Human Fertilisation and Embryology Bill [HL]

My Lords, I beg to move that the House do agree with the Commons in their Amendment No. 55. I shall also speak to Amendments Nos. 57 to 61, Amendment No. 72, Amendments Nos. 89 to 93, Amendment No. 106 and Amendment Nos. 108 to 113 in this group. Consent forms one of the cornerstones of the 1990 Act. A person’s gametes cannot be used to create embryos without their express consent. Schedule 3 to the Bill amends the consent provisions in the 1990 Act bringing them up to date with new techniques for creating embryos, for example, by requiring consent for the use of cells to create embryos. The Government listened very carefully to concerns raised in this House about this framework for consent in relation to the use of stored cells and cells from children with serious diseases, but also made it clear that any exceptions to the requirement for consent needed to be compatible with convention rights. The government amendments in this group provide for certain exceptions while also providing safeguards in recognition of those rights. With regard to stored cells, the government amendments apply only to cells taken and stored before commencement of the Bill’s provisions and the exception applies only if the HFEA is satisfied that the cells are anonymous and thus the donor cannot be identified, or that the licence holder cannot reasonably trace the donor. If the researcher can identify and trace the donor, then unless the donor consents themselves their cells cannot be used. If the person identifies the donor, and they are found to be deceased, consent would be required from a person, for example a close relative, as set out in a hierarchy modelled on that found in the Human Tissue Act 2004. Before the cells can be used, the HFEA must be satisfied that scientific research would be adversely affected to a significant extent, if the only cells that can be used are cells that consent has been obtained for. The amendments reflect the fact that rare or well researched samples are a valuable asset better to understand and treat serious disease. We have weighed the burden of being unable to use those cells against the rights of the person who originally donated them, and believe we have struck the right balance in the terms of the suggested amendments. Further amendments tabled on Report in the other place rectified concerns about the interaction of clauses relating to the use of cells from deceased donors, and untraceable donors. The amendments enable a researcher to use the cells of untraceable donors where there is reason to believe they are dead, where no relatives can be traced to consent to use of the cells. The amendments also allow cells to be used if a donor’s family can be traced but it is not known, only reasonably believed, that the donor is dead. In these cases, a person in a qualifying relationship can now consent to use of the cells in the same way that they can when it is known the person is dead. In these cases, the HFEA must still be satisfied that the other safeguards are fulfilled before the cells can be used, including the significant adverse impact upon science test. Regarding consent to the use of cells from children, these amendments apply where those children would never be able to give their consent because of age or a lack of capacity. This is the case with children affected by certain aggressive forms of diseases such as muscular dystrophy, Batten disease and spinal muscular atrophy. To this end these amendments propose that children with such conditions who are too young to consent or lack capacity should be excluded from the requirement for effective consent, if a person with parental responsibility gives consent. This exception is subject to strict safeguards which ensure that a child’s cells cannot be used unless the HFEA is satisfied that the child suffers from a serious medical condition; that the research is intended to increase knowledge about that condition or about its treatment; and that there are reasonable grounds for believing that research of comparable effectiveness cannot be carried out using the cells of a person who could give their own consent. On further consideration of the exception for cells from children, it became clear that it was also desirable to make provision to enable the use of cells from an adult who lacked capacity in very limited circumstances. This would be to address situations where, for example, rare genetic conditions lead to the sudden onset of lifelong incapacity. Following the precedent of the Mental Capacity Act, the Government’s amendments propose that in such cases the researcher would need to approach an individual’s carer and consult them on their views about the wishes of the person. The Government felt, for several reasons, that it was appropriate to extend the provisions to adults who lack capacity: first, for the sake of consistency. Without the provisions, cells could be taken from a ““child”” of 17 if they were unable to consent, perhaps because of illness rather than a lack of understanding, whereas tissue could not be taken from someone who was a year older in the same situation. In addition, if this provision was not made, researchers might favour using tissue or cells from children rather than adults when researching these serious medical conditions, because exceptions were made only for these circumstances. It is my view that this would not be appropriate. Again, the exception relating to cells from adults who lack capacity is subject to a number of stringent safeguards. The HFEA must be satisfied that, at the time, the adult lacks capacity and is unlikely to have capacity again; that the adult suffers from a serious medical condition; that the proposed research is intended to increase knowledge about that condition or about its treatment; that there is no evidence that the adult would have refused to participate; and, most importantly, that there are reasonable grounds for believing that research of comparable effectiveness cannot be carried out using the cells of a person who could give consent themselves. In all cases, it will be for the researcher to provide evidence that satisfies the HFEA that all the conditions have been met before a licence to undertake the research may be given. The safeguards set out in the Bill are modelled on the protection provided under the Mental Capacity Act 2005. Research involving people who lack capacity, and the use of their tissue to create embryos, are excluded from the Mental Capacity Act by provisions in the Bill. This prevents any overlap between the two pieces of legislation. These amendments follow the precedent of the Mental Capacity Act and set out stringent safeguards that must be adhered to before the research can take place. Specifically, there is a requirement for the researcher to approach a carer of the person who lacks capacity to consult them on their views about the wishes of the person. Moved, accordingly, and, on Question, Motion agreed to.