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EU HTA Regulation (EU) 2021/2282: JCAs, JSCs and Implementation Shaping National Pricing and Reimbursement for Medicines and High-risk Devices

Published by a LexisNexis Life Sciences expert

Practice notes

Pricing and reimbursement decisions for new healthcare technologies and treatments begin with a health technology assessment (HTA).

The EU’s Health Technology Assessment Regulation (EU) 2021/2282—often called the HTA Regulation (HTAR)—marks a significant change in the appraisal of medicines and specified medical devices for clinical value at EU level. Finalised in December 2021 after lengthy talks, HTAR sets up a standing system for joint clinical assessments (JCAs) of emerging health technologies, replacing the earlier model of voluntary, project-led collaboration. Its objectives are to streamline evidence development, prevent duplicative national HTA activity, and ultimately enable swifter, more evidence-driven access to cutting-edge medicines and devices across Europe. In essence, HTAR provides a harmonised framework for evaluating the clinical effectiveness and safety of new medicines and certain high-risk medical devices throughout the EU. HTAR entered into force on 11 January 2022, with application commencing on 12 January 2025 for oncology medicines, advanced therapy medicinal products (ATMPs) and certain medical devices. Across 2024–25, the European Commission issued six Implementing Regulations, while the Member State Coordination Group on HTA (HTACG) delivered substantial procedural and methodological guidance and initiated joint scientific consultations (JSCs) and JCA workflows. Manufacturers must now adhere to EU-level clinical evidence processes, such as...

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Web page updated on 21/05/2026

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