Directed and conditional deceased donor organ donations: Laws and misconceptions

Medical Law Review

Volumn 18, Issue 3, 2010, Pages 275-301

  Cronin, Antonia J ^a,b   Douglas, James F ^c  

^a KING'S COLLEGE LONDON   (United Kingdom)

^b GUY'S AND ST THOMAS' NHS FOUNDATION TRUST   (United Kingdom)

^c QUEEN'S UNIVERSITY BELFAST   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; ETHICS; GOVERNMENT REGULATION; HEALTH CARE POLICY; HUMAN; INFORMED CONSENT; LEGAL ASPECT; MEDICAL ETHICS; TRANSPLANTATION; UNITED KINGDOM;

ETHICS, MEDICAL; GOVERNMENT REGULATION; GREAT BRITAIN; HEALTH POLICY; HUMANS; INFORMED CONSENT; TISSUE AND ORGAN PROCUREMENT;

EID: 77956256188     PISSN: 09670742     EISSN: 14643790     Source Type: Journal    
DOI: 10.1093/medlaw/fwq019     Document Type: Article

References (144)

1. The Human Tissue Act 2004 (the 2004 Act) is now the primary legislation regulating transplantation in those countries. The Act does not apply in Scotland (save for s 45, prohibiting the taking and analysis of DNA samples without consent). Separate legislation applies in Scotland; see the Human Tissue (Scotland) Act 2006. The 2004 Act repeals and replaces the Human Tissue Act 1961, the Anatomy Act 1984 and the Human Organ Transplant Act 1989. The authorisation of activities for scheduled purposes is outlined in s 1 of the 2004 Act. It covers seven scheduled purposes requiring general consent, one of which is transplantation.
2. Scheduled purposes requiring general consent are outlined in Part 1 of Schedule 1 of the Act.
3. The HTA was set up under the Human Tissue Act 2004. It is charged with regulating the removal, storage, use, and disposal of human bodies, organs, and tissue from the living and deceased (excluding gametes and embryos).
4. The NHS Blood and Transplant (NHSBT, ) Organ Donation and Transplant Directorate (NHSBT ODT) is now the body responsible for deceased donor organ allocation in the UK.
5. It replaced UK Transplant (UKT, ), the body formerly responsible for deceased donor organ allocation in the UK, in 2009.
6. Human Tissue Authority statement on directed donation of organs after death. Issue date 14 April 2008.
7. Conditional donation is when a donor organ (or organs) is (are) offered to (or possibly withheld from) a specific class of recipient. Directed donation is when a donor organ (or organs) is (are) directed to a specific person, or a nominated individual is given priority.
8. For a recent definition, distinction, and ethical discussion, see ML Volk and PA Ubel, 'A Gift of Life: Ethical and Practical Problems with Conditional and Directed Donation' (2008) 85(11) Transplantation 1542-1544.
9. Report of the Panel, An Investigation into Conditional Organ Donation (Department of Health 2000).
10. The inquiry conclusions are outlined in L Beecham, 'Donors and Relatives Must Place No Conditions on Organ Use' (2000) 320 BMJ 534.
11. For a discussion, see AJ Cronin and D Price, 'Directed Organ Donation: Is the Donor the Owner?' (2008) 3 Clinical Ethics 127-131.
12. See e.g. Report of the Task Force on Organ Transplantation, Department of Health & Human Services, 1986, p 77.
13. And Congress Resolution 8 in W Land and J Dossetor (eds), Organ Replacement Therapy: Ethics, Justice, Commerce (Springer, Berlin 1991) 556.
14. See generally J Glover (ed), Utilitarianism and Its Critics (Macmillan, London, 1990).
15. J Harris, 'Organ Procurement: Dead Interests, Living Needs: Cadaver Organs Should Be Automatically Available' (2003) 29 JME 130-134.
16. Harris (n 10).
17. See also AJ Cronin, 'Equitable Access to Organs' in W Weimar, MA Bos, JJ Busschbach (eds), The Ethical, Legal and Psychological Aspects of Organ Transplantation (Pabst Publishers, Lengerich, 2008) 99-110.
