Sistema Nacional de Controle de Medicamentos (SNCM): seria uma oportunidade para reduzir a falsificação de medicamentos no Brasil?
Data
2024-08-23
Autores
Gonçalves, Nataly dos Santos 
Orientadores
Ferraz, Helena Onishi
Tipo
Trabalho de conclusão de curso
Título da Revista
ISSN da Revista
Título de Volume
Resumo
A Lei nº 11.903, de 14 de janeiro de 2009 instituiu o Sistema Nacional de Controle de Medicamentos (SNCM) que é um sistema de rastreabilidade de medicamentos com a implementação do mecanismo digital e números de série (serialização nas embalagens do medicamento), gerido e supervisionado pela Agência Nacional de Vigilância Sanitária (ANVISA). A finalidade deste Sistema é monitorar o trajeto dos medicamentos em todas as etapas da sua produção, desde a fabricação até o seu uso pela população, com o propósito também de combater a disseminação de remédios falsificados em território nacional. No entanto, a recente Lei nº 14.338/2022, que dispõe sobre a bula digital de medicamentos, alterou a Lei nº 11.903/2009, modificando o modelo de rastreabilidade de medicamentos, com a consequente revogação da necessidade de serialização de medicamentos no Brasil. Sendo assim, este trabalho teve como objetivo abordar a importância do SNCM no combate à falsificação de medicamentos no Brasil e a suspensão deste sistema pela Lei nº 14.338/2022, que resultou em desperdício de recursos e comprometeu o controle sanitário, destacando a necessidade de integrar a inovação da bula digital ao SNCM sem enfraquecer os mecanismos de rastreabilidade. Também é importante ressaltar a necessidade do compromisso constante das autoridades governamentais e a colaboração de todos os envolvidos na cadeia de produção e distribuição de medicamentos, pois somente com esforços conjuntos, o SNCM e a bula digital poderão cumprir seu objetivo de proteger e inovar a saúde publica brasileira.
Law No. 11,903, of January 14, 2009, established the National System for Medication Control (SNCM), which is a drug traceability system involving the implementation of digital mechanisms and serial numbers (serialization on medication packaging), managed and supervised by the National Health Surveillance Agency (ANVISA). The purpose of this system is to monitor the journey of medications through all stages of their production, from manufacturing to use by the population, with the aim of combating the spread of counterfeit drugs in the national territory. However, the recent Law No. 14,338/2022, which addresses the digital package insert of medications, amended Law No. 11,903/2009, changing the drug traceability model and consequently revoking the need for drug serialization in Brazil. Thus, this work aimed to address the importance of SNCM in combating drug counterfeiting in Brazil and its suspension by Law No. 14,338/2022, which resulted in resource waste and compromised health control, highlighting the need to integrate the innovation of the digital package insert into SNCM without weakening the traceability mechanisms. It is also important to emphasize the need for continuous commitment from government authorities and the collaboration of all involved in the production and distribution chain of medications, as only through joint efforts can SNCM and the digital package insert achieve their goal of protecting and innovating Brazilian public health.
Law No. 11,903, of January 14, 2009, established the National System for Medication Control (SNCM), which is a drug traceability system involving the implementation of digital mechanisms and serial numbers (serialization on medication packaging), managed and supervised by the National Health Surveillance Agency (ANVISA). The purpose of this system is to monitor the journey of medications through all stages of their production, from manufacturing to use by the population, with the aim of combating the spread of counterfeit drugs in the national territory. However, the recent Law No. 14,338/2022, which addresses the digital package insert of medications, amended Law No. 11,903/2009, changing the drug traceability model and consequently revoking the need for drug serialization in Brazil. Thus, this work aimed to address the importance of SNCM in combating drug counterfeiting in Brazil and its suspension by Law No. 14,338/2022, which resulted in resource waste and compromised health control, highlighting the need to integrate the innovation of the digital package insert into SNCM without weakening the traceability mechanisms. It is also important to emphasize the need for continuous commitment from government authorities and the collaboration of all involved in the production and distribution chain of medications, as only through joint efforts can SNCM and the digital package insert achieve their goal of protecting and innovating Brazilian public health.