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Published online by Cambridge University Press: 02 January 2018
Much of the legal attention surrounding human embryonic stem (ES) cell research within the UK has, to date, focused on cloning techniques. Whilst this is both understandable and appropriate given litigation on this topic, there has been less focus on other areas. This paper identifies and analyses areas of incoherence and deficiency within the regulatory architecture governing human ES cell derivation and research within the UK. This is not merely a theoretical exercise, as there are indications that many of the policy objectives currently being pursued in this area have, at best, a shaky jurisdictional basis. It is all too easy to recall that lobby groups have challenged the Human Fertilisation and Embryology Act 1990, the legislative foundation for embryo research and most infertility treatment, on the basis of jurisdictional uncertainty and statutory interpretation. Whilst many pro-life campaigners are opposed to ES cell research on ethical grounds, the arguments utilised thus far in relation to litigation have been entirely legal, involving issues of statutory interpretation and whether the regulator, the Human Fertilisation and Embryology Authority (HFEA), or the Department of Health have acted ultra vires the 1990 Act. This paper will reveal that there are a number of further areas which might be open to attack on this basis.
1. Thomson, J.A. et al Embryonic stem cell lines derived from human blastocysts’ (1998) 282(5391) Nature 1145.Google ScholarPubMed
2. See, eg, Brownsword, R. Regulating human genetics: new dilemmas for a new millennium’ (2004) 12(1) Medical Law Review 14 CrossRefGoogle Scholar; ; ; ; ;
3. Department of Health Reconfiguring the Department of Health’s Arm’s Length Bodies (2004) pp 12–13, available at http://www.dh.gov.uk/PublicationsAndStatistics/Publications/PublicationsPolicyAndGuidance/PublicationsPolicyAndGuidanceArticle/fs/en?CONTENT_ID=4086081&chk=y4UIfP. Within this policy document, it was proposed that the new consolidated body should be entitled the Regulatory Authority for Fertility and Embryology (RAFT). However, now RATE has been adopted as the favoured nomenclature (see White Paper, below n 5, p 26, para 3.2).
4. See ‘Speech by Melanie Johnson MP, 21st January 2004: Donor anonymity and review’ Department of Health Speeches (21 January 2004), available at http://www.dh.gov.uk/en/News/Speeches/Speecheslist/DH_4071490 and Department of Health Review of the Human Fertilisation and Embryology Act: A Public Consultation (2005), available at http://www.dh.gov.uk/Consultations/ClosedConsultations/ClosedConsultationsArticle/fs/en?CONTENT_ID=4123863&chk=zy5dcI.
5. Department of Health Review of the Human Fertilisation and Embryology Act Cm 6989, 2006, available at http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_073098.
6. Ibid, p v (foreword of Caroline Flint MP, Minister of State for Public Health).
7. Ibid, p 1, para 1.2.
8. Thomson et al , above n 1.
9. The interested reader should refer to the 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 (2000), available at http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4065084; President’s Council on Bioethics Monitoring Stem Cell Research (2004), available at http://www.bioethics.gov/reports/stemcell; and National Institutes of Health Stem Cells: Scientific Progress and Future Research Directions (Department of Health and Human Services, 2001), available at http://stemcells.nih.gov/info/scireport/2001report.htm.
10. Much work has already been carried out using embryonal carcinoma (EC) cells taken from tumours (see, eg, Andrews, P.W. et al ‘Pluripotent embryonal carcinoma clones derived from the human teratocarcinomas cell line Tera-2. Differentiation in vivo and in vitro ’ (1984) 50(2) Laboratory Investigation 147).Google ScholarPubMed
11. Tzukerman, M. et al An experimental platform for studying growth and invasiveness of tumor cells within teratomas derived from human embryonic stem cells’ (2003) 100(23) Proceedings of the National Academy of Sciences of the United States of America 13507.CrossRefGoogle ScholarPubMed
12. Trans-species infection of pryonic, bacteriological or viral material via implantation of animal tissue into humans. However, the Centre for Genome Research at the University of Edinburgh has made some headway in the development of feeder layers to circumvent this problem. A molecule developed by the centre, named ‘Nanog’ from the Gaelic ‘Land of the Young’ (Tír na nÓg), might spell the end of using animal serums for the maintenance and propagation of ES cell lines if replicated in human ES cell lines ( Chambers, I. et al ‘Functional expression cloning of Nanog, a pluripotency sustaining factor in embryonic stem cells’ (2003) 113 Cell 643).CrossRefGoogle ScholarPubMed
