The Ombudsman carried out a strategic initiative on how the European Medicines Agency (EMA) ensures proactive transparency of clinical trial data concerning medicines seeking EU marketing authorisation. EMA launched a policy of proactive transparency in 2016, however it suspended this policy in 2018 due to its relocation to Amsterdam and, subsequently, the need to prioritise other urgent tasks related to the COVID-19 pandemic. In October 2023, the policy was partially relaunched - for products containing new active substances - but EMA consequently also has to process a backlog of data, which has built up in recent years.

The strategic initiative sought to assess how EMA would deal with the backlog of clinical trial data received during the suspension of the policy, between 2018 and 2023. The Ombudsman also asked about EMA’s plans regarding new data submitted to it but not related to new active substances, as well as how EMA ensured transparency and public participation in the process for relaunching the publication policy.

The Ombudsman welcomed EMA’s efforts to fully relaunch its proactive publication policy, and encouraged it to work through the backlog of unpublished data as quickly as possible. She encouraged EMA to share information about options for the next phases of the relaunch with the public as soon as possible.