The First 2 Years of the European Medicines Agency’s Policy on Access to Documents: Secret No Longer

JAMA Intern Medicine: March 11, 2013

On November 30, 2010, the regulatory agency for medications in Europe, the European Medicines Agency (EMA), announced a policy on access to “any document originated, received or held by the Agency.” The policy made a wide range of regulatory documents potentially accessible to anyone who asks for them, including clinical study reports. Documents are released without charge, primarily in PDF format, and made available via a web-based download. We used this policy and received 25 000 pages of previously unreleased clinical study reports on Roche’s oseltamivir phosphate (Tamiflu) trials, all unredacted. Read more