Shaping stem cell therapies in Argentina: regulation, risk management and innovation policies
Autor(a) principal: | |
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Data de Publicação: | 2019 |
Outros Autores: | , |
Tipo de documento: | Artigo |
Idioma: | eng por |
Título da fonte: | Sociologias (Online) |
Texto Completo: | https://seer.ufrgs.br/index.php/sociologias/article/view/88238 |
Resumo: | This paper aims to analyze innovation pathways for stem cell technology in Argentina. Firstly, we present a theoretical perspective on the co-construction of regulation and technology development, positing four main tensions that underlie regulatory building and the shaping of national strategies for regenerative medicine. Regulation is understood as a negotiated process among interests, values, benefits, rewards, and different understandings of safety, efficacy, access and availability. The framework is useful to explore how actors and their visions of desired futures shape the creation of standards and, in turn, how they configure the way these emerging technologies are produced, accessed and used. Secondly, we discuss in detail the Argentine case. We focus on (a) the deployment of state actions on capacity and regulatory building, (b) the creation of new businesses in response to patient expectations, particularly umbilical cord stem cell banks and the supply of experimental treatments, and (c) state-led actions to build a specific regulatory framework (still in the making). Ambiguities and gaps in the current legislation as well as scarce enforcement capabilities configure a legal “grey area” for for-profit experimental treatments. Building a specific regulatory framework is understood to be a part of Science, Technology and Innovation (STI) state agencies’ struggle to govern technology development in terms of national envisaged innovation strategies. Lastly, we show how STI authorities and scientists managed to align a broad coalition of actors that encourage international harmonization strategies, following the pharmaceutical model of drug evaluation based on the multi-phase trial system. |
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Shaping stem cell therapies in Argentina: regulation, risk management and innovation policiesStem cellsRegenerative medicineScience Technology and Innovation PoliciesRegulationEmergent technologiesThis paper aims to analyze innovation pathways for stem cell technology in Argentina. Firstly, we present a theoretical perspective on the co-construction of regulation and technology development, positing four main tensions that underlie regulatory building and the shaping of national strategies for regenerative medicine. Regulation is understood as a negotiated process among interests, values, benefits, rewards, and different understandings of safety, efficacy, access and availability. The framework is useful to explore how actors and their visions of desired futures shape the creation of standards and, in turn, how they configure the way these emerging technologies are produced, accessed and used. Secondly, we discuss in detail the Argentine case. We focus on (a) the deployment of state actions on capacity and regulatory building, (b) the creation of new businesses in response to patient expectations, particularly umbilical cord stem cell banks and the supply of experimental treatments, and (c) state-led actions to build a specific regulatory framework (still in the making). Ambiguities and gaps in the current legislation as well as scarce enforcement capabilities configure a legal “grey area” for for-profit experimental treatments. Building a specific regulatory framework is understood to be a part of Science, Technology and Innovation (STI) state agencies’ struggle to govern technology development in terms of national envisaged innovation strategies. Lastly, we show how STI authorities and scientists managed to align a broad coalition of actors that encourage international harmonization strategies, following the pharmaceutical model of drug evaluation based on the multi-phase trial system.Programa de Pós-Graduação em Sociologia da Universidade Federal do Rio Grande do Sul2019-02-23info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersion"Avaliado pelos pares"application/pdfapplication/pdfhttps://seer.ufrgs.br/index.php/sociologias/article/view/8823810.1590/15174522-02105004SOCIOLOGIAS; Vol. 21 No. 50 (2019): Agendas biomédicas: interfaces do conhecimento em saúde no século XXISOCIOLOGIAS; Vol. 21 Núm. 50 (2019): Agendas biomédicas: interfaces do conhecimento em saúde no século XXISociologias; v. 21 n. 50 (2019): Agendas biomédicas: interfaces do conhecimento em saúde no século XXI1807-03371517-4522reponame:Sociologias (Online)instname:Universidade Federal do Rio Grande do Sul (UFRGS)instacron:UFRGSengporhttps://seer.ufrgs.br/index.php/sociologias/article/view/88238/52069https://seer.ufrgs.br/index.php/sociologias/article/view/88238/52070Copyright (c) 2019 Gabriela Bortz, Achim Rosemann, Federico Vaseninfo:eu-repo/semantics/openAccessBortz, GabrielaRosemann, AchimVasen, Federico2021-08-30T02:21:18Zoai:seer.ufrgs.br:article/88238Revistahttps://seer.ufrgs.br/sociologiasPUBhttps://seer.ufrgs.br/sociologias/oai||revsoc@ufrgs.br1807-03371517-4522opendoar:2021-08-30T02:21:18Sociologias (Online) - Universidade Federal do Rio Grande do Sul (UFRGS)false |
