Article updated on Thursday (02), at 9:45.

The future of the regulation of cannabis cultivation for medicinal purposes in Brazil has entered a new waiting period. On Tuesday (30), the deadline set by the Superior Court of Justice (STJ), the Federal Government requested from Minister Regina Helena Costa, the case's rapporteur, a 180-day extension to publish the regulation that will define the rules for the planting and commercialization of the plant in the country.

The justification for the extension request, according to the Ministry of Health (MS) and Anvisa, is the "high technical and regulatory complexity of the subject," which would require an internal restructuring at the agency, in addition to the need for a Regulatory Impact Analysis (RIA) and a public consultation to ensure social participation. The new proposed schedule extends the stages until March 2026.

The original action plan, whose deadline has expired, included crucial steps that were not met, such as the consolidation of contributions, the legal analysis of the draft, and the final approval of the ordinance. Faced with the impasse, the question that remains is: what will be the next step for the STJ? Can the Court accept the request, deny it, or impose new conditions? 

In a statement to Sechat, the STJ informed that Minister Regina Helena will analyze the parties' statements and then publish her decision in the Electronic Justice Gazette (DJe). Before her decision, four legal experts on the subject speak to the Portal to explain the possible scenarios.

Scenario 1: Extension of the deadline

The trend, according to the experts, is that the STJ grants the new deadline, mainly because it is an action against the Union. Lawyer Murilo Nicolau explains that the Judiciary's approach tends to be more cautious. "Since we are talking about the state entity, the judiciary cannot interfere so directly. She could always deny the extension request, but since it is well-founded, I believe the Minister will not deny it," he evaluates.

Lawyer Clayton Medeiros agrees with the premise and adds that rushed regulation could be ineffective. For him, the recent change in Anvisa's board of directors and the dialogue initiated with patient associations may weigh in favor of the extension. "Maintaining the harmony of powers, the tendency is to have more time. Because if the regulation comes now, it will fail to directly meet the interests of patients. There is no point in meeting the stipulated deadline, drafting the draft, and amending the regulatory act in six months," he points out.

Scenario 2: Refusal or imposition of new rules

Despite the likely extension, the STJ has tools to tighten the conditions. Lawyer Juliana Gomes emphasizes that the history of non-compliance by the government weakens its position. "The non-compliance with crucial steps of the previous plan significantly weakens the credibility of the new schedule, although it does not prevent the granting of a new opportunity," she states.

According to her, the Court can act to ensure that the decision is enforced. "The Superior Court of Justice has constitutional competence to preserve its authority. In practice, this means that the STJ can grant the extension but imposing stricter conditions, such as setting a schedule with shorter deadlines, applying daily fines in case of new non-compliance, and requiring periodic reports," explains Gomes.

Lawyer Bianca Uequed details the consequences of a possible refusal. "In the case of the request being denied, coercive measures can be taken, with the application of fines and, even, holding the agents accountable for not complying with the judicial determination," she emphasizes. She also raises the possibility of the STJ granting a shorter deadline than the requested 180 days, as a middle ground.

The alleged complexity and the impact on patients

A central point in the government's request is the need for a more comprehensive regulation, which includes, for example, tetrahydrocannabinol (THC), which would require the revision of other regulations, such as Ordinance 344/98. For Bianca Uequed, although the argument is valid, it does not erase years of omission.

"They argue that they want to create a more comprehensive regulation. From a health perspective, it could be very important," Uequed ponders. "However, regarding THC, we have an impediment in Ordinance 344 of 98. It would have to be reviewed, which is why they argue that it is a work involving many agents," she concludes.

While the legal and administrative debate unfolds, patients remain in limbo. The regulatory vacuum forces judicialization and the search for habeas corpus for self-cultivation. Clayton Medeiros is emphatic in pointing out the main affected party: "The most affected are the patients, without a doubt. For now, nothing new under the sun: state omission and disappointed patients".

Bianca Uequed concludes by highlighting that prolonged omission may constitute a wrongdoing and generate the duty to compensate. "This unjustified delay can indeed be understood in legal actions as an illicit omission by the State. Patients who have proven health deterioration due to this lack of access may be entitled to compensation," she concludes.