Ambiguity of the embryo protection in the human rights and biomedicine convention: Experiences from the Nordic countries

European Journal of Health Law

Volumn 14, Issue 2, 2007, Pages 131-148

  Walin, Laura ^a  

^a UNIVERSITY OF HELSINKI   (Finland)

Author keywords

European Convention on Human Rights and Biomedicine; Protection of embryos; Research on human embryos; The Nordic countries

Indexed keywords

ARTICLE; BIOMEDICINE; EMBRYO RESEARCH; EUROPE; HUMAN RIGHTS; LAW; MEDICAL RESEARCH; PROTECTION;

BIOETHICS; EMBRYO RESEARCH; EUROPE; FINLAND; HUMAN RIGHTS; HUMANS; REPRODUCTIVE TECHNIQUES, ASSISTED; SCANDINAVIA;

EID: 34548783770     PISSN: 09290273     EISSN: 15718093     Source Type: Journal    
DOI: 10.1163/092902707X199104     Document Type: Article

References (58)

1. This work has been financially supported by the grant No. 1213432 of the Academy of Finland to Professor Raimo Lahti. Raimo Lahti, Salla Lötjönen and the editors are warmly thanked for their instructive comments which greatly improved the manuscript.
2. The technique involves replacing the nucleus of an enucleated egg cell with a nucleus from a somatic cell of a patient. Apart from the mitochondrial genes the resulting entity is genetically identical to the source of the somatic cell and hence cell or tissue replacement therapy with such a cell culture would not result in an immunorejection reaction. See Lanza et al. infra note 37.
3. This is probably the rationale behind adding "research on identifiable human material or identifiable data" to the scope of the medical research on human beings in the Declaration of Helsinki in Edinburgh in year 2000. See Carlson, R.V., Boyd, K.M.,Webb, D.J., "The revision of the Declaration of Helsinki: past, present and future" British Journal of Clinical Pharmacology, 57, No. 6 (2004), 695-713. The authors point out that this particular amendment has caused surprisingly little academic conversation.
4. Convention for the protection of human rights and dignity of the human being with regard to the application of biology and medicine. CETS No.:164 Oviedo, 4 April 1997.
5. See Assisted Reproduction in the Nordic Countries (TemaNord 505:2006), p. 15 for an overview.
6. Lag om åtgärder i forsknings- eller behandlingssyfte med befruktade ägg från människa 1991:115. (Act concerning measures for purposes of research or treatment involving fertilised human ova). The Act was amended in 2005 (Governmental Bill 2003/4:148) to allow SCNT, and simultaneously the word 'fertilised' (befruktade) was dropped from the title.
7. Lov 2003-12-05 nr 100: Lov om humanmedicinsk bruk av bioteknologi m.m. (bioteknologiloven) som endret ved lov nr. 45 av 25. juni 2004. (Act on the medical use of biotechnology). The first act on the same issue dates from 1994.
8. Laki lääketieteellisestä tutkimuksesta 9.4.1999/488.
9. Lag om genetisk integritet m.m. 351:2006.
10. There may be a change, as in January 2007 a Government Bill (Ot. prp. No 26 (2006-2007) was given in order to allow research on so-called surplus embryos (from in vitro fertilisation treatments) and preimplantation genetic diagnosis (PGD).
11. In a globalised world the position of a total ban may be difficult to maintain. See S. Pattinson, D. Beyleveld "Globalisation and human dignity: Some effects and implications for the creation and use of embryos", in: R. Brownsword (ed.), Global Governance and the Quest for Justice. Vol IV: Human Rights (Oxford, Hart, 2005), pp. 185-202.
12. See Walin, L., "The regulation of genetic research and the commercialization of its results in Finland" Medical Law International 7, No. 4 (2006), 318-319.
13. Although the Finnish legislation seems to allow at least research on germ line gene therapy of certain serious defects. See Walin 2006 supra note 12, pp. 316-317.
14. Government Bill 229/1998, detailed grounds for s. 26.
15. Note that whereas this ban is formulated as an exact injunction in Finland, in Sweden this must be deduced from the ban to implant research embryos into a uterus.
16. T. Te Braake "Research on human embryos", in: J.K.M. Gevers, E.H. Hondius, J.H. Hubben (eds.), Health Law, Human Rights and the Biomedicine Convention. Essays in Honour of Henriette Roscam Abbing (Leiden, Martinus Nijhoff Publishers, 2005), p. 191.
17. J. Dute "The leading principles of the Convention on Human Rights and Biomedicine", in: J.K.M. Gevers, E.H. Hondius, J.H. Hubben (eds.), Health Law, Human Rights and the Biomedicine Convention. Essays in Honour of Henriette Roscam Abbing (Leiden, Martinus Nijhoff Publishers, 2005), pp. 7-9.
18. Admittedly, of the three countries only Norway has ratified the Biomedicine Convention. In two fairly recent cases against the United Kingdom, however, the European Court of Human Rights has referred to the Convention as a relevant international text even though the UK has not even signed the Convention. Hence, the Biomedicine Convention is gaining legal importance beyond its being a convention. See Evans v. United Kingdom, 7 March 2006, application number 6339/05, s. 40, and Glass v. United Kingdom, 9 March 2004, application number 61827/00, s. 58.
