A pharmaceutical regulator based in Brazil has given the go-ahead for medical cannabis products to be distributed across the South American country. Anvisa – which is essentially Brazil’s version of the United States’ Food and Drug Administration (FDA) – made the decision to approve guidelines that allow the sale of cannabis-derived medicinal products on Tuesday December 3. 

However, the regulatory body rejected a proposal that would permit domestic medical cannabis cultivation in Brazil; instead, industrial hemp cultivation was authorized by a judge.

“It should be noted that the present action is not intended for the importation, planting or marketing of Cannabis sativa, but for industrial hemp, which is a plant of the species Cannabis ruderalis, a member of the Cannabis sativa family, also known as cannabis is a different species,” affirmed Judge Renato Coelho Borelli, of the 9th Federal Civil Court of SJDF. “Thus, in the case of Cannabis sativa, the seal contained in the ‘E’ List of Ordinance / SVS No. 344 of 12 May 1998, which expressly cites Cannabis sativa, and not Cannabis ruderallis, does not apply to the present case.”

Anvisa’s approval of Brazil’s medical cannabis rules indicates that bigger things could be on the horizon for the huge country, where cannabis was partially decriminalized for personal use back in 2006. Included in Brazil’s medical cannabis proposals are procedures pertaining to the manufacturing and importing of products, as well as the rules regarding sale, packaging, marketing, supervision and prescriptions for patients. 

Bill No. 5295 was put before the Brazilian Senate in October of this year. It comprises of language focused on the hurdles that Brazil faces in regards to medical cannabis and industrial hemp cultivation. The regulatory approval was officially announced in a statement by Anvisa; stating that the rules will be effectuated within 90 days of a local newspaper printing the news.

An overview of the launch of Brazil’s medical cannabis industry

Patients in Brazil were permitted by Anvisa to acquire prescriptions for medical cannabis products in 2015. Two main types of prescriptions can be obtained by patients; one for terminally ill patients who require in excess of 0.2 percent THC and another for products with a THC content below 0.2 percent. HEMPMEDS Brazil became the first company to present patients with products, of which it currently boasts 18 different types. An additional eight products are on offer from Formula Swiss.

Prior to Anvisa allowing medical cannabis prescriptions in Brazil, patients were required to fill out forms, before getting a prescription from the doctor; the prescription would be used to request import authorization from the government for cannabis-based medicines. Not only was the previous procedure time-consuming, but it also burned a hole in the pocket of most patients. The cost of medication and import is around R$1000; equivalent to $237. Since national minimum wage workers earn approximately USD$250 per month, the price of medicine is far beyond their budget.

To make matters worse, individuals who wanted to sidestep import costs were limited to acquire Sativex, which used to be the only legal product available from Brazil’s medical cannabis market. Sativex – called ‘Mevatyl’ in the South American country – is far from cheap at around R$2000. This is equivalent to USD$475; almost double the monthly wage of low-income individuals. 

Brazil’s medical cannabis market: Industrial hemp cultivation authorized

A judge at the Federal Court of the Federal District of Brasilia also decided to allow the importation and cultivation of industrial hemp seeds containing no more than 0.3 percent THC, meaning that Brazil’s medical cannabis market will get an added boost. The incident occurred just hours after Anvisa introduced a proposal for cannabis research-focused plant cultivation in Brazil.

Schoenmaker Humako Agri-Floriculture is the name of the company – which is a part of the Terra Viva group –  that has received authorization to import and grow low-THC hemp seeds. The federal district judge also ruled that Terra Viva’s subordinate can sell hemp seeds, fibers and leaves from its crops. Oil will be extracted from these plant materials to produce food supplements and herbal medicines for distribution throughout Brazil’s medical cannabis market.

Additionally, hemp plant materials from Terra Viva may be utilized to produce a broad scope of products, including beauty products, textiles, clothing and footwear, washing detergents installation and paints.

“[The company] may still trade in seeds, leaves and fibers for purely industrial purposes (including in the form of inputs or supplies),” said the magistrate; inspections are to be conducted by Anvisa and the Ministry of Agriculture. “I also determine that the Ministry of Agriculture provides for the inclusion of industrial hemp or hemp on the National Cultivar Register list.”

“Industrial hemp is not confused with marijuana, has no ability to generate psychotropic effects, is intended exclusively for medicinal and industrial use, and is commonly cultivated for fiber production in several countries,” Judge Borelli continued. “Finally, I emphasize that for the planting and commercialization of industrial hemp in Brazil, its inclusion in the National Register of Cultivars – RNC, created by Law no. 10.711 / 2003, and regulated by Decree no. 5,153 / 2004.”