France’s Medical Cannabis Study Takes the First Step

France's medical cannabis study is progressing well, despite the ongoing Covid-19 pandemic that's causing some interruptions, with the first round of results being released earlier in November this year. Jointly piloted by the DGS and the ANSM, the primary objective of the medical cannabis study is to validate the prescription and dispensing circuits for cannabis-based treatments.

Launched last March, France’s medical cannabis study is continuing its deployment throughout the country. 243 reference centers have volunteered, and 1,000 patients have been recruited.

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France’s Medical Cannabis Study: The Numbers

At the end of November, the French National Agency for the Safety of Medicines (ANSM) and the General Directorate of Health (DGS) shared a first progress report on the medical cannabis study in our country. Despite the epidemic context which is slowing down its progress, the recruitment of patients and experimental centers is continuing.

Of the 1,000 patients already included in the medical cannabis study, nearly 780 are being effectively monitored by the reference structures, some patients having had to leave the experiment due to undesirable effects or insufficient effectiveness of the treatments.

Of the 1,035 healthcare professionals who have completed and validated the compulsory training prior to their participation, the majority (735) work in the experimental reference centers, mainly located in the Île-de-France and Auvergne-Rhône-Alpes regions. Others involved in the medical cannabis study are pharmacists (212) and general practitioners (48).

It should be remembered that the medical cannabis study plans to test the usefulness and effectiveness of therapeutic cannabis in five indications: refractory neuropathic pain (objective: 750 patients), certain forms of severe and resistant epilepsy (500 patients), certain rebellious symptoms in oncology (500 patients), certain palliative situations (500 patients) as well as painful spasticity in MS (multiple sclerosis) or other CNS (central nervous system) pathologies (750 patients).

A Two-Year Medical Cannabis Study

Jointly piloted by the DGS and the ANSM, the primary objective of the medical cannabis study is to validate the prescription and dispensing circuits for cannabis-based treatments.

However, many questions will remain unanswered by the medical cannabis study, such as what will be the status of cannabis with a view to its reimbursement by the health insurance system, and at what price levels can these treatments be marketed? If we look at some foreign countries, prices could be relatively high. For example, Sativex® (Nabiximols, a mixture of THC and CBD) is marketed on average between €400 and €450 depending on the European country. How will the prices of flowering tops be set? Will they have DM (medical device) status or will they benefit from a specific status? Which distribution channels will be authorized to dispense them? Will self-cultivation of cannabis for medical use be authorized, as is the case in Canada?

Answers to these questions are all things that should follow from this medical cannabis study in 2023.

Legal and Industrial Issues

This medical cannabis study does not only have medical and medico-economic implications. It should also enable the transition from a black market to a regulated market and support the development of a French medical cannabis industry. Its production is still prohibited in France, which obliges the authorities to import the products prescribed to patients (pairs have thus been formed to associate foreign suppliers and distribution laboratories established on the French market).

Outside of the ongoing medical cannabis study, the ANSM has already started to work on this subject. Last August, it announced the creation of a “temporary scientific committee” dedicated to the establishment of French industry. Made up of experts and representatives from several ministries (Health, Interior, Agriculture, Economy), INRA (National Research Institute for Agriculture), and the National Council of the Order of Pharmacists, it will have to give an opinion by the end of the year on THC and CBD levels, as well as on the plant varieties that will be authorized. It will also have to give its opinion on traceability, controls, and pharmaceutical quality criteria.

(Featured image by Richard T via Unsplash)

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J. Frank Sigerson

J. Frank Sigerson is a business and financial journalist primarily covering crypto, cannabis, crowdfunding, technology, and marketing. He also writes about the movers and shakers in the stock market, especially in biotech, healthcare, mining, and blockchain. In the past, he has shared his thoughts on IT and design, social media, pop culture, food and wine, TV, film, and music. His works have been published in Investing.com, Equities.com, Seeking Alpha, Mogul, Small Cap Network, CNN, Technology.org, among others.