Brazil regulates manufacture and sale of cannabis-derived goods

The resolution of Brazil’s National Sanitary Surveillance Agency (Anvisa) on the manufacture, import, and trade of cannabis-derived products for medical purposes has been brought into force.

Anvisa has been available to receive requests since 2015, but cases are considered individually and require the acquisition of products overseas, which makes this therapy considerably more expensive. After the resolution in effect as of Monday (Mar. 9), the agency differentiates cannabis-derived products from cannabis-based medication.

Derivatives will not be considered medicine, but are given a category of their own. The resolution paves the way for the trade of such substances, necessary in the treatment of a number of neurological diseases, from chronic pain to Parkinson’s.

They are not regarded as medicine because, the body said, “there are not enough data to confirm the safety, effectiveness, and the quality of most of the products obtained.” As a result, the decision took into account information on their use in treatment in other countries, like Germany, the US, Canada, and Israel.

Requirements

To purchase the products, patients have to carry a prescription that can only be prepared by a doctor. Goods may have up to 0.2 percent of THC, above which the use can only be prescribed for terminal patients with no other treatments available, aimed at palliative care.

The sanitary authorization will be provided only for substances consumed nasally and orally. Those inhaled or applied sublingually are not included.

The resolution also bans the trade of what it terms “the vegetable form of the plant or its parts, even after the process of stabilization and drying, or in its scraped, ground, or pulverized form, even when made available in any pharmaceutical form.” Cannabis-based cosmetics, cigarettes and other products for smoking or eating are also left out.

To enter the business, domestic and foreign companies must be allowed to operate by Anvisa. For imports, firms must demonstrate the product is legal in its country of origin.

National companies are banned from growing the plant in Brazil, and may import semi-elaborated raw materials to manufacture the processed goods in Brazil.

In the view of Rodrigo Mesquita, member of the regulatory commission of Brazil’s Bar Association (OAB) and former member of the National Council on Drugs, the new regulation consolidates the medical role of cannabis, and expands its access for patients and the ways companies may explore this market in Brazil.

However, banning the cultivation of cannabis in Brazil hinders the development of a domestic industry and research, in addition to influencing costs, as supplies must be imported. “This will have a significant impact on prices, as crude extracts must be imported before they are manufactured here. The production chain is thus limited and must rely on other markets, which affects the final price as well as access,” he pointed out.