Experiments are coming soon! The National Agency for the Safety of Medicines and Health Products (ANSM) announces on March 4 that the first consultations aimed at including patients in medical cannabis trials will begin by “A few days“, in the 200 selected reference centers.

3,000 patients for two years

In practice, how will these experiments take place? The first consultation must be carried out in one of these reference centers, the list of which has not yet been made public.

3,000 patients will be recruited for this large clinical trial which will last two years. If one of the participants stops treatment before the end of the trial, due to poor tolerance or poor efficacy, he may be replaced by another. The ultimate goal is to assess the usefulness and effectiveness of the medical use of cannabis.

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Epilepsy, chemo, multiple sclerosis …

How are these participants recruited? These are people who have serious illnesses (certain forms of epilepsy, neuropathic pain, side effects from chemotherapy, palliative care, or multiple sclerosis) that cannabis could have an effect on.

These patients are either already followed in these specialized hospital services, or referred by their attending physician. In both cases, they can only be selected if they are insufficiently relieved by existing treatments or if they tolerate them poorly.

Last important point: “There will be the possibility to include children“, according to Nathalie Richard, director of the project at ANSM. Because”in certain clinical situations, the use of medical cannabis may be useful“in minors.

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Five long consultations

Once selected, patients will receive a prescription for up to 28 days. It can be renewed by a general practitioner, trained and willing to participate in the project. Their training and that of the participating pharmacists has already started in early March.

Patients will also benefit from five “long consultations“, intended for”collection of more in-depth medical information“on the tolerance and efficacy of drugs,” specifies the ANSM.

Experimentation with a narcotic product which is otherwise illegal in France will be good “supervised and secure“, reassured Christelle Ratignier-Carbonneil, general manager of the ANSM, in a press point.

Oils, capsules and dried flowers

From a practical standpoint, the cannabis-based drugs tested in this trial will come in the form of oils, capsules, and dried flowers to inhale after vaporization.

We are importing the drugs“supplied by the selected manufacturers in January, which will then be”distributed to different pharmacies“, said Nathalie Richard, before ensuring to be”in working order to start this experiment (…) before March 31“, date fixed by decree.

France lagging behind?

An important clarification because the launch of this experiment has already been delayed. The project approved in 2019 by the National Assembly was initially scheduled to begin in September 2020. It had been postponed to January and then March 2021, due in particular to unforeseen events related to the management of the covid-19 epidemic.

Cannabis for medical use is already authorized in around 30 countries around the world. In Europe, the Netherlands were the pioneers in 2003, followed since by 22 countries of the European Union.

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