Transparency is essential to allow better access to safe, high-quality medicines with real patient relevant benefit. ESIP particularly welcomes EMA’s release of clinical reports on new medicines for human use that have been granted market authorisation in the European Union. The policy to grant open access to clinical data is a major step in the right direction. In particular it has the potential to facilitate pharmacovigilance activities for medicines post-authorisation and ultimately access to safer healthcare for patients.

These key elements have been brought forward previously in the framework of the review of the EU legislation on clinical trials and in our joint position regarding access to innovative medicines published on 13 October 2015. In this position, ESIP advocates for greater transparency of clinical trial data including those that do not lead to a marketing authorisation application. In addition, ESIP will continue to campaign for greater transparency as regards research and development costs, and prices and expenditures for pharmaceuticals which it believes is necessary in order to further improve patients’ access to high quality medicines.