Regulação dos gases medicinais no Brasil
Autor(a) principal: | |
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Data de Publicação: | 2022 |
Tipo de documento: | Dissertação |
Idioma: | por |
Título da fonte: | Repositório Institucional do FGV (FGV Repositório Digital) |
Texto Completo: | https://hdl.handle.net/10438/33007 |
Resumo: | Different atmospheric gases, such as oxygen, nitrogen and argon - as well as process gases (which arise due to a chemical reaction) and certain gas mixtures - have been used over the years by mankind in a number of industrial and medical applications. Specifically, medical gases – those used in the health area and intended to come into contact with the human body for diagnosis, treatment or prophylaxis – came under regulation by the Brazilian Health Regulatory Agency – Anvisa, with the entry into force of two resolutions on the subject in the first decade of this century. In this context, the present work has as research problem the analysis of the need for regulatory intervention in the medical gases sector. Considering the duty of the State to (i) regulate, supervise and control health activities - provided for in Articles 196 and 197 of the Federal Constitution – and at the same time (ii) avoid the abuse of regulatory power, which was recently established by Law No. 13.874 of September 20th, 2019 (Economic Freedom Act - LLE), as well as (iii) meeting Anvisa's institutional mission to promote the protection of the population's health, by executing sanitary control of both the production and marketing of products and ingredients, the following question is made: is the regulation in the medical gases sector justified? The hypothesis is that, due to the social risks inherent to the activities involving medical gases, the State must exercise its regulatory power and intervene to define technical parameters regarding the manufacturing, filling, distribution and transportation of these products. There are risks to human health and serious accidents involved in the activities. Likewise, there are market failures due to the characteristics of the sector (information asymmetry and externalities, most notably) which justify the need for intervention. On the other hand, the new law introduced by the Economic Freedom Act necessary to mitigate market failures and performed in a rational and proportional way. To test this hypothesis, the work proposes to use the case study regarding the regulation being carried out by Anvisa in Brazil as of the first decade of this millennium concerning medical gases, verifying whether such regulation meets the constitutional duty of the State to regulate, supervise and control health activities and, concurrently, is in line with the Economic Freedom Act. This work also offers a critical analysis and proposes regulatory adjustments to adapt the current regulation, correcting imperfections detected with the purpose of mitigating market failures and, at the same time, observing the legal imposition of minimum intervention in economic activity. In order to discuss the above theme with a real example, a flexibility promoted by the Regulatory Agency during the Covid-19 pandemic will be analyzed, when the minimum purity requirement for medical oxygen manufactured in cryogenic plants outside health facilities was reduced, which reinforced one of the detected adjustments. |
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Costa, Gustavo Aguiar daEscolas::DIREITO RIOGuerra, Sérgio Antônio SilvaJusten Filho, MarçalSampaio, Rômulo Silveira da Rocha2022-12-21T14:31:15Z2022-12-21T14:31:15Z2022-07-19https://hdl.handle.net/10438/33007Different atmospheric gases, such as oxygen, nitrogen and argon - as well as process gases (which arise due to a chemical reaction) and certain gas mixtures - have been used over the years by mankind in a number of industrial and medical applications. Specifically, medical gases – those used in the health area and intended to come into contact with the human body for diagnosis, treatment or prophylaxis – came under regulation by the Brazilian Health Regulatory Agency – Anvisa, with the entry into force of two resolutions on the subject in the first decade of this century. In this context, the present work has as research problem the analysis of the need for regulatory intervention in the medical gases sector. Considering the duty of the State to (i) regulate, supervise and control health activities - provided for in Articles 196 and 197 of the Federal Constitution – and at the same time (ii) avoid the abuse of regulatory power, which was recently established by Law No. 13.874 of September 20th, 2019 (Economic Freedom Act - LLE), as well as (iii) meeting Anvisa's institutional mission to promote the protection of the population's health, by executing sanitary control of both the production and marketing of products and ingredients, the following question is made: is the regulation in the medical gases sector justified? The hypothesis