Fri. Jun 2nd, 2023
Brussels, 22 June 2021,

The Commission welcomes the political agreement on the Health Technology Assessment (HTA) Regulation reached by the European Parliament and the Council early this morning. 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.

Welcoming the agreement, Commissioner for Health and Food Safety Stella Kyriakides made the following statement:

“I am very pleased that the European Parliament and the Council have reached a long-awaited political agreement on the Health Technology Assessment Regulation. The Regulation will be a significant step forward to enable joint scientific assessments of promising treatments and medical devices at EU level.

Such high-quality scientific assessments will help the Member States to take more timely and evidence-based decisions on patient access to their healthcare systems.

The new Regulation will be crucial for the objectives of the EU’s Pharmaceutical Strategy and Europe’s Beating Cancer Plan, in particular when it comes to facilitating access to innovative medicines and addressing unmet medical needs with important benefits for patients across the EU. Having a strong system for HTA in place is key for a strong European Health Union.

I would like to thank the previous Presidencies and the Portuguese Presidency for the work achieved over the past year for the European Parliament’s involvement on this important file. The Commission presented its legislative initiative on 31 January 2018 already, and while the European Parliament closed its first reading in February 2019, discussions in Council have been challenging. This result was a major achievement for EU cooperation and I am looking forward to a swift adoption by both institutions in the coming months.”

The Regulation will replace the current system of EU-funded project-based cooperation between the 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.

Next steps

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 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.

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