Regulating in developing countries: Multiple roles for medical research and products regulation in Argentina and India
Regulating in developing countries: Multiple roles for medical research and products regulation in Argentina and India
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DOI：
10.1016/j.techsoc.2015.07.002
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发表时间：
2015-11-01
影响因子：
9.2
通讯作者：
Kale, Dinar
中科院分区：
文献类型：
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作者：
Harmon, Shawn H. E.;Kale, Dinar
本文探讨了创新与人类健康之间的复杂关系，以及监管在将两者结合起来方面的作用，并在此过程中促进新兴经济体的包容性创新。在概述了监管的争议作用后，我们提供了两个案例研究：阿根廷的再生医学监管和印度的医疗器械监管。虽然这些基于实践的案例研究考察了不同司法管辖区的不同科学部门，因此具有不同的背景基础，但它们表明了监管政策与成功促进创新之间的重要联系。通过他们，我们挑战了经常重复的抱怨，即监管扼杀创新，表明缺乏监管（阿根廷）和监管不力（印度）对创新，对行为者的福祉，以及最终对人类健康都有同样的损害。我们认为，设计新的监管形式可以促进创新，从而提高技术（和经济）竞争力（即：社会/监管创新可以导致改善技术/科学创新）。(C)2015爱思唯尔有限公司版权所有。
This paper engages with the complex relationship between innovation and human health and the role of regulation in bringing the two together, and, in doing so, facilitating inclusive innovation in emerging economies. After outlining the contested role of regulation, we provide two case studies: regenerative medicine regulation in Argentina, and medical devices regulation in India. While these empirically-based case studies examine different scientific sectors in different jurisdictions and therefore have different contextual foundations, they demonstrate the important link between regulatory policies and the successful promotion of innovation. Through them we challenge the oft-repeated complaint that regulation stifles innovation, demonstrating that both a lack of regulation (Argentina) and poorly conceived regulation (India) are equally damaging to innovation, to actor wellbeing, and, ultimately, to human health. We argue that devising new forms of regulation can facilitate increased innovation and thus improved technological (and economic) competitiveness (ie: social/regulatory innovation can lead to improved technological/scientific innovation). (C) 2015 Elsevier Ltd. All rights reserved.