The Heads of HTA Agencies Group (HAG) met in Rome on October 24th. for their eight face-to-face encounter. The meeting, with more than 70 participants from 29 member agencies, was hosted and organised by the Italian National Agency for Regional Healthcare Services (AGENAS), the Italian Medicines Agency (AIFA) and the Italian Ministry of Health.
80 days before the application of the Health Technology Regulation (HTAR), 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 implementing acts, the drafting and validation of the guidance documents by the HTA Coordination Group and the development of the IT platform. The European Commission, represented by the Director Marco Marsella (DG SANTE), and the HTA Coordination Group, through the Chair Roisin Adams, provided an update on the status of the key-activities in preparation for the HTAR. Future actions were discussed with a view to carrying out the work scheduled to commence on 12 January 2025. The HAG adopted a joint statement on the implementing regulations on Interactions with EMA and Conflicts of Interest (here). In the view of the HAG members, “these developments represent tangible steps toward the operationalization of a unified European HTA system”.
A portion of the meeting was dedicated to the discussion of national developments for the implementation of HTAR. The HAG Communication Working Group presented the results of a questionnaire on the actions put in place in the different HAG member organizations and their countries to implement the EU HTA Regulation and shared national experiences, both of which indicating high-level in preparedness. . The HAG members highlighted the importance of adaptation of national legislation and the need to strengthen the agencies’ operational and resource capacity as priorities for the coming months, given the expected need of joint clinical assessment.
The Group gave a first step in the development the Strategic Plan of the HAG 2025-2028 and strategic priorities have been identified.
The HAG also approved a proposal on the creation of the Observer Member status for HTA body, agency or departments from EU/EEA Member States. This could lead to an increase in the number of Member States and HTA organisations represented in the Group and strengthen European HTA collaboration.
