Shaping stem cell therapies in Argentina: regulation, risk management and innovation policies

Autores

DOI:

https://doi.org/10.1590/15174522-02105004

Palavras-chave:

Stem cells, Regenerative medicine, Science Technology and Innovation Policies, Regulation, Emergent technologies

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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Biografia do Autor

Gabriela Bortz, Universidade Federal do Rio Grande do Sul

PhD in Social Sciences (Universidad de Buenos Aires), a postdoctoral fellowship from the National Council for Scientific and Technical Research (CONICET) at the Institute of Science and Technology Studies, Universidad Nacional de Quilmes (IESCT-UNQ), Buenos Aires, Argentina.

Achim Rosemann, University of Exeter

Research Fellow at the Department of Sociology, Philosophy and Anthropology, University of Exeter, United Kingdom

Federico Vasen, Universidad de Buenos Aires

Assistant Researcher at the National Council of Scientific and Technical Research (CONICET), Argentina. Researcher at the Institute of Education Sciences, School of Philosophy and Letters, Universidad De Buenos Aires (UBA), Buenos Aires, Argentina.

Publicado

2019-02-23

Como Citar

BORTZ, G.; ROSEMANN, A.; VASEN, F. Shaping stem cell therapies in Argentina: regulation, risk management and innovation policies. Sociologias, [S. l.], v. 21, n. 50, 2019. DOI: 10.1590/15174522-02105004. Disponível em: https://www.seer.ufrgs.br/index.php/sociologias/article/view/88238. Acesso em: 28 set. 2022.