Brexit could disrupt EU drug approvals – EMA chief

Brexit could disrupt the approval of drugs across all of Europe, with a knock-on effect on industry, the head of the European Medicines Agency has warned.

In an interview with the Financial Times, Guido Rasi, executive director of the European Medicines Agency said Brexit is already causing disruption at the London-based agency, with seven senior executive members quitting following the UK’s vote to leave the EU last June.

But the decision to quit the EU could have even wider ramifications in the event of a “hard Brexit” style decision. This would guarantee that the EMA would have to relocate away from London, and the disruption could affect the running of the agency.

A poll conducted in early December by pharmaphorum of 11 UK pharma industry leaders (including six UK general managers) found most (seven, 64%) feared that Brexit would cause “long term damage to the UK pharmaceutical industry”.

This damage would not just be limited to the UK.

Rasi said that running the EMA is like an “assembly line”, with complex logistics organising meetings, which is why it would need “the longest possible time” to organise any move.

It would take at least two years to move the agency away from London, said Rasi, to ensure recent improvements in approval times to not stall, or move into reverse.

This could make Europe less attractive to pharma and biotech countries considering investing in the region, said Rasi.

“If we are losing expertise we have to focus on managerial things, HR issues, of course our capacity and commitment to provide additional support to this community would be decreased, and that would make a fragmented Europe in terms of pricing and enforcement. We will give the opposite of being competitive.”

A staff survey presented to the agency’s board last week showed about 50% would leave if the EMA moves to an undesirable city.

Rasi added that morale is becoming “worse and worse” at the agency had been affected by the political uncertainty, and there is a lack of candidates in selection procedures.

His comments echoed views expressed by senior figures at the agency’s annual review of the year meeting, held last month in conjunction with TOPRA.

The figures expressed frustration that they felt like passengers while politicians decide the future and location of the EMA.

The EMA employs almost 900 people – but also faces a large loss of capacity in the event of a move.

Rasi noted that the UK Medicines and Healthcare Products Regulatory Agency approves around a fifth of all drugs in the EU.

The UK’s pharma industry is lobbying to keep the UK within the European regulatory system after Brexit – and Rasi warned that severing the MHRA from the EU’s network would present huge challenges.

Rasi warned that a hard Brexit would require the creation of a standalone UK regulator, and would be a huge undertaking.

“I assume if we are going to lose the 20% [of capacity], it means they [the MHRA] are going to lose the 80%,” said Rasi.

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