2024 Advances in Cannabis Regulation in Brazil
The year 2024 brought significant changes to the regulatory and legal landscape surrounding Cannabis in Brazil. Decisions by the Brazilian Federal Supreme Court (“STF”), the Superior Court of Justice (“STJ”), and the Brazilian Health Regulatory Agency (“ANVISA”) shaped important developments, while the Legislative Branch demonstrated resistance.
The Federal Senate approved Proposed Constitutional Amendment (“PEC”) No. 45/2023, which seeks to amend Article 5 of the Federal Constitution to criminalize the possession and carrying of narcotics and related drugs without authorization or in violation of legal or regulatory provisions. This initiative emerged as an immediate reaction to the judgment of Extraordinary Appeal (“RE”) No. 635,659 by the STF, which decriminalized the possession of up to 40 (forty) grams of Cannabis or up to 6 (six) female Cannabis plants.
Although Law No. 11,343/2006 (the “Drug Law”) does not expressly establish such quantities, the STF’s decision distinguished between users and drug traffickers, seeking to reduce mass incarceration, particularly among vulnerable populations, as well as to strengthen constitutional principles such as equality and the eradication of inequalities, marking a victory for social justice over punitive policies.
While the Legislative and Judicial Branches have adopted divergent approaches, growing pressure from economic sectors and civil society has encouraged a more rational and progressive approach to the use of Cannabis, both for medical purposes and for other applications.
The second half of 2024 also brought significant changes. In October, ANVISA updated Ordinance SVS/MS No. 344/1998, authorizing the prescription of Cannabis-based products for animals. This measure provides greater legal certainty to veterinary professionals, who previously operated in a scenario of regulatory uncertainty.
However, the Agency clarified that, although it is responsible for regulating substances subject to special control, the establishment of guidelines for veterinary products falls within the purview of the Ministry of Agriculture, Livestock and Food Supply (“MAPA”), highlighting the need for greater coordination among different government bodies in order to fully explore the potential of the plant.
In November, the STJ ruled on Incident of Assumption of Jurisdiction (“IAC”) No. 16 in Special Appeal No. 2,024,250/PR, authorizing the planting, cultivation, industrialization, and commercialization of industrial hemp (“Hemp”) exclusively for medical and/or pharmaceutical purposes. The authorization requires that the tetrahydrocannabinol (“THC”) content not exceed 0.3% and that specific regulations be established by ANVISA and the Federal Government.
The decision established deadlines and guidelines for regulation, prioritizing the safety of the production chain and the integrity of the companies involved. However, ANVISA and the Federal Government filed Motions for Clarification seeking an extension of the deadline for implementing the regulations from six to twelve months, due to the complexity of the matter and the involvement of several government bodies.
Another important milestone was the update of the Brazilian Pharmacopoeia by ANVISA through Collegiate Board Resolution (“RDC”) No. 960/2024, which incorporated, among other methods, monographs and pharmacopoeial texts concerning Cannabis. The pharmaceutical compendium establishes quality standards for active pharmaceutical ingredients and medicines subject to health surveillance and serves as a reference for quality control of extracts and products already available on the Brazilian market.
The medical cannabis market has significant growth prospects. According to the Kaya Mind Medical Cannabis Yearbook, the market grew from R$3.7 million in 2018 to R$852.6 million in 2024, with projections indicating that it could reach R$1.159 billion in 2026.
2024 will be remembered as a turning point in Cannabis regulation in Brazil, highlighting the transformative potential of judicial decisions, regulatory adjustments, and economic initiatives. These developments demonstrate the efforts of different sectors to address the growing demand for Cannabis regulation in Brazil.
For 2025, Brazil is expected to take even firmer steps toward a regulatory framework that balances innovation, safety, and access, consolidating the country’s position as a global reference in the sector.
[1] Available at: Attorney General’s Office of Brazil (“AGU”), AGU requests additional time from the STJ for the regulation of Cannabis use for medical purposes. Accessed December 15, 2024.
[2] Available at: Kaya Mind, 2024 Medical Cannabis Yearbook. Accessed December 15, 2024.
