Opinião | PL 200/2015

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*Por Aline Almeida

Nos dias 24 e 25 de novembro de 2016, o presidente da Comissão Nacional de Ética em Pesquisa- CONEP do Conselho Nacional de Saúde do Ministério da Saúde, Sr. Jorge Venâncio e alguns membros da equipe vieram realizar um Treinamento de representantes dos Comitês de Ética em pesquisa do Estado do Paraná e de Santa Catarina na Pontifícia Universidade Católica do Paraná (PUC-PR).

O que é a CONEP?

A Comissão Nacional de Ética em Pesquisa – CONEP- é uma comissão do Conselho Nacional de Saúde – CNS, criada através da Resolução 196/96 e com constituição designada pela Resolução 246/97, com a função de implementar as normas e diretrizes regulamentadoras de pesquisas envolvendo seres humanos, aprovadas pelo Conselho. Tem função consultiva, deliberativa, normativa e educativa, atuando conjuntamente com uma rede de Comitês de Ética em Pesquisa – CEP- organizados nas instituições onde as pesquisas se realizam.

O propósito da CONEP dentro do Ministério da Saúde é garantir a proteção do participante da pesquisa, para que não ocorram atrocidades como ocorridas nas pesquisas durante a 2ª. Guerra Mundial, onde seres humanos foram “usados” como cobaias para experimentos médicos e clínicos.

O Brasil por possuir uma peculiaridade social e econômica da população, é muito importante que esses Comitês de ética em pesquisa estejam atuantes para que pessoas em situação de vulnerabilidade financeira ou mesmo por compreensão de termos acadêmicos e científicos mais complexos sejam impulsionadas a participar de pequisas que possam lhes gerar constrangimento ou mesmo seqüelas.

A atuação dos Comitês de ética em pesquisa acontece em grande maioria nas instituições de ensino tendo sempre a preocupação de zelar pela dignidade do participante da pesquisa e sua proteção.

Esclarecido o funcionamento dessas instituições, mais do que apenas realizar o treinamento dos membros e representantes de usuários dos comitês de ética em pesquisa que envolve seres humanos, o Sr. Jorge apresentou uma solicitação de urgência aos membros dos CEP´s devido a tramitação da PL 200/2015 que está em processo para ser aprovada pelo Senado.

A PL 200/2015 é de autoria da Senadora Ana Amélia e outros, estabelece novos critérios e princípios e diretrizes para desenvolvimento de pesquisas clínicas, ela desvincula os CEP`s das instituições de ensino e do Ministério da Saúde, significa que haverá uma desregulamentação das pesquisas que ocorrem no país, tornando viável a criação e financiamento de CEP`s por empresas farmacêuticas, com legislação específica, sem aparato nacional como hoje existe-Resolução n.466/2012.

No artigo 30 parágrafo 3, inciso V, retira o direito do participante da pesquisa em continuar recebendo o medicamento ou tratamento decorrido 2 anos após participação do estudo, atualmente, o participante da pesquisa tem garantido o tratamento ou medicamento enquanto precisarem.

Ex: Não há desculpa de oneração financeira por parte das empresas farmacêuticas em realizarem essa doação de medicação ou tratamento aos participantes de pesquisa, pois no Brasil constam apenas 180 participantes de estudo que pós-pesquisa continuam recebendo o medicamento, de acordo com Ministério da Saúde.

Ou seja, se essa PL for aprovada, participantes de pesquisa, por exemplo, mães de filhos com microcefalia devido a contaminação pelo vírus do Zika após 2 anos de serem recrutados como participantes da pesquisa, medicamento ou tratamento que foram muito satisfatório durante a pesquisa realizada, essas mães decorridos o prazo determinado ficarão sem o medicamento ou tratamento.

Atualmente, a CONEP também regulamenta o funcionamento de Biobancos, que são centros de armazenamento de material biológico humano para pesquisa, que atendem um critério rigoroso pelo Ministério da Saúde para preservação do direito da dignidade e sigilo de seres humanos. Como o texto da PL 200/2015 não remete em nada sobre a regulamentação e funcionamento de Biobancos, corre-se o risco de se perder o sigilo desse material humano, assim como recolhimento aleatório, inclusive sem consentimento das pessoas e utilização em pesquisas.

Enfim, o Sr. Jorge exemplificou o que ocorreu na Índia recentemente sobre essa desregulamentação de pesquisas clínicas no país, e tem viajado com sua equipe por todo o país pedindo que todos que neste momento todos que trabalham e atuam com Comitês de ética em pesquisa façam 3 tarefas:

•    Façam um abaixo-assinado contra a PL 200/2015;
•    Acessem o site do senado sobre a PL 200/2015 votando contra; http://www12.senado.leg.br/ecidadania/visualizacaomateria?id=120560
•    Entrem em contato com senadores de sua região para que eles se posicionem contra este PL 200/2015.

Carta Aberta da CONEP para comunidade sobre PL 200/2015:
http://conselho.saude.gov.br/ultimas_noticias/2015/docs/05mai14_CartaAbertaConep_ProjetoLei_200_2015.pdf

*Aline Almeida é técnica administrativa na UTFPR.

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