According to the European Medicines Agency (EMA), “Scientific advice (SA) is when the Agency gives advice to a developer on the appropriate tests and studies in the development of a medicine. This is designed to facilitate the development and availability of high-quality, effective and acceptably safe medicines, for the benefit of patients”.
Currently, the SA discussions between pharmaceutical manufacturers and the top European regulator take place in absolute secrecy. Only very limited information is available on the content and outcome of SA by the EMA. Due to this lack of transparency, it is unclear to what extent EMA achieves the objectives of SA and to what extent individual companies make appropriate use of the SA provided.
This set of concrete, actionable and comprehensive policy recommendations aims to enhance the provision of scientific advice by making it more transparent.
Yannis Natsis
Policy Manager for Universal Access and Affordable Medicines
