Introduction to HTA Regulation

In 2021, the European Union (EU) adopted the Health Technology Assessment Regulation (HTAR). This regulation has the aim to harmonise, improve and foster cooperation in Health Technology Assessment (HTA) processes across the EU and between the various relevant Member State HTA bodies.

This regulation introduces a permanent framework for joint work on HTA across the EU and between the Member State HTA authorities that will be applicable from 2025 onwards. The aim is to contribute to improving the availability for EU patients of innovative technologies in health, such as medicines and certain medical devices, to ensure an efficient use of resources and to strengthen the quality of HTA across the Union.

Information on health technology assessment regulation is available from the European Commission's website: Implementation of the Regulation on health technology assessment - European Commission

It remains the remit of the individual MS HTA bodies to assess domains such as economic and social, and to  make recommendations and/or decisions on the reimbursement on health technologies at the national level.

Organisation and Key HTA activities of the Regulation  

The following figure depicts the various working groups and their respective tasks. Each of these subgroups perform a vital role in the EU HTA process. The following content will cover each ‘headline’ and explain their role, responsibility and how they are set up.

Figure 1: Adapted from Governance and key elements of the HTAR Source: European Commission, 2023. Available at: hta_20230918_co01_en.pdf (europa.eu)