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

Hogan Lovells

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 Tuesday's Report: FDA revokes Battelle decontamination system EUA; HHS announces reimbursement program for providers that vaccinate certain patients; NY to require new workplace health protections; Germany passes foreign investment control expansion; and a podcast on the South African economic trajectory.

Tuesday, 4 May 2021

  • On Friday, the U.S. Food and Drug Administration (FDA) revoked the emergency use authorization (EUA) of the Battelle CCDS Critical Care Decontamination System, which was authorized for use in decontaminating compatible N95 respirators for multiple-user reuse by health care personnel. FDA revoked the EUA in response to Battelle's request for voluntary withdrawal of the authorization. In response to changing customer needs, as of 31 March, Battelle has ceased all Battelle CCDS decontamination site operations and marketing activities. Decontaminated respirators and respirators that have undergone bioburden reduction should be used only when there are insufficient supplies of new filtering facepiece respirators (FFRs) or any new respirators. Earlier in April, FDA had issued a letter to health care providers recommending transitioning from use of decontaminated disposable respirators. (Authored by Randy Prebula)

  • 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. FDA is reportedly preparing to authorize the Pfizer vaccine to children 12 to 15 years-old. The U.S. Department of Health and Human Services (HHS) announced Monday a new reimbursement program for providers that vaccinate patients enrolled in health plans that either do not cover vaccination fees or cover them with patient cost-sharing. New York, New Jersey, and Connecticut are lifting most COVID-19-related restrictions on 19 May, allowing many businesses to re-open fully. NY Gov. Andrew Cuomo announced the easing of pandemic restrictions on Monday, including lifting curfews for food and beverage service. The Biden Administration will ban most travel from India starting Tuesday amid a surge in coronavirus cases in the country. Read more about these developments online here: 3 May and 30 April. (Authored by Ivan Zapien)

  • On 21 April, both houses of the New York state legislature announced passage of the NY Hero Act, which will require NY employers to implement extensive new workplace health and safety protections in response to the COVID-19 pandemic. Governor Cuomo is expected to sign the Act into law in the coming weeks. When it takes effect, all New York employers, regardless of size, will need to take action to comply with the new obligations that this law will impose. Read more online here. (Authored by Michael E. DeLarco)

  • Regulators are becoming increasingly active in imposing measures on deals or prohibiting them altogether under foreign direct investment (FDI) rules – with prohibitions happening in the EU’s largest economies Germany, France, and Italy in the past months. Against this backdrop, Germany is moving forward on its plans for stricter foreign investment control laws. On 27 April, the German government voted on a revised regulation, following a draft that was presented in January for public consultation. Among the key results of this consultation are a couple of changes to the draft that should be welcomed. First, the revised regulation makes it clear that intra-group restructurings do not fall into the scope of the German FDI rules anymore. Moreover, concerning the additional areas of target activities which require a mandatory filing, the voting share threshold has been increased from the initially suggested 10 to 20 percent. Read more online here. (Authored by Falk Schoening)

  • In the latest episode of the A Perspective Podcast, Andrew Skipper talks with Jacko Maree, non-executive the Deputy Chairman at Standard Bank Group and Chairman of the Liberty Group. Having been CEO of Africa’s largest bank, Standard Bank, for 13 years, including building their pan African business across 20 countries and securing a 20% investment in the bank by Chinese investors; he is a renowned and experienced leader in South Africa. Listen as they discuss a wide range of topics at the center of South African economic trajectory including the challenging targets set for delivering investment into the country, the roadblocks to delivering these targets and how COVID-19 has impacted the market. Jacko also shares his thoughts about the development of South Africa’s trade relationships, how well the nation is working together to deliver success, and his six reasons to be cheerful about the country’s future.

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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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