EU lawmakers reach agreement on new health innovation rules

The Commission welcomes the political agreement on the Health Technology Assessment (HTA) Regulation reached by the European Parliament and the Council on 22nd June 2021. 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 establishes a new member state coordination group which will include representatives and experts from each EU country, who are not permitted to have any interests in the health technology developers’ industry that could affect their independence or impartiality. The coordination group will be expected to engage and consult widely with relevant stakeholders, including organisations representing patients, healthcare professionals, clinical experts, HTA developers, and consumers to ensure inclusiveness and transparency.