Clinical Trials and Clinical Research Capability

(Limited Text - Ministerial Extracts only)

Thursday 23rd May 2019 Westminster Hall

[The Minister for Care (Caroline Dinenage)]

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 to 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.

[Chris Green]

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.

[Caroline Dinenage]

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 make 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 the 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.