Clinical Trials and Clinical Research Capability

Jonathan Ashworth Excerpts

Thursday 23rd May 2019 Westminster Hall

[Jonathan Ashworth (Leicester South) (Lab/Co-op)]

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.

[Chris Green]

Over the past three years, it has been a fantastic experience to be always about two or three minutes behind the hon. Gentleman.

[Jonathan Ashworth]

I think the hon. Gentleman beat me three years ago, although I have just beaten him this year.

[David Hanson (in the Chair)]

I didn’t run.

[Jonathan Ashworth]

I have not yet decided whether to run next year’s marathon, but should we decide to run, it would be great to have you running with us, Mr Hanson—or indeed the Minister.

[Marion Fellows]

As a fellow Front-Bench spokesperson, may I withdraw from any suggestion that I might run the marathon next year?

[Jonathan Ashworth]

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.

[Chris Green]

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.

[Jonathan Ashworth]

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 that 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.