Abstract
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.
Highlights
Throughout the past 20 years stem cell therapies have acquired a priority role in health research agendas worldwide
Regenerative medicine comprises treatments in which stem cells are induced to differentiate into the specific cells required to repair such damages
This paper aims to analyze the process of shaping innovation pathways for stem cell technology in Argentina
Summary
Throughout the past 20 years stem cell therapies have acquired a priority role in health research agendas worldwide. For the past decade, scientists, STI agencies, bioethicists and patient organizations have warned against the risks of experimental treatments and the limitations of cryopreserving cord blood stem cells for autologous use They have started shaping a specific framework to regulate these emerging technologies and practices, setting standards in relation to quality, safety and effectiveness. The development and selection of regulatory alternatives for stem cells implies complex negotiation processes among stakeholders (firms, scientists, regulation authorities, lobby groups, physicians, patients, investment groups, biobanks, health insurances, etc.) These different regulatory models weigh between diverse options that entail benefits, risks, interests and values in terms of economic competitiveness and business profit, safety and efficacy control, widening/restricting people’s access to healthcare goods and services (Vasen, 2008). What are the local funding capacities to sustain long-drawn-out multi-stage clinical trials? Do the productive capacities to manufacture and commercialize these national developments exist? What are the social expenditure capacities to include these therapies within collective health systems?
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