Introduction Organ transplantation is one of the great success stories of modern medicine and demand is high. It is the primary treatment for patients with end-stage organ failure, and often the only means of preventing their deaths, yet transplantable organs are in short supply both nationally and globally.1 In the United Kingdom (UK), this gap between demand and supply resulted in 457 patients dying in 2016-2017 whilst on the active waiting list for a transplant, with a further 875 patients being removed from the transplant list, mostly due to deteriorating health, many of whom would have died shortly afterwards.2 These preventable deaths have provided the impetus for a “paradigm shift” in the end-of-life care received by potential organ donors3 - a shift that presents significant ethical and legal challenges surrounding the autonomy interests and rights of the potential donor. The mainstay of the law on medical interventions in general, and on deceased organ donation in particular, is widely upheld at a national, regional and international level to be the principle of patient autonomy or self-determination. This principle is promulgated by the torts of negligence and trespass to the person,4 by the statutes that regulate the treatment of the 1 The International Registry in Organ Donation and Transplantation (IRODaT) maintains a database of donation and transplantation figures, see http://www.irodat.org/?p=database. As of 11/09/17, the most recent figures are given in IRODaT, ‘Preliminary Numbers 2016’ (IRODaT, August 2017), available at http://www.irodat.org/img/database/pdf/NEWSLETTER2017_firstedition.pdf. International figures for preventable deaths are less easily obtainable. 2 NHS Blood and Transplant, Organ Donation and Transplantation Activity Report 2016/2017, available at https://www.organdonation.nhs.uk/supporting-my-decision/statistics-about-organ- donation/transplant-activity-report/ , p.2 (last accessed 11/09/17) [‘Activity Report’]. 3 D. Price, ‘End-of-life Treatment of Potential Organ Donors: Paradigm Shifts in Intensive and Emergency Care’ (2011) 19 Med Law Rev 86 [‘Paradigm Shifts’] 4 These torts are evaluated in Chapter 3. 10 dead and the dying,5 by the “opt-in” system for organ donation that exists throughout most of the UK, and allegedly even by the “opt-out” system that has recently been introduced in Wales.6 It is championed by the judgements of the European Court of Human Rights,7 and law- and policy-makers in the UK are required under the Human Rights Act 1998 to take its pronouncements into account.8 It is emphasised in the World Medical Association’s Statement on Human Tissue for Transplantation and in the World Health Organisation Guiding Principles on Human Cell, Tissue and Organ Transplantation.9 However, the status of autonomy as the ethical and legal foundation for organ donation is threatened by new policies that aim to improve organ transplantation rates by changing the way that potential donors are treated at the end of life,10 but that are not accompanied by any changes to the information and consent procedures available to potential registrants on the National Health Service (NHS) Organ Donor Register (ODR).11 5 The provisions of the Human Tissue Act 2004 and the Mental Capacity Act 2005 will be discussed later in this chapter. 6 See eg. H.Welbourn, ‘A Principlist Approach to Presumed Consent for Organ Donation‘(2014) 9(1) Clin Ethics 10-16; also M.B.Gill, ‘Presumed Consent, Autonomy and Organ Donation’ (2004) 29 J Med Philos 37–59. 7 Eg. Tysiac v Poland (App no. 5410/03) (2007) 45 EHRR 947; Pretty v UK (App no. 2346/02) (2002) 35 EHRR 1. 8 S. 2, 3 & 6. 9 World Medical Association Statement on Human Tissue for Transplantation, Adopted by the WMA Assembly, Copenhagen, Denmark, October 2007, [3]; WHO Guiding Principles on Human Cell, Tissue and Organ Transplantation, as endorsed by the 63rd World Health Assembly in May 2010, in Resolution WHA63.22 available at http://www.who.int/transplantation/Guiding_PrinciplesTransplantation_WHA63.22en.pdf (last accessed 11/09/17). 10 National Institute for Health and Care Excellence (NICE), Organ Donation for Transplantation: Improving Donor Identification and Consent Rates for Deceased Organ Donation (Clinical Guidance 135, 2011, updated 2016) [‘Improving Donor Identification’]; Organ Donation Taskforce (ODT), Organs for Transplants: A Report from the Organ Donation Taskforce (2008) [‘Organs for Transplants’]; Department of Health (D0H), Legal Issues Relevant to Non-heartbeating Organ Donation (2009) [‘Legal Issues’]; UK Donation Ethics Committee (UKDEC), An Ethical Framework for Controlled Donation after Circulatory Death (2011) [‘Ethical Framework’]; see also BMA Medical Ethics Committee, Building on Progress: Where Next for Organ Donation Policy in the UK? (2012) [‘Building on Progress’]. 11 I highlight this problem in S-J. Brown, ‘The Legal Justification for Donor Optimisation Procedures’ (2016) 11(4) Clin Ethics 122-129, [‘Legal Justification’]: this article is based on my doctoral research and some of the discussion contained within it is repeated in this and later chapters (particularly chapter 4) of this thesis.