In March 2025, amidst a political turnaround, the French government submitted three documents to the European Union detailing its proposal for a national system of medical cannabis.

A recent report, titled "State of the Medical Cannabis Industry in France – 2025", signed by experts Benjamin-Alexandre Jeanroy and Aurélien Bernard, states that although the new framework is challenging for many companies, its strict pharmaceutical model brings benefits.

“Overall, the system is serious, pharmaceutical, and designed to reduce stigma and improve access. It may not be the fastest implementation, but it will likely be a durable and exportable framework to other countries,” the authors told Business of Cannabis.

Regulatory processes and implementation timeline

The proposal follows two parallel paths, the first being formal regulation. Jeanroy explains that the texts went through the three-month period of the EU's TRIS system and were submitted to the Conseil d'État (Council of State), which evaluates legal aspects. The process is expected to be completed by September 2025, followed by signing by the Ministries of Health and Economy, and subsequent publication in the Official Journal.

In the second path, the Haute Autorité de Santé (HAS) is responsible for defining reimbursement criteria, prescriber training, and other operational guidelines. On July 29, 2025, the HAS published a roadmap for the evaluation of cannabis-based medicines, focusing on products without marketing authorization (AMM) falling under five therapeutic indications:

- Refractory neuropathic pain;

- Drug-resistant epilepsy (adults and children);

- Painful spasticity in multiple sclerosis or CNS disorders;

- Treatment-resistant symptoms in cancer patients;

- Palliative care with persistent symptoms.

The process includes open public consultations until September 16, 2025, and hearings with stakeholders such as ANSM, patient associations, and user groups. The final decision is expected by the end of the first quarter of 2026.

Integration with the national pharmaceutical system

Unlike other countries, France aims to integrate medical cannabis into the existing healthcare system. This choice aims to avoid the mistakes of markets that created parallel structures.

“French authorities have built something more streamlined – more ‘French’ – which makes sense from a commercial and regulatory standpoint,” the authors said.

The exclusion of raw flower (except in sealed vaporizers) reduces stigma and facilitates prescription. Forms such as oils, capsules, and vaporizers are preferred by doctors and pharmacists.

Professional training and gradual prescription

There is still resistance from generalist doctors due to a lack of training and protocols. Nevertheless, the prescription regimen is already structured: it starts with a hospital specialist or a doctor in an authorized center and is then passed on to a general practitioner.

France has around 2,000 to 3,000 trained professionals, including specialists, pharmacists, and primary care physicians. “Training is now modular, short, and designed to attract more prescribers quickly,” Jeanroy explains in the report.

Market outlook and business opportunities

According to Prohibition Partners, the French market could reach €806 million in annual revenue by 2035. The first opportunities will focus on importing products, as long as they are conducted by registered pharmaceutical entities or in partnership with a ("exploitant pharmaceutique").

Establishing a local pharmaceutical company requires structure, registration with ANSM, and hiring licensed professionals. Therefore, the recommendation is to partner with already established companies.

European companies with products approved by the EU will have an easier time meeting French requirements, but non-standard formats may require additional validations.

“This requirement opens up space for innovation and differentiation in the market. France can become a testing ground for new formulations and distribution strategies,” conclude the authors.

With information from Cannabis Health