Incorporation of non-registered medicines in the Brazilian Unified Health System (SUS): a study of the recommendations of the National Commission for Incorporation of Technologies, 2012–2016
Autor(a) principal: | |
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Data de Publicação: | 2018 |
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/1042 |
Resumo: | Introduction: Drug registration is an essential tool in assessing quality, safety and efficacy.In Brazil, the current regulatory framework prohibits the incorporation of any technology into the Brazilian Public Health System (SUS) without prior registration by the Brazilian regulatory authority, the National Health Surveillance Agency (Anvisa). The National Committee for Technology Incorporation (Conitec) advises the Ministry of Health on which health technologies should be incorporated. Objective: Conitec’s recommendations to incorporate non-registered medicines and their federal procurement between January 2012 and June 2016 were studied. Method: The study was based on the information from Conitec’s website and on purchases registered in the Integrated General Services Management System database. Results: Six of the 93 drugs incorporated by SUS during the period were not registered in the Brazilian Health Regulatory Agency (Anvisa). The main reasons for incorporation of non-registered medicines were severity of disease, minor adverse events, and low budgetary impact. In 50% of the cases, medicines were already present in the SUS for the approved indications, but in presentations that made it difficult for them to be used in pediatric patients or situations of greater severity. R$ 3,159,085.96 were spent on the purchase of these drugs. Conclusions: The recommendation of incorporation of medicines not registered by Anvisa contravenes the legislation related to Conitec and the public acquisition of medicines. On the other hand, it is important to highlight the importance of drug incorporations that meet relevant therapeutic gaps. |
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Incorporation of non-registered medicines in the Brazilian Unified Health System (SUS): a study of the recommendations of the National Commission for Incorporation of Technologies, 2012–2016Incorporação de medicamentos sem registro sanitário no SUS: um estudo das recomendações da Comissão Nacional de Incorporação de Tecnologias no período 2012–2016MedicamentosRegistro de MedicamentosAvaliação de Tecnologias em SaúdeTomada de DecisãoSistema Único de SaúdeMedicinesDrug RegistrationHealth Technology AssessmentDecision MakingBrazilian Unified Health SystemIntroduction: Drug registration is an essential tool in assessing quality, safety and efficacy.In Brazil, the current regulatory framework prohibits the incorporation of any technology into the Brazilian Public Health System (SUS) without prior registration by the Brazilian regulatory authority, the National Health Surveillance Agency (Anvisa). The National Committee for Technology Incorporation (Conitec) advises the Ministry of Health on which health technologies should be incorporated. Objective: Conitec’s recommendations to incorporate non-registered medicines and their federal procurement between January 2012 and June 2016 were studied. Method: The study was based on the information from Conitec’s website and on purchases registered in the Integrated General Services Management System database. Results: Six of the 93 drugs incorporated by SUS during the period were not registered in the Brazilian Health Regulatory Agency (Anvisa). The main reasons for incorporation of non-registered medicines were severity of disease, minor adverse events, and low budgetary impact. In 50% of the cases, medicines were already present in the SUS for the approved indications, but in presentations that made it difficult for them to be used in pediatric patients or situations of greater severity. R$ 3,159,085.96 were spent on the purchase of these drugs. Conclusions: The recommendation of incorporation of medicines not registered by Anvisa contravenes the legislation related to Conitec and the public acquisition of medicines. On the other hand, it is important to highlight the importance of drug incorporations that meet relevant therapeutic gaps.Introdução: O registro sanitário de medicamentos é instrumento essencial na avaliação da qualidade, segurança e eficácia. O marco regulatório vigente veda a incorporação de novas tecnologias sem registro no Sistema Único de Saúde (SUS), cabendo à Comissão Nacional de Incorporação de Tecnologias (Conitec) assessorar o Ministério da Saúde nessas decisões. Objetivo: Foram estudadas as recomendações de incorporação de medicamentos sem registro sanitário realizadas pela Comissão entre janeiro/2012 e junho/2016, e suas compras pelos órgãos federais nacionais. Método: Utilizaram-se informações presentes no website da Conitec e as compras registradas no SIASG. Resultados: Seis dos 93 medicamentos incorporados pelo SUS no período não possuíam registro na Agência Nacional de Vigilância Sanitária (Anvisa). Somente duas das decisões foram submetidas à consulta pública. As principais justificativas associadas às recomendações foram a gravidade da doença, presença de menores eventos adversos, e o baixo impacto orçamentário. Metade dos fármacos na situação estudada já se encontravam presentes no SUS, mas em apresentações que dificultavam seu uso pediátrico ou em situações de maior gravidade. Foram gastos R$ 3.159.085,96 com a compra desses medicamentos. Conclusões: A recomendação de incorporação de medicamentos não registrados pela Anvisa contraria a legislação relativa à Conitec e às aquisições públicas de medicamentos. Por outro lado, ressalta-se a importância da incorporação de medicamentos que atendem a relevantes lacunas terapêuticas.Instituto Nacional de Controle de Qualidade em Saúde2018-08-31info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersion"Editor de seção"application/pdfapplication/pdfhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/104210.22239/2317-269X.01042Health Surveillance under Debate: Society, Science & Technology ; Vol. 6 No. 3 (2018): Agosto; 12-21Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 6 Núm. 3 (2018): Agosto; 12-21Vigil Sanit Debate, Rio de Janeiro; v. 6 n. 3 (2018): Agosto; 12-212317-269Xreponame:Vigilância Sanitária em Debateinstname:Fundação Oswaldo Cruz (Fiocruz)instacron:FIOCRUZporenghttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1042/490https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1042/1108Copyright (c) 2018 Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnologia (Health Surveillance under Debate: Society, Science & Technology) – Visa em Debatehttps://creativecommons.org/licenses/by-nc-nd/4.0info:eu-repo/semantics/openAccessPedro, Érica MilitãoCaetano, RosângelaTeodoro, Cristiane Roberta dos SantosSteffen, Ricardo EwbankSilva, Rondineli Mendes2021-09-30T18:56:08Zoai:ojs.visaemdebate.incqs.fiocruz.br:article/1042Revistahttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebatePUBhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/oaiincqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br2317-269X2317-269Xopendoar:2021-09-30T18:56:08Vigilância Sanitária em Debate - Fundação Oswaldo Cruz (Fiocruz)false |
