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Health Research Authority (Amendment) Regulations 2012

Volume 737: debated on Wednesday 13 June 2012

Motion to Take Note

Moved by

That the Grand Committee takes note of the Health Research Authority (Amendment) Regulations 2012 (SI 2012/1108).

My Lords, I should start by declaring interests as the chair of a foundation trust, as a consultant in the health service and as a trainer with Cumberlege Connections Ltd.

As well as moving this Motion, I shall also speak to my second Motion, which also relates to the Health Research Authority.

On the face of it, the regulations and order are unexceptionable and they passed through the Secondary Legislation Scrutiny Committee without comment. They provide for the board to be reconstituted with independent non-executives and an independent chair.

The responsibility that falls to the members of the authority is indeed weighty. The noble Earl, Lord Howe, has a long-standing record of commitment to health research, which is considerably reassuring to all those with an interest in this area. I have no doubt at all that health research is as important to the economy of this country as it is to the quality of patient experience and outcome. Indeed, embraced with the high quality of life sciences in the UK, it is crucial that we prioritise health research to the fullest extent possible. Certainly my experience in chairing the Pharmaceutical Industry Competitiveness Task Force some years ago convinced me of the essential link between the health of the person, the health of the NHS and the health of the economy, and that is why I think it is so important for the National Health Service to support health research. Our debates during the passage of the Health and Social Care Bill indicated the strength of support for research and for the Secretary of State’s responsibility for it to Parliament.

The HRA has been set up to protect and promote the interests of patients and the public in health research. The aim is to lead to the creation of a unified approval process and to promote consistent and proportionate standards of compliance and inspection. The HRA has a number of functions, including being the appointing authority for research ethics committees in England, and it provides the National Research Ethics Service. Also, by agreement with the devolved Administrations, it supports a UK-wide system for ethical review in the UK. It has an important ongoing programme of work and it also provides the integrated research application system through which applications for regulatory and governance approvals of health research are made in the UK. It also agrees plans to provide a platform for the unified approval process from the IRAS, as it is known.

I turn to the details of the regulations and order. I ask the noble Earl whether it is intended that the non-executives should be a majority on the board. I should also like to ask him about the Government’s intention regarding the publication of draft clauses to establish the HRA as a non-departmental public body. I do not know whether he can give any indication at all about the timing of and commitment to the eventual legislation that has been promised. Will he also comment on the Government’s approach to, and policies for, enhancing health research in the UK?

How are we to ensure that we make the most of the excellence of our life sciences? Can the Minister give some reassurance about the priority to be given to research by the NHS Commissioning Board? Does he believe that academic medicine is given sufficient support by the National Health Service? Is he confident that the HRA has the capacity to streamline research application processes? That point has been made to me by a number of organisations that have been interested in the order and in our debate.

The noble Earl will be aware of the continuous debate over probably the past decade about the bureaucracy involved in the application processes and a feeling that the UK has lost its competitive edge because of that. I know that the previous Government and this one have continued to do work in this area and I wonder whether he can report any further progress. I should like him to comment on whether he believes that the UK will be able to maintain a competitive edge in research in the years to come and whether he believes that the intention is to maximise large-scale patient recruitment.

Alongside that is the importance of site selection and the question of whether it is going to be easier for applicants in the future to conduct multi-centre research. My understanding is that one of the problems is that applications for multi-centre research have to go to the individual institutions concerned, which can sometimes hold up approval. My understanding is that there is going to be a concerted attempt to speed up that process. Again, if the noble Earl could give some comfort there, it would be much appreciated.

It is also important that the National Health Service recognises the importance of its role in supporting, developing and encouraging research. That is partly to do with the appointment of academic clinicians within the National Health Service, partly about a willingness to accept that it is important for clinicians to take part in research and also about the importance of ensuring that individual bodies in the NHS have good processes for offering opportunities for clinical trials. Any positive messages that the noble Earl could give on that would be appreciated.

On the private sector, if the Government are to develop a market in the NHS, what obligation will there be on private companies to maintain and support research if they win contracts to provide services to patients? I attended the launch of the Clinical Practice Research Datalink, at which the noble Earl spoke and which I thought was very impressive. How does he think this will link to the work of the Health Research Authority? I was very taken with the potential to use such a wide database of anonymised information, which the NHS can provide. The issue that arose from that debate and that launch is whether we are really able to make the most of the opportunity that is being given.

