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Public Bodies Bill [HL]

My Lords, I begin by expressing my thanks to all noble Lords for the opportunity to debate these amendments. As the noble Baroness, Lady Thornton, pointed out at the beginning of her remarks, following the Government’s concession in withdrawing Schedule 7 in its entirety, these amendments would have the effect of putting the Human Tissue Authority and Human Fertilisation and Embryology Authority out of scope of the Bill. Our starting point in approaching these issues is a clear objective to streamline the process of regulation and, consequently, reduce costs and the administrative burden on establishments while continuing to offer the necessary protection for the public. The Bill presents us with an opportunity to achieve that. Our aim is to streamline healthcare and medical research regulation and so reduce bureaucracy. That approach is supported by leading assisted reproduction clinicians and their professional bodies and by the Academy of Medical Sciences. The scope for streamlining is clear. We estimate that around 80 per cent of the centres currently licensed by the HFEA are also either regulated by the Care Quality Commission or are in premises that the commission regulates. Some 60 per cent of the centres licensed by the HTA are similarly covered by the CQC. It therefore seems unsustainable to continue to have these regulatory systems running in parallel. The question posed by my noble friend Lord Newton of Braintree as to whether the CQC wants to take on this work can best be answered by reference to the regulatory activity that it already performs. In any event, as regards the pace at which we take this, we intend to develop arrangements for the transfer of functions in consultation with the CQC over the next few years, and no transfer of functions will take place until that process is complete. However, the Government recognise that there are number of noble Lords with concerns about the proposal to transfer the functions of these two bodies, and not for a minute would I wish to minimise the nature of those concerns. Let me be clear—both the HFEA and the HTA are models of regulatory authority that were right for the times in which they were created and which have done an admirable job in meeting the demands placed on them. However, as my noble and learned friend Lord Mackay of Clashfern pointed out, times change, and most pertinently so has the way in which we regulate the delivery of healthcare. With the establishment of the CQC along with the possibility—and I put it no stronger than that at the moment—of the creation of a new regulatory body for medical research, alternative structures are becoming available to ensure a more joined-up system. This provides, as I have said, the opportunity to streamline the process of regulation and reduce costs. The powers in Clause 5 would allow us to achieve that without disturbing the underlying legislation, which captures the ethical safeguards that Parliament has so carefully set in place. Any future proposals to abolish these two bodies will be provided for in future primary legislation. I am happy to reiterate my assurance that there is no intention to revisit the provisions in either the Human Tissue Act or the Human Fertilisation and Embryology Act that provide the important ethical safeguards necessary to maintain public confidence in these sensitive areas. I would say to my noble friend Lord Willis and to the noble and learned Baroness, Lady Butler-Sloss, and the noble Baroness, Lady Deech, that means that future arrangements to regulate tissue and embryos must adhere strictly to the provisions of the two relevant Acts. Noble Lords have raised particular concerns about the need to preserve the expertise these bodies have built up in the ethically sensitive subjects they deal with and the need to preserve the confidence of both professionals and the public in the way that these regulatory functions are carried out. The Government recognise the genuine nature of these concerns and we are determined that changes will not be at the expense of regulatory rigour or expertise. I say to my noble friend Lord Willis that expertise will not be lost. It is envisaged that expertise will follow functions; for instance, through staff transfers and expert reference groups. Noble Lords have questioned the capacity of the CQC to assume these responsibilities. It will be given the capacity and the resources to carry out any widened functions. The CQC already has a proven track record of taking on the oversight of a specialist area. It took on the Mental Health Act Commission functions and I believe has successfully maintained oversight and focus on that area. The noble Baroness, Lady Thornton, expressed concern that our whole approach in this area seemed unnecessarily complex. The powers that we are debating today 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 ALB 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 may help if I try to provide a rough outline as to how and when we expect things to happen. We intend publically to consult on proposals to transfer all of the HFEA and HTA functions to other bodies in the late summer of 2011. Then during 2012-13 we would prepare draft orders for formal consultation under the provisions of this Bill dealing with the transfer of functions other than research functions. If appropriate we would then be able to lay the orders before Parliament. The process would enable noble Lords and other interested parties to see, comment on and debate the proposals as they progress. In order to avoid the piecemeal transfer of functions we would intend to ensure that the timetables for necessary future primary legislation and the commencement date of orders made under this Bill are aligned so that they come into force at the same time. Without the inclusion of these bodies in Schedule 5 to the Public Bodies Bill we would have to provide for the transfer of their functions entirely within future primary legislation and this would significantly increase the risk that the underlying ethical provisions of the Human Fertilisation and Embryology Act and the Human Tissue Act could be reopened for debate and would afford less time for consideration and comment than the progressive approach which I have just outlined. I seek to impress upon noble Lords that that is a very powerful reason for wishing to grant the Government the powers we are seeking as regards these two bodies. The noble Lord, Lord Warner, indicated that, in his view, the report by the Academy of Medical Sciences does not give sufficient backing to the idea that embryo research should be covered by the new research regulator. I would simply point him, if I may, towards paragraph 9.5.1 of the report which explicitly refers to the new body, if it is set up, having responsibility, "““for ‘specialist’ approvals and licences within the HRA around data, tissue and embryos, gene therapy and exposure to radiation””." I think, as I read that, it was very much in the minds of the authors of the report that the research functions of the HFEA should be brought within the scope of a health research regulatory agency. The noble and learned Baroness, Lady Butler-Sloss, expressed her worries about the information functions of the HFEA and the absence of a clear plan by the Government for what should happen to those functions. She is right, we have not fully made up our minds about where those functions should best sit, but that is one of the main reasons why we wish to consult on this. We need to ask the public and interested parties where these functions should sit, and there will be an impact assessment with the consultation. My noble friend Lord Willis asked about the possibility of setting up a single research agency without primary legislation. He is technically right; we could do that. I should emphasise that we have not decided whether to accept the AMS recommendation to establish a single research agency—we think that there are merits in the proposal and we will be making an announcement shortly—but if we were to propose setting up such an agency we could do so initially by creating a special health authority. However, we could not legally transfer the research-related functions of either the HTA or the HFEA to that body. We could not make a transfer of functions to a special health authority without amending the 2006 Act. The case was simply put by my noble and learned friend Lord Mackay of Clashfern. Essentially, we are asking the Committee to agree to grant the Government permission to consult on these matters. I hope that the noble Baroness will not seek to press her amendment today but instead will consider that a good purpose will be served by reflecting on the comments that I have made in response. In view of our concessions—