Legal possibility of marketing authorization and commercialization of advanced therapy medicinal products in Brazil

Detalhes bibliográficos
Autor(a) principal: Garcia, Luisa Abreu Obici
Data de Publicação: 2018
Outros Autores: Takao, Marilia Rodrigues Mendes, Parca, Renata Miranda, Silva Junior, João Batista da
Tipo de documento: Artigo
Idioma: por
eng
Título da fonte: Vigilância Sanitária em Debate
DOI: 10.22239/2317-269X.01075
Texto Completo: https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1075
Resumo: In view of the provisions of the Constitution of 1988, of the Federative Republic of Brazil, article 199, paragraph 4, which prohibits any form of marketing of organs, tissues and human substances for transplants, research and treatment, the possibility of commercialization and marketing authorization of human origin products in Brazil has been questioned. With the advent of advanced therapies, legal uncertainty on the subject has reached regulatory issues and permeated scientific and investments concerns over the sector. Such perception based the detailed analysis on the matter by Anvisa´s Federal Attorney’s Office, which was expressed on the Legal Opinion n. 12/2016/PF-Anvisa/PGF/AGU and exposed in this article. Outline, in this article, the main aspects concerning the legal possibility of marketing authorization and commercialization of advanced therapy medicinal products in Brazil, based on the Legal Opinion n° 12/2016/PF-Anvisa/PGF/AGU. Assessment of the Legal Opinion content and extraction from the document of its main issues. The document concluded for the possibility of a marketing authorization of the advanced therapy medicinal products, considering the principle of human dignity and fundamental rights to life and health, and conditioned it to the elaboration of a strictregulatory framework.
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spelling Legal possibility of marketing authorization and commercialization of advanced therapy medicinal products in BrazilPossibilidade jurídica de registro e comercialização de produtos de terapias avançadas no Brasil LegalAdvanced TherapiesStem CellsRegulationMarketing AuthorizationConstitutionTerapias AvançadasCélulas-troncoRegulamentaçãoComercializaçãoConstituiçãoIn view of the provisions of the Constitution of 1988, of the Federative Republic of Brazil, article 199, paragraph 4, which prohibits any form of marketing of organs, tissues and human substances for transplants, research and treatment, the possibility of commercialization and marketing authorization of human origin products in Brazil has been questioned. With the advent of advanced therapies, legal uncertainty on the subject has reached regulatory issues and permeated scientific and investments concerns over the sector. Such perception based the detailed analysis on the matter by Anvisa´s Federal Attorney’s Office, which was expressed on the Legal Opinion n. 12/2016/PF-Anvisa/PGF/AGU and exposed in this article. Outline, in this article, the main aspects concerning the legal possibility of marketing authorization and commercialization of advanced therapy medicinal products in Brazil, based on the Legal Opinion n° 12/2016/PF-Anvisa/PGF/AGU. Assessment of the Legal Opinion content and extraction from the document of its main issues. The document concluded for the possibility of a marketing authorization of the advanced therapy medicinal products, considering the principle of human dignity and fundamental rights to life and health, and conditioned it to the elaboration of a strictregulatory framework.Em vista do disposto no parágrafo 4° do art. 199 da Constituição Federal Brasileira, de 1988, que veda todo tipo de comercialização de órgãos, tecidos e substâncias humanas para fins de transplante, pesquisa e tratamento, a possibilidade de registro sanitário e comercialização dos produtos de origem humana no Brasil passou a ser indagada. Com o advento das Terapias Avançadas, a insegurança jurídica sobre o tema alcançou as questões de caráter regulamentar e permeou preocupações de ordem científica, tecnológica e financeira relacionadas ao setor. Tal percepção ensejou a análise detalhada da matéria pela Procuradoria Federal junto à Anvisa, expressa no Parecer Cons. n° 