Moved by Baroness McIntosh of Pickering
78: Clause 20, page 17, line 14, at end insert—“14Z39A Duty to review latest innovations with a view to local commissioning (1) Integrated care boards must review all new—(a) medicines,(b) medical devices, and(c) other health care solutions that may benefit the local population.(2) Integrated care boards must—(a) appoint a dedicated innovation officer to their board, and(b) develop and maintain a system to keep up to date with medicines and devices innovation and review suitability for patient usage, including engagement with the relevant—(i) academic health science network, and(ii) local pharmaceutical committee.”Member’s explanatory statementThis amendment would mandate ICBs to monitor and assess innovation for the benefit of the local population.
I have four amendments in this group; I will speak to each in turn and look forward to hearing what the noble Lord, Lord Sharkey, says on his two amendments.
I thank the noble Lords, Lord Hunt of Kings Heath, Lord Patel and Lord Kakkar, for supporting Amendment 78. It looks at innovation, recognising that it is an ongoing iterative process that every ICB should be aware of to ensure that patients have access to the most efficient and effective healthcare solutions of the day. To that end, is purpose is to oblige integrated care boards to formalise the obligations of the board to horizon-scan for the latest innovations, as approved by regulatory bodies, to cover their population.
This new clause would require the appointment of an “innovation officer”, or potentially identifying an officer to take up that role, and place an obligation on the board to constantly review innovative medicines and devices, as they become available. This is a separate and additional duty to that to promote research.
This amendment is very much supported by the Association of British HealthTech Industries, which has its own chief innovation officer campaign that has been supported by several noble Lords. Essentially, its thinking is that it is at the moment nobody’s job to horizon-scan for new innovations that may bring huge benefit to patients and, therefore, they are often not being prescribed. As we know, the NHS is under pressure and, if no one is responsible for this, it most likely will not happen. I specifically refer to the Academic Health Science Networks—there are 15 across England—as they are spread over the country and provide a good link between research and hospitals.
I turn now to Amendments 81, 96 and 135. Research is critical to the continued treatment of medical conditions in the UK, with our world-leading life sciences sector playing a critical role. However, the system is currently fragmented, and research has struggled to access patients for use in clinical trials. This means that joined-up research to address national health challenges or emergencies is extremely difficult. It is also difficult for research to access patient groups across ICS footprints in order to develop rare and ultra-rare treatments. Personally, I am not entirely clear what the status of clinical trials within the European Union is at this stage; we debated that in earlier legislation and it would be helpful to have an update from the Minister, if possible.
To address these gaps, each ICB should be required, through these amendments, to put in place a research strategy to enable them to proactively engage in or support research into local healthcare issues or challenges and to enable participation in national research projects. Secondly, to ensure operational delivery of this strategy, each ICB should be obliged to consider any request for a local or national clinical trial that benefits the local patient community or supports the national NIHR research programmes. They should then undertake appropriate patient recruitment and obtain the necessary consent. Further, each ICB should be required to publish annually the research it has undertaken in that year, which should be included in an annual report. NHS England should be obliged to collate this information and present it to Parliament.
Amendment 81 in my name would require ICBs to establish a research strategy across healthcare and other connected measures. Amendment 96—for which I am delighted to have the support of the noble Lords, Lord Patel and Lord Kakkar, and I thank them for that support—would require integrated care boards to consider annual requests to engage in clinical trials and offer patients the opportunity to participate. Finally, Amendment 135 would require integrated care boards to publish an account of their research activity and would require the report that the Secretary of State must prepare and lay before Parliament, under Section 247D of the National Health Service Act 2006, to include a section that reproduces and comments on the research activity of all ICBs.
With these few remarks, I beg to move.
My Lords, it is a pleasure to follow and to agree with the noble Baroness, Lady McIntosh. I will cover some of the same ground in my remarks.
I start by declaring my interests as chair of the Association of Medical Research Charities and of the Specialised Healthcare Alliance. The alliance campaigns on behalf of those 3.5 million of us who have rare or complex conditions. The members of the AMRC spend around £1.7 billion a year on medical research, mostly through universities in the United Kingdom. That is more than is spent by the Government via either the Medical Research Council or the National Institute for Health Research.
I will speak to Amendments 79 and 196 in my name and the names of the noble Lords, Lord Kakkar and Lord Patel, and the noble Baroness, Lady Blackwood. It is a privilege to have the support of such extremely distinguished and expert Members, and I am very grateful to them. The amendments also have the support of much of the medical research sector. Both amendments concern research within the NHS. This subject is a long-standing preoccupation of the medical research community, the NHS and the Government.
As long ago as 2011, the Academy of Medical Sciences published an influential paper setting out some key findings, prominent among which was the difficulty in attaining NHS permissions for research. In fact, this was identified as the single greatest barrier to health research. In 2017, the NHS and NIHR published a joint paper called 12 Actions to Support and Apply Research in the NHS. The NHS Long Term Plan, published in 2019, was generally received positively but actually had little to say about research. As your Lordships would expect, the NIHR did have something to say about research in its work of March last year, “Embedding a Research Culture”, which rehearsed the benefits of a research-intensive NHS. Three of the main actions called for were:
“Improving visibility and making research matter to the NHS … Making research more diverse and more relevant to the whole UK … Strengthening public, patient and service user involvement in research.”
These are obviously very important goals, but setting them out as clearly as the NIHR does makes it clear that the NHS’s performance in this vital area really does need improvement.
Also in March last year, the Government published a ministerial paper focused entirely on the delivery of UK clinical research. The paper set out the value of clinical research and our world-leading position. It made the assertion that
“research is the single most important way in which we improve our healthcare—by identifying new means to prevent, diagnose and treat disease.”
It concluded that that meant
“embedding clinical research at the heart of patient care and the NHS, making participation as easy as possible and ensuring all health and care staff feel empowered to support research.”
