Over 90% of patients taking part in a landmark medical cannabis trial in France are in favour of full legalisation.
The nationwide trial, launched by the National Agency for the Safety of Medicines and Health Products (ANSM) in March 2021, was designed to evaluate how medicinal cannabis could be prescribed and dispensed legally in France.
According to local media, 91% of patients have indicated that they are in favour of general legalisation. The majority have reported positive outcomes in terms of symptom management, particularly for pain relief and palliative care.
A government report, submitted to parliament at the end of September 2022, was in favour of the widespread provision of medical cannabis, but found that GPs had too little involvement in the treatment process. No issues of cannabis abuse or diversion were reported.
The scheme allows up to 3,000 patients to access free cannabis products on prescription, for five approved indications. These include: refractory neuropathic pain, drug-resistant epilepsy, spasticity in multiple sclerosis (MS), cancer-related symptoms and palliative care.
Nathalie Richard, director of the trial at the ANSM, told local media that there are currently 1,453 patients participating, including; 792 with refractory neuropathic pain, 215 with MS-related spasticity, 181 with drug-resistant epilepsy, 105 oncology patients, 104 receiving palliative care and 56 with spasticity in conditions other than MS.
Positive clinical outcomes
While the purpose of the trial is not intended to ‘assess the effectiveness of medical cannabis,’ according to Ms Richard, the data indicates that it is having a positive effect on the symptoms of these conditions.
Dr Nicolas Authier (Clermont-Ferrand) presented the first findings 12 months on from the launch of the trial.
In 80% of cases, patients are prescribed CBD first, with THC introduced at the three month point.
At the beginning of the trial, 81% of patients had ‘severe’ (67%) or ‘unbearable’ (14%) pain. After six months, over a third of patients are said to have reported a decrease of more than 30% in the intensity of their neuropathic pain.
According to a standardised questionnaire, the Patient Global Impression of Change (PGIC) scale, the improvement was ‘significant’, or ‘very significant’, for just over 40% of patients by the third month.
The data on the effects of medical cannabis in palliative care was taken from 150 patients, with an average age of 54-years-old. Cannabis was perceived to have a significant impact on patients’ health over an average treatment time of three months.
Dr Laure Copel, of the Diaconesses Croix Saint-Simon hospital group in Paris, said: “I think it’s a drug that soothes rather than relieves. Another advantage is that it leads to a gradual decrease over six months in the consumption of opioids and psychotropic drugs.”
The trial was due to run until March 2023, but in October last year it was announced that it would be extended for another 12 months. Changes to legislation to permit the widespread prescribing of medical cannabis in France are now not expected until at least March 2024.