Experts from the cannabis, agriculture, and health sectors met in September at the Chamber of Deputies in Brasília to discuss the production of industrial hemp in Brazil. With the topic promoted by the Ministry of Agriculture and Livestock (MAPA), whose representatives were present, and other stakeholders, the regulation of medicinal cannabis and industrial hemp is progressing but still faces regulatory obstacles.
"The cannabis agenda has been on the ministry's table for a long time. It can no longer remain as it is," commented Ana Paula Porfírio, head of the Social Participation and Diversity Advisory Office at MAPA. "There is a huge litigation cost for a medicine with a very low original price. Through science, studies, and working groups, we will change this reality. We are united on this issue," she added.
According to Porfírio, due to the high number of people who need the medicine, Minister Carlos Fávaro is committed to addressing the current demands for cultivation regulation.
As of today, according to data from the 2023 Medicinal Cannabis Yearbook by Kaya Mind, around 430,000 Brazilians are medicinal cannabis patients. Of these, 219,000 import products, 114,000 obtain them through associations, and 97,000 purchase oils from pharmacies.
The yearbook also estimates that, considering 23 different medical conditions, 6.9 million patients in Brazil could benefit from cannabis therapy.
However, MAPA's initiatives—responsible for regulating products of animal and plant origin—are hindered by the lack of regulation for cannabis cultivation in the country.
The Impasse with Anvisa
Currently, the National Health Surveillance Agency (Anvisa) prohibits cannabis cultivation under Ordinance No. 344/98, which regulates substances and medicines subject to special control. According to Pedro Gabriel Lopes, a lawyer for the Ficus Institute, greater clarity is needed regarding the current regulations.
"Anvisa must change its rules to allow MAPA to act," said Lopes. He noted that Anvisa has previously made similar decisions, such as permitting the cultivation of poppy seeds (Papaver somniferum L.) for food purposes. "Though the cultivation of this plant is prohibited, an addendum to the ordinance allows it," Lopes explained.
Porfírio emphasized that, under current legislation, all cannabis subspecies are treated the same way, with no distinction between high-THC plants and hemp, which contains lower THC levels than those permitted by regulatory authorities in various countries.
The Economic Potential of Hemp
The Economic Impact of Cannabis report, developed by Kaya Mind and released in 2021, estimated that hemp sales in Brazil could reach R$1.64 billion per harvest by the fourth year of regulation, generating around R$330 million in taxes.
Due to the lack of cultivation regulation, Porfírio warned that Brazil is "falling behind" compared to other countries. In 2023, Colombia, where cultivation is regulated, exported US$10.8 million (R$60.5 million) in cannabis-based products, with US$3.4 million (R$19 million) destined for Brazil, according to data from ProColombia.
CannTen, a Brazilian pharmaceutical company focused on medicinal cannabis, conducts all its production outside of Brazil. "The API (Active Pharmaceutical Ingredient) comes from Spain, the extraction technology from Israel, and production is done in Switzerland, with the final product arriving in Brazil," explained José Almeida, the company's Marketing, Sales, and Medical Relations Director.
Almeida stated that regulation would attract investment and allow production to start in Brazil, generating jobs and reducing costs. However, the regulatory delay remains an obstacle. "Several factors need to be considered. We are interested in studying the implementation of a factory that meets Anvisa's criteria for foreign companies, and exploring the use of Brazilian crops," he added.
Movements on Other Fronts
In addition to discussions within Anvisa, other developments may lead to the regulation of cannabis cultivation in Brazil. Bill 5511/2023, introduced by Senator Mara Gabrilli, is being processed in the Senate but has no immediate prospects for a vote. The bill sets standards for the cultivation, production, import, export, marketing, and use of medicinal cannabis and industrial hemp.
In the Chamber of Deputies, Bill 399/2015, proposed by former deputy and current governor of Sergipe, seeks to amend Law No. 11,343 to permit the marketing of cannabis-based medicines. "It is unlikely that Anvisa will take immediate action. Bill 399/2015 offers a comprehensive regulatory framework and is the safest path to cannabis cultivation and production in Brazil," said Lopes.
Additionally, in April of this year, the Superior Court of Justice (STJ) held a public hearing on Incident of Assumption of Jurisdiction 16 (IAC 16), which discusses the possibility of granting concessions for the importation and cultivation of hemp in Brazil.
Although the outlook is positive, there is no timeline for a decision.
Lopes concluded: "Regulation does not depend on just one actor, but on coordinated efforts across multiple sectors."
Source: sechat.com.br