I strongly agree with both these assessments, and I am very glad to see them as firm policy goals. I welcome the clear and directive language and the signals of intent, which is why I was extremely disappointed to see such a very weak obligation as regards research in the Bill.
New Section 14Z40, inserted by Clause 20 on page 17, sets out what it describes as a duty in respect of research for ICBs. It simply says:
“Each integrated care board must, in the exercise of its functions, promote— (a) research on matters relevant to the health service, and (b) the use in the health service of evidence obtained from research.”
This is essentially the same kind of duty as imposed by the 2012 Act, and it is extraordinarily weak. The word “promote” is not really meaningful. What would satisfy this condition? Mere exhortation would probably qualify. Imposing a duty to actually do research would be much clearer, much simpler and more likely to have an effect. This would also be consistent with the Government’s view of the critical importance set out in the ministerial paper. That is what our Amendment 79 seeks to do. It is a “must actually do something” obligation rather than a “promote the doing of something” obligation. It requires that ICBs must ensure that those eligible organisations for which the ICB is responsible conduct research on matters relevant to improving patient outcomes and healthcare delivery and promote the use in health and care of evidence obtained by research.
The amendment has two additional parts. The first is to impose a requirement for ICBs to co-produce research aims with local place-based partnerships and to ensure diversity of participation. This acknowledges both the benefits and the necessity of place-centred research and close partnership in the production of research aims. The second additional part of our amendment is simply a requirement that the ICB publishes via its annual reports and joint forward plans the steps it has taken or plans to take to deliver clinical research.
Our Amendment 196 is also in this group. It deals with research directly in trusts and foundation trusts. As things stand, Schedule 4(16) of the 2006 Act says only that
“An NHS trust may undertake and commission research and make available staff and provide facilities for research by other persons.”
This is clearly permissive and not directive. Our Amendment 196 would remove this paragraph and replace it with a requirement for both trusts and foundation trusts to actually carry out research, as in Amendment 79. The amendment would also preserve, from the 2006 Act, making available staff and providing facilities for research by other persons.
I strongly believe that both amendments—all parts of them—are in keeping with the ministerial paper, Saving and Improving Lives: The Future of UK Clinical Research Delivery. I hope that the Minister will recognise the cross-party and not adversarial character of our proposals. We really agree with the Government about the paramount importance of research in the NHS—we just need to make it happen. I look forward to the Minister’s reply and to further discussions between now and Report.
The noble Lord, Lord Howarth of Newport, is participating remotely. I invite him to speak now.
My Lords, if, as I hope, the Bill will be amended to establish a quadruple aim for the NHS—the fourth aim being the reduction of health inequalities—then it will follow that we must have systematic research into the origins and remedies of health inequalities. In this connection, we need to understand options for using cultural, natural and community assets within the changing structures of health and social care, in particular at ICS level. Research should lead to better understanding the relationship of such assets to health inequalities, with a view to health systems mobilising those assets in prevention and intervention strategies, particularly to benefit people living with complex needs in deprived areas. The spectrum of research receiving public funding needs to run from laboratory-based clinical research to public health and community-level action research. The system needs to build capacity at that latter end of the spectrum, training and providing funding and opportunity for new cohorts of such researchers.
Let me give a few instances of the kind of down-to-earth research that needs to be funded. How are improvements to well-being, including staff well-being, to be measured, valued and integrated most effectively with policy at ICS level? More research is needed on the cost-effectiveness of community-based programmes. More research is needed on the cost and health benefits of the link worker model in social prescribing and on financial models for integrating community assets into health systems. Social prescribing needs to be underpinned by robust research on what we might call dosage. How much of such activities should be prescribed, and for how long, to bring about measurable behaviour changes and health outcomes? More evidence is required regarding the sustained, longitudinal effects of engaging in non-clinical programmes across specific health conditions such as cancer, stroke, dementias, diabetes and heart disease.
Such needs are being recognised by UKRI and, under its umbrella, the ESRC, the NERC, the MRC and the AHRC. What is also striking is the growing international interest and evidence base for this kind of research, as demonstrated by the World Health Organization scoping review by Daisy Fancourt and Saoirse Finn, entitled What is the Evidence on the Role of the Arts in Improving Health and Well-being?, and the establishment of the WHO Collaborating Centre for Arts & Health, based at University College London. The aims of this centre are to carry out world-class research into how the arts, culture and heritage affect mental and physical health; to work with world-leading researchers in the UK and internationally to develop and improve arts and health policy globally; and to provide training opportunities, toolkits and resources to support development in the field, including facilitating opportunities for early career researchers.
One admirable model is SHAPER, a £2 million research programme funded by Wellcome to assess the implementation of three creative health interventions by embedding them in clinical pathways across King’s Health Partners, bringing together academics in psychiatry and epidemiology with the King’s Centre for Implementation Science, as well as clinicians and researchers across King’s and King’s Health Partners, and three arts organisations, Breathe Arts Health Research, the English National Ballet and Rosetta Life. This programme will explore the barriers and enablers for taking effective interventions to scale and learning from it will inform the spread of creative health interventions in other parts of the country. The interventions include Melodies for Mums, a 10-week singing and music programme for mothers with postnatal depression, which has reached 300 mothers in Lambeth and Southwark.
The National Centre for Creative Health, a charity of which I am chair, is working with Professor Helen Chatterjee of UCL on a UKRI-funded, cross-council research programme, led by the AHRC, to better understand how cultural, natural and community assets can help mitigate health inequalities. The programme will support research in pilot sites across the UK, with a focus on how prevention and intervention strategies can be scaled up from small, locally based approaches to whole communities and systems. As a charity, one of NCCH’s purposes is to seek to ensure that key gaps in research relating to creative health are filled and appropriate skills developed and embedded in healthcare systems, along the lines of what may be envisaged in the Bill and what is spelled out in some of these amendments. Amendments 79 and 196, just introduced by the noble Lord, Lord Sharkey, are particularly valuable in specifying obligations for ICBs and NHS trusts to conduct local research.
