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.
Key words:
Cannabis sativa; Cannabis; Government regulation; Cannabis use
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
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 sativa; 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 5,912/20069 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. 5,912/20069, 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 et al.21; 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).
Party ideology of parliamentarians proposing bills on Cannabis 2019-2022 in the National Congress.
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 out26:
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, in as much as some Bills do not recommend any parameters.
Bill 7,187/2014 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 1,48529 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 7,270/201430 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 10,549/201842 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 4,565/201946 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 6,475/201947, 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 1,485/202148 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
- 1 Oliveira MB. A regulamentação do canabidiol no Brasil: como nasce a expertise leiga. Liinc Rev 2017; 13(1):190-204.
- 2 Brasil. Agência Nacional de Vigilância Sanitária (Anvisa). Resolução da Diretoria Colegiada - RDC nº 17, de 6 de maio de 2015. Define os critérios e os procedimentos para a importação, em caráter de excepcionalidade, de produto à base de Canabidiol em associação com outros canabinóides, por pessoa física, para uso próprio, mediante prescrição de profissional legalmente habilitado, para tratamento de saúde. Diário Oficial da União 2015; 8 maio.
- 3 Brasil. Ministério da Saúde (MS). Portaria/SVS nº 344, de 12 de maio de 1998. Aprova o Regulamento Técnico sobre substâncias e medicamentos sujeitos a controle especial. Diário Oficial da União 1998; 15 maio.
- 4 Zuardi AW, Shirakawa I, Finkelfarb E, Karniol IG. Action of cannabidiol on the anxiety and other effects produced by delta 9-THC in normal. Psychopharmacology (Berl) 1982; 76(3):245-250.
- 5 Rodrigues APLS, Lopes IS, Mourão VLA. "Eficácia, segurança e qualidade": parâmetros discursivos nas audiências públicas da Anvisa sobre regulamentação e pesquisas com cannabis para fins medicinais. Teoria Cult 2020; 15(2):134-147.
-
6 Brasil. Superior Tribunal de Justiça (STJ). RHC nº 14.7169 / SP (2021/0141522-6) [Internet]. 2021 [acessado 2022 nov 18]. Disponível em: https://processo.stj.jus.br/processo/pesquisa/?aplicacao=processos.ea&tipoPesquisa=tipoPesquisaGenerica&termo=RHC 147169
» https://processo.stj.jus.br/processo/pesquisa/?aplicacao=processos.ea&tipoPesquisa=tipoPesquisaGenerica&termo=RHC 147169 -
7 Agência Nacional de Vigilância Sanitária (Anvisa). Anvisa autoriza pesquisa científica nacional com produtos derivados de Cannabis [Internet]. 2022 [acessado 2022 dez 20]. Disponível em: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2022/anvisa-autoriza-pesquisa-cientifica-nacional-com-produtos-derivados-de-cannabis
» https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2022/anvisa-autoriza-pesquisa-cientifica-nacional-com-produtos-derivados-de-cannabis - 8 Brasil. Lei nº 11.343, de 26 de agosto de 2006. Institui o Sistema Nacional de Políticas Públicas sobre Drogas - Sisnad; prescreve medidas para prevenção do uso indevido, atenção e reinserção social de usuários e dependentes de drogas; estabelece normas para repressão à produção não autorizada e ao tráfico ilícito de drogas; define crimes e dá outras providências. Diário Oficial da União; 2006.
- 9 Brasil. Decreto nº 5.912, de 27 de setembro de 2006. Regulamenta a Lei nº 11.343, de 23 de agosto de 2006. Trata das políticas públicas sobre drogas e da instituição do Sistema Nacional de Políticas Públicas sobre Drogas - SISNAD, e dá outras providências. Diário Oficial da União; 2006.
- 10 Ormond JGP. Glossário de termos usados em atividades agropecuárias, florestais e ciências ambientais. 3ª ed. Rio de Janeiro: BNDES; 2006.
