Policy analysis on the regulation of the medicinal use of products derived from Cannabis spp. in Brazil (2014-2021)

Detalhes bibliográficos
Autor(a) principal: Araujo, Patricia Sodré
Data de Publicação: 2022
Outros Autores: Costa, Ediná Alves, Sandes, Carla Freitas Benamor, Cruz, Emylle Cardoso Dias da, Rocha, Juliana Santos, Soares, Laíse Caroline Costa, Pereira, Marcelo Tavares
Tipo de documento: Artigo
Idioma: por
eng
Título da fonte: Vigilância Sanitária em Debate
Texto Completo: https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2043
Resumo: Introduction: The medicinal use of Cannabis derivatives divides opinions in civil society. However, for many patients who need treatment, the regulation of the importation and use of these products represents hope and quality of life. Objective: To identify the main facts and positions related to the regulation of medicinal products based on Cannabis from 2014 to 2021 by Anvisa, the Ministry of Health, the Chamber of Deputies and the Federal Councils of Pharmacy and Medicine. Method: This is a case study resulting from the analysis of the facts and positions identified by different actors, selected considering a time frame from 2014 to 2021. The production of data included sources from the Thematic Axis database Medicines, Blood, Pharmaceutical Assistance and Health Surveillance Policies, developed in partnership with researchers from the State University of Bahia, which is part of the Observatory of Policy Analysis in Health of the Collective Health Institute of the Federal University of Bahia. Results: Several countries, such as Argentina, Mexico, Thailand, Canada, Israel, and several states in the USA, have changed their legislation so that it is possible to expand the use of Cannabis-based drugs. In Brazil however, this is a long process, which involves several divergences and positions of different political actors. Conclusions: The topic is relevant; discussions and debates allow society to be informed about how the government is conducting the regulation to allow the production of Cannabis-based medicines as a therapeutic alternative for conditions that do not yet have drug therapies.
id FIOCRUZ-9_930d368430ba706f99a923894ba726ef
oai_identifier_str oai:ojs.visaemdebate.incqs.fiocruz.br:article/2043
network_acronym_str FIOCRUZ-9
network_name_str Vigilância Sanitária em Debate
repository_id_str
spelling Policy analysis on the regulation of the medicinal use of products derived from Cannabis spp. in Brazil (2014-2021)Análisis de políticas sobre la regulación del uso medicinal de productos derivados de Cannabis Spp. en Brasil Análise política sobre a regulamentação do uso medicinal dos produtos derivados da Cannabis spp. no Brasil (2014-2021)Maconha MedicinalRegulação GovernamentalVigilância SanitáriaMedicamentosregulação economicaregulação de medicamentosMedical MarijuanaGovernment RegulationHealth SurveillanceMarihuana MedicinalRegulación GubernamentalVigilancia SanitariaIntroduction: The medicinal use of Cannabis derivatives divides opinions in civil society. However, for many patients who need treatment, the regulation of the importation and use of these products represents hope and quality of life. Objective: To identify the main facts and positions related to the regulation of medicinal products based on Cannabis from 2014 to 2021 by Anvisa, the Ministry of Health, the Chamber of Deputies and the Federal Councils of Pharmacy and Medicine. Method: This is a case study resulting from the analysis of the facts and positions identified by different actors, selected considering a time frame from 2014 to 2021. The production of data included sources from the Thematic Axis database Medicines, Blood, Pharmaceutical Assistance and Health Surveillance Policies, developed in partnership with researchers from the State University of Bahia, which is part of the Observatory of Policy Analysis in Health of the Collective Health Institute of the Federal University of Bahia. Results: Several countries, such as Argentina, Mexico, Thailand, Canada, Israel, and several states in the USA, have changed their legislation so that it is possible to expand the use of Cannabis-based drugs. In Brazil however, this is a long process, which involves several divergences and positions of different political actors. Conclusions: The topic is relevant; discussions and debates allow society to be informed about how the government is conducting the regulation to allow the production of Cannabis-based medicines as a therapeutic alternative for conditions that do not yet have drug therapies.INTRODUCCIÓN: El uso medicinal de los derivados del cannabis divide opiniones en la sociedad civil. Sin embargo, para muchos pacientes que necesitan tratamiento, la regulación de la importación y uso de estos productos representa esperanza y calidad de vida. OBJETIVO: Identificar los principales hechos y posiciones relacionados con la regulación de medicamentos a base de Cannabis de 2014 a 2021 por la Anvisa, el Ministerio de Salud, la Cámara de Diputados y los Consejos Federales de Farmacia y Medicina. MATERIALES Y MÉTODO: Se trata de una investigación cualitativa del tipo estudio de caso resultante del análisis de los hechos y posiciones identificados por los diferentes actores seleccionados considerando el marco temporal de 2014 a 