english.prescrire.org > Topics > Advancing healthcare policy > Transparent, independent health authorities > Actions vis-à-vis regulatory agencies > Prescrire maintains 5 complaints against EMA for refusal to provide information (3/2011)

Advancing healthcare policy

Transparent, independent health authorities

Summary

Prescrire filed 5 complaints with the European Ombudsman on 30 August 2010, citing repeated refusals by the European Medicines Agency (EMA) to provide documents and information, in particular concerning drugs with a negative risk-benefit balance. After EMA's response in January 2011, Prescrire decided in March 2011 to maintain all 5 of its complaints.
Prescrire's complaints reflect maladministration practices by the EMA:
- unacceptably long delays before disclosing information, particularly about adverse effects;
- insufficiently explicit responses, that rarely enable us to fine-tune our requests;
- blatant refusals to provide documentation.

In its reply to EMA's opinion issued in this matter, Prescrire called on the EMA:
- to provide immediate public access through its website to all supporting documents in its possession, relating to its recommendations.
- to provide public access to the raw data held in its databases, and especially the EudraVigilance database.
- to rapidly meet all its obligations in terms of transparency. For example, it is high time the Commissions’ detailed agendas were released.
- to rapidly provide public access to the minutes and scientific opinions of all of its committees, working parties and other groups.
- to rapidly provide public access through its website to conflict of interest statements for all of its experts and participants of committees, working parties and other groups.
- to provide more constructive responses to concerned parties, and to help them determine how best to formulate their requests where appropriate.

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