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

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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 Tuesday's Report: a panel discussion on the U.S. election, Americans warned of COVID-19 surge, Moderna files for FDA EUA, Hong Kong proposes corporate rescue bill, new Foreign Direct Investment rules in Spain, the EU moves on tissue, blood, and cells legislation, and how to fight online lockdown scams.

Tuesday, 1 December 2020

  • Leaders of our Life Sciences and Health Care team recently met for a panel discussion of the impacts on the industry of the 2020 U.S. election. This was the first event in a series of conversations, with other webinars scheduled for 1 December and 16 December. We are excited to share online here the following highlights from the webinar, and we look forward to future discussions as we forecast and help clients prepare for what’s to come in 2021 under a new presidential administration.

  • The Hogan Lovells Government Relations and Public Affairs group is tracking all of the latest developments in the U.S. Congress and relevant news stories. On Sunday, White House Coronavirus Task Force coordinator Dr. Deborah Birx warned Americans to “assume that you’re infected” with COVID-19 if you traveled or gathered for Thanksgiving and advised being tested about five to 10 days later. Both Dr. Birx and the nation’s top infectious disease expert, Dr. Anthony Fauci, are warning about a “surge upon a surge” before the Christmas and New Year’s holidays, noting that travel restrictions and recommendations are likely to stay in place. A bipartisan group of senators is attempting to restart stalled coronavirus stimulus talks during the lame duck. Members of the White House Coronavirus Task Force covered the Sunday talk shows to promise a rapid rollout of coronavirus vaccines to millions of Americans by year-end. But distribution will have to overcome several hurdles in the health care system and mistrust in the virus, especially in the country’s underserved rural states. Moderna filed today for a Food and Drug Administration (FDA) emergency use authorization (EUA) of its experimental coronavirus vaccine. The biotech company said the vaccine was 94.1 percent effective against COVID-19 and 100 percent effective at preventing severe COVID-19 in an analysis of a stage three trial. Read about these and other updates here: 30 Nov. (Authored by Ivan Zapien)

  • The first wave of COVID-19 lockdowns this year led to a significant increase in online scams. Whilst in “normal times” individuals might identify these scams as being “too good to be true”, isolation coupled with financial fears meant that people were more susceptible to fraudulent offerings. With a second wave of lockdowns sweeping across Europe this winter, we anticipate another uptick in these types of frauds. Here we explore the ways in which the joined-up IP and Financial Services Litigation and Investigations team at Hogan Lovells can assist businesses to protect themselves against fraudsters.

  • The Hong Kong government is proposing much-anticipated legislation for the introduction of a corporate rescue procedure and insolvent trading regime. Hong Kong has, for years, struggled to introduce a statutory corporate rescue procedure (CRP), having previously made unsuccessful attempts in 2000-2001, 2008-2009, and 2014. Now – with COVID-19 severely impacting the economy – the government has finally tabled the Companies (Corporate Rescue) Bill. Read more online here.

  • The Spanish government last week approved a new reform of the legal regime that establishes a screening regime for certain foreign direct investments ("FDI") in Spain, through the enactment of Royal Decree-Law 34/2020, of 17 November, on urgent measures to support business solvency and the energy sector as well as on tax matters. The Fourth Final Provision of Royal Decree-Law 8/2020 of 17 March regarding extraordinary urgent measures to deal with the economic and social impact caused by the COVID-19 crisis amended the Spanish Act 19/2003 of 4 July on the legal regime of capital movements and economic transactions abroad (the "Act 19/2003"). Read more online here.

  • On 17 November 2020, the European Commission (EC) published an inception impact assessment for a revision of the Tissue Directive and the Blood Directive. With this proposal, the European Commission aims to tackle existing shortcomings and gaps in the current legislation. Three policy options are proposed in the impact assessment. Following an evaluation of the existing BTC legislation, the EC identified certain gaps and shortcomings. According to the EC, these challenges have been emphasized due to the COVID-19 pandemic. The key differences among the three scenarios concern the body in charge of establishing the technical requirements, and the degree of enforcement at EU and national level. The European Commission’s potential legislative proposal is expected by the fourth quarter of 2021. Read more here. (Authored by Fabien Roy)

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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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