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International Clinical Trials

The Imminent Exit

Brexit: it seems to dominate the news (in the UK, at least) and the reporting is getting ever more frantic and misleading. It seems to me that far too many people have been swept into the Brexit system of fear that appears to be the basis of all public policy these days. Edmund Burke said, no passion so effectually robs the mind of all its powers of acting and reasoning as fear. It may well be that this is the case for all the participants in the Brexit debate, be they pro, anti, second vote, or of any other opinion.

In the pharmaceutical arena, it seems that the membership, or otherwise, of the EMA and adherence to its regulation is the one most desired by the UK government and by the industry. Currently, most novel drug applications go through the centralised procedure, which allows pharma companies to apply for market access across the EU through a single application with the EMA. Although the UK has indicated it would like to continue using this procedure, in March 2018, the EU rejected any possibility of the UK remaining a member of the EMA post Brexit, and guidelines for Brexit published by the EMA state that they are working on the basis of the UK not having access to the centralised procedure after 30 March 2019. This makes it unlikely that the UK will be part of the centralised procedure in the future. However, although we read recently that 95% of the deal is done, there is no clarity on the possibility of the UK remaining part of the EUs EMA.

If the UK is outside the EMA scheme, an alternative scenario to retaining access to some European drug regulatory pathways would be for the UK to operate entirely outside the EUs drug regulatory process. This could result in slower access to novel and generic drugs by several years, since drug companies will likely prioritise application for marketing authorisation in the significantly larger US and EU markets, before turning to the UK. However, I ask, if the UK is still of the belief that the EMA is a responsible and scientifically rigorous organisation (many UK staff would presumably still be retained by the EMA), then what is to prevent the UK automatically adopting a recognition procedure identical to the one that is already in place? Only fear of the unknown, perhaps?

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