Therapeutical cloning and the protection of embryonic life: Different approaches, different levels of protection - A view from the United Kingdom 1

Transcription

1 Therapeutical cloning and the protection of embryonic life: Different approaches, different levels of protection - A view from the United Kingdom 1 Professor Søren Holm, BA, MA, MD, PhD, DrMedSci 2 Cardiff Law School; Cardiff Centre for Ethics, Law and Society; and the Centre for the Economic and Social Aspects of Genomics & Section for Medical Ethics, University of Oslo Introduction 3 Commentators in the rest of Europe often have difficulty in understanding why the United Kingdom has a very liberal regulation of embryo research and often misinterpret it as based on the view that embryos are not morally important. In the present paper I will try to explain how the UK reached its present regulatory position, and what it implies about the status of the embryo. In the United Kingdom somatic cell nuclear transfer (SCNT) for research, and potentially in the future therapeutic purposes, is legally permitted if it falls within the purposes specified in Schedule 3 of the Human Fertilisation and Embryology Act 1990 as amended in the HFE (Research Purposes) Regulations of January 2001: The original 1990 purposes are all linked in some way to the reproductive sphere: promoting advances in treatment of infertility; increasing knowledge on causes of congenital disease; increasing knowledge on causes of miscarriage; developing more effective techniques of contraception; developing methods for detecting gene/chromosome abnormalities in embryos prior to implantation; increasing knowledge about development of embryos; Additional 2001 purposes: increasing knowledge about serious disease; enabling any such knowledge to be applied in developing treatment for serious disease. All research on human embryos, and therefore also all research on embryos derived by SCNT requires a specific license from the Human Fertilisation and Embryology 1 The initial version of this paper was prepared for the Judging Values conference in Karlsruhe, Germany, May Professor Søren Holm Cardiff Law School, Museum Avenue, Cardiff CF10 3AX, UK holms@cardiff.ac.uk or Professor Søren Holm Section for Medical Ethics, PO Box 1130 Blindern, N-0318 Oslo, Norway 3 My own views on embryo research and SCNT can be found in the papers numbered 1-3 in the list of references.

2 Authority (HFEA) and the Authority has to be convinced that the research is within the allowed purposes and that it is necessary or desirable 4. The test for necessity is not what we could call absolute necessity, that performing SCNT is the only way of answering the research question, but some kind of relative necessity, that performing SCNT is a so much better method for answering the research question than any other current method that its use can be justified. The HFEA has currently issued two licenses for SCNT. In one case the purpose is to develop stem cell lines from persons with motor neurone disease to be used in basic research, in the other the purpose is to investigate the derivation of immunologically compatible cells for the treatment of diabetes. The HFEA makes it a condition of the licenses that all derived stem cell lines must be deposited in the UK national stem cell bank, where they will be available to other bona fide researchers in the UK and abroad. What can we deduce about the protection of embryonic life from the present UK legislation and regulations? The seemingly most obvious deduction is that there is no significant protection of embryos and embryonic life, since it is possible both to destroy embryos during research and to create embryos (including by SCNT) for research. The problems with this deduction are 1) that it only looks at the current end stage of regulation and not the complicated path by which it was reached and 2) it ignores the terminology of the UK debate where protection of embryonic life is not a dominant theme. So let us look at how the UK got to its current relatively liberal 5 legal regime for embryo experimentation 6. The development of UK embryo experimentation policy In understanding the development of UK embryo experimentation policy we need to keep a number of historical facts and some features of UK society in mind. The following is not an exhaustive list, but it list things that most would agree have been important: Although England 7 has an established church, and 26 bishops have seats in the House of Lords (the UK second chamber of parliament) the UK is a very secular society with a low percentage of people engaging on a regular basis with their religious tradition 4 A legal challenge was mounted by Bruno Quintavalle, a well known pro-life activist and director of the Pro-Life Alliance claiming that embryos derived by SCNT did not fall under the HFE Act s definition of embryo, but this was rejected by the House of Lords. R (on the application of Quintavalle) v Secretary of State for Health [2001] 4 All ER 1013, [2002] 2 All ER 625, [2003] 2 All ER When I characterise the approach as relatively liberal the comparison is not with other legal regimes in Europe or elsewhere, but with the kind of legal regime that would follow from the analysis of contemporary consequentialist and libertarian bioethicists 6 In this paper I will not discuss arguments based on slippery slopes from therapeutic to reproductive cloning. These have been prominent in the debate but do not directly engage issues concerning the status of the embryo. Reproductive cloning is currently banned in the UK by the Human Reproductive Cloning Act England is the only part of the United Kingdom that has an established church. There is no established church in Scotland, Wales or Northern Ireland.

