On Wednesday October 25, the Prime Minister held the Government responsible for the “expenses” part of the Social Security Financing Bill (PLFSS) for 2024, at the same time validating the presence of the “medical cannabis” amendment. filed by the government on October 23.
The PLFSS must now be confirmed in the Senate.
What does the “medical cannabis” amendment contain?
The amendment tabled by the government provides a temporary status for medical cannabis products. Here are the essential points:
- Medical products containing cannabis will now be subject to “temporary authorization” for five years, with the possibility of being renewed by the ANSM for additional periods of five years.
- Products will be authorized on a case-by-case basis
- Generalization will not occur before January 2025
- When the current experiment ends in April 2024, there will be a “transition period” of up to nine months, after which generalization is expected
- The government has planned a budget of 10 million euros for this transition period, which will allow patients to continue to access their medicines and be reimbursed. This is five times the current budget for the experiment
- After generalization, access to cannabis for medical use will remain limited to a treatment of last resort and can only be prescribed in hospital.
- The prices of each product remain to be determined, but they will take into account the prices charged in European countries with a comparable market size.
- The criteria for prescribing medical cannabis will be set later by decree upon upcoming proposal from the ANSM
- Flowers and other inhaled forms of cannabis products will be excluded
While the move has been widely welcomed by the industry, which has rightly attributed the amendment to continued pressure from patient groups and industry businesses, a number of key questions remain unanswered.
Firstly, activists question why access remains so restrictive for patients, who must have tried all other avenues of treatment before they can benefit from medical cannabis.
Additionally, as no budget has yet been set for widespread use, many wonder if reimbursement will continue as it did for the experiment.
French drug policy reform group L630 also raised concerns about data protection, as the current text states that companies supplying medical cannabis to patients must collect data on patients’ consumption and response to treatment .