Thursday 23 May 2019
[David Hanson in the Chair]
Clinical Trials and Clinical Research Capability
I beg to move,
That this House has considered the matter of supporting clinical trials and the UK’s future clinical research capability.
It is a pleasure to serve under your chairmanship, Mr Hanson. I thank the Backbench Business Committee for granting time for this important debate on supporting clinical trials and the UK’s future clinical research capability.
This is an immensely important sector. Any generation wants its successor generation to be healthier and have a better standard of living, whether the treatments that are produced are life-enhancing ones or life-saving and life-protecting ones. That is increasingly important: there is an ageing population, not just in the UK but globally, so there is an increasing need for a variety of new treatments coming through the life sciences sector. Clinical trials play such a large part in that.
Monday was international Clinical Trials Day, marking the anniversary of the first clinical trial, conducted by surgeon’s mate James Lind on HMS Salisbury in 1747. Scurvy was a huge problem at that time, not just for the Royal Navy but for navies all over the world. Lind set up a clinical trial with 12 sailors who had scurvy, and in groups of two he administered cider, sulphuric acid, vinegar, seawater, oranges and lemons, and a spice paste washed down with barley water. The sailors who took citrus fruits made good progress, but the other participants did not make any progress, so Lind had evidence that citrus fruits worked to help those sailors recover from scurvy. Notably, there was a small, incremental improvement in the health of those sailors who drank cider; no doubt there are other, wider health benefits that come from cider, but it was a reasonably clear trial. Although it took many years, the Royal Navy later adopted the approach of compelling sailors to take lemon juice initially, and lime juice later on, to protect against scurvy. That is why American sailors began to call British sailors “limeys”.
Clinical trials have evolved substantially since that time. In 2017-18, there was a record number of participants and trials in the UK. It is so important, not just for people’s healthcare but for the life sciences sector of which clinical trials are such an important part, that Britain wants to maintain that position. People find fascinating, incredibly rewarding jobs in that sector.
As in all things, all sectors and all times, funding is of immense importance, and we have to ensure that our clinical research environment is properly funded in a number of different ways. My favourite part of the 2017 Conservative manifesto was the commitment to increase research and development spend in the UK from 1.7% to 2.4% of GDP by 2027. That is an important target, taking us up to the top quartile of OECD countries. The scientific community more broadly would like to see that increase as a stepping stone to a target of spending 3% of UK GDP on R&D. That would really enhance our position, which is world-leading at the moment; however, in an increasingly competitive world, we need to focus and enhance that contribution.
In the previous Parliament, I was a member of the Select Committee on Science and Technology, which was a very positive Committee. There was a huge amount of consensus across the party divide about the agenda that we wanted to set and pursue, and an important agenda to increase our R&D spend came out of that Committee. It was very positive to see that commitment in the 2017 Conservative manifesto; however, we have to deliver on it. At a time of funding challenges across all Departments and all areas, we have to maintain that level of investment.
It is important to recognise the Government’s commitment, outlined in the life sciences sector deal 2, with the Government working in conjunction with industry to strengthen further the environment for clinical research in the UK, and the infrastructure for the safe and responsible use of patient data through the digital innovation hub programme. We should also recognise the contribution that can be made to the continued development of the National Institute for Health Research, which should receive an uplift in line with the increases to funding through UK Research and Innovation, as recommended in the life sciences industrial strategy.
There are also further considerations when it comes to funding, such as whether the UK will fully participate in the EU’s flagship framework programme 9. At the moment, we participate fully in Horizon 2020; we are committed until the end of that project, and to any ongoing research projects beyond the end of that programme. However, we do not yet know whether the United Kingdom will participate in Horizon Europe, either fully or partly, post Brexit. That is a huge concern to so many people from the scientific community, as it is for many sectors and industries, not only because we want investment in buildings and laboratories and the development of skills and talents in the UK but because we want to bring in people from abroad. People need that confidence. This is not just about funding, which is immensely important, but about the networks, the communications and the community that go with participating in that group.
I am certainly sympathetic to the idea that Brexit, no matter how well we deliver it, will be a challenging time for the United Kingdom and for organisations, whether in the charitable sector, business or academia. Delivering a healthy research clinical trials environment post Brexit will pose a challenge, and if we could make a commitment to—or at least express sympathy towards—our participation in Horizon Europe, the scientific community would appreciate being given that kind of confidence.
Funding is of great importance, and that topic may be further developed by other hon. Members present, but regulation is also an enormous priority for the UK. There is perhaps no other area like life sciences, clinical trials and the wider research community; it is such an international undertaking. Often, clinical trials are UK-only, but in many cases—especially those that deal with rare and very rare diseases, or with paediatrics—the potential population within the UK may be too small to deliver an effective trial. Nearly 30% of Cancer Research UK’s clinical trials involve an additional EU member state, showing the importance of international collaboration to that organisation. More widely, 50% of all UK cancer research is international.
The global direction of travel is towards the harmonisation of regulations and standards. The EU-UK relationship is of immense importance; it makes it easier and faster to set up trials, and to deliver on the conclusions of those trials. It would be useful if the Government could highlight what they were doing with regard to the clinical trials regulation, which is superseding the clinical trials directive. There is a concern in this. One concern that I have with the EU is that it can be slow to advance and assess what it has done, where it is and how it needs to move on. The clinical trials directive was first developed in 2001 and implemented in 2004. The decision to change and that the regulation should supersede the directive should have been taken in 2016, but there have been delays from that time. There is an ambition to deliver the regulation later this year, but there is concern as to whether that will be achieved. I appreciate that the Government’s position is that they will seek to fully participate in the regulation and adopt it wholly, but that is only part of what needs to be done.
