INTRODUCTION

  1.  The Department of Health welcomes this opportunity to assist the Science and Technology Committee in its consideration of therapeutic cloning.

THE HUMAN FERTILISATION AND EMBRYOLOGY AUTHORITY AND HUMAN GENETICS ADVISORY COMMISSION REPORT

  2.  The HFEA/HGAC report Cloning Issues in Reproduction, Science and Medicine was published in December 1998. In making its recommendations the report distinguished between human reproductive cloning (ie designed to lead to the implantation of an embryo in a woman and the birth of a cloned human being) and research involving cell nuclear replacement or "therapeutic cloning".

  3.  On therapeutic cloning the HFEA/HGAC indicated that they saw potential benefits from research involving cell nuclear replacement order to develop treatments for:

(i)  mitochondrial disorders; and

(ii)  diseased or damaged tissues or organs.

  4.  The purposes for which the HFEA may currently authorise research involving human embryos are set out in the Human Fertilisation and Embyology Act 1990 (see Annex A.) Further purposes maybe specified in affirmative regulations. The HFEA/HGAC report invited the Government to consider such regulations to allow research on embryos for the two purposes they had identified.

THE GOVERNMENT RESPONSE

  5.  The Government Response published in June 1999 also indicated that before deciding whether to make regulations to allow further research purposes the Government wished to take additional views on the potential benefits of the additional purposes suggested; whether there are alternative approaches which might offer the same benefits and whether there are additional or different research purposes which the technology might point to.

  6.  In making its response the Government took account of the fact that Parliament, on a free vote, has determined that research on embryos should be permitted under carefully controlled circumstances. However it also recognised that, as reflected in the HFEA/HGAC public consultation which preceded their report, there are a number of people who are opposed to such research under any circumstances. The Government therefore felt it was important to investigate further the suggested potential health benefits of research involving human nuclear replacement before deciding whether expanding the research purposes for which human embryos may be created or used is justified.

ADDITIONAL RESEARCH PURPOSES

  7.  The HFEA/HGAC report notes that in the weeks immediately before the report was issued there had been reports of significnt developments in research in the US involving stem cells, of which the HFEA/HGAC had not been able to take full account. This research involved taking stem cells from early fetuses as well as embryos and had succeeded in establishing stable cell cultures.

  8.  This research appears to open up the possibility of therapeutic purposes beyond those specified by the HFEA/HGAC (at paragraph 5.10 of their report) such as treatment of leukaemia; use in gene therapy; and use as a tool in drug development for new treatments in a wide range of inherited and somatic disorders. In deciding whether or not to expand the permitted research uses of embryos the Government would wish to take account of the implications of this most recent research and the additional research and therapeutic possibilities it might suggest, over and above those outlined in the HFEA/HGAC report.

ALTERNATIVES TO EMBRYO RESEARCH

  9.  The research referred to at paragraph seven also raises the question as to whether embryos createdin vitro will or should be the main or preferred source of stem cells. Significant research is underway in the UK and elsewhere using stem cells and other pluripotent cells obtained from blood, cord blood and fetal tissue. Both ethical and practical considerations (including the scarcity of embryos and eggs for IVF treatment or research purposes) suggest that these alternatives merit serious consideration.

CMO EXPERT GROUP

  10.  In the light of the considerations outlined above, the Government Response announced the intention to establish an ad hoc Expert Advisory Group, chaired by the Chief Medical Officer on the need for, anticipated benefits and risks of, and alternatives, to the use of human embryos in research for the additional purposes suggested by the HFEA/HGAC Report. The membership and terms of reference of this group were announced on 18 August (press release at Annex B). At the same time, the CMO wrote to those who responded to the HFEA/HGAC's consultation and a range of additional experts working in relevant fields worldwide seeking their views on the following questions:

—  what are the current areas of research in therapeutic cloning including stem cell studies, and which are the most important?

—  what are the areas of human health in which the use of therapeutic cloning techniques is most likely to provide benefits?

—  how close are we to being able to replicate animal work in humans?

—  what are the technical problems which might arise?

—  are you aware of any safety issues?

—  are there alternatives to research on human embryos, created in vitro, to achieve the same ends? If so, is it likely that they will be available within the next five years?

—  what are the ethical and social implications of such research and its potential therapeutic application?

—  what would be the likely future consequences of the development of therapeutic cloning technology for health care provision?

  11.  The responses, which have been requested by the end of October, will help inform the Group's conclusions. The Government expects to receive the Expert Advisory Group's advice early in the New Year.

November 1999