Medical Research - Question for Short Debate

– in the House of Lords at 7:27 pm on 28 March 2017.

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Photo of Lord Sharkey Lord Sharkey Liberal Democrat 7:27, 28 March 2017

To ask Her Majesty’s Government what plans they have to help maintain the United Kingdom’s position in medical research.

Photo of Lord Sharkey Lord Sharkey Liberal Democrat

My Lords, I declare an interest as chair of the Association of Medical Research Charities, whose members spend more than £1.4 billion a year on medical research. The UK is a world leader in medical research. We have discovered and developed 25 of the top 100 prescription medicines globally. We produce around 20% of the world’s most cited academic publications in the life sciences. The UK life sciences industry generates for the UK a combined estimated annual turnover of £61 billion. This is a timely debate. Tomorrow, the Prime Minister will trigger Article 50. There are significant implications for UK medical research in exiting the European Union, and I will speak to these. I will also speak to the implications of the recently announced changes to the funding of NICE-approved drugs and technologies and to the funding of medical research by government.

Let me start with the changes to the drug approval process announced on 15 March by NICE. In simple terms, up until now, once NICE had approved a drug, the NHS was obliged to supply it within three months. The new regime means that from 1 April the NHS may not supply some newly approved drugs for up to three years. This has very serious and worrying implications. Some recent technologies that have been approved by NICE would breach the new budget impact threshold and could be delayed for three years. For example, abiraterone, a breakthrough treatment for the advanced stages of prostate cancer, might not have been available to patients if the new regime had been in force. Many medical research organisations including Prostate Cancer UK, Cancer Research UK, Breast Cancer Now, Alzheimer’s Research UK and the MS Society are deeply concerned about the consequences of the NICE changes both for research and patients.

There are three principal areas of concern. The first is the potential harm to patients. For those with life-threatening and other serious conditions, waiting three years to receive a life-enhancing or transforming technology is not acceptable. For instance, ocrelizumab, the first treatment for the primary progressive form of MS, is soon to undergo an appraisal. As it stands to be the first disease-modifying licensed treatment for this type of MS, it is unlikely to come cheap and its introduction may well be delayed under the new arrangements.

Secondly, innovative research and scientific breakthroughs matter only if patients are able to reap the benefits. This new regime make the benefits of research difficult to forecast and could make investment in research in the UK less attractive. Delaying patient access by three years could make England a less attractive place to do clinical trials.

Thirdly, medical research is a complex ecosystem bringing together charities, a variety of industries, academia and public bodies. This decision sends the wrong signal to the life sciences sector at a time when we are preparing to negotiate Brexit, and is contrary to the thrust of the industrial strategy. The Association of the British Pharmaceutical Industry has warned that these new plans will prevent patients receiving NICE-approved, cost-effective medicines. The BioIndustry Association has called it a “lose/lose/lose” situation for rare disease NHS patients, the UK life science sector and the union, given the different regime that obtains in Scotland.

Clearly the NHS is under significant financial pressure, but this new regime is not an appropriate solution to the affordability of medicines issue. Instead, an improved dialogue and early negotiations with industry are needed. That is what the accelerated access review recommended and that is what we should do, rather than taking this arbitrary approach that puts at risk people with serious health conditions and our research infrastructure.

The new regime will come into effect from 1 April—in less than a week’s time. The potential impact on patients must be given immediate consideration. I urge the Minister to persuade her colleagues to think again. If they do not, they risk patients’ lives and our attractiveness as a location for medical research.

I now turn to Brexit. The UK’s decision to leave the EU has the potential to impact greatly on medical research. The priorities for science are shared across the medical research community. They include continued participation in Horizon 2020 and future funding programmes. Not only is the UK the second biggest beneficiary of Horizon 2020, but the collaborations that arise from these programmes are significant and highly valued by the UK medical sector. However, there is already anecdotal evidence that recruiting and retaining researchers from the EEA is becoming more difficult. Right now we need the Government to clarify the situation and give certainty to EEA nationals working in the UK. In the longer term we will need an immigration system that reflects the intrinsically collaborative and international nature of science and research.

The Minister will know that there are a number of EU regulations for dealing with medical research, including the clinical trials directive, which is soon to be replaced by the clinical trials regulation. Shared regulatory frameworks enable cross-border collaboration, which is critical for medical research, particularly research into rare disease. The larger EU population makes research on rare conditions possible and the European Medicines Agency’s single approval process for medicines for rare conditions makes it cost effective for manufacturers to bring new treatments to patients. We do not want to be outside this process. We need to remain part of the larger research test bed. To uphold our position as a leader in medical research, I urge the Government to seek ongoing regulatory co-operation with the EU. The UK must remain part of the scientific processes at an EU level.

I shall now touch briefly on UKRI and the role it will play in maintaining the UK’s position as a global leader in medical research. I very much welcome the appointment of Sir Mark Walport as UKRI’s CEO. UKRI will, I hope, provide strong leadership for the medical research and broader research sector throughout the Brexit negotiations, but I want to register my disappointment that the quality-related research funding for universities will remain flat in 2017-18. This funding is critical to maintaining and growing medical research in our university sector. I urge UKRI, with its future funding role, to examine the support provided to researchers and universities.