- 11 Brasil. Lei nº 13.840, de 5 de junho de 2019. Altera as Leis nos 11.343, de 23 de agosto de 2006, 7.560, de 19 de dezembro de 1986, 9.250, de 26 de dezembro de 1995, 9.532, de 10 de dezembro de 1997, 8.981, de 20 de janeiro de 1995, 8.315, de 23 de dezembro de 1991, 8.706, de 14 de setembro de 1993, 8.069, de 13 de julho de 1990, 9.394, de 20 de dezembro de 1996, e 9.503, de 23 de setembro de 1997, os Decretos-Lei nos 4.048, de 22 de janeiro de 1942, 8.621, de 10 de janeiro de 1946, e 5.452, de 1º de maio de 1943, para dispor sobre o Sistema Nacional de Políticas Públicas sobre Drogas e as condições de atenção aos usuários ou dependentes de drogas e para tratar do financiamento das políticas sobre drogas. Diário Oficial da União; 2019.
-
12 Senado Federal. Canabis Medicinal: realidade a espera de regulamentação [Internet]. [acessado 2022 dez 20]. Disponível em: https://www12.senado.leg.br/noticias/infomaterias/2021/07/cannabis-medicinal-realidade-a-espera-de-regulamentacao
» https://www12.senado.leg.br/noticias/infomaterias/2021/07/cannabis-medicinal-realidade-a-espera-de-regulamentacao - 13 Rodrigues APLS, Lopes IS, Mourão VLA. "Eficácia, segurança e qualidade": parâmetros discursivos nas audiências públicas da Anvisa sobre regulamentação e pesquisas com cannabis para fins medicinais. Teoria Cult 2020; 15(2):134-147.
-
14 Santos MJLS, Vasconcelos B. Breve histórico da recente regulamentação da Cannabis para fins medicinais e científicos no Brasil [Internet]. 2020 [acessado 2022 dez 20]. Disponível em: https://d1wqtxts1xzle7.cloudfront.net/65091605/Marina_Jacob_Lopes_da_Silva_Santos_e_Beto_Vasconcelos_1_-with-cover-page-v2.pdf?Expires=1668795067&Signature=LZs7-ZqIo25i8sV14opHF3On7nKjerolylIK0kOTwZdVySqOz--Sc4adI22y7l0xZ9Sd5fy4Vz-Vh9rSISHcSUexkczBzRIC3vQvfhHFE67tGYdEjRpc5~k1qVwwP8x10No62uONWxyvhynNMMYH4XPUdBwRqEk~WAnf6YX4yrfQhg0VZ3AkdWVn4am7sKBUA-1lwNi0ry-PwDxfk4PP0XGc8OrAGvWJXbJyWigB7HVBbZMNP83mnyhoQXrWyWe5kL1pxtiA-kkPnH~Tq8nRRrBUdraXjwlh~JXoKtJmAaS2stXwTgOWcp9agU-6sAFqSb6e1dt0Ni11DJJOKAd7bw__&Key-Pair-Id=APKAJLOHF5GGSLRBV4ZA
» https://d1wqtxts1xzle7.cloudfront.net/65091605/Marina_Jacob_Lopes_da_Silva_Santos_e_Beto_Vasconcelos_1_-with-cover-page-v2.pdf?Expires=1668795067&Signature=LZs7-ZqIo25i8sV14opHF3On7nKjerolylIK0kOTwZdVySqOz--Sc4adI22y7l0xZ9Sd5fy4Vz-Vh9rSISHcSUexkczBzRIC3vQvfhHFE67tGYdEjRpc5~k1qVwwP8x10No62uONWxyvhynNMMYH4XPUdBwRqEk~WAnf6YX4yrfQhg0VZ3AkdWVn4am7sKBUA-1lwNi0ry-PwDxfk4PP0XGc8OrAGvWJXbJyWigB7HVBbZMNP83mnyhoQXrWyWe5kL1pxtiA-kkPnH~Tq8nRRrBUdraXjwlh~JXoKtJmAaS2stXwTgOWcp9agU-6sAFqSb6e1dt0Ni11DJJOKAd7bw__&Key-Pair-Id=APKAJLOHF5GGSLRBV4ZA - 15 Brasil. Agência Nacional de Vigilância Sanitária (Anvisa). Resolução da Diretoria Colegiada-RDC nº 327, de 9 de dezembro de 2019. Dispõe sobre os procedimentos para a concessão da Autorização Sanitária para a fabricação e a importação, bem como estabelece requisitos para a comercialização, prescrição, a dispensação, o monitoramento e a fiscalização de produtos de Cannabis para fins medicinais, e dá outras providências. Diário Oficial da União 2019; 11 dez.
