Regulation of the use of cannabis for medicinal purposes is a subject widely debated and developed in European and North American countries. In Brazil, however, the debates are still at an embryonic stage. We will try to point out in this text some of the current challenges encountered by those wishing to commercially exploit the production of cannabis for medicinal purposes.

Classification as prohibited substance and Anvisa’s oversight

The regulation of narcotics and psychotropic substances in Brazil, including cannabis, can be found at several levels. Brazil is a signatory to and internalized the two major international treaties of the UN on the subject: the Single Convention on Narcotic Drugs of 1961 and the Convention on Psychotropic Substances of 1971. In general, the signatories of these conventions undertake to collaborate to combat the production and trafficking of narcotic and psychotropic substances, each country being responsible for issuing its own regulations on the subject in accordance with the principles of the conventions.

At the national level, the provisions set forth in the Federal Constitution and in Law No. 11,343/2006, of August 23, 2006, widely known as the Drug Law, should be highlighted. The Constitution treats drug trafficking as a public security issue to be tackled by police authorities, and the Drug Law establishes measures to prevent drug use and regulates the unauthorized production and illicit trafficking of narcotic and psychotropic substances.

Regarding the cultivation of cannabis, the Drug Law strictly prohibits the planting, cultivation, harvesting, and exploitation of plants and substrates from which drugs can be extracted or produced. However, the same legislation establishes exceptions, regarding the possibility of cultivation for medical and scientific purposes, under specific supervision and with the authorization of the Federal Government.

Cannabis is currently classified as banned by the National Agency for Sanitary Surveillance - Anvisa, through SVS/MS Ordinance No. 344, of May 12, 1998, but access to it may be permitted for medical and scientific purposes. Cannabidiol (CBD) and Tetrahydrocannabinol (THC) are currently the only cannabis extracts permitted by the sanitary surveillance agency for individuals only and subject to specific regulations. This permission is the result of numerous lawsuits brought by parents of children and also by adults with severe medical conditions for which these substances are the only remedy that achieves positive treatment results.

Regarding the regulation of the use of cannabis for medicinal purposes, Anvisa, in turn, has not indicated a firm position on the subject. Its regulatory agenda varies according to the composition of its internal departments. Over a period of time, the organization has positioned itself in favor of regulation of cannabis for medicinal purposes, publicly advocated by the president at the time, but no concrete measures have been taken. Currently, the organization does not prioritize regulation of cannabis for medicinal purposes, and the potential for issuance of new standards does not appear to be on the horizon.

Legislative and judicial slowness

In the legislative context, there are three bills presented before the National Congress (numbers 10,549/2018, 7,270/2014, and 7,187/2014) whose intention is to regulate cannabis for recreational and/or medicinal purposes, but none of them has been submitted for a vote. In different ways and at different levels, these bills seek to remove the unlawful nature of cannabis and, consequently, the development of any recreational, business, and/or medicinal activities related to the plant.

The subject is also debated within the scope of the Federal Supreme Court (STF), in the Direct Action of Unconstitutionality No. 5,708, in which political parties and various civil rights organizations are petitioning the court to establish a time limit for Anvisa to regulate the medicinal use of cannabis, among other requests.

Importation and commercial activity

Anvisa is also the agency responsible for regulating and authorizing the importation of cannabis. The specific regulation provides that entities wishing to import cannabis for research purposes must register with the Integrated Foreign Trade System (Siscomex), regulated by the Brazilian Internal Revenue Service, and obtain an import license.

In addition to this license, Anvisa will be responsible for issuing a specific import authorization exclusively for education, research, and laboratory analysis entities, as established by the agency in Resolution No. 11, of March 6, 2013. Such activities must be expressly stated in the contract or bylaws and in the entity's registry with the Federal Revenue Service. Market players seeking to establish themselves in Brazil should perform one or more of these activities in order to conduct their business in Brazil in relation to medicinal cannabis.

Since the current regulations do not deal with cannabis for medicinal purposes in a thorough manner, entities cannot conduct research and develop business in a free manner to ensure the development of medicinal cannabis as a commercial product.

General overview

The medical cannabis sector in Brazil faces a series of challenges and obstacles, for which no solution was offered by the regulators or by the Legislative and Judiciary branches. There is enormous uncertainty among market players regarding the possibility of developing their businesses in the medicinal cannabis sector in Brazil, which hampers and will likely continue to hamper investments by domestic and foreign players in the sector.