EXECUTIVE SUMMARY

  1.  The Science and Technology Committee reviewed Government proposals regarding hybrids and chimeras as published in the Government's December 2006 White Paper: Review of the Human Fertilisation and Embryology Act: Proposals for revised legislation (including establishment of the Regulatory Authority for Tissue and Embryos). [9]

  2.  This memorandum provides a short summary of the history leading up to the publication of Government proposals, and a summary of progress and development since publication of the Government's response to the Science and Technology Committee.

LEAD UP TO THE SCIENCE AND TECHNOLOGY COMMITTEE REPORT

  3.  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. 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 in a White Paper.

  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 White Paper was informed by, among other things, reports from the Chief Medical Officer's Expert Advisory Group, [10]the House of Lords Stem Cell Research Committee[11] and the House of Commons Science and Technology Committee. [12]

  6.  The White Paper included proposals for the regulation of hybrid and chimera embryos. Of primary importance was that the law should clarify which hybrids and chimeras warrant regulation by the Authority. On 5 April, the House of Commons Science and Technology Committee published a report on those proposals, following a short inquiry.

  7.  The Science and Technology Committee's recommendations concerned the regulation, risk management and legal limits of inter-species embryo research. Other recommendations were on other related topics such as legal definitions, ethical concerns, the value of research, and public awareness and engagement. The Committee recommended a more liberalised approach to inter-species embryo research, and that such research should be permitted for research, subject to regulation.

  8.  The Government published a formal response to the Committee's recommendations in June 2007, shortly after publication of a Bill in draft form.

PROGRESS SINCE THE SCIENCE AND TECHNOLOGY COMMITTEE'S REPORT

  9.  On 17 May 2007, the Government published draft legislation to revise and update the Human Fertilisation and Embryology Act 1990, in the form of the Human Tissue and Embryos (Draft) Bill. [13]The provisions of the draft Bill were based on proposals published in the December 2006 White Paper. [14]However, we made clear in the introduction to the draft Bill that we were prepared to accept the principle that legislation should provide for inter-species embryo research using human cybrid, chimera and transgenic embryos.

  10.  A Joint Committee of both Houses of Parliament was established to undertake pre-legislative scrutiny of the draft Bill. The Joint Committee examined the draft Bill closely on a number of proposals, taking evidence from 46 oral witnesses in addition to 115 submissions of written evidence. Following the inquiry, the Committee published a report on 1 August 2007.

  11.  A number of the recommendations made by the Science and Technology Committee, are issues which have now been re-examined by the Joint Committee report including issues such as public engagement, and the regulation of hybrid and chimera embryos.

  12.  The Government published a response to the Joint Committee on 8th October 2007.

HFEA Consultation

  13.  In November 2006, the HFEA received applications from two different research teams for a licence to derive stem cells from human embryos, created using animal eggs instead of human eggs.

  14.  The HFEA felt that in order to ensure that it was able to make an appropriate and reasoned decision, it needed to ensure that it had a comprehensive and robust evidence base as a foundation for their decision. In April the HFEA launched a public consultation to explore people's views on whether or not scientists should be allowed to create embryos containing animal DNA in embryo research. This consultation was supported by the Government's Sciencewise programme.

  15.  The consultation included a published paper, an online questionnaire, a public meeting with interest groups, scientists and members of the public, a public opinion poll, and deliberative work including discussion groups and workshops. This approach allowed participants to make informed judgements on this research.

  16.  On 5 September the HFEA announced that "Having looked at all the evidence the Authority has decided that there is no fundamental reason to prevent cytoplasmic hybrid research. However, public opinion is very finely divided with people generally opposed to this research unless it is tightly regulated and it is likely to lead to scientific or medical advancements".

AMS Report

  17.  In June, the Academy of Medical Sciences produced a report[15] on inter-species embryo research. The report was produced by a working group of the Academy, chaired by Professor Martin Bobrow CBE FRS FMedSci.

  18.  The report concluded that research involving inter-species embryos should be permitted under regulation, especially in developing tools to understand human development and to further knowledge about the process of cell nuclear transfer. The report acknowledged that at this time there is no scientific reason to generate "true" hybrids, created by the mixing of human and animal gametes, but they felt that they could not rule out the emergence of valid reasons in the future.

  19.  The report also concluded that, "provided good laboratory practice is rigorously followed, research involving cytoplasmic hybrids or other inter-species embryos offers no significant safety risks over and above regular cell culture research."

Health and Safety Executive

  20.  The Health and Safety Executive have made an assessment that the risks to human health and the environment by the creation and use of inter-species embryos will be low, as the embryos will only grow in very specialised media, and will not survive outside this. The work would normally be carried out in a "clean room" in a safety cabinet, so exposure of workers/environment should not be a concern. If the organisms did pose a risk to human health, then the general provisions of the Health and Safety at Work regulations, and the Control of Substances Hazardous to Health Regulations would apply. These would require appropriate measures to be taken to minimise exposure to the organisms.

CONCLUSION

  21.  Since the Science and Technology Committee's report on Government proposals for the regulation of hybrid and chimera embryos, the Government has published it's Bill in draft form, and the specific clauses of the Bill have been examined by a Joint Committee of both Houses.

  22.  The Government has taken forward many of the Science and Technology Committee's recommendations in drafting the Bill, and we remain grateful for their examination of these difficult issues. The Government's proposals on hybrids were published on 8th October, in its response to the Joint Committee's recommendations (Cm 7209). Copies have been placed in the Library.

  23.  We are now re-drafting the Bill following the Joint Committee's report, ready for introduction to Parliament in the next parliamentary session. We are working closely with the HFEA, the AMS, and other stakeholders to this end.

October 2007

10   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 to benefit human health, 2000. Back

11   Report from House of Lords Stem Cell Committee: Stem Cell Research, HL83(i). Back

12   Human Reproductive Technologies and the Law, HC-7. Back

13   Human Tissue and Embryos Draft Bill, Cm 7087. Back

14   ???????? Back

15   Inter-species embryos-A report by the Academy of Medical Sciences 
http://www.acmedsci.ac.uk/index.php?pid=118&pressid=34 Back