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Products in a Pandemic: Liability for Medical Products and the Fight against COVID-19
European Journal of Risk Regulation Pub Date : 2020-05-20 , DOI: 10.1017/err.2020.54
Duncan FAIRGRIEVE , Peter FELDSCHREIBER , Geraint HOWELLS , Marcus PILGERSTORFER

A multitude of medical products are being developed and produced as part of efforts to tackle COVID-19. They are varied in nature and range from test kits to tracing apps, protective equipment, ventilators, medicines and, of course, vaccines. The design, testing and manufacture of many of these products differs from production in normal times due to the urgency of the situation and the rapid increase in demand created by the pandemic. This article considers the legal issues arising as a result of the production of emergency products, particularly from a products liability perspective. To what extent do existing concepts under the European Product Liability Directive, such as defect, causation and the various defences, permit the pandemic to be taken into account when a Court is considering issues of liability? What is the impact on liability of the modified regulatory regime? In light of that discussion, the case for alternative responses is examined from a comparative and European perspective, including the issue of Government indemnities for the manufacturers of products, legal exemptions from liability and alternative no-fault compensation schemes.

中文翻译:

大流行中的产品:医疗产品的责任和与 COVID-19 的斗争

作为应对 COVID-19 努力的一部分,正在开发和生产多种医疗产品。它们的性质各不相同,从检测试剂盒到追踪应用程序、防护设备、呼吸机、药物,当然还有疫苗。由于形势的紧迫性和大流行造成的需求迅速增加,其中许多产品的设计、测试和制造与正常时期的生产不同。本文从产品责任的角度考虑了因生产应急产品而引起的法律问题。欧洲产品责任指令下的现有概念,如缺陷、因果关系和各种抗辩在多大程度上,允许法院在考虑责任问题时考虑到大流行病?修改后的监管制度对责任有何影响?根据该讨论,从比较和欧洲的角度研究了替代响应的案例,包括政府对产品制造商的赔偿问题、法律责任豁免和替代无过错补偿计划。
更新日期:2020-05-20
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