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Human Fertilisation and Embryology Bill [HL]

My Lords, in speaking to this amendment, so skilfully moved by the noble Baroness, Lady Knight of Collingtree, I must declare two interests: first, many years ago, I was president of the General Medical Council; secondly, I am now an honorary life president of the Muscular Dystrophy Campaign. When I was president of the GMC, we struggled for years with the problem of informed consent. However, there is no question but that the medical profession accepts that the principle of informed consent lies at the core of medical practice. It is absolutely right that a doctor may recommend to a patient the appropriate treatment for his condition but it is up to the patient, having fully appreciated the circumstances relating to the treatment recommended, whether he should accept such treatment. Therefore, he must give his informed consent. Within the law and within medical practice, he is fully entitled, if he so wishes, to refuse that consent, even if it results in death. The same principles were adumbrated in the General Medical Council’s advice about medical research. It was made absolutely clear that an individual patient could be involved in medical research only with his fully informed consent. However, the issue arose of whether a child who was below the age of valid consent, in other words a child who was not Gillick-competent in terms of law, could give consent. If the child was not, the issue arose as to what would be the proper course of action in relation to such research. Although I wholly appreciate the valid points made by my noble friend Lord Neill, the GMC recommended, and that recommendation still holds, that it would be proper for a parent to give consent on behalf of a child to participate in research if it could be shown that the research in question could lead to developments that would be to the benefit of that child as an individual. I think that that remains at the core of this problem. In terms of the amendment tabled by the Government, that would only be possible if the child suffers from a serious medical condition or illness and if the research is linked to that condition—such as muscular dystrophy, spinal muscular atrophy, and so many more conditions which are progressive and potentially fatal. An additional safeguard, which is essential in such cases, is that there must be reasonable grounds for believing that research of comparable effectiveness could not take place with cells from a person who could consent. That is the important issue in relation to research involving children. Amendments tabled in the Commons addressed the issue of cells from an adult who does not have capacity to give consent. They drew particularly on the Mental Capacity Act 2005 to frame appropriate safeguards, including a requirement to consult carers and a requirement that the adult is suffering from or is likely to develop a serious disease or serious disability about which the proposed research is intended to increase knowledge. Again, the important issue is that the research in question would be likely, ultimately, to be to the benefit of that individual. The issue of cells or cell lines stored before the legislation is brought into force is one that has been raised for many years. I was much involved in the discussions in your Lordships' House on the Human Tissue Act 2004. It was clearly stated then that archival material stored over some time and derived from an individual for whom it is no longer possible to give or withhold consent, can be used for research purposes. It is now quite clear that where a cell donor cannot be identified or traced or has died since the cells were stored, the requirement for effective consent can reasonably be waived subject to the criterion that, in the view of the Human Fertilisation and Embryology Authority, research would be adversely affected to a significant degree if the cells or cell lines cannot be used. Where the cell donor has died and can be traced, consent would be required from a person such as a close relative as set out in the clear hierarchy modelled on that found in the Human Tissue Act. I do not believe that the amendment so carefully and explicitly moved by the noble Baroness would be to the benefit of patients at all. I therefore strongly support the amendments tabled by the Government.