is that, due to the social risks inherent to the activities involving medical gases, the State must exercise its regulatory power and intervene to define technical parameters regarding the manufacturing, filling, distribution and transportation of these products. There are risks to human health and serious accidents involved in the activities. Likewise, there are market failures due to the characteristics of the sector (information asymmetry and externalities, most notably) which justify the need for intervention. On the other hand, the new law introduced by the Economic Freedom Act necessary to mitigate market failures and performed in a rational and proportional way. To test this hypothesis, the work proposes to use the case study regarding the regulation being carried out by Anvisa in Brazil as of the first decade of this millennium concerning medical gases, verifying whether such regulation meets the constitutional duty of the State to regulate, supervise and control health activities and, concurrently, is in line with the Economic Freedom Act. This work also offers a critical analysis and proposes regulatory adjustments to adapt the current regulation, correcting imperfections detected with the purpose of mitigating market failures and, at the same time, observing the legal imposition of minimum intervention in economic activity. In order to discuss the above theme with a real example, a flexibility promoted by the Regulatory Agency during the Covid-19 pandemic will be analyzed, when the minimum purity requirement for medical oxygen manufactured in cryogenic plants outside health facilities was reduced, which reinforced one of the detected adjustments.O presente trabalho tem como problema de pesquisa a análise da necessidade de intervenção regulatória no setor dos gases medicinais. A hipótese é que, pelos riscos sociais presentes nas atividades que envolvem os gases medicinais, o Estado deve exercer o seu poder regulatório e intervir para definir parâmetros técnicos quanto à fabricação, envase, armazenagem, distribuição e transporte desses produtos. O novo comando legal introduzido pela Lei da Liberdade Econômica reforça a proteção à livre iniciativa, impondo que a Administração Pública não abuse do poder regulatório. A intervenção, assim, deve ser a mínima necessária para mitigar as falhas de mercado, feita com racionalidade e proporcionalidade. Para testar essa hipótese, o trabalho se propõe a utilizar o estudo de caso a respeito da regulação levada a efeito pela Anvisa no Brasil a partir da primeira década deste milênio com relação aos gases medicinais, verificando se tal regulação atende ao dever constitucional do Estado de regulamentar, fiscalizar e controlar as atividades de saúde e, ao mesmo tempo, está em linha com a Lei da Liberdade Econômica. O trabalho oferece ainda uma análise crítica e propõe ajustes regulatórios para adequar a atual regulação, corrigindo imperfeições detectadas, com o propósito de mitigar as falhas de mercado e ao mesmo tempo observar a imposição legal de intervenção mínima na atividade econômica. Por fim, foi analisada uma flexibilização promovida pela Agência Reguladora durante a pandemia da Covid-19, quando foi reduzida a exigência de pureza mínima para o oxigênio medicinal fabricado em usinas criogênicas fora dos estabelecimentos de saúde, o que veio a reforçar um dos ajustes detectados.porRegulationMedical gasesRegulaçãoGases medicinaisAnvisaDireitoDireito regulatórioGases medicinais - BrasilTerapia respiratória - Equipamento e acessóriosAgência Nacional de Vigilância Sanitária (Brasil)Regulação dos gases medicinais no Brasilinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/masterThesisinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional do FGV (FGV Repositório Digital)instname:Fundação Getulio Vargas (FGV)instacron:FGVTEXTRegulacao dos Gases Medicinais no Brasil - Gutavo Aguiar da Costa (4).pdf.txtRegulacao dos Gases Medicinais no Brasil - Gutavo Aguiar da Costa (4).pdf.txtExtracted 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|
dc.title.por.fl_str_mv |
Regulação dos gases medicinais no Brasil |
title |
Regulação dos gases medicinais no Brasil |
spellingShingle |
Regulação dos gases medicinais no Brasil Costa, Gustavo Aguiar da Regulation Medical gases Regulação Gases medicinais Anvisa Direito Direito regulatório Gases medicinais - Brasil Terapia respiratória - Equipamento e acessórios Agência Nacional de Vigilância Sanitária (Brasil) |
title_short |
Regulação dos gases medicinais no Brasil |
title_full |
Regulação dos gases medicinais no Brasil |
title_fullStr |
Regulação dos gases medicinais no Brasil |
title_full_unstemmed |
Regulação dos gases medicinais no Brasil |
title_sort |
Regulação dos gases medicinais no Brasil |
author |
Costa, Gustavo Aguiar da |
author_facet |
Costa, Gustavo Aguiar da |
author_role |
author |
dc.contributor.unidadefgv.por.fl_str_mv |
Escolas::DIREITO RIO |
dc.contributor.member.none.fl_str_mv |
