France is launching an experiment to test the therapeutic benefits of cannabis.
On Tuesday, French lawmakers approved the government’s Social Security budget for 2020, which includes an amendment on the use of cannabis for medicinal purposes. The amendment allows the French Agency on the Security of Medicine and Health Products (Agence Nationale de Sécurité du Médicament et des produits de Santé, or ANSM) to conduct an experiment that will allow doctors to “offer pain relief for many patients who are already on a heavy drug treatment,” said representative Olivier Véran on the floor of the Assembly, welcoming the consensus in the assembly.
A neurologist turned politician, Véran was in charge of drafting the amendment. He added that cannabis-based drugs aren’t meant to replace common pain relievers such as Paracetamol (Tylenol) or Ibuprofen, and that the experiment will take place “in hospitals in a very secured framework.” If the experiment shows a benefit for the patients and is validated by the government, costs of care will be covered by the Social Security, France’s universal health-care system.
It is a small-scale experiment, carefully thought out by the Ministry of Health. About 3,000 patients experiencing illness-related pain will be enrolled and, starting in January 2020, they will be monitored for six months. For now, the cannabis-based drugs will be imported from other European countries. At the end of the experiment, an assessment will be handed to the ANSM, which will in turn submit its recommendations to the Ministry of Health as early as fall 2020.
When the amendment was first presented in early October, it had widespread support, though some representatives expressed reservations, arguing that cannabis is potentially a “dangerous drug.” But Tuesday’s vote was the tipping point of an eighteen-month-long process that started in May 2018, when the French Health Minister, Agnes Buzin, said that France should not “close its doors to a product that could help in cases of illness for which there aren’t enough drugs available.”
She then quickly asked the ANSM to assess the benefits of medicinal cannabis. A couple of months later, the ANSM formed a special scientific committee, with a mission to examine the available cannabis-based therapeutic drugs and to weigh benefits and risks. The committee also had to determine whether it would be preferable to import the drug, or to have it produced locally by private or public companies.
The CSST quickly released its recommendations in December 2018, writing in its report that it would be “useful” to authorize cannabis to “release pain” or in cases of “low tolerance to conventional drugs.” It said that cannabis could either “complete or replace” traditional therapies, but only for specific cases: neuropathic pain resistant to traditional drugs, severe forms of epilepsy, to relieve symptoms of nausea and anorexia among cancer patients, for patients with multiple sclerosis, or palliative care.
In June, the CSST laid out a detailed framework to start the experiment, with two objectives: It would assess its own recommendations, and it would, for the first time in France, collect data on the benefits of cannabis, and on its side effects. A few weeks later, the ANSM validated the CSST’s evaluation, and, with Tuesday’s vote, lawmakers approved the experiment.
The Social Security bill passed this Tuesday also allocated a budget for the experiment. Costs include the training of medical doctors and pharmacists through e-learning and the monitoring of patients through a registry that details dosages, benefits, and side effects. It also covers the cost of cannabis itself.
In its description of the rules of the experiment, the agency advises caution. The rules warn against smoking cannabis and instead recommend vaporizing dried leaves or ingesting oil. It also recommends providing cannabis in forms such as oil pills or a drinkable solution. There will be five types of prescriptions with a variation of THC/CBD ratios and doctors are advised to start with a low dosage, slowly increasing it so as to find the lowest effective level.
It is not clear yet who the provider will be. In 2013, France authorized importation of cannabis-derived drugs for patients with multiple sclerosis. One of those drugs is Sativex, produced by the British company GW Pharmaceuticals. It never made it to the French market because of disagreement on the price.
A representative with the Francophone Union for the use of Cannabinoïdes in Medicine said in a meeting with the Committee back in 2018 that, in France, “There are 600,000 patients with epilepsy, and the number of new cases of cancer is 400,000 per year. About 160,000 patients are also treated for Parkinson’s, 153,000 are living with HIV, and 100,000 suffer from Multiple Sclerosis.”
Is Wider Legalization on the Horizon?
Meanwhile, last summer, while the ANSM was moving forward with the experiment on therapeutic use, a group of lawmakers seized the momentum to draft a bill for the legalization of cannabis for both therapeutic and recreational use.
In the bill, they wrote that France represents a large market with potentially significant profits. They added that prohibition has failed, jamming the courts, and that 90% of police drug efforts are aimed at cannabis. Prohibition, they noted in the draft, benefits drug gangs “instead of the States.” Their draft bill plans to create a government-owned monopoly that would control the production and consumption of cannabis. It would be produced by farmers and sold at tobacco stores.
At the same time, another report, titled “How to take back control,” made it to the desk of the French Prime Minister, Edouard Philipe. Written by the Council of Economic Analysis at the request of the office of the Prime Minister, the report advises the government that legalizing cannabis would be a great source of income for the government.
The authors, two well-known economists, write that legalization of cannabis at €9 for one gram would represent an income of €2.8 billion in taxes for the government. “The legalization of recreational cannabis, which is strictly regulated, makes it possible both to fight against organized crime, to restrict access to the product for the youngest, and to develop an economic sector that creates jobs and tax revenues,” they wrote.
A sign that France will move forward with complete legalization soon? Not as long as Emmanuel Macron is at the Elysee. The French president said last Friday in a press conference that he was against the legalization of cannabis because he had never heard of a “robust study showing that cannabis had no effects on vigilance, particularly among young people.”