Brazil Approves Licensed Medical Marijuana Cultivation for First Time, Expands Patient Access to Cannabis Treatments

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Brazil’s national health agency Anvisa has given approval to sweeping new rules that, for the first time in the nation’s history, allow the cultivation of marijuana within the country for pharmaceutical and scientific purposes, while also expanding access to cannabis-based treatments for patients. The decision by Anvisa follows a ruling by the Superior Court of Justice ordering the federal government to establish clear regulations for marijuana cultivation strictly for medicinal and pharmaceutical use. Recreational use of marijuana remains illegal.

Until now, a lack of formal regulations had created a patchwork system in which some patients and associations were able to grow marijuana only after obtaining court authorization, leading to widespread legal uncertainty.

Under the new framework, Anvisa created three separate regulatory pathways. One allows companies to cultivate marijuana in secure, controlled environments, with plants limited to a maximum THC concentration of 0.3%. Another establishes rules for scientific research, allowing cultivation without THC limits and granting authorization to institutions rather than individual research projects. A third introduces an experimental model for patient associations, which will be selected through a public call and supervised directly by the agency.

Anvisa also revised its broader rules for cannabis-based products. The changes expand approved methods of use to include buccal, sublingual and dermatological applications, in addition to the oral and inhaled routes already allowed. Pharmacies will now be allowed to compound cannabis-based products on an individual prescription basis, and eligibility for higher-THC therapies has been expanded beyond palliative care to include patients with severe, chronic and debilitating conditions.

Emilio Nabas Figueiredo, a drug policy attorney who has been a key legal advocate for medical marijuana in Brazil, called the move “positive, historic and innovative,” particularly because it formally recognizes patient associations within the regulatory structure.

“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 in Brazil, only about 25 previously had court authorization to cultivate marijuana, underscoring the level of legal uncertainty that existed.