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Do uso humano da Cannabis sativa: o que dizem os parlamentares brasileiros sobre o tema?

On the human uses of Cannabis sativa: What do Brazilian Congressmen say about the subject?
Del uso humano de la Cannabis sativa: ¿qué dicen los parlamentarios brasileños sobre el tema?


Raquel Pereira Guimarães
Agência Nacional de Vigilância Sanitária
Email: raquel.gpdf@gmail.com
ORCID – 0000-0001-6708-1843


Sandra Mara Campos Alves
Fundação Oswaldo Cruz
E-mail: smcalves@gmail.com
ORCID – 0000-0001-6171-4558


Maria Célia Delduque
Universidade de Brasília
ORCID - 0000.0002.5351.3534
E-mail: mcdelduque@gmail.com


Resumo
O artigo apresenta resultados de pesquisa que analisou os projetos de lei na Câmara dos Deputados e Senado Federal, entre 2019-2022, para verificar os projetos parlamentares sobre o uso humano da Cannabis sativa. Tratou-se de pesquisa qualitativa, de base documental, em fonte primária a partir de consulta aos projetos de lei, disponíveis nos sítios eletrônicos das duas casas legislativas. Foram identificados 17 projetos de lei, sendo três de iniciativa do Senado Federal. Ao menos quatro projetos, tratam sobre o uso terapêutico da Cannabis e 13 projetos sobre outros usos. Não há PL de iniciativa do Poder Executivo. O Congresso Nacional não avança na regulamentação dos usos da Cannabis e atua de modo acanhado, sendo que nenhum dos projetos apresentados foi transformado em lei.
Palavras-chave: Cannabis sativa. Canabis. Regulamentação governamental. Uso de Cannabis.

Abstract
This article presents results of a research that analyzed the bills in progress in the House of Representatives and Federal Senate, from 2019 to 2022, in order to verify parliamentary intentions about the human use of Cannabis sativa. This was a qualitative, documentary-based research, using a primary source based on consultations of bills, available on the websites of the House of Representatives and the Federal Senate. Seventeen bills were identified, three of which were proposed by the Federal Senate. At least four bills deal with the therapeutic use of Cannabis and 13 bills deal with other uses. No bills were proposed by the Executive Branch. The National Congress does not advance in the regulation of the uses of Cannabis, and none of the proposed projects was transformed into law.
Keywords: Cannabis sativa. Cannabis. Government regulation. Cannabis use

Resumen
El artículo presenta los resultados de una investigación que analizó los proyectos de ley en la Cámara de Diputados y el Senado Federal entre 2019 y 2022, con el objetivo de verificar las iniciativas parlamentarias sobre el uso humano de la Cannabis sativa. Se trató de una investigación cualitativa, de base documental, utilizando como fuente primaria la consulta a los proyectos de ley disponibles en los sitios web de ambas cámaras legislativas. Se identificaron 17 proyectos de ley, de los cuales tres fueron de iniciativa del Senado Federal. Al menos cuatro proyectos abordan el uso terapéutico de la Cannabis y 13 proyectos tratan sobre otros usos. No existe ningún proyecto de iniciativa del Poder Ejecutivo. El Congreso Nacional no avanza en la regulación de los usos de la Cannabis y actúa de manera tímida, ya que ninguno de los proyectos presentados fue convertido en ley.
Palabras-Clave: Cannabis. Regulación Gubernamental. Uso de Cannabis


