French Medical Cannabis Trial Officially Extended for One Year

Suspicions that France would extend its medical cannabis trial first arose a couple of weeks ago. Now, the DGS has provided confirmation. The decision to postpone the end of the trial, and thus the date of any potential legalization, is justified by the DGS due to low participation rates in the trial by both doctors, and a lack of data on medical cannabis efficacy vs existing treatments.

The General Directorate of Health (DGS) did not wait for the results of the medical cannabis trial – which was to be submitted to the Parliament today – to make its decision. Instead, it announced to the industrialists and doctors last Friday and to the patients’ associations this morning the extension of the medical cannabis trial by a minimum of one year.

While the announcement confirms suspicions from the last couple of weeks that the trial would be extended, there are still many details lacking. To follow the evolution, download our free cannabis news app.

DGS Justifies Extension to Medical Cannabis Trial

The DGS justifies the decision to extend the medical cannabis trial due to:

• The weak participation in the medical cannabis trial by general practitioners (only 200 GPs participated)
• The lack of economic data on the advantages over usual treatments to which the symptoms are refractory – even though these treatments have already failed patients participating in the medical cannabis trial
• The need to comply with European discussions without wanting to wait for the end of these discussions

A medical source close to the case also reports resistance from the Ministry of the Interior to legalize cannabis for medical use.

Patients’ Associations Condemn Medical Cannabis Trial Extension

The DGS initially announced the decision to the industry and not the patients. This timing they now regret, and the DGS has acknowledged a “clumsiness.”

In a press release, the patients’ associations “deeply regrets not having been consulted or even informed of this decision before it was leaked to the press… This method is symptomatic of little consideration given to patients in this decision.”

They also question the reasons mentioned by the industry for a one-year extension to the medical cannabis trial and, thus, a one-year delay before any legalization will take place in France.

The reasons given for prolonging the medical cannabis trial, namely the unpreparedness of the French agro-industrial sector and the risk of foreign players taking up positions on the market, can in no way dictate our health policy. Privileging economic interests over the improvement of health and quality of life of tens of thousands of patients suffering from chronic and severely disabling symptoms constitutes a dangerous break with public health ethics and even the doctrine of “whatever it takes” adopted at the time of the Covid-19 crisis.

The associations call for a provision from March 2023 and the largest number “of cannabis-based medicines from regulated production channels and conditioned to a primary hospital prescription and subject to reimbursement.”

What Are the Consequences of Lengthening the Medical Cannabis Trial?

Mado Gilanton, President APAISER S&C and patient representative on the temporary scientific committee Cannabis Therapeutics of the ANSM, is concerned that a one-year extension to the medical cannabis trial will not deliver more results.

“If there is an extension, we are asking for a firm commitment that this year of “deferral” will be used to refine the indications and make medical cannabis products available on the market. Otherwise, legalization would be postponed indefinitely.”

Work began in 2018 on the other two points that remain to be clarified – the pharmaceutical status of these products and whether or not they will be reimbursed by health insurance.

While the assessment of the medical cannabis trial was supposed to be submitted according to the 2020 decree to the Parliament today, the DGS revealed that it will finally be submitted to the deputies only a few days before the start of the PFLSS 2023 discussions. 

Details Are Still Lacking

This tight timing will leave little time for MPs to prepare the subject at a time when the parliamentary work on the PLFSS promises to be particularly substantial.

Patient associations are inviting MPs to an information meeting on the medical cannabis trial before this date.

For the moment, no budgetary indication has been communicated about the postponement of the medical cannabis trial. The 3000 patients not having been reached, the current suppliers of medical cannabis could be proposed to continue to provide their products free of charge. A “lightning” of the charges was also evoked without more precision.

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(Featured image by Alesia Kozik via Pexels)

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