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Published online by Cambridge University Press: 02 January 2018
The Human Fertilisation and Embryology Act 1990 (HFE Act) has been described as a ‘milestone in biomedical regulation’. Yet as a milestone, it marks out the frontier of medical science as it stood at 1990. It was always accepted that the Act would not be the ‘last word on the subject’ of embryology. Five years on and, inevitably, the frontiers of the reproductive revolution have been pushed forward by scientific and clinical developments, and, again inevitably, those developments have thrown up new social, ethical and legal problems. Thanks to the passing of the 1990 Act, the new techniques do not exist in a vacuum: one of the achievements of the HFE Act is that it provides the institutional and legal framework in which new problems can be debated and resolved as they arise. The key element in that framework is the statutory licensing authority created by the 1990 Act-the Human Fertilisation and Embryology Authority (HFEA).
1. Montgomery ‘Rights, Restraints and Pragmatism: The Human Fertilisation and Embryology Act 1990’ (1991) 54 MLR 524.
2. Morgan and Lee Guide to the Human Fertilisation and Embryology Act 1990 (London: Blackstone, 1991) p 32.
3. HFE Act 1990, s 5.
4. HFEA Donated Ovarian Tissue in Embryo Research and Assisted Conception: Public Consultation Document (London, 7 January 1994).
5. Freeman ‘Responding to the Reproduction Revolution’ in McLean (ed) Law Reform and Human Reproduction (Aldershot: Dartmouth, 1992) p 36.
6. Beauchamp & Childress Principles of Biomedical Ethics (Oxford: OUP, 1994) p 260.
7. Report of the Committee of Inquiry into Human Fertilisation and Embryology (HMSO 1984) Cmnd. 9314.
8. Eg Professor Winston in Observer Life magazine, July 1995. More generally see F Price ‘Beyond Expectation: Clinical Practices and Clinical Concerns’ in Edwards et al (eds) Technologies of Procreation (Manchester: Manchester UP, 1993) pp 20–41.
9. (1995) Times 3 July.
10. Op cit, n 7, above.
11. Warnock Report, para 1.6.
12. Ibid para 2.4.
13. Ibid para 2.12.
14. Ibid para 11.15.
15. Ibid para 11.18.
16. Ibid paras 6.6 and 11.24.
17. HFE Act 1990, s 13(5).
18. Note that the concept of ‘benefit’ is notoriously controversial and that utilitarians themselves differ over its formulation. For a comprehensive review of the different varieties of utilitarianism see J Griffin ‘Bentham and Modern Utilitarianism’Revue Internationale de Philosophie (1982) 141 pp 332–375.
19. JS Mill Utilitarianism (Collins 1962) ch 11, p 267. A modern version of the utility principle is to be found in J. Harris' injunction that ‘There is value in numbers: Precisely because each person's life is individually valuable, two lives are more valuable than one.’The Value of Life (London: Routledge, 1985) p 21.
20. T Hill Autonomy & Self-respect (Cambridge: CUP, 1991) p 48.
21. Ibid p 31.
22. HFE Act 1990, Sch 3, para 2.5.
23. Sch 3, para 3
24. Sch 3, para 1.
25. Sch 3, para 2(2).
26. HFEA Code of Practice para 3.35.
27. HFEA Donated Ovarian Tissue in Embryo Research and Assisted Conception: Public Consultation Document (7 January 1994).
28. Eg Dr R Gosden at the BMA Conference on Donated Ovarian Tissue (London, July 1994).
29. J Harris The Value of Life (London: Routledge, 1985) p 18. See also M Tooley ‘Abortion and Infanticide’ in P Singer (ed) Applied Ethics (Oxford: OUP, 1986) pp 58–59. First published in Philosophy & Public Affairs 2 No 1 (Fall 1972).
30. Harris stresses that capacity for self-consciousness should not be confused with potenrial: ‘I only have the potential if I lack the capacity’ (p 26).
31. Professor John Harris at the Third International Conference on Philosophical Ethics in Reproductive Medicine (Leeds 18–21 April 1994) and Dr Charles Errin at the BMA Conference on Donated Ovarian Tissue (London, July 1994).
32. See S Maclean's forceful attack on utilitarian reasoning in medical ethics in The Elimination of Morality (London: Routledge, 1993).
33. See R Hursthouse's seminal Beginning Lives (Oxford: Blackwell, 1987).
34. Nuffield Council on Bioethics Human Tissue: Ethical and Legal Issues (London, April 1995).
35. Op cit n 31.
36. Harris The Value of Life (London: Routledge, 1985) p 147.
37. Professor S Golombok BMA Conference on Donated Ovarian Tissue (London, July 1994).
38. See M Strathern ‘A Relational View’ in Edwards et al (eds) Technologies of Procreation (Manchester: Manchester UP, 1993).
39. HFEA Report on Donated Ovarian Tissue in Embryo Research & Assisted Conception (London, July 1994) para 20.
40. HFE Act 1990, s 3 A (as amended by the Criminal Justice and Public Order Act 1994, s 156).
41. Op cit, n 39, footnote 1.
42. HFE Act 1990, Sch 3 paras 2(1), 2(2), 5(1,2), 6(1,3) and para 8.
43. Pepper v Hart [1992] 3 WLR 1032.
44. Opcit n 7 at p 15.
45. 513 HL Official Report (5th series) col 1004.
