Summary Proposed FASTER Act defines sesame as a major allergen under the Federal Food, Drug and Cosmetic Act; FDA Draft Guidance recommends the declaration of sesame as an ingredient in flavors and spices. Although non-binding, these actions foreshadow the regulation of sesame as a major food allergen in the future. Two recent legislative actions and an FDA publication address emerging concerns about sesame as an allergen. The U.S ...
KPPU has recently issued its long-anticipated guidelines on the Indonesian merger control rules (“KPPU Guidelines”) under KPPU Regulation No. 3 of 2019 on The Assessment of Mergers or Consolidations of Business Entities or Acquisitions of Shares in Companies (“KPPU Regulation 3/2019”) issued at the end of last year. The guidelines are relatively long and detailed (almost 100 pages), and some of their content is still subject to the KPPU’s interpretation ...
Is coronavirus vaccination a cure that will solve many challenges faced by employers or does it just inject further issues for employers to deal with? We answer the key questions. To be vaccinated or not to be vaccinated? That is the question... being discussed in homes and in workplaces up and down the country ...
With employees potentially returning to the workplace, we take a look at what will need to be done to tackle a number of mental health challenges – both for people and the companies they work for. Part three of our mental health series. With the second lockdown now over and the tier system fully in play, some employers are finding themselves able to open and trade again ...
Key Points Employers may mandate employee COVID-19 vaccination programs, subject to certain exemptions. When requiring employee vaccinations, employers should consider the fact that these COVID-19 vaccines are currently approved under the FDA's Emergency Use Authorization (EUA). Mandatory employer COVID-19 vaccination programs must include religious and disability-related employee exemptions. INTRODUCTION On Dec ...
All eyes were on health care in 2020, as the industry faced unprecedented challenges presented by the global coronavirus pandemic. Stories and images of overburdened frontline health care workers dominated the news cycle for most of the year, and the rapid development of one or more seemingly effective vaccines has engendered a cautious optimism for a return to normalcy in 2021 ...
Non-surgical extended duration therapeutic services (NSEDTS) are services which have a significant monitoring component that can: extend for a lengthy period of time, are not surgical, and typically have a low risk of complications after the assessment at the beginning of the service ...
On 27 November 2020, the Secretary for Justice, Ms Teresa Cheng SC, and the Vice-President of the Supreme People’s Court, Mr Yang Wanming, signed the Supplemental Arrangement Concerning Mutual Enforcement of Arbitral Awards between Mainland China and the HKSAR (Supplemental Arrangement) ...
On Nov. 20, 2020, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) issued two final rules, which implement changes to the Physician Self-Referral Law (Stark Law) and the Anti-Kickback Statute (AKS) regulations (respectively the CMS Final Rule and the OIG Final Rule, collectively the Final Rules) ...
On November 12, 2020, the Washington Supreme Court extended corporate attorney-client privilege protection to appropriate ex parte communications between defendant hospitals and their non-employee agents. The court’s decision in Hermanson v. MultiCare Health Sys., Inc ...
With many medical practices and healthcare practitioners moving to telemedicine during the COVID-19 pandemic, questions abound on legal requirements, privacy, and the future of healthcare. Schwabe’s Healthcare team has taken a closer look at the legal issues surrounding the rise of telemedicine during the pandemic and the implications for our healthcare future in the four articles below ...
By resolution adopted on October 7, 2020, the state of emergency has been extended until January 31, 2021 ...
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 ...
Vassily Rudomino, Senior partner of ALRUD, Ksenia Tarkhova and Ruslana Karimova, Senior associate of ALRUD, Roman Vedernikov, Associate of ALRUD, and Anastasia Kayukova, ALRUD Senior attorney, prepared an article for the eighth edition of 'The Foreign Investment Regulation Review' by Law Business Research. This review focuses on the main aspects of foreign investment regulation in various jurisdictions ...
Trademark owners with registrations in EU where the UK is designated should soon receive notification for treatment of registrations and applications following the Brexit transition period. The Brexit transitional period, during which EU laws and rights have continued in force in the UK, will end on December 31, 2020. Thereafter, EU Trade Mark and Design applications and registrations (and designations of the EU) will only cover the remaining 27 EU member states ...
The Ohio Board of Pharmacy (Board) recently issued updated guidance detailing certain conduct pharmacists and other regulated personnel (Licensees) must report to the Board ...
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 ...
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 ...
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 ...
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
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 ...
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) ...
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 ...
