European Medicines Agency access to documents practices not in line with good administration, says European Ombudsman

The European Ombudsman has criticised two practices that the European Medicines Agency (EMA) applies when handling access to documents requests.

The first concerns EMA’s handling of certain requests for public access to documents by placing them in a chronological queue. In the Ombudsman’s view, this practice does not meet the requirement in the EU transparency regulation that the EU administration handle access requests promptly.

The second practice concerns EMA restricting individuals to a maximum of five requests in the chronological queue at a given time and limiting each of these requests to no more than two documents. This ‘5-2 rule’ is arbitrary and does not take account of the length, complexity, or total number of documents falling within the scope of individual requests. As a result, the Ombudsman found it to constitute maladministration.

The Ombudsman noted that EMA is already taking steps to phase out the chronological queue and asked the agency to report to her on its progress by 30 March 2024.

The Ombudsman’s findings emerged as part of an inquiry into public access to documents concerning a vaccine for infectious bovine rhinotracheitis. (source: ombudsman.europa.eu/photo: europa.eu)

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Editorial

Editorial
George Kazoleas, Lawyer

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