HTA Regulation - Publication of Implementing Regulation containing Rules for Cooperation involving European Commission and European Medicines Agency
- 22/10/2024
- News
The Official Journal of the European Union published yesterday the second of six Implementing Regulations of the Regulation on Health Technology Assessment (HTA) (Regulation (EU) 2021/2282 of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU) (see, Van Bael & Bellis Life Sciences News & Insights of 15 December 2021 and Van Bael & Bellis Life Sciences News & Insights of 22 December 2021) (the HTA Regulation).
The Implementing Regulation sets out procedural rules for the cooperation between (i) the Member State Coordination Group on HTA and the European Commission, which acts as the Coordination Group’s secretariat; and (ii) the European Medicines Agency, which acts as secretariat for expert panels tasked with carrying out joint work under the HTA Regulation (Commission Implementing Regulation (EU) 2024/2699 of 18 October 2024 “laying down, pursuant to Regulation (EU) 2021/2282 of the European Parliament and of the Council, detailed procedural rules for the cooperation of the Member State Coordination Group on Health Technology Assessment and the Commission with the European Medicines Agency in the form of exchange of information as regards the joint clinical assessment of medicinal products and medical devices and in vitro diagnostic medical devices and as regards the joint scientific consultation on medicinal products and medical devices”; the Second Implementing Regulation – see, attached copy).
The Second Implementing Regulation defines the scope of the exchanging of information for (i) the planning and forecast of the joint clinical assessments and joint scientific consultations; (ii) the identification of patients and clinical and other experts to be involved in joint clinical assessments and joint scientific consultations; and (iii) general scientific and technical matters related to HTA. Additionally, it sets out rules to ensure that information is exchanged securely, and that commercially confidential information and other confidential information is protected.
As the HTA Regulation will apply on 12 January 2025, the Second Implementing Regulation will apply on the same date. At first, new oncology medicines and advanced therapy medicinal products will be the only medicines to be assessed at the EU level. Orphan medicines will be added in January 2028. The joint assessment work is expected to cover all new medicines in January 2030.
The first Implementing Regulation of the HTA Regulation was published in May 2024 and lays down procedural rules regarding the conducting and updating of joint clinical assessments (Commission Implementing Regulation (EU) 2024/1381 of 23 May 2024 “laying down, pursuant to Regulation (EU) 2021/2282 on health technology assessment, procedural rules for the interaction during, exchange of information on, and participation in, the preparation and update of joint clinical assessments of medicinal products for human use at Union level, as well as templates for those joint clinical assessments”; see, attached copy).
