Health and Social Care Bill

Lord Willis of Knaresborough Excerpts

Wednesday 7th December 2011 Lords Chamber

Moved by

[Lord Willis of Knaresborough]

258: After Clause 57, insert the following new Clause—
“The Health Research Authority
(1) There shall be a body corporate called the Health Research Authority (referred to as “the HRA”).
(2) The Secretary of State shall make all necessary regulations to establish the HRA within 12 months of the Act receiving Royal Assent.
(3) The HRA shall manage a co-ordinated process for all aspects of the approval of health research involving human participants or their data, including—
(a) the provision of ethics committee opinions and other approvals,(b) with the National Institute for Health Research and NHS trusts, delivering a consistent, efficient process for obtaining permission for research carried out under the scope of the Research Governance Framework for Health and Social Care (referred to as “NHS R&D permissions”),(c) with the Medicines and Healthcare Products Regulatory Authority, improving the regulation of clinical trials of medicinal products, and(d) other such functions as may be specified in regulations including those currently being undertaken by organisations which will cease to function following the implementation of future legislation.(4) The HRA shall have the following general functions—
(a) providing general oversight and guidance as it considers appropriate in relation to activities within its remit,(b) publishing annual metrics and indicators on all research approvals within its remit, (c) working with relevant bodies across England, Wales, Scotland and Northern Ireland to address differences in practice and legislation, and providing supporting guidance or codes of practice that apply across the UK,(d) superintending compliance with requirements imposed by legislation relevant to its remit,(e) monitoring developments relating to activities within its remit, and(f) facilitating and promoting health research involving human participants or their data.(5) The HRA must carry out its functions effectively, efficiently and economically.
(6) In carrying out its functions, the HRA must, so far as relevant, have regard to the principles of best regulatory practice (including the principles under which regulatory activities should be transparent, accountable, proportionate, consistent and targeted only at cases in which action is needed).
(7) The Special Health Authority known as the Health Research Agency is abolished and its functions transferred to the HRA.”

[Lord Willis of Knaresborough]

My Lords, I beg to move, at last, Amendment 258 and will speak to Amendments 260A, 260B and 260C, which stand in my name and those of other noble Lords. I put on record my thanks to noble Lords across the Chamber for the way in which they have supported a series of proposals and amendments concerning research. This has been a non-party political area of the Bill and I am deeply grateful to them.

On Monday, the Prime Minister launched a new strategy for UK life sciences with all the hype that he could muster—quite right too, as it is an outstanding document and contribution to life sciences. Our research is world beating, our National Health Service has a patient database unrivalled anywhere in the world and we are putting together a research and governance framework that will make the UK the place to do health and medical research. It is UK patients who will benefit by having novel and ground-breaking treatment literally years earlier than could have been hoped for five years ago when the noble Lords, Lord Darzi and Lord Sainsbury, set out with a very similar message. There is no difference between either side of the House on that issue.

By coincidence, the amendments before us today will help deliver that strategy—and deliver it earlier. At the heart of the delivery platform for the strategy for improved outcomes for patients is the Health Research Authority, established not as a creature of Government but as a full NDPB. In essence, the amendments in this group would put in the Bill the commitments that the Prime Minister gave this week, and that the Secretary of State gave when he accepted the proposals made by the Academy of Medical Sciences in its ground-breaking report, A New Pathway for the Regulation and Governance of Health Research.

To date, establishing the Health Research Authority via the Bill has not been the Government’s preferred option; I think I am safe in saying that to the Minister. Instead, the usual cautious Civil Service-driven approach of creating a temporary vehicle meant that a special health authority was set up on 1 December to carry out many of the functions of a future NDPB. However, much of the confusion, duplication, delay and obfuscation outlined in Sir Mike Rawlins’s report will continue to exist, as we wait for another Bill that may or may not come in the next Session of this Parliament. If a single Member of this House actually believes that any Government would be enthusiastic about bringing in a new Bill, having sat through this particular Bill—which is by no means finished—then, quite frankly, they are on a different planet.

The Minister argues that the special health authority will do almost everything that such a Health Research Authority will do, but is this really the case? Will it really have the authority or the power to change much at all? The research community welcomed, as I did, the transfer of the National Research Ethics Service to the special health authority, but what about the plethora of other regulatory bodies? Ethical approvals, including the storage of tissue, from the HTA, and embryo project licences from the HFEA will still be required. Ethics and Confidentiality Committee approval will still be needed for exemptions to common-law confidentiality. Permissions from the Administration of Radioactive Substances Advisory Committee will be needed if research clinicians wish to administer radioactive substances. All the powers of the Medicines and Healthcare products Regulatory Agency will remain exactly where they are.

As a special health authority, the Health Research Authority has absolutely no authority to deal with the different legislative regulatory arrangements across the devolved nations. It was quite interesting that with Amendment 260, tabled by the noble Lord, Lord Patel, the Government prayed against creating a special health authority because it would be able to deal only with England; it would not be able to deal with the rest of the United Kingdom. This is exactly the sort of organisation that has been set up to deal with this crucial area of health research.