Data from the trials will be collected in a variety of countries. While we may be able to contribute our data, there is no guarantee that we will be able to access that data in that international network post-Brexit. It is immensely important that we have certainty that we can use the portal post-Brexit and access the data to ensure that our scientific community has that information. It is an important part of providing confidence and a strong ongoing position for our research community.
Mobility of people is immensely important. It truly is a global undertaking to have an effective life sciences sector and the clinical trials that go with it. The people who contribute to the sector are very mobile. Our charitable sector is incredibly strong—stronger than it is in many other countries—and is a huge asset. We can go to any charitable organisation, business or university and see a wealth of talent that comes not only from the UK but especially from the EU. We also have people from America, Africa and Asia. We have people from across the world, but our close physical proximity to EU countries lends itself to a large number of people from the EU coming here.
We have to value our relationship with EU nation states. Post-Brexit, we want people to be able to go to EU countries, because people leaving the UK to go to France or Germany make an immense contribution to those countries. There is huge value in the sharing of ideas. When people perhaps come back later in their careers, they have that wealth of knowledge that they can bring with them, which may be lost if we do not allow and support mobility. There is particular concern over the £30,000 income threshold that people coming to the UK would have to meet. There is ongoing debate about the threshold and whether it will stand and suggestions on how it will be amended. It is worth noting that it is a challenge for post-doctoral researchers and their research technicians, who may not be above that threshold. The threshold is more of a challenge outside London and the south-east, and other parts of the country and other nations within our United Kingdom will see a greater impact. The Government need to consider that.
We need to re-examine the costly and burdensome visa process. In 2008, it was estimated that a five-year visa for a researcher with a partner and three children coming to the UK would cost more than £11,000. The same researcher and family could obtain a four-year French talent passport for a little over £1,000. We do not want the UK to have barriers to people coming here, participating and making an enormous contribution. Immigration is a very sensitive subject for the country as a whole. It is positive that in the two or three years since the referendum vote in 2016, tensions or concerns have come down ever so slightly. There still is significant concern, which is a problem, but when I talk to people and raise the UK’s current approach or possible approach to immigration, they have immense pride in seeing our country as a destination for some of the most talented scientists and technicians from the EU and the wider world. They want to come to the United Kingdom and make an immensely positive contribution. We should be proud about so much in our immigration system and the people who come here. We should make more of how strong the scientific community is in the United Kingdom.
In my closing remarks, I want to highlight and repeat that the United Kingdom has a long and proud history of being a world leader in clinical trials. Not only were we the first nation to conduct one but we should be proud of the wealth of talent involved and the scale of our clinical trials. The Government are doing the right thing and are going in the right direction. We are being immensely ambitious with what we are doing for the future of medical research, but there are obviously challenges in making that a reality. Getting the regulatory framework is important, as is the immigration system. The national health service is immensely important as an organisation, but it is not quite playing up to its strengths and its potential with its data. That data is an incredibly valuable asset that is of increasing value as time goes on, both in how it can be used and how clinical trials can be held. Practitioners can access that data to develop the next generation of drugs to save lives and to enhance our lives.
We are going in the right direction, but more needs to be done. There are concerns about Brexit, but we can deliver a good relationship with the EU and the rest of the world. It can be a positive thing. The Government need to set out a more robust position. Academia and business in the UK want that, and I especially thank the UK’s charitable research sector, which does such an immense amount of good work. I highlight and thank Cancer Research UK, Parkinson’s UK and Breast Cancer Care.
It is a pleasure to serve under your chairmanship, Mr Hanson. I congratulate the hon. Member for Bolton West (Chris Green) on securing this important debate. I particularly enjoyed his opening remarks on scurvy, and I thank him for reminding me about where the term “limeys” came from. He is obviously passionate and knowledgeable about this subject. I have quickly skimmed through some of the things he spoke about and, I have to say, I found very little to disagree with in his speech.
The hon. Gentleman said that Brexit will be challenging for many reasons, especially getting clinical trials properly conducted post-Brexit, particularly when, at the moment, no one knows what is happening. He pointed out something that had not crossed my mind: if we do not get those relationships right post-Brexit, the UK is too small a country to conduct positive and technically feasible trials in new and important areas.
The hon. Gentleman talked about the importance of harmonisation across Europe, and about something especially important to Scotland and to my party: the ability of people to move freely. We must take a European and a broader, transnational view at how much people working in the sector can bring to this country, and what UK nationals can bring back when they return from working abroad.
The hon. Gentleman also mentioned visa costs, another highly important issue for Scotland and the Scottish Government. Astonishingly, a visa for a researcher and their family can cost 11 times as much in this country as it would in France. That would be a no-brainer for a clinical researcher looking at where to go to further his or her career.
Clinical trials are essential for bringing new medicines to people. They test whether new treatments are safe and effective, and allow patients to access new medicines earlier. The UK regulatory environment for clinical trials is led by the Health Research Authority and the Medicines and Healthcare products Regulatory Agency. Wellcome, whose report I will mention later, found that more than 4,800 UK-EU clinical trials took place between 2004 and 2016. Around 40% of the trials currently run in the UK are being run with other member states. Clinical research supported by the National Institute for Health Research clinical research network has generated an estimated £2.4 billion and nearly 40,000 jobs. This is not an insignificant sector.
