Limiting access to unapproved therapies: A paternalistic practice?
Autor(a) principal: | |
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Data de Publicação: | 2019 |
Tipo de documento: | Artigo |
Idioma: | eng por |
Título da fonte: | Revista Espaço Jurídico/Espaço Jurídico Journal of Law |
Texto Completo: | https://periodicos.unoesc.edu.br/espacojuridico/article/view/23247 |
Resumo: | The aim of the article is to answer the question of whether the limitations of the access to unapproved therapies outside of clinical trials are permissible in light of the modern paradigm of health care which is based on the patients’ autonomy of will. We only focus on the therapies consisting in the provision of unregistered medicinal products. The law is often restrictive in allowing patients to be provided with experimental therapies even if they grant fully informed consent. The Czech law and a recent Czech case of an unapproved stem cell therapy provide a basis for the analysis of the problem with universally applicable conclusions. We argue that the regulation of access to unapproved therapies serves an important public interest of the protection of public trust in the health system and hence is justified. The law should only permit access to experimental therapies that have sufficient scientific justifications. Under certain conditions, the patients can be allowed to cover the costs of the therapy. |
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Limiting access to unapproved therapies: A paternalistic practice? Limitando o acesso a terapias não aprovadas: Uma prática paternalista?Health lawUnapproved therapiesStem cell therapiesMedical paternalismThe Czech RepublicLegislação sanitáriaTerapias não aprovadasTerapias com células-troncoPaternalismo médicoRepública TchecaThe aim of the article is to answer the question of whether the limitations of the access to unapproved therapies outside of clinical trials are permissible in light of the modern paradigm of health care which is based on the patients’ autonomy of will. We only focus on the therapies consisting in the provision of unregistered medicinal products. The law is often restrictive in allowing patients to be provided with experimental therapies even if they grant fully informed consent. The Czech law and a recent Czech case of an unapproved stem cell therapy provide a basis for the analysis of the problem with universally applicable conclusions. We argue that the regulation of access to unapproved therapies serves an important public interest of the protection of public trust in the health system and hence is justified. The law should only permit access to experimental therapies that have sufficient scientific justifications. Under certain conditions, the patients can be allowed to cover the costs of the therapy.O objetivo deste artigo é responder sobre se são permitidas as limitações do acesso a terapias não aprovadas fora dos ensaios clínicos, à luz do paradigma moderno dos cuidados de saúde, que se baseia na autonomia de vontade dos pacientes. O debate do texto se concentra nas terapias que consistem no fornecimento de medicamentos não registrados. A lei é muitas vezes restritiva ao permitir que os pacientes recebam terapias experimentais, mesmo que concedam consentimento totalmente informado. A lei tcheca e um recente caso tcheco de terapia com células-tronco não aprovada fornecem uma base para a análise do problema com conclusões universalmente aplicáveis. Argumentamos que a regulamentação do acesso a terapias não aprovadas atende a um importante interesse público da proteção da confiança pública no sistema de saúde e, portanto, é justificada. A lei deve permitir apenas o acesso a terapias experimentais com justificativas científicas suficientes. Sob certas condições, os pacientes podem cobrir os custos da terapia.Universidade do Oeste de Santa Catarina, UNOESC2019-12-12info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionAvaliado por Paresapplication/pdftext/htmlhttps://periodicos.unoesc.edu.br/espacojuridico/article/view/2324710.18593/ejjl.23247Espaço Jurídico Journal of Law [EJJL]; Bd. 20 Nr. 2 (2019): Espaço Juridico Journal of Law [EJJL]; 215-232Espaço Jurídico Journal of Law [EJJL]; Vol. 20 No. 2 (2019): Espaço Juridico Journal of Law [EJJL]; 215-232Espaço Jurídico Journal of Law [EJJL]; Vol. 20 Núm. 2 (2019): Espaço Juridico Journal of Law [EJJL]; 215-232Espaço Jurídico Journal of Law [EJJL]; Vol. 20 No. 2 (2019): Espaço Juridico Journal of Law [EJJL]; 215-232Espaço Jurídico Journal of Law [EJJL]; v. 20 n. 2 (2019): Espaço Juridico Journal of Law [EJJL]; 215-2322179-79431519-5899reponame:Revista Espaço Jurídico/Espaço Jurídico Journal of Lawinstname:Universidade do Oeste de Santa Catarina (UNOESC)instacron:UNOESCengporhttps://periodicos.unoesc.edu.br/espacojuridico/article/view/23247/13516https://periodicos.unoesc.edu.br/espacojuridico/article/view/23247/14059Copyright (c) 2019 Martin Solcinfo:eu-repo/semantics/openAccessŠolc, Martin2020-10-16T20:18:53Zoai:ojs.periodicos.unoesc.edu.br:article/23247Revistahttps://portalperiodicos.unoesc.edu.br/espacojuridico/indexhttp://editora.unoesc.edu.br/index.php/espacojuridico/oaieditora@unoesc.edu.br||ejjl@unoesc.edu.br2179-79431519-5899opendoar:2020-10-16T20:18:53Revista Espaço Jurídico/Espaço Jurídico Journal of Law - Universidade do Oeste de Santa Catarina (UNOESC)false |
