Beyond bristol and alder hey: The future regulation of human tissue

Medical Law Review

Volumn 13, Issue 2, 2005, Pages 170-223

  Liddell, Kathleen ^a   Hall, Alison ^b  

^a UNIVERSITY OF CAMBRIDGE   (United Kingdom)

^b CGKP ^*  (United Kingdom)

Author keywords

[No Author keywords available]

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EID: 27844591758     PISSN: 09670742     EISSN: None     Source Type: Journal    
DOI: 10.1093/medlaw/fwi012     Document Type: Review

References (281)

1. Certain documents we have referenced are not publicly available. In these circumstances the authors' identity is anonymised.
2. The title is prompted by: 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 Modern Law Review 710-29. It should be noted that many other hospitals were shown to have retained children's (and adults') organs and body parts following post-mortem examinations. For the sake of brevity, we mention only the Bristol Royal Infirmary and Liverpool's Alder Hey Hospital in this article but these references should be understood to refer to the other sites of retention as well.
3. For this and other historical points, we are grateful to Professor Naomi Pfeffer http://www.ihs.ox.ac.uk/perl/ethox/us160.pl?id=138 (accessed 25 February 2005). See also D. Price, 'From Cosmos and Damian to Van Velzen: The Human Tissue Saga Continues' (2003) 11 Med. L. Rev. 5-6.
4. Human Tissue Act 1961, s. 1(2).
5. A. Grubb, '"I, Me, Mine": Bodies, Parts and Property' (1998) 6 Medical Law International 247.
6. For example, DNA sequencing, splicing, cloning, automated screening, and comparative proteomics.
7. B.C. Parry, 'Trading the Genome: Investigating the Commodification of Bio-information' Columbia University Press 2004) at 42-101.
8. Nuffield Council on Bioethics Human Tissue: Ethical and Legal Issues (1995);
9. Grubb, op.cit., n. 5
10. G. Dworkin, 'The Law Relating to Organ Transplantation in England' (1970) 33 Modern Law Review 353-77.
11. Price, op.cit., n. 3.
12. For background on the retention of human tissue without relatives' consent: Learning from Bristol: The Report of the Public Inquiry into Childrens' Heart Surgery at the Bristol Royal Infirmary Cm. 5207 (2001);
13. Report of the Inquiry into the Royal Liverpool Children's Hospital (Alder Hey) HC 12-II (2001);
14. Department of Health The Investigation of Events that followed the death of Cyril Mark Isaacs (2003a);
15. Department of Health Isaacs Report Response (2003),
16. Department of Health Human Bodies, Human Choices: The Law on Human Organs and Tissue in England and Wales: A Consultation Report (2003b);
17. Department of Health Human Bodies, Human Choices: Summary of Responses to the Consultation Report (2003c);
18. The Shipman Inquiry, Third Report: Death Certification and the Investigation of Death by Coroners Cm 5854 (2003);
19. Department of Health Families and Post mortems: A Code of Practice (2003d);
20. Department of Health The Use of Human Organs and Tissue: An Interim Statement (2003e);
21. Retained Organs Commission, Remembering the Past, Looking to the Future: The Final Report of the Retained Organs Commission including the Summary Accountability Report for 2003/2004 (2004).
22. For commentary: Price, op.cit., n. 3.
23. Price, op. cit., n. 3 at 46.
24. Op. cit., n. 1
25. Department of Health, Department of Education and Employment and the Home Office Report of a Census of Organs and Tissues retained by Pathology Services in England (2001) at para. 74
26. Department of Health, Department for Education and Employment and the Home Office The Removal, Retention and use of Human Organs and Tissue from Post-Mortem Examinations: Advice from the Chief Medical Officer (The Stationery Office 2001) 36 (referred to hereafter as Advice from CMO);
27. M. McLean 'Letting Go ... Parents, Professionals and the Law in the Retention of Human Material after Post Mortem' in A. Bainham, S. Day Sclater, M. Richards (eds), Body Lore and Laws (Hart Publishing 2002) at 79-89
28. Bristol Royal Infirmary Enquiry The Inquiry into the Management of Care of Children Receiving Complex Heart Surgery at Bristol Royal Infirmary; Interim Report (2000) at para. 64, http://www.bristol-inquiry.org.uk/ interim_report/index.htm (accessed 26 January 2005).
29. M. Brazier, 'Organ retention and return: Problems of consent' (2002) 29 J.M.E. 30-3 at 31.
30. Price, op.cit., n. 3 at 2
31. Advice from C.M.O., op.cit., n. 12, 38.
32. Explanatory Notes to the Human Tissue Act 2004, at para. 4-5 (referred to hereafter as 'EN'). www.hmso.gov.uk/acts/en2004/2004en30.htm (accessed 22 November 2004).
33. Human Tissue Act 2004, http://www.hmso.gov.uk/acts/acts2004/40030-a.htm (accessed 22 November 2004). All references to sections are to the Act unless otherwise stated.
34. S. Pincock, 'Human Tissue Bill could Jeopardise Research, Scientists Warn' (2004) 328 B.M.J. 1034, quoting Lord May.
35. Correspondence between pathologists and other scientists (June 2004); Baroness O'Neill, Hansard [HL 2R] 22 July 2004, col. 396.
36. Academy of Medical Sciences, 'Statement on Human Tissue Bill' (January 2004) (copy with authors).
37. Academy of Medical Sciences and the Council of Heads of Medical Schools, 'Joint Letter to Ms Rosie Winterton, Minister of State' (February 2004).
38. Brazier, op. cit., n. 13 at 31.
39. For further commentary see McLean, op.cit., n. 12 at 80-2.
40. Price, op.cit., n. 3 at 4, 46.
41. Dewar and Boddington put the case even more strongly arguing that the Royal Liverpool Inquiry 'allowed the cultural and historical traditions of horror over the use and misuse of body parts to suffuse the logical analysis of past wrongs and future rights' and 'makes an inappropriate conflation between seeking redress for past wrongs and shaping future policy': S. Dewar and P. Boddington, 'Returning to the Alder Hey Report and its Reporting: Addressing Confusions and Improving Inquiries' (2004) 30 J.M.E. 463-9 at 463 (emphasis added).
