French patients taking part in the country’s medical cannabis experiment are to lose their supply of pharmaceutical CBD oil, as Little Green Pharma pulls out.
Reports from French cannabis media site, Newsweed, regarding a possible shortage of products in the country’s medical cannabis trial, have now been confirmed in communication with stakeholders.
Last year the National Agency for the Safety of Medicines and Health Products (ANSM) announced an extension to its medical cannabis experiment, which allows up to 3,000 patients to access free medicinal cannabis, to evaluate how products could be prescribed and dispensed legally in France.
However, the experiment is expected to lose its supply of (non-THC) pharmaceutical CBD oil from Little Green Pharma, which represented around 60% of the products prescribed.
According to information from Newsweed, the manufacturer does not wish to continue to offer its product for free or at €14 per bottle – a price well below its production, transport and customs costs – as proposed by the Ministry of Health for the extension of the experiment.
The advice for patients on the scheme who are currently being treated with this product are to replace it with the following:
- Epidyolex for children with epilepsy whose condition is stabilised
- A CBD:THC 20:1 oil for adults with spasticity and/or multiple sclerosis
Adult patients who have found success with a pure CBD oil are being advised to change treatment and experiment with a product containing THC, which some may not know how to tolerate.
According to Newsweed, France’s Directorate General for Health (DGS) has been singled out by many sources for a lack of anticipation and interest around the experiment, to the detriment of ill patients.
Yann Bisiou, a specialist in drug law, expresses it head-on.
“There are CBD shops on every street corner and the DGS is not able to find pharmaceutical CBD,” he told Newsweed.
“The legal fragility of the system chosen by the DGS was clearly constituted and a source of litigation. Either they are incompetent, or they want to ruin the experiment.
By searching the call for tenders, which was available online, Newsweed also reports that the funding for the extension of the experiment was taken from the budget of the associations of victims of medical accidents.
A situation Bisiou describes as ‘scandalous and shameful’.
The DGS is also reported to have belatedly noticed that a supplier for one of the products had not been found following a call for tenders, despite numerous warnings from manufacturers. The department has since been trying to find solutions to avoid product shortages.
New temporary rules for CBD products
Last week French authorities approved temporary rules, bypassing the ANSM, to remove CBD-based products from the list of narcotics and place them instead on the list of poisonous substances.
It is thought that this change in classification is intended to reduce import costs, with legal trade in ‘narcotics’ being extremely controlled and expensive, and thus to facilitate supply for the experiment.
Newsweed has contacted the DGS for a response and will update the article as required.
This article was originally published by Newsweed and is reprinted here with permission.
