What happened to the report on the medical cannabis experiment?

The 2020 Social Security Financing Plan (PLFSS), which allowed for the testing of medical cannabis In France, the law required that a report on the trial be submitted to Parliament six months before its conclusion. The National Agency for Medicines and Health Products Safety (ANSM) had announced September 26. Lawmakers are still waiting.

In the process of ministerial consolidation

When we contacted the General Directorate of Health (DGS), it confirmed that it is in possession of the reports. It intends to consolidate them «based on the information recently received» (sic) and then bring them «to the attention of Parliament as part of the debates on the 2023 Social Security Financing Bill» in mid-October.

However, the report’s main findings are already known. The report is based on the ReCann registry, which tracks the progress of the trial, as well as reports from the pharmacovigilance network and patient feedback.

Part of the evaluation was therefore conducted by members of the Temporary Scientific Committee (CST) «Monitoring the French Pilot Program on the Medical Use of Cannabis,» who attended a roundtable discussion organized by patient advocacy groups last Thursday at the National Assembly in an effort to raise lawmakers’ awareness of their cause.

A Successful Experiment

«The trial has yielded positive results; the system is now operational,» summarized Nicolas Authier, president of the CST, during the event.

The overall health status of «more than 700 patients» with refractory neuropathic pain enrolled in the medical cannabis trial was «found to have improved by 30%» after six months of treatment.

Refractory neuropathic pain was «the indication that included the most patients.» The number of patients reporting so-called «unbearable» pain was reduced by a factor of 2.5. “Two-thirds of patients reported a significant improvement in their quality of life. Regarding anxiety, at least 40% of the patients reported a significant improvement.”.

«One in two doctors considers improving the patient’s overall health to be at least important,» he added, citing feedback from the field in the absence of an available report.

The pilot program was also intended to validate the distribution chain for medical cannabis and confirm that there was no potential for misuse—that is, that medical cannabis was not being diverted to recreational users. Both of these points were reported to have been validated.

What is still needed for the legalization of medical cannabis?

So what is still needed to move toward the widespread adoption of the medical marijuana ? According to data from the Ministry of Health, the trial has so far enrolled just over 2,100 patients out of a possible 3,000. This numerus clausus was, however, a budgetary adjustment inherent in the design of the experiment; the medical cannabis suppliers who provide it free of charge for the duration of the pilot program.

But perhaps we should look at the amendments that have already been submitted as part of the Social Security Financing Bill. While Renaissance, under the leadership of Caroline Janvier and a bipartisan group of lawmakers, as well as in separate proposals from LFI and EELV, call for the widespread adoption of medical cannabis, while two amendments propose extending the duration of the pilot program.

The first, sponsored by members of Les Républicains, calls for a two-year extension. The second, sponsored by Horizons, Edouard Philippe’s party, expresses the desire to extend the pilot program for a total of 5 years, with a justification that echoes the Key messaging points from French manufacturers members of the Santé France Cannabis association: «This amendment proposes to extend the pilot program on the use of medical cannabis in order to better evaluate it while establishing a French supply chain in the event that the measure is made permanent.».

Santé Cannabis France states that it has not submitted any amendments to any member of parliament.

«We trust lawmakers to move this legislation forward. Like many stakeholders in the sector, we regret this decision and deplore the fact that the conditions are not currently in place to allow patients access to cannabis-based medicines. Over the past two years, we have consistently worked alongside patient advocacy groups to urge French authorities to expedite the development of the regulatory framework.»

Santé France Cannabis brings together companies such as Hemp it ADN—the innovation and plant breeding division of HEMP-it and the National Federation of Hemp Producers, Overseed or Boiron.