Sector News

The European Medicines Agency (EMA) has officially begun operating out of its new temporary home in Amsterdam. Staff will move into the offices throughout the coming week having left the U.K. as it enters a critical moment in the Brexit process.

The EMA left its London offices at the start of the month but initially only moved a skeleton crew into the Spark building in Amsterdam to deal with emergencies. The rest of the workforce has been working remotely since the closure of the London offices but that is changing this week as the Spark building welcomes more EMA staff.

The start of operations at the Spark building, while being a key milestone in the move to Amsterdam, is just one part of an ongoing staggered relocation to the Netherlands. To accommodate employee needs related to schooling, housing and the employment of spouses, the EMA began allowing staff to move to the Netherlands in the summer of 2018. And it will allow other employees to work remotely from the U.K. until the second half of 2019.

Despite providing employees with these flexible relocation terms, the EMA is set to lose about 25% of its staff in the move to Amsterdam. The EMA reiterated that figure, which it first published earlier this year, in its notice about the commencement of operations in the Netherlands.

Given the advanced state of the relocation, the 25% prediction now looks like a fairly firm forecast. If EMA does retain 75% of its staff, the agency will be left with a workforce that is comfortably larger than what it says it needs to perform timely drug approval and safety monitoring activities.

The seemingly smooth transition stands in contrast to the U.K.’s advance toward its exit from the European Union. At the time of writing, there is little certainty about the nature of the U.K.’s ties to the EU after March 29 and, by extension, little clarity on the drug regulatory environment.

That may change later today when politicians vote on whether to accept the withdrawal terms Prime Minister Theresa May agreed to with the EU. The same politicians comprehensively rejected the deal in January, but since then May has sought changes designed to allay concerns with the agreement. May emerged from last-minute talks with the EU yesterday claiming to have secured important, “legally binding” changes, but some opponents to the deal claim the additional text offers nothing new.

If May persuades enough politicians to back her deal, the U.K. will leave the EU later this month but enter a transition period that largely maintains the status quo until the end of next year. However, if the deal is voted down any number of outcomes could occur.

In that scenario, politicians will then vote on whether to leave the EU without a deal. If, as expected, politicians reject a no-deal exit they will then vote on whether to delay Brexit. If parliament votes for a delay, the EU will need to decide whether to grant the extension or not. European politicians have expressed reservations about granting the U.K. more time unless it has a clear plan for how to use it.

The upshot of the uncertainty is that biopharma companies have to proceed as if the U.K. is going to leave without a deal on March 29. The U.K. and EU have independently proposed measures to lessen the impact of a no-deal Brexit on biopharma but the prospect of a cliff edge exit has nonetheless led companies to move some activities to mainland Europe.

By Nick Paul Taylor

Source: Fierce Biotech