Physicians and medical professionals throughout the world are facing and attempting to treat one of the most serious and deadly viruses that has affected the world in our lifetime. Medical professionals are on the front lines and in a position, despite their best efforts to protect themselves, to contract the disease. Medical professionals do not only fear for their own lives but also for the lives of their family members if they unintentionally bring this disease home ...
On 30 March 2020, the Ukrainian Parliament adopted the Law "On Amendments to Certain Legislative Acts Aimed to Ensure Additional Social and Economic Guarantees Due to the Coronavirus Disease (COVID-2019) Spread" (the Law), which introduces to the Ukrainian legislative environment new complex rules aimed at minimizing the negative impact of the spread of the COVID-19 in Ukraine. The below summary focuses on key changes introduced by the Law ...
INFARMED has published a set of exceptional measures – which will remain in force during the period of risk to public health – to be adopted by sponsors, clinical trial sites, and research teams, to guarantee the safety, protection and rights of clinical trial subjects.It has also defined INFARMED’s evaluation of trials intended to treat or prevent the new Coronavirus disease (SARS-CoV-2) as a priority ...
On April 6, 2020, the National Consumer Service (SERNAC) published the "Interpretative Circular on distance contracts during the COVID-19 pandemic", which seeks to set general guidelines regarding distance contracting with consumers during the constitutional state of catastrophe due to public calamity. To safeguard the basic rights embodied in Law No ...
Nursing homes have been on the front lines throughout the COVID-19 pandemic as they care for the persons most at risk. In an effort to improve safety and curb the spread of COVID-19, federal and state authorities are relaxing certain compliance obligations. Despite this regulatory latitude, nursing facilities should remain aware that federal and state agencies continue to closely monitor nursing home compliance ...
Below is a summary of key new measures and initiatives that have been implemented and announced by various UAE authorities since 6 April 2020 and the time of this inBrief, 6:00 p.m. on Wednesday, 8 April 2020 ...
The U.S. Department of Justice (DOJ) has issued a series of memoranda that discloses the department’s enforcement priorities and provides public guidance related to the ongoing coronavirus crisis ...
Today, Governor Wolf signed an order to allow the administration to transfer supplies and information between medical facilities ...
As misinformation on COVID-19 continues to spread, there is another more serious threat being dispersed through back trade channels and that is of counterfeit goods either for sale at exorbitant prices or fake goods proclaiming to cure or treat the virus. In 2018, Forbes announced that counterfeiting was the largest criminal enterprise in the world[1] and the sales of counterfeit and pirated goods totals $1.7 trillion per year, which is more than drugs and human trafficking ...
Below is a summary of key new measures, as well as clarifications on previous measures we reported on, that have been implemented by various UAE authorities since 5 April 2020 and the time of this inBrief, 6:00 p.m. on Tuesday, 7 April 2020 ...
Since the publication of our legal update on COVID-19 Legal Challenges for Pharmaceutical Companies on 31 March 2020, new important measures were adopted or announced on both national and EU level ...
Effective on April 6, 2020, an Order was published to establish the technical guidelines (the “Technical Guidelines”) for the activities described in Article 1, Section II, sub-sections (c) and (e) of the order that adopted extraordinary measures to deal with the health emergency caused by the SARS-CoV2 virus” (the “Order”). (We published an article on the Order, which may be foundhere ...
In order to avoid the shortage of antiseptic and disinfectant products for external use, the Colombian Ministry of Health issued Resolution 520 of March 28, 2020 in order to establish new requirements for the manufacture of the above-mentioned products within the Colombian territory ...
The new measures adopted by the European Commission Last Friday, the European Commission (“Commission”) has adopted an amendment to existing State aid rules to widen the perimeter of the national measures which can be authorized based on the exceptional legal framework to cope with the current crisis. a. In particular, the Commission considered the following measures:a. More support for research and development related to the current health crisis ...
This supplements our inBrief dated 3 April 2020, which reported on measures implemented by the UAE authorities in response to COVID-19 up to 9:00 a.m. that day. Many new measures have been introduced since then. We now report on new measures taken up to 9:00 a.m. on Monday 6 April 2020 ...
On March 30, 2020, the Secretary of the Department of Health and Human Services ("Secretary") announced a blanket waiver ("Waiver") of sanctions for violations of Section 1877 of the Social Security Act, also known as the physician self-referral law or Stark law ("Stark Law") ...
With national governments scrambling to take measures in order to counter the Covid-19 pandemic, we are again confronted with the fact that a EU common policy in the healthcare field is quasi inexistent. This is equally so in respect of the pricing and reimbursement of medicines ...
Due to the active spread of coronavirus infection COVID-2019, the Russian authorities, at both the federal and regional levels, are taking significant measures to ensure the self-isolation of citizens. These measures include increasing the liability for violation of measures for preventing the spread of coronavirus infection, which caused adoption of a number of legislative acts. 1 ...
The UAE continues to implement new measures on a daily basis to curb the spread of COVID-19. Those measures are being adopted, announced and implemented at a very rapid pace. For ease of reference, we present here a summary of the key measures that have been implemented by various UAE authorities between 18 March 2020 and the time of this inBrief, 9:00 a.m. on Friday, 3 April 2020 ...
Introduction The UK government has recently adopted a series of recommendations aimed to face the Coronavirus outbreak due to the rise in the number of infections and deaths caused by this virus. The strict approach of the UK Government would be in line with the measures adopted by the other countries in Europe, such as Italy or Spain ...
“With our nation’s health care providers on the front lines in the fight against COVID-19, dollars and cents shouldn’t be adding to their worries.” - CMS Administrator Seema Verma. During this Public Health Emergency, the Centers for Medicare & Medicaid Services (“CMS”) has expanded its accelerated and advanced payment program (“Program”) to all Medicare-enrolled providers and suppliers (“Providers”) ...
On Friday, March 27, 2020, the CARES ACT was signed into law. The Cares Act includes provisions for changing deadlines for patents, trademarks, and copyrights. For patents and trademarks, the Act permits the Under Secretary of Commerce for Intellectual Property and the Director of the United States Patent and Trademark Office to change the deadlines imposed by Title 35 of the United States Code, the Trademark Act, Section 18 of the Leahy-Smith America Invents Act ...
Federal and state agencies continue to deliver tools and information to help healthcare providers respond to the COVID-19 pandemic since the President declared the COVID-19 outbreak a national emergency. The declaration gave the Secretary of the U.S. Department of Health and Human Services (“HHS”) authority to temporarily waive or modify certain requirements of federal healthcare programs ...
The Coronavirus pandemic is impacting every business sector across the globe. Many new resources, however, including the new Coronavirus Aid, Relief, and Economic Security (CARES) Act, provide franchise and hospitality businesses with opportunities for relief. The following information is intended to aid franchise and hospitality companies in understanding options available to them during this time ...
On March 24, 2020, the Commodity Futures Trading Commission (“CFTC” or the “Commission”) unanimously approved its final interpretive guidance (“Final Guidance”) regarding retail commodity transactions involving certain digital assets ...