In particular, I highlight the charity research support element of QR funding, known as the charity research support fund. The CRSF supports the indirect costs of research that charities cannot fund. It has been fixed at £198 million per annum since 2010—a real-terms decrease of nearly £40 million over the six years since then. To repeat a point I made earlier, medical research charities are an important part of the UK’s unique medical research environment. I strongly recommend that UKRI commits to increasing the CRSF in real terms.

Finally, there is the NHS itself as an important research institution and test bed. NHSE’s 2016-17 business plan promised a research strategy for 2016-17. That period ends in two weeks and there is still no published research strategy, and nor was there one for 2015-16. We need the NHS to take seriously its mandate to promote and support research in the service. Will the Minister say when we can expect to see an NHS England research strategy?

To conclude, the UK has a medical research sector to be proud of. It contributes to the health of people in our country and across the world. It is a provider of jobs and investment. Our medical research sector is a genuine world leader. The Government must not only consolidate this position but use any opportunities, and any opportunities created by Brexit, to build upon it. I look forward to hearing how they plan to do exactly that when the Minister responds.

Photo of Lord Patel Lord Patel Chair, Long-Term Sustainability of the NHS Committee, Chair, Long-Term Sustainability of the NHS Committee 7:36, 28 March 2017

My Lords, I shall speak about regulation relating to data privacy in medical research. The UK should have a vision to make an internationally competitive legal framework to support the use of personal data in health research—fully connected law and governance that is easy to navigate, pragmatic and risk proportionate, and regulation that ensures public confidence and trust in the use of personal data in research.

I have five recommendations to achieve this vision. The first is to ensure that movement of research-relevant data between the UK and the EU is not restricted. The UK is a world leader in genomics and research using longitudinal cohorts, medical informatics and data linkage. Research relies on international collaboration and sharing of data across borders. To maintain this position it is important that UK law allows free exchange of data with the EU after Brexit. The most straightforward option is for the UK framework to be considered adequate by the EU through implementing the general data protection regulation or equivalent rules. If adequacy is not achieved, the UK should seek to establish as simple a mechanism as possible for data transfers across Europe.

My second recommendation is to simplify and clarify the UK’s legal framework. The UK’s legal framework for the use of personal data in health research strikes a good balance between permitting research and protecting individuals, but it is highly complex and confusing. The legal framework should be simplified by providing a clear public interest legal basis for research by private and public organisations, and by bringing standards of consent and safeguards for health research in data protection law and the common law duty of confidentiality closer together. Following Brexit and the great repeal Bill, the Government should use the flexibility to review and revise data protection law to ensure it is clear and simple.

My third recommendation is to maintain the UK’s proportionate and pragmatic approach to regulation and governance. The Information Commissioner’s Office takes a pragmatic and risk-proportionate approach to regulation. This is a strength that must be maintained for the UK to be competitive. In particular, the ICO takes a proportionate and context-dependent approach to what is considered personal data.

My fourth recommendation is to ensure that the right governance is in place to manage data flows across the system. The Department of Health should implement the proposal for a national data guardian for health and social care.

My fifth recommendation is to develop an innovative framework for the regulation of data-driven technology. The UK has an opportunity to be a world leader in such regulation. This should allow access to the volume and quality of data required for machine learning to be effective, while ensuring public confidence and accountability. This requires regulating both the release of data and the novelty of a product that self-updates. I hope the Minister can assure us that the Government are looking at this and will work with research organisations and regulators to make sure that our regulation of data privacy in research is a world leader.

Photo of The Earl of Dundee The Earl of Dundee Conservative 7:40, 28 March 2017

My Lords, I thank the noble Lord, Lord Sharkey, for enabling this debate. Very briefly, I will mention three aspects: first, the aim for health strategies and their deliveries to become much better co-ordinated internationally than at present; secondly, the current role and future prospects of product development partnerships; and thirdly, the priority of medical research into neurological diseases.

Pneumonia is the principal cause of death in children worldwide. It kills an estimated 1.1 million children under the age of five every year—more than AIDS, malaria and tuberculosis combined. For the same age group of children, diarrhoea is the second biggest killer, each year accounting for 760,000 deaths. Globally, there are nearly 1.7 billion instances every year of diarrhoeal disease, which is also chiefly responsible for malnutrition.

Arising from viruses, bacteria or fungi, pneumonia can be mainly prevented by vaccines and enough food, yet only 30% of children with pneumonia receive antibiotics. Equally, while diarrhoea can be controlled through safe drinking water and adequate sanitation and hygiene, largely due to poor co-ordination among different healthcare deliveries, these simple measures are still far too neglected.

