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Новости/Аналитика

How France is preparing to legalize the use of cannabis for medical purposes

14.12.2018

The positive conclusion of the Committee is regarded as a key step towards the legalization of the use of the therapeutic properties of cannabis in medicine. If a negative decision had been made, any further discussion on this would have no meaning.
 
A committee of experts authorized by the National Agency for the Safety of Medicinal Products and Health Products (Agence nationale de sécurité du médicament et des produits de santé, ANSM) gave a positive opinion on the possibility of prescribing cannabis for medical use in France. ANSM President Nicolas Authier, in a conversation with media representatives, describes the importance of this step towards legalizing the use of therapeutic cannabis, as well as the algorithm according to which patients can legally use the medical properties of cannabis. In order to understand how the officials of the French Republic are planning to legalize the possibility of using the therapeutic properties of cannabis, we give excerpts from an interview with Mr. Autier, which he gave after the announcement of the positive decision of the Committee.
 
The keynote of the statement of the French official is the fact of the positive conclusion of the Committee, which is regarded as a key step towards the legalization of the use of the therapeutic properties of cannabis for medical purposes. If a negative decision had been made, any further discussion on this would have no meaning.
 
What is the basis for the position and procedure for amending the legislative framework?
 
French specialists, as well as our colleagues in other developed countries, are of the opinion that it is unethical to refuse patients treatment that can be effective in solving their medical problems. We plan to discuss all aspects related to the use of cannabis for medical purposes during the first half of 2019. In the future, a decision should be made whether it is necessary to amend the law or whether the adoption of bylaws alone is sufficient. Of course, specialists need to thoroughly understand this issue.
 
What diseases are planned to be treated with the therapeutic properties of hemp
 
Psychoactive cannabis can be used only in cases where the existing methods of treatment are ineffective or poorly tolerated by the patient, i.e. The use of cannabis by a doctor can be offered to the patient solely as a last resort and only after the ineffectiveness of any other treatment becomes apparent. The following diseases currently belong to this kind of extreme cases: chronic pain, oncology, palliative medicine, multiple sclerosis, certain forms of epilepsy, as well as some other, including rare diseases.
 
The situation in the field of application of therapeutic properties of cannabis in France
 
The opportunity to work with therapeutic hemp in the country has existed since 2013. Pharmaceutical companies can already apply for marketing authorization and selling cannabis-based products, provided that they can demonstrate the effectiveness of using this kind of medicine. Sativex, which in a number of states is used to treat multiple sclerosis, received the necessary documents for use in the republic, but at the moment it is not available for sale due to the fact that there is no agreement on the selling price between the manufacturer and the relevant government agencies. Epidiolex is soon to be licensed for the treatment of pediatric epilepsy.
 
The possibility of using leaves and inflorescences of cannabis, for the use of which there is no need for obtaining permits
 
The use of methods involving smoking cannabis should be prohibited due to an increased risk of pulmonary or cardiovascular diseases. Inhalation provides a quick relief to the patient’s negative symptoms, but it should only involve the spraying of active substances with a therapeutic effect. In addition, there are many other ways to use the therapeutic properties of hemp, much less dangerous for the body, such as the use of electronic cigarettes or various types of vaporizers. In any case, it is necessary to avoid burning, which involves the introduction of carcinogens into the body, as well as high temperature, which destroys a significant amount of the therapeutic properties of cannabis. Variants in which it would be possible to effectively use the therapeutic properties of hemp - capsules containing the dried "green mass" of hemp, creams, ointments, oil patches or tinctures. The principle of using various forms of therapeutically active part of a plant should be based on finding the most appropriate method of application depending on the needs of the patient.
 
Studies confirming the therapeutic properties of cannabis conducted in target groups
 
Experiments conducted in various countries of the world community, clearly demonstrate that hemp is an excellent painkiller. The therapeutic properties of the plant are already actively used to treat a number of neurodegenerative and oncological diseases.
 
Is there a risk of new addictions associated with the massive use of hemp?
 
Perhaps the regular use of the psychoactive properties of cannabis is addictive, but the potential for dependence on tetrahydrocannabinol is much less than with any other drugs, such as benzodiazepines (anxiolytics) or opioid analgesics, and even various types of sleeping pills.

How will the issue of the source of legal psychoactive raw materials be resolved?
 
The decision about the possibility of self-cultivation of medical cannabis for personal use seems rather doubtful. There are several reasons for this, however, one of the main factors is that it is difficult to imagine how in such a case the quality of the product will be monitored and it is not clear by what criteria such permission can be granted or denied their receipt. The agrarian lobby has already voiced its interest in the legal production of psychoactive cannabis. In France, there is a developed hemp industry, so legalizing the use of the therapeutic properties of hemp will not be a difficult process. There are no technological or economic issues for French cannabis in this regard.
 
Mechanisms for recovering the cost of using cannabis for medical purposes
 
There are states in which there is a mechanism for partial or full compensation for the possibility of using medicinal products made on the basis of hemp. In a number of countries, there are no such mechanisms for repaying the cost of pharmacological preparations made on hemp base. In France, the decision on the possibility of developing compensatory mechanisms will be taken by the Health Authority (Haute Autorité de santé). Mutual and supplementary insurance systems common in the country may be interested in the development of such mechanisms of reimbursement of the cost of cannabis drugs. However, in any case, in order to receive compensation, it will be necessary to submit supporting documents that they improve the patient's condition. It will be possible to confirm the effectiveness of the use of cannabis with documents that the patient began to use less pharmacological drugs during the treatment or set to work faster. As a first step, it would be ideal to agree with the relevant ministry a pilot program, which over the course of 3-5 years would fully work out all aspects related to the use of the plant and the reimbursement of the cost of its use. And only having received the appropriate array of necessary information, it would be correct to consider the question of the expediency of reimbursing part of the funds for the use of cannabis for medical purposes.
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