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Practice Industry: Dispute Resolution, Healthcare & Pharmaceuticals
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ALTIUS/Tiberghien | November 2020

The legal status of CBD, a naturally occurring compound found in the cannabis plant, is murky. Certain Member States are more restrictive about it than others. The Court of Justice of the EU has very recently provided clarification in the context of a preliminary ruling (case C-663/18 of 19 November 2020). This case revolves around CBD’s ban in France, after it had been imported from the Czech Republic where it was lawfully produced ...

Deacons | November 2020

In the recent judgment of Leung Kwok Hung (also known as “Long Hair”) v. Commissioner of Correctional Services [2020] HKCFA 37, the Court of Final Appeal (CFA) ruled in favour of Leung Kwok Hung (Leung) in his fight against the Commissioner of Correctional Services (Commissioner). After being convicted and sentenced to imprisonment, Leung, the appellant, was required to have his hair cut at Lai Chi Kok Reception Centre pursuant to Standing Order 41-05 ...

Hunton Andrews Kurth LLP | November 2020

The Retail Industry team would like to provide you with an update on legal developments in the retail and consumer products industries as posted on the Hunton Retail Law Resource blog. If you wish to receive email alerts when new posts are published, please visit our blog and enter your email address in the subscribe field ...

Arendt & Medernach | November 2020

On 18 November 2020, the Luxembourg Competition Council issued decisions against German biscuit manufacturer Bahlsen, as well as against the Luxembourg supermarket outlet Cactus and the internationally active Auchan and Delhaize groups for engaging in resale price maintenance agreements and distorting competition on the Luxembourg market. The decisions impose fines of in total EUR 3,3 million and mark the end of a five year long investigation process.Legal FrameworkArt ...

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

Deacons | November 2020

With the Universal Community Testing Programme for COVID-19 detection by the Hong Kong Government and temperature screening in the workplace, the collection and use of biometric data (such as DNA samples, fingerprints and facial images) have raised concerns among the public. In August 2020, the Privacy Commissioner (PC) has updated its guidance note on how data users should collect and use biometric data in compliance with the Personal Data (Privacy) Ordinance (Guidance Note) ...

ALTIUS/Tiberghien | November 2020

The Court of Justice of the European Union delivers judgments regarding the concept of “communication to the public” faster than legal scholars can read and dissect them. While we are eagerly awaiting the Court’s analysis of different types of hyperlinking, it has taken less than two months to follow Advocate General Hogan’s opinion regarding the emailing of evidence containing copyrighted works to a court in legal proceedings ...

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 ...

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 ...

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 ...

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 ...

On November 5, 2020, in Valeant Pharms. N. Am. LLC  v. Mylan Pharms. Inc., No. 2019-2402, the Federal Circuit held that venue in Hatch-Waxman cases brought under 35 U.S.C. § 271(e)(2)(A) is proper “only in districts where actions related to the submission of an Abbreviated New Drug Application (‘ANDA’) occur, not in all locations where future distribution of the generic products specified in the ANDA is contemplated.”  Slip op. at 3 ...

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 ...

A minority of states have enacted statutes and taken other action to protect business owners from claims by persons who allegedly were infected by COVID-19 on their premises.1 The purpose of this article is to compare these statutes and discuss some of the differences between them. This article addresses statutes in effect as of October 27, 2020. The article does not address pending legislation ...

Dinsmore & Shohl LLP | November 2020

The Ohio Department of Health’s July 23, 2020 Order regarding facial covering mandates has been amended in light of the increasing number of COVID-19 cases in Ohio. The order became effective today, Nov. 16, 2020. See the order here. This new order includes the following additional mandates for retail stores (enterprises offering goods to the public) only. 1. Each business will be required to post at all public entrances to the store: A. A face covering requirement sign; B ...

Dinsmore & Shohl LLP | November 2020

On November 16, 2020, the Department of Health and Human Services Office of Inspector General (HHS OIG) issued Special Fraud Alert: Speaker Programs (Fraud Alert) to “highlight the fraud and abuse risks associated with the offer, payment, solicitation, or receipt of remuneration relating to speaker programs by pharmaceutical and medical device companies ...

Dinsmore & Shohl LLP | November 2020

Under the Medicare Secondary Payer Act (MSPA), a Medicare Secondary Payer is the entity which has an obligation to pay medical expenses before Medicare. In the face of rising costs, legislation was passed in 1980 making Medicare a secondary payer to various primary plans in order to shift medical expenses to those Medicare believed should be the primary source of payment ...

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 ...

The HHS Office for the National Coordinator of Health Information Technology issued an interim final rule on October 29, 2020, extending the compliance date for the information blocking rule under the 21st Century Cures Act to April 5, 2021 ...

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 ...

Afridi & Angell | November 2020

The Sharjah Court of Appeal recently declined to apply the principle of separability of an arbitration clause, on the basis that the underlying agreement (i.e. in which the arbitration clause was contained) was not defective or argued to be invalid by the appellant. This judgment has potentially significant implications for parties who intend to rely on an agreement which contains an arbitration clause to assert claims in court ...

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 ...

Schwabe, Williamson & Wyatt | November 2020

On November 5, 2020, the Washington Supreme Court altered a 60-year provision of Washington’s Minimum Wage Statute when it issued its decision in Martinez-Cuevas v. DeRuyter Brothers Dairy. The court held that the agricultural overtime exemption at RCW 49.46.130(2)(g), which exempted agricultural employers from paying overtime at a rate of 1.5 times the regularly hourly rate, violated article I, section 12 of the Washington State Constitution as applied to dairy workers ...

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) ...

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