Therapeutic Cannabis finally begins
The departure was a bit delayed. Approved in 2019 by the National Assembly, but delayed by the Covid-19 health crisis, experimentation with medicinal cannabis begins in France. The Minister of Health, Olivier Véran, went to the CHU of Clermont-Ferrand (Puy-de-Dôme) on Friday March 26 for "the first prescription" of this drug, announced his services. In the coming weeks, at least 3,000 patients suffering from a serious illness will be able to obtain cannabis from their pharmacies.
How to explain that France, whose government does not hesitate to show its hostility to cannabis, decides to test its therapeutic benefits? Which patients will be selected for this experiment? What kind of drugs will they be able to receive? Who will fund these trials? Franceinfo recaps.
Why did France decide to experiment with medicinal cannabis?
“Several elements led to this reflection”, explains Professor Nicolas Authier, pharmacologist-psychiatrist at the CHU of Clermont-Ferrand (Puy-de-Dôme). First of all, the emergence of scientific literature on this subject. "Since the 1980s, medicine has moved from empiricism on medicinal cannabis to true scientific rationality", explains franceinfo, which was chosen to chair the temporary specialized scientific committee (CSST) set up by the Medicines Agency. to promote the contours of this experience.
“For example, we have seen that the human body produces its own molecules similar to those found in cannabis. And it turns out that this system, called the endocannabinoid, plays a very important role in the balance of our body: it can function, even cause pathologies”.
Nicolas Authier, president of the scientific committee for medicinal cannabis at franceinfo
These advances in scientific research have prompted many countries to allow the use of cannabis for medical purposes. In Europe, the Netherlands was already a pioneer in 2003, since followed by 22 of the 27 Member States of the Union.
“Many countries, such as the United States, Canada, Israel and Australia, are well advanced in the distribution of cannabis for medical use,” said Robin Reda, member of the French National Assembly from the Liberal Party of l'Essonne and chairman of the joint committee. fact-finding mission on the regulations and the consequences of the various uses of cannabis at the Assembly.
A final point has prompted health authorities to take the path of medicinal cannabis: the accelerated opening of stores specializing in the sale of products rich in cannabidiol (CBD), a non-psychotropic cannabis molecule with relaxing properties.
The European Court of Justice ruled in November that CBD is not a narcotic and that France's position, which until now prohibited the import of the natural substance from other European countries, was illegal.
Which patients will be selected to test medical cannabis?
Approximately 3,000 patients will be prescribed cannabis. They will be monitored in one of the 200 reference centers selected by the Agency, the list of which has not yet been made public. Patients are only eligible if they have serious illnesses, such as certain types of epilepsy, neuropathic pain, side effects from chemotherapy, palliative care or multiple sclerosis, according to the ANSM website.
Nathalie Richard, director of the project at the ANSM, told the press in early March that "in certain clinical situations, the use of medicinal cannabis can be beneficial" for minors.
An additional condition: conventional treatments must not have worked in patients before. "For the moment, the level of scientific evidence on medical cannabis does not allow these drugs to be at the forefront", admits Nicolas Authier.
He adds that cannabis will be contraindicated for patients with cardiovascular disease, as well as for patients with psychosis or schizophrenia.
In the first case, the presence of THC (tetrahydrocannabinol), the psychotropic molecule of cannabis, "can affect blood pressure in some cases", and in the second, this molecule can also "aggravate their disease", explains the psychiatrist.
In what form will cannabis be distributed to patients?
"Nobody wants medical cannabis to become a smoked joint on the hospital bed!" summarizes Commissioner Robin Reda, whose parliamentary fact-finding mission devoted a report to this subject.
"The idea is to offer patients anything but a product to smoke: we are talking about oils to put under the tongue , infusions , inhalations ... We are far from the somewhat caricatural vision of cannabis" , she summarizes. Parliamentary.
In practice, the selected patients will mainly be prescribed vials of oil to be administered orally. "These products are generally the most prescribed because they allow patients to be given a more precise dosage", confirm to Franceinfo the representatives of Tilray, the heavyweight of medical cannabis.
How medical cannabis changed Sylvie's life
Founded in Canada in 2013, this company won the ANSM tender for two types of oils.
To win these contracts, Tilray had to prove to the French health authorities that its products complied with the good manufacturing practices used in the rest of the pharmaceutical industry. "This implies strict control of the products, but also a guarantee of reproducibility: the composition and quality of the products must not differ from one batch to another", specifies the manufacturer.
