Health and Social Care Bill

Earl Howe Excerpts

Wednesday 7th December 2011 Lords Chamber

[Lord Walton of Detchant]

My Lords, I give very warm support to these amendments, which were so expertly introduced by the noble Lord, Lord Willis. As he said, the report of the Academy of Medical Sciences, after a long period of study and a committee chaired by Sir Michael Rawlins, made a number of important proposals, which the Government, in principle, accepted.

This takes the matter very much further. Following last night’s very exciting and far-sighted Statement by the Government about the developments in research and their sponsorship of translational research, the need to translate the discoveries of basic medical science into practical developments in patient care, the crucial importance of making access available to the NHS database to enable clinical trials to be carried out, and the crucial importance of more rapid access to new medicines and so on through the NHS, it is crucial to recognise that all those proposals are very important. These amendments would carry that forward.

It is also important that the Health Research Agency, which has already been established, is as yet an inadequate vehicle to further the developments to which the noble Lord, Lord Willis, referred in great detail. It is essential to recognise that to carry forward the developments envisaged in the Government’s Statement last night on translational research on the governance of clinical trials and the overall governance of research as a whole in the NHS, something like these amendments must be put in the Bill.

I want to comment briefly on the proposals set out in one of the amendments, to the effect that it would be sensible to remove from the Human Tissue Authority and the Human Fertilisation and Embryology Authority their research components and that these would much more happily settle in the newly defined Health Research Authority. There is a lot of sense in that, because the research carried out by these organisations is important, and it is research that is in many ways crucial to the development envisaged in these amendments.

However, it is important to recognise too that the Human Tissue Authority in its present existence has a major responsibility for regulation—regulating the departments, for instance, in which anatomical work is carried out, and regulating departments of pathology and other teaching functions which are absolutely vital. Similarly, the Human Fertilisation and Embryology Authority is not primarily concerned with research but also has major licensing functions, in licensing organisations in which work under the Human Fertilisation and Embryology Act can be carried out.

I understand that there has been a proposal by the Government that the functions of the HTA and the HFEA might be transferred to the Care Quality Commission. I would only comment, as John McEnroe said, that you cannot be serious. The Government cannot really be serious. This is not an organisation which is set up to handle that type of information. It is crucial to recognise that the Care Quality Commission has very specific responsibilities. It has taken on the responsibilities of three previous bodies, which were involved in looking at healthcare, social care and psychiatric care. It is carrying a major load—

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

Will the noble Lord give way? I am sure the noble Lord will know that through this Bill we cannot transfer the functions of either the HTA or the HFEA to any body at all. Indeed, that was the substance of my undertakings to this House under the Public Bodies Bill debate—that we would defer consideration of those matters until a later Bill. This Bill simply covers the reform of the health service, obviously, and my noble friend has sought to introduce an amendment to set up the Health Research Authority as a statutory body. But I gave an undertaking to this House that I take very seriously: that the consultation process on the transfer of functions from the HTA and the HFEA has to take place. It would be premature for this Bill to cover that matter. For that reason alone, I urge noble Lords to be very cautious about my noble friend’s amendment, about which, nevertheless, I will say some warm words.

I wanted to specifically cover that matter, as I notice the noble Baroness, Lady Warwick, looks as if she wants to rise to her feet. I can understand why, because it is important for the Committee to understand that the matters to which the noble Lord has just referred are matters which we will reach in due course, rather than today.

[Lord Walton of Detchant]

I am very grateful to the noble Earl for clarifying the position, but it is important that in the longer term we shall have to learn more about the future of those two very important authorities. In the mean time, the crucial importance of these amendments is to clarify in the Bill the responsibilities of this new organisation which is going to be responsible for regulating research in the UK, and which will streamline and improve the present mechanisms for research approval in many different situations. Therefore, I strongly support these amendments.

