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 ...
One of the more serious consequences of the pandemic will be awave of business litigation. However, strong arguments and credible evidence are not enough to win adispute. It also takes resources to pursue alawsuit, and soon that may be particularly difficult to come by. The whole economy under pressure is preparing for the consequences of the pandemic and drastic steps taken by states to combat it ...
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 ...
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 ...
The main measures included in the Government’s 491 Decree are: The service of process regarding Administrative acts will be online Terms and deadlines of Administrative proceedings are suspended. Suspension may be partial or total and related to some or to all the proceedings. Terms and deadlines will continue the day after the emergency ends. Suspension of the Statute of limitations related to administrative proceedings until the day when proceedings restart ...
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) ...
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 ...
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 ...
The United States Trade Representative (USTR) announced a period for public comment on excluding medical goods from Section 301 China tariffs if they are needed to fight the coronavirus pandemic. The USTR notice was published in the Federal Register on March 25, 2020. The USTR previously granted approximately 200 exclusions from Section 301 tariffs for medical goods because they are needed to fight the COVID-19 pandemic. The U.S ...
Dinsmore Intellectual Property Partner Adrian Cyhan and Christopher Smith of Brooks Kushman wrote the following article, "Dawn of a New Era: Licensing Standards in the Coming Age of 5G" for The Licensing Journal. 5G: What’s the Big Deal? The advent of 5G cellular wireless technology represents a major advance in speed and bandwidth of wireless communications ...
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 ...
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 ...
The outbreak of Coronavirus (COVID-19) which has been recently declared as a Pandemic by the World Health Organization, has affected our country and the entire world.In Guatemala, the Government has been taking an active role by implementing progressive measures to prevent the spread of the virus, measures that will have a significant impact on the country's economy ...
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 ...
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 ...
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 ...
Amid the spread of COVID-19, the Romanian President decreed a state of national emergency in Romania, with express measures to be taken in the justice system. Although the Decree does not refer to arbitration, the state of national emergency and the need of social distancing inevitably impact it as well ...
Force Majeure clauses are used in many contracts in the most diverse business areas. These contractual provisions are rarely invoked in practice in Latvia, as the parties usually do not face any circumstances that could qualify as Force Majeure ...
Thousands of disputes are dealt with by way of international arbitration every year and it is inevitable that when most countries started introducing social distancing measures, a number of arbitrations were either part heard or just about to start and will have been derailed, at least to some extent ...
Through External Circular No. 001 of March 23, 2020, the Superintendence of Industry and Commerce (SIC) made clear that mobile phone operators and private entities in general have legal grounds to provide to the National Planning Department (DNP), as well as to public entities that so require it, personal data that is necessary to address, prevent, treat and/or control the spread of COVID-19 and mitigate its effects ...
When Congress passed the Families First Coronavirus Response Act ("CRA"), it left much for the U.S. Department of Labor ("DOL") to explain. The DOL has started offering vital interpretations employers need to consider in making decisions over the next few weeks. 1. When does the CRA become effective? April 1, 2020. 2 ...
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 ...
On March 25, 2020, the Ohio General Assembly unanimously passed legislation providing emergency relief to Ohio municipalities, businesses, schools, and families related to COVID-19. Critical to civil litigants in Ohio, the legislation evolved to include emergency measures that will toll statute-of-limitations on forthcoming lawsuits and discovery deadlines in currently pending lawsuits ...
Directions pertaining to the communications sector were issued on 26 March 2020 by the Minister of Communications and Digital Technologies (the "Minister"), to ensure the smooth operations of the electronic communications sector – as essential services – during the disaster period to combat the spread of the coronavirus (COVID-19) in South Africa ...
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 ...
