Health Research Authority (Amendment) Regulations 2012

Lord Hunt of Kings Heath Excerpts

Wednesday 13th June 2012 Grand Committee

Moved by

[Lord Hunt of Kings Heath]

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

[Lord Hunt of Kings Heath]

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.

[Lord Turnberg]

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.

--- Later in debate ---

[Earl Howe]

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.

[Lord Hunt of Kings Heath]

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.

[Earl Howe]

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.

[Lord Hunt of Kings Heath]

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.