Regulation (EU) Nº 536/2014 on clinical trials on medicinal products for human use: opportunities for innovation and ethical challenges

Detalhes bibliográficos
Autor(a) principal: Ribeiro, Maria Alexandra
Data de Publicação: 2021
Tipo de documento: Artigo
Idioma: por
Título da fonte: Cadernos Ibero-Americanos de Direito Sanitário (Online)
Texto Completo: https://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/775
Resumo: Objective: to identify the main innovative aspects of the Regulation on clinical trials of medicines for human use, in terms of opportunities for research and development and to reflect on the ethical challenges of this new legal framework. Methods: documentary, descriptive, comparative study of the Regulation in regard with the Directive 2001/20/EC, reading bibliography published in PubMed, using combined or simple research terms such as clinical, trials, European, Regulation, Directive, opportunities, challenges and innovation. Results: the main innovative aspects identified were the Portal for submission of the clinical trial dossier and joint evaluation between the Member States involved in a clinical trial; public dissemination of clinical trial´s information, results and lay summary. The idea of co-sponsor and new categories of trials depending on to the risks were created; new procedures for obtaining informed consent and requirements for the protection of the most vulnerable individuals, and the regulatory framework for conducting clinical trials in an emergency were established. Discussion: in order to counteract the loss of competitiveness in Europe, some procedures were implemented in order to promote innovation, some of which are not exempt from ethical questioning. Conclusion: simplification, harmonization and transparency for the submission and conduction of clinical trials have the potential to boost research, but brings some concerns regarding the protection of participants in clinical trials.
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spelling Regulation (EU) Nº 536/2014 on clinical trials on medicinal products for human use: opportunities for innovation and ethical challengesReglamento (UE) Nº 536/2014 sobre los ensayos clínicos de medicamentos de uso humano: oportunidades de innovación y desafíos éticosO Regulamento (UE) N° 536/2014 relativo aos ensaios clínicos de medicamentos para uso humano: oportunidades de inovação e desafios éticosHarmonizationTransparencyCompetitivityInnovationEthicsArmonizaciónTransparenciaCompetitividadInnovaciónÉticaHarmonizaçãoTransparênciaCompetitividadeInovaçãoÉticaObjective: to identify the main innovative aspects of the Regulation on clinical trials of medicines for human use, in terms of opportunities for research and development and to reflect on the ethical challenges of this new legal framework. Methods: documentary, descriptive, comparative study of the Regulation in regard with the Directive 2001/20/EC, reading bibliography published in PubMed, using combined or simple research terms such as clinical, trials, European, Regulation, Directive, opportunities, challenges and innovation. Results: the main innovative aspects identified were the Portal for submission of the clinical trial dossier and joint evaluation between the Member States involved in a clinical trial; public dissemination of clinical trial´s information, results and lay summary. The idea of co-sponsor and new categories of trials depending on to the risks were created; new procedures for obtaining informed consent and requirements for the protection of the most vulnerable individuals, and the regulatory framework for conducting clinical trials in an emergency were established. Discussion: in order to counteract the loss of competitiveness in Europe, some procedures were implemented in order to promote innovation, some of which are not exempt from ethical questioning. Conclusion: simplification, harmonization and transparency for the submission and conduction of clinical trials have the potential to boost research, but brings some concerns regarding the protection of participants in clinical trials.Objetivo: identificar los principales aspectos innovadores del Reglamento sobre ensayos