Brexit Clinical Trials Sector Implications
In this extract from our first Brexit whitepaper we look at the implications of Brexit for the clinical trials sector.
Britain’s divorce also raises uncertainties as to how clinical trials will be affected. ‘Brexit’ comes at a time of major upheaval in clinical trial legislation in Europe with the repeal of Clinical Trials Directive 2001/20/EC and its replacement with Regulation (EU) No. 536/2014. Two key factors will determine the shape of all things clinical in Britain – (1) the timing of implementation of regulation 536/2014 and (2) whether Britain decides to join the European Economic Area (EEA) after leaving the EU.
On timing, the European Medicines Agency expects the new regulation to come into effect by end of 2017 at the earliest, and by October 2018 at the latest, when the clinical trial database and portal are fully functional. Were Britain to begin applying the new regulation, as has already happened with Spain, post ‘Brexit’ Britain may stick with the status quo. On EEA membership, a Britain within this framework would see little change in the way clinical trials would operate, as 536/2014 applies to the EEA. They would, however, become a mere observer, and lose their current position of influence and expertise. The new regulation promises to harmonise the regulatory environment in Europe, with a single, centralised portal for application dossiers. From our own experience of clinical trial applications under the outgoing directive, country specific nuances and requirements make the process particularly onerous. A Britain outside of the EEA and this streamlined process will surely be a less attractive place for clinical research.
The future is very unclear, as there is mixed opinion as to whether Britain would even choose to join the EEA. Indeed there is a possibility the referendum decision could be vetoed by Westminster, or even Holyrood. A Britain outside the EEA would then more closely resemble Switzerland, where clinical trials are overseen by their domestic regulator, Swissmedic.
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How will clinical trials be impacted by the UK’s decision to leave the European Union?
The currently expected Brexit day of October 31st 2019 is approaching and with a no-deal or cliff edge Brexit a very real possibility, there are several key areas for medical device companies to consider in terms of impact to their business in the event of a no-deal Brexit scenario. We wish to highlight here two areas for consideration for the medical devices sector:
- Non-European medical device manufacturers that currently use a UK based Authorised Representative
- Medical device manufacturers who rely on the services of a UK based Notified Body for their certification