Shaping stem cell therapies in Argentina

Regulation, Risk Management and Innovation Policies

Bibliographic Data

ID4354637
AuthorsGabriela Bortz (0000-0001-7151-6686, Consejo Nacional de Investigaciones Científicas y Técnicas), Achim Rosemann (0000-0003-3184-3441, University of Exeter), Federico Vasen (0000-0001-9132-6206, Consejo Nacional de Investigaciones Científicas y Técnicas)
Year2019
Volume21
Issue50
Pages116-155
Publication date2019-04-01
Peer ReviewedYes
Open AccessYes
TypeARTICLE
VenueSociologias (JOURNAL)
Journal identifiersISSN: 1517-4522 • E-ISSN: 1807-0337
PublisherFapUNIFESP (SciELO) (PUBLISHER)
DOI10.1590/15174522-02105004
OpenAlexW2922350927
SCIELO_PIDS1517-45222019000100116
LanguageEN
Citations received3
References cited26

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

Business · Enforcement · Harmonization · Industrial organization · Political science · Procurement · Sociology · Vision · Biomedical Ethics and Regulation · Neuroethics, Human Enhancement, Biomedical Innovations · Pluripotent Stem Cells Research · Marketing