The European Commission has carried out an audit of the European Medicines Agency’s (EMA) management of conflicts of interest among those involved in its activities. It took two years of procedures as well as the intervention of the European ombudsman before the association Formindep managed to obtain a copy of this audit, which the EMA refused to hand over. The results are shocking.

The auditors studied a sample of decisions taken by the EMA in 2008, involving 36 external experts, 15 EMA product team leaders in charge of marketing authorisation procedures, and 8 marketing authorisation applications.

"Incidents" were recorded in the case of 26 experts: these included missing or out-of-date information in the EMA’s register of interests, unsigned declarations, different information on printed documents and in the electronic file, etc.

In several cases, product team leaders handling the marketing authorisation application for a particular drug had previously worked for the applicant company.

In 5 out of the 8 marketing authorisation applications audited, 6 experts who were not registered in EMA’s database of experts had taken part. In 11 cases where the initial analysis had revealed a high risk of conflicts of interest, there had been no follow-up, contrary to EMA regulations. For 3 drugs, the declarations of 6 experts were out of date.

EMA’s irresponsible management of conflicts of interest no doubt partially explains the flaws in the granting of European marketing authorisations. The Agency was penalised by the European Parliament which refused to grant it discharge for 2010.

Have the heads of the EMA taken the necessary corrective measures? We will only find out if the EMA or the European Commission publish the results of the 2011 audit without being forced to do so yet again by the ombudsman.

©Prescrire 1 November 2012

"European Medicines Agency: riddled with conflicts of interest" Prescrire Int 2012; 21 (132): 278. (Pdf, free).