EU HTA Regulation

Historically, health technology assessment (HTA) decision making for health technologies in the EU has been made at a national level, with limited cooperation between countries. The EU HTA Regulation (HTAR; EU 2021/2282) is a framework that aims to harmonise the clinical evaluation of these technologies across EU member states, reducing the duplication of work and providing a common scientific basis for national HTA bodies (who still maintain authority over pricing and reimbursement decisions).

The regulation’s implementation is phased:

• From January 2025: EU HTAR applies to new cancer medicines and advanced therapy medicinal products (ATMPs).
• From January 2028: EU HTAR will expand to include orphan medicinal products.
• From January 2030: EU HTAR will cover all new medicinal products that receive a centralised marketing authorisation.

The HTA Coordination Group (HTACG) is responsible for coordinating and overseeing this joint HTA work across member states, and it is composed of representatives from national HTA bodies and authorities across the EU. The HTACG’s primary role is to facilitate Joint Clinical Assessments and Joint Scientific Consultations.