Draft Care and Support Bill - Joint Committee on the Draft Care and Support Bill Contents

10  Human Fertilisation and Embryology Authority and Human Tissue Authority

337.  Clause 75 of the draft Bill, innocuously entitled "Amendments to the Public Bodies Act 2011", would in fact result in the abolition of the Human Fertilisation and Embryology Authority (HFEA) and Human Tissue Authority (HTA).

338.  Section 1 of the Public Bodies Act 2011 gives ministers the power by order to abolish any of a large number of public bodies listed in Schedule 1 to the Act and to transfer their functions to another body. Section 5 allows ministers to modify the functions of the bodies listed in Schedule 5, or to transfer those functions, or some of them, to another body. Orders under section 1 or section 5 are subject to the super-affirmative procedure, which allows either House to refer the draft Order to a Committee of that House, and requires the Minister to have regard to any recommendations the Committee may make.[268]

339.  Currently both the HFEA and the HTA are listed in Schedule 5 to the Act, so that the minister may modify or transfer their functions, but may not abolish them. Clause 75 of the draft Bill would transfer both bodies from Schedule 5 to Schedule 1, so that the minister could abolish either or both of them and transfer their functions to other bodies (in which case he would of course have no need to modify their functions).

340.  On 28 June 2012 the Department of Health issued a consultation paper entitled "Consultation on proposals to transfer functions from the Human Fertilisation and Embryology Authority and the Human Tissue Authority". The paper noted that there was considerable overlap between the functions of both bodies and the Care Quality Commission (CQC). This point was repeated in oral evidence by Ted Webb, the Department's Deputy Director for Health and Bioethics, who told us that "There is an apparent overlap of their role and that of the Care Quality Commission. Something like 300 places that the Care Quality Commission goes to are also regulated by the HFEA or the HTA, and something like 90% of the places that the HFEA regulates in England are also regulated by the CQC or are situated in places that the CQC already regulates."[269]

341.  The Department's preferred option was to abolish both bodies and transfer their functions to the CQC, with the exception of the HFEA research functions which would be transferred to the HRA. A second option was to abolish both bodies but with different provisions for the transfer of their functions. Option 3 was for both bodies to retain their functions but to deliver further efficiencies. Responses to the consultation were invited by 28 September 2012. 109 responses were received. They were placed on the Department's website at the end of January 2013. The overwhelming majority of them favoured Option 3. Consultees were particularly afraid of losing the expertise which both bodies had built up.

342.  In our Call for Evidence we also asked for views on these proposals. Those we received were from the major research organisations and their funders, and they unanimously opposed the abolition of either body or the transfer of their functions. The Academy of Medical Sciences replied: "There is a great deal of support among our community for the HFEA and the HTA; both are perceived as having developed the experience to respond in a balanced, practical way to the changing landscape that reflects the evolving risks and benefits of research. The relatively small savings to be made through disbanding the HFEA and the HTA need to be balanced against the inevitable period of disruption and uncertainty, and any potential risk of loss of expertise, efficiency, effectiveness and coherence that could hinder research and practice and result in the loss of public and professional confidence…. We therefore support retaining both the HFEA and the HTA, providing they work closely with the HRA and other regulators to further streamline the regulation, inspection and governance process for patient and public benefit."

343.  The Wellcome Trust reiterated much of the response they had given to the Department: "Transferring functions away from the HFEA and HTA would present a significant risk for loss of specialised expertise and specialist function within the HFEA and HTA, and potential corresponding impacts on researcher and public confidence in the regulatory system. Furthermore, we considered the proposal to split the HFEA's functions by transferring its research functions to HRA, and the rest of its functions to the CQC, carried a risk of losing cohesion between the HFEA's clinical and research functions and diminishing its ability to keep pace with emerging treatments and techniques. … In light of these concerns, we broadly supported Option 3 in which the HFEA and HTA would retain existing functions but deliver further efficiencies."

344.  Cancer Research UK supported the option of retaining the HTA and HFEA while streamlining their functions, but did believe that "the Department's preferred model could potentially be an acceptable means to restructure the functions of the HTA and HFEA in the future once it has been established that the CQC is able to perform the functions to a standard that will support researchers in gaining approvals and also public confidence in the handling of human tissue and embryos." But the Royal College of Surgeons did not believe that the CQC would be able to perform these functions: "The College is concerned that the safe and ethical use of human tissue is complicated and requires specialist expertise and appropriate regulation which is sufficiently different from the general regulation of health and social care currently undertaken by the Care Quality Commission (CQC)."

345.  Dame Jo Williams, the outgoing Chair of the CQC, had said that the preference of the CQC was that the functions of the HFEA and the HTA should not be transferred to the CQC. At his pre-appointment hearing with the House of Commons Health Select Committee on 5 December 2012 David Prior, the newly appointed Chair of the CQC, was asked whether he agreed. He replied: "I think I probably do, without knowing enough about it to give you a considered answer. My basis of probably agreeing is simply that we have enough to do, I think, in CQC to get our existing shop in order without taking on a new responsibility. But I would have to take more advice on that. That would be my gut feeling."[270]

346.  On 25 January, four months after the consultation had closed, the Department published their response to the consultation. They said: "In the light of the above, we have decided, on balance, that we will not pursue a transfer of functions at the present time. However, retaining the HFEA and the HTA with further efficiencies must take account of the support for a review of the way in which the two bodies undertake their functions, with a view to reducing the regulatory burden. It must also include a programme of work on achieving efficiencies to deliver streamlining of their non-specialist functions." Anna Soubry MP, the Parliamentary Under-Secretary of State, said in the course of a statement: "Taking all views into consideration, the department has decided, on balance, that it will not pursue a transfer of functions at this time."

347.  The words "at this time" caused us some anxiety, and when Dr Poulter gave oral evidence we asked him to confirm that it was his intention not to include the current clause 75. He replied: "… the clause as it stands will not be part of the Bill."[271]

348.  Deletion of the whole of clause 75 would ensure that ministers could not now abolish either the HFEA or the HTA. It would however retain the current entry of both bodies in Schedule 5 to the Public Bodies Act 2011, allowing ministers to modify or transfer their functions, if not now, at some future date. We believe that ministers should retain this flexibility, which will in particular allow any changes to be made which are needed as the work of the HRA develops. We believe that ministers should not have the power to abolish the HFEA or the HTA, and we recommend that clause 75 should be deleted.

268   Section 11 of the Act. Back

269   Q 33. Back

270   House of Commons Health Select Committee, 5th report, session 2012-2013, Evidence, Q 36. Back

271   Q 356. Back

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Prepared 19 March 2013