My final point brings me to value-based pricing. My understanding is that the Government still intend to introduce value-based pricing. I express again to the noble Earl my reservations about the impact of that on flexibility within the pharmaceutical industry and the pricing structure, which might then have an impact on their willingness to invest in R&D in this country. The Department of Health, I understand, is still a sponsor of the pharmaceutical industry. It is, of course, always torn; there is always a tension between the cost of drugs to the NHS and sponsorship of the industry. I hope that we are not going to see short-term decisions taken in relation to the cost of drugs at the expense of long-term investment in R&D in this country. Value-based pricing is a quite complex and technical subject, but it is important that there is transparency about the decisions that lie behind a move to value-based pricing and its likely impact on the UK as a whole, and not just the cost of drugs to the NHS. I beg to move.

My Lords, the development of the Health Research Authority has been extremely welcome and the research community is very grateful that we have it; it has a number of very important roles in relation to the research ethics committees.

My questions relate to the extension of those functions as it plays out, because, of course, the Academy of Medical Sciences report expected this to apply to rather more than just the ethics committee; they relate to what is planned for it as it moves along. In particular, when is it likely that the ethical approval for the use of patient data—not anonymised data but unanonymised data, if there is such a word—which are currently with the Secretary of State, will come under the jurisdiction of the new authority? My noble friend Lord Hunt referred to the major hurdle that is put in the way of research and which takes time: the problem of getting approval from several health authorities or trusts. At that level, it is unclear whether the Health Research Authority will have any power over that process. I would like to hear more about what is intended for the future, now that we have it set up. I know that there are intentions and I would like to hear more about them.

My Lords, my apologies to the Minister. I was not quick enough to get up. First, I welcome this order, which establishes the Health Research Authority. Like the noble Lords who have already spoken, I ask when we will have further legislation defining all the roles of the Health Research Authority. Can the noble Earl also confirm that this new authority will be required to give ethical approval to all research, no matter how it was funded? I am particularly keen to find out whether research that might be funded by individual trusts or, for that matter, by the department will also come under the ethical scrutiny of the Health Research Authority. Will the authority at this point be promoting research from the NHS, as the new NHS Act requires the foundation trusts and the commissioners to do?

My Lords, I start by thanking the noble Lord, Lord Hunt of Kings Heath, for setting out so helpfully the intended roles for the Health Research Authority, which, I think by common consent, is a very positive move forward. It has got off to a solid start. I am grateful to him as well for giving us the opportunity to debate these instruments. They are the second of three steps in the establishment of the Health Research Authority. They amend instruments, laid last year, that established the Health Research Authority in December 2011 as a special health authority with an executive board. That was the first step in fulfilling the Government’s commitment in the March 2011 Plan for Growth to create a new body to streamline the approvals for health research, following an independent review of health research regulation and governance by the Academy of Medical Sciences.

The Health Research Authority was initially constituted with an executive-only board to allow it to begin work quickly on its important agenda. We were able to make suitable interim ex officio appointments from among the initial staff who transferred in.

The instruments that we are debating today provide for the Health Research Authority to have a chair and non-officer members as well, so that it has greater independence and credibility to perform its functions for the purpose of protecting and promoting the interests of patients and the public in health research. That is the second step.

From this point, the Health Research Authority will have stronger leadership, governance and oversight to steer its strategy and help it to fulfil its purpose of protecting and promoting patient and public interests, so that it can take forward work that calls for leadership and governance. That will involve an independent chair and non-executive directors if it is to command patient and public confidence in its performance of that work—as it must, in particular, in its forthcoming engagement strategy, including the important component of public and patient involvement.

The third step is to establish the Health Research Authority as an executive, non-departmental public body, to give it even greater independence and stability. The noble Lord, Lord Hunt, asked me about that. We will publish clauses to this end for pre-legislative scrutiny as part of the draft care and support Bill announced in the Queen’s Speech last month. I anticipate that those clauses will be published later this year. In the mean time, the Health Research Authority already has substantive functions as a special health authority, in addition to activities related to the National Research Ethics Service. They cover, in particular, co-operating with a range of other bodies to create a unified approvals process for health research and to promote consistent, proportionate standards for compliance and inspection.

The Health Research Authority’s role in rationalising processes and standards for health research approvals is intended to help make decisions about research proposals more timely and reduce the regulatory burden on research-active businesses, universities and the NHS. That will improve the cost-effectiveness of delivering health research in this country, increasing opportunities for patients here to benefit.

