Clinical Trials and Clinical Research Capability

Debate between Lord Hanson of Flint and Chris Green

Thursday 23rd May 2019 Westminster Hall

[Chris Green (Bolton West) (Con)]

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.

[David Hanson (in the Chair)]

I thank the hon. Gentleman for introducing the debate. We now move seamlessly to the Front-Bench responses.