The French government has proposed an amendment for broader access to medical cannabis after previously excluding it from the recent Social Security Financing Bill. The amendment, if accepted, will assign a temporary status to cannabis-based medicines, renewable on a five-year basis, and universal access to cannabis-based medicines is anticipated to come into effect by January 1, 2025.
The French government has recently put forward an amendment aimed at broadening the access to medical cannabis. This significant move, articulated through Amendment n° 3296 initially and later substituted by Amendment n° 3298 on October 23, comes after a decision not to include this expansion in the Social Security Financing Bill.
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French Amendment to Medical Cannabis Access
Originally, the French government chose not to encompass the universal access to medical cannabis in the Social Security Financing Bill. It also dismissed all amendments suggesting this broadening in the Committee.
However, there was a shift in stance when the government eventually proposed its own amendment concerning medical cannabis access, highlighting the evolving legal and societal landscape concerning cannabis in France.
Specifics of the French Proposal
According to analysis by the Union of Industrialists for the Valorization of Hemp Extracts (UIVEC) and Health France Cannabis, the French amendment advocates for the creation of a provisional, specific status for cannabis-based medicines. These are delineated as “any medicine whose active substance is composed of a preparation based on Cannabis sativa L. extract”.
Each of these medicines would be subject to a temporary authorization, provided on a case-by-case basis, valid in France for a renewable period of five years.
Prescription and Accessibility
Should the amendment be accepted, these medications would initially be available by prescription in French hospitals, with renewals being part of a standard care process. This approach mirrors practices undertaken during experimental phases, ensuring a level of continuity and regulatory oversight.
Pricing and Medical Insurance Coverage
The price of cannabis-based medicines in France will be assessed based on their attributes, composition, and pharmaceutical form. Additionally, the pricing will be aligned with European prices or rates from markets of a comparable size, adhering to future decrees.
The conditions for the coverage of these medicines by French health insurance will be determined through official decisions, facilitating patient access and affordability.
Quality, Safety Regulations, and Timeline
Parameters concerning the quality and safety of pharmaceuticals, as well as the eligible therapeutic indications for medical cannabis treatments, will be established by French ministerial order, ensuring a comprehensive and regulated framework for medicinal cannabis use.
The universal availability of cannabis-based medicines is not expected before January 1, 2025. In the meantime, French patients already included in experiments ending in March 2024 will continue to receive their treatments until general availability is implemented.
The transition period in France is anticipated to last a maximum of nine months, with general availability commencing once a cannabis-based medicine is authorized and accessible.
French Patient Advocacy and Future Directions
Mado Gilanton, the president of the French association Apaiser S&C, commends this development as “excellent news for patients,” recognizing it as a “first step” while emphasizing the need to remain “mobilized” concerning the amendment’s passage and the realization of its general implementation.
Several aspects remain uncertain, either because they will be determined by decree or official order — such as rules concerning French cultivation and security — or due to the text not elaborating on the specifics. For instance, the format of cannabis-based medicines has not been explicitly described: will they be flowers, oils, and/or extracts?
A meeting of the French Directorate General of Health clarified this aspect on October 24, confirming that cannabis flowers would not be included in the definition of cannabis-based medicines. This adjustment caters to a broad array of regulatory and practical considerations within the medical cannabis framework.
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