Better late than ineffective

Expectations were not the best. Since October 2024, the Brazilian Cannabis market has been on hold awaiting the first regulation of plant cultivation in Brazil since the proclamation of the Republic. The most recent deadline for the Union to take this historic step was September 30. No one had much hope that the government would present a robust regulatory decree, encompassing all the possibilities raised in the action plan presented to the STJ in May. It turned out that the government presented nothing, except for a new request for an extension of the deadline. And that can be good news.

Because the truth is that the government has done practically nothing since the STJ gave it an extra deadline to regulate the matter. Of the nine items provided for in the schedule, the AGU says it has only fulfilled 5, one of which was to present the request for an extension of the deadline. The other two included carrying out “bilateral agendas” between the government entities involved, “directive consultation with experts and public dialogue sessions.” If these steps were taken, they were done in an opaque manner and did not produce any documents, as expected. After all, only two of the nine steps provided for in the plan were executed - a decree and a technical note that depended exclusively on the MAPA. It is very little.

Tarso Araujo confirmed at Cannabis Connection 2025

Journalist, documentarian, and consultant, specializing in health and drug policies, Tarso Araújo is among the confirmed speakers at Cannabis Connection 2025, taking place on November 6.

In addition to him, the event will feature the following announced experts:

• Beatriz Emygdio - researcher at Embrapa and president of the Permanent Committee for Strategic Advisory on Cannabis 

• Filipe Campos - Market Insights leader at Close-Up International, specialist in pharmaceutical market data and trends 

• João Paulo Perfeito - Specific Medicines and Phytotherapics Manager at Anvisa, clinical and industrial pharmacist, master in Health Sciences, with experience in regulation, formulation, and therapeutic use of cannabis

Secure your spot

Furthermore, the only other document produced so far was a draft amendment to ordinance 344/1998, which updates the lists of substances and plants subject to special control by the Drug Law (11.343/2006) and is the very first regulation that needs to change for the regulation to take shape.

In the proposed draft to update the ordinance, Anvisa authorizes cultivation only for the pharmaceutical industry, with a THC limit of 0.3%. Patient associations are ignored, research is not mentioned, hemp cultivation for food and fibers is not allowed. Only the pharmaceutical sector's monopoly is ensured. If this draft is to be considered as “the regulation,” it is better to have nothing at all and ask for more time.

This draft does not even meet the interests of the pharmaceutical industry since the nationalization of crops requires significant investments, and the sector has already realized that within the limits of 0.3% THC, there is a high risk that cultivation will not be economically viable. For the manufacturer of medicines or Cannabis products, it will be safer to continue importing inputs for packaging, as is already done with 95% of the medicines sold in Brazil. In other words, if the regulation follows what Anvisa has proposed so far, it could become something completely ineffective, not even of interest to the sector for which it was made with such care.

Actually, as it stands, the draft amendment to ordinance 344/1998 may be even worse, rather than ineffective. Because it is clear that this draft has the potential to trigger a new wave of litigations. From agricultural producers who want to plant to produce food and fibers, from producers who do not want to lose their harvest because their crop exceeded the 0.3% THC allowed with the passage of El Niño, from pharmacists who want to voluntarily exceed this limit to make their crops economically viable for medicine production.

For all these reasons, it is better to wait. Better late than ineffective, or for a few. After all, we have been waiting since 2006 when the Drug Law created the power/duty for the Union to regulate the cultivation of Cannabis and other prohibited plants for medicinal and scientific purposes.

Let's see if this time the STJ will do as before and simply give the defendant more time, without monitoring the compliance with the intermediate steps, as it has done since May. Judging by everything the Union has done (or failed to do) to comply with the sentence in the last 12 months, it may be necessary to keep a close watch.

And let's hope that this new board of Anvisa embraces this cause without fear of complexity. And without the sluggishness with which it has treated the Cannabis agenda. It is worth remembering that RDC 327 was supposed to have been revised in 2022. And here we are in 2025, with no sign of a new version of the regulation.