In July the French drug agency gave the green light for the first large-scale experiment with therapeutic cannabis in the country, while specifying the framework governing its use for certain diseases. Now the vote of the National Assembly allows the process to begin, although the measure will only take effect after approval by the Senate. The Government plans to implement it in the first half of 2020.
Late last year the National Agency for Drug Safety (ANSM) approved the conclusions of a committee of experts who endorsed the authorisation of medical cannabis "in certain clinical situations". Thousands of French consumers were awaiting the agency's announcement of an experiment with cannabis before the end of 2019, for its full implementation over the course of 2020, but this was contingent upon a political decision to introduce a legislative amendment to legalize its use.
LREM party representative Olivier Veran announced in mid-October that he would support this amendment to the Social Security Funding Bill (PLFSS), authorising a two-year experiment, funded with public money, on the medical use of cannabis, thereby reopening the debate on its legalisation for therapeutic purposes.
Last Friday, October 25, in a raised-hand vote, the French National Assembly approved this amendment, announcing that the experiment will start in the first half of 2020 and will involve 3,000 patients, who will be chosen from all across the country.
What diseases are included?
The trial is expected to last two years: six months of implementation, six months for the inclusion of candidates, six months of patient follow-up, and six months of data analysis, with the presentation of a final report by a scientific committee.
An attempt will be made to evaluate the positive impact of cannabis by-products on various serious diseases. The ANSM has divided the list of pathologies into five groups:
- Refractory neuropathic pain.
- Certain forms of severe and drug-resistant epilepsy.
- Ancillary care for oncological patients in palliative situations.
- Painful spasticity in Multiple Sclerosis patients.
- Other pathologies affecting the central nervous system.
What will the framework of the experiment be?
According to the ANSM expert committee, "around 4 million French citizens have no solutions for these types of pain, and could justify cannabis treatment." But only 3,000 will be able to participate in the trial, which will be carried out at several hospitals, leading centres for the pathologies in question.
The initial prescription will be made by a specialised doctor or a neurologist. The patients must first acquire their medication at the hospital’s pharmacy, although they can then renew their treatments at pharmacies in their cities.
According to the French drug agency, the cannabis will be distributed in sublingual and inhaled forms (oil and dried flowers, for spraying) or orally (oral solution and oil capsules). And the different doses may feature very variable proportions between the plant’s two active ingredients: tetrahydrocannabinol (THC) with psychoactive effects, and cannabidiol (CBD). Depending on the disease, the doctor will decide to administer more CBD or more THC.
Everything will be financed by the Social Security Administration, as the experiment aims to expand the supply of analgesics available to patients suffering from severe pain.
Some questions that still need to be resolved
However, there are still some loose ends to tie up, such as the issue of the supply chain. After the vote by the National Assembly, InVivo, one of the first French agricultural cooperatives, submitted an application to the ANSM to position itself on the market. But the law currently prohibits the cultivation of cannabis plants in France; more precisely, those containing THC levels over 0.2%.
Therefore, it remains to be seen where the therapeutic cannabis used for the experiment will come from. If the plan is to start in the next six months, the French production will not be available, as the industry will not be ready on time. Thus, as of May 15, the demand will be met, presumably, by foreign producers, who will be asked for information on their processes, and audits will be carried out as if they were pharmaceutical laboratories.
A step towards the legalisation of medical cannabis?
With this experiment, France is hardly a pioneer in this area. Canadians with certain serious illnesses have been able to obtain licenses to use cannabis since 2001. In total, about 30 nations have authorized the use of therapeutic cannabis; this is the case in 17 of the 28 countries of the European Union, 6 Latin American countries, and Australia; in addition to 33 US states.
"I hope we can rely on patients' experience. The evidence shows that users who self-medicate are already knowledgeable," said the author of the amendment, representative Olivier Véran (LREM), a neurologist by profession. "If we realise after six months, a year, a year and a half, that it is not necessary to continue the experiment because we already have enough evidence, on the ground, that cannabis is beneficial, we will have to move towards the generalisation of its medical use".
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