Embedding the Patient Voice Within EU HTA: How Can We Balance Inclusivity, Representativeness, and Scientific Rigor?

ISSUE: The implementation of the HTA Regulation in Europe introduces new opportunities and challenges for integrating patient perspectives into Joint Scientific Consultations (JSC) and Joint Clinical Assessments (JCAs). Despite implementation in early 2025, there remain key outstanding questions: How do we establish clear and consistent frameworks for patient involvement? How do we balance inclusivity with representativeness by engaging patient organisations and carers? How do we manage conflicts of interest without excluding valuable expertise? How to ensure patient confidentiality of health status while allowing for open dialogue? How can we ensure access to understandable, timely information through plain language summaries? How should patient relevant outcomes be captured and interpreted? OVERVIEW: Per Regulation 2021/2282, patients contribute as external experts in both the JSC and JCA procedures. They also engage via patient organisations in a stakeholder network maintaining dialogue with the HTA Coordination Group. Panelists will explore practical solutions to the challenges, aiming to strengthen the legitimacy, transparency, and relevance of HTA processes across Europe. Ruairi O’Donnell (moderator) will introduce the panel and the broader context of the discussion (10min). Matteo Scarabelli will explore the policy shifts that have changed how the patient perspective is incorporated into decision-making, while identifying key challenges and opportunities inherent within the new HTA Regulation (12min). Antonella Cardone will share insights from the patient organisation perspective, highlighting key initiatives undertaken to effectively integrate patient voice and perspective within HTA procedures (12min). Justin Doan will share findings of the health technology developer (HTD) experience, exploring how companies can pragmatically integrate patient perspectives and outcomes into their development programmes and prepare for evidence-based procedures such as the JSC and JCA (12min). Time (14min) allowed for questions/ panel discussion. Session will benefit those with involvement in national HTA procedures, from patient, assessor or HTD perspectives.