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

My Lords, the House will be grateful to the Minister for introducing and explaining the regulations. For the most part, the regulations, although of considerable importance, are not controversial, but the Minister will be aware that segments of them have excited a certain amount of criticism from the Merits Committee of your Lordships’ House. That criticism could not fairly be described as root and branch. Rather, the committee seeks further and better particulars as to why the Government have chosen to adopt the course that they have. The regulations on which its concern has focused are those that cover the approval procedures for the donation of regenerative tissue, such as bone marrow and blood, where the donor is either a non-competent child or an adult who lacks capacity. It will come as no surprise to the Minister that I propose to pick up the points that the committee has so succinctly made on that topic. The first and perhaps principal issue raised by the committee is proportionality in relation to risk. The regulations would establish a procedure that would require the Human Tissue Authority to approve a bone marrow donation where the proposed donor was any non-competent child or an adult lacking capacity. The committee was uneasy about this new layer of procedural bureaucracy given that, as it put it,"““The Department have provided no evidence of current abuse””." In other words, the committee expected rather more by way of explanation of why it is thought necessary to involve the HTA at all in the process, given that codes 2 and 6 are detailed and complex sets of procedural ground rules that must be adhered to in all cases, and given that the degree of risk for the donor when blood or bone marrow is removed is not great. If we take it as read that clinicians have previously satisfied themselves that the procedures may properly and ethically be carried out according to the codes, what added value does HTA approval bring? Is it right that the transplant procedure should be held up because of the need for approval from an outside body? We need to hear something from the Minister about that, especially on the issue of risk. Why do the Government consider that the risk attaching to such procedures for those categories of donor is of such a degree as to warrant the involvement of the HTA? As I understand it, the results of the public consultation were not clear cut on the issue. In passing, I note the committee’s criticism that the consultation document contained less in the way of specifics than it might usefully have done. Not only do the regulations require a new, additional approval process for such cases, but it imposes criminal sanctions for two offences: failure to comply with the consent procedures laid down; and using reward to attract donors of bone marrow and blood cells. We all appreciate that there must be sanctions in the event of non-compliance with the laid-down procedures, but both codes 2 and 6 contain considerable sanctions in the form of withholding licences. Why do the Government feel it necessary to move a procedure currently subject to no regulation whatever into a regime that is not only regulated but the subject of criminal penalties? I recall our lengthy debates on the Human Tissue Act and the Mental Capacity Act and the importance that we all attach to the overarching principle of best interests, especially where a procedure is not for the therapeutic benefit of the donor. As the committee notes, we come back to risk. In the case of regenerative tissue as opposed to whole organs, there appears to be no incidence of trafficking, the consent regime appears to have been unproblematic, the clinical risk to the donor is relatively small and, as I have said, sanctions already exist in the event that anyone is tempted to ignore the rules. Against that background, the committee has implicitly posed the question: are not criminal penalties for these particular infringements excessive? The committee’s final criticism is that the new rules are not as clear as they might be. One example is the meaning of the word ““reward””. The HTA, when giving approval for a procedure, must be satisfied that no reward has been given for a donation. As the committee’s report asks, however,"““if a child is given a toy aeroplane for donating bone marrow to his brother, would that count as a reward under this definition?””" On a broader level, the donation of bone marrow by competent children and adults is not covered by the regulations, but the donation of bone marrow by a non-competent child or an adult lacking capacity is to be regulated for the first time. The regulations are quite complicated, even with the benefit of the Explanatory Notes. What steps are being taken to issue clear guidance to professionals in the field on what the rules comprise? I hope that the Minister will be able to shed some light on these issues.