ANSM announces the continuation of work prior to the implementation of medical cannabis trials in France

In a press release, the ANSM has announced the resumption of the discussions required to set up medical cannabis trials in France.

Like we previously published, French medical cannabis trials have made little headway since late 2019, first halted «due to strikes», then «because of the need to mobilize health authorities to manage the COVID-19 epidemic».

Nicolas Authier, Chairman of the ANSM's Temporary Scientific Committee (CST) on the implementation of medical cannabis trials in France, told us that he had been able to continue working remotely with the CST on the main issues. He was nonetheless awaiting the strong administrative decisions needed to move beyond the current deadlock. that we attribute to the Direction Générale de la Santé, In particular, the publication of a decree authorizing experimentation.

The ANSM is now announcing that the decree will be in place «by the summer», i.e. within two and a half weeks. The start of the experiment has thus been postponed until «January 2021 at the latest».

The final elements on which the CST has been working will be shared after publication of the decree:

• patient inclusion and non-inclusion criteria
• design of the national electronic register for monitoring patients included in the trial
• specifications for the selection of future suppliers and distributors of cannabis-based medicines used in experiments
• the development of a training platform for healthcare professionals. Operational in December 2020, it will enable trained doctors to prescribe cannabis for medical use, and pharmacists to dispense it.
• the list of volunteer expert centers that will include patients in the trial.

The next step will be to find a budget to finance the experiment. While the idea of providing cannabis treatments free of charge was once mooted for certain potential suppliers, the overall situation of legal producers of medical cannabis is likely to complicate the task of securing supplies at lower cost. The aim here is to finance one year's consumption for 3,000 patients, a budget estimated at a minimum of €4 to €6 million with strong negotiating power, and €15 to €20 million otherwise.

Training professionals, creating a patient registry and distributing cannabis will also involve costs that will be taken from the ANSM's budget.

Edit 04/06/2020: we were basing ourselves on the «best deal» made by Germany for medical cannabis, i.e. €2.30 per g of dried flowers (excluding oils or capsules). Nicolas Authier has quoted €15 to €20 million to supply the experiment, a figure we have added to the article.