Transparency: Disclosure and Dissemination of Regulatory Data in the EU

In the last 70 years, participative, EU-level democracy has been encouraged through an evolving institutional architecture. Inmore recent times, public engagement has been fuelled by a push for greater levels of transparency from institutions, bodies, offices and agencies (“regulatory data holders”) as to when they protect or share with the public, information submitted to them. As part of the various premarket approval schemes developed by the EU for a range of products, applicants are required to generate and submit substantial (scientific) data packages. These typically enable an evaluation of the safety and efficacy of those products. A demandfor greater transparency intheseprocesseshas been articulated with particular vigour by environmental NGOs. Some have litigated refusals to grant full or partial access, before the Court of Justice of the EuropeanUnion (“CJEU”). On other occasions, the targets of that litigation have sought to seize the initiative by adopting approaches to information which are more open – perhaps hoping to avoid litigation and build public trust in the work they undertake.