clínicos de medicamentos de uso humano, en términos de oportunidades de investigación y desarrollo y reflexionar sobre los desafíos éticos de este nuevo marco legal. Metodología: estudio documental, descriptivo, comparativo del Reglamento en relación con la Directiva 2001/20/CE, y lectura de bibliografía publicada en PubMed, utilizando términos de investigación combinados o simples como clinical, trials, European, Regulation, Directive, opportunities, challenges y innovation. Resultados: los principales aspectos innovadores identificados fueron el Portal de presentación del expediente de ensayo clínico y evaluación conjunta entre los Estados miembros implicados en un ensayo clínico; disponibilidad pública de información, resultados de pruebas y un resumen de resultados para laicos; se creó la figura del co-promotor, categorías de pruebas según el riesgo; se han establecido nuevos procedimientos para obtener el consentimiento informado y requisitos para una mayor protección de las personas más vulnerables; y definió el marco regulatorio para la realización de ensayos clínicos en una situación de emergencia. Discusión: se prevén procedimientos para contrarrestar la pérdida de competitividad en Europa, promoviendo la innovación, algunas de las cuales no están exentas de cuestionamientos éticos. Conclusión: la simplificación, armonización y mayor transparencia en todo el proceso de envío y realización de ensayos clínicos tiene el potencial de promover la investigación, pero trae algunos aspectos inquietantes en términos de protección de los participantes en los ensayos clínicos.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.Fundação Oswaldo Cruz Brasília2021-09-16info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/77510.17566/ciads.v10i3.775Iberoamerican Journal of Health Law; Vol. 10 No. 3 (2021): (JUL./SEPT. 2021); 211-224Cuadernos Iberoamericanos de Derecho Sanitario; Vol. 10 Núm. 3 (2021): (JUL./SEPT. 2021); 211-224Cadernos Ibero-Americanos de Direito Sanitário; v. 10 n. 3 (2021): (JUL./SET. 2021); 211-2242358-18242317-839610.17566/ciads.v10i3reponame:Cadernos Ibero-Americanos de Direito Sanitário (Online)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZporhttps://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/775/844Copyright (c) 2021 Maria Alexandra Ribeiro (Autor)https://creativecommons.org/licenses/by-nc/4.0info:eu-repo/semantics/openAccessRibeiro, Maria AlexandraRibeiro, Maria AlexandraRibeiro, Maria Alexandra2023-03-08T15:04:33Zoai:ojs.cadernos.prodisa.fiocruz.br:article/775Revistahttp://www.cadernos.prodisa.fiocruz.brPUBhttp://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/oaicadernos.direitosanitario@fiocruz.br2358-18242317-8396opendoar:2023-03-08T15:04:33Cadernos Ibero-Americanos de Direito Sanitário (Online) - Fundação Oswaldo Cruz (FIOCRUZ)false
dc.title.none.fl_str_mv Regulation (EU) Nº 536/2014 on clinical trials on medicinal products for human use: opportunities for innovation and ethical challenges
Reglamento (UE) Nº 536/2014 sobre los ensayos clínicos de medicamentos de uso humano: oportunidades de innovación y desafíos éticos
O Regulamento (UE) N° 536/2014 relativo aos ensaios clínicos de medicamentos para uso humano: oportunidades de inovação e desafios éticos
title Regulation (EU) Nº 536/2014 on clinical trials on medicinal products for human use: opportunities for innovation and ethical challenges
spellingShingle Regulation (EU) Nº 536/2014 on clinical trials on medicinal products for human use: opportunities for innovation and ethical challenges
Ribeiro, Maria Alexandra
Harmonization
Transparency
Competitivity
Innovation
Ethics
Armonización
Transparencia
Competitividad
Innovación
Ética
Harmonização
Transparência
Competitividade
Inovação
Ética
title_short Regulation (EU) Nº 536/2014 on clinical trials on medicinal products for human use: opportunities for innovation and ethical challenges
title_full Regulation (EU) Nº 536/2014 on clinical trials on medicinal products for human use: opportunities for innovation and ethical challenges
title_fullStr Regulation (EU) Nº 536/2014 on clinical trials on medicinal products for human use: opportunities for innovation and ethical challenges
