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Human Fertilisation and Embryology Bill [HL]

moved Amendment No. 25: 25: Schedule 3, page 65, line 2, 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 a human admixed embryo in vitro; and any embryo or human admixed 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 Schedule 3 to the Human Fertilisation and Embryology Act 2008 comes into force. (4) Condition C is that the human cells, embryos or human admixed 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 human admixed 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 is another amendment that was tabled on Report by my noble friend Lord Patel. Its purpose is to allow existing holdings of anonymised cells and cell lines to be used in embryo research in circumstances where it is not possible to obtain specific consent. The principle of consent underpins this Bill. Consent must be obtained wherever it is reasonably possible to obtain it. The Bill, as drafted, rightly introduces a new legal requirement that consent must be obtained from donors of tissues and cells before such material is used in research involving somatic cell nuclear transfer, in which embryos, or human admixed embryos, are created to generate embryonic stem cells. However, huge collections of cells and cell lines, pre-dating this Bill and scrupulously gathered over many years, have not been specifically consented for use in embryo research and cannot now be reconsented because the donors are untraceable or deceased, the samples were anonymous, or it was agreed with the donor that the individuals in question would not be contacted again. Many of these collections are very scientifically valuable and cannot be reproduced readily, either in a reasonable timescale, or at a reasonable cost. Indeed, they may not be reproducible at all, particularly where they relate to very rare diseases or are accompanied by a wealth of historic associated data, collected over long periods. The use of these collections in embryo research may offer tremendous insights into the development and causes of the serious and rare diseases from which their donors suffered. In the future, of course, researchers will have to take into account the requirement to obtain specific consent in designing and building tissue collections that may be used in embryo research but, retrospectively, this is impossible. This amendment therefore provides a limited, but very important, transitional exception to the requirement for specific consent introduced by Schedule 3. The exception applies only in relation to existing holdings where it is not reasonably possible to go back to donors to obtain specific consent, where the cells or cell lines have been anonymised, and where it is not possible to use other materials for which specific consent has been obtained. The amendment also provides that the material must have been lawfully obtained in the first place and that there must be no indication of any objection from the donor. I quote one major example, from Professor Chris Shaw at King’s College London: "““Over the past 5-10 years we have established primary fibroblast cultures and transformed lymphoblast cultures from patients with motor neurone disease … Because MND is rapidly fatal the vast majority of these patients have now passed away and we could not obtain consent from them. In some of these patients we have subsequently discovered unique genetic mutations.""It is precisely these cells that we would like to use in nuclear transfer experiments to create embryonic stem … cells. The ES cells generated will carry a gene defect that is harmful to motor neurones. We can drive these embryonic cells to differentiate into motor neurones and hope to identify””—" abnormal— "““biochemical events through studies of gene and protein expression and cellular behaviour. These cells may also be used to screen for therapeutic compounds””." There could never be any intention or, indeed, any possibility, that such embryos, created by nuclear transfer and derived from people with these diseases, could ever be implanted into humans or animals. The only purpose of this amendment, and the cell lines that are in existence, is to investigate the processes of diseases occurring in the individuals from whom these cells were obtained. The Minister agreed at Report stage to take this matter away and to come back. I am very grateful for the letter from the noble Lord, Lord Darzi, which says that the Government take the view that such an exception, if accepted, must be proportionate and necessary, and that the terms of the exception will require, "““careful consideration and should be made subject to appropriate safeguards. It will be particularly important that the exception””," if the principles underlying the amendment were accepted, "““should only apply where there would be a significant adverse impact on scientific research in the public interest, if existing cells could not be used. The exception could not be used to overcome mere administrative inconvenience, and to ensure it could not be relied upon inappropriately. External scrutiny will be needed of the operation of the exception and to ensure that the research is in the public interest””." He went on to say: "““The Government believes that a very compelling case has been made for an exception to the consent provisions in the Bill as drafted. We have given a clear commitment to take this issue away for further consideration in the other place””." I understand that that is exactly what the Government intend to do. If I can have an assurance on that issue, I would certainly not wish to pursue the amendment further. I beg to move.