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Practice Industry: Crossborder Trade & Investment, Healthcare & Pharmaceuticals, Life Sciences
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Dinsmore & Shohl LLP | March 2020

With the onset of COVID-19, certain areas of academic and government-fueled research are exploding. However, universities and governments at all levels are also scaling down nonessential research tasks and limiting the enrollment of essential new human subjects or new animal experiments.[1] Similarly, private companies may be suspending or cancelling their research projects in an attempt to conserve financial resources and accommodate researchers working from home ...

The spread of the highly contagious coronavirus has reach pandemic status. Over 550,000 cases have been confirmed across more than 175 countries, and the United States now has over 86,000 confirmed cases across all 50 states and four territories. In other countries, the threat of coronavirus has already impacted prison operations — lockdowns have been implemented in Italy and thousands of prisoners were released in Iran ...

Hanson Bridgett LLP | March 2020

As a growing number of the workforce is being affected by the COVID-19 pandemic, employers are raising several benefit related questions, particularly with respect to group health plans. The Employee Benefits Group at Hanson Bridgett will be providing updated information on possible issues arising in the benefits area through Benefits Alerts and postings on Hanson Bridgett's Online COVID-19 Resource Center ...

SMS Buenos Aires | March 2020

Perhaps, one of the facts which creates the highest expectations among those of us who manage the second or third defense line is risk materialization. That is to say, for a risk to become an event and generate some kind of impact. And from there on, the possibility of verifying the effectiveness of the controls designed, the residual risk and feeding back the matrix ...

Wardynski & Partners | March 2020

The Minister of Health is issuing successive anti-export lists covering an increasingly wide catalogue of products at risk of shortages. This is to ensure access to drugs and medical devices for patients in Poland, especially during the difficult time of the COVID-19 pandemic ...

Carey | March 2020

Q&A procedures before the Public Health Institute (ISP)   May I file for sanitary registrations? Requests for sanitary registrations for pharmaceutical products, cosmetics and others regulated, as well as for their modifications, may be filed for through the GICONA portal, and official tariffs shall be paid only through electronic transfer of funds ...

Carey | March 2020

In the context of the current sanitary alert, several bills of law have been filed with Congress, seeking to regulate certain aspects associated to states of emergency and sanitary crises in particular.To such ends, the bills that stand out are:I. Bill prohibiting and penalizing price increases in the face of epidemics or pandemics:On Tuesday 17 March 2020, a bill was filed with the Lower Chamber (Newsletter 13 ...

Brigard Urrutia | March 2020

In recent days, COVID-19 has been the greatest destabilizer worldwide. The World Health Organization defines coronavirus as an extensive family of viruses that cause respiratory infections that can range from common cold to serious health complications such as Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS) ...

Brigard Urrutia | March 2020

INVIMA’s specialized board for Medical Devices and other technologies issued a list of declared as Non-Available Vital Products to attend the emergency arising from COVID-19, which means that the import and / or local distribution of said products will be allowed in Colombia without having a Marketing Authorization ...

Brigard Urrutia | March 2020

Due to the preventive isolation order issued through Decree 457 of March 22nd, 2020 and the powers granted to INVIMA in the sense of guaranteeing the prevention, diagnosis and treatment of Covid-19, within the current state of Economic, Social and Ecological energency ...

Cechova & Partners | March 2020

Pharmaceutical companies are meeting with numerous legal challenges resulting from the ongoing COVID-19 pandemic and the corresponding Government measures. Among the most discussed topics are the legal obligations relating to availability of medicinal products, securing of medicinal products for treatment of patients with COVID-19, control over the distribution channel, clinical trials, and relations with healthcare professionals ...

Kocian Solc Balastik | March 2020

Impact of the Czech Government measures on employment relations The current situation has a considerable impact on employment relations ...

Kocian Solc Balastik | March 2020

COVID II programme – Government financial support for self-employed and small and medium-sized enterprises   Aid for self-employed persons ('self-employed') and small and medium-sized enterprises ('SMEs') affected by anti-coronavirus measures pursuant to the Czech Government’s 'COVID GUARANTEE' programme was exhausted in one day ...

