Haute Autorité de Santé to rule on the integration of medical cannabis in France

Minister of Health, Yannick Neuder, announced that the government would rely on French Health Authority (HAS) to decide on the integration or not of cannabis-based medicines In the national health system.

In France, the French Health Authority (HAS) is responsible for evaluating the medical value of treatments before they are authorized for widespread use. Initially, the cannabis-based medicines were to benefit from a five-year derogation status. However, the government now seems to favor their integration into the traditional pharmaceutical approval process.

«We must allow cannabis therapeutic sector to develop in France,» declared Mr. Neuder, highlighting the need for a structured approach. As cardiologist, he acknowledged that ’there is refractory pain... that is only sensitive to these molecules.«.

According to Professor Neuder, the HAS will evaluate whether the medical marijuana bring «positive health benefits, particularly in terms of" pain management, compared to other therapies.» The minister's office confirmed that this assessment would be conducted «quickly.».

A long experiment

The French government has launched its medical cannabis experimentation in 2021, in order to evaluate the delivery system. The experiment should have led to the legalization of cannabis-based treatments two years later but ended end of 2024 after two overtime periods. A 6-month amnesty was approved to continue supplying patients with some of the remaining treatments in stock until June 2025.

The stakeholders in the experiment, doctors and industry representatives, were rather expecting the government to finally transmit to European authorities the texts relating to the generalization of medical cannabis., as Spain did a few weeks ago. This deposit is a prerequisite for any progress on the subject.

Furthermore, as Professor Nicolas Authier points out, «The authorization of medicines in France falls under the ANSM and not the HAS. [...] Once the ANSM has granted authorization for medicines proposed by pharmaceutical companies, it will remain to discuss their price and reimbursement possibilities.».

He already recommends maintaining access to cannabis-based medicines for patients in the trial until December 31, 2025, as the texts have still not been sent to the European Commission, which has up to 5 months to respond.

The HAS has already been consulted regarding a cannabis-based medication: Sativex. It had determined that the medical benefit provided by Sativex for spasticity associated with multiple sclerosis was low and recommended reimbursement at 15%, which, in practice, had blocked access to Sativex for French patients. Sativex was then reimbursed in 9 European countries, Canada, and Israel.