This is a real alert for patients included in the experimentation of therapeutic cannabis. According to our information, several stakeholders in phase 1 of the experimentation with therapeutic cannabis in France, representing some 70% of the products delivered, did not respond to the call for tenders for the continuation of the experiment, in because of an excessive financial burden.
The consequence could be a shortage of medical cannabis products for patients.
Free-wheeling experimentation
For 2 years, the pharmaceutical laboratories included in the experiment have been providing medical cannabis-based products free of charge. This delay was to be used to validate the distribution circuit of medical cannabis before possibly proceeding with a generalization, provided that the experimentation is conclusive.
However, the generalization has not been recorded even though the patient feedback has been convincing.
On the side of the ANSM, we plead the arrival of the Covid to explain the failure of the generalization, while many fingers point to the reluctance of the Ministry of the Interior, which without having the vocation to deal with a subject of public health, extends its repressive policy with regard to cannabis to a treatment potentially prescribed for sick people.
No one is kind to the Directorate General of Health (DGS) either. All the people interviewed, who wish to remain anonymous, report 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 on the plane,” we hear.
After 4 years of work, the status of these products has still not been defined. And its reimbursement or not by health insurance, blocking subjects for a generalization and to determine a price, has still not been recorded. However, discussions took place last December, without any transparency on the subject.
Why is experimentation expensive for manufacturers?
Since France does not have an indigenous medical cannabis market, the few companies authorized to cultivate cannabis have it for research use. The patients included in the experimentation with therapeutic cannabis in France therefore consume products imported from Israel, Australia or Canada.
Two types of products are available for these patients: oils, delivered in first intention, and dried flowers which represent less than 5% of the products prescribed. In addition to manufacturing costs, with cultures grown in controlled, pharmaceutical-grade environments, suppliers must bear transportation costs – refrigerated and 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€.
Moreover, while the initial specifications mentioned one bottle of CBD or THC-dominant oil per patient per month, some patients were delivered nearly ten bottles of CBD oil per month, without being able to test CBD:THC oil, THC oil or dried flowers, indicating an absence of effects and a lack of information for health professionals depending on the pathologies.
If these products have so far been provided free of charge, the call for tenders upstream of the extension provides for compensation of €14 per 10ml bottle of oil and €14 per 10 gram bottle of dried cannabis flowers, to the great displeasure of industrialists who demanded fair compensation. And hence the refusal of some to continue bearing these costs any longer.
An experiment without products?
What would happen then for the patients included in the experiment? Their processing will stop.
“A shortage would be extremely serious because there are people whose lives it has changed,” reacts Mado Gilanton, president of the Apaiser S&C association. “Our surveys and feedback from the field have already revealed the concern of patients in the event of a CBD oil rupture”.
Questioned by us, Nicolas Authier, president of the temporary Scientific Committee for the follow-up of the experimentation of cannabis for medical use, does not yet have information on the products which 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 urgency is less but the disappointment is just as likely for French manufacturers who have started working on a potential opening of medical cannabis in France. Some have offered solutions Made in France but without the vision given by the DGS, hopes are dim.
The DGS has not yet answered our questions.