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Covid-19 Legal Updates for Employment Law: The Conversion Into Law of the August Decree and the “Ristori” Decree
Gianni, Origoni, Grippo, Cappelli & Partners, December 2020

By resolution adopted on October 7, 2020, the state of emergency has been extended until January 31, 2021...

The CDC’s New Definition of “Close Contact”: What You Need To Know
Dykema, November 2020

                The Centers for Disease Control and Prevention has expanded the definition of close contact to now evaluate exposure cumulatively over a 24-hour period such that “15 cumulative minutes of exposure at a distance of 6 feet or less can be used as an operational definition for contact investigation,”[1] Because the newly expanded definition is not limited, it impacts many different industries (inclu

The Philosophy Behind the Successful Economic Substance Regime of the BVI
Morgan & Morgan, November 2020

Following the introduction in the British Virgin Islands (BVI) of the Economic Substance (Companies and Limited Partnerships) Act, 2018 (ESA), which became effective on January 1st, 2019, some questioned the sustainability of BVI’s position as a leading international financial centre. While we cannot underestimate those concerns, we believe that there is also evidence that ESA will not have a negative impact on the BVI...

OIG Releases Alert for Speaker Programs Sponsored by Healthcare Companies
Waller, November 2020

The Department of Health and Human Services (HHS) released a Special Fraud Alert from the Office of Inspector General (OIG) highlighting the fraud and abuse risks associated with the offer, payment, solicitation, or receipt of remuneration related to speaker programs sponsored by healthcare companies...

“If I've Told You Once, I've Told You Eight Times…” HHS OIG Issues Another Audit Report on Hospitals’ Failure to Report Credits for Explanted Cardiac Devices and Lays the Groundwork Collection of Over
Verrill, November 2020

Each year, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issues dozens of audit reports. While each is important in its own way, some stand out with language that appears to reflect OIG’s fraying patience and may lay the groundwork for possible future enforcement action. A report issued on November 16, 2020, falls into this category...

Regional Comprehensive Economic Partnership Signed
DFDL, November 2020

On 15 November 2020, leaders of the ASEAN Member States, Australia, China, Japan, Republic of Korea and New Zealand witnessed the signing of the Regional Comprehensive Economic Partnership (“RCEP“) Agreement. The RCEP Agreement marks ASEAN’s biggest free trade pact to date, covering a market of 2.2 billion people with a combined size of US$26.2 trillion...

OIG Takes Aim at Speaker Programs in Special Fraud Alert
Bradley Arant Boult Cummings LLP, November 2020

On November 16, 2020, the Office of Inspector General of the Department of Health and Human Services (OIG) issued a Special Fraud Alert addressing the fraud and abuse risks of speaker programs that are commonplace in the pharmaceutical and medical device industries...

Highly Anticipated Final Rules on Stark Law Anti-Kickback Statute Published
Waller, November 2020

The Department of Health and Human Services (HHS) further codified the shift to a value-based care model with the first major overhaul of both the Stark Law and Anti-Kickback Statute since they were first introduced three decades ago. Earlier this week, the White House completed the final review of the changes, and on Friday, Nov...

Long-Awaited Changes to Stark Law and Anti-Kickback Statute Imminent
Waller, November 2020

The White House has completed the final review to clear a path for the Department of Health and Human Services (HHS) to publish the final rule to modernize and clarify regulations promulgated for the Stark Law and Anti-Kickback Statute. In June 2018, HHS Deputy Secretary Eric Hargan announced a regulatory reform initiative entitled the “Sprint to Coordinated Care...

FTC Sues to Block Methodist Le Bonheur-St. Francis Transaction
Bradley Arant Boult Cummings LLP, November 2020

On November 12, 2020, the Federal Trade Commission (FTC) sued to block the acquisition of two Memphis-area hospitals by Methodist Le Bonheur Healthcare. Eleven months earlier, on December 12, 2019, Methodist entered into an agreement with Dallas-based Tenet Healthcare Corporation to purchase Saint Francis-Memphis and St. Francis-Bartlett (along with their associated physician practices, urgent care centers, and other ancillary care providers) for $350 million...

Healthcare & Life Sciences Department Report
Beccar Varela, November 2020

In this report, you will find a summary of two important decrees published yesterday in the Official Gazette. Regulatory Decree of Law No. 27,350 of medical and scientific research on the medicinal use of the cannabis plant and its derivatives By means of Executive Branch’s Decree No...

Joint Resolution No. 1/2020: Health Emergency - Maximum Prices for Certain Drugs
Beccar Varela, November 2020

The Joint Resolution No...

Exceptional Rules for Products to Prevent Spread of COVID-19
PLMJ, November 2020

Introduction The rapid spread of COVID-19 pandemic has led to a significant increase in demand for medical devices (MDs) and personal protective equipment (PPE), masks for social use (textile articles) and other products destined to prevent the spread of the disease. As a result, it became clear that there was insufficient supply to meet existing needs during the state of emergency and the subsequent period...

