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Access to anti-acne drug documents

Summary of the decision on complaint 2493/2008/(BB)(TS)FOR against the European Medicines Agency

The European Medicines Agency supervises the placing of medicinal products on the EU market. In this capacity, it receives information, concerning suspected adverse reactions to drugs, from the competent authorities in the Member States and from drug companies. The complainant, an Irish citizen, asked the Agency for access to documents containing details of all suspected serious adverse reactions relating to an anti-acne drug. The Agency refused this request. The complainant then turned to the Ombudsman.

In its opinion, the Agency argued that the EU transparency rules did not apply to the suspected serious adverse reaction reports. The Agency stressed that their release would not benefit citizens because it could result in the circulation of data that could prove to be misleading or unreliable.

Following his investigation, the Ombudsman concluded that the EU rules on access to documents apply to all documents held by the Agency. He therefore made a draft recommendation calling on the Agency to review its refusal to grant access to the adverse reaction reports.

In response to the Draft Recommendation, the Agency released the documents in its possession after having redacted personal data.

Subsequently, the complainant informed the Ombudsman that he was still not satisfied. He argued that the Agency had not released all the relevant documents in its possession and that it had wrongly redacted the documents sent to him. The Ombudsman then carried out further inquires, which included a meeting with the Agency. As a result, he was able to confirm that the Agency had not withheld relevant documents from the complainant and that the redactions of the documents sent to the complainant were justified in order to protect personal data. He thus closed the inquiry with a finding that his Draft Recommendation had been accepted by the Agency.