New legislation—the EU clinical trial regulation—will replace the EU clinical trials directive in 2020. Under the CTR, all trial applications, data and co-ordinated decisions from member states will be communicated through a single portal. Streamlined systems and communications will help to simplify compliance with the CTR, potentially saving researchers in the EU £600 million a year, as well as offering savings of £60 million a year to UK researchers.
Clinical trials are managed nationally in the UK by the MHRA, although some aspects of clinical trials are shared across the EU medicines regulatory network. For example, a clinical trial sponsor or legal representative for clinical trials in the EU should be based in the EU or European economic area. Currently, 40% of UK-based trials also have a site in the EU.
Wellcome’s report “Brexit and Beyond: Clinical trials” stated that the best option for trials is
“full UK participation in the EU clinical trials system”.
Wellcome found alternative options, but posited that all
“involve significant trade-offs that would have an impact on UK–EU clinical trials.”
The Scottish National party advocates a second EU vote. However, failing that, and failing full participation, the UK should meet its commitment to put the EU clinical trial regulation into law, and should remain aligned to the EU framework.
The UK Government stipulate that in the case of no deal, the MHRA would take on responsibilities currently undertaken through the EU system. However, Wellcome found that, even if the withdrawal agreement is voted through, which after the last few days seems impossible,
“the MHRA would not be able to lead on reviewing applications, a role known as being a ‘reporting Member State’.”
No deal would likely lead to significant uncertainty over the legal arrangements for clinical trials.
Brexit is already having a negative effect, with Reuters finding that the
“number of new clinical trials started in Britain last year was 25 percent lower than the average for 2009-16”.
It highlights Brexit as the reason for the fall in numbers. A total of 597 trials were initiated in Britain in 2017, against an average of 806 over the previous eight years. The UK Government have committed to exploring the option of full association to research and innovation programmes, but there are no guarantees of success.
As we were discussing before the debate, the United Kingdom is a world leader in research and development and, because of the excellence in the UK, we receive disproportionate funding from the European Union. Does the hon. Lady share my concern, and agree that, post Brexit, the UK Government need to maintain that enhanced level of funding?
I thank the hon. Gentleman for his intervention, and I agree. As we were discussing, Scotland punches above its weight per head of population. From memory, we receive 11% of Erasmus+ funding, which is more than we should. Again, that is because of the excellence of the research in Scottish universities, in conjunction with EU nationals and other universities across Europe.
Where are the UK Government currently in exploring the option of full association to research and innovation programmes with the EU? The Department of Health and Social Care wrote in August 2018:
“A scenario in which the UK leaves the EU without agreement (a ‘no deal’ scenario) remains unlikely”.
“facts are chiels that winna ding”—
I will spell that for Hansard later. The ground is moving beneath our feet as we speak, just before the recess. It is vital that we do not leave without a deal, but—although we can all hope—a no deal is becoming more likely. We need to think very carefully. Can the Minister give us any reassurance that there will not be a no-deal Brexit? That is asking a lot, I know, but it has to be asked. The quote that I have been given is:
“Negotiations are progressing well and both we and the EU continue to work hard to seek a positive deal.”
Can the Minister provide an update on all negotiations taking place?
The Brexit Health Alliance brings together a range of health professional, patient, and health and care organisations. The highly influential group has called for a deal that delivers the closest possible alignment and regulatory co-operation between the UK and the EU with respect to medicines and medical devices, to guarantee patient safety and public health. I do not think that anyone in the Chamber would disagree with that. We really need to ensure that it happens.
We believe in Scotland that, at least in the short term, the best way to protect clinical trials in the UK and their future is to vote for the SNP today in the EU elections. The Government’s handling of Brexit could severely damage, if not ruin, the UK’s reputation as a world leader in medical research, having produced around 25 of the top 100 prescription treatments. The UK currently benefits from access to research funding from EU funding programmes such as Horizon 2020 and the Innovative Medicines Initiative.
Innovation and progress are impossible without funding, and it can take many years to get from funding to outcome. Reducing funding now therefore has a negative effect for the future. The UK Government confirmed that Horizon 2020 provides about €80 billion of funding, available over seven years—that is, until 2020—of which the UK has secured €5.1 billion of funding to date, which is 14.3% of the total. Europe is therefore really important to us. Although it has been confirmed that the UK will participate for the remainder of the programme, what will happen in any future programmes remains undetermined.
The Innovative Medicines Initiative has committed more than £5 billion to support large-scale, ambitious research. IMI-supported projects have generated more than 4,000 peer-reviewed projects. From 2008 to 2016, the UK received 28% of total IMI funding from the EU Commission—the largest amount for any country, totalling €302.8 million. UK academic institutions and small and medium-sized enterprises receive the highest levels of IMI funding of any country.
The UK is very successful at conducting clinical trials. It sponsors approximately around 1,500 trials that include other EU countries. Half of those trials will still be occurring in 2019. It is important to collaborate internationally, particularly for rare disease trials, because there are not enough patients in one country alone. Without large-scale drug or medical device approval processes, the approval of drugs and devices could be delayed, resulting in slower access to new treatments for patients. None of us wants that.
