European Union of Private Hospitals

Regulation on Health Technology Assessment

The European Commission just published a factsheet summarizing the Health Technology Assessment Regulation, its governance and implementation (attached). It is also available in 23 EU languages: https://health.ec.europa.eu/latest-updates/factsheet-implementation-hta-regulation-2023-10-05_en

The Regulation (EU) 2021/2282 on health technology assessment (HTAR) contributes to improving the availability for EU patients of innovative technologies in the area of health, such as medicines and certain medical devices. It ensures an efficient use of resources and strengthens the quality of HTA across the Union. It provides a transparent and inclusive framework by establishing a Coordination Group of HTA national or regional authorities, a stakeholder network and by laying down rules on the involvement in joint clinical assessments and joint scientific consultations of patients, clinical experts and other relevant experts. The HTAR will also reduce duplication of efforts for national HTA authorities and industry, facilitate business predictability and ensure the long-term sustainability of EU HTA cooperation. This Regulation replaces:

  • the current system based on the voluntary network of national authorities (HTA Network), and
  • the EU-funded project-based cooperation (Joint Actions EUnetHTA) with a permanent framework for joint work

The new framework covers joint clinical assessments, joint scientific consultations, the identification of emerging health technologies, and voluntary cooperation. The Regulation on HTA entered into force in January 2022 and applies as of January 2025.