Brexit Slows European Drug Agency Work With 30% Staff Loss

(Bloomberg) -- About a third of employees at the European Union's drug regulator are expected to quit as it leaves Britain because of Brexit, prompting the agency to temporarily scale back operations to focus on essential public health activities.

Staff who aren't relocating to Amsterdam with the European Medicines Agency have already started to leave, a trend that's set to accelerate, the regulator said in a statement Wednesday. The agency expects to lose more staff than it anticipated, with 135 short-term contractors no longer able to work due to labor laws in the Netherlands.

The staff losses are disrupting work at the agency, which is the EU's equivalent of the U.S. Food and Drug Administration and oversees medication safety for about 500 million people. With a workforce of about 900, the EMA is making a major move at a time when it's beginning to evaluate more complex products, such as therapies to correct gene defects.

Along with the staff loss of about 30 percent, as the EMA warned of a “a high degree of uncertainty regarding mid-term staff retention.” The agency's announcement confirms warnings that Executive Director Guido Rasi gave in a June interview with Bloomberg News, when he said that a host of issues, including the effect of local employment regulations on contracts, could boost personnel losses beyond 19 percent, the level estimated last year.

"There's no doubt that there will be a slowing down, or a dip, in productivity," said Liz Cohen, a life sciences lawyer at Bristows in London. The impact may depend on which divisions lose the most personnel, she said, with specialty areas like gene therapies of particular concern.

Companies including AstraZeneca Plc, Novartis AG, and Sanofi have said they're raising stockpiles of their products to make sure supplies can be maintained if there are border delays after the U.K. leaves the EU. Industry officials have pushed for an agreement that will keep U.K. drug regulation in alignment with that of the EU.

“Any disruption is likely to impact on patients across the U.K. and the EU,” said Sheuli Porkess, deputy chief scientific officer at the Association of the British Pharmaceutical Industry, and the two sides should work “to reach an agreement on post-Brexit arrangements as soon as possible.”

The EMA projected in 2017 that losing less than 35 percent of its workers would allow on-time approval of new medicines and safety monitoring to be largely maintained. When the European Union picked the Dutch capital over 18 other contenders as the regulator's new home last year, it was the EMA staff's top choice and the option viewed as least likely to hinder its work.

The regulator said it will start the next phase of its continuity plan by the beginning of October to protect its main activities evaluating medicines. The work that staff losses will affect initially includes international collaboration, revision of guidelines and clinical data publication, the EMA said.

--With assistance from Suzi Ring.

To contact the reporter on this story: James Paton in London at jpaton4@bloomberg.net

To contact the editors responsible for this story: Eric Pfanner at epfanner1@bloomberg.net, John Lauerman

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