Brazil’s Lula Government Unveils Plan to Regulate Medical Cannabis by September

The Brazilian government, led by President Luiz Inácio Lula da Silva, submitted a comprehensive plan this week to regulate medicinal cannabis use nationwide.

The Attorney General’s Office (AGU) presented the proposal in response to a November 2024 Superior Court of Justice (STJ) ruling that mandated regulation of domestic cultivation and production.

The interministerial plan involves collaboration between the National Health Surveillance Agency (ANVISA) and the Ministries of Health, Justice, Agriculture, and Agrarian Development.

Officials expect to publish the complete regulatory framework by September 2025, establishing rules for every stage from cultivation to distribution.

Medical cannabis has been authorized in Brazil since 2015, initially through importation only. ANVISA later permitted domestic commercialization in 2019, but still required imported raw materials.

This restriction has created significant barriers to access for many patients. Currently, over 670,000 Brazilians use cannabis-based medications to treat conditions like refractory epilepsy, chronic pain, and multiple sclerosis.

Brazil Moves Toward Regulating Medical Cannabis

The Ministry of Health has received 820 court orders demanding cannabis medication provision since 2022, highlighting the widespread need.

“The high cost of cannabidiol-based medical products in Brazil creates serious inequities in treatment access, as the requirement to import raw materials increases production costs and prices,” states the government plan.

The STJ decision that prompted this action was reported by Justice Regina Helena Costa. She emphasized that the lack of regulation harms both the national industry and patients seeking effective therapies.

The court established a six-month deadline for ANVISA and the federal government to present regulatory solutions. Despite the absence of consolidated federal regulations, numerous patient associations have already secured judicial authorizations.

These allow them to cultivate and produce cannabis-based medicines for therapeutic purposes. The new regulations aim to reduce costs, expand access, and strengthen the domestic production chain.

The plan focuses on cannabis with THC content below 0.3% for medicinal, pharmaceutical, and industrial purposes. It explicitly excludes recreational use while recognizing the strategic role of patient associations in providing affordable treatment options.

Industry experts project that Brazil’s medical cannabis market will exceed R$1 billion by the end of 2025, representing a significant economic opportunity for the country’s agricultural sector.