I recently chaired the Council of Europe’s health committee, and our emphasis was upon the urgent need for an integrated approach and for this to become the standard for the international healthcare policies of the affiliation’s 47 states. For his contributions to that consensus, I pay tribute in particular to the achievements and memory of Jim Dobbin, who was a professional microbiologist and in another place the Member of Parliament for Heywood and Middleton from 1997 until his death in 2014. Does my noble friend the Minister agree that integrated healthcare solutions should feature prominently within the current sustainable development goals framework and that the Government should seek to persuade other UN member states accordingly?

If competent deliveries should thus provide vaccines and hygiene together, rather than just the one without the other, product development partnerships have already assisted improved outcomes overseas in low and middle-income countries. Advancing R&D to serve those countries, PDPs are non-profit organisations and partnerships between academia, industry, the public sector and multilateral agencies. They have facilitated effective and affordable technologies and products, also encouraging the pharmaceutical industry to work on the diseases of poverty. Can the Minister say in what ways DfID and our Government will support the further work and diversification of bodies such as PDPs?

Research into neurological afflictions—to which the noble Lord, Lord Sharkey, has already referred—including Alzheimer’s and Parkinson’s, lags behind that into cancer, heart disease and infectious diseases. What plans, therefore, do the Government have to redress this imbalance and to persuade our international partners to do the same?

In summary, timely adjustments, as necessary, in medical research also reflect those required in poorer countries, such as of integrated medical delivery. Not least will the maintenance of the United Kingdom’s reputation and position depend on its ability to lead in these useful directions.

Photo of Baroness Morgan of Drefelin Baroness Morgan of Drefelin Crossbench 7:43, 28 March 2017

My Lords, I thank the noble Lord, Lord Sharkey, for securing this debate and congratulate him on his thoughtful opening remarks. I declare an interest as chief executive of Breast Cancer Now and chair of the National Cancer Research Institute.

We will surely maintain the UK’s position at the forefront of global medical research through a focus on securing the best talent, intelligent regulation and strong investment. We must continue to attract, secure and keep the best scientific talent in the UK, including those EU nationals who populate our excellent research centres around the UK. Those people need to know that their position in this country is secure.

Alongside this, we need a regulatory framework, aligned with the new EU clinical trials regulation that will enable us to collaborate. Collaboration is at the heart of successful research, so we need to be able to collaborate with partners across borders for the benefit of UK patients and the UK life sciences sector.

Underpinning this is the need for investment and the support that charities give. Government and industry investment secures patients’ access to the most cost-effective modern treatments while allowing our economy to thrive. On the one hand, we have heard much about the Government’s commitment to research funding, not least in the Autumn Statement and the recent industrial strategy, but on the other, the reality of what is happening on the ground can feel very different.

As the noble Lord has explained, despite it being extremely difficult for drugs to be approved under the NICE cost-effectiveness appraisal process, NICE and NHS England are about to introduce a cap that could restrict access to treatments that cost more than £20 million for up to three years. In some cases, that could be even longer. Millions of patients could face major delays in accessing the life-saving and life-extending treatments they need which have already been deemed by our system to be clinically and cost effective by NICE. If this test comes into effect, as we are advised it could do shortly, it could cost the lives of patients, particularly those with incurable conditions. Not only could the proposals have devastating implications for patients but they run counter to the Government’s own ambitions for the UK as a global hub for research and innovation. As we have heard, such drugs need to be accessed by patients through the NHS for us to see our life sciences industry joined up with the NHS and thriving.

One in five new treatments would be likely to be affected by the new cap, so can the Minister explain the legal basis for it, as I understand that NICE is established in statute? I, too, urge the Minister to do what she can to encourage NICE and NHS England to think again.

Photo of Lord Willis of Knaresborough Lord Willis of Knaresborough Liberal Democrat 7:47, 28 March 2017

My Lords, the noble Lord, Lord Sharkey, has already demonstrated just how important it is to continue government investment in UK medical research and in so doing recognise significant contributions from the charity and industrial research sectors.

The £7.2 billion annual investment in UK research has delivered spectacular results: beta blockers, cardiac pacemakers, CAT and MRI scans, DNA sequencing, and monoclonal antibodies, with a few having long-term human and commercial impact.

While the MRC leads much of this work, the increasing importance of NIHR in delivering research near to bedside is also impressive. Thanks to the foresight of Sir David Cooksey in 2006 and the continued support of successive Governments, NIHR is building a research capability within the NHS which is truly impressive. Part of that success is due to the outstanding work of the 13 CLAHRCs, which are responsible for building clinical/academic research capacity across the country and which tackle issues affecting today’s patients. I declare an interest as the chair of the Yorkshire and Humber CLAHRC. We have in two years levered £13 million in matched funding from commercial, charity, NHS and academic organisations, doubling our resource to £26 million. This in turn has helped us to deliver on 164 projects, produce 49 peer-reviewed publications and train 56 PhD students. Crucially, we have been able to effect real improvement in health outcomes.

Our “towards smoke-free mental health services” survey has informed NICE guidance on smoking cessation in secondary care for mental health patients previously denied access to smoking cessation programmes, while an electronic frailty index, using existing electronic record data to enable GPs identify the frailest people in their practice, is now used by 90% of GPs in the country.

