Health Technology Assessment (HTA) summarises information about medical, economic, social and ethical issues related to the use of a health technology. Examples of health technologies include medicinal products, medical equipment for diagnostic and treatment, prevention methods.
How does it work?
When HTA bodies are asked to evaluate a new health technology, they have to assess whether it works better, equally well, or worse than existing alternatives. For this, they typically need to assess the therapeutic effect of the drug, but also potential side-effects, influence on quality of life and means of administration.
HTA also assess other aspects of the use of the technology, for example its cost implications for the patient and its impact on the organisation of healthcare systems in the administration of treatment. It is therefore a multidisciplinary process that reviews the medical, economic, organisational, social and ethical issues related to the use of a health technology in a systematic manner.
Regulation on Health Technology Assessment
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 replaced
- 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.