Transparency Policies of the European Medicines Agency: Has the Paradigm Shifted?
This article reflects on the state of play as regards access to non-summary clinical trial data in the European Union (EU). In particular, it examines the scope of access under the recent transparency policies of the European Medicines Agency (EMA) that attempt to break away from the presumptively confidential treatment of clinical trial data. In light of the emerging case law of the Court of Justice of the European Union on clinical trial data disclosure, it remains highly uncertain what data, and under what conditions, can be lawfully released by the EMA. Under the applicable regulations, the scope of the accessible data depends on the interpretation of commercially confidential information-the notion derived from the exception to the fundamental right of access to documents. Accordingly, the analysis focuses on the application of this exception, taking into account the specifics of clinical data, the context in which disclosure occurs, and the interests that are at stake. The main complexity is found in defining the scope of the relevant and legitimate interests to be balanced when applying the exception. Overall, it is argued that the current regulatory framework does not provide a sufficient legal basis to support the objectives pursued by the EMA's policies.
Max-Plank Institute for Innovation and Competition, Munich, Germany.
Daria
D
Kim
D003219:Confidentiality; D030881:Disclosure; D004345:Drug Industry; D005062:European Union; D006801:Humans
Access; Clinical trial data; Commercially confidential information; The European Medicines Agency