Brazil’s health regulator Anvisa approved new guidelines this week for cannabis-based products, but they sided with the government in refusing to legalize domestic cultivation. Both decisions have been criticized as restricting access for patients who need the products for treatment.
Currently, Anvisa allows select cannabis-based medications to be imported, such as GW Pharmaceuticals’ Sativex, but the price of a one-month supply is higher than one month’s salary at Brazil’s minimum wage. The new regulations set rules for broader importation of cannabis-based products, and extracts that can domestically be turned into products, and for sales in pharmacies.
Congressmember Natália Bonavides of Brazil’s Workers’ Party, a member of a special congressional committee that debates the regulation and use of medical cannabis in Brazil, told Cannabis Wire the new rules will continue to limit access to only the wealthiest citizens.
“While Anvisa approved manufacture with imported cannabis substrate, unless they also approve domestic production, only specific industry groups will have the budget to import and produce, keeping prices high,” Bonavides said. She added that she’s advocating for changes to allow family-based associations and NGOs to cultivate cannabis “to make the production and access less elitist.”
In its ruling, Anvisa created a separate class of regulated substances specifically for cannabis-based products, but stopped short of classifying these products as medicines, arguing there hasn’t been enough research into the efficacy of medical cannabis. “They aren’t even calling it medicine,” Bonavides said about the decision, “which just shows how prejudiced they are against cannabis-based products.”
Anvisa also maintained a rule that allows only for access to products with a THC level of less than 0.2% for patients who are not terminally ill. “This doesn’t match the conclusions of global studies about the level of THC necessary for treatments,” said Bonavides. For products with a THC percentage above 0.2%, the prescription is authorized only for terminally ill patients “who have exhausted therapeutic alternatives.”
Under the new rules, those seeking a prescription will face new restrictions. Before, any doctor could issue a prescription for patients to import medical cannabis products (though the high cost discouraged most people from seeking the treatment). “Now, the new regulation considers these to be psychotropics, so the doctor needs a specific type of prescription that’s regulated by Anvisa. This is a step back for widespread access,” said Leandro Ramires, president of the Brazilian Association of Medicinal Cannabis Patients, in an interview with Cannabis Wire.
It an official statement, Anvisa said the new rules will be published in the country’s official gazette in the coming days and will come into law 90 days later. The regulation will be in effect for the next three years.
Margarete Brito, president of the Association to Support Medical Cannabis Research and Patients, told Cannabis Wire that, at least in the short term, the resolution won’t change anything for patients. “We’re not celebrating just yet.”
Anvisa’s new rules, advocates believe, will help to lower the stigma of medical cannabis in Brazil. But in the long term, Bonavides only sees real progress happening in Congress. “We already have a committee debating the subject, so this is driving our representatives to become more familiar with the positive sides of medical cannabis,” she told Cannabis Wire.