Session (CTI)

Issue The EU HTA Regulation (EU HTAR) marks a significant step in harmonizing HTA across Europe. While aiming to reduce duplication and improve timely access, its implementation raises questions about feasibility, stakeholder alignment, and national uptake. This panel explores what the development of the European Medicines Agency (EMA), a comparable effort in EU-level harmonization three decades earlier, can teach us about the opportunities and challenges facing the EU HTAR. Overview The session begins with a presentation (±10min) of a comparative analysis by the researchers (Francine Brinkhuis/Wim Goettsch), examining the development of the EU HTAR alongside the EMA’s historical trajectory. Both initiatives were driven by a need for greater EU-level coordination but differ in mandate, legal authority, and integration into national systems. Nevertheless, both began with informal collaboration and faced similar challenges in aligning diverse national systems, offering a valuable basis for learning. Drawing on this analysis, the panel will explore which elements of the EMA’s experience might inform EU HTAR implementation, which pitfalls to avoid, and where HTA may require a fundamentally different approach. Each panelist will briefly present their perspective (policy, regulatory, and industry, ±20min total). The panel will then engage in a structured debate and interactive audience discussion (±30min), moderated by Wim Goettsch. Polling tools will be used to gather audience input and stimulate real-time discussion between audience and panelists: How do today’s political and technological contexts shape HTA harmonization differently from the EMA’s path? Should JCAs take on a more binding role? The aim is to foster open exchange, highlight areas of consensus and disagreement, and reflect on trade-offs shaping the EU HTAR’s long-term success. The session will interest regulators, policymakers, HTA bodies, industry, and academics seeking insight into how past institutional experiences can inform the ongoing implementation of the EU HTAR.