Commercially Confidential Information - A Reviewed Understanding of the European Disclosure Regime for Medicinal Products

Abstract: Over the last couple of decades, the European Union has enacted several pieces of legislation to improve insight into its agencies and institutions. This trend has been particularly significant for the pharmaceutical industry, as documents submitted to the EMA in order to have medicinal products approved have been increasingly subjected to public access requirements. Most recently, the 2014 regulation on clinical trials was enacted, which mandates the EMA to set up an online database and proactively publish data from clinical trials. It is expected to become applicable in 2019. The EMA, in an attempt to prepare itself for this paradigm shift, has vastly modified its policies on transparency: More documents than ever before are to be released upon requested access. This thesis studies the legality of these policies and asks whether the EMA exceeds its discretion. The analysis is enabled by the three cases adjudicated by the General Court of the European Union in February 2018, which constitutes the most significant legal source for this thesis. These cases affirmed that the EMA has been correctly applying the old legislation on public access when granting third-party access to toxicology studies, clinical study reports for orphan medicinal products, and CHMP reports on similarity and clinical superiority; the court furthermore implies that this is the correct application of the CTR (once it becomes applicable). Several conclusions can be drawn from the greenlighting of the EMA policies: i) the EMA is correct in assessing requests on a case-by-case basis rather than, as it previously did, presume that access requests to the documents concerned are to be denied; ii) even though none of these documents were treated in their entirety, the General Court has stated that future documents may be, provided that the compilation of publicly accessible and non-publicly accessible information constitutes an “inventive strategy which bequeaths added value to science.” However, such a treatment will most likely be a rarely used exception; iii) the exception for commercially confidential information is to be given a rather narrow interpretation even when taking into account protection of trade secrets in accordance with art. 39 of the TRIPS Agreement.