On April 26th 2023, the European Commission adopted a proposal for a new Directive and a new Regulation, which revise and replace the existing general pharmaceutical legislation. In the proposal, addressing unmet medical needs (UMN) is a critical aspect aimed at encouraging research and development of innovative therapies to tackle these conditions. The concept of (H)UMN plays an important role in decision making by a range of stakeholders, including regulators, health technology assessment (HTA) agencies, payers, academia and the pharmaceutical industry. It informs investment and the setting of priorities.

In this parallel session, the Regulatory Science Network Netherlands brings together stakeholders from industry, academia and perspectives from regulators to discuss the implications of the new pharmaceutical legislation and its focus on UMN. In our programme, we will reflect on the current debate and highlight where regulatory solutions and dialogue may help progress.