In September 2018, the French National Agency for Medicines and Health Products Safety (Agence nationale de sécurité du médicament et des produits de santé, ANSM) started to work on cannabis for medical use by the establishment of a scientific committee to assess the relevance and feasibility of legalizing medical cannabis in France (see also French pilot programme for medical cannabis).
Dossier on cannabis for medical use
In addition to the pilot programme information published in 2019, the ANSM has published a dossier on cannabis for medical use. This dossier presents:
the therapeutic cases for which cannabis is relevant,
the scope of the investigation,
the stages of the investigation,
the work (as videos) of the French temporary specialized committee on cannabis (Comité scientifique spécialisé temporaire, CSST)
Is it allowed to grow cannabis for medicinal purposes in France? No. Even during the pilot phase with cannabis for medical use, article R.5132-86 of the Public Health Code (code de la santé publique, CSP) remains in force, which maintains the prohibition of growing cannabis, including for therapeutic purposes, in France.
May products containing CBD be imported, exported, manufactured, distributed or marketed in shops or online? First of all, it is pointed out that the ANSM is not intended to review or authorize commercial projects. Nevertheless, the ANSM reminds operators to consult the update of legislation on this subject (Cannabidiol (CBD) le point sur la législation) published by the MILDECA (Mission interministérielle de lutte contre les drogues et les conduites addictives) on 11 June 2018. It states, among other things, that CBD-based products are prohibited if they contain THC (even in small quantities) and/or are derived from unauthorized varieties and plant parts. Furthermore, manufacturers and sellers of CBD products are not allowed to make any therapeutic efficacy claims.
Use of medicinal cannabis in certain cases
The use of cannabis for medical purposes is considered relevant by the ANSM for patients in certain clinical situations and in cases of insufficient relief or poor tolerability of other available therapies. Therapeutic situations in which the use of cannabis for medical purposes is relevant are:
pain resistant to available therapies (medicinal or non-medicinal),
certain forms of severe, drug-resistant epilepsy,
supporting care in oncology,
painful spasticity in multiple sclerosis.
Programme planned to start in the second half of 2020
The launch of the medical cannabis programme is scheduled for the second half of 2020. One of the objectives is to collect the first French efficacy and safety data. The ANSM recommends (analogous to the information of the pilot programme) the delivery of dried cannabis flowers and full spectrum extracts of the following five THC/CBD ratios:
THC 1 : 1 CBD,
THC 1 : 20 CBD,
THC 1 : 50 CBD,
THC 5 : 20 CBD,
THC 20 : 1 CBD.
Dose adjustment should be made by the physician until the minimum effective dose and/or the maximum tolerable side effects are reached. Data on prescription and dispensing conditions, contra-indications and precautions for use, patient compliance and adverse events should be collected and evaluated.