FRANCE’s ongoing medical cannabis ‘experiment’, in which 3,000 patients are offered free products, has reported an overwhelmingly positive patient response.
According to the first clinical data to be published since the experiment launched in March 2021, 91% of patients report being satisfied with the medication.
Despite this positive response, the results are expected to have little or no impact on France’s wider medical cannabis trial, which was recently extended for another year in order for more data to be gathered.
While it is great PR for the companies currently supplying products for the trial, suppliers will now be required to undergo a tender process to be selected to supply their products for the extra year, meaning there’s no guarantee they’ll be reselected.
According to the newly released data from the National Medicines Safety Agency (ANSM), as of October 18, 2022, 2,204 patients have been included in the experiment.
Of the 1,453 not taken out of the study, 792 were being treated for refractory neuropathic pain, 215 for painful spasticity from multiple sclerosis, 181 for drug-resistant epilepsies, 105 in oncology, 104 in palliative situations and 56 for spasticity.
For treatment-resistant neuropathic pain indications, the results showed that medical cannabis reduced the percentage of patients reporting ‘severe’ or ‘unbearable’ pain from 81% to just 29% after six months.
Just under a third of patients reported a 30% reduction in their pain intensity score after six months, according to a ‘Brief Pain Inventory’ (BPI) questionnaire, while just over 40% reported a ‘significant’ or ‘very significant’ reduction in pain by the third month, a reduction which continued past the six- and nine-month marks.
According to the data, which was presented by university professor and chair of the ANSM scientific committee on medical cannabis Dr Nicolas Authier, 28% of the 739 neuropathic pain patients left the experiment – 49% due to adverse effects and 41% due to ineffectiveness of the treatment.
The results were similarly positive for palliative care patients, specifically relating to insomnia and pain – 51% reported a ‘significant improvement’, and 45% reported a ‘moderate improvement’.
Across the study, 91% of patients said that they were in support of medical cannabis legalisation in France.
While the results were overwhelmingly positive, they are expected to have little impact on the French government’s verdict on whether to legalise cannabis for medical use in France.
Firstly, as pointed out by the ANSM’s director Nathalie Richard, the purpose of this trial was ‘not intended to assess the effectiveness of medical cannabis, even if clinical data is collected’.
It is instead 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’, only providing safety and efficacy data as a ‘secondary objective’.
Benjamin-Alexandre Jeanroy of Paris-based cannabis consultancy Augur Associates echoed this, adding that it would have been ‘surprising’ if these results weren’t positive, as these indications were selected specifically for the trial because medical cannabis had already been ‘assessed as efficient’.
Although this data is likely to ‘mean very little’ for the wider trial, it is expected to provide a significant boon for the companies that have been supplying the trial with free products for over a year.
Speaking to Marijuana Business Daily in 2020, Dr Authier said: “It would not be legal to give exclusivity to suppliers, but with hundreds of patients already treated (at the end of the experiment) and doctors used to prescribing their products, this is probably a marketing advantage.”
He added that these companies would also be ‘first on the market’ if and when legalisation of medical cannabis was brought in, while these companies would also make ‘savings’ on clinical research.
The companies currently supplying France’s medical cannabis experiment at their own cost include 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.
However, now that the project has been extended for a further year, there is no guarantee these supply deals will remain in place.
BusinessCann understands that a second tender process is currently under way and that the potential suppliers will have to undergo a rigorous vetting process in order to be selected.
A key difference this time around is that the suppliers are expected to be paid for their contributions, with the National Health and Medicines Agency understood to have already asked the current suppliers for a price list to estimate the cost of the extended trial.
The current trial is due to end in March this year, and questions remain over how the following year will be funded and how much these companies will be paid for their products.