HTA Regulation: Infarmed’s organizational and competence changes

Regulation (EU) 2021/2282, of December 15, 2021, on the assessment of health technologies (the “HTAR”), has become applicable as of January 12, 2025[1]. 

Following this,

Given the demanding evolution of the regulatory framework of the health technology assessment, in particular the introduction of the Joint Clinical Assessments (JCA), Ordinance no. 4/2025/1 of January 3 was published, amending Infarmed’s Statutes. The Government has opted to amend Infarmed’s internal structure, to ensure that the authority can respond, at both national and international level, to its new responsibilities and attributions.

In this sense, this Ordinance reorganized Infarmed’s internal organization, introducing into the possibility of creating, amending or extinguishing up to 27 flexible organizational units, so that it can respond to the new attributions and competences provided for in the HTA Regulation.

In addition, the competencies of the Health Technology Assessment Directorate have been amended, in particular to clarify that this Directorate is responsible for, amongst other:

• Ensure, in terms of health technology assessment, the tasks arising from the Community framework for the clinical assessment of health technologies and the holding of joint scientific consultations;
• Ensure intervention in European cooperation procedures;
• Intervening in initiatives and projects aimed at discussing new payment models in connection with joint procurement processes;
• Promote better coordination among national authorities in joint collaboration actions regarding pricing and reimbursement to enhance collaboration, share analyses, and define working methodologies which ensure the continuity of the EU agendas.

In line with this, the Chairman of Infarmed’s Board of Directors has stated that Infarmed is committed to implementing this new European system and will actively participate in joint clinical assessments and scientific consultations at the European level.

Although the HTAR is directly applicable within the Portuguese legal framework, it is expected that the national HTA regime, approved by Decree-Law no. 97/2015, will undergo adjustments in order to be aligned with the new assessment systems resulting from the HTAR.