COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

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Hogan Lovells

The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time.

In this week's Report: FDA issues EUAs to Janssen and ACON, and issues a warning letter to Strategia over COVID-19 claims; Italy requires vaccine pass to enter workplaces; and an analysis of developments in the UK's insolvency regime.

Wednesday, 6 October 2021

  • Last week, the U.S. Food and Drug Administration (FDA) authorized an emergency use authorization (EUA) for one additional batch of the Janssen COVID-19 vaccine manufactured at the Emergent facility. To date, a total of nine batches of Janssen COVID-19 vaccine that were manufactured at the Emergent facility have been authorized. Also, on Monday, FDA issued an EUA for ACON Laboratories Flowflex COVID-19 Home Test, an over-the-counter COVID-19 antigen test. It can be used to test both symptomatic and asymptomatic individuals without the need for repeat testing over several days, known as serial testing. Separately, last week, FDA also issued a warning letter to Strategia Project Management, Inc. for selling an unapproved product with unproven COVID-19 claims.  (Authored by Randy Prebula)

  • After a long debate, the Italian government issued Law Decree no. 127/2021 providing the obligation for all kind of Italian workers to show the Green Pass to enter any workplace, included third-party workplace. The Green Pass is a QR code generated by the Health Minister confirming alternatively: (i) the COVID-19 vaccination; (ii) a negative COVID-19 test result (both molecular and rapid antigen test included in the European List are valid); or (iii) recovery from COVID-19. To such extent, all employers must implement by 15 October 2021 appropriate organizational procedures ruling how they will verify compliance with Green Pass by the workers. In case of non-compliance, besides possible ordinary disciplinary measures, administrative sanctions are provided by the Decree. We analyzed this decree in greater depth online here. (Authored by Vittorio Moresco)

  • In a new analysis online here, we look at current trends and developments at the intersection between insolvency and dispute resolution in the UK, including a rundown of some of the latest legislative changes, and issues to consider when litigating against parties in financial distress. The coronavirus pandemic had ushered in a much-awaited reform of UK insolvency legislation, in the form of the Corporate Insolvency and Governance Act 2020 (CIGA 2020). As its explanatory notes record, the policy objective behind CIGA 2020 is to provide businesses with necessary flexibility and breathing space in the light of the effects of the coronavirus pandemic to maximize their chances of survival.  (Authored by John Tillman)

Compiled by Aaron Armstrong

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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