EAA Spring Convention: Discussions on EU Market Access

23. April 2024


The recent EAA Spring Convention, themed ‘Finding the Right Balance,’ held at Erasmus Universiteit Rotterdam, brought together industry experts and stakeholders to explore the complexities of navigating the European Union’s market access for medicines and devices. Co-organized by ASCERTAIN alongside Maureen Rutten-van Mölken, Joerg Ruof, and Elaine Julian, the convention delved into key issues surrounding Health Technology Assessment (HTA) regulation and the potential of Joint Clinical Assessment (JCA) to expedite access to new therapies.

Navigating the EU’s market access for medicines and devices involves balancing uncertainty and managing the trade-off between potential risks and benefits, including type 1 and type 2 errors. The aim of Health Technology Assessment (HTA) regulation is to expedite access to new drugs with added value, harmonizing processes, and reducing redundancy. The pivotal question remains: Does Joint Clinical Assessment (JCA) truly accelerate access?

JCA may offer a promising solution for enhancing access to new cancer drugs in the EU through mechanisms like consolidating resources and expertise, streamlining evaluations, and promoting harmonization of evaluation criteria and standards. Furthermore, JCA may have the potential to ensure comprehensive evaluation by engaging diverse stakeholders, but discussions revealed challenges in achieving this balance, with stakeholders expressing doubts about its feasibility.

Key discussion points included balancing stakeholder involvement in EU HTA regulation, effectively managing uncertainty, understanding the risk-benefit balance in regulatory decisions, defining evidence for new treatments, and navigating the delicate trade-off between undertreatment and overtreatment. These discussions underscored the critical importance of collaborative approaches, evidence-based decision-making, and ensuring equitable access to innovative therapies for improving healthcare outcomes across the EU.

At the EAA, we also presented the ASCERTAIN project, focusing on developing a policy support tool encompassing new pricing models, a comprehensive HTA framework, and innovative reimbursement and payment schemes. Attendees showed keen interest in the use cases, evidence, and decision support tool.