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Bill (PL) 399/2015 suggests cultivation for commercial and therapeutic purposes, but fails to cover other types of cultivation, like home or personal cultivation.

Last week, on August 18th, we got really surprised with some news: Congressman Paulo Teixeira (PT-SP) submitted to Congress the replacement for bill 399/2015, a proposal that provides for the legalization of cannabis cultivation for therapeutic use and industrial purposes. Among the main provisions of the document is the popularization of cannabis-based medicines, which must also be included in the list of medicines distributed by the Unified Health System (SUS).

The proposal has generated debate in the cannabis field in recent days: although it is a step towards more comprehensive regulation in the country, many see the law project (PL) as insufficient because it does not account for all types of cultivation that can be done to meet the demands of the population. Haven’t seen the project yet? Here, let’s talk about some of the main provisions of the document!

Focus on therapeutic cannabis

Since 2015, therapeutic cannabis and the import of some cannabis and hemp derived products are already allowed here in Brazil. However, as we have already discussed here on the blog, there are many obstacles that make access difficult for the majority of the population: bureaucracy can be overcome by some, however the high values impose a barrier that is practically impossible to get over – especially in a country where a large part of the population lives on less than the minimum wage.

According to those responsible, the main focus of this bill is to democratize access to therapeutic cannabis in the national territory, taking treatment to patients with conditions such as cancer, epilepsy, chronic pain, rare syndromes and many others. According to Teixeira, the law hears the appeal of patient associations and seeks to lower the costs of medication (which, under current conditions, may exceed R $ 2,500 per unit).

Paulo Teixeira and Luciano Ducci

Main provisions of the Bill

We had access to the document, which is an attempt to regulate the activities of cultivation, processing, storage, transportation, research, production, industrialization, commercialization, export and import of cannabis-based products for therapeutic and industrial purposes. The project is not about personal cultivation, nor about recreational, religious or ritualistic use.

The plants are intended for products derived from cannabis, manufactured exclusively by pharmaceutical companies, according to RDC 327/2019 of Anvisa. The production of non-psychoactive cannabis, with less than 0.3% THC, is treated in the law as hemp and its use is foreseen industrially.

Cultivation is only allowed through legal entities, with the prior authorization of the government. According to this bill, it is not yet possible to cultivate the plant on your own. In addition, the government can cultivate and distribute it through Unique Health System (SUS) Living Pharmacies. Legally constituted Patient Associations can also plant, manufacture and distribute medications, but it is mandatory to adapt to the good practices of SUS Living Pharmacies, which have simpler rules than the industry. Associations will have two years (24 months) to adapt.

Who can provide:

  • Handling pharmacies;

  • SUS;

  • Patient Associations;

  • Companies.

Also according to the project, plants grown for therapeutic purposes can be used in products regulated by RDV 327/2019 of Anvisa and veterinary products. Hemp, on the other hand, has a greater variety of purposes, ranging from the textile industry to construction products, cosmetics and others.

What is considered “therapeutic cannabis”?

According to the project, the therapeutic conditions of cannabis are as follows:

  • Cannabis plants with more than 1% THC are considered psychoactive;

  • Cannabis plants with less than 1% THC are considered non-psychoactive;

  • For veterinary purposes, only non-psychoactive cannabis is allowed;

  • Cannabis-based medicines for human use are considered psychoactive if they have more than 0.3% THC;

  • The drug with a THC content below 0.3% is non-psychoactive.

Other Highlights of the Bill

According to the text initially presented, only companies will be able to cultivate, with government authorization, of course. To control production, each company will have a quota of cultivation, in addition to having the production tracked and counting with the approval of a technical manager. The politicians responsible for drafting the document emphasized, in an Instagram live, so there is still the right of other parliamentarians to observe and amend the proposal.

Inspection will be the responsibility of the Ministry of Agriculture. The proposal also allows research institutions to plant, grow, transport and store cannabis, provided they are previously authorized.

One of the great targets of politicians, through the bill, is the economy and the promotion of activities related to the cultivation and handling of cannabis – be it therapeutic or industrial. According to Luciano Ducci (PSB-PR), “agriculture gains one more input, which can be exported to the world. Brazil can be one of the leaders in this market alongside the USA and China”.

We believe that many important points are still missing in this huge discussion that Brazil is participating in. In other models of international regulation, such as Uruguay and Canada, we can see some provisions in common, which are still missing from the Brazilian text: individual cultivation and outdoor planting – which can also help in the recovery of much of the national soil and make this process sustainable.

In the coming weeks, what we must do is observe the development of this situation and put pressure on those responsible, so that we can pass on to the Senate a more just and comprehensive law.. We are also awaiting the outcome of the long-awaited position of the Supreme Court on the decriminalization of drug possession. The prohibitionist drug policy puts undue burden on the prison system, violating human rights and causing even more harm to vulnerable populations.

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