New consortium of HTA agencies to support implementation of EU HTA regulation

Two weeks after the European Union’s Health Technology Assessment Regulation came into effect, the formation of a new consortium marks a significant milestone in its implementation.

A consortium of 34 health technology assessment (HTA) agencies from 21 EU Member States has been established to implement the European Union's Health Technology Assessment Regulation (EU HTAR). Led by the Belgian National Institute for Health and Disability Insurance (RIZIV-INAMI), the consortium has secured €35 million in funding through the EU4Health program, managed by the European Health and Digital Executive Agency (HaDEA), to oversee joint clinical assessments (JCAs) and joint scientific consultations (JSCs) under the new regulatory framework. The framework contract, signed on January 22, 2025, will run for 48 months and represents the final component of the legislative and procedural structure supporting EU HTAR.

The EU HTAR, which came into effect earlier this month, introduces a unified, EU-level submission process for JCAs focusing on the relative clinical effectiveness and safety of new medicines and high-risk medical devices, including in vitro diagnostic tools. By pooling resources and expertise across Member States' HTA authorities and bodies, the regulation aims to strengthen the scientific quality of HTAs, reduce duplication at the national level, and accelerate patient access to innovative therapies. Initially applicable to new cancer medicines and advanced therapy medicinal products (ATMPs), the regulation will gradually extend to include all new medicinal products and selected high-risk medical devices by 2030.

The press release from RIZIV-INAMI outlines its role in leading this critical launch phase, with the agency ensuring all assessments are conducted accurately, workloads are distributed equitably, and EU regulations are upheld. The resulting reports from these assessments will be made available to all 27 Member States.

However, key operational details remain unclear, leaving some questions unanswered. In a LinkedIn post, Neil Grubert highlighted notable gaps, including the exclusion of several EU member states from the consortium and the interplay between the JCA and JSC sub-groups with the consortium’s operational structure. He commented:

"Given that the HTA Regulation states that the JCA and JSC sub-groups will appoint assessors and co-assessors for their respective exercises, it will be interesting to see the working relationship with the new consortium. With only 21 countries represented in the consortium, some Member States are evidently not currently included."

As the implementation advances, stakeholders will closely monitor how these issues are addressed to ensure the EU’s harmonized HTA system operates effectively and equitably across all Member States.