- Voted at the end of October by the National Assembly, the experimentation with therapeutic cannabis in France should start in September.
- It is expected to last two years and will include some 3,000 patients suffering from conditions that can be relieved by cannabis.
- With a market that currently does not exist in France, foreign laboratories are in a good position to supply the cannabis that will be used. Among them, Tilray, 20 Minutes of which was able to visit the production site in Portugal. But a French market for medical cannabis could emerge in the medium term.
It had been expected for years. Now it's on track, and there are only a few months left to wait. The experimentation with therapeutic cannabis in France, to which the deputies gave the green light last fall, should start in "September" and last two years, announced this week the National Agency for the Safety of Medicines (ANSM). "The objective is that the experiment can be offered to patients at the start of the 2020 academic year," said the deputy director general of the ANSM, Christelle Ratignier-Carbonneil, during the first hearings of the parliamentary information mission. on cannabis launched in the National Assembly.
But how will this experiment take place? From a logistical point of view, is France ready to carry out this test? Who will supply cannabis to patients? Can a French industry be set up by then? Many questions for which a solution will quickly have to be found.
Foreign labs in the starting blocks
In practice, the ANSM has less than eight months to finalize the framework of this trial, and find the modalities allowing to provide their treatment to the approximately 3,000 patients who will be recruited to participate in this experiment. It will therefore be necessary to have medical cannabis in sufficient quantities. However, "to date, French law prohibits the cultivation of plants containing levels greater than 0.2% THC" (tetrahydrocannabinol, one of the active principles of the plant), informs Me Eveline Van Keymeulen, of the cabinet of 'lawyers Allen & Overy, which has positioned itself on cannabis-related issues and intervenes before the scientific committees of the ANSM. And like "September is tomorrow, it's very close," concedes Christelle Ratignier-Carbonneil. To be on time, the ANSM plans “rather to use foreign producers”. And the French in all this? "If a national producer is able to meet the criteria, he may be selected," said Christelle Ratignier-Carbonneil, adding that discussions are underway between the Ministry of Health and that of Agriculture. Thus, despite the current ban, InVivo, one of the first French agricultural cooperative groups, has submitted a request to the ANSM to position itself on the market.
Foreign labs are already ready and are in the starting blocks. "The cannabis market is, still today, an emerging market where everything is to be conquered," plants the firm Allen & Overy, which also advises foreign companies and investors from around the world wishing to develop their activities in France in the sector of medical cannabis. And in this new Eldorado of green gold which stirs up all lusts, some already have a good head start. "Canadians, like Canopy Growth, Aurora and Aphria, are pioneers and are among the world leaders in the cannabis market," explains Van Keymeulen. Among these giants is also Tilray, founded in 2013, which has the assets to find a place in France. With a 2.4 hectare operational production site located in Portugal, the lab has positioned itself to supply France as part of the experiment.
Extremely strict health standards
Direction Cantanhede, an hour's drive from Porto, where 20 Minutes visited during a rare press visit to the factory, which was very secure. As soon as the gates of the site are crossed, a particular smell quickly tickles the nostrils. Yes, it smells like cannabis, but unlike the coffee shops in Amsterdam, there is no question of rolling a joint. Here, the thousands of cannabis plants that stretch as far as the eye can see in the tropical heat of the gigantic greenhouse are produced for therapeutic purposes only. "Several varieties of cannabis plants grow here, with varying levels of THC and CBD (cannabidiol), the two most powerful cannabinoids in cannabis, known for their analgesic and relaxing properties," says Cristina Almeida, pharmacist and quality manager at within the Portuguese factory, which conditions the crops in the form of dried flowers or oil in a bottle with pipette.
Before entering the greenhouse and taking care of the plants which can measure up to two meters, each employee puts on an integral suit, "so as not to introduce germs which could weaken the plants, then the patients, explains Sascha Mielcarek, European director of Tilray. We have extremely strict health standards. We also have GMP (Good Manufacturing Practices) certifications, which testify to the safety and quality of our products ”. For its part, "the ANSM must establish a list of criteria ensuring the irreproachable health security of the samples provided for the experimentation", underlines Me Van Keymeulen. "Our only objective remains the quality of the products that must be made available to patients," confirms Christelle Ratignier-Carbonneil, from the ANSM. A good point for Tilray, therefore, who already has all the certifications in his pocket. "We are fully prepared to supply France as part of this trial," says Sascha Mielcarek, adding that Tilray "has already contacted French health authorities" for this purpose.
"We will have to go very very quickly towards generalization"
In the ranks to supply France, Tilray is already present on the European market, and exports in particular to Germany, Croatia or the United Kingdom. "We have a lot of testimonials from patients about the benefits of medical cannabis and how it has changed their daily lives, especially in patients with epilepsy and chronic pain," says Sascha Mielcarek. In France, as of September, 3,000 patients suffering from serious illnesses - certain forms of epilepsy, neuropathic pain, side effects of chemotherapy, palliative care or multiple sclerosis, will in turn test the virtues of medical cannabis. The experiment must be carried out in several hospitals in France, in particular reference centers for the pathologies concerned. The patients selected "will be able to benefit from cannabis for free", and they will be prescribed "as a last resort", if other existing treatments fail, said the ANSM. An initial prescription will be made by a specialist doctor, neurologist or pain doctor in particular, and patients must first obtain supplies from a hospital pharmacy, before being able to renew their treatment at a city pharmacy. They will consume the prescribed cannabis in the form of oil or dried flowers.
“I will try, as a neurologist, to take part in this experiment, says Olivier Véran, MP (LREM), author of the amendment authorizing the experimentation of the medical use of cannabis. A colleague specializing in pain medicine at the Grenoble University Hospital contacted me on this subject, and we would like to work together on this issue. ” The neurologist plans to train eventually, “with the idea of then training my colleagues and sisters in the treatment of patients with therapeutic cannabis. This is why I expect this experiment to prove scientifically and irrefutably the effectiveness of cannabis for medical use, which I deeply believe. There are so many people who write to me, sick people who hope to benefit from it, he continues. The urgency is to show that it works for the sick. Then, it will be necessary to go very very quickly towards a generalization ”.
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