High times?

Brazil is likely to approve the cultivation of cannabis sativa for medicinal purposes later this year, setting a legal precedent, although how the legislation would work is still to be defined, according to Isabela Amorim Diniz Ferreira, a corporate lawyer at Farroco Abreu Advogados in São Paulo.

isabela amorim of Farroco AbreuBrazil’s National Health Surveillance Agency (Anvisa) is expected to establish a new regulation on the use of hemp for medical purposes, and which would allow the controlled cultivation of Cannabis sativa for medicinal purposes and the registration of medicines produced with active ingredients of the plant in the country.

“Approximately 40 countries have already authorised the use of cannabis for medical purposes, and if Anvisa meets the international health trend, Brazil will also be part of this avantgarde group,” Isabela Amorim Diniz Ferreira (pictured), a corporate lawyer at Farroco Abreu Advogados, tells The Latin American Lawyer.

She says that regulating the use of substances extracted from this plant will not only bring social gains, but also economic benefits. US-based consultancy New Frontier Data estimates that the cannabis business could attract $5 billion in investments over the next three years. The move would respond to demand for the plant as medication, with studies showing that patients with severe ailments such as epilepsy, Parkinson’s disease, multiple sclerosis, autism and malignant neoplasms can achieve relief from their symptoms by using cannabis.

Anvisa’s approach to cannabis has softened in recent years, allowing since 2015 the import of cannabidiol-based products in combination with other cannabinoids, including THC, for patients, and current data provided by the regulatory agency indicates that between 2015 and 2019 more than 9,000 authorisations were granted to import medicines made from cannabis extract. And in 2017, cannabis sativa was included in the list of medicinal plants and Anvisa granted the first registry of Cannabidiol and THC-based medicine Mevatyl, used in the treatment of multiple sclerosis.

ECONOMIC AND HEALTH BENEFITS

“The number of court decisions authorising the import of medicines containing cannabis for therapeutic purposes has dramatically increased in recent years, and the push towards regulation to allow the controlled cultivation of cannabis sativa for medicinal purposes therefore makes sense,” Diniz Ferreira says.

For example, the Brazilian judiciary recently authorised the parents of an autistic child with severe epileptic seizures to grow cannabis for medicinal uses and, in another case, a stomach cancer patient was granted a Habeas Corpus not to be arrested for importing and planting cannabis seeds to extract oil for medicinal purposes. Anvisa has so far held two public consultations to debate the clear and transparent rules required for the medicinal use of cannabis, and while there is public acceptance of a policy to allow safer access to medication, in addition to the possible economic benefits, such as job creation, increased tax collection and a reduction in the number of lawsuits relating to the purchase of cannabis, there is concern that Anvisa will bow to pressure from politicians and the pharmaceutical industry when it comes to ruling on the use of cannabis by patients, Diniz Ferreira says.

“There are also fears that pharmaceutical companies will market the drug at high prices, given that the discussions have not yet begun on whether individuals would be able to legally grow cannabis for medicinal consumption,” she says. “The conservative administration believes that any loosening of legislation relating to cannabis could lead to an increase in recreational use, with the belief that the plant should not be grown in Brazil but imported from abroad.”

“We therefore need to await Anvisa’s position and see whether the regulatory agency will give in to political and pharmaceutical pressures or cherish the democratisation of medicinal cannabis, an initiative that could be an important first step to extending the horizon of cannabis use beyond medicinal purposes,” she says.

She also points to the use of cannabis for the production of hemp and paper, and its potential as a vital raw material in the textile industry. “We could be seeing a new agricultural commodity.” “Considering that agribusiness is a fundamental contributor to the national economy, and Brazil is one of the world’s leading suppliers of agricultural products, we look forward to seeing the next chapters of the national public policy on this matter.”

adam.critchley@iberianlegalgroup.com

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