My Lords, a great many points have been raised in this debate, so I may take a little time to respond. I hope that the Committee will bear with me. Amendments 58B to 62 seek to give the Health Research Authority a stronger role in streamlining the management of research, particularly in the NHS. I am the first to recognise that delays in obtaining research approvals
in the NHS remain a problem for many researchers and that there is an expectation that the Health Research Authority will help to improve this situation through its relationship with the NHS.
I also appreciate that noble Lords, particularly in relation to Amendments 61 and 62, seek reassurance that all providers of NHS services will be required to pay attention to the guidance that the authority is required to produce under Clause 98(6). This issue was highlighted by both the Academy of Medical Sciences and the Wellcome Trust during pre-legislative scrutiny of the Bill. The clauses in the Care Bill would give the Health Research Authority a unique, free-standing duty to promote the co-ordination and standardisation of practice in the UK relating to the regulation of health and social care research. At this point I reassure the noble Lord, Lord Turnberg, that the duty of co-ordination and standardisation necessarily involves co-ordinating and standardising the practice of NHS trust research and development committees.
In addition, the Health Research Authority will have a reciprocal duty to co-operate with other regulatory bodies or individuals that have statutory functions in the regulation of health and social care research. Statutory functions are an important point. I take this opportunity to address the three amendments listed here that are concerned with this duty. In doing so, it is important to explain why Clause 98(1) would place a duty of co-operation on the HRA and in particular the Chief Medical Officer of the Department of Health. The reason is that the Chief Medical Officer holds functions relating to research under the Abortion Regulations 1991. These require notice to be given to the Chief Medical Officer of any abortion and any information relevant to it.
The disclosure of such information is restricted, except in specific circumstances, which include disclosure for the purposes of scientific research. The Chief Medical Officer is responsible for determining whether disclosure can be made. It is because of the Chief Medical Officer’s functions in approving the disclosure of information about abortions for the purposes of scientific research that the authority, the Chief Medical Officer and the bodies and individuals listed must co-operate with one another with a view to standardising and co-ordinating practice relating to the regulation of health and social care research. Similarly, other bodies and individuals listed have functions relating to the regulation of health or social care research. So it links in those statutory functions.
I listened with great care and a great deal of understanding to the noble Lord, Lord MacKenzie, my noble friend Lady Cumberlege, the noble Baroness, Lady Emerton, and others on their wish to expand the duty of co-operation to include the Chief Nursing Officer. The Chief Nursing Officer is an NHS England role, while the Department of Health has a director of nursing. Neither of these posts has any statutory functions relating to the regulation of health or social care research. That is the key point. For this reason, Clause 98(1) does not create a duty of co-operation on the HRA either with the Chief Nursing Officer of NHS England or with the Department of Health’s
director of nursing and the bodies and individuals listed in Clause 98(1). I hope that this explanation is helpful.
On Amendments 58B and 58C, the medical royal colleges, the General Medical Council, the General Dental Council and the Nursing and Midwifery Council do not have such statutory functions in this context either. The noble Lord, Lord Walton, made an important and powerful point about the GMC. However, the Health Research Authority would have powers, under paragraph 13 of Schedule 7, to work with the GMC and the other medical regulators to help and advise them in their work. That, I hope, will reassure the noble Lord that that aspect of the HRA’s work has not been forgotten about.
Amendment 60A would require the Health Research Authority to assess the impact of proposed changes to the system for setting pharmaceutical prices on health and social care research. I pay tribute to the noble Lord, Lord Hunt, for introducing this extremely interesting topic to our debates. I believe that this function is best undertaken by the National Institute for Health and Care Excellence rather than making it part of the authority’s role in promoting the co-ordination and standardisation of regulatory practice. As he will know, we have already announced that NICE will play a central role in the pharmacoeconomic evaluation of new medicines in the context of the framework for value-based pricing, once that is announced.
The noble Lord made a point about value-based pricing, in that it is important for the Government—I agree with him—to take account of the need to attract investment into this country. As set out in our plan for growth and our Strategy for UK Life Sciences, the Government are absolutely committed to ensuring that the UK continues to offer an environment that supports and encourages investment and innovation by the life sciences sector, and where the NHS is a world leader in clinical trials. However, there are some legitimate points of debate here about the impact of medicine prices on companies’ decisions on where to locate investments or conduct research. As highlighted in the 2007 NERA study, Key Factors in Attracting Internationally Mobile Investments by the Research-Based Pharmaceutical Industry, this is a global market. Companies locate where they can find the best science base at reasonable cost, taking into account other factors such as taxation, flexible labour markets and economic stability. It is not self-evident that the pricing of medicines drives decisions of this kind. It is an interesting debate to have, but perhaps it is one for another occasion.
The noble Lord also asked about the cancer drugs fund. It is very heartening that more than 30,000 patients in England have now benefited from that fund, which in total amounts to £650 million over three and a half years. We are committed to building on that success. In the context of developing new pricing arrangements for branded medicines, I can reassure the noble Lord by saying that we are exploring ways in which new patients can benefit from innovative cancer drugs at a cost that represents value to the NHS. NHS England is very much included in that discussion, and we well appreciate how important it is for patients.
