• Podnesite pritužbu
  • Zahtjev za informacijama
60th Rome Treaty anniversaryYour Europe - The portal to on-line European and national public services

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

Dostupni jezici: en
  • Slučaj: 2030/2015/PL
    Otvoren 2016.03.04 - Preporuka o 2017.07.07 - Odluka donesena 2018.03.20
  • Predmetna/e institucija/e: Europska agencija za lijekove

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.