As in most parts of the UK, the cost and effectiveness of emergency and urgent care pose real challenges. Here, we have developed the largest regional dataset of emergency and urgent care patient episodes in the country, linking data from the very first call to discharge. With the support of the Health Research Authority, this database provides a unique resource to help deliver more appropriate care and reduce avoidable attendances and admissions to hospital.

CLAHRCs provide an environment for exploring novel technologies where commissioners, providers and local authorities require rapid evaluations to inform decision-making and service planning. They pioneer new models of evidence-based practice for the delivery of health and social care. They work in tandem with the Clinical Research Network, academic health science networks and nationally with the other 12 CLAHRCs. In the new, post-Brexit world, what plans are there to continue CLAHRCs beyond their current period?

Photo of Baroness Masham of Ilton Baroness Masham of Ilton Crossbench 7:50, 28 March 2017

My Lords, there needs to be safe regulation of medical trials. The Government must ensure that they have appropriate scientific advice during the Brexit negotiations. Have they decided to have a chief scientific adviser in the Department for International Trade?

Nervousness about immigration and nationality persists in the scientific community. The delay in solid reassurances and mixed messages from senior Ministers is having a corrosive effect on the UK research base. At this difficult time and with growing anxiety about global antimicrobial resistance—an alarming threat—the UK must not lose its place as a leader in medical research. The UK-based leading scientific journal Nature notes that European research generates more highly cited research publications than the USA. The European Research Council is a major supporter of scientific research in the UK and the UK needs to safeguard its lead in the growth areas of science and technology through a bilateral science collaboration treaty with Brussels, similar to those currently operated by non-EU countries.

The recent reduction in federal funding for US scientific research will further reduce external sources of collaborative research funding for UK research centres. To maintain Britain’s leading role in translational outcome-driven research, HMG must act swiftly and strategically to create and underwrite a new collaborative research environment. How will the Government ensure that the best research talents—those with enthusiasm, intelligence, interest and drive—and the most innovative organisations stay in the UK after we leave the European Union? We will be competing globally so we must encourage the people we need to come here. They should feel welcome and barriers should not be put in their way. Without research, there cannot be progress.

Photo of Lord Ryder of Wensum Lord Ryder of Wensum Conservative 7:52, 28 March 2017

My Lords, I, too, thank the noble Lord for initiating this debate with his opening speech. We listened to that with great attention and I congratulate him on it.

I used to be chairman of the Institute of Cancer Research but the views expressed today are my own. I make one point only: there is a pressing need to reform the 2007 European paediatric regulation which hampers cancer medicine for children by denying them access to the latest drugs. Pharmaceutical companies use a loophole in the EU legislation to avoid trialling cancer drugs in children, despite evidence that they could benefit patients. In fact, an analysis of data from the European Medicines Agency over the past five years shows that the loophole prevented no fewer than 33 new cancer drugs being evaluated in children.

Children’s cancers are rare. There is little financial incentive for pharmaceutical companies to develop drugs for children. The 2007 loophole enables these companies to ignore children by trialling drugs only on adults. In particular, children miss out on treatments that target genetic causes in cancer. As we know, cancer drugs are now more targeted on specific mutations. This means that an adult’s cancer drug could also combat the same mutation in children’s cancer.

The Institute of Cancer Research is at the forefront of paediatric research in Europe. We must enable its scientists and others around the United Kingdom to use their expertise to the maximum. Innovation should not be suppressed by the 2007 regulation. While we remain in the European Union, the Government must put pressure on the Commission to revise the 2007 regulation. Likewise, after we leave the European Union, the Government must giver freer rein to our own outstanding scientists and medical researchers so that they can do everything possible to vanquish childhood cancers.

Photo of Lord Kakkar Lord Kakkar Crossbench 7:55, 28 March 2017

My Lords, I join others in thanking the noble Lord, Lord Sharkey, for securing and introducing this important debate so effectively. I declare my own interests as chairman of University College London Partners, professor of surgery at University College London, director of the Thrombosis Research Institute and UK business ambassador for healthcare and life sciences.

As the noble Lord indicated, medical research is a great national success story. Its application has been responsible for improving human health over recent decades, advancing clinical outcomes and ensuring that the workforce is healthier and therefore more productive. The life sciences sector, after financial services, represents one of the most important in our country. As we heard, this is because, over decades, our nation has built a unique ecosystem of our fine National Health Service, four of the top 10 biomedical universities in the world, two major pharmaceutical companies based here in the United Kingdom, more than 3,500 small and medium-sized enterprises in the life science and med-tech sectors, and countless very effective medical research charities. There is also the capacity for our nation to collaborate internationally in medical research and seek funding to support those efforts, and the ability to attract international talent to come and contribute to our national medical research outputs.

