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

• Published in: Sociologias 2019-04, Vol.21 (50), p.116-155
• Main Authors: Bortz, Gabriela, Rosemann, Achim, Vasen, Federico
• Format: Article
• Language: English
• Subjects: Biobanks; Capacity building approach; Células-tronco; Deployment; Developing countries; Economic development; Efficacy; Enforcement; Funding; Governança tecnológica; Government agencies; Growth rate; Harmonization; Innovations; LDCs; Legislation; Medicina regenerativa; Medicine; Políticas de ciência, tecnologia e inovação; Private sector; R&D; Regulation; Regulação; Research & development; Risk management; Safety regulations; Science and technology; Scientists; SOCIOLOGY; Stem cells; Strategies; Treatment methods; Umbilical cord
• ISSN: 1517-4522; 1807-0337; 1807-0337
• DOI: 10.1590/15174522-02105004

Abstract 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. Resumen Este artículo tiene como objetivo analizar las trayectorias de innovación en terapias con células madre en Argentina. En primer lugar, presentamos una perspectiva teórica sobre la co-construcción de la regulación y del desarrollo tecnológico, y planteamos cuatro tensiones principales que subyacen a la construcción regulatoria y a la conformación de estrategias nacionales para la medicina regenerativa. La regulación es entendida como un proceso de negociación entre intereses, valores, premios, beneficios y diferentes comprensiones sobre las nociones de seguridad, eficacia, acceso y disponibilidad. El marco conceptual es útil para explorar cómo los actores y sus visiones sobre futuros deseados moldean la creación de normativas y, a su vez, cómo éstas