13. Human Fertilisation and Embryology Act 1990, s 1(1).
14. UK Stem Cell Bank Steering Committee Code of Practice for the Use of Human Stem Cell Lines Cell Bank version 3 (2006) p 8, para 3.2, available at http://www.ukstemcellbank.co.uk/code.html.
15. See Human Fertilisation and Embryology Authority Twelfth Annual Report and Accounts 2002–2003 (2003) p 21, available at http://www.hfea.gov.uk/cps/rde/xchg/SID-3F57D79B-0E98DD41/hfea/hs.xsl/394.html; and Human Fertilisation and Embryology Authority Regulation of Research on Human Embryos (2004) paras 11, 16 and 18.
16. UK Stem Cell Bank, above n 14, pp 7–8, para 3.2.
17. Ibid, p 14, para 8.3.
18. Ibid.
19. Currently Ms Shirley Harrison. Previously, an additional member of the HFEA was also a full member of the Steering Committee (Professor Tom Baldwin, Department of Philosophy, University of York). Whilst Professor Baldwin remains on the Steering Committee, he is no longer a member of the HFEA. In addition, Professor Sir Martin Evans (Professor of Mammalian Genetics, Cardiff University) is a member of both the UK Stem Cell Bank Steering Committee and the HFEA’s Horizon Scanning Expert Panel.
20. Human Fertilisation and Embryology Authority Code of Practice (6th edn, 2003) p 82, para 8.10, available at http://www.hfea.gov.uk/cps/rde/xchg/SID-3F57D79B-A3EFDADE/hfea/hs.xsl/371.html.
21. Human Fertilisation and Embryology Act 1990, s 17(1)(c).
22. HFEA Code of Practice, above n 20, p 82.
23. [2002] EWHC 2785 (Admin), [2003] 2 All ER 105; [2003] EWCA Civ 667, [2004] QB 168; [2005] UKHL 28, [2005] 2 AC 561 (also called ‘the CORE litigation’ in this paper).
24. [2002] EWHC 2785 (Admin), [2003] 2 All ER 105.
25. [2003] EWCA Civ 667, [2004] QB 168.
26. [2005] UKHL 28, [2005] 2 AC 561.
27. Above n 24, para [12].
28. A fact upon which Mance LJ commented in the Court of Appeal: ‘The language of the HFEA’s press notice and licence are open to the forensic comment that at points they equate embryonic cells with an embryo from which they have been removed, and treat PGD (here both screening and tissue typing) as activities themselves requiring to be licensed. But these documents cannot construe for us the true scope of the legislative provisions’ (above n 25, para [111]).
29. Above n 24, para [12].
30. Ibid.
31. Above n 25, paras [43] and [44] (Lord Phillips of Worth Matravers MR); para [87] (Schiemann LJ); and paras [126]–[127] and para [145] (Mance LJ).
32. Above n 24, para [11].
33. Above n 25, para [20].
34. ‘A licence may authorise any of the following in the court of providing treatment services …(d) practices designed to secure that embryos are in a suitable condition to be placed in a woman or to determine whether embryos are suitable for that purpose.’
35. Human Fertilisation and Embryology Act 1990, s 12(a). This point was made in the Court of Appeal by Mance LJ in the context of shipping a biopsied cell to a third party laboratory for analysis (above n 25, para [110]).
36. Ibid, para [20].
37. Ibid, para [87].
38. Ibid, paras [20]–[21].
39. Ibid, para [111].
40. Agreed, derivation of an ES cell involves the destruction of the embryo, and as such does not fall within the definition of biopsy as envisaged by Mance LJ. However, it is difficult to see how this is relevant from the regulatory perspective of the legal status of an ES cell.