In the current context there is some concern because there is much change on the horizon. We already heard about the potential impact of Brexit on a national medical research strategy. There is the creation of UK Research and Innovation. This new and important structure will result in differences in the way that dual support for medical research is applied in future. Of course, cost pressures in the NHS will have an impact on potential NHS contributions to medical research in future.

Going forward, how will this delicate but finely structured ecosystem be co-ordinated with all these new challenges? Will these issues be addressed as part of the life sciences section of the industrial strategy? For more than a decade we have had the Office for Strategic Coordination of Health Research. Will it continue, and will it be responsible for ensuring that the funding available in UKRI for medical research is appropriately co-ordinated with the substantial funding now available in the National Health Service through the National Institute for Health Research? That type of strategic co-ordination was an important objective of the Office for Strategic Coordination of Health Research and should be maintained in future once UKRI is established.

Finally, what assessment is being made of the delivery of the obligation set on the Secretary of State for Health and all other elements of the NHS to promote research in the National Health Service? This is a vital element of the Health and Social Care Act 2012. What assessment has been made of the ability of the NHS to deliver on that particular objective and obligation, and how will that be monitored and protected in future?

Photo of Lord Crisp Lord Crisp Crossbench 7:59, 28 March 2017

My Lords, I congratulate the noble Lord, Lord Sharkey, on securing this debate and raising such important questions. I will touch briefly on three areas.

First, as other noble Lords have said, the UK is a world leader in medical research and the international recruitment of researchers is of paramount importance to maintaining that position. I will reiterate that point by using the bold words of the Science and Technology Select Committee in its recent report that,

“it is not enough to allow talented scientists from around the world to work in the UK: we must attract them vigorously”.

Are the Government going to do this—vigorously?

Secondly, as my noble friend Lord Kakkar has just said, there is a vital symbiotic relationship between medical research and the NHS. The NHS, as the largest integrated health system in the world, is an essential platform for medical research and the biomedical and life sciences that spring from it. At the same time, medical research contributes to the constant improvement of the NHS in everything from drug discovery and the development of therapies to health informatics and patient engagement. This in turn contributes to a healthier, better-educated population, which can improve productivity and bring economic as well as social benefits. We know that this vital two-way relationship does not work perfectly at the moment and the recent decision by NICE that the noble Lord, Lord Sharkey, referred to makes this matter even worse. What, therefore, are the Government doing to strengthen the NHS as a platform for science and technology and to ensure that the products of science and technology benefit the NHS and its patients?

Thirdly, and taking medical research as a proxy for wider health-related research, I want to speak about research on the impact of nursing. The All-Party Parliamentary Group on Global Health recently published a report on nursing globally. Here I pay tribute to the noble Lord, Lord Willis, who was part of that group and has done so much personally to strengthen nursing in the UK. There are three relevant issues here. First, nurses are half the health workforce globally and what happens with them and how they are developed will impact on how health systems develop in this country and elsewhere. Secondly, our interviewing of nurses revealed that nurses feel they are systematically undervalued and underutilised. It is less of a problem here in the UK but nevertheless there is a strong feeling that nurses could do more, were they enabled to do so. The third and most relevant point is that there is very little quality research on the impact of nursing and the sorts of questions Ministers and planners might ask, such as: when is it appropriate to have specialist nurses? Where is it effective to replace doctors on on-call rotas? How can we measure the impact of trained nurses on different diseases? What more could nurses do?

We need decent evidence on these questions. At the moment we simply do not have it. This is relevant to the UK’s role both at home and in development abroad. Therefore, I ask the Minister: do the Government recognise the importance of research on the impact of nursing? If so, what are they doing to promote it?

Photo of Baroness Walmsley Baroness Walmsley Liberal Democrat Lords Spokesperson (Health) 8:02, 28 March 2017

My Lords, I congratulate my noble friend Lord Sharkey on introducing this debate, which has actually been quite worrying for those of us who believe that unless we maintain the UK’s position in medical research, UK patients will continue to lose out. Only this morning we heard in the news about how our performance in diagnosing and treating cancer is well behind that of our neighbours in Europe, so this is no time to be imposing further restrictions on the availability of new oncology medicines for UK patients.

My noble friend Lord Sharkey has outlined his concerns, which I share, about NICE’s new affordability cap. As the noble Baroness, Lady Morgan, said, 20% of all medicines would fall within the £20 million cap—these are proven, effective drugs—which makes me think that the cap is far too low. Have the Government assessed the impact of this on patients who have already waited too long for medicines that could benefit them? I am very concerned about patients dying while they wait for NICE to decide to allow them the medicines they need. The current 90-day accessibility obligation is reasonable but is to be increased to three years and, given all the delays in the application process and 12 weeks for consultation, it could easily turn out to be four years.

It is the most innovative medicines that would have reached the new price threshold if it had been in place in the past, and it is those same cutting-edge medicines that will be affected by it in the future. If companies inventing and developing these medicines cannot find a market in this country of a size to make it worth licensing them here, they will just go to other markets and UK patients will lose out.

