Embryonic stem cells and consent: Incoherence and inconsistency in the UK regulatory model

Medical Law Review

Volumn 15, Issue 3, 2007, Pages 279-319

  Morgan, Ryan ^a  

^a UNIVERSITY COLLEGE CORK   (Ireland)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CELL NUCLEUS TRANSPLANTATION; CLONING; DONOR; EMBRYO RESEARCH; EMBRYONIC STEM CELL; ETHICS; GOVERNMENT REGULATION; HUMAN; INFORMED CONSENT; LEGAL ASPECT; STANDARD; TRANSPLANTATION; UNITED KINGDOM;

CLONING, ORGANISM; EMBRYO RESEARCH; EMBRYONIC STEM CELLS; GOVERNMENT REGULATION; GREAT BRITAIN; HUMANS; INFORMED CONSENT; NUCLEAR TRANSFER TECHNIQUES; TISSUE DONORS;

EID: 35449000650     PISSN: 09670742     EISSN: 14643790     Source Type: Journal    
DOI: 10.1093/medlaw/fwm014     Document Type: Article

References (237)

1. C. 37 (also referred to as 'the 1990 Act' in this article).
2. House of Lords' Select Committee, Report on Stem Cell Research (H.L. 83(i), 2002).
3. Ibid., para. 8.33. For further discussion, see below at 12-25.
4. Human Fertilisation and Embryology Authority, Code of Practice, 6th edn (2003) at 51, para. 5.9(vi).
5. See also the stipulations of the UK Stem Cell Bank (UK Stem Cell Bank Steering Committee, Code of Practice for the Use of Human Stem Cell Lines, version 3 (Medical Research Council, 2006) at 15-17.
6. See below at 284-286.
7. See below at 292-297.
8. See below at 297-303.
9. See below at 294-295.
10. See below at 304-306.
11. See below at 305.
12. See below at 306-307.
13. See below at 307-319.
14. C. 30 (also referred to as 'the 2004 Act' in this article).
15. Directive 2004/23/EC on Setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells.
16. See below at 311-317
17. S.1(1), 2 and 3 (Human Tissue Act 2004) and Article 13 (Tissue and Cells Directive), respectively.
18. See below at 317-319.
19. Department of Health (Cm 6989 2006).
20. Ibid., at 26, para 3.2.
21. Human Fertilisation and Embryology Act, s. 3(3)(d).
22. Ibid., Schedule 2, para. 1(4).
23. Supra n. 18 at 23, para. 2.77 and 16-17, paras 2.48-2.52, respectively.
24. Ibid., at 23, para. 2.78.
25. For example, whether basic research or research with the objective of alleviating serious trauma is permissible (see R. Brownsword 'Stem Cells, Superman, and the Report of the Select Committee' (2002) 65 Modern Law Review 568-587).
26. The White Paper (supra n. 18) proposes to put such issues beyond any doubt.
27. Supra n. 18 at 12, para 2.34.
28. Ibid., at 11-12, paras. 2.30-2.32.
29. Ibid., at 11, para. 2.2 8.
30. Ibid., at 1, para 1.2.
31. Ibid., at v (foreword of Caroline Flint MP, Minister of State for Public Health).
32. J.A. Thomson et al., 'Embryonic Stem Cell Lines Derived from Human Blastocysts' (1998) 282 (5391) Science 1145-47.
33. Sometimes termed Somatic Cell Nucleus Transfer (SCNT).
34. I. Wilmut, et al., 'Viable Offspring Derived from Foetal and Adult Mammalian Cells' (1997) 385 Nature 810.
35. Unless the cell nucleus donor is also the donor of the enucleated egg, the mitochondrial DNA of the embryo or its derivatives would not be identical to that of the cell nucleus donor.
36. No verifiable successes have yet been reported (see below at 302).
37. See e.g. President's Council on Bioethics (PCBE), Monitoring Stem Cell Research (PCBE, 2004) 131-133
38. R. Jaenisch,'The Biology of Nuclear Cloning and the Potential of Embryonic Stem Cells for Transplantation Therapy' in Monitoring Stem Cell Research at 385-414, Appendix N;
39. CMO's Expert Group Report (infra n. 36) at 23-24, paras. 2.26-2.32.
40. Principally, Human Genetics Advisory Commission (HGAC) and Human Fertilisation and Embryology Authority (HFEA), Cloning Issues in Reproduction, Science and Medicine (Department of Trade and Industry, 1998);
41. and Chief Medical Officer's Expert Group Reviewing the Potential of Developments in Stem Cell Research and Cell Nuclear Replacement to Benefit Human Health, Stem Cell Research: Medical Progress with Responsibility (Department of Health, 2000).
