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Europe Hits Pause Button on Clinical Data As Brexit Stirs Staff Upheaval

August 6, 2018

European regulators have stopped accepting and publishing clinical trials data, blaming the uncertainty of Brexit for staff cutbacks that the agency claims has disrupted its ability to function properly.

Officials at the European Medicines Agency (EMA) announced the decision last week but say it’s only temporary. The UK’s decision to leave the European Union has forced the EMA to move its headquarters from London to Amsterdam by March, which has caused “significant staff loss,” the regulator said in announcing the pause.

Last year, the EMA estimated it had around 700 employees. It predicted that the move from London to Amsterdam would cost about 200 jobs.

“The temporary cuts in activities are required because it has also become clear that the agency will lose more staff than initially anticipated,” the EMA said. “Staff who will not relocate to Amsterdam have already started to leave the agency and this trend is expected to accelerate.”

Dutch labor law also means that the EMA will have to shed some 135 short-term contractors in the move. Overall, the agency said it expects to lose about 30 percent of its staff by March.

The agency did not provide further specifics on the number or types of jobs lost or the timeline for its temporary measures. The cutbacks do not appear to affect clinical trials themselves but European regulators have stressed the importance of data transparency.

The EMA also wants to put some of its international efforts on hold, noting that for now it will focus on “urgent” drug safety guidelines and limit travel to “Brexit-related interactions.”

Even before last week’s announcement, European regulators had been sounding alarms about Brexit. Last month, the EMA released the results of a survey of drugmakers that found hundreds would have to rearrange at least part of their inspection or database operations because European law no long covers them in the UK.

A thin majority of voters supported a referendum pulling the UK out of the European Union in 2016. The following March, British Prime Minister Theresa May sent formal notice to the EU that her government was leaving, giving both sides a year to settle on terms of the divorce.

The EMA Brexit may disrupt drug approvals and safety inspections for two to three years after Brexit takes effect.

 

-By Bill Myers