COVID-19 Report for Life Sciences and Health Care Companies

Thursday, 15 April 2021

• 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 13 April, the Centers for Disease Control and Prevention (CDC) and Federal Drug Administration (FDA) paused the use of the Johnson & Johnson vaccine after six women in the U.S. developed a rare blood clotting disorder within about two weeks of receiving the vaccine. White House coronavirus coordinator Jeff Zients said Tuesday that FDA's recommendation to pause the use of the Johnson & Johnson COVID-19 vaccine would not hinder the Biden Administration's distribution strategy. A panel of vaccine experts that advises the CDC was deadlocked Wednesday on whether to limit the use of the Johnson & Johnson’s vaccine based on age or sex, requiring more time to assess the risks involved. FDA released guidance on Wednesday outlining how it will conduct remote, voluntary evaluations of drug, biologic, and veterinary firms during the pandemic, and how the agency will use those findings. Denmark on Wednesday announced that it would no longer be administering Astra Zeneca’s coronavirus vaccine amid concerns on links to rare blood clots. Read more about these developments online here. (Authored by Ivan Zapien)

• In response to the economic effects of the COVID-19 pandemic and market uncertainty, a plethora of financing measures were introduced at EU level, German federal level, and German states levels. In their joint effect, these measures are aimed at shielding enterprises from the crisis by offering different liquidity programs for overbridging temporary, crisis-evoked liquidity shortages. Our note summarizes our understanding of the key EU, German federal, and German states’ financial and state aid measures. This note includes updates to our initial version published on 1 April 2020, which relate, among other things, to the criteria of KfW-Sonderprogramm 2020 and the relevant financing products available on German state levels. Questions remain about the scope of some of these measures. (Authored by Katlen Bloecker)

Tuesday, 13 April 2021

• 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. Congress returns this week from their two-week spring recess. The Senate will continue its consideration of President Biden’s health care nominees. President Biden released his $1.52 trillion FY 2022 discretionary budget request on 9 April, focusing on domestic programs. The HHS budget request asks Congress to anticipate the next pandemic and provides more than a 23 percent increase for HHS over the 2021 enacted level. On 15 April, HHS Secretary Xavier Becerra will testify before the House Appropriations subcommittee on the FY fiscal 2022 HHS budget request. Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky told reporters on 7 April that the highly contagious B.1.1.7 variant is now the main form of COVID-19 in the U.S. A late-stage clinical trial of 1,500 people suggests that the antibody cocktail made by Regeneron reduced the risk of symptomatic COVID-19 by 81 percent in people living with a person infected with the virus, the company said Monday. Read about these developments online here. (Authored by Ivan Zapien)

• On 9 April, the U.S. Food and Drug Administration (FDA) recommended that health care personnel and facilities transition away from crisis capacity conservation strategies, such as decontaminating or bioburden reducing disposable respirators for reuse. Based on the increased domestic supply of new respirators currently available to facilitate this transition, FDA and CDC said they believe there is adequate supply of respirators to transition away from use of decontamination and bioburden reduction systems. FDA recommends that health care personnel and facilities: (1) limit decontamination of disposable respirators, as decontaminated respirators and respirators that have undergone bioburden reduction should be used only when there are insufficient supplies of new FFRs or if you are unable to obtain any new respirators; (2) transition away from a crisis capacity strategy for respirators, such as decontamination of N95 and other FFRs; and (3) increase inventory of available NIOSH-approved respirators — including N95s and other FFRs, elastomeric respirators, including new elastomeric respirators without an exhalation valve that can be used in the operating room, and powered air-purifying respirators (PAPRs). (Authored by Randy Prebula)

• On 6 April 2021, the U.S. Department of Labor Secretary Marty Walsh placed a “hold” on the implementation of a potential U.S. Occupational Safety and Health (OSHA) COVID-19 Emergency Temporary Standard (ETS), which would set a national COVID-19 safety standard for OSHA-covered employers throughout the United States. While President Biden’s inauguration day Executive Order directed OSHA to focus its enforcement on COVID-19 efforts and set a 15 March deadline for determining whether an ETS was necessary and issuing it, Secretary Walsh stated that any ETS needs to “reflect the latest scientific analysis of the state of the disease” and is delaying its implementation until such scientific review is completed. At this time there isn’t any more information regarding how long the review period will last, and we don’t yet know when (if?) an ETS will ultimately be issued. That said, Walsh ordered a “rapid update based on [CDC] analysis and latest information regarding the state of vaccinations and the variants” stating that it would hopefully be turned over to the “next level” (presumably the White House’s Office of Information and Regulatory Affairs for review) “very soon.” (Authored by George W. Ingham)

