The UK is maintaining its globally competitive role as an attractive place to run clinical trials, despite the ongoing political turmoil of Brexit. The life sciences industry, and the UK’s position as an R&D powerhouse, have continued to be prioritised by the government throughout the Brexit process.

The UK attracts approximately 25-29% of the EU’s clinical trial applications, and has remained a key country for Advanced Therapy Medicinal Products (ATMP) clinical trials globally over the past five years.

These details were given by Dr Martyn Ward, Senior Responsible Owner, Clinical Trials Programme, Medicines and Healthcare products Regulatory Agency (MHRA), speaking at the BIA’s Regulatory Innovation Conference on September 17, 2019. Dr Ward stated that there is no obvious indication that Brexit is affecting clinical trial numbers, given that it will still be possible for UK sponsors to run multistate trials involving sites across the EU and the rest of the world, and that data generated in UK trials will still be admissible to support marketing authorisations in the EU and globally. He also emphasised that the MHRA remains committed to implementing, and subsequently aligning with, the EU Clinical Trials Regulation 536/2014 as it comes into force next year.

Dr Sarah Blagden, Associate Professor of Experimental Cancer Therapeutics, University of Oxford, also spoke and touched upon some of the challenges Brexit is posing to clinical trials, however, including the difficulties of attracting skilled EU scientists to staff trial units, and concerns over the risk of delays of investigational medicinal products.

In the event of the UK exiting the EU without a withdrawal deal, it will be necessary for a UK sponsor to have an EU local representative. The UK has confirmed that EU sponsors will be accepted without the need for an EU representative in the UK, however.

As detailed in our Healthcare Brexit blog post, although the UK is committed to adhering to the Clinical Trials Regulation post Brexit, there are challenges ahead, including in relation to access to the EU’s shared central IT portal, and the EU’s single assessment model, both of which would require a negotiated UK/EU agreement regarding UK involvement. In a statement released last year, the MHRA made clear that no matter what the outcome of the Brexit negotiations, the UK is committed to offering a competitive service for clinical trial assessment. If the UK ends up outside of the EU network, it will still be possible for sponsors to run multistate trials involving the UK. Sponsors would have to apply to the MHRA, as well as to the EU concerned states, but the MHRA would take every effort to ensure this parallel submission is as streamlined and efficient as possible (for example by using the same application dossier).

For further information please contact Julia Gillert or Jaspreet Takhar of our London office.

Author

Julia Gillert is a Senior Associate in the Corporate Department of Baker & McKenzie's London office and is a key member of the Healthcare industry group within the London office and European and Global networks. Julia advises both domestic and international companies in the med-tech, pharma and healthcare sectors on a wide range of regulatory and general compliance matters. Julia has contributed to a variety of regulatory healthcare related publications and practice handbooks and co-edits the firm's European Healthcare Newsletter. Julia sits on the ABHI's Legal Issues Committee.

Author

Jaspreet is an associate in the Tech & Commercial department of Baker McKenzie's London office. She joined Baker McKenzie as a trainee in March 2013 and was admitted as a Solicitor of England and Wales in March 2015 following a secondment to Unilever. Jaspreet's practice focuses on the tech and life sciences sectors, and she drafts and negotiates a range of domestic and international agreements in these spaces. Jaspreet also regularly advises on commercial and regulatory issues in the healthcare space, including uses of patient / healthcare professional personal data, applied AI, research collaborations, contracting for goods and services in the healthcare space, and supply chain issues. Jaspreet has a particular interest in the intersection between tech and healthcare.

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