In a tight vote, the commission responsible for analyzing the bill that deals with medical marijuana in Brazil approved on Tuesday (8) the text that authorizes the manufacture and sale of medicines and products based on cannabis.
The vote on the report, prepared by deputy Luciano Ducci (PSB-PR), ended in a tie: there were 17 votes in favor and 17 against. Ducci broke the tie, taking the score to 18 to 17.
The analysis was marked by an attempt to obstruct deputies allied with President Jair Bolsonaro (no party), who has already said he would veto the bill. The bill was being processed by the commission in a terminative manner, that is, if approved, it would go to the Senate.
Deputies against the text, however, will file an appeal for the proposal to be considered by the plenary of the Chamber. For this, they need the support of at least 52 deputies. If the appeal is approved, the text will have to be voted on by the House’s plenary.
The commission was the stage for fierce clashes between its members. In May, the pocket member Diego Garcia (Podemos-PR) pushed the president of the collegiate, the PT member Paulo Teixeira (SP), giving rise to a tussle between the opposition and allies of President Jair Bolsonaro.
On Tuesday, the committee’s votes showed the division around the issue. Opposing deputies argued that the text legalizes marijuana, while supporters argued that the only permitted use is medicinal and scientific.
For Congresswoman Natália Bonavides (PT-RN), the approval of the project, especially in the context of a pandemic, is essential. “There are several diseases and disorders treatable with cannabis products, which can avoid hospitalization, exposure to Covid-19 and more overload on the health system,” he said.
“The planting of cannabis and its use for medicinal purposes is already legalized in Brazil, but for a very restricted group of those who have money and can pay for the medicine sold or imported. This bill is necessary to allow the expansion of access by reducing costs, from the regulation of cultivation and the inclusion of patient associations in the production chain.”
Deputy Tiago Mitraud (Novo-MG) considers the text a great advance and says that it will bring possibilities for the offer of the drug to be greatly expanded and cheaper. “The report deals exclusively with medical and industrial issues. There are a series of regulations, some even excessive, so that there is no opening for adult use, which is another discussion”, he said. “Therefore, I hope it is approved and can overcome the existing prejudice to benefit patients and their families who need the drug.”
The project allows companies to grow cannabis in the country for medicinal and industrial purposes. According to the text, certified seeds or seedlings must be used, and interested companies must be previously authorized by the government.
Cultivation will go through controls. The companies will have a cultivation quota to meet pre-contracted demand or for a pre-determined purpose. The quota must specify the amount of psychoactive and non-psychoactive medicinal cannabis plants and, in the case of cultivation for industrial purposes, the area planted with industrial hemp.
Companies must also indicate the origin and characterization of the type of cannabis plant. Production must be traceable from seed acquisition to final processing and disposal.
The project provides for a safety plan that meets the safety requirements and a technical person responsible for ensuring the application of techniques of good agricultural practices, in accordance with standards and guidelines issued by the federal agricultural agency.
The bill indicates that the site for growing medicinal cannabis or industrial hemp plants should be fenced, protected and controlled, in order to prevent access by unauthorized persons. The area must be monitored by video at all entry points, with restricted access and an alarm system.
In addition, for the cultivation of medicinal cannabis plants, the perimeter of the facilities will also be required to be protected with galvanized steel wire mesh or masonry walls, with a minimum height of 2 meters and electrical fences with sufficient tension to prevent the invasion of people unauthorized.
The place cannot be identified with the trade name, corporate name or any other denomination that allows verifying the activities carried out.
The authorization to grow medicinal cannabis plants will be sent to the federal health agency. For industrial hemp plants and medicinal cannabis plants intended for the manufacture of medicinal and medicinal cannabis products for veterinary use, authorization will be sought from the federal agricultural agency.
The text says that research with cannabis plants and their derivatives is free, as long as the requirements are met. It also authorizes the planting, cultivation, handling and processing of the plant, inputs, extracts and derivatives of cannabis by institutions.
The disposal of medical cannabis intended for the manufacture of medicinal cannabis products and medicinal products for human use and of industrial hemp and medical cannabis intended for the preparation of medicinal cannabis products and products for veterinary use will be defined by health and agricultural bodies.
The bill indicates that medicines and medical cannabis products for human or veterinary use should be marketed in tamper-evident and easily identifiable packaging.
Medicines or medical cannabis products for human or veterinary use must be prescribed by a legally qualified professional. The patient or legal guardian or owner of the animal must agree with the prescription.
According to the bill, the SUS (Unified Health System) Vivas Pharmacies are authorized to cultivate and process medicinal cannabis plants to produce masterful or officinal herbal products.
Non-profit patient associations created specifically for this purpose, registered in the National Register of Legal Entities, will be able to cultivate and process medicinal cannabis plants, in addition to producing products for their members. They will have 24 months to conform to the rules.
The text allows for the production and sale of products made from industrial hemp, such as cosmetics, personal care items, cellulose, fibers, non-medicinal veterinary articles, foodstuffs and food supplements.
Companies can import and export seeds, cannabis itself or products exclusively for medicinal or industrial purposes.
The bill prohibits the prescription, delivery, distribution and sale to individuals of medicinal teas or any cannabis products in the form of plant drug, its parts or seeds, even after the stabilization and drying process.
In addition, it authorizes medicines and medical cannabis products to be incorporated into the SUS.
The text also changes the law on the National System of Public Policies on Drugs to indicate that the Union will authorize the planting, cultivation and harvesting of vegetables and substrates from which drugs can be extracted or produced, for medicinal, veterinary, industrial and scientific.