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Practice Industry: Crossborder Trade & Investment, Healthcare & Pharmaceuticals, Life Sciences
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Gianni & Origoni | December 2020

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

O'Neal Webster | December 2020

British Virgin Islands entities and structures are frequently used to hold assets located onshore, outside the BVI. Sometimes these assets represent the proceeds of wrong-doing including breach of fiduciary duty, breach of express trust, or pure fraud. The vast majority of the 400,000 active BVI companies on the register tend to be holding companies, holding real property, investments, or shares in other companies including shares in trading companies ...

Dinsmore & Shohl LLP | December 2020

The Ohio Board of Pharmacy (Board) recently issued updated guidance detailing certain conduct pharmacists and other regulated personnel (Licensees) must report to the Board ...

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

Hong Kong has in recent times seen an increasing use of remote on-boarding of customers by banks as a result of COVID-19. Banks are generally required to pay more attention to the remote on-boarding assessment of corporate customers as opposed to individual ones due to the higher money laundering and terrorist financing risks associated with corporate vehicles ...

Veirano Advogados | November 2020

On November 25, 2020, the Brazilian Senate approved Bill of Law No 4,458/2020 ("BL 4458"), which amends Law No 11,101/2005 ("BBL"), to update the legislation regarding the judicial reorganization, pre-packaged reorganization and bankruptcy liquidation of businessmen and companies. BL 4458, which provisions have already been approved by the House of Representatives, will now be sanctioned by the President ...

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

Following the issuance of new rules governing the Qualified Foreign Investors (QFI) regime in September 2020 (New QFI Rules, for more information, you may refer to our earlier article here), China equities and futures trading exchanges (including the Shanghai Stock Exchange (SSE), the Shenzhen Stock Exchange (SZSE), the National Equities Exchange and Quotations (NEEQ) and the China Financial Futures Exchange (CFFEX)) issued new implementation rules for QFIs at the end of October ...

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) ...

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 ...

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 ...

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 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 ...

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 ...

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 ...

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 ...

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) ...

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 ...

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