One notable characteristic of Brexit has been a race for the bottom by journalists, politicians and pundits alike. There seems to have been a blatant disregard for the truth. Made up ‘facts’ have been touted from all sides, as all parties have used the current moratorium on untruths to support their arguments. The more ‘considered’ among the UKs population might view current events in the UK and think that April Fool’s Day had arrived early.
Not so the pharma industry and those involved in regulating new medicines. You might be forgiven for thinking that our industry has behaved both stoically and impeccably. We bore the departure of the European Medicines Agency (EMA) from its London offices without drama – all parties expressing deep sadness at the political maelstrom that precipitated their departure. The MHRA has done its best to fill the vacuum providing endless briefs on how the industry can address the challenges ahead. It has also engaged proactively with European and UK industry bodies discussing the past and the future.
However, the gun was fired on our own industry race yesterday. Reuters of London reported that the number of new clinical trials in the UK has been falling and last year was 25% lower than the average for 2009–16. It also extrapolated that the cause is anxiety about Brexit’s impact on future medicines [1]. According to the article, 597 trials were initiated in Britain in 2017, against an average of 806 over the previous 8 years (details taken from a Fitch analysis released Tuesday). As with much Brexit reporting, journalists eager to generate newsworthy stories without providing much by the way of context or understanding.
If news editors had taken the time to attend some of the outreach efforts made by MHRA representatives over the last 2 years they might not have jumped to the conclusion that the reason for this change has been due to ‘drugmakers’ losing confidence over the regulatory value of data collected in Britain after the UK leaves the EU [2,3]. They may have learned that early phase clinical research, which is what most clinical studies are, has been changing. In the past, developing drugs meant doing many studies that looked at different parts of an experimental product. These days, adaptive design multi-part studies are used instead.
Pharmaceutical and biotech firms use adaptive design clinical studies to better manage risk, speed up and improve the efficiency of drug development programmes, and make better use of their budgets and resources. The most important thing about these approaches is that they help find failed drugs early on and give companies a way to get possibly successful drugs to market faster, which increases their return on investment. We have been at the head of these changes in the UK, thanks to the MHRA and the clinical research organisations that run early phase clinical studies. The UK has been a leader in the growth of these programmes that are changing the way early clinical research is done.
We shouldn’t forget that the UK will continue to adhere to global ICH-GCP and EU regulations state that it must accept any data from studies performed under similar standards (and we expect the UK to continue to share the same regulatory framework for some time). Reports published in the scientific literature have detailed these discussions by learned societies at various congresses and so you might expect those involved in the industry to be surprised by Reuter’s interpretation of the change in trial reporting. However, in a recent posting Marc Thouin, president and general manager of QPS, a global contract research organization (CRO) with offices in The Netherlands (new home of the EMA), is quoted as relating the reason for this change being that the UK is grappling with Brexit [4].
The study also talks about the effect on Horizon 2020 project funding in the European Union, which has set aside €8.2bn ($9.23bn) for health research right now. Again, it seems a bit dishonest to say that this will have an effect on the biotech business, since "health research" refers to a lot of different things and project funding is mostly focused on helping patients rather than making money. The senior vice president and global head of preclinical research at QPS, Dr. Zamas Lam, also seems to be very pessimistic about the future of the UK. There will be a lot of common preclinical and bioanalytical research tools this time.
Based on the scariest 'Red Top' media stories about shortages, it looks like bringing in non-human primates could be hard for preclinical and bioanalysis research projects in the UK, especially those that study gene therapy and biosimilars. We hope that the different "disaster" scenarios that Dr. Lam is said to have talked about were just a mistake on the part of the reporter. UK CROs that offer these specialised services have had a lot of time to think about what they will do after Brexit. Few have expressed worry about continuing their gene and cell therapy research projects as well as their pharmacology, DMPK, and toxicology studies for biosimilars. It doesn't make sense to come to the conclusion that the UK will no longer be a place where bioanalytical discovery is possible. The UK has long been known as a leader in innovation, and this may just be wishful thought on the part of a competitor. The MHRA is the second largest donor to the EMA, so it's also possible to wonder where the pain will be the worst.
Leading the world in terms of new gene and cell therapies and alternatives for animal testing, the UK will retain its lead of the biotech sector for years to come 'despite Brexit.' In conclusion, don’t believe everything you read. Contrary to the opinion of the less well informed, the UK is open for business and will continue to be so.
References
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