In this article we report on a virtual meeting of the Heads of HTA Agencies Group (HAG) held on January 14, 2025, two days after the implementation of the EU Health Technology Assessment (HTA) Regulation. The meeting discussed key developments, including the drafting of implementing acts for joint scientific consultations and clinical assessments. Also, they focused on the operationalization of the 2025 Work Programme for the new joint EU-level HTA framework. The HAG also addressed various initiatives, such as the HAG INSIGHT initiative and the launch of the HAG Digital Medical Device Working Group.

Key Insights

The HAG meeting concentrated on the implementation of the EU Health Technology Assessment Regulation, particularly the drafting and approval of procedural rules for joint scientific consultations (JSC) and joint clinical assessments (JCA) of medical devices and IVD medical devices.

The group discussed ongoing initiatives, including the HAG INSIGHT initiative aimed at enhancing the capacity and expertise of EU HTA bodies. They also discussed the launch of the HAG Digital Medical Device Working Group.
– Positive feedback from stakeholder events organized in 2023 and 2024 was highlighted, alongside discussions about the development of the HAG Strategic Plan 2025-2028.
– Data transparency in EU joint clinical assessments and the evaluation of the EU Health Technology Assessment Regulation under Article 31 were also key topics.

Context

The EU Health Technology Assessment Regulation (EU) 2021/2282 came into effect on January 12, 2025. Its goal is to reduce duplication for national HTA authorities and the industry while improving the evidence base for HTA assessments. The regulation encompasses joint clinical assessments and scientific consultations, which are essential for harmonizing HTA processes across EU member states. The preparatory phase of this regulation lasted from January 2022 to January 2025, involving the development of implementing legislation, guidance documents, and stakeholder engagement.

Implications

The implementation of the EU Health Technology Assessment Regulation is expected to streamline and standardize the HTA process, potentially leading to more efficient and cost-effective assessments of health technologies. This reform may significantly impact patient access by lessening the financial burden linked to duplicate assessments and by enhancing the quality of evidence for decision-making. Enhanced data transparency in joint clinical assessments, as discussed by the HAG, will likely boost the reliability and comparability of HTA outcomes, benefiting both healthcare providers and patients. The HAG INSIGHT initiative and other capacity-building efforts will ensure that EU HTA bodies possess the expertise necessary to implement the HTA Regulation effectively while maintaining high standards in health technology evaluations.

The regulation emphasizes voluntary cooperation among member states and stakeholder engagement, which includes patient and clinician organizations, industry representatives, and national authorities. This collaboration can drive better health outcomes and more informed policy decisions. The inclusion of new members in the HAG and the expansion of its working groups, such as the HAG Digital Medical Device Working Group, will further increase the group’s representativeness and efficacy in supporting the implementation of the HTA Regulation across the EU.