Brazil Authorizes Private Medical Cannabis Cultivation in Regulatory Shift

Brazil's health regulator approved rules Wednesday allowing private companies to cultivate low-THC medical cannabis for the first time, marking a significant expansion of the country's nascent medical program.

The Brazilian Health Regulatory Agency (Anvisa) voted to implement the new framework in response to a Federal Supreme Court ruling from November 2024 that required the government to establish regulated cultivation pathways. The reforms also expand approved methods for administering medical cannabis products beyond the previously limited options.

Under the new rules, licensed private companies can now grow cannabis specifically for medical use, provided the plants contain low levels of THC—the psychoactive compound that produces a "high." The framework represents Brazil's first formal structure for domestic medical cannabis cultivation after years of relying solely on imports.

Market Implications

Brazil's medical cannabis market has grown rapidly despite restrictive regulations. The country currently allows patients to access imported CBD and THC products through prescriptions, but domestic cultivation remained prohibited until this week's vote. Industry analysts estimate Brazil's medical cannabis market could reach $4.7 billion by 2030 if cultivation restrictions continue to ease.

Several international cannabis companies have been positioning for entry into the Brazilian market, anticipating regulatory changes. The new cultivation rules could accelerate investment in local production facilities and reduce dependence on imported products, which currently face high costs due to import duties and shipping expenses.

The low-THC restriction means companies will likely focus on CBD-dominant strains for conditions like epilepsy, chronic pain, and anxiety. Brazil's medical cannabis program has primarily served patients seeking alternatives to traditional pharmaceuticals for these conditions.

What the Rules Allow

Anvisa's approved framework establishes licensing requirements for cultivation facilities, quality control standards, and distribution protocols. Companies must meet specific security and tracking requirements similar to those used in more established medical cannabis markets.

The expanded administration methods give doctors more flexibility in prescribing cannabis-based treatments. Previously, patients faced restrictions on how they could use medical cannabis products, limiting treatment options for certain conditions.

Regional Context

Brazil joins a growing number of Latin American countries developing medical cannabis programs. Colombia has emerged as a major regional exporter, while Mexico continues working toward broader legalization. Argentina, Peru, and Uruguay have also implemented varying degrees of medical cannabis access.

The Supreme Court's November ruling that prompted these reforms came after patient advocacy groups challenged existing restrictions. The court found that prohibiting domestic cultivation violated patients' rights to access medicine, forcing Anvisa to develop the new regulatory structure.

Industry observers expect additional reforms as Brazil's program matures. The current low-THC restriction may face future challenges from patients and doctors seeking access to higher-THC products for specific medical conditions.

This article is based on original reporting by ganjapreneur.com.