I congratulate the hon. Member for Bolton West on recognising the work of charitable institutions such as Cancer Research UK. It is really important to people throughout the UK that funding and collaboration does not cease, because people are waiting for answers to diseases, some of which have not yet been named. The idea of UK Research and Innovation has not been dealt with; the delegated legislation to deal with it has yet to come to the Floor of the House. We wait with bated breath to see whether the Minister can answer any of my questions to her today.
It is a pleasure to serve under your chairmanship this afternoon, Mr Hanson. I congratulate the hon. Member for Bolton West (Chris Green), my fellow London marathon runner. We have run three London marathons together and we always finish in roughly the same time.
That is disappointing, but several SNP colleagues ran it this year. Anyway, today’s debate is not about the London marathon—important though it is.
The hon. Member for Bolton West made an excellent speech. I understand that a reshuffle of junior Ministers is going on; based on the quality of his speech, he is very deserving of elevation to the Government Front Bench. He might not want to join it at the moment, but that is a different issue. He well deserves a call from Downing Street.
The hon. Gentleman made some points that muster consensus across the House, as we heard from the hon. Member for Motherwell and Wishaw (Marion Fellows). We agree with what the hon. Gentleman said about R&D investment and the implications for medical research and trials post Brexit. If I may gently tease him, I think that he and I were on different sides of the debate in the Brexit referendum. I believe that some of the issues that he raised today were not given the prominence that they deserved in the referendum campaign the first time round. He may disagree, but I think that many of the concerns that he rightly raised will come to the fore and prove particularly damaging for our clinical research if we leave the European Union on World Trade Organisation terms. If that is the prospect that the country faces, I believe that we should have another opportunity to ask the British people whether that is what they want—but, again, I digress.
The hon. Gentleman made an interesting observation about the history of clinical trials. I did not know where the term “limey” came from, so I am pleased that he has educated me on that front. He could also have mentioned Edward Jenner, who was born 270 years ago and who discovered a vaccine for smallpox through a clinical trial. Because of Edward Jenner’s work, the world was rid of smallpox; the World Health Organisation declared the world free of smallpox in 1980, its first and only such declaration about any human disease.
That example brings home the importance not only of clinical trials, but of understanding and being guided by the science, especially in an age when more and more anti-vaccination propaganda and disinformation is spreading far too rapidly on social media—typing in “anti-vax” on Facebook or Instagram brings up all kinds of disturbing, poisonous nonsense. Sadly, while more and more measles outbreaks are happening throughout Europe and in parts of the United Kingdom, our measles, mumps and rubella vaccination rates are falling. I put on record the importance of being guided by science and understanding the impact and outcomes of clinical trials, which can make a huge difference to saving lives and improving health.
I entirely endorse the hon. Gentleman’s well-made point about the £30,000 visa cap. It is not just that the cap will affect the country’s science base and our ability to attract the best scientists, research technicians and so on to our shores; at a time when we have 100,000 vacancies across the national health service, including 40,000 for nurses and thousands for midwives and paramedics, and when hospital trusts are struggling to recruit, it is completely counterproductive for the Government to propose a £30,000 visa cap.
This country has a proud history of the national health service attracting people from across the world, including clinicians, nurses and technicians. Of course our international recruitment should always be ethical, but to hinder the NHS in this way will do huge damage to our ability to attract the staff we need in the future. We are told that the Dido Harding review of the workforce will propose that the NHS should recruit 5,000 international nurses a year. I presume that the Government would endorse that, but it suggests that one hand of Government does not know what the other is doing. I appreciate that this is a Home Office matter and not necessarily within the Minister’s remit, but I urge Health Ministers to pressure the Home Office on it, because it is not remotely in the interests of our science community or of our NHS generally.
Throughout the 70-year history of the national health service, scientific research and innovation, of which clinical trials have been a part, has made great advances. Sixty years ago, the first mass immunisation programmes offered polio and diphtheria vaccines to under-15s. I think back to the hospital wards full of iron lungs for people suffering from polio; I was not born then, of course, but we have all seen them in grainy black and white photos. What was once an everyday occurrence for too many children in this country is no longer a feature of our national health service—a striking example of the importance of vaccines, research and clinical trials. An everyday aspect of doctors’ and nurses’ care—tending to people in iron lungs in hospital wards—has been completely transformed because of our research and clinical trials.
There have been all kinds of remarkable innovations in the NHS over the past 70 years. We pioneered the first heart transplants here. Forty years ago, we pioneered in vitro fertilisation. We developed CT scanners, MRI scanners and clinical thermometers. We made great advances with DNA. Seminal trials funded by the British Heart Foundation found that aspirin and clot-busting drugs can save lives after a heart attack. Extraordinary, amazing innovations have taken place in the United Kingdom because of the strength of our science base. We must celebrate that, build on it and give it all the support we can.
As the hon. Member for Bolton West rightly said, the issue has become ever more important in the context of an ageing population. In 1948, at the birth of the NHS, 11% of the UK population were 65 or over. Life expectancy was 71 for women and 66 for men. Today, those figures stand at 82 and 79 respectively, and the so-called “oldest old”—those with a substantial risk of requiring long-term care—are now the fastest-growing age group in the UK. It is projected that by 2040 nearly one person in seven will be over 75; the number of over-85s is set to double over the next 20 years. The changing demographic profile of our society will demand greater investment in science to deliver medical advances.
