Judicialization of cannabidiol-based products in Brazil: an analysis from 2019 to 2022

Detalhes bibliográficos
Autor(a) principal: Portela, Ronaldo
Data de Publicação: 2023
Outros Autores: Marques Mota, Daniel, José Gonçalves Ferreira, Paulo, Dias Lula, Mariana, Barcala Reis, Bruno, Nunes de Oliveira, Helian, Mariano Ruas, Cristina
Tipo de documento: Artigo
Idioma: por
Título da fonte: Cadernos de Saúde Pública
Texto Completo: https://cadernos.ensp.fiocruz.br/ojs/index.php/csp/article/view/8353
Resumo: The study analyzed the lawsuits of patients who requested cannabidiol (CBD)-based products from the Brazilian Unified National Health System during the period from 2019 to 2022, describing sociodemographic, clinical, and legal characteristics. This is a cross-sectional study composed of the evaluation of the technical notes issued by the Center for Technical Support of the Judiciary (NatJus), which supports judicial decisions. The data were obtained from the e-NatJus system, of the Brazilian Ministry of Justice, using web scraping techniques. Logistic regression was used to estimate odds ratios with 95% confidence intervals. We analyzed 1,115 technical notes of the CBD plaintiffs, of which 54.7% of the male patients, with a mean age of 18.4 years, mostly from the South Region of the country (38.8%), and 49.6% sought treatment for epilepsy. Regarding the actions with favorable opinions, 28.8% had no scientific evidence, 26.5% pleaded for products without registration with the Brazilian Health Regulatory Agency, and 25.3% of those that had registration were not in compliance with the therapeutic indication. Patients from the Northeast Region had a chance of a favorable opinion increased by 3.0 times and those diagnosed with epilepsy by 2.3. The expert opinions that supported the magistrates for the judicial decisions regarding the demands of patients for cannabidiol-based products in Brazil were mostly in accordance with scientific evidence, denoting the importance of NatJus in the qualification of access to medicinal products in the country.
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spelling Judicialization of cannabidiol-based products in Brazil: an analysis from 2019 to 2022Judicialización de productos a base de cannabidiol en Brasil: un análisis de 2019 a 2022Judicialização de produtos à base de canabidiol no Brasil: uma análise de 2019 a 2022Canabidiol; Cannabis; Judicialização da Saúde; Avaliação de Tecnologias em SaúdeCannabidiol; Cannabis; Judicialización de la Salud; Evaluación de la Tecnología BiomédicaCannabidiol; Cannabis; Health’s Judicialization; Biomedical Technology AssessmentThe study analyzed the lawsuits of patients who requested cannabidiol (CBD)-based products from the Brazilian Unified National Health System during the period from 2019 to 2022, describing sociodemographic, clinical, and legal characteristics. This is a cross-sectional study composed of the evaluation of the technical notes issued by the Center for Technical Support of the Judiciary (NatJus), which supports judicial decisions. The data were obtained from the e-NatJus system, of the Brazilian Ministry of Justice, using web scraping techniques. Logistic regression was used to estimate odds ratios with 95% confidence intervals. We analyzed 1,115 technical notes of the CBD plaintiffs, of which 54.7% of the male patients, with a mean age of 18.4 years, mostly from the South Region of the country (38.8%), and 49.6% sought treatment for epilepsy. Regarding the actions with favorable opinions, 28.8% had no scientific evidence, 26.5% pleaded for products without registration with the Brazilian Health Regulatory Agency, and 25.3% of those that had registration were not in compliance with the therapeutic indication. Patients from the Northeast Region had a chance of a favorable opinion increased by 3.0 times and those diagnosed with epilepsy by 2.3. The expert opinions that supported the magistrates for the judicial decisions regarding the demands of patients for cannabidiol-based products in Brazil were mostly in accordance with scientific evidence, denoting the importance of NatJus in the qualification of access to medicinal products in the country.El estudio analizó las acciones legales de pacientes que solicitaron al Sistema Único de Salud brasileño productos a base de cannabidiol (CBD) durante el período de 2019 a 2022, describiendo características sociodemográficas, clínicas y legales. Se trata de un