18. Cronin and Price (n 7).
19. EH Kluge, 'Designated Organ Donation: Private Choice in Social Context' (1989) 19 Hastings Center Report 10.
20. RA Sells, RWG Johnson and J Hutchinson, 'Recommendations on the Use of Living Donors in the UK' (1986) 293 BMJ 257-258.
21. PI Terasaki and others, 'High Survival Rates of Kidney Transplants from Spousal and Living Unrelated Donors' (1995) 333 NEJM 333-336.
22. The requirements for living donor transplantation are set out in the 2004 Act s 33-34 and in the Human Tissue Act 2004 (Persons who Lack Capacity to Consent and Transplants) Regulations 2006 ss 9-14 These regulations are detailed at .
23. The Human Tissue Act 2004, Revised Code of Practice 2 'Donation of Solid Organs for Transplantation' (September 2009) Section para 26 outlines the types of living organ donation that may take place. .
24. In 2008-2009, out of a total of 927 live kidney donations, 16 were paired or pooled and 15 altruistic non-directed. See Transplant Activity in the UK, 2008-2009 Table 3.1.
25. See the NHSBT and UKT Transplant Report 2009. .
26. A genetically related donation is one in which the potential donor is a blood relative of the potential recipient. An emotionally related donation is one in which the potential donor has a personal relationship with the potential recipient, for example, spouse, partner, or close friend.
27. Transplant Activity in the UK, 2008-2009, Table 3.1.
28. See the NHSBT and UKT Transplant Report 2009. .
29. D Price, 'Legal Systems for Organ Distribution in Europe: Justice in Allocation' in W Weimar, MA Bos, JJ Busschbach (eds), The Ethical, Legal and Psychological Aspects of Organ Transplantation (Pabst Publishers, Lengerich, 2008) 163-174.
30. See for example, the applicable laws in Poland and the Czech Republic, and the evolution of policies of the relevant national and supranational organ allocation agencies. See also Council of Europe Additional Protocol to the Convention on Human Rights and Biomedicine, on Transplantation of Organs and Tissues of Human Origin, 2002, Strasbourg, Article 3.
31. .
32. A living person who has never met the possible recipient may become an organ donor. According to NHSBT transplant activity reports, between July 2007 and March 2009 there were twenty-one non-directed altruistic living donor transplants.
33. .
34. Cronin and Price (n 7).
35. .
36. Paired donation and transplantation is possible when a potential donor is unable to donate directly to his/her relative, spouse, or friend, but can donate to an unknown person (also a potential transplant recipient) whose relative, spouse, or friend can, in exchange, donate to the original patient. In paired exchange, then, an incompatible living donor and recipient 'pair' can 'swap' organs with another 'pair' in the same situation. If more than two living donors and two recipients are involved in the swap and more than one exchange takes place, it is called 'pooled donation'. See also The Human Tissue Act 2004 (Persons who Lack Capacity to Consent and Transplants) Regulations 2006 SI 2006 No. 1659.
37. And the Human Tissue Authority Code of Practice 2, Donation of Solid Organs for Transplantation, 2009, at paras 26.
38. A 'matching run' refers to a series of tests performed to identify tissue compatibility between organ donors and potential transplant recipients. In the UK, 'matching runs' are currently performed 3 monthly; however, matching runs will be carried out at intervals determined by the rate at which incompatible couples join the paired donation list.
39. For further details, see .
40. A Matas and others, 'Non-directed Donation of Kidneys from Living Donors' (2000) 343 NEJM 433-436.
