Medicinal cannabis: Lula government defends planting in Brazil – 07/11/2023 – Daily life

The Lula government (PT) intends to regulate the planting of cannabis for medicinal purposes in Brazil to replace imports of products, says the national secretary of Policies on Drugs and Asset Management of the Ministry of Justice, Marta Machado.

Currently, planting is allowed only in case of obtaining a favorable court decision. In March, the ministry had already defended in a lawsuit that the STJ (Superior Court of Justice) authorize the plantation here in Brazil.

In the demonstration, the folder says it considers convenient a broad and adequate regulation of the importation and cultivation of cannabis with low concentration of THC (component that generates psychoactive effects), for industrial, pharmaceutical and medicinal purposes.

In an interview with Sheet, the head of Senad stated that releasing the plantation will be one of Conad’s (National Council for Drug Policy) priorities. Members of the Ministry of Health, Anvisa (National Health Surveillance Agency) and the Federal Police, as well as other portfolios, also form part of the council.

According to Marta Machado, the idea is to discuss which model of regulation is best for the country. The intention, she says, is to reduce the price of products based on cannabis and thus avoid the judicialization that occurs throughout the country.

Justice has already granted more than 2,000 planting authorizations in Brazil. In his view, the current scenario is one of distortion because there is little control.

“There are models that make this authorization only for the pharmaceutical industry, others recognize the associations. Senad does not have any a priori model, the intention is to widely discuss with all the actors involved a prudent system of regulation, inspection and monitoring that avoids deviation for recreational use and that prioritizes local production and the Brazilian industry able to enter this market”, he added.

The secretary’s position reinforces what was exposed by the ministry at the STJ.

“This is an imperative measure to remedy the obscurities of the current regulatory framework and correct the distortions generated by it, especially the great difficulty of control by public security agencies and other inspection bodies of plantations currently existing in the national territory, whether they are authorized by the casuistry of judicial decisions or supported by acts of civil disobedience”, said the folder.

Another sign that the cannabis for medicinal use will be one of the government’s guidelines is the indication of names linked to the sector to the Economic Social and Sustainable Development Council, called “Conselhão”. Among them is Viviane Sedola, CEO and founder of the digital platform Dr. Cannabis, which connects doctors and patients in Brazil.

Created by Lula in 2003 and extinguished by former president Jair Bolsonaro (PL), the Conselhão serves as a dialogue between the government and civil society to discuss measures involving the country’s development.

While the government is debating the issue, Anvisa is also working on a new rule to regulate planting for use in research.

“Within the scope of clinical research that is the responsibility of regular Anvisa, the agency can regulate planting for research purposes. What we have been working on is a norm that regulates planting for clinical research purposes for drug registration or health authorization of cannabis-based products,” said Daniel Meirelles, one of the agency’s directors.

Bruna Rocha, lawyer and CEO of BRCann (Brazilian Association of Cannabinoid Industries) said it was necessary to advance in regulation for the market to grow more.

“The only way to make this market viable is through a clear and consistent regulatory structure. There are countless benefits because where you have legal certainty, you naturally associate investment, which benefits the patient himself. A 327 and 660 [normas da Anvisa] are transitional regulations, the latter being based on a public civil action that has not become final and unappealable”, he said.

Anvisa authorizes two ways to obtain products based on cannabis. The first is through importation through resolution 660. In this case, the products are exclusively for personal use and do not undergo technical evaluation by the regulatory agency.

Such as Sheet showed, a parallel market for “legalized marijuana” for recreational use develops in the country because of a loophole in this resolution.

Agency data show that in 2022, 80,258 authorizations were granted for the import of products with the substance, double the number of 2021 (40,165).

The other way to obtain these products is through resolution 327, in which Anvisa authorizes the sale of a product based on cannabis in pharmacies. In this case, the regulatory agency assesses quality, efficacy and safety prior to authorization.

According to BRCann, the commercialization of products based on cannabis medicinal products in Brazilian pharmacies registered a growth of 304% in volume in the comparison between the years 2022 and 2021.

Doctor Valdecir Carlos Tadei, professor at Famerp (Rio Preto Medical School), says that currently several conditions respond well to these products, such as autism, epilepsy and anxiety.

According to the doctor, this market has grown a lot and helped in the lives of several patients. Tadei claims to see an average of ten people per day who are treated with products based on cannabis.

“I understand and practice my medicine with a clear concept: cannabidiol is an adjuvant treatment. For each person, the treatment is different, and may or may not be done in conjunction with other medications, such as anxiolytics for anxiety,” he said.

Tadei is in favor of planting cannabis in Brazil as long as it is for industrial production with all the safety and quality of the final product.

Metallurgist Paulo Henrique Nunes said that his son Pedro Henrique Nunes, 9, had meningitis at the age of four months, resulting in cerebral palsy and quadriplegia. A year later, the disease reappeared, and Pedro started having several seizures a day.

Paulo says he discovered treatment with cannabidiol before 2015 and that he even obtained authorization from Anvisa, but did not put it into practice due to the price of the drugs.

After the help of Abracuca (Brazilian Association for the Support and Care of Cannabis), Paulo got the appointment and the help to file the lawsuit and guarantee the treatment of his son. The seizures stopped in 2022, after Pedro took the products recommended by the doctor, he reports. He was also able to reduce the dose of other medicines.

“We have to hope that everyone understands what medication is, because we already suffer from prejudice”, he says.

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Evolution of the market for cannabis-based products in Brazil

2014

First individual lawsuits in the Judiciary claim permission to access the product

2015

Anvisa publishes the agency’s first normative act to authorize imports of products based on cannabis, on an exceptional basis. The permission was intended for individuals, for their own use, upon medical prescription.

2017

Approval of the first registration in Brazil of medicines based on cannabis medicinal

2019

Start of authorization by Anvisa for products to be sold in pharmacies and drugstores