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ENS | April 2019

AFRICA: African Continental Free Trade Area Agreement developments Botswana and Zambia signed the African Continental Free Trade Area Agreement (“ACFTA”) on 10 February 2019 at the 32nd summit of the African Union in Addis Ababa, whereas the Ethiopian Council of Ministers approved the ACFTA on 2 February 2019 and the Parliament of Senegal on 23 January 2019 ...

ENS | April 2019

In the listed sector, shareholders may be presented with various elections to be made as regards the nature of distributions made by companies in which equity investments are held. Shareholders can therefore be faced with an election to receive payment of a cash dividend, or in lieu thereof, to receive capitalisation shares from the underlying company or to partake in a dividend reinvestment plan ...

ENS | April 2019

Sections 113 and 115 of the Companies Act, 2008 provide for an automatic statutory merger of two companies. The transfer occurs by way of operation of law, and barring any express prohibition to the contrary in a contractual arrangement, no third party consent is generally required to implement the merger. This type of transaction may typically give effect to a desired corporate reorganisation, in terms of which an existing company is liquidated, wound up and/or deregistered ...

ENS | April 2019

The reportable arrangement provisions were established by the South African Revenue Service (“SARS”) with the objective of obtaining information on certain types of transactions. The circumstances under which a person should report an “arrangement” to SARS, as defined in section 34 of the Tax Administration Act, 2011 (the “TAA”), are contained in sections 34 to 39 of the TAA ...

Dinsmore & Shohl LLP | April 2019

On April 1, 2019, the Health Resources and Services Administration (HRSA) launched a secure website that lists the maximum price drug manufacturers may charge 340B-covered entities for 340B-eligible drug purchases (the 340B Ceiling Price Site).  Drug manufacturers and 340B-covered entities may access the 340B Ceiling Price Site through their HRSA Office of Pharmacy Affairs information system (the 340B OPAIS) account here: https://340bopais.hrsa ...

Dinsmore & Shohl LLP | March 2019

A trio of federal statutes often referred to collectively as the P&A Acts, which includes the Protection and Advocacy for Individuals with Mental Illness Act (PAIMI), the Developmental Disabilities Assistance and Bill of Rights Act (PADD), and the Protection and Advocacy of Individual Rights Act (PAIR), authorize the creation and operation of a protection and advocacy system (P&A system) to monitor the care of individuals with mental illness and developmental disabilities ...

Dinsmore & Shohl LLP | March 2019

Beginning March 19, 2019, naltrexone drug products, including Vivitrol, dispensed pursuant to an outpatient prescription and indicated for the treatment of alcohol dependence or the prevention of relapse to opioid dependence must be reported to the Ohio Automated Rx Reporting System (OARRS) ...

Sponsored wellness plans that include incentives to employees who voluntarily disclose personal health information as part of disability-related inquiries or medical examinations are in legal limbo after the EEOC removed the underlying rules from the Americans with Disabilities Act (“ADA”) and Genetic Information Nondiscrimination Act (“GINA”) ...

Arendt & Medernach | March 2019

The most important corporate tax measures concern the reduction of the maximum corporate income tax (“CIT”) rate and the introduction of the option provided by the anti-tax avoidance directive (“ATAD”)[1]. This allows for the application of the interest limitation rules at the level of a fiscal unity: For the time being CIT is levied at a rate of (i) 15% in case the net profits do notexceed EUR 25,000 and (ii) 18% in case the net profits exceed EUR 30,000 ...

Arendt & Medernach | February 2019

In this context, the judgements provide useful guidance on the concepts of abuse and beneficial ownership. Abuse concept According to the CJEU, it is settled case-law that there is, in EU law, a general legal principle that EU law cannot be relied on for abusive or fraudulent ends ...

Dinsmore & Shohl LLP | February 2019

Senate Bill 273 goes into effect on March 20, 2019, and creates new requirements for Ohio insurance companies, including health insurance plans, to develop and implement specific information security programs to safeguard nonpublic business and personal information. Senate Bill 273 is based upon the National Association of Insurance Commissioners’ Insurance Data Security Model Law (also referred to as "MDL-668") ...

Dinsmore & Shohl LLP | February 2019

The Ohio medical marijuana market saw a robust start to sales on January 16, 2019.  First-day sales totaled more than $75,000, per the state’s Medical Marijuana Control Program, and total sales exceeded $330,000 in the first several weeks. This initial sales boom is magnified by the fact that only five of the 50-plus state-approved provisional dispensaries are operational (and only four on the initial date of sales) ...

Hanson Bridgett LLP | February 2019

On February 13, 2019, Assembly Member Ash Kalra, District 27 (San Jose), introduced AB-506. If passed, AB-506 would amend California Health and Safety Code Sections 1423, 1424, and 1424.5 to grant the Department of Public Health the authority to issue more citations and higher penalty amounts ...

