Head of Legal Department European Medicines Agency

 

Dear Mr X,

We thank you for EMA’s reply to the Ombudsman’s suggestions for improvement in the above case.

We welcome EMA’s continuous efforts to identify documents, which are of particular interest to the public and which could possibly be published proactively. We have taken note of the measures EMA has taken to phase out its chronological queue and to deal with the backlog of public access requests. We are pleased to see that these measures have already led to a decrease in the backlog.

We also note that EMA acknowledges the Ombudsman’s finding of maladministration with regard to the ‘5-2-rule’, whereby EMA limits the number of requests per applicant to five at a given time and the number of documents that can be requested at a time to two documents. However, EMA has not committed to cease applying that practice. We will therefore continue to monitor EMA’s implementation of Regulation 1049/2001 to determine whether the Ombudsman needs to pursue this matter on her own initiative.

Yours sincerely,

Rosita Hickey

Director of Inquiries

Strasbourg, 12/07/2024