Thursday, 8 April 2021

• Our Asia Pacific Data Protection and Cybersecurity Guide 2021 will take you through the developments and key initiatives of APAC countries and discuss the implications of an ever-shifting landscape. Our Guide discusses (1) the impact of COVID-19 on data protection and cybersecurity in APAC; (2) key legislative and regulatory developments in 2020 and looking forward into 2021; (3) APAC data protection regulatory heat map; and (4) individual country data protection developments. Online here you can download the full version of the Asia Pacific Data Protection and Cyber Security Guide 2021 and the Snapshot of our APAC data protection and cybersecurity practice. (Authored by Sherry Gong)

• On Tuesday, the U.S. Food and Drug Administration (FDA) granted its first emergency use authorization (EUA) to an at-home serology test. Symbiotica Inc.’s prescription-only COVID-19 Self-Collected Antibody Test System permits people 18 and older to use a fingerstick to collect their own blood sample, and an adult must collect a sample for people ages 5 to 17. However, FDA said the Symbiotica test “should not be used to diagnose or exclude acute SARS-CoV-2 infection” because “[a]t this time, it is unknown how long antibodies persist following infection and if the presence of antibodies confers protective immunity.” (Authored by Randy Prebula)

• In the U.S. Consolidated Appropriations Act, 2021, are significant changes to intellectual property law and practice, touching upon trademarks, copyrights, patents, domain names, false advertising, and more. Owners of these assets and those with an interest in enforcing in these fields must take note of the changes. We analyze the copyright implications of the U.S. appropriations law online here, and the trademark and brand implications online here. (Authored by Anna Shaw)

• On 12 March 2021, U.S. President Biden signed the American Rescue Plan Act (ARPA) into law, aiming to provide relief to individuals and businesses suffering from the COVID-19 pandemic. ARPA impacts employer-sponsored health plans in several ways, including the implementation of a COBRA premium subsidy. Employers should be aware of the actions they must take in response to this change, which we analyzed online here. (Authored by Kurt L.P. Lawson)

Tuesday, 6 April 2021

• The U.S. Food and Drug Administration (FDA) said last week that it is concerned that virus mutations could lead to false results with certain COVID-19 tests, and that it has found some tests are prone to lower sensitivity, publishing a new FDA webpage that aggregates information to spotlight concerns about mutations that could lead to lower test sensitivity and false results. FDA singled out four molecular tests that have been given emergency use authorization (EUA) that may be prone to giving false results due to emerging mutations. Separately, FDA authorized several over-the-counter (OTC) COVID-19 antigen tests for use without a prescription on Thursday, offering a way for schools, workplaces and other groups to conduct rapid screening. Rapid antigen tests will be especially useful for serial testing, which involves "testing the same individual multiple times within a few days, and can increase chances of detecting asymptomatic infection that might not always show up with a single test," FDA said. FDA has also indicated in public meetings that additional OTC submissions are under review. (Authored by Randy Prebula)

• New York state passed legislation on 12 March 2021 to provide employees in the state with up to four hours of paid leave for each COVID-19 vaccination injection they receive. On 21 March, the New York Department of Labor released Frequently Asked Questions (FAQs) that clarify several aspects of the new NY paid vaccination leave law; for example, if an employee took time off to get the COVID-19 vaccination prior to 12 March, employers may voluntarily provide paid leave benefits, but the new law does not require employers to provide the benefits retroactively. We analyze these new clarifications online here. (Authored by Kenneth Kirschner)

• On 19 March 2021, California Governor Newsom signed into law SB 95 (adding sections 248.2 and 248.3 to the Labor Code), which requires employers to pay California employees up to two weeks of COVID-19 supplemental paid sick leave (COVID-19 SPSL). This new law revives and expands the supplemental paid sick leave law that expired on 31 December 2020. As a result of these changes from the prior iteration of California’s Supplemental Paid Sick Leave law, many more California employers will be required to provide, and many more employees will be eligible for, COVID-19 SPSL. We analyze the new law online here.  (Authored by Tao Leung)

Compiled by Aaron Armstrong