42. Department of Health, Government Response to the Recommendations Made in the Chief Medical Officer's Expert Group Report: Stem Cell Research: Medical Progress with Responsibility (Cm 4833 2000).
43. S.I. 2001 No. 188 (also referred to as 'the 2001 Regulations' in this article).
44. Article 2(2)(a).
45. Article 2(2)(b).
46. Article 2(2)(c).
47. Schedule 2, para. 3(1).
48. Hansard [HL Deb.] 22 January 2001, cols. 107-108 and 124 Hansard [HL Deb.] 7 March 2001, col. 207. See below at 290.
49. Supra n. 2.
50. Supra n. 2 at paras. 8.1-8.5.
51. R v. Secretary of State for Health, ex parte Bruno Quintavalle (on behalf of Pro-life Alliance) [2001] EWHC Admin 918 (QBD); [2002] EWCA Civ 29 (CA); [2003] UKHL 13 (HL).
52. Ibid. (QBD judgment) at [62].
53. C. 23.
54. S.1(1).
55. Supra n. 14.
56. Recital 7. See below at 311-319.
57. Article 2(1) and Recital 11.
58. S.53(2).
59. S. 1(1)(d).
60. See below at 0000.
61. Supra n. 18.
62. See J. Laing and A. Grubb, 'Medically Assisted Reproduction' in A. Grubb and J. Laing (eds), Principles of Medical Law, 2nd edn (Oxford University Press 2004) at 698-702.
63. Schedule 3, para. 1. S.12(c) of the 1990 Act makes it a condition of every licence 'that the provisions of Schedule 3 to this Act shall be complied with'.
64. Schedule 3, para. 2(1)(c).
65. Schedule 3, para. 2(4)(b) and 6(1).
66. Supra n. 58.
67. Schedule 3,para. 3(1)(b) and HFEA Code of Practice (supra. n. 4) at 50-51, paras. 5.8-5.10.
68. Schedule 3, para. 3(1)(a) and HFEA Code of Practice (ibid.) at 73-74, paras. 7.16-7.18.
69. Schedule 3, para. 2(1)(c). The embryo may only be used fora limited number of research purposes (see Schedule 2, para. 3(2) and the Human Fertilisation and Embryology (Research Purposes) Regulations 2001, Article 2(2) (supra n. 38)).
70. Supra n. 4 (HFEA) at 50, para. 5.8(vi).
71. See e.g. Evans v. Amicus Healthcare Ltd and Ors [2003] EWHC 2161 (Fam); [2004] EWCA Civ 727.
72. Typified by R v. Human Fertilisation and Embryology Authority, ex parte Blood [1997] 2 All E.R. 687 (CA).
73. This is still the case today. See the HFEA Code of Practice (supra n. 4) at 51, para. 5.9(ii)-(v).
74. Human Fertilisation and Embryology Authority, Code of Practice, 5th edn (Human Fertilisation and Embryology Authority, 2001) at 29, para. 6.9(a).
75. Although tumourogenesis (formation of cancer cells) through uncontrolled differentiation within ES cell lines remains a problem.
76. The House of Lords' Select Committee on Stem Cells recommended the HFEA impose a condition on all research licences that any ES cell line derived in the UK should be deposited in the UK Stem Cell Bank (supra n. 2 para. 8.29).
77. The HFEA has followed this recommendation (Human Fertilisation and Embryology Authority, Twelfth Annual Report and Accounts 2002-2003 (2003) at 21
78. Human Fertilisation and Embryology Authority, Regulation of Research on Human Embryos (2004) paras. 11, 16 and 18).
79. People, Science and Policy Ltd., Public Consultation on the Stem Cell Bank: A Report for the Medical Research Council (PSP 2003).
80. Ibid., at 20, para. 3.9.
81. Ibid., at 26, para. 3.12.1.
82. Ibid., at 20, para. 3.9.
83. Ibid., at 26, para. 3.12.1.
84. Ibid.
85. Supra n. 36 (CMO's Expert Group Report).
86. Ibid., at 46, para. 5.10 (Recommendation 3).
87. Supra n. 36 (CMO's Expert Group Report) at 46, para. 5.10.
88. Supra n. 64.
89. Supra n. 36 (CMO's Expert Group Report) at 17-18, paras. 2.6-2.7 and 21, paras. 2.21-2.2.3.
90. Reference was made to this in the original article by Thomson (supra n. 30).
91. 793 P.2d 479 (Cal. 1990).
