Presentation (CTI)

OBJECTIVES: In health technology assessment, legitimacy is earned through transparency and participation. The EU HTA framework introduced new stakeholder-engagement mechanisms while protecting commercially sensitive information. This study examined whether the emerging governance architecture strikes the right balance between transparency, participation, and operational efficiency.
METHODS: A governance analysis was conducted using Regulation (EU) 2021/2282, implementing regulations, stakeholder consultation procedures, transparency principles, and HTA Coordination Group documentation. The study evaluated participation opportunities for patients, healthcare professionals, industry, and other stakeholders across scoping, assessment, and consultation stages. The analysis focused on transparency of process rather than disclosure of confidential data.
RESULTS: The review found that the HTAR introduced substantially more structured stakeholder engagement than existed under previous voluntary cooperation mechanisms. Nevertheless, several governance challenges remain. Participation opportunities are distributed unevenly across assessment stages, while transparency regarding the consideration of stakeholder input remains variable. The interaction between confidentiality requirements and stakeholder participation may reduce external visibility of how competing perspectives influence assessment outcomes. Furthermore, the increasing complexity of JCA processes may create barriers for smaller patient organisations and stakeholders with limited technical resources. The findings suggest that trust in the system depends not only on participation opportunities but also on transparent demonstration of how stakeholder contributions are incorporated into final outputs.
CONCLUSIONS: Trust will increasingly hinge on governance, not method alone. Showing not just that stakeholders were heard but how their input shaped outputs is what will sustain confidence in the JCA framework.