French Medical Cannabis Pilot Delayed Until January 2021
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France’s medical cannabis pilot program launch is to be delayed due to the impact of the coronavirus, the French Medicines Agency (ANSM) and the Health Ministry have confirmed in a press release.
Initially scheduled to begin in September, the need to mobilize resources from the health authorities in order to tackle the coronavirus pandemic now means that the commencement of the medical cannabis program will be postponed until January 2021 at the latest.
France remains committed to the pilot trial
In the press release, the General Directorate of Health (DGS) and the ANSM reiterate their continued commitment to ensuring that the medical cannabis pilot program goes ahead in France.
To illustrate this, the DGS and ANSM report that, in collaboration with members of the ANSM Scientific Committee and other learned societies, they have been continuing to work on the implementation measures for the program, including:
- The criteria for the inclusion/non-inclusion of patients
- The design of the electronic national register for monitoring patients enrolled in the pilot program
- The specifications that will allow suppliers and distributors of cannabis-based medicines to be selected
- The establishment of a training platform for healthcare professionals, which is expected to be fully operational by December
- The collation of a list of volunteer expert centers that will include patients in the pilot program
More information on these tasks and measures will be made publicly available “by summer” in the publication of a new decree, say the DGS and ANSM.
Medical cannabis in France
Now that Canada has legalized both medical and recreational cannabis at the federal level, and 11 US states have opted to do the same, there is a certain perception of North America being at the forefront of cannabis reform. But the cannabis reform effort has an equally long history in Europe.
In the Netherlands, cannabis use has been decriminalized since 1976. The Dutch nation was also the first in the world to fully legalize cannabis for medicinal use in 1999. As of late 2019, medical cannabis is legal for use in 22 European countries. Luxembourg intends to become the first European country to legalize recreational cannabis in the near future.
In contrast to these European neighbors, France has some of the strictest cannabis laws in Europe. In 2014, the Ministry of Health amended the country’s public health code to allow the use of one cannabis-based medicine – Sativex, for patients with multiple sclerosis – but did not move to bring about a larger medical cannabis treatment program.
The ANSM began working on widening access to medical cannabis in September 2018, with the establishment of a scientific committee tasked with evaluating the “relevance and the feasibility of making cannabis available for therapeutic use in France.” This medical cannabis pilot is the culmination of that work – an opportunity for French health authorities to test a medical cannabis model under real conditions.
More information on the medical cannabis pilot program
The ANSM has said that the purpose of this medical cannabis pilot program is not to demonstrate the effectiveness or usefulness of cannabis as a medicinal treatment. The organization’s experts already recognize that cannabis could be effective in treating certain conditions.
The main objective of the planned pilot program is to evaluate the practical realities of whether the nation could support a medical cannabis system in terms of the required product supply, patient monitoring, and other logistical factors. Patient data will be collected and analyzed over the course of the pilot, but this is a secondary objective done in order to gather the first set of French data on cannabis treatments.
The pilot program is expected to run for at least 6 months and involve around 3,000 patients suffering from conditions such neuropathic pain, treatment-resistant epilepsy, and central nervous system disorders, to name a few. The medical cannabis provided to these patients is expected to be in the form of dried cannabis flower and/or sublingual cannabis tinctures. Further details are expected to be revealed with the publication of the new decree this summer.