Summary of the decision in case 2030/2015/PL on the European Medicines Agency’s refusal to disclose the name of a company that made a request for public access to safety reports
Closing summary - Date Friday | 04 March 2016
Case 2030/2015/PL - Opened on Friday | 04 March 2016 - Recommendation on Friday | 07 July 2017 - Decision on Tuesday | 20 March 2018 - Institution concerned European Medicines Agency (Recommendation agreed by the institution)
The case concerned the refusal by the European Medicines Agency (EMA) to disclose the name of a company that asked for public access to the latest ‘periodic safety update report’ on the drug Zyclara. The complainant is the pharmaceutical company that markets Zyclara.
EMA stated that, since 2015, its policy had been not to release the name of companies that request access to documents, in order to protect their commercial interests.
The Ombudsman found that refusing to release the identity of the company requesting public access constituted maladministration. She recommended that EMA review its policy of outright refusal to release the identity of organisations that request public access to documents. Instead, EMA should consult the company that made the initial request for access before deciding whether or not its name should be withheld.
EMA accepted the Ombudsman’s recommendation and implemented the suggested changes. The Ombudsman welcomes the immediate steps taken by EMA and closes the inquiry.