In a unanimous ruling, the STJ authorized the planting, cultivation, industrialization, and sale of industrial hemp—a variety of Cannabis sativa containing less than 0.3% THC—for medical and pharmaceutical purposes only. This pivotal move aligns with global trends recognizing hemp’s medical potential while maintaining strict safeguards against misuse.
The STJ’s decision is rooted in the Brazilian Narcotics Act (Law #11,343/2006), which does not classify industrial hemp as a prohibited substance. With its minimal THC levels, industrial hemp lacks the psychoactive properties capable of causing dependency, according to the court. Justice Regina Helena Costa, who authored the opinion, noted that Brazil’s previous lack of regulation unjustly restricted access to this resource, impinging on the constitutional right to health.
“This ruling addresses an undue restriction on fundamental health rights,” Justice Costa stated. However, she emphasized that the court’s authorization is narrowly focused on medical and pharmaceutical needs. Justice Costa clarified, “The examination of the case is limited to the feasibility of importing hemp seeds and cultivating them solely to meet health-related demands.”
The Five Key Principles of the Ruling
The STJ formalized its decision with five binding principles to clarify the scope and implications of the ruling:
- Hemp is Not a Prohibited Substance: Under Brazilian law, industrial hemp, defined as Cannabis sativa with less than 0.3% THC, is not classified as a narcotic due to its inability to produce psychoactive effects or dependency.
- Regulation Falls to the Government: Responsibility for managing all cannabis varieties, including industrial hemp, rests with the government. However, the court limited its ruling to medical and pharmaceutical uses, leaving recreational or industrial applications outside its jurisdiction.
- Anvisa’s Role Adjusted: Brazil’s Food and Drug Agency (Anvisa) previously prohibited the importation of hemp seeds and domestic cultivation. The court ruled that this prohibition does not apply to industrial hemp intended for health-related purposes.
- Legal Entities Authorized: Licensed organizations can now plant, cultivate, process, and sell industrial hemp exclusively for medical or pharmaceutical purposes. These activities will be tightly regulated by Anvisa and the Federal Government.
- Safety Measures Required: Anvisa and the government must establish strict guidelines to prevent misuse or diversion of hemp seeds and plants. They are also tasked with ensuring the integrity of authorized legal entities and the supply chain.
To ensure swift implementation, the STJ set a six-month deadline for Anvisa and the Federal Government to finalize the necessary regulatory framework. This includes creating protocols for cultivation, production, and safety measures. The decision is pending official publication, expected in the coming days, and will likely accelerate Brazil’s entry into the burgeoning global hemp market.
The ruling signifies a monumental shift in Brazil’s stance on industrial hemp. By balancing health benefits with stringent oversight, the court has paved the way for a more progressive approach to cannabis regulation. While challenges remain, such as implementing effective controls and avoiding diversion for illicit use, the decision highlights Brazil’s growing recognition of hemp as a valuable medical resource.
As the nation waits for Anvisa’s guidelines, this ruling marks the beginning of a new era for patients, healthcare providers, and legal entities eager to explore the possibilities of industrial hemp in Brazil.
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