41. FL Delmonico, 'Exchanging Kidneys: Advances in Living Donor Transplantation' (2004) 350 NEJM 1812.
42. AR Weale and PA Lear, 'Organ Transplantation and the Human Tissue Act - Changes in the Law May Have a Positive Impact on Organ Donation' (2007) 83 Postgrad Med J 141-142.
43. The authors comment: (a)... 'the Act provides a framework by which (paired transplants) can occur both legally and ethically; and (b) 'Non-directed donation will. .. be made legal by the Act'.
44. Human Organ Transplant Act 1989 s 2(3).
45. Human Organ Transplant (Unrelated Persons) Regulations 1989 s 3 (Statutory Instrument 1989 SI No. 2480).
46. S Chowdhry and others, 'Unrelated Living Organ Donation: ULTRA Needs to Go' (2003) 29 JME 169-170.
47. This could have been examined by judicial review.
48. WH Marks and others, 'Organ Donation and Utilization, 1995-2004: Entering the Collaborative Era' (2006) 6 Am J Transplant 1101-1110.
49. In 2004, 88 out of 2343 living unrelated donors in the USA were non-directed.
50. The Human Tissue Act 2004 s 33(4) does provide for a mechanism for 'reconsideration' of the HTA's decisions with respect to living donation.
51. Cronin and Price (n 7).
52. The law protects individuals' rights to control the use of their bodies for medical purposes.
53. See generally J Herring, 'Crimes Against the Dead' in B Brooks-Gordon and others (eds), Death Rites and Rights (Hart Publishing, Oxford, 2007) 219-239.
54. It is by virtue of this right that the Human Tissue Act 2004 empowers an individual to appropriately say 'yes' or 'no' to (consent or refuse) organ donation. See Human Tissue Act 2004, s 3.
55. The Human Tissue (Scotland) Act 2006 uses the term 'authorisation'.
56. Human Tissue Act 2004 s 33.
57. In the UK, Dr Raymond Crockett was struck off the medical register by the General Medical Council in May 1990. He was found guilty of procuring human organs from living donors in exchange for money, as part of a 'kidneys for sale' scam.
58. Organs from four Turkish patients were transplanted into private patients at the Wellington Humana Hospital in St John's Wood, London. .
59. Human Organ Transplants (HOT) Act 1989 s 1; now replaced by the Human Tissue Act 2004 s 32.
60. Human Tissue Act 2004 s 3.
61. Human Tissue Act 1961 s 1(2)(a).
62. In contrast with most other scheduled activities under the 2004 Act, no licence is required to remove material for transplantation. In contrast with medium to longer term therapeutic tissue banking, no licence is required for storage of organs for transplantation either.
63. This is in contrast to its counterpart in the USA. The Organ Procurement Transplant Network (OPTN).
64. .
65. UK Transplant (UKT, ) was the body responsible for deceased donor organ allocation in the UK at the time of the 'Ashworth Affair'.
66. Human Tissue Authority statement on directed donation of organs after death. Issue dated 14 April 2008.
67. TM Wilkinson, 'What's not Wrong with Conditional Organ Donation?' (2003) 29 JME 163-164.
68. Human Tissue authority statement (n 47).
69. The Ashworth case contrasts well with a case referred to by Sir Roy Calne in his autobiography The Ultimate Gift (Headline Book Publishing, 1998) of a daughter (Patti) who was permitted to provide a heart to her father (Chester Szuber) after her death in Michigan, USA, in 1994.
70. Patti was killed in a car accident. She had a donor card and there was general agreement that she would have wanted to have donated to her father. The donation was allowed by virtue of discretionary powers expressly vested in OPTN-see Code of Federal Regulations (CFR) 42 121.4 and 121.8, 2005.
71. For a defence of this assumption, see A Maclean, 'Organ Donation, Racism and the Race Relations Act' (1999) 149 NLJ 1250-1252.
