Medical use of cannabis
In principle, the production, manufacture, transport, import, export, holding, offer, transfer, acquisition or use of cannabis (plant and resin) and THC are prohibited.
Nonetheless, derogations exist, and medical use is allowed:
- for the purposes of research, product control or the production of authorised derived products, as authorised by the Director of the French Health Agency (ANSM);
- f the concerned product received a Market Authorisation (MA) or a Temporary Marketing Authorisation (ATU).
Any cannabis-based medicine must obtain a Market Authorisation or a Temporary Marketing Authorisation (ATU) which is granted according to scientific criteria of quality, safety and efficacy like any other medicinal product. If the Health Agency deems appropriate, a treatment protocol can be established by both the ANSM and the MA holder, in order to assess side effects, efficiency of the drug and data about the targeted population.
Authorised drugs containing THC will require a prescription by a physician. Moreover, since cannabis-based drugs are considered narcotic drugs, the prescription procedure is more strict.
In the event that infringements are detected within the framework of the treatment protocol established by the Health Agency, the following sanctions apply: (i) fine not exceeding 10% of the turnover achieved, up to a maximum of EUR 1m (ii) a daily penalty payment which may not exceed EUR 2,500 per day if the offender has not complied with its requirements by the end of the period set by a formal notice.
Moreover, the unlawful transport, possession, offer, transfer, acquisition or use of drugs is punishable (i) by 10 years’ imprisonment and a fine of EUR 7.5m if committed by natural persons, and (ii) by 10 years’ imprisonment and a fine of EUR 37.5m and various other sanctions that lead to the entity’s dissolution if committed by legal persons.
Recreational use of cannabis
In France it is forbidden to produce, import and sell recreational cannabis.
Industrial use of cannabis
Certain varieties of cannabis, without narcotic properties, can be used for industrial and commercial purposes under some cumulative conditions:
- the plant is one of the authorised varieties of cannabis;
- only seeds and fibers can be used;
- the use of flowers is prohibited;
- the plant (and not the end product) must have a THC content of less than 0.2%. France has no specific regulation on CBD. CBD-based products are legal if they comply with the general regulatory scope.
Patentability of cannabis-based products
The French Intellectual Property Code provides that inventions whose commercial exploitation would be contrary to public policy shall not be patentable. Pursuant to this principle, if the invention is not contrary to public policy then it is possible to obtain a patent.
The “Agence nationale de sécurité du médicament et des produits de santé” (ANSM) is currently assessing the viability of a specific program in order to allow the medical use of cannabis, particularly for epilepsy, multiple sclerosis and palliative care. The “Comité Scientifique Spécialisé Temporaire” (CSST) should report on the feasibility of using therapeutic cannabis in late 2019. This potential development shall only apply, in the near future, to certain clinical situations and in cases of insufficient relief or poor tolerance.
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