Heads of HTA Agencies Group (HAG) meeting marks start of application of EU HTA Regulation

The Heads of HTA Agencies Group (HAG) met virtually on January 14th. The meeting, which took place two days after the EU HTA Regulation came into application, counted with more than 60 participants from 28 member agencies.

The members of the HAG discussed the latest developments and actions in the implementation of the HTAR, in particular the drafting and approval of the remaining two implementing acts (Procedural rules for JSC of medical devices and IVD medical devices and the Procedural rules for JCA of medical devices and IVD medical devices) and the operationalisation of the work expected under the 2025 Work Programme for the new joint EU-level HTA framework (HTAR).

Looking ahead to 2025, the Group discussed various ongoing initiatives in which HAG members are actively involved:

  • the HAG INSIGHT initiative that will strengthen the long-term capacity and expertise of EU HTA bodies in executing the HTAR effectively and in a sustainable manner, and
  • the launch of the HAG Digital Medical Device Working Group (HAG DMD WG).

The HAG Communication Working Group presented the feedback received from the HTA Info Days. The HAG members highlighted the positive results of the stakeholder events organised during 2023 and 2024 in collaboration with the European Commission.

Additional discussion topics included the development of the HAG Strategic Plan 2025-2028, the evaluation and reporting of EU HTA Regulation under the Article 31 of the regulation, and data transparency in EU joint clinical assessments (JCA).

Finally, the HAG also approved the application of three new members:

  • the Ministry of Health of the Republic of Cyprus and the Ministry of Health of the Republic of Slovenia, as observer members;
  • the Agency for Health Technology Assessment and Tariff System (AOTMiT, Poland)

With the admission of these members, the Heads of HTA Agencies Group now has 35 members from 23 EU/EEA Members States thus ensuring greater representativeness among organisations responsible for HTA in Europe.

The Group will meet again in Oslo, Norway, on 19th and 20th of May 2025.