Three important issues related to early access for medicines have been presented to the French Senate in a report of June 2018. France seeks to update its policies in this area, and to encourage inward investment by pharmaceutical companies, so it is keen to address:
- Whether the autorisations temporaires d’utilisation (ATU, temporary authorisations of use) is fit for purpose, or if its entry criteria may be widened. According to Thomson Reuters, this could also change the system to be categorised per indication not per product, and that the retroactive price reduction scheme of 2017 can apply
- New price fixing models and an accelerated marketing authorisation procedure based on the priority and efficacy of new products
- Increasing resources for clinical trials, and refining the role of, e.g., ethics committees in the process
We look forward to seeing how the French system adapts to the potential new policies that result from the report.