France Sets July Deadline for Medical Cannabis Regulations, as Study Shows Opioid Reductions

Now,  thanks to a formal request to the Commission d’accès aux documents administratifs (CADA) by French cannabis association l’Union des industriels pour la valorisation des extraits de chanvre (UIVEC), the figures have been published.

Ludovic Rachou, President of UIVEC, said in a press release to members: “The scientific data is stacking up and converging. It is French, it is public, it is solid. We are asking the government to publish the texts before the end of June 2026. Patients in therapeutic impasse have waited long enough.”

France’s medical cannabis limbo

France’s medical cannabis pilot programme, launched in 2021, was originally intended as a two-year proof of concept ahead of a generalised national framework. Five years on, that framework has yet to be enacted. Dogged by political inaction, the pilot has been repeatedly extended, with participating patients dropping from a peak of 3,000 to around 700.

A more stable political environment changed the calculus. The 2024 Social Security Finance Act made generalisation a legal obligation, and by early 2026 the final regulatory steps were finally in motion.

At Cannabis Europa Paris in February, officials from the Direction Générale de la Santé and the Direction de la Sécurité Sociale presented the draft decree setting out how cannabis-based medicines would be evaluated and priced under France’s social security framework.

That decree remains unpublished. Until it is, HAS cannot deliver a formal reimbursement opinion; without that opinion, companies cannot register products with ANSM, and generalised prescribing cannot begin. July’s expected confirmation will mark the start of this final process.

U.CANNABIS Study

The publication of the data from the U.CANNABIS study was a critical factor in securing a timeline commitment from the French health minister. Only after reviewing the results was AFP prompted to seek a direct response on when the regulations would be published.

However, the release of the results themselves is also a significant development. The U.CANNABIS was commissioned directly by ANSM, France’s medicines regulator, as the official scientific evaluation of the country’s medical cannabis experimentation programme.

It was conducted independently by Inserm UMR 1219 and the AHeaD epidemiology team at the Université de Bordeaux.

Researchers were instructed to track what happened to patients’ healthcare consumption in the twelve months before and the six months after they started medical cannabis treatment.

Unlike many real-world studies, these were not self-reported outcomes, but were based on reimbursement data. The research team cross-referenced the ReCann clinical registry, which records every patient enrolled in the experimentation, against the SNDS, France’s national social security reimbursement database.

The study was finalised in September 2025, but remained sealed until UIVEC’s CADA request, nine months later. Against the current backdrop of delayed deliberations on how medical cannabis should be reimbursed, figures tracking patients’ interaction with healthcare more broadly represent a critical factor in the equation.

What the study found

The study, seen by our sister publication, Business of Cannabis, covered 1,971 patients across the five approved indications. As an observational study using interrupted time series methodology, it can identify changes in healthcare use associated with cannabis initiation, but it cannot accurately establish causation in the way a randomised controlled trial would.

Readers wishing to access the full document should contact UIVEC directly.

The authors concluded that medical cannabis initiation shows ‘a positive impact, albeit of low intensity, on healthcare use.’ The results are statistically significant across most indications, but the effect sizes are modest.

The clearest signal comes from refractory neuropathic pain, the largest cohort at 1,105 patients. The share receiving analgesics fell by approximately four in every 100 after initiation, from around 73% to 69%.

Gabapentinoid use dropped by around three per 100, strong opioid use by 1.4 per 100, and benzodiazepine use by 1.6 per 100. Monthly attendances at specialist chronic pain day hospitals fell by around 0.9 per 100 per month.

Palliative care shows the largest absolute numbers, with approximately 21 in every 100 patients fewer on strong opioids after initiation, and average daily opioid doses declining by 13.6 defined daily doses per patient.

The study notes, however, that analgesic use in this group was already declining in the months before medical cannabis initiation, complicating direct attribution.

In oncology, around 12 in every 100 patients fewer received analgesics after initiation. Among patients with MS spasticity, the frequency of non-opioid analgesic use fell by about six in every 100, but the study’s dose analysis showed an increase in analgesic quantity after initiation, a pattern the authors attribute to modelling artefacts in the segmented regression rather than a true increase in medication burden.

In refractory epilepsy, benzodiazepine reductions were observed but did not reach statistical significance, with the authors citing insufficient sample size.

Five treatment lines, one medicine

Taken together, the neuropathic pain data alone shows reductions across five separate treatment lines, gabapentinoids, non-opioid analgesics, benzodiazepines, strong opioids, and specialist pain clinic visits.

For HAS, which must determine whether cannabis-based medicines displace existing treatments or supplement them, that is a more useful signal than patient self-report. The SNDS methodology, tracking actual reimbursement claims, is the specific type of evidence the reimbursement evaluation is designed to weigh.

The results sit alongside a safety record the reimbursement argument will also require. ANSM pharmacovigilance monitoring across the full experimentation has recorded zero cases of addiction or misuse. The most recent monitoring period logged 30 pharmacovigilance cases, eight serious, primarily neurological and psychiatric adverse events, and none involving dependency.

If the decree is published on the new timeline, clears Conseil d’État review, and HAS delivers its reimbursement opinion in autumn as expected, the first prescriptions under the generalised framework are unlikely to come before 2027.