19. Vienna Convention on the Law of Treaties. Vienna May 23, 1969. UN Treaty Series vol. 1155, p. 331.
20. Ko, M.S.H., "Molecular biology of preimplantation embryos: primer for philosophical discussions" Reproductive BioMedicine Online 10, Supp. 1 (2005) 80-87.
21. Explanatory report on the Convention for the protection of human rights and dignity of the human being with regard to the application of biology and medicine: Convention on human rights and biomedicine. ETS 164. http://conventions.coe.int./Treaty/en/Reports/Html/164.htm.
22. See also Roscam Abbing, H.D.C., "The Convention of Human Rights and Biomedicine. An appraisal of the Council of Europe Convention", European Journal of Health Law 5, No. 4 (1998), 378.
23. Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, on the Prohibition of Cloning Human Beings CETS No.:168, Paris, 12 January 1998.
24. See Hansen, B., "Embryonic stem cell research: terminological ambiguity may lead to legal obscurity." Medicine and Law 23, No.1 (2004), 24-25 for a critique on the wording on Additional Protocol on Cloning.
25. Bernard Mathieu has interpreted the Biomedicine Convention and Additional Protocol on Cloning so that the ban to create embryos also unequivocally covers the results of therapeutic cloning and this cannot be narrowed by interpretation of the Additional Protocol. B. Mathieu, The right to life in European constitutional and international case-law (Belgium, Council of Europe Publishing, 2006), pp. 113-114.
26. Declaration contained in a Note Verbale from the Permanent Representation of the Netherlands, dated 29April1998, handed to the Secretary General at the time of signature, on 4 May 1998: 'In relation to Article 1 of the Protocol, the Government of the Kingdom of the Netherlands declares that it interprets the term "human being" as referring exclusively to a human individual, i.e. a human being who has been born.'
27. Art. 29 of the Human Rights and Biomedicine Convention.
28. Vo v. France, 8 July 2004. Application number 53924/00.
29. One must bear in mind when drawing analogy based conclusions, however, that the case of Mrs. Vo concerned a six-month-old fetus within a woman's body whereas the scope of this article is the six-day-old embryo on a petri dish in a laboratory.
30. Vo v. France, s. 84. Italics here. However, it has been argued that mere species membership is not a guarantee of a moral status. Brock, D.W., "Is consensus possible on stem cell research? Moral and political obstacles" Journal of Medical Ethics 32, No. 1 ( January 2006), 38.
31. Vo v. France, s. 85.
32. Governmental Bill (Ot. Prop.) 108 (2001-2002), p. 23.
33. See e.g. Gogarty, B., "What exactly is an exact copy? And why it matters when trying to ban human reproductive cloning in Australia", Journal of Medical Ethics 29, No. 2 (April 2003), 84-89.
34. First the High Court ruled that entities resulting from SCNT were not covered by the definition of embryo, but later this decision was reversed by the Court of Appeal. See R (on the application of B. Quintavalle on behalf of Pro-Life Alliance) v. Secretary of State for Health, 15th November, QBD, High Court, Crane J (case no: CO/4095/2000) [2001] 4 All ER 1013 and R (on the application of B. Quintavalle on behalf of Pro-Life Alliance) v. Secretary of State for Health [2002] EWCA Civ 29, respectively.
35. In their statement dating from 2001, the Finnish embryo and stem cell researchers have interpreted the Medical Research Act as allowing for therapeutic cloning and expressed their wish that the permissive legislative atmosphere would continue to exist in the country.
36. At some point of preparation it was proposed that the Convention would stipulate similar specific bans as the Finnish law, such as limiting the research to embryos under 14 days of age and banning totally e.g. creation of hybrids. These were in the end, however, left for the anticipated additional protocol. Te Braake in supra note 16, p. 200.
37. See also Roscam Abbing in supra note 22, pp. 383-384, being critical on the Convention in impeding the scientific advances in the field of health care.
38. The culturing of human embryonic stem cells was published firstly in November 1998 (see Th omson, J.A., Itskovits, Eldor, J., Shapiro, S.S., Waknitz, M.A., Swiergiel, J.J., Marshall, V.S., Jones, J.M., "Embryonic stem cell lines derived from human blastocysts" Science 282, No. 5391 (November 1998), 1145-1147),
39. and therapeutic cloning was not brought up in the scientific community until September 1999 (see Lanza, R.P., Cibelli, J.P., West, M.D., "Human therapeutic cloning" Nature Medicine 5, No. 9 (September 1999), 975-977.
