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Human Fertilisation and Embryology Bill [HL]

I thank my noble friend for moving the amendment for me, and I apologise to the Committee for having been caught up. The amendment is intended to increase the scope of licences to include creating stem cell lines for therapy. The current provision under Schedule 2 to the Act sets out the activities for which licences can be granted by the HFEA. There are three categories: treatment, storage and research. Schedule 2(1) lists the activities that may be authorised under a treatment licence. It states: "““A licence under this paragraph may authorise any of the following in the course of providing treatment services””." Section 2(1) of the Act defines treatment services as, "““medical, surgical or obstetric services provided to the public or a section of the public for the purposes of assisting women to carry children””." That provision remains the same in the Bill. Paragraph 3(1) of Schedule 2 provides that a licence may authorise the creation and use of embryos for a project of research which has been held to include authorisation of the creation and use of embryos for the derivation of embryonic stem cell lines. Paragraph 3(2) then lists the purposes for which the research licence may be granted. The Bill includes a new purpose: "““developing treatments for serious disease or other serious medical conditions””." However, it is a condition of all research licences that embryos created for research purposes may be used only for the purpose of that project. The problem with that is that there are no provisions in the 1990 Act or the Bill that provide for the creation or use of embryos for the derivation of embryonic stem cells, particularly for the purpose of treating conditions other than reproduction. At present, embryonic stem cell lines from embryos and nuclear transfer for the derivation of embryonic stem cell lines is carried out under a research licence. That will continue until the technology is optimised. However, it is anticipated that, within the next five to 10 years, it will be necessary to derive such ES cell lines specifically for treatment, rather than research. Our current embryonic stem cell lines are all created using rabbit sera as feeder lines. For treatment, it is assumed that these lines will not be useable for treatment. I say assumed because they will use such lines in the United States for the first-stage trial in the treatment of spinal injuries. Regenerative medicine treatments will require the ongoing provisions of therapeutic-grade embryonic stem cell lines. These may be derived from surplus embryos from IVF treatment or following nuclear transplant. In the latter case, they will be genetically similar to the patient and can be used for therapy without the need for anti-rejection drugs. Embryonic stem cell lines may also be derived by nuclear transplant using the nucleus of a patient with a specific disease. Such lines will be used to investigate the disease in the laboratory. This may lead to an improved understanding of the disease and the development of new treatments. We now also have the UK Stem Cell Foundation, which is a government/privately funded enterprise to try to take stem cell therapy to treatment. There are problems with regulatory issues. There is, for example, a high probability that the first clinical trials using ES-derived cells may be approved by the FDA and commence in the US. Due to the differences between the United States and the EU in the regulations that govern standards and the compliance of good manufacturing practice, it will be necessary for any embryonic stem cell for clinical use in the UK to be derived under EU/UK regulations and standards. That is, the cells proposed for the US trial would not be acceptable for use according to the EU cells and tissue directive, which came into force in the United Kingdom in July this year. Many universities and hospital trusts are upgrading their laboratories, even those for in vitro fertilisation treatment, to comply with the current GMP regulations for cell therapy. Our own UK Stem Cell Bank has already been given accreditation for GMP standards by the MHRA and the regulatory authorities. UK scientists and clinicians are discussing a co-ordinated approach for deriving clinical-grade embryonic stem cell lines for future therapeutic use. At this stage, we do not know how many lines we might require, but we are not talking about thousands. Discussions are going on somehow to identify how many lines of clinical-grade embryonic stem cell lines will be required to satisfy the need for research and treatment. Because of the characteristics of embryonic stem cell lines—some people refer to them as being immortal—they can, if kept in ideal conditions, survive and grow for a very long time. I do not think that defining the potential therapeutic use of ES cells derived either from surplus embryos from IVF or through cell technology research is satisfactory, or that legislation keeps pace with scientific and medical developments, and I realise that the amendment goes further than allowing licences for research. I am told that some commercial institutions already have clinical-grade embryonic stem cell lines, but they are not produced in this country. Following the report on stem cells by the committee chaired by the noble and right reverend Lord, Lord Harries of Pentregarth, some of your Lordships recommended that all embryonic stem cell lines created in the United Kingdom should be deposited in the UK Stem Cell Bank and be available to all scientists for research and developing therapy. That applies here too. My amendment would extend this licence to allow this under licence and under regulation: my proposed new Section 3ZA defines the kind of regulation that would be required, so that the HFEA controls the licences that are awarded.