Introduction
The debate over the use of Cannabis for therapeutic purposes has been intensifying in Brazil over the last few years. The emblematic case of the girl, Anny Fischer, who suffered from severe refractory epilepsy, with up to 40 seizures per day, gained visibility on television in 2014, after a documentary was shown about the beneficial effects of cannabidiol, a substance obtained from Cannabis, and its illegal use in the country1. Anny Fischer underwent treatment with cannabidiol, showing significant improvement in her clinical condition1.
The National Health Surveillance Agency (Anvisa), through the Resolution of the Collegiate Board (Resolução da Diretoria Colegiada – RDC) No. 17, of May 6, 20152, authorized the import of cannabidiol by families previously registered with the Agency.
Cannabidiol was removed from the list of banned substances and became part of the list of controlled substances C1 (list of other substances subject to special control) of Ordinance/SVS No. 344, of May 12, 19983. The Cannabis sativa L. species remains on list E (list of plants that can produce narcotic or psychotropic substances), while THC, the substance responsible for the plant\'s hallucinogenic effects4, remains on list F (list of substances whose use is banned in Brazil), with the exception of those registered products that meet “the requirements to be regulated prior to the granting of registration” of the aforementioned regulation3. However, access to the substance remained limited, considering that the cultivation of Cannabis, possession of the plant, and the sale of Cannabis-based products in Brazil remain prohibited, except in cases of judicial authorization1,5,6. Despite this, in December 2022, the Agency granted special authorization to the Federal University of Rio Grande do Norte (UFRN) to plant Cannabis for research seeking to “evaluate the efficacy and safety of combinations of phytocannabinoids in the management of signs and symptoms associated with neurological and psychiatric disorders”7. This was Anvisa\'s first decision in this regard and occurred after an appeal filed by the university against the previous decision, which had been unfavorable7.
In short, the legislation authorizing the cultivation, planting, and harvesting of plant species, from which substances that can be derived into prohibited drugs can be extracted, serves only medicinal or scientific purposes and has not been fully observed by the authorities.
Law 11,343/20068, in its article 2, sole paragraph, established the following:

Art. 2 - Drugs, as well as the planting, cultivation, harvesting, and exploitation of plants and substrates from which drugs can be extracted or produced, are prohibited throughout the national territory, except in the case of legal or regulatory authorization, in addition to that which is established in the Vienna Convention of the United Nations on Psychotropic Substances, of 1971, regarding plants for strictly ritualistic-religious use.

Sole Paragraph - The Union may authorize the planting, cultivation, and harvesting of the plants referred to in the caput of this article, exclusively for medicinal or scientific purposes, in a predetermined place and time frame, subject to supervision, respecting the aforementioned reservations.


