Though France's population has a high rate of cannabis consumption, the country's consumers have yet to see a formal medical cannabis program materialize due to legislators’ conservative approach to the topic.

Currently the only two cannabis-based products with marketing approval in the country are Sativex and Epidyolex, each authorized in exceptional circumstances to treat a very narrow population of patients with specific conditions, though patients have not yet had access to the either due to ongoing price negotiations. Though Sativex has no real prospects on the horizon, Epidyolex is expected to reach consumers by 2021. In addition, Marinol, nabilone and Bedrocan products lack a formal marketing authorization but may be prescribed in exceptional circumstances on a named-patient basis through a temporary use authorization (ATU).

However, France - home to some of the strictest cannabis laws in the European Union - has begun to show promising developments in moving towards a wider formal program. Though the country was expected to start its medical cannabis trial program by late 2020, allowing 3,000 patients to be treated with medical cannabis products, given delays related to the diverting of health authorities’ resources toward COVID-19, the Directorate General of Health (DGS) and the French Agency for the Safety of Medicines and Health Products (ANSM) postponed the program’s start date until March 2021. There remains doubt as to whether the program will effectively launch by this date, however. The decree enabling the experiment to commence was published in October 2020, and though important, this was only a first step toward getting cannabis into the hands of patients. Several other events need to take place before that is the case:

• The Minister of Health, as advised by the French Agency for the Safety of Medicines and Health Products (ANSM), must still determine the number of patients to be authorized for cannabis treatment under each of the five qualifying conditions: neuropathic pain, severe epilepsy, painful spasticity in those with multiple sclerosis, specific nervous system pathologies, and patients undergoing palliative care.
• Product suppliers – who will be expected to furnish pilot program product for free – must be selected. It is thought that supplying the pilot will place manufacturers in a favorable position for supplying the French market after the experiment ends, as well as helping them establish patient familiarity and loyalty, both beneficial if a fully operational, commercial medical program were eventually introduced. However, given the lack of legal cannabis cultivation opportunities in France, product will be imported – and since many of the global medical cannabis players traditionally interested in these opportunities (Canadian LPs in particular) are currently cash-strapped, there may be delays in recruiting qualified suppliers to provide pharma-quality product free of cost. Furthermore, suppliers must establish partnerships with French pharmacies in order to participate, and though this is not insurmountable, it may further limit the pool of viable and interested candidates.
• Participating doctors and pharmacists must undergo training prior to prescribing or dispensing cannabis.

Beyond those authorized to purchase Epidyolex on an exceptional basis and nabilone and Marinol through temporary use authorizations (ATU), between 2021 and 2023, patients will only be able to formally access cannabis through this medical trial program. The French government will decide on a wider medical cannabis program's future after evaluating the trial program's results, and as such a fully active medical cannabis program is not expected in the country until at least late 2023.

Attitudes among the French population have also shifted towards a more favorable outlook on legalizing medical cannabis in all forms. This cultural shift, combined with the materialization of a pilot program, make medical legalization look probable over the medium term. Brightfield Group anticipates that France will enact some variant of its medical program after the trial is complete, likely in 2024.

With the third-largest population in Europe and a huge potential patient base, France's medical program has the potential to expand greatly once established, though growth will likely be incremental and hampered by government restrictions, given the country’s historical approach to cannabis regulation. One factor likely to prompt growth will be the establishment of a French supply chain, and prospects look positive though domestic operations will not be active in time to supply the pilot.

France has one of the highest rates of cannabis consumption despite strict drug laws in both the country and European Union. In recent years, however, several regulatory changes have indicated a slow but promising move towards legalizing medical cannabis.

In 2013, a law passed to allow restricted use of medical cannabis in France, enabling prescription of medical products containing cannabis derivatives. Although the measure passed nearly a decade ago, the market has failed to develop as the only cannabis-based medicinal products approved by the French Ministry of Health prior to the pilot program were Sativex, designed to ease the symptoms of patients with spasticity due to Multiple Sclerosis, and Epidyolex, used to treat seizures related to LGS, Dravet syndrome, or TSC in children. Not only do these products have very specific and limited use instances, but neither has yet been made available on the market (except limited Epidyolex, through a French regulatory agency-sponsored ATU early access program). The French High Authority of Health only approved a reimbursement of 15% for Sativex, leading the National Agency of Drugs to request an extremely low price of €60 for a 20-day supply from distributor Almirall, which the company rejected (for comparison, the same amount of Sativex costs €330 in Germany). Since this took place, negotiations between the French government and Almirall have been deadlocked, stymieing the market almost entirely until the introduction of Epidyolex – which is also undergoing price negotiations but likely to see them close by 2021.