dc.title.none.fl_str_mv |
Incorporation of non-registered medicines in the Brazilian Unified Health System (SUS): a study of the recommendations of the National Commission for Incorporation of Technologies, 2012–2016 Incorporação de medicamentos sem registro sanitário no SUS: um estudo das recomendações da Comissão Nacional de Incorporação de Tecnologias no período 2012–2016 |
title |
Incorporation of non-registered medicines in the Brazilian Unified Health System (SUS): a study of the recommendations of the National Commission for Incorporation of Technologies, 2012–2016 |
spellingShingle |
Incorporation of non-registered medicines in the Brazilian Unified Health System (SUS): a study of the recommendations of the National Commission for Incorporation of Technologies, 2012–2016 Pedro, Érica Militão Medicamentos Registro de Medicamentos Avaliação de Tecnologias em Saúde Tomada de Decisão Sistema Único de Saúde Medicines Drug Registration Health Technology Assessment Decision Making Brazilian Unified Health System |
title_short |
Incorporation of non-registered medicines in the Brazilian Unified Health System (SUS): a study of the recommendations of the National Commission for Incorporation of Technologies, 2012–2016 |
title_full |
Incorporation of non-registered medicines in the Brazilian Unified Health System (SUS): a study of the recommendations of the National Commission for Incorporation of Technologies, 2012–2016 |
title_fullStr |
Incorporation of non-registered medicines in the Brazilian Unified Health System (SUS): a study of the recommendations of the National Commission for Incorporation of Technologies, 2012–2016 |
title_full_unstemmed |
Incorporation of non-registered medicines in the Brazilian Unified Health System (SUS): a study of the recommendations of the National Commission for Incorporation of Technologies, 2012–2016 |
title_sort |
Incorporation of non-registered medicines in the Brazilian Unified Health System (SUS): a study of the recommendations of the National Commission for Incorporation of Technologies, 2012–2016 |
author |
Pedro, Érica Militão |
author_facet |
Pedro, Érica Militão Caetano, Rosângela Teodoro, Cristiane Roberta dos Santos Steffen, Ricardo Ewbank Silva, Rondineli Mendes |
author_role |
author |
author2 |
Caetano, Rosângela Teodoro, Cristiane Roberta dos Santos Steffen, Ricardo Ewbank Silva, Rondineli Mendes |
author2_role |
author author author author |
dc.contributor.author.fl_str_mv |
Pedro, Érica Militão Caetano, Rosângela Teodoro, Cristiane Roberta dos Santos Steffen, Ricardo Ewbank Silva, Rondineli Mendes |
dc.subject.por.fl_str_mv |
Medicamentos Registro de Medicamentos Avaliação de Tecnologias em Saúde Tomada de Decisão Sistema Único de Saúde Medicines Drug Registration Health Technology Assessment Decision Making Brazilian Unified Health System |
topic |
Medicamentos Registro de Medicamentos Avaliação de Tecnologias em Saúde Tomada de Decisão Sistema Único de Saúde Medicines Drug Registration Health Technology Assessment Decision Making Brazilian Unified Health System |
description |
Introduction: Drug registration is an essential tool in assessing quality, safety and efficacy.In Brazil, the current regulatory framework prohibits the incorporation of any technology into the Brazilian Public Health System (SUS) without prior registration by the Brazilian regulatory authority, the National Health Surveillance Agency (Anvisa). The National Committee for Technology Incorporation (Conitec) advises the Ministry of Health on which health technologies should be incorporated. Objective: Conitec’s recommendations to incorporate non-registered medicines and their federal procurement between January 2012 and June 2016 were studied. Method: The study was based on the information from Conitec’s website and on purchases registered in the Integrated General Services Management System database. Results: Six of the 93 drugs incorporated by SUS during the period were not registered in the Brazilian Health Regulatory Agency (Anvisa). The main reasons for incorporation of non-registered medicines were severity of disease, minor adverse events, and low budgetary impact. In 50% of the cases, medicines were already present in the SUS for the approved indications, but in presentations that made it difficult for them to be used in pediatric patients or situations of greater severity. R$ 3,159,085.96 were spent on the purchase of these drugs. Conclusions: The recommendation of incorporation of medicines not registered by Anvisa contravenes the legislation related to Conitec and the public acquisition of medicines. On the other hand, it is important to highlight the importance of drug incorporations that meet relevant therapeutic gaps. |
publishDate |
2018 |
dc.date.none.fl_str_mv |
2018-08-31 |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion "Editor de seção" |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1042 10.22239/2317-269X.01042 |
url |
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1042 |
identifier_str_mv |
10.22239/2317-269X.01042 |
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/1042/490 https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1042/1108 |
dc.rights.driver.fl_str_mv |
https://creativecommons.org/licenses/by-nc-nd/4.0 info:eu-repo/semantics/openAccess |
rights_invalid_str_mv |
https://creativecommons.org/licenses/by-nc-nd/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. 6 No. 3 (2018): Agosto; 12-21 Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 6 Núm. 3 (2018): Agosto; 12-21 Vigil Sanit Debate, Rio de Janeiro; v. 6 n. 3 (2018): Agosto; 12-21 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 |
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1797042047456116736 |