2021. La producción de datos contó con fuentes de la base de datos del Eje Temático Medicamentos , Sangre, Asistencia Farmacéutica y Políticas de Vigilancia en Salud, desarrollado en colaboración con investigadores de la Universidad del Estado de Bahía. RESULTADOS: Varios países, como Argentina, México, Tailandia, Canadá, Israel y varios estados de los EE. UU., han cambiado su legislación para que sea posible expandir el uso de drogas a base de cannabis. En Brasil, sin embargo, este es un proceso largo, que involucra varias divergencias y posiciones de diferentes actores políticos. CONSIDERACIONES FINALES: El tema es relevante, las discusiones y debates permiten informar a la sociedad sobre cómo el gobierno está conduciendo la regulación para permitir la producción de medicamentos a base de cannabis como alternativa terapéutica para padecimientos que aún no cuentan con terapias farmacológicas.Introdução: O uso medicinal dos derivados da Cannabis divide opiniões na sociedade civil. Entretanto, para muitos pacientes que necessitam do tratamento, a regulamentação da importação e o uso desses produtos representam esperança e qualidade de vida. Objetivo: Identificar os principais fatos e posicionamentos   relacionados à regulamentação dos produtos medicinais à base de Cannabis no período de 2014 a 2021 por parte da Anvisa, do Ministério da Saúde, da Câmara dos Deputados e Conselhos Federais de Farmácia e de Medicina. Método: Trata-se de uma pesquisa qualitativa do tipo estudo de caso, resultado das análises dos fatos e posicionamentos identificados pelos distintos atores selecionados, considerando o recorte temporal de 2014 a 2021. A produção de dados incluiu fontes do banco de dados do eixo temático Políticas de Medicamentos, Sangue, Assistência Farmacêutica e Vigilância Sanitária, desenvolvido em parceria com pesquisadores da Universidade do Estado da Bahia. O eixo integra o Observatório de Análise Política em Saúde do Instituto de Saúde Coletiva da Universidade Federal da Bahia. Resultados: Vários países como Argentina, México, Tailândia, Canadá, Israel e diversos estados dos EUA têm alterado sua legislação para que seja possível ampliar o uso de medicamentos à base de Cannabis. No Brasil, no entanto, este é um processo longo, que envolve várias divergências e posicionamentos de diferentes atores políticos. Conclusões: O tema se mostra relevante, discussões e debates permitem que a sociedade seja informada sobre como o governo está conduzindo a regulamentação para permitir a produção de medicamentos à base de Cannabis como uma alternativa terapêutica para condições que ainda não contam com terapêuticas medicamentosas.Instituto Nacional de Controle de Qualidade em Saúde2022-11-30info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersion"Peer-reviewed article""Artículo revisado por pares""Artigo avaliado pelos pares"application/pdfapplication/pdfhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/204310.22239/2317-269x.02043Health Surveillance under Debate: Society, Science & Technology ; Vol. 10 No. 4 (2022): November - Commemorative Edition: 10 Years of Visa in Debate; 69-78Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 10 Núm. 4 (2022): Noviembre - Edición Conmemorativa: 10 Años de Visa en Debate; 69-78Vigil Sanit Debate, Rio de Janeiro; v. 10 n. 4 (2022): Novembro - Edição comemorativa: 10 anos da Visa em Debate; 69-782317-269Xreponame:Vigilância Sanitária em Debateinstname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZporenghttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2043/1468https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2043/1504Copyright (c) 2022 Patricia Sodré Araujo, Ediná Alves Costa, Carla Freitas Benamor Sandes, Emylle Cardoso Dias da Cruz, Juliana Santos Rocha, Laíse Caroline Costa Soares, Marcelo Tavares Pereira (Autor)https://creativecommons.org/licenses/by/4.0info:eu-repo/semantics/openAccessAraujo, Patricia SodréCosta, Ediná AlvesSandes, Carla Freitas BenamorCruz, Emylle Cardoso Dias daRocha, Juliana SantosSoares, Laíse Caroline CostaPereira, Marcelo Tavares2023-12-14T14:32:21Zoai:ojs.visaemdebate.incqs.fiocruz.br:article/2043Revistahttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebatePUBhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/oaiincqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br2317-269X2317-269Xopendoar:2023-12-14T14:32:21Vigilância Sanitária em Debate - Fundação Oswaldo Cruz (FIOCRUZ)false
dc.title.none.fl_str_mv Policy analysis on the regulation of the medicinal use of products derived from Cannabis spp. in Brazil (2014-2021)
Análisis de políticas sobre la regulación del uso medicinal de productos derivados de Cannabis Spp. en Brasil
Análise política sobre a regulamentação do uso medicinal dos produtos derivados da Cannabis spp. no Brasil (2014-2021)
title Policy analysis on the regulation of the medicinal use of products derived from Cannabis spp. in Brazil (2014-2021)
spellingShingle Policy analysis on the regulation of the medicinal use of products derived from Cannabis spp. in Brazil (2014-2021)
Araujo, Patricia Sodré
Maconha Medicinal
Regulação Governamental
Vigilância Sanitária
Medicamentos
regulação economica
regulação de medicamentos
Medical Marijuana
Government Regulation
Health Surveillance
Marihuana Medicinal
Regulación Gubernamental
Vigilancia Sanitaria
