French experience in regulating the possibilities of using the therapeutic properties of cannabis

The specialized association of Ukrainian cannabis growers initiated the development of a departmental normative legal act, within the framework of which the possibility of using the leaves and inflorescences of technical hemp of a therapeutic orientation (with a huge therapeutic potential) for industrial purposes (in food products, cosmetic preparations, food / feed / biologically active additives) already in 2021.

On the pages of the specialized electronic edition of Ukrainian cannabis growers, the attention of our dear readers has been focused several times on the developed algorithms and mechanisms by which in economically developed countries changes are made to the current legislation regulating the possibilities for the use of cannabis for medical purposes. In particular, attention was focused on “ How the French are approaching amendments to legislation concerning various aspects of modern cannabis growing ”, “ How France is preparing to legalize the use of cannabis for medical purposes ”, and also that “ France is on the verge of launching a trial medical programs to use the therapeutic properties of cannabis”. Given the active lobbying of this issue by individual forces on the territory of Ukraine, it is worth taking a closer look at how this issue is being implemented in the country that is the leader of industrial hemp farming in the EU - France.

The official publications of the Republic published the Order of October 16, 2020, establishing the specifications for hemp-based drugs, provided for conducting experiments, provided for in Article 43 of Law No. 2019-1446 of December 24, 2019.

In particular, the aforementioned document states that the pharmaceuticals used in the pilot pilot program will be in the form of oils, capsules or spray. Their use is intended exclusively for patients suffering from severe illnesses in the framework of ongoing experiments. Hemp pharmacological preparations will be prescribed in case of impossibility of treatment with traditional methods, significant side effects of modern therapy, or in case of insufficient relief of symptoms of the disease with traditional methods of treatment.

About 3000 patients will participate in the experimental program

Indications for the use of hemp-based pharmacological preparations

The list of therapeutic indications or clinical conditions within which the therapeutic use of hemp-based pharmacological preparations is allowed in the framework of the above experiment is limited by the following symptoms:

- neuropathic pain that cannot be stopped by available treatment methods;

- certain forms of drug-resistant epilepsy;

- some intractable symptoms of oncology associated with cancer treatment or anticancer treatment;

- palliative situations;

- painful spasticity from multiple sclerosis or other pathologies of the central nervous system.

Responsible for distribution and production

The hemp medicines used in the experiment will be manufactured in accordance with Good Manufacturing Practices in accordance with the Public Health Code or any other internationally recognized standard. They must meet the pharmaceutical quality criteria set out in the specifications, which describe the technical characteristics and expected quality, as well as the necessary control measures for the manufacture of such drugs.

The National Agency for the Safety of Medicines and Health Products is the competent authority responsible for receiving applications for the selection of service providers for the free supply and distribution of hemp-based medicines to patients who will participate in experiments in the medicinal use of the plant.

On the one hand, the supplier will ensure the supply of the hemp-based drugs used during the experiment throughout the experiment, and on the other hand, the importing pharmaceutical institution is responsible for the use of the drugs used during the experiment.

ANSM - medical cannabis regulator

The French Agency for the Safety of Medicines and Health Products (Agence Nationale de Sécurité du Médicament et des Produits de Santé, ANSM) reserves the right to request the need to visit the plant's cultivation and processing sites from the supplier. In the event of a violation of good agricultural practice or a similar standard in the country of origin, Agency staff should report the violation to the competent authority of the respective country of export. In the event of non-compliance with the characteristics of medical cannabis used in a medical experiment, delays in supplies, negligence, complete or partial non-compliance with ANSM requirements, poor compliance with specifications or order forms, Agency employees may decide to terminate the specifications for the supplier or to search for an alternative supplier.

Those. ANSM, depending on the deficiencies identified at the enterprise, can initiate a procedure for clarifying the reasons for the violation before suppliers, require corrective measures and prevent their recurrence in the future.

Commentary of experts of the Association "Ukrainian technical hemp"

The state structures of France, despite the enormous pressure from the public, as well as various kinds of lobbying groups, are very responsible in amending the current legislation aimed at regulating the possibility of using the therapeutic properties of cannabis for medical purposes. It should be noted the thoroughness of the preparatory stage preceding the consideration of this issue - regulation of the possibility of conducting research within the framework of pilot programs; their financing; the formation of conditions under which specialists from government agencies can significantly influence the course of the experiment, as well as adjust the activities of companies that will provide raw materials or pharmaceuticals based on hemp. Considering the thoroughness with which the officials of the French Republic approach this issue, as well as the experience of our German colleagues, who since March 2017 have been unable to enter the German medical cannabis market, I would like to warn Ukrainian officials against adopting regulations imposed on us from outside on the use of hemp plant for medicinal purposes, which are not primarily prepared for the benefit of national companies. Including taking into account the activity of lobbying groups working to regulate the use of the hemp plant for medical purposes, the specialized association of Ukrainian cannabis growers initiated the development of a departmental normative legal act, within the framework of which the possibility of using the leaves and inflorescences of technical hemp for therapeutic purposes (with a huge therapeutic potential) will be regulated. for industrial purposes (in food, cosmetics, food / feed / biologically active additives) already in 2021.