The Haute Autorité de Santé (HAS) published its revised ‘Early access authorisation for medicines: HAS evaluation doctrine’ (Autorisation d'accès précoce aux médicaments : doctrine d'évaluation de la HAS) on 13 November 2025. This document, issued by the HAS College under President Fabienne Bartoli, replaces the 2021 framework. It aims to reduce clinical uncertainty when granting early funding, a move that aligns with the fiscal discipline of the 2026 Social Security Financing Bill.
A key change is the demand for comparative data. These data are now expected from the first application to support a ‘presumption of innovation.’ Previously, this was often granted based on non-comparative trials. While indirect comparisons or real-world evidence are permitted, they must now be backed by a rigorous justification explaining why a randomised trial was not possible.
The definition of ‘appropriate treatment’ has also narrowed. A treatment is now considered a relevant comparator if it is used in common practice, even without a formal marketing authorisation for that specific use, provided it is supported by clinical guidelines. This replaces a more lenient previous interpretation where only authorised products were typically considered.
Industry trade bodies have noted that these standards may delay access to breakthrough therapies where patient recruitment is difficult. The 90-day review period remains, but dossiers lacking comparative benchmarks face a higher risk of rejection.
These measures will likely result in fewer approvals and a lower success rate for early access requests. Greater emphasis on robust clinical development plans means that global trial designs must align with these French requirements much earlier to secure market entry.
Source: Haute Autorité de Santé (HAS)
Link: Doctrine d’évaluation relative à l’accès précoce / Evaluation doctrine for early access
Date: 13 November 2025