Sativex has had marketing authorization in France since January 8, 2014, granted for moderate to severe spasticity related to multiple sclerosis. Despite this marketing authorization, the drug has never been marketed in French territory. This situation creates a gap between a theoretical right to access and a much more restrictive practical reality for the affected patients.
Sativex and experimental medical cannabis: two distinct frameworks
The confusion between Sativex and medical cannabis from the national experiment arises regularly. Both fall under separate regulatory logics.
Sativex is a cannabinoid-based medication (THC and CBD) in the form of an oral spray, holding marketing authorization targeted at spasticity from multiple sclerosis. The medical cannabis experiment, led by ANSM, covered five broader indications, with various pharmaceutical forms (oils, dried flowers, capsules).
Since March 27, 2024, no new patients can join the experiment, regardless of the indication. Patients already included continue to be cared for under a transitional framework extended by the Ministry of Health, but this framework does not concern Sativex. To obtain a prescription for Sativex, the process goes through regulatory mechanisms specific to medications that have marketing authorization but are not marketed.
Prescription of Sativex in France: why the process remains blocked
A medication can have marketing authorization without ever reaching pharmacies. Sativex illustrates this deadlock for over ten years. The laboratory holding the marketing authorization has not initiated commercialization, due to reasons related to price negotiations with the Economic Committee for Health Products (CEPS).
In the absence of commercialization, a doctor cannot write a standard prescription for Sativex and send it to a local pharmacy. The medication is simply not listed in the French distribution circuit.
Theoretical access pathways
Historically, two mechanisms allowed access to a medication with marketing authorization but not available:
- The temporary authorization for individual use (ATUn), granted by ANSM on a case-by-case basis for an identified patient, upon request from a hospital physician. This mechanism has been replaced by compassionate access since the 2021 reform.
- Exceptional importation, regulated by ANSM, which requires a solid medical justification and the absence of available therapeutic alternatives in France.
- The compassionate framework (early access or compassionate access), which requires the laboratory to submit a request or for ANSM to take the initiative for public health reasons.
In practice, none of these pathways have allowed smooth access to Sativex. Individual requests remain exceptional, and their success depends on ANSM’s assessment at the time of submission.
Sustainable framework for medical cannabis: a law passed, decrees absent
The legislator has passed a framework allowing ANSM to authorize certain cannabis-based medications for a renewable period of five years. This text was theoretically supposed to pave the way for generalization, including for specialties like Sativex.
As of October 2026, implementation remains suspended pending the publication of regulatory texts. The High Authority of Health (HAS) has not completed its evaluation within the initially planned timeline. Fourteen patient associations have called on the Prime Minister to demand the effective application of the law.
This situation has direct consequences. Patients with multiple sclerosis who could benefit from Sativex remain without a legally accessible solution through their local neurologist. The Ministry of Health has extended the care of patients included in the previous experiment beyond March 31, 2026, but this measure does not cover new patients or Sativex specifically.
What HAS still needs to decide
The extension of transitional care will continue until three months after the publication of HAS’s opinion. As long as this opinion is not issued, the sustainable framework remains an empty shell. The available data do not allow for a precise prediction of the implementation date.
Hospital neurology consultation: the only realistic entry point
For a patient suffering from spasticity related to multiple sclerosis, the most concrete step today is to consult in a hospital neurology department. Neurologists working in university hospital centers (CHU) are best positioned to assess the failure of conventional antispastic treatments and, if necessary, initiate a derogatory request to ANSM.
A general practitioner cannot prescribe Sativex. The initial prescription falls to a hospital specialist, in accordance with the conditions of the marketing authorization. The general practitioner can refer to the appropriate service, but their role stops there.
In practice, the hospital neurologist must document:
- The failure or inadequacy of at least one reference antispastic treatment (baclofen, tizanidine, dantrolene).
- The severity of the spasticity and its functional impact on the patient’s daily life.
- The absence of a satisfactory therapeutic alternative among the medications marketed in France.
This file can then serve as the basis for a request for compassionate access or importation, but the outcome depends entirely on ANSM’s position at the time of review.
Sativex and self-medication with CBD: a shortcut to avoid
Faced with administrative blockages, some patients turn to CBD products sold freely in stores or online. These products do not contain THC (or only trace amounts) and do not replicate the effect of Sativex, which relies on a precise ratio of THC and CBD.
Sativex delivers standardized and controlled doses. Commercial CBD oils do not undergo any comparable clinical evaluation and are not medications. Field reports vary on their usefulness in managing spasticity, and no published data allows them to be considered a substitute.
The French regulatory framework places Sativex in the category of cannabis-based medications, subject to strict prescription and dispensing rules. Replacing a regulated treatment with an over-the-counter product carries risks, particularly the risk of delaying appropriate care.
The situation of Sativex in France remains a regulatory case study: an authorized medication, never sold, and patients waiting for the implementing texts to catch up with the law. As long as HAS has not issued its opinion and the decrees have not been published, the process to access it will remain a series of derogatory steps, with no guarantee of success.
