The cultivation of cannabis for medical use is now authorized in France. The decree published in the Official Journal today February 18 will enter into force on March 1, 2022.
Pharmaceutical state monopoly
The decree concerns above all the addition of the terms “culture” in article R. 5132-74 of the public health code which governs the use of narcotic plants in medicine.
If in substance the decree thus treats cannabis for medical use like any medicine, in form, Yann Bisiou, lecturer in private law and criminal sciences and specialist in drug law, points out some inconsistencies.
“It’s the gasworks we could expect. For example, the decree deprives the CBD decree of legal basis, without referring to the new article 5132-86-1 which will henceforth govern the uses of industrial hemp” laughs Yann.
Nothing serious for the CBD decree, which retains all its value, but an indication of the lack of discussion between the various authorities which govern 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 he is absent on industrial hemp.
Legal comical incident: delta-9-THC becomes illegal again! Article 5132-86, rewritten by the decree, removes the passage which made delta 9-tetrahydrocannabinol an exception to the prohibition of cannabis molecules. Synthetic cannabinoids are now at the same level as natural cannabinoids.
The choice is made by a state monopoly, which will appoint its operators, who themselves will choose the producers concerned, with stricter regulatory conditions than those already known for the production of poppy, for example.
For Yann Bisiou, the main risk associated with the decree lies in the future organization of the medical cannabis sector. “The ANSM can refuse to develop a competitive system, like what is done on opium in France”.
In this hypothesis, the agency can entirely choose a single industrial operator who would delegate production to a limited number of producers, a scheme which strongly limits real access to medical cannabis in foreign examples.
The decree will be supplemented later by decrees to further define the regulation of the medical cannabis industry in France.
A CST for form
In parallel, the Temporary Scientific Committee (CST) “Culture in France of cannabis for medical use – technical specifications of the production chain from plant to drug” of the National Agency for the Safety of Medicines and Health Products (ANSM ) will hold its first meeting today.
The CST, whose value will be purely informative, will meet to discuss the following points:
- The delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) levels of plants
- Cannabis strains used
- The methods of traceability of the plants until the harvest of the flowers
- The expected pharmaceutical forms of cannabis-based medicines
- The pharmaceutical quality criteria as well as the necessary controls