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Human Fertilisation and Embryology Bill [HL]

My Lords, after consulting the Minister, it seems appropriate that I should now speak to Amendment No. 26 which is also tabled in my name. This amendment relates to consent by parents and guardians on behalf of children lacking capacity and seeks to ensure that research involving the tissue and cells of such children to create embryos and human admixed embryos can be undertaken in important but limited circumstances, subject to strict safeguards. The Bill does not currently make any provision for parents or guardians to consent on behalf of their children. This has the regrettable side effect that it will in future be impossible to carry out embryo research using cells from sufferers of serious or life-threatening diseases that exclusively affect and usually kill children, such as muscular dystrophy, Batten disease and many more. This removes a vital route to increasing our understanding of the development and causes of these terrible diseases. This amendment makes provision for those with parental responsibility to give consent for their children where they lack capacity to consent, provided each of the conditions set out in the amendment are met. The conditions include that it is not possible to undertake the research using tissue or cells from donors with capacity and that the tissue or cells were lawfully collected, deriving, for example, from blood, muscle or tumour tissue removed with parental consent for treatment or diagnostic purposes. There must also be no knowledge that the donor indicated any objection. This research would, of course, be subject to the scrutiny of the HFEA and an NHS research ethics committee to the requirements of the common law concerning the removal of the tissue and to the regulatory requirements of the Human Tissue Act. This is a vital amendment. I gave an example in Committee. Much of my earlier research involved muscular dystrophy. The most severe form of muscular dystrophy is called the Duchenne type and occurs in young boys. It begins to cause difficulty in walking early in life. By the age of nine or 10 those boys are confined to a wheelchair and many do not survive beyond the age of 20 or thereabouts. It is now known that it is possible to diagnose that condition in the newborn infant by taking a blood sample and a small sample of muscle by needle biopsy. If a therapeutic opportunity arises, if a new treatment becomes available, it is clearly important that the treatment should begin immediately after birth in order to prevent the breakdown of the muscle which is so significant a feature of that disease. There are now five trials of treatment continuing in the UK and in other parts of the world using various forms of treatment for muscular dystrophy. On Report the Minister suggested that, because an infant or child below the age of consent was incapable of giving valid consent, this would not be a possible form of research. If that argument were pursued to its logical conclusion, it would make the practice of paediatric medicine virtually impossible because, for diagnostic procedures and treatment to be given to young infants and children, parental approval is necessary. The General Medical Council and the BMA in its handbook, Medical Ethics Today, have made clear the carefully defined circumstances in which research involving children with explicit parental consent is feasible. For that reason it is crucial that this amendment or something very like it should go in the Bill to enable such diagnostic work on infants to be carried out. In the case of the muscular dystrophy patient, if you can diagnose the condition at birth, it would not be impossible to take a tiny sample of skin to create an admixed embryo and a stem cell development of muscle cells to treat the condition. This kind of research is at the cutting edge and must be pursued.