Articulating human rights to health and the benefits of scientific progress in the assessment and incorporation of medicines: from global to local
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Data de Publicação: | 2021 |
Outros Autores: | |
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/856 |
Resumo: | From the perspective of the human right to health and to access the benefits of scientific progress, this article examines the legal, institutional and argumentative structure framing the assessment of new technologies and their and incorporation into health systems, as key to guaranteeing access to medicines. The international and Brazilian frameworks were investigated and contrasted by way of a review of documentation and of the international and Brazilian literature, focusing on the repercussions of technical and scientific facts (extrasystemic reasons) on legal statements (systemic reasons), and related reconciliation, in assuring those rights. The locally and globally conceptions were found to predominate, favouring health systems’ economic efficiency and sustainability to the detriment of an ethical and political approach to incorporating pharmaceutical innovations as a human right grounded in solidarity, social justice and equity. Brazil has advanced in the process of evaluating and incorporating new medicines by introducing legal criteria and parameters similar to those of other countries and compatible with international health recommendations. The fragilities observed were instances of increasingly flexible legal criteria for the practice of incorporation, which impose a heavier onus of technical and scientific proof on citizens filing applications; the introduction and ampliation of economic and budget elements into the analyses; and the lack of any provision for user representative participation in the evaluation process, which is so highly valued in other countries. It was concluded that the main tension between the norms and practices examined and human rights is that priority is given to economic, financial and budget considerations over the proven potential health benefits of pharmaceutical innovations. In that respect, the framework examined undermines efforts to assure human rights in health care policies, thus significantly impairing fair and equal access to therapeutic innovations locally and globally. |
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Articulating human rights to health and the benefits of scientific progress in the assessment and incorporation of medicines: from global to localArticular los derechos humanos a la salud y los beneficios del progreso científico en la evaluación e incorporación de medicamentos: de global a localArticulando os direitos humanos à saúde e aos benefícios do progresso científico no processo de avaliação e incorporação de medicamentos: do global ao localDireitos HumanosDireito à SaúdeAvaliação Tecnológica em SaúdeLegislação & JurisprudênciaHuman RightsRight to HealthHealth Technology AssessmentLegislation & JurisprudenceDerechos HumanosDerecho a la SaludEvaluación de la Tecnología SanitariasLegislación & JurisprudenciaFrom the perspective of the human right to health and to access the benefits of scientific progress, this article examines the legal, institutional and argumentative structure framing the assessment of new technologies and their and incorporation into health systems, as key to guaranteeing access to medicines. The international and Brazilian frameworks were investigated and contrasted by way of a review of documentation and of the international and Brazilian literature, focusing on the repercussions of technical and scientific facts (extrasystemic reasons) on legal statements (systemic reasons), and related reconciliation, in assuring those rights. The locally and globally conceptions were found to predominate, favouring health systems’ economic efficiency and sustainability to the detriment of an ethical and political approach to incorporating pharmaceutical innovations as a human right grounded in solidarity, social justice and equity. Brazil has advanced in the process of evaluating and incorporating new medicines by introducing legal criteria and parameters similar to those of other countries and compatible with international health recommendations. The fragilities observed were instances of increasingly flexible legal criteria for the practice of incorporation, which impose a heavier onus of technical and scientific proof on citizens filing applications; the introduction and ampliation of economic and budget elements into the analyses; and the lack of any provision for user representative participation in the evaluation process, which is so highly valued in other countries. It was concluded that the main tension between the norms and practices examined and human rights is that priority is given to economic, financial and budget considerations over the proven potential health benefits of pharmaceutical innovations. In that respect, the framework examined undermines efforts to assure human rights in health care policies, thus significantly impairing fair and equal access to therapeutic innovations locally and globally.Adoptando la perspectiva de los derechos humanos a la salud y de gozar de los beneficios del progreso científico, el artículo analiza el marco jurídico-institucional y argumentativo de la evaluación e incorporación de nuevas tecnologías en los sistemas de salud, como imprescindibles para garantizar el acceso a los medicamentos. Con base en la revisión documental y en la literatura internacional y brasileña, se investigó el marco internacional en comparación con el brasileño, enfocándose en la repercusión y compatibilidad de los hechos técnicos y científicos (razones extrasistemáticas) con los enunciados legales (razones sistemáticas) en la realización. de