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Brazil’s Superior Court of Justice (STJ) unanimously approved the planting, cultivation, industrialization and sale of industrial hemp for medical and pharmaceutical purposes, under strict rules.
The STJ ruling opens significant opportunities for both domestic and international players who are making and researching cannabinoid compounds, most notably hemp-derived CBD. With a population of over 200 million and increasing acceptance of cannabis-based treatments, Brazil is poised to become a major hub for the global medical CBD market.
Brazil’s total market for medical CBD and medical marijuana (THC) is expected to be $185 million this year, according to Statista. Other sources say CBD makes up the larger portion at 70-80% of the total – due to their wider range of uses and fewer regulatory hurdles compared to THC, which is restricted to a limited number of specific medical conditions.
‘Right to health’
The STJ ruling originated from a legal case brought by a company seeking to import industrial hemp seeds and cultivate the crop for medical and pharmaceutical purposes. The case challenged Brazil’s regulatory framework, particularly restrictions imposed by ANVISA (Brazil’s Food and Drug Agency), which prohibited the importation of hemp seeds and the domestic cultivation of hemp.
Justice Regina Helena Costa, delivering the opinion for the court, noted that the court’s ruling applies exclusively to hemp products used for health-related purposes, stating, “The examination of the controversy should be limited to the feasibility of importing hemp seeds and subsequent cultivation to meet demands involving the right to health, which is the cause of this lawsuit.”
‘Lost in translation’
That left stakeholders a bit disappointed.
“It was a historical moment for the Brazilian regulatory landscape for sure, but it wasn’t all we hoped for,” said Lorenzo Rolim da Silva, President of the Latin American Industrial Hemp Association (LAIHA).
While the decision obligates ANVISA to regulate the planting of hemp for medicinal and pharmaceutical supply chains, it does not mention industrial hemp in the context of its broader agricultural potential, according to da Silva.
Da Silva provided technical arguments used in the case before the Superior Justice Tribunal – arguments he said focused more on industrial uses of hemp than on medical applications. “But I believe something got lost in translation because people wanted to see the medicinal side approved first since it is more directly impactful on people’s lives,” he said.
‘Door will be opened’
While hemp was not recognized for its non-medical applications in the ruling, da Silva said most legal opinions are suggesting it nonetheless signals “the door will be opened” for hemp eventually, although it could take “another couple of years waiting.”
“Either way, it paves the way to position Brazil as a major producer of Cannabis in the near future,” he said.
The ruling could mean competition for Ireland-based Jazz Pharmaceuticals, the producer of Epidiolex – the first FDA-approved prescription CBD medicine for epilepsy. The high-concentration CBD medicine was first sold in Brazil in 2019 under approval by ANVISA. It was initially imported under special permits, and the Brazilian government later made provisions for its sale through official pharmaceutical channels, under strict regulatory guidelines.
Opportunities
In addition to other multinational and Brazilian CBD producers, the landmark decision creates opportunities for growers and companies involved in extraction and processing, as Brazil develops its supply chain to support the burgeoning sector.
The STJ case was brought by a producer against the country’s drug authorities, the court ruled that industrial hemp with less than 0.3% THC, does not fall under the restrictions of Brazil’s Narcotics Act, as it cannot produce psychotropic effects or cause dependency.
The plaintiff was successful in arguing that the prohibition created unnecessary barriers to consumers accessing medical and pharmaceutical products derived from industrial hemp.
Five binding rulings
The STJ outlined five binding rulings as part of its decision:
Industrial hemp, with a THC concentration below 0.3%, is not classified as a prohibited substance under Brazil’s Narcotics Act, as it cannot cause dependency.
The government retains authority to manage and control all cannabis varieties, including industrial hemp, under the Brazilian Narcotics Act and international conventions. Courts cannot authorize hemp for non-medical or non-pharmaceutical purposes.
Regulations by Anvisa prohibiting seed imports and domestic cultivation must align with the Narcotics Act, allowing for industrial hemp under the specified THC limit.
Legal entities may plant, cultivate, industrialize, and sell industrial hemp exclusively for medical and pharmaceutical purposes, subject to future regulations by Anvisa and the federal government.
Anvisa and the federal government must implement measures to prevent misuse or diversion of seeds and plants, ensuring safety and integrity within the production and commercial chain.
The STJ gave Anvisa and the federal government a six-month deadline to establish a regulatory framework for industrial hemp. The ruling also mandates guidelines to safeguard the industry from misuse and to “maintain public safety.”
“}]] The court ruled that industrial hemp with less than 0.3% THC, does not fall under the restrictions of Brazil’s Narcotics Act. Read More
