Regulation (EU) 2021/2282 on Health Technology Assessment (the “HTAR”) entered into force in January 2022 and becomes applicable as of 12 January 2025. Since 2022, preparatory work has been ongoing for the commencement of joint health technology assessment work, as provided for by the HTAR. The HTAR provides for joint clinical assessments and joint scientific consultations using a common framework of procedures and methodologies across the EU. It will only cover the clinical aspects of the assessment and will not make any economic assessment or conclusion on pricing and reimbursement.

A “health technology” is defined in a separate piece of EU legislation (Directive 2011/24/EU) and refers to a medicinal product, a medical device or medical and surgical procedures as well as measures for disease prevention, diagnosis or treatment used in healthcare.

The HTAR provides for the establishment of the Member State Coordination Group on Health Technology Assessment (the “HTACG”). At its most recent meeting, on 28 November 2024, the HTACG adopted its work programme for 2025 which was then published on 3 December 2024.

The European Commission’s HTA Secretariat supports the joint work led by HTACG, provides administrative, technical and IT support as well as to the actors taking part in joint clinical assessments and joint scientific consultations. A HTA Stakeholder Network has also been established and its members include patient associations and industry groups. More details can be found here.

From 12 January 2025, joint clinical assessments will be carried out for medicinal products with new active substances for which the applicant declares in its application for authorisation submitted to the European Medicines Agency that it contains a new active substance for which the therapeutic indication is the treatment of cancer and medicinal products which are regulated as advanced therapy medicinal products pursuant to Regulation (EC) No 1394/2007. A selection of medical devices will also be subject to joint clinical assessment. In 2028, orphan medicinal products will be added to the joint work and in 2030 all new medicines will come under the scope of the HTAR.

The HTAR is accompanied by a number of Implementing Regulations, the most recent of which was published on 18 December 2024.

For more information please contact our Life Sciences Group.