Public Bodies Bill [HL]

My Lords, I thank noble Lords who have moved or spoken to these amendments. I recognise and understand the sentiments underlying them. I do not in the least wish to argue against or downplay the importance of cost effectiveness in any legislative changes that we propose, or of ensuring that the right successor arrangements are in place for discharging the relevant functions of the HFEA and HTA. I therefore hope that what I am about to say will satisfy noble Lords that in most key respects I am in the same place as they are regarding the points at issue. Since our debate on Report I have written to the noble Baroness, Lady Thornton, to set out my reflections on the points that she and others have made. There were common themes: a desire for greater clarity on where the Government intend to transfer the functions of the HFEA and HTA to; concern that the dispersal of functions across a range of bodies would risk fragmenting regulation; and concern over loss of expertise. I have considered these concerns carefully. As I have made clear, we intend to consult in the late summer on the options as to where certain functions would be most appropriately transferred. That remains our aim. However, having taken into account the strength of feeling about keeping functions together, we now intend to proceed on the basis that our preferred option is for all HFEA and HTA functions to be transferred to the Care Quality Commission, except for certain research-related functions that will transfer to the proposed health research regulatory agency. We shall therefore consult on this basis but, at the same time, remain open to receiving views on the way forward from all stakeholders through the consultation process. I hope noble Lords will agree that this preferred option will address concerns about the potential impact of fragmentation. The noble Baroness, Lady Deech, expressed the fear that the Government’s proposals would lead to a vacuum as regards the ethical focus of these bodies—in the decision-making process for research and treatment involving embryos in particular. Let me explain what we intend. Ethical safeguards—for example, the type of embryo and gamete that can be used in treatment, the need to consider the welfare of the child, and the need for consent in respect of human tissue—are clearly enshrined in legislation in accordance with the wishes of Parliament. These safeguards will remain firmly in place. In keeping an integrated approach to HFEA functions, the CQC would be the focal point for ethical considerations of treatment licensing that arise from the Human Fertilisation and Embryology Act. There is no reason whatever to suppose that it is not up to fulfilling that role. I say to my noble friend Lord Newton that my department’s officials have had discussions with the CQC senior managers about the proposed transfer of functions. The CQC is confident that these can be taken on effectively. The health research agency will provide a focal point for the ethical consideration of research using embryos. It will draw on expert advice, as the HFEA does now. The aim is to simplify and rationalise the ethical approvals process for all kinds of research. Far from the ethical focus for each type of activity being lost, it will be actively preserved. My noble friend Lord Willis suggested that we might use the Health and Social Care Bill, now in another place, as the vehicle for the proposed changes, rather than this Bill. I recognise the force of his proposal. He will know why we have chosen not to go down that road. We do not want to add to what is already a substantial Bill. It is important, too, that the Government retain momentum for their planned changes across the ALB sector. The ALB review process has already garnered significant rationalisation across the health sector and we do not want that rolled back. By keeping the HTA and the HFEA within the Public Bodies Bill, we can deal discretely with complex issues and undertake detailed consultation and impact assessments in a timely and considered way. We also, as I have indicated on several earlier occasions, wish to avoid reopening the Human Tissue Act and the Human Fertilisation and Embryology Act, which command widespread agreement. Our desire to maintain momentum is why we plan to establish a special health authority to continue and strengthen the work of the National Research Ethics Service and to be a starting point for the simplification of research approval processes. That special health authority would be the platform on which we would build the fully fledged research regulator.