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Select Committee on Stem Cell Research Report


CHAPTER 7: THE INTERNATIONAL DIMENSION

7.1 Stem cell research and cloning are not purely domestic issues. Scientific research and its commercial exploitation operate on a global basis: both are sensitive to differences in the regulatory environment.

7.2 Some aspects of stem cell research and cloning are covered by international instruments and other declarations; and some commentators take the view that there should be a greater degree of international regulation in this field. The issues that we have been considering have arisen in similar form in other countries and in formulating our views we have sought to take account of their experience.

International instruments: the concept of human dignity

7.3 Most of the relevant provisions of international instruments in this field are concerned with reproductive cloning rather than research on human embryos.[47] However, Article 18 of the Council of Europe Convention on Human Rights and Biomedicine states categorically that "the creation of human embryos for research purposes is prohibited". The United Kingdom has not signed this Convention.

7.4 The European Parliament has also taken a close interest in the subject. On 7 September 2000 it passed a resolution on human cloning in reaction to the new Regulations brought forward by the British Government.[48] The resolution emphasised the need to respect human dignity and human life, called on the United Kingdom Government to review its position on human embryo cloning and repeated calls for each Member State to enact binding legislation prohibiting all research into human cloning and to provide for criminal penalties. The Parliament subsequently set up a Temporary Committee on Human Genetics and Other New Technologies of Modern Medicine; we were able to meet some of its members when they visited the United Kingdom. The Temporary Committee reported on 8 November 2001.[49] The report itself recommended a cautious approach to stem cell research and raised a number of questions. It recognised that decisions would probably—and rightly—continue to be taken at Member State level, whereas the EU would decide where and how it should direct its research and funding priorities. The draft resolution proposed for adoption by the Parliament, however, was in uncompromising terms, calling in effect for a ban on all research on human embryos and embryonic stem cells.

7.5 When the report was debated on 29 November 2001, the Parliament voted by 316 to 37 (with 47 abstentions) to reject the final motion for a resolution after amendments in favour of "therapeutic cloning" were earlier approved.

7.6 In instruments such as the European Convention, as in much modern bioethical thinking, the starting point for regulation is taken to be the principle of respect for human dignity. A secular principle of respect for human dignity goes back to the Enlightenment and is closely linked to the development of claims about human rights. On one view human dignity is seen as synonymous with human worth and is said to form the basis of human rights. On another view it is specifically associated with particular human rights, such as those concerned with the basic conditions for working people. More recently the concept of human dignity has been invoked by those opposed to certain biomedical developments, notably cloning.

7.7 The concept of human dignity raises interesting philosophical issues, but has proved hard to analyse.[50] We have not been able to derive much practical guidance from recent claims about human dignity as to what should and should not be permitted in the field of research on human embryos. One reason for this is that most people can agree that persons should be treated as having dignity and not be used as mere means; but mere reiteration of this point with respect to early embryos begs the question of whether they count as persons, which we discussed in Chapter 4.

National differences

7.8 The differences in attitudes to stem cell research between different countries and in its regulation are striking. As many of our witnesses testified, these differences largely reflect differences in cultural and religious traditions. We have sought to inform ourselves about international developments, but legal and regulatory regimes are changing so rapidly in many countries that we have not attempted to produce a comprehensive account of the situation in other countries.

7.9 In the countries of the European Union, a variety of regulatory regimes for research on early embryos are currently in operation, though in this regard too the scene is rapidly changing. Reproductive cloning is either illegal or in practice prohibited everywhere. In several countries there is currently no legislation governing stem cell research. Sweden and the Netherlands (along with the United Kingdom) are generally regarded as having the most "liberal" rules. In December 2001, the Swedish Research Council issued guidelines endorsing the use of CNR (but not of the creation of embryos by IVF for research) subject to certain conditions, including legislation to prohibit placing such embryos in a woman. In the Netherlands the Parliament passed a law in October 2001 allowing research on surplus embryos; and allowing CNR after a moratorium of five years. At the other end of the scale, embryo research is banned in Ireland and in Germany. However, in Germany the Bundestag decided on 30 January 2002 (by a free vote of 339 to 265) to call for legislation permitting the import for research of stem cell lines which were established before 2 January 2002. In most other countries research using surplus embryos is permitted. Where there are rules they limit permissible research to early embryos up to 14 (in the Netherlands 15) days. A considerable variety of governmental or quasi-governmental agencies have been created to oversee and in some cases license such research.

7.10 The United Kingdom goes further than most countries in permitting the creation of embryos for research and the use of CNR. But it is worth noting that, as many overseas commentators acknowledge, the United Kingdom's position has been reached only after a period of lengthy debate going back over fifteen years and a system of effective regulation that has been in place for over ten years and has been widely admired and used as a model in other countries. The debates currently taking place in other European countries seem to indicate, broadly speaking, movement away from a total prohibition on embryonic stem cell research.

7.11 The situation in the United States has attracted a great deal of attention, partly because some of the ground-breaking work in ES cell research has been undertaken there and partly because of the publicity that attended President Bush's decision in August 2001 to permit federal funding of research on human embryonic stem cells, but only if they were derived from stem cell lines established before 9 August 2001. The rationale of this decision was that there should be no federal support for research involving the destruction of human embryos but that, if the embryo had already been destroyed, the status it previously enjoyed no longer attached to the stem cells extracted from it. President Bush's announcement referred to some 60 such stem cell lines throughout the world (none of them generated in the United Kingdom).[51] This decision reflected the fact that the main control that the federal government exercises on human embryo research is through its funding of research. There is no federal control of privately funded research, which is generally subject to State rather than federal regulation. This has led to significant variations between the States. In some States research on human embryonic stem cells is prohibited altogether, in others there is no regulation and therefore little control on what takes place in private research facilities.

