Brexit: Bust or Boon for the Clinical Trials Industry?

Article 50 was triggered on March 29, 2017, and officially started the two-year negotiation period before the U.K. exits the European Union. The uncertainty of Brexit has left researchers and others in the clinical trials industry nervous about their future. Many of the largest changes for researchers in the U.K. depend on what happens during the next two years.

The U.K. is entering negotiations armed with scant information about how Brexit will affect clinical trial applications and procedures. Many expect the U.K. to leave the European Medicines Agency (EMA). The London-based EMA will likely move to a different member state and take 900 of their skilled workers with them. Many member states are already bidding for these workers.

The loss of skilled workers leaves many concerned about the clinical aspects of research in the U.K. Such a large loss of highly trained scientists and specialized associates could slow the pace of research as sponsors search for replacement workers.

Some clinical trial experts are concerned that operating outside the harmonized regulatory landscape of the EU will reduce patient access to clinical trials. One U.K. newspaper reported that as many as 600,000 patients could miss the opportunity to participate in clinical trials in that the larger participant pool of the EU would attract more researchers than the smaller U.K. participant pool. This is particularly true for rare disease research, as it requires a large geographic reach to access a sufficient participant pool.

The Potential Benefits of Brexit

Others think breaking away from EMA could facilitate Britain’s research output. The EMA shackled U.K. researchers to constraining EU directives, such as Clinical Trials Directive 2001/20/EC, which caused clinical trial applications to drop 5.3 percent in the U.K. This directive and others are also associated with disastrous effects across the entire European Union, including a 25 percent drop in clinical trial applications and a 90 percent increase in delays.

Brexit could actually help innovation by helping the U.K return to a freer, researcher-led, more creative approach to regulating medical studies. Without the checks and limitations imposed by EU directives, scientists can get back to doing what they do best – saving lives through innovation.

The overly bureaucratic system employed by the EU squelches creativity. It also allows powerful lobbyists to control the types of research performed. This clinical trial culture prevents researchers from conducting original, inventive research. It also stops many scientists from securing the funding or contracts they need to perform innovative research in the U.K.

In developing its own regulatory structures for clinical trial applications and procedures, the U.K. will have the advantage of participating in Regulation EU No 536/2014, which streamlines approval processes and resolves many of the regulatory issues that had been plaguing researchers across the European Union. The U.K. will likely adopt the parts of Regulation EU No 536/2014 that removed undue burdens on the clinical trials industry and leave out any regulations that do not enrich the research environment for scientists working in Britain.

Brexit may create a new system when investment from philanthropists and big business can kick-start a new era of pioneering studies. Innovative investment strategies from new and established players can optimize the benefits of Brexit on the clinical trials industry while mitigating some of the drawbacks of Britain’s departure from the EU.

Hear Dr. Colin Hayward’s thoughts on these and other topics from the conference on “Brexit and its Impact on the Pharma Industry – Do we have a Plan B?” hosted by pharmacovigilance consultant, IntuVigilance.

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