Presentation (CTI)

OBJECTIVES: Disclosure is the default tool for managing conflicts of interest — but is disclosure enough? The EU HTA framework sets detailed conflict-of-interest (COI) provisions for assessors, co-assessors, experts, and stakeholders. This study evaluated that model and asked whether disclosure-based approaches alone can secure confidence in assessment outcomes.
METHODS: A comparative governance analysis was performed using Regulation (EU) 2021/2282, Implementing Regulation (EU) 2024/2745, and established COI frameworks used by the European Medicines Agency, NICE, HAS, and other HTA bodies. The analysis distinguished between individual conflicts, organisational influences, and broader institutional trust considerations.
RESULTS: The review identified a comprehensive disclosure framework that exceeds many historical European HTA arrangements. The framework addresses financial interests, professional relationships, and participation restrictions. However, several challenges remain. Disclosure mechanisms focus primarily on individual-level conflicts, while questions relating to institutional influence, concentration of methodological leadership, and national representation receive less attention. In addition, disclosure systems may improve transparency without necessarily addressing public perceptions of impartiality. Comparative experience suggests that trust is influenced not only by formal compliance mechanisms but also by transparency, diversity of expertise, and perceived fairness of governance processes.
CONCLUSIONS: The COI framework is a real achievement, but individual disclosure cannot address institutional influence or concentrated methodological leadership. Confidence will depend on broader mechanisms for transparency, balanced representation, and diversity of expertise.