As a reminder to our life sciences clients including drug manufacturers, medical device manufacturers, and group purchasing organizations, all Open Payments data from the 2020 program year must be reported to CMS by no later than March 31, 2021. Organizations that participate in the Open Payments program are also reminded that they must submit a final attestation that their data is timely, complete and accurate in addition to reporting data from fiscal year 2020 ...
The Insurance Authority has recently gazetted the Insurance (Group Capital) Rules. They will come into effect on 29th March, the same day as the Insurance (Amendment) (No. 2) Ordinance which makes provision for the Insurance Authority to supervise on a consolidated basis designated insurance holding companies and members of their supervised group (see our Client Alert dated 27th May, 2020 regarding designated insurance holding companies) ...
On February 25, 2021, the Ministry of Health and Social Protection issued Resolution 223 of 2021 (the “Resolution”) to update the general biosecurity measures set for the management of Covid-19 in Colombia. The main novelties included in this regulation are mentioned below: 1. Scope The Resolution extended the scope of the general biosecurity measures to all "social and economic activities carried out by individuals" ...
In connection with the adoption of a new law on the ethical treatment of clinical trials of medical devices, the Folketing has made a number of changes to the rules on the affiliation and financial support of pharmaceutical and medical companies to healthcare professionals. The amendments will enter into force on 26 May 2021 ...
The Insurance Authority has now gazetted the Insurance (Special Purpose Business) Rules. They will come into effect on 29th March, 2021, the same day as the Insurance (Amendment) Ordinance which makes provision for special purpose insurers (see our Client Alert dated 27 May 2020 regarding special purpose insurers). The Rules restrict the sale of insurance linked securities. Insurance linked securities are securities issued through insurance securitisation i.e ...
FINANCIAL SERVICES BNM announces new funds for SMEs On 5 February 2021, Bank Negara Malaysia ("BNM") announced: an additional RM2 billion for the Targeted Relief and Recovery Facility (“TRRF”); the establishment of a RM200 million Disaster Relief Facility (“DRF”) 2021. TRRF The TRRF was a facility announced in the Budget 2021, established to assist eligible SMEs in the services sector ...
In September 2020, a team of MIT researchers published a paper in the IEEE Open Journal of Engineering in Medicine and Biology, testing the hypothesis that coronavirus carriers—even asymptomatic ones—could be accurately detected using artificial intelligence (AI) based on only a phone recording of a forced cough.If this hypothesis is correct, the COVID-19 test can be accessible to people worldwide ...
CRIMINAL Counterfeit VaccinesBy Andre Augusto Mendes Machado and Mariana Murad Leiva Counterfeiting vaccines may lead to criminal liability, usually for the crime foreseen in article 273 of the Brazilian Penal Code, that punishes with imprisonment from 10 to 15 years in addition to the payment of a fine the acts of "falsifying, corrupting, adulterating or modifying products intended for therapeutic or medicinal purposes" ...
Claims of bad faith present unique challenges for insurers (and their counsel) with respect to attorney-client privilege: if the insurer’s state of mind is at issue, is the legal advice on which the insurer relied also at issue, thereby waiving the privilege? And if so, under what circumstances? The following addresses this issue in the context of a common practice for insurance counsel—authoring denial letters—and two recent holdings that should serve as warnings in th
As we near the second year of the COVID-19 pandemic, trademark maintenance deadlines in 2021 create new obstacles for registrants. To maintain a federal trademark registration, registrants must periodically file an affidavit of use under Section 8, swearing that the mark is in use in commerce or that the registrant has an acceptable excuse for nonuse. Recent office actions show that the U.S ...
Introduction On 21 January 2021 a new royal decree was published in the Official Gazette which has temporarily extended occupational doctors' role in combating the COVID-19 pandemic in the workplace ...
The judgment of the United Kingdom Supreme Court On 1 May 2020, the Financial Conduct Authority (“FCA”), the body that oversees the insurance industry in the United Kingdom, announced that it wanted to obtain a ruling from the English courts on the meaning and effect of the sample of business interruption clauses that it selected from eight insurers in particular ...
Following the differences that came to light with AstraZeneca at the end of last week, the European Commission approved Implementing Regulation (EU) 2021/111 of 29 January 2021, which came into force on Saturday, 30 January. The Regulation prohibits the unauthorised exportation of vaccines against SARS-CoV-2 outside the European Union ...
A recent UK Supreme Court Judgment, the Financial Conduct Authority v Arch