In a second step, patients will be prescribed dried flowers , similar to the grass that cannabis users are familiar with, with varying concentrations of THC and CBD. But here too, smoking is prohibited: these flowers are heated with a vaporizer , which allows the active molecules to be inhaled without burning , thus limiting the toxicity associated with combustion.
How will patients be able to obtain their medicines?
This experience was very well framed. An initial consultation of voluntary patients will take place in one of the reference centers designated by the French Medicines Agency. The prescription issued at the end of this consultation will allow patients to obtain cannabis-based medicines from pharmacies.
“The purpose of this experiment is primarily to assess the feasibility of the medical cannabis distribution circuit. So we want the circuits to be close to the circuit for the patients.
Nicolas Authier at Franceinfo
"At first, you will have to go to a hospital pharmacy which will have a small stock to ensure the first deliveries. The patients' usual pharmacist will then be notified and then trained to be authorized to use these drugs. Order", explains Nicolas Authier.
Voluntary general practitioners will be able to renew these prescriptions, but also after having followed a two-hour distance training. In total, “between 4,000 and 5,000 health workers will receive training as part of this experience,” adds the specialist.
An important detail : the possession of cannabis is still prohibited by law, so patients participating in the experiment must have a permit to transport their medication.
How will they be monitored?
Once included in the experiment, patients will be monitored in two ways. They will attend traditional follow-up consultations, in particular to be prescribed their cannabis-based medications every 28 days through a secure prescription system. These consultations can be carried out by the patients' own doctors, who are thus pre-trained.
Long, so-called “complex” consultations will take place during the first, third, sixth, twelfth and eighteenth months of the experience within the reference structures.
These consultations will aim to "gather more advanced medical elements" on the tolerance and effectiveness of drugs, said the ANSM.
Who will supply and pay for the distributed cannabis?
In a decision published on January 25, the Agency announced that all cannabis-based medicines would be manufactured by specialized companies, all foreign. “In France, the legislation prohibits the production and exploitation of hemp flower, which is used in medicine. This means that it is materially impossible, as it stands, to create a French exploitation sector,” said lamented MP Robin Reda.
"It was not impossible to make an exception for the production of medicinal cannabis in France"
It is certainly a profitable public financing solution, but one that the members of the fact-finding mission do not appreciate. “We are worried because this could put the foot in the door of a possible generalization of treatments which would kill the market before we can put a French industry in the foreground”, regrets Robin Reda.
If medicinal cannabis were to be legalized, it could benefit 700,000 patients in France, according to the estimate published in the report of the cannabis information mission.
Could this experience pave the way for the legalization of cannabis?
Not at this time. The next step is to wait or not for the validation of the experience by the legislator at the end of the two-year trial period. “We have several debates: the debates on recreational cannabis are more complex and shared, it is a process that will take longer than for medicinal cannabis”, explains Robin Reda.
The deputy does not fail to mention that, according to a survey published in April 2019 by the French Observatory of Drugs and Drug Addiction, more than 9 out of 10 French people (91%) say they are in favor of therapeutic cannabis, while simply more one respondent out of two (54%) is against the general legalization of cannabis.
Can medical cannabis be replaced by recreational use?
Nicolas Authier does not believe it. "With the exception of the dried flowers highest in THC, the drugs held by the Agency are not particularly suitable for use by those who use cannabis as a narcotic," said the psychiatrist, who nevertheless recognizes that precautions will have to be taken. to hit.
"It is a product that will have to be controlled, in the same way that we already control codeine or morphine."
Nicolas Authier at Franceinfo
I was lazy to read it all, can you give me a summary?
Implemented by the legislator in 2019, the first consultations in France to involve patients in experimenting with cannabis for medical use will begin.
About 3,000 people suffering from serious illnesses (epilepsy, neuropathic pain, side effects of chemotherapy or multiple sclerosis) will be able to be prescribed cannabis-based medicines in specialized structures for two years.
In most cases, these patients are prescribed oils to coat under the tongue, more or less dosed in THC (the psychoactive molecule of cannabis) and in CBD (another molecule with relaxing properties, but without psychotropic effects), but also spray and inhale dried flowers.
They will be able to obtain these drugs from pharmacies and renew their prescription with their doctor once trained.
The products provided to patients will be provided free of charge by the medical cannabis giants for two years. All foreign - French law prohibits the exploitation of cannabis flowers - these companies hope that the experiment will be validated at the end of the two-year trial to conquer a new market estimated at 700,000 patients.