title_full_unstemmed Regulation (EU) Nº 536/2014 on clinical trials on medicinal products for human use: opportunities for innovation and ethical challenges
title_sort Regulation (EU) Nº 536/2014 on clinical trials on medicinal products for human use: opportunities for innovation and ethical challenges
author Ribeiro, Maria Alexandra
author_facet Ribeiro, Maria Alexandra
author_role author
dc.contributor.author.fl_str_mv Ribeiro, Maria Alexandra
Ribeiro, Maria Alexandra
Ribeiro, Maria Alexandra
dc.subject.por.fl_str_mv Harmonization
Transparency
Competitivity
Innovation
Ethics
Armonización
Transparencia
Competitividad
Innovación
Ética
Harmonização
Transparência
Competitividade
Inovação
Ética
topic Harmonization
Transparency
Competitivity
Innovation
Ethics
Armonización
Transparencia
Competitividad
Innovación
Ética
Harmonização
Transparência
Competitividade
Inovação
Ética
description Objective: to identify the main innovative aspects of the Regulation on clinical trials of medicines for human use, in terms of opportunities for research and development and to reflect on the ethical challenges of this new legal framework. Methods: documentary, descriptive, comparative study of the Regulation in regard with the Directive 2001/20/EC, reading bibliography published in PubMed, using combined or simple research terms such as clinical, trials, European, Regulation, Directive, opportunities, challenges and innovation. Results: the main innovative aspects identified were the Portal for submission of the clinical trial dossier and joint evaluation between the Member States involved in a clinical trial; public dissemination of clinical trial´s information, results and lay summary. The idea of co-sponsor and new categories of trials depending on to the risks were created; new procedures for obtaining informed consent and requirements for the protection of the most vulnerable individuals, and the regulatory framework for conducting clinical trials in an emergency were established. Discussion: in order to counteract the loss of competitiveness in Europe, some procedures were implemented in order to promote innovation, some of which are not exempt from ethical questioning. Conclusion: simplification, harmonization and transparency for the submission and conduction of clinical trials have the potential to boost research, but brings some concerns regarding the protection of participants in clinical trials.
publishDate 2021
dc.date.none.fl_str_mv 2021-09-16
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv https://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/775
10.17566/ciads.v10i3.775
url https://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/775
identifier_str_mv 10.17566/ciads.v10i3.775
dc.language.iso.fl_str_mv por
language por
dc.relation.none.fl_str_mv https://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/775/844
dc.rights.driver.fl_str_mv Copyright (c) 2021 Maria Alexandra Ribeiro (Autor)
https://creativecommons.org/licenses/by-nc/4.0
info:eu-repo/semantics/openAccess
rights_invalid_str_mv Copyright (c) 2021 Maria Alexandra Ribeiro (Autor)
https://creativecommons.org/licenses/by-nc/4.0
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Fundação Oswaldo Cruz Brasília
publisher.none.fl_str_mv Fundação Oswaldo Cruz Brasília
dc.source.none.fl_str_mv Iberoamerican Journal of Health Law; Vol. 10 No. 3 (2021): (JUL./SEPT. 2021); 211-224
Cuadernos Iberoamericanos de Derecho Sanitario; Vol. 10 Núm. 3 (2021): (JUL./SEPT. 2021); 211-224
Cadernos Ibero-Americanos de Direito Sanitário; v. 10 n. 3 (2021): (JUL./SET. 2021); 211-224
2358-1824
2317-8396
10.17566/ciads.v10i3
reponame:Cadernos Ibero-Americanos de Direito Sanitário (Online)
instname:Fundação Oswaldo Cruz (FIOCRUZ)
instacron:FIOCRUZ
instname_str Fundação Oswaldo Cruz (FIOCRUZ)
instacron_str FIOCRUZ
institution FIOCRUZ
reponame_str Cadernos Ibero-Americanos de Direito Sanitário (Online)
collection Cadernos Ibero-Americanos de Direito Sanitário (Online)
repository.name.fl_str_mv Cadernos Ibero-Americanos de Direito Sanitário (Online) - Fundação Oswaldo Cruz (FIOCRUZ)
repository.mail.fl_str_mv cadernos.direitosanitario@fiocruz.br
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