estos derechos. A nivel local y global, predominó una concepción a favor de la eficiencia económica y la sostenibilidad de los sistemas de salud, en detrimento de la visión ética y política de la incorporación de las innovaciones farmacéuticas como derecho humano, basado sobre solidaridad, justicia social y equidad. A nivel nacional, se avanzó en la institucionalización del proceso de incorporación y evaluación, con criterios y parámetros legales similares a los de otros países y compatibles con las recomendaciones internacionales de salud. Las debilidades nacionales observadas fueron la flexibilización de criterios legales en la práctica de la incorporación, lo que aumenta la carga probatoria técnico-científica de la ciudadanía para el envío de solicitudes; la ampliación y priorización de elementos económicos y presupuestarios en el análisis; y la falta de disposiciones para la participación de representantes de los usuarios en el proceso de evaluación. Se concluye que la principal tensión en las normas y prácticas analizadas con los derechos humanos es la priorización de razones predominantemente económicas, financieras y presupuestarias, en detrimento de los probables beneficios potenciales para la salud de las innovaciones farmacéuticas. En este sentido, el marco analizado compromete la realización de los derechos humanos en las políticas de salud, con un daño significativo al acceso justo e igualitario a las innovaciones terapéuticas.Na perspectiva dos direitos humanos à saúde e aos benefícios do progresso científico, o artigo analisa o arcabouço jurídico-institucional e argumentativo da avaliação e incorporação de novas tecnologias nos sistemas de saúde, como essencial na garantia do acesso a medicamentos. Com base na revisão documental e na literatura internacional e brasileira, investigou-se o arcabouço internacional em confronto com o brasileiro, com foco na repercussão e compatibilização dos fatos técnicos e científicos (razões extrassistemáticas) com os enunciados jurídicos (razões sistemáticas) na efetivação desses direitos. Constatou-se, no âmbito local e global, o predomínio de uma concepção que prioriza a eficiência econômica e sustentabilidade dos sistemas de saúde, em detrimento à visão ética e política da incorporação das inovações farmacêuticas como um direito humano, fundamentado na solidariedade, justiça social e equidade. No âmbito nacional, houve avanços na institucionalização do processo de incorporação e avaliação, com critérios e parâmetros legais semelhantes a outros países e compatíveis com as recomendações sanitárias internacionais. As fragilidades nacionais observadas foram as flexibilizações de critérios legais na prática da incorporação que elevam o ônus probatório técnico-científico dos cidadãos para o encaminhamento dos pedidos; a ampliação e priorização de elementos econômicos e orçamentários na análise; e a ausência de previsão de participação de representantes de usuários no processo avaliativo. Conclui-se que a principal tensão nas normas e práticas analisadas com os direitos humanos é a priorização de razões predominantemente econômicas, financeiras e orçamentárias, em detrimento aos benefícios potenciais comprovados para a saúde de inovações farmacêuticas. Nesse sentido, o arcabouço analisado compromete a efetivação dos direitos humanos nas políticas de atenção à saúde, com prejuízos significativos no acesso justo e igualitário às inovações terapêuticas.Fundação Oswaldo Cruz Brasília2021-12-10info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/85610.17566/ciads.v10iSuplemento.856Iberoamerican Journal of Health Law; Vol. 10 No. Suplemento (2021): Comemorative issue; 11-31Cuadernos Iberoamericanos de Derecho Sanitario; Vol. 10 Núm. Suplemento (2021): Edición comemorativa; 11-31Cadernos Ibero-Americanos de Direito Sanitário; v. 10 n. Suplemento (2021): Edição comemorativa; 11-312358-18242317-839610.17566/ciads.v10iSuplementoreponame:Cadernos Ibero-Americanos de Direito Sanitário (Online)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZporhttps://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/856/865https://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/856/1024Copyright (c) 2021 Cadernos Ibero-Americanos de Direito Sanitáriohttps://creativecommons.org/licenses/by-nc-sa/4.0info:eu-repo/semantics/openAccessVentura , Miriam Ventura , Deisy de Freitas Lima Ventura , Miriam Ventura , Deisy de Freitas Lima Ventura , Miriam Ventura , Deisy de Freitas Lima 2023-06-21T17:36:57Zoai:ojs.cadernos.prodisa.fiocruz.br:article/856Revistahttp://www.cadernos.prodisa.fiocruz.brPUBhttp://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/oaicadernos.direitosanitario@fiocruz.br2358-18242317-8396opendoar:2023-06-21T17:36:57Cadernos Ibero-Americanos de Direito Sanitário (Online) - Fundação Oswaldo Cruz (FIOCRUZ)false |
dc.title.none.fl_str_mv |
Articulating human rights to health and the benefits of scientific progress in the assessment and incorporation of medicines: from global to local Articular los derechos humanos a la salud y los beneficios del progreso científico en la evaluación e incorporación de medicamentos: de global a local Articulando os direitos humanos à saúde e aos benefícios do progresso científico no processo de avaliação e incorporação de medicamentos: do global ao local |
title |
Articulating human rights to health and the benefits of scientific progress in the assessment and incorporation of medicines: from global to local |
spellingShingle |
Articulating human rights to health and the benefits of scientific progress in the assessment and incorporation of medicines: from global to local Ventura , Miriam Direitos Humanos Direito à Saúde Avaliação Tecnológica em Saúde Legislação & Jurisprudência Human Rights Right to Health Health Technology Assessment Legislation & Jurisprudence Derechos Humanos Derecho a la Salud Evaluación de la Tecnología Sanitarias Legislación & Jurisprudencia |