I have some questions for the Minister; if he is not able to answer them this afternoon, I would ask him to write to me. To what extent does he intend that the gathering and reporting of data by ICBs should be standardised and how do the Government intend to proceed on this? Will success measurement focus on not just process but outcomes, both near-term and sustained? How will the Government harvest and use the evidence on innovation provided by the work of academic health science networks?
I wonder also whether the Minister could tell us something about the thinking of the National Institute for Health Research, going beyond the helpful remarks of the Baroness, Lady Chisholm, in her response to the last debate on Thursday. I appreciate that its budget, albeit very substantial, is under constant pressure from the insatiable demands of clinical research and that many high-quality research bids have to be turned down. I also appreciate the requirement not to compromise academic standards. However, does the NIHR appreciate the need to fund and develop research methodologies that differ from the time-honoured models such as RCTs and support other types of research, including coproduction methodologies, vital to improving our capacity for both prevention and bringing about a health-creating society?
My Lords, I want to direct a few remarks to the issue of research, in broad support of the speeches made so far. The amendments in this group, taken individually, are generally to be welcomed, not least because they highlight the issues involved. However, taken as a whole, they suggest that there is a need for a more coherent approach, based on the common principles that apply across the whole range of providers and the whole spectrum of health and social care.
The point of principle is that there is a demonstrable association between the provision of high-quality care and participation in high-quality research. Put simply, patient outcomes in services that actively take part in research are better. This does not mean just future improvements in care, diagnosis and so on; the actual care provided alongside the research benefits from involvement in that research. It is reasonable to assume that the same is true of care services; I direct my remarks at healthcare, but I am sure these principles apply equally to those involved in the provision of social care.
Given the principle that research is so important, it is worth making a few additional points. First, research must be an essential element in a system of healthcare, involving both the bodies that deliver healthcare and service users. Hence ICBs need to have a research strategy and not just promote research but take practical steps to facilitate it. In this context, the importance of national research objectives should be emphasised. The involvement of these bodies in research should be more than just one more administrative hoop they have to jump through. It should be part and parcel of their core function, delivering better mental and physical healthcare. They also need to commit to training clinical staff in how they can participate to best effect in research, or at least in the importance of research to clinical care.
Secondly, there is a need to consider a duty on private providers of NHS services to participate in research. Of course, private providers have a duty to support and contribute to the training as well. It is easy for private providers to ignore the need for research, and this reduces the opportunities for those for whom they care.
Thirdly, on Amendment 96, I suggest that we need to go beyond the idea that clinical trials need to be considered by ICBs and other relevant agencies. We could go further and require ICBs to use their best endeavours to encourage and accept reasonable requests to support clinical trials and offer opportunities for patients to take part.
Fourthly, as we have touched on in previous debates in this Committee, it must be emphasised that, when addressing the issue of research, there is a need to refer explicitly to mental as well as physical health.
Finally, all of us should bear in mind the importance of service users being involved in research and of ICBs and other agencies keeping this in mind throughout the process of providing care. This includes the involvement of service users in developing the priorities of research in its design and in overseeing its carrying out. This is vital for making sure that the outcomes can be easily embedded in clinical and care services. It is worth emphasising this in the context of mental health, where most advances in patient involvement have taken place.
My Lords, I thank the noble Baroness, Lady McIntosh of Pickering, and the noble Lord, Lord Sharkey, for the thoughtful way in which they introduced the amendments in this group to which I have added my name. In so doing, I remind noble Lords of three interests: I am chair of the Office for Strategic Coordination of Health Research, chair of the board of trustees of UK Biobank and chair of King’s Health Partners.
As we have heard in this debate, research is not only fundamental to securing the best outcomes for patients being treated in our hospitals and throughout our healthcare system; it is critically important for the sustainability of the healthcare system itself. Numerous reports and strategies have been published over the last 10 years, to the great credit of Her Majesty’s Government, in terms of putting innovation and research at the heart of repeated NHS strategies. It is therefore only right that your Lordships’ House pays particular attention to how securing the opportunity for that research and promoting the opportunities that will flow from it are reflected in the Bill. There is no question but that Her Majesty’s Government are deeply committed to this area, but, as the Bill is currently drafted, there is some anxiety that the provisions and clauses do not provide sufficient emphasis or obligation for the new NHS organisations, the integrated care systems and the integrated care boards—and, indeed, the continuing obligation for NHS trusts—to be actively involved in research.
Now why is this important? At the very least, we know that we need to continue to innovate, be it therapeutic innovation or innovation through devices—or, indeed, innovation of new working practices, pathways of care and delivery—if we are to continue the important advances in outcomes that we have been able to achieve in recent years and decades. As we have heard, research is at the very heart of our ability to improve the experience and clinical outcomes of our patients. Research is also fundamental in improving our ability to prevent disease. We have an obligation in this Bill to promote healthcare services and well-being and to avail ourselves of the substantial opportunities that exist with regard to a more focused prevention agenda. Much of that agenda must inevitably be driven by prospective research, to be conducted across broad and diverse populations on our fellow citizens.
There is the question of sustainability—the fundamental sustainability of the NHS. Here we recognise that, without research and the adoption of innovation resulting from that research, the demographic changes and increasing demands that attend the delivery of healthcare in our country will make the NHS unsustainable in future. Therefore, there is a very deep obligation, beyond what we can do for patients in terms of clinical outcomes, to put at the heart of NHS thinking and strategy, as well as delivery, the delivery of a substantial research agenda. We know that that that research agenda is secured centrally through the substantial commitment of public funds to the National Institute for Health Research, UKRI and Research Councils, which provide funding for research—and, indeed, for other contributions from government departments, including the third sector contribution and the substantial contribution for research provided by the pharma and biotech industries, and associated research opportunities.
