Tribunal forces resignation of EU's top drugs regulator

Europe's top drug regulator has been forced to step aside after a rival who was passed over for the job three years ago won a tribunal judgment annulling the appointment.

The ruling has thrown into doubt the future of Guido Rasi, who has led the European Medicines Agency since 2011.

Lawyers at the agency and the European Commission were on Friday scrambling to assess whether the decision could be challenged.

The fiasco leaves in limbo one of Europe's most important regulatory bodies at a time when it is pushing through contentious new rules on clinical trials as well its usual busy schedule of new drug appraisals.

The European Union Civil Service Tribunal on Thursday ruled that the commission had not followed proper procedures during the recruitment of Mr Rasi in 2011.

This followed a complaint from Emil Hristov, a former top Bulgarian drug regulator, who applied for the job but was left off the shortlist.

In a statement, the EMA said: "The court has, on purely formal grounds, annulled the commission's decision adopting a shortlist of potential candidates for the position of executive director.

"As a consequence, the decision by the management board to select Guido Rasi from the shortlist and appoint him as executive director on 6 October 2011 has also been annulled."

Sir Kent Woods, chairman of the EMA's management board, said: "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."

Andreas Pott, the EMA's deputy executive director, has taken over from Mr Rasi while the commission and the EMA take legal advice to decide their next steps.

Mr Rasi, previously head of the Italian medicines regulator, is a widely respected figure among both policy makers and industry. His leadership has been notable for efforts to increase transparency around the data used by pharmaceutical companies to push for approval of new medicines.

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Under new rules announced last month, the EMA will from January publish the clinical reports that underpin the agency's decisions on new drugs - a decision that Mr Rasi said at the time "sets a new standard for transparency in public health and pharmaceutical research and development". Some campaigners say the overhaul did not go far enough.

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