Legalization of medical cannabis in France probably postponed until 2026

Will France succeed in legalizing medical cannabis? While the National Agency for Medicines and Health Products Safety (ANSM) stated earlier this year that that cannabis-based treatments would be available by 2025, the widespread adoption of medical cannabis in France is unlikely to happen before 2026.

To meet the statutory deadline—namely, for marketing authorizations for cannabis-based medicines to be issued by December 31, 2024—France should have notified the European Commission (EC) of the inclusion of the production and distribution of cannabis-based medicines in general law during the first half of 2024.

According to our information, everything was ready before the summer break, even as the dissolution of the National Assembly was being finalized—a development that, we were told, did not disrupt the process. Decisions had even been made regarding the possibility of producing flowers in secure cartridges for patients to vaporize and for export to manufacturers.

Now that the holidays are over, we have learned that new decisions have been made regarding the project—even though it had already been approved—notably by Mildeca. Furthermore, the General Directorate of Health (DGS) explained to us that «in the context of day-to-day operations,» the notification could not be issued.

Above all, our various sources tell us that it is the fear—whether justified or not—that the project will not win the approval of the future government that has stalled the project in certain political circles.

However, this notification is a prerequisite for the widespread use of medical cannabis in France. After notification, the European Commission has 3 months to review it and an additional 3 months if it wishes to provide comments. The texts must then be incorporated into French law by decree and/or administrative order. Next, the ANSM must collect and process applications for drug approvals before they become available to the small number of patients who will have to make do with oils and other non-flower-based formulations.

At a meeting held last Thursday between the ANSM and industry representatives, the Agency explained that it had done as much as it possibly could and was now awaiting political decisions that fall outside its purview.

Since the DGS has made it clear to us that the project will have to wait until a new government is in place and is willing to address the issue, the widespread adoption of medical cannabis will not take place on January 1, 2025, as previously announced. Given the time required for each stage and based on our calculations, it will be postponed until the vote on the next Social Security Financing Bill (PLFSS), with implementation scheduled for 2026.

What might happen then?

Uncertainty reigns regarding 2025. The transition period between the pilot phase and full implementation could be extended into 2025, still without cannabis flowers and with a major uncertainty regarding both funding and the possibility of enrolling new patients.

The patients included in the trial whom we contacted—who already felt sidelined by the lack of cannabis flowers in the widespread distribution— generally tell us that their only option will be to either return to growing cannabis themselves or turn to the black market to obtain supplies, with the risk of coming across flowers containing bacteria that are harmful to their compromised immune systems, which have been weakened by their various illnesses.

Manufacturers ready for 2025—there are two of them in France—will also have to wait and finance the year 2025 out of their own pockets, with no possibility of producing oils outside the R&D framework or exporting their flower production for the time being, for example to Germany. The only activity permitted for them is the destruction of their crop, even though French patients could benefit from it. This absurdity has been noted by everyone.