7.12 A Bill to prohibit all forms of cloning which has the support of President Bush was passed by the House of Representatives in July 2001 but has not as yet been scheduled for debate in the Senate.

7.13 In Australia, the House of Representatives Standing Committee on Legal and Constitutional Affairs recently completed a two-year long inquiry into a national approach to regulations for stem cell research and cloning. Its report, recommended, among other things, a ban on the creation of embryos (by IVF) solely for research purposes; allowing the extraction of stem cells from spare IVF embryos; a ban on reproductive cloning; and a three year moratorium on the use of CNR.[52]

The scope for international regulation

7.14 Apart from the Council of Europe Convention on Human Rights and Biomedicine, which specifically prohibits human reproductive cloning and the creation of human embryos for research, most of the international instruments have been in fairly broad declaratory terms. We have considered whether there is scope for a greater measure of international regulation in this area. Some witnesses argued that there was a need for such regulation because of the ease with which research and treatment facilities can be transferred to countries with more favourable regulatory regimes, thus encouraging what is sometimes termed "reproductive tourism". On the other hand, a number of scientific witnesses argued strongly that reputable scientists do not look for a research environment with minimum regulation but want an effective regulatory regime which sets out clearly what is and what is not permitted, so that they know where they stand both scientifically and ethically; and that is why the regulatory environment in the United Kingdom is attractive to researchers.

7.15 In our view, any attempt at detailed regulation at international level, even if theoretically desirable, would inevitably founder on the wide differences in policy and practice which we have described above. A number of witnesses put it to us that the United Kingdom should be advocating the principles of the 1990 Act and the regulatory regime operated by the HFEA as the basis of international regulation. But that too, it seems to us, would probably be impractical.

An international ban on reproductive cloning?

7.16 It has been suggested that at the very least there should be an international ban on human reproductive cloning, and the Government have indicated that they would support one.[53] Others, notably the Royal Society, have called for a moratorium rather than an outright ban.

7.17 Securing international agreement is never easy, whatever the field of activity, and there would no doubt be formidable practical difficulties in negotiating a ban (or moratorium) even on such an apparently straightforward issue, on which there is known to be widespread agreement.

7.18 Nevertheless, despite the difficulties, we believe that there would be advantage in seeking to secure international agreement on prohibiting reproductive cloning. It would send a powerful signal of international opposition to the practice; it would put moral pressure on countries not to permit facilities in their jurisdictions to be used for this purpose; and it would afford further reassurance to the public that there was protection against the use of CNR for research purposes becoming a slippery slope to reproductive cloning.

7.19 We have not examined in detail what would be the most appropriate international body to negotiate such an agreement, but it should be a world-wide rather than a regional body, which points to the United Nations. The enforcement of an agreement, which might take the form of a Convention, would be the responsibility of the States party to it.

7.20 We have also considered whether action might be taken internationally through professional medical bodies by exerting pressure on scientists and medical practitioners not to attempt reproductive cloning of humans. Such bodies exercise considerable control and influence over their members and it is desirable that they should make their position clear, even if this is unlikely to deter the most determined maverick doctors. However, we do not see professional codes as a substitute for a formal prohibition.

7.21 As mentioned above, the Royal Society has suggested a moratorium rather than an outright ban. The rationale for a moratorium is that it would allow time for all the issues to be explored in detail so that if the scientific objections were overcome, a fresh look could be taken at the acceptability of the practice. We understand the thinking behind this proposal but in our view a moratorium would weaken the moral and presentational effect of an outright prohibition, because it would suggest that there was uncertainty about the ethical objections to reproductive cloning. In addition, the time taken to negotiate a moratorium would be likely to be disproportionate to its length. An alternative might be for any prohibition to have a review procedure built in to it. That would not suffer from the disadvantages of a moratorium to the same extent but would still be weaker than an outright ban.

CONCLUSION

7.22 The Committee recommends that the Government should take an active part in any move to negotiate an international ban on human reproductive cloning.


47   The UNESCO Universal Declaration on the Human Genome And Human Rights states that "practices which are contrary to human dignity, such as reproductive cloning of human beings, shall not be permitted"; Article 1 of the Additional Protocol to the Council of Europe Convention on Human Rights and Biomedicine provides that "any intervention seeking to create a human being genetically identical to another human being whether living or dead is prohibited"; and Article 3 (2) of the Charter of Fundamental Rights of the European Union states that the prohibition of the reproductive cloning of human beings must be respected. There is no directly relevant provision in the European Convention on Human Rights. Some have argued that restrictions on reproductive technology could violate the right to respect for private and family life contained in Article 8 (1) but no one has yet sought to test this proposition. Back

48   B5-0710. Back

49   PE 300.127. Back

50   Professor John Harris has described it, more unequivocally, as "comprehensively vague" (John Harris, Clones, Genes and Immortality (Oxford: OUP, 1998) p.31.) Back

51   There has been some dispute about the accuracy of this figure as many have not been documented in detail. Back

52   Human cloning: scientific, ethical and regulatory aspects of human cloning and stem cell research, Canberra, August 2001. Back

53   Lord Hunt of Kings Heath in the debate on the Human Reproductive Cloning Bill, 26 November 2001, Col 58. Back


 
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