The regulatory system for market authorisation is a critical factor in the development of new medicines. This system has to take into consideration the protection of public health while, at the same time, ensuring that patients have timely access to medicines, including the ones that address unmet medical needs. During the past decades, a drop in the introduction of new innovative drugs has been observed, despite progress in biomedical research and development. Although the reasons for this innovation deficit are not fully understood, many observers see the increasing demands of the regulatory systems as one of the main drivers.
This year, the Annual CORS conference will focus on the role of regulation in both protecting public health and promoting innovation. Through discussions and presentations by invited speakers, we will explore and discuss what the implications of incentives and requirements set up by medicine regulations represent for innovation, public health and ethics.