After choosing not to include the generalization of medical cannabis in the Social Security Financing Bill, after having rejected all the amendments proposing generalization in Committee, the government finally proposed its amendment on medical cannabis, as announced clumsily by the Minister of Health on October 11.
As deciphered by the Union of Industrialists for the Valorization of Hemp Extracts (UIVEC) and by Santé France Cannabis, the amendment proposes the creation of a status ad hoc temporary for cannabis-based medicines, defined as “any medicine whose active substance is composed of a preparation based on Cannabis sativa L. including an extract”. These medications will be subject to temporary authorization, issued on a drug-by-drug basis, for a period of 5 years, renewable accordingly.
If the amendment is adopted, these drugs will be available as a first prescription in hospital with renewal as part of a traditional care pathway, as during the experiment.
The price of cannabis-based medicines will be determined based on their characteristics, composition and pharmaceutical form. In addition, these prices will be aligned with European prices or tariffs for a comparable total market size, in accordance with a future decree. The terms of coverage of these medications by health insurance will be set by decree.
The pharmaceutical quality and safety criteria as well as the therapeutic indications eligible, ultimately, for treatment with medical cannabis, will be defined by ministerial decree.
Generalization will not occur before January 1, 2025. In the meantime, patients included in the experiment at the end of March 2024 will continue to receive their treatment until generalization. The second extension must last a maximum of 9 months. Medicines used in this context will be covered by health insurance on the basis of an amount set by ministerial decree.
Several questions remain unanswered, either because they will be fixed by decree or order – the order establishing the conditions of culture and related security for example – or because the text does not go into detail. For example, the form of cannabis-based medicines is not clearly defined: flowers, oils and/or extracts?
Mado Gilanton, president of the Apaiser S&C association, welcomes “excellent news for patients” and recognizes a “first step taken” while obliging herself to remain “mobilized” on the passage of the amendment then on the implementation work of generalization.