To meet the duty of co-operation in this whole area, the Health Research Authority will be required to take the lead in actively identifying ways in which to remove duplication, streamlining the regulation of health and social care research and seeking to ensure that regulation is proportionate. At this point, I reassure noble Lords that the authority must facilitate all types of high-quality ethical research, including research that is multidisciplinary in nature and research by multiprofessionals. In keeping under review matters relating to the regulation of health or social care research, the authority may provide advice to the Secretary of State and must do so on request. Such advice could include recommendations to improve the regulatory landscape for research.
The existing Health Research Authority, the Special Health Authority, has already begun an ambitious programme of work to speed up the research journey in the UK, including the creation of a unified approval process and consistent, proportionate standards for compliance and inspection. I hope that will be welcome news to the noble Lord, Lord Patel, in particular. In doing so, it is working closely with other bodies, including representation from the NHS, to identify and implement effective solutions to make it faster and easier to initiate research.
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Clause 98(6) requires the HRA to publish guidance setting out principles of good practice in the management and conduct of health and social care research, and any statutory requirements that people conducting such research are subject to. This guidance would replace current guidance issued by my department, the research governance framework.
Amendments 61, 61A and 62 are concerned with the bodies that this guidance will apply to and how it will relate to them. This guidance will be applicable to anyone managing or conducting health or social care research. The HRA will be the authoritative voice that brings together and disseminates what is good practice. Having heard that the main residual barrier to research in the health service is at the level of the trust, as I believe many noble Lords are well aware, we have sought to strengthen the status of the HRA’s guidance by requiring NHS trusts and NHS foundation trusts to have regard to it.
My noble friend Lady Jolly and the noble Lord, Lord Patel, questioned the strength of that provision. The duty to have regard to the guidance shows that the guidance must be given great weight; it is not mere advice that its addressees are free to follow or not as they choose. It means instead that, in this case, NHS trusts, NHS foundation trusts and local authorities that provide or arrange care will be under a duty to consider with great care the guidance published by the HRA and will be expected to follow it unless they have very clear and cogent reasons for not doing so. The legal meaning of “have regard to” has been interpreted in the courts to mean that such guidance must be followed by those to whom it is addressed unless there are clear and cogent reasons for them not doing so. In fact, providers, including private providers of NHS services, can be required to have regard to the guidance
by placing conditions within their operating frameworks and contracts, for example. In the final analysis, this matter could also be subject to judicial review.
The noble lords, Lord Hunt, Lord Turnberg and Lord Patel, spoke about multicentre research and the HRA’s role in that context. The Health Research Authority special health authority already has a programme of work to enable the implementation of a unified approval process, as I have mentioned. This programme includes a feasibility study with a number of pilots to test the effect of rationalising and combining elements of NHS study-wide review with elements of the research ethics committee review into a single HRA assessment. The findings are expected to identify and show how to realise potential to improve both study set-up times and the quality and consistency of review. We expect this work to continue.
The guidance is also extended, as I have mentioned, to local authorities. Given that the HRA’s remit will now also extend to social care research, the statutory duty to have regard to the authority’s guidance means that these bodies must consider the guidance with great care. It will be expected that they will follow such guidance, as I have explained. We are not seeking to establish the HRA as an inspectorate with enforcement powers. Such powers would be required if a statutory duty to follow guidance were to be imposed on private providers, because there would have to be an express enforcement mechanism, such as powers to apply a sanction, if these providers failed to have regard to the guidance.
The existing special health authority is demonstrating, I believe, another way of working. A great deal can be achieved by working and co-operating with others. It is collaborating with its stakeholder community, including the NHS, charities and the private sector. For instance, securing buy-in through early engagement was key to the successful adoption of the integrated research application system by all research approval bodies across the whole of the UK. We want the HRA to continue to put that spirit of co-operation into practice and to get support for the guidance that it will be required to produce.
Giving the HRA powers to take enforcement action would be counterproductive if it made it more difficult for the authority to take a collaborative approach to carrying out its work and fostering informed support among the range of stakeholders. However, a number of mechanisms may be used as a means to secure compliance with the research governance framework. I have already mentioned contracts. Funding for research may be conditional on ensuring compliance with the framework. Compliance with the current guidance has also been achieved through the system of care regulation, so there are various ways in which to achieve what the noble Lord, Lord Patel, and no doubt my noble friend Lady Jolly, wants to achieve.
The Care Quality Commission’s guidance about compliance lists applicable publications, including the research governance framework. The guidance about compliance states that providers should reflect the key expectations of listed publications for their service as they relate to the essential standards of safety and
quality. There is no reason why these mechanisms could not continue to be used to achieve compliance by providers commissioned to deliver services for the NHS or local authorities.
I hope that I have provided reassurances on the issues raised by this group of amendments. With those reassurances, I hope that the noble Lord will feel able to withdraw the amendment.