12/2016/PF-Anvisa/PGF/AGU. Expor, no presente artigo, os principais aspectos concernentes à possibilidade jurídica de registro e comercialização de produtos de terapias avançadas no Brasil, com base no teor do Parecer Cons. n° 12/2016/PF-Anvisa/PGF/AGU. Descriçãodo conteúdo do respectivo parecer, considerando os aspectos principais emanados no documento. Por meio da releitura constitucional, o Parecer concluiu pela possibilidade do registro e comercialização dos produtos de terapias avançadas, com fundamento no princípio da dignidade da pessoa humana e nos direitos fundamentais à vida e à saúde, e condicionada a um arcabouço regulatório rigoroso, a ser elaborado.Instituto Nacional de Controle de Qualidade em Saúde2018-02-28info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersion"Peer-reviewed article""Artículo revisado por pares""Artigo avaliado pelos pares"application/pdfapplication/pdfhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/107510.22239/2317-269X.01075Health Surveillance under Debate: Society, Science & Technology ; Vol. 6 No. 1 (2018): February - Tecnologias celulares avançadas: desafios biotecnológicos e regulatórios; 6-14Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 6 Núm. 1 (2018): Febrero - Tecnologias celulares avançadas: desafios biotecnológicos e regulatórios; 6-14Vigil Sanit Debate, Rio de Janeiro; v. 6 n. 1 (2018): Fevereiro - Tecnologias celulares avançadas: desafios biotecnológicos e regulatórios; 6-142317-269Xreponame:Vigilância Sanitária em Debateinstname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZporenghttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1075/424https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1075/1049Copyright (c) 2018 Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnologia (Health Surveillance under Debate: Society, Science & Technology) – Visa em Debatehttps://creativecommons.org/licenses/by-nc-nd/4.0info:eu-repo/semantics/openAccessGarcia, Luisa Abreu ObiciTakao, Marilia Rodrigues MendesParca, Renata MirandaSilva Junior, João Batista da2023-06-27T15:07:41Zoai:ojs.visaemdebate.incqs.fiocruz.br:article/1075Revistahttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebatePUBhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/oaiincqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br2317-269X2317-269Xopendoar:2023-06-27T15:07:41Vigilância Sanitária em Debate - Fundação Oswaldo Cruz (FIOCRUZ)false
dc.title.none.fl_str_mv Legal possibility of marketing authorization and commercialization of advanced therapy medicinal products in Brazil
Possibilidade jurídica de registro e comercialização de produtos de terapias avançadas no Brasil Legal
title Legal possibility of marketing authorization and commercialization of advanced therapy medicinal products in Brazil
spellingShingle Legal possibility of marketing authorization and commercialization of advanced therapy medicinal products in Brazil
Legal possibility of marketing authorization and commercialization of advanced therapy medicinal products in Brazil
Garcia, Luisa Abreu Obici
Advanced Therapies
Stem Cells
Regulation
Marketing Authorization
Constitution
Terapias Avançadas
Células-tronco
Regulamentação
Comercialização
Constituição
Garcia, Luisa Abreu Obici
Advanced Therapies
Stem Cells
Regulation
Marketing Authorization
Constitution
Terapias Avançadas
Células-tronco
Regulamentação
Comercialização
Constituição
title_short Legal possibility of marketing authorization and commercialization of advanced therapy medicinal products in Brazil
title_full Legal possibility of marketing authorization and commercialization of advanced therapy medicinal products in Brazil
title_fullStr Legal possibility of marketing authorization and commercialization of advanced therapy medicinal products in Brazil
Legal possibility of marketing authorization and commercialization of advanced therapy medicinal products in Brazil
title_full_unstemmed Legal possibility of marketing authorization and commercialization of advanced therapy medicinal products in Brazil
Legal possibility of marketing authorization and commercialization of advanced therapy medicinal products in Brazil
title_sort Legal possibility of marketing authorization and commercialization of advanced therapy medicinal products in Brazil
