The government proposes an amendment to make medical cannabis widely available

After choosing to not to include the widespread use of medical cannabis in the Social Security Financing Bill, after rejecting all of the amendments proposing the generalization in Committee, the government finally proposed its amendment on medical cannabis - the n° 3296 tabled on October 20, which has since been withdrawn and replaced on Monday October 23 by amendment no.3298 - as awkwardly announced by the Minister of Health October 11.

As deciphered by the Union des industriels pour la valorisation des extraits de chanvre (UIVEC) and Santé France Cannabis, the amendment proposes the creation of a status of ad hoc temporary authorization for cannabis-based medicinal products, defined as «any medicinal product whose active substance is composed of a preparation based on Cannabis sativa L., including an extract». These medicines will be subject to a temporary authorization, issued on a medicine-by-medicine basis, for a period of 5 years, renewable for a further 5 years.

If the amendment is adopted, these drugs will be available as initial hospital prescriptions, with renewals as part of a standard care pathway, as during the trial.

The price of cannabis-based medicines will be determined according to 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 forthcoming decree. The terms and conditions governing the reimbursement of these drugs by the health insurance scheme will be set by decree.

Pharmaceutical quality and safety criteria, as well as the therapeutic indications eligible for last-line treatment with medical cannabis, will be defined by ministerial decree.

Generalization will not take place before January 1, 2025. In the meantime, patients included in the trial at the end of March 2024 will continue to receive their treatment until generalization. The second extension should last a maximum of 9 months, but generalization will not take effect until a cannabis-based medicine will be authorized and available. Medicines used in this way will be reimbursed by the health insurance scheme on the basis of an amount set by ministerial decree.

Mado Gilanton, President of the Apaiser S&C association, hails «excellent news for patients» and acknowledges that «the first step has been taken», while insisting that we must remain «mobilized» for the passage of the amendment, and then for the implementation of generalization.

A number of questions remain unanswered, either because they will be determined by decree or order - the order laying down the conditions for cultivation and related safety, 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? A meeting of the French Directorate General for Health clarified this point on Tuesday October 24: cannabis flowers will not be included in the definition of cannabis-based medicines.