The Government considers that there is a need for this change in the law as a result of a High Court judgement on 15 November which established that embryos created other than by fertilisation are not regulated by the 1990 Human Fertilisation and Embryology Act. This is an outcome that the Science and Technology Select Committee warned the Government against in 1997 (More details about this are outlined in the press release I recently issued on the subject.) The Select Committee recommended that the Government should change the definition of embryo in the HFE Act to make it clear that it includes those created by cell nuclear replacement (cloning) or any manipulation of cells which results in an organism potentially capable of growing into a human, and not just conventional fertilisation. This would have the effect of ensuring that all research on embryos, however created, was fully regulated by the Human Fertilisation and Embryology Authority. However, the Government has rejected this approach. An appeal is being lodged against the High Court judgement and although there is no imminent threat of cloned embryos being created nor of resultant cloned babies being born, the Government is introducing emergency legislation. The Human Reproductive Cloning Bill has been introduced in the Lords and will be considered by the Commons on Thursday 29 November.

The legislation places a complete ban on Human Reproductive Cloning which will become an offence, punishable by up to 10 years imprisonment or a fine, or both, if a person places in a woman any embryo that has not been created by fertilisation (using sperm and eggs). Whilst I support this legislation in principle, as I agree human reproductive cloning should be banned, unless the Government is successful in its appeal, it will still be necessary to revisit the issue of "therapeutic" cloning which, in the light of the High Court judgement, is currently unregulated.

The Government’s position on the use of embryos created by cell nuclear replacement for research (therapeutic cloning) is to await the result of its appeal and also the publication of the Report of the House of Lords Select Committee on stem cell research.

Research on embryos is permitted up to 14 days after fertilisation and requires approval and a licence from the Human Fertilisation and Embryology Authority (HFEA) set up under the 1990 Act to strictly regulate these matters. The 14 day cut-off is based on the earliest time at which the microscopic clump of cells starts to form the beginnings of what would eventually turn into the central nervous system. Up to that stage, the embryo is a hollow ball of about 100 cells, called a blastocyst, smaller than a full stop. The component cells are called stem cells because they have not differentiated but each one has the potential to develop into the different cell types which make up the body.

The purposes for which such research is permitted were set out in a list in the HFE Act and it was always envisaged that this could be added to by secondary legislation. The original list included infertility and contraception. Since 1990, research has opened up the possibility of using early embryonic cells to investigate how mature cells can be reprogrammed to the more immature state found in stem cells and made to turn into replacement cells or tissue for diseased organs. The cells used for this research can continue to be derived from IVF treatment or could be blastocysts "cloned" from the nucleus of an adult cell and a human egg cell from which its own nuclear DNA has been removed. The eggs used could only be taken with the consent of a woman donor, most likely a woman undergoing fertility treatment.

Both the HFEA, the Human Genetics Commission and the Donaldson Committee, expert groups set up by the Government, have now concluded that this type of research does not raise fundamentally new ethical issues than those debated when the 1990 Act was introduced. The Act was amended in December 2000 to broaden the range of research that will be permitted to include stem cell studies that have the aim of treating disease and disorders. Despite warnings from the Science and Technology Select Committee the Government, on legal advice, took the view that reproductive cloning (the creation of a viable human life) was already technically illegal but stated its intention to legislate to make it specifically illegal. There is no clinical reason why society would wish to make a genetic copy of a person and to attempt to do so would be extremely difficult and dangerous.

Opponents of the use of embryonic stem cells have pointed out that stem cells can be derived from other sources, notably blood cells taken from the umbilical cord at the time of birth and some adult tissue. These stem cells hold real promise but there are some significant limitations to what can be accomplished with them. The expert groups took the view that the understanding that will come from studying the process of differentiation in embryonic stem cells will enable the techniques that are only presently possible with embryonic stem cells to be possible with stem cells from adult tissue or cord blood. In licensing any research using embryos the HFEA must satisfy itself that there are no other means of meeting the objectives of the research. If the research is successful, it will be possible to derive all stem cells needed through direct conversion of a patient’s skin cells without the need to use embryos. However, as the only source of appropriate stem cells at present is from early embryos, some limited research work on embryonic tissue is essential if we are to achieve an understanding of the conditions under which cells can be programmed.

The Association of Medical Research Charities and the Parkinsons’ Disease Society are strongly in favour of the research which could lead to breakthroughs in the treatment of many debilitating conditions but "pro-life" groups are opposed strongly citing a European Parliament vote in favour of a ban on stem cell research. However, the EU motion also opposes the IVF techniques mentioned above that have been permitted in this country since the 1990 Act. Almost all Labour, Tory and Liberal Democrat MEPs opposed the Christian Democrat motion. Furthermore, the European Union does not have legislative competence in the area of scientific research, and so this Resolution acts to express an ethical opinion only.