Abstract
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.
Highlights
The global war against severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), and the disease it causes (COVID-19), is being fought by many countries on many fronts
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
The European Medicines Agency (EMA) is cooperating with the World Health Organization (WHO) to help the development of potential COVID-19 treatments by facilitating large-scale clinical trials,[32] and we review these potential treatments below
Summary
The global war against severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), and the disease it causes (COVID-19), is being fought by many countries on many fronts. Faced with the current pandemic, a vast global demand has arisen for an array of products, from test kits and chemicals, personal protective equipment (PPE), hand sanitisers and other biocidal products, ventilators and similar devices, as well as medicines, treatments and () a vaccine. Producers are scrambling to meet that demand by ramping up production, developing modified and new products at astonishing speeds, as well as manufacturing in novel ways. Our purpose is not to erect legal road blocks in the way of meeting demand for essential healthcare products; quite the contrary. It is to contribute to the consideration of the application of laws covering product liability and regulation at an early stage, when ex ante measures (such as providing warnings, obtaining indemnities from government, etc.) are still available to producers and lawmakers
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