92. Supra n. 18.
93. See above at 280-282.
94. Supra n. 2 at para. 8.33 (original emphasis).
95. However, many voiced frustration at establishing a Select Committee to review the operation of legislation after it had been affirmed by Parliament. Baroness Warnock stated that the House had been 'bullied and pushed to do things more quickly than we should' (Hansard, [HL Deb.] 22 January 2001, col. 45).
96. Supra n. 4 (HFEA) at 51, para. 5.9(vi).
97. Supra n. 4 (UK Stem Cell Bank) at 16.
98. See supra. n. 4 (UK Stem Cell Bank) at Annex 3. This forms part of pro forma for the deposition of a stem cell line with the Bank. This asks the depositor, inter alia, whether it was explained to the donors 'that stem cell lines may not be generated where the consent places a constraint on future use' (at Annex 3, 3 (ix)).
99. Ibid., at 7.
100. Supra n. 2 at paras. 4.25(a), 8.24 and 8.33.
101. Report of the Committee of Inquiry into Human Fertilisation and Embryology (Cmnd. 9314 1984) at 63, para. 11.17.
102. Supra n. 18 at v (Foreword of Caroline Flint MP and Minister of State for Public Health).
103. Ibid., at 2, para. 1.8.
104. Schedule 2, para. 3(2).
105. Schedule 2, para. 3(6).
106. Such as the WiCell Research Institute (the repository established by Dr James Thomson in Wisconsin) or, indeed, the UK Stem Cell Bank itself once sufficient samples have been deposited.
107. Supra n. 92.
108. Embryos Act 2002 (Wet houdende regels inzake handelingen met geslachtscellen en embro's: Embrowet), s.6(3).
109. See S. Halliday, 'A Comparative Approach to the Regulation of Human Embryonic Stem Cell Research in Europe' (2004) 12(1) Med. L.R. 40-69.
110. National Bioethics Advisory Commission, Ethical Issues in Human Stem Cell Research, vol. 1 (1999) at 72, Recommendation 5.
111. Supra n. 36 (CMO's Expert Group).
112. See above at 289.
113. Supra n. 83.
114. 264 F. Supp. 2nd 1064 (S.D. Fla. 2003).
115. A thorough analysis of the area of property law as it affects human tissue is outside the remit of this article. However, the interested reader should refer to J.K. Mason and G.T. Laurie, Mason and McCall Smith's Law and Medical Ethics, 7th edn (Oxford University Press 2006) at 511-538
116. G. Dworkin and I. Kennedy, 'Human Tissue: Rights in the Body and its Parts' (1993) 1(3) Med. L.R. 291-319
117. A. Grubb, '", Me, Mine": Bodies, Parts and Property' (1998) 3(4) Medical Law International 299-317, etc.
118. 249 Cal. Rptr. 494 (21 July 1988) at 508.
119. Supra n. 83 at 494.
120. Supra n. 84 at 1064 (per District Judge Moreno).
121. For a startling study involving pathology specimens, see P. Furness and R. Sullivan, 'The Human Tissue Bill' (2004) 328 British Medical Journal 553-4 (a pathology laboratory was able to locate only 48% of consent forms, 40% of these forms were incomplete).
122. J. McHale, 'Regulating Genetic Databases: Some Legal and Ethical Issues' (2004) 12(1) Med. L.R. 70-96 at 80.
123. Supra n. 72.
124. Supra n. 18.
125. R. Brownsword, 'Regulating Human Genetics: New Dilemmas for a New Millennium' (2004) 12(1) Med. L.R. 14-39.
126. Supra n. 72.
127. See above at 288-289.
128. Supra n. 2.
129. See above at 290-292.
130. Supra n. 109 at 87.
131. An exception to this is a cell line produced from an embryo created by cell nuclear replacement (discussed below at 290-291).
132. See above at 302-303.
133. J. Montgomery, 'Law and the Demoralisation of Medicine' (2006) 26(2) Legal Studies 185-210.
134. Ibid., at 188.
135. Department of Health and NHS Department of the Welsh Assembly Government, Human Bodies, Human Choices: The Law on Human Organs and Tissue in England and Wales (2002) at 9, para. 1.24 and 67-70, paras. 10.1-10.9.
