O Regulamento (UE) N° 536/2014 relativo aos ensaios clínicos de medicamentos para uso humano: oportunidades de inovação e desafios éticos

Autores

DOI:

https://doi.org/10.17566/ciads.v10i3.775

Palavras-chave:

Harmonização, Transparência, Competitividade, Inovação, Ética

Resumo

Objetivo: identificar os principais aspetos inovadores do Regulamento relativo aos ensaios clínicos de medicamentos para uso humano, em termos de oportunidades para a investigação e desenvolvimento e refletir sobre os desafios éticos deste novo quadro legal. Metodologia: estudo documental, descritivo, comparativo, do Regulamento face à Diretiva 2001/20/CE, e leitura de bibliografia publicada no PubMed, usando termos de pesquisa combinados ou simples como clinical, trials, European, Regulation, Directive, opportunities, challenges e innovation. Resultados: os principais aspetos inovadores identificados foram o Portal da União Europeia para submissão do dossiê do ensaio clínico e avaliação conjunta entre os Estados-Membros envolvidos num ensaio clínico; disponibilização pública de informação, resultados dos ensaios e um sumário de resultados para leigos; foram criadas a figura do copromotor, categorias de ensaios em função do risco; estabelecidos novos procedimentos para obtenção de consentimento informado e requisitos para uma maior proteção para os indivíduos mais vulneráveis; e definido o quadro normativo para a realização de ensaios clínicos em situação de emergência. Discussão: estão previstos procedimentos que visam contrariar a perda de competitividade da Europa, promovendo a inovação, alguns dos quais não estão isentos de questionamento ético. Conclusão: a simplificação, harmonização e maior transparência em todo o processo de submissão e condução dos ensaios clínicos tem o potencial de promover a investigação, mas traz alguns aspetos inquietantes em matéria de proteção dos participantes nos ensaios clínicos.

Biografia do Autor

Maria Alexandra Ribeiro, Universidade Nova de Lisboa

Doutora em Biologia, Fisiologia e Bioquímica, Faculdade de Ciências,  Universidade de Lisboa, Lisboa, Portugal; professora auxiliar convidada, NOVA Medical School, Faculdade de Ciências Médicas, Universidade Nova de Lisboa, Lisboa, Portugal; presidente, Comissão de Ética para a Investigação Clínica (CEIC), Lisboa, Portugal. https://orcid.org/0000-0003-1947-0523. E-mail: maribeiro@nms.unl.pt

Referências

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Publicado

16-09-2021

Como Citar

1.
Ribeiro MA. O Regulamento (UE) N° 536/2014 relativo aos ensaios clínicos de medicamentos para uso humano: oportunidades de inovação e desafios éticos. Cad. Ibero Am. Direito Sanit. [Internet]. 16º de setembro de 2021 [citado 28º de outubro de 2021];10(3):211-24. Disponível em: https://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/775

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JURISPRUDÊNCIA E LEGISLAÇÃO SANITÁRIA COMENTADAS