The temporary authorisation for use (Autorisation Temporaire d’Utilisation, ATU) programme in France is intended to provide early access to medicines for patients with a severe or rare disease with high unmet need and for which no authorised therapeutic alternatives are available. In this article published in European Pharmaceutical Review, CRA’s Cécile Matthews, Ioanna Stefani and Paula Urrutiocoechea discuss the new ATU program and what it means for pharma moving forward.
The ATU programme, previously divided into six systems, has now been grouped into two: an early access authorisation programme (Accès précoce aux médicaments, EAP) which includes the cATU and a compassionate access programme (Accès compassionnel aux médicaments, CAP) which includes nATU, among others. While it remains to be seen how the EAP and CAP systems will impact pricing and market access in the future, the French authorities seem to have increased the hurdles to early access.
Under the reforms, fewer products are likely to be approved compared with the previous ATU system. For many years, France has claimed its early access programme is the most generous and fairest for patients in Europe. Will this still be the case in the future?