42. Department of Health et. al., op.cit., n. 12, at para. 18.
43. An additional 50 000 organs, body parts stillbirths and fetuses were held in historical collections and archives. Around 11 000 further organs were retained in Scotland: Scottish Executive, Report on Phase 3 (2003) at para. 18; http://www.show.scot.nhs.uk/sehd/publications/romp3/ romp3.pdf (accessed 26 January 2005).
44. Explanatory Notes to the Human Tissue Bill as introduced in the House of Commons on 3 December 2003 at para. 80.
45. P. Furness and R. Sullivan, 'The Human Tissue Bill' (2004) 328 B.M.J. 553-4.
46. G. Lewis, 'Tissue Collection and the Pharmaceutical Industry: Investigating, Corporate Biobanks' in R. Tutton and O. Corrigan (eds), Genetic Databases: Socio-ethical Issues in the Collection and Use of DNA (Routledge 2004) 181-202 at 181-2, 188,
47. citing M. Stuart, 'Sourcing Human Tissue: Biorepositories' in Start Up, Windhovers Review of Emerging Medical Ventures (2001).
48. R. Weir and R. Olick, The Stored Tissue Issue: Biomedical Research, Ethics, and Law in the Era of Genomic Medicine (Oxford University Press 2004) at 23, citing E. Eiseman and S. Haga.
49. The idea that individuals 'donate' their tissue is contested. It is argued that 'donation' assumes a certain a priore proprietary relationship and that the individual is genuinely willing to concede all rights and interests in the tissue. Accordingly we use the word 'donor' advisedly.
50. Parry, op.cit., n. 7, 57 citing M. Strathern. An example of how our relationship with tissue may change over time is the collection and storage of blood from the umbilical cord of newborn babies, for which there is now a developing market.
51. J. Savulescu, 'Death, Us and Our Bodies: Personal Reflections' (2003) 29 J.M.E. 127.
52. J. Harris, 'Law and Regulation of Retained Organs: The Ethical Issues' (2001) 22 Legal Studies 527 at 549.
53. Harris, ibid. at 546.
54. Harris, op.cit., n. 31 at 538, 540, 548
55. J. Harris, 'Editorial: Organ Procurement: Dead Interests, Living Needs' (2003) 29 J.M.E. 130-4.
56. V. English and A. Somerville, 'Presumed Consent for Transplantation: A Dead Issue after Alder Hey?' (2003) 29 J.M.E. 147-152 at 148.
57. See also the competing basis for property-type interests in body parts described by Price (from the idea of self-ownership advanced by Locke and Nozick, the idea of some but limited rights from Munzer and Radin, through to rights of self-control, and the frank idea that 'you can't take it with you'): Price, op.cit., n. 3 at 9-25
58. and the exchange between Harris and Brazier in Legal Studies about other interests in human tissue: Harris, op.cit., n. 31
59. M. Brazier, 'Retained Organs: Ethics and Humanity' (2002) 22 Legal Studies 550-69.
60. J. Rawls, Political Liberalism, 2nd edn. (Columbia University Press 1996).
61. A. Gutmann and D. Thompson, Democracy and Disagreement: Why Moral Conflict Cannot Be Avoided in Politics and What Should Be Done About It (Harvard University Press 1996).
62. K. Liddell, Biolaw and Deliberative Democracy: Regulating Genetic Technology in a Morally Pluralist Society (DPhil thesis, University of Oxford, 2003).
63. A possible objection is that the idea of public reason is itself a particular moral theory in competition with others noted above. However this would misunderstand the subject and objective of the idea of public reason. It is not intended as a theory of the value of human tissue or the ethics of using it without consent or any of the other issues internal to human tissue policy. Rather it deals with a higher-order, external issue: The principles, procedures and attitudes that are required for fair and legitimate policy-making in a basically liberal (and it follows, morally pluralist) society. That said, there is a question whether Rawls' theory is just one of several plausible political theories of legitimacy and fairness for a morally pluralist society. This might mean that one needs to face a second order question of how to deal with disagreement amongst reasonable theories of policymaking. On this point it is significant that Rawls' argues that there is a family of theories that can properly be described as political conceptions of justice or ideas of public reason: Rawls, op.cit., n. 36 at xlix, li-liii;
64. J. Rawls 'The Idea of Public Reason Revisited' in S. Freeman (ed.), John Rawls: Collected Papers (Harvard University Press 2001) at 581, 583, 605.
65. At the very least, the Rawlsian idea of public reason prompts deeper reflection on the goals of bioethical policymaking (in particular the degree to which analytic ethics is a ready guide for legal policy). This is a neglected topic in bioethical literature: Liddell, op.cit., n. 38.
66. Rawls primarily proposes his theory as a contribution to literature on constitutional legitimacy. He is careful to stipulate that he is dealing with 'constitutional essentials' and 'basic matters of justice': Rawls, op.cit., n. 36 at xxix, 215.
67. However there are several reasons to consider that the idea of public reason ought also to be the touchstone of legitimacy for middle democratic policies such as laws governing the use of human tissue and human genetics: Liddell, op.cit., n. 38 at 66-7.
68. Provisions concerned with DNA analysis extend to Scotland. See s. 59 for more detailed explanation and EN, para. 7.
69. There has been an extended process of consultation in Scotland. One significant difference from the English approach is that the Scottish Independent Review Group (chaired by Professor Sheila McLean) proposed that, rather than speaking of consent from family members in the context of posthumous organ retention, the law should speak of authorisation. Reasons are explained in Brazier, op.cit., n. 13 at 30.
70. Department of Health, 'The Human Tissue Act 2004: New Legislation on Human Organs and Tissue' (February 2005).
71. And equivalents in Northern Ireland. The Acts are saved in so far as they apply in Scotland.
72. More specifically the Act requires 'appropriate consent'. Discussed infra.
73. Independent Review Group in Scotland, Final Report on the Retention of Organs at Post-Mortem (2001) at para. 115-9.
74. That said, s. 44 permits 'surplus tissue' from treatment, diagnosis or research to be discarded without consent.
75. Discussed infra.
76. Royal College of Physicians, 'Response to the Human Tissue Bill' (14 May 2004).
77. Discussed infra.
78. Discussed infra.
79. Discussed infra.
80. Discussed infra.
81. A specific exception for clinical diagnosis and treatment of the person whose body manufactured the DNA is included in Schedule 4, para. 5(1)(a).