author Garcia, Luisa Abreu Obici
author_facet Garcia, Luisa Abreu Obici
Garcia, Luisa Abreu Obici
Takao, Marilia Rodrigues Mendes
Parca, Renata Miranda
Silva Junior, João Batista da
Takao, Marilia Rodrigues Mendes
Parca, Renata Miranda
Silva Junior, João Batista da
author_role author
author2 Takao, Marilia Rodrigues Mendes
Parca, Renata Miranda
Silva Junior, João Batista da
author2_role author
author
author
dc.contributor.author.fl_str_mv Garcia, Luisa Abreu Obici
Takao, Marilia Rodrigues Mendes
Parca, Renata Miranda
Silva Junior, João Batista da
dc.subject.por.fl_str_mv Advanced Therapies
Stem Cells
Regulation
Marketing Authorization
Constitution
Terapias Avançadas
Células-tronco
Regulamentação
Comercialização
Constituição
topic Advanced Therapies
Stem Cells
Regulation
Marketing Authorization
Constitution
Terapias Avançadas
Células-tronco
Regulamentação
Comercialização
Constituição
description In view of the provisions of the Constitution of 1988, of the Federative Republic of Brazil, article 199, paragraph 4, which prohibits any form of marketing of organs, tissues and human substances for transplants, research and treatment, the possibility of commercialization and marketing authorization of human origin products in Brazil has been questioned. With the advent of advanced therapies, legal uncertainty on the subject has reached regulatory issues and permeated scientific and investments concerns over the sector. Such perception based the detailed analysis on the matter by Anvisa´s Federal Attorney’s Office, which was expressed on the Legal Opinion n. 12/2016/PF-Anvisa/PGF/AGU and exposed in this article. Outline, in this article, the main aspects concerning the legal possibility of marketing authorization and commercialization of advanced therapy medicinal products in Brazil, based on the Legal Opinion n° 12/2016/PF-Anvisa/PGF/AGU. Assessment of the Legal Opinion content and extraction from the document of its main issues. The document concluded for the possibility of a marketing authorization of the advanced therapy medicinal products, considering the principle of human dignity and fundamental rights to life and health, and conditioned it to the elaboration of a strictregulatory framework.
publishDate 2018
dc.date.none.fl_str_mv 2018-02-28
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
"Peer-reviewed article"
"Artículo revisado por pares"
"Artigo avaliado pelos pares"
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1075
10.22239/2317-269X.01075
url https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1075
identifier_str_mv 10.22239/2317-269X.01075
dc.language.iso.fl_str_mv por
eng
language por
eng
dc.relation.none.fl_str_mv https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1075/424
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1075/1049
dc.rights.driver.fl_str_mv https://creativecommons.org/licenses/by-nc-nd/4.0
info:eu-repo/semantics/openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by-nc-nd/4.0
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv Instituto Nacional de Controle de Qualidade em Saúde
publisher.none.fl_str_mv Instituto Nacional de Controle de Qualidade em Saúde
dc.source.none.fl_str_mv Health Surveillance under Debate: Society, Science & Technology ; Vol. 6 No. 1 (2018): February - Tecnologias celulares avançadas: desafios biotecnológicos e regulatórios; 6-14
Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 6 Núm. 1 (2018): Febrero - Tecnologias celulares avançadas: desafios biotecnológicos e regulatórios; 6-14
Vigil Sanit Debate, Rio de Janeiro; v. 6 n. 1 (2018): Fevereiro - Tecnologias celulares avançadas: desafios biotecnológicos e regulatórios; 6-14
2317-269X
reponame:Vigilância Sanitária em Debate
instname:Fundação Oswaldo Cruz (FIOCRUZ)
instacron:FIOCRUZ
instname_str Fundação Oswaldo Cruz (FIOCRUZ)
instacron_str FIOCRUZ
institution FIOCRUZ
reponame_str Vigilância Sanitária em Debate
collection Vigilância Sanitária em Debate
repository.name.fl_str_mv Vigilância Sanitária em Debate - Fundação Oswaldo Cruz (FIOCRUZ)
repository.mail.fl_str_mv incqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br
_version_ 1822182070510682112
dc.identifier.doi.none.fl_str_mv 10.22239/2317-269X.01075

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