Products in a Pandemic: Liability for Medical Products and the Fight against COVID-19

Products in a Pandemic: Liability for Medical Products and the Fight against COVID-19
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DOI:
10.1017/err.2020.54
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发表时间:
2020-05-20
影响因子:
2.9
通讯作者:
PILGERSTORFER M QC
PILGERSTORFER M QC
中科院分区:
其他
文献类型:
--
作者:
FAIRGRIEVE D;FELDSCHREIBER P;HOWELLS G;PILGERSTORFER M QC

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作为应对COVID-19努力的一部分,正在开发和生产大量医疗产品。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的迅速增加,许多这些产品的设计、测试和制造与正常时期的生产不同。本文特别从产品责任的角度考虑了因生产应急产品而产生的法律问题。《欧洲产品责任指令》规定的现有概念,如缺陷、因果关系和各种抗辩,在多大程度上允许法院在审议责任问题时考虑到大流行病?修订后的规管制度对法律责任有何影响?根据这一讨论,从比较和欧洲的角度审查了备选办法的情况,包括政府对产品制造商的赔偿、法律上免除责任和备选无过失赔偿办法的问题。
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.
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影响因子: 7.6
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