82. Note Schedule 1, para. 4 may be relevant to clinical use of tissue if the results are relevant to family members.
83. Contributor, Human Tissue Workshop (Bioethics Research Project, Kings College Cambridge Research Centre and CGKP, 20-21 January 2004) (Chatham House Rules);
84. Baroness O'Neill, Hansard [HL 2R] 22 July 2004, col. 396.
85. A defence similar to this (i.e. where the defendant reasonably believes he did the activity with qualifying consent) is not mirrored in the offence of non-consensual analysis of DNA. A logical explanation for this difference is not immediately obvious.
86. The exception in s. 39 for criminal justice purposes applies only to activities of the Authority. Bizarrely, the policy in s. 8 echoes a recommendation made by the Human Genetics Commission but does not apply to the analysis of DNA in tissue. This suggests that the ring-fencing of tissue collections may have been an unintended consequence of s. 8. See Human Genetics Commission Inside Information: Balancing Interests in the use of personal genetic data (2002) at para. 5.50 and 9.55.
87. It is possible that compensation for wrongful retention or use in research might now be obtained through criminal injury compensation schemes. But otherwise wronged families and individuals will continue to find it difficult to obtain compensation. AB v. Leeds Teaching Hospital N.H.S. Trust [2004] E.W.H.C. 644 (QB) is illustrative. Three lead claimants in a group action sought compensation for the retention of organs in the 1990s from their children and still-born fetus. They based their claims on breach of the 1961 Act (which like the new Act made no mention of financial remedies being available for breach), wrongful interference in the body of a child, and negligence. All claims failed save that one of the claimants was awarded £2750 for negligent breach of duty. The claimants argued that the law should be further developed given the background to Article 8 in the Human Rights Act 1998. Article 13 of the European Convention on Human Rights provides that an effective remedy other than criminal proceedings should be available for breach of rights. However Gage J. took the view that it would be inappropriate to construct a new cause of action particularly when compensation would be awarded in certain circumstances for negligent retention of organs.
88. (For further discussion: V. English, R. Mussell, J. Sheather and A. Sommerville, 'Ethics Briefings: Retention and Use of Human Tissue' (2004) 30 J.M.E. 235-6). There is little reason to think that Gage J. would have decided the questions differently had the facts occurred after the 2004 Act commences. That said, other judges might distinguish the case or overturn aspects of the reasoning. It is also possible that an argument based on the Human Rights Act 1998 would have more success if tissue obtained from a living person was used without consent for illegimate purposes. A full discussion is beyond the scope of this paper.
89. See Department of Health, Our Inheritance, Our Future: Realising the Potential of Genetics in the NHS (Cm 5791-II 2003) at para. 6.31.
90. HGC, op.cit., n. 56 at para. 3.59.
91. Lord McColl of Dulwich referring to a letter of 23 August 2004, Hansard (HL GC) 11 October 2004, col GC31.
92. A 'proband' is the 'index case' or the first person in a family to be identified clinically as being affected by a genetic disorder.
93. HGC, op.cit., n. 56 at para. 3.60.
94. R. Pattenden, The Law of Professional-Client Confidentiality: Regulating the Disclosure of Confidential Personal Information (Oxford University Press 2003) at 365.
95. For example, P. Case, 'Confidence Matters: The Rise and Fall of Informational Autonomy in Medical Law' (2003) 11 Med. L. Rev. 208-36
96. D. Bell and B. Bennett, 'Genetic Secrets And The Family' (2001) 9 Med. L. Rev. 130-61 at 132, 143
97. L. Skene, 'Genetic Secrets And The Family: A Response To Bell And Bennett' (2001) 9 Med. L. Rev. 162-9 at 168-9.
98. [1990] Ch. 359, C.A.
99. In such a case, it is only practicable to test an unaffected family member after identifying the gene mutation in a person who is known to be affected: See N. Hallowell, C. Foster, R. Eeles, A. Ardern-Jones, V. Murday and M. Watson, 'Balancing Autonomy and Responsibility: The Ethics of Generating and Disclosing Genetic Information' (2003) 29 J.M.E. 74-9
100. Joint Committee on Medical Genetics, 'Letter to Lord Warner' (September 2004).
101. For example, the Genetics Interest Group.
102. Reportedly, the British Medical Association, the Nuffield Council on Bioethics, the Human Genetics Commission, the World Medical Association, the World Health Association, the Council of Europe, and the American Society of Human Genetics, as cited by Rosemary Pattenden, op.cit., n. 63 at 365.
103. The General Medical Council and Medical Research Council also appeared to support the former position in so far as they allow the disclosure of confidential information where it is necessary to avoid serious harm or death: Medical Research Council Personal Information in Medical Research (2000) at para. 2.2.2
104. General Medical Council Confidentiality. Protecting and Providing Information (April 2004) at para. 22-7.
105. A comparative survey found that the majority of advisory committee statements support the approach that formerly applied in England: B.M. Knoppers, M. Hirtle, S. Lormeau, C. Laberge, M. Laflamme, 'Control of DNA Samples and Information' (1998) 50 Genomics 385.
106. For example, G. Laurie, Genetic Privacy: A Challenge to Medico-Legal Norms (Cambridge University Press 2002) at 116, 181, 261-6
107. Skene, op.cit., n. 64 at 168
108. R. Pattenden, op.cit., n. 63 at 29-30
109. Bell and Bennett, op.cit., n. 64 at 156, 159.
110. The government argued that its position was consistent with judicial precedents. It pointed to obiter remarks in Re MB (An Adult: Medical Treatment) [1997] 38 B.M.L.R.175 (CA), which it said indicated judicial support for the view that a competent adult woman's refusal of medical intervention could not be overridden even where the likely consequence was the death or serious handicap of the child she was carrying or her own death.
