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The European Medicines Agency's refusal to give public access to parts of a clinical study report concerning a drug for the treatment of schizophrenia and bipolar disorder


Případ 444/2022/MIG - Otevřeno dne Pondělí | 07 března 2022 - Rozhodnutí ze dne Pondělí | 20 června 2022 - Dotčený orgán Evropská agentura pro léčivé přípravky (Nebyl zjištěn nesprávný úřední postup )

The case concerned a refusal by the European Medicines Agency (EMA) to grant full public access to a clinical study on the safety and efficacy of a medicine. In refusing access, it invoked an exception provided for under the EU legislation on public access to documents, arguing that disclosing the remaining information could undermine privacy of the individuals concerned. Specifically, the complainant was dissatisfied that EMA refused to disclose the personal data of the patients, notably, their gender and the pseudonyms used for the patients during the clinical trial.

The Ombudsman found that it was reasonable for EMA to have withheld the personal data concerned. She therefore closed the inquiry finding no maladministration.