Brazil – Anvisa, “approved a new set of rules expanding the use of medical cannabis and authorizing, for the first time, cultivation of the plant within the country for pharmaceutical and scientific purposes, as well as on a limited basis by patient associations. Recreational use of cannabis remains illegal.” | Cannabis Law Report | How to order Skittles Moonrock online

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ANVISA

Court House News Reporter

RIO DE JANEIRO (CN) — Brazil’s health regulator Anvisa on Wednesday approved a new set of rules expanding the use of medical cannabis and authorizing, for the first time, cultivation of the plant within the country for pharmaceutical and scientific purposes, as well as on a limited basis by patient associations. Recreational use of cannabis remains illegal.

The decision complies with a ruling by Brazil’s Superior Court of Justice, which ordered the federal government to regulate cannabis cultivation exclusively for medicinal and pharmaceutical purposes.

Until now, the lack of clear rules had been partially addressed by court decisions allowing patients or associations to grow cannabis, creating a fragmented legal landscape and regulatory uncertainty.

Under the new framework, Anvisa approved three distinct regulatory tracks. One allows companies to cultivate cannabis in controlled and secure facilities, with plants limited to a maximum THC concentration of 0.3%.

Another sets specific rules for scientific research, allowing cultivation without THC limits and granting authorizations to institutions rather than individual research projects.

A third creates an experimental regulatory model for patient associations, which will be selected through a public call and supervised directly by the agency.

Beyond cultivation, Anvisa also revised its regulatory framework for cannabis-based products. The changes expand the authorized routes of administration to include buccal, sublingual and dermatological use, in addition to the oral and inhaled routes previously allowed.

The agency also authorized the compounding of cannabis-based products by pharmacies upon individual prescription and broadened the group of patients eligible for therapies with higher THC concentrations. Previously restricted to palliative care, access to such products has now been extended to patients with severe chronic and debilitating conditions.

Emilio Nabas Figueiredo, drug policy attorney and one of the main legal advocates behind the medical cannabis movement in Brazil, described the decision as “positive, historic and innovative,” highlighting the formal inclusion of patient associations as one of its most significant advances.

“There was a joint effort by social movements, the regulatory agency and the government to create a viable path for these institutions,” he said.

Figueiredo noted that of the roughly 350 cannabis patient associations operating in Brazil, only about 25 had previously obtained court orders allowing cultivation. “The level of legal uncertainty that existed before was unsustainable,” he said.

Despite the advances, the new regulation does not eliminate key points of tension that have driven litigation over medical cannabis in Brazil.

One of them is the 0.3% THC cap imposed on authorized medicinal cultivation, a threshold commonly adopted in temperate-climate countries but widely viewed as difficult to maintain under Brazil’s tropical growing conditions.

Attorney Raphaella Nogueira, who specializes in cannabis and psychedelics, said the THC restriction remains a major obstacle for people who rely on higher concentrations of the compound to manage their symptoms.

In her assessment, patients and associations that require cannabis with higher THC levels are likely to continue turning to the courts to secure authorization to cultivate or access specific treatments.

Other unresolved issues, according to Figueiredo, include how existing court-authorized cultivation will transition into the new regulatory framework, how already cultivated plants will be regularized and how patient associations will interact with research institutions under the new rules.

Even so, he emphasized that the regulation should be seen as a starting point rather than a finished product.

“This is a living regulation that will evolve over time,” Figueiredo said. “But it represents a first step toward changing Brazil’s regulatory reality and creating better conditions for patients who rely on cannabis as medicine.”

Courthouse News reporter Marília Marasciulo is based in Brazil.