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Human Fertilisation and Embryology Bill [HL]

moved Amendment No. 75: 75: Schedule 3, page 64, line 41, at end insert— ““Cases where consent not required for storage and use for research 10A (1) The human cells of a person (““the donor””) may be used to bring about the creation of an embryo or inter-species embryo in vitro and any embryo or inter-species embryo so created may be used or stored for the purposes of any project of research without the donor’s consent if the following conditions are met. (2) Condition A is that the human cells are lawfully taken from or provided by the donor. (3) Condition B is that the human cells were first stored or used prior to the day on which section 12 of the Human Fertilisation and Embryology Act 2008 comes into force. (4) Condition C is that the human cells, embryos or inter-species embryos are used in circumstances such that the person carrying out the research (““the researcher””) is not in possession and not likely to come into possession of information from which the donor can be identified. (5) Condition D is that it is not reasonably possible to contact the donor to obtain their consent. (6) Condition E is that there are reasonable grounds for believing that research of comparable effectiveness cannot be carried out if the project of research for which the human cells, embryos or inter-species embryos are stored or used has to be confined to, or relate only to, material in relation to which there is an effective consent. (7) Condition F is that it does not appear to the researcher that the donor has indicated any objection to such use or storage (as applicable).”” The noble Lord said: My Lords, this amendment concerns allowing existing cells and cell lines to be used in research involving somatic cell nuclear transfer or admixed embryos. As noble Lords are well aware, medical and biological research is about taking tissue, cells and cell lines from diseased patients to better understand the progression of diseases in the attempt to find treatments and cures. All medical research is based on this principle. The Bill as drafted requires the explicit consent from the donors of any cell used to create an embryo. This effectively blocks the use of many existing cells or cell lines in somatic cell nuclear research. They could include many valuable lines representing specific and rare diseases. I recognise the centrality of consent in research of any sort. However, I also recognise that such research involves a transient, embryo-like stage to permit the derivation of stem cells. The research would never create embryos for further development or implantation. The amendment is not about the donation of material for fertility treatment. However, there are existing cells and cell lines which have been completely anonymised so that the original donor is untraceable. In other cases, donors have been told that they will not be contacted again about research. The amendment creates a limited exception for some of these cells or cell lines to be used. Provision was made in the Human Tissue Act 2004 for existing holdings of tissue containing cells to be legally stored and used for research purposes when anonymised in form. They were thus exempt from the consent requirement of that Act. This amendment will impose strict safeguards on the application of the exception, which will be overseen by the regulator and research ethics committees. These safeguards have been expanded following Committee, and the amendment now lists seven different exceptions. The discussions in Committee most notably turned on limiting the existing holdings of anonymised tissue where it is not reasonably possible to contact the donor to seek consent. The exception is subject to a number of important conditions, including the condition that no alternative sources of tissue for which effective consent can be obtained are available, and that there should be no evidence that the donor would have objected to this use. As with any research, approval would have to be required from both the HFEA and the relevant research ethics committee. This will ensure that in exceptional, deserving cases, vital resources are not wasted and important research can be carried out. The significance of a collection gathered over many years of tissue, cells and cell lines from patients with severe, life-threatening diseases, which my amendment refers to, must not be underestimated. To demonstrate the level of support for this outside this House, I shall quote from a letter from various patient-based charities written to the noble Lord, Lord Darzi. The bodies include the Association of Medical Research Charities, the Muscular Dystrophy Campaign, the Parkinson’s Disease Society and many others. They said: "““The creation of pluripotent embryonic cell lines using somatic cell nuclear transfer will be a valuable research tool to gain greater knowledge of specific disease conditions. Scientists in the UK currently use tissue and cell samples donated by patients for basic research although a substantial number of human cell lines are also commercially available. These valuable donated resources will become unavailable as soon as the retrospective requirement for donor consent to use these cells for SCNT currently in the bill comes into effect. These tissues and cells were donated with the explicit condition that the donor/patient was giving consent for their use in research to help find treatments and potential cures and in many cases it is now impossible to trace them back to the original donors. A specific and telling example relates to Spinal Muscular Atrophy. At a clinic in the US, there are tissue and cell samples donated from over one hundred patients with SMA which could be used to create human embryonic stem cell lines that could model this devastating disease in the lab. As the Bill stands, it would become illegal to use these cell lines””." Let me give an indication of how scientists who work in this field feel. Today in the Times there are three relevant articles, one of which is a letter from scientists working in stem cell science or related stem cell research. It is headed by three Nobel Laureates in medicine and physiology—Sir Martin Evans, Sir Paul Nurse and Sir John Sulston. It is signed by others such as Sir Ian Wilmut and Dame Julia Pollock. I shall not go through the whole list; 27 of the most distinguished men and women scientists and others in our country have signed the letter. Would they do so if they did not think this was of the utmost importance? Would they put their credibility on the line as serious scientists if they did not think that this was a very important issue that they wish the Government to consider? The lead article on the ““Comment”” page in the Times also makes the point. It states: "““Stem cell research as a whole opens up huge opportunities for progress in the effort to cure or contain conditions such as Parkinson’s disease, diabetes or motor neurone disease among many others. Yet the use of embryonic tissue also, of course, raises ethical questions””." We all recognise that. The article continues: "““There is a need to strike a balance between these considerations … The principle of consent as such is not at stake here. There is no dispute about it, nor is there debate over whether those who make contributions of this kind in the years ahead should be asked if they would care to make an exception, on moral grounds, to anything which might become connected with embryonic stem cell activity. What is being suggested, however, is that it should be presumed retrospectively that, as some donors who it is impossible to contact might have objected to being associated with this branch of research, there should be a blanket prohibition in this area””." There is also a further article written by the science editor which makes exactly those points. This is an important issue. These cell lines, tissue banks and cells are an important collection. Scientists exchange them throughout the world to study diseases and disease progression in an attempt to find treatments and to test and find new drugs. Without being able to research on the existing lines they will have to create further lines. This will take resources and a very long time. Others outside the United Kingdom may not be bound by such a regulatory regime. I am not asking for blanket coverage to allow scientists to use this collection; seven stringent conditions in the amendment will have to be met. I beg to move.