France is about to launch a hemp medical trial

How does the approach to amending this issue in civilized countries differ from that which Ukraine is trying to impose, one can understand at least from the fact that the initiated bill No. 10313 of 05.20.2019 does not have any informative base at all. Both its name “On ensuring the fundamental human right to life” and the structures lobbying for its promotion appeal not to logic, numbers and facts (as is customary in civilized countries), but to emotions, which often have clearly defined financial interests specifically taken structures from Israel, Canada and the UK.

The government committee responsible for this issue in France has paved the way for initiating a two-year program to test the therapeutic uses of hemp for medicinal purposes, due to begin in late 2019. The above legal acts provide an opportunity at the initial stage of export of raw materials and finished pharmacological preparations made on the basis of the therapeutic properties of hemp. In the event that the program becomes permanent, it could make France one of the largest medical cannabis markets in the European Union.

A special committee created in 2018 by the French Agency for the Safety of Medicines and Medical Devices (ANSM) presented its final recommendations for the test program last week for consideration by French government officials (parts of the upcoming document were submitted for consideration in June).

The approach to the use of the therapeutic properties of hemp for medical purposes is comparable to a similar test program in Denmark, which, like the French one, is designed to provide access to the healing properties of hemp plants for patients in need, but the French program is much more restrictive than similar procedures. conducted by Denmark.

In Denmark, the above experiment has already been going on for the past 4 years, and the hemp business in the country has already begun to position itself on the international market as a “magnet for foreign investment for the legal production of psychoactive hemp.”

At the initial stage, it is planned that the approach of French officials to the possibility of using hemp for medical purposes will be a pilot project designed for two years and aimed at analyzing how this experiment will work in practice. In turn, government officials will use this opportunity to collect the necessary data on the effectiveness of the use of cannabis-based pharmacological agents, as well as the safety of its use, both from the point of view of patients' health and to monitor possible mechanisms for the illicit trafficking of significant amounts of psychoactive raw materials.

According to experts from the French hemp market, this project is likely to be implemented during 2020-2021. In the event that the tests are successful, the possibility of using hemp for medical purposes will be formalized by amending the relevant regulatory framework no earlier than 2022. In particular, the program will begin work only after the project “gives the green light to the Ministry Health of France ”and the possibility of financing it will be found. 

In the event that a two-year experiment is found to be successful, for the legal regulation of the possibility of using hemp for medical purposes, it will be necessary to amend the French Public Health Code. Industry experts say that at least at the initial stage of the pilot program, France will rely on imported products from countries where this activity is currently regulated. Over time, national players of this extremely highly profitable market will be formed on the territory of the country. 

The essence of the program is reduced to the following key points:

- The use of the therapeutic properties of hemp for medical purposes will be available to patients in France only as a last resort. Only doctors who will be specialists in this field of therapy under the conditions to which this program will be able to begin treatment with cannabis-based pharmacological agents. As soon as the patient “stabilizes”, the general practitioner can continue the treatment, having previously agreed to this with the above hemp specialist;

- indications for applying the program to the patient (chronic pain that cannot be treated with existing treatment methods; some forms of severe and refractory epilepsy; supportive treatment in oncology; palliative care; multiple sclerosis);

- hemp-based drug titration to ensure that the minimum effective dose is reached with acceptable side effects;

- sublingual hemp preparations and flowers for evaporation are recommended as products for immediate effect, while oils and capsules will be available in terms of long-term effect;

- medical personnel who wish to participate in this program must undergo compulsory training;

- ANSM will create an electronic registry to track the growth of the patient base, which will allow doctors to evaluate the progress of the program;

- at the initial stage, hemp-based preparations will be sold exclusively in pharmacies at hospitals participating in the program. Sales in other pharmacies will be possible when the number of patients becomes “stable”.

The above committee expects the two-year trial to begin with a six-month implementation period and end with a final report evaluating the various provisions of the entire project.

Commentary of the Ukrainian Technical Hemp Association

The pages of the profile electronic publication of Ukrainian hemp breeders have repeatedly described the mechanisms for amending the regulatory legal acts of various countries planning to regulate the legal use of hemp for medical purposes. This mechanism is extremely simple and logical - at the initial stage, the corresponding pilot programs are initiated and only after a thorough study of the experience of using hemp for medical purposes, weighing all the pros and cons for the country's economy, and for people who need this kind of treatment, a decision is made amending the current regulatory framework. I would like to focus on one more important detail. Both in Germany and France, at the initial stage, the possibility of importing raw materials into the country from countries where this activity is legal is considered in order to replace these deliveries with raw materials of a national producer in the future. How does the approach to amending this issue in civilized countries differ from that which Ukraine is trying to impose, one can understand at least from the fact that the initiated bill No. 10313 of 05.20.2019 does not have any informative base at all. Both its name “On ensuring the fundamental human right to life” and the structures lobbying for its promotion appeal not to logic, numbers and facts (as is customary in civilized countries), but to emotions, which often have clearly defined financial interests specifically taken structures from Israel, Canada and the UK.