Brazil to hold public consultations over medical use of Cannabis

Brazil’s Health Surveillance Agency—Anvisa in the original acronym—approved two public consultations on the regulation of the controlled cultivation of Cannabis sativa in Brazil for medical and scientific purposes and the registration of medication produced with the plant’s active ingredients.

One of the consultations will focus on the technical and administrative requirements for pharmaceutical companies planning to grow Cannabis exclusively for medical and scientific purposes. The other will discuss procedures for the registration and monitoring of Cannabis-based medication, derivatives and synthetic equivalents.

The consultations will be open to contributions from universities, companies, the government, health care and consumer service agencies, and the population at large.

Anvisa authorities said that the initiative aims to make sure future regulation “is clear, transparent, and built with wide participation of society.”

New rules

The current procedures outlining the technical requirements for the controlled cultivation and surveillance of Cannabis in Brazil started in 2018, when a group of experts was assembled. The topic is among the agency’s priorities, Anvisa said.

The rules outline the measures to monitor and track down medications from manufacturers to patients, including transporters and drugstores. “Regulation will be strict with regards to the production chain, distribution and consumption,” Anvisa added.

The legislation will be limited to patients with chronic debilitating or life-threatening diseases, with no alternate treatments.

History

The import of Cannabidiol-based medicines and other cannabinoids for personal use was authorized by Anvisa in 2015. Current legislation sets the criteria and the procedures for the import of Cannabidiol-based medications in association with other cannabinoids on an exceptional basis, when prescribed by authorized professionals as part of a health treatment, for patients’ own use.

In 2017, Anvisa also registered Mevatyl, the first medication in Brazil based on Cannabis sativa.