111. Department of Health officials also referred in informal exchanges to X v. Commission of the European Communities (C404/92P) [1994] E.C.J. (E.C.R.I-4737). The government's implicit argument was that its provisions were consistent with prevailing law, not a significant alteration. However to impute equivalence overlooked the special facts of those cases. Most notably, Re MB dealt with the competing rights of an adult woman and an unborn fetus. In X v. Commission the Commission could protect its interests without proceeding to analyse the tissue (it could simply have declined to employ the applicant). It is a well-established principle that the legal rights to privacy and confidentiality are not absolute but subject to being balanced against the needs of other people and the community. The government relies heavily on the latter rules when managing the National Forensic DNA database, but it has seen fit to override these principles in the field of clinical genetics.
112. The twist that requires this modifier is that criminal penalties for non-consensual testing apply only where a person analyses bodily material to draw conclusions about a person's DNA. If a clinical geneticist consults a written record about the proband's DNA or analyses DNA pellets (discussed infra), this would not constitute an offence under s. 45. These modes of DNA analysis continue to be regulated by the Data Protection Act 1998 and the common law of confidentiality.
113. See e.g. L. Skene, op.cit., n. 64 at 166
114. D. Bell and B. Bennett, op.cit., n. 64 at 130-1
115. N. Hallowell et.al., op.cit., n. 66
116. A. Clark, 'Commentary on Hallowell et al.' (2003) 29 J.M.E. 80-2 at 80.
117. M. Parker and A. Lucassen, 'Concern for families and individuals in clinical genetics' (2003) 29 J.M.E. 70-3 (emphasis in the original);
118. M. Parker and A. Lucassen, 'Genetic information: A joint account?' (2004) 329 B.M.J. 165-7.
119. HGC, op.cit., n. 56, para. 2.10-2.11.
120. Sch. 4, para. 9.
121. See generally, O. O'Neill, 'Some limits of informed consent' (2003) 29 J.M.E. 4-7
122. O. O'Neill, Autonomy and Trust in Bioethics (Cambridge University Press 2002) at 155-60.
123. O'Neill, (2003), op.cit., n. 76
124. O'Neill, (2002), op.cit., n. 76, 97-9, 149, 158-60. Professor O'Neill explained her views at greater length with Dr Neil Manson at a workshop entitled 'Informed Consent and Genetic Data' (King's College, Cambridge, 11-12 January 2005).
125. The legal position is not well-established. Most judicial decisions on information disclosure for valid consent have concerned advice about surgical intervention where the risks include serious physical injury or psychiatric harm. In the instant scenario, where excised tissue (obtained with consent) is used or stored, the 'risk' is less significant. It is more likely to be limited to emotional distress or feelings that one's autonomy has been diminished. Rather than look to the law of negligence, the more appropriate area of precedent might be consent and waiver in an action for breach of confidence.
126. Rosie Winterton, Minister for State, Department of Health, Hansard [HC Com.] 29 January 2004, col. 81.
127. 'We need the flexibility of a code that provides guidance but, ultimately, leaves decisions on individual cases to the courts. It is not for us to enshrine in statute the offence of failure to obtain consent. It would be too restrictive to anticipate every circumstance, and it would not be practical or legally appropriate to define every single situation': Rosie Winterton, ibid., and at col. 79-80.
128. '[C]onsent means that someone has been adequately consulted and asked. [In the case of someone who gives blood] it might be adequate and appropriate for consent to have been seen to have been given by ... notices in surgeries or hospital waiting rooms. Consent beyond that, for further medical research, would involve specific consent, perhaps by a tick box ... Different types of consent could be used, as defined by the Human Tissue Authority guidance building on current best practice': Rosie Winterton, Minister of State, Department of Health, Hansard, [HC Com.] 27 January 2004, col. 15.
129. Hansard [HL 2R] 22 July 2004, col. 369-70. This view was confirmed in a letter: Department of Health, 'Letter to scientists' (July 2004).
130. Rosie Winterton, Hansard [HC Com.] 3 February 2004, col. 188.
131. The Human Tissue Authority has authority to prepare codes pursuant to s. 26 and 27. Before they have legally binding effect, the codes must be approved pursuant to s. 29. This requires approval from the Secretary of State and that the proposal be laid before both Houses of Parliament for 40 days without either House resolving not to approve the draft.
132. For example, storage or use for public display or anatomical examination: S. 3(3)-(5).
133. This is 'a technical difference arising because the DNA provisions extend to Scotland while the rest of the Act does not': Correspondence from Department of Health (December 2004).
134. Section 3(2) and Sch. 4, para. 2(1).
135. To be valid, the advance directive must have been 'in force immediately before he died': S. 3(6).
136. Section 3(6) and 4.
137. Section 27(4) and 54(9).
138. Section 27(8)(c).
139. This is the implication of Sch. 4, para. 11. It is not entirely clear whether this paragraph is intended to allow a nominated representative to give consent to DNA analysis, given that Sch. 4 does not explicitly provide for this.
140. A term defined by reference to the Children Act 1989 and Children (Northern Ireland) Order 1995 (S.I. 1995/755 (N.I.2)), s. S4.
141. Section 2(3) and Sch. 4, para. 2(2) (living child) and s. 2(7) and Sch. 4, para. 2(4) (deceased child).
142. Only a competent child can make this choice, and it must be evidenced in writing in the presence of at least one witness: S. 2(4)-2(6).
143. For example, K. Liddell, D.K. Menon and R. Zimmern' The Human Tissue Bill and the Mental Capacity Bill' (2004) 328 B.M.J. 1510
144. Joint Committee on the Draft Mental Incapacity Bill Draft Mental Incapacity Bill (HL Paper 189-1 HC 10831), chapter 15. www.publications.parliament.uk/pa/jt200203/jtselect/jtdmi/189/189.pdf (accessed 16 June 2004).
145. Section 6; Mental Capacity Act 2005 ss. 30-34. (The title of the Bill changed from Meal Incapacity to Mental Capacity after the joint committee's report.) http://www.hmso.gov.uk/acts/acts2005/20050009.htm (accessed 21 April 2005).
