EXECUTIVE SUMMARY

  1.  The Government has made clear its support for legitimate medical research that promises advances in knowledge about, and treatment of, diseases and disorders, including through embryonic stem cell research. It has undertaken a review of the law in response to, in particular, advances in technology and probable changes in attitudes, and has published its proposals to update the law in this area. The Government has proposed that the law should deal with the emerging science regarding hybrid and chimera embryos. In view of arguments for the usefulness of such creations in research, the Government proposes that Parliament will have the power via secondary legislation to make exceptions to a prohibition on the creation of hybrid and chimera embryos in vitro to allow hybrid and chimera embryos for research purposes only. These proposals will be subject to democratic scrutiny via the Parliamentary process, including pre-legislative scrutiny in draft.

THE GOVERNMENT'S REVIEW OF THE HUMAN FERTILISATION AND EMBRYOLOGY ACT 1990

  2.  In January 2004 the Government announced its intention to undertake a review of the Human Fertilisation and Embryology Act 1990, beginning that year and to include a public consultation exercise in 2005.

  3.  The Government considered that a review was necessary in the light of, in particular, advances in technology and possible changes in attitudes since the formulation of the original Act. Following the review, proposals were published on 14 December 2006 for revision of the law in Review of the Human Fertilisation and Embryology Act: Proposals for revised legislation (including establishment of the Regulatory Authority for Tissue and Embryos). [23]

  4.  The Government's principal aims in proposing revisions to the legal and regulatory framework were:

—  to ensure that legitimate medical and scientific applications of human reproductive technologies can continue to flourish;

—  to promote public confidence in the development and use of human reproductive technologies through effective regulatory controls applicable to them; and

—  to secure that regulatory controls accord with better regulation principles and encourage best regulatory practice.

  5.  The Queen's Speech on 15 November 2006 announced that draft proposals will be published to reform the regulation of human embryology. This referred to the Government's intention to bring forward a bill in draft form, for pre-legislative scrutiny in Parliament.

PROPOSALS FOR THE REGULATION OF HYBRID AND CHIMERA EMBRYOS

  6.  Paragraph 2.85 of the White Paper[24] stated that:

"Revised legislation will clarify the extent to which the law and regulation applies to embryos combining human and animal material. The Government will propose that the creation of hybrid and chimera embryos in vitro, should not be allowed. However, the Government also proposes that the law will contain a power enabling regulations to set out circumstances in which the creation of hybrid and chimera embryos in vitro may in future be allowed under licence, for research purposes only."

  7.  The Government's proposal, if approved by Parliament in the form of revised legislation, will have the effect of extending existing restrictions within the 1990 Act, which prohibit the mixing of human and animal gametes other than in very limited circumstances, to embryos created by processes other than fertilisation. The proposal does not, however, close the door to such entities in recognition of arguments for their potential usefulness in research—such as in the derivation of stem cells, and in the testing of stem cell pluripotency.

  8.  Detailed drafting of revising legislation is underway at present. This will take into account the broad spectrum of possibilities for creating embryos combining human and animal material which may involve several different processes and result in a diverse range of entities, some of which may involve human embryos, or result in embryos that are human in terms of their nuclear DNA. It will also take account of the fact of existing regulatory controls, such as those exercised by the Home Office under the Animal in Scientific Procedures Act.

  9.  One advantage of the proposed secondary legislative power would be to enable distinctions to be drawn between different types of entity that may fall under a general description of "hybrid" and "chimera" embryos, as scientific knowledge increases.

BACKGROUND TO THE PROPOSALS ON HYBRID AND CHIMERA EMBRYOS

  10.  In making its proposal, the Government took account of a wide range of factors which included, inter alia, the intent and practical effect of the existing law, relevant legislative commitments previously made by the Government, and responses to the Department of Health's consultation.