All that needs to be directed towards NHS institutions that are ready to receive that substantial commitment to research and conduct in particular those clinical research opportunities which, regrettably, have been subject to variable performance over many years in the NHS. It is for that reason that this Bill must take the opportunity to address that variability in research participation and performance. If we do not achieve that, we are not going to utilise the full potential of the NHS to be able to deliver the benefits that have been so rightly predicted. Most of all, without ensuring a broad research culture across all NHS institutions and organisations, we are going to lose the direct consequences of such a research culture and infrastructure in terms of the fact that patients in research-active institutions have better clinical outcomes.
To move away from those two broad areas—the important impact on patients and the important opportunity to provide the broader research agenda with the innovation that flows from it—there is a third imperative: our capacity to attract and retain staff. As with any facet of manpower planning, it is vital to provide the opportunity for NHS staff members and healthcare professionals to be research-active. It provides a substantial incentive and encouragement and allows for career development, ensuring that we retain colleagues for longer and are able to develop them to make different contributions—all vitally important. If we take this as a whole, it is appropriate that Her Majesty’s Government give some very careful thought to the purpose of these different amendments and how what is being said in your Lordships’ House today might be included in the Bill in such a way to strengthen these research obligations and ensure that NHS organisations deliver on the health agenda.
In finishing, I make one further observation. Beyond the health gain that drives a research strategy applied across the entire NHS, there is a broader wealth gain for society and our economy. It is well recognised that after financial services, the field of life sciences represents one of the most important economic sectors in our country. To fully mobilise that opportunity, we need to ensure that, while its primary objective is to secure high quality, effective and safe care for all patients, every part of the NHS is also mobilising that public investment to ensure that what can be done to promote research and innovation, is being done, so that the second opportunity—driving wealth creation in our country—is also achieved.
I will begin again. I rise to speak on behalf of my noble friends Lady Blackwood and Lord Bethell, neither of whom is in their place. I should, out of an abundance of caution—particularly given how well I have spoken so far—declare the interests of both my noble friend Lady Blackwood and me, as the present and past chairs of Genomics England.
In speaking to Amendments 79 and 196, we wish to support the noble Lords, Lord Sharkey, Lord Kakkar and Lord Patel, in calling for trusts and integrated care boards to have a duty to conduct research and to report on the steps they have taken to deliver it. We know that there are excellent research-active NHS organisations in the UK, ranging from our acute tertiary university hospitals, such as Oxford, to our district general hospitals, such as Portsmouth.
There are many initiatives to promote research, such as Saving and Improving Lives: The Future of UK Clinical Research Delivery, which sets out a bold and exciting vision. In particular, my noble friends and I await with interest the Find, Recruit and Follow-up service, which plans to use digital tools to identify patients who may be suitable subjects for research. When speaking to patients, one of the refrains that we all hear most often is that they find it hard to find suitable clinical trials, and we welcome any initiative that can make it easier for patients to take part in clinical research.
As well as supporting patients in finding trials, we need to make it as easy as possible for them to participate. In some cases, the pandemic has accelerated a move towards remote monitoring tools—wearables and other devices that allow individuals to participate in trials while reducing the number of visits they have to make to hospitals. We welcome the NIHR remote trial delivery toolkit, which makes recommendations on how some of these positive practices can be continued and so broaden participation and promote patient retention in a beneficial way.
My noble friend Lady Blackwood, as a rare disease patient herself, knows that clinical research is often the only way for patients to get access to innovative treatment. Yet we are saddened to see, in the annual NIHR publication on initiating and delivering clinical research, that some trusts are still not delivering trials every quarter. We continue to see a large disparity in the number of trials being offered in each trust, which leads to a postcode lottery. Those individuals fortunate enough to be under the care of a research-active hospital have an increased chance of being recruited on to a trial, and therefore have better outcomes than patients under the care of less research-active hospitals.
Patients admitted to more research-active hospitals also have more confidence in staff and are better informed about their condition and medication. And as the noble Lord, Lord Davies of Brixton, has said, there is very clear evidence that research-active trusts deliver better outcomes—in part, I am sure, because of their ability to retain and energise staff, as the noble Lord, Lord Kakkar, has mentioned.
The last couple of years, however, have been challenging for the health research community. In 2020, the Association of Medical Research Charities predicted a £320 million shortfall in research spending, forcing many medical research charities to make tough choices about which projects to prioritise. Data also suggests that the UK has been slower to return to pre-pandemic levels of commercial clinical research compared with other European countries.
The Life Sciences Vision sets out the Government’s objective to be a science superpower, but this requires research to be embedded in every part of the NHS, including primary, community and mental health services. That will happen only if NHS organisations, including the new integrated care boards, have a duty to conduct research, as these amendments propose.
In addition, we all know that what gets measured gets done, which is why these amendments place a duty on trusts and ICBs to report the steps that they are taking to deliver clinical research in their annual reports or forward plans. This not only enables progress to be tracked but helps patients understand what research is being done in their area and will encourage NHS organisations to invest in research that meets the needs of their local communities and—
I am sorry to intervene. I am fascinated by everything that is being said but, given the cliché that money does not grow on trees, I am a bit surprised that we have not heard as much as we might have about international collaboration. Is that not a big deal? How would that be measured, as it were, as compared with the issues that the noble Baroness, Lady Harding, has already raised?
I personally believe that international collaboration and engagement in research across all parts of the United Kingdom go hand in hand. It should not be either/or; it is a combination, and we need to do both. The amendments that I am speaking to call for every NHS organisation to participate and become research active.
Finally, and briefly, I urge the Minister to embrace this opportunity to embed what is genuinely cross-party support for clinical research in legislation. We all want to put the UK on the path to being the best place in the world to participate in health research. We will do that, as the noble Lord suggests, by collaborating internationally, but we will address the health inequalities that we have all spoken about over the many days of Committee only if all NHS trusts have a duty to conduct research.
