Human Tissue Act 2004 (Persons who Lack Capacity to Consent and Transplants) Regulations 2006

rose to move, that the draft regulations laid before the House on 24 May be approved [28th Report from the Joint Committee and37th Report from the Merits Committee]. The noble Baroness said: My Lords, noble Lords will recall that the issues addressed in these regulations were the subject of much debate during the passage of the Human Tissue Bill. The concept of consent is the principle that underlies the whole of the Human Tissue Act. Part 1 of the Act sets out the requirement for consent to carry out activities for particular purposes. The first aim of the regulations is to set out, in Part 2, the circumstances where there is deemed to be consent to activities regulated by the Act in relation to adults who lack the capacity to consent for themselves. Section 6 of the Act states that where a living adult lacks capacity to give consent to the storage and use of their bodily material, the Secretary of State can specify in regulations circumstances where consent can be deemed to have been given. The circumstances in which it was envisaged that Section 6 would be used was signalled by Ministers in Parliament during the passage of the Act. These circumstances are realised in the regulations. They are: first, where it would be in the best interests of an incapacitated person from whose body the material came; secondly, for research, where the research is authorised under the Medicines for Human Use (Clinical Trials) Regulations 2004; and, finally, for research in circumstances that would be consistent with Sections 30 to 33 of the Mental Capacity Act 2005. Part 3 of the regulations deals with transplantation. Section 33 of the Act provides for regulations to: first, allow live donor transplantation if the Human Tissue Authority is satisfied that no reward has been, or is to be, given and that conditions and requirements specified in regulations are satisfied; secondly, provide for a mechanism for the Human Tissue Authority to reconsider its decisions—in other words, an appeals system; and, finally, define what is meant by ““transplantable material”” for the purposes of Section 33. Regulation 10 defines transplantable material as whole or part organs and bone marrow and peripheral blood stem cells. These are the materials that are subject to control and scrutiny, although Regulation 10(3) limits the regulation of bone marrow and peripheral blood stem cells to that taken from an adult or child who is not competent to consent. These potentially vulnerable donors need a higher degree of protection, in line with the requirements of the European bioethics convention, through the introduction of a properly independent element into decisions where the procedure is principally for the treatment of another person. While most donation cases can be dealt with by the authority through a simple executive procedure, Regulation 12 sets out the cases that must be considered by a panel of at least three members of the Human Tissue Authority. Cases requiring this procedure for approval are: the donation of an organ or part organ by a child; the donation of an organ or part organ by an adult who lacks capacity; or where the donor is an adult who has the capacity to consent, but the case involves paired donations, pooled donations or a non-directed altruistic donation. There are cases where a higher degree of protection is necessary because of a combination of factors, including the higher risks involved in removing an organ or part organ compared to regenerative tissue, the inability of the donor to give consent, and, in the case of paired, pooled or non-directed altruistic donations, the novelty of the procedure. Regulations 13 and 14 set out the circumstances in which the Human Tissue Authority may reconsider its decision, and the procedure for dealing with such reconsiderations. Section 34 of the Act provides for regulations to specify what information must be supplied, by whom and to what authority, about transplants, and creates an offence for non-compliance. This power is exercised mainly through the Human Tissue Act 2004 (Ethical Approval, Exceptions from Licensing and Supply of Information about Transplants) Regulations 2006, which were laid before Parliament on 10 May 2006. These require a person who removes transplantable material from a human body for transplantation, or receives such material for transplantation into a recipient, to provide certain information to NHS Blood and Transplant. However, the regulations that we are considering today define in Regulation 9 what constitutes ““transplantable material”” for the purposes of the provision of information. The Department of Health has worked closely with stakeholders, including representatives in Scotland, Wales and Northern Ireland, patient representative groups, healthcare professionals and interested individuals, while drafting these regulations. They were the subject of a formal consultation exercise for a period of 12 weeks between 11 July and 4 October 2005. In my view, the provisions of the Human Tissue Act 2004 (Persons who Lack Capacity to Consent and Transplants) Regulations 2006 are compatible with the European Convention on Human Rights. Before I conclude, I must declare an interest as a patron of Kidney Wales. I believe that these regulations provide a clear and workable framework for dealing with difficult issues relating to transplantation and consent, and I commend them to the House. I beg to move. Moved, That the draft regulations laid before the House on 24 May be approved [28th Report from the Joint Committee and37th Report from the Merits Committee].—(Baroness Royall of Blaisdon.)