Kocian Solc Balastik | March 2020

Czech Government Approves Mitigation Measures Related to Coronavirus Emergency UPDATED   In connection with the coronavirus emergency, the Czech government has approved a liberation tax package aimed at mitigating the consequences of the emergency ...

Kocian Solc Balastik | March 2020

Czech Health Ministry's Special Measures UPDATED   The government explicitly stated in the Emergency Resolution that the Health Ministry’s existing emergency measures are not to be affected by the state of emergency, which means that they remain valid and must be observed. All the Health Ministry’s special measures introduced valid after the emergency was announced must be observed as well. A brief summary (updated on 19March 2020) is outlined below ...

Kocian Solc Balastik | March 2020

The offence of spreading coronavirus From what point exactly is the spreading of COVID-19 a criminal offence? Is it only intentional spreading that is punishable or is negligence also a criminal offence? What is at stake? What are the aggravating circumstances and when do the penalties increase? And can these criminal offences also be committed by a legal entity? The Government of the Czech Republic adopted, as a part of emergency measures due to health threat, Regulation No ...

Afridi & Angell | March 2020

Significant responsibility for ensuring compliance with directives to stop the spread of the Covid-19 virus has been delegated to the law enforcement authorities of the UAE. Last week, the Cabinet promulgated Resolution No. 17 of 2020, requiring all natural and juristic persons to comply with the measures mandated by the concerned authorities to combat Covid-19 ...

Waller | March 2020

Just 24 hours after the President signed the CARES Act into law, the Centers for Medicare & Medicaid Services (CMS) expanded the scope of its Accelerated and Advance Payment Program to include additional Part A providers and Part B suppliers. CMS outlined the program expansion in a fact sheet. The accelerated payments are intended to provide immediate cash flow relief to providers and suppliers focused on treating the flood of COVID patients ...

Waller | March 2020

Rural and community hospitals could fill a major gap in a healthcare system that will likely be overloaded, in varying degrees, for at least the next 18 months due to the COVID-19 global pandemic. Congress is in the process of passing the Coronavirus Aid, Relief, and Economic Security Act (“the Cares Act”) that provides unprecedented relief designed to help business in general, but specific allocations for hospitals ...

The U.S. Environmental Protection Agency has announced its temporary policy regarding environmental enforcement activities during the COVID-19 pandemic. The policy is retroactive to March 13, 2020, and will apply for the foreseeable future, until seven days after EPA gives notice that the policy will terminate.     The policy applies to actions for which EPA has federal enforcement authority ...

We knew this year was going to be an especially bad one for the flu. In its November 2019 issue, Scientific American, one of the country's leading science publications, included a twenty-page article titled "The Influenza Outlook", which highlighted the escalating threat of influenza for the year 2020. Unfortunately, at present, the emergence and spread of the novel coronavirus makes the flu pale by comparison ...

Kocian Solc Balastik | March 2020

The General Meeting during the State of Emergency? Can it take place? And can it be convened? Do crisis measures contain an exception for meetings of the statutory organs of the company (e.g ...

Brigard Urrutia | March 2020

INVIMA adopts measures aimed at efficiently facing the current health situation related to COVID-19, optimizing the processes that allow the commercialization of products necessary for the prevention of the virus and the evaluation of protocols to prevent it. 1. Declaration of products as Vital Unavailable. Due to the shortage of some supplies in general, the authority has declared that masks, antibacterial gel and disinfecting solutions as Vital Products Not Available ...

Brigard Urrutia | March 2020

The Ministry of Health and Social Protection dictates measures tending to guarantee the prevention, diagnosis and treatment of Covid-19 The Ministry of Health and Social Protection has issued Decree 476 of 2020 by which it has decided to make the necessary changes for regulatory requirements to have flexibility in all proceedings related with Pharmaceutical, Phytotherapeutics, Medical Devices, Biomedical Equipment, In-Vitro Diagnostic Reagents, cosmetics and products of Domestic hygie

Carey | March 2020

Covid-19 has had an impact on ongoing consumer contracts and their relations with suppliers. The rapid spread of the virus led the authorities to declare State of Disaster in the country, raising concern about the (i) fulfillment of consumer contracts of goods and services and (ii) an eventual price manipulation ...

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