Guerra, Sérgio Antônio Silva Justen Filho, Marçal |
dc.contributor.author.fl_str_mv |
Costa, Gustavo Aguiar da |
dc.contributor.advisor1.fl_str_mv |
Sampaio, Rômulo Silveira da Rocha |
contributor_str_mv |
Sampaio, Rômulo Silveira da Rocha |
dc.subject.eng.fl_str_mv |
Regulation Medical gases |
topic |
Regulation Medical gases Regulação Gases medicinais Anvisa Direito Direito regulatório Gases medicinais - Brasil Terapia respiratória - Equipamento e acessórios Agência Nacional de Vigilância Sanitária (Brasil) |
dc.subject.por.fl_str_mv |
Regulação Gases medicinais Anvisa |
dc.subject.area.por.fl_str_mv |
Direito |
dc.subject.bibliodata.por.fl_str_mv |
Direito regulatório Gases medicinais - Brasil Terapia respiratória - Equipamento e acessórios Agência Nacional de Vigilância Sanitária (Brasil) |
description |
Different atmospheric gases, such as oxygen, nitrogen and argon - as well as process gases (which arise due to a chemical reaction) and certain gas mixtures - have been used over the years by mankind in a number of industrial and medical applications. Specifically, medical gases – those used in the health area and intended to come into contact with the human body for diagnosis, treatment or prophylaxis – came under regulation by the Brazilian Health Regulatory Agency – Anvisa, with the entry into force of two resolutions on the subject in the first decade of this century. In this context, the present work has as research problem the analysis of the need for regulatory intervention in the medical gases sector. Considering the duty of the State to (i) regulate, supervise and control health activities - provided for in Articles 196 and 197 of the Federal Constitution – and at the same time (ii) avoid the abuse of regulatory power, which was recently established by Law No. 13.874 of September 20th, 2019 (Economic Freedom Act - LLE), as well as (iii) meeting Anvisa's institutional mission to promote the protection of the population's health, by executing sanitary control of both the production and marketing of products and ingredients, the following question is made: is the regulation in the medical gases sector justified? The hypothesis is that, due to the social risks inherent to the activities involving medical gases, the State must exercise its regulatory power and intervene to define technical parameters regarding the manufacturing, filling, distribution and transportation of these products. There are risks to human health and serious accidents involved in the activities. Likewise, there are market failures due to the characteristics of the sector (information asymmetry and externalities, most notably) which justify the need for intervention. On the other hand, the new law introduced by the Economic Freedom Act necessary to mitigate market failures and performed in a rational and proportional way. To test this hypothesis, the work proposes to use the case study regarding the regulation being carried out by Anvisa in Brazil as of the first decade of this millennium concerning medical gases, verifying whether such regulation meets the constitutional duty of the State to regulate, supervise and control health activities and, concurrently, is in line with the Economic Freedom Act. This work also offers a critical analysis and proposes regulatory adjustments to adapt the current regulation, correcting imperfections detected with the purpose of mitigating market failures and, at the same time, observing the legal imposition of minimum intervention in economic activity. In order to discuss the above theme with a real example, a flexibility promoted by the Regulatory Agency during the Covid-19 pandemic will be analyzed, when the minimum purity requirement for medical oxygen manufactured in cryogenic plants outside health facilities was reduced, which reinforced one of the detected adjustments. |
publishDate |
2022 |
dc.date.accessioned.fl_str_mv |
2022-12-21T14:31:15Z |
dc.date.available.fl_str_mv |
2022-12-21T14:31:15Z |
dc.date.issued.fl_str_mv |
2022-07-19 |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/masterThesis |
format |
masterThesis |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
https://hdl.handle.net/10438/33007 |
url |
https://hdl.handle.net/10438/33007 |
dc.language.iso.fl_str_mv |
por |
language |
por |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.source.none.fl_str_mv |
reponame:Repositório Institucional do FGV (FGV Repositório Digital) instname:Fundação Getulio Vargas (FGV) instacron:FGV |
instname_str |
Fundação Getulio Vargas (FGV) |
instacron_str |
FGV |
institution |
FGV |
reponame_str |
Repositório Institucional do FGV (FGV Repositório Digital) |
collection |
Repositório Institucional do FGV (FGV Repositório Digital) |
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repository.name.fl_str_mv |
Repositório Institucional do FGV (FGV Repositório Digital) - Fundação Getulio Vargas (FGV) |
repository.mail.fl_str_mv |
|
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1810023794614468608 |