ANSM assures that cannabis treatments will be available by 2025

Launched in 2021, France's medical cannabis trial has reached its participation target with 3,035 patients who have now joined the program, including 1,842 who continue to be monitored and treated.

According to a progress report published to clarify the details of the final year of the experiment, the’The effectiveness of medical cannabis has been confirmed in the various indications covered by the trial, with efficacy maintained over several months for most patients.

Future regulatory framework for cannabis-based medicines

The road to widespread use of medical cannabis in France lies in a regulatory framework overseen by the’French National Agency for the Safety of Medicines (ANSM). The agency specifies that the experiment will end on March 26, 2024 and will then enter a transitional period, until cannabis-based medicines authorized by the ANSM become available.

In the meantime, «the conditions of the trial remain the same, and the drugs that can be prescribed during this transitional period remain those of the trial, including flowering tops for vaporization», says the Temporary Scientific Committee (TSC).

The ANSM states that cannabis-derived medicines will have to be approved by December 31, 2024 before they can be prescribed for medical purposes. The recent social security financing law for 2024 laid the foundations for the authorization and accessibility of cannabis-based medicines, defining their status and prescription conditions.

The final year of the trial will therefore see current patients continue their treatment as part of a follow-up program, while new registrations will cease after March 26, 2024. In addition, inhalation flowers will be phased out over the coming weeks, forcing prescribers to switch patients to alternative forms such as oil or tablets.

As announced by us, From December 31, 2024, the dried cannabis flowers can no longer be prescribed or dispensed to patients. Although included in the therapeutic cannabis experiment, and accounting for 50 to 70% of cannabis medicines prescribed on foreign medical markets, the Ministry of the Interior has, according to our information, vetoed making cannabis flowers available to sick people. When questioned on this point, Frédéric Valletoux, the Minister Delegate for Health and Prevention, did not reply.

The ANSM is therefore requesting that no further treatment with flowering tops be initiated during the transitional period, «except for patients in whom their use will only be for a short period, as in certain palliative situations, for example», and that treatment be phased out for current patients.