Public Bodies Bill [HL]

Earl Howe Excerpts

Wednesday 9th March 2011 Lords Chamber

[Lord Patel]

My Lords, I think I have lost my thread, but I have said what I wanted to say.

[The Parliamentary Under-Secretary of State, Department of Health (Earl Howe)]

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—

[Lord Warner]

I am sorry to interrupt the Minister. I have been listening intently to what he has said. I am extremely confused about the order in which things are going to be done. As I understood what he was saying, we are going to get a series of orders that transfer functions through a process of consultation, which I welcome, but we may or may not know at that point what the Government are going to do about setting up a health research agency, either by statute or otherwise. As I understood him, we could be in the position of being asked to agree those orders before we know what the final endgame is. It would be helpful if, before the next stage of the Bill, the Minister could set this out more clearly for us in writing so that we can understand the sequence. I found it rather difficult to understand.

[Earl Howe]

I must apologise to the Committee if I was not sufficiently clear and I will be happy to write to those who have participated in this debate to make the position clearer. I was seeking to say that we do not wish to take a disjointed, piecemeal approach. There is a natural flow of process that, if Parliament agrees, can lead us to a position where we are able in one move, so to speak, to transfer the various functions more or less simultaneously—although I would not wish to undertake that the whole thing would be done on the same day—so as to arrive at that point.

In our view it is desirable to consult during the late summer of this year. We will then set about the process of designing statutory instruments based on that consultation and go out to consultation on them. All being well, we will then introduce a second-Session health Bill that will have within it the provisions to establish a single research regulator, assuming that that is what we decide to do. Therefore, the whole process should work in a seamless way. However, I shall be very happy to write to noble Lords setting that out.

I return to the point at which I left off, which is to express the hope that the noble Baroness will not press her amendment this evening. I hope that she will accept our assurance that we have a clear intention to consult on the proposed transfers of functions and that she will be willing to withdraw the amendment.

[Baroness Thornton]

My Lords, I thank everybody who has contributed to this debate. I knew that it would be an interesting debate and a long one. I have been told by my noble friend that I have to be brief, as the Committee still has a lot of things to get through and the rest of us can go home when we have finished this. As I say, I thank all those who have taken part in this debate. The remarks of the noble and learned Baroness, Lady Butler-Sloss, were forensic and, as usual, very helpful. The noble Lord, Lord Walton of Detchant, spoke with great wisdom and knowledge about both the HFEA and the HTA. The noble Lord, Lord Newton, spoke wisely about the CQC. Having been one of the architects of the CQC in the previous Government, I wish to put on record that I very much admire the work that it does. However, it is being asked to do a great deal more, which worries me.

I am pleased that the noble Baroness, Lady Deech, continues to support us as we work towards resolving this matter. The noble and learned Lord, Lord Mackay of Clashfern, my noble friend Lord Winston and the noble Lord, Lord Patel—a trio of very distinguished professionals in their respective ways—said that, although progress has been made, the most important thing is to make more progress. I am not a scientist but in a way the scientists and the experts got us into trouble on both these issues and that led to the creation of the HFEA and the HTA, as imperfect as they might be. Those bodies were established to tackle the need to regulate and to restore public confidence. That is where we came in, as it were. It seems to me that challenges and problems still exist in terms of public confidence, to which I will return in a moment.

I accept that if we need to move to a more overarching medical research body, we need to go through a proper process. I am not convinced that the powers granted to the Government in this Bill are the way to do that or that what looks like a rather complex and very piecemeal process is the right way forward. However, I am grateful to the Minister for explaining this in great detail.

I am worried. A floating ethical framework sprang into my mind because I could not see where the ethical framework of what is being proposed will sit. If we cannot see where it will sit, what hope is there for the public? It seems to me that that is where the Government need to start. It is not a question of having a mechanical process and saying, “We will put this bit here and that bit somewhere else and have a regulation that will make sure that the research goes somewhere else”, because if we cannot understand where the ethics sit we are in very serious trouble.

The Minister has given us a great deal to think about and I am grateful to him for his detailed answer. I will read the record and I look forward to receiving his letter. We will need to think about what he had to say and discuss it further before Report. I will not press the amendment now, so I beg leave to withdraw it.