🇫🇷 France Overview
After several years of continually extending a small-scale medical cannabis trial programme, with seemingly little appetite from French regulators for engaging with medical cannabis more meaningfully, the government has now created a legislative framework to establish permanent medical cannabis treatment within the healthcare system, as well as a domestic industry.
The new system is expected to be in place by at least April 2026, as the Minister of Health stated that the 1,600 patients still being treated as part of the ongoing trial will continue to be able to access their medicine until then. The assumption is that they could then access their medicine through the new system.
The new laws will come into effect with the signing of three decrees detailing the legislation.These decrees have been submitted to the European Union (EU), and once they have been signed off at the EU level, they will then be signed at the ministerial level in France. Both of these steps are expected to be formalities, so the path to implementation is clear.
Granulated flower products may be included in the new system, a shift from the latter stages of the trial where only extract products were permitted.
🇫🇷 Regulations
In March 2025, France notified the European Commission of their intention to legalise medical cannabis authorisation and production. The Technical Regulations Information System (TRIS) procedure will take several months before the European Commission approves the regulation, which will be followed by the French high health authority (HAS) ruling on the public insurance reimbursement framework for medical cannabis.
Although the pilot programme moved to only allow extract products, the new framework might allow flower products in granulated form. However, patients will be strictly prohibited from smoking these via traditional methods, and they must consume them via a Conformité Européenne (CE)-certified dry herb vaporisation device.
Products entering the new market will be approved via a process of ‘temporary use authorisations (ATUs)’, which is set to be established. France’s National Agency for the Safety of Medicines and Health Products (ANSM) will oversee the process, validating prescriptions for five-year periods, with renewal available nine months before expiration. The ANSM will have 210 days to respond to applications and will publish all decisions to authorise, refuse, or suspend products on its website.
Domestic cultivation and manufacture will also be permitted under the new system. Domestic cultivators must grow strictly indoors, with outdoor or greenhouse cultivation prohibited. Cultivators must have an existing binding contract with an authorised establishment before they can grow any cannabis and must cultivate for the sole purpose of selling to them.
🇫🇷 Patient Access
Who Can Prescribe?
Under the new generalised medical cannabis framework, only trained and certified physicians will be able to prescribe medical cannabis and training programmes are set to be created after consultation with Haute Autorité de Santé (HAS).
There are currently 274 specialists trained in medical cannabis prescription.
Whate are the treatable pathologies?
- Neuropathic pain
- Drug-resistant epilepsy
- Spasticity associated with multiple sclerosis and other central nervous system disorders
- Relief from the side effects of chemotherapy
- Nausea and loss of appetite, particularly in chemotherapy patients
- Palliative care when symptoms are persistent and unrelieved
Cannabis will remain a treatment of last resort, as it has been in the experiment, and patients must be able to prove that they are intolerant of all other standard therapies, or that these therapies have failed.
Reimbursement:
The French High Health Authority (HAS) still needs to determine how medical cannabis will be reimbursed under public health insurance.