Health and Social Care Bill

My Lords, I beg to move, at last, Amendment 258 and will speak to Amendments 260A, 260B and 260C, which stand in my name and those of other noble Lords. I put on record my thanks to noble Lords across the Chamber for the way in which they have supported a series of proposals and amendments concerning research. This has been a non-party political area of the Bill and I am deeply grateful to them. On Monday, the Prime Minister launched a new strategy for UK life sciences with all the hype that he could muster—quite right too, as it is an outstanding document and contribution to life sciences. Our research is world beating, our National Health Service has a patient database unrivalled anywhere in the world and we are putting together a research and governance framework that will make the UK the place to do health and medical research. It is UK patients who will benefit by having novel and ground-breaking treatment literally years earlier than could have been hoped for five years ago when the noble Lords, Lord Darzi and Lord Sainsbury, set out with a very similar message. There is no difference between either side of the House on that issue. By coincidence, the amendments before us today will help deliver that strategy—and deliver it earlier. At the heart of the delivery platform for the strategy for improved outcomes for patients is the Health Research Authority, established not as a creature of Government but as a full NDPB. In essence, the amendments in this group would put in the Bill the commitments that the Prime Minister gave this week, and that the Secretary of State gave when he accepted the proposals made by the Academy of Medical Sciences in its ground-breaking report, A New Pathway for the Regulation and Governance of Health Research. To date, establishing the Health Research Authority via the Bill has not been the Government’s preferred option; I think I am safe in saying that to the Minister. Instead, the usual cautious Civil Service-driven approach of creating a temporary vehicle meant that a special health authority was set up on 1 December to carry out many of the functions of a future NDPB. However, much of the confusion, duplication, delay and obfuscation outlined in Sir Mike Rawlins’s report will continue to exist, as we wait for another Bill that may or may not come in the next Session of this Parliament. If a single Member of this House actually believes that any Government would be enthusiastic about bringing in a new Bill, having sat through this particular Bill—which is by no means finished—then, quite frankly, they are on a different planet. The Minister argues that the special health authority will do almost everything that such a Health Research Authority will do, but is this really the case? Will it really have the authority or the power to change much at all? The research community welcomed, as I did, the transfer of the National Research Ethics Service to the special health authority, but what about the plethora of other regulatory bodies? Ethical approvals, including the storage of tissue, from the HTA, and embryo project licences from the HFEA will still be required. Ethics and Confidentiality Committee approval will still be needed for exemptions to common-law confidentiality. Permissions from the Administration of Radioactive Substances Advisory Committee will be needed if research clinicians wish to administer radioactive substances. All the powers of the Medicines and Healthcare products Regulatory Agency will remain exactly where they are. As a special health authority, the Health Research Authority has absolutely no authority to deal with the different legislative regulatory arrangements across the devolved nations. It was quite interesting that with Amendment 260, tabled by the noble Lord, Lord Patel, the Government prayed against creating a special health authority because it would be able to deal only with England; it would not be able to deal with the rest of the United Kingdom. This is exactly the sort of organisation that has been set up to deal with this crucial area of health research. Crucially, there will still be the vexing issue of individual National Health Service research and development approvals. Unless the HRA is set up as an NDPB in this Bill, approval processes, which are often taken sequentially rather than in parallel, with often conflicting advice from different bodies, will continue to cause confusion, delays and frustration, and the UK will continue to see research programmes haemorrhage away to international competitors as clinical trials persist in being problematic—exactly the opposite of what A New Pathway for the Regulation and Governance of Health Research is preaching to us this week. Amendment 258 would establish the Health Research Authority in primary legislation—now—as an NDPB and set out the HRA’s role in co-ordinating the approval and regulation of health research. Subsection (3) provides for the transfer to and the management of, "““all aspects of the approvals of health research””." Subsection (3)(a) covers the transfer of functions of the National Research Ethics Service to the HRA when it is established as a full NDPB, but the wording is broad enough to cover other research approvals that could be transferred—for example, those of the Human Fertilisation and Embryology Authority, the Human Tissue Authority, the Ethics and Confidentiality Committee and the Administration of Radioactive Substances Advisory Committee—all without the need for further legislation. This could all be done through secondary legislation in an orderly time and allowing for full consultation. Subsection (3)(b) covers the HRA’s role in providing NHS R&D permissions, which it would undertake jointly with NHS trusts. Amendment 260C, which I will come to in a minute, allows for a more detailed exploration of the exact role of the HRA in NHS R&D permissions. Subsection (3)(c) covers the HRA’s role in supporting the MHRA in the regulation of clinical trials. Subsection (4) explores the general functions of the HRA. At the moment, some regulatory organisations are very good at providing advice and support; others, quite frankly, are not. High-quality guidance is needed in some areas, and where this is currently absent or confusing—for example, in the use of patient data in research, which is an absolute minefield—subsection (4)(a) would ensure that researchers apply appropriate standards consistently across all studies, with the HRA becoming an authoritative source of guidance both to support researchers and NHS trusts and to build patient confidence in research. Subsection (4)(b) would support the HRA’s quality remit, as it would be required to publish, "““annual metrics and indicators on all