Does the hon. Gentleman agree that, with an ageing population, it is not just about additional support and individual treatments? One of the great challenges with an older population is multiple morbidities, where individuals need a whole series of different treatments. It is quite challenging to deliver, because there are side effects, and drugs and treatments have an impact on each other. The whole environment in which the older population gains that support is far more complicated than it is with younger people.
The hon. Gentleman makes an excellent point. Partly thanks to 70 years of advances in medical research, life expectancy has generally improved. We have seen huge advances—although there are some problems at the moment, as they appear to be tailing off. We have seen huge advances in tackling mortality rates for heart disease, stroke, chronic obstructive pulmonary disease and so on, although there are still problems in the most deprived areas of the country, which is understandable. Medical research has helped to tackle some of the great killers, and people are living longer. That means we have to tackle a different challenge, which brings me to dementia.
It is Dementia Action Week and I pay tribute to all the volunteers across the country who have organised events for people living with dementia. Every three minutes, someone in the UK develops dementia. Almost all of us know someone who has been affected by dementia. Recent mortality statistics show that dementia and Alzheimer’s disease were the leading causes of death in 2017 for the third consecutive year, accounting for more than one in eight of all deaths.
Some 1 million people in the UK will have dementia by 2025, and that figure will increase to 2 million by 2050. That is the equivalent of a 35% increase in the number of people with dementia by 2025, and a 146% increase by 2050. That large projected increase makes finding a treatment to slow or stop dementia as soon as possible absolutely essential. We will not find a cure or a therapy to slow its progress without real investment, innovation, research and clinical trials. There are no treatments yet that can slow the progression or delay the onset of the diseases that cause dementia, but clinical trials are proving crucial for cures and disease-modifying therapies. For example, the progress in understanding the structure of the relevant proteins, by researchers at the MRC Laboratory of Molecular Biology, could help identify areas of the proteins that could be targets for future treatment.
Finding a cure for dementia would be revolutionary and it would touch the lives of every single person in this country. That in itself is enough to make the case for continuing clinical trials—to convince us that we should do all we can to continue to invest in medical research and to support clinical trials, as the hon. Member for Bolton West has said.
Across many types of different diseases and disease groups, the importance of clinical trials to finding cures is obvious. Let us take cancer. Cancer Research UK is currently supporting the international BEACON clinical trial, the first ever randomised clinical trial to treat children with first relapsed neuroblastoma across Europe. This rare form of cancer, which affects young children, has seen significant improvements in treatment owing to scientific research, meaning global survival rates are higher than ever. We should be proud that the UK is considered the leader in clinical trials, ensuring that the most innovative treatments are available to UK patients. We need to continue to hold that enviable global position.
As the hon. Member for Bolton West said, clinical trials are not just about treatments and cures, they are also good for the UK economy. KPMG has estimated that clinical research in the life sciences supported by the National Institute for Health Research clinical research network has generated £2.4 billion, and supports nearly 40,000 jobs.
Our strength in the UK translates into EU strength, because of our co-operation with the EU. The UK contributed to almost 20% of the total research work carried out in EU health programmes between 2007 and 2016. The UK helps maintain Europe’s key registries and research networks on rare diseases. We co-ordinate the highest number of European registries of all EU member states, including those for childhood lung diseases, Huntington’s disease and familial pancreatic cancer. In 2018, the UK accounted for 28% of all new applications for clinical trial authorisation in the EU.
Given the scale of trade and research between the UK and EU on medicines, and given that disease knows no borders and we share many similar health and demographic challenges, will the Minister reassure us that the effective joint working that we have developed with our EU partners over 40 years will be maintained and not hindered by whatever may be our future relationship with the EU? I appreciate she may not be able to answer the question—things are moving very rapidly on the Conservative Benches, are they not?—but if she can give us some indication, that would be very welcome.
Developing new medicines depends on the international co-operation that is fundamental for access to clinical trials. At the moment, patients in the UK are able to gain access to EU-wide trials for new treatments and the UK has the highest number of phase 1 clinical trials across the EU, as well as the highest number of trials for rare and childhood diseases. It is so important to improving health outcomes in the UK and EU that the UK can continue to access those networks post Brexit. Again, will the Minister give us the reassurances we are looking for?
The Opposition have called for ruling out no deal, and the House supported that; I appreciate that things are going on in the Tory party and we may well get a new Prime Minister who wants no deal, but if that is where we end up, I remind the Minister that the Association of Medical Research Charities has warned that a no-deal, World Trade Organisation-based arrangement would:
“risk patient safety and jeopardise pioneering medical research in the UK.”
The association adds:
“Collectively, members of the Association of Medical Research Charities fund almost half of all publicly funded medical research nationally as well as over 17,000 researchers. A no-deal Brexit could irreversibly damage our relationship with our most important research partner.”
Will the Minister confirm that it is still her position and the position of the Department of Health and Social Care to rule out a no-deal Brexit?
Will the Minister also tell us about the EU clinical trials directive, which, as she knows, governs clinical trials? From 2020, the new EU clinical trial regulation will come into force. As I understand it, the Government have made a commitment to align with the clinical trial regulation, in response to pressure from campaign and charity groups such as Cancer Research UK, the British Heart Foundation and the Wellcome Foundation, which the hon. Member for Motherwell and Wishaw mentioned, and to which I pay tribute.