In the same year, Decree 5912/20069 was issued, granting the Ministry of Health (Ministério da Saúde – MS) the authority to authorize the planting, cultivation, and harvesting of plants from which substances are extracted. However, this authority only applies if, and only if, the extraction of active ingredients from these plants has medicinal or scientific purposes. It is the purpose of cultivation or planting that determines the authority of the MS, whose entity responsible for the matter is the National Health Surveillance Agency (Anvisa)9.
The wording of Law 11,343/20068, as well as its regulatory decree no. 5912/20069, confuses more than it clarifies. Cultivation means activity dedicated to the creation, development, and reproduction of plants or animals, or to the production of certain derivatives thereof. Planting, or plantation, is an operation that consists of installing plant species in a desired location10, therefore, essentially agricultural activities.
The subsequent amendment to Law 11,343/20068, undertaken by the enactment of Law No. 13,840/201911 did not change this context, as the prohibition on planting, growing, and harvesting plants that can produce drugs remained, only allowing exceptions through federal governmental authorization, exclusively for medicinal or scientific purposes.
Due to these particularities, in August 2021, Anvisa was adamant in stating that the Agency would not be competent to authorize the cultivation of Cannabis for exclusively medicinal and scientific purposes, arguing that it did not have the expertise to deal with the subject12. In view of the lack of clarification provided by the law that established the National System of Public Policies on Drugs (Sisnad), authorizations for cultivation and planting have been granted through injunctions and rulings from the Judiciary.
In 2019, Anvisa held Public Consultations (Consultas Públicas – CP) to address the issue. CP 654 discussed a regulatory proposal for the registration and monitoring of Cannabis-based medicines, their derivatives, and synthetic analogues, as well as the cultivation of derived products in Brazil, and CP 655 discussed the cultivation of the plant for medicinal and scientific purposes.
The consultations had broad participation from society, with more than 500 contributions in each CP13. Proposals for the cultivation of the plant for therapeutic purposes and its import in natura were rejected by the Anvisa Board of Directors14; however, Resolution RDC No. 327, of December 9, 201915, was approved, which provides for the procedures for granting health authorizations for the manufacture and import of Cannabis products for medicinal purposes, as well as for establishing requirements for its commercialization, prescription, dispensing, monitoring, and inspection15.
At the time, the Agency acted to rule out the possibility of authorization for cultivation, but took upon itself the responsibility for authorizing the manufacture and import of products, activities within its scope of action. However, Anvisa prohibited the import of Cannabis in natura, by individuals, as of July 20, 2023, through Technical Note No. 35/2023/SEI/COCIC/GPCON/DIRE5/ANVISA16.
In Brazil, as of July 2023, there were 27 Cannabis-based products registered with Anvisa, of which 16 were formulated with cannabidiol and 11 Cannabis extracts, of which only three were manufactured in Brazil17. Of the imported products, seven were manufactured in Switzerland, seven were manufactured in Canada, seven were manufactured in Colombia, two were manufactured in the United States, and one was manufactured in Uruguay17. The three products in Brazil are based on cannabidiol and no Cannabis extract is manufactured in Brazil17. The authorizations for the manufacture of these products, as well as the inspection of their production, are supported by RDC 327/201916.
However, while medicinal and scientific purposes are advancing slowly in national legislation, there is no legal authorization in the country for the individual or industrial cultivation of the plant for medicinal purposes, as well as for other human uses of Cannabis, which await regulation by the National Congress.
The Brazilian State Legislative Branch, represented by the National Congress, consists of two legislative houses: the House of Representatives and the Federal Senate.
It is the legislative branch of the State that represents the will of the people, which legislates through its elected representatives. Therefore, it must guide the discussion on the uses of Cannabis and formulate public policy on the cultivation, individual planting, possession, and uses of the plant, including recreational use, overcoming the regulatory vacuum on the subject in Brazil.
In view of the above, a survey was conducted in the legislative realms of the National Congress in order to learn what parliamentarians are proposing on Cannabis.


Methodology
This study consisted of qualitative, documentary research that used primary data from a consultation on the websites of the House of Representatives (www.camara.leg.br) and the Federal Senate (https://www12.senado.leg.br) using the following filters: ‘Cannabis’ or ‘Canabis’ in the subject line, ‘Bill (Projeto de Lei – PL)’ in the type of proposal, and selecting the option ‘yes’ in the ‘in progress’ field.
The research in the legislative records was carried out between October 1 and December 22, 2022, the closing date of the 56th legislature, with only projects in progress between 2019-2022 being classified, regardless of the date they were proposed. The full content of the original proposals that specifically dealt with the cultivation of Cannabis was analyzed. The time frame is justified by the fact that it is the most recent legislature concluded, allowing for analyses throughout its entire period. To classify the propositions found, Lemos\' subcategories18 were used, for whom the propositions have the form of diffuse benefits (for the entire population) or concentrated benefits (for individuals or groups).
The bills found were gathered, with the following variables: bill number, year of proposal, house of origin (House of Representatives or Federal Senate), name of the sponsor, party, state and party ideology, profession, as well as the summary and form of the proposal (diffuse/concentrated). The definition of the parties\' position in relation to the government was made based on the definitions constructed by Tarouco and Madeira19,20; Maciel, Alarcon, and Gimenes21; and, alternatively, by consulting the parties\' programs available on their websites. The party affiliation of the bill’s sponsor at the time of the presentation of the bill was adopted. To identify the profession of the Congressman, his official biography was consulted on the internet.