146. When evaluating the person's best interests it is permissible to consider, amongst other things, the person's past and present wishes and feelings, the beliefs and values that would be likely to influence his decision if he had capacity, and the other factors that he would be likely to consider if he were able to do so: Mental Capacity Act 2005 s. 4(6). It would appear this might include the importance of solidarity and altruism. The research community and disease organisations trust this will mean that non-therapeutic research is permissible with safeguards. The common law at present is unclear. Additional provisions provide scope for emergency and critical care research where treatment commences as a matter of urgency (e.g. when a patient presents in an unconscious state to an intensive care unit).
147. Contrast recommendations in the Redfern report (Royal Liverpool Children's Inquiry Report, op.cit., n.10)
148. and the Independent Review Group in Scotland, op.cit., n. 45.
149. At the prompting of the in vitro diagnostics industry, performance assessment was subsequently added to the clutch of consent-exempt activities to ensure that storage and use of relevant material in in vitro diagnostic medical devices are excluded from the scope of section 1 where this is already regulated by Directive 98/79/EC.
150. Contrast the suggestion in the Human Bodies, Human Choices discussion paper that implicit consent might be assumed for public health surveillance provided patients know about these purposes and have an opportunity to register an objection. The Act adds the category of clinical audit and does not provide a formal mechanism for objection (though Lord Warner's comments recorded in Hansard may apply some informal pressure: See infra n.119).
151. EN para. 13.
152. In its response to the Bristol inquiry, the government agreed that clinical audit should be compulsory for all health care professionals providing clinical care. Department of Health, op.cit., n. 10 at 168 (response to recommendation 145).
153. Dr Stephen Ladyman, Hansard [HC Com.] 27 January 2004, col. 73.
154. Note that Lord Warner provided Peers with a definition of public health monitoring by letter dated 15 October 2004: Hansard [HL Rep.] 25 October 2004, col. 1087. He differentiated between 'public health monitoring' (population-based or epidemiological techniques to ascertain the prevalence, spread and pattern of an established disease or condition in the community and relating its occurrence to public health programmes and activities) and 'public health research' which uses similar techniques to discover new knowledge about the natural history of diseases, their causes, mechanisms and risk factors'. Lord Warner asserted 'no public health activities will be adversely affected by the Bill' since most epidemiological research has REC approval and uses anonymised tissue.
155. Rosie Winterton, Minister for State, Department of Health, Hansard [HC Rep.] 28 June 2004, col. 105.
156. 'If we consented to the use of material from our bodies for diagnostic purposes, it should be used for those purposes and it should not be assumed that the bit that is left over may be used for any other purpose': Dr Stephen Ladyman, Hansard, [HC Com.] 27 January 2004, col. 65.
157. '[T]he clinician did not suddenly decide, in the middle of his work, 'Ah! time for research,' and put on a research hat. Research is merely part and parcel of the clinician's way of life': Lord McColl of Dulwich (a former doctor), Hansard [HL GC] 15 September 2004, col. GC 416.
158. The Academy of Medical Sciences also highlighted what they perceived as the arbitrariness of the distinction between public health monitoring and epidemiological research: 'Determining the proportion of women attending antenatal clinics who are hepatitis B positive or HIV positive is an example of public health monitoring. This, in principle, is no different from determining the proportion of people with and without heart disease who are Chlamydia positive to see if Chlamydia infection may be a cause of heart disease. However, under the Bill as it is currently drafted this would be classified as epidemiological research. There is surely no logical reason why one should be done without the other': Academy of Medical Sciences, op.cit., n. 19 at 4-5.
159. For example when asbestos was first linked to lung cancer it was essential to go back to earlier cases to identify that mesothelioma of the lungs was specifically linked to exposure. More recently, to ascertain that the new variant of CJD was indeed a new disease required review of earlier specimens to make sure it had not been overlooked: D. Williams, 'The Human Tissue Bill: Problems Relating to Tissue Removed at Surgical Operation' (correspondence, January 2004).
160. Generally, R. Hakimian and D. Korn, 'Ownership and Use of Tissue Specimens for Research' (2004) 292 Journal of American Medical Association 2500.
161. The government's handling of medical research was foreshadowed in its consultation documents: E.g. Department of Health, Interim Statement, op.cit., n. 10. However, few in the research community noticed these clues and the government did not circulate a Bill for pre-legislative scrutiny.
162. P. Furness, 'Consent to using human tissue. Implied consent should suffice' (2003) 327 B.M.J. 759-60.
163. P. Furness, 'The Human Tissue Bill. Criminal Sanctions Linked to Opaque Legislation Threaten Research' (2004) 328 B.M.J. 533-4.
164. Hansard [HL 2R] 22 July 2004, col.395.
165. General Medical Council, 'GMC response to the publication of the Human Tissue Bill' (4 December 2003). http://www.gmc-uk.org/news/current/ human_tissue_bill.htm (accessed 26 January 2005); email from Department of Health to scientist (February 2004). Pathologists queried the relevance of the GMC's statement on the basis that it applied to tissues taken or retained in the first instance for research rather than tissue taken, with consent, for clinical reasons and stored as blocks and slides for diagnostic purposes, which subsequently became useful for medical education, training and research.
166. 'We certainly envisage that once electronic patient records are introduced, mechanisms can be used to record each patient's consent on that record so that it will be clear and available to all health professionals with access to it': Lord Warner, Hansard [HL 2R] 22 July 2004, col. 430.
167. Furness and Sullivan, op.cit., n. 25.
168. P. Furness and M. Nicholson, 'Obtaining Explicit Consent for the Use of Archival Tissue Samples: Practical Issues' (2004) 30 J.M.E. 561-4.