Will the Government confirm that clinical research will remain a negotiating priority with the EU? Will the Minister also confirm that agreement will be reached in the negotiations on the UK’s participation in the single assessment procedure and access to the shared central IT portal and database, which underpin the cross-national clinical trials regulation and come into operation in the next year? Not having access to the portal will severely reduce the ease of setting up UK-EU trials, and will hurt our thriving life sciences environment. As things stand, UK researchers will enter the implementation period unsure of what regulatory conditions they will face when they exit it next year. If the Minister can offer us some guidance on that, we would appreciate it.
The hon. Member for Bolton West and the hon. Member for Motherwell and Wishaw also mentioned the EU’s Horizon 2020 scheme, which is due to invest billions in health research across the UK over the next couple of years. It is significant funding and its long-term nature is vital to give security to those medical institutions and universities planning major research projects, but institutions are still waiting for clarity from the Government on where we stand with respect to Horizon 2020 post Brexit. Again, I would welcome some clarification from the Minister.
I wonder whether the Minister can say something about transparency. We must ensure there is transparency in all publicly funded medical research. What efforts is the Department making to ensure that UK Research and Innovation and the Medical Research Council publish the results of publicly funded research in a timely manner? She might be aware that a debate is currently raging at the World Health Assembly on an Italian resolution on the transparency of clinical trials, research and development costs and medicine prices. I understand that the Minister in the Lords, Baroness Blackwood, represented the UK at the World Health Assembly.
The UK is not supporting the resolution that the Italians propose. It might well be that there are very good reasons—around intellectual property rights and so on—why we would not want to support that resolution. However, I would welcome some clarification or explanation from the Minister on why the UK does not support the resolution on transparency, which lots of EU member states including the Netherlands support—others in the EU are not supporting it, but a significant number of EU member states are supporting it. It would be helpful if we could have that on the record, because there is huge concern about the way the pharmaceutical industry operates. We should celebrate its contributions to the economy, but that does not mean we should not hold it to account.
The Minister will know about the very heated debate that has taken place, both in public and between NHS England and Vertex, on the availability of Orkambi for cystic fibrosis sufferers. Frankly, I think Vertex has behaved shamefully. I now understand that the NHS has made Vertex an offer on a two-year managed access arrangement, and I believe it is offering more for Orkambi. I really hope Vertex takes up the offer.
Time after time, we hear stories of pharmaceutical companies acting quite disgracefully. There was another story today, about four pharmaceutical companies colluding over an anti-nausea drug and causing the NHS to spend 700% more on the drug than it should have done. We need more transparency. It might well be that the Government have good reasons for opposing the resolution at the World Health Assembly, and I would welcome the Minister’s explanation. If we cannot support that resolution because of the implications for our life sciences, what are the Government doing internationally to pursue a transparency agenda on R&D, drug pricing and so on?
I thank the hon. Member for Bolton West for securing the debate for this week—I believe we had Clinical Trials Day on Monday. It might well be that other things are going on elsewhere in our constituencies and in the Commons corridors, which is why only a few of us are present, but that does not mean it has not been a high-quality debate. I thank the hon. Gentleman and look forward to the Minister’s response.
It is a great pleasure to serve under your chairmanship, Mr Hanson. I start in a similar vein to my colleagues, by thanking my hon. Friend the Member for Bolton West (Chris Green) for securing this really important debate on such a vital issue. I also associate myself with the comments made by the hon. Member for Motherwell and Wishaw (Marion Fellows)—I, too, have absolutely no intention to run the London marathon.
I thank my hon. Friend for taking us on a trip down memory lane back to the early days of our country’s great historical legacy in clinical trials, and back to the days of James Lind. I am particularly grateful to the hon. Gentleman for mentioning Lind, because he is synonymous with my home town of Gosport. After his great initial work on the trials for scurvy, he worked at Haslar Hospital, which was one of Europe’s largest institutions for treatments and a Royal Navy hospital. He continued a lot of his valuable work there between 1758 and 1774. He is well known in our area as one of the great stars of Haslar Hospital, and of whose work we are most proud. Once it was eventually rolled out across the Navy, his work undoubtedly saved lives and prevented immeasurable suffering. It was very interesting to hear about those early trials. I would have been very grateful to have been the one having oranges and lemons every day, and not the one having diluted sulphuric acid —I cannot imagine how that would have turned out.
Let me say from the outset that the Government absolutely recognise the importance of clinical research in this country, including clinical trials. As hon. Members have already said—I thank them for their contributions, too—it is appropriate to have this debate in the same week as Clinical Trials Day. Clearly, access to world-leading clinical trials and research can offer real hope to patients who suffer from conditions with limited treatment options. We are absolutely committed to continuing to offer patients opportunities to access potentially life-saving treatments through clinical research. For many patients, participating in clinical research can be about more than improving their own condition. Patients feel empowered by having the chance to contribute to the search for a cure that might benefit other patients in the future. I pay tribute to such patients, and to all individuals and organisations working in this important field.
This country is a world leader in clinical research. We have a world-class science base and three of the top 10 globally ranked universities. Centres such as Moorfields, Birmingham, the Christie and the Royal Marsden are undertaking vital, world-leading cancer trials and research. UK-based scientists have won more than 80 Nobel prizes in chemistry, physics and medicine. Indeed, 25 of the world’s 100 most-used medicines were developed in the UK, using a public and philanthropic research infrastructure that is, pound for pound, more effective than anywhere else on earth. We have to be very proud of that.