136. O. O'Neill, 'Some Limits of informed consent' (2003) 29 J.M.E. 4, at 5 and 6.
137. Ibid. at 6.
138. Ibid.
139. See above at 284-286.
140. See above at 282.
141. The claims of Dr Hwang Woo-suk in this regard (W.S. Hwang et al., 'Evidence of a Pluripotent Human Embryonic Stem Cell Line Derived from a Cloned Blastocyst' (2004) 303(5664) Science 1669-1674
142. W.S. Hwang et al., 'Patient-Specific Embryonic Stem Cells Derived from Human SCNT Blastocysts' (2005) 308(5729) Science 1777-1783 have subsequently been revealed as fabricated (D. Kennedy, 'Editorial Retraction' (2006) 311 (5759) Science 335), and are currently the subject of criminal fraud investigation in South Korea.
143. See, e.g. 'Derivation of Human Embryonic Stem Cell Lines Using Nuclear Transfer and Parthenogenically Activated Oocytes' HFEA Research Licence No. R0152 (Centre for Life, Newcastle-upon-Tyne) and 'Derivation of Human Embryo Stem Cells by Cell Nuclear Replacement for Technology Development and the Study of Motor Neuron Disease' HFEA Research Licence No. R0158 (Roslin Institute, Edinburgh).
144. Discussed in more detail below at 304-306.
145. Supra n. 14.
146. For an overview, see A.-M. Farrell, 'Governing the Body: Examining EU Regulatory Developments in Relation to Substances of Human Origin' (2005) 27 Journal of Social Welfare and Family Law 427-437.
147. Article 2.
148. Recital 11.
149. Supra n. 130.
150. Article 2.
151. See above at 312.
152. Supra n. 46 (QBD).
153. Ibid., at [58].
154. Supra n. 46 (CA).
155. Supra n. 46 (HL).
156. Supra n. 54 at para. 48.
157. A. Plomer, 'Beyond the HFE Act 1990: The Regulation of Stem Cell Research in the UK' (2002) 10 Med. L.R. 132 at 157-158.
158. Under s. 23.
159. Human Fertilisation and Embryology Authority, Code of Practice, 7th edn. Public Consultation (2006). Although, given the Government's reform plans detailed in the White Paper (supra n. 18), the future of the HFEA's consultation is unclear.
160. Supra n. 18.
161. Supra n. 4 (HFEA) at 93, paras. 10.6-10.9.
162. Department of Health, Governance Arrangements for NHS Research Ethics Committees (2001) at 26-27, para. 9.17
163. Department of Health, Research Governance Framework for Health and Social Care (2005) at 6-7, paras. 2.2.3-2.2.4.
164. For an overview of the operation of research ethics governance in the UK, see J. McHale, 'Clinical Research' in A. Grubb with J. Laing (eds), Principles of Medical Law (supra n. 57) at 853-910.
165. The reader should be aware that the NHS REC system has recently been the subject of a review by Lord Warner, Report of the Ad Hoc Advisory Group on the Operation of NHS Research Ethics Committees (Department of Health 2005). The report does not speak directly to these issues, however.
166. See e.g. N.A. Maskell et al., 'Variations in Experience in Obtaining Local Ethical Approval for Participation in a Multi-centre Study' (2003) 96 The Quarterly Journal of Medicine 306-307
167. J. Savulescu et al., 'Are Research Ethics Committees Behaving Unethically? Some Suggestions for Improving Performance and Accountability' (1996) 313 British Medical Journal 1390-1393, etc.
168. Supra n. 145.
169. Supra n. 146.
170. Former Parliamentary Under-Secretary of State for Health.
171. Supra n. 146 at 8-11.
172. Central Office for Research Ethics Committees, Building on Improvement (National Patient Safety Agency 2006).
173. Supra n. 92 at 66, para. 11.24 for further on the Committee's views regarding informed consent.
174. See also Hansard, [HC Deb.] 20 June 1990, col. 962, per Mrs Virginia Bottomley MP (Minister for Health).
175. See above at 284-286.
176. Royal College of Nursing v. Department of Health and Social Security [1981] AC 800.
177. See R. v. Secretary of State for Health, ex parte Bruno Quintavalle (on behalf of Prolife Alliance) (supra. n. 46).
178. Supra n. 155 per Lord Wilberforce at 822.
179. Ibid.
180. G. MacPherson (ed.), Black's Medical Dictionary, 3rd edn (A. and C. Black Ltd. 1999) at 219.
181. J. Walton et al. (eds), The Oxford Medical Companion (Oxford University Press 1994) at 300.
182. Supra n. 46 (CA and HL). See above at 305-306.
183. Ibid., (CA) at para. 48.
184. Ibid., (HL) at para. 16.
185. Ibid., Lords Scott, Steyn and Hoffman agreed with the reasoning of Lord Bingham.
186. See below at 317-319 for suggestions.
187. Supra n. 46 (HL).
188. For examples of preliminary work relating to the creation 'artificial gametes' see A.J. Newson and A.C. Smajdor, 'Artificial Gametes: New Paths to Parenthood?' (2005) 31 J.M.E. 184-186
189. Z. Master, 'Embryonic Stem-Cell Gametes: The New Frontier in Human Reproduction' (2006) 21 Human Reproduction 857-863, etc.
