Select Committee on Science and Technology Second Report


Memorandum by the Human Genetics Advisory Commission and the Human Fertilisation and Embryology Authority

THERAPEUTIC CLONING

  1.  As requested, here is a short note regarding our jointly published report on Cloning Issues in Reproduction, Science and Medicine (December 1998).

  2.  We held a public consultation exercise during 1998 to explain the issues raised by cloning technology and stimulate wide and informed debate. Our Report reflected the views of those who responded, and made recommendations to Ministers about, inter alia, therapeutic cloning.

  3.  Many respondents to the consultation saw benefit in new therapeutic uses of cell nucleus replacement (CNR) techniques ("therapeutic cloning"), which might be developed to treat serious medical conditions. Some of the therapeutic advances now being developed were never envisaged when the 1990 Act was drafted. Therefore, the Report recommended that the Secretary of State for Health should consider specifying in regulations two further purposes for which the HFEA might issue licences for research, so that potential benefits could clearly be explored: first, for developing methods of therapy for mitochondrial disease; and second, for developing in vitro cell-based methods of therapy for diseased or damaged tissues or organs.

  4.  The most likely objective of a research project involving the use of CNR would be to create a cultured cell line for the purposes of cell or tissue therapy. The eventual clinical use of such procedures would be to provide immunologically compatible tissues for the treatment of degenerative diseases of, for example the heart, liver, kidneys and cerebral tissue, or repair damage to skin or bone. The potential value of such techniques to human medicine is enormous. We noted, however, that these possibilities were speculative, and unlikely to be available for clinical testing for a decade or two, but agreed that it would seem unwise to rule out absolutely any lines of research (not involving reproductive cloning) that might prove of therapeutic value. Our review of the published research at that time led us to conclude that it seemed likely that applications for research projects involving CNR in human oocytes may be received by the HFEA within the next few years.

  5.  Since therapeutic approaches to disease or tissue damage are not at present included in the purposes for which research can be licensed under the Human Fertilisation and Embryology Act 1990, the making of new regulations would be required to extend the scope of the Act to include these purposes.

  6.  Another potential future application of CNR would be for the avoidance of mitochondrial diseases. It has been suggested that a woman suffering from such a disease could have a healthy child if the nuclear material from one of her eggs was transferred before fertilisation into a donor egg from which the nuclear material had been removed. Nuclear replacement from one egg to another is not cloning, since after fertilisation the embryo is not identical to the mother, nor to any other embryo. Similarly, because the use of CNR for the avoidance of mitochondrial disease is not at present included in the purposes for which research can be licensed under the HFE Act, the making of new regulations would be required to extend the scope of the Act to include this purpose.

  7.  We should also point out that there was a significant response, primarily from individuals, rejecting all research using human embryos. However, the Human Fertilisation and Embryology Act permits licensed research on human embryos up to 14 days of development (this stage of development immediately precedes the primitive streak stage at which development of individual embryos is established and cell determination for the future foetus sets in). During the passage of the Bill, an amendment to prohibit the creation of embryos for research was defeated by a large majority in the House of Commons and by a very large majority in the House of Lords. Thus the production of a human embryo by CNR for research purposes could be permitted, provided that the research project was licensed by the HFEA according to the strict criteria that such a licence demands.

  8.  Since publication of our Report, there has been a number of further developments in the fast moving field of stem cell research and calls by scientists for this research to be permitted. We therefore welcome the establishment by the Government of the Chief Medical Officer's expert advisory group on therapeutic cloning in humans, which has been asked to give this issue further consideration and report quickly.

October 1999


 
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