Battling COVID-19: Mechanisms for Access to Antiviral Products and Diagnostics
ENSafrica, November 2020

IP landscape While the world is in the grip of the deadly COVID-19 pandemic, the patenting of pharmaceutical and biological compositions and the launch of generic products is even more hotly debated than before, particularly in the world's developing and least-developed countries...

Hospital Price Transparency Rule: Full Steam Ahead
Verrill, November 2020

Neither COVID-19 nor continued legal challenges appear likely to derail the Centers for Medicare & Medicaid Services (CMS) Hospital Price Transparency Rule from going into effect on January 1, 2021. Hospitals therefore should continue to comply with the requirements by the deadline...

Can Parallel Importers Rebrand Generic Medicines?
ALTIUS/Tiberghien, November 2020

If a branded medicine and its generic version are put on the EEA market by economically linked undertakings, is a parallel importer then allowed to rebrand and repackage the imported generic version as the branded reference medicine? This has been a hotly debated issue in recent years and recently led the Brussels Court of Appeal (CoA) to refer three questions to the European Court of Justice (ECJ) (Cases C-253/20 and C-254/20)...

Home Office - A Risk for Privacy and Cyber Security? What Companies Need To Do
Heuking Kühn Lüer Wojtek, November 2020

The Coronavirus pandemic has caused a shift in the paradigm of modern-day workplaces. Companies across the globe have seen a rapid and widespread shift to remote work, making compliance with the GDPR harder than ever. The Federal Office of Information Security (BSI), in its recent report on the ‘State of IT Security in Germany 2020’, expressed its concern and indicated a ‘tense situation’ for data protection in the country...

Top tips on comparative advertising
MinterEllisonRuddWatts, November 2020

Comparative advertising is a risky method of advertising. But if care is taken to address those risks, comparative advertising can be an incredibly effective tool for your business. It also has an important part to play in regulating competition and educating consumers. Comparative advertising compares a product produced or service provided by the advertiser to an equivalent product or service produced or provided by a competitor (or competitors)...

Environmental Claim ‘Flushable' Not False or Misleading
MinterEllisonRuddWatts, November 2020

The Full Australian Federal Court recently upheld the decision that Kimberly-Clark’s Kleenex Cottonelle Flushable Cleansing Cloths (Kleenex Wipes) did not make false or misleading claims in using the word ‘flushable'. The guidance on the evidence required and weight given to complaints is instructive for New Zealand entities making environmental claims...

How to Avoid False or Misleading Pricing Representations
MinterEllisonRuddWatts, November 2020

Pricing representations receive ongoing scrutiny from the Commerce Commission. The Commission frequently brings enforcement action in this area and in recent years the Commission has signalled that it receives a significant number of complaints from consumers who have been misled by or are concerned about pricing practices...

Is Your Business Fit to Lead in the New World Economy?
MinterEllisonRuddWatts, November 2020

There can be few tougher tests of leadership than the ones that 2020 has thrown at company directors and leaders. The days of worrying about disruption driven by technology seem like a dream in comparison with the urgency, pace, breadth and scale of the challenges that have pounded companies and sectors up and down New Zealand – and around the world...

Do Not Forget to Provide Any of Your Employees Who Must be Present in Your Workplace with a Document to Certify this Fact
ALTIUS/Tiberghien, November 2020

Belgium is, for the second time, in lockdown. The new Ministerial Decree of 1 November 2020 stipulates that, as from today until 13 December 2020, all workers are obliged to telework. However, an exception applies when either the employee’s role or the continuity of business operations, activities and services does not allow for teleworking...

Cambodia: Additional Measures to Support Private Sector Workers & Revive the Post-COVID-19 Economy
DFDL, November 2020

On 30 September 2020, the Royal Government of Cambodia (“RGC”) issued a press release and rolled out ‘Round 6’ of measures aimed at mitigating the impacts of COVID-19 on businesses and workers in Cambodia. These represent a combination of new and existing measures (that have been extended)...

A Cure for Covid-19 and a Vaccine for Creditors?
TSMP Law Corporation, November 2020

Balance has been tipping over from creditors to shareholders and the pandemic is only bringing this deepening fault line to the fore. Covid-19 slammed into the global consciousness this March and, as expected, immediately torpedoed the markets. But despite the worsening economic data hogging news headlines, exacerbated by intensifying US-China tensions, the markets have paradoxically strengthened since...

Buchalter COVID-19 Client Alert: San Francisco Moves to Lowest COVID Tier in California, Begins Process of Reopening Non-Essential Offices; Other Bay Area Counties Slower to Follow
Buchalter, November 2020

On October 20, 2020, San Francisco County was upgraded to the “minimal” tier within the California COVID-19 tracking system, meaning it has the fewest restrictions on reopening all businesses as promulgated by the State of California. In order to qualify for the “minimal” tier, a county must have an infection rate of less than one daily new positive COVID case per 100,000 residents and have a positive test rate of less than 2% for two consecutive weeks...

 

 

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