Brazilian Superior Court of Justice authorizes cultivation of industrial hemp for medical purposes and sets regulation deadline for Anvisa

November 18, 2024

Brazilian Superior Court of Justice authorizes cultivation of industrial hemp for medical purposes and sets regulation deadline for Anvisa

argin-bottom:10px;On November 13, 2024, the First Panel of the Brazilian Superior Court of Justice (STJ) unanimously authorized the planting, cultivation, industrialization, and sale of industrial hemp – a variety of Cannabis sativa with a THC content below 0.3% – solely for medical and/or pharmaceutical purposes. The STJ's primary rationale for this decision was that industrial hemp cannot be classified as a substance prohibited by Law #11,343/2006 (Brazilian Narcotics Act) given its low THC concentration, insufficient to produce the psychotropic effects capable of inducing dependency.

The cultivation of Cannabis sativa has not been regulated in Brazil, which, according to Reporting Justice Regina Helena Costa’s opinion, has imposed an “undue restriction on the exercise of the fundamental right to health, constitutionally guaranteed and a duty of the State”. Justice Costa emphasized that the authorization given by the decision is restricted to the medical and/or pharmaceutical purposes, indicating that “although the plaintiff's request has a broad scope, the examination of the controversy should be limited to the analysis of the feasibility of importing hemp seeds and their subsequent cultivation to meet only demands involving the right to health, whose protection is the cause of the lawsuit.”.

Formally at the end of the trial session STJ set 5 binding rulings:

  1. Pursuant to Articles 1, Sole Paragraph, and 2, caput, of the Brazilian Narcotics, industrial hemp (a variety of Cannabis sativa with a THC content below 0.3%) is not a prohibited substance as it cannot produce psychotropic effects capable of causing dependency;
  2. Pursuant to Decree #54,216/1964 (Single Convention on Narcotic Drugs) and the Brazilian Narcotics Act, it is up to the Government to deal with the management and control of all varieties of cannabis, including industrial hemp. Since there is no statutory nor regulatory provisions authorizing industrial hemp for non-medical and non-pharmaceutical purposes, courts do not have authority over these areas;
  3. Given the regulatory framework for the medical and/or pharmaceutical purposes of cannabis, Anvisa (Brazil’s Food & Drug Agency) regulation prohibiting the importation of seeds and the domestic cultivation of the plant should be interpreted in accordance with the Brazilian Narcotics Act, and therefore do not apply to the variety described in binding ruling #1 (industrial hemp with a THC content of less than 0.3%);
  4. Legal entities may be authorized to plant, cultivate, industrialize, and sell industrial hemp solely for medical and/or pharmaceutical purposes, linked to the protection of health rights and subjected to the regulations to be issued by Anvisa and the Federal Government;
  5. Anvisa and the Federal Government, in their administrative discretion, shall evaluate guidelines aimed at preventing the diversion or misuse of seeds and plants, as well as to ensure the integrity of authorized legal entities, notwithstanding other measures to preserve safety in the production and/or commercial chain.

The STJ also fixed a six-month deadline for Anvisa and the Federal Government to regulate the matter. The entire decision is still pending publication, which is expected to occur in the coming days.

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