This is yet another example of rationing in the NHS, and we are getting to the point where patients’ rights under the NHS constitution are being breached. But instead of being honest about it and having a national debate about what should be funded, the Government are hiding behind NICE and restricting its freedoms. Only this morning we heard about banning prescriptions for gluten-free foods and other medicines, which will affect the poor and vulnerable, who normally get free prescriptions. This is arbitrary rationing.

The UK currently gets a disproportionate amount of the EU’s R&D and clinical trials, and Brexit threatens that. I agree with every word my noble friend Lord Sharkey said but, since I have said the same words myself in your Lordships’ House at least five times since last June, I will not bore your Lordships by repeating it. He expressed it much better than I could, anyway. But is this really the time to be putting in place further deterrents to companies making cutting-edge medicines available here? The industrial strategy said a lot of the right things about the Government’s intention to promote scientific research, yet their actions do not match their words.

So I ask the Minister: how soon does the DoH plan to assess the impact of the new NICE cap? I have heard that the Government plan to leave it for three years, which is far too long. I suggest that an impact assessment should be carried out on the first five medicines affected to ensure that the impact on patients is no greater than the Government predict. Will the Minister agree to do that?

Photo of Lord Hunt of Kings Heath Lord Hunt of Kings Heath Shadow Spokesperson (Health), Shadow Deputy Leader of the House of Lords 8:06, 28 March 2017

My Lords, first, I declare an interest as a trustee of the Royal College of Ophthalmologists, which of course has a keen interest in medical research. The noble Lord, Lord Sharkey, has made a very powerful case for the importance of medical research in the UK. This is very much under threat at the moment. No doubt the Minister will be tempted to read out a list of initiatives being undertaken by the Government to support research in the life sciences sector. Welcome though those initiatives are, I hope that she will focus her response on what seems to me to be the core issue, which is the imperfect relationship between the scale and quality of medical research in this country and the uptake and outcomes of that medical research.

The evidence is that the record of the NHS is very poor in actually adopting proven new medicines, treatments and devices. Of course, it is NHS patients who lose out. As noble Lords have already said, this is now being exacerbated by the unprecedented level of rationing that is taking place, both locally and nationally, in our National Health Service. A fairly recent report by the leading charities Breast Cancer Now and Prostate Cancer UK showed that NHS cancer patients are missing out on innovative treatments that are available in any comparative country in the world.

We then come to NICE. When the previous Labour Government set up NICE, it was actually designed to speed up the introduction of innovative new treatments. We are now seeing the Government develop NICE as, in essence, a rationer of treatments. I ponder whether the restrictions being brought in really are true to the legal position of NICE as established, and certainly to its moral position. We have already heard about the impact of the new £20 million cap. That will have a devastating impact on patients. At the heart of the problem of medical research is this: we rely hugely on the pharmaceutical sector for investment in R&D. How long can we expect that investment to continue with the incredibly poor take-up of the results of that investment by our National Health Service? That is the core question that the Minister has to answer. I believe that our medical research and life sciences sector is at risk. The Brexit issue has been well documented, but at the heart of this is that unless the National Health Service changes gear and is consistently seen to welcome and embrace the uptake of new medicines, the Government can talk about medical research and the life sciences sector, but all will come to naught unless they sort out the National Health Service and the incredibly debilitating rationing that we are now seeing take place.

Photo of Baroness Buscombe Baroness Buscombe Baroness in Waiting (HM Household) (Whip) 8:10, 28 March 2017

My Lords, noble Lords will appreciate that in the past however many minutes I have been asked a lot of questions. I may not be able to answer them all, in which case, I hope noble Lords will accept a letter. I will write in detail in reply. I thank all noble Lords, particularly the noble Lord, Lord Sharkey, for their valuable contributions to this important debate.

“The Government is committed to building on the UK’s world-leading science base—including more Nobel Laureates than any country outside the United States—and making the UK the go-to nation for scientists, innovators and investors in technology”.—[Official Report, 24/3/17; col. 310.]

That was said by my noble friend Lord Prior last Thursday in a debate on EU withdrawal and science. Our focus this evening is on the importance and value of medical research to this country as part of our science.

I am sure all those present would agree that the UK research base is world-class. With just 0.9% of the global population and 4.1% of researchers, the UK accounts for 11.6% of citations and 15.9% of the most highly cited articles. Times Higher Education ranks three UK universities in the top 10, and 12 in the top 100, with the University of Oxford in first place overall.

We have an enviable track record in medical research, and we want to keep it that way. How will we do that? We have to do it by continuing to strive to improve our knowledge in this area. That is why this Government have been, and will continue to be, so dedicated in supporting research, both research in general and specifically medical research. Our support for research overall can be seen in the 2015 spending review announcement, where we protected the science resource budget in real terms for the rest of the Parliament at its 2015-16 level of £4.7 billion. In the 2016 Autumn Statement we went even further and committed to substantial real-terms increases in government investment in R&D, rising to an extra £2 billion a year by 2020-21 to help put Britain at the cutting edge of science and technology. This is an increase of around 20% of total government R&D spending and more than any increase in any Parliament since 1979.