We continue to punch above our weight in many areas, and rank second globally—behind only the United States—in the number of clinical trials delivered. Our regulatory environment is forward-thinking and pragmatic, and it welcomes innovation. Through the National Institute for Health Research, the Government are investing over £1 billion a year to fund research and provide the skills and facilities to enable high-quality research in our health and care system. Through its people, programmes, centres of excellence and systems, the NIHR is the most integrated health research system in the world, designed to transform scientific breakthroughs into life-saving treatments. It is doing just that.
In 2017-18, the NIHR’s early transitional research infrastructure generated more than £231 million of industry research investment, supported over 1,770 industry-collaborative and contract research studies, filed 199 patents and created five spin-out companies. The NIHR Clinical Research Network announced this week that a record 870,000 people took part in network-supported clinical research studies in 2018-19, including over 81,000 in children’s research studies. That is a huge increase from the previous year.
The UK’s life sciences sector contributes almost £74 billion a year and supports close to a quarter of a million jobs across the country. In addition, members of the Association of Medical Research Charities support over one third of all publicly funded medical research in the UK, investing over £1.6 billion in health research in 2016. Our NHS has a track record of being very active in research, with 100% of trusts and 38% of GP surgeries in England delivering some form of clinical research in 2018-19—acting on the commitment in the NHS constitution to conduct and use research to improve the health and care of the population. Clinical research does not benefit only the patients who participate; evidence has shown that NHS trusts that are active in clinical research deliver better overall clinical outcomes.
Strong clinical research unlocks a virtuous circle for patients, the economy and the NHS. Part of the stimulus for the growth of this sector is the Government’s commitment to reach a target of investing 2.4% of GDP in research and development by 2027, and 3% in the long term. That places us in the top quartile of OECD countries, as we heard from my hon. Friend.
The life sciences industrial strategy sets out the vision to build on that and make the UK a top-tier global hub for biomedical and clinical research. The two life sciences sector deals, published in 2017 and 2018, have already transformed a significant part of the strategy into Government policy. They are no lightweight commitment. Taken together, they have leveraged more than £2 billion in private sector investment in the life sciences sector, supported by more than £500 million from the Government. The second sector deal set out the Government’s clear ambition to see faster, more efficient clinical research. NHS England’s long-term plan confirmed that the NHS endorses and will play its full part in delivering the life sciences sector deals, and set out our ambition to see 1 million people registered to participate in health research by 2023-24, and to treble commercial research in the health system over the next 10 years.
The Government are committed to creating the very best environment for clinical trials, both to achieve the ambition set out in the life sciences industrial strategy and to prepare for exiting the EU, about which hon. Members have spoken. The system is coming together to deliver that. The implementation of Health Research Authority approval has streamlined processes and led to improvements in the timelines for clinical trial approvals. It is now possible for efficient clinical trials to be set up in the UK within 100 days from first regulatory application to the first participant recruited.
This week, the NIHR published a policy on clinical trial transparency, about which my hon. Friend the Member for Bolton West asked. The policy aims to improve practice in prospective registration and timely disclosure of results to ensure full transparency of clinical trials funded by the NIHR. It sits within and is consistent with the Health Research Authority’s UK policy framework for health and social care research, and guidance on the publication and dissemination of research findings. The Government’s arm’s length bodies and partners are committed to clinical trials transparency. The Health Research Authority has an active work programme on transparency, and later in the year will launch a consultation to improve it further.
NHS England and the NIHR are implementing their “12 Actions to Support and Apply Research in the NHS”, which sets out a vision for further simplifying and strengthening clinical research within the NHS in England. In the summer, the NIHR clinical research network will launch a competition to establish five purpose-designed centres dedicated to late-phase commercial research within the NHS, launched as part of the second life sciences sector deal. Increasing the NHS’s capacity to deliver research will enable significant growth and will provide more opportunities for patients to benefit from early access to innovation. Our vision is make the UK home to data-driven research, scientific advances and innovation in healthcare. It is all about improving patient outcomes. To help that, we have committed £37.5 million through the life sciences sector deals to develop up to five digital innovation hubs.
The UK is also leading the way in improving clinical trial designs, undertaking novel and more efficient trial designs that will develop new medicines, diagnostics and medical devices for patients. Although a record 870,000 people took part in the NIHR clinical research network-supported studies in 2018-19, the network is also exploring mechanisms to ensure that all patients are offered the opportunity to participate in research that is relevant to them, whether or not it is delivered by their regular healthcare provider. With that in mind, the NIHR recently launched a new website called “Be Part of Research”, which helps people to find out easily about health research of relevance to them taking place across the UK, not just in their own areas. NHS patients will be able to view opportunities to participate and register their interest in research via the NHS app by 2020.
As part of Brexit negotiations, which a lot of Members mentioned, we are working to ensure that we continue to have the best possible environment in which to support clinical trials. Our overall aim is to ensure that patients in the UK and across the EU continue to be able to access the very best and most innovative medicine. As part of our preparations for leaving the EU, the Government are working across a great number of areas to ensure that the UK has the best possible environment for basic, biomedical, health, and life sciences research.
Does the Minister understand my concern that, although many people from the life sciences sector are involved in Parliament in one way or another and visit it, and are aware of what Brexit means and the challenges around it, for many people in the sector, which is very international in its nature and supportive of remaining in the EU, information about what the Government are doing and their intentions is not as widespread as it might be? Therefore, the Government need to do more and be more effective in communicating what we are doing on Brexit and why we are doing it.
