Brazil authorizes the cultivation of medical cannabis by patient associations

On January 28, the collegial council of the’Anvisa, the country's national health monitoring agency, has approved a series of regulatory changes that broaden patient access, redefine culture rules and officially recognize the role of patient associations.

This decision is in line with a recent ruling by the French Superior Court of Justice (STJ) and marks one of the most comprehensive updates of the Brazilian cannabis regulatory framework to date.

The new resolution authorizes the individualized compounding of cannabidiol products in pharmacies, allows for a broader therapeutic use of products with a high THC content, and paves the way for cannabis cultivation for medical and scientific purposes.

Cultivation rules and association recognition

For the first time, Brazil has set clear standards for the large-scale cultivation of cannabis for medical and scientific purposes. Pharmaceutical and research companies will be allowed to cultivate plants containing up to 0.3% of THC, in accordance with STJ decision which excluded low-THC cannabis from the scope of national narcotics law.

Culture through patient associations, who have long been operating in a legal grey zone, will take a different route. Rather than granting a blanket authorization, Anvisa will issue public calls to select non-profit associations to participate in a phase of «controlled testing». This regulatory sandbox model allows the agency to closely supervise production, collect data and assess the health feasibility of small-scale, non-industrial cultivation.

The associations selected will have to meet strict safety, traceability and quality standards, from seed to delivery to the patient. These rules will initially be valid for five years, which means that will give Anvisa the time assess whether and how the production carried out by the associations can be permanently integrated into the national regulatory system.

Greater access to treatments and formulations

Patient access to medical cannabis will also be expanded. Compounding pharmacies are now authorized to dispense cannabis products on personalized medical prescriptions, a measure that should reduce costs and improve continuity of treatment. Anvisa has also expanded the list of approved routes of administration, adding dermatological, sublingual, buccal and nasal routes to the existing oral and inhalation options.

Another major change concerns THC thresholds. Previously, treatments containing more than 0.3% THC were reserved for terminally ill or palliative patients. Under the new rules, access is extended to patients with serious and disabling illnesses, considerably widening the therapeutic field for chronic and complex diseases.

On the industrial front, Anvisa now authorizes the import of Cannabis plants and extracts for pharmaceutical production in Brazil. This measure could help reduce dependence on imported finished products, and ultimately lower prices for patients.

Legal implications and criminal cases

Anvisa Order 344 also removes Cannabis containing up to 0.3 % THC from the list of prohibited substances. According to local experts, this change could have a direct impact on ongoing criminal cases against association leaders accused of drug trafficking for producing and distributing medicines. With low-THC cannabis no longer classified as prohibited, the legal basis for many prosecutions could be called into question.

Anvisa president Leandro Safatle acknowledged that the patient associations have filled the gaps left by the state and the market, guaranteeing access to thousands of families. The new regulations, he said, aim to lift these groups out of a situation of permanent legal vulnerability.

Beyond patient access and culture, Anvisa has also approved a framework dedicated to the cannabis research. Universities and research institutes will be authorized to work with plants containing more than 0.3 % THC, provided the material is legally imported and subject to maximum safety requirements. Marketing and direct distribution to patients will remain prohibited.