-
16 Brasil. Agência Nacional de Vigilância Sanitária (Anvisa). Nota Técnica nº 35/2023/SEI/COCIC/GPCON/DIRE5/ANVISA. Apresenta a lista de produtos derivados de Cannabis de que trata o parágrafo 3º do Artigo 5º da RDC nº 660/2022 [Internet]. 2023 [acessado 2024 jul 4]. Disponível em: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2023/copy2_of_NT35.pdf
» https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2023/copy2_of_NT35.pdf -
17 Agência Nacional de Vigilância Sanitária (Anvisa). Consultas [Internet] 2023 [acessado 2024 jul 4]. Disponível em: https://consultas.anvisa.gov.br/#/cannabis/.
» https://consultas.anvisa.gov.br/#/cannabis - 18 Lemos LBS. O Congresso Brasileiro e a Distribuição de Benefícios Sociais no Período 1988-1994: Uma Análise Distributivista. DADOS 2001; 44(3):561-605.
- 19 Tarouco GDS, Madeira RM. Os partidos brasileiros segundo seus estudiosos: análise de um expert survey. Civ 2015; 15(1):24.
- 20 Tarouco GS, Madeira RM. Partidos, programas e o debate sobre esquerda e direita no Brasil. Rev Soc Polít 2013; 21(45):149-165.
- 21 Maciel APB, Alarcon AO, Gimenes ER. Partidos políticos e espectro ideológico: parlamentares, especialistas, esquerda e direita no Brasil. Rev Eletr Cien Polít 2017; 8(3):72-88.
-
22 Estadão. CFM restringe uso de Cannabis medicinal e veta palestras sobre o tema [Internet]. [acessado 2023 jul 25]. Disponível em: https://www.uol.com.br/vivabem/noticias/agencia-estado/2022/10/15/cfm-restringe-uso-de-cannabis-medicinal-e-veta-palestras-sobre-o-tema.htm?cmpid=copiaecola
» https://www.uol.com.br/vivabem/noticias/agencia-estado/2022/10/15/cfm-restringe-uso-de-cannabis-medicinal-e-veta-palestras-sobre-o-tema.htm?cmpid=copiaecola -
23 Agência Câmara de Notícias. A representação feminina e os avanços na legislação [Internet]. 2018 [acessado 2022 nov 18]. Disponível em: https://www.camara.leg.br/noticias/546180-a-representacao-feminina-e-os-avancos-na-legislacao/.
» https://www.camara.leg.br/noticias/546180-a-representacao-feminina-e-os-avancos-na-legislacao -
24 Câmara dos Deputados. Sistema de busca de propostas legislativas: projetos de lei [Internet]. [acessado 2023 jul 25]. Disponível em: https://www.camara.leg.br/busca-portal/proposicoes/pesquisa-simplificada
» https://www.camara.leg.br/busca-portal/proposicoes/pesquisa-simplificada - 25 Bem IP, Delduque MC, Silva JAÁ. Como pensam os parlamentares brasileiros sobre álcool, tabaco e drogas: Uma investigação no Congresso Nacional. Rev Portu Enferm Saude Mental 2016; 15(15):45-52.
-
26 Delmanto J. Camaradas caretas: drogas e esquerda no Brasil após 1961 [Internet]. 2013 [acessado 2023 jul 25]. Disponível em: http://www.teses.usp.br/teses/disponiveis/8/8138/tde-29052013-102255/.
» http://www.teses.usp.br/teses/disponiveis/8/8138/tde-29052013-102255 - 27 Melo LA, Santos AO. O uso do Canabidiol no Brasil e o posicionamento do Órgão Regulador. Cad Ibero Am Direito Sanitário 2016; 5(2):43-55.
- 28 Perini GB, Prochmann IR, Gonçalves LSSP. O cultivo de Cannabis sativa para fins medicinais terapêuticos e a impetração de habeas corpus preventivo. In: Alves SMC, Lemos ANLE. Direito Sanitário: Coletânea em homenagem à Profa. Dra. Maria Célia Delduque. Matrioska Editora; 2020.