46. 241 HC Official Report (6th series) col 158.
47. HFE Act 1990, s 3(3)(a) and s 3(4).
48. Review of the Evidence on the Research Use of Fetuses and Fetal Material (The Polkinghorne Report) Cmnd 762 (HMSO 1989).
49. Opcit n 48 para 2.4.
50. Ibid.
51. Ibid.
52. Op cit n 48 paras 3.10 and 6.3.
53. Op cit n 48 para 6.7.
54. Parliamentary Assembly of the Council of Europe, Recommendation 1046 (1086) on the Use of Human Embryos and Foetuses in Scientific Research and Recommendation 1100 (1989) on the Use of Human Embryos and Foetuses for Diagnostic, Therapeutic, Scientific, Industrial and Commercial Purposes, Council of Europe Yearbook of the European Convention on Human Rights (London 1989).
55. National Institutes of Health Revitalization Act 1993 US 103 PL–43.
56. Federal Register/vol 58 No 166, 45495.
57. Paras 5 and 17.
58. Paras 4.1 and 4.2.
59. Paras 4.6, 6.5, 6.6 and 6.14.
60. Paras 4.5 and 4.6.
61. Op cit n 54, Recommendation 1046 (1986)
62. Op cit n 54, Recommendation 1046 (1986) Appendix B vi.
63. Op cit n 56 at 45495.
64. Op cit n 56 at 45496.
65. Para 7.
66. See below.
67. Para 7.
68. European Parliament, Committee. on Legal Affairs and Citizens's Rights Ethical and Legal Problems of Genetic Engineering and Human Artificial Insemination Rapporteurs: Mr W Rothley and Mr C Casini (Luxembourg 1990) Resolution 38.
69. Op cit n 54 Recommendation 1100 (1989).
70. Op cit n 55 103 PL 43.
71. HFEA Third Annual Report (1994) p 33. The HFEA also announced that it had set up a special working group to examine the ethical issues arising from the payment of donors and the implications of prohibiting payments.
72. Para 2.3 and ss 5 and 7.
73. Op cit n 68, resolution 31.
74. Para 8.5.
75. Council of Europe: Draft Convention for the protection of Human Rights and dignity of the Human being with regard to the application of biology and medicine: Bioethics Convention and explanatory report, Strasbourg, July 1994 (Dir/JUR (94) 2).
76. Ibid art 21.
77. J Harris The Value of Life (London: Routledge, 1985) p 119.
78. J Harris ‘The Survival Lottery’ in P Singer (ed) Applied Ethics (Oxford: OUP, 1986) originally published in Philosophy 50 (1975).
79. By A Maclean in The Elimination of Morality (London: Routledge, 1993) ch 6.
80. C Errin BMA Conference on Donated Ovarian Tissue (London, July 1994).
81. R Dworkin Life's Dominion (London: Harper Collins, 1993).
82. Dr Gosden BMA Conference on Donated Ovarian Tissue (London 1994).
83. See I Kennedy and A Grubb Medical Law (London: Butterworths, 1994) p 1148.
84. Para 15.
85. Paras 16 and 19.
86. 643 HC Official Report col 846.
87. HFEA Code of Practice (1993) para 3.35.
88. Paras 16 and 19.
89. Gillick v West Norforlk and West Norfolk and Wisbech AHA [1985] 3 All ER 402.
90. See M Nicholls: ‘Keyholders and Flak Jackets; Consent to Medical Treatment for Children’ in [1994] 24 Fam Law 81–86 and J. Montgomery ‘Consent to Health Care for Children’ [1993] 5 J Ch Law 117–124.
91. Re C (Refusal of Medical Treatment) [1994] 1 FLR 31.
92. Lord Donaldson in Re W [1992] 4 All ER 627.
93. J Harris was the main proponent of such a system at the King's Fund Institute conference on Cadaveric Organ Donation (London, 22 March 1993).
94. E Brody Biomedical Technology & Human Rights (Dartmouth 1993).
95. B New, M Solomon, R Dingwall & J McHale A Question of Give and Take: Improving the Supply of Donor Organs for Transplantation (King's Fund Institute, 1994).
96. (1994) The Guardian, 27 July.
97. Op cit n 95 p 82.
98. For diverging interpretations of who may count as being ‘lawfully in possession of the body’ for the purpose of the Act see Kennedy & Grubb Medical Law (Butterworths 1994); Mason & McCall Smith Law and Medical Ethics (Butterworths 1991) and M Brazier Medicine, Patients and the Law (Penguin 1992).
99. Human Tissue Act 1961, s 1(2).
100. Para 15.
101. As opposed to an indirect objection which would rely on respect for the sensibility of the relatives.
102. By Errin at the BMA Conference on Donated Ovarian Tissue (London, July 1994).
103. HFE Act 1990, s 26. The HFEA's Code of Practice has therefore the status of ‘quasi-legislation’. For a useful discussion of “quasi-legislation” see Baldwin-Houghton ‘Circular Arguments: The Status and Legitimacy of Administrative Rules’ (1986) Public Law pp 239–284.