Table 1.

Role definition of stakeholders and collaborators based on pre-convention questionnaire and working group outcomes.

Stakeholder/Collaborator	Role
Patients	Patients are independent “equal level” stakeholders that should be involved throughout the EU HTA process (i.e., not only in the content, such as specific input on a specific product), including governance, decision-making, dissemination, and advocacy. Involvement both on an EU and national level is important.
Clinicians	Clinicians are to be engaged as advisors adding expertise to the process by: Giving clinical context Defining the standard of care Determining appropriate outcome measurements/endpoints The established and well-functioning cooperative model of the EMA and clinicians should be considered by the EU HTA.
Regulators	Regulatory and HTA bodies have different remits. Regulators collaborate with HTA bodies but are not stakeholders in the meaning of the EU HTA Regulation. Collaboration includes: Contribution throughout the implementation to ensure relevant links through the processes sharing experience, best practices engage in development of capacity and guidance of mutual interest Working together for mutual benefit with the HTA Coordination Group evidence planning/scientific knowledge sharing relevant data and information
HTDs	HTDs develop innovative medicines and provide evidence that allows HTA agencies to conduct a solid and unbiased assessment of the value of the innovation. While communication with HTA agencies to ensure the appropriateness of the submitted evidence is required, this is limited to ensure the independence of HTAs is maintained. Both on a generic methodological level (e.g., input into methodological guidelines) and an applied product-specific level, HTDs contribute scientific excellence throughout the process. HTDs support embedding the EU assessment reports into national appraisals and are addressing any remaining uncertainty.
National HTA bodies and payers	National Expertise Centers of Excellence have a dual role, both as drivers and producers of reports and as users of the EU HTA assessments. National Centers participate in designing and setting up the EU HTA organization and governance structure. They further participate in developing the operational guidelines and they review their internal organization and processes in order to avoid duplication of tasks already performed at the EU level.

National HTA bodies and payers are both drivers and users of the EU HTA assessment and the generated assessment report. Key challenges on their side include low capacity to support the elaboration of EU HTA reports by assessors from national HTA bodies and missing legal frameworks and procedural rules for the adoption of the EU HTA within the national context. Furthermore, addressing heterogeneity across national systems and achieving inclusiveness in all EU countries is seen as a major challenge. EMA: European Medicines Agency; EU HTA: European Union Health Technology Assessment; HTD: health technology developer.