The Philippine Government has issued a slew of resolutions and circulars as part of its response to the COVID 19 pandemic and unsurprisingly, a number of legal and practical issues have beset businesses and persons under the Luzon-wide enhanced community quarantine (ECQ)1. Like the rest of the world, the country is bracing itself for a new normal – in the way enterprises are run, services are rendered, everyday tasks are undertaken ...
INVIMA will prioritize the procedures for pharmaceutical products identified as essential for the treatment of symptoms and complications of COVID-19 ...
We would like to provide you with an update on some changes in the legal regulation of medicines in Russia made due to dynamic spread of the coronavirus (COVID-19) ...
Today, the federal government enacted the Paycheck Protection Program and Health Care Enhancement Act (the “PPP/HCE Act”) to provide additional funding for loan and grant programs in response to the COVID-19 pandemic. The PPP/HCE Act modifies and increases funding for the Paycheck Protection Program and the Small Business Administration Economic Injury Disaster Loan program, as discussed in greater detail here ...
Yesterday, in Romag Fasteners, Inc. v. Fossil, Inc., the U.S. Supreme Court unanimously held that a plaintiff in a trademark infringement suit is not required to show that the infringing defendant acted “willfully” to avail itself of the Lanham Act’s disgorgement remedy ...
On April 15th, Exempt Resolution No. 258, that determines certain maximum prices in accordance with the abilities granted to the Ministry of Health by Decree No. 4/2020, was published in the Official Gazette ...
In order to allow the importation of medicines and other products for human health,during the State of Emergency, the National Directorate of Pharmacy and Drugs (DNFYD) of the Ministry of Health, has issued Resolution 280 of April 6, 2020 published in Official Gazette No ...
New products related to the health emergency by COVID-19 are declared as Non-Available Vitals. Since the issuance of Minute Num. 3 dated March 24, 2020, the Colombian Sanitary Authority, INVIMA, has declared certain products, subdivided in 16 categories, as NON-AVAILABLE VITALS, which as such, can be commercialized without a sanitary registration ...
In response to the economic impact of the COVID-19 pandemic, the federal government has passed several new laws to provide trillions of dollars of funding to affected businesses and individuals. But this also means there are new compliance considerations for entities receiving federal funds, especially as it relates to the False Claims Act’s “false certification” theory of liability ...
The COVID-19 pandemic has had a disproportionate impact on skilled nursing and assisted living facilities. While the following CMS recommendations and guidelines identify nursing homes as the target recipients, they are applicable to all facilities that receive Medicare and Medicaid funds, and are therefore subject to CMS's oversight ...
The Costa Rica´s General Directorate of Customs issued the statement DGA-010-2020, which expands the list of products for surgical use that have export and re-export restrictions, which they had initially established through directive DGA-003-2020. The products added are as follows: Mono-glasses: Mono-glasses with indirect ventilation, transparent lens, foam covered frame and adjustable headband. Ergonomic and panoramic design. HSC: 9004.90.10.00 ...
Key Points: Since Governor Newsom announced a state of emergency due to the COVID-19 outbreak, private Proposition 65 enforcement has increased by about 50%. Effective April 1st, new regulations clarify how manufacturers can satisfy their Proposition 65 warning obligations. These new regulations also clarify when retail sellers assume the burden under Proposition 65 to warn Californians ...
We have previously reported on the order that adopted the extraordinary measures under the COVID-19 health emergency declaration, published on March 31, 2020 (the “Order”), and the Technical Guidelines regarding certain essential activities described in Order, published on April 6, 2020 ...
Decree Number 557 intends to take economical and tax related measures to relieve economic burden to some companies and charity and social solidarity organizations in the context of the economic emergency caused by COVID-19. Specifically, micro and small business as well as associations and solidarity non-profit organizations, will have special discounts applicable to the payment of administrative fees before the sanitary authority, INVIMA ...
The Plurinational State of Bolivia, within the framework of its governmental powers and in accordance with the Declaration of Sanitary Emergency and Quarantine established in recent days, has determined to strengthen the latest measures. The government has conviniently declared that the total quarantine, extends until April 30, 2020, maintaining the suspension of public and private activities ...
In the midst of the COVID-19 waves, the EU Commission rejected the delay proposals on the Emission Trading Scheme (ETS)’s mandatory annual deadlines ...
We recently discussed how the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) allocates $100 billion to the Public Health and Social Service Emergency Fund, to be distributed as relief funds to hospitals and other healthcare providers on the front lines of the coronavirus response (“Provider Relief Fund”) ...
The Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”), a historic $2 trillion relief package signed into law on March 27, 2020, seeks to address the economic impact of the COVID-19 pandemic on several industries ...
In recognition of the ability to detect the Coronavirus (COVID-19) in sewage and the critical role of basic hygiene in combatting COVID-19, the Minister of the Department of Human Settlements, Water and Sanitation has published directions in terms of the Disaster Management Act, 2002. The Directions implement the emergency procurement of water supply and sanitation services to identified areas to combat the spread of COVID-19 ...
On March 27, 2020, President Donald Trump signed into law a $2 trillion emergency relief bill to ease the economic impact of coronavirus (COVID-19) and support response efforts. The CARES Act[1] included an allocation of $80 million in funding to the U.S. Food and Drug Administration (FDA) to continue its COVID-19 response efforts. The additional agency funding will be used, in part, for the development of medical countermeasures and vaccines ...
Through data analysis, hospitals can track denials, improve appeals success rates and recoup revenue losses that threaten their very survival. Early last year, when Modern Healthcare reported that a deluge of reimbursement claim denials had driven U.S. hospitals toward a “crisis point,” it highlighted an alarming market imbalance between payers and providers ...
The continuing COVID-19 pandemic has caused an unprecedented disruption of business worldwide, and many businesses and organisations will be scouring their current contracts to identify avenues of relief. In many cases, the pages containing the force majeure clause will be the first to be turned ...