dc.title.none.fl_str_mv |
Limiting access to unapproved therapies: A paternalistic practice? Limitando o acesso a terapias não aprovadas: Uma prática paternalista? |
title |
Limiting access to unapproved therapies: A paternalistic practice? |
spellingShingle |
Limiting access to unapproved therapies: A paternalistic practice? Šolc, Martin Health law Unapproved therapies Stem cell therapies Medical paternalism The Czech Republic Legislação sanitária Terapias não aprovadas Terapias com células-tronco Paternalismo médico República Tcheca |
title_short |
Limiting access to unapproved therapies: A paternalistic practice? |
title_full |
Limiting access to unapproved therapies: A paternalistic practice? |
title_fullStr |
Limiting access to unapproved therapies: A paternalistic practice? |
title_full_unstemmed |
Limiting access to unapproved therapies: A paternalistic practice? |
title_sort |
Limiting access to unapproved therapies: A paternalistic practice? |
author |
Šolc, Martin |
author_facet |
Šolc, Martin |
author_role |
author |
dc.contributor.author.fl_str_mv |
Šolc, Martin |
dc.subject.por.fl_str_mv |
Health law Unapproved therapies Stem cell therapies Medical paternalism The Czech Republic Legislação sanitária Terapias não aprovadas Terapias com células-tronco Paternalismo médico República Tcheca |
topic |
Health law Unapproved therapies Stem cell therapies Medical paternalism The Czech Republic Legislação sanitária Terapias não aprovadas Terapias com células-tronco Paternalismo médico República Tcheca |
description |
The aim of the article is to answer the question of whether the limitations of the access to unapproved therapies outside of clinical trials are permissible in light of the modern paradigm of health care which is based on the patients’ autonomy of will. We only focus on the therapies consisting in the provision of unregistered medicinal products. The law is often restrictive in allowing patients to be provided with experimental therapies even if they grant fully informed consent. The Czech law and a recent Czech case of an unapproved stem cell therapy provide a basis for the analysis of the problem with universally applicable conclusions. We argue that the regulation of access to unapproved therapies serves an important public interest of the protection of public trust in the health system and hence is justified. The law should only permit access to experimental therapies that have sufficient scientific justifications. Under certain conditions, the patients can be allowed to cover the costs of the therapy. |
publishDate |
2019 |
dc.date.none.fl_str_mv |
2019-12-12 |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion Avaliado por Pares |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
https://periodicos.unoesc.edu.br/espacojuridico/article/view/23247 10.18593/ejjl.23247 |
url |
https://periodicos.unoesc.edu.br/espacojuridico/article/view/23247 |
identifier_str_mv |
10.18593/ejjl.23247 |
dc.language.iso.fl_str_mv |
eng por |
language |
eng por |
dc.relation.none.fl_str_mv |
https://periodicos.unoesc.edu.br/espacojuridico/article/view/23247/13516 https://periodicos.unoesc.edu.br/espacojuridico/article/view/23247/14059 |
dc.rights.driver.fl_str_mv |
Copyright (c) 2019 Martin Solc info:eu-repo/semantics/openAccess |
rights_invalid_str_mv |
Copyright (c) 2019 Martin Solc |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
application/pdf text/html |
dc.publisher.none.fl_str_mv |
Universidade do Oeste de Santa Catarina, UNOESC |
publisher.none.fl_str_mv |
Universidade do Oeste de Santa Catarina, UNOESC |
dc.source.none.fl_str_mv |
Espaço Jurídico Journal of Law [EJJL]; Bd. 20 Nr. 2 (2019): Espaço Juridico Journal of Law [EJJL]; 215-232 Espaço Jurídico Journal of Law [EJJL]; Vol. 20 No. 2 (2019): Espaço Juridico Journal of Law [EJJL]; 215-232 Espaço Jurídico Journal of Law [EJJL]; Vol. 20 Núm. 2 (2019): Espaço Juridico Journal of Law [EJJL]; 215-232 Espaço Jurídico Journal of Law [EJJL]; Vol. 20 No. 2 (2019): Espaço Juridico Journal of Law [EJJL]; 215-232 Espaço Jurídico Journal of Law [EJJL]; v. 20 n. 2 (2019): Espaço Juridico Journal of Law [EJJL]; 215-232 2179-7943 1519-5899 reponame:Revista Espaço Jurídico/Espaço Jurídico Journal of Law instname:Universidade do Oeste de Santa Catarina (UNOESC) instacron:UNOESC |
instname_str |
Universidade do Oeste de Santa Catarina (UNOESC) |
instacron_str |
UNOESC |
institution |
UNOESC |
reponame_str |
Revista Espaço Jurídico/Espaço Jurídico Journal of Law |
collection |
Revista Espaço Jurídico/Espaço Jurídico Journal of Law |
repository.name.fl_str_mv |
Revista Espaço Jurídico/Espaço Jurídico Journal of Law - Universidade do Oeste de Santa Catarina (UNOESC) |
repository.mail.fl_str_mv |
editora@unoesc.edu.br||ejjl@unoesc.edu.br |
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1800220447210471424 |