Cultivation and production of medical cannabis authorized in France

The cultivation of cannabis for medical use is now authorized in France. The decree published in the Journal Officiel today, February 18, will come into force on March 1, 2022.

State pharmaceutical monopoly

The decree primarily concerns the addition of the words «of cultivation» to article R. 5132-74 of the French Public Health Code, which governs the use of narcotic plants in medicine.

While the decree treats cannabis for medical use like any other medicine, Yann Bisiou, a lecturer in private law and criminal science specializing in drug law, points out a number of inconsistencies.

«It's the gas factory you'd expect. For example, the decree deprives’CBD order legal basis, without reference to the new article 5132-86-1 which will henceforth govern the uses of industrial hemp», laughs Yann.

Nothing serious for the CBD order, that retains all its value, It's a sign of the lack of discussion between the various authorities governing industrial and medical cannabis. Also, the Minister of Industry is absent from the organization of medical cannabis, while he is present on industrial hemp, but not the Ministry of the Interior, while it is absent on the industrial hemp.

Legal quirk in passing: the delta-9-THC becomes illegal again ! Article 5132-86, rewritten by the decree, removes the passage that made delta 9-tetrahydrocannabinol an exception to the ban on cannabis molecules. Synthetic cannabinoids are now on the same level as natural cannabinoids.

We have opted for a state monopoly, which will designate its operators, who in turn will choose the growers concerned, with stricter regulatory conditions than those already in place for poppy production, for example.

For Yann Bisiou, the main risk associated with the decree lies in the future organization of the medical cannabis industry. «The ANSM may refuse to develop a competitive system, like the one used for opium in France».

In this case, the agency may well choose a single industrial operator who would delegate production to a limited number of producers, a scheme that would be very similar to the one described above. which severely limits real access to medical cannabis in foreign examples.

The decree will later be supplemented by orders to further define the regulation of the medical cannabis industry in France.

A CST for form

At the same time, the Temporary Scientific Committee (CST) «Cultivation of cannabis for medical use in France - technical specifications of the production chain from plant to medicine» of the Agence nationale de sécurité du médicament et des produits de santé (ANSM) will hold its first meeting today.

The CST, whose first meeting will be for information only, will meet over 4 months to address the following issues:

• Levels of delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) of plants
• The cannabis varieties used
• Traceability procedures from planting to flower harvesting
• Expected pharmaceutical forms of cannabis-based medicines
• Pharmaceutical quality criteria and controls