Noble Lords covered a good many issues, and I shall attempt to address as many as I can now; those that I cannot, I will happily follow up in writing. It is worth my setting out first how I see the potential of the HRA to improve the research environment generally—a theme rightly emphasised by the noble Lord, Lord Hunt. Alongside continuing to provide the National Research Ethics Service, the HRA has been taking forward work on its other functions. It recently published its business plan for 2012-13, setting out its business objectives and key performance indicators for the year.

In addition to its business plan, the HRA has also published the planned deliverables for its programme of work to provide a unified approval process for research and to promote proportionate standards for compliance and inspection. That sets out a number of deliverables for this summer, with further milestones for winter 2012—for example, to provide a single application package through the integrated research application system, the IRAS—with one set of declarations. The plan also identifies a number of areas for immediate attention to define deliverables, and makes a number of recommendations for future consideration.

Yesterday, the HRA hosted an event announcing its plans for the electronic submission of applications to take forward the IRAS to develop it as the platform for creating a unified approval process. In addition to the responsibilities that the HRA already has, we intend to give it the function of approving the processing of patient information and research purposes by April 2013—a subject to which the noble Lord, Lord Turnberg, alluded. That will allow for a managed transition between now and next April, when the National Information Governance Board—the NIGB—is abolished.

Noble Lords will know that the NIGB currently provides advice to the Secretary of State on the appropriate use, sharing and protection of patient and service user information. In particular, it has set up an ethics and confidentiality committee for the purpose of its advice on the processing of patient information, including confidential patient information under the Health Service (Control of Patient Information) Regulations 2002. Confidential patient information may be processed under those regulations only where the processing has been approved by the Secretary of State and, in the case of medical research, also by a research ethics committee. It is intended that the HRA will take on the Secretary of State’s role in approving the processing of such information for research by next year as part of its role in streamlining approvals for health research.

On its establishment in December, the HRA brought together functions relating to research ethics committees previously performed by the Secretary of State, the National Patient Safety Agency and strategic health authorities. The authority has substantive functions. As I have said, it will combine and streamline approvals for health research. It operates a single system for researchers to apply for approval to research ethics committees and trusts, the MHRA, the National Information Governance Board and the Administration of Radioactive Substances Advisory Committee. By April 2013, as I have said, it will bring in the functions that are currently performed by the Secretary of State and advice from the NIGB.

In general, we see the authority as having necessarily to work closely with all the bodies that I have referred to, as well as bodies such as the Care Quality Commission, the Human Tissue Authority, the National Institute for Health Research, which is playing its own part in streamlining research in the NHS, the NHS Information Centre and the NHS Commissioning Board, with a view to co-ordinating relevant functions, standards and processes. Where primary legislation is required to consolidate functions and develop the role of the HRA, we intend to introduce it at the earliest opportunity following pre-legislative scrutiny of the draft provisions, as I have referred to.

The noble Lord, Lord Hunt, asked me whether we intend there to be a majority of non-execs on the board. We do; the board will have one non-executive chair, whom we have just appointed, two to three other non-executive members and two to three executive members, including the chief executive. The chair has the casting vote if the executive and the non-executive membership is equal.

The noble Lord also asked me about the priority given to research by the NHS Commissioning Board, and I agree this is a very important area for the board. The document published by Sir David Nicholson in his role as chief executive designate of the board, Developing the NHS Commissioning Board, sets out the initial proposals for the operation and organisation of the board. It states explicitly that one of the board’s most important functions will be to support,

“a culture which promotes research and innovation”.

With regard to the board’s structure, the document proposes that tasks should be organised at national level within six broad functional portfolios, each organised under a director reporting to the board’s chief executive. It proposes that the commissioning development portfolio would include,

“the development of commissioning tools and commissioning guidance ensuring that patient care is commissioned so as to support the conduct of research in the NHS”.

That is a very clear statement of intent, and I am advised that work is proceeding along those lines.

The noble Lord, Lord Hunt, also asked me about the HRA’s capacity to streamline bureaucracy generally. I have referred to a number of ways in which it will do that, but it is interesting to note that the devolved Administrations wish the Health Research Authority to take on some functions on their behalf under the Medicines for Human Use (Clinical Trials) Regulations 2004, and to take on some functions of the devolved Administrations in relation to their research ethics committees. Arrangements to this effect have been made under various statutory powers between the authority and the devolved Administrations.