- 29 Brasil. Câmara do Deputados. Projeto de Lei nº 1.485, de 20 de abril de 2021. Altera a Lei nº 11.343 de 23 de agosto de 2006, para autorizar a Empresa Brasileira de Pesquisa Agropecuária (Embrapa), vinculada ao Ministério da Agricultura, Pecuária e Abastecimento, e as universidades federais a implementarem o plantio, a cultura e a colheita, do vegetal denominado Cannabis sativa, exclusivamente para fins medicinais ou científicos. Diário Oficial da União; 2021.
- 30 Brasil. Câmara do Deputados. Projeto de Lei nº 7.270, de 19 de março de 2014. Regula a produção, a industrialização e a comercialização de Cannabis, derivados e produtos de Cannabis, dispõe sobre o Sistema Nacional de Políticas Públicas sobre Drogas, cria o Conselho Nacional de Assessoria, Pesquisa e Avaliação para as Políticas sobre Drogas, altera as leis nºs 11.343, de 23 de agosto de 2006, 8.072, de 25 de julho de 1990, e 9.294, de 15 de julho de 1999 e dá outras providências. Diário Oficial da União; 2014.
- 31 Brasil. Câmara do Deputados. Projeto de Lei nº 158, de 3 de fevereiro de 2015. Altera a Lei nº 11.343 de 23 de agosto de 2006, que institui o Sistema Nacional de Políticas Públicas sobre Drogas - Sisnad; prescreve medidas para prevenção do uso indevido, atenção e reinserção social de usuários e dependentes de drogas; estabelece normas para repressão à produção não autorizada e ao tráfico ilícito de drogas; define crimes e dá outras providências, para excluir a exigência de autorização judicial e da presença do Ministério Público, para considerar como droga ilícita a maconha, a cocaína, o crack e o ecstasy, não passíveis de liberação para o consumo. Diário Oficial da União; 2015.
- 32 Rocha JVPD. Maconha e preconceito: representações sociais de uma droga. Rev Textos Graduados 2016; 2(1):70-88.
- 33 Elias JSJ, Oliveira BMJF, Barbosa MNR. Anseios e devaneios: a memória social envolta ao progresso de legalização da maconha para fins medicinais no Brasil. Perspect Cien Inform 2020; 25(3):63-81.
- 34 Brasil. Câmara do Deputados. Projeto de Lei nº 573, de 24 de fevereiro de 2021. Dispõe sobre as condutas de adquirir, guardar, ter em depósito, transportar ou trazer consigo, para consumo pessoal CANNABIS SATIVUM, popularmente conhecida como "maconha", alterando a Lei nº 11.343, de 23 de agosto de 2006. Diário Oficial da União; 2021
-
35 Infarmed. Canábis Medicinal - Evolução da Atividade [Internet]. 2017 [acessado 2022 nov 18]. Disponível em: https://www.infarmed.pt/documents/15786/2893227/Can%C3%A1bis+Medicinal+-+Evolu%C3%A7%C3%A3o+da+atividade/96f794da-9c71-3928-1c73-b4224d74b58c
» https://www.infarmed.pt/documents/15786/2893227/Can%C3%A1bis+Medicinal+-+Evolu%C3%A7%C3%A3o+da+atividade/96f794da-9c71-3928-1c73-b4224d74b58c - 36 Tavares DH, Jardim VMR, Franchini B, Bionde HS, Rodrigues CGSS, Bazzan JS. Regulamentação do consumo de Cannabis no Uruguai e suas influências sobre a fronteira brasileira. SMAD 2021; 17(4):23-32.
-
37 Carneiro DA. Uso Medicinal de Cannabis Sativa [Internet]. 2018 [acessado 2022 nov 18]. Disponível em: http://repositorio.aee.edu.br/bitstream/aee/562/1/Monografia%20-%20Daniel%20Alves.pdf
» http://repositorio.aee.edu.br/bitstream/aee/562/1/Monografia%20-%20Daniel%20Alves.pdf - 38 Jesus ACJ, Fernandes LR, Elias PS, Souza ARG. Legalização da maconha para fins medicinais. Rev Curso Direito Centro Universitário Brazcubas 2017; 1(1):1-16.
