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EU Drug Oversight May Become ‘Mission Impossible’ After Brexit

  • Finding expertise is key challenge, says regulator’s director
  • European Medicines Agency work grows even as staff declines

Keeping up with the demands of overseeing drug safety across Europe was already difficult. Brexit could make it impossible.

The European Medicines Agency, based in London, is likely to be relocated after the U.K. voted to leave the European Union, spelling uncertainty for its almost 900 employees. Even as the workload swells, some staff have left and the regulator faces the possibility of more departures, said Guido Rasi, its executive director.

“That discrepancy is leading to mission impossible if it continues,” Rasi said in an interview at the agency’s headquarters at Canary Wharf. “The major challenge is expertise, which is made more severe by the possibility of losing what we already have with Brexit.”

At stake is the quality and the efficiency of the agency’s work and the timing of approvals, he said. The regulator must ensure the safety of medicines sold across the 28-nation European bloc. In the past year, it’s made recommendations on gene therapies as well as cutting-edge treatments for rheumatoid arthritis, advanced breast cancer and hepatitis C. 

Long List

Evolving science that brings new drug combinations, cures for rare diseases, and alternative ways of delivering medicines only up the challenge of securing the right experts, according to Rasi.

The agency, which regulates a market of more than 500 million consumers, already has to cut about 60 positions by 2018, even as it gains a small number of additional jobs due to its expanding drug-surveillance role. It has lost about a half a dozen senior staff recently and found in a survey that as many as half its employees could leave if it relocates, Rasi said. 

“We lost more in a few months than we lost in previous years,” he said, adding that it’s unclear if all the departures are related to Brexit. “We are also experiencing more difficulties in candidate selections.”

The regulator acts as a hub that works with national authorities, bringing together scientific experts across Europe. To alleviate the pressure, the EMA will encourage those authorities to bolster ties with academia, said Rasi, a former physician and researcher who has taught at the University of Rome and at the University of California, Berkeley.

Lining Up

The regulator needs to be based in a city with frequent flights serving countries such as the U.S., China and Japan, as well as significant hotel capacity and ground transport options, according to Rasi. While the U.K. is making a strong case to keep the agency, Sweden, France, Denmark and Hungary are among countries that have made pitches.

Some nations have contacted the agency, even though the decision is in the EU’s hands. “The list of who has not approached us is much shorter,” Rasi said.

Moving to a new European home would be complicated, but “the uncertainty seems to be even worse,” he said.

The regulator’s fate is raising concern across the industry. Once the EMA leaves, international drugmakers may follow suit, moving their European offices out of the country, Michael Rawlins, chairman of the U.K.’s Medicines & Healthcare Products Regulatory Agency, told a House of Lords committee on Tuesday. The disruption may also cause delays in drug approvals in both Britain and Europe, industry representatives told lawmakers in October. 

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