My hon. Friend is quite right. We must do everything we can to communicate and reassure individuals in the UK and across the rest of the EU about our intentions. We have a strong track record of working together to tackle global challenges, and there are strong links in place between our research and innovation communities. We want to maintain that and build on it as best we can. We want to continue collaborating in areas of shared interest through the ongoing partnerships. We perhaps need to do a better job of communicating that. I hope that today’s debate will help to that end, so I congratulate my hon. Friend again on securing it.
My hon. Friend spoke about access to global talent. Through the NIHR Academy, we are investing in the development and co-ordination of NIHR academic training, career development and research capacity development. Clinical trials training is supported from pre-doctoral training right the way through to senior post-doctoral research through a range of awards as part of the NIHR fellowships programme. More than half of the UK’s research output is the result of international collaboration, and the most pressing global scientific challenges of today require scientists from around the world to work together across borders. The UK Government are absolutely committed to continuing to participate fully in all international scientific endeavours, including through pooling and sharing resources and infrastructure with other countries. Hon. Members have raised concerns about that. We are also making it easier to recruit and retain overseas researchers and scientists. We want to ensure that the new regime works for life sciences companies, and supports the recruitment of skilled and talented people without excessive bureaucracy, which often gets in the way.
In September 2018, the independent Migration Advisory Committee reported on the economic and social impacts of the UK’s exit from the EU and on how the immigration system should be aligned with a modern industrial strategy. That includes removing the number cap on the skilled workers route and removal of the resident market labour test. Hon. Members will know that the White Paper currently retains the £30,000 minimum threshold, but the Government have committed to 12 months of extensive engagement with employers on the future of the immigration system to ensure that it works and to address any concerns that have been raised. The hon. Member for Leicester South (Jonathan Ashworth) mentioned other medical and health staff. He will know that nurses and paramedics are already on the exempted professions list. In the 2019 spring statement, the Chancellor announced that we would be completely exempting PhD-qualified migrants from visa caps.
On accessing EU funding, should Parliament pass the withdrawal agreement, the UK will continue to participate in EU science programmes until the end of 2020 through the withdrawal agreement, and the Government would very much like the option to associate to programmes beyond 2020, including the Horizon Europe programme, which has been mentioned. As a contingency in the event that the withdrawal agreement is not ratified, the Government have guaranteed funding for scientists and innovators who secure awards before EU exit and those who are successful in EU competitions on a third-country basis after exit.
The EU and the UK start from a position of close regulatory alignment. The EU has created a comprehensive scheme for the regulation of clinical trials of medicines through the clinical trials directive and the good clinical practice directive, both of which have been transposed into UK law through the Medicines for Human Use (Clinical trials) Regulations 2004. The EU is planning to implement new regulations for clinical trials in 2020, as my hon. Friend the Member for Bolton West knows, which will further integrate clinical trial processes and requirements across the EU. Ministers have stated that the Government have committed to align with the EU’s new clinical trials regulation as far as we possibly can without delay when it comes into force in the EU, subject to usual parliamentary approvals.
Our preferred future relationship includes the UK’s involvement in all of the elements of EU regulation that are not in the UK’s gift—namely, the EU common portal and single assessment framework. Of course, that is subject to negotiations, which are ongoing.
Regardless of EU exit, the MHRA and partners across the UK healthcare ecosystem are already taking steps to improve further the clinical trials application process. That will ensure that those engaged in clinical trials can continue to develop innovative and cost-effective treatments, and that patients recruited in trials can continue to have safe and prompt access to medicines.
Once the UK is outside the EU network, it will still be possible for sponsors to run multi-state trials involving the UK. Data generated in a UK clinical trial will also be admissible to support regulatory activity in the EU and globally. The MHRA and UK ethics committees will take every effort to ensure that any parallel submissions to the UK are streamlined and efficient, for example by accepting the same application dossier and offering competitive timelines for assessment.
For medical devices and in vitro diagnostics, the new EU regulations entered into force in May 2017, with three and five-year transition periods respectively. The MHRA leads on the UK regulatory framework for medical devices and IVDs, including the appropriate alignment with international standards.
The Department for Digital, Culture, Media and Sport, the Information Commissioner’s Office and NHS England have all published EU exit operational readiness guidelines, including the actions that organisations need to take to ensure continuity of access to the processing and sharing of personal information and data.
I hope that I have made it clear to my hon. Friend Member for Bolton West that we are fully committed not just to keeping pace with the rest of the world but to taking strides ahead despite the uncertainty that we face with EU exit. The life sciences industrial strategy sets out the blueprint for that, and we continue to make rapid progress on implementation, to the benefit of the UK population, patients, the NHS and our economy.
This debate has been very positive on both sides of the Chamber. We see the challenges ahead with Brexit. We do not know at the moment when, if or how we will leave, but all of us in the Chamber and more widely across the country recognise the immense contribution that our scientific community makes, whether that involves the private sector, academia or our fantastic charitable research sector. We have a very positive future. Our consensus on increasing and improving our investment in research and development and devoting a greater part of our national budget to it sends the very positive message, not just to the United Kingdom but across the world, that we are a place to invest in, locate in and move to in order to participate. I thank everyone who spoke in the debate very much.
Question put and agreed to.
That this House has considered the matter of supporting clinical trials and the UK’s future clinical research capability.