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

My Lords, the issues dealt with in these regulations are complex and sensitive, but I am extremely grateful for the broad support from the noble Earl, Lord Howe, and the noble Baroness, Lady Neuberger. I, too, have read the views expressed by the Merits Committee. As a former member of the committee, I take them extremely seriously. The noble Earl, Lord Howe, spoke of his concern on risk and proportionality, mirroring the concern expressed by the Merits Committee. The donation of bone marrow can be painful and carries significant risks. It is not a minimal intervention. I must stress that HTA scrutiny will be required only in those cases involving donation by a child or an adult who is unable to consent for him or herself. It is consistent with the Council of Europe’s Convention on Human Rights and Biomedicine. We are talking about vulnerable people who cannot consent to the procedures themselves. Therefore, they need a higher level of protection, which is why we believe that this is proportionate. It is right that these cases are fully regulated to ensure that they are subject to proper independent scrutiny. For all procedures relating especially to stem cell procedures, which are rather new, there has not been time to evaluate properly any potential risks. That is another reason why it is important when making regulations to cover those relatively new fields of medicine. The Government believe that it is right that an offence under the Human Tissue Act may be committed if a person knowingly removes transplantable material from the body of a living person for transplantation without complying with the requirements of these regulations. As the noble Earl pointed out, such an act would be an offence. We believe that that is the right way forward and in line with the Human Tissue Act. The noble Baroness, Lady Neuberger, asked what would constitute a reward. The authority will give guidance based on the Act, which defines it as,"““any description of financial or other material advantage””." Having just read the guidance that I have been given, I realise that perhaps that is not as detailed an explanation as noble Lords would wish. I will certainly seek to provide further information in writing. The guidance on the operation of the scheme is set out fully in the codes of practice which have been prepared in close collaboration and in consultation with those working in the field. As I understand it, the codes of practice have been laid before Parliament, so noble Lords are able to see them. I am afraid that I must write to the noble Baroness on whether hair and nail are covered by the regulations. They are rather more specific questions than I am able to answer at this time. Having listened to the debate, I hope that noble Lords will feel that the question of proportionality and risk is in accordance with the serious issues being dealt with in these new regulations. We believe that they are proportionate and that the risks are best addressed in this way. These regulations provide the clearest and most workable framework for dealing with the difficult issues relating to transplantation and consent. They are the product of most careful consideration. While I heard what the noble Earl said about the consultative process and the documents relating to it, I have asked questions about it and I personally am content that the consultation was carried out properly and effectively, and that in drawing up the regulations the responses were taken fully into account. With that, I commend the regulations to the House. On Question, Motion agreed to.