The Department of Health has asked the Social Care Institute for Excellence to be the appointing authority for the national Social Care Research Ethics Committee. Many studies deal with both health and social care, so it makes sense for the systems for health and social care to remain consistent. We expect the SCIE to continue to work with—and the national Social Care Research Ethics Committee to continue to operate in a way that fits with—the system that the Health Research Authority is operating.

The noble Lord, Lord Hunt, asked me a series of questions about the CPRD, which is a major step forward in making this country uniquely attractive as a base for research, and about its link to the HRA. On that theme and on a number of others that bear upon making the UK the base of choice for inward investors in health research, I will, if he will allow me, write him a letter, which I will copy to noble Lords present.

On value-based pricing, about which I will also write, there is no evidence that the pricing of medicines in this country acts as an influence one way or the other on decisions whether to invest in this country for research purposes. It is clear that pharmaceutical companies look for the speedy uptake of innovative treatments when assessing the UK as a worthwhile place in which to launch products, but that is a rather different issue from the research investment question. However, one of the driving philosophies behind value-based pricing is to ensure that patients gain access to innovative treatments on the NHS. That means that we want pharmaceutical companies to appreciate that innovation matters to us, to the economy and to patients.

To that extent, we have always said that we wish to encourage pharmaceutical companies to invest in areas of research that address unmet need and therapeutic benefit for patients and that, if they do so, they can expect to be fairly rewarded for it. A price that a medicine commands in the National Health Service will reflect the value that it brings to patients and to wider society. I believe that that general concept is welcomed by industry. There is much to do to work out the detail of the system, but if we can get it right, it is a win-win for the NHS and the industry.

I agree with a great deal of what the noble Lord, Lord Hunt, said about the need to tackle the loss of competitive edge that the UK has undoubtedly suffered during the past few years in attracting inward investment for research. We are starting to reverse that. If nothing else, industry appreciates that the Government are serious about reversing it and that we have taken a number of steps—not only through setting up the HRA but through our report, Innovation, Health and Wealth, and the growth strategy generally—to ensure that we turn the tide. We are working with the industry, as the noble Lord, Lord Hunt, successfully did when he was in office, to make sure that there are good channels of communication and proper understanding between government and industry on what the problems are.

I share his view that academic medicine is a key part of this. We must incentivise academic medicine properly and ensure that we have sufficient numbers to provide the clinical leadership in research that we so badly need. However, we must not forget that in this country we are very fortunate in having a number of assets on which we can capitalise, including our excellent universities and a very high standard of scientific education. We have the charitable sector as well as industry and multifunded research at all levels—from basic research to translational research to clinical research—in a way that few other countries have. We also have the advantage of the National Health Service as a platform for those trials.

I think that I have covered most of what I am able to cover today. Perhaps I may say to the noble Lord, Lord Hunt, who raised the question of maximising patient recruitment, that the clinical research network of the National Institute for Health Research is very much focused on increasing recruitment to high-quality research. For instance, one in three cancer patients now participates in a clinical trial, which is a considerable achievement compared to a few years ago.

Finally, the noble Lord, Lord Patel, asked me whether the HRA would deal with all ethical approvals however the research is funded. Yes, it will. Where research ethics committee approval is required, the HRA will provide for those committees, irrespective of the funder of the research.

I hope that those remarks are helpful and serve to put these statutory instruments into their proper context. The purpose of the HRA is to protect and to promote the interests of patients and the public in health research. It protects patients from unethical research while enabling them to benefit from participating in research by simplifying the processes around it. I hope I have reassured noble Lords that the amendment order and regulations that we have debated make a significant contribution to the fulfilment of this purpose. They provide for the HRA to have a non-executive majority board that can credibly balance the protection of patient and public interests with their promotion. I commend these instruments to the Committee.

My Lords, the conversation today has been limited to medical and health research. During the passage of the Bill, we had long debates about multiprofessional involvement being included in the research. I am very concerned that the conversation has been very much geared towards medical and health research and has not mentioned the fact that there are healthcare professionals other than those involved with medicine.

The noble Baroness is right to draw attention to that omission in my coverage of these instruments. Of course, she is right that there are many different kinds of research that will involve the HRA in one form or another. I have emphasised only the medical and pharmaceutical elements of the HRA’s remit, because these matters were high up on the agenda of the Academy of Medical Sciences when it produced its report in the context of UK plc.

