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Post-Brexit Crystal Ball Gazing: The future for Phase 1 clinical trials in the UK

When Brexit was announced on the morning of 24 June 2016 a multitude of questions emerged including the fate of current EU provisions and their future applicability within the UK.

Union jack and EU flag
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Gene Matthews (pictured) is the lead partner in the clinical trials team at Leigh Day where he is assisted by paralegal Nancy Williams.
Gene Matthews and Nancy Williams’ paper, which was presented to the Medico-Legal Society earlier this year, underlines this notion of future applicability in relation to the Clinical Trials Directive (2001/20/EC), which currently governs the way in which clinical trials are conducted within the EU, and its successor Clinical Trial Regulation 536/2014, which is expected to come into force in the second half of 2019. The article considers the likely impact that a decision to implement the Regulation within the UK would have, including the implications of non-implementation.

The purpose of the Regulation, as discussed in the article, is to harmonise the approval and supervision processes for clinical trials throughout the EU to ensure uniformity across the EU. The article notes that if the UK were to adopt a different approach it would mean that trials approved in the UK would have to be separately approved in the EU in order to be conducted there, meaning potential commercial fallout and isolation for the UK. Most importantly it could result in patients who benefit from the experimental drugs that are tested during clinical trials losing out as a result of its non-implementation.

Overall the article notes that while the UK’s current involvement in the development of the Regulation remains intact, as the 29 March 2019 approaches, its future involvement remains less clear and what that future may look like inside or outside the EU requires a good deal of crystal ball gazing. More recent government comments are to be welcomed but, as has been said many times in the Brexit negotiations, “nothing is agreed until everything is agreed”.

Post-Brexit Crystal Ball Gazing: The future for Phase 1 clinical trials in the UK has now been published in Medico-Legal Journal Volume 86 Issue 2, June 2018 and can be viewed at doi.org/10.1177/0025817218767265 

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