EU HTA

Examples of health technologies include medicinal products, medical devices, medical equipment for the prevention, diagnosis and treatment of health conditions, or even surgical procedures. HTA contributes to ensuring that patients receive effective, safe and high-quality treatments, and helps countries decide which health technologies should be used and paid for, based on the best available evidence.

Until January 2025, each EU member state conducted its own assessment of new health technologies as part of national reimbursement processes, which often resulted in duplication of work, delays and unequal access for patients in the EU. The EU HTA Regulation (2021/2282) aims to reduce duplication, promote equal access, and strengthen the role of patients, carers, as well as clinical experts and other relevant experts in informing clinical decision-making on health technologies.

The Regulation introduces two major joint procedures at the European level, in which patients, carers and clinical experts are required to be involved:

• the Joint Clinical Assessment (JCA), and
• the Joint Scientific Consultation (JSC).

These procedures are conducted by Member State HTA bodies working together through the Health Technology Assessment Coordination Group (HTACG), with assessors appointed from different countries to carry out the work.

The new EU HTA process will not decide for each country whether a medicine is paid for or how patients can get it; instead, it gives all countries shared scientific information, and each Member State remains responsible for decisions on access and reimbursement.