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Human Fertilisation and Embryology Bill [HL]

My Lords, thank you. There are two particular issues of concern. One is related to licence to create storage and to use embryos for therapeutic purposes and the other is that of related regulations. I have left aside what I was going to say, because the letter that was circulated, addressed to the noble Lord, Lord Darzi, from the Association of Medical Research Charities, covering the Genetic Interest Group, Muscular Dystrophy Campaign, Parkinson’s Disease Society and Progress Educational Trust, puts it in simple terms that can be clearly understood. The association supports this amendment and says: "““Many avenues of research which target the conditions supported by the signatories of this letter hold significant potential. For some of these conditions, there is currently no cure or effective long-term treatment available to patients. On-going research projects are therefore the subject of much hope for patients with these conditions, who have the opportunity to be treated with specific cell types (such as skin or nerve cells) that have been derived from embryonic stem cells. These will replace the cells that are not functioning correctly, or which have died, and ultimately may provide a cure for the illness. It is vital that this research continues at the exciting pace that it currently shows.""““The HFE Bill, as it stands, has no provision for the granting of licences for the creation, storage and use of embryos in order to provide treatments derived from embryonic stem cells. Like the1990 Act, the Bill only provides for the creation, storage and use of embryos for research purposes. Therapies derived from embryonic stem cells that will require such licences for their creation will hopefully be with us soon; an estimate of five years for some treatments is not overly optimistic. Indeed, a California company, Geron, is in dialogue with the US Food and Drug Administration to initiate a clinical trial with human embryonic stem cells in 2008 for acute spinal cord damage. A number of UK, US, European and Asian academic research groups and companies are testing human embryonic stem cell populations in animal models of Parkinson’s disease, diabetes, multiple sclerosis, heart disease, retinal disorders, and many other serious human conditions, with the goal of translating this important research to the clinic as quickly as possible. It would be very unfortunate if the application of these therapies has to be delayed due to the passage of further legislation””." It is also the view of these organisations, "““that this barrier to the development of therapies through these research avenues will impede investment and slow the pace of research. The worst case scenario, of course, is the development of a save, viable treatment that is then forced to languish unused for years whilst new legislation is drafted and debated, and the HFEA develops a new system to grant licences. This would seem to be a perverse undermining of the core objective of putting this legislation on the statute book in the first place.""““The use of embryos for such therapies was clearly envisaged by Parliament in 2001 when both MPs and peers voted overwhelmingly to allow therapeutic cloning research to take place as that was part of the justification for extending the research purposes to include developing treatments of serious disease. It is also reflected in the terms of the EU Human Tissues and Cells Directive and the EU Advanced Therapies Medicinal Products Regulation, both of which explicitly cover the use of stem cell therapies””." On the regulations, which are rather complex, I have some comments about the context in which the amendment is tabled. The amendment would permit embryos to be created, stored and used for purposes of therapy rather than just, as at present, for infertility treatment and research. There has been extensive debate and consideration of how best to regulate the use of stem cell therapies and that is reflected in the existing body of law and policy. An additional category of licences for therapies should not be seen as a step into the unknown, but an amendment to bring the legislation into line with the wider context of regulation in this area. There is already a considerable body of regulation relating to cell-based therapies in the UK, with which we would have to comply in order to take a cell-based therapy from the laboratory to clinical practice. The research licence granted by the HFEA represents only an early step in an ongoing process, which is now dominated by the regulation of advanced therapies, including stem cell therapies. However, HFEA licensing is an important initial stage, not least because good manufacturing practice facilities’ requirements will track back to ensure that the correct regulatory requirements have been met at each stage. I shall demonstrate that with an example. If the HFEA had granted a licence for research purposes to carry out research on an embryonic stem cell line that was created, and that line was subsequently taken for treatment purposes, it will help us to go for an initial clinical-phase trial, which will be carried out in animals. If it progresses to being used for therapy in humans, it will require the approval of the MHRA, and it will have to comply with the Human Tissue Act and the European Union directive. I could go into a lot of detail about that. In effect, it would not be recognised by those directives and a new line would have to be created under GMP facilities, which would have to be tested again in a first-phase trial in animals before it could go to clinical trials. That process in itself might take up to two years, so that much time will be lost as regards trials for human therapy if we do not allow the creation of embryos and storage for therapy purposes. In this country, both the MRC and the NHS have invested in upwards of five departments, each costing more than £1 million, providing facilities for good medical practice. To allow those departments to carry out in vitro fertilisation, embryos are created in that environment and, therefore, stem cell lines are also created in those GMP facilities. We also have a stem cell bank, with an investment of nearly £3 million a year, to maintain stem cell lines in appropriate condition, not only for research, but to characterise them, to improve them, to make them the best available lines in the world and to make those lines available for therapy. To this day we have no line that can be used for therapy in a bank which has 48 lines. Others in the world have lines that are usable for therapy; some of them are commercial and they will charge a lot of money. If it were permissible under the regulatory authority, our scientists are considering forming a consortium, and those lines would be available for both research and treatment subsequently. It is not necessary that they lie dormant until a therapy is found—they could be used for research. Importantly, they will meet the regulatory directives of the MHRA, the tissue authority and the European directives. When one thinks about it, it seems rather foolish that, when we are about to embark on many clinical trials, we do not have such lines for therapy. It is only a matter of agreeing whether that should be allowed and that the HFEA should have regulatory powers to deal with it. I am trying to be brief, but I hope I have convinced the House that there is a need for such lines. I am pleased that others have put their names to the amendment. I beg to move.