- 39 Barbosa MGA, Barros ÉFA, Lima GR, Silva GF, Souza PGVD. O uso do composto de Canabidiol no tratamento da doença de Alzheimer (revisão da literatura). Res Soc Dev 2020; 9(8):e442986073.
- 40 Santos MJLS, Vasconcelos B. Breve histórico da recente regulamentação da Cannabis para fins medicinais e científicos no Brasil. Rev Advogado 2020; 96-104.
- 41 Souza MR, Henriques AT, Limberger RP. Medical cannabis regulation: an overview of models around the world with emphasis on the Brazilian scenario. J Cannabis Res 2022; 4(1):33.
- 42 Brasil. Câmara do Deputados. Projeto de Lei nº 10.549, de 10 de julho de 2018. Disciplina o controle, a fiscalização e a regulamentação do uso da "cannabis" e de seus derivados e dá outras providências. Diário Oficial da União; 2018.
-
43 Grinspoon L. History of cannabis as a medicine [Internet]. 2005 [cited 2024 jun 20]. Available from: http://maps.org/mmj/grinspoon_history_cannabis_medicine.pdf
» http://maps.org/mmj/grinspoon_history_cannabis_medicine.pdf - 44 Garcia JBS, Barbosa Neto JO. Efeitos adversos do uso dos canabinoides: qual o paradigma de segurança? BrJP 2023; 6(Supl. 1):S38-S43
- 45 Morais MV, Almeida M, Oliveira Junior JO. A eficácia e o poder analgésico dos canabinoides à luz dos dados atuais disponíveis. BrJP 2023; 6(Supl. 1):S12-S18.
- 46 Brasil. Câmara do Deputados. Projeto de Lei nº 4.565, de 20 de agosto de 2019. Atualiza a Lei n° 11.343, de 23 de agosto de 2006, e dá outras providências. Diário Oficial da União; 2019.
- 47 Brasil. Câmara do Deputados. Projeto de Lei nº 6.475, de 17 de dezembro de 2019. Altera a Lei nº 11.343 de 23 de agosto de 2006, para estabelecer percentual mínimo destinado aos agricultores familiares ou empreendedores familiares rurais que atendam ao disposto no art. 3º da Lei nº 11.326, de 24 de julho de 2006, em caso de autorização para o plantio, a cultura e a colheita, dos vegetais e substratos dos quais possam ser extraídas ou produzidas drogas. Diário Oficial da União; 2019.
- 48 Brasil. Câmara do Deputados. Projeto de Lei no 1.485, de 20 de abril de 2021. Altera a Lei nº 11.343 de 23 de agosto de 2006, para autorizar a Empresa Brasileira de Pesquisa Agropecuária (Embrapa), vinculada ao Ministério da Agricultura, Pecuária e Abastecimento, e as universidades federais a implementarem o plantio, a cultura e a colheita, do vegetal denominado Cannabis sativa, exclusivamente para fins medicinais ou científicos. Diário Oficial da União; 2021.
- 49 Gregorio LE, Mascarenhas NG. O uso medicinal da Cannabis sativa L.: regulamentação, desafios e perspectivas no Brasil. Concilium 2022; 22(3):191-212.
- 50 Oliveira MB, Vieira MS, Akerman M. Cannabis self-cultivation and social technology. Saude Soc 2020, 29(3):1-14.
- 51 Fankhauser M. History of cannabis in Western Medicine. New York: The Haworth Integrative Healing Press; 2002.
- 52 Kiepper A, Esher A. A regulação da maconha no Senado Federal: uma pauta da Saúde Pública no Brasil. Cad Saude Publica 2014; 30(8):1-3.
-
53 São Paulo. Lei Estadual 17.618, de 31 de janeiro de 2022. Institui a política estadual de fornecimento gratuito de medicamentos formulados de derivado vegetal à base de canabidiol, em associação com outras substâncias canabinóides, incluindo o tetrahidrocanabidiol, em caráter de excepcionalidade pelo Poder Executivo nas unidades de saúde pública estadual e privada conveniada ao Sistema Único de Saúde - SUS [Internet]. [acessado 2023 jul 25]. Disponível em: https://www.al.sp.gov.br/norma/206820
» https://www.al.sp.gov.br/norma/206820
The data sources adopted in the research are indicated in the article’s body.


Source: Authors, based on the findings.