41. Brownsword (2004), above n 2.
42. Ibid.
43. R (Quintavalle) v Secretary of State for Health [2001] EWHC Admin 918, [2001] 4 All ER 1013; [2002] EWCA Civ 29, [2002] QB 628; [2003] UKHL 13, [2003] 2 AC 687 (also called ‘the Pro-life Alliance litigation’ in this paper).
44. Report of the Committee of Inquiry into Human Fertilisation and Embryology Cmnd 9314, 1984.
45. House of Lords’ Select Committee on Stem Cells Report on Stem Cell Research HL 83(i) (2002), para 8.29, available at http://www.publications.parliament.uk/pa/ld/ldstem.htm.
46. Chief Medical Officer’s Expert Group Report, above n 9, p 48, para 5.10, Recommendation 9.
47. Ibid.
48. UK Stem Cell Bank, above n 14, p 10 (original emphasis).
49. Ibid, p 12, para 8.1.1 (original emphasis).
50. Above n 9, p 42, para 4.34.
51. Above n 45, para 8.25.
52. Human Fertilisation and Embryology Act 1990, Sch 2, para 3(2).
53. Important though this is for some people.
54. Human Fertilisation and Embryology Act 1990, Sch 2, para 3(2)(a).
55. Ibid, Sch 2, para 3(2)(b), although this may well come within the definition of ‘serious disease’ anyway.
56. Ibid, Sch 2, para 3(2)(c).
57. Ibid, Sch 2, para 3(2)(d).
58. Ibid, Sch 2, para 3(2)(e).
59. Human Fertilisation and Embryology (Research Purposes) Regulations 2001, SI 2001/188, reg 2(2)(a).
60. Above n 14, p 14, para 8.3. See also Annex 5 to the code for application pro forma for importing human ES cell lines into the UK.
61. For example, the EU via FP6/FP7 funding.
62. And their sponsoring organisations.
63. The reader should note that a further regulatory mechanism, Research Ethics Committee (REC) approval, is put in place by the HFEA’s own rules represented in the Code of Practice (above n 20. p 93, paras 10.6–10.9).
64. Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells [2004] OJ L102/48, Art 9.
65. UK Stem Cell Bank, above n 14, pp 9, 13 and 17.
66. Department of Health A Code of Practice for Tissue Banks Providing Tissues of Human Origin for Therapeutic Purposes (2001), available at http://www.dh.gov.uk/PublicationsAndStatistics/Publications/PublicationsPolicyAndGuidance/PublicationsPolicyAndGuidanceArticle/fs/en?CONTENT_ID=4006116&chk=8VQR%2B5.
67. Above n 64.
68. Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use [2001] OJ L121/34. The Directive has been implemented via the Medicines for Human Use (Clinical Trials) Regulations 2004, SI 2004/1031.
69. This is a relatively new body, which coordinates the activities of both the Medicines Control Agency (MCA) and Medical Devices Agency (MDA).
70. UK Stem Cell Bank, above n 14, p 13.
71. Ibid, p 12 and Annex 2.
72. Above n 9, p 34, para 3.14. This formed the basis for Recommendation 8: ‘The need for legislation to permit the use of embryo-derived cells in treatments developed from this new research should be kept under review’ (p 48, para 5.10).
73. 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, p 6, para 10, available at http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4123598.
74. Hansard HC Deb, vol 356, col 1180, 17 November 2000 per Yvette Cooper MP, Parliamentary Under-Secretary of State for Health.
75. Hansard HL Deb, vol 621, col 19, 22 January 2001 per Lord Hunt of King’s Heath (Parliamentary Under-Secretary of State for Health). Consider also the implication in the following sentence, ‘Without these regulations we shall not be able to use embryos in research leading to cures for serious diseases like Parkinson’s disease and Alzheimer’s disease’ (col 121 per Lord Hunt of King’s Heath (emphasis added)). Once again, the focus is upon legitimising research, maybe even applied research, but not outright therapy.