72. Alasdair Maclean argues that whether it is only the conditions or the 'gift' as a whole that is rendered void depends on whether the conditions are precedent or subsequent to the 'gift'. He maintains that, in the context of deceased donor organ donation, these are conditions subsequent and that it would be lawful to accept the 'gift' and ignore the illegitimate pre-conditions in all cases. We consider Maclean's argument in more detail below.
73. Requested allocation of a deceased donor organ .
74. The document was developed and agreed by all UK Health Administrations, together with the HTA and NHSBT.
75. Dr Handyside's case (1749) 3 East PC 652; Williams v Williams (1852) 20 Ch D 657.
76. See R Hardcastle, Law and the Human Body (Hart Publishing, Oxford, 2007).
77. P Matthews, 'The Man of Property' (1995 Autumn) 3 Med Law Rev 251-274.
78. See also R Nwabueze, 'Donated Organs, Property Rights and the Remedial Quagmire' (2008 Summer) 16 Med Law Rev 201-224.
79. And K Mason and G Laurie, 'Consent or Property? Dealing with the Body and Its Parts in the Shadow of Bristol and Alder Hey' (2001) 64 MLR 710-729.
80. See Moore v University of California793 PD 479 (Cal 1990).
81. And generally B Dickens, 'Living Tissue and Organ Donors and Property Law: More on Moore' (1992) Spring J Contemp Health L Pol'y 73-95.
82. R v Kelly [1998] 3 All ER 741, 750.
83. See also Report of Nuffield Council on Bioethics, Human Tissue: Ethical and Legal Issues (1995) 9.10-10.6. www.nuffieldbioethics.org/go/ourwork/humantissue/publication_298.html.
84. Kelly (n 58).
85. [2009] EWCA Civ 37, [2009] All ER (D) 33 (Feb).
86. Cronin and Price (n 7).
87. J Penner, The Idea of Property (OUP, Oxford 1997).
88. Cronin and Price (n 7).
89. Williams v Williams (n 54).
90. Dobson v N. Tyneside Health Authority [1996] 4 All ER 474.
91. Kelly (n 58).
92. An Investigation into Conditional Donation (n 6), Ch 4.45.
93. It has been argued that civil liability might have ensued for non-compliance with the 1961 Act. But no case was ever brought under it, and the authors appear to concede that the absence of sanctions would have excluded criminal liability.
94. See Mason and McCall Smith, Law and Medical Ethics, JK Mason and GT Laurie (eds) (7th edn OUP, Oxford 2006) s 14.38, p 493.
95. nd edn Sweet and Maxwell 2007) 1100-1101.
96. See, for example, YC Zhou and JM Cecka, 'Preservation' in Clinical Transplants 1992 (UCLA Tissue Typing Laboratory, Los Angeles 1993) 203.
97. National Health Service Act 1977, s 1(1).
98. J Neuberger and D Mayer, 'Conditional Organ Donation: the Views of the UK General Public Findings of an Ipsos-Mori Poll' (2008) 85 Transplantation 1545-1547.
99. An Investigation into Conditional Organ Donation (n 6).
100. 'Dobson: "No health apartheid" ' .
101. Cf. Maclean (n 52).
102. An Investigation into Conditional Organ Donation (n 6).
103. Emphasis added.
104. UKT Allocation Protocol 2003.
105. See SV Fuggle and others, 'Human Leucocyte Antigen and the Allocation of Kidneys from Cadaver Donors in the United Kingdom' (2007) 77 Transplantation 618-620.
106. Human Tissue Act 2004 s 32 (formerly Human Organ Transplants Act 1989 s 1).
107. Race Relations Act 1976 s 1.
108. UKT Allocation Protocol 2003. See Fuggle and others (n 81). Ethnic minorities (who have a high incidence of blood group B) comprised 22% of the UK transplant waiting list, but only 2% of deceased organ donors. In 2002, by allowing certain organs from blood group O donors to be allocated to blood group B recipients, an increased donation rate for this group was achieved, to the disadvantage of the blood group O recipients (mainly white) who would otherwise have received them.
