A newly-obtained report by France’s Directorate General of Health (DGS) evaluating the impact of the medical cannabis pilot, recommended the roll out of a temporary regulatory framework last year.
The Union of Industrialists for the Valorization of Hemp Extracts (UIVEC) in France says the report, dated 20 November 2023, confirms the benefits of medical cannabis and recommended the creation of a temporary legal framework to guarantee continuity of care for the 1,800 patients still enrolled in the trial.
UIVEC submitted a request for the publication of the report to the Commission for Access to Administrative Documents (CADA) in May 2024, on the basis that its findings were in the public interest.
France’s medical cannabis pilot launched in 2021, enabling around 3,000 patients to access cannabis-based medicines free of charge, while data was collected to assess outcomes and impact.
It was initially intended to run for two years but after a number of extensions, health officials promised the country would see the general legalisation of medical cannabis by 2025.
This now looks unlikely and the trial period has now been extended again due to delays, compounded by recent political uncertainty, including the dissolution of the National Assembly.
Further concerns were raised after the publication of the PLFSS (France’s social security finance bill) for 2025, which still does not mention medical cannabis or the extension of the experiment.
Report shows ‘significant and lasting improvement in quality of life’
The DGS report highlights that medical cannabis offers benefits in several refractory indications, such as neuropathic pain, spasticity related to multiple sclerosis and some forms of drug-resistant epilepsy.
Data collected during the trial shows a significant and lasting improvement in patients’ quality of life.
Between three and 12 months of follow-up, the percentage of patients describing their pain as ” severe or unbearable” fell from 79% to 29%. In patients with drug-resistant epilepsy, the frequency of seizures per month decreased from an average of 48.7 to 26.1.
The report highlights the fact that “the results of the first evaluation [are] encouraging”, emphasising that “no new pharmacovigilance or addictovigilance signals have been highlighted by these new studies”.
The DSG called for the establishment of a temporary regulatory framework for a period of five years to overcome the limits of the current experiment, while guaranteeing rigorous monitoring of benefits and risks.
This would ensure patient safety while the necessary systems for the prescription and dispensing of cannabis-based medicine was established.
The report states: “The data collected demonstrate clinical efficacy and tolerance acceptable, encouraging a progressive integration of cannabis for medical use into a national regulatory framework.”
Recommendations must be translated into action
The UIVEC now says it is essential that the DGS’s recommendations are translated into action.
“Patients’ waiting time cannot be prolonged indefinitely,” it stated in an email.
“A temporary framework would provide a concrete response to the urgent needs of patients and healthcare professionals, while preparing for a gradual entry into common law at national and European level.”
While many European countries have already integrated medical cannabis into their healthcare systems, France now has data to which could be used to help structure future regulations.
The UIVEC added: “While waiting for European harmonisation, the implementation of a temporary status represents a pragmatic and responsible solution to meet the needs of patients and healthcare professionals.”
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Author: Sarah Sinclair
