On 14 December 2020, the French Social Security Financing Act for 20211 (article 78) reformed early market access mechanisms in France and simplified the former systems of derogatory reimbursement for medicines, which included the temporary authorisation for use (ATU) and temporary recommendation for use (RTU) regimes.
Two new regimes have been created: early access authorisation (AAP – exceptional use of certain drugs for specific therapeutic indications, intended to treat serious, rare, or disabling diseases) and compassionate use (exceptional use of certain medicines in specific therapeutic indications).
