On January 21, 2021, the European Commission opened two public consultations on the review of the EU Blood Directive and the EU Tissues and Cells Directive. Both Directives are more than fifteen years old, and their implementation diverges widely across the member states. The rules on human blood and tissue gain increasing importance for companies … Continue Reading
The Affordable Care Act (ACA) has been an issue in every Congress since it was enacted in 2010 and this next Congress will be no different. There are so many health care issues that need to be debated—a national vs state pandemic strategy; funding for testing; additional relief for health care providers; surprise billing; treatment … Continue Reading
A growing number of African countries have begun to ease COVID-19 related regulatory restrictions. Some countries, such as Kenya, Rwanda, and Senegal resumed international flights in August, while other countries like South Africa and Nigeria are only now opening their borders. For a continent that slipped into recession for the first time in a quarter … Continue Reading
Governor Newsom has signed Senate Bill (SB) 1383 to significantly expand the California Family Rights Act (CFRA). The CFRA is California’s counterpart to the federal Family and Medical Leave Act (FMLA) and provides unpaid family and medical leave of up to 12 weeks for eligible employees. The new law’s key revisions are summarized below and … Continue Reading
On 10 September 2020, the German Federal Social Court (Bundessozialgericht – “BSG”) has issued an important decision with significant impact on the drug pricing and reimbursement system. It ruled that a pharmaceutical company can file a direct legal action against the early benefit assessment in the so-called AMNOG process. This was not possible so far. … Continue Reading
Drug manufacturers have responded to the COVID-19 pandemic by adopting measures to ensure continuity in their operations—continuity that is vital to safeguarding the global drug supply. In doing so, some have faced unprecedented challenges with regard to ensuring the health of their employees, preventing COVID-19 transmission at their facilities, and mitigating associated risks to product … Continue Reading
The Trump Administration has released the much-anticipated executive order entitled “Lowering Drug Prices by Putting America First” (commonly referred to as the “Most-Favored-Nation” or “MFN” executive order). President Trump initially had announced the MFN executive order during his July 24, 2020 press conference highlighting four separate executive orders aimed at drug pricing. However, while the … Continue Reading
On August 15, 2020, the Minister of Cooperative Governance and Traditional Affairs (COGTA) announced the extension of the national state of disaster. The national state of disaster was declared under Government Gazette No 43096 of 15 March 2020 (and extended by Government Gazette Nos 646 of June 5, 2020 and 765 of July 13, 2020), … Continue Reading
Last week, President Trump issued an executive order aimed at encouraging the expansion American manufacturing of essential medical products — Executive Order on Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States (August 6, 2020) (the “Order”). The Order sets forth an ambitious plan requiring extensive agency action on a … Continue Reading
The government’s response to the coronavirus pandemic implicates a host of authorities of interest to contractors, from those under the Stafford Act to its recently invoked Defense Production Act powers. The government has another critical, and perhaps under-examined, set of tools at its disposal to meet the demands of the pandemic: FAR Part 18, “Emergency … Continue Reading
If COVID-19 spreads across Africa, it would not only be a human catastrophe for the continent, but one that threatens the Northern Hemisphere with future outbreaks and further human and economic losses. What is true in the United States, where people in poor and minority neighborhoods are dying in disproportionate numbers, is true for the … Continue Reading
America’s political leaders overcame political differences to enact $2 trillion in national economic support bill, while the Federal Reserve took historic steps to assure liquidity for the economy to address COVID-19. Important steps for sure, but a bigger challenge lies around the corner. This is a global pandemic causing global economic crisis; the United States … Continue Reading
As previously reported on this blog, on 1 April 2020 Belgium adopted a complete ban on exports of certain medicines and raw materials to non-EEA countries to avoid shortages during the COVID-19 outbreak. On 8 April 2020, Belgium reversed this ban, and instead installed a system of export controls. Coincidentally or not, the same day … Continue Reading
As a complement to our March 26, 2020 blog “Covington’s Ability to Help Respond to the COVID-19 Pandemic in Africa,” you may access the audio of our briefing call here. Key takeaways from the briefing can be accessed here. With African governments increasingly taking strong actions to impede the spread of the COVID-19 virus, including … Continue Reading
South Africa did not record the first case of Covid-19 in Africa, but it now has the highest number of reported cases on the continent. Having had the benefit of watching governments respond to the outbreak of the pandemic in Asia, Europe and the United States, President Cyril Ramaphosa on March 15, 2020, with only … Continue Reading
Contractors sidelined by facility closures and stay-at-home orders in the wake of the COVID-19 pandemic may now have a new pathway to recovering idle labor costs. The Coronavirus Aid, Relief, and Economic Security (“CARES”) Act includes a provision, Section 3610, that provides a new form of relief for contractors facing delays and additional costs as … Continue Reading
The rapid spread of COVID-19, along with the effectiveness of existing public health response plans and the impacts of social distancing on the economy, have raised the question of how new technology can be used to address and manage the pandemic. On April 1, 2020, the Stanford Institute for Human-Centered Artificial Intelligence hosted “COVID-19 and … Continue Reading
On March 30, 2020, the inspectors general of several major agencies selected the Department of Defense Inspector General, Glenn Fine, to lead a newly created federal oversight entity that will investigate waste, fraud, and abuse in connection with the massive new coronavirus economic relief legislation. The inspectors general were exercising new authority contained in the … Continue Reading
Recent legislation significantly expanded many workers’ entitlement to paid sick leave and paid family leave. These new benefits take effect on April 1st. Our employment and benefits experts have described those requirements in a series of posts, including overviews here and here, and New York-specific considerations here. Federal government contractors should pay particular attention to … Continue Reading
Covington COVID-19 Task Force This afternoon Congress passed the Coronavirus Aid, Relief, and Economic Security (CARES) Act—the third wave of coronavirus relief legislation known by many as “Coronavirus 3.0.” President Trump is expected to quickly sign the bill into law. This alert provides analyses of some of the key provisions. Each linked section contains key … Continue Reading
COVID‑19 has caused a public health crisis and extreme disruption to economic markets. As communities, governments, and businesses come together to combat these challenges, questions are naturally arising about how to comply with the antitrust laws under such extraordinary circumstances. The United States antitrust agencies have advised that, with limited exception, companies should rely on … Continue Reading
As millions of American workers, students, and patients stay home to help combat the novel coronavirus (COVID-19), the $2 trillion Coronavirus Aid, Relief, and Economic Security (CARES) Act includes funding for the transition to remote life among its many relief provisions. With specific funding for broadband connections, distance learning, telehealth, and telework, the CARES Act … Continue Reading
With African governments increasingly taking strong actions to impede the spread of the COVID-19 virus – including in a number of jurisdictions, imposing full lockdowns – we are able to provide assistance to our clients, financial institutions, developmental finance organizations, companies and organizations on the continent. We are available to get on a call at … Continue Reading
This month, the U.S. Department of Health and Human Services (“HHS”) issued guidance waiving enforcement of certain provisions of the Health Insurance Portability and Accountability Act (“HIPAA”) in response to the COVID-19 nationwide public health emergency. Covered Health Care Providers On March 17, 2020, the Department of Health and Human Services Office for Civil Rights … Continue Reading
