Reproducing regulation: issues arising from the Human Tissue and Embryos (Draft) Bill

A Parliamentary committee has recently challenged several proposals in the UK Government's draft revised legislation for assisted reproduction and embryo research, published earlier this year. These areas of biomedical research and personal reproductive decisions raise important ethical and social issues. As such, the committee report is welcome, because it re-opens much-needed debate on these issues. It is expected that the Human Tissue and Embryos Bill will be in the Queen's Speech in November, making this year a crucial one for assisted reproduction, pre-implantation genetics and human embryonic stem cell (ES cell) research.

The Joint Committee of both Houses of Parliament, set up to undertake pre-legislative scrutiny on the draft Bill, reported at the end of July. It rejects the Government's key proposal to merge existing regulators to form the Regulatory Authority for Tissue and Embryos (RATE). Retaining the Human Fertilisation and Embryology Authority (HFEA) and the Human Tissue Authority (HTA), it says, will provide better regulatory oversight through each having a sufficient number of members with the relevant expertise. The committee also recommends establishing a clear framework of devolved regulation, giving greater regulatory freedom and authority to the regulator and clinicians, except where there is good reason to do otherwise.

Many professional and lay organisations have been involved in the debate over human embryo research and the services that flow from it since the 1980s. Particularly influential in the run up to the 1990 Human Fertilisation and Embryology (HFE) Act was the research progress in developing PGD a clear example of benefit to families threatened by genetic disease. However, despite it avoiding the need to consider an abortion, the pro-life lobby argued against PGD because, like embryo research, it results in the destruction of pre-implantation human embryos. After very wide debate, the HFE Act was passed, establishing the HFEA to license treatments involving IVF and permitting licensed research on human embryos up to 14 days in culture.

Since the HFE Act, the offer of PGD has become an important adjunct to prenatal diagnosis as a service to couples whose reproductive confidence has been destroyed by the high chance of transmitting a serious genetic disease. A case has to be made to the HFEA for each new type of PGD that a centre performs. The draft Bill proposes that a licence can only be granted for this purpose if 'there is a significant risk that a person with the abnormality will have or develop a serious physical or mental disability, a serious illness or any other serious medical condition' (Schedule 2, 3 (2)). The wording follows the current HFEA Code of Practice and indeed reflects the law relating to abortion for fetal abnormality. A number of factors to be considered in applying this rule are listed (para (3)(a) to (e)) - the extent of the impairment having regard to treatment available, the age of onset, the rate of degeneration, the proportion of those testing positive who would be affected and the reliability of the test. Again, there is a close fit with the HFEA Code. However, while the Code of Practice says that the views of the prospective parents concerning the meaning of 'significant' and 'serious' should be taken into account, the draft Bill does not. This will be of concern to those seeking PGD.

In the same way that the scientific advances in PGD acted as an important backdrop in the lead up to the 1990 Act, so human ES cell research is performing a similar function now. With the claims of the Korean scientist, Woo-Suk Hwang discredited, it has become clear that establishing human ES cell lines for research by using SCNT to transfer nuclei from patient cells into enucleated human ova - 'therapeutic cloning' - is currently extremely challenging, with a very poor success rate. More methodological research is needed if ES cells of a particular genetic makeup are to be obtained. Given the understandable shortage of suitable human ova, a promising alternative is to use animal (eg. rabbit or bovine) enucleated eggs. Other forms of inter-species embryos are already being used in research or have potential research uses in the future, but the Government still proposes to ban some forms of hybrids or chimeras even though, as research embryos, they fall within the 14-day limit in culture and transfer to a woman is prohibited. One view is that there is no logical reason why research on embryos that are arguably 'less human' should be subject to legislation that is more restrictive. Amongst those who oppose the use of inter-species embryos there will be some whose views are simply opposed to all types of research on human embryos. The joint committee was divided on this point and called for a free vote in Parliament on whether or not the creation and use of inter-species embryos in research should be prohibited.

If Parliament votes for the use of licensed inter-species embryos in research, then in keeping with their general view of devolved regulation, the joint committee believes the regulator should decide on individual research proposals regarding inter-species embryos as defined in the Bill.

Attempting to prescribe in law the precise nature of embryos that may be created for research purposes could prove unwise, since no-one knows exactly where future lines of inquiry may lead. Equally, many feel that there are good reasons to resist the temptation to try and define too precisely in primary legislation what embryo selection (PGD) can or cannot be permitted for. These intensely personal decisions need to be handled on a case-by-case basis. Another intensely personal parental decision is when to inform children that they were conceived using donor gametes. The committee favours putting this fact on the child's birth certificate and asks the Government to consider this.

The controversial parts of the draft Bill described above - along with the issues surrounding infertility treatment 'tourism' and patient confidentiality - will be discussed at Progress Educational Trust's annual conference, to be held on 1 November 2007 at the Institute of Child Health in London. All interested individuals are invited to join us, both to hear the opinions of others and to add your own voice to the debate during this key time for the future regulation of fertility treatment and embryo research in the UK. Bookings are now being taken - see 'Recommends' for details of speakers and how to register for this event.