The French National Medicines Safety Agency (ANSM) has confirmed that flowers will not be included in its upcoming generalised medical cannabis framework.
While not wholly unexpected, the abrupt nature and failure of the ANSM to provide any viable alternative to patients currently dependent on cannabis flower has sparked outrage.
The confirmation will also come as a disappointment to French cannabis businesses, which will be distinctly aware of the dominance of medical cannabis flower in markets across Europe.
It comes as more details of how France’s long-awaited medical cannabis generalisation will look are released, following years of delays and uncertainty for patients and businesses alike.
What happened?
In late February, the ANSM published a ‘progress update on the last year of experimentation and the arrival of cannabis-based medicines’.
It marked the first official update on the upcoming ‘transition period’ and eventual generalisation of medical cannabis since a last-minute amendment was passed late last year, ensuring that patients would retain access to treatment indefinitely.
This amendment suggested that only oral solutions would be pursued, but did not confirm that flower would not form part of the programme moving forward.
In a public update and accompanying letter to healthcare professionals, the ANSM confirmed this in no uncertain terms.
“Medicines in the form of flowers (flowering tops to be inhaled) will cease to be made available in the coming weeks. Prescribing doctors must therefore gradually stop flower treatment for their patients and not initiate new treatments with this form.”
As of March 26, cannabis flower will cease being provided by the programme’s soul flower supplier, Aurora, and once reserve stocks have been exhausted, patients will have no legal route to secure medical cannabis flower.
Although only around 100 patients were being prescribed medical cannabis flower as part of the pilot programme, the abrupt cessation of their treatment and lack of alternative medication have sparked outrage among France’s medical community.
Dr Nicolas Authier, who was a key part of the pilot programme, told Liberation: “What surprises us as doctors is the brutality of the decision.”
“We thought we would have time to gradually stop therapy. Stopping a treatment taken for several years cannot be done over two weeks, but over several months. This could have a significant impact on the pain felt by patients.”
It is understood that during the transition period between April and 2025, when the generalisation will launch in earnest, the pilot scheme will be supplied by existing stock reserves.
Set up to fail
According to Paris-based cannabis consultancy Augur Associates, France’s pilot scheme has been structured ‘against the use of flowers through different means’ since day one.
Its CEO and co-founder Benjamin-Alexandre Jeanroy told Business of Cannabis that not only were the vaporisation devices required to consume flower more expensive than oils, but the complex nature of prescribing flower worked against its wider usage.
“Prescribers are much less used to handling those kinds of products than oils, so the training that prescribers need to go through would be much more time consuming and expensive. It’s a much more complex product. So the emphasis was heavily on the side of non-flower prescriptions.
“All those elements created an environment where it was much easier to go with oil, that’s why we have seen so few users (of flower) in the experiment.”
He added that the lack of uptake in the pilot has now been cited as a reason for its omission from the generalised framework.
The government, in response to questions regarding flower’s future, sought to shift the blame on Aurora, stating: “(it) is explained by the wish of the manufacturer not to continue the supply of products.”
However, as Mr Jeanroy points out, they fail to mention that Aurora has supplied product free of charge throughout the pilot, and it is understandably reluctant to continue doing so.
This ‘shaky’ justification could, Mr Jeanroy suggests, see the decision overturned in the courts.
“It’s also my personal belief that this will be attacked in the courts by patients in one form or another, and it will be difficult for the courts to uphold. I would say the justification is a little bit shaky.”
Further details of the upcoming generalisation
The ANSM’s announcement also provided some new information on how the new generalised scheme will develop moving forward.
Any patients who have been included in the pilot scheme prior to March 27, 2024 will be able to continue their treatment with medical cannabis, and ‘treatment will continue to be provided according to the same methods as before’. However, no one will be able to join the pilot after this date.
Furthermore, new healthcare professionals will be able to be trained to participate in the experiment and support their patients.
Crucially, the ANSM says that drugs that are to be included in the generalisation in 2025 must have ‘obtained authorisation issued by the ANSM no later than December 31, 2024’.
Business of Cannabis understands that details of how this registration process will work are now being communicated by the The Directorate General of Health (DGS), and it is looking likely that products will be ready for patients by January 2025.
Read more about how France’s medical cannabis programme has developed over the past year here.
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Author: Business of Cannabis
