EU HTA Overview

The envisaged cooperation under the HTAR will include adherence to an agreed methodology and processes across the EU, featuring:

  • Joint Scientific Consultations (Article 16–21): A Joint Scientific Consultation (JSC) aims to advice the Health Technology Developer on evidence likely to be required in a subsequent Joint Clinical Assessment of a health technology. Health technologies eligible for Joint Scientific Consultations are those for which a Joint Clinical Assessment hasn't been planned but are likely candidates. These consultations occur at the request of the developer.
  • Joint Clinical Assessments (Articles 7–15): A Joint Clinical Assessment (JCA) of a health technology involves a comparative analysis of available clinical evidence on the health technology in comparison with other health technologies or existing procedures.

Additionally, the lack of a unified framework based on formal cooperation, has led to cooperation primarily being voluntary and project-oriented, as seen in initiatives like the EU Network of HTA organisations (EUnetHTA). HTA organisations across Europe are interconnected through EUnetHTA, , which collaborates with the EU Commission and other relevant stakeholders to conduct specific tasks such as formulating HTA methodology guidelines and promoting good practice in HTA processes. For more information, you can visit the EUnetHTA page on the EUPATI Toolbox.

However, it is important to note that these tasks are usually related to activities that are time-limited, EU-funded and voluntary. Therefore, Member States typically choose to collaborate on a case-by-case basis.

As each Member State is responsible for conducting their own HTAs, and the approach is not standardised, it has led to variations and differences in how HTAs are conducted across the EU. These differences have raised the question of whether harmonisation and standardisation for HTA across the EU would be beneficial.

Given the direct binding nature of the HTAR on Member States it is expected that coordination on HTA at the EU level will be more effective.

 The EU HTA Regulation 2021/2282 aims to simplify and harmonise the assessment process of several domains on the clinical aspects of HTA. These include evaluating the relative clinical effectiveness and relative safety of a health technology in relation to existing ones, as well as examining the health problem, current technologies in use, and the description of the technology under assessment. By having these domains objectively assessed at the EU level through a permanent cooperation system, the regulation aims to streamline and expedite the overall HTA process. It ensures an efficient use of resources by minimising duplication efforts for national HTA bodies and industry stakeholders. Additionally, it strengthens the quality of HTA across the EU and enhances the long-term sustainability of EU HTA cooperation. For further details, please visit the European Commission's Health Technology Assessment Regulation page.

From 2022 to 2025 (known as the transition period), the European Commission has a rolling plan to implement the regulation. For the latest updates on the Commission’s plan, visit the European Commission's website.