Performing Democratic Innovation: The European Medicines Agency’s Public Assessment of Valproate

It is notoriously challenging to create democratic innovations at the transnational level. Existing studies document a range of limitations, but have not investigated the way in which democratic innovations are staged or performed at the transnational level, and the limitations of doing so. In September 2017 the European Medicines Agency (EMA) created a public hearing to gather evidence first-hand from pregnant women who had taken a dangerous drug – Valproate – that despite being issued over several decades to pregnant women as a treatment for epilepsy, was linked to severe birth deformities. The hearing itself was avidly promoted by the EMA as a democratic innovation, the first of its kind at the European level, and was broadcast live on the Agency’s website. It represents an ideal opportunity to evaluate a democratic innovation being performed at a transnational level, including how it is staged, the actors involved performing symbolic roles, and how they interpret its function in relation to the governance process as a whole. Based on detailed coding of eight hours of video, four interviews with EMA public engagement staff, and document analysis of submissions to the Valproate assessment, this article shows how the Valproate hearing was performed to balance competing participatory, judicial and organisational functions. It argues that the Valproate case demonstrates how transnational democratic innovations are caught in a bind of having to contribute to organisational outcomes and conform to judicially sanctioned processes and procedures, such that participatory goals are displaced throughout the process and the exercise itself does not live up to its participatory hype.