Health Research Authority (Amendment) Regulations 2012
(Limited Text - Ministerial Extracts only)
Read Full debate
Lord Patel
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?
The Parliamentary Under-Secretary of State, Department of Health (Earl Howe)
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.
Baroness Emerton
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.
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.