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 ...
We would like to inform you that the Russian President has signed amendments to Article 1360 the Civil Code of the Russian Federation ('Russian Civil Code'), in terms of providing compulsory licenses to use an invention, utility model or industrial design ('patent rights') on 30 April, 2021. The amendments came into force on 11 May, 2021 ...
The third wave of COVID-19 is now spreading all over Thailand. The rise in confirmed numbers of cases and deaths has been reported by the Centre for the COVID-19 Situation Administration (“CCSA”). In response to the outbreak, the Ministry of Public Health announced a vaccination plan which ultimately aims to reduce the spread of COVID-19 infections by having around 50 million people (roughly 70% of the population) in Thailand vaccinated by the end of the year ...
OSHA Adopts CDC Vaccine Guidance. On May 17, 2021, the federal Occupational Health and Safety Administration (“OSHA”) updated its online COVID-19 portal to announce that OSHA is revising its employer materials to reflect recent interim guidance from the Centers for Disease Control and Prevention (“CDC”). In the meantime, OSHA recommends that employers “refer to the CDC guidance for information on measures appropriate to protect fully vaccinated workers ...
The world is in an upheaval now with the pandemic raging for over a year. The discussions and decisions that probably would never have been made a few years ago are being made today in the interest of the greater good and the public at large. When Bill Gates expressed his reservations against lifting IP protection on vaccine patents, it left the world reeling and his comments understandably criticised by experts and laymen alike ...
The Eighth Circuit Court of Appeals held that a D&O liability insurer could not rely on ambiguous endorsements as a basis to deny coverage for claims brought by investors against its insured company and its CEO. Reversing the Eastern District of Missouri, the appellate court in Verto Medical Solutions LLC et al. v. Allied World Specialty Insurance Co., No. 19-3511 (8th Cir ...
Decree-Law 36/2021, which amends Decree-Law 176/2006 of 30 August ("Medicines Statute"), was published on 19 May. The new Decree-Law introduces a ban on the advertising of discounts on the price of medicines subject to medical prescription that are reimbursed by the National Health Service ("NHS") or that contain narcotic or psychotropic substances ...
Digemid authorized Pfizer the second conditional sanitary registration of the COVID-19 vaccine manufactured in the United States. A total of 4 vaccines authorized by the Peruvian health authority are added to this registry ...
New measures for state contracting for economic reactivation. Through Decree 579 of 2021, issued on May 31 by the National Planning Department, certain transitory paragraphs enshrined in Decree 1082 of 2015 or the sole Regulatory Decree of the Administrative Planning Sector, were replaced in matters of state contracting ...
Introduction The Covid-19 vaccine is currently being rolled out, and according to the authorities’ vaccination-plan, a large part of the population will receive their first dose during the summer months. As a rule, one must take the vaccine in one’s own home municipality, and not in the municipality where one has a summer house etc. In addition, the authorities are working on a corona certificate ...
Our latest article in the series looking at the impact of the pandemic on different groups focuses on how COVID-19 has affected those within ethnic minorities, what this has meant for the BLM movement and what employers can do to better support employees. Impact of COVID-19 The latest statistics all point to the fact that the COVID-19 pandemic has disproportionately affected those within ethnic minorities ...
Regulation (EU) 2017/745 of 5 April came into force on 26 May to create a single set of rules applicable to all medical devices, other than in vitro diagnostic medical devices. Here are some of the main changes to the rules that now come into force: 1. Broadening of the scope of application of the rules and of the concept of medical device With this Regulation, medical devices without a medical purpose that have characteristics similar to medical devices (e.g ...
The rapid spread of Covid-19 has placed the healthcare system in Thailand under severe pressure. Following the outbreak of the pandemic, new startups focusing on telemedicine have sprung up to take on the challenge of innovating the way healthcare services can be provided to patients ...
On May 14, 2021, the Centers for Medicare and Medicaid Services (CMS) issued a new final rule that will further delay the effective date of the Medicare Coverage of Innovative Technology (MCIT) and Definition of Reasonable and Necessary Final Rule (the Final Rule) until no earlier than Dec. 15, 2021 ...
Haynes and Boone, LLP Counsel Raquel Alvarenga talked with HR Magazine about continued COVID-19-related accommodations for vaccinated employees.Below is an excerpt:Many businesses have developed policies on providing reasonable accommodations to employees who refuse to get a COVID-19 vaccine for religious or disability-related reasons. Employers shouldn't forget that fully vaccinated workers may need accommodations, too.In recently updated guidance, the U.S ...
Workplace testing has proven to be a crucial piece in the UK government’s jigsaw to get British business back on its feet. But how can businesses implement a workplace testing programme and will the vaccine roll out make a difference? What is a lateral flow test? In March 2021, the government confirmed that almost 50,000 businesses had registered for free and regular lateral flow tests through the government funded workplace testing scheme ...
Many people have used their time at home to consider their health and well-being. Some have taken up exercise, yoga or getting a dog. Others have decided to find out more about their health in order to make healthier choices and use online portals like 23andMe (saliva test), Thriva (blood test) or Pharmacy2u (blood or urine test) to point them in the right direction ...
Back in mid-March, the Department of Labor (DOL) notified key stakeholders of the likelihood it would be issuing new regulations concerning COVID-19. Yesterday, the Occupational Safety and Health Administration (OSHA) of the DOL issued the long-awaited Emergency Temporary Standard (ETS) regarding safety requirements that healthcare employers must implement and adhere to in light of COVID-19 ...
Last week, the Occupational Safety and Health Administration (OSHA) issued a COVID-19 Emergency Temporary Standard (ETS) for employers only in the health care sector in response to President Joe Biden’s January Executive Order on Protecting Worker Health and Safety. The ETS becomes effective on the date it is published in the Federal Register, which is yet to be determined. In addition, OSHA promulgated new non-binding guidance for employers in all other sectors ...
On June 7, 2021, the Department of Managed Health Care (“DMHC”) issued an All Plan Letter (APL-21-016) to the health care service plans it regulates, announcing that health care service plans must continue to cover certain COVID-19 testing for their enrollees beyond the now-expired DMHC’s emergency regulation[1] (“Emergency Regulation”) ...
More recently, many more people are using fertility treatment to conceive; particularly same sex couples, single women and surrogates (Human Fertilisation and Embryology Authority data). This echoes a societal shift in so far as relationships, the formation of families and lifestyles are concerned. As such, there needs to be more emphasis on the development and evolution of the law and sector generally ...
New York State Lifts Restrictions. On June 7, 2021, New York Governor Andrew Cuomo declared that the State would lift most remaining COVID-19 restrictions when 70% of adult New Yorkers had received their first dose of a COVID-19 vaccine. On June 15, 2021, Governor Cuomo held a press conference to announce that New York had reached the 70% first-dose threshold ...
On June 10, 2021, the Standing Committee of the National People’s Congress adopted the Anti-Foreign Sanctions Law (the “Anti-Sanctions Law”) ...
Dinsmore health care partner Joseph Zielinski was published in the most recent edition of New Perspectives on Health Care Risk Management, Control and Governance, the publication of the Association of Health Care Internal Auditors. His article, "The Effectiveness of Your Compliance Program," covers how to effectively audit your organization's compliance program while gaining valuable insights. An excerpt is below ...
Before adjourning its 2021 session, the Oregon legislature passed an act that will make it more difficult for health care systems, insurers, and other health care entities to merge with, acquire, or otherwise join forces with their industry counterparts. Proponents of the Equal Access to Care Act, which is also known as House Bill 2362, contend that the new legislation is necessary to combat access limitations and price increases caused by consolidation in the health care arena ...
