The future of France’s medical marijuana trial hangs in the balance, with a crucial decision looming on the horizon. Despite a proposed amendment to extend the trial until December 2025, political obstacles and bureaucratic delays are casting a shadow of uncertainty over the program. This leaves thousands of patients relying on medical cannabis for relief in a precarious situation, their access to treatment hanging by a thread.
The initial trial, set to conclude in March 2024, was extended last October after positive results. However, the latest amendment is facing hurdles that could derail the program’s progress. The amendment, introduced by Ensemble pour la République deputies Michel Lauzzana and Jean-François Rousset, aims to correct what they call an “oversight” in the 2025 Social Security Financing Bill (PLFSS). This oversight could leave close to 2,000 patients without access to medical marijuana.
The proposed legislation intends to extend the trial until medication is authorized or December 31, 2025, whichever comes first. The amendment is a testament to the growing recognition of the potential benefits of medical cannabis, with the country’s former health minister, Aurélien Rousseau, acknowledging the positive clinical outcomes observed during the trial.
However, the road to full medical marijuana legalization in France remains fraught with challenges. The main stumbling block is the lack of “European marketing authorization.” This authorization, crucial for the wider rollout of medical cannabis, is yet to be granted. The process of obtaining this authorization involves a complex notification process with the European Commission (EC), which can take up to six months to review. This notification, which was expected to be submitted by mid-2024, has been delayed due to ongoing political issues, leaving the future uncertain. The EC’s approval is essential for the program’s advancement as it allows for the integration of medical marijuana legislation into French law, paving the way for the French National Agency for Medicines and Health Products Safety (ANSM) to process drug applications.
Currently, the program is in a transition phase, with new patients unable to enroll. Existing patients, however, will continue to receive their medication and reimbursements until a full medical marijuana program is established. The fate of the proposed amendment, and the future of France’s medical marijuana trial, will be determined during the first reading of the 2025 PLFSS on October 28th. The outcome will have far-reaching implications for patients reliant on medical cannabis, as well as the country’s broader approach to this rapidly evolving field of medicine.