190. Supra n. 18 at 8, para. 2.13.
191. Supra n. 46 (QBD) at [18].
192. For suggested amendment of the current legislative provisions, see below at 317-319.
193. Human Tissue and Embryos (Draft) Bill 2007 (May 2007). Cm 7087.
194. Cl. 15 '"nucleus" in relation to an embryo, includes pronucleus and, accordingly, "nuclear DNA", in relation to an embryo, includes DNA in the pronucleus of the embryo'.
195. Supra n. 13.
196. The Report of the Public Inquiry into Children's Heart Surgery at the Bristol Royal Infirmary 1984-1995: Learning from Bristol (Cm. 5207 (I) 2001) Annex C.
197. The Royal Liverpool Children's Inquiry, Report (2001).
198. The Investigation of Events that Followed the Death of Mr. Cyril Mark Isaacs (Department of Health 2003).
199. C. 54.
200. C. 31.
201. C. 14. It also repeals the Corneal Tissue Act 1986, c. 18.
202. For an overview of the Human Tissue Act 2004, readers should refer to S.D. Pattinson, Medical Law and Ethics (Sweet and Maxwell 2006) at 418-455
203. and K. Liddell and A. Hall, 'Beyond Bristol and Alder Hey: The Future Regulation of Human Tissue' (2005) 13(2) Med. L.R. 170-223 at 180-209.
204. S.1 refers to Schedule 1, Part 1 of the Act, which lists activities that are lawful with consent.
205. S.1(1) (d)-(g).
206. S.13-15.
207. Supra n. 46 (HL).
208. See e.g. s. 45.
209. S.1(8).
210. S.1(7).
211. S.1(9)(a).
212. S.1(9)(b).
213. J. Herring, Medical Law and Ethics (Oxford University Press 2006) at 351.
214. The Human Tissue Act 2004 (Ethical Approval, Exceptions from Licensing and Supply of Information about Transplants) Regulations 2006 (S.I. 2006 No. 1260).
215. Article 3(2)(b). 'Research ethics authority' is defined as either a research ethics committee established under Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004 No. 1031), Article 1(2)(a), or any committee or person appointed 'to advise on, or on matters which include, the ethics of research investigations on relevant material which has come from a human body' insofar as recognition has been obtained from the Secretary of State, National Assembly for Wales, or Department of Health (Article 1(2)(b)). This would include NHS RECs.
216. See above at 306-307.
217. Human Tissue Authority, Code of Practice - Consent (2006 (Code 1).
218. Ibid., at 8, para. 29.
219. Ibid., at 8, para. 28.
220. A non-dissimilar concern was raised by the Nuffield Council on Bioethics on the ethical propriety of ES cell research and therapy (Nuffield Council on Bioethics, Stem Cell Therapy: The Ethical Issues (2000) at 9-10, para. 25.
221. S.3(3)-(7).
222. S.2.
223. Supra n. 180 at 189
224. Ibid. at 190-1.
225. Hansard [HC Com.] 27 January 2004, col. 15 per the Minister for Health, Ms Rosie Winterton MP: 'Consent... for further medical research, would involve specific consent, perhaps by a tick box'.
226. Hansard [HL 2R] 22 July 2004, col. 369-70 per the Parliamentary Under-Secretary of State for Health, Lord Warner: 'Let me state clearly that the Bill does not require consent to be specific to each research project for which tissue might be used. Consent can be broad. Consent to research can be enduring and generic'.
227. Supra n. 194.
228. Ibid., at 25, paras. 114-115.
229. Ibid., at 18, para. 77.
230. Ibid.
231. Ibid.
232. See above at 304-306.
233. Supra n. 194 at 18, para. 79.
234. Ibid., at 18, para. 80.
235. A further amendment to the 1990 Act would have to be made with regard to storage. Schedule 3, para. 8(2) would have to be amended as follows: (2) An embryo the creation of which was brought about in vitro must not be kept in storage unless there is an effective consent, by each person whose gametes were used to bring about the creation of the embryo [or by both the donor of the human cell, human cell nucleus or other human DNA and the donor of the egg used to bring about the creation of the embryo], to the storage of the embryo and the embryo is stored in accordance with those consents.
236. Cl. 14(5).
237. Supra n. 18.