Health Research Authority (Amendment) Regulations 2012

Lord Turnberg Excerpts

Wednesday 13th June 2012 Grand Committee

[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.