By Richard Mann
RIO DE JANEIRO, BRAZIL – The measures are part of a proposal submitted by Anvisa (National Health Surveillance Agency) on Tuesday, June 11th, to try to liberalize the cultivation of cannabis in Brazil, with a focus on research and the production of medicinal products. The proposal will now be submitted for public consultation for 60 days.
Currently, marijuana planting is forbidden in Brazil. Since 2006, however, Law 11.343 provides for the possibility for the federal government to authorize planting “for medicinal and scientific purposes at a predefined location and within a predefined period and under supervision”.
The proposal for rules for the planting of cannabis thus represents a first regulatory attempt by the agency, which should increase the prospects for medicinal use of marijuana in Brazil.
For this purpose, each company is required to provide a safety plan with measures to prevent deviations. The approval will also be conditional upon a criminal background check of company officers and directors. Even if Anvisa approves, the Federal Police must be consulted.
If approved, planting must comply with specific rules and be carried out in closed and unidentified places, sealed by a double door with a locking system and protected by alarms and security systems. Access should be monitored employing biometrics.
The plants can be grown for research and for medicines to be produced by the company itself or sold to research institutions, manufacturers of pharmaceutical products, and laboratories that produce medication. Sale to individuals and compounding pharmacies will be prohibited.
Despite restrictions, Anvisa’s members expect that the measure will encourage a new sector for the production of cannabis-based drugs in Brazil, which may reduce the price of these products. Anvisa has been authorizing orders for the import of cannabidiol-based oils and medicines since 2015.
However, as they are produced abroad, there is no production quality control, and costs are high. In some instances, a three-month treatment costs approximately R$2,000 (US$500), which has led to an increase in legal actions demanding that health plans and the national health system supply the products.
Despite the apparent consensus among Anvisa’s directors, the proposal could still create friction with the government, which has adopted a stricter stance over drugs.