The future of France’s medical cannabis programme has been thrown into doubt this week as the government failed to introduce any sort of regulatory framework or allocate any funding in its annual budget.
Days later, a group of 17 patients’ associations published a letter in local news publication Le Parisien expressing their concern that the government was now reneging on formal commitments made in 2022, ‘prolonging the suffering of nearly 300,000 patients’.
Government infighting, budgetary issues and an inability of the industry to effectively influence policy mean that this experiment is now highly unlikely to be upgraded into a fully fledged medical cannabis framework in the near future.
However, according to industry expert Benjamin-Alexandre Jeanroy of Paris-based Augur Associates, this is not the final nail in the coffin for medical cannabis in France, but ‘just another minuscule step’.
“It’s disappointing, but the cat will never get back in the box.”
2024 Social Security Financing Bill
France launched its medical cannabis experiment in 2021, offering around 3000 patients free cannabis products with an initial intended run-time of two years.
The trial was intended ‘to evaluate, in a real situation, the recommendations of the committee in terms of prescribing and dispensing conditions and the adherence of health professionals and patients to these conditions’, providing safety and efficacy data as a ‘secondary objective’.
Despite near universally positive feedback from patients, largely expected though this was, France’s Directorate General of Health (DGS) pushed ahead with plans to extend the trial by a minimum of one year without waiting for the results of the trial to be submitted to parliament in September 2022.
Patients and industry stakeholders alike had expected that the experiment would be a near certain precursor to full regulation.
As detailed in the letter from the 17 collective associations: “The commitment made by the government in 2022 was clear: at the end of the experimentation extension period, France would finally legalise medical cannabis to make it accessible to those who need it most.”
However, the publication of France’s Social Security Financing Bill (PLFSS) for 2024, which determines the state’s budgetary allocations for the coming year, made no mention of the medical cannabis project, once again leaving the future of the industry in limbo.
Why was this omitted?
The university professor and chair of the National Agency for the Safety of Medicines and Health Products (ASNM) scientific committee on medical cannabis, Dr Nicolas Authier, told Newsweed recently that ‘contrary forces are waking up’.
“They will do everything to restrict access to these drugs as much as possible, even though they are intended for patients in therapeutic impasse and in severe suffering. We must be convincing in the coming weeks and contrast their ideology with the relevance and rigour of the approach undertaken during these five years of work and experimentation.”
The collective of patient associations also suggested the proposals are ‘currently under threat from within’.
This was echoed by Mr Jeanroy, who told Business of Cannabis that there is a ‘clear conflict within the government’, with various entities now starting their presidential bids to succeed Macron.
“It has to be understood within the larger policy orientations of the government I believe. They are making budget cuts everywhere, and medical cannabis is not a priority.
“They have not computed what it could save, only what it will cost. So it’s really not surprising it’s getting cut. What will be interesting to see are the parameters set for the continuation of the experimentation.”
He added that it was also telling of the ‘incapacity of the industry to unite and be impactful in influencing policy’.
“They are not supporting patients (claiming they don’t have the funds, which arguably is a matter of internal budget choices), and therefore the patients are not there to push to influence the need for the generalisation.
“Ultimately the patients are paying the price, not only of not being a priority politically, but also of the poor state of the European cannabis industry, which is in no shape to do what is necessary in terms of influence in the country to make that topic a political priority.”
The PLFSS is now being considered by parliamentarians, who will pick apart its contents and vote on amendments before it is enacted.
According to The Union of Industrialists for the Valorization of Hemp Extracts (UIVEC), a union representative of the cannabinoid and medical cannabis sector in France, the ‘only opportunity for its inclusion lies in the possibility of MPs proposing amendments’ to include medical cannabis in the PLFSS.
One group, Access Aux Soins (Access to Care), has now launched a petition calling for patients to ‘put pressure on our representatives to add cannabinoid-based medicines to the 2024 PLFSS’, ahead of the beginning of debates on October 10.
However, Mr Jeanroy said he believes this is ‘missing an important point’.
“The parliament under Macron has not been known for its autonomy. It’s a chamber of enactment and very few of its initiatives come internally, which means decisions are not being taken there.
“The only possibility of such an amendment passing is with the agreement of the government. Which is not going to happen I’m afraid.”
A final but unlikely beacon of hope, UIVEC suggests, is the usage of Article 49-3 ‘to impose the text, which could potentially include provisions relating to medical cannabis’.
Article 49-3 of the French Constitution is a constitutional provision that allows the French government to force the passage of a bill in the National Assembly (the lower house of the French Parliament) without a vote.
This is a powerful tool used by the government to bypass potential legislative gridlock and push through important bills. However, it can also be a contentious and polarising mechanism.
Mr Jeanroy concluded: “Efforts should also now be focused on making sure the generalisation will be in the next PLFSS as well as strengthening and enlarging the framework of the experimentation with larger pool of patients, increasing number of accepted conditions and adapted tenders.”