40. The other half of the therapeutic cloning technique, namely the SCNT procedure, was published slightly earlier in March 1996 (see Campbell, K.H.S., McWhir, J., Ritchie, W.A., Wilmut, I., "Sheep cloned by nuclear transfer from a cultured cell line" Nature 380, No. 6569 (March 1996) 64-66.
41. See Gunning, J., "Article 18 of the European Biomedicine Convention: What impact on assisted reproduction?", European Journal of Health Law 6, No. 2 (June 1999), 168 on the impact of the Convention to the development of assisted reproduction techniques.
42. See Te Braake, T.A.M., "The Dutch 2002 Embryos Act and the Convention on Human Rights and Biomedicine: Some issues", European Journal of Health Law 11, No. 2 (June 2004), 146, where the scope of embryo protection is understood to be somewhat wider and defined as 'protection of embryos in general and may consist of guarantees that no embryo will be used in research for trivial reasons'.
43. Th is lack of defining 'the adequate protection' has also been noted by Halliday, S., "A comparative approach to the regulation of human embryonic stem cell research in Europe", Medical Law Review 12, No. 1 (Spring 2004), 45. Some guidelines are drawn in the Resolution 1352 (2003) of the Parliamentary Assembly of the Council of Europe, where it is stated that '[if a given country allows research that requires embryo destruction it has to ensure that the research] is duly authorized and monitored by the appropriate national bodies'.
44. Decree 986/1999, s. 4.2.
45. Medical Research Act, s. 17.
46. Also the definition of 'research on human beings' seems to be somewhat wider than in Finland, where e.g. research based on interviews and questionnaires falls outside the definition. See Governmental Bill 229/1999, at detailed grounds for s. 1. I warmly thank Ewa Axelsson for confirming this specific issue for me as it is always more difficult to find something missing than existing in a foreign legislation.
47. Act on Ethical Approval on Research on Human Beings, s. 7-11.
48. It has been argued that flexible administrative measures rather than absolute bans are the most effective way to regulate such ethically and socially complex issues as embryonic stem cell research. Caulfield, T., Knowles, L., Meslin, E.M., "Law and policy in the era of reproductive genetics", Journal of Medical Ethics 30, No. 4, (August 2004), 414-417.
49. Also the means of the European Union are limited, as the subsidiarity principle places the embryonic research regulation as a matter of individual Member States. The Union can mainly have an influence via research funding mechanisms. See Halliday in supra note 40, 65-68.
50. The same regulatory variation in culturally similar countries has been observed by Caulfield, T., "The regulation of embryonic stem cell research: A few observations on the international scene", Health Law Journal (Special Edition 2003), p. 93.
51. See articles by Häyrinen-Alestalo, M., Snell, K. and Achen, T. in: Häyrinen-Alestalo, M., Kallerud, E. (eds.), Mediating Public Concern in Biotechnology (Oslo, Rapport 2/2004, NIFU) especially pp. 49-57 and 125-127.
52. In supra note 5, 31-39.
53. Although a general move towards permissive harmonisation has been anticipated in Solter, D. Beyleveld, D., Friele, M. B., Ho?ówka, J., Lilie, H., Lovell-Badge, R., Mandla, C., Martin, U., Pardo Avellaneda, R., Embryo Research in Pluralistic Europe (Heidelberg, Springer-Verlag, 2003), pp. 153-154.
54. The protection of the human embryo in vitro. Report by the Working Party on the Protection of the Human Embryo and Fetus (CDBI-CO-GT3 (2003) 13), 4-8, 37. See also te Braake supra note 39 p. 149.
55. Manuel, C., Hairion, D., Auquier, P., Reviron, D., Gioganti, D., Terriou, P., Pellisier, V., San Marco, J.L., "Is the legislation of European states in keeping with the recent Convention on Human Rights and Biomedicine?", European Journal of Health Law 6, No. 1 (March 1999), 55-69.
56. Callus, T., "Omnis definitio periculosa est: On the definition of the term "embryo" in the Human Fertilisation & Embryology Act 1990", Medical Law International 6, No. 1 (2003), 7-8.
57. Hansen, J.-E. S., "Embryonic stem cell production through therapeutic cloning has fewer ethical problems than stem cell harvest from surplus IVF embryos", Journal of Medical Ethics 28, No. 2 (April 2002), 86-88.
58. Of the leading principles of the Biomedicine Convention, the access to health care needs to be balanced with the protection of embryos. Te Braake, Trees, in supra note 16, p. 202. Also the Jewish culture puts a very high value on curing born humans and hence the use of SCNT to cure ill people would be totally acceptable. Ravin, M., "Human reproductive cloning, embryo stem cells and germline gene intervention: An Israeli perspective", Medicine and Law 22, No. 4 (2003), 722-723, 726-727.