My Lords, I declare an interest as chair of the Association of Medical Research Charities, whose members spend more than £1.4 billion a year on medical research. The UK is a world leader in medical research. We have discovered and developed 25 of the top 100 prescription medicines globally. We produce around 20% of the world’s most cited academic publications in the life sciences. The UK life sciences industry generates for the UK a combined estimated annual turnover of £61 billion. This is a timely debate. Tomorrow, the Prime Minister will trigger Article 50. There are significant implications for UK medical research in exiting the European Union, and I will speak to these. I will also speak to the implications of the recently announced changes to the funding of NICE-approved drugs and technologies and to the funding of medical research by government.
Let me start with the changes to the drug approval process announced on
There are three principal areas of concern. The first is the potential harm to patients. For those with life-threatening and other serious conditions, waiting three years to receive a life-enhancing or transforming technology is not acceptable. For instance, ocrelizumab, the first treatment for the primary progressive form of MS, is soon to undergo an appraisal. As it stands to be the first disease-modifying licensed treatment for this type of MS, it is unlikely to come cheap and its introduction may well be delayed under the new arrangements.
Secondly, innovative research and scientific breakthroughs matter only if patients are able to reap the benefits. This new regime make the benefits of research difficult to forecast and could make investment in research in the UK less attractive. Delaying patient access by three years could make England a less attractive place to do clinical trials.
Thirdly, medical research is a complex ecosystem bringing together charities, a variety of industries, academia and public bodies. This decision sends the wrong signal to the life sciences sector at a time when we are preparing to negotiate Brexit, and is contrary to the thrust of the industrial strategy. The Association of the British Pharmaceutical Industry has warned that these new plans will prevent patients receiving NICE-approved, cost-effective medicines. The BioIndustry Association has called it a “lose/lose/lose” situation for rare disease NHS patients, the UK life science sector and the union, given the different regime that obtains in Scotland.
Clearly the NHS is under significant financial pressure, but this new regime is not an appropriate solution to the affordability of medicines issue. Instead, an improved dialogue and early negotiations with industry are needed. That is what the accelerated access review recommended and that is what we should do, rather than taking this arbitrary approach that puts at risk people with serious health conditions and our research infrastructure.
The new regime will come into effect from
I now turn to Brexit. The UK’s decision to leave the EU has the potential to impact greatly on medical research. The priorities for science are shared across the medical research community. They include continued participation in Horizon 2020 and future funding programmes. Not only is the UK the second biggest beneficiary of Horizon 2020, but the collaborations that arise from these programmes are significant and highly valued by the UK medical sector. However, there is already anecdotal evidence that recruiting and retaining researchers from the EEA is becoming more difficult. Right now we need the Government to clarify the situation and give certainty to EEA nationals working in the UK. In the longer term we will need an immigration system that reflects the intrinsically collaborative and international nature of science and research.
The Minister will know that there are a number of EU regulations for dealing with medical research, including the clinical trials directive, which is soon to be replaced by the clinical trials regulation. Shared regulatory frameworks enable cross-border collaboration, which is critical for medical research, particularly research into rare disease. The larger EU population makes research on rare conditions possible and the European Medicines Agency’s single approval process for medicines for rare conditions makes it cost effective for manufacturers to bring new treatments to patients. We do not want to be outside this process. We need to remain part of the larger research test bed. To uphold our position as a leader in medical research, I urge the Government to seek ongoing regulatory co-operation with the EU. The UK must remain part of the scientific processes at an EU level.
I shall now touch briefly on UKRI and the role it will play in maintaining the UK’s position as a global leader in medical research. I very much welcome the appointment of Sir Mark Walport as UKRI’s CEO. UKRI will, I hope, provide strong leadership for the medical research and broader research sector throughout the Brexit negotiations, but I want to register my disappointment that the quality-related research funding for universities will remain flat in 2017-18. This funding is critical to maintaining and growing medical research in our university sector. I urge UKRI, with its future funding role, to examine the support provided to researchers and universities.
In particular, I highlight the charity research support element of QR funding, known as the charity research support fund. The CRSF supports the indirect costs of research that charities cannot fund. It has been fixed at £198 million per annum since 2010—a real-terms decrease of nearly £40 million over the six years since then. To repeat a point I made earlier, medical research charities are an important part of the UK’s unique medical research environment. I strongly recommend that UKRI commits to increasing the CRSF in real terms.
Finally, there is the NHS itself as an important research institution and test bed. NHSE’s 2016-17 business plan promised a research strategy for 2016-17. That period ends in two weeks and there is still no published research strategy, and nor was there one for 2015-16. We need the NHS to take seriously its mandate to promote and support research in the service. Will the Minister say when we can expect to see an NHS England research strategy?
To conclude, the UK has a medical research sector to be proud of. It contributes to the health of people in our country and across the world. It is a provider of jobs and investment. Our medical research sector is a genuine world leader. The Government must not only consolidate this position but use any opportunities, and any opportunities created by Brexit, to build upon it. I look forward to hearing how they plan to do exactly that when the Minister responds.