Comment on Reproductive Ethics (CORE) is a public interest group involved since 1994 in the ethics of assisted reproduction, cloning and stem cell technology. We have given oral and written evidence to the Science and Technology Committee on reform of the HFE Act, and have participated in relevant consultations called by the Department of Health and the Human Fertilisation and Embryology Authority. We have organised conferences on women's health issues within the European Parliament, where concerns about egg donation for research and the ethics of stem cell research have been addressed.

  We welcome this opportunity to raise some of our many concerns in relationship to the creation of animal/human hybrid and chimera embryos.

SUMMARY

  The scientific and legal complexities surrounding the creation of animal/human hybrids and chimeras are colossal, with currently no consensus on definitions, no consensus on either the feasibility or necessity of such creations, and no possibility of any workable international accord. It must be noted, however, that to date more countries are opposed to than in favour of such hybrids.

  In this climate of uncertainty and disagreement, we can see no justification for the UK to rush into decisions, and we recommend absolute caution. Furthermore, despite the claims made by the HFEA, it is in no way certain who has authority in this field. CORE is not convinced that the HFEA has jurisdiction. This matter alone demands serious clarification.

  We recommend that considerable time and discussion be spent in thorough investigation of these issues, both nationally and internationally, and taking proper notice of the position of other countries. This must be done both at the highest academic and scientific levels but also as broadly as possible so that the public is properly and accurately informed. The economic implications of international agreements on human tissue must not be underestimated.

  Having looked at the current evidence, CORE's position is that animal/human hybrids and chimeras are neither necessary nor desirable.

CONCERNS

1.   Why such haste?

  Given the serious implications and novelty of the science in question, we welcome the initiative of the Science and Technology Committee in inviting public commentary on the Government's proposals for the regulation of animal/human hybrid and chimera embryos for research purposes. We feel nevertheless that it is unfortunate that this consultation is taking place within such limited time constraints, as this will be the first occasion when these controversial matters has been discussed in any real depth.

  Animal/human hybrids were considered during the earlier Science and Technology Consultation on Reform of the Act, but neither then nor during the Department of Health's subsequent consultation was this proposal singled out for any specific consideration.

  We also note that the current initiative of the Science and Technology Committee has not been widely publicised and inevitably only those closely involved with the issues in question will participate.

  Recent criticism of the Government White Paper's recommendations dismissed the "partisan" nature of those who had contributed to the consultation exercise, suggesting that the opinions of religious and pro-life lobbies had predominated.

  It would be equally possible to argue that the pro-cloning scientific lobby in the UK has been allowed exaggerated influence. Certainly the media coverage of animal/human hybrids recently has been anything but impartial, giving the impression that there are no scientific arguments against such research, and that the only opposition comes from those opposed to destructive embryo research. As we will elaborate later, the international picture is much more complex, as is the science itself.

  CORE encourages balanced and informed debate, and urges the Government to ensure that this takes place.

2.   Scientific considerations

  Before establishing the legal status of animal/human hybrids and chimeras, it is essential that we have agreement as to the exact scientific nature of the proposed entities.

  We suggest that nothing in this area of science is currently very clear and to give you just a taste of the level of uncertainty involved, we refer you to minutes of HFEA meetings where these issues have been discussed. Please note the following quotes as examples, taken from a paper prepared for the Scientific & Clinics Advances Group (SCAG) of the HFEA (26 April 2006):

"Members discussed the fact that it is unknown what the proportion of contribution from human and animal mitochondria will be in these hybrid embryos."

"It is questionable whether this technique can produce physiologically normal stem cells lines."

"One member suggested that for the first 5 or 6 days of development the entity would initially be predominantly rabbit. It would then become gradually humanised. It will become predominantly human by eight or nine days of development."

  Contrast this last statement with a comment made by renowned neurologist, Lord Walton of Detchant, during a debate in the House of Lords on hybrids and chimeras (9 January 2007):

"Such cells produced by tissue culture would be free of any significant component of animal mitochondrial DNA". Given that such cells would be derived around days five or six of embryo development it is hard to know what to make of either statement.

  Public Health Minister, Caroline Flint, in a letter to The Observer, 21 January, 2007, remarks that there is no firm consensus, "about precisely which human-animal creations should be allowed, any immediate imperative for doing so, or the availability and interpretation of supporting evidence."

  CORE could produce pages of contradictory statements, made at the highest level, re the significance or not of maternal mitochondria and the risks or not of physiological abnormalities. We draw the Committee's attention, for example, to a major European research project, in which Newcastle University is participating, focusing on abnormalities of mitochondrial origin (www.mitodata.org).

  The point we wish to make, however, is simply that nothing is currently at all clear about the science involved, and it would be extremely unwise to rush into decisions without a rigorous objective scientific basis to deliberations.

  It is unthinkable that decisions as to the nature of an animal/human hybrid should be left to the deliberations of the HFEA, let alone their subcommittees on Ethics and Law, or the aforementioned Scientific and Clinical Advances Group, and we can see little purpose to the Authority conducting their own consultation later this year. Such a consultation should be undertaken by Parliament.

3.   Legal considerations

  With so much uncertainty relating to scientific definitions of animal/human hybrids it is extraordinary that the Chief Executive Officer of the HFEA, Angela McNab, has issued a press statement claiming licensing authority in this field. Minutes of the meetings of the Ethics and Law Committee (ELC) of the HFEA themselves reiterate the uncertainties of the scientific nature of animal/human hybrids. As a consequence therefore there is even more uncertainty as to their legal status as this clearly depends on a definitive agreement on the science.