109. And more specifically by s 1A, inserted (19 July 2003) by the Race Relations Act 1976 (Amendment) Regulations 2003 (SI 2003/1626). These expressly apply to health care.
110. .
111. Human Tissue Act 2004 (n 1).
112. Human Tissue Authority statement (n 47).
113. For children (s 2), for persons without legal capacity (s 6), by nominated representatives (s 4) and, in the absence of consent, by persons in a 'qualifying relationship' (ss 3.8 and 27 (4)).
114. Human Tissue Authority Code of Practice on Consent (Code 1, July 2006)- specifically required by s 26(3). This code should now be considered in conjunction with the Revised Codes of Practice, Donation of Solid Organs for Transplantation issued by the HTA in September 2009.
115. McHale and Fox (n 71) 1100, 1131.
116. On the objections to generic consent as a negation of donor autonomy or possible religious and cultural objections, see McHale and Fox (n 71) 1127.
117. See also JV McHale, 'Regulating Genetic Databases: Some Legal and Ethical Issues' (2004) 11 Med Law Rev 70.
118. Revised Code of Practice 2, Donation of Solid Organs for Transplantation issued by the HTA in September 2009 paras 30-34.
119. Pickstone v Freeman [1989] AC 61, (Lord Oliver).
120. See Cronin and Price (n 7). See also McHale and Fox (n 71) at 1100, 1128-29.
121. R v Home Secretary ex parte Simms [2000] AC 115, 1131 (Lord Hoffman).
122. Chatterton v Gerson [1981] 1 All ER 257.
123. Chatterton v Gerson (n 104) (Bristow J).
124. Human Tissue Authority statement (n 47).
125. Although the HTA's agents could in theory be personally liable under s 5(2) of the 2004 Act, the delegated nature of their work and the central identification of the HTA with the policy statement of 14 April 2008 (n 4) make it unnecessary to consider their position here.
126. Human Tissue Act 2004, s 13.
127. The option of a fine as penalty under s 5(7) of the 2004 Act reinforces this position.
128. See Kite (Peter Bayliss) [1996] 2 Cr App R (S) 295, CA 249.
129. See Tesco Supermarkets v Nattras [1972] AC 153.
130. In general, there is a tendency for the courts to be lenient. For two opposing cases, see Sec of State for Trade and Industry v Hart [1982] WLR 481 and Grant v Bond [1982] WLR 638. But since neither of these cases involved a statutory body, it is not clear what view the courts might take of breaches of the law mistakenly committed by members of such bodies.
131. Human Tissue Act 2004, s 3(6).
132. Human Tissue Authority statement (n 47).
133. Maclean (n 52).
134. Requested allocation of a deceased donor organ (n 53).
135. See National Organ Transplant Act, US Code, Title 42 ss 273-274 and Code of Federal Regulations (CFR) 42 (Public Health) Subchapter K 121.1-11, 2005.
136. CFR 42 121.10(c), 2005. See SV McDiarmid and others, 'The Oversight of Solid Organ Transplantation in the United States' (2008) 8 Am J Transplant 739-744.
137. CFR 42 121.4 and 121.8, 2005.
138. All the US states have adopted in their state laws one version or another of the Uniform Anatomical Gift Acts.
139. Uniform Anatomical Gift Act 2006 ss 11(b) and 11(g)(3).
140. We would like to acknowledge the help of Mr Ronald Richenburg, Principal Assistant Librarian, Bodleian Law Library, Oxford University in accessing this information.
141. J Neuberger and D Mayer (n 74). In a representative quota sample of 2015 adults (aged 15 years and over), there was a wide spread of opinion. While 60% of respondents, in general, favoured unconditional donation, some conditions had significant support-e.g. priority to children (59%), exclusion of alcoholics from liver donation (39%), and priority to family (36%).
142. Neuberger and Mayer (n 124).
143. See D Price, 'The Human Tissue Act 2004' (2005) 68 MLR 798-821, 812.
144. An Investigation into Conditional Organ Donation (n 6).