France soon to be deprived of medical cannabis?

Edit of 03/22 at 11:35: DGS response added at bottom of article.

This is a real wake-up call for patients included in the therapeutic cannabis trial. According to our information, several stakeholders in phase 1 of the therapeutic cannabis trial in France, representing some 70% of products delivered, have not responded to the call for tenders for the continuation of the trial, due to too high a financial burden.

The consequence could be a shortage of medical cannabis products for patients.

A freewheeling experiment

For the past 2 years, the pharmaceutical laboratories involved in the experiment have been supplying medical cannabis products free of charge. This period was to be used to validate the distribution circuit for medical cannabis before proceeding with a general roll-out, provided the experimentation was conclusive.

However, it has not yet been generalized. even though patient feedback has been convincing.

At the ANSM, they plead the arrival of Covid to explain the failure of the generalization, while many fingers point to the reluctance of the Ministry of the Interior, which without having any vocation to deal with a public health issue, extends its repressive policy towards cannabis to a treatment potentially prescribed for sick people.

Nor is anyone soft on the Direction Générale de la Santé (DGS). All those interviewed, who wished to remain anonymous, reported a cruel lack of involvement on the part of this body.

«It's the only free medical experiment that has ever existed. And it's an experiment without a pilot in the plane,» we're told.

After 4 years of work, the status of these products has still not been defined. And whether or not they will be reimbursed by the national health insurance system, which is a key issue for the widespread use of these products and for determining their price, has still not been decided. Discussions took place last December, without any transparency on the subject.

Why is experimentation expensive for manufacturers?

As France has no indigenous market for medical cannabis, the few companies authorized to cultivate cannabis do so for research purposes. Patients included in therapeutic cannabis trials in France consume imported products Israel, Australia or Canada.

Two types of product are available for these patients: oils, delivered as a first-line treatment, and dried flowers, which account for less than 5% of prescribed products. In addition to manufacturing costs, with cultivation in controlled, pharmaceutical-grade environments, suppliers must bear the cost of transport - refrigerated and at constant temperature in the case of oils - and customs taxes. A 10mL CBD oil delivered to a patient then costs the manufacturer between €60 and €120.

Furthermore, while the original specifications mentioned one bottle of CBD- or THC-dominant oil per patient per month, some patients were issued nearly a dozen bottles of CBD oil per month, without having been able to test CBD:THC oil, THC oil or dried flowers, indicating an absence of effects and a lack of information for healthcare professionals depending on the pathologies.

While these products have so far been supplied free of charge, the call for tenders ahead of the extension provides for compensation of €14 per 10mL bottle of oil and €14 per 10-gram bottle of dried cannabis flowers, much to the dismay of manufacturers who were demanding fair remuneration. And hence the refusal of some to bear these costs any longer.

A product-free experiment?

What would happen to the patients included in the experiment? Their treatment would stop.

«A shortage would be extremely serious, because there are people whose lives it has changed,» says Mado Gilanton, president of the Apaiser S&C association. «Our surveys and feedback from the field already show that patients are worried about a CBD oil shortage.

When questioned, Nicolas Authier, Chairman of the Temporary Scientific Committee for Monitoring the Experimentation of Cannabis for Medical Use, has no information yet on the products that will be available for the third year of experimentation. «But I can't imagine that we wouldn't have 3 oils for the 3 ratios and 3 flower ratios,» he says.

The DGS confirms that «a public procurement procedure has been launched [to extend the trial], the results of which will be announced shortly. A transitional period is planned to give the selected companies time to make their product available. The contract covers the extension year. The selected companies undertake to supply a volume sufficient to cover requirements.

Regular exchanges take place with the manufacturers involved in the trial to ensure continuity of treatment for patients.»

The urgency is less, but the disappointment just as prescient for French manufacturers who have begun work on the potential opening up of medical cannabis in France. Some have proposed « Made in France »But without a vision from the DGS, hopes are slim.