This article was written by Kennedys in cooperation with Sara Orchard, Senior Lifescience Underwriter, New Risk Solutions at Munich Re. and Petra Mates, Underwriter, Life Science Risk Solutions at Munich Re..
The COVID-19 pandemic has had an unprecedented impact on stakeholders in the UK and EU’s life sciences industry - from companies, to third parties, governments, regulators and insurers.
The actions of relevant European life sciences regulators have been comprehensive and varied, aimed at maintaining high levels of product safety whilst mobilising the life sciences industry in the fight against the pandemic, either through measures aimed at COVID-19 products themselves and/or peripheral measures that assist to that end. New policies introduced, whatever their nature, are generally specific, defined and temporary in nature, however.
Regulators’ actions have been supplemented in parallel by the actions of governments, including the UK Government – who have provided indemnities in respect of future liability (in contrast to immunities granted by other countries) – and the actions of technical standards bodies – who have made their products available free of charge.
Against this backdrop, companies and their insurers need to continually assess compliance with this ever-changing product safety framework, and review reliance on short-lived regulatory derogations. They also need to consider long-term product liability exposure in order to avoid strict liability, contractual and tortious claims that may expose companies to fines or, on some occasions, criminal sanctions.
We will be publishing further articles on a range of current and emerging topics, followed by a webinar later this year to provide a forum for discussion and practical tips.
Below is a high-level list of some of the more noteworthy actions taken by regulators and third parties during the course of the COVID-19 pandemic across the EU and UK medical devices and medicines industries.