Global Diversification in Medicine Regulation: Insights from Regenerative Stem Cell Medicine
dc.contributor.author | Rosemann, A | |
dc.contributor.author | Vasen, F | |
dc.contributor.author | Bortz, G | |
dc.date.accessioned | 2018-12-21T11:46:34Z | |
dc.date.issued | 2018-12-20 | |
dc.description.abstract | Medicine regulation worldwide has undergone a process of regulatory diversification. The evidence-based medicine (EBM) paradigm, centered on multi-phase randomized controlled trials, is increasingly contested and replaced by new models of clinical validation. To explain these changes, STS research has cited just a few factors, e.g. growing pressure form health consumers; the role of pharmaceutical companies to lobby for fast, affordable drug development; the influence of neoliberal ideas and libertarian advocacy of deregulation; and the agency of national governments to enable domestic innovation opportunities in the context of global competition and inequalities. Those factors individually cannot account for the increasing variation in medicine regulation at both national and global levels. Instead it is helpful to integrate elements of existing explanations into a framework with four pairs of conflicting regulatory choices, which play a central role in the formation of medicine regulation. We use this framework to compare regulatory changes in the USA, European Union, China, India, Argentina, and Japan. Across these jurisdictions, the case studies illustrate four dynamics of diversification. Key regulatory concepts such as evidence, risk, safety, efficacy, responsibility and accountability acquire different meanings, reshaping medicine innovation in far-reaching and often contradictory ways. The boundaries between medical research and healthcare provision, commerce and humanitarian service, as well as state control and medical self-regulation are re-defined. | en_GB |
dc.description.sponsorship | Economic and Social Research Council (ESRC) | en_GB |
dc.description.sponsorship | European Research Council | en_GB |
dc.description.sponsorship | Universidad Nacional de Quilmes | en_GB |
dc.identifier.citation | Published online 20 December 2018 | en_GB |
dc.identifier.doi | 10.1080/09505431.2018.1556253 | |
dc.identifier.grantnumber | ES/I018107/1 | en_GB |
dc.identifier.grantnumber | 283219 | en_GB |
dc.identifier.grantnumber | PUNQ 1408/15, 2015-2019 | en_GB |
dc.identifier.uri | http://hdl.handle.net/10871/35262 | |
dc.language.iso | en | en_GB |
dc.publisher | Taylor & Francis (Routledge) | en_GB |
dc.rights | © 2018 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. | en_GB |
dc.subject | science policy | en_GB |
dc.subject | regulatory conflicts | en_GB |
dc.subject | evidence-based medicine | en_GB |
dc.subject | clinical trials | en_GB |
dc.subject | health care provision | en_GB |
dc.subject | unequal development | en_GB |
dc.title | Global Diversification in Medicine Regulation: Insights from Regenerative Stem Cell Medicine | en_GB |
dc.type | Article | en_GB |
dc.date.available | 2018-12-21T11:46:34Z | |
dc.identifier.issn | 0950-5431 | |
dc.description | This is the final version. Available on open access from Taylor & Francis via the DOI in this record. | en_GB |
dc.description | Data Access Statement: The research data supporting this publication are provided within this paper. | en_GB |
dc.identifier.journal | Science as Culture | en_GB |
dc.rights.uri | http://creativecommons.org/licenses/by/4.0/ | en_GB |
dcterms.dateAccepted | 2018-11-30 | |
rioxxterms.version | VoR | en_GB |
rioxxterms.licenseref.startdate | 2018-12-20 | |
rioxxterms.type | Journal Article/Review | en_GB |
refterms.dateFCD | 2018-12-20T22:52:37Z | |
refterms.versionFCD | VoR | |
refterms.dateFOA | 2018-12-21T11:46:38Z | |
refterms.panel | C | en_GB |
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Except where otherwise noted, this item's licence is described as © 2018 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.