The 1990 Act

  11.  The 1990 Act prohibits the mixing of human and animal gametes other than for the purpose of testing the fertility or normality of human sperm (by the so-called "hamster test"), with the proviso that the product must be destroyed no later than the two cell stage. This position was based on consultations undertaken prior to the 1990 Act based upon the recommendations of the Warnock Committee of Inquiry. [25]

  12.  A White Paper that preceded the 1990 Act (Human Fertilisation and Embryology: A Framework for Legislation) [26]had set out a range of activities that it proposed should be prohibited, subject to a power for Parliament to make exceptions by affirmative resolution if new developments made that appropriate. These activities included "creation of hybrids". Paragraph 39 of the document stated:

"[t]he Bill will also contain provisions prohibiting the transfer of a human embryo to the uterus (or any other part) of another species and vice versa: and prohibiting any procedures involving the fusion of cells of a human embryo with cells of the embryo of another species to produce a chimera."

  13.  Paragraph 42 clarified the proposed position with regard to the mixing of human and non-human gametes:

"[a]s there is universal agreement about the need to prevent the creation of hybrids using human gametes (if this were ever to be attempted), the Bill will specify that no licence may permit the fertilisation of a human egg with the sperm of another species. [.. ] It would also be an offence to fertilise the egg of another species with human sperm except under licence from the [statutory licensing authority]. Licences may be given for use of this technique only in connection with the assessment or diagnosis of sub-fertility before the completion of the fertilisation process. This will be deemed to be completed when the two-cell stage is reached."

Report of the Chief Medical Officer's Expert Advisory Group

  14.  In June 1999 the Government asked the Chief Medical Officer to establish an expert advisory group—comprised of leading experts in science, medicine and ethics—to advise on whether new areas of research using human embryos should be permitted that could lead to broader understanding of, and eventually new treatments for, disease. This was in response to a joint HFEA/Human Genetics Advisory Commission Report "Cloning issues in Reproduction Science and Medicine", published in December 1998, which had considered novel methods for creating embryos, and had recommended extension of the purposes for which human embryos could be used in research.

  15.  The subsequent report of the Expert Advisory Group ("Stem Cell Research: Medical Progress with Responsibility"), published in July 2000, made nine recommendations, principally to extend the purposes of research permissible under the 1990 Act to include increasing understanding about human diseases and disorders and their cell based treatments. Another recommendation was to ensure that human reproductive cloning remained a criminal offence.

  16.  Of most relevance to the present inquiry, the Expert Advisory Group "concluded that the use of eggs from a non-human species to carry a human cell nucleus was not a realistic or desirable solution to the possible lack of human eggs for research or subsequent treatment".[27] Recommendation 6, recognising the apparent limitations of the 1990 Act's controls on mixing human cells and animal eggs, stated that "[t]he mixing of human adult (somatic) cells with the eggs of any animal species should not be permitted", and called on bodies funding research to make a declaration that they would not fund or support research involving the creation of such hybrids.

Implementation of the Expert Advisory Group's recommendations

  17.  The recommendations of the Expert Advisory Group were accepted in full by the Government, [28]with the principal recommendations being implemented via the Human Fertilisation (Research Purposes) Regulations in January 2001. These extended the purposes of permissible research via affirmative regulations to include:

(a)  increasing knowledge about the development of embryos;

(b)  increasing knowledge about serious disease, or

(c)  enabling any such knowledge to be applied in developing treatments for serious disease.

  18.  A legal ban on reproductive cloning followed in December 2001. The Human Reproductive Cloning Act 2001 fulfilled the Government's commitment to bring in legislation to put a ban on human reproductive cloning on a statutory footing. It was brought forward following the judgment of the High Court on 15 November 2001 which held that embryos created by cell nuclear replacement were not governed by the 1990 Act. The House of Lords' judgement in the case of R (Quintavalle) v Secretary of State for Health[29] subsequently ruled that human embryos created by cell nuclear replacement are governed by the 1990 Act.

  19.  The Government undertook to implement recommendation 6—to prohibit the mixing of human somatic cells with the eggs of animal species—via primary legislation when the Parliamentary timetable allowed. This was the Government's expressed position prior to the review of the law announced in 2004.

