EMA's Rasi on Brexit: Climate of Uncertainty Straining Worker Motivation

Regulatory NewsRegulatory News | 08 November 2016 |  By 

At a meeting of the European Parliament’s Committee on the Environment, Public Health and Food Safety on Tuesday, the European Medicines Agency’s Executive Director Guido Rasi said the agency needs additional measures to support its staff as the uncertainty over Brexit is taking its toll on staffers.

“We need additional measures to support the staff,” Rasi told the committee, noting that there were six resignations at the drug regulator in the first month after Britain voted to leave the EU.  He also said the agency has seen a trend “where good candidates are withdrawing their applications” to work for the agency.

The comments come as the future of EMA’s headquarters in London is unknown, particularly as the path for how Britain will go about departing from the EU has yet to be fully determined.

In July, EMA said that member states will decide where EMA’s headquarters will move to, and at least six EU countries are vying to host the agency.

“We’re not so concerned about the location but the workability,” Rasi said on Tuesday, noting that one of the main issues is that the agency headquarters must host thousands of people each year so the locale should be near airports, reliable ground transportation and hotels.

“Our influence is zero. We have no role in where to go,” he added. “The decision is completely in the hands of the Council. The best we can do is explain how we operate.”

Drug Pricing and Other Issues

Rasi also offered the committee some background information on EMA’s PRIME scheme, which recently added three new treatments, drug shortages and how EMA can only address quality issues, antibiotic resistance, counterfeit medicines and the recent push on increased clinical trial transparency.

On the transparency front, Rasi said 10,000 pages of the trial reports have been downloaded in the past three weeks and EMA is expecting the online portal to be useful for researchers and health professionals, as well as patients.

In terms of drug pricing, Rasi acknowledged the importance of the issue but also noted, “We don’t have any direct power.

“What we’re trying to do is be as efficient as we can to reduce any unnecessary burdens on the development [of medicines] which can translate into market benefit,” he added. “What we can do is cooperate more with HTA bodies [see more information on pilot project here] to determine real added values of new medicines but how that’s translated into the pricing is beyond us, and to my understanding, is beyond the union and is dealt with solely by the member states.”


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