2026 reserves crucial legislative advances for medicinal cannabis in Brazil

The year 2026 begins with a decisive regulatory agenda for the medicinal cannabis sector in Brazil. While the National Health Surveillance Agency (Anvisa) prepares to resume the vote on the revision of RDC 327, the legal scenario requires attention.

At the same time, the Federal Government is racing against time to comply with an important court order. The deadline set by the Superior Court of Justice (STJ) to regulate national cultivation is approaching.

The definitions, expected in the first quarter, promise to directly impact the legal security of the pharmaceutical industry. Additionally, the operation of associations and patient access to medicinal cannabis are expected to undergo significant changes.

Review of RDC 327 impacts the medicinal cannabis market

The first meeting of the Collegiate Board (Dicol) of Anvisa in 2026 is scheduled for January 28. Although the official agenda has not yet been published, expectations are high. The market is awaiting deliberation on the revision of the regulation that governs the sale of products in pharmacies.

The process was suspended on December 10, 2025, after a request for a review by director Thiago Campos. According to lawyer Diogo Busse, the return of the topic is likely due to the agency's procedural routine, but he warns the sector.

"We cannot guarantee the continuation without another request for review. Even so, I believe we are very close to the new text of the new RDC," the specialist assesses.

Import restrictions and patient access

One of the most sensitive points of the draft proposed by rapporteur Rômison Rodrigues Mota is the possible restriction on importation by individuals. The measure aims to limit the use of RDC 660 when there is an equivalent medicinal cannabis product available in the national market.

If approved, the rule would come into effect 12 months after the publication of the regulation, aiming for a market transition. The text also maintains the requirement for predominance of CBD, limiting THC to 0.2%, except for palliative care.

Busse criticizes the limitation, arguing that it may reduce competitiveness. "Limiting production only to products manufactured in Brazil will stimulate speculation by large industry. There will be no competition. Patients should have the freedom to choose whether to obtain medications from Brazilian or foreign producers," he states.

Deadline for regulating the cultivation of medicinal cannabis

On the other hand, the Executive faces the final deadline of March 31, 2026, to regulate the national cultivation of cannabis for medicinal and scientific purposes. This date was established in Incident of Assumption of Competence (IAC) 16 of the STJ and encompasses medicinal and scientific purposes.

Recently, the Minister of the General Secretariat of the Presidency, Guilherme Boulos, met with representatives of the sector. The goal was to discuss public policy proposals that will be forwarded to other government departments by early February.

Lawyer Marina Bortolom analyzes the scenario cautiously, noting the trend towards regulation focused on the business sector. "Regulating national cultivation will bring more legal security to the pharmaceutical industry, allowing for reduced production costs by eliminating dependence on imported inputs," she points out.

Legal challenges and sanitary security

However, Bortolom warns of the possible maintenance of legal insecurity for the third sector and individual patients. "The legal scenario will remain complex if the current trend of the Agency to focus cultivation regulation on pharmaceutical companies materializes," she explains.

According to the specialist, associations and patients who engage in self-cultivation of medicinal cannabis may continue to be vulnerable. They would depend on judicialization and Habeas Corpus to secure their operations.

In light of the changes, companies' compliance with sanitary regulations becomes crucial. Busse emphasizes that "any entrepreneur thinking of organizing a cannabis business needs to pay attention to compliance." He highlights that traceability must be total, "from genetics to the final product."

Despite bureaucratic hurdles, the safety of use is reinforced. "In the last 5 years, there has been absolutely no record of drug interaction or serious adverse reaction resulting from cannabis medications being dispensed," Busse observes.

The year promises to be one of expansion, but also of profound adjustments to the rules of the game. For Bortolom, this moment could drive the "democratization of access for patients." However, Busse concludes with a warning: "It is of no use to work so hard for so long for legal and regulatory changes if these changes are not accompanied by a cultural shift."