My Lords, I agree with the thrust of all these amendments. Most of the discussion has been about research—encouraging research in clinical trials within NHS trusts and foundation trusts—but I want to speak in support of Amendment 78, in the name of the noble Baroness, Lady McIntosh, which looks at the issue of commissioning and the role of integrated care boards, because I believe that it is just as important to ensure that integrated care boards have in mind the need, through their commissioning policies, to encourage innovation. In our last debate on NICE, last week, we discussed the same issue, which is the fact that the reason NICE exists is that there are many innovative new medicines and treatments coming on stream, many of them developed in the UK, which the health service has found difficulty in adopting more generally.
The noble Baroness’s Amendment 78, about ICBs, is designed to encourage the ICB boards to consider that they have a responsibility in relation to innovations. It also proposes that integrated care boards must appoint a dedicated innovation officer to the board. I do not want to open up the issue raised by my noble friend Lady Thornton as we went into Committee, but we come back to the issue of the composition of ICB boards. She referred to guidance issued by NHS England a few days ago, which is not obtainable in the public domain. It is obtainable through something called “NHS Net”, but the Library has not been able to get hold of it. It is a bit much that advice on the contents of the Bill has been given out which we cannot even see. I hope that, as part of his response to my noble friend Lady Thornton, the Minister will look into that.
On the question, “Why add another postholder to the board of an ICB?”, I point to the Nuffield Trust report, which says that no organisation in the health service at the moment—or very few places—has someone with a direct responsibility for encouraging innovation. The Nuffield Trust thinks that having chief innovation officers with broad oversight could make what it calls a fundamental difference. I refer the noble Lord to research by the ABHI, which is essentially the trade association for medical devices. It showed that fewer than 20 NHS trusts across the UK have a member of their board with explicit responsibility for the uptake of innovative technologies.
Sometimes one must be wary of having a board appointment that may seem to be a token appointment. However, when it comes to commissioning, having someone around the table who is constantly reminding the board that through commissioning we must encourage and invest in innovation, would be very helpful. The slew of amendments tabled by the noble Baroness, Lady McIntosh, is valuable in getting that message across.
My Lords, I am only teasing.
I declare an interest as a fellow of the Royal Society of Edinburgh and of the Academy of Medical Sciences, and as a professor emeritus at the University of Dundee, where I have spent all my life bar the first 18 years. I say this because we have lost something in the United Kingdom. A key strength of our academic clinical departments was a worldwide reputation for conducting health service-related research. We were second to none, and I mean that. We have lost that because we have changed the environment. People who work in clinical academic institutions—our so-called teaching hospitals—no longer have the environment to promote that. It was the duty of those of us who worked in clinical academic departments to grow the next generation of academics. It was important that we were all involved in conducting clinical research that produced innovation, better care for patients and a first-rate, first-class, internationally renowned next generation of academics. We do not have that any more, and anything we can do through this Bill to bring that back would be a major plus.
I will speak to the amendments tabled by the noble Baroness, Lady McIntosh of Pickering, and the noble Lord, Lord Sharkey. Much has been said, excellently, and I will try not to repeat it, but a strengthened research mandate through this Bill could support patients, clinicians, NHS organisations and research. The patient benefits from increased research activity have already been mentioned, but there is a significant variability across the UK in the opportunity for patients to engage in research. A strengthened mandate could support ensuring that all patients can access clinical trials and their associated benefits. Therefore, wider changes are needed to increase the competitiveness of the UK as a destination for research, particularly through the proposed changes to clinical trials legislation, and through increases in Department of Health and Social Care and NIHR funding.
This could include measures to support faster approval timelines and closer multiagency collaborations. Clinical research has clear benefits to patients, as has already been mentioned. NHS trusts with higher levels of research have a higher rating from the CQC and better outcomes, as have already been said. During Covid, the UK has demonstrated its potential with the success of Covid-19 research, with 68 commercial Covid trials launched in the UK in 2020—the third-highest globally, beating the United States and the rest of Europe.
How did we manage to do that? It is because, during the emergency, we set up methodologies that allow patients to be involved in trials more quickly by creating a voluntary registry, where patients themselves volunteer to take part in research. I also note the clinical recovery trials that we set up—some noble Lords might have seen the article in the Times, with Sir Martin Landray suggesting that we follow that process in the future to try to find treatments for other common diseases. If we do that, we will lead globally. The NHS has the capacity to do that, but it now requires the will and the leadership from the centre to drive that. The clinical academics will be up to it—they just want to be given a chance. Let us do that, because we have demonstrated that we can.
However, since Covid, we have begun to drop again. We ranked only fifth in Europe for phase 3 trials in 2020. Across all phases, the UK has seen a decrease in commercial trial volume of 24%—or 34%, excluding Covid-19 research. There are clear economic benefits that we will miss out on—I could give the figures, but I will refrain.
The Clinical Research Network and NIHR supported £2.7 billion of gross value added in research and 47,000 jobs. The loss of commercial research across NHS trusts during the pandemic is estimated to have created a deficit of £447 million because we are slow to restart the clinical research that we had to stop because of the pandemic, while other countries—Germany, the Czech Republic, Slovakia, Hungary et cetera—have accelerated.
For a global organisation, trial placement decisions are based on a holistic set of factors, including study set-up timelines, cost, contracting and recruitment. UK Office for Life Sciences 2019 data shows the UK to be seventh in the average time from the core package being received to the first patient being enrolled—behind the US, Spain, Canada, Australia, Italy and Germany.
Before this debate, I spoke to several companies: Silence Therapeutics, EMIG—the ethical group of companies—Pfizer, AstraZeneca and others. I will mention one company: Pfizer, whose study set-up planning timelines fall behind those of many comparable countries, such as the US, Canada, Australia, Spain et cetera. To achieve its goal in clinical research, the UK must realise the potential of its unique health data. That is the key—we have unique health data.
I will give an example of a company that has produced a small-molecule drug to treat patients who might go into cardiac failure. It needs patients who are at risk of this. We have a health database that is unique in the world and that, through clinicians, can identify patients who might be at risk to enter the clinical trial. No one else has that. It does not counter patient-data legislation because it is done through the clinicians. It could be done through primary or secondary-care clinicians.
