Medical cannabis experiment extended for a year. Patient associations condemn.

The General Directorate of Health (DGS) did not wait for the Review of the Medical Cannabis Pilot Program – which was to be submitted to Parliament today – in order to make its decision. It announced to industry representatives and doctors last Friday, and to patient advocacy groups this morning, that the medical cannabis pilot program would be extended for at least one year.

The DGS justifies this mandatory decision on the following grounds:

• the low level of participation in the trial among private-practice physicians (only 200 private-practice physicians took part)
• the lack of economic data on the benefits over standard treatments for symptoms that are refractory to such treatments—even though, as we are told, patients treated with cannabis have failed to respond to these treatments and are no longer taking them
• the need to bring our practices into line with European discussions, without, however, waiting for those discussions to conclude

A medical source familiar with the matter also reports that the Ministry of the Interior is resisting the legalization of medical cannabis.

Patient advocacy groups condemn the decision

The DGS decided to announce the decision initially to manufacturers, rather than to the patients—a timing that the patients regret. The DGS acknowledged this as a «misstep.».

In a statement, patient advocacy groups «deeply regret that they were neither consulted nor even informed of this decision before it was leaked to the press via a press release from representatives of the agribusiness sector. »This approach is symptomatic of the lack of consideration shown to patients in this decision.”.

They also call into question the reasons cited by manufacturers calling for a one-year delay in the legalization of medical cannabis in France.

«The reasons cited for extending the trial—namely, the lack of preparedness of the French agro-industrial sector and the risk of foreign players gaining a foothold in the market—must under no circumstances dictate our public health policy. Prioritizing economic interests over improving the health and quality of life of tens of thousands of patients suffering from chronic and severely disabling symptoms constitutes a dangerous departure from public health ethics and even from the doctrine of «whatever the cost» adopted during the COVID-19 crisis.»

The organizations are calling for «cannabis-based medications derived from regulated production chains, available starting in March 2023 to as many people as possible, subject to an initial hospital prescription, and eligible for reimbursement.».

What happens next?

Mado Gilanton, President of APAISER S&C and patient representative on the ANSM’s temporary scientific committee on medical cannabis, is concerned that a postponement will not yield better results in a year’s time.

«If there is an extension, we are asking for a firm commitment that this «postponement» year will be used to refine the guidelines and make cannabis-based medical products available on the market. Otherwise, legalization would be put off indefinitely.»

Two more points also need to be clarified – the pharmaceutical classification of these products and whether or not they are covered by health insurance – a work that began in 2018.

While the report on the medical cannabis pilot program was supposed to be submitted to Parliament today, in accordance with the 2020 decree, the DGS has revealed that it will ultimately be submitted to lawmakers just a few days before the start of deliberations on the 2023 Social Security Financing Bill (PFLSS). This tight schedule will inevitably leave lawmakers with little time to prepare for the issue, even as parliamentary work on the PLFSS is expected to be particularly substantial.

Patient advocacy groups are inviting members of Congress to an informational meeting on the subject ahead of that date.

No budgetary details have been provided at this time regarding the postponement of the pilot program. Since the trial has not yet reached its target of 3,000 patients, current medical cannabis suppliers may be offered the opportunity to continue providing their products free of charge. A «streamlining» of the program has also been mentioned, though no further details have been provided.