Therapeutic cannabis finally begins
The departure was a little delayed. Approved in 2019 by the National Assembly, but delayed by the COVVI-19 health crisis, the experimentation of medicinal cannabis begins in France. The Minister of Health, Olivier Véran, went to the Clermont-Ferrand University Hospital (Puy-de-Dôme) on Friday March 26 for the "first prescription" of this drug, his services announced. In the coming weeks, at least 3000 patients with serious illness will be able to get cannabis in their pharmacy.
How to explain that France, whose government does not hesitate to show its hostility to cannabis, decides to test its therapeutic benefits? What will be the patients selected for this experience? What kind of drugs can they receive? Who will finance these tests? Franceinfo summarizes.
Why did France decided to experiment with medicinal cannabis?
"Several elements have led to this reflection," explains Professor Nicolas Authier, pharmacologist-psychiatrist at the CHU de Clermont-Ferrand (Puy-de-Dôme). First of all, the emergence of scientific literature on this subject. "Since the 1980s, medicine has moved from empiricism to medicinal cannabis to real 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 endocannabinoid, plays a very important role in the balance of our Body: it can work, even cause pathologies ”.
Nicolas Authier, president of the scientific committee of medicinal cannabis at Franceinfo
This progress in scientific research has prompted many countries to authorize the use of cannabis for medical purposes. In Europe, the Netherlands were already a pioneer in 2003, followed for 22 of the 27 member states of the Union for 22.
"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 of the Liberal Party of Essonne and president of the mixed committee. Information mission on the regulations and the consequences of the different uses of cannabis in the Assembly.
A final point prompted the 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 the CBD is not an amazing and that the position of France, which so far prohibited the importation of natural substance from other European countries, was illegal.
What will be the patients selected to test medical cannabis?
About 3,000 patients will be prescribed cannabis. They will be followed 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 suffer from serious illnesses, such as certain types of epilepsy, neuropathic pain, side effects of 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 should not have worked in patients before. "For the moment, the level of scientific evidence on medical cannabis does not allow these drugs to be in the foreground," 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 certain cases", and in the second, this molecule can also "worsen their disease", explains the psychiatrist.
In what form will cannabis be distributed to patients?
"No one wants medical cannabis becomes a smoked joint on the hospital bed!" summarizes Commissioner Robin Reda, whose parliamentary information mission has devoted a report to this subject.
"The idea is to offer patients anything but smoking: we are talking aboutoils to put under the language, d 'infusions, d 'inhalations ... We are far from the somewhat caricatured vision of cannabis, ”she sums up. Parliamentary.
In practice, selected patients will mainly prescribe oil bottles to be administered orally. "These products are generally the most prescribed because they give patients a more precise dosage," confirm the representatives of Tilray, the heavy goods vehicle.
How therapeutic cannabis changed the life of Sylvie
Founded in Canada in 2013, this company won the ANSM call for tenders for two types of oils.
To win these contracts, Tilray had to prove to the French health authorities that its products were in accordance with good manufacturing practices used in the rest of the pharmaceutical industry. "This implies a strict product control, but also a reproducibility guarantee: the composition and quality of the products must not differ from one lot to another," said the manufacturer.
Secondly, patients will be prescribed dried flowers, similar to the grass that cannabis consumers know well, with variable concentrations of THC and CBD. But there too, it is forbidden to smoke: these flowers are heated with a vaporizer, which allowsinhale active molecules burn, thus limiting toxicity linked to combustion.
How can patients get their medication?
This experience was very well supervised. A first consultation of volunteer 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 drugs from pharmacies.
“The purpose of this experience is mainly to assess the feasibility of the medical cannabis distribution circuit. We therefore want the circuits to be close to the circuit for patients.
Nicolas Authier in Franceinfo
"At first, it will be necessary to go to a hospital pharmacy which will have a small stock to ensure the first deliveries. The usual pharmacist of the patients will then be warned 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 distance training of two hours. In total, "between 4,000 and 5,000 health workers will receive training as part of this experience," added the specialist.
An important detail : The possession of cannabis is always prohibited by law, patients participating in experience must therefore have a permit to transport their drugs.
How will they be monitored?
Once included in the experience, patients will be followed in two ways. They will attend traditional follow -up consultations, especially for prescribing their cannabis -based drugs every 28 days via a secure prescription system. These consultations can be carried out by the own doctors of the patients, who are thus pre-formed.
Long consultations, called "complex", will take place during the first, third, sixth, twelfth and eighteenth months of experience within the reference structures.
These consultations will aim to "collect more advanced medical elements" on the tolerance and effectiveness of drugs, the ANSM said.
Who will provide and pay the distributed cannabis?
In a decision published on January 25, the agency announced that all cannabis drugs would be manufactured by specialized, all foreign companies. "In France, the legislation prohibits the production and exploitation of the hemp flower, which is used in medicine. This means that it is materially impossible, as it stands, to create a French operating sector", A deplored the deputy 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 that members of the investigation mission do not appreciate. "We are worried because it could set foot in the door of a possible generalization of the treatments that 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 Information Mission on Cannabis.
Could this experience pave the way for the legalization of cannabis?
Not right now. The next step is to wait or not to validate the experience by the legislator at the end of the two -year trial period. "We have several debates: debates on recreational cannabis are more complex and shared, it is a process that will take more time 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 addictions, more than 9 French out of 10 (91%) say they are favorable to therapeutic cannabis, while simply more 'One in two respondents (54%) declares himself against the general legalization of cannabis.
Can medical cannabis be replaced by recreational use?
Nicolas Authier does not believe it. "With the exception of dried flowers richest in THC, drugs held by the agency are not particularly suitable for the use of those who consume cannabis as stupid," said the psychiatrist, who nevertheless recognizes that precautions will be taken. hit.
"It is a product that should be checked, in the same way that we already control codeine or morphine."
Nicolas Authier in Franceinfo
I was lazy to read everything, can you give me a summary?
Application by the legislator in 2019, the first consultations in France to involve patients in the experimentation of cannabis for medical use will start.
About 3,000 people suffering from serious illnesses (epilepsy, neuropathic pain, side effects of chemotherapy or multiple sclerosis) can be prescribed cannabis drugs in specialized structures for two years.
In most cases, these patients are prescribed oils to be coated under the language, more or less dosed in THC (the psychoactive molecule of cannabis) and CBD (another molecule with relaxing virtues, but without psychotropic effects), but also Dried flowers to spray and inspire.
They will be able to obtain these drugs from pharmacies and renew their prescription to their doctor once trained.
The products provided to patients will be provided free of charge by therapeutic cannabis giants for two years. All foreigners - French law prohibits the exploitation of cannabis flowers - These companies hope that experience will be validated after the two -year trial to conquer a new market estimated at 700,000 patients.
