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Parliamentary questions
22 May 2012
Question for written answer
to the Commission
Rule 117
Monica Luisa Macovei (PPE) and Michèle Rivasi (Verts/ALE)

 Subject: European Medicines Agency: the case of Eric Abadie

Eric Abadie, a French specialist in diabetes and heart-related diseases, was a scientific expert at the European Medicines Agency (EMA) for 15 years. From 2007 to April 2012, he chaired the EMA’s Committee for Medicinal Products for Human Use (CHMP), which is the committee responsible for conducting the initial assessment of medicines for which an EU‑wide marketing authorisation is sought.

On 4 April 2012, Eric Abadie resigned from the EMA after losing his position at France’s National Agency for the Safety of Medicines, formerly the AFSSAPS, which is under scrutiny for not having withdrawn authorisation for the diabetes drug Mediator. As the scientific advisor to the General Director of AFSSAPS, Eric Abadie was implicated in the Mediator case. During his career, Eric Abadie has also been director of medical affairs for the federation of French pharmaceutical industries and in 2002 received an award from the Drug Information Association for his outstanding services to the pharmaceutical industry.

On 3 April 2012, the European Medicines Agency adopted a breach of trust procedure on conflicts of interests for scientific committee members and experts. This procedure foresees an automatic checking of the integrity of the scientific outputs adopted by the committee to which the expert was providing his inputs.

Given its responsibility as final decision-making authority and given Eric Abadie’s background, will the Commission request the EMA to launch a breach of trust procedure against its former expert and to initiate a full review of the scientific outputs adopted by the CHMP during the chairmanship of Eric Abadie?

 OJ C 254 E, 04/09/2013
Last updated: 12 June 2012Legal notice