IPEC e-newsletter - Excipients Insight April 2017 - 30-04-17


Inside this issue


Pharma leaders call for smooth EMA move post-Brexit

The R&D heads of some of the largest biopharma companies have appealed for a smooth relocation for the European Medicines Agency (EMA), saying that it is imperative that the agency's "world class" regulatory oversight is not undermined.

In an open letter published on the website of the European Federation of Pharmaceutical Industries & Associations (EFPIA), senior R&D figures from 19 multinationals say they fear that pharmacovigilance and safety monitoring activities could be affected if the move from London leads to disruption.

"The system that has been established for the safety monitoring of medicines within Europe is fully reliant on the knowledge and expertise that is incorporated within the EMA and, more specifically, within its seven scientific committees, which are composed of experts sourced from every member state of the EU," say the pharma leaders.

"It is a stark and alarming reality that such fundamental activities would undoubtedly be impeded were the operations of the agency to be disrupted as a result of the UK's exit from the EU," they write. "To put it concisely: in the event of obstruction or failure, Europe possesses no backup option."

Big pharma companies are not the only organizations worried about the fallout of the relocation of the EMA post-Brexit. EMA executive director Prof Guido Rasi has suggested the uncertainty has already resulted in staff departures, while the European Parliament has also called for a rapid decision on a new home for the agency.

At last count, 21 of the 27 post-Brexit member states have pitched to house the EMA, while UK Secretary of State for Exiting the EU – David Davis - has even suggested that it may be possible for the regulatory to remain in London and that its fate is subject to the exit negotiations triggered by activating Article 50.

That view has been rejected by European Commission and EU Parliamentarians however, who insist that the EMA must move to an EU27 member state. There have also been reports that EU negotiators intend to ask the UK to pay for the relocation of the regulator from London.




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