Joint clinical assessment of health technologies

Joint clinical assessment is the procedure by which EU Member States jointly assess the relative clinical value of a medicinal product or of certain medical devices, under Regulation (EU) 2021/2282 on health technology assessment. Applicable since 12 January 2025, it produces a joint report to which national authorities, such as the French National Authority for Health, must give due consideration. It covers clinical aspects only, with decisions on price and reimbursement remaining national.

Gradual scope of application

The Regulation applies first to medicinal products containing new active substances intended for the treatment of cancer and to advanced therapy medicinal products, where the application for authorisation is filed under the centralised procedure from 12 January 2025. It extends to orphan medicinal products from 2028, then to all medicinal products falling under the centralised procedure and containing new active substances from 2030. Certain high-risk medical devices, selected by the Coordination Group, come within its scope from 2026.

The procedure

The assessment is conducted under the aegis of a Coordination Group made up of representatives of the Member States, with the support of the Commission. Its scope is defined by questions combining population, intervention, comparators and outcomes, which reflect the needs of the various States. The health technology developer must file a complete dossier within the set time limits, failing which the assessment may be discontinued. The report is in principle published shortly after the authorisation decision. Joint scientific consultations may be requested upstream to guide clinical development.

Issues for companies

The definition of comparators at European level directly shapes the subsequent national assessment of the improvement in actual clinical benefit. The tight timetable requires the authorisation dossier and the assessment dossier to be prepared simultaneously, which increases the volume of data submitted to the authorities and raises the question of their confidentiality.

Key points

Joint clinical assessment moves to European level part of the assessment that precedes price and reimbursement. It should be determined very early whether the product falls within the scope of the Regulation, and the likely comparators anticipated. The joint scientific consultation, requested during development, is the best way to reduce the risk of an unfavourable report.

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This glossary entry is general in scope and does not constitute legal advice.

Dhenne Avocats acts in pharmaceutical patent disputes and on the medicines regulatory questions that accompany them, from the marketing authorisation to the supplementary protection certificate.

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