In response to the coronavirus (COVID-19) we continue to undertake a series of measures to: 1. protect our employees; 2. provide continuity of support to our clients; and 3. work with critical elements of our supply chain to enable us to fulfil 1 and 2 Shoosmiths senior leadership, including our Chairperson, CEO, COO, business support Directors and business unit heads, are meeting as and when required to consider and act upon developments regarding COVID-19 ...
The recently published project of the National Development Plan (“PND”) 2022-2026 “Colombia World Power of Life” embodies the objectives, goals and priorities of the National Government for the next four years. In the PND, the National Government introduces rules or regulations that would make it easier to achieve the objectives pursued ...
How new technologies and changing consumer expectations is signaling disruption to the health industry and the importance of finding ways to better measure and translate patient satisfaction and outcomes. Do you know if your clinician is doing a good job? What about the track record of your surgeon? Should you be entitled to know as a consumer? The industry is being disrupted – no longer is the family GP the dispenser of all health advice ...
Financial Services Malaysia Overnight Rate as Alternative Reference Rate Bank Negara Malaysia (“BNM”) announced on 24 September that the Malaysia Overnight Rate (“MYOR”) is an alternative reference rate for Malaysia. The MYOR: will be administered and calculated by BNM as the volume-weighted average rate of unsecured overnight Ringgit interbank transactions, including BNM’s overnight monetary operations (excluding Standing Facilities) ...
Compounding of Offences under the Malaysian Trademarks Act 2019 and RegulationsSection 136 (2) of the Trademarks Act 2019 (“Act”) grants the Controller with the power to compound offences under the Act. In essence, compounding means payment as a settlement in lieu of prosecution of an offence.Further, section 136 (1) of the Act empowers the Minister to make regulations pertaining to compounding with the approval of the Public Prosecutor ...
The manufacturer of a product generally has a duty to warn the end-consumer of any serious risks associated with that product. In the context of prescription drugs and medical devices, however, the “learned intermediary” doctrine holds that the manufacturer need not warn the end-consumer (i.e., patient). Instead, the manufacturer discharges its obligations by warning the prescribing physician ...
The Seventh Circuit has revived a class action against Neiman Marcus for losses customers allegedly suffered as a result of a data breach involving payment card information. A federal district court had dismissed the claims, finding – consistent with federal courts around the country – that the plaintiffs lacked standing because they failed to allege they suffered concrete harm from the breach ...
On May 16, 2023, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) announced a $350,000 settlement with MedEvolve, Inc., a practice and revenue cycle management and practice analytics software services company, to resolve alleged violations of the Health Insurance Portability and Accountability Act (“HIPAA”) regulations ...
Complementary Law No. 175/2020, enacted in September 23, 2020, determined that the Service Tax (ISS) must be shared between the municipalities where the service providers and the clients are located. Complementary Law No. 175/2020, enacted in September 23, 2020, determined that the Service Tax (ISS) must be shared between the municipalities where the service providers and the clients are located ...
On April 20, 2020, the National Consumer Service (SERNAC) published the "Interpretative Circular on Supplier’s Good Practices in the context of the Covid-19 Pandemic", which seeks to establish the main concepts and criteria for companies to promote good commercial practices in order to protect consumers, especially with regard to their health and physical and psychological integrity ...
On April 6, 2020, the National Consumer Service (SERNAC) published the "Interpretative Circular on distance contracts during the COVID-19 pandemic", which seeks to set general guidelines regarding distance contracting with consumers during the constitutional state of catastrophe due to public calamity. To safeguard the basic rights embodied in Law No ...
In recent months, the National Consumer Service has published multiple opinions interpreting various rules of Law No. 19,496 on the protection of consumer rights ("CPA") that were amended in recent times, responding to practical requirements of the public, in matters of interest to suppliers and consumers. When reviewing these rulings, it is important to remember the scope and application of the interpretations made by this service ...
Media reports are letting us know that the "Serbia - A Strategic Crossroads between Western and Eastern Europe," conference was held in Paris on 15 September, where the French companies were presented with the political and economic environment in Serbia, as well as with the ensuing investment opportunities and the possibility of financing economic projects ...
In an August 14, 2020 response to a letter written on behalf of the American Seniors Housing Association and Argentum, the General Counsel’s office of the Department of Health and Human Services has determined that senior living communities are a “covered person” under the Public Readiness and Emergency Preparedness (PREP) Act, which creates immunity from liability for the administration or use of “Covered Countermeasures” in response to COVID-19 ...
Summary of Public Policy and Prior Amendments The Minimum Fuels Storage Public Policy (the “Public Policy”) was released by Mexico’s Ministry of Energy (“SENER”) on December 12, 2017. The objective is to improve energy security in Mexico and ensure adequate energy supply and competitive prices, through the establishment of mandatory minimum fuel inventories and reporting obligations ...
A bipartisan U.S. Senate committee has asked both the Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services to study the proliferation of physician owned distributorships (PODs), citing a lack of regulatory guidance on how these arrangements square with existing federal law ...
In response to questions regarding the legality of Cannabidiol (CBD) oil products, the State of Ohio Board of Pharmacy (Board) announced that only licensed and operating Medical Marijuana Control Program dispensaries may sell CBD oil products. In June, the Board announced the award of 56 provisional medical marijuana dispensary licenses. All of those provisional licensees will have six months to comply with operational requirements in order to obtain a certification of operation (COO) ...
Commission Guidelines for the Notification of Dangerous Consumer Products to the Competent Authorities of the Member States by Producers and Distributors in accordance with Article 5(3) of Directive 2001/95/EC (Commission document No ...
Once their compound patents have expired many blockbuster drugs remain protected by secondary 'method of treatment' patents. The validity and enforceability of these secondary patents can be less certain in many jurisdictions. In Sanofi-Aventis Australia Pty Ltd v Apotex Pty Ltd (No ...
The Second Circuit Court of Appeals recently granted a petition for interlocutory review to decide whether a violation of the FCA’s first-to-file rule can be cured by filing an amended pleading. Both the D.C. Circuit and Fourth Circuit1 recently addressed this issue, concluding that the plain language of the first-to-file rule precludes amending around the rule ...
In recent remarks to a compliance conference for the pharmaceutical industry, the SEC’s Director of Enforcement, Andrew Ceresney, addressed FCPA issues that commonly arise in the industry. According to Ceresney, the SEC is continuing to focus on pharmaceutical companies because their operations typically pose a high risk for FCPA violations ...
In a statement to Parliament on 14 December 2021, John Swinney, the Deputy First Minister, confirmed the appointment of Court of Session judge Lady Poole as the chair of the Scottish inquiry into the COVID-19 pandemic. The Scottish Government also announced the terms of reference for the public inquiry on the same date, with the inquiry investigating the period between 1 January 2020 and 31 December 2022. You can read the full ministerial statement here ...
Many employers currently have employees on staff on temporary work visas, and employers likely know that in order to continue to employ employees not born in the U.S., the employer must sponsor the employee for permanent residency in the U.S. (i.e,. a green card). The green card process has multiple steps, which, depending on a variety of factors, may take several years to complete ...
