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Summary of the decision in case 1602/2016/JAS on the European Medicines Agency’s handling of an access to documents request related to clinical study reports

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  • Caso :  1602/2016/JAS
    Aperto(a) il 21-nov-2016 - Decisione del 8-feb-2018
  • Istituzione(i) interessata(e) :  Agenzia europea per i medicinali

The case concerned the manner by which the European Medicines Agency (EMA) dealt with a request by a researcher to obtain public access to clinical study reports. EMA has been disclosing redacted versions of the reports in batches. As the complainant was not satisfied with the rate of release and the redactions made to the documents, the researcher made a complaint to the Ombudsman.

The Ombudsman found that the time EMA was taking to handle the complainant’s request was reasonable given that the requests concerned several tens of thousands of pages.

Regarding the redactions made by EMA, the complainant did not agree with how EMA dealt with codes referring to the patients participating in the studies. EMA redacted these codes to ensure that patients could not be indirectly identified. The complainant wanted EMA to replace these codes with other codes so that he could verify if the studies’ findings were sound. 

The Ombudsman agreed with EMA that replacing codes would not eliminate the risk of patients being identified and concluded that there was no maladministration by EMA.