Head of Legal Department

 

Dear Mr X,

The Ombudsman has received a complaint against the European Medicines Agency (EMA) from a group of dairy farmers from the Netherlands, represented by a law firm. The complaint concerns EMA’s practices of (1) queuing requests for public access to documents (‘deferred processing’) and (2) limiting the number of documents applicants can request. The Ombudsman has asked me to deal with this case on her behalf.

We have decided to open an inquiry into this complaint.

In July 2020, one of the complainants made a request for public access to documents[1] concerning the CVMP report ‘EMEA/CVMP/768/99 - FINAL - Corrigendum - EN’. EMA informed the complainant that it placed his request in a queue and that it would deal with queued requests in chronological order from the time they were received.

In May 2021, EMA informed the complainant that his access request would be dealt with shortly and asked him to confirm that he was still interested in receiving the documents.

In July 2021, EMA released documents in “Batch 1” to the complainant. After having received the documents, the complainant asked EMA some follow-up questions. In particular, he wanted to know whether the attachments, to which some of the released documents in Batch 1 referred, would also be released. He stated that he was most interested in the extraneous viruses tested for the methods and materials used.

EMA informed the complainant that he would have to submit a new request for public access to documents if he was interested in the attachments. It further stated that it was currently operating under business continuity measures, that an access request could not exceed two documents and that a requester could only have a maximum of five requests in queue.

We have now concluded that it would be useful to receive a written reply from EMA to this complaint. The reply should address, in particular, the following points:

(1) What is the basis for EMA’s practice of placing requests for public access into a chronological queue?

(2) What is the basis for EMA’s practice of limiting the number of requests per applicant to five in the queue?

(3) What is the basis for EMA’s practice of limiting the number of documents an applicant can request to two documents?

(4) How does EMA determine which access requests to place in the queue?

(5) If a request concerns more than two documents, does EMA provide the applicant with a list of documents falling within the scope of the request, thereby allowing the applicant to choose the documents, in which they are most interested?

(6) If the request concerns more than two documents or if more than five requests of an applicant are in queue, does EMA offer the applicant the possibility to narrow down the number of documents/requests, for instance in a phone call?

It would also be useful to receive any guidelines EMA publishes or shares with applicants for public access to documents, which inform them on how EMA will handle their requests.

Once we have assessed EMA’s reply to the complaint, it may also be necessary to schedule a meeting to discuss this case.

Please note that we are likely to send your reply and related enclosures to the complainant for comments[2]. We would therefore be grateful if EMA could submit a translation of the reply itself in Dutch, which is the language of the complaint. We may also decide to publish your reply. The responsible case-handler is Ms Silvia Fuller.

We would be grateful to receive EMA's reply by 8 May 2023.

Yours sincerely,

Rosita Hickey
Director of Inquiries

Strasbourg, 14/02/2023

 

[1] Under Regulation 1049/2001.

[2] If you wish to submit documents or information that you consider to be confidential, and which should not be disclosed to the complainant, please mark them ‘Confidential’. Encrypted emails can be sent to our dedicated mailbox.