France Takes a Stride Towards Mainstreaming Medical Cannabis with New Legislation

On October 23, the French government introduced a significant amendment to the Social Security Financing Bill (PLFSS), marking a pivotal moment for the integration of medical cannabis within France's healthcare framework. According to the new proposal, medical cannabis products will be granted a ‘temporary authorization' for a five-year period, with the possibility of indefinite renewal by French authorities.

France initiated its medical cannabis experiment in 2021, providing free cannabis products to around 3,000 patients for an initially planned two-year trial period. The experiment aimed to assess prescribing and dispensing conditions, gather safety and efficacy data, and involve health professionals and patients in the process.

However, when France's PLFSS was published last month, it conspicuously omitted any mention of the ongoing cannabis experiment, causing concern among patients and industry stakeholders. The experiment was set to conclude in March 2024.

Following industry pushback and concerns about patients losing access to their medicine, France's Minister of Health announced an amendment to the bill in mid-October, addressing the issue of medical cannabis regulation.

The Amendment

• Medicinal products containing cannabis will now undergo a ‘temporary authorization' for five years, potentially extendable for five-year periods by the ANSM.
• Authorization for products will be assessed on a case-by-case basis.
• Generalization is expected no earlier than January 2025, pending European authorities' decision.
• A transition period of up to nine months will follow the conclusion of the current experiment in April 2024, during which generalization is anticipated.
• The government allocated a €10 million budget for this transition period, a significant increase from the experiment's current budget.
• After generalization, medical cannabis will remain a last-resort treatment and will only be prescribed in hospitals.
• Product prices will be determined later, considering market prices in comparable European countries.
• Criteria for medical cannabis prescription will be established through decree following ANSM proposals.
• Inhaled forms of cannabis, including flowers, are excluded from the program.

While welcomed by the industry, the amendment raises questions about the restrictive access conditions for patients who must exhaust other treatment options before being considered for medical cannabis. Additionally, concerns persist regarding reimbursement and data protection as companies supplying medical cannabis are required to collect patient consumption data and treatment responses.