Session (CTI)

ISSUE The EU HTA Regulation and Joint Clinical Assessments introduce a common European approach to clinical evidence assessment, but countries differ in HTA maturity, resources, procedures, and readiness to use JCA outputs in national decision-making. This panel will debate how Central and Eastern European countries and neighbouring systems can prepare for JCA while maintaining national responsibility for pricing, reimbursement, and access decisions. The key issue is whether JCA will reduce duplication, improve consistency, and support faster access to innovation, or whether evolving HTA systems may face methodological, procedural, and capacity-related challenges. The discussion will focus on practical readiness and the ability to translate European assessments into locally relevant decisions. OVERVIEW With the first JCA reports for medicinal products expected to become available in June, this panel comes at a timely moment to discuss how these early assessments may resonate across CEE countries and influence national HTA, pricing, reimbursement, and access processes. The issue panel will bring together WHO/Europe and national HTA authority perspectives on JCA preparation in Central and Eastern Europe. Tarang Sharma will present the “Strengthening the National Health Technology Assessment Framework” initiative, supported by WHO/Europe and the European Commission through DG REFORM and technical support mechanisms, using a CEE country as an example of HTA capacity-building aligned with European norms. Jacek Walczak will present Poland’s preparation process, focusing on institutional and methodological adaptation. Boryana Ivanova will present Bulgaria’s preparation process, highlighting alignment with European HTA developments while preserving national pricing and reimbursement responsibilities. Dr. Sharma will deliver a 20-minute overview of the WHO programme for HTA in CEE countries, followed by 10-minute country presentations and 20 minutes of moderated discussion and debate. The panel will benefit HTA bodies, payers, policymakers, industry, patients, and researchers interested in European HTA implementation and equitable access to innovation.