research approvals””," while subsection (4)(c) addresses the important area of UK-wide research frameworks. The regulation and governance pathway is currently fragmented across the whole of the United Kingdom. Some research approvals, such as those of the HFEA, apply to the whole of the UK; some apply to England and Wales, with different arrangements in Scotland, as happens with the HTA and the ECC; and some are managed separately in each Administration, as happens with the NHS R&D permissions in individual healthcare trusts. The complexity of the system can create additional barriers for researchers, which is a huge barrier to the UK being the prime destination in terms of research. Subsection (4)(f), "““facilitating and promoting health research involving human participants or their data””," is a massive issue, which again, if it were on the face of the Bill, could be dealt with in secondary legislation. Put simply, Amendment 258 would allow the Health Research Authority to be set up with a minimum of detail, allowing the details to be worked out in consultation with the broad community, and indeed with public consultation, but it would mean that any future government would have to work on putting it into action, rather than waiting for some legislation, which may or may not come down the track. The real issue is that if we are left with a special health authority, we will be left with it in four, five, or perhaps even 10 years’ time. We will have lost the opportunity to move forward. It is that serious. Amendment 260A is a probing amendment, which sets out the specific health research functions that should be transferred to the Health Research Authority. What we are saying is that, in addition to the National Research Ethics Service, it would be easy in this piece of legislation, which the Government may or may not take forward—and this is entirely a probing amendment—to bring in, in addition to the Ethics and Confidentiality Committee, the research functions of the Human Tissue Authority, the Human Fertilisation and Embryology Authority and the Administration of Radioactive Substances Advisory Committee. It does not require a new Bill to do that. It could simply be done on the back of this Bill. Amendment 260B is again a probing amendment, which seeks to strengthen the link between the Medicines and Healthcare products Regulatory Agency, the MHRA, and the proposed Health Research Authority. In effect, it would establish a duty of co-operation between the two organisations. It is expected that the new Health Research Authority will take on most aspects of the regulation of health research, except for the regulation of clinical trials of investigational and advanced therapy medicinal products, which will continue to be regulated by the MHRA. This simple amendment seeks clarity from the Government around their expectations for the relationship between the Health Research Authority and the MHRA. Finally, Amendment 260C is the crucially important probing amendment because what it would do is establish an organisation called the ““National Research Governance Service””. This is hugely important because one of the biggest barriers to effective development of clinical trials at the moment is getting NHS R&D permissions. It took one hospital five weeks to get the necessary permissions for a kidney research clinical trial; in another it took 29 weeks. Getting a stroke programme up and running took one week on one site and 35 weeks on another. The average time it takes to get a cancer trial up and running is something like 80 weeks. It is absolute nonsense, and how the Minister can turn to this House and say we have an opportunity to do something about that and not take it is something only the Minister can respond to—which I am pretty sure he will do very strongly and very supportively of these amendments in the near future. NHS R&D permissions are currently the greatest barrier in the regulation and governance of health research, with multiple, duplicative checks undertaken at every NHS site. The Academy of Medical Sciences recommended creating a national research governance service—this comes directly from the AMS report—within the HRA to centralise as many of these checks as possible to avoid duplication. The Government have ignored this recommendation and instead introduced standard operating procedures and incentives to make improvements to the current system. Only a civil servant could have done that, when in fact what we want is action. I say to the Minister that these developments are welcome but it is far from clear whether they will be sufficient to remove this major barrier. Amendment 260C would provide the framework to remove vast amounts of duplication. Subsection (2)(a) of the proposed new clause would mean that the governance checks that apply to every site would be undertaken just once by a central body and would therefore reduce duplication. Let us imagine the effect that that would have on getting clinical trials up and running, particularly large trials. Some may argue—the Minister may in his response—that it is not possible for a central body to undertake governance checks or to grant NHS R&D permissions on behalf of NHS trusts because trusts are autonomous bodies. I say that that is nonsense. It is essential that we find a way to deliver that. The idea that trusts will not work together and will not rely on a responsible body to do that work for them is something for which there is no evidence to support those claims. Many trusts currently are able and willing to delegate responsibility for the checks, provided that they trust the body undertaking the checks. An independent body, an NDPB, would deliver that, rather than what is proposed by the Government. I now draw the attention of noble Lords to subsection (2)(c), which deals with the urgent need for, "““NHS trusts to determine local feasibility””," swiftly. On the recommendation of the Academy of Medical Sciences, we have set out a 20-day timescale for NHS trusts to undertake this part of their governance checks. At the moment, NHS R&D permissions are the time-limiting factor in all research approvals and examples have been given where it has taken in excess of a year to get a permission at a single site. Twenty days is ambitious. The role of trusts in the process would be reduced as more things are done centrally. But all in all this is a real opportunity for us to deliver a major change in the way in which we put together research programmes. I hope that my noble friend in his reply, and other noble Lords who will speak to these amendments, will accept that this is a one-and-only chance for us to do something momentous in this House. I trust that the Minister will give full support. I beg to move.