EMA Preps for Staff Shortages, Possible 'Major' Budget Deficit

Regulatory NewsRegulatory News | 06 October 2017 |  By 

Although the new European Medicines Agency's (EMA) location will not be known until November, EMA on Friday said again that it's anticipating heavy staff losses which will not only challenge its operability but "could also result in a major deficit in its budget," according to highlights published Friday from a management board meeting this month.

The comments follow the agency saying last week that it could lose between 19% and 94% of its staff depending on which of the 19 cities (Amsterdam, Barcelona, Vienna, Copenhagen and Milan have been eyed as the frontrunners) will host the nearly 900 staffers.

"If operations are delayed or have to stop because of massive staff losses, the agency could experience a dramatic drop in fee income which would in turn result in reduced payments to the national competent authorities," EMA said. "The financial consequences would be further exacerbated by the cost of replacing staff. Such shortfall would need to be made up from the Union budget."

As part of efforts to shore up staff, EMA issued a $42 million tender for temporary workers. Among the staffers the agency said it's seeking are bilingual/multilingual scientific administrative staff and staff with legal, auditing and policy backgrounds.

In addition, EMA also has been working to figure out how to rework its assessment of medicines to make up for the staff losses after the UK has left the EU, with final recommendations and the final budget to be presented at the next management board meeting in December.

Other Updates

EMA also discussed early access to medicines through the accelerated assessment framework, under which 57% of requests were granted and of those granted, 75% of the marketing authorization applications (MAAs) met the accelerated timetable during the first half of 2017.

For human medicines, EMA said 36 new MAAs were received in the first half of 2017 (versus 42 in the first half of 2016), though "the overall forecast for 2017 is in line with 2016 figures."

And given the increasing number of medicines with orphan designation coming to market, Bruno Sepodes, chair of the Committee for Orphan Medicinal Products (COMP) also "highlighted the need to fully exploit the legal possibilities in the Regulation to reduce protection periods for orphan medicines that do not meet the criteria over time. This also entails the need to generate relevant data for these products after authorisation."

The agency also said its schedule was aligned for the EU Clinical Trial Regulation to come into force in the second half of 2019.

EMA Management Board: highlights of October 2017 meeting


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