What funding has been provided for medical research in particular? Noble Lords have referred to some of the numbers this evening. In 2015-16, the MRC’s gross research expenditure, funded through the budgetary allocation of the Department for Business, Innovation and Skills and contributions from other bodies was £927.8 million, providing support for world-class medical research to improve human health and enhance the economic competitiveness of the UK. Through the Department of Health, the Government are investing more than £1 billion a year in health and care research through the National Institute for Health Research. Funded by the Department of Health, NIHR benefits the future of health by: funding high-quality research to improve health; training and supporting health researchers; involving patients and the public in health research; providing facilities for research funded by other organisations; and working with the life sciences industry to benefit patients.

Through the NIHR, we have this year announced record funding to support our leading NHS and university partnerships. This includes the largest ever investment in health research infrastructure: £816 million over the next five years for 20 new NIHR biomedical research centres in our leading NHS and university partnerships across England. Each of these 20 biomedical research centres will translate lab-based discoveries into new cutting-edge treatments, technologies, diagnostics and other interventions in clinical settings for patients in a wide range of diseases, such as cancer and dementia. Through the NIHR, the Government are also investing £112 million over the next five years in 23 clinical research facilities for experimental medicine to help speed up the translation of scientific advances for the benefit of patients through dedicated and purpose-built facilities in the NHS with specialist clinical research and support staff. The NIHR has created a national clinical research network which co-ordinates and supports the delivery of industry, charity and other publicly funded research across the NHS in England. Annual recruitment to clinical trials and studies by the NIHR clinical research network has reached more than 600,000 people. To make it simpler for researchers to apply for funding, while retaining our commitment to research excellence, the NIHR will be rolling out a streamlined and faster application process from May. We are very encouraged by what the noble Lord, Lord Willis, said about improving outputs, but the important thing is talking about issues, such as linking data to discharge.

The contribution of charities is hugely important to this and it would be inappropriate to neglect that contribution to medical research. Noble Lords referred to it this evening. REF 2014 demonstrated the outstanding contribution to clinical medicine and to the world-leading position of the UK in biomedical science and clinical/translational research, and it highlighted that much of this work was underpinned by the vast charitable investment made in clinical medicine in the UK, with more than a third of the income over the period derived from UK-based charities. Members of the Association of Medical Research Charities have together invested more than £1 billion into UK medical research in each of the past seven years. We of course want to encourage this investment to continue, which is why the research councils and NIHR work closely with charities on many large projects. For example, noble Lords will know of the Francis Crick Institute, which is a partnership between the Medical Research Council, Cancer Research UK, the Wellcome Trust, UCL, Imperial College London and King’s College London. In addition to funding the cost of building the institute, the founders will provide ongoing research support. The Wellcome Trust will fund interdisciplinary research spanning biology, chemistry and bioengineering. The world’s largest health imaging study—UK Biobank—is jointly funded by the MRC, the Wellcome Trust and the British Heart Foundation. It will create the biggest collection of scans of internal organs and transform the way scientists study a wide range of diseases, including dementia, arthritis, cancer, heart attacks and strokes.

Many charities are greatly appreciative of the Charity Research Support Fund, part of the quality-related research funding administered by the Higher Education Funding Council for England. HEFCE determines how much to provide for this fund from within its overall allocation from BEIS, and has maintained it at £198 million per annum through to 2016-17. Once UKRI is established, decisions on the priorities for funding and how much to allocate for this will be a matter for Research England.

My noble friend Lord Dundee asked questions regarding product development partnerships, but they are more within the scope of DfID, so I will write to reply on that point. He also asked about neurological research for Alzheimer’s. As part of the Government’s 2020 dementia challenge, they are increasing research funding for dementia. This includes the Dementia Research Institute—which is being co-funded by the MRC, the Alzheimer’s Society and Alzheimer’s Research UK—the new Dementias Platform UK and the NIHR Dementia Translational Research Collaboration, which has been set up to catalyse dementia research across world-leading NIHR biomedical research centres.

Our position post the EU referendum was of concern to all noble Lords taking part in this debate, quite rightly. Leaving the EU allows us to make fresh choices about how we shape our economy and presents an opportunity to deliver a bold, long-term industrial strategy that builds on our strengths and prepares us for the years ahead. The Green Paper we launched in January marks the beginning of a dialogue to develop this strategy and to make sure the UK remains one of the very best places in the world to innovate, carry out research and do business. We are putting the UK’s strengths in science, research and innovation at the heart of our industrial strategy. We have highlighted the life sciences industry as a key area of future success for the UK. We are delighted that Professor Sir John Bell has agreed to lead the development of a new strategy for the long-term success of UK life sciences, and we hope this can lead to an early sector deal.

