Presentation (CTI)

OBJECTIVES: Joint Scientific Consultations (JSCs) under the EU HTA Regulation are intended to align evidence generation between industry, HTA bodies, and regulators. However, the limited number of JSCs planned for 2025 raises important concerns regarding access, value, and sustainability during this pivotal launch period. This review aims to examine how restricted JSC availability may impact industry participation, the coherence of evidence generation, and policy development for the long-term success of EU HTA operations.
METHODS: A focused review of EUnetHTA 21 pilot documents, stakeholder publications (EFPIA, EUCOPE, ARM), and national HTA reports was conducted. A qualitative synthesis was performed on key issues such restricted access, fragmented processes, and uncertainty.
RESULTS: The restricted JSC slots in 2025 present significant access barriers, especially for small and medium-sized enterprises and products outside high-priority areas. Many developers excluded from the process revert to national advice, reintroducing the fragmentation the Regulation seeks to overcome. Uncertainty around JSC scheduling disrupts evidence planning and increases the risk of misalignment with Joint Clinical Assessments, ultimately reducing confidence in the long-term utility of the mechanism.
CONCLUSIONS: The current JSC implementation reveals clear limitations in capacity, access, and predictability. Without timely action, these gaps risk undermining the Regulation’s harmonization goals. Short-term expansion of JSC capacity, clearer prioritization criteria, and more inclusive, flexible formats—such as hybrid or decentralized consultations—are vital to encourage wider participation. Addressing these issues is essential to ensure JSCs become a sustainable and equitable part of the EU HTA framework.