FRANCE’s medical cannabis pilot programme, which was extended for another year in October 2022, is facing significant supply issues putting patients’ access to treatment in jeopardy.
Suppliers for the ongoing experiment, which was launched in March 2021, are understood to have shunned tender calls to continue their involvement due to significant cost burdens.
According to Newsweed, more than half of the 2,000 patients involved in the scheme have now been left without access to treatment.
With the French government yet to allocate a budget for the programme, or finalise any framework surrounding the regulation of medical cannabis, experts say there is a ‘very big need for a new push to come from the industry supporting patient voices’.
The ‘experiment’
France’s troubled medical cannabis ‘experiment’ was the only such programme in the world where suppliers are required to provide product for free.
Initially, companies responded positively to tender calls to provide their products for the French experiment.
While no guarantees or exclusivity deals were promised, the chance for exposure and first-mover advantage if and when legalisation of medical cannabis was rolled out in France, the EU’s second most populous country, saw a number of major businesses pledge to provide product free of charge.
These included Canadian giant Aurora Cannabis in partnership with Ethypharm, Tilray in partnership with Medipha Sante, Israel’s Panaxia Pharmaceutical in partnership with Neuraxpharm France, Australia’s Little Green Pharma in partnership with Intsel Chimos, and Emmac Life Sciences, which has since been acquired by US player Curaleaf.
With the initial experiment due to end last month, many industry stakeholders and patient groups had expected the National Agency for the Safety of Medicines (ANSM) to launch a permanent medical cannabis framework across the country.
However, in October 2022, an amendment was pushed through to extend the trial for a further 12 months, amid claims that the experiment ‘has not yet been able to produce sufficient clinical results for us to be able to decide on (medical cannabis) generalisation’.
https://businessofcannabis.com/france-reports-highly-positive-patient-response-to-medical-cannabis-trial-but-results-unlikely-to-impact-decision-to-legalise/
According to Paris-based cannabis consultancy Augur Associates’ Benjamin-Alexandre Jeanroy, both this delay and subsequent supply issues are a result of budget mismanagement and lack of political drive.
“The experimentation was mostly started for political reasons, to show, notably to some parties within the french health high administration, that it would not cause any problem. That’s one of the reason why efficiency of the products was not a fundamental in the judgement of the success of the experimentation.
“The real issue is that they decided not to allocate any budget for this, which ended up becoming the experimentation that we know where the companies had to give products for free, which is unique in the world. It’s because they’ve chosen not to put any money into this. It’s a political choice.”
He explained that the opportunity for the government to properly allocate funding towards the medical cannabis programme was obviously missed during a vote on the Social Security Financing Bill in October 2022.
“That’s where they were supposed to allocate, from the social security budget, the money to make medical cannabis work for the parameters they had chosen. Except that they have still not finished their work on what administrative status medical cannabis products that don’t have MAA is and that impacts how it is reimbursed.”
After effectively failing to allocate any budget to the programme, ‘there was a great risk that it would have just shut down’, instead, the decision was made to simply extend the programme as a result.
Supply shortages
As Business of Cannabis reported earlier this year, a further tender was sent out for companies to supply the project for the following year.
Although, for the first time, some compensationwas offered to those taking part, this came well below the minimum production costs for companies, even when the entire supply chain was located in the EU.
According to reports from Newsweed, companies were being offered €14 per 10ml bottle of oil and €14 per 10 grams of dried flower.
The oils, which are offered in various concentrations of THC and CBD, represent over 90% of the product used in the trial and are understood to cost suppliers between €60 and €120 per bottle (including the cost of transportation, refrigeration, import taxes, etc.).
The €14 figure was calculated based simply on how much product was needed for the coming year, and how much money they were able to squeeze from another fund.
Indeed, the funds at disposal of the health authorities in regard to the prolongation of the experimentation were reportedly taken directly from the budget of the associations of patients victims of therapeutic accidents.
Concerns were raised after a number of stakeholders who were part of the tender call, representing 70% of the products delivered, initially did not respond.
While suppliers for the majority of the trial’s products have now been found (though no backup supply agreements are thought to be in place if a supplier pulls out), these fears have ultimately come to pass.
A subsequent ‘communication to the stakeholders’ suggests that Little Green Pharma, which has supplied the programme since 2021, is now pulling its supply of CBD oil.
It is understood that this oil represented around 60% of the products supplied, as it is used to treat refractory epilepsy.
Business of Cannabis has contacted Little Green Pharma to clarify its position, but is yet to hear back at the time of publishing.
While Mr Jeanroy says he believes the situation will be resolved, he also says the ‘pressure needs to be’ on the government to act.
“When I speak to our clients and other industry actors, I tell them that right now there is a very big need for a new push to come from the industry supporting patient voices.
“This needs to go further than words, where everyone seems to agree on the necessity to support patient access and voices, while there remains very little concrete impact on the ground. Financially (and transparently) supporting patient groups is more than “just” the right thing to do, it’s also a sound investment.
“We still don’t have that in France, and as long as it is the case, the industry will remain at the mercy of the will of the people that are in charge, and they have a lot of other stuff to deal with. It’s not a priority.”
