Accelerated access to innovative medicines: more than 120,000 French patients concerned

In France, as in other European countries, derogation mechanisms exist to provide rapid, so-called "early" access to presumed innovative medicines before their marketing authorization or reimbursement, for patients suffering from a rare, serious or disabling disease in a therapeutic impasse. It is the European country with the largest number of medicines offered to a cohort of patients under derogation access, compared to its neighbors (Germany, England, Spain, France, Italy), according to the European Observatory on Delays in Access to Medicines.

This observatory, the result of a joint initiative between the French Health Insurance, health authorities in France, and their European counterparts, measured the availability and access times of 57 recent drugs that provide recognized therapeutic progress, particularly in the treatment of cancer. Of these treatments, whose reimbursable expenditure amounts to €4.8 billion in 2024 (excluding rebates), 49 drugs (86%) were subject to early exemption access, which allowed patients without effective solutions to benefit from these innovations more quickly.

The financing of these devices is based on 100% coverage by health insurance on the basis of an allowance, the amount of which is freely set by the laboratory throughout the early access period.