EMA's Top Drug Regulator, Guido Rasi, Forced to Step Down

In a major development, the head of the European Medicines Agency (EMA), Guido Rasi, has been forced to step down by the EU Civil Service Tribunal after adjudicators found that the European Commission had improperly selected him in 2011.

The case against Rasi's appointment was filed by Emil Hristov, formerly with the Bulgarian Drug Agency and a member of EMA's board, who maintained that EMA and the European Commission had improperly assembled a short list of candidates for the position of EMA's executive director after the controversial departure of former executive director Thomas Lönngren in 2010.

Hristov had applied to the position, but after reaching the interview process for the interview, was ranked last among eight candidates and was not selected to be on a "short list" of candidates presented to EMA's Board of Directors as being the most suitable for the position. The assembly of that "short list" of candidates by a selection committee was improper, the court found, and the EMA board should have been able to consider the candidacy of Hristov, who they were familiar with.

Therefore, the selection of Rasi by the European Commission is to be annulled, the court ordered.

The decision has immediately ramifications for EMA and Rasi, who has been removed from his position and replaced on an acting basis by Andreas Pott, now deputy executive director of EMA.

“I note with regret today’s judgment by the European Union Civil Service Tribunal," said Professor Sir Kent Woods, chair of the Management Board, in a statement. "It is important to remember that the ruling is about a procedural formality. It is not a reflection on Guido Rasi’s competence or ability to run the Agency, something which he has done successfully since November 2011.”

Both EMA and the European Commission are scrambling to see if the decision can be overturned, they said.

The departure of Rasi comes at a particularly tricky time for EMA, which is in the process of implementing a massive change in the way it treats clinical data transparency. Transparency has been one of the hallmarks of Guido's tenure as EMA's executive director, and his departure could very well derail some of his signature initiatives.

EMA Statement

Court Case