EU Health Technology Assessment Regulation (HTAR)
Topic outline
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After completing this course, you will be able to:
- Describe the principles, structure, objectives, and key components of the EU HTA Regulation 2021/2282 (HTAR), and its implications for patients
- Distinguish and outline the HTAR institutional arrangements and processes, including the joint actions, and the roles and responsibilities of Member States
- Discuss patient representation under the HTAR, its purposes, relevance, and how patients can contribute
- Know when and where to access publicly available HTAR information and reports.
EUPATI Open Classroom content is free for all learners.
Enrol & Access the assessment
At the end of each course you can test your knowledge and earn a certificate for a 10-euro administrative fee. If interested, click the button below:This module has been designed to build upon the existing modules available on the Open Classroom by focusing specifically on the European Union Health Technology Assessment Regulation 2021/2282 and its implications for the harmonised part of EU Health Technology Assessments.
We recommend familiarising yourself with the concept of Health Technology Assessment (HTA) before engaging with this module. HTA plays a crucial role in evaluating health technologies.
You can access relevant introductory material on HTA here: 📑 Access the HTA module where you will find relevant introductory material.
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In 2021, the European Union (EU) adopted the Health Technology Assessment Regulation (HTAR). This regulation has the aim to harmonise, improve and foster cooperation in Health Technology Assessment (HTA) processes across the EU and between the various relevant Member State HTA bodies.
This regulation introduces a permanent framework for joint work on HTA across the EU and between the Member State HTA authorities that will be applicable from 2025 onwards. The aim is to contribute to improving the availability for EU patients of innovative technologies in health, such as medicines and certain medical devices, to ensure an efficient use of resources and to strengthen the quality of HTA across the Union.
Information on health technology assessment regulation is available from the European Commission's website: EU Health Technology Assessment Regulation.
It remains the remit of the individual MS HTA bodies to assess domains such as economic and social, and to make recommendations and/or decisions on the reimbursement on health technologies at the national level.
Organisation and Key HTA activities of the Regulation
Figure 1: Adapted from Governance and key elements of the HTAR Source: European Commission, 2023. Available at: hta_20230918_co01_en.pdf (europa.eu)
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EU Health Technology Assessment Regulation (HTAR)
After completing this course, you will be able to:
- Describe the principles, structure, objectives, and key components of the EU HTA Regulation 2021/2282 (HTAR), and its implications for patients
- Distinguish and outline the HTAR institutional arrangements and processes, including the joint actions, and the roles and responsibilities of Member States
- Discuss patient representation under the HTAR, its purposes, relevance, and how patients can contribute
- Know when and where to access publicly available HTAR information and reports.