New European policy – greater transparency and access to data from drug regulator

The European Medicines Agency (EMA – the public body carrying out the centralised review and approval of new medicines across Europe) has announced a new policy promising greater openness and transparency with regard to its decision making process. Details of the policy are available online. This policy applies to all “business related documents” which are part of the agency’s activities (with some exceptions), and this includes making publicly available data resulting from clinical trials which were included as part of a marketing application to the agency. Importantly, this policy will include making publicly available data from trials for drugs which were declined marketing approval.

At present the policy means that the clinical trials data (or other documents) will only be disclosed in response to written requests; EMA has said that it promises to reply within 15 working days of an application for data. However the agency is working to develop a publicly accessible electronic register over the next five years which will increase the level of accessibility to data from its activities. There are provisions for protecting “confidential information” but it is anticipated that these will generally relate to personal data of individuals. EMA has undertaken extensive consultation with the public, and with the pharmaceutical industry, before finalising this policy.

The initiative is a major step forwards towards greater transparency in clinical trials research: previously, commercial interests restricted the agency with regards to what information could be publicly released. In the US, the Food and Drugs Administration already makes much information publicly available via its website (see its Transparency Initiative http://www.fda.gov/AboutFDA/Transparency/TransparencyInitiative/default.htm for more information), but does not as yet reveal data about drugs which are declined approval.