CRF-SP warns of risk of setback and legal uncertainty in the review of the Cannabis regulation

The Regional Pharmacy Council of the State of São Paulo (CRF-SP) issued a warning about the risks of setback in the current review of the Cannabis regulation. The discussion revolves around the Collegiate Board Resolution (RDC) 327 and raised concerns about the preservation of access to different therapeutic modalities.

Marcelo Polacow Bisson, president of CRF-SP, vigorously defended the maintenance of magistral preparations within the regulatory scope. According to him, limiting the customization of treatment in the Cannabis regulation can lead to serious issues of lack of assistance to patients.

"The eventual removal or restriction of magistral preparations, in this context, would constitute a setback, with direct impacts on treatment access," stated Bisson. He also emphasized the negative effects on therapeutic individualization capacity and on the sanitary safety of therapies.

The debate on the update of the Cannabis regulation took place on Wednesday (10), during a meeting of the Collegiate Board (Dicol) of Anvisa. The voting was suspended after a request for review by director Thiago Campos, postponing the decision for the regulatory period of up to 30 days.

The importance of customization in the Cannabis regulation

The Council's position is firm: regulation must follow the clinical reality already consolidated in Brazil. Currently, compounding pharmacies fill important gaps left by the industry, something that should be considered in the Cannabis regulation.

"Our statement is to highlight the technical, clinical, and sanitary importance of maintaining magistral preparations containing Cannabis-derived inputs within the regulatory scope," reinforces the president.

Bisson's central criticism lies in the forced standardization that the new Cannabis regulation could impose if it ignores the magistral sector. The Brazilian healthcare model historically recognizes the importance of magistral preparations to assist patients with specific therapeutic needs.

The president of CRF-SP argues that maintaining this model is vital to "allow fine adjustments of dose, concentration, and volume". This ensures greater precision and adaptation to the clinical particularities of each individual, something essential in cannabinoid treatment.

He also highlights that compounding is the only way to offer personalized therapeutic alternatives. Often, the industrial options provided for in the Cannabis regulation do not encompass the variability of responses among patients.

Legal uncertainty in the Cannabis regulation and Article 77

In addition to the direct health impact, Bisson raises a serious procedural issue in the draft presented by the reporting director Rômison Mota. The point of discord is the wording of Article 77 of the proposal for the revision of the Cannabis regulation, which would mix discussions of distinct natures.

"The current wording of Art. 77 is not fully aligned with the procedural rite approved by Dicol itself, generating a risk of legal uncertainty," criticizes Bisson. According to the specialist, this could lead to divergent interpretations and premature regulatory commitments.

He recalls that the minutes of the previous Dicol meeting determined the autonomy of regulatory processes. The intention was to ensure broad social participation and methodological coherence in the construction of the Cannabis regulation. For him, the current proposal fails to reflect these formal deliberations.