Reporting of harms outcomes: a comparison of journal publications with unpublished clinical study reports of orlistat trials | Trials | Full Text

"In December 2009, Roche was the first global healthcare company to release ‘Clinical Study Reports’ after growing concerns over their product Tamiflu [8]. Their policy now allows researchers to access the CSRs and summary reports used for regulatory purposes since 1 January 1999. In 2010, the European Medicine Agency (EMA) [11] became the first major regulatory agency to agree to an open-access policy to confidential documents, including CSRs. However, in 2013, the EMA was forced to step backwards when the general court of the European Union (EU) ordered them to limit the access to their reports due to legal cases from two drug companies [12]...."