dc.title.none.fl_str_mv |
Shaping stem cell therapies in Argentina: regulation, risk management and innovation policies |
title |
Shaping stem cell therapies in Argentina: regulation, risk management and innovation policies |
spellingShingle |
Shaping stem cell therapies in Argentina: regulation, risk management and innovation policies Bortz, Gabriela Stem cells Regenerative medicine Science Technology and Innovation Policies Regulation Emergent technologies |
title_short |
Shaping stem cell therapies in Argentina: regulation, risk management and innovation policies |
title_full |
Shaping stem cell therapies in Argentina: regulation, risk management and innovation policies |
title_fullStr |
Shaping stem cell therapies in Argentina: regulation, risk management and innovation policies |
title_full_unstemmed |
Shaping stem cell therapies in Argentina: regulation, risk management and innovation policies |
title_sort |
Shaping stem cell therapies in Argentina: regulation, risk management and innovation policies |
author |
Bortz, Gabriela |
author_facet |
Bortz, Gabriela Rosemann, Achim Vasen, Federico |
author_role |
author |
author2 |
Rosemann, Achim Vasen, Federico |
author2_role |
author author |
dc.contributor.author.fl_str_mv |
Bortz, Gabriela Rosemann, Achim Vasen, Federico |
dc.subject.por.fl_str_mv |
Stem cells Regenerative medicine Science Technology and Innovation Policies Regulation Emergent technologies |
topic |
Stem cells Regenerative medicine Science Technology and Innovation Policies Regulation Emergent technologies |
description |
This paper aims to analyze innovation pathways for stem cell technology in Argentina. Firstly, we present a theoretical perspective on the co-construction of regulation and technology development, positing four main tensions that underlie regulatory building and the shaping of national strategies for regenerative medicine. Regulation is understood as a negotiated process among interests, values, benefits, rewards, and different understandings of safety, efficacy, access and availability. The framework is useful to explore how actors and their visions of desired futures shape the creation of standards and, in turn, how they configure the way these emerging technologies are produced, accessed and used. Secondly, we discuss in detail the Argentine case. We focus on (a) the deployment of state actions on capacity and regulatory building, (b) the creation of new businesses in response to patient expectations, particularly umbilical cord stem cell banks and the supply of experimental treatments, and (c) state-led actions to build a specific regulatory framework (still in the making). Ambiguities and gaps in the current legislation as well as scarce enforcement capabilities configure a legal “grey area” for for-profit experimental treatments. Building a specific regulatory framework is understood to be a part of Science, Technology and Innovation (STI) state agencies’ struggle to govern technology development in terms of national envisaged innovation strategies. Lastly, we show how STI authorities and scientists managed to align a broad coalition of actors that encourage international harmonization strategies, following the pharmaceutical model of drug evaluation based on the multi-phase trial system. |
publishDate |
2019 |
dc.date.none.fl_str_mv |
2019-02-23 |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion "Avaliado pelos pares" |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
https://seer.ufrgs.br/index.php/sociologias/article/view/88238 10.1590/15174522-02105004 |
url |
https://seer.ufrgs.br/index.php/sociologias/article/view/88238 |
identifier_str_mv |
10.1590/15174522-02105004 |
dc.language.iso.fl_str_mv |
eng por |
language |
eng por |
dc.relation.none.fl_str_mv |
https://seer.ufrgs.br/index.php/sociologias/article/view/88238/52069 https://seer.ufrgs.br/index.php/sociologias/article/view/88238/52070 |
dc.rights.driver.fl_str_mv |
Copyright (c) 2019 Gabriela Bortz, Achim Rosemann, Federico Vasen info:eu-repo/semantics/openAccess |
rights_invalid_str_mv |
Copyright (c) 2019 Gabriela Bortz, Achim Rosemann, Federico Vasen |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
application/pdf application/pdf |
dc.publisher.none.fl_str_mv |
Programa de Pós-Graduação em Sociologia da Universidade Federal do Rio Grande do Sul |
publisher.none.fl_str_mv |
Programa de Pós-Graduação em Sociologia da Universidade Federal do Rio Grande do Sul |
dc.source.none.fl_str_mv |
SOCIOLOGIAS; Vol. 21 No. 50 (2019): Agendas biomédicas: interfaces do conhecimento em saúde no século XXI SOCIOLOGIAS; Vol. 21 Núm. 50 (2019): Agendas biomédicas: interfaces do conhecimento em saúde no século XXI Sociologias; v. 21 n. 50 (2019): Agendas biomédicas: interfaces do conhecimento em saúde no século XXI 1807-0337 1517-4522 reponame:Sociologias (Online) instname:Universidade Federal do Rio Grande do Sul (UFRGS) instacron:UFRGS |
instname_str |
Universidade Federal do Rio Grande do Sul (UFRGS) |
instacron_str |
UFRGS |
institution |
UFRGS |
reponame_str |
Sociologias (Online) |
collection |
Sociologias (Online) |
repository.name.fl_str_mv |
Sociologias (Online) - Universidade Federal do Rio Grande do Sul (UFRGS) |
repository.mail.fl_str_mv |
||revsoc@ufrgs.br |
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1799766142062952448 |