France will launch a two-year medical cannabis trial program to assess plant’s efficacy

Five cannabinoid combinations will be prescribed to patients under the ANSM's clinical trial on cannabis

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France will launch a two-year medical cannabis trial program to assess plant’s efficacy

Bethan Rose Jenkins, Cannabis News Writer/Editorial

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Later this year, a two-year medical cannabis trial program is expected to begin in France. The news comes after an important government committee submitted recommendations for the program’s commencement last September.

Established in 2018 by the French Agency for the Safety of Medicines and Health Products (ANSM), the committee responsible for initiating the trial program published its draft framework last month. Introducing such a trial would open up a door for overseas cannabis imports.

“The French Minister of Health, Agnès Buzyn, has previously indicated to be in favor of such pilot program provided it is based on the ANSM’s scientific recommendations,” said Van Keymeulen, adding that, “in principle, a change in legislation should not be required to implement the pilot given that it concerns an experimental phase, but certain regulations may have to be adopted to implement the experiment.”

Reports and data pertaining to the plant’s safety and suitability as a medical aid will be investigated by the committee, which will monitor the program’s progress using an electronic registry. French doctors participating in France’s medical cannabis trial program will do so voluntarily.

What framework did the committee suggest for France’s medical cannabis trial program?

To begin with, France’s medical cannabis trial program will roll out for two years, with the possibility of being implemented on a permanent basis. In the event that French lawmakers decide the program is beneficial and can enhance practices in the pharmaceutical field, the European country could quickly become a leading player in the medical cannabis market.

A patient must be deemed “stable” by a licensed healthcare practitioner in order to obtain medical cannabis as a treatment under the trial program. Only specialist healthcare physicians will be granted access to the program, which will be made available to patients who are:

  • Currently receiving palliative care

  • In need of treatment for chronic pain after having exhausted alternative treatments

  • Enduring spasticity caused by multiple sclerosis (MS)

  • Currently receiving supportive care in oncology

  • Suffering from severe and refractory epilepsy.

The following five cannabinoid combinations will be prescribed to patients under the ANSM’s clinical trial on cannabis:

  1. 1:1 THC to CBD

  2. 1:20 THC to CBD

  3. 1:50 THC to CBD

  4. 5:20 THC to CBD

  5. 20:1 THC to CBD

To reduce the risk of patients experiencing unwanted side effects from medical cannabis treatments in France, the committee have suggested drug titration, which they say could help patients get relief from their symptoms with low dosages. The aforementioned cannabinoid combinations will be tested for six months and evaluated for the remainder of the trial period.  A report will be drawn up at the end of the two-year trial.

European cannabis market could be worth €123 billion in 2028

Other countries in the European Union are already integrating cannabis medicines into the healthcare market, including Germany and the United Kingdom. In Q1 2019, Germany’s pensioner-dominated medical cannabis market demanded 1,650 pounds of flower. In 2018, medicinal cannabis-derived treatments were moved to Schedule 2 of the 2001 Misuse of Drugs Regulations, enabling clinicians to prescribe them to patients.

By the year 2028, analysts at Prohibition Partners predict that Europe’s medical cannabis market will be worth USD$139 billion. If France integrates cannabis into its healthcare market, these projections could very well become a reality. As of February 2019, USD$564 million had already been invested in the European Union’s blossoming cannabis industry.

Should the ANSM trial program be successful, the French Public Health Code must be amended. It is not quite certain exactly how the supply chain will be dealt with if medical cannabis is legalized in France; the committee is putting a patient-focused framework at the top of its agenda.