The French government has shown progress on the legislation of medical cannabis since its initial limited legalization, however. In 2018, then-Minister of Health Agnes Buzyn acknowledged that France had fallen behind regarding medical cannabis research and showed support for a medicinal cannabis program. Following this statement, the French Agency for the Safety of Medicines and Health Products (ANSM) formed the Temporary Specialized Scientific Committee (CSST) to evaluate “the relevance and the feasibility of the provision of therapeutic cannabis in France.” The CSST was launched to determine how best to develop a medical cannabis market, to evaluate currently available scientific data relating to medical cannabis, and to assess how other countries have enacted their medical cannabis program and how patient experience differs between said established markets.

By the end of 2018, the CSST 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 therapeutics … This use can be considered in addition to or as a replacement for certain therapies.” As the committee included respected doctors and scientists, the recommendations had credibility. According to their final recommendations that were published in June 2019, France will approach this program as an experimental project that will last two years. They will collect data about the efficacy and safety of the products and analyze how medical access works in practice. The committee suggested that medical cannabis be used as a last resort, prescribed by specialists to patients with chronic pain, certain nervous system pathologies, multiple sclerosis spasticity, severe and refractory epilepsy, and those who are in supportive care in oncology or palliative care. The committee also made recommendations regarding cannabinoid combinations, THC and CBD ratios (THC-dominant, CBD-dominant, and balanced THC:CBD), and product types (flower, oil and gelcaps), which have since been adopted.

The program was initially expected to start in late 2020, with the first 6 months used to identify 3,000 patients and the second 6 months used to recruit doctors and clinicians. However, a series of delays partly attributable to the COVID-19 crisis resulted in the experiment’s start date being postponed until March 2021 at the earliest. Start date aside, once various preparatory steps are completed and product suppliers have been confirmed, the program will be officially operational. The study’s results will be shared with the French Parliament, which will then determine the future of the program. A government commission on cannabis regulations has been formed to discuss the regulatory framework after the experiment is completed.

There is no indication that France will introduce adult-use cannabis in the near future. New regulations passed in 2018 softened the consequences of possession for personal use, reducing the punishment to a fine of around €200 instead of prosecution and jail time; though this did not equate to decriminalization. In July 2020, the new prime minister Jean Castex announced a nationwide crackdown amid concerns around drug-related violence and introduced on-the-spot fines for cannabis consumption. Selling or distributing cannabis in larger amounts is considered trafficking, which constitutes an offense punishable by lengthy prison sentences and hefty fines. Although hemp is legal, cultivation remains restricted to the production of fiber and seed for industrial purposes.

Given cannabis’ largely illegal status in France, competition is virtually non-existent. Until a full formal medical program launches, cannabis will not be formally sold for financial gain in any capacity beyond GW Pharmaceuticals’ Epidyolex (and perhaps, eventually, its Sativex product), Marinol, nabilone, and Bedrocan products, which are in fact sold through a legal loophole rather than the formal market, and have been used to treat only a few hundred patients over the course of 18 years. With competitors largely limited to the pilot program, wherein product will be furnished to all participants free of charge for two years, there will likely be few vying for share – but those who do are likely to be well-capitalized, committed players invested in long-term success.

The French Agency for the Safety of Medicines and Health Products (ANSM) has published the proposed framework for distribution for the trial commencing in 2021. During the initial six-month stabilization phase, prescriptions must be dispensed in hospital pharmacies, referred to as pharmacies for internal use (PUI). Following the stabilization period prescriptions can be dispensed in standard pharmacies, with the potential for general practitioners to issue prescriptions in addition to specialists. In all cases, physicians and pharmacists must be both participating and trained in the program. A similar structure is expected in an eventual fully-authorized medical cannabis program.

There are currently no products being sold on the French market, other than the handful authorized to be dispensed on an individual, exceptional basis and making up an extremely small market. The product types that will become available to the 3,000 treatment-resistant trial patients in 2021 will include full spectrum extracts in the form of capsules and oils, as well as dry flower.

¹ Though it does not have formal market authorization to be sold as medical cannabis, Marinol, a brand of dronabinol, has been on the French market since 2004. The synthetic cannabis formulation has fallen into a legal vacuum allowing it to be issued through a Temporary Authorization for Nominal Use (ATUn) for patients with persistent pain of neuropathic origin, only if prescribed only by specialists or practitioners at the Centers for the Study and Treatment of Pain (CETD), and only to be distributed through hospital pharmacies. In 16 years, it has only been sold to roughly 400 patients and in small quantities, thus the market size remains negligible.