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 ...
On November 16, 2020, the Department of Health and Human Services Office of Inspector General (HHS OIG) issued Special Fraud Alert: Speaker Programs (Fraud Alert) to “highlight the fraud and abuse risks associated with the offer, payment, solicitation, or receipt of remuneration relating to speaker programs by pharmaceutical and medical device companies ...
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 ...
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 ...
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 ...
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) ...
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 ...
Facing Australia's first recession in 30 years, Australian businesses are attempting to steer a course not only for survival but for the growth needed to be a viable long term. But alongside uncertainty comes opportunity. Our new report, prepared in partnership with Acuris, explores the key steps for companies and investors to take advantage of the opportunities – and decisive, informed and proactive action is critical ...
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 ...
On 25 September 2020 Parliament approved the final draft of the revised Data Protection Act (rev-DPA).(1) The rev-DPA is expected to enter into force in 2022. However, it is subject to a facultative referendum and the corresponding ordinance will be adapted accordingly – thus, the rev-DPA is still a work in progress ...
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 ...
In a judgment of 8 September 2020, the Court of Justice of the European Union (“CJEU”) ruled that Member States are not allowed to exclude performers who are nationals of States outside the European Economic Area (“EEA”) from perceiving the equitable remuneration provided by Article 8(2) of the Rental and Lending Rights Directive ...
The COVID-19 pandemic has forced many hospitality professionals and their clients to confront bankruptcy, insolvency, and loan workout issues for the first time since the Great Recession. Chapter 11 presents a host of unique issues for hotels and other hospitality businesses ...
As COVID-19 continues to alter our daily lives, many of us have found comfort in barn time spent with our four-legged friends. With so many spring and summer events cancelled, we are eager to get back in the saddle and into the show ring. However, the legal implications facing horse show boards and competition venues are complex and ever-evolving ...
Coronavirus Digest no. 4 Patents and other intellectual property rights 1. Patents Moderna reveals that it may not hold the patent rights for the vaccine against Covid-19, because it was not the first to file the patents. This came after the US National Institute of Health claimed co-ownership of the rights to this vaccine. Read more here ...
The global COVID-19 pandemic has devastated the hospitality industry. Hotel occupancy rates have fallen greatly in many markets, with employee layoffs and property closures affecting even the largest and otherwise best performing hotels. It is uncertain when the industry will recover. Many hotel properties will require a chapter 11 bankruptcy case to successfully reorganize their debt obligations and operations and preserve the value of the business ...
The Department of Justice is stepping up its scrutiny of health-care fraud, especially in testing laboratories, during the Covid-19 pandemic. Former federal prosecutor Jason Mehta, a partner with Bradley, says now is not the time to tout profits over patient care and offers insights on compliance. In the midst of a global pandemic, much attention and praise is rightfully being showered on health-care providers ...
The Food and Drug Administration (“FDA”) issued its Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry on June 30, 2020. This nonbinding guidance is intended to remain in effect for the duration of the COVID-19 public health emergency declared by the Secretary of Health and Human Services. The guidance advises vaccine development and licensure following the standard trial progression but on an accelerated timeline ...
As of July 1, the Russian requirements on digital labelling of medications and transmitting the data on medications’ turnover to the Chestny ZNAK system have become mandatory.Start of mandatory digital labellingFrom 1 July, all market participants of the pharmaceutical industry (manufacturers, distributors, pharmacies, etc.) must reflect information on all operations made with medications in the monitoring system ...
July 10, 2020 By: John Epperson The State Water Resources Control Board (“SWRCB”) released a draft of its General Waste Discharge Requirements for Winery Process Water (“Draft WDR”) on July 3, 2020 for public comment. Comments will be accepted by the SWRCB until August 5, 2020. California wineries should review the Draft Order carefully to determine whether they will be subject to its requirements and, if so, how it will impact their operations ...
By: John Epperson San Francisco’s Board of Supervisors passed an Emergency Ordinance on July 7 entitled “Cleaning and Disease Prevention Standards in Tourist Hotels and Large Commercial Office Buildings” (the “EO”). The EO is expected to be signed by the Mayor and go into effect soon ...
The impact on human health of the global pandemic of the SARS-CoV-2 virus and the resulting disease termed COVID-19 cannot be overstated. Not since the influenza pandemic of 1918 have so many regions of the world been so acutely impacted by a single pathogen. Society in 2020 has the advantage of a more sophisticated biotechnology industry. Testing is considered crucial in controlling (or at least mitigating) the pandemic, and tests from several companies have become widely available ...
On June 16, 2020 the German government released its Corona-Warn-App. There are some key points employers should be aware of concerning the app: NO OBLIGATION FOR EMPLOYEES TO USE THE APP ON THEIR PERSONAL SMARTPHONES An employer may be thinking about instructing its employees to install and use the Corona-Warn-App on their own devices to reduce the infection risk among its employees. That is not permitted ...
