A Day That Should Have Been Historic

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Published at 10/02/2025

Tuesday, 09/30, was supposed to be historic, a moment to contemplate the decades-long struggle, at dawn the news should have been only the best, however, ANVISA's blatant audacity put an end to everything.

 

Judicial Disobedience and Weak Arguments

 

Once again disobeying the judicial order, under flimsy arguments, now requiring additional time, six months to two years, between dispatch, technical note, and process, along with Federal Law No. 13,848/19 and Decree No. 10,411/2020, and international experience, the need for a Regulatory Impact Analysis (RIA) was observed. These are technically important issues, and in the end, a new schedule is presented for the next six months.

 

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Reflection on the Fight for Regulation

 

It is time for us to reflect, and remembering is part of it. When I say it has been a little over a decade, it is not an exaggeration, it is the reality. The first RDC dealing with cannabis in Brazil is from 2015, and this only happened after a lot of public demonstrations with thousands of lawsuits. Since then, our neighboring countries that started much later than us, such as Argentina and Paraguay, are already becoming Latin American references, while here ANVISA continues to insist on a weak and outdated discourse.

 

Legal Basis and International Permission

 

The Single Convention on Narcotic Drugs, signed by Brazil at the UN, which became Decree Law No. 54,216 of 1964, authorizes the use of medicinal and industrial cannabis, as well as scientific research. The Narcotics Law No. 11,343 of 2006, article 2, sole paragraph authorizes the Union to regulate the matter internally, precisely through an RDC.

 

Legal Structure and Real Demand

 

It must be recognized that the main legal structure has already been in place for many years, and today we have a real demand regarding medicinal cannabis and industrial hemp since at least 2015. In other words, time has passed and ANVISA continues to be silent, not addressing the issue with due respect, disregarding the Judiciary and setting a harmful precedent in the art of procrastination.

 

Omission and Consequences

 

In addition to having the legal obligation to regulate cannabis, it has had enough time and resources at its disposal, but it has never been observed that concrete measures have been taken to address the demand. It only produces unilateral documents, aiming to delay compliance with the court order. The regulatory agency ANVISA's actions to postpone the rules are hindering the development of our society's future, science loses, the patient loses, as well as the worker. It puts the Judiciary in an uncomfortable position, being forced to take strict measures to enforce the court order.

 Author Bio Fabricio Ebone Zardo
Fabricio Ebone Zardo

Fabricio Ebone Zardo is a lawyer specialist in cannabis law, vice president and legal director of the Cannabis Brazil Science and Technology Institute.