Regulations that “hold any business here back” should be scrapped, said Michael Gove, a key figure in the Brexit campaign. Gove’s belief is that pharmaceuticals are important to Britain’s success: less regulation will permit faster access to the NHS for novel treatments, and more sales will benefit the UK economy. Gove, amongst other Brexiteers, also believes access to new drugs is being held back by EU bureaucracy; once EU regulation has been dispensed with, new treatments can be “trialled in a particular way, to help those suffering with advanced conditions.”
Let’s get one thing clear before we start: to sell drugs in the EU, we will have to follow EU regulation; to sell drugs in the US, we will have to follow FDA regulations—now we can move on.
Will the UK therefore create a new regulatory system for doing clinical trials? The answer is more complex than a throw away comment, but it is possible, and likely. To understand this answer we have to look at why the EU Trials Directive needed changing, and consider countries like Switzerland—who are inside the customs union, but not the EU—and what they are doing.
In 2014, EU Regulation No 536/2014 on clinical trials on medicinal products, published regulation to streamline authorisation processes and harmonisation for clinical trials of medicines in Europe. Problems with the previous directive meant EU trial applications had been falling significantly by 25%; costs of trials had increased disproportionately; and delays in trial initiation had also risen by 90%. The ability to do a trial across different countries was further hampered by the need to approve the same clinical trial by each country: “the old Clinical Trials Directive was a catastrophe,” said Michael Rawlins, chair of an Academy of Medical Sciences review of clinical trials.
With the aim of speeding up approval, the new directive implemented a system of one decision per country to replace the old system of separate approvals. The decision of where to locate a trial is affected more by harmonisation and speed of approval than it is by the actual costs of running a trial. Has the directive gone far enough in speeding up the process of approval? For multicentre, pan European trials, it certainly helps. But a 2013 UK Science and Technology Committee review on the barriers to conducting trials in the UK reported that the lack of clarity in the details of EU regulation could lead to problems across Member States; particularly low-risk trials are regulated in an over-burdensome manner, and countries could interpret regulations in very different ways, leading to confusion and delays.
So, what has Switzerland done? They are seen as an attractive location for clinical trials. Whilst the rest of Europe was haemorrhaging trials, the Swiss were approving more than ever. The 2011 Swiss Human Research Act created favourable conditions for research involving human beings and ensured quality and transparency of research. The Swiss framework established clearer, simplified procedures for approval, and made it easier to conduct multicentre studies.
In Europe, the authorisation and oversight of clinical trials still remains the responsibility of each Member State. It is not inconceivable that the UK will have its own human research act; however, we won’t be “scrapping” the trials directive. Largely, because the directive follows Good Clinical Practice (GCP), something many countries endorse, to protect patients and volunteers and define the different roles for those involved in trials. Moreover, harmonisation and mutual recognition of standards between the UK and the EU post Brexit is the most important issue for Association of the British Pharmaceutical Industry to sort, so that drugs trialed in the UK can be approved in the EU.
Another key aim of the Trial Directive is to increase transparency; something AllTrials campaigns for, and that I am a strong supporter of. The UK Government “viewed positively the elements of the proposal designed to do this“. New legislation could also go further by addressing the problem of missing results for medicines currently in use. The 2013 UK Government’s select committee report recommended that universal trial registration was crucial to increase transparency, and future trials should be included in a publicly-accessible register; that summary-level results should be made publicly available for all clinical trials and that retrospective disclosure is important if the benefits of clinical trial transparency are to be realised.
Therefore we can expect, post Brexit, that UK trials legislation will largely harmonise with the EU trials directive. The UK could adopt measures to speed up low risk trials and go further on trials transparency. We could remove some of the bureaucratic legislation at the front end of trials, slowing down the speed of getting started, and add some legislation to the back end of trials: to ensure that all results of research done in the UK is made available and published in full.
Carl Heneghan is professor of EBM at the University of Oxford, director of CEBM, and a GP.
His research interests span chronic diseases, diagnostics, use of new technologies, and investigative work with The BMJ on drugs and devices that you might stumble across in the media. He is also a founder of the alltrials.net campaign.
Competing interests: Carl Heneghan jointly runs the Evidence Live conference with The BMJ and is a founder of the AllTrials campaign. He has received expenses and payments for his media work. He has received expenses from the World Health Organization (WHO) and the US FDA, and holds grant funding from the NIHR, the National School of Primary Care Research, the Wellcome Trust, and the WHO.