Presentation (CTI)

OBJECTIVES: The EU HTA Regulation rests on a delicate bargain: assess together, decide nationally. This study examined the constitutional foundations of that bargain and how the JCA framework navigates the boundary between internal-market harmonisation and Member State responsibility for healthcare decisions.
METHODS: A doctrinal legal and policy analysis was undertaken using the Treaty on European Union (TEU), the Treaty on the Functioning of the European Union (TFEU), the Charter of Fundamental Rights of the European Union, Regulation (EU) 2021/2282, and relevant Court of Justice jurisprudence. Particular attention was given to the interaction between Articles 114 and 168 TFEU and the governance architecture established by the Regulation.
RESULTS: The HTAR is founded upon a carefully balanced constitutional compromise. On one hand, the Regulation seeks to reduce duplication and support internal market objectives through common clinical assessments. On the other, it expressly preserves Member State authority regarding pricing, reimbursement, resource allocation, and healthcare organisation. The analysis found that this balance represents both a strength and a source of ongoing tension. Efforts to expand the practical influence of JCAs beyond their intended clinical assessment function may create pressures at the boundary between EU-level cooperation and nationally retained competences. The sustainability of the framework therefore depends on maintaining a clear distinction between common evidence assessment and national decision-making authority.
CONCLUSIONS: EU HTA cooperation will stand or fall on legitimacy as much as method. Keeping a clear line between common evidence assessment and national decision-making is what will secure Member States' long-term acceptance of the framework.