Results and discussion
The present study identified 14 bills from the House of Representatives and three from the Federal Senate.
There are two proposals in the Federal Senate arising from the e-Cidadania (e-Citizenship) program, which are manifestations of popular sovereignty and whose processing has been put forward in the Human Rights and Participatory Legislation Committee, demonstrating society\'s interest in the initiative.
No bills on the subject were identified in 2020, which can be explained by the health emergency experienced in the country during the period, when the priority to address issues related to the COVID-19 pandemic filled the agenda of the National Congress. In 2021, there were five proposals, with proposals for regulation in the scope of Veterinary Medicine and product labels. There were no proposals on the subject in 2022, clearly due to the priority of Congressmen to act in their states for reelection and/or avoid the subject in an election year22.
Chart 1

Among the authors of the analyzed bills, the absence of female Congressmen as authors stands out. This situation reflects the low representation of women in the most recent legislatures23 in the National Congress.
Regarding the professional profile of the authors, significant diversity can be observed, yet it was impossible to determine the prevalence of any of their professions. Professional diversity is explained by the approach of the bills themselves, since none had an exclusively medical purpose.
The number of bills, compared to the number of proposals in the health area (broad sense) is low, with bills on Cannabis accounting for 0.2% of the total on the issue of health. When compared to all the proposals in progress, this percentage drops to 0.1%.
In terms of health in the broad sense, the bills followed the following quantities: 2019: 7,202 bills; 2020: 7,032 bills; 2021: 8,230 bills; 2022: 4,045 bills24.
At the end of the Congress’s term, there was no sign of any of the Bills concerning Cannabis presented during the four-year period that had been transformed into law.
Figure 1

Regarding the party affiliations of the Congressmen, it was noted that the largest number represent centrist parties. No Congressmen affiliated with center-right parties were identified. This data contradicts the literature, which shows that left-wing parties historically defend more progressive agendas, while the right-wing presents more conservative agendas25. The Workers\' Party (Partido dos Trabalhadores – PT) has four proposals on the subject currently under consideration and is the party with the largest number of proposals.
Delmanto26, when conducting a broad study on the positioning of the Brazilian left on the issue of drugs, beginning in 1961, reveals deep ambiguities on this issue, ranging from silence to repression to treating it as a health issue.
Specifically regarding the positioning of the PT, the following excerpt from Delmanto\'s research stands out:
The subject had so little weight in the PT\'s internal politics that, in an interview for this work, the journalist, sociologist and former PT Representative, Marcos Rolim, opined that the issue was never addressed by the party: “I believe that the issue was never important. The PT never looked into it, nor produced any political resolution on the subject,” he declared.

His study26 also highlights that even in the recent governments of Lula and Dilma Roussef, the PT failed to make significant progress in tackling the issue, thus maintaining its ambiguous nature.
Chart 2

