Extension of experimentation of the medical use of cannabis in France for an additional six month period

In a press release dated 2 January 2025, the French minister of health announced the extension of the experimentation of the medical use of cannabis, initiated in 2019. This extension only concerns patients already involved in the experimental program and will continue for an additional six month period, until 30 June 2025. 

The launch of this experimentation had already marked a significant step forward in pharmaceutical and narcotics regulations, with the aim of evaluating the efficacy and safety of the medical use of cannabis.

As a reminder, first experimentations for the medical use of cannabis were conducted in 2018 by the French National Agency for Medicines and Healthcare Products’ Safety (ANSM), with the creation of a multidisciplinary scientific committee gathering healthcare professionals and patients. This initiative answered to a growing demand from patients and healthcare professionals, and was based both on scientific data showing the value of cannabis in treating various pathologies and on feedback on the medical use of cannabis in several other countries such as Canada, Germany and the Netherlands.

Following the recommendations made by this committee, the experimentation of the medical use of cannabis was approved in France in 2019, as part of the adoption of the French Social Security Finance Act for 2020 n°2019-1446 of 24 December 2019. The first patient was included in the experimentation in March 2021.

The experimentation was created for patients suffering from pathologies such as epilepsy, intractable oncology symptoms linked to cancer, or refractory neuropathic pain for which relief from existing treatments was insufficient, or who suffered from poor tolerance to these treatments.

Initially launched for two years, this experimentation was extended for a further year by the French Social Security Finance Act for 2023 n°2022-1616 of 23 December 2022.

According to the ANSM, the experimentation had demonstrated a secured distribution circuit and efficacy in the treatment of pathologies, with a reassuring safety profile and few serious side effects.

The organization of the end of the experimentation was introduced by the French Social Security Finance Act for 2024 n°2023-1250 of 26 December 2023, which stipulated that cannabis-based medicines used during the experimentation would be authorized for use for a temporary period of 5 years, provided by the ANSM. As a result, this law provided a cut-off date on 31 December 2024 for the experimentation of the medical use of cannabis unless a cannabis-based medicine receives a marketing authorization before.

Implementing decree n°2024-259 of 23 March 2024 excluded the arrival of new patients from 27 March 2024, while still allowing the 1 200 patients participating in this experimentation to continue their treatments.

The experimentation was supposed to end on 31 December 2024, but many healthcare professionals and members of the temporary scientific committee have alerted the French prime minister and the French minister of health on the need to ensure continuity of treatment for the patients included. Indeed, the existing cannabidiol- or cannabis-based therapeutic specialties do not cover all the indications that are captured in the current experimentation.

For these reasons, the French minister of health has confirmed that the experimentation will continue after 31 December 2024, until 30 June 2025 for patients already included, while maintaining a firm opposition to the recreational use of cannabis.

Authored by Mikael Salmela, Joséphine Pour, and  Charlotte Sors.

Hogan Lovells (Luxembourg) LLP is registered with the Luxembourg bar.