Reports by the House of Lords Stem Cell Research Committee and the House of Commons Science and Technology Committee

  20.  The Government published its response to the Science and Technology Committee's report "Human Reproductive Technologies and the Law"[30] together with its consultation document on the review of the 1990 Act. As the Committee will be aware, these included recommendations on human-animal hybrids and chimeras. Paragraph 66 of the report had stated that "[w]hile a chimera is unlikely to be able to develop very far, it may have value as a research tool ...", and, "[s]imilarly, hybrids formed by cell nuclear replacement might have value in deriving embryonic stem cells for research purposes", whilst noting also that there is "revulsion in some quarters" to such creations. The Government undertook to consult on the majority of the report's recommendations, including the proposal that the creation of hybrid and chimera embryos should be allowed for research.

  21.   Human Reproductive Technologies and the Law also referred to an earlier report by the House of Lords Stem Cell Research Committee, published in February 2002, which had briefly discussed the issue of replacement of a nucleus of an animal egg with a human somatic cell nucleus. The Lords report noted that "if placing a human nucleus in an animal egg provided a way of creating human embryonic stem cells for research, some might argue that it was more acceptable to use such an entity for research, the creation of which involves no human gametes, than an embryo created by cell nuclear replacement", but made no specific recommendation on this point. [31]

The Department of Health's consultation on the review of the Human Fertilisation and Embryology Act

  22.  Notwithstanding its earlier commitment to an outright ban as recommended by the Expert Advisory Group, the Government's consultation paper invited views on whether the law should permit the creation of human-animal hybrids or chimeras for research (subject to a maximum limit of 14 days development in vitro). The consultation paper stated that the Government was aware of arguments that there may be benefits from the creation of such entities for research, including as a means to circumvent the shortage of good quality human eggs available for research.

  23.  Whereas the overall tenor of responses to the consultation was opposed to the creation of hybrids and chimeras, the Government's policy proposals announced in December 2006 do not close the door to such creations. This reflects the Government's recognition of powerful arguments for the creation and use of these entities, or some forms of such entities, in some circumstances. However, we have not seen so far a firm consensus within the scientific community—judging by views expressed in a variety of fora—about precisely which human-animal creations should be allowed, any immediate imperative for doing so, or the availability and interpretation of supporting evidence. The Government also recognises that there may be different arguments—both scientific and ethical—applying to, say, creation of hybrids by cell nuclear transfer which in terms of their nuclear DNA are ostensibly human, and to embryos containing both human and non-human nuclear DNA.

  24.  These will be matters for Parliament to consider in its scrutiny of the necessary legislation, and it is proposed that Parliament will first scrutinise the proposals in draft form. The Government will obviously consider carefully any conclusions and recommendations arising from pre-legislative scrutiny ahead of formal introduction of legislation.

CONCLUSION

  25.  The Government has proposed that the law should be clarified with regard to human-animal embryos, initially by not allowing their creation. This would make such embryos created by non-fertilisation methods—such as those created by replacing the nucleus of an animal egg with a human somatic cell nucleus—subject to the same prohibition as already applies to mixing human and animal gametes.

  26.  However, the Government also proposes that the law will contain a power whereby Parliament can permit—via secondary legislation in the form of regulations—the creation of human-animal embryos for research under licence. The Government has not taken a view on whether or when such regulations may be made, but nonetheless wishes to provide the flexibility to make regulations—subject to the agreement of Parliament. The Government will be very interested to see any recommendations produced during pre-legislative scrutiny on this matter, as well as any recommendations arising from the present inquiry.

January 2007

24   A full extract of the relevant section is at Annex A to this memorandum. Back

25   Discussed at paragraph 12.2 of the Warnock Report (Cmnd. 9314), under the heading "trans-species fertilisation". Back

26   Cm 259, published November 1987. Back

27   Paragraph 2.62. Back

28   Government response published in August 2000 as Cm 4833. Back

29   2003, UKHL 13. Back

30   Report published as HC 7-1, and special report by 5 dissenting members HC 491. Back

31   HL Paper 83(i), paragraph 8.18. Back