169. Whilst potential donors widely believe they should be notified or given a choice about the uses to which their tissue is put, studies have found that once contacted the majority of individuals willingly support the use of tissue removed during surgery for medical education and research. This casts further doubt on the allocation of extensive resources to the consent process: R.D. Start, W. Brown, and R.J. Bryant et. al., 'Ownership and Uses of Human Tissue: Does the Nuffield Bioethics Report Accord with the Opinion of Surgical Inpatients' (1996) 313 B.M.J. 1366-8
170. P. Furness, op.cit., n. 110
171. A.L. Jack and C. Womack, 'Why Surgical Patients do Not Donate Tissue for Commercial Research: Review of Records' (2003) B.M.J. 262
172. M. Richards, M. Ponder, P. Pharoah, S. Everest and J. Mackay, 'Issues of Consent and Feedback in a Genetic Epidemiological Study of Women with Breast Cancer' (2003) 29 J.M.E. 93-6.
173. Also of interest are the studies that indicate the public is more concerned by the use of tissue for clinical audit than research: COI Communications and IPSOS Research to Evaluate Topline Public Opinion, Knowledge and Understanding of Retained Organs for Medical Practice, Teaching and Research within England and Wales (Retained Organs Commission, April 2003);
174. Wellcome Trust Human Tissue and Biomedical Research - Public Attitudes (forthcoming 2005).
175. For example, O. Corrigan, 'Empty Ethics: The Problem with Informed Consent' (2003) 25(7) Sociology of Health & Illness 768.
176. Disappointing because verifiable transparency is an important element of public reason: O. O'Neill, A Question of Trust (Cambridge University Press 2002);
177. Liddell, op.cit., n. 38, chapter 9. While openness can have damaging effects of other sorts (for instance O'Neill notes it may make it harder for policymakers to explore unpopular options), on this occasion the risk of overall negative impact was unlikely. Controversies of equal magnitude were canvassed in Parliament.
178. Section 1(7), (8), (9), (10). The regulations about ethical approval have not yet been drafted but are likely to require approval from a research ethics committee. Lord Warner added a gloss during Parliamentary debates which suggests that future policy documents (e.g. a code from the Human Tissue Authority) may give individuals a right of veto even where tissue is anonymised: 'Ministers have made it quite clear that, notwithstanding the fact that it may be lawful to use it without consent if it is anonymised, if an individual particularly does not wish his tissue to be used in research, then it would not be good practice to do so. We would not expect tissue to be used in those circumstances. Code of practice guidance on this will be issued by the Human Tissue Authority and tissue storage facilities and their records will be licensed and inspected accordingly': Hansard [HL GC] IIS September 2004, cot. GC419.
179. Section 1(9). The question whether tissue must be irreversibly anonymised was a source of abiding concern as the Bill proceeded through Parliament. The government indicated it would not be a strict requirement: E.g. 'The Bill allows samples that are anonymised in ways that will retain their linkage to the clinical record' (Lord Warner Hansard [HL 2R] 22 July 2004, col. 426). However, some situations remain unclear. Would research be lawful without consent if the organisation which employs the researcher (e.g. an NHS Trust) - but not the researcher himself - possesses information from which the identity of the tissue source could be ascertained? This turns on whether 'person carrying it out' refers to a legal or natural person.
180. Section 7(4). The government indicated this power should only be exercised in the most extreme situations, offering the unlikely example of an outbreak 'of some highly infectious disease similar to Ebola': Rosie Winterton, Hansard [HC Rep.] 28 June 2004, col. 27.
181. Email from scientist to other scientists copied to Department of Health (June 2004a).
182. Email from scientist to other scientists copied to Department of Health (June 2004b).
183. Email from scientist to other scientists copied to Department of Health (June 2004c).
184. See also ABPI et al., 'Human Tissue Bill: Amendments Proposed by the Bioindustry Association with the Support of the Association of the British Pharmaceutical Industry and the British In Vitro Diagnostics Association' (2004) at 8.
185. R. Zimmern, A. Hall and K. Liddell, 'The Human Tissue Bill Following its Third Reading in the House of Commons': http://www.cgkp.org.uk/resources/pdf/htb_briefing.pdf (accessed 21 January 2005).
186. See in particular Sch. 3 para. 8.
187. See obiter in R v. Department of Health ex parte Source Informatics [2001] Q.B. 424 (CA)
188. and general jurisprudence of Campbell v. MGN Ltd [2004] 2 All E.R. 995 (HL);
189. R v. Chief Constable of South Yorkshire Police ex parte S and Marper [2004] U.K.H.L. 39 (HL).
190. This was a live issue under the Data Protection Act 1998 until the Court of Appeal's judgement in ex p. Source Informatics (the accuracy and ethics of which have been questioned). The government made some further effort to resolve the issue through the Health Services (Control of Patient Information) Regulations 2002 (S.I. No. 1438). Oddly, the government failed to make the same sort of efforts under the Human Tissue Act 2004. A possible reading of the Act is that the process of anonymisation requires 'appropriate consent' because it involves a 'use' of human tissue performed for no other purpose than the purpose of research. But a more likely outcome is that government and the research community will collectively adopt a purposive reading which allows tissue to be used for the act of anonymisation without first seeking 'appropriate consent'. The future is not entirely clear however, given Lord Warner's gloss to the effect that individuals retain a right to veto the use of anonymised tissue in research: Warner, op. cit., n. 119.
191. EN para. 10.
192. Department of Health (2003b), op.ci t., n. 10, para. 17.22-17.23
193. Department of Health (2003c), op.cit., n. 10, para. 2.23.
194. For commentary on the ethics of using archived tissue samples: D.G. Jones, R. Gear, K.A. Galvin 'Stored Human Tissue: An Ethical Perspective on the Fate of Anonymous Archival Material' (2003) 29 J.M.E. 343-7
195. R. Ashcroft, 'The Ethics of Reusing Archived Tissue for Research' (2000) 26(5) Neuropathology and Applied Neurobiology 408-11. 'Appropriate consent' is not required where one removes, stores or uses tissue from the body of a person who died more than 100 years before the commencement of the Act. The Act also provides for de-accession of human remains believed to be up to 1,000 years old: S. 47.
196. See also s. 45(2)(b).
197. Department of Health (2005) above n. 42.
198. Various ways in which DNA can be stored are described in Joint Committee on Medical Genetics Report on Consent and Confidentiality in Genetic Practice (forthcoming 2005). Some but not all will be caught by the s. 45 offence.