Among the projects in which the material object is the therapeutic purpose of Cannabis, there is a lack of standardization regarding the requirements for the cultivation of the plant, inasmuch as some Bills do not recommend any parameters.
Bill 7187/2014 addresses cultivation for both medicinal and recreational use27. It establishes the need for prior registration and authorization from the Ministry of Agriculture, Livestock, and Food Supply (MAPA), which would be responsible for its direct control, after consulting MH, in the case of therapeutic purposes28. The proposal takes away the health agency’s full jurisdiction as guaranteed by Law 11,343/20068 and its update granted by Law No. 13,840/201911, since the medicinal purpose is what should guide the jurisdiction for authorization of cultivation or planting. Bill 148529 follows the same line, deauthorizing the health agency’s right to provide authorizations.
The complete lack of knowledge of the subject on the part of some proponents leads to legislative proposals that suggest situations contrary to what is already established by law. Such projects, during processing, end up being disregarded when they pass through the Committee on Constitution and Justice and Citizenship (Comissão de Constituição e Justiça e de Cidadania – CCJ), which detects ambiguity.
Bill 7270/201430 is the most extensive project, with 67 articles, divided into 4 parts: i) regulation of the production and sale of Cannabis; ii) amnesty and public policies to reduce violence and crime related to illicit drug trafficking; iii) amendments to Law No. 11,343/20068 of August 23, 2006; and; iv) creation of the National Council for Advisory, Research, and Evaluation of Drug Policies. In the justification for the proposal, there is a clarification that the Bill is inspired by the existing regulations on alcohol and tobacco, since there was no Anvisa standard regulating the use of the plant at the time, although hearings and discussions on the matter had taken place.
The proposal is to remove Cannabis from the list of substances and medicines subject to special control, as well as the inspection and supervision of Cannabis derivatives and products in their bromatological and sanitary aspects, would be the responsibility of the MH. Regarding the cultivation of Cannabis for medicinal purposes, the proposal is not limited to this purpose, establishing requirements for domestic planting and for planting by ‘self-cultivator clubs’, a term whose definition was not described in the text of the proposal.
Bill 158/201531 is the only one that proposes a total ban on the consumption of ‘marijuana’ (the term used in the proposal), not accepting the idea of its use for medicinal purposes or scientific research. It proposes the creation of an additional paragraph to Article 1 of the Drug Law8, aimed at considering marijuana and other drugs – cocaine, crack and ecstasy – as ineligible for consumption by the competent federal agency. This prohibition would make the cultivation of the plant for medicinal purposes unfeasible, as it would not be feasible to cultivate a product that could not be consumed. The justification presented for the Bill was: “evidence showing that, if drugs are legalized, consumption will increase”31 without, however, presenting evidence to corroborate this statement. Furthermore, the use of the term ‘marijuana’ is used in a pejorative manner by groups opposed to the use of the plant32. The project revisits the historical discourse on the criminalization of marijuana, which, in the Brazilian context, has its origins in the association between the consumption of the herb by slaves and the adoption of the theories of criminologist Lombroso, who sought to relate and understand criminal behavior based on physical and mental traits33. The use of marijuana then began to be identified with the black population and, although this is not the scope of the analysis of this article, it cannot be forgotten that even today the topic is shrouded in prejudiced and discriminatory approaches, leading to the polarization of the debate and preventing its advancement.
In contrast, Bill 573/202134 removes Cannabis from the conduct specified in Article 28 of the Drug Law8, which would allow unrestricted consumption and cultivation. In its justification, the Bill cites the case of countries where consumption of the plant is authorized. This is a controversial point because, on the one hand, there are examples of countries that authorize medicinal and/or recreational cultivation and consumption, such as Uruguay, the USA, Canada, Portugal, Spain, the Netherlands, and Israel35-38. By contrast, there are studies that have already indicated that Cannabis contains psychotropic substances that can have hallucinogenic effects if the plant is not used appropriately39-41. In this context, a lack of regulation that establishes minimum parameters for use and establishes only the decriminalization of personal use can generate harm for users.
Bill 10549/201842 presents a list of diseases for which the plant can be prescribed, but not exhaustively, enabling the inclusion of other illnesses through a medical certificate. In addition, it requires authorization from Anvisa for the planting, production, and supply of psychoactive Cannabis for therapeutic purposes.
The proposal for an exemplary prescription list is in line with the literature43, which has observed an increase in the prescription of Cannabis for various diseases, such as chronic pain, insomnia, migraines, menstrual cramps, among others, thus surpassing the initial recommendation for use in patients with a history of severe epilepsy and seizures. However, there is still scientific divergence regarding the robustness, quality, and sufficiency of the evidence to ensure safety and minimize adverse effects in the administration of the substance, thus justifying monitoring its use and expanding its indications44,45.
Bill 4565/201946 proposes the update of Law No. 11,343/20068 and establishes some parameters for the cultivation of Cannabis and other plants from which substances or products considered illicit drugs can be extracted. It also provides that cultivation for therapeutic purposes must comply with certain conditions, such as communication “to the local health surveillance agency,” without requiring authorization for medicinal cultivation.
Bill 6475/201947, in turn, does not present a proposal aimed at cultivation for therapeutic use. It deals with issues related to the allocation of the area where the sowing of “plants and substrates from which drugs can be extracted or produced” will be carried out, without specifying any purpose. It establishes that at least half of the total area authorized by the Federal Government for such planting should be on properties belonging to family farmers or rural family entrepreneurs. The proposal is justified by the possibility of financial gains from the emerging cannabis trade, which could benefit small farmers. Bill 1485/202148 authorizes the Brazilian Agricultural Research Corporation (Embrapa) and federal universities to implement the “planting, cultivation, and harvesting of cannabis exclusively for medicinal or scientific purposes”, but without establishing parameters for such cultivation or the need for authorization by any government agency. Despite being a project with the proposal to insert only one paragraph into article 2 of Law No. 11,343/20068, the modification could imply advances in research into therapeutic uses of Cannabis, if in fact objective criteria for cultivation were established, since the illegality of cultivation by these institutions makes the research process more expensive and difficult49, in addition to generating dependence on importing this raw material from countries that have legalized this activity50.
Although these are bills with different scopes, none of the analyzed proposals have authorized the cultivation of cannabis by pharmaceutical industries, since no industry in the country has authorization to grow cannabis, using only imported plants in its production. This fact also explains the high cost of medications that contain this ingredient51.
A general analysis of the proposals shows that, despite the progress of proposals to regulate the use of cannabis, the idea of absolute prohibition still resides in the federal legislative branch, which ends up holding back the State from adopting measures that encourage research into its medicinal use and other advances in the field of public health52. The modulation between the repressive discourse and the medicinal discourse on the use of cannabis still presents a challenge.

