Sativex is a buccal spray combining two cannabis extracts (THC and CBD), which has held a marketing authorization (MA) in France since January 8, 2014. Its indication: moderate to severe spasticity related to multiple sclerosis, when conventional antispastic treatments do not provide sufficient relief. Despite this MA, the medication has never been marketed in France, placing patients in a unique regulatory situation.
Why Sativex remains unavailable in pharmacies despite its MA
The MA granted in 2014 was supposed to pave the way for a quick market launch. The blockage occurs downstream, at the level of price negotiations between the Almirall laboratory and the French health authorities. These negotiations have never reached a conclusion.
The Economic Committee for Health Products (CEPS) sets the prices for reimbursable medications in France. For Sativex, the gap between the price requested by Almirall and the level deemed acceptable by the authorities has prevented any reimbursement listing. Without a negotiated price, there is no distribution in pharmacies.
This situation has persisted for over ten years. Patients with multiple sclerosis who could benefit from Sativex find themselves facing a medication that is authorized on paper but physically absent from pharmaceutical circuits. As detailed in the guide from Le Réseau Santé, several regulatory pathways still allow access under strict conditions.
Early access and temporary authorization for use: concrete legal pathways
In the absence of traditional marketing, French law provides for derogatory mechanisms for medications with an MA but not available on the market. Two systems deserve distinction.
The former nominative ATU
Before the 2021 reform, the nominative temporary authorization for use (ATU) allowed a hospital physician to request access to a non-marketed medication from the ANSM for a specifically named patient. This procedure was used for Sativex in certain cases of refractory spasticity related to MS.
The nominative ATU required a detailed clinical justification and the absence of an appropriate therapeutic alternative. The request had to go through a hospital prescriber, never a general practitioner.
The early access system post-2021
Since the 2021 social security financing law, the framework has evolved. The early access system replaces the former ATUs. For a medication like Sativex, which has an MA but is not marketed, the procedure now involves a request to the Haute Autorité de santé (HAS), which evaluates the presumed clinical benefit.
The conditions remain strict:
- The prescriber must be a specialist physician working in a healthcare facility (neurologist in the case of MS)
- The patient must present moderate to severe spasticity resistant to first-line treatments
- The request must document the failure or intolerance to conventional oral antispastics
No general practitioner can initiate this process alone. The pathway always begins at the hospital, in a neurology department.
Medical cannabis experimentation in France: a framework distinct from Sativex
A common confusion is to equate Sativex with the French experimentation on therapeutic cannabis launched by the ANSM. These two systems operate under different logics.
The experimentation, which began in 2021, focuses on cannabis-based preparations (dried flowers, oils, capsules) prescribed for five indications, including refractory neuropathic pain, certain forms of epilepsy, and palliative care. Spasticity related to MS is included in the scope, but the products used are not Sativex: they are standardized preparations provided within the experimental framework.
As of September 2026, the definitive system intended to succeed this experimentation was not yet operational. A decree on the reimbursement of medical cannabis was submitted to the Council of State in July 2026, indicating that the transition to sustainable access is progressing but not yet complete.
Practical steps for a patient with MS
The first step is to consult their hospital neurologist. Only this specialist can assess whether the patient’s spasticity justifies a request for access to Sativex or a cannabinoid preparation within the experimental framework.
The neurologist then compiles a medical file detailing:
- The history of tested antispastic treatments and their results
- The spasticity score (modified Ashworth scale or equivalent)
- The side effects or insufficient response to reference molecules such as baclofen
This file is sent to the hospital pharmacy, which manages the request with the ANSM or the HAS depending on the applicable system. The patient does not have to contact these institutions themselves.
If the request is accepted, the medication is dispensed by the health facility’s pharmacy, not in a city pharmacy. Follow-up remains hospital-based, with regular consultations to assess efficacy and side effects.
Prohibition of personal importation and legal risks
Sativex contains THC, classified as a narcotic in France. Importing this medication from a European country where it is marketed (United Kingdom, Germany, Spain) without authorization constitutes a criminal offense, even with a foreign prescription.
French legislation does not recognize medical cannabis prescriptions issued abroad. Crossing the border with Sativex purchased from a Spanish pharmacy exposes one to prosecution for possession of a narcotic, regardless of therapeutic motivations.
The only legal framework remains the one described above: French hospital prescription, institutional validation, dispensing in a health facility pharmacy. This pathway is cumbersome, but it protects the patient legally and ensures appropriate medical follow-up for a medication whose pharmacological profile requires specific monitoring.