estudio transversal compuesto por la evaluación de las notas técnicas emitidas por los Núcleos de Apoyo Técnico del Poder Judicial (NatJus) que basaron las decisiones judiciales. Los datos se obtuvieron del sistema e-NatJus, del Ministerio de Justicia brasileño, mediante técnicas de web scraping. La regresión logística se empleó para estimar los odds ratios con intervalos del 95% de confianza. Fueron analizadas 1.115 notas técnicas de las acciones demandantes de CBD que tenían 54,7 % de los pacientes del género masculino, con una edad media de 18,4 años, en su mayoría de la Región Sur del país (38,8%) y 49,6% buscaban tratamiento para la epilepsia. De las acciones con opiniones favorables, el 28,8% no tenían evidencias científicas, el 26,5% pleitearon productos sin registro en la Agencia Nacional de Vigilancia Sanitaria y el 25,3% de los que tenían registro, no estaban en conformidad con la indicación terapéutica. Los pacientes de la Región Nordeste tuvieron la posibilidad de opiniones favorables aumentada en 3,0 veces y los que tenían diagnóstico de epilepsia en 2,3. Los dictámenes técnicos que dieron apoyo a los magistrados para las decisiones judiciales de las demandas de los pacientes por productos a base de cannabidiol en Brasil estaban en su mayoría en conformidad con las evidencias científicas, denotando la importancia de NatJus en la calificación del acceso a productos medicinales en el país.Este estudo analisou as ações judiciais de pacientes que solicitaram ao Sistema Único de Saúde produtos à base de canabidiol (CBD) durante o período de 2019 a 2022, descrevendo características sociodemográficas, clínicas e jurídicas. Trata-se de um estudo transversal composto pela avaliação das notas técnicas emitidas pelos Núcleos de Apoio Técnico do Judiciário (NatJus), que embasaram as decisões judiciais. Os dados foram obtidos do sistema e-NatJus, do Ministério da Justiça, utilizando técnicas de web scraping. Regressão logística foi empregada para estimar razões de chances com intervalos de 95% de confiança. Foram analisadas 1.115 notas técnicas das ações demandantes de CBD, das quais 54,7% dos pacientes eram do sexo masculino, com idade média de 18,4 anos, em sua maioria da Região Sul do país (38,8%), e 49,6% buscavam tratamento para epilepsia. Das ações com pareceres favoráveis, 28,8% não tinham evidências científicas, 26,5% pleitearam produtos sem registro na Agência Nacional de Vigilância Sanitária e 25,3% dos que tinham registro não estavam em conformidade com a indicação terapêutica. Os pacientes da Região Nordeste tiveram a chance de parecer favorável aumentada em 3 vezes; e os que tinham diagnóstico de epilepsia, em 2,3 vezes. Os pareceres técnicos que deram suporte aos magistrados para as decisões judiciais das demandas de pacientes por produtos à base de canabidiol no Brasil estavam, em sua maioria, em conformidade com evidências científicas, denotando a importância dos NatJus na qualificação do acesso a produtos medicinais no país.Reports in Public HealthCadernos de Saúde Pública2023-08-25info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersiontext/xmlapplication/pdfhttps://cadernos.ensp.fiocruz.br/ojs/index.php/csp/article/view/8353Reports in Public Health; Vol. 39 No. 8 (2023): AugustCadernos de Saúde Pública; v. 39 n. 8 (2023): Agosto1678-44640102-311Xreponame:Cadernos de Saúde Públicainstname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZporhttps://cadernos.ensp.fiocruz.br/ojs/index.php/csp/article/view/8353/18647https://cadernos.ensp.fiocruz.br/ojs/index.php/csp/article/view/8353/18648Copyright (c) 2023 Cadernos de Saúde Públicainfo:eu-repo/semantics/openAccessPortela, RonaldoMarques Mota, DanielJosé Gonçalves Ferreira, PauloDias Lula, MarianaBarcala Reis, BrunoNunes de Oliveira, HelianMariano Ruas, Cristina2023-08-25T13:23:22Zoai:ojs.teste-cadernos.ensp.fiocruz.br:article/8353Revistahttps://cadernos.ensp.fiocruz.br/ojs/index.php/csphttps://cadernos.ensp.fiocruz.br/ojs/index.php/csp/oaicadernos@ensp.fiocruz.br||cadernos@ensp.fiocruz.br1678-44640102-311Xopendoar:2024-03-06T13:09:32.242188Cadernos de Saúde Pública - Fundação Oswaldo Cruz (FIOCRUZ)true
dc.title.none.fl_str_mv Judicialization of cannabidiol-based products in Brazil: an analysis from 2019 to 2022
Judicialización de productos a base de cannabidiol en Brasil: un análisis de 2019 a 2022
Judicialização de produtos à base de canabidiol no Brasil: uma análise de 2019 a 2022
