Health and Social Care Bill

My Lords, I declare an interest as chair of the Human Tissue Authority, whose work is affected by the review of arm’s-length bodies and is referred to in one of the amendments. The desire to streamline the governance and regulation arrangements to support high-quality research underlies both the Government’s intentions and the amendments relating to the new Health Research Authority. These are laudable aims which I certainly support and which the HTA also supports wholeheartedly. Researchers want to get on with their research, and from their perspective what is important is that they see a seamless end-to-end and proportionate process for regulation and governance. The HTA has always striven to do exactly that within its focused regulatory remit relating to research while ensuring that the interests of the public are protected. But transferring the HTA’s work in research to the new body, as Amendment 260A proposes, may undermine these aims. I want to focus my brief remarks on that point. The Department of Health clearly has favoured an option to keep all the HTA’s functions together, including research, and will consult on that basis shortly. I believe this is to a large extent because of the HTA’s track record of collaborative working to ensure that the regulatory burden on researchers is minimised. I would be happy to provide a range of examples dealing with NRES, the MHRA, the HFEA, tissue banks and clinical pathology accreditation, but in the interests of brevity I certainly will not iterate them now. Suffice it to say that, in the absence of detail at this stage about how the HRA will operate, it would be premature to make decisions now in haste that we may live to regret later. However, I will briefly set out three reasons why I believe that the HTA’s research functions should not be part of the Health Research Authority. First, if the HTA research function transferred to the HRA, some organisations that now have a single HTA licence for all their human tissue activities, including storage of tissue for research, would then be regulated by both organisations, because their other functions would also need to be licensed. There would, inevitably, be duplication. That could affect 200 establishments or more in the post-mortem sector, which also uses tissue for patient treatment, and the anatomy sector, which also uses tissue for the training of healthcare professionals. Not only would there be duplication but it would increase complexity, increase the burden and increase costs, particularly within the NHS. Secondly, and perhaps most importantly, the HTA is the guardian of consent. Splitting it up, which would be the result of this amendment, could risk a different understanding and interpretation of consent and create potentially lower or conflicting standards in different sectors over time. Thirdly, when the Academy of Medical Sciences review looked at the key issues for researchers, it identified clinical trials approval, NHS R&D approvals and patient information. It is a misnomer to talk about the HTA’s research functions in the same breath as these. Although the HTA has a broad regulatory remit, its licensing remit in relation to research is relatively discrete—it extends only to storage of tissue and its removal from the deceased. The HTA does not license the use of tissue for research, approve clinical trials or approve individual research projects. The HTA reduced licence fees by 30 per cent in the research sector this year and it will make further reductions in 2012-13 as a result of improved efficiency. The marginal cost of regulating research among other activities is relatively low. The HTA will work closely with the Health Research Authority to provide the single point of access for researchers that retains all the strengths of its current systems and fully meets the requirements of the legislation. The HTA wants and expects to be judged on how it achieves that for the benefit of research.