3 The UK has no written constitution and the European Convention on Human Rights was only incorporated directly into UK law in Louise Brown the first test tube baby was the result of UK science and although her birth occasioned considerable ethical and societal disquiet, it also engendered pride in relation to the role of UK scientists Between the birth of Louise Brown in 1978 and the final legal regulation of IVF practices including research 12 years elapsed, this meant both that certain practices had been routinised and thereby difficult to abolish and that the public perception of IVF as a medical treatment option had been stabilised With this background in place let us briefly survey the legislative and regulatory history and the language involved in the debates 9. The history begins before the birth of Louise Brown where embryo research was taking place in an essentially unregulated environment. Steptoe and Edwards conducted many experiments involving human embryos before finally reaching an IVF method that worked in humans. Whether these embryos were created for reproductive or research purposes is a moot point, but whatever our analysis is on this point their creation was in a legal vacuum. Embryos have never been legal persons in English or Scottish law and before Louise Brown there had, very understandably been no interest in regulating the in vitro embryo. With the birth of Louise Brown all of this changed and it was quickly realised that regulation was necessary, but given the contentiousness of the issue and the inavailability of a deduction from a constitution or a more general human rights framework 10 it was argued by many that the issues required societal deliberation and not rash legislation. The government therefore decided to establish an expert committee to consider the issues and propose regulation in The eminent philosopher Mary Warnock was chosen as its chairperson and the committee came to be known as the Warnock committee. At the same time the emerging IVF field established a voluntary regulatory body, the Voluntary Licensing Authority with support from the Medical Research Council and the Royal College of Obstetrics and Gynaecology. In 1984 the expert committee reported and 3 of its recommendations are relevant here, all endorsed by a large majority on the committee: Embryos do not have legal rights, but they do deserve our special respect Research with embryos is acceptable until 14 days after conception (with various restrictions) (3 members opposed this) If necessary for scientific reasons it can be acceptable to create embryos specifically for research (5 members opposed this) 8 The UK signed and ratified the ECHR much earlier, but it was not directly incorporated into UK law and could not be directly pleaded in UK courts. 9 This is not an attempt to provide a full legal history but just an overview. 10 I am not here claiming that it is actually possible to logically deduce policy towards in vitro embryos from any extant constitution or human rights convention. There are, however some who claim that it is possible and my point is simply that even the possibility did not exist when UK policy was formulated.

4 The 14 day limit was mainly supported on the basis of the argument that until the appearance of the primitive streak at about day 14 there is still a possibility of homozygous twinning, so it is only at this point that we can be certain that we are dealing with one individual. Because of the contentiousness of the issues it took 6 years to get legislation through parliament and it was not until 1991 that the HFE Act came into force establishing the HFEA. After the demonstration in 1998 of the possibilities to derive human embryonic stem cell lines and of reproductive (and by implication therapeutic ) cloning in mammals it became clear that the derivation of stem cell lines was not an allowable purpose under the HFE Act. The government therefore asked the Chief Medical Officer (the main government advisor on matters of health and public health) to convene an expert group to consider the new ethical issues. The report from this group was published in The group conceptualised its task in the following way in the chapter on the ethical issues: The purpose of this Chapter 11 is not to revisit that earlier debate. It focuses only on whether research involving the extraction of stem cells from embryos, or the creation of embryos for such research using cell nuclear replacement, raises any new ethical issues, as the terms of reference of the Expert Group required 12. In particular it considers whether these new possibilities for research cross a new moral boundary, representing an unjustified extension of the uses of embryos already authorised by the 1990 Act 13. (4, p. 37, my emphasis) And in regard to cell nuclear replacement the report concludes, using the language of necessity also used in the HFE Act that: For some people, particularly those suffering from the diseases likely to benefit from the treatments that could be developed, the fact that research to create embryos by cell nuclear replacement is a necessary step to understanding how to reprogramme adult cells to produce compatible tissue provides sufficient ethical justification for allowing the research to proceed. (4, p. 40, my emphasis) The group therefore recommended that the allowable purposes in the HFE Act should be extended to allow for the derivation of stem cell lines and that the use of SCNT to produce embryos for research should be allowed. 11 And presumably the whole report. 12 It is questionable whether this is actually what the Terms of Reference require since the relevant sections there talk about assessing the risks, benefits and any alternative approaches that might be pursued: and in the light of this to consider whether there are any new ethical and social implications. New ethical implications is not the same as new ethical issues. The issue might be the same, but if the balance between positive and negative ethical considerations shift the ethical implications might be quite different. 13 The Human Fertilisation and Embryology Act 1990.

