Sistema de rastreamento de medicamentos passa por Comissão no Senado e segue para Câmara

Publicado 08/12/2015

Foram aprovadas nesta quarta-feira (2) pela Comissão de Assuntos Sociais (CAS) etapas para teste e posterior implantação do Sistema Nacional de Controle de Medicamentos, que permitirá rastrear medicamentos em todo o percurso, desde a indústria farmacêutica até o consumidor final.

O texto aprovado é um substitutivo da senadora Vanessa Grazziotin (PCdoB-AM) ao PLS 276/2015, do senador Humberto Costa (PT-PE), que segue para a Câmara dos Deputados. A relatora discordou da prorrogação de três anos para 10 anos no prazo para implantação do sistema, como previsto no texto original do projeto.

Vanessa Grazziotin concorda que os três anos previstos na Lei 11.903/2009, que institui o sistema, foram insuficientes, mas propõe prazos mais curtos que os sugeridos pelo autor e etapas para teste, correção de erros e implantação do sistema.

Conforme o substitutivo aprovado, a Agência Nacional de Vigilância Sanitária (Anvisa) terá quatro meses para concluir as normas de regulamentações do sistema, definindo, por exemplo, as categorias de medicamentos que estarão sujeitas ao rastreamento.

Depois de concluída a regulamentação, indústria, importadores e representantes da distribuição e do varejo escolhidos pela Anvisa terão até um ano para, em caráter experimental, receber e transmitir dados referentes a, no mínimo, três lotes de medicamentos.

Depois disso, o órgão fiscalizador terá até oito meses para análise e correção dos resultados obtidos na fase experimental. A partir daí, serão mais três anos para a completa implementação do sistema.

Banco de dados

O texto prevê a formação de um banco de dados, centralizado pelo governo federal, para armazenamento e consulta sobre a movimentação de medicamentos. Fabricantes, distribuidores e varejistas serão responsável por transmitir todos os registros a respeito da circulação dos medicamentos sob sua responsabilidade.

As informações do banco de dados serão confidenciais e não poderão ser divulgadas ou comercializadas. Um membro da cadeia de movimentação dos medicamentos poderá consultar apenas os dados por ele inseridos e aqueles necessários à inclusão de novas informações.

Com a definição dos novos prazos, Vanessa Grazziotin diz que será possível a estruturação do sistema com o rigor necessário para coibir a circulação de medicamentos falsificados ou que tenham sido roubados.

Na discussão da matéria, Romero Jucá (PMDB-RR) e Ana Amélia (PP-RS) elogiaram o substitutivo elaborado pela relatora.

— Não adianta ter uma lei com prazos irreais, que não serão cumpridos, pois isso dificulta e joga por terra a ideia fundamental do programa, que é rastrear e acompanhar a venda de medicamentos — afirmou Jucá.

Fonte: Agência Senado

Foto: GS1



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