76. Above n 45, para 8.23.
77. Ibid.
78. Similarly, the government response to this recommendation was that it would consider whether any further oversight of ES cell clinical trials/applications was necessary. Again, this presupposes that their use for such purposes is permissible (Department of Health Government Response to the House of Lords’ Select Committee Report on Stem Cell Research Cm 5561, 2002, pp 16–17, para 8.23, available at http://www.dh.gov.uk/PublicationsAndStatistics/Publications/PublicationsPolicyAndGuidance/PublicationsPolicyAndGuidanceArticle/fs/en?CONTENT_ID=4083481&chk=D89A6d).
79. Above n 68.
80. Human Fertilisation and Embryology Act 1990, s 11(1)(a).
81. Ibid, s 11(1)(b).
82. Ibid, s 11(1)(c).
83. Ibid, Sch 2, para 2(3).
84. See below.
85. Article 8.
86. Article 16.
87. Article 28. The interested reader should also refer to the Commission Directives on the topic, which provide far greater detail concerning quality assurance and procedures (Commission Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC of the European Parliament and the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells [2006] OJ L38/40; and Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells [2006] OJ L294/32).
88. Article 2(1) and recital 11.
89. Above n 25.
90. Ibid, paras [38] and [40].
91. Ibid, para [120].
92. Above n 26, para [13].
93. Above n 74.
94. Human Fertilisation and Embryology Act 1990, s 2(1) and Sch 2, para 1(1).
95. Ibid, s 11(1).
96. Above n 5, pp 23–24, para 2.79 (original emphasis).
97. Ibid, p 24, para 2.80.
98. Above n 2.
99. The Committee concluded that the HFEA went beyond the scope of its own consultation document when allowing tissue typing alongside PGD. Particularly scathing was the following comment on the evidence of a former Chair of the HFEA, Dame Ruth Deech: ‘We take issue with Dame Ruth’s assertion that the fact that the HFEA took the decision on PGD “protects Members of Parliament from direct involvement in that sort of thing.” Parliament does not need protecting and democracy is not served by unelected quangos taking decisions on behalf of Parliament’ (House of Commons’ Science and Technology Select Committee Developments in Human Genetic and Embryology: Fourth Report of Session 2001–2002 HC 791, 2002, p 13, para 26, available at http://www.publications.parliament.uk/pa/cm200102/cmselect/cmsctech/cmsctech.htm#reports).
100. Above n 64.
101. Article 6 and recitals 20–21 and 25–28.
102. Recital 7.
103. For example, see Middle, C. et al Ethics approval of a national postal survey: recent experience’ (1996) 311 British Medical Journal 659 CrossRefGoogle ScholarPubMed; ; ; . The interested reader should also note that the operation of research ethics committees in the NHS has recently undergone a review chaired by Lord Warner which may lead to greater efficiencies in the area (Report of the Ad Hoc Advisory Group on the Operation of NHS Research Ethics Committees (Department of Health, 2005), available at http://www.dh.gov.uk/PolicyAndGuidance/ResearchAndDevelopment/ResearchAndDevelopmentAZ/ResearchGovernance/fs/en#6222539).
104. UK Stem Cell Bank, above n 14, p 13, para 8.1.3.
105. For excellent analysis of the rise of pro-life groups as legal actors within the UK, see Beyleveld, D and Brownsword, R. Human Dignity in Bioethics and Biolaw (Oxford: Oxford University Press, 2001)Google Scholar (particularly chapters 1 and 2); and R Brownsword ‘Bioethics today, bioethics tomorrow: stem cell research and the “Dignitarian Alliance” ’ (2003) 17 Notre Dame Journal of Law, Ethics and Public Policy 15.
106. Above n 5.
107. Department of Health Government Response to the UK Stem Cell Initiative Report and Recommendations (2005), available at http://www.dh.gov.uk/PolicyAndGuidance/HealthAndSocialCareTopics/StemCell/StemCellGeneralInformation/StemCellGeneralArticle/fs/en?CONTENT_ID=4124082&chk=5mbZjS.
108. Ibid.
