Brazil legalised medical cannabis cultivation, and left the import gap untouched

In February 2026 Brazil's health regulator, Anvisa, published five Collegiate Board Resolutions — RDCs 1,011 through 1,015 — that together rewrite how medical cannabis is grown, researched, manufactured, tested and sold in the country [s1]. An opinion analysis published in Ciência & Saúde Coletiva on 21 March calls the package the most comprehensive proposal ever put forward for cannabis regulation in Brazil, and then spends most of its length on what the package still leaves unresolved [s1].

What Brazil had before

Until 2025, medical cannabis in Brazil rested on two rules. RDC 327/2019 created a regulatory category called "cannabis product" for domestic manufacture and sale; RDC 660/2022 governed exceptional personal importation by individuals holding a prescription, with authorisation issued by Anvisa [s1]. Neither addressed cultivation. The analysis argues this was the structural flaw: because growing the plant was neither authorised nor regulated, the gap was filled by litigation, with individuals filing habeas corpus petitions for personal use and patient associations suing for permission to plant and produce [s1].

What the five resolutions actually do

Each resolution takes one segment of the chain [s1]:

• RDC 1,011 updates the controlled-substances lists under Ordinance 344/1998, creating exceptions for cannabis and its derivatives and clarifying definitions of the plant and its therapeutically relevant active compounds.
• RDC 1,012 governs cultivation for scientific research, by authorisation granted to legal entities.
• RDC 1,013 sets cultivation criteria for medicinal and pharmaceutical purposes under a special authorisation.
• RDC 1,014 creates a regulatory sandbox — an experimental environment for testing non-industrial production arrangements, aimed particularly at patient associations.
• RDC 1,015 consolidates requirements for producing and marketing cannabis products, and revokes RDC 327/2019.

Two operational details carry weight. Cultivation is now split by THC content: varieties above 0.3% THC are authorised only for research, pharmaceutical cultivation must use varieties below that threshold, and material exceeding 0.3% total THC by weight in dried inflorescences must be destroyed [s1]. And RDC 1,015 gives authorised products a five-year window, extendable once by the same period, in which to assemble enough clinical evidence to apply for registration as a medicine — otherwise the authorisation may be revoked [s1].

The prescribing rules changed less than the supply rules. The 0.2% THC limit stays [s1]. What shifted is the clinical criterion attached to it: where the previous wording tied higher-THC use to patients in "palliative care," it now refers to people with "severe, debilitating and life-threatening diseases" [s1]. The analysis reads this as mainly terminological, while noting that the lay reading of "palliative care" as end-of-life-only may have narrowed use in practice, so the new wording could widen it [s1].

RDC 1,015 also tightens labelling, restricting imprecise marketing terms including "full spectrum," "broad spectrum," "oil," and "complete extract" [s1].

The sandbox, and why patient associations are the point

The regulatory sandbox in RDC 1,014 is the most novel element. Patient associations — which the analysis describes as having existed in a de facto legal limbo — gain special authorisation to produce under a pilot arrangement [s1]. Brazil is not alone in trying this: the analysis points to France, one of Europe's larger cannabis markets, which began a controlled experimentation model for patients with serious illnesses in 2021, with temporary use authorisations issued by the regulator ANSM and the assessed therapeutic value determining whether supply continues afterwards [s1].

What it means inside the public health system

Very little, immediately. The analysis is explicit that the new rules have no direct impact on Brazil's Unified Health System (SUS) [s1]. Cannabis products remain "products," not registered medicines, precisely because they have not completed the clinical development pathway that registration requires [s1]. They have not been incorporated into SUS by CONITEC, the national health technology incorporation commission, and incorporation would require technology assessment and inclusion in the national essential medicines list — neither of which has happened, the analysis attributes to insufficient robust evidence [s1].

The therapeutic positioning is stated plainly: clinical protocols generally follow stepped treatment lines, and medical cannabis appears, at most, as an alternative in refractory cases such as some childhood epilepsies [s1]. Combined with high costs, especially for imported products, that leaves what the analysis calls a sensitive combination — no technology incorporation, limited clinical evidence, and high prices [s1]. Under shared-financing rules and Supreme Federal Court decisions, much of the cost of court-ordered treatments below certain financial ceilings falls on states and municipalities [s1].

The gap that was not closed

The analysis reserves its sharpest point for imports. Today any patient with a prescription can import cannabis products through automatic authorisation on Anvisa's website, with no post-marketing surveillance provided for [s1]. The new framework does not address this. The concern the authors raise is asymmetry: if domestic rules become substantially more demanding than the import channel, the stricter regime applies only to Brazilian producers.

Three further problems are flagged. First, Cannabis sativa L. remains listed as a prohibited plant on List E of Ordinance 344/1998 even as its cultivation becomes authorised in specific regulated circumstances — a status the analysis calls singular, noting that no other List E plant has comparable exceptions, including Papaver somniferum, the source of morphine, whose cultivation stays prohibited [s1]. Of the 15 addenda to Ordinance 344/1998, nine concern cannabis and its derivatives [s1]. Second, cultivation oversight exceeds Anvisa's direct competence and requires coordination with other government bodies [s1]. Third, the rules substantially expand Anvisa's own remit — crop monitoring, running the sandbox, quality control, laboratory analysis, traceability — which presumes institutional capacity the analysis does not assume the agency currently has [s1].

What to watch

Whether the five-year evidence window produces actual registration applications. The analysis raises the underlying incentive problem directly: developing a medicine is expensive, and if profit is already assured from selling products under the current category, the commercial case for funding costly trials with uncertain results is weak [s1]. That question — not cultivation licensing — is what determines whether medical cannabis ever reaches SUS patients.

Sources

• Challenges for the new regulatory framework of medical Cannabis in Brazil — Ciência & Saúde Coletiva, 21 March 2026