Diretor da Anvisa explica agenda regulatória para o varejo farmacêutico

Anvisa final

Publicado 19/08/2015

A Agência Nacional de Vigilância Sanitária (Anvisa) esteve presente do 5° Conbrafarma nesta quarta-feira (19), na pessoa do diretor de Coordenação e Articulação do Sistema Nacional de Vigilância Sanitária, Ivo Bucaresky. Ele apresentou os pontos de maior importância para o varejo farmacêutico dentro da agenda regulatória da entidade para os anos de 2015 e 2016.

Boas práticas em farmácia (Revisão da RDC 44/09)

Segundo o diretor, há um grande debate de temas como o descarte de medicamento, fracionamento, promoção do uso racional, rastreabilidade, produtos e serviços que podem ser vendidos dentro das farmácias. A ausência de regulamentação desses temas tem gerado insegurança jurídica, principalmente na questão de venda de produtos que não sejam os voltados para saúde e cosméticos. Apesar de estar na agenda, o tema ainda não foi sorteado e, por isso, não se iniciou as discussões.

Gerenciamento de resíduos de serviços de saúde

Neste item, o tema principal é a logística reversa. O Programa Nacional de Resíduos Sólidos exige que todas as cadeias produtivas tenham políticas de logística reversa, e a área de medicamentos foi considerada uma das prioridades. O diretor explica que o caso do medicamento é mais delicado, já que o material que retorna não tem nenhuma utilidade. Com isso, fica em aberto quem vai financiar essa logística. “De acordo com a lei, todo mundo paga a conta, incluindo o consumidor final. A questão é quem paga quanto. Esse tem sido o impasse”. Por essa razão a discussão foi levada de volta para o Ministério do Meio Ambiente, pois não houve acordo entre os elos da cadeia.

Autorização de Funcionamento de Empresa (AFE)

Até um ano atrás, havia uma fila enorme para renovação da AFE. A partir da RDC do ano passado, a AFE passa a ser permanente. Hoje não tem filas para a renovação da AFE, apenas alguns problemas antigos que já estão sendo resolvidos.

Regra para Medicamentos Isentos de Prescrição

Atualmente, o processo para um medicamento se tornar isento de prescrição é tão burocrático que há dez anos isso não acontece. Pela nova regra, que ainda não foi votada, serão determinados os requisitos para que o medicamento seja considerado sem tarja. Assim que a indústria solicitar a mudança de classificação do medicamento e ele se enquadrar nestes requisitos, automaticamente ele perde a tarja. Dentre os requisitos está que o medicamento deve ter no mínimo dez anos de comercialização no Brasil e que, nos 12 meses seguidos de sua liberação como MIP, ele precisará de dispensação de um farmacêutico.

Registro de medicamentos

Ainda que afete apenas indiretamente o varejo farmacêutico, o diretor aponta que acha interessante destacar os novos processos para registros de medicamentos usados pela Anvisa. Ele afirma que já estão conseguindo diminuir os prazos para aprovação de medicamentos novos, mas também querem atingir os medicamentos genéricos e similares. “Isso não é um trabalho fácil porque não envolve só a melhoria de processos, envolve também aumento de pessoal”.

Rastreabilidade

Esta matéria foi aprovada pelo Congresso Nacional, o papel da Anvisa é de regulamentar e implementar a lei. O processo está atrasado em três anos. O início está previsto para o final deste ano. Mas além de problemas de logística, houve uma grande discussão sobre o banco de dados. Pela regra da Anvisa, o banco de dados pertenceria à indústria, mas outros elos (varejo e distribuidores) não concordaram.

Diante os impasses, algumas partes estão reivindicando adiamento do prazo para a implantação deste sistema. “Nós, diretores da Anvisa, não vamos alterar os prazos. Caso isso venha a acontecer, terá que vir do Congresso ou do judiciário. Porque se a Anvisa alterar a data, nós podemos ser responsabilizados pelo Ministério Público por crime de responsabilidade por não implementar uma lei”.

O rastreamento é importante por diversos fatores. Para o varejo será mecanismo para controle de perdas, melhorar logística, entre outros benefícios. Bucaresky conta na Turquia, primeiro país a implantar um sistema de rastreabilidade, todo e setor da cadeia tiveram ganhos. “O choque de custo é só no início, mas todos recuperaram o investimento com ganho em logística, diminuição de perdas no período posterior”.

Fonte: Assessoria de Comunicação FEBRAFAR

Foto: Imagem da transmissão simultânea via Internet

 

 

 



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