What is ‘EU HTA’?

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Health Technology Assessment (HTA) is a multidisciplinary process that 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 devices, medical equipment for the prevention, diagnosis, and treatment of health conditions, or even surgical procedures.

In simple terms, HTA helps answer questions like:

How effective is this new medicine, device, or diagnostic test compared to current options?
Does it offer additional clinical benefit or improved safety for patients?
In terms of clinical benefit, does it improve quality of life, health outcomes, or survival for patients?

HTA helps governments and health systems decide:

Should we use this technology?
Should we pay for it?
Which patients will benefit most?

Up to now, each EU member state has conducted its own assessment of new health technologies as part of national reimbursement processes. This has often resulted in duplication of work, delays, and unequal access for patients in the EU.

The EU HTA Regulation (2021/2282) introduces a more unified and efficient process for evaluating these technologies at the European level. The Regulation applies from January 2025 and will be phased in gradually.

The EU HTA Regulation will:

Conduct Joint Clinical Assessments (JCAs) to assess the relative clinical effectiveness and relative safety of health technologies at EU level.
Provide Joint Scientific Consultations (JSCs) to give early advice on how to generate appropriate clinical evidence for a future JCA.
Involve patients, carers, as well as clinical experts and other relevant experts in the production of the work.

This shared approach to HTA in Europe will 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 integrity of the EU HTA framework is maintained by strict confidentiality and conflict of interest rules.

What to check out?

🔗 Read: European Commission – HTA Overview
🔗 EUCAPA leaflet – Key aspects in the EU HTA regulation
🎥 Watch: EUCAPA – Module 2: EU HTA Regulation (12:37)
📘 EU Regulation 2021/2282 – Official Text