France authorizes the cultivation and production of medical cannabis

Professor Nicolas Authier is a psychiatrist at the Clermont-Ferrand University Hospital. Until now, he was the president of the Temporary Scientific Committee on the experimentation of cannabis for medical use. He details the stakes for this committee: "It aims to develop the French supply chain for the cultivation and manufacture of cannabis-based medicines. This committee will, on the one hand, examine a ministerial order that will define the conditions for cultivating this cannabis intended for the manufacture of medicines: where will it be cultivated, how will it be secured? It will not be in open fields; it will be cannabis in enclosed areas. The committee will examine a second order that will define the specifications of these future cannabis-based medicines, their quality, their composition, their status." In short: the decree authorizes the cultivation of cannabis for medical purposes in France and the preparation of medicines. Something that was impossible until now in France.

The substance of the decree is clear: it treats medical cannabis like any other medicine. The form, however, contains contradictory aspects. This is the opinion of Me Yann Bisiou, senior lecturer in private law and criminal sciences and specialist in drug law: "It's the bureaucratic mess we could have expected. For example, the decree deprives the basic CBD decree of its legal basis, without referring to the new article 5132-86-1 which will now regulate the uses of industrial hemp."

The CBD decree in question retains its full value. However, this implies that the different bodies that govern industrial and medical cannabis do not communicate effectively. It should also be noted that the Minister of Industry is not present in the medical cannabis organizational framework... while he is a driving force for industrial hemp. The opposite is true for the Minister of Interior, who is absent from industrial hemp but present for medical cannabis.

An important detail: the delta-9-THC molecule is once again illegal. This is noted in article 5132-86. The decree removes the paragraph that considered delta 9-tetrahydrocannabinol as an exception to the prohibition of cannabis molecules. Synthetic cannabinoids are now on the same level as natural cannabinoids.

A probable state monopoly on medical cannabis

Another insight: France seems to be opting for a state monopoly, which will appoint its operators, similar to Colombia. These same operators will choose the producers involved, with stricter regulatory conditions than those already known in similar sectors (e.g., poppies).

Yann Bisiou sees an organizational economic risk here: "The ANSM may refuse to develop a competitive system, similar to what is done with opium in France."

If this option is chosen, the ANSM will be free to choose a single industrial operator who will subcontract production to a limited number of producers. This model would greatly limit actual access to medical cannabis.

Whatever the decision, the ANSM, which is leading the medical cannabis experiment, will aim to define the specifications and requirements for cannabis-based medicines that the future French sector will produce. Until now, cannabis-based treatments, which are subject to strict controls, have all been imported products.

For information, the agenda for the first meeting of the Temporary Scientific Committee, although informative, will be as follows:

• The delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) content of the plants
• The cannabis varieties used
• The traceability methods for plants up to the harvesting of flowers
• The expected pharmaceutical forms of cannabis-based medicines
• Pharmaceutical quality criteria and necessary controls