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: Trump issues "Buy American" Executive Order, Gates and Serum partner on vaccine production, FDA issues umbrella EUA for surgical masks, new Virginia workplace safety standards, a podcast on supply chain management, and U.S. Congressional moves.

Tuesday, 11 August 2020

  • On 6 August 2020, U.S. President Donald Trump issued his much-anticipated "Buy American" Executive Order (EO), intended to increase and support domestic manufacture and Federal government procurement of "essential medicines," "medical countermeasures," and "critical inputs" (including API, raw materials, and medical device components), and decrease dependency on non-domestic sources. The directives included in the EO are many and far-reaching. The order imposes requirements aimed at maximizing US production capability for essential medicines, medical countermeasures, and their components, and, along those lines, addresses regulatory barriers to domestic production. At the same time, the order directs Federal agencies involved in contracting for these medical products to apply preferences aimed at increasing procurement of products made in the US. Notably, to allow for application of domestic procurement preferences, the order directs the US Trade Representative (USTR) to modify existing trade agreements to eliminate reciprocal treatment afforded to signatory countries. Many of these reciprocal structures have been in place for decades under the World Trade Organization (WTO) Agreement on Government Procurement and other international agreements. It is far from clear that these steps are consistent with existing agreement frameworks. Key directives within the EO are analyzed here. (Authored by Joy Sturm)

  • To address the increased usage and shortages of surgical masks as a result of combating COVID-19, on 5 August 2020, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for disposable, single-use surgical masks for use by health care personnel in health care settings. The Letter of Authorization states that surgical masks that have been designed, evaluated, and validated in accordance with the specific performance criteria described in the EUA Letter of Authorization. Read more here. (Authored by Michael Heyl and Seth Olson)

  • COVID-19 has caused widespread disruption, and, for many businesses, the biggest impact has been to their supply chain. In the latest episode of our Litigation Landscape podcast series, Antonia Croke, Angus Rankin and Kelly Tubman Hardy discuss the trends and issues they've been seeing as they work with clients to keep their supply chains moving. They also look forward, and discuss whether there are any steps businesses should be taking now to prepare themselves to the future.

  • 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 8 August, U.S. President Trump announced four executive actions aimed to extend economic aid to Americans while Congress remains in a stalemate over the next coronavirus relief package. The orders expanded unemployment benefits, paused student loan payments, extended the moratorium on evictions, and authorized the Treasury Department to defer payroll taxes for individuals making less than $100K a year. The executive actions’ effectiveness and legality are in question and likely to be challenged in court due to them exceeding the Constitutional powers of the executive office. Treasury Secretary Mnuchin said the White House is open to resuming negotiations and are still willing to “put more money on the table” and willing to compromise saying “if we can get a fair deal we’ll do it this week.” The Gates Foundation and the Serum Institute of India, the world’s largest vaccine maker, have announced a partnership to produce a coronavirus vaccine available for distribution in poor countries for less than US$3 a dose. Read about these and other updates online here. (Authored by Ivan Zapien)

  • Effective 27 July 2020, Virginia employers must comply with new COVID-19 workplace safety standards, known as the Emergency Temporary Standard (ETS). The U.S. state's ETS applies to all employers subject to the jurisdiction of the Virginia Occupational Safety and Health (VOSH) Program, which includes virtually all private and non-federal public employers in the Commonwealth. Failure to comply with the ETS can result in fines as high as US$130,463 per each "repeat;" or "willful" violation. Read more here. (Authored by George W. Ingham)

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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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