Steering biomedicine: regulatory dynamics of therapeutic technologies in the European Union and beyond
Steering biomedicine: regulatory dynamics of therapeutic technologies in the European Union and beyond
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指导生物医学：欧盟及其他地区治疗技术的监管动态
DOI：
10.1080/13511610.2012.730226
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发表时间：
2012
期刊：
影响因子：
--
通讯作者：
Faulkner A
中科院分区：
文献类型：
--
作者：
Faulkner A
当代社会的治理努力解决创新技术科学、公民、工业、学术界、公共服务、市场、价值观和道德之间日益复杂和令人不安的关系。在医学和人类健康的科学和技术方面，这一点最为明显。生命科学和生物医学创新已被提上许多政府的议程，并已成为国际合作和竞争的主要竞技场，也是公众关注风险和收益的主要主题。事实上，“创新”本身已经成为许多政府政策议程上的一个高度优先事项。各国越来越多地参与各种战略，以刺激、促成、引导和控制知识型创新的进程和产品。这些事态发展对正式和非正式、公共和私营部门的法律、监管和治理构成了巨大挑战。《创新：欧洲社会科学研究杂志》的这期特刊汇集了一系列经验性、理论性的研究论文，分析了在欧盟及其他地区对人类健康有影响的一系列治疗技术的治理和监管趋势。该项目的想法的萌芽来自于这样一种认识，即虽然在科学和技术研究以及生物医学治理政治中有许多单一部门或单一技术的案例研究，但比较分析或收集的研究相对较少，鼓励更系统的比较思考。本汇编是在2008年8月在鹿特丹举行的欧洲科学技术研究协会和科学社会研究学会“与科学和技术合作”会议上组织的“欧洲联盟治疗技术的监管动态”会议的基础上编写的。本介绍性说明概述了该项目的主要目标，提请注意主要主题和关键方面，其中治疗技术创新和监管治理的模式在七位贡献者提出的案例研究中各不相同。当代知识经济的特点是创新生物医学和治疗技术领域的大规模扩展，并且人体具有相应增加的和复杂的范围的可用于治疗目的的技术。一系列不断升级的技术正在从根本上改变医学、医疗保健和人类健康本身的特征。
The governance of contemporary societies grapples with increasingly complex and disturbing relationships between innovative techno-science, citizenship, industry, academia, public services, markets, values and ethics. Nowhere is this more in evidence than in the sciences and technologies of medicine and human health. The life sciences and biomedical innovation have crept up many governments’ agendas and have become a major arena of international collaboration and competition, and a major subject of public concern about risks and benefits. Indeed,‘‘innovation’’itself has emerged in its own right as a high priority on the policy agenda amongst many governments. States increasingly involve themselves in a variety of strategies to stimulate, broker, steer and control the processes and products of knowledge-based innovation. These developments pose massive challenges for law, regulation and governance, both formal and informal, public and private. This special issue of Innovation: The European Journal of Social Science Research brings together a set of empirical, theoretically informed research papers analyzing governance and regulatory trends in a range of therapeutic technologies that have implications for human health in the context of the European Union and beyond. The germ of the idea for the project came from the perception that, although there are many single-sector or single technology case studies in Science and Technology Studies and in the politics of biomedical governance, there is relatively little comparative analysis or collection of studies encouraging more systematic comparative reflection. The present collection builds on a session,‘‘Regulatory dynamics of therapeutic technologies in the European Union’’, organized at the ‘‘Acting with Science and Technology’’Conference of the European Association for Studies of Science and Technology and the Society for Social Studies of Science (EASST/4S), Rotterdam, August 2008. This introductory note outlines the main aims of the project, drawing attention to major themes and key dimensions in which patterns of therapeutic technological innovation and regulatory governance vary across the case studies presented by the seven contributors.The contemporary knowledge economy is marked by a massively expanding domain of innovative biomedical and therapeutic technology, and the human body has a correspondingly increasing and complex range of technologies available to it for therapeutic purposes. An escalating array of technologies is being promoted as radically changing the character of medicine, healthcare and human health itself.
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DOI：
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影响因子：
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作者：
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