France’s New ATU Process: Why only truly innovative therapies should now apply

By Nicola Allen, Associate Director & Andrea Bernardini, Analyst Email: nallen@partners4access.com or abernardini@partners4access.com The French Authorisation for Temporary Use (ATU) was originally established in 1994 [1] to enable pharmaceutical companies to sell certain medicinal products prior to marketing authorisation and reimbursement negotiations. The original ATU program has since evolved into six different pathways with overlapping…

France to place restrictions on Nominative ATU

By Erfan Akbraian, Analyst Email: eakbraian@partners4access.com France’s National Agency for the Safety of Medicines and Health Products (ANSM)1 governs the early access program called autorisation temporaire d’utilisation (ATU). The ANSM are expected to implement changes set by the French social security law to the nominative ATU program later this year to ease the cost burden…