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 States omission.

Finally,the National Health Surveillance Agency Anvisa enacted the long-awaitedregulation for cannabis-based products. After so much speculation, RDC No. 327/2019was unanimously approved at the Collegiate Board Meeting from Anvisa (Dicol),held on December 3, 2019.

Theapproved regulation, which will take effect on March 10, 2020, establishesprocedures and requirements for the manufacture, importation, packaging,marketing and registration of medicinal cannabis-based products in Brazil.

The newclass of cannabis-based products was created to simplify the registrationprocedure of these products. Theirclassification as medicine would depend on studies and clinical research at anadvanced technical-scientific stage, which would currently make the approval ofmedical cannabis in such category unfeasible. The recent edited regulation must be revisitedby Anvisa within three years of its publication in the Brazilian officialgazette.

Nowdomestic and foreign companies can explore the Brazilian market by making productsup to 0.2% THC in their application available to patients with medicalprescription. Products with THC greaterthan 0.2% may only be prescribed for terminally ill patients or hazards thatdepleted alternative treatment therapies.

Althoughthe new regulatory framework was been considered an important advance for theopening of the Brazilian cannabis market, Anvisa decided to withdraw theproposed regulation for cannabis planting by justifying that the regulation ofnot existing economic activity in the country and prescribed by law would exceedthe competence of the Agency.

WithAnvisas veto, there is no other alternative for manufacturers ofcannabis-based products than the importation of pharmaceutical ingredients inthe form of plant derivatives or industrialized products, once the newregulation does not allow the importation of Cannabis spp plant or partsthereof.

In fact,since the Federal Law No. 11,343/2006 (Brazilian Drug Law) was enacted, theUnion, through the Executive Branch, is entitled to authorize cannabis plantingand harvest exclusively for medical or scientific purposes, which means thatfor 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, theexpectation is now placed in the National Congress. Bill No. 399/15 is still pending in theSpecial Committee of the Chamber of Congress and, given the social pressure, itmay have its scope broadened to also regulates cannabis planting for medicinalpurposes.

On the onehand, we have the omission of the State, by the Executive Branch, to deliberatethis matter. But on the other, we face the Judiciary assuming this role. Currently there are 52 (fifty-two) courtrulings authorizing the individual cultivation of marijuana for medicinal purposes. Those rulings were granted to people withserious or chronic diseases.

In the caseof planting and growing cannabis for collective purposes, the AssociaoBrasileira de Apoio Cannabis Esperana Abrace, located at the city ofJoo Pessoa Paraba, is the only legally authorized association to grow and processmarijuana and supply cannabinoid products to its members.

Morerecently, a company located in the countryside of So Paulo has just obtained ajudicial authorization to import and grow industrial hemp seeds with THCconcentration below 0.3%, as well as trade seeds, leaves and fibers forexclusively industrial purposes. The judicialdecision was granted on the same day that Anvisa approved the RDC No. 327/2019and decided to file the proposal of a regulation for cannabis planting.

The veto ofcannabis planting prevents Brazil from having a vertical industrialization forthe manufacture of cannabis-based products, with lower costs and affordable forthe population.

If the Stateis not exercising its regulatory function, the Judiciary, in response to the socialdemand is doing so. The absence ofspecific regulations for cannabis planting and the favorable precedents mentionedhere contribute to the granting of new favorable court decisions. In fact, the tendency is to multiply thisdemand over Brazilian courts on diverse fronts by: (i) universalizing patientsaccess to cannabis-based products by means of the Brazilian Unified HealthSystem SUS (Sistema nico de Sade) and by granting habeas corpus forplanting and cultivation of cannabis plant; or (ii) enabling investorsinterested in cannabis projects and initiatives develop this market.Althoughwe have not achieved the ideal regulatory environment, we cannot fail torecognize the progress that RDC No. 327/2019 made on this subject. Because we are facing a transitionalregulatory situation, now it is the perfect timing for the Brazilian society topersist in the fight for more extensive cannabis-based products regulation.

Written by:

Isabela Amorim Diniz Ferreira, Corporate lawyer from Farroco Abreu Advogados, specialized on regulatory matters and post-graduated in Economic Law by Fundao Getlio Vargas de So Paulo (FGV/SP).

http://www.farrocoabreu.com.br

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Because of the inertia of the Executive Branch, the Judiciary starts to regulate the growing of cannabis in Brazil - Global Legal Chronicle