Brazil: health authorities want to regulate medical cannabis production

The board of directors of the National Health Surveillance Agency (ANVISA), Brazil’s equivalent of the ANSM, recently unanimously approved the launch of a public consultation on making cannabis available for scientific and medical purposes. Concerned about the «increasing judicialization» of access to medical cannabis, The agency submitted two regulatory proposals the production of medical cannabis.

Regulating an existing practice

Since the passage of Law 11-343 in 2006, the agency has had the authority to authorize the cultivation of cannabis «for medical or scientific purposes, at a specific site and for a specific period, and under government supervision.» So far, Anvisa has not done so. However, in 2015, in response to pressure from civil society, the agency authorized imports of medical cannabis. Later, She approved Mevatyl, the first and only cannabis-based medication to have received marketing authorization in the country.

Since 2015, imports have tripled. That said, the prices and procedural requirements remain prohibitive for many patients. Some continue to turn to the black market, but an increasing number are turning to the courts to gain access to the plant. In fact, in recent times, we have observed in Brazil an increase in legal actions patients seeking the right to self-cultivation under the constitutional right to healthcare and life.

In response to this growing trend toward legal action, health authorities have decided to take action and regulate the domestic production of medical cannabis. The two proposals submitted for public consultation concern the regulation of technical and administrative requirements related to cannabis cultivation and the definition of «specific procedures for the registration and monitoring of cannabis-based medicines or their derivatives and synthetic analogs.».

«By adopting these two regulations, the public will have access to safer, higher-quality medication at a lower price than today,» explains William Dib, the director general of Anvisa. The public consultation will last two months. An attempt to legalize medical cannabis had already taken place in the Senate but has seen no progress since last November. According to William Dib, this time around, the production of cannabis for research purposes could be approved within the year.

Regulations

In its proposals, Anvisa has set forth extremely strict safety regulations:

• Preliminary check of the applicant's criminal history. The federal police will provide their opinion.
• Production in a closed system accessible only through dual-door access control systems with self-closing interlocking mechanisms and electronic locks featuring «biometric security doors.».
• The walls must be built of durable material, and the windows must be sealed with double-pane glass.
• The facility is equipped with a 24/7 security alarm and video surveillance system, as well as an independent generator.
• The product packaging must bear a numbered inspection seal.
• Transportation will be provided by specialized companies using special vehicles.

As for sales, cannabis may only be sold to research institutions and manufacturers of pharmaceutical supplies. The plant may not be sold to individuals or pharmacies. Only cannabis-based medications may be marketed, and these must first undergo double-blind clinical trials. «Anvisa’s role is to regulate medications. We regulate the production of cannabis-based medications,» the agency’s director explained.