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.
The U.S. Safer Federal Workforce Task Force has issued its guidance regarding the COVID-19 safety protocols that federal contractors must implement under President Biden’s recent Executive Order 14042. The guidance requires covered contractors and subcontractors to adopt a “hard” vaccine mandate — that is, to ensure that covered employees are fully vaccinated for COVID-19, subject only to legally required medical and religious exemptions, by 8 December 2021. The mandate extends broadly not only to employees working directly on federal contracts, but also to those such as human resources, billing, and legal personnel who perform work “in connection with” covered contracts, and to all other employees working in the same location as such employees. Certain employees who work remotely are also covered. Covered contractors must implement safety protocols related to masks and social distancing in their workplaces as well. We have analyzed this guidance online here. (Authored by William Ferreira)
Australia's Department of Health has opened a public consultation on the review of the National Medicines Policy (NMP). As part of the review, the Expert Advisory Committee is seeking feedback on a number of proposals, including the possibility of expanding the definition of medicine under the NMP to include medical devices and vaccines. One of the primary considerations is whether the NMP has been able to adequately maintain its relevance and respond to changes in the health landscape in light of the significant advancements in a number of key areas (e.g. biotechnology and medical science). This is particularly relevant with the current rollout of COVID-19 vaccinations to Australians. The consultation is now open and will close on Friday, 8 October 2021. Read more online here. (Authored by Mandi Jacobson)
Last week, the U.S. Food and Drug Administration (FDA) took additional steps to help ensure that the performance of authorized COVID-19 tests is not impacted by emerging SARS-CoV-2 viral mutations. FDA revised the authorizations of certain molecular, antigen, and serological tests for COVID-19 by requiring additional conditions of authorization concerning viral mutations. FDA's updated web page provides information regarding the impact of viral mutations on COVID-19 tests, recommendations for clinical laboratory staff and health care providers, and information about certain tests for which the FDA has identified potential impacts on performance due to SARS-CoV-2 genetic mutations. (Authored by Randy Prebula)
Supply chains are increasingly vulnerable to a range of risks. In recent years businesses have focused upon streamlining their supply base to minimize costs. They have sought to reduce inventory to free up working capital but these ostensibly sensible economies have left many of them more than ever at the mercy of events beyond their control. It is vital that businesses, irrespective of their jurisdictions or type, understand the dynamics of their supply chains and any weaknesses inherent in them if they are to plan effectively for the opportunities and challenges of a post-COVID world. Online here, we discuss how supply chain management is more important now than ever. (Authored by Joe Bannister)
Last week, the U.S. Food and Drug Administration (FDA) issued a revised guidance entitled, "Enforcement Policy for Face Masks, Barrier Face Coverings, Face Shields, Surgical Masks, and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency," aiming to help expand the availability of face masks, barrier face coverings, and face shields, including surgical masks and particulate filtering facepiece respirators (FFRs), and N95 respirators. FDA revised this guidance to: include barrier face coverings intended for a medical purpose but not intended to provide liquid barrier protection within the scope of this guidance; provide recommendations about submicron particulate filtration efficiency, airflow resistance, and leakage assessments for barrier face coverings as described in "ASTM F3502-21: Standard Specification for Barrier Face Coverings"; remove reference to alternatives when FDA-cleared or NIOSH-approved N95 respirators are not available based on current recommendations that health care facilities should not be using crisis capacity strategies at the time of issuance of this guidance; and to add a policy that, during the public health emergency, FDA generally does not intend to object to stockpiled, non-NIOSH-approved respirators being further distributed and used as face masks for source control (as opposed to being used as FFRs for respiratory protection) where such use does not create an undue risk in light of the public health emergency. (Authored by Michael Heyl and Randy Prebula)
As businesses in Asia grow in scale and complexity, exploiting new digital channels and facing new cost-cutting pressures, they are increasingly turning to outsourcing and other forms of technology transformation, including the deployment of cloud technologies, to support their operations and gain competitive advantage. The COVID-19 pandemic has also impacted, the way we do business giving organizations cause to look at new ways of reaching their customers, new ways of working and new ways of reducing their operating costs. For example, the pandemic has led to growth in demand for vendors specializing in automation, such as through the deployment of robotics and artificial intelligence. In this environment, technology transformation takes many forms, but at its core, we see businesses focusing on leveraging technology to redesign operations to better support the achievement of business objectives. Our new analysis online here discusses the legal and regulatory challenges that organizations face in pursuing technology transformation in Asia. (Authored by Mark Parsons)
Late last week, in the latest step to curb the COVID-19 pandemic, U.S. President Joseph R. Biden announced new Federal contractor employee vaccination requirements that are set to go into effect as of 15 October. The Administration also will require vaccination for members of the Federal workforce and health care workers in hospitals and other institutions that receive Medicare and Medicaid funding, as well as vaccination or weekly testing for large (100+) U.S. private sector employers. We analyzed these new requirements online here. (Authored by William Ferreira)
President Biden's new initiatives aimed at increasing COVID-19 vaccination rates in U.S. private sector workplaces include directing the Occupational Safety and Health Administration (OSHA) to develop a new Emergency Temporary Standard (ETS) covering the nation’s larger employers. Specifically, the proposed ETS would require all employers with 100 or more employees to impose a “soft” vaccination mandate – that is, to require their employees either to be fully vaccinated, or to produce a negative COVID-19 test result on at least a weekly basis before coming to work. The Administration states that the ETS will impact over 80 million workers. The details of the ETS are yet to be seen – it has not been issued – however, in anticipation of potential issuance of the ETS, online here are some key considerations for employers. (Authored by George Ingham)