title_short |
Articulating human rights to health and the benefits of scientific progress in the assessment and incorporation of medicines: from global to local |
title_full |
Articulating human rights to health and the benefits of scientific progress in the assessment and incorporation of medicines: from global to local |
title_fullStr |
Articulating human rights to health and the benefits of scientific progress in the assessment and incorporation of medicines: from global to local |
title_full_unstemmed |
Articulating human rights to health and the benefits of scientific progress in the assessment and incorporation of medicines: from global to local |
title_sort |
Articulating human rights to health and the benefits of scientific progress in the assessment and incorporation of medicines: from global to local |
author |
Ventura , Miriam |
author_facet |
Ventura , Miriam Ventura , Deisy de Freitas Lima |
author_role |
author |
author2 |
Ventura , Deisy de Freitas Lima |
author2_role |
author |
dc.contributor.author.fl_str_mv |
Ventura , Miriam Ventura , Deisy de Freitas Lima Ventura , Miriam Ventura , Deisy de Freitas Lima Ventura , Miriam Ventura , Deisy de Freitas Lima |
dc.subject.por.fl_str_mv |
Direitos Humanos Direito à Saúde Avaliação Tecnológica em Saúde Legislação & Jurisprudência Human Rights Right to Health Health Technology Assessment Legislation & Jurisprudence Derechos Humanos Derecho a la Salud Evaluación de la Tecnología Sanitarias Legislación & Jurisprudencia |
topic |
Direitos Humanos Direito à Saúde Avaliação Tecnológica em Saúde Legislação & Jurisprudência Human Rights Right to Health Health Technology Assessment Legislation & Jurisprudence Derechos Humanos Derecho a la Salud Evaluación de la Tecnología Sanitarias Legislación & Jurisprudencia |
description |
From the perspective of the human right to health and to access the benefits of scientific progress, this article examines the legal, institutional and argumentative structure framing the assessment of new technologies and their and incorporation into health systems, as key to guaranteeing access to medicines. The international and Brazilian frameworks were investigated and contrasted by way of a review of documentation and of the international and Brazilian literature, focusing on the repercussions of technical and scientific facts (extrasystemic reasons) on legal statements (systemic reasons), and related reconciliation, in assuring those rights. The locally and globally conceptions were found to predominate, favouring health systems’ economic efficiency and sustainability to the detriment of an ethical and political approach to incorporating pharmaceutical innovations as a human right grounded in solidarity, social justice and equity. Brazil has advanced in the process of evaluating and incorporating new medicines by introducing legal criteria and parameters similar to those of other countries and compatible with international health recommendations. The fragilities observed were instances of increasingly flexible legal criteria for the practice of incorporation, which impose a heavier onus of technical and scientific proof on citizens filing applications; the introduction and ampliation of economic and budget elements into the analyses; and the lack of any provision for user representative participation in the evaluation process, which is so highly valued in other countries. It was concluded that the main tension between the norms and practices examined and human rights is that priority is given to economic, financial and budget considerations over the proven potential health benefits of pharmaceutical innovations. In that respect, the framework examined undermines efforts to assure human rights in health care policies, thus significantly impairing fair and equal access to therapeutic innovations locally and globally. |
publishDate |
2021 |
dc.date.none.fl_str_mv |
2021-12-10 |
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/856 10.17566/ciads.v10iSuplemento.856 |
url |
https://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/856 |
identifier_str_mv |
10.17566/ciads.v10iSuplemento.856 |
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/856/865 https://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/856/1024 |
dc.rights.driver.fl_str_mv |
Copyright (c) 2021 Cadernos Ibero-Americanos de Direito Sanitário https://creativecommons.org/licenses/by-nc-sa/4.0 info:eu-repo/semantics/openAccess |
rights_invalid_str_mv |
Copyright (c) 2021 Cadernos Ibero-Americanos de Direito Sanitário https://creativecommons.org/licenses/by-nc-sa/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. Suplemento (2021): Comemorative issue; 11-31 Cuadernos Iberoamericanos de Derecho Sanitario; Vol. 10 Núm. Suplemento (2021): Edición comemorativa; 11-31 Cadernos Ibero-Americanos de Direito Sanitário; v. 10 n. Suplemento (2021): Edição comemorativa; 11-31 2358-1824 2317-8396 10.17566/ciads.v10iSuplemento reponame:Cadernos Ibero-Americanos de Direito Sanitário (Online) instname:Fundação Oswaldo Cruz (FIOCRUZ) instacron:FIOCRUZ |
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Fundação Oswaldo Cruz (FIOCRUZ) |
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FIOCRUZ |
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FIOCRUZ |
reponame_str |
Cadernos Ibero-Americanos de Direito Sanitário (Online) |
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Cadernos Ibero-Americanos de Direito Sanitário (Online) |
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Cadernos Ibero-Americanos de Direito Sanitário (Online) - Fundação Oswaldo Cruz (FIOCRUZ) |
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cadernos.direitosanitario@fiocruz.br |
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