Business interruption insurance claims related to the COVID-19 pandemic have raised numerous questions for practitioners, businesses, and insurers ...
Natural products play an important role in pharmaceutical innovation. They are active components in many medicines. For example, nearly half of the small molecules used to treat cancer are natural products or directly derived from natural products.1 They are also components of vaccines. The pharmaceutical industry is constantly seeking access to natural products and the traditional knowledge associated with them ...
The Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (“SUPPORT Act”)[1] was enacted on October 24, 2018. Among other things, the SUPPORT Act amended the Physician Payments Sunshine Act (“Sunshine Act”)[2] to expand the definition of “covered recipients”[3] for payment tracking and reporting purposes ...
Do I have a COVID-19 business interruption claim? Particularly if you operate in the leisure, retail or hospitality sectors, your business has likely suffered significant financial losses from the disruption caused by COVID-19. In trying to alleviate the impact of those losses, you might have identified that your business’s insurance policy offered cover for ‘business interruption’ (or ‘BI’) ...
The Commission for the Financial Market (“ CMF ”), on May 28, 2020, has issued the Official Letter No. 22,260 (the “ Official Letter ”) in response to the pronouncement request sent by the Treasury Minister of the Chilean Government, Mr Ignacio Briones Rojas, to clarify the scope of the enforcement and the effects of the new article 30 of Law No. 21,227, which empowers the access to the unemployment insurance benefits provided in Law No ...
On April 6, 2020, Law No. 21,227 entered into effect, authorizing access to the benefits of the unemployment insurance in the context of the sanitary crisis caused by Covid-19 (hereinafter, the “Law on Employment Protection” or “LEP”). In order to improve the practical application and implementation of the aforementioned act, on June 1, 2020, Law No ...
The unstable economic situation connected with the COVID-19 pandemic is also impacting the insurance industry. Dependent on global phenomena and trends, the insurance market will soon have to face anew economic reality, develop appropriate solutions for clients, and prepare to defend against claims ...
This time we address solutions from the front lines: devices for remote diagnostics which can improve effective detection of the coronavirus and also unburden the health service in other areas. These solutions can also serve as aproving ground for the regulatory approach to oversight of algorithms. The immediate inspiration for writing this text was asolution from the company StethoMe presented at the DemoDay organised by the MIT Enterprise Forum CEE ...
MDR postponement On 17 April 2020 the European Parliament decided to postpone the transition timeline to implement the EU Medical Device Regulation (MDR), which was set to expire on 26 May 2020, until 26 May 2021. The EU MDR postponement was published in the Official Journal of the European Union and entered into force on 24 April 2020 ...
Vietnam, a country of 97 million people, has been widely recognized for its successful handling of the novel coronavirus outbreak. On January 27, as the country celebrated the Lunar New Year holiday, Prime Minister Nguyen Xuan Phuc declared war on the coronavirus, having said "fighting this epidemic is like fighting the enemy". The Prime Minister and his cabinet acted expediently in controlling the spread of the virus ...
Pharmaceuticals and medical devices in Malaysia are governed by the following main legislation and regulations:the Sale of Drugs Act 1952 (SODA 1952);the Control of Drugs and Cosmetics Regulations 1984 (CDCR 1984);the Dangerous Drugs Act 1952 (DDA 1952);the Poisons Act 1952 (PA 1952);the Medicines (Advertisement and Sales Act) 1956 (MASA 1956); andthe Medical Device Act 2012 (MDA 2012) ...
We are seeing an increase in the use of warranty and indemnity insurance (W&I) on transactions, which is a theme we expect to continue as buyers target companies that are in financial distress in the wake of Covid-19. W&I has become commonplace in the UK M&A market as a way to ‘bridge the gap’ between buyer and seller when allocating risk ...
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 ...
To the average person, what constitutes an “accident” is likely clear. If someone trips and falls—in most instances, it would be considered an accident. If someone bumps her head getting out of a car—it’s probably just an accident. And if someone were to drop something heavy onto his foot—it would likely be deemed a careless accident ...
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 ...
Thousands of denied claims and hundreds of lawsuits pending around the country are testament to the fact that business interruption coverage for losses sustained during the COVID-19 pandemic depends on the existence of “physical loss or damage ...
On June 16, 2020, Governor Mike DeWine signed into law House Bill 81. Its impact is significant for employers in the context of workers’ compensation. Governor DeWine touted the amendment that provided workers’ compensation coverage for medical diagnostic services to investigate whether a detention facility employee’s exposure to another’s blood or bodily fluids resulted in an injury or occupational disease ...
In what appears to be the first substantive dispositive ruling on a COVID-19 related business interruption insurance claim, a Michigan court has dismissed an insured’s business interruption claim, finding that the insured did not suffer a direct physical loss and no insurance coverage exists for the insured’s claim ...
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 ...
So, you want to start a hemp company. You have your big idea and a business plan ready. At some point, though, you begin to wonder whether you should be thinking about any legal issues as you get your company off the ground. That’s where we come in. Bradley’s Cannabis Industry team has a deep understanding of the many unique legal and business issues that impact hemp companies ...
The economic downturn engendered by the COVID-19 pandemic likely will lead to a significant increase in acquisitions of distressed targets. Representation and warranty (“R&W”) insurance policies as well as related insurance products can facilitate these transactions ...
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 ...
The Insurance Commission (“IC”) of the Philippines has issued a circular letter dated June 14, 2020 on the adoption of a regulatory sandbox framework for the experimentation and testing of insurance technology innovations (IC Circular Letter No. 2020-73 (“ICL 2020-73”): “Guidelines on the Adoption of a Regulatory Sandbox Framework for Insurance Technology (InsurTech) Innovations).” The full text of Circular Letter No ...
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 ...