On 6 September, New York state Governor Hochul declared COVID-19 as an “airborne infectious disease” thereby triggering the NY Hero Act. We previously wrote about how the NY Hero Act did not require immediate implementation since COVID-19 was not previously declared an airborne infectious disease, and thus employers only needed to adopt, but not implement a NY Hero Act prevention plan. Now, the time has come for NY state employers to immediately implement the plan that employers had adopted (whether that be the model plan promulgated by New York (specific to a particular industry) or a plan devised by an employer that meets the minimum requirements of the model plan), due to the recent designation by Governor Hochul. We analyzed the new requirements for NY state employers online here. (Authored by Kenneth Kirschner)
The UK Government announced that it will proceed with the phasing out of temporary measures introduced to protect businesses from creditor action during the COVID-19 pandemic, whilst also announcing new measures to protect smaller businesses from winding up petitions. The legislation required to implement these amendments was laid before Parliament and will come into force on 29 September 2021. The new measures will be in place from 1 October 2021 until 31 March 2022, and we have analyzed them online here. (Authored by Tom Astle)
The U.S. Food and Drug Administration (FDA) again updated its clinical studies Q&A guidance document (“FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency,” originally issued in March 2020) to clarify whether data that have been remotely monitored during the pandemic should be re-monitored during an on-site monitoring visit once pandemic-related restrictions that prevented on-site monitoring visits have been lifted. In new Q. 28, FDA says that the decision as to whether remote monitoring conducted for a given site or clinical investigation was adequate [or should be followed up with additional on-site monitoring visits] should be based on the sponsor’s ongoing risk assessment. For example, the Q&A guidance document now specifies, it is more likely that sites should be re-monitored during an on-site monitoring visit if there are certain data anomalies or a higher frequency of errors, important protocol violations, or dropouts relative to other sites. FDA adds that remote monitoring “should be focused on critical data and processes for human subject protection and trial integrity, such as the site’s conduct of key study procedures and documentation related to important efficacy endpoints and safety assessments.” (Authored by Randy Prebula and Kristin Zielinski Duggan)
The UK Financial Conduct Authority (FCA) has written to the Boards of personal and commercial line (PL&CL) insurers to give an updated overview of what the FCA considers are the key risks of harm PL&CL insurers pose to their customers and the markets in which they operate, to outline the FCA’s expectations of insurers and provide an overview of the FCA’s supervisory strategy for the next two years. The letter was published in August, but it is dated April 2021 and it updates the FCA’s view of the key risks of harm since its last letter to PL&CL insurers in January 2020 by taking into the account the impact of COVID-19. Read more online here. (Authored by Victor Fornasier)
On 20 July 2021, the UK government launched a consultation containing substantial proposals that could herald the most important reform of the UK competition regime in 25 years and represent seismic changes to how consumer law is enforced. If implemented, these proposals will result in a stronger and more powerful Competition and Markets Authority (CMA), albeit one that is more overtly the subject of influence from government. The stated aims of the proposals are to produce an improved competition regime, in order to help the government to address its “levelling up” agenda and “build back better” strategy in the context of recovery from the COVID-19 pandemic. We have analyzed these potential reforms online here. (Authored by Christopher Hutton)
On 27 August, the U.S. Food and Drug Administration (FDA) authorized the use of the monoclonal antibodies bamlanivimab and etesevimab, administered together. The Emergency Use Authorization applies only in states, territories, and U.S. jurisdictions in which recent data shows the combined frequency of variants resistant to bamlanivimab and etesevimab administered together is less than or equal to 5%. Separately, on 30 August, FDA issued a letter to veterinarians and retailers asking for assistance in sharing important safety information with consumers about the dangerous misuse of animal ivermectin to prevent or treat COVID-19 in people. Poison control centers across the U.S. are seeing a sharp spike in reports of people suffering adverse health effects after taking animal ivermectin. FDA warned that treating human medical conditions with veterinary drugs can be very dangerous. FDA also announced September virtual Town Hall dates for test developers for SARS-CoV-2, which will take place on 8 and 22 September. (Authored by Randy Prebula)
On 9 August, Washington state announced that it will be requiring state employees and in-state health care workers to be fully vaccinated against COVID-19 by 18 October 2021, which was followed by a similar announcement from Oregon on 19 August. Other U.S. states announced earlier in July that state employees, including patient-facing employees in state-run health care facilities, will be required to get vaccinated for COVID-19 or else will be required to be tested for COVID-19 on a weekly basis after 6 September. This announcement came shortly after the U.S. federal government’s announcement that all federal employees would similarly be required to get vaccinated or be subjected to weekly tests and other safety measures. Read more online here. (Authored by Tao Leung)
In Snow Phipps Group, LLC v. KCAKE Acquisition, Inc. (C.A. No. 2020-0282-KSJM), the Delaware Court of Chancery ordered specific performance of a US$550 million acquisition, rejecting the buyer’s argument that the impact of COVID-19 was reasonably expected to constitute a materially adverse event (MAE). The court found specific performance appropriate because the plaintiff failed to use reasonable best efforts to obtain appropriate financing, including making unreasonable demands of the potential lenders. Ultimately, the court characterized its decision as a “victory for deal certainty,” reaffirming that Delaware courts set a high bar for purchasers seeking to terminate an acquisition agreement on the basis of an MAE. The holding demonstrates that while other deal parties recently were able to demonstrate MAEs, including AB Stable VIII LLC and Akorn, the burden to do so remains high and requires a “persistent and sustained” failure in an acquisition target’s business. We analyzed this case in depth online here. (Authored by Ryan Philp)
Compiled by Aaron Armstrong
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COVID-19 Report for Life Sciences and Health Care Companies (August 2021)
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