Medicinal Cannabis in Brazil: Lula's Government Proposes Regulation of Cultivation to Replace Imports

By Sechat with information from Folha

The government of President Luiz Inácio Lula da Silva, from the Workers' Party (PT), is committed to regulating cannabis cultivation for medicinal purposes in Brazil, aiming to replace imports of these products, stated Marta Machado, national secretary of Drug Policy and Asset Management at the Ministry of Justice.

Currently, cannabis cultivation is only permitted with a court decision. In March, the Ministry of Justice had already argued in a case that the Superior Court of Justice (STJ) should authorize cultivation in the country.

In its statement, the ministry emphasizes the importance of comprehensive and appropriate regulation for the importation and cultivation of cannabis with low concentrations of Tetrahydrocannabinol (THC) - the component responsible for psychoactive effects - for industrial, pharmaceutical, and medicinal purposes.

In an interview with Folha, Marta Machado stated that the legalization of cultivation will be one of the priority issues for the National Drug Policy Council (Conad). The council is composed of members from the Ministry of Health, the National Health Surveillance Agency (Anvisa), the Federal Police, and other ministries.

According to Marta, the intention is to discuss what will be the best regulatory model for the country, aiming to reduce the price of cannabis-based products and avoid the legal disputes that currently occur. The judiciary has already granted more than 2,000 cultivation authorizations in Brazil, but there are few controls, leading to dualities.

The National Secretary of Drug Policy also emphasizes that there are different models of authorization, from those aimed exclusively at the pharmaceutical industry to those that recognize associations. Senad does not have a predefined model but intends to discuss with all stakeholders a prudent system of regulation, oversight, and monitoring to avoid deviations and prioritize local production and the Brazilian industry, which, according to the secretary herself, is capable of entering this market.

This position of the government reinforces the statement of the Ministry of Justice before the STJ, which considers the measure necessary to correct the obscurities of the current regulatory framework and resolve the confusions generated, especially the difficulty of control by public security agencies and oversight of existing plantations in the country, whether authorized by court decisions or supported by acts of civil disobedience.

Additionally, the indication of names linked to the sector for the Council of Economic and Social Development, known as "Conselhão," is another indication that cannabis for medicinal use will be one of the government's agendas. 

While the government debates the issue, Anvisa is also working on a new regulation to govern the cultivation of cannabis for use in clinical research.

Anvisa data shows that in 2022, 80,258 authorizations were granted for the importation of cannabis-containing products, double the number recorded in 2021. The second method of obtaining is through resolution 327, which authorizes the commercialization of cannabis-based products in pharmacies, with the regulatory agency evaluating quality, efficacy, and safety before authorization.