The French government buries medical cannabis. Or is it?
A previous version of this article, which relied solely on the minister’s remarks before the committee, reported that the Ministry of Health had refused to make medical cannabis widely available once the pilot program ended in March 2024. The latest information we have gathered indicates that this is not the case. We are therefore updating the article to reflect the latest developments.
When questioned by Representative Caroline Janvier during a meeting of the National Assembly’s Social Affairs Committee—held in connection with the review of the 2024 Social Security Financing Bill (PLFSS)—regarding the future of medical cannabis in France, Health Minister Aurélien Rousseau, stated on Wednesday, October 11, that the medical cannabis pilot program would be extended beyond 2024 and that a solution would be put in place for current participants in the program, who should be able to continue receiving their treatments.
He also mentioned the introduction of an amendment to establish a status ad hoc for cannabis-based treatments, which would allow them to be dispensed outside the scope of their approved indications. The amendment in question would also include provisions to extend the pilot program, as proposed by the General Directorate of Health at the beginning of the year, during a transitional period before medical cannabis becomes part of general law.
Mr. Rousseau also confirmed the positive feedback from patients, which the pilot program designed to evaluate the prescription and distribution system for medical cannabis was not intended to measure.
«We are in a situation where we have clinical feedback indicating a benefit for the patient,» said Mr. Rousseau.
He then mentioned the lack of a marketing authorization (MA) at the European level for medical cannabis, which explains the use of a status ad hoc for cannabis-based medications, pending marketing authorizations for cannabis flowers and extracts. Twenty countries in Europe, including Germany, already offer cannabis-based treatments.
He clarified that such authorization should be available by 2025; otherwise, compassionate access could be implemented. It was this point, in fact, that caused our confusion, as compassionate use—according to the minister’s remarks—was mentioned in the event of a refusal of a European marketing authorization, and thus after 2025, with no explicit transition period between the end of the trial and this «compassionate use.».
Compassionate access, which is by definition very restrictive, is, to our understanding, one of the scenarios that was on the table for «widening access» to medical cannabis. This is a scenario that patients and doctors are fighting against, as it is so complex to manage for large-scale prescriptions. It could, however, be useful after the implementation of a European marketing authorization for off-label uses.
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Ultimately, one or more amendments to the Social Security Budget Bill (PLFSS 2024) are likely to be proposed to ensure that all participants in the pilot program can continue to benefit from it and to establish a legal status ad hoc for cannabis-based medications.
From many patient organizations, French medical cannabis companies and a bipartisan group of lawmakers had rallied to include the widespread availability of medical cannabis in the 2024 Social Security Financing Bill (PLFSS). In this latest op-ed, published in *Libération*, it stated that 'ignoring the positive results of the pilot program and failing to expand access to medical cannabis in 2024 would be a betrayal of those who suffer, particularly from cancer, epilepsy, multiple sclerosis, or other chronic pain .».
Medical cannabis could help 300,000 sick French people in the medium term and generate nearly 300 million euros a year.
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fabien
13 October 2023 at 9 h 31 min
The minister juggled dates, permits, and a hint of compassion, leaving the public waiting for a resolution that seems far off. Is this a suspense strategy or just a French-style comedy? We don’t know, but it certainly deserves a review on Netflix! ✨ fabien cbdtech