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 replaces
- the current system based on 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.
- Regulation on HTA
- Press release on the adoption of new rules to improve access to innovative technologies
- Q&As: Adoption of Regulation on health technology assessment
Implementation of the Regulation
The European Commission is carrying out several activities in the framework of the implementation of the Regulation.
The European Commission adopted its proposal for a Regulation on HTA on 31 January 2018.
The European Parliament closed its first reading position in February 2019 while the Council adopted its first reading position in November 2021.
Shortly after the vote of the European Parliament in early second reading in December 2021, the Regulation was adopted in December 2021.
- Towards more innovative health technologies for patients
- Legislative proposal (click on the linguistic icon to see the linguistic versions)
- Press release
During the development of the legislative proposal, the European Commission performed an impact assessment in line with its Better Regulation guidelines. This established the need for EU action and summarised the potential impact of specific options in a report. An independent board (Regulatory Scrutiny Board) assessed the report before issuing its opinion.
- Executive summary
- Impact Assessment report (click on the linguistic icon to see the linguistic versions)
- Opinion of the Board
- Study on impact analysis of policy options for strengthened EU cooperation on HTA
- Mapping of HTA methodologies in EU and Norway
- Mapping of HTA national organisations, programmes and processes in EU and Norway
Prior to the impact assessment phase, an online public consultation on the initiative was launched on 21 October 2016. The consultation, which ran until 13 January 2017, gathered opinions on the future of EU cooperation on HTA. The results are summarised in the impact assessment report and were carefully considered during the development of the legislative proposal.
As part of the consultation several bi-lateral meetings were held with stakeholders, the minutes of meetings with stakeholders are also available.
Inception impact assessment
In September 2016 an inception impact assessment, which constitutes the first step in defining any EU initiative, was published. The document outlines the current state of play, and possible ways forward to address identified shortcomings.