Final considerations
The use of Cannabis is a topic that involves approaches of a political, health, social, and economic nature. The number of legislative proposals proposed during the period studied is low, when compared to the total number of proposals on the subject of health, and even lower when considering the overall number of proposals presented during the legislature. Of the proposals analyzed, none were transformed into law.
The National Health Surveillance Agency must assume its responsibility defined in the Drug Law for authorizations for the cultivation, planting, and harvesting of Cannabis for medicinal and scientific purposes, avoiding lawsuits and repeated authorizations by the Judiciary to authorize planting by users.
None of the Resolutions of the Collegiate Board (Resoluções da Diretoria Colegiada – RDC) of Anvisa provide for the cultivation of the plant; unfortunately, only its use is regulated by RDC, demonstrating a regulatory void for cultivation.
While this article was being written, a bill from the Legislative Assembly of the State of São Paulo was sanctioned by the governor on January 31, 2022, ratifying State Law 17.618/202353, to guarantee the supply of Cannabis-based medicines in public and private health units affiliated with the SUS in the state. This is undoubtedly an important example for the rest of Brazil.
No bills were identified to authorize cultivation, planting, and harvesting by pharmaceutical industries, compromising the market for these products in Brazil, implying the need to import the plant for the registration of Cannabis-based products with the Anvisa, considering that there is no authorization for cultivation by industries or purchase of the input cultivated by associations.
At no time did the Executive Branch show any interest in presenting a bill on the subject and the bills were all authored by a single author, which for the purposes of legislative processing does not strengthen the understanding of the houses that there is a collective parliamentary effort.
The two projects presented by e-cidadania are confirmation that Brazilian society is aware of the issue and has been urging the Legislative Branch to address the matter.
The projects need to be discussed in more detail, with the different bodies and entities of the Public Administration involved in regulating the cultivation of Cannabis, with civil society and with the productive sector, in public hearings in the National Congress, in order to make it possible to establish legislation that regulates the cultivation of Cannabis without putting the health of the population at risk.
The end of the 56th Legislature without the approval of any of the analyzed projects crystallizes the legislative vacuum, once again perpetuating the failure of the legislative power of the State to respond to an issue that is necessary for society.

References
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