Although the Executive Branch has the prerogative to regulate this subject, legal decisions in favor of cannabis cultivation in the national territory are becoming increasingly common to compensate the State’s omission.
Finally, the National Health Surveillance Agency – Anvisa enacted the long-awaited regulation for cannabis-based products. After so much speculation, RDC No. 327/2019 was unanimously approved at the Collegiate Board Meeting from Anvisa (“Dicol”), held on December 3, 2019.
The approved regulation, which will take effect on March 10, 2020, establishes procedures and requirements for the manufacture, importation, packaging, marketing and registration of medicinal cannabis-based products in Brazil.
The new class of cannabis-based products was created to simplify the registration procedure of these products. Their classification as medicine would depend on studies and clinical research at an advanced technical-scientific stage, which would currently make the approval of medical cannabis in such category unfeasible. The recent edited regulation must be revisited by Anvisa within three years of its publication in the Brazilian official gazette.
Now domestic and foreign companies can explore the Brazilian market by making products up to 0.2% THC in their application available to patients with medical prescription. Products with THC greater than 0.2% may only be prescribed for terminally ill patients or hazards that depleted alternative treatment therapies.
Although the new regulatory framework was been considered an important advance for the opening of the Brazilian cannabis market, Anvisa decided to withdraw the proposed regulation for cannabis planting by justifying that “the regulation of not existing economic activity in the country and prescribed by law” would exceed the competence of the Agency.
With Anvisa’s veto, there is no other alternative for manufacturers of cannabis-based products than the importation of pharmaceutical ingredients in the form of plant derivatives or industrialized products, once the new regulation does not allow the importation of Cannabis spp plant or parts thereof.
In fact, since the Federal Law No. 11,343/2006 (Brazilian Drug Law) was enacted, the Union, through the Executive Branch, is entitled to authorize cannabis planting and harvest exclusively for medical or scientific purposes, which means that for thirteen years Brazilian society awaits the regulation of such subject.
If Anvisa, which has the competence to regulate in this matter, did not do it, the expectation is now placed in the National Congress. Bill No. 399/15 is still pending in the Special Committee of the Chamber of Congress and, given the social pressure, it may have its scope broadened to also regulates cannabis planting for medicinal purposes.
On the one hand, we have the omission of the State, by the Executive Branch, to deliberate this matter. But on the other, we face the Judiciary assuming this role. Currently there are 52 (fifty-two) court rulings authorizing the individual cultivation of marijuana for medicinal purposes. Those rulings were granted to people with serious or chronic diseases.
In the case of planting and growing cannabis for collective purposes, the Associação Brasileira de Apoio Cannabis Esperança – Abrace, located at the city of João Pessoa – Paraíba, is the only legally authorized association to grow and process marijuana and supply cannabinoid products to its members.
More recently, a company located in the countryside of São Paulo has just obtained a judicial authorization to import and grow industrial hemp seeds with THC concentration below 0.3%, as well as trade seeds, leaves and fibers for exclusively industrial purposes. The judicial decision was granted on the same day that Anvisa approved the RDC No. 327/2019 and decided to file the proposal of a regulation for cannabis planting.
The veto of cannabis planting prevents Brazil from having a vertical industrialization for the manufacture of cannabis-based products, with lower costs and affordable for the population.
If the State is not exercising its regulatory function, the Judiciary, in response to the social demand is doing so. The absence of specific regulations for cannabis planting and the favorable precedents mentioned here contribute to the granting of new favorable court decisions. In fact, the tendency is to multiply this demand over Brazilian courts on diverse fronts by: (i) universalizing patients’ access to cannabis-based products by means of the Brazilian Unified Health System – SUS (Sistema Único de Saúde) and by granting habeas corpus for planting and cultivation of cannabis plant; or (ii) enabling investors interested in cannabis projects and initiatives develop this market. Although we have not achieved the ideal regulatory environment, we cannot fail to recognize the progress that RDC No. 327/2019 made on this subject. Because we are facing a transitional regulatory situation, now it is the perfect timing for the Brazilian society to persist in the fight for more extensive cannabis-based products regulation.
Isabela Amorim Diniz Ferreira,
Corporate lawyer from Farroco Abreu Advogados, specialized on regulatory matters and post-graduated in Economic Law by Fundação Getúlio Vargas de São Paulo (FGV/SP).