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EMA cuts Britain out as Brexit approaches

Tuesday 4th September 2018
The MHRA is already feeling the potential effects of a no-deal Brexit in the medicines licensing sector.
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The European Medicines Agency (EMA) has stopped appointing members of the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) to work on reviews of complex medicines as Brexit approaches.

According to a report in the Guardian, the EMA has shut the door on new appointments from Britain due to concerns about a no-deal Brexit, which would mean the UK being isolated from the European drugs regulation system. 

This would run contrary to the British government's intention that the UK should remain involved with the EMA after Brexit.

Prior to the EU referendum in 2016, Britain provided more people to oversee centralised reviews of complex medicines - known as rapporteurs - than any other country. However, the EMA position now is that if the MHRA follows its own system after Brexit, its members could not be relied on to comply with EMA procedures. 

With reviews taking around a year, any work being started now would not be complete before Britain leaves the EU on March 29th 2019. 

So far this year, the MHRA has applied for 36 EMA contracts, but has only been awarded two, while the number of British rapporteurs appointed fell from 22 in 2016 to six last year. 

In a statement, the MHRA said: “We want to retain a close working partnership with the EU to ensure patients continue to have timely access to safe medicines and medical devices. 

"This involves us making sure our regulators continue to work together, as they do with regulators internationally and we would like to explore with the EU the terms on which the UK could continue to participate in the EMA."

The EMA is already moving its headquarters out of London to a new base in Amsterdam, with 900 staff being relocated. The Dutch capital saw off a challenge from Milan after the two cities tied in the third round of voting. Milan had led in the first two rounds, but was eventually defeated when lots were drawn. 

Written by James Puckle

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