Human Fertilisation and Embryology Bill [Lords]

The hon. Gentleman has intervened a lot and he has also spoken. If I could make some progress in answering the points that he has already made, I would be happy to give way later. He owes the Committee an explanation of whether his motivation is just that he is completely against this Bill and its provisions. That would be a legitimate position, but it would be helpful if he could make that clear. Amendment No. 18 would limit to regenerative tissue the cases in which embryo testing can be used where the intention is to use tissue other than bone marrow or cord blood. It is our view that that might prevent the use of some potentially desirable types of tissue in the future, such as cells of the umbilical cord itself. Amendments Nos. 15, 16 and 17 address the issue of whether a disease is life-threatening. Embryo testing allows families with inherited genetic conditions to avoid passing on the particular condition that affects them. The HFEA has licensed more than 80 conditions for pre-implantation genetic diagnosis, including Huntington's disease, muscular dystrophy and cystic fibrosis. Three of the purposes for which an embryo can be tested relate specifically to medical conditions, and the Bill specifies that embryo testing for those three purposes can be done only when the condition is serious. I accept the points made in the debate that that Bill does not contain a definition of ““serious””. The HFEA will have to determine how that term should be used in practice when considering the appropriateness of embryo testing for any particular condition. We expect its ethics committee, using its full experience as an authority, to make appropriate interpretations. Amendments Nos. 15 and 16 would change the test required to license a condition for some of the embryo-testing purposes from ““serious”” to ““life-threatening”” or"““severely impairs…quality of life””." The effect will be to tighten the criteria for which some types of embryo testing can be carried out. As I have said, embryo testing is not a trivial process. It involves invasive stages of IVF including the drug regime and egg collection, plus an additional stage of testing, which will ultimately reduce the numbers that are suitable to be placed in the woman. People would not and do not undertake the process lightly or for trivial conditions. How much effect the amendments would have on practice would depend on how the criteria are applied. The HFEA would still need to consider what makes a condition life-threatening: whether such a condition is one that shortens the life of the affected person by a number of years, or one that causes death in childhood. How much of an impairment must the condition be to the person's quality of life? Those are difficult decisions. The use of the word ““serious”” in the Bill is to determine for which conditions embryo testing is appropriate. It gives a strong steer about what kinds of conditions can be tested, while allowing scope for the HFEA to apply definitions using its licensing experience. Amendments Nos. 24 to 30, tabled by the hon. Member for Oxford, West and Abingdon (Dr. Harris), relate to the use of the word ““abnormality”” in embryo-testing provisions. He seeks both an alternative description and an extension of the provisions. Under the amendments, the embryo-testing provisions would be extended to allow the testing of combinations of genes, as well as genes that are not necessarily harmful on their own but could be in combination with another factor. That would involve testing for genes that in the majority of the population are normal variants and would not necessarily cause a medical condition. The amendments go further than the provisions in the Bill, and the Government have concerns that as currently drafted the effect might not be as intended. The Bill reflects current HFEA policy, and we are not aware of anyone having used the technology for the wider uses envisaged by the amendments to date. For some people, that type of testing would be considered a step too far. However, we recognise the desire for future-proofing of the legislation. Accordingly, we have allowed for that via a secondary power enabling the provisions relating to embryo testing to be amended in the future. Such regulations would be subject to the affirmative procedure. The amendments are not appropriate as they would allow testing for conditions that to date the HFEA has not licensed. If necessary in future, the legislation could be amended using the regulation-making power. Amendments Nos. 19 and 20 seek to remove the regulation-making power so that the provisions in the Bill when enacted could not be updated if necessary—a point to which Members keep referring. To ensure that the desirable purposes of testing can be permitted, and the undesirable ones prohibited, the regulation-making power is appropriate. The amendments would not allow the legislation to keep pace with science and would limit the longevity of the new Act. Let me deal with amendments Nos. 14, 31 and 32, on licences for therapy. Under the 1990 Act, the HFEA is given the power to issue licences in respect of four types of activities: treatment, non-medical fertility services, storage and research. The Bill does not change that. The amendments tabled by the hon. Members for South Cambridgeshire (Mr. Lansley) and for Oxford, West and Abingdon would add the further specific category of the licensing of the creation and use of embryos for therapy—that is, the creation of embryos to generate embryonic stem cells for use in the treatment of disease that is not infertility related. The Government have always supported the use of embryonic stem cells in the development of treatments for serious diseases and medical conditions. Following discussion in the House of Lords, we gave the need to license non-reproductive therapies serious consideration. The Government are of the view that the licensing framework that would be in place following the introduction of the Bill would allow for the derivation of embryonic stem cells if it took place as part of a research project. In the vast majority of cases, it is highly likely that clinical research would be involved. The Bill would then allow the development of those cells into a therapeutic product without the need for further amendment. Any embryonic stem-cell line that is intended for therapeutic use will need to undergo considerable safety assessment and then a substantial research phase involving pre-clinical and clinical studies. Each and every cell produced with the intention of treating disease would be different, and therefore each and every cell line produced would require the same clinical research, including pre-clinical and clinical studies. It is therefore unlikely that stem cells will be taken directly from an embryo and inserted into the patient. Even with the most advanced and effective protocols for stem cells and for the differentiation of those stem cells into the tissue required, the pre-clinical and clinical testing of those cells will invariably be required before wider use can be sanctioned. As we have explained in detail and in a letter circulated to the House of Lords, it is therefore difficult to envisage a situation, despite the propositions that we have heard, where stem cells will be used for patients without some element of research involving pre-clinical and clinical studies. That would be the appropriate time at which to consider what further regulatory framework we need. Some hon. Members are concerned that if embryonic stem cells are derived under a research licence they cannot be used in treatment, because that goes beyond research. Let me address those concerns. Regulatory oversight by the HFEA finishes once a stem cell line is derived. That means that once embryonic stem-cell lines have been developed, the HFEA regulatory framework under which the embryo was produced is not relevant to any further use of that cell line, whether for further research or for treatment. The Medical Research Council has recently made available £3 million in order to allow the consideration of 25 embryonic stem-cell lines for therapeutic application, which is to be awarded to research projects in that area. That reflects recognition of the potential for the creation of embryonic stem cells for use in therapy. The House should consider what it does next when that potential is closer to realisation. I hope that my comments have been helpful and have shown why the Government's view is that the clause and schedule, as drafted, should remain unamended.