5 The government responded positively to these recommendations and they were implemented through the HFE (Research Purposes) Regulations in 2001 (5). Throughout this development three main positions can be identified in the public debate, a pro-life position focusing on the right to life of the embryo, a pragmatic 14 position endorsing what we could call the special respect but no rights view, and a radical position claiming on consequentialist, ultra-liberal or libertarian grounds that embryos warrant no special status whether in respect or rights terms. One difference between the UK debate and the debate in some other European countries is that the concept of dignity has not been prominent in UK discourse, probably due to the fact that Kantian philosophy has never had a major influence on UK philosophy, legal scholarship or jurisprudence. Many UK philosophers claim not to be able to understand the concept of dignity, or to find it so vague that it has no normative import. Until 1990 it was at times unclear which of the three positions that would win, or perhaps more accurately exactly which of the possible set of implications of the middle position that would be implemented in legislation. Because of the close connection between embryo research and IVF practice it was always unlikely that research would be completely banned, but the UK might have ended up with a prohibition on the creation of embryos for research and a more narrowly circumscribed set of allowable purposes for research. After the passing of the HFE Act in 1990 it has been clear that the two radical positions have been rejected as the basis for public policy, although they persist in the public debate. What decides whether a new research or therapeutic option will eventually be allowed is the kind of analogical reasoning employed by the CMO s expert group in the quote above: whether these new possibilities for research cross a new moral boundary, representing an unjustified extension of the uses of embryos already authorised by the 1990 Act. Where crossing new moral boundaries is understood as unjustified extension of the uses already allowed. Given this approach after 1990 allowing the creation of embryos by SCNT can be seen as an almost inevitable side-effect of the original decision in 1990 to allow embryo creation, given that the embryos produced are similar. How is respect for the embryo expressed in UK regulation? The main expression of the notion of respect for the embryo in UK regulation is the simple fact of the existence of a restrictive regulatory scheme. Although the permitted uses of embryos are wider than in many other jurisdictions they still significantly curtail the use of embryos. To put it very simply embryos can only be created and used for what is perceived as valuable and non-frivolous goals, and the values that can count in deciding whether something counts as a valuable goal are circumscribed to what we could call scientific and health care values. This for instance entails that a 14 Pragmatic here used in its normal meaning not to describe a particular school of philosophy.

6 license cannot be issued for a valuable commercial purpose, even if it was objectively more valuable than some of the health research projects where licenses have been issued. It might also be possible to conceptualise the 14 day limit for embryo experimentation as a way to express respect for the embryo, or if we are convinced by the individuation argument an expression of respect for the embryonic individual proper that can only be said to exist from this time. From the point of view of decision making a regime built on the respect view has two advantages. It is more flexible than a view built on a right to life of the embryo, and it can justify the creation and eventual discarding of supernumerary embryos during IVF procedures which is difficult to justify on a right to life view. But its flexibility is also the main problem of the approach. Exactly what does respecting the embryo prohibit us from doing, apart from totally frivolous acts? An obvious criticism of the UK position is that it is difficult to keep together the concept of respect and the legal possibility to create and destroy for the purposes of others. Is it not a basic aspect of respecting another individual that we refrain from killing him or her, or at least only kill on the request of the individual in question? This argument which can also be found in the UK debate is correct in the sense that one, very important way of respecting a biological entity is by not destroying it, but it overstates the case in various ways. The recent discussion of the manner in which Saddam Hussein was executed for instance show that it might be possible to make sense of a distinction between a respectful and a non-respectful execution of the death penalty. Conclusion It is clear that in the UK the law has not and will not adopt a position based on a conception of rights of the embryo. This does not mean that anything goes. The UK probably has the world s most exacting licensing, inspection and audit regime for IVF clinics and researchers using embryos in their research. And within the scheme embryos enjoy a high level of protection (The issue of IVF clinics losing or mislaying embryos is, for instance taken very seriously). However, the dominant analogical approach to analysing new issues will probably in the long run give rise to a development towards a more and more liberal regulatory regime with regard to both treatment and research. The only thing that could lead to embryo derivation by SCNT for research purposes to be banned in the UK is the complete failure of the technique as a research tool, but in that case a ban would not be needed. References 1. Holm S - Embryonic stem cell research and the moral status of human embryos Reproductive Biomedicine Online, 10 (Sup 1) (2005) Holm S - Does the End Sanctify the Means? Cloning in Biomedical Research and Reproduction, Bonn University Press, Bonn (2004),

7 3. Holm S - The ethical case against stem cell research Cambridge Quarterly of Health Care Ethics, 12 (4) (2003) Stem Cell Research: Medical Progress with Responsibility A Report from the Chief Medical Officer s Expert Group Reviewing the Potential of Developments in Stem Cell Research and Cell Nuclear Replacement to Benefit Human Health. London: 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. London: Department of Health, 2000.