Public Bodies Bill [HL]

My Lords, I do not think that I am chancing my arm by saying that that is my understanding of what the impact assessment ought to look like in that a typical impact assessment will have within it several alternatives so that it is possible to compare different options. I would be happy to come back to the noble and right reverend Lord with a definite answer on that but my understanding from previous impact assessments is that that kind of benchmarking ought to be possible. The noble Baroness, Lady Thornton, has previously raised her concerns about where the ethical framework for any new arrangements will sit. Ethical safeguards, for example concerning the embryos and gametes 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 continue to remain firmly in place and will underpin the regulation of treatment and research as currently, by whoever is responsible for regulating. Where there are specific ethical issues surrounding new treatments, the department will consider how best to commission expert advice on an individual basis, as is currently being done for mitochondrial transfer, for example. A number of noble Lords have shown interest in and support for the Government’s announcement last week, as part of the growth review, about streamlining research regulation and governance. The Government announced in the Plan for Growth on 23 March that they will create a health research regulatory agency to combine and streamline approvals for health research which are at present scattered across many organisations. As a first step, the Government will establish this year a special health authority with the National Research Ethics Service as its core. When established, the new agency will work closely with the Medicines and Healthcare Products Regulatory Agency to create a unified approval process and promote proportionate standards for compliance and inspection within a consistent national system of research governance. This will reduce the regulatory burden on firms and improve the timeliness of decisions about clinical trials and hence the cost-effectiveness of their delivery in the UK, and has clear support from the Academy of Medical Sciences review of medical research regulation and governance. In this context, it is important for me to remind the House of a key point. Here I refer particularly to the question posed by the noble and right reverend Lord, Lord Harries. The AMS report recognised at paragraph 9.5.1 that there are significant benefits in bringing all medical research regulation, including embryo research currently undertaken by the HFEA, within the remit of a single health research regulatory agency. Indeed, remarks made by Sir Michael Rawlins in the Guardian on 11 January firmly backed up that view. We agree with that proposition but again the consultation will invite views on it. My noble friend Lord Willis expressed his fears about the Government adopting a piecemeal approach to reorganisation, as did some other noble Lords. I accept that our approach to the HFEA and the HTA may indeed seem rather complex. The powers of the Public Bodies Bill will enable us to transfer some of the functions of the HFEA and HTA to other bodies but they do not enable us to do everything that we have set out in the arm’s-length body review. In order to abolish the HFEA and HTA, or to transfer their research-related functions to any new research agency, we will require powers under future primary legislation. It might help if I provided a rough outline of how and when we could take this forward. We intend publicly to consult on proposals to transfer all the HFEA and HTA functions to other bodies in the late summer of this year. During 2012-13, under the provisions of the Bill, we will prepare draft orders for formal consultation dealing with the transfer of functions, other than research functions. If appropriate, we would then be able to lay the orders before Parliament. This process would enable noble Lords and other interested parties to see, comment on and debate the proposals, as they progress. Without the inclusion of these bodies in Schedule 5, we would have to provide for the transfer of their functions entirely within future primary legislation. I simply say again, particularly to the noble Lord, Lord Warner, that not including these bodies would significantly increase the risk that the underlying ethical provisions of the Human Fertilisation and Embryology Act and the Human Tissue Act were reopened for debate.