  The legal position remains unclear and this opinion is being expressed from many varied quarters.

  It must be remembered that, under the HFE Act 1990, the HFEA is only responsible for human gametes and human embryos. In the instance of animal/human hybrid cloning, no human gametes are involved, and it has yet to be established whether any embryo that might develop from an animal egg is animal or human, particularly in the early period when stem cells would be extracted.

  In the same Lords' Debate cited earlier, Government Spokesperson for Health, Lord Hunt of Kings Heath, states "Our understanding is that the law is unclear about the regulation of human and animal embryos created by novel processes." Lord Walton of Detchant has no such doubts and argues that cells produced in this way cannot be construed as embryos under the terms of the HFE Act.

  The Health Minister, Ms Flint, again in her letter to The Observer, 21 January 2007, speaks of the need "to clarify the extent to which regulation will apply to the creation and human-animal hybrids and chimeras for research".

4.   Justifying the use of human embryos

  Whilst it is important to contain the debate on animal/human hybrids and chimeras within certain clear parameters, we cannot completely ignore the history of research in this area and the significant ethical issues associated with use of the human embryo and human cloning.

  The use of embryos was argued initially as being indispensable to progress, and the law was developed as a balancing exercise between respect for the embryo and the purported need to do research on it. In the HFE Act this concept is contained in the term "necessary and desirable", qualities which have to be demonstrated before such research is permitted.

  CORE reiterates its total opposition to destructive embryo research, but feels that even within the model of the balancing exercise, not enough rigorous assessment of the need for human embryos for research has been undertaken.

  We suggest that the time has come for a thorough analysis of the history of embryo research. It is 17 years since the 1990 Act was passed and we should be assessing honestly how many embryos have been used in this time, and what real benefits have derived from the experiments to date. This analysis should cover both fertility treatment and stem cell research, and include the most recent licenses issued for cloning using cell nuclear transfer. Only in this way can an objective assessment be made as to the real necessity of using human embryos in this way, irrespective of how they have been obtained or created.

5.   The international perspective

  Without re-opening the debate on the use of the human embryo per se it must nevertheless be noted that, whilst there are varied positions taken on the use of embryo surplus to IVF requirements, there are very few countries in the world who permit the deliberate creation of embryos for research purposes. It should be noted, too, that opposition to human cloning either for reproduction or research purposes is the majority position worldwide. It is untenable to polarise opposition as coming primarily from religious quarters.

  The UK, therefore, is already out on a limb in relationship to world opinion, and current proposals to create animal/human hybrids are distancing the UK ever further from world, and particularly European, thinking. It is arrogant to suggest that we know better than most other countries.

  We recommend an objective assessment of the rationale behind the position of these countries, and in particular draw your attention to the deliberations of the Australian Senate, which culminated in a unanimous rejection of animal/human hybrids in December 2006. The rejection was based on a pragmatic scientific basis of either poor or unnecessary science but also included interestingly concerns for the welfare of animals.

6.   Economic considerations

  We are hearing too frequently these days that scientists should be able to do whatever they like, providing there are no tangible risks involved, a libertarian approach which CORE certainly does not endorse. However, even if one does not accept the justification for ethical limitations to research, there are nevertheless serious economic implications which cannot be ignored.

  We cannot afford to fund every research project that is proposed and so further balancing exercises must be performed to assess how best to spend available resources. Public funding must be directed towards research which is scientifically sound. There is a duty, therefore, to analyse with proper scientific rigour the claims made about embryonic stem cell research and cloning, and even more urgently in relationship to the alleged benefits of animal/human hybrid cloning. In particular the status of adult stem cell research, and the use of post-natal stem cells (amniotic, placental and umbilical cord) must be considered more seriously.

  We have a continued duty to objectivity and the proposed assessment of previous research involving the human embryo will also be invaluable in following these economic considerations.

  In the European context these considerations are particularly important, as no therapy involving human tissue is likely to be marketable if not developed in accordance with EU regulations. We feel that any future Government initiative should take this on board much more seriously than has been the case to date.

7.   Are there acceptable alternatives?

  The most widely stated justification for going ahead with animal/human hybrid and chimera research at the moment is that it will provide an ethical source of mammalian eggs and avoid putting human donors at risk. CORE is one of the first to argue that egg donation for research is too risky and invasive to be justified, but we are also the first to argue that combining human and animal tissue in this way is not an appropriate or safe alternative.

  Animal cross species work has not been perfected, animal cloning processes are still light years from delivering high success rates, and human cloning does not seem to be working properly (if at all) in any country in the world. To argue that we need to do animal/human hybrid and chimera research when the results are so poor in similar fields which are nevertheless far more straightforward, seems quite extraordinary.

  There are already research projects investigating the derivation of embryonic-like human stem cell tissue, bypassing any creation of human embryos. Obviously such possibilities require individual analysis, but are sufficiently numerous and interesting that they should be taken into consideration. CORE recommends that the Science and Technology Committee reads "Alternative Sources of Human Pluripotent Stem Cells", A White Paper from the US President's Council on Bioethics in this regard. (www.bioethics.gov)

January 2007