The French Social Security Finance Bill (PLFSS) for 2021 was officially presented to the Council of Ministers on 7 October 2020. One of the main innovation presented under the PLFSS for 2021, Article 38 completely overhauls the system of Authorizations for Temporary Use (ATU) and Recommendation for Temporary Use (RTU) by means of two new systems of access and coverage by the health insurance.
Early access authorization, on the one hand, will be reserved only for innovative medicines for which the pharmaceutical company undertakes to submit a Marketing Authorization Application (MAA) within a specific period of time. The general purpose of this system is to harmonize the current systems for cohort ATU (ATUc), nominative ATU (ATUn) and RTU for which an MAA will be requested. This early access authorization will be based on a decision taken by the French National Authority for Health (HAS) acting with the advice and consent of the French National Agency for Medicines and Health Products Safety (ANSM) and will have to be issued within a specific period of time (within 60 to 80 days from the date of submission).
Compassionate access authorization, on the other hand, will cover medicines that will not be the subject of an MAA request but which meet an unmet therapeutic need. It may be requested either by a hospital prescriber for a named patient (if the drug is not authorized and not available in France) or by the ANSM in the form of a recommendation covering a cohort of patients (if the drug is subject to a well-established off-label use on the French territory).
These measures will automatically be covered by the health insurance as soon as the early access or compassionate access authorization is granted. However, the terms and conditions of coverage for these systems differ, ranging from a free pricing system by the pharmaceutical company to a system of limit prices set by the Minister for Solidarity and Health.
Please note this blog post was written by a Clifford Chance LLP employee. Clifford Chance LLP is the parent company of Clifford Chance Applied Solutions (CCAS). The content within this post does not constitute legal advice.
Projet de loi de financement de la sécurité sociale pour 2021 (ECOX2023815L)