The European regulation on Health Technology Assessment Balancing European and National Levels

The European Health Technology Assessment (HTA) regulation was adopted at the end of 2021. HTA is “a multidisciplinary process that summarizes information about the medical, patient and social aspects and the economic and ethical issues related to the use of a health technology in a systematic, transparent, unbiased and robust manner”. While HTA has been conducted at national level, the regulation is provided for the harmonization of procedures to avoid redundancy of evaluation processes, misallocation of resources, and inequitable access to new technologies within the European Union (EU). The regulation will be implemented step by step, starting with Advanced Therapy Medicinal Products (medicines based on genes, cells, and tissues) and cancer drugs by 2025. Then it will be implemented for orphan drugs by 2028, and finally, for all medicines by 2030. Although EU Member States remain responsible for drawing conclusions on added value of health technologies for their health system and taking decisions on their pricing & reimbursement, a new coordination group (HTACG) is established at the EU level. The latter will manage the entire HTA process, relying on a Secretariat provided by the European Commission, national bodies providing their expert views on HTA, and a stakeholder network supporting its work. More specifically, the HTACG will coordinate the joint clinical assessments of health technologies and ensure the identification of emerging technologies. It will also carry out joint scientific consultations and facilitate the voluntary cooperation regarding the exchange of scientific information among Member States in the field of HTA. Therefore, this poster will present and discuss the balance established by the new regulation, between European and national activities in the field of HTA, in accordance with the Treaty provisions on the sharing of competences between the European Union and the Member States