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[Earl Howe]

My Lords, the amendments in this group aim to create a Health Research Authority. My noble friend has explained the rationale for the authority very succinctly and I want to make it clear at the outset that I am on precisely the same page as him as to what he is seeking to achieve for health research. We announced in the Plan For Growth in the Budget in March that we would create a body to combine and streamline the approvals for health research, which are at present scattered across many organisations. We also said that wherever we can achieve this simplification without primary legislation, we will. We have already laid legislation to establish the Health Research Authority, which started its work on 1 December 2011 as a special health authority, as was reported in Monday’s Statement on our strategy for UK life sciences. In that form it will take on a number of key functions and I will come to those in a moment.

Looking ahead, as I mentioned earlier, we will be consulting on the future of the HFEA and the HTA. That consultation, as the noble Lord, Lord Beecham, has pointed out, has been delayed but we are still very much intent on launching it and hope to do so shortly. We look forward to stakeholders’ views on the option of passing the research-related functions of the HFEA to the HRA as proposed in the AMS report. In that regard, where primary legislation is required to consolidate functions, we intend to subject it to pre-legislative scrutiny during the next Session and to introduce it as soon as parliamentary time allows.

It may interest my noble friend to know that I am upbeat. I am advisedly upbeat and want to stress to him and other noble Lords that contrary to the apprehensions that have been expressed, the Health Research Authority will have substantive functions as a special health authority. It will combine and streamline approvals for health research through unification of functions and processes wherever that is possible without additional legislation and through co-ordination where it is not. I say to my noble friend without any hesitation that we can achieve a very high proportion of what we wish to achieve with the HRA in this form as a special health authority. It will bring together functions relating to research ethics committees currently performed by the Secretary of State, the National Patient Safety Agency and strategic health authorities. It will operate a single system for researchers to apply for approval to research ethics committees, NHS trusts, the Medicines and Healthcare products Regulatory Agency, the National Information Governance Board and the Administration of Radioactive Substances Advisory Committee.

By April 2013, it is intended also to bring in functions currently performed by the Secretary of State on the advice of the National Information Governance Board’s ethics and confidentiality committee. The Health Research Authority will also work closely with the bodies I have just mentioned, as well as the Care Quality Commission, the Human Fertilisation and Embryology Authority, the Human Tissue Authority and the National Institute for Health Research to co-ordinate relevant functions, processes and standards. That is why, despite my noble friend’s understandable desire to see an NDPB established as soon as possible, I suggest to him that for practical purposes, setting aside the HFEA issue for one moment, the amendment is unnecessary.

However, there is another reason why it would not be right to establish the agency in this Bill—it would not be for the good of research in this country. I say that for the following reasons: it would weaken parliamentary scrutiny by stopping Parliament being able to debate primary legislation on the functions of the agency because it would consign much of the detail to secondary legislation—I do not think that is something that in the past your Lordships’ House has been keen on. It would pre-empt public consultation; for example, on the future of the HTA and the HFEA, and in my view it would put haste ahead of getting it right by dealing with a complex issue without due discussion and consideration.

[Lord Willis of Knaresborough]

I am listening carefully to what my noble friend is saying. However, Amendment 258 would not compromise in any way the consultations which he has rightly promised on the HTA and the HFEA. The proposed new subsection (3)(a) in Amendment 258 refers to,

“the provision of ethics committee opinions and other approvals”.

It does not state what those other approvals are. Therefore, if the amendment were passed, the Minister could consult in a year’s time or in two years’ time and come to a decision without compromising those approvals.

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[Earl Howe]

I hear what my noble friend says but I cannot agree that his approach is the best for research in this country. Very real risks would accompany trying to shoehorn a very important and complex issue into this Bill in what I have to say to my noble friend is an inappropriate legislative form. The noble Lord, Lord Warner, asked about the view of the Academy of Medical Sciences on this matter. The last time that I spoke to staff at that body, which was not very long ago, they were dead set against my noble friend’s approach. They believe that the approach the Government are taking, which is a step-by-step approach, is exactly right. They recognise that the Special Health Authority can achieve a very great deal, we do not need to rush into primary legislation and we would do very much better to take our time over that process.

My noble friend mentioned the devolved Administrations. We have also directed the Health Research Authority to collaborate with the devolved Administrations in the exercise of its functions. We expect it to maintain effective communications with the UK health departments on the practical implications of implementing legislation, policy and guidance, building on the success of the national research ethics service at developing a single UK-wide system for research ethics committee review. Therefore, I do not regard that problem as at all insurmountable.

We agree with the intention behind Amendment 260C of improving the consistency and efficiency of reviews of the bodies carrying out research. We consider the National Institute for Health Research to be a more appropriate mechanism than the Health Research Authority for taking action to achieve outcome improvements, such as those called for in the Academy of Medical Sciences report. My noble friend may wish things were otherwise but noble Lords need to remember that NHS trusts are autonomous bodies. It is important that there is a clear division between the responsibilities accepted by them when planning and conducting research and the responsibilities of the body that regulates their practice. In this environment, the NIHR is in a strong position to support and influence them. The NIHR has already introduced mechanisms to achieve the effect of Amendment 260C through its co-ordinated system for gaining NHS permissions, its research support services framework of standard operating procedures and good practice guidance and its research passport scheme. It is also introducing benchmarks for NHS trusts’ performance in the initiation and delivery of research. NIHR funding will become conditional on meeting such benchmarks, so there is a direct incentive for NHS organisations to comply with those benchmarks.

As regards the Health Research Authority monitoring developments relating to activities within its remit, I thank my noble friend for raising the horizon-scanning point. I will gladly consider that further to see what can be done.

In sum, I do not see this amendment as appropriate. I appreciate that my noble friend intended it as a probing amendment, but I hope that I have set out clearly why I do not think that this would be the right way to go. Noble Lords can be relaxed that we are already embarked on a course which should deliver major improvements in all the areas where we want to see improvements as regards the clinical trials process in this country. As I say, I am optimistic that we are embarked on the road to the sunlit uplands in this sense. We will in due course—I hope that that will be sooner rather than later—come to a point where we can embody these things in primary legislation. However, I urge noble Lords to consider the need to take our time and to consider those matters very carefully.

[Lord Willis of Knaresborough]

My Lords, I thank the Minister, as always, for his courteous and passionate reply to this debate. He has used the words upbeat, relaxed and enthusiastic about the amendments and the aim behind them and I appreciate what he said. He made the point—and has made it often—that the Special Health Authority, which was set up on 1 December, will be able to take on, over a short period of time, many of the functions which I have outlined in Amendment 258. I would be grateful if the Minister would put in writing the timetable for delivering all those elements. It would be hugely advantageous to know just how they would fit and dovetail in.

My noble friend Lord Warner—well, he is a friend—commented on the views of the Wellcome Trust and the Academy of Medical Sciences; the Minister said that the Academy of Medical Sciences was against the Willis amendment. In fact, the last time that we met the Academy of Medical Sciences—the noble Lord, Lord Turnberg, and I were on the same platform with it about a month ago—the academy made it clear that, while it did not want to have any detail in the Bill because that would compromise the detailed discussions, it was happy to see the architecture in the Bill. This is something which the Wellcome Trust supported; in fact, I was helped by both the trust and the Academy of Medical Sciences in drafting these amendments. The Association of Medical Research Charities, which I chair, was also incredibly helpful. There are, perhaps, some crossed wires here.

On Amendment 260C, I hear what the Minister says about bringing those two issues together, particularly for the R&D functions of NHS trusts. I said that there is a real issue about autonomous organisations. Why has the NIHR not actually done it? If this is the biggest obstacle to getting clinical trials developed quickly in the UK, why has it not already forged those relationships, and what confidence do we have that it will be able to do so over the next year or so?

This has been a good debate and I am incredibly grateful to noble Lords throughout the House for their support for these amendments. I still believe that the proposals in Amendment 258 could be in the Bill but given the Minister’s assurances and his willingness to debate these issues further, I beg leave to withdraw the amendment.