Policy analysis on the regulation of the medicinal use of products derived from Cannabis spp. in Brazil (2014-2021)
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Data de Publicação: | 2022 |
Outros Autores: | , , , , , |
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. |
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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 |
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Fundação Oswaldo Cruz (FIOCRUZ) |
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FIOCRUZ |
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FIOCRUZ |
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Vigilância Sanitária em Debate |
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Vigilância Sanitária em Debate |
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Vigilância Sanitária em Debate - Fundação Oswaldo Cruz (FIOCRUZ) |
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incqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br |
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