The situation regarding medical cannabis is evolving, albeit with some difficulty, in France. After a period of waiting, the decree authorizing theexperiment with therapeutic cannabis in France has been published. This was followed by the order establishing the specifications. CBD.FR focuses on this in this article.
The recommendation for this experiment with therapeutic cannabis in France
Indeed, before discussing the decree itself, it is important to review the previous recommendations, which culminated in the current authorization and the specifications outlined in the terms of reference. In fact, cannabis is a narcotic in France. Consequently, its possession and use are prohibited by Law No. 70-1320 of December 31, 1970 . However, Decree No. 2013-473 of June 5, 2013, amending the provisions of Article R. 5132-86 of the Public Health Code concerning the prohibition of operations involving cannabis or its derivatives, allows the marketing of cannabis-based medicines and their derivatives. In this context, this provision facilitates the emergence of two cannabis-based products in France: SATIVEX and DRONABINOL (MARINOL). The former, a mixture of two cannabis extracts, received authorization in 2014. Its primary purpose is to treat symptoms related to moderate to severe spasticity associated with multiple sclerosis, as a second-line treatment in adult patients. Unfortunately, difficulties in reaching an agreement on its price are hindering its commercialization in France. The latter ( DRONABINOL
), however, has been available since 2003. In this regard, the relevant indications are: neuropathic pain after failure of all treatments, nausea and vomiting in the context of anticancer chemotherapy, and anorexia in HIV patients. These two major varieties have brought to the forefront the issue of a possible trial of medical cannabis in France.
In this context, the ANSM (French National Agency for Medicines and Health Products Safety) created a Temporary Specialized Scientific Committee (CSST) in 2018. Its purpose was to conduct anEvaluation of the relevance and feasibility of making medical cannabis available in France.
It should be noted that the two specialties mentioned above are not included in this study. In December 2018, the CSST published its conclusions. The Committee concluded:
“that it is relevant to authorize the use of cannabis for therapeutic purposes for patients in certain clinical situations and in cases of insufficient relief or poor tolerance of available therapies, whether medicinal or non-medicinal (and in particular, available cannabis or cannabinoid-based products).”
Furthermore, certain indications were selected. These include the use of medical cannabis for:
- pain that is refractory to available therapies (medicinal or non-medicinal);
- Certain severe and drug-resistant forms of epilepsy;
- supportive care in oncology;
- palliative care;
painful spasticity in multiple sclerosis.
At the end of December 2018, the ANSM (French National Agency for Medicines and Health Products Safety) issued a favorable opinion on these conclusions of the CSST (French National Committee for the Study of Therapeutic Cannabis). Consequently, it proposed that this use first be the subject of an experiment. The CSST then met again, studied the modalities of the experiment, and consulted with stakeholders. The ANSM accepted the CSST’s recommendations on the experimental phase on July 11, 2019.That said, the next step following this recommendation is the publication of the decree authorizing theexperiment with medical cannabis in France.
Followed by the ministerial order establishing the specifications.
Regarding the decree authorizing the experiment with medical cannabis in France In fact, it is dated October 7, 2020, and was published in the official journal on October 9, 2020. That said, what is its essence?
First, let’s discuss the start date, the number of patients involved, and the duration. The medical cannabis trial in France
- began, at the latest, on March 31, 2021. A total of 3,000 patients are involved. The trial period is set at two years.
- Next, what medications are recommended by the CSST (French National Authority for Health) for the
medical cannabis trial in France? These are primarily:medications based on dried cannabis flowers and full-spectrum extracts;immediate-effect forms (sublingual and inhaled forms based on oil and dried flowers for vaporization);
extended-effect forms (oral forms such as oral solutions or oil capsules).
It should be noted that, in this regard, the CSST (French National Authority for Health) recommends making available 5 different Tetrahydrocannabinol (THC)/Cannabidiol (CBD) ratios.
- Finally, what about the recommended dosage for this medical cannabis trial in France? As indicated by VIDAL (French National Institute of Health Data), it:
- (…) must be titrated by the physician until the minimum effective dose and/or side effects tolerable to the patient are reached.
- Furthermore, what are the other relevant specifications? We present them point by point.
- Medications: are subject to an initial prescription by physicians and are provided free of charge by the companies participating in the trial.
- Physicians: volunteers and trained, practicing in reference facilities that manage the 5 therapeutic indications or clinical situations refractory to available treatments and selected for the trial. Prescription renewal: can be carried out by any previously trained physician (via the dedicated platform). Information
Patients included in the trial are informed about specific precautions for using cannabis-based medications, potential side effects, contraindications, and effects on driving or operating machinery at the time of prescription.
The protocol: VIDAL describes it as follows: The implementation schedule for the experimental phase will include 6 months of setup, 6 months of patient enrollment, 6 months of patient follow-up with submission of an interim report, and 6 months of data analysis.
This evaluation will be conducted by a multidisciplinary scientific committee, including patient representatives. This committee will be responsible for analyzing registry data, regularly monitoring safety data, and writing study reports. Furthermore, he will work on developing specifications for suppliers of the medications used for the trial, developing training materials (modules for prescribers, dispensers, and patients), defining thecontent of the registry
and drafting a guide of recommendations for prescribers.
Documentation
- On the decree and the order
To obtain the decree of October 7, 2020, you can:
- Visit LEGIFRANCE.
To obtain the order of October 16, 2020, setting the specifications for cannabis-based medications used during the trial, you can:
- Visit LEGIFRANCE.
On the specifications
Regarding the specifications, we have made several specific documents available to you.
- Download the presentation of the specifications by Newsweed.
