The Commission welcomed today the political agreement on the Health Technology Assessment (HTA) Regulation reached by the European Parliament and the Council. The Regulation will improve the availability of innovative health technologies such as innovative medicines and certain medical devices for EU patients, ensure efficient use of resources and strengthen the quality of HTA across the EU. Examples of health technologies include medicinal products, medical equipment and diagnostics. It will also facilitate business predictability, reduce duplication of efforts for HTA bodies and industry and ensure the long-term sustainability of EU HTA cooperation.

The Regulation will replace the current system of EU-funded project-based cooperation between Member States on health technology assessment with a permanent framework for joint work. The new framework will also, in addition to work on joint clinical assessments, cover joint scientific consultations, the identification of emerging health technologies, and voluntary cooperation.

The Regulation does not impact on Member States' current responsibility for the management of their health services, including pricing and reimbursement. The Regulation will now have to be formally adopted by the Council and the European Parliament before it can enter into force.

The Commission's proposal for a regulation on health technology assessment (HTA) was adopted in January 2018. The European Parliament closed its first reading position in February 2019 and has maintained this position under the new Parliamentary mandate. Negotiations in Council were more challenging, however, the Portuguese Presidency obtained a first partial mandate in March 2021 to start informal negotiations with the European Parliament and a second mandate in June 2021 to secure the adoption of the file.

Both the co-legislators and the Commission showed a strong commitment to achieving adoption of this very important file that will contribute to the objectives of the Pharmaceutical Strategy for Europe in terms of supporting innovation, addressing unmet medical needs and facilitating patient access to innovative medicines.

Image © European Commission, 2020