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Pressionada, Anvisa libera medicamento da China usado para imunizar pacientes

A Agência Nacional de Vigilância Sanitária (Anvisa) liberou nesta terça-feira (3) a importação de imunoglobulina comprada pelo Ministério da Saúde para ser distribuída à rede pública. Como o jornal O Estado de S.Paulo revelou, o estoque do produto estava “baixíssimo”, segundo fontes do governo. A expectativa de secretários estaduais era de que o medicamento terminasse em cerca de 30 dias.

A droga é usada para imunizar pacientes de diversas doenças e, na leitura do Ministério da Saúde, poderá servir para casos mais graves do novo coronavírus.

Liberada pela Anvisa, a importação de imunoglobulina poderá servir para casos mais graves do novo coronavírus (Foto: Divulgação)

Cerca de 45 mil frascos do produto estão guardados em aeroporto no Brasil à espera de aval da Anvisa para serem distribuídos. Trata-se de parte de um contrato de R$ 209 milhões, fechado pelo governo em dezembro de 2019 com empresa da China para entrega de 300 mil frascos. O resto do produto deve ser embarcado em breve.

O governo também fechou em dezembro contrato de R$ 70 milhões para entrega de 100 mil frascos de empresa da Coreia do Sul. A liberação desta carga ainda terá de passar pela Anvisa. Segundo pessoas da indústria e do governo, o consumo médio mensal no SUS de imunoglobulina é de 40 mil frascos.

Anvisa receosa

O aval para a importação foi dado em reunião sigilosa da diretoria colegiada da Anvisa. Representantes da empresa chinesa e do Ministério da Saúde foram impedidos de acompanhar.

O caso teve de ser levado à discussão dos diretores por ser excepcional: o produto não têm registro sanitário no Brasil, ou seja, não passou pelo crivo da Anvisa.

A compra do remédio sem registro feita pelo Ministério da Saúde levanta desconfiança da Anvisa e da indústria nacional.

Em uma primeira discussão, no fim do ano passado, a Anvisa exigiu que o ministério fizesse testes de qualidade sobre o produto para liberá-lo. As análises foram aprovadas pelo Instituto Nacional de Controle de Qualidade em Saúde (INCQS).

Semanas antes da votação na Anvisa, o ministro da Saúde, Luiz Henrique Mandetta, esteve na agência para pressionar os diretores do órgão. Ele argumentou que os estoques estavam “zerados” e que a chegada do novo coronavírus poderia aumentar a demanda pelo produto.

Integrantes da Anvisa avaliam que o governo não poderia ter feito uma compra de produto sem registro. As regras para aquisição de medicamentos não avaliados pela agência são rígidas e tidas como barreira para evitar entrada no País de produtos falsos ou perigosos aos pacientes.

O presidente substituto da Anvisa, Antonio Barra Torres, reuniu-se com o presidente Jair Bolsonaro, no Palácio do Planalto, horas após a decisão de liberar a imunoglobulina. Questionado por jornalistas, ele não revelou a decisão da Anvisa Sugeriu que buscassem a resposta via Lei de Acesso à Informação.

O Estado apurou que a Anvisa aprovou a importação, mas com ressalvas. Os diretores pedem que o Ministério da Saúde realize testes para garantir a segurança dos pacientes que receberem o medicamento.

Impasse

A disputa para importar a imunoglobulina se estende desde o fim de 2018, quando um contrato de R$ 280 milhões teve o preço questionado pelo Tribunal de Contas da União (TCU). O Ministério da Saúde argumenta que, após recomendação do tribunal, começou a busca no exterior pelo medicamento sem registro, porque não encontrou empresa no País que apresentasse os preços regulares.

A distribuição da droga para o governo está em disputa na Justiça e no TCU. Uma entrega de 55 mil frascos do produto, por exemplo, foi impedida neste mês pelo Judiciário, pois o medicamento estaria novamente acima do preço fixado pela Câmara de Regulação de Medicamentos (CMED/Anvisa), órgão que define estes preços.

Em meio ao imbróglio, o governo Jair Bolsonaro chegou a tentar a compra em uma empresa da Ucrânia, que não cumpria exigências mínimas da Anvisa. A agência negou a importação do ministério e, nos bastidores, deixou claro à época que o produto poderia ser ineficaz e perigoso aos pacientes.

De acordo com o presidente do Conselho Nacional de Secretários de Saúde (Conass), Alberto Beltrame, a disputa fez com que os frascos chegassem aos Estados em volumes menores em 2019. A droga está sendo “racionada”. “É uma importação excepcional. Não vai ser regra daqui para frente. Mas é o que tem de possível para evitar que pessoas morram. O que se espera é sensibilidade da Anvisa”, afirma Beltrame.

Fonte: https://d24am.com/

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A Agência Nacional de Vigilância Sanitária (Anvisa) liberou nesta terça-feira (3) a importação de imunoglobulina comprada pelo Ministério da Saúde para ser distribuída à rede pública. Como o jornal O Estado de S.Paulo revelou, o estoque do produto estava “baixíssimo”, segundo fontes do governo. A expectativa de secretários estaduais era de que o medicamento terminasse em cerca de 30 dias.

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