199. For the definition of 'bodily material': S. 45(5).
200. For example, the newspapers reported that a private investigator surreptitiously collected Stephen Bing's discarded toothbrush from a hotel in order to test his DNA to determine whether he was the father of Liz Hurley's child: Matthew Engel, Washington Guardian, reprinted in The Guardian Bing Sues MGM Boss for $1bn over Bin Search in New Paternity Case (18 May 2002). Whereas private investigators collect DNA from human cells, clinicians and researchers often use DNA stored in a non-cellular form.
201. Section 1(12) and EN para. 13
202. Rosie Winterton, Hansard [HC Rep.] 28 June 2004, Col. 99.
203. Dr Stephen Ladyman, Hansard [HC Com.] 27 January 2004, Col. 65.
204. Rosie Winterton, responding to proposals for presumed consent to posthumous organ transplantation (discussed further below) Hansard [HC Rep.] 28 June 2004, col. 83-4.
205. Ibid.
206. Dr Stephen Ladyman, Hansard [HC Com.] 27 January 2004, col. 66.
207. Baroness Andrews, Hansard [HL GC] 16 September 2004, col. GC 480, in response to an amendment proposed by the opposition to empower the High Court to hear applications and, if appropriate, approve a proposed use of the tissue or DNA analysis where a living person had refused consent.
208. Contributor at Human Tissue Workshop, op.cit., n. 54
209. ABPI et al., op.cit., n. 124 at 2.
210. These arrangements are common in the US as well: E.g. R. Hakimian and D. Korn, op.cit., n. 108 at 2503.
211. Rosie Winterton, Hansard [HC Rep.] 28 June 2004, col. 115.
212. Section 32(8)(c).
213. See the definition of controlled materials: S. 32(9)(c), EN para. 48. The connection with the common law rule that, prima facie, there is no property in bodies is discussed further below.
214. Section 32(3).
215. Section 32(6) and (7).
216. Note though that there is no requirement under the Act to obtain 'appropriate consent' from donors when importing organs or tissues for transplantation (or any other Schedule 1 purpose): S. 1(6). This unequal treatment of donors in other countries is concerning, and further policy development is urgently needed. We presume the issues will be addressed when the EU Tissue Directive 2004/23/EC is implemented, and that the Authority will also prepare applicable guidance. The Department of Health's interim code on import and export, published in 2003, does not apply to tissue for diagnostic or therapeutic use (e.g. transplantation), DNA, cell lines, embryos, gametes, tissue blocks or slides, sweat, hair or nails.
217. It is beyond the scope of this article to discuss in detail living donor transplants: See generally D. Price, Legal and Ethical Aspects of Organ Transplantation (Cambridge University Press 2001). Suffice to say that this was relatively uncontroversial during the passage of the Bill. The government insisted on dealing with the issue in regulations and promised a public debate at that time. Section 33 sets up a flexible framework through which regulations could either extend or restrict current legal policy. Issues foreshadowed for discussion include donations between strangers (which are not permitted at present), and the need for stricter oversight of the psychological pressures which may arise with genetically-related donations.
218. Lord Warner, Hansard [HL GC] 11 October 2004, col. GC10-11.
219. See in particular Commons committee debates and the Commons report stage: E.g. Hansard [HC Rep.] 28 June 2004, col. 39-94. The government eventually won a whipped vote by a majority of 307 to 60.
220. V. English and A. Somerville, op.cit., n. 34
221. BMA, 'Human tissue and organs-shortages' (May 2004) http://www.bma.org.uk/ap.nsf/Content/Humantissueorgans-shortages (accessed 26 January 2005).
222. One issue for an opt-in system is whether retrieval of organs is lawful if no relatives are available in the hours immediately following death and the deceased made no explicit request to donate: D. Price, op.cit., n. 3 at 42. Strictly speaking, organs cannot be retrieved without consent. However s. 43 allows steps to be taken to preserve the body parts of a deceased person for transplantation. The power expires once it is established that consent to transplantation will not be given. The steps taken must be the minimum necessary and least invasive, but in some circumstances this might permit organ retrieval without consent.
223. Rosie Winterton, Hansard [HC Rep.] 28 June 2004, col. 83-4.
224. V. English and A. Somerville, op.cit., n. 34 at 148.
225. Rosie Winterton, Hansard [HC Rep.] 28 June 2004, col. 84.
226. V. English and A. Somerville, op.cit., n. 34 at 149-50. Although donation rates lie in the vicinity of 13.1%, public opinion polls report that 70% of people are willing to donate their organs after death.
227. 1998 ONS statistics suggest that of 304,350 deaths which took place in hospital, 59,264 were followed by post-mortem examination of which 55,929 were at the request of the coroner (some 94%): Mavis McClean, op.cit., n. 12 at 83.
228. Baroness Andrews, Hansard [HL GC] 16 September 2004, col. GC 490. If a coroner acted in this way they would be subject to disciplinary proceedings by the Lord Chancellor or criminal proceedings under the Act.
229. EN para. 54.
230. R v. Kelly [1999] QB 621 (CA) at 630-1
231. AB and others v. Leeds Teaching Hospital N.H.S. Trust and another [2004] E.W.H.C. 644 (QB) at para. 148.
232. The widespread language that individuals make a 'gift' of their tissue or 'abandon it' already presupposes some property orientated concept for the individual of ownership, possession or at least implied transference: Price, op.cit., n. 3 at 26.
233. Brazier also drew attention to the language of relatives who claim that the body parts of their loved one's were stolen from them: Brazier op.cit., n. 13 at 32.
234. 'For instance, in Dobson it was stated that mere preservation of pathological or anatomical specimens by fixing would not constitute such a change yet in Doodeward Griffiths C.J. held (although Higgins J. disagreed) that mere preservation of a fetus would do so': Price, op.cit., n. 3 at 136-7
235. citing Dobson v. North Tyneside H.A. [1996] 4 All E.R. 474
236. and Doodeward v. Spence (1908) 6 C.L.R. 406 (HC of A).