title_short Policy analysis on the regulation of the medicinal use of products derived from Cannabis spp. in Brazil (2014-2021)
title_full Policy analysis on the regulation of the medicinal use of products derived from Cannabis spp. in Brazil (2014-2021)
title_fullStr Policy analysis on the regulation of the medicinal use of products derived from Cannabis spp. in Brazil (2014-2021)
title_full_unstemmed Policy analysis on the regulation of the medicinal use of products derived from Cannabis spp. in Brazil (2014-2021)
title_sort Policy analysis on the regulation of the medicinal use of products derived from Cannabis spp. in Brazil (2014-2021)
author Araujo, Patricia Sodré
author_facet Araujo, Patricia Sodré
Costa, Ediná Alves
Sandes, Carla Freitas Benamor
Cruz, Emylle Cardoso Dias da
Rocha, Juliana Santos
Soares, Laíse Caroline Costa
Pereira, Marcelo Tavares
author_role author
author2 Costa, Ediná Alves
Sandes, Carla Freitas Benamor
Cruz, Emylle Cardoso Dias da
Rocha, Juliana Santos
Soares, Laíse Caroline Costa
Pereira, Marcelo Tavares
author2_role author
author
author
author
author
author
dc.contributor.author.fl_str_mv Araujo, Patricia Sodré
Costa, Ediná Alves
Sandes, Carla Freitas Benamor
Cruz, Emylle Cardoso Dias da
Rocha, Juliana Santos
Soares, Laíse Caroline Costa
Pereira, Marcelo Tavares
dc.subject.por.fl_str_mv Maconha Medicinal
Regulação Governamental
Vigilância Sanitária
Medicamentos
regulação economica
regulação de medicamentos
Medical Marijuana
Government Regulation
Health Surveillance
Marihuana Medicinal
Regulación Gubernamental
Vigilancia Sanitaria
topic Maconha Medicinal
Regulação Governamental
Vigilância Sanitária
Medicamentos
regulação economica
regulação de medicamentos
Medical Marijuana
Government Regulation
Health Surveillance
Marihuana Medicinal
Regulación Gubernamental
Vigilancia Sanitaria
description Introduction: The medicinal use of Cannabis derivatives divides opinions in civil society. However, for many patients who need treatment, the regulation of the importation and use of these products represents hope and quality of life. Objective: To identify the main facts and positions related to the regulation of medicinal products based on Cannabis from 2014 to 2021 by Anvisa, the Ministry of Health, the Chamber of Deputies and the Federal Councils of Pharmacy and Medicine. Method: This is a case study resulting from the analysis of the facts and positions identified by different actors, selected considering a time frame from 2014 to 2021. The production of data included sources from the Thematic Axis database Medicines, Blood, Pharmaceutical Assistance and Health Surveillance Policies, developed in partnership with researchers from the State University of Bahia, which is part of the Observatory of Policy Analysis in Health of the Collective Health Institute of the Federal University of Bahia. Results: Several countries, such as Argentina, Mexico, Thailand, Canada, Israel, and several states in the USA, have changed their legislation so that it is possible to expand the use of Cannabis-based drugs. In Brazil however, this is a long process, which involves several divergences and positions of different political actors. Conclusions: The topic is relevant; discussions and debates allow society to be informed about how the government is conducting the regulation to allow the production of Cannabis-based medicines as a therapeutic alternative for conditions that do not yet have drug therapies.
publishDate 2022
dc.date.none.fl_str_mv 2022-11-30
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
"Peer-reviewed article"
"Artículo revisado por pares"
"Artigo avaliado pelos pares"
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2043
10.22239/2317-269x.02043
url https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2043
identifier_str_mv 10.22239/2317-269x.02043
dc.language.iso.fl_str_mv por
eng
language por
eng
dc.relation.none.fl_str_mv https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2043/1468
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2043/1504
dc.rights.driver.fl_str_mv https://creativecommons.org/licenses/by/4.0
info:eu-repo/semantics/openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by/4.0
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv Instituto Nacional de Controle de Qualidade em Saúde
publisher.none.fl_str_mv Instituto Nacional de Controle de Qualidade em Saúde
dc.source.none.fl_str_mv Health Surveillance under Debate: Society, Science & Technology ; Vol. 10 No. 4 (2022): November - Commemorative Edition: 10 Years of Visa in Debate; 69-78
Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 10 Núm. 4 (2022): Noviembre - Edición Conmemorativa: 10 Años de Visa en Debate; 69-78
Vigil Sanit Debate, Rio de Janeiro; v. 10 n. 4 (2022): Novembro - Edição comemorativa: 10 anos da Visa em Debate; 69-78
2317-269X
reponame:Vigilância Sanitária em Debate
instname:Fundação Oswaldo Cruz (FIOCRUZ)
instacron:FIOCRUZ
instname_str Fundação Oswaldo Cruz (FIOCRUZ)
instacron_str FIOCRUZ
institution FIOCRUZ
reponame_str Vigilância Sanitária em Debate
collection Vigilância Sanitária em Debate
repository.name.fl_str_mv Vigilância Sanitária em Debate - Fundação Oswaldo Cruz (FIOCRUZ)
repository.mail.fl_str_mv incqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br
_version_ 1797042046662344704