title Judicialization of cannabidiol-based products in Brazil: an analysis from 2019 to 2022
spellingShingle Judicialization of cannabidiol-based products in Brazil: an analysis from 2019 to 2022
Portela, Ronaldo
Canabidiol; Cannabis; Judicialização da Saúde; Avaliação de Tecnologias em Saúde
Cannabidiol; Cannabis; Judicialización de la Salud; Evaluación de la Tecnología Biomédica
Cannabidiol; Cannabis; Health’s Judicialization; Biomedical Technology Assessment
title_short Judicialization of cannabidiol-based products in Brazil: an analysis from 2019 to 2022
title_full Judicialization of cannabidiol-based products in Brazil: an analysis from 2019 to 2022
title_fullStr Judicialization of cannabidiol-based products in Brazil: an analysis from 2019 to 2022
title_full_unstemmed Judicialization of cannabidiol-based products in Brazil: an analysis from 2019 to 2022
title_sort Judicialization of cannabidiol-based products in Brazil: an analysis from 2019 to 2022
author Portela, Ronaldo
author_facet Portela, Ronaldo
Marques Mota, Daniel
José Gonçalves Ferreira, Paulo
Dias Lula, Mariana
Barcala Reis, Bruno
Nunes de Oliveira, Helian
Mariano Ruas, Cristina
author_role author
author2 Marques Mota, Daniel
José Gonçalves Ferreira, Paulo
Dias Lula, Mariana
Barcala Reis, Bruno
Nunes de Oliveira, Helian
Mariano Ruas, Cristina
author2_role author
author
author
author
author
author
dc.contributor.author.fl_str_mv Portela, Ronaldo
Marques Mota, Daniel
José Gonçalves Ferreira, Paulo
Dias Lula, Mariana
Barcala Reis, Bruno
Nunes de Oliveira, Helian
Mariano Ruas, Cristina
dc.subject.por.fl_str_mv Canabidiol; Cannabis; Judicialização da Saúde; Avaliação de Tecnologias em Saúde
Cannabidiol; Cannabis; Judicialización de la Salud; Evaluación de la Tecnología Biomédica
Cannabidiol; Cannabis; Health’s Judicialization; Biomedical Technology Assessment
topic Canabidiol; Cannabis; Judicialização da Saúde; Avaliação de Tecnologias em Saúde
Cannabidiol; Cannabis; Judicialización de la Salud; Evaluación de la Tecnología Biomédica
Cannabidiol; Cannabis; Health’s Judicialization; Biomedical Technology Assessment
description The study analyzed the lawsuits of patients who requested cannabidiol (CBD)-based products from the Brazilian Unified National Health System during the period from 2019 to 2022, describing sociodemographic, clinical, and legal characteristics. This is a cross-sectional study composed of the evaluation of the technical notes issued by the Center for Technical Support of the Judiciary (NatJus), which supports judicial decisions. The data were obtained from the e-NatJus system, of the Brazilian Ministry of Justice, using web scraping techniques. Logistic regression was used to estimate odds ratios with 95% confidence intervals. We analyzed 1,115 technical notes of the CBD plaintiffs, of which 54.7% of the male patients, with a mean age of 18.4 years, mostly from the South Region of the country (38.8%), and 49.6% sought treatment for epilepsy. Regarding the actions with favorable opinions, 28.8% had no scientific evidence, 26.5% pleaded for products without registration with the Brazilian Health Regulatory Agency, and 25.3% of those that had registration were not in compliance with the therapeutic indication. Patients from the Northeast Region had a chance of a favorable opinion increased by 3.0 times and those diagnosed with epilepsy by 2.3. The expert opinions that supported the magistrates for the judicial decisions regarding the demands of patients for cannabidiol-based products in Brazil were mostly in accordance with scientific evidence, denoting the importance of NatJus in the qualification of access to medicinal products in the country.
publishDate 2023
dc.date.none.fl_str_mv 2023-08-25
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dc.rights.driver.fl_str_mv Copyright (c) 2023 Cadernos de Saúde Pública
info:eu-repo/semantics/openAccess
rights_invalid_str_mv Copyright (c) 2023 Cadernos de Saúde Pública
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dc.publisher.none.fl_str_mv Reports in Public Health
Cadernos de Saúde Pública
publisher.none.fl_str_mv Reports in Public Health
Cadernos de Saúde Pública
dc.source.none.fl_str_mv Reports in Public Health; Vol. 39 No. 8 (2023): August
Cadernos de Saúde Pública; v. 39 n. 8 (2023): Agosto
1678-4464
0102-311X
reponame:Cadernos de Saúde Pública
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reponame_str Cadernos de Saúde Pública
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