Medicinal cannabis pilot program in France

This January the French agency (ANSM) has selected the products and companies that will supply these products within the medical cannabis pilot program in France.

Cannabis companies from Australia, Canada, Israel and the United Kingdom, in association with French pharmaceutical distributors, will provide the products for 3,000 patients selected by the type of their pathologies. The list of indications developed by the ANSM includes diseases such as cancer, certain types of epilepsy, multiple sclerosis, as well as palliative care and pain, where conventional treatments do not work. The products must comply with the pharmaceutical quality standards.

The French authorities selected the main suppliers as well as the substitute suppliers to cover any shortfalls.

COMPANIES SELECTED FOR THE PILOT PROGRAM

The list of suppliers includes:

  • Althea, based in Australia (one batch as a substitute) and Little Green Pharma (two batches as a main supplier and one batch as a substitute).
  • Aurora Cannabis, based in Canada (three batches as a main supplier) and Tilray (two batches as a main supplier and two batches as a substitute).
  • Panaxia, based in Israel (two batches as a main supplier and two batches as a substitute).
  • Emmac Life Sciences, based in the United Kingdom (two batches as a substitute).

The companies were evaluated based on product, manufacturing and supply criteria.

DESCRIPTION OF THE PILOT PLAN

The program will last two years and will provide medicinal cannabis products to 3,000 patients who meet the established criteria.

Selected doctors, nurses and pharmacists, who participate in this program, will receive a special training to register and issue prescriptions for medicinal cannabis to patients, with the first prescriptions being made on March 31, 2021.

Upon completion of the program, the French authorities will make a decision on the license for the use and sale of medicinal cannabis products in France.

Neither the government nor patients will have to pay for medicinal marijuana, which will be supplied by participating companies at their own expense.

The participating companies have no guarantee that they will remain suppliers in the event that France expands access to medicinal cannabis after the experiment, but they have valued that with hundreds of patients already evaluated and doctors accustomed to prescribing their products, accompanied by some commercial actions it can be a great marketing for their products and companies.

Selected products and suppliers

THC dominant

Batch 1.1: Flower with more than 8% THC and less than 1% CBD.

  • Main provider: Aurora in association with Ethypharm.
  • Substitute: Tilray in association with Medipha Sante.

Batch 1.2: Sublingual oil with more than 5 milligrams of THC per milliliter and less than 1 milligram of CBD per milliliter.

  • Main provider: Tilray in association with Medipha Sante.
  • Substitute: Panaxia in Neuraxpharm France company.

Batch 1.3: Oral oils with more than 5 milligrams of THC per milliliter and less than 1 milligram of CBD per milliliter.

  • Main provider: Panaxia in association with Neuraxpharm France.
  • Substitute: Emmac Life Sciences in collaboration with Boiron.

Balanced THC and CBD

Batch 2.1: Flower with more than 5% THC and 5% CBD.
  • Main provider: Aurora in association with Ethypharm.
  • Substitute: Tilray in association with Medipha Sante.
Batch 2.2: Sublingual oil with more than 5 milligrams of THC and 5 milligrams of CBD per milliliter.
  • Main provider: Tilray in association with Medipha Sante.
  • Substitute: Little Green Pharma in association with Intsel Chimos.
Batch 2.3: Oral oils with more than 5 milligrams of THC and 5 milligrams of CBD per milliliter.
  • Main provider: Panaxia in association with Neuraxpharm.
  • Substitute: Emmac Life Sciences in collaboration with Boiron.

CBD dominant

Batch 3.2: Sublingual oil with less than 1 milligrams of THC per milliliter and more than 5 milligram of CBD per milliliter.

  • Main provider: Little Green Pharma in association with Intsel Chimos.
  • Substitute: Althea in Laboratoires Bouchara Recordati society

Batch 3.4: Flower with less than 5% THC and more than 5% CBD.

  • Main provider: Aurora in association with Ethypharm.
  • No substitute.

Batch 3.5: Sublingual oil with less than 5 milligrams of THC per milliliter and more than 5 milligram of CBD per milliliter.

  • Main provider: Little Green Pharma in Intsel Chimos society.
  • Substitute: Panaxia in association with Neuraxpharm France.

The dominant CBD category originally had six batches in the application process, but suppliers were selected only for the three batches mentioned above.

Conclusions on the first medicinal cannabis pilot program in France

Some striking points of this pilot plan:

  • The French agency designates a wide range of products and companies to provide this Cannabis pilot plan
  • Neither the patient nor the state pays for this supply.
  • The private companies and pharmaceutical distributors carry out the supply and the logistics of supply of these drugs
  • These same companies will provide the necessary and mandatory training in parallel to the health personnel to prescribe this type of products

France, with about 67 million inhabitants, has around 700,000 patients who could opt for a treatment with medicinal cannabis, therefore the initiative of these companies by being in this pilot program places them in a privileged situation to be able to access this market.

Author:

Frederic Pascual
Valtria Mena & QA Manager

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