Sativex is a medication based on delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD), packaged as an oral spray. It was developed to treat spasticity related to multiple sclerosis when conventional muscle relaxant treatments are insufficient. In France, its regulatory status remains complex, and access to this medication does not function like an ordinary prescription.
Sativex and experimental medical cannabis: two distinct systems
A common confusion is to equate Sativex with medical cannabis as it has been distributed under the French experimentation. The two fall under different regulatory logics.
Sativex is a standardized medication, manufactured by a pharmaceutical laboratory, with a fixed composition of THC and CBD. The national experimentation launched in March 2021 was based on preparations of medical cannabis provided according to a specific protocol led by the ANSM, with several forms (oils, dried flowers, capsules).
The experimentation ended on December 31, 2024. Only patients already included were able to continue receiving their treatments during a transition period.
As detailed in the article from Le Réseau Santé, the steps to access Sativex follow a very specific pathway, distinct from this experimentation.
Therefore, the end of the experimentation does not mean that Sativex is now available in pharmacies on simple prescription. No general prescription authorization has been opened following this closure.
Regulatory framework for Sativex in France: what the HAS is preparing
Sativex has a marketing authorization (MA) in several European countries for moderate to severe spasticity of multiple sclerosis. In France, the situation has remained blocked for years, mainly due to price negotiations and positioning within the therapeutic strategy.
On July 23, 2025, the HAS adopted a specific evaluation method for cannabis-based medications. This method, commissioned by the Ministry of Health, aims to frame the examination of these products by the transparency committee. It explicitly excludes medications that already have an MA, creating an area of ambiguity for Sativex depending on its exact administrative status in France.
This methodological framework does not constitute a marketing authorization or reimbursement. It lays the groundwork for the HAS to provide a structured opinion, taking into account the specificities of these products and the societal context. The transparency committee will evaluate each medication on a case-by-case basis, relying on available clinical data and the decree that will specify the regulatory modalities.
Prescription of Sativex: the concrete conditions for access
To date, a patient suffering from spasticity related to multiple sclerosis cannot request Sativex from their general practitioner and pick it up at a city pharmacy. The access pathway, when it exists, goes through exceptional circuits.
Possible exceptional access routes
In the absence of conventional marketing, medications not available on the French market can sometimes be obtained through mechanisms regulated by the ANSM:
- Compassionate access (formerly named nominative ATU) allows a hospital doctor to request authorization to use a medication for a specific patient when no suitable therapeutic alternative exists. The request is evaluated on a case-by-case basis by the ANSM.
- The framework for compassionate prescription (formerly cohort ATU) concerns a defined group of patients based on clinical criteria. The ANSM publishes decisions related to these frameworks on its website.
- Exceptional importation may be considered in certain situations, but it remains subject to prior agreement from the ANSM and involves a hospital prescriber.
In all cases, the initial prescription falls under a hospital specialist, generally a neurologist working in a reference or specialized center for multiple sclerosis.
Role of the neurologist and the MS reference center
The patient must be monitored for multiple sclerosis with spasticity resistant to usual treatments. The neurologist assesses whether the available muscle relaxants (baclofen, tizanidine, dantrolene) have been insufficiently effective or poorly tolerated. Spasticity affects a large majority of patients with MS to varying degrees, and it remains one of the most refractory symptoms to common drug treatments.
If the neurologist believes that Sativex is a relevant option, they prepare a request file to the ANSM. The patient cannot initiate this process alone: it is the prescriber who submits the administrative request.
Monitoring treatment and regulatory precautions
When a patient obtains Sativex through an exceptional framework, the treatment is accompanied by follow-up obligations. The prescriber must transmit pharmacovigilance data to the ANSM, and the patient is informed of specific precautions for use.
Since Sativex contains THC, it is classified among narcotics. This implies specific prescription rules: secure prescription, limited prescription duration, and dispensing in hospital pharmacies or retrocession depending on the chosen circuit.
- The patient must be informed of possible effects on alertness and driving.
- Renewal is not automatic: each new prescription undergoes clinical reevaluation.
- Treatment may be discontinued if spasticity does not improve after a trial period defined by the prescriber.
The regulatory situation of Sativex in France remains dependent on the opinion that the HAS will render after applying its new evaluation method. As long as this opinion has not been published and a decree has not set the definitive framework, access is exclusively through the exceptional circuits of the ANSM, with a hospital neurologist as the main contact. Affected patients have every interest in discussing this directly with their specialized multiple sclerosis care team.
