STJ publishes ruling that defines guidelines for hemp cultivation in Brazil this Tuesday (19)

On November 13, 2024, the First Section of the Superior Court of Justice (STJ) issued a ruling that legally authorizes the granting of sanitary authorization for the planting, cultivation, and commercialization of industrial hemp (a variety of Cannabis sativa with a tetrahydrocannabinol – THC – content of less than 0.3%) by legal entities, exclusively for medicinal and pharmaceutical purposes. The decision establishes a six-month deadline, starting from the publication of the ruling, this Tuesday, November 19, for the National Health Surveillance Agency (Anvisa) and the Union to issue the necessary regulations to enable this activity.

Access the ruling here

The court based its decision on the distinction between industrial hemp and other varieties of Cannabis sativa used for the production of psychoactive substances. The low THC content present in industrial hemp eliminates the possibility of psychoactive effects, differentiating it from marijuana and other variations of the plant used for the production of narcotics. Consequently, the STJ understood that hemp is not subject to the prohibitions set forth in the Drug Law (Law 11.343/2006) and other regulations, allowing its cultivation in national territory.

The decision was made within the scope of the Incident of Assumption of Competence (IAC 16) and must be observed by all judicial instances in the country. In April of this year, the STJ held a public hearing on the subject, gathering representatives from various public agencies and private entities to discuss aspects related to the cultivation of industrial hemp.

With the publication of the ruling, a path is opened for Brazilian companies to, with sanitary authorization, cultivate and commercialize industrial hemp for the production of medicines and other pharmaceutical products. However, the effective implementation of this activity depends on the regulations to be issued by Anvisa and the Union within the deadline established by the STJ. This regulation should address aspects such as criteria for granting authorizations, quality control, inspection, and measures to prevent the diversion or misuse of the plants and their derivatives.

The STJ's decision represents a significant milestone for the health sector and the pharmaceutical industry in Brazil, enabling the national production of cannabidiol (CBD)-based medicines and other derivatives of industrial hemp, which can expand patient access to innovative treatments and reduce dependence on imports. However, it is essential that the regulation is developed carefully, ensuring patient safety and compliance with current sanitary standards, the authors emphasized.