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Human Fertilisation and Embryology Bill [HL]

My Lords, these amendments seek to place strict criteria upon the requirements which must be satisfied before an embryo or human-admixed embryo research licence can be issued for any research project. We have set out in the Bill a framework of regulation for human admixed embryos, which is equally as robust as that in place for human embryos at present. There will be an absolute time limit banning the keeping of embryos beyond 14 days’ development and an absolute prohibition upon the implantation of a human admixed embryo in a woman or an animal. Amendments Nos. 9 and 41 seek to change the criteria by which the HFEA considers applications for a research licence. Such research will be permissible only with a licence from the HFEA, and only in circumstances in which the HFEA deems the research necessary or desirable for one of the statutory purposes, and the creation of embryos is necessary. In making such decisions the HFEA will be required to take into account other avenues of research available which may achieve the same end, according to the criteria already imposed in the legislation. The HFEA has for nearly two decades licensed embryo research. In that time it has, through the provisions of the 1990 Act, been given the flexibility to form and utilise its own tests on whether the use of embryos is necessary in each licence application. The extra criteria which this amendment seeks to impose on the HFEA do not need to appear in the legislation. The authority already considers each of the new criteria stated, as part of its interpretation of the test of necessity. In addition, the requirement that research should already have been successfully attempted using animal embryos is appropriate in some, but not all, cases. Any application to undertake embryo research should have a firm evidence base upon which the detail of the research project is founded. The evidence base may include information gained through animal embryo research, or could equally be data from research conducted through other means. Human and animal physiology and genetics are close enough for animal embryo experimentation to provide a good model upon which to test research methodologies. However, we need to recognise that the differences which are present can mean that research which works in an animal model does not work in humans, as highlighted by my noble friend Lord Winston. This principle also works in the other direction, and research may fail to get satisfactory results in animal models, where clear successes occur in human models. Animal research is clearly vital for better achieving success in human embryo research. However, research using human embryos must not be strictly limited to being undertaken only in cases where animal models have shown success. The authority has effectively made decisions on the necessity of using human embryos in research, and will always look to animal-based evidence in deciding whether a research project application is valid. It should retain the flexibility, however, to be able to license research in those cases where evidence from animal embryo experimentation is not available or not relevant. Regarding the requirement in the amendments that the research should be likely to produce satisfactory results, I should point out that this approach is undertaken by the authority through the peer review process for each research licence application, as highlighted by the noble and right reverend Lord, Lord Harries. Lastly, as regards the requirement that the research cannot be satisfactorily achieved by means other than through embryo research, adult stem cell research, embryonic stem cell research, and reprogrammed stem cell research each hold out promise to the sufferers of many wide-ranging diseases and medical conditions, as we heard. The sufferers of these diseases should not have valid avenues of research, such as embryonic stem cell research, limited because of the possibility that a treatment may be developed in the future by other means. Until diseases such as these, and many others, have a clear treatment available it is only right that we allow all avenues of research to proceed—I stress under regulation—in the hope of cures being developed as soon as possible. A rigid framework of criteria set out in legislation would seriously limit the research which the HFEA can license, which would surely be a great loss to those suffering from serious medical conditions, who are hoping that cell-based therapies will be developed and used within their lifetime. As regards the point made by the noble Lord, Lord Patten, on the appointment of HFEA members, a wide range of criteria is used to determine the type of members appointed. These take into account the skills and expertise that the HFEA requires at that particular time. It would obviously be difficult for someone to be appointed to the HFEA who, for example, fundamentally disagreed with IVF. I invite the noble Baroness to withdraw the amendment.