“The cycle is now national”: Anvisa's CEO details new milestone in cannabis cultivation and predicts up to 60% cost reduction

The new regulation of medicinal cannabis and research in Brazil inaugurates a structural change in the sector and may result in a "up to 60% reduction in the final cost of products" for patients. This assessment comes from Leandro Safatle, acting CEO of the National Health Surveillance Agency (Anvisa), in an interview with the CB.Poder  program of Correio Brasiliense. The norm, which entered a six-month vacatio period, is seen as a watershed for access, research, and strengthening of the national production chain.

National production and cost reduction

According to Safatle, the main advancement of the new rule is the full authorization of the cannabis production cycle in Brazilian territory. This measure reduces the dependence on imported inputs, currently one of the main factors driving up treatment costs. Studies cited by Anvisa indicate that, with the maturation of investments and the consolidation of local production, consumer prices are expected to drop significantly.

Vertical integration of cultivation in Brazil

“The production process is now fully authorized by Anvisa. From scratch, producers can start planting cannabis and carry out the entire process within Brazil, without needing to bring in any inputs from abroad,” stated Safatle. Vertical integration, according to him, allows for greater quality control, regulatory predictability, and encouragement of technological innovation in the country.

Associations come under regulatory scrutiny

One of the most sensitive points of the regulation involves patient associations, historically responsible for expanding access to cannabis-based treatments. Safatle acknowledged the importance of these entities and stated that Anvisa sought a specific regulatory solution to include them safely and legally.

Regulatory sandbox: inclusion with technical criteria

For this, a regulatory sandbox was created, a mechanism that establishes an experimental environment with proportional technical requirements. “We created a tool to bring these associations, especially the smaller ones, into the regulatory process, with a specific norm that streamlines procedures, without compromising safety and efficacy,” explained the director.

Control, traceability, and THC limit

Despite the openness, Anvisa emphasizes that control will be rigorous. Authorized cultivation will be focused on plants with up to 0.3% THC, intended for pharmaceutical and scientific purposes. The model includes monitoring through georeferencing and integrated supervision with the Ministry of Agriculture and Livestock (MAPA).

From research to registered medication

Safatle also highlighted the strategic role of clinical research. Currently, out of about 50 products available in pharmacies, only one is registered as a medication. “Anvisa decides based on scientific evidence. We want these products to progress and reach the medication phase,” he stated. For access through the Unified Health System (SUS), the process still depends on price definition and evaluation by Conitec.

Impacts on access and the future of SUS

With over 660,000 import requests registered in the last decade, Anvisa takes an important step for Brazil to move from a unique importer position to assuming a strategic role in the production of technology, research, and innovation in the cannabis health sector. According to Safatle, the goal is to advance towards scientific and industrial self-sufficiency. “While we authorize the production process, we also authorize research, so that all stages occur in the country. Brazil has a widely expanded research network, capable of generating important discoveries,” he affirmed. The director's expectation is that this movement will have direct impacts on patient access and the formulation of public policies in the coming years.