However, the noble Baroness should bear in mind my remarks about joining up health research and social care research. The HRA will co-operate with various bodies for the purposes of creating a unified approval process, not just for health research but to promote a consistent national system for research governance generally. Where this includes a social care or nursing element, the HRA will work closely with the relevant bodies to promote processes and standards that are consistent with the NHS and social care elements.

My Lords, I thank the Minister for his positive response. I also thank the noble Baroness, Lady Emerton, the noble Lord, Lord Patel, and my noble friend Lord Turnberg for taking part in this interesting debate. I believe that the appointment and development of the HRA is a positive move forward, and of course we support the appointment of a majority of non-execs. The Minister mentioned the appointment of a chair. I do not know whether that is yet in the public domain or whether he has the name to hand, but it would be helpful to know.

I welcome the publication of draft clauses on the establishment of the HRA as a non-departmental public body in due course.

My Lords, I am happy to inform the Committee, for noble Lords who were unaware of it, that Professor Jonathan Montgomery was appointed chair of the HRA on 11 June, that interviews for non-exec directors will be held on Friday, that interviews for the substantive chief executive were held on 11 June, and that the other executive members will be appointed by the rest of the new board as soon as possible.

My Lords, that is very helpful. On the question of the reduction of the regulatory burden and the Minister’s reference to improving the cost-effectiveness of the whole process of approvals, that of course is welcome so long as patient consent and confidentiality are maintained and research is ethical. There is common agreement on that. I welcome his commitment to streamlining the approach in general for health research. I also welcome the decision by the devolved Administrations to encompass some of the work within the HRA, particularly the work of research ethics committees, which I assume will mean that cross-UK multi-centre trials will be subject to the streamlined process that the Minister has referred to.

On the role of the National Health Service in encouraging research, I take the noble Lord’s point about the NHS Commissioning Board’s statement of intent. I have no doubt that at that level Sir David and his colleagues will wish to support research. I am more concerned about the individual organisations in the NHS. I do not think that all NHS bodies quite realise the importance of research not only to patients but to UK plc. Anything that can be done to encourage the NHS to recognise that importance is vital. Sometimes that might mean the practicalities of recognising that their clinicians need time to take part in research activities. At a time when the NHS is having to find large efficiency savings, that may not always be welcome to chief execs of NHS organisations or to clinical commissioning groups. None the less, it would be disastrous if practising clinicians in particular were dissuaded or prevented from taking part in research activities. Again, messages on that matter from Ministers and the NHS Commissioning Board are vital.

Academic health science networks, particularly those outside London, are an important development. They will, I am sure, enhance research efforts. Again, the more support that can be given to them, the better. However, it is important that those networks focus on research—there has been some indication that almost everything about their intent is being put into the bath. One needs to come back to the fact that they are about enhancing our research capacity in the interests of the quality of patient services.

I agree with the Minister that the CPRD is a major step forward. We are uniquely attractive, but can we translate that into research money coming to the UK for what undoubtedly can be offered?

The Minister knows that I have always been sceptical about value-based pricing. He said that there was much to do. I urge him and his department to take their time on this matter. The PPRS allows industry flexibility to set the price within a profits cap. Although the UK is not a great purchaser of branded pharmaceuticals globally, the fact that it is able to set a price has an influence on price throughout Europe. My concern is that taking that away might have an impact on industry’s willingness to invest in R&D in this country, given that we so are slow to take up innovative new medicines. We developed NICE to encourage the health service to do that, and it is still a struggle because unfortunately the default position of the NHS and of clinicians is to be slow to invest in and agree to innovation.

If value-based pricing can encourage the NHS towards innovation in the way that the Minister suggests, that is of course to be welcomed. However, looking more generally at the impact of research, we do not seem yet to have a philosophy that goes hard on innovation where it can definitely improve the quality and outcome of patient care. That is to do partly with the conservative nature of clinicians in the UK and partly, probably, with the mindset of finance directors in the NHS. I know that the noble Earl is the Minister for Innovation and that he is wrestling with those issues. It is very important when we look at both research and value-based pricing that we encourage the NHS as both commissioner and provider to do everything that it can to take advantage of the huge amount of innovation that takes place in this country on the back of a fantastic resource in life sciences, in our universities and in the medical devices industry. Overall, we have had a very good debate and I am glad to support these statutory instruments.

Motion agreed.