Presentation (CTI)

OBJECTIVES: The European Union (EU) has long prioritized harmonizing public health and drug regulation, exemplified by the European Medicines Agency (EMA) and the recently adopted EU Health Technology Assessment Regulation (EU HTAR). Both aim to streamline processes, reduce duplication, and improve patient access to innovative health technologies. This study compares the EMA’s and EU HTAR’s historical and policy developments to identify lessons for the EU HTAR’s ongoing implementation.
METHODS: A mixed-methods approach was employed, including a narrative literature review and online focus groups ("Digital Tables") with 18 regulatory and policy experts. The review explored the EMA’s and EU HTAR’s evolution, while the Digital Tables provided insights into stakeholder perspectives on collaboration and policy implementation.
RESULTS: The review highlighted the EMA’s shift from fragmented national systems to a centralized regulatory framework, balancing EU oversight with national autonomy. Similarly, the EU HTAR follows phased implementation while preserving Member States' authority over reimbursement. Key differences include the binding nature of decisions and the variation in assessment scope. Participants of the Digital Tables emphasized the importance of trust-building, consensus, and phased harmonization. They identified challenges in aligning Member States with varying capacities and legal frameworks, and balancing EU-level coordination with national sovereignty.
CONCLUSIONS: The EMA’s evolution offers valuable insights for the EU HTAR, highlighting the importance of trust-building, leveraging national differences, and iterative learning. The EU HTAR’s success will depend not only on technical execution, but on building the coordination and commitment needed to make harmonization both meaningful and workable across Member States.