On May 17, 2021, the United States Health Resources and Services Administration (HRSA) publicly disclosed letters which were sent to six major pharmaceutical manufacturers. HRSA’s letters expressly state that each manufacturer is currently in violation of the Federal 340B Program statute as a result of policies restricting contract pharmacies and covered entities from access to 340B Program discounted medication ...
Private open-ended fund companies (OFCs) in Hong Kong are subject to regulation by the Securities and Futures Commission (SFC). The SFC has taken a streamlined approach to regulating private OFCs. (I) High degree of flexibility No investment restrictions: Pursuant to the SFC’s revised Code on Open-Ended Fund Companies (OFC Code) all investment restrictions for private OFCs have been removed ...
Following Prime Minister Boris Johnson’s recent announcement in Parliament, it is now certain that there will be a Public Inquiry into the handling of the pandemic. What is the planned Inquiry likely to consider, and who might be involved? For over a year now, the government’s focus has been on the here and now - managing and responding to the rollercoaster that is the COVID-19 crisis ...
The internet may be global, but enforcement is always local—and there are plenty of (expensive) ways to find out the wrong way that you should have been doing something where you might not expect it. A typical example is the legal requirement to appoint an EU data protection representative if you’re not based in the EU, or a UK representative if you’re not based in the UK ...
Preface On 26 April 2021, the Futures Law of the People’s Republic of China (Draft for Consultation) (“Futures Law (Draft)”) was deliberated at the 28th Meeting of the 13th Standing Committee of the National People’s Congress, and was later issued for public consultation on 29 April 2021, receiving keen, widespread interest of the domestic futures industry and the over-the-counter (“OTC”) derivatives market ...
Recently, several African startups have been making positive impact in their communities leading to a number ofcountriesenactingor planning to establish a Startup Act. In this article, our Oluwapelumi Omoniyi examines the benefits of a Startup legislation and considers if Nigeria’s nascent startup ecosystem needs a startup Act ...
On Thursday, May 13, 2021, the Centers for Disease Control (CDC) announced new guidance stating it is safe for fully vaccinated people to not wear masks or physically distance in any non-health care setting.1 Per this guidance, fully vaccinated people can now resume most activities without wearing a mask or physically distancing ...
On April 27, 2021, the Center for Medicare & Medicaid Services (CMS) announced revised guidance for Interim Final Rule, CMS-3401-IFC related to Long-Term Care Facility Testing Requirements and the COVID-19 Focused Survey Tool. CMS published the initial interim final rule with comment period on Aug. 25, 2020 ...
On May 11, 2021, the Center for Medicare & Medicaid Services (CMS) announced a new rule that will require long-term care facilities and residential facilities serving clients with intellectual disabilities to educate and offer COVID-19 vaccines to residents, clients and staff. This new requirement will closely align with current requirements for influenza and pneumococcal vaccines in long-term care facilities ...
On April 27, 2021, the Center for Medicare & Medicaid Services (CMS) announced revised guidance for Nursing Home Visitation. CMS issued its initial guidance in March 2020, via memorandum QSO-20-14-NH. Under this memorandum, all visitation by visitors and non-essential health care personnel was restricted, except for situations involving compassionate care, such as end-of-life ...
On May 12, Schwabe collaborated with Moss Adams to host a virtual roundtable that explored legal realities around owning and operating a hemp business in Oregon. Schwabe attorneys Lisa Schaures and Joe Hobson were joined by Jacob Crabtree of Columbia Hemp Trading Company, Sunny Summers of the Oregon Department of Agriculture, and Ryan Kuenzi of Moss Adams. Our panelists discussed the evolving nature of the hemp industry at the state and federal level in Oregon ...
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The Federal Supreme Court of Brazil concluded the judgment of the lawsuit claiming the unconstitutionality of the sole paragraph of article 40, of the Industrial Property Law, referring to the minimum term of validity of patents in Brazil ...
The European Council has just adopted a new dual-use regulation. The new dual-use regulation is a recast of the current dual-use regulation and aims, among other things, to modernize European export controls in a number of areas. The regulation is directly applicable in all EU Member States and is expected to enter into force in 2021. In this Insight, Plesner's export control specialists outline the main changes resulting from the new dual-use regulation ...
Below, you will find the issue of our Banking and Finance and Capital Markets newsletter for the 1st quarter of 2021, which compiles the most significant news in this area. BANKING AND FINANCE I. Banco de Portugal Banco de Portugal press release on the countercyclical capital buffer for the 2nd quarter of 2021. The countercyclical capital buffer percentage in force from 1 April 2021 will remain at 0% of the total amount of exposures (link) ...
Living in Uncertain Times More than a year has passed since our lives were turned upside by the outbreak of COVID-19. Across the globe, millions of people have succumbed to the virus and countless businesses have collapsed. In Thailand, although the loss of life has been relatively low, the pandemic has devastated the country’s economy ...
The Office of Inspector General (OIG) has issued a favorable advisory opinion addressing an investment in an ambulatory surgery center (ASC) made by a health system, certain physicians employed by the same health system, and a management company. OIG Advisory Opinion No. 21-02 is the first advisory opinion since 2009 to provide guidance on ASC investments and related safe harbors to the Anti-Kickback Statute ...
By: Carol K. Lucas At a time when many are questioning the continued utility and viability of the corporate practice of medicine ban, California may be doubling down. On May 3, 2021, the California Senate Health Committee approved SB-642, the stated purpose of which is to protect medical decision-making from lay control. The bill is currently pending in the California Senate. Assembly Bill AB-705 is a substantially identical bill in the California Assembly ...
For Mental Health Awareness Week, Caroline Watson, head of Shoosmiths Family Law team, offers practical advice on looking after your emotional wellbeing if you’re going through a divorce or a separation. When someone close to you dies, it’s generally accepted that there are five stages of grief: shock, denial, anger, bargaining, depression and acceptance. Some psychiatrists say that the emotional stages of a relationship breakdown are the same ...
On 30 April 2021, the State-owned Assets Supervision and Administration Commission of the State Council (“SASAC”) issued the Circular on Matters Related to Further Strengthening the Administration of Financial Derivatives Businesses (《关于进一步加强金融衍生业务管理有关事项的通知》), which follows SASAC's earlier issuance of a circular on the same topic on 13 January 2020 (namely, the Circular on Matters Related to Effectively Strengthening the Administration of Financial Derivatives Businesses (《关于切实加强金融衍生
Open banking is an emerging financial services model that focuses on the portability and open availability of customer data held by financial institutions. It involves opening up banking systems, particularly customer data, to third parties to allow them provide services directly to customers ...