Funding is hugely critical, as the noble Lord, Lord Sharkey, mentioned in his opening speech. The Government have made a series of announcements to provide assurance and certainty to stakeholders in the research community since the referendum. The Treasury has made it clear that it will underwrite all successful bids for Horizon 2020 funding that are approved by the Commission, even when specific projects continue beyond our departure from the EU. This gives British participants and their EU partners the assurance and certainty needed to plan ahead for projects that can run over many years. It is too early to speculate on the UK’s future relationship with Horizon 2020 and successor programmes, but noble Lords can be assured that the UK Government are committed to ensuring that the UK remains a world leader in international research and innovation.

Another important issue was referenced by the noble Baronesses, Lady Morgan and Lady Masham. As noble Lords have said, attracting talent is absolutely key. We are in a strong position but it is important that we attract the best talent, and stakeholders have made clear that funding on its own is not sufficient. A lot has been said, some of it perhaps in a hurry, post the EU referendum, and I appreciate that there has been a misconception that the UK is no longer welcoming to overseas researchers. This is simply not true. As David Davis has said:

“We will always welcome those with the skills, the drive and the expertise to make our nation better still”.

In the Budget, we announced that over £100 million will be invested in global research talent over the next four years to attract the brightest minds to the UK and help maintain the UK’s position as a world leader in R&D. This includes £50 million of NPIF funding ring-fenced for fellowship programmes to attract global talent in areas that align with the industrial strategy, and over £50 million of existing international funds to support fellowships that attract researchers to the UK from emerging research powerhouses such as India, China, Brazil and Mexico. We have also provided assurance about postgraduate support through the Research Council studentships, which will remain open to EU students starting courses in the 2017-18 academic year. The funding support will cover the duration of their course, even if the course concludes after the UK has left the EU.

As the Government have made clear previously, there has been no change to the rights and status of EU nationals in the UK or of British citizens in the EU as a result of the referendum. The Prime Minister has been clear that during negotiations she wants to protect the status of EU nationals already living here. The only circumstances in which that would not be possible is if British citizens’ rights in European member states were not protected in return.

I know I am running short of time but I want to speak briefly about collaboration and very quickly refer to some of the questions. We have taken no final decisions on our future relationship with the EU on research. The White Paper made it clear that we would welcome an agreement to continue to collaborate with our European partners on major science, research and technology initiatives. The noble Lord, Lord Kakkar, talked about the ecosystem, which is quite complex—believe me, I have been on something of a learning curve here—and it is critical that we collaborate. We are considering a number of options, but I stress that international collaboration is nothing new.

We are thinking through how UK researchers can best be able to continue to work with the best of their international counterparts, both European and more widely. As long as we continue to be a research powerhouse, other nations will continue to collaborate with us. As I have set out, the Government are working hard to ensure that we continue to build on our reputation.

The noble Lord, Lord Patel, talked about regulation and data privacy.

Photo of Lord Hunt of Kings Heath Lord Hunt of Kings Heath Shadow Spokesperson (Health), Shadow Deputy Leader of the House of Lords

The noble Baroness is clearly not going to respond on the NHS. Does she not realise that none of this means anything unless the NHS uptakes these new medicines? This is the core argument that we are putting to her, but she is not responding to it.

Photo of Baroness Buscombe Baroness Buscombe Baroness in Waiting (HM Household) (Whip)

If I may, this debate is about how we maintain medical research.

Photo of Baroness Buscombe Baroness Buscombe Baroness in Waiting (HM Household) (Whip)

I am trying to get to the point, if I may, but perhaps it would be better if I write to the noble Lord in detail specifically on the new proposals for NICE and the cap. I think that would be better in the circumstances.

The noble Lord, Lord Patel, talked about regulation, data privacy and data transfer post Brexit. We will take seriously his wise recommendation to work with researchers and regulators to ensure that our data privacy is a world leader, proportionate and pragmatic. My noble friend Lord Ryder talked of the pressing need to reform the 2007 paediatric regulations, whereby there is an avoidance of trialling cancer drugs for children. I will certainly take that back to the department.

There was reference to NHS England’s research plan. It will be published in the next few weeks. Publication of the plan and monitoring of progress on its delivery is one of the deliverables on research in the Government’s mandate to NHS England for 2017-18, published on 20 March. The research plan will be followed by development of a comprehensive research strategy. NHS England will engage with its stakeholders during the spring and summer to support development and plan delivery of the strategy. The implementation of the AAR and the industrial strategy includes talking to industry about the changes. Positive features include a fast-track process and a threshold weighted by gain.

There were a number of other questions that I wish I could answer quickly. The noble Lord, Lord Willis, asked about CLAHRCs. Collaborations for leadership in applied health research and care are funded by NIHR with £120 million. There are more than 13 of them around England. The Department of Health is currently examining options for future funding after the current contract. This includes asking current CLAHRCs about what is working and what could be done better to support applied health research.

To conclude, it is clear from what we have heard this evening that the UK’s medical research is world-class and something that we should be proud of. Retaining and building on our science and research base remains a top priority for this Government. We will continue to work with stakeholders and parliamentarians to achieve it. I again thank the noble Lord, Lord Sharkey, and all noble Lords who have taken part in the debate this evening.