Medical cannabis: France finally submits its project to Europe

After years of waiting, France has taken a key step towards the authorization of medical cannabis, both for production and dispensing.

On Wednesday March 19, the European Commission (EC) was notified of the 2 decrees governing the specifications of cannabis-based medicinal products for medical use and the security of their production. This notification, via the TRIS procedure, is an essential regulatory step before the integration of medical cannabis into common law.

TRIS notifications from France on medical cannabis

These texts, finalized nearly two years ago, were awaiting a green light from the government before being forwarded to Brussels. Following notification, a three-month standstill period begins, allowing the Commission and other member states to examine the texts and make comments. If a detailed opinion is issued, this period may be extended by three months, obliging France to justify the measures envisaged in response.

If there are no major objections, the regulation of medical cannabis in France could be validated by Europe after this period. The decrees will then have to be signed by the executive to come into force.

Does this mean that medical cannabis will be prescribed to French patients before the end of the year? Not necessarily.

Beyond the deadlines imposed by the EC, each drug will still have to obtain individual authorization from the health authorities. The French Minister of Health recently indicated that he would defer to the Haute Autorité de Santé (HAS) to rule on the integration of cannabis-based medicines into the French healthcare system. A questionable statement, given that this responsibility normally falls to the Agence nationale de sécurité du médicament et des produits de santé (ANSM), as Professor Nicolas Authier recently reminded us :

«The authorization of drugs in France is the responsibility of the ANSM, not the Haute Autorité de Santé. [...] Once the ANSM has given its approval to the drugs proposed by pharmaceutical companies, we will have to discuss their price and reimbursement possibilities.

Historically, the HAS has tended to curb access to medical cannabis, as shown by the following examples the blocking of Sativex since 2014. France could therefore find itself with limited access, as the HAS is in a position to assess the therapeutic potential of medical cannabis as low compared to existing treatments, in spite of the numerous positive evaluations of the experiment.

Other countries that have legalized medical cannabis have already experienced similar restrictions. While notification of the decrees to the EC marks a step forward, the ultimate goal remains effective access to treatment for patients.

«We mustn't lose sight of the issue of price and reimbursement, which can delay patient access,» says Franck Milone, founder of LaFleur - one of two French companies producing medical cannabis for research purposes - and himself suffering from multiple sclerosis.

According to various studies, between 300,000 and 800,000 people could be eligible for a prescription of medical cannabis in France for the five indications included in the trial.