Governo deverá rever regras sobre medicamentos similares

Da Redação
O governo vai rediscutir a criação de uma nova classe de medicamentos, batizada de equivalentes. A proposta, lançada em janeiro, previa que os remédios hoje chamados similares, ganhariam o novo nome e o status semelhante ao dos genéricos, desde que adotassem a mesma política de preços: o valor não poderia ser superior a 65% do que é cobrado por medicamentos de referência.

Diante da polêmica criada entre os fabricantes, a ideia agora é revista por um grupo de trabalho. Na mesa, estão duas alternativas à ideia inicial: sepultar a nova marca ou torná-la opcional para o fabricante.

Nesta segunda-feira (24), terminou o prazo da consulta pública aberta para avaliar o texto que previa a criação dos equivalentes. Até as 17 horas, o placar indicava altos índices de reprovação da proposta, considerada intervencionista e, na avaliação dos produtores, uma ameaça ao equilíbrio conquistado nesse mercado.

Ao lançar a ideia, o então ministro da Saúde, Alexandre Padilha, que deixou o cargo para disputar o governo de São Paulo pelo PT, afirmou que o recurso poderia ser uma arma importante para aumentar a concorrência e, por tabela, reduzir o preço dos produtos.

O presidente da Agência Nacional de Vigilância Sanitária (Anvisa), Dirceu Barbano, durante o lançamento disse estar convicto de que a proposta impulsionaria a venda de similares e genéricos. Pelas projeções de Barbano, em três anos, essas duas classes de medicamentos serão responsáveis por 80% do mercado. Hoje, representam 62%.

Com o fim da consulta pública, a tendência é de se intensificarem as reuniões dentro do grupo de trabalho, formado por representantes do setor produtivo, por integrantes do Ministério da Saúde e da Anvisa. O atual ministro da Saúde, Arthur Chioro, disse estar aberto a mudanças no texto. A próxima reunião está marcada para março.

O grupo tem 120 dias para discutir a criação dos equivalentes e outros três temas correlatos: a possibilidade de troca de medicamentos de referência por genéricos ou similares (chamada intercambialidade); mecanismos para rastrear toda a cadeia produtiva, afim de evitar falsificações e desvios (rastreabilidade); regras que permitam colocar em prática a obrigatoriedade da apresentação de receita na hora da compra e a logística reversa, sistema para recolher produtos não usados por consumidores.

Destes temas, são considerados polêmicos a intercambialidade e a criação dos equivalentes. A mudança nas regras para similares devem estar concluídas este ano, quando termina o prazo para que todos os medicamentos chamados similares apresentarem testes de bioequivalência e biodisponibilidade, que comprovam ser cópias fiéis dos medicamentos de referência.

PRERROGATIVA

Uma parte do setor produtivo reivindicava que, com essa mudança, similares também pudessem substituir prescrições de medicamentos de marca – prerrogativa que no momento vale apenas para os genéricos. O governo aceitou a mudança, mas com a condição da mudança do preço.

Para o presidente do Sindicato da Indústria de Produtos Farmacêuticos no Estado de São Paulo, Nelson Mussolini, o ideal é que tudo permaneça como está.
Fonte: O Estado de S. Paulo



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