After years of controversial debates, the French regulatory framework relating to cannabis and cannabis-derived products has been evolving rapidly the past two years towards the implementation of an experimental phase in the medical field.
Following the recent move initiated by the French National Agency for Medicines and Health Products Safety (l’Agence nationale de sécurité du médicament et des produits de santé, the “ANSM”) towards the availability of cannabis for therapeutic use in certain situations, the legislator has decided to roll out the pilot program to assess the medical use of cannabis to perhaps create a new economic sector.
1. The French regulator’s green light for therapeutic cannabis experiment as a first step
On September 10, 2018, the ANSM created a one-year temporary specialized scientific committee (Comité Scientifique Spécialisé Temporaire, “CSST”) to assess the relevance and feasibility of making therapeutic cannabis available on the French market.
After a first favorable opinion released in December 2018, the CSST issued final recommendations on June 27, 2019 for the implementation of a medical cannabis pilot program in France for certain therapeutic indications and clinical situations.
The program aims to assess, in real-life situations, the CSST’s recommendations relating to prescribing and dispensing conditions, as well as the adherence of healthcare professionals and patients to these conditions, and to gather French efficacy and safety data.
The CSST thus defined an entire tailor-made regulatory framework for making therapeutic cannabis available: the relevant pharmaceutical forms, modes of administration, ratios and recommended doses, prescribing and dispensing conditions, contraindications and precautions for use, patient follow-up (through the creation of a national registry of treated patients to ensure adequate monitoring and to evaluate the risk/benefit ratio of therapeutic cannabis), the collection and assessment of adverse effects and efficacy data and the relevant communication and information tools.
The CSST also selected certain therapeutic indications for the pilot program. At this stage, only cases of insufficient relief or poor tolerance of available therapies (i.e. neuropathic pain refractory to therapies (medicinal or not) available, certain drug-resistant forms of epilepsy, certain persistent symptoms in oncology, palliative situations and painful spasticity of multiple sclerosis or other pathologies of the central nervous system) are concerned.
On July 11, 2019, the ANSM fully endorsed the CSST’s recommendations and committed to set up the technical implementation details of the pilot program in collaboration with the French Health Ministry.On October 15, 2019, a new committee (Comité Scientifique Temporaire, “CST”) in charge of the implementation of the French medical cannabis pilot program was appointed by the ANSM for six months. This committee is responsible for drafting recommendations on the program specifications (cahier des charges) especially with regard to the type of medicines used during the experiment, the content of the training for health care professionals, the content of the patient monitoring registry, as well as recommendations for prescribers. Publication of the program specifications is planned for February 2020.
During the pilot program, the CST will also monitor and analyze the data of the national registry, including efficacy and safety data, and will draft an assessment report. The program is expected to be launched in September 2020.
2. Legal basis for the medical use of cannabis under the pilot program
The 2020 Social Security Financing Bill recently endorsed the experimentation of the use of cannabis for therapeutic purpose (i.e. article 43 of law No.2019-1446 of 24 December 2019). The law secures that it will be launched for two years, and shall be limited to certain indications and clinical situations where existing therapies provide insufficient relief or are not well tolerated.
It also aims to ensure that the costs for the purchase of the products, but also the creation of the patient monitoring registry and its scientific assessment, and the training of physicians and pharmacists who may prescribe or deliver cannabis products, are adequately funded. However, a decree will have to detail the funding conditions.
Importantly, it also secures that cannabis for therapeutic use shall be manufactured in compliance with pharmaceutical standards.
Six months before the end of the two-year pilot phase, the government will publish a global report on the experimentation, to decide whether or not it should be broadened.
The ANSM expects 3,000 patients to be eligible for the pilot program. If the results of the experiment – expected for 2022 – are conclusive, a large number of patients could ultimately use cannabis for medical treatment. This new sector could also represent an important market opportunity. According to the French Council of Economic Analysis, this market could generate up to € 2 billion of general tax revenue for the country1.