Incorporação de medicamentos sem registro sanitário no SUS: um estudo das recomendações da Comissão Nacional de Incorporação de Tecnologias no período 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
Data
2018
Autores
Pedro, Érica Militão
Caetano, Rosângela
Teodoro, Cristiane Roberta dos Santos
Steffen, Ricardo Ewbank
Silva, Rondineli Mendes
Journal Title
Journal ISSN
Volume Title
Publisher
Vigilância Sanitária Em Debate
Resumo
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.
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.
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.
Description
Palavras-chave
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
Citação
Pedro Em, Caetano R, Teodoro CRS, Steffen RE, Silva RM. Incorporação de medicamentos sem registro sanitário no SUS: um estudo das recomendações da Comissão Nacional de Incorporação de Tecnologias no período 2012–2016 [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]. Vigil. sanit. debate. 2018 ago;6(3):12-21. doi: 10.22239/2317-269X.01042.