237. See generally references in n. 161-4. For detailed examination of the work and skill exception, see R. Hardcastle, 'Legal Protection of Biological Materials' (DPhil thesis, University of Oxford, 2004).
238. Mason and Laurie, op.cit., n. 2
239. Price, op.cit., n. 3.
240. Section 32(9).
241. AB v. Leeds Teaching Hospital N.H.S. Trust [2004] E.W.H.C. 644 (QB), at para. 148, 160.
242. Gage J. did not clarify this point: Ibid., at para. 283.
243. The Retained Organs Commission recommended that retained blocks and slides be transferred back to the custodianship of the NHS Trust or other appropriate authority fulfilling this role after the coroner has concluded his enquiry into the death of an individual: The Retained Organs Commission Recommendations on the Legal Status of Tissue Blocks and Slides (2003) at 1.
244. Although para. 4 of Sch. 1 of the Act might add an additional requirement to seek 'appropriate consent' from the donor where the tissue is used to obtain information relevant to another person.
245. The common law of battery will also continue to regulate the taking of tissue from live donors.
246. See AB v. Leeds Teaching Hospital N.H.S. Trust [2004] E.W.H.C. 644 (QB).
247. Unless s. 33 applies. See the first data protection principle in DPA Sch. 1 and Sch. 3, Condition 8.
248. DPA Sch.1 Pt 2. See discussion supra about the implications of the DPA for the governance of existing tissue holdings.
249. Parry, op.cit., n. 7.
250. See discussion infra on the relationship between the HFEA and Human Tissue Authority.
251. See e.g. s. 47, s. 14(5) and s. 1(12).
252. Initially the Bill proposed to set up two inspectorates: An Inspectorate of Anatomy and Pathology (to replace Her Majesty's Inspectorate of Anatomy) and an Inspectorate of Organs and Tissue for Human Use (to replace the Unrelated Live Transplants Regulatory Authority (ULTRA) and to deal with transplantation and issues of public health). This proposal was abandoned in light of the government's separate commitment to prune the size, numbers and running costs of arms-length bodies. Discussed infra.
253. Section 25.
254. Section 26(2).
255. Section 29.
256. A fourth function, beyond the scope of this paper, is that the Human Tissue Authority will regulate human tissue banking for transplant purposes under the EU Tissue Directive (2004/23/EC).
257. Baroness Helene Hayman has been appointed as Chair. She has more than 30 years' experience working in the voluntary sector and the NHS and recently has been the Chair of Cancer Research UK. She will be assisted by up to 12 members drawn from professional and lay backgrounds as diverse as archaeology, anatomy, finance, and ethics.
258. As the Bill progressed through Parliament, concerns were raised that the HTA would insist on issuing a separate licence for each activity and premises.
259. Lord Warner, Hansard [HL 2R] 22 July 2004, col. 371.
260. See further, Lord Warner, Hansard [HL GC] 16 September 2004, col. GC 508.
261. See Sch. 2, para. 1.
262. See Lord Warner, Hansard [HL 2R] 22 July 2004, col. 372
263. House of Commons Science and Technology Committee, Human Reproductive Technologies and the Law (2005), at para. 376.
264. R. Brownsword 'The Cult of Consent: Fixation and Fallacy' (2004) 15(2) Kings College Law Journal 223, 229-40 (fallacy of necessity), 240-50 (fallacy of sufficiency).
265. DPA and Health Services (Control of Patient Information) Regulations 2002 (S.I. No. 1438).
266. Implementing European Directive 2001/20/EC. Commenced 1 May 2004.
267. For example, Pearce v. United Bristol Healthcare N.H.S. Trust (1998) 48 B.M.L.R. 118 (CA).
268. EU Directive 2004/23/EC on setting standards of quality and safety for the donation, procurement, testing, processing, storage, and distribution of human tissues and cells.
269. For this conceptual point, we are grateful to Stephen John (in conversation).
270. W. Lowrance, Learning from Experience: Privacy and the Secondary Use of Data in Health Research (Nuffield Trust 2002) at 37.
271. Brownsword, op.cit., n. 187.
272. O, O'Neill and N. Manson, Informed Consent and Genetic Data: Discussion Papers (working papers) circulated to participants at a workshop of that name, cited op.cit., n. 77 at 43.
273. Royal College of Physicians, op.cit., n. 48.
274. Dr Stephen Ladyman, Parliamentary Under Secretary of State, Hansard [HC Com.] 27 January 2004, col. 68.
275. Royal College of Pathologists, 'Comments on the Human Tissue Bill as Brought from the Commons on 29 June 2004' (9 July 2004) http://www.rcpath.org/resources/pdf/HTB_Lords_RCPath.pdf (accessed 26 January 2005). By way of an example, compare the terms describing human tissue, which put critical limits on the scope of various provisions: 'relevant material' (s. 1), 'bodily material' (s. 45), 'material' (s. 44), 'donated material' (s. 8), 'controlled material' (s. 32), 'transplantable material' (s. 33), 'part of a body' (s. 43), 'human remains' (s. 47), 'anatomical specimens' (s. 41), 'existing holdings' (s. 9).
276. M. Coleman, B. Evans, G. Barrett, 'Confidentiality and the Public Interest in Medical Research: Will We Ever Get it Right?' (2003) 3 Clinical Medicine 219-28.
277. See generally, C. Warlow, 'Clinical Research Under the Cosh Again' (2004) 329 B.M.J. 241-2.
278. The government summary of responses to the Human Bodies, Human Choices clearly shows that the responses covered a limited range of perspectives (or that its summary was deficient): Department of Health, (2003c), op.cit., n. 10, para 2.6, 2.9, 2.16, 2.23, 3.15.
279. For further discussion of the limits of public consultation: Liddell, op.cit., n. 38, chapter 8.
280. Admittedly it is difficult to be certain that the changes can be attributed wholly to a genuine moral reciprocity from the policymaker. Some evidence suggests looming deadlines in the Parliamentary timetable played a role, particularly towards the end of the Bill's passage.
281. See in particular Human Rights Act 1998 Art 8(2), and DPA s. 10, 33 and Sch. 3, para. 8 and 10.