I think that I have said enough, but I refer again to Sir Martin Landray, who is known for his Recovery trial and use of dexamethasone for treatment of Covid. He is going to use Covid-style clinical trials by setting up a new company to try to find treatments for other common diseases. I urge the Minister to accept this amendment: it will do more good than most.
My Lords, I shall speak briefly in support of this group of amendments, particularly Amendments 79, 81, 96 and 196, which concern both research and clinical trials. I am grateful to the noble Lords who have put their names to them.
As other noble Lords have noted, the Government have actually recognised the need for integrated care boards to have research among their general duties—but one would be hard pressed to realise from the Bill’s drafting that this was a priority. As the noble Lord, Lord Sharkey, said well, the drafting is weak. We need something much more explicit and action oriented. Frankly, “promote” is a vague term that can mean anything or nothing. We need action-oriented language of a kind that puts the NHS and the resources that this country has right at the centre of medical research.
We need an amendment of the type that my noble friend Lady McIntosh of Pickering has put down to give us a national research strategy and join up the national and local levels in achieving it. The noble Lord, Lord Kakkar, has given us many reasons why we need to move on the whole subject of research and make it central to the National Health Service’s mission. We need something that is explicit in charging the NHS to conduct research and enable relevant bodies to do so as well. The results should be exploited in healthcare. Linking research to local needs will also increase their relevance, and the adoption of these results and the obligation to report on them will ensure that things really happen.
I could not find in the drafting any reference to the need to do clinical trials. Surely this is a central element in research and could be extraordinarily advantageous to the UK. As the noble Lord, Lord Patel, has just said, the NHS has a database that is unparalleled in the world. It provides us with an extraordinary advantage. I recall that when I was on the Science and Technology Committee, we heard considerable evidence about the barriers that were put in the way by rather pettifogging EU regulations. I recall the desire, when free of these, to be able to conduct clinical trials. I am aware that some people argue that the UK market is too small, but, with our database, that is not the case—and we can ensure that we have co-operation from abroad.
It is very important that this becomes a central element in our research programmes. It puts us on the map internationally, and it ensures that the NHS, which, after all, is a great consumer of the public expenditure in this country, is also part of wealth creation. That should be part of the result of the research that it conducts.
I do not think that the Government disagree with the thrust of the thinking here, but I very much hope that they will agree that the Bill’s drafting, as it exists at the moment, is inadequate. I hope that, when my noble friend comes to reply, he accepts that the language on both of these elements needs strengthening, giving a central role to research and clinical trials in the NHS.
My Lords, I am grateful to noble Lords for putting forward these amendments, all of which seek to strengthen the Bill and build on what the noble Baroness, Lady McIntosh, opened with: the need for clear lines of responsibility and for a joined-up strategy—in other words, for us to get to the point that we are looking for.
My noble friend Lord Hunt spoke of the embodiment, perhaps, of that through a chief innovation officer, who could be a reminder—not on their own—of the need to build in research and innovation as core throughout commissioning. I am sure that the Minister has heard that this debate is a cry for us to embed in the Bill and in our NHS not just a requirement for but a delivery of research and innovation to the appropriate standard to serve the country. It will not just happen on its own.
We have seen significant variation of opportunity for patients to engage in research and disparities in participation reported on geographic and socioeconomic lines, by ethnic origin and across different disease areas. This is due to the fact that the NHS has been unable to prioritise resourcing and delivery of research, which has been a particular feature over the past decade.
In the Bill, we have a major opportunity to embed a research-active culture—words used by the noble Baroness, Lady Harding—within the NHS which could build on the response to Covid-19, which the noble Lord, Lord Patel, emphasised. That response saw more NHS sites, staff and patients engage in research than ever before. Let us not waste this opportunity.
The Bill offers little different to the Health and Social Care Act 2012, which also did not and does not mandate clinical research activity, stating just a duty for clinical commissioning groups “to promote” research. Your Lordships will notice the similarity in wording in the current Bill. The noble Lord, Lord Sharkey, is quite right, as are other noble Lords, to speak of the weakness of just using the words “to promote”. This set of amendments is about how we make it actually happen. The amendments are about mandating integrated care boards to conduct research and to monitor and assess innovation, because without that, it will just not happen.
Legislation is indeed a critical element, but it is important to stress that it must be accompanied by the necessary infrastructure: for example, through staffing levels—to which we will return in our next debate—research capability, digital resources and tools and access to services, as well as efficient trial approval processes, the ability reliably to recruit patients, the offering of guidance and, of course, dedicated staff time for research. All of those will make the legislation actually mean something.
As well as a strengthened legislative mandate which moves beyond the current duty simply to promote research, it would support patients, clinicians and NHS organisations across the country to have equal access to the benefits brought about by research participation. This will be better for patients, give greater staff satisfaction and deliver economic benefits not just for the NHS but for the broader economy. The noble Lord, Lord Kakkar, talked about the life sciences being a major player as a contributor to our economic well-being and prosperity in this country—something also emphasised by my noble friend Lord Davies.
Such a mandate would also ensure support for levelling up and make it possible to address health inequalities. This in turn would support the ambition set out in the Government’s clinical research vision: to make access and participation in research as easy as possible for everyone across the UK, including those in rural, diverse and underserved populations. I hope the Minister will take the opportunity to reflect on the points made in this debate, because this group of amendments provides an opportunity to strengthen the Bill to actually deliver.
Like many of the debates on this Bill in Committee, this has been a fascinating one. It has been really interesting to hear from experts who themselves have engaged in clinical research. I start by thanking my noble friends Lady McIntosh of Pickering and Lady Blackwood and the noble Lords, Lord Sharkey and Lord Kakkar, for bringing this debate before the Committee today. I also thank the noble Lord, Lord Howarth, for his points about the arts and social prescribing.