ENS | February 2019

The Taxation Laws Amendment Act, 2018 (“TLAA”), which was promulgated on 17 January 2018, amended South African tax legislation by overhauling two provisions relating to the reduction of debt, (the “Debt Benefit Rules”), namely section 19 of the Income Tax Act, 1962 (the “ITA”) and paragraph 12A of the Eighth Schedule to the ITA (the “Eighth Schedule”) ...

Dinsmore & Shohl LLP | February 2019

On January 31, 2019, the United States Department of Health and Human Services (HHS) Office of Inspector General (OIG) announced a proposed rule that would significantly change the federal Anti-Kickback Statute (AKS) regulatory safe harbors regarding prescription drug rebates and discounts ...

Dinsmore & Shohl LLP | January 2019

On December 28, 2018, the Department of Health and Human Services (HHS), in partnership with the Health Sector Coordinating Council (HSSC), published the “Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients” (HICP Publication), which is a four-volume publication designed to provide voluntary cybersecurity practices to health care organizations of all types and sizes, ranging from local clinics to large health care systems ...

Dinsmore & Shohl LLP | January 2019

The Department of Health and Human Services Office for Civil Rights (OCR) has published a Request for Information on Modifying HIPAA Rules to Improve Coordinated Care (RFI). OCR announced the publication of the RFI through a December 12, 2018 press release available here.  OCR Director Roger Severino stated that OCR is “looking for candid feedback about how the existing HIPAA regulations are working in the real world and how we can improve them ...

Dinsmore & Shohl LLP | January 2019

Eliminating Kickbacks in Recovery Act Overview On October 24, 2018, Congress enacted the Eliminating Kickbacks in Recovery Act of 2018 (EKRA) as part of the SUPPORT Act, which is a comprehensive attempt to combat the opioid epidemic.  EKRA established an all-payer anti-kickback prohibition that extends to arrangements with recovery homes, clinical treatment facilities, and laboratories. Unlike the Anti-Kickback Statute (AKS) under 42 U.S ...

Hanson Bridgett LLP | January 2019

On January 28, 2019, the California Department of Social Services issued a letter informing all licensed Residential Care Facilities for the Elderly that Title 22, Section 87224 of the California Code of Regulations has been revised. Section 87224 previously provided for a 30-day eviction notice to residents upon the change of use of a facility. This notice period was inconsistent with the applicable statute, Health and Safety Code Section 1569.682(a)(2) ...

Shearn Delamore & Co. | January 2019

IN THIS ARTICLE, ABHILAASH SUBRAMANIAM DISCUSSES THE POTENTIAL IMPLICATIONS OF THE MOVE FROM GST TO SST.   Introduction The much anticipated Sales Tax Act 2018 and the Service Tax Act 2018(commonly referred to as “SST”) was rolled out on 1 September 2018, together with their respective subsidiary legislations, to replace the previous Goods and Services Tax Act 2014 (“GST”) ...

Veirano Advogados | January 2019

The Federal Council of Pharmacy published Resolution No. 658/2018 to regulate publicity, advertisement and announcement of activities related to the pharmaceutical profession. Such include any disclosure arising or promoted by pharmacists, regardless of the means of communication ...

Dinsmore & Shohl LLP | January 2019

The use of marijuana in patient care has undergone widespread growth and acceptance nationwide. Thirty-three states and the District of Columbia have laws authorizing the use of marijuana in some form. Two of those states – Utah and Missouri – joined that list this past mid-term cycle, as voters passed initiatives authorizing the use of medical marijuana. Others, such as Kentucky and Virginia, have pending legislation seeking to authorize the use of medical marijuana ...

ALRUD Law Firm | January 2019

2018 has passed; it was full of events and changes in legislation. We would like to share the main trends in registration of business in Russia in 2018 with you. Federal Tax Service (hereinafter the “FTS”) continued its campaign on introducing records on non-reliable data about business into the Unified State Register of Legal Entities (hereinafter “USRLE”), even in respect of the compliant businesses ...

Morgan & Morgan | January 2019

The regulation of Transfer Pricing is one of the mechanisms through which the Directorate General of Revenue (DGI) seeks to avoid the erosion of the tax base. In Panama, it is regulated in the Fiscal Code in its Chapter IX from Article 762-A to 762-Ñ. The obligation on the issue of Transfer Pricing and specifically with the study is generated since the 2011 period ...

ALRUD Law Firm | January 2019

During 2017-2018, the Federal Antimonopoly Service of Russia (“FAS”) paid close attention to advertisements of OTC medicines and considered large number cases of violations of advertising legislation by pharmaceutical companies. At the end of 2018, FAS in collaboration with the Association of International Pharmaceutical Manufacturers and other market players, established a guideline on recommended advertising of OTC medicines (“Guideline”) ...

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