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Practice Industry: Healthcare & Pharmaceuticals, Life Sciences, Taxation

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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...

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...

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...

What Happened to My Capital Account? New Partnership Reporting Requirements for 2020 and Beyond
Dykema, November 2020

On June 5, 2020 the Department of the Treasury and the Internal Revenue Service (“IRS”) issued Notice 2020-43 (the “Notice”) proposing two alternative methods to satisfy tax capital account reporting requirements as the only methods for reporting partner’s capital accounts under the tax basis method for taxable years that end on or after December 31, 2020...

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...

Indian Project Office of Foreign Company Not Engaged In Core Business Activities Not a Permanent Establishment (PE): Supreme Court
Kochhar & Co. Advocates & Legal Consultants, November 2020

Strap: In a recent case of Samsung Heavy Industries, the Indian Supreme Court held that the Project Office of the company cannot be termed as PE under the provisions of India-Korea Tax Treaty as it is solely carrying out activities of an auxiliary nature...

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)...

Does VAT Apply to Bare Land that is Leased to a Tenant Who will Develop It?
Afridi & Angell, November 2020

The supply of undeveloped (bare) land is exempt from value added tax (VAT) pursuant to Article 46 (3) of UAE Law No 8 of 2017. Bare land (as opposed to covered land) is defined as ‘land that is not covered by completed, partially completed buildings or civil engineering works’ pursuant to Article 44 of Cabinet Decision 52 of 2017...

Shearn Delamore & Co. Legal Update October 2020 (Tax and Revenue)
Shearn Delamore & Co., November 2020

Income tax The Income Tax (Prescribed Fees under Schedule 5 to the Act) Rules 2020 have been gazetted on 22 September 2020 and have come into operation on 25 September 2020. The following public rulings and guidelines have recently been published on the Inland Revenue Board of Malaysia’s official website:i. Appeal Against an Assessment and Application for Relief (Public Ruling No. 7/2020) issued on 7 October 2020 to replace Public Ruling No. 12/2017 dated 29 December 2017;ii...

Tax Updates October 2020: SyCipLaw Tax Issues and Practical Solutions (T.I.P.S.) Vol. 4
SyCip Salazar Hernandez & Gatmaitan, November 2020

The SyCipLaw T.I.P.S. for October cover the following tax issues: 1. When the taxpayer cannot be located, what are the options available to a Revenue Officer in serving an electronic Letter of Authority?  2. Is the sale, barter, exchange or other disposition through Initial Public Offering of shares of stock in closely held corporations subject to tax? 3...

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...

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...

Information Blocking Rule Compliance Date Extended Due to Pandemic
Bradley Arant Boult Cummings LLP, October 2020

The U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) released an interim final rule on October 29, 2020, delaying the implementation of the information blocking rule under the 21st Century Cures Act (Information Blocking Rule)...

DOJ Announces First Life Sciences Settlement Involving the Open Payments Program
Dinsmore & Shohl LLP, October 2020

The U.S. Department of Justice (DOJ) announced on October 29, 2020 it reached a more than $9.2 million settlement with Medtronic USA Inc. to resolve allegations it violated the False Claims Act (FCA) and Open Payment Program.[1] Specifically, Medtronic agreed to pay $8.1 million to resolve FCA allegations it paid kickbacks to induce a South Dakota neurosurgeon to use its SynchroMed II intrathecal infusion pumps...

India Attempts to Thwart Import of Chinese Goods Under FTAs
Kochhar & Co. Advocates & Legal Consultants, October 2020

Introduction The balance of trade between India and China continues to be heavily tilted in favour of China. Trade remedies such as anti-dumping and countervailing duties have been used frequently by India to curtail import of Chinese goods. To overcome such barriers, India has long suspected that China has been routing its goods through the ASEAN countries by misusing the Free Trade Agreements (‘FTA’)...

Coronavirus Angola: Update of Public Calamity Situation Measures
PLMJ, October 2020

Due to the worrying evolution of the epidemiological situation currently afflicting the country, Presidential Decree no. 276/20 of 23 October 2020 has been enacted to update the preventive and control measures for the spread of COVID-19. Overall, there is a strengthening of the previous preventive measures established in Presidential Decree no. 256/20, of 8 October 2020...

COVID-19 Legal & Tax Resource Center: Moving Forward Together
Nestor Nestor Diculescu Kingston Petersen, October 2020

The coronavirus disease (COVID-19) outbreak continues to put pressure on the public and private sectors alike. As we are entering new phases of the COVID-19 pandemic, we have to switch our focus towards safely and gradually reopening our businesses and economies while continuing to implement prevention measures...

Additional Fiscal Measures in the Context of COVID-19 - Tax Flash no.16/2020
Nestor Nestor Diculescu Kingston Petersen, October 2020

27.10.2020 –Emergency Ordinance no...

CDC Expands the Definition of Close Contact for COVID-19
Dinsmore & Shohl LLP, October 2020

On Oct. 21, 2020, the Centers for Disease Control and Prevention (CDC) released a new definition for “close contact.” The new definition was expanded to account for the cumulative amount of exposure one might have had with a person infected with COVID-19. Under the new definition, close contact is defined as being “within six feet of an infected person for a cumulative total of 15 minutes or more over a 24-hour period beginning two days before illness onset...

Life Sciences Enforcement Trends in 2020 and Outlook for 2021
Dinsmore & Shohl LLP, October 2020

Although the U.S. Department of Justice (DOJ) reported a slight decrease in settlements with life sciences companies in FY2019 (the most recent year for which data is available),[1] this likely will be a temporary trend. Several significant settlements and investigations in 2020 provide key insights into government enforcement priorities as we look toward 2021...

 

 

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