Before I turn to the amendments, perhaps I could make two personal reflections. One is from my early academic career as a postdoctoral research fellow. I saw the benefit of taking the results of my research directly into my teaching. It made the courses more dynamic—it was not just a repeat of last year’s slides for this year’s students—and it showed what progress we were making in that field of research.
Secondly, during my appointment as the Minister for Technology, Innovation and Life Sciences, it has been really exciting to see the level of research and innovation across this country, not only in the golden triangle that people talk about—London, Oxford and Cambridge—but throughout the country. It is evidence-led, research-led and really interesting, positioning the UK as a leading place for research and a hub for life sciences. We have looked at where our strengths are. One example is clinical trials. A number of companies say to us, “What is really interesting about the UK is that, especially with social care joined up, we will have data on patients literally from cradle to grave throughout their life”. But there are also all the different pathways and some of the exciting stuff we are doing with Genomics England, which opens up whole new possibilities.
In our previous debate, we heard from the noble Lord, Lord Rennard, about type 1 diabetics and how the technology is improving quickly. When I speak to relatives and friends who are type 1 diabetics, they are excited by the advances being made, which gives them greater confidence that they can lead as near as possible a long and healthy life.
Let me start by addressing Amendment 78, on integrated care boards reviewing all innovations. Although I appreciate the intention behind the amendment, for reasons that I will explain it is unclear what additional benefit such a review would produce. The National Institute for Health and Care Excellence already plays an important role in ensuring that patients have access to promising new innovations by recommending whether health technologies represent a clinically and cost-effective use of NHS resources. Where NICE so recommends, NHS commissioners are under statutory obligations to fund the technology. I note the previous debate on NICE and the points made by the noble Lord, Lord Hunt, but we expect that this requirement will carry over to integrated care boards.
On appointing a dedicated innovation officer and developing and maintaining a system to keep up to date with innovations on boards, this is part of the overall debate on how much you mandate at the ICB level, and I am sure that a number of noble Lords will recognise how many requests there have been to mandate particular places on the ICBs. I suggest that we consider that in the round.
The Accelerated Access Collaborative, the umbrella organisation overseeing health innovation and its ecosystem, will work with NHS partners to look to embed research and innovation within the new statutory ICBs. For example, in their proposed job descriptions, there is a clear requirement for ICB chief executives and chairs to foster a culture of innovation. I have seen a lot of such innovation in many places.
We also have existing reporting tools to monitor the use of innovative medicines and medicinal products. This includes NHS Digital’s innovation scorecard and the AAC scorecard. The AAC is also scoping the development of an innovation metric to help to identify and address unwarranted variation.
On Amendment 79, I share the noble Lord’s intention that the NHS should be research active, that research participation is diverse and research needs are met. The existing research duty in the Bill requires each ICB to promote research on matters relevant to the health service and the use in the health service of evidence obtained from that research. The existing research duty in the Bill is broad and wide-ranging, encompassing actions including facilitating and enabling research, such as through their commissioning functions. I am concerned that the amendment may narrow the research duty to a small number of actions which would not necessarily capture the existing range of activity.
Proposed new paragraph (a) in the amendment would also apply to
“those eligible organisations for which the integrated care board is responsible”.
Although ICBs will be able to influence and affect organisations through their functions, they are not directly responsible for any organisation. Rather than directly funding or conducting research, ICBs will primarily facilitate and enable research. But where it is appropriate for an ICB itself to play a more direct role in research, it will have the power to commission and conduct research, just as CCGs do currently.
A requirement for ICBs to
“co-produce with place-based partnerships research aims to meet the needs of their local communities and ensure diversity of participation”,
risks replicating the requirement for integrated care partnerships to prepare an integrated care strategy setting out how the “assessed needs” of their areas, which can include research needs, are to be met by the functions of the ICBs and others.
The Government are committed to diverse patient participation in research. I am sure that many noble Lords are aware of data, particularly for example in the area of artificial intelligence—as we know, it is not really intelligence but analysing large datasets to look at patterns and help the decision-making of clinicians and others. There has been a lack of diversity in data; we have seen racial bias, for example, in recruitment and college admissions. It is important that we do not repeat that in this country, especially since we do have a diverse population, and that we ensure that we have a diverse a research set as possible. I know from speaking to my noble friend Lady Blackwood that Genomics England is concerned about this and is looking to make sure that its datasets are as diverse as possible, especially with the increased use of AI.
There are requirements for researchers on equality, diversity and inclusion. These have been strengthened in research funded by the Department of Health and Social Care through the NIHR. Researchers are now expected to demonstrate how they will ensure that recruitment is inclusive and representative of the population. The Bill also requires that the forward plan must set out how the ICB and others propose to exercise their functions and the annual report must report on how it has discharged these functions. This must include how ICBs will plan and promote research and deliver clinical research.
Amendment 81 would mandate ICBs to develop a research strategy for patient benefit each year, following engagement with the NIHR and all relevant regional and national health and care organisations. However, ICBs already have a duty to promote research, and the power to commission and conduct research, so they will already need to plan their research activity to be able to discharge these functions. Where they are aware of local research needs, this should be addressed when they plan their activity. As a result, we do not think that it would add value to require ICBs to develop a separate strategy.
On the requirement for ICBs to engage with all relevant regional and national health and care research organisations, we expect ICBs to collaborate with relevant bodies where necessary without requiring this through primary legislation. Integrated care partnerships—ICPs—as joint committees of ICBs, local authorities and others, also have a huge role to play here. They must prepare an integrated care strategy setting out how the “assessed needs” of an area are to be met by the functions of the ICBs and others. Local research need could fall under an “assessed need” as it is capable of being met by ICBs and could be affected by the actions of the responsible local authority, so would need to be addressed by the integrated care strategy without the need for a separate strategy relating only to research.
The Government, through the NIHR and UK Research and Innovation funding, provide support to organisations to undertake research and develop strategies. This includes providing funding directly to meet support costs so that the NHS can deliver non-commercial research, through the NIHR Clinical Research Network, for example.
