On December 2, 2020, through its Commission on Narcotics, the United Nations approved a recommendation issued by WHO – World Health Organization through its Committee of Experts on Drug Addiction and removed Cannabis from Schedule 4 of its Single Narcotic Convention (1961, amended in 1972). Schedule 4 contains the substances considered as the most dangerous to human health and whose possible therapeutic benefits do not outweigh their risks – reason why they should be considered outlawed. Among the substances in Schedule 4 is, for example, heroin.
With the approval of WHO recommendation 5.1, P&D with Cannabis is now easier. It should be noted, however, that Cannabis remains on Schedule 1 of the same Convention (the same where several opioids are, such as fentanyl), being subject to the following controls:
• Limitation of use for medical and scientific purposes of all phases of the substance's trade (manufacturing, domestic and international trade);
• Government authorization requirement for the domestic market and specific authorization (import and export authorization) for each individual international transaction;
• Obligation of all participants in the trade to keep detailed records of their transactions with the substance;
• Requirement of a medical prescription to supply or dispense medications to individuals;
• Submission to a system to limit the quantities of medicines available, by manufacture or import or both, in each country and territory, for those necessary for medical and scientific purposes.
WHO had also recommended the downgrading of THC, Dronabinol and their isomers to Schedule 1, as well as the removal of CBD from the scope of the Convention and the inclusion of preparations in which it is predominant in Schedule 3 of the Convention (less restrictive). However, these other recommendations were not approved.
The approval of Recommendation 5.1 has the potential to modify Anvisa's position on research with cannabinoids, both for marketing purposes and with regard to previous consent of patent applications.
*This newsletter is only a general update on the subject and should not be considered as legal advice.