COVID-19

Following the COVID-19 pandemic and the relatively slow approval of vaccines in the EU versus other key jurisdictions, as part of the EU’s General Pharmaceutical Legislation amendment proposal, published on 26 April 2023, the European Commission has proposed to introduce temporary emergency marketing authorizations (“TEMAs”) for use when there is a “public health emergency.”  The TEMA will be an “agile, fast and streamlined” process to allow products to be developed and made available as soon as possible in emergency situations.  However, it remains to be seen whether in practice the TEMA process will provide a faster procedure than existing routes for early and expedited approval of medicinal products, such as conditional marketing authorizations (“CMAs”) or Member State procedures for temporary approval.

Reason to Introduce the TEMA

The EU took a coordinated approach to approval and procurement of vaccines during the COVID-19 pandemic.  In the EU, COVID-19 vaccines were approved using the CMA procedure combined with a rolling expedited review.  According to the European Medicines Agency (“EMA”), CMAs were the “the most appropriate tool to grant access to COVID-19 vaccines to all EU citizens at the same time and to underpin mass vaccination campaigns.”  Vaccines approved with a CMA included Comirnaty, Nuvaxovid and Spikevax (amongst others).

However, the approval of COVID-19 vaccines in the EU was slower than in other jurisdictions.  For example, the UK MHRA granted Comirnaty a temporary authorization on December 2, 2020.  The US FDA gave the vaccine an Emergency Use Authorization on December 11, 2020.  Whereas, the Commission did not grant a CMA for the vaccine until December 21, 2020.Continue Reading EU Pharma Legislation Review Series: Temporary Emergency Marketing Authorizations

By Libbie Canter, Anna D. Kraus, Olivia Vega, Elizabeth Brim & Jorge Ortiz on April 14, 2023

On April 11, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) announced that four Notifications of Enforcement Discretion (“Notifications”) that were issued under the Health…

Continue Reading HHS Issues Notice of Expiration of COVID-19 HIPAA Enforcement Discretion

This half-yearly update on insurance coverage litigation summarises significant insurance coverage cases in the English courts and provides a detailed analysis of the Corbin & King v AXA Insurance UK Plc case, highlighting the key takeaways for policyholders. In the first half of 2022, the English courts have delivered important judgments on a number of critical issues for policyholders, including Covid-19 business interruption insurance, aggregation clauses, insurers’ implied obligation to pay claims within a “reasonable” time, and the effect of lenders’ mortgagee interest insurance policies; some of which are policyholder friendly, some less so.  

Significant cases 2022 H1

Corbin & King v AXA Insurance UK Plc [2022] EWHC 409 (Comm): In the most anticipated decision of the last half-year relating to Covid-19 business interruption losses, the English High Court determined in favour of a restaurant business, that a prevention of access clause in its policy was triggered by the Government-mandated lockdowns arising from Covid-19 in 2020 and 2021. Given the importance of this case for policyholders, we analyse the court’s findings in further detail below.

Spire Healthcare Limited v Royal & Sun Alliance Insurance Limited [2022] EWCA Civ 17: This decision is the latest word on the interpretation of “aggregation clauses” in insurance policies that require a policyholder to aggregate similar or related losses into a single claim against the insurer, which is then subject to a liability cap on each claim. The Court of Appeal held that several claims against the policyholder could be aggregated into one claim against the insurer on the basis that there was “one source or original cause” of the policyholder’s loss. As a result, the policyholder’s recovery was limited to £10 million, the policy limit per claim.Continue Reading Half Year Review: Insurance Coverage Litigation (H1 2022)

On Thursday 10 March, the UK Covid-19 Inquiry launched a public consultation regarding the terms of reference that will establish the parameters for the Inquiry’s forthcoming work.   The consultation will conclude on Thursday 7 April.

The draft terms of reference set out two key objectives for the Inquiry: (1) examining…
Continue Reading UK Covid-19 Inquiry Launches Consultation on Terms of Reference

In a development that will sound familiar to employers, California has reinstated the requirement, which had expired last fall, to make available to employees up to 80 hours of COVID-19 supplemental paid sick leave (“Supplemental Sick Leave”).  The new measure, Senate Bill (“SB”) 114, was signed by Governor Newsom on February 9, 2022, and the requirement to provide the new sick leave went into effect on February 19. Employees may use the new sick leave retroactive to January 1, 2022.

New Supplemental Sick Leave Requirements

Following is an overview of the new and more expansive requirements under SB 114, which applies to employers with more than 25 employees.

Hours of Leave.  Full-time employees are entitled to up to 80 total hours of Supplemental Sick Leave for specified reasons and divided into two 40-hour buckets, described below.  Part-time employees are entitled to prorated leave equivalent to either their typical hours worked in a week, or seven multiplied by the average number of hours they have worked each day in the last six months.

The two buckets of leave are as follows:

First, full-time employees may use up to 40 hours of Supplemental Sick Leave when they are unable to work or telework for any of these reasons:

The employee is subject to a quarantine or isolation period related to COVID-19, as defined by an order or guidelines of the California Department of Public Health, the U.S. Centers for Disease Control and Prevention, or a local health officer who has jurisdiction over the workplace (if the employee is subject to more than one order/guideline, the employee may use Supplemental Sick Leave for the minimum quarantine or isolation period under the order or guidance that provides for the longest such minimum period);
Continue Reading California Reinstates and Updates COVID-19 Supplemental Paid Sick Leave for 2022

From 25 to 29 January 2022, the 150th session of the World Health Organization’s (“WHO”) Executive Board (“EB”) took place in Geneva, Switzerland.  Two years into the COVID-19 pandemic, a central theme for this session was the management of global health emergencies.  This post briefly outlines the main take-aways…
Continue Reading Key take-aways from the 150th session of the WHO Executive Board

From 25 to 29 January 2022, the 150th session of the World Health Organization’s (“WHO”) Executive Board (“EB”) took place in Geneva, Switzerland.  Two years into the COVID-19 pandemic, a central theme for this session was the management of global health emergencies.  This post briefly outlines the main take-aways…
Continue Reading Key Take-aways from the 150th Session of the WHO Executive Board

Federal government contractors face many uncertainties as they implement President Biden’s COVID-19 vaccine mandate. This includes the distinct possibility of civil lawsuits arising out of their implementation of the mandate, including potential allegations of invasion of privacy, wrongful termination, lost wages, discrimination, personal injury or other common law claims…
Continue Reading Are Federal Contractors Immunized From Vaccination Litigation? Mitigating The Risk Of Civil Liabilities Arising Out Of The COVID-19 Vaccine Mandate

Covington’s Senior Advisor Carl Bildt, former prime minister and foreign minister of Sweden, analyses the key trends expected to drive geopolitics and business over the near term.

Globally, strategic competition between the United States and China, and to some extent with a revisionist Russia, continues to be a source…
Continue Reading Geopolitics & Business: Quarterly Update with Carl Bildt, Senior Advisor