I now turn to Amendment 96, which would create a duty for ICBs to consider requests to engage in clinical trials and would mandate that participation to any eligible patient within their area. I understand and share the desire of your Lordships’ House for ICBs to take research seriously. A research-active NHS culture brings benefits for patients, staff, the NHS and the wider economy. I am keen that we harness those benefits to build on the progress made by CCGs as well as the research that I have become aware of since becoming the Minister for Technology, Innovation and Life Sciences.
In wanting to give ICBs the flexibility to develop the processes and structures that work most effectively, we feel that a statutory duty for ICBs to consider requests would be overly prescriptive. Also, a duty only to consider requests is likely to have little effect in practice. We expect ICBs to consider requests put to them without needing this to be in primary legislation. While ICBs will play a role in enabling and facilitating research in the NHS, in many instances we would expect that it would be for trusts rather than ICBs to consider participation in individual clinical trials.
We believe that a more effective way to broaden participation in these trials is to ensure adequate funding and infrastructure to support research in all parts of the country. The Government do this through NIHR funding and infrastructure; 100% of NHS Trusts in England are research active. This is due to support such as the NIHR Clinical Research Network, which meets many costs, including of equipment.
I turn to some of the questions on diverse trial participation. As noble Lords have alluded to, the Government published in March last year the UK vision for clinical research delivery. This includes provisions on diversity. It supports diversity in child participants through such initiatives as INCLUDE, funded by the NIHR. Other examples include partnership with the centre for black and minority ethnic health. In Leicester, the NIHR is addressing low participation by black, Asian and minority ethnic communities in research, in particular Covid-19 studies. These are just a couple of examples.
I turn now to Amendment 135, which aims to ensure that the ICB’s annual report covers research activity. In this Bill, ICBs have a broad duty to promote research and the evidence obtained from research, and they will be able to fulfil this duty by exercising their power to commission and conduct research. But ICBs will also be uniquely positioned to facilitate and enable research in ways broader than direct activity, such as through the exercise of their commissioning function. For example, ICBs could promote research by commissioning services from providers that are research active or are proactive in facilitating research—a much broader range of research, as the noble Lord, Lord Howarth, said.
The Bill’s drafting on the ICB’s annual report is deliberately broad and permissive, and sets out that an ICB must prepare the annual report
“on how it has discharged its functions”.
This already includes research activity, as well as broader actions to promote research. The Bill provides that NHS England may give directions to ICBs as to the form and content of an annual report.
On a requirement for an ICB’s annual report to cover the progress of applications considered by the relevant research ethics committee, I reassure my noble friend that the Health Research Authority, which administers research ethics committees, already publishes performance data on its website regarding the time taken to approve such studies. The HRA’s transparency strategy also asks research sponsors to include a plain-language summary of their findings in their final report; these can be found on the HRA’s website.
The requirement that the Secretary of State’s annual report on the performance of the health service should cover the research activity that ICBs have included in their annual report is something that we consider unnecessary as it would duplicate the performance assessment regime already provided for in the Bill.
I end my remarks on this group with Amendment 196. I understand the intention behind this amendment: making sure that research is taken seriously by NHS trusts is something that I think all noble Lords would agree on. However, we consider that an amendment to require trusts and foundation trusts to conduct research is unnecessary, since 100% of acute NHS trusts and foundation trusts in England are already active. The amendment would impose a duty for trusts to promote the use in health and care of evidence obtained from research. In fact, there is already a range of legislative and non-legislative means by which providers are required to provide services that are informed by the evidence from research. The equivalent duty already applies to CCGs, and will do so for ICBs.
As regards the requirement for NHS trusts to
“co-produce with place-based partnerships research aims to meet the needs of their local communities and ensure diversity of participation”,
I have already referred to a number of the requirements for diversity. On the requirement for NHS trusts and foundation trusts to publish, via their annual report, the steps they have taken to deliver clinical research, the NHS Act 2006 already requires this, and trusts must send their reports to the Secretary of State. NHS foundation trusts can similarly already report their research activity through their annual reports, which they are required to make publicly available.
The Government do not therefore believe that it is necessary to require on the face of legislation that trusts set out their clinical research plans in their joint forward plans. This is because the existing requirements in the Bill are deliberately broad. Having said all this, I have heard from a number of clinical research experts. Although the Government believe this, some research experts in this Chamber believe that it should be in the Bill. It is obvious, therefore, that further discussion is needed before Report so that we can consider this in the round. In that spirit, I thank all noble Lords for this helpful debate, which has been very informative, and ask noble Lords not to press their amendments.
My Lords, I am grateful to all who have contributed to what has been an excellent debate. I welcome my noble friend’s offer to have further discussions, which I am sure will be taken up actively by all those concerned.
However, there seems to be a bit of a mismatch between my noble friend’s reply and the very real concerns expressed across the House, including by the noble Baroness, Lady Merron, in summing up. The noble Lord, Lord Kakkar, said that there was insufficient emphasis and obligation for integration, and that the whole country would benefit from wealth creation—a point well made by my noble friend Lady Neville-Jones as well.
I was very moved by the reference of the noble Lord, Lord Patel, to the loss of status and standing of teaching hospitals. My father, a GP, always used to say that if you want something done, have it done in a teaching hospital. My late uncle was a surgeon at the Royal Infirmary, where his students rather fondly called him “Mack the Knife”—I hope for positive reasons, because he used it skilfully, but unfortunately it is too late to ask.
We need to press my noble friend further on strengthening the obligation and making it much firmer in the Bill. Is he prepared to move in that direction? I would like to say how proud I am to be British and living in a country where we have such a strong record on research and the data available. My noble friend the Minister did not respond on where we are with clinical trials—my noble friend Lady Neville-Jones and I particularly asked him about that—and I would be very grateful if he could write to me separately. On the basis that we can have further discussions on this, I beg leave to withdraw my amendment at this stage.
Amendment 78 withdrawn.
Amendments 79 to 82 not moved.