The soon to commence therapeutic cannabis trials taking place in France are eagerly awaited by many. While, for obvious reasons, this trial will not be about generating a profit, there are many industry actors who see this as a potential first stepping stone to developing a thriving cannabis industry in France; a nation that is sorely behind when it comes to easing outdated cannabis regulations.
The trial is eagerly awaited by some companies because the market could prove to be juicy; patients will soon benefit from therapeutic cannabis-based drugs. This experiment was made possible by an amendment by Olivier Véran when he was a Member of Parliament in October 2019. The trial was supposed to start in the first half of 2020 but was delayed due to the Covid-19 epidemic.
Tender for therapeutic cannabis suppliers
The ANSM finally launched a call for tenders in October 2020 to select French and foreign laboratories to supply therapeutic cannabis, so the trial will be able to start “before March 31, 2021”. For the moment, the experiment supervised by the Agency for Medicines concerns only 3,000 patients suffering from pain related to multiple sclerosis or cancer. But eventually, the market could represent nearly one million French.
Laboratories like Ethypharm are therefore positioning themselves. Its role is to distribute medicines from abroad. “One of the objectives of the health authorities is to test the distribution circuit to city pharmacies, not only in hospitals,” explains Jean Monin, Director of Commercial Operations at Ethypharm.
We’re going to see how distribution is done. We are experts in the distribution of controlled drugs in France. We will try to monitor all pharmacovigilance signals, then the authorities will collect clinical data to analyze the impact and benefits of this therapeutic cannabis from this selected population in specific indications”.
“There is a real therapeutic interest”
These medicines in the form of therapeutic cannabis oils or capsules will be provided free of charge. So for the moment obviously, there is no financial stake. Because the hope for these laboratories is that French legislation will be relaxed.
This would be logical according to Jean Monin: “There is a real therapeutic interest for patients who have pain that is refractory to current treatments. It is necessary to lead to a regulated market of therapeutic cannabis; therefore legalization of therapeutic cannabis. I believe that we’re getting there little by little, but we’re doing this in a very structured way in France.”
Manufacture of therapeutic cannabis drugs will not take place in France
The drugs used for this trial, which will last two years, will not be manufactured in France since the law prohibits manufacture for the moment. The French laboratories are associated with Canadian, Australian, and Israeli producers.
However, there are many French companies specializing in research on therapeutic cannabis and who ensure that they are able to manufacture remedies. For example, there is the laboratory DelleD but for its founder, Franck Milone, France has fallen behind.
“France is lagging behind on many subjects. It is active when it has a few train wagons that have passed.” – Franck Milone
“It’s all very well to talk about a start-up nation, but you also have to adopt American strategies or models,” continues Franck Milone. Therapeutic cannabis has to be a real subject of innovation, a real subject of research and development”. In the meantime, DelleD continues its research on its side in Angers with the hope that the manufacture of cannabis-based medicines will one day be authorized.
Already the first European producer of hemp
Above all, France has an advantage: it has the raw material. It is even the first European producer of hemp, i.e. cannabis almost devoid of THC, the famous psychoactive substance. The plant is used in the textile, construction, automobile, and cosmetics industries.
But farmers could plant other varieties suitable for therapeutic use. And everything is ready, assures Aurélien Delecroix, a farmer in Corrèze and president of the hemp union. “It could go relatively quickly, knowing that among our members there are actors for whom everything is ready: investment plans, infrastructures, etc.,” said Delecroix.
“Everything has already been studied, so it would take less than a year for some of them to be able to produce. We are waiting for the end of the experimentation and the delivery of cultivation authorizations to national actors.”
These professionals of the sector can now count on the support of deputies of the presidential majority who, in a report delivered last September, denounced the delay taken by France in this field.
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