France set to launch landmark medical cannabis trial

A first-of-its-kind medical cannabis pilot is expected to launch by the end of March 2021. Cannabis Health speaks to one of the companies recently selected as an official supplier.

This week, the French Agency for the Safety of Medicines and Health Products (ANSM) revealed the companies that will supply cannabis products for a landmark medical cannabis trial.

Four main suppliers from Australia, Canada, Israel and the UK will partner with French pharmaceutical distributers to provide a total of nine cannabis-based medical products for up to 3,000 patients. With no funding from patients or the French government, the participating companies will have to cover the production and distribution costs themselves.

Taking place over a two-year period, patients with one of five medical conditions, including chronic pain, epilepsy, oncology and spasticity will be eligible for the pilot.

Physicians, nurses and pharmacists will be selected for the programme and will undergo special training for issuing and dispensing medical cannabis prescriptions to patients.

The concept of the trial was first suggested in 2018 when the ANSM brought together a committee to consider the feasibility of making medicinal cannabis available to French patients.

Over the past two years, the French government has been accused of dragging its feet in putting the pilot in motion, however after finally opening applications in October 2020, the long-awaited trial is set to commence by the end of March 2021.

Aurora’s managing director for France, Hélène Moore

Aurora Europe, a subsidiary of Canadian company, Aurora Cannabis Inc., has been selected to provide the entire supply of cannabis flower for the trial, which includes three types: high-THC, balanced THC to CBD and high-CBD flowers. The company is partnering with French-born pharmaceuticals company, Laboratoires Ethypharm.

Aurora’s managing director for France, Hélène Moore, told Cannabis Health: “This is what we wanted, we decided to offer the product for which we are already a leader in Europe. We went for what we do well, and we won all the [flower] lots; we were very proud of that.

“It really shows how we have mastered the art of growing pharmaceutical-grade medical cannabis.”

Flower is a difficult product to develop when it comes to medicinal cannabis. Ensuring that the plant contains the same concentration of cannabinoids from batch to batch can be challenging and relies on precisely controlling the growing environment.

“All of our cannabis is grown indoors where every single variable that you can think of for growing a plant is controlled to the [letter; it takes a long time to get it right.

“You need to have it validated, you have to demonstrate to the authorities that you can do the same batch after batch, and we have done that.”

At the end of the pilot, the French government will decide on permitting the use and sale of medical cannabis products, however Moore stresses that the pilot’s purpose is not to test the efficacy of cannabis-based medicine.

Photo: Aurora Europe

“The intention is really to test the distribution system, to test prescribers; the whole machine. The pilot is not a clinical trial, and this has to be very clear.” Moore added.

“What’s going to be assessed is the feasibility of putting together a larger scale medical cannabis programme for patients in France.

“If this pilot is successful, and there are no big roadblocks, the understanding is that they will generalise the offering of medical cannabis to a larger scope of patients.”

Although participating companies are not offered any guarantee as to whether they will remain as official suppliers after the trial, Moore says Aurora’s intention is to continue working with French stakeholders and be “part of the equation in the long run”.

Photo: Aurora Europe

“Our partner is well established, they want to get into this market, and we will do this together,” Moore said. “Now we have a partner that knows how to do things in France, our goal is to extend the relationship from a post-pilot perspective.”

In addition to the four main suppliers, French authorities also selected a number of substitute suppliers to cover any gaps.

Canadian company, Tilray, will supply two sublingual oils as a main supplier and two types of flower as a substitute.

Meanwhile, Israel’s largest manufacturer of medical cannabis, Panaxia, will supply four products, two as a main supplier and two as a substitute. In partnership with Neuraxpharm, the company is providing two cannabis-based oils in various doses of THC/CBD and two types of sublingual tablets.

Deemed a “huge success” for the company, Panaxia’s CEO, Dr Dadi Segal believes the trial is the first step towards France becoming one of the world’s “most advanced medical cannabis markets”.

Dr. Malgorzata (Gosia) Meunier, VP Innovation at Panaxia, added: “Being personally linked to France, I’m especially proud that Panaxia will participate in this prestigious experiment and provide a response to the enormous need of patients in France […] this is an amazing regulatory achievement for us.”

The Australian company Little Green Pharma will be a main supplier for two CBD-dominant sublingual oils and a substitute for a balanced CBD-THC oil.

Other substitute suppliers include Australia-based, Athlea, and UK-based independent cannabis company, EMMAC Life Sciences Group, which will supply two types of orally administered cannabis medicines together with Paris-based distributor, Boiron.

CEO of EMMAC, Antonio Costanzo, hopes the company’s involvement with the trial will “advance the industry’s understanding of the benefits of medical cannabis”.

Due to the country’s strict regulations surrounding cannabis, none of the chosen suppliers are French companies, however partnering with a French distributor was mandatory for all participants. Moore believes that involving the existing pharmaceutical ecosystem could be a key factor in the success of France’s future cannabis sector.

“This is really unique. There are no other countries in Europe that have made that distinction. I think this is something that could provide a key success factor for France in the long run.”