Crucially, there will still be the vexing issue of individual National Health Service research and development approvals. Unless the HRA is set up as an NDPB in this Bill, approval processes, which are often taken sequentially rather than in parallel, with often conflicting advice from different bodies, will continue to cause confusion, delays and frustration, and the UK will continue to see research programmes haemorrhage away to international competitors as clinical trials persist in being problematic—exactly the opposite of what A New Pathway for the Regulation and Governance of Health Research is preaching to us this week.

Amendment 258 would establish the Health Research Authority in primary legislation—now—as an NDPB and set out the HRA’s role in co-ordinating the approval and regulation of health research. Subsection (3) provides for the transfer to and the management of,

“all aspects of the approvals of health research”.

Subsection (3)(a) covers the transfer of functions of the National Research Ethics Service to the HRA when it is established as a full NDPB, but the wording is broad enough to cover other research approvals that could be transferred—for example, those of the Human Fertilisation and Embryology Authority, the Human Tissue Authority, the Ethics and Confidentiality Committee and the Administration of Radioactive Substances Advisory Committee—all without the need for further legislation. This could all be done through secondary legislation in an orderly time and allowing for full consultation.

Subsection (3)(b) covers the HRA’s role in providing NHS R&D permissions, which it would undertake jointly with NHS trusts. Amendment 260C, which I will come to in a minute, allows for a more detailed exploration of the exact role of the HRA in NHS R&D permissions. Subsection (3)(c) covers the HRA’s role in supporting the MHRA in the regulation of clinical trials.

Subsection (4) explores the general functions of the HRA. At the moment, some regulatory organisations are very good at providing advice and support; others, quite frankly, are not. High-quality guidance is needed in some areas, and where this is currently absent or confusing—for example, in the use of patient data in research, which is an absolute minefield—subsection (4)(a) would ensure that researchers apply appropriate standards consistently across all studies, with the HRA becoming an authoritative source of guidance both to support researchers and NHS trusts and to build patient confidence in research.

Subsection (4)(b) would support the HRA’s quality remit, as it would be required to publish,

“annual metrics and indicators on all research approvals”,

while subsection (4)(c) addresses the important area of UK-wide research frameworks. The regulation and governance pathway is currently fragmented across the whole of the United Kingdom. Some research approvals, such as those of the HFEA, apply to the whole of the UK; some apply to England and Wales, with different arrangements in Scotland, as happens with the HTA and the ECC; and some are managed separately in each Administration, as happens with the NHS R&D permissions in individual healthcare trusts. The complexity of the system can create additional barriers for researchers, which is a huge barrier to the UK being the prime destination in terms of research.

Subsection (4)(f),

“facilitating and promoting health research involving human participants or their data”,

is a massive issue, which again, if it were on the face of the Bill, could be dealt with in secondary legislation.

Put simply, Amendment 258 would allow the Health Research Authority to be set up with a minimum of detail, allowing the details to be worked out in consultation with the broad community, and indeed with public consultation, but it would mean that any future government would have to work on putting it into action, rather than waiting for some legislation, which may or may not come down the track. The real issue is that if we are left with a special health authority, we will be left with it in four, five, or perhaps even 10 years’ time. We will have lost the opportunity to move forward. It is that serious.

Amendment 260A is a probing amendment, which sets out the specific health research functions that should be transferred to the Health Research Authority. What we are saying is that, in addition to the National Research Ethics Service, it would be easy in this piece of legislation, which the Government may or may not take forward—and this is entirely a probing amendment—to bring in, in addition to the Ethics and Confidentiality Committee, the research functions of the Human Tissue Authority, the Human Fertilisation and Embryology Authority and the Administration of Radioactive Substances Advisory Committee. It does not require a new Bill to do that. It could simply be done on the back of this Bill.

Amendment 260B is again a probing amendment, which seeks to strengthen the link between the Medicines and Healthcare products Regulatory Agency, the MHRA, and the proposed Health Research Authority. In effect, it would establish a duty of co-operation between the two organisations. It is expected that the new Health Research Authority will take on most aspects of the regulation of health research, except for the regulation of clinical trials of investigational and advanced therapy medicinal products, which will continue to be regulated by the MHRA. This simple amendment seeks clarity from the Government around their expectations for the relationship between the Health Research Authority and the MHRA.

Finally, Amendment 260C is the crucially important probing amendment because what it would do is establish an organisation called the “National Research Governance Service”. This is hugely important because one of the biggest barriers to effective development of clinical trials at the moment is getting NHS R&D permissions. It took one hospital five weeks to get the necessary permissions for a kidney research clinical trial; in another it took 29 weeks. Getting a stroke programme up and running took one week on one site and 35 weeks on another. The average time it takes to get a cancer trial up and running is something like 80 weeks. It is absolute nonsense, and how the Minister can turn to this House and say we have an opportunity to do something about that and not take it is something only the Minister can respond to—which I am pretty sure he will do very strongly and very supportively of these amendments in the near future.

NHS R&D permissions are currently the greatest barrier in the regulation and governance of health research, with multiple, duplicative checks undertaken at every NHS site. The Academy of Medical Sciences recommended creating a national research governance service—this comes directly from the AMS report—within the HRA to centralise as many of these checks as possible to avoid duplication. The Government have ignored this recommendation and instead introduced standard operating procedures and incentives to make improvements to the current system. Only a civil servant could have done that, when in fact what we want is action.

--- Later in debate ---

[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.

[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.

Amendment 258 withdrawn.