Hemp in Brazil: a promising omen coming from the judiciary

A ruling by the Superior Court of Justice (STJ)[2] considered that Anvisa’s (the Brazilian health regulatory agency) interpretation incorrectly did not differentiate between Cannabis sativa derivatives, banning all of them equally because tetrahydrocannabinol (THC) is considered an addictive substance. Therefore, the planting, cultivation, industrialisation and commercialisation of hemp by legal entities for medicinal and pharmaceutical purposes has been treated as cannabis and, therefore, generally prohibited (but for a few exceptions based on a 2019 regulation encompassing industrialisation and sales).

Despite hemp having low THC levels and being non-narcotic, it was subjected to the same restrictions as psychoactive cannabis. This prevented the full development of industrial, commercial and medicinal activities with the plant.

However, the recent ruling from the STJ established that Hemp cannot be considered proscribed in Brazil, since it is unsuitable for producing narcotics, and its economic exploitation for exclusively medicinal and pharmaceutical purposes is permitted.

Regulation

In Brazil, Anvisa’s Ordinance 344/1998 specifies the controlled substances that may enable the production of narcotic substances. Cannabis sativa is included in this list, with no distinction between hemp (with a low THC content) and other cannabis varieties with a high THC content (psychoactive cannabis).

The Brazilian ban on products derived from Cannabis sativa directly references the international conventions internalised by the country. For example, the 1961 Single Convention on Narcotic Drugs, the Convention on Psychotropic Substances, and the Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances have fostered a legal framework of total and unrestricted prohibition of Cannabis sativa in the country.

Law 11.343/2006 (the Narcotics Law) consolidated prohibition but also allowed the cultivation and manipulation of substances for medicinal and scientific purposes with prior authorisation. In 2014, due to great pressure from patients and court decisions, Anvisa began to allow the import of cannabidiol (CBD)-based products for medicinal use, in a compassionate use pathway. In 2015, CBD was removed from the list of banned substances in the country and its importation for health treatment was allowed, subject to a doctor’s prescription.

Even with CBD removed from the list of banned substances, Cannabis sativa remained. As a result, any cultivation, planting, commercialisation and importation of Hemp continued to be illegal.

The STJ precedent

In an unprecedent decision, the STJ reversed the entire logic behind the ban on hemp in Brazil. Unlike previous regulations, mostly from Anvisa, the Court clarified that psychoactive cannabis and hemp are not the same thing: they are different varieties of Cannabis sativa.

Psychoactive cannabis is a derivative of the plant that contains large quantities of THC, with a high psychoactive capacity and the possibility of producing narcotics. Hemp, on the other hand, with a high concentration of CBD and generally less than 0.3 per cent THC, has no effective capacity to produce narcotics.

The entire STJ decision was elaborated based on this main differentiation, promising to change the current regulatory scenario that prohibits the economic exploitation of Hemp. The Court established five Holdings that must be followed by first- and second-instance judges in Brazil.

First, the Holdings establish that hemp cannot be considered proscribed by the Narcotics Law, as it is unsuitable for producing psychotropic substances. However, it is up to the Brazilian government to establish public policies for the management of all varieties of cannabis, including hemp, recognising the lack of legal provision for its industrial use.

In addition, it was determined that Anvisa’s rules prohibiting the import of seeds and the domestic handling of the plant should be interpreted in accordance with the Narcotics Law, which does not encompass hemp. As a result, the granting of sanitary authorisation for the planting, cultivation, industrialisation and commercialisation of hemp by legal entities for exclusively medicinal and pharmaceutical purposes was defined as lawful, with regulations to be issued by Anvisa and the federal government within six months (a period that ends in May 2025). Anvisa and the federal government must adopt guidelines to prevent the detour or misuse of seeds and plants, guaranteeing the suitability of the legal entities involved.

The most important STJ Holdings

Holding 1

‘Hemp, a variety of cannabis with a tetrahydrocannabinol (THC) content of less than 0.3 per cent, cannot be considered proscribed, as it is unsuitable to produce drugs, meaning psychotropic substances capable of causing dependence.’

The ruling made a teleological interpretation of the normative scope of the Narcotics Law, to understand that its purpose was to avoid the abusive use of narcotic or psychotropic substances. In other words, the prohibitions on Cannabis sativa should not apply to hemp, since it is incapable of producing these substances.

Holding 2

‘[I]t is up to the Brazilian State to establish public policy regarding the management and control of all varieties of cannabis, including hemp, and there is currently no legal or regulatory provision authorising its use for industrial purposes other than medicinal and/or pharmaceutical purposes, a circumstance that prevents the Judiciary from acting.’

Since there is no law or regulation dealing specifically with the industrial use of hemp, the STJ (and the judiciary as a whole) could not get involved in this specific aspect. It was considered that if they were to deal with this issue, they would be broadening the scope of the lawsuit, characterising it as a procedural problem and a legislative action by the Judiciary.

Holding 3

‘In view of the normative discipline for the medical and/or pharmaceutical uses of cannabis, the rules issued by Anvisa [...] prohibiting the import of seeds and the domestic handling of the plant must be interpreted in accordance with the provisions of Law n. 11.343/2006, and consequently do not affect the variety described in item I (hemp), whose THC content is less than 0.3 per cent.’

This is the aforementioned teleological interpretation. Law 11.343/2006 aims to combat the manufacture of narcotics, which is not possible with hemp. Banning the import, cultivation and sale of hemp is not in line with the aim of the law, which is to prevent the use of addictive substances.

Holding 4

‘It is lawful to grant health authorisation for the planting, cultivation, industrialisation and commercialisation of hemp by legal entities, for exclusively medicinal and/or pharmaceutical purposes linked to the protection of the right to health, subject to the regulations issued by [...] Anvisa and the federal government, within the scope of their respective attributions, within six months of the publication of this ruling.’

The STJ clarifies Anvisa’s remit to regulate the issue but also anticipates that the economic exploitation of hemp will be conditional on the authorisation issued by the agency. This is also relevant because, in the past, Anvisa had already discussed with the Ministry of Health which body would be responsible for regulating the issue.

Holding 5

‘It is the responsibility of [...] Anvisa and the federal government, in the exercise of administrative discretion, to evaluate the adoption of guidelines aimed at preventing the detour or improper destination of seeds and plants [...], as well as to guarantee the suitability of legal entities authorised to carry out such activities [...], without prejudice to other measures to preserve safety in the respective production and/or commercial chain.’

The STJ further emphasises that Anvisa and the federal government are responsible for product authorisation and traceability. With the advances established by the Court, one thing is clear. In the coming months, there should be an Anvisa regulation for hemp’s medicinal and pharmaceutical purposes, and companies planning to exploit these economic activities will be subject to the agency’s oversight.

Conclusion

The STJ’s decision to authorise the cultivation of hemp for medicinal and pharmaceutical purposes represents a significant development in Brazilian narcotics policy. Anvisa has until May 2025 to establish the necessary rules to regulate this activity.

Simultaneously, other promising steps can be expected as the Ministry of Agriculture and Livestock (MAPA) is considering creating specific regulations for the industrial use of hemp, in addition to medicinal and pharmaceutical purposes.[3]

Expanding the regulations to include a broader range of industrial uses, such as fibre and bioplastic production, would align Brazil with the international practices of countries like Canada and the United States. This approach would not only guarantee the safety and control of cultivation but would also allow Brazil to take full advantage of hemp’s economic and environmental potential.

It is important to note that the decision has not yet become final and binding. Therefore, it should be approached with caution and carefully analysed, considering its current status and potential implications.