The French National Medicines Safety Agency (ANSM) has officially stated that flowers will not be incorporated into its forthcoming comprehensive medical cannabis framework. Although somewhat anticipated, the sudden decision and the ANSM's failure to propose any feasible alternatives for patients reliant on cannabis flower have triggered widespread outrage.
This announcement is also likely to dismay French cannabis enterprises, who are keenly aware of the prevalence of medical cannabis flower in European markets.
This development unfolds as additional information about France's eagerly awaited medical cannabis expansion is unveiled, marking the end of years of delays and uncertainty for both patients and businesses. The decision does not effect the status of CBD in France as a non-harmful and healthy cannabinoid.
What transpired?
In late February, the ANSM issued an 'update on the progress of the past year's experimentation and the introduction of cannabis-based medicines.'
This update marked the first official communication regarding the forthcoming 'transition period' and eventual expansion of medical cannabis since a last-minute amendment was passed late last year, guaranteeing ongoing patient access to treatment.
While this amendment hinted that only oral solutions would be pursued, it did not definitively exclude the inclusion of flower in the program going forward.
However, in a public update and accompanying letter to healthcare professionals, the ANSM unequivocally confirmed the exclusion of flower.
"In the upcoming weeks, medicines in the form of flowers (flowering tops for inhalation) will no longer be available. Therefore, prescribing physicians must gradually discontinue flower treatment for their patients and refrain from initiating new treatments with this form."
Effective March 26, cannabis flower distribution will cease from the program's exclusive supplier, Aurora. Once the reserve stocks are depleted, patients will have no legal means to access medical cannabis flower.
Although approximately 100 patients were receiving medical cannabis flower under the pilot program, the sudden halt in their treatment and the absence of alternative medications have sparked outrage within France's medical community.
Dr. Nicolas Authier, a key figure in the pilot program, expressed his surprise: "What surprises us as doctors is the abruptness of the decision. We anticipated having time to gradually taper off therapy. Discontinuing a treatment that patients have been taking for several years cannot be accomplished in two weeks, but rather over several months. This could significantly impact the pain experienced by patients."
It is understood that during the transition period until April 2025, when the generalization will officially commence, the pilot scheme will rely on existing stock reserves.
Set Up for Failure
According to Paris-based cannabis consultancy Augur Associates, France's pilot scheme has been designed from the outset to discourage the use of flowers through various means.
Benjamin-Alexandre Jeanroy, CEO and co-founder of Augur Associates, informed Business of Cannabis that not only were the vaporization devices required for consuming flower more expensive than oils, but the intricate process of prescribing flower acted as a barrier to its widespread adoption.
"Prescribers are far less accustomed to dealing with these types of products compared to oils, so the training required for prescribers would be more time-consuming and costly. Flower is a much more complex product. Therefore, the focus was heavily on non-flower prescriptions. All these factors created an environment where it was much simpler to opt for oil, which is why we've seen so few users of flower in the experiment."
He further noted that the low uptake in the pilot program is now being cited as a rationale for its exclusion from the generalized framework.
In response to inquiries about the future of flower, the government attempted to shift the blame onto Aurora, stating: "(it) is explained by the wish of the manufacturer not to continue the supply of products."
However, as Mr. Jeanroy points out, they fail to mention that Aurora has supplied products free of charge throughout the pilot, and it is understandably reluctant to continue doing so.
This "shaky" justification, Mr. Jeanroy suggests, could lead to the decision being challenged in court.
"It's also my personal belief that this will be contested in the courts by patients in one form or another, and it will be challenging for the courts to uphold. I would say the justification is somewhat dubious."
More Insights into the Upcoming Expansion
The ANSM's announcement also shed light on the future development of the forthcoming generalized scheme.
Patients who were enrolled in the pilot scheme before March 27, 2024, will be permitted to continue their medical cannabis treatment, with "treatment continuing to be provided according to the same methods as before." However, no new participants will be accepted into the pilot program after this date.
Moreover, new healthcare professionals will have the opportunity to undergo training to partake in the experiment and assist their patients.
Of significant importance, the ANSM stipulates that drugs intended for inclusion in the generalization in 2025 must have obtained authorization from the ANSM no later than December 31, 2024.
According to insights from the Business of Cannabis, the Directorate General of Health (DGS) is currently disseminating details about how this registration process will operate. It appears probable that products will be available for patients by January 2025.
Bottom Line
The exclusion of cannabis flower from France's medical cannabis program underscores significant challenges in patient access and regulatory framework. The abrupt decision has sparked outrage and raised concerns about patient care, particularly for those reliant on cannabis flower treatment. Critics argue that the pilot program's design may have contributed to this outcome, with logistical complexities and a lack of feasible alternatives cited as reasons for exclusion. The government's attempt to shift blame onto the supplier has been met with skepticism, suggesting potential legal challenges ahead. Moving forward, the ANSM's announcement provides insights into the future expansion of the program, with existing patients allowed to continue treatment and new healthcare professionals undergoing training. However, the timeline for product availability and the implications of excluding cannabis flower remain uncertain. Ultimately, the decision highlights the intricate balance between patient needs, industry interests, and regulatory considerations in shaping France's evolving medical cannabis landscape.
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