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

JAMA: 12/19/12

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.”¹ The policy made a wide range of regulatory documents potentially accessible to anyone who asks for them, including clinical study reports.²Documents 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. This formed the basis of our recent Cochrane review on neuraminidase inhibitors.³ The release of such documents contrasts with the approach of the US Food and Drug Administration (FDA), which similarly has a freedom of information policy but treats industry-sponsored clinical trial data as confidential and trade secret, denying public release on the grounds that disclosure could cause competitive harm to original study sponsors.⁴ We sought to inform discussion of access to clinical trial data by describing how the EMA’s policy is being used. Read more