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How will Brexit affect the MHRA and its EU roles?


The UK MHRA’s latest annual report reveals how much income the agency receives for activities it carries out on behalf of the European Medicines Agency, and looks among other things at how the MHRA should address the challenges raised by Brexit.

The UK’s departure from the EU is one of the key challenges facing the UK Medicines and Healthcare products Regulatory Agency (MHRA), which last year received £14.5m in income for conducting assessments of medicines, scientific advice and inspections on behalf of the European Medicines Agency.

This examination of the report explores the potential risks Brexit will bring to the MHRA and how it will impact EU projects.

Download the full article that originally appeared on Scrip here.

MThe MHRA, which plays an important role in many of the activities of the EMA and the wider EU regulatory network, has outlined some of the possible impacts of Brexit on its operations in its 2016-17 annual report, including its ability to continue undertaking its public health protection role, and the roll-out of its digital transformation program. But it is also clear from the report that there are many areas where the MHRA has played, and continues to play, a crucial role in EU regulatory activities, and where its possible ejection from the EU network could leave significant gaps to be filled.

In his foreword to the report, Sir Michael Rawlins, chair of the MHRA, says that while the day-to-day work of the agency, “which is so vital to the protection of public health, continues as before, I and my fellow Board members take a deep interest in the work to develop the agency’s strategic response to Brexit, to ensure we get the best outcome for the protection of UK’s public health for the UK.”

The report looks at some of the effects the UK’s departure from the EU might have on the MHRA, and lists the mitigating actions the agency might need to take to counter these effects.
Under the heading, “Threat to the agency stemming from Brexit and the impact on the ability of the agency to undertake its public health protection role”, the report says that “the cross-agency task force has undertaken a range of analyses of different potential scenarios and implications for the agency.”

Download the full article that originally appeared on Scrip here.

About the author: Ian Schofield has been writing on issues affecting the pharmaceutical and biotech industry since the mid-1980s, specialising in EU and global policy and regulatory affairs. As well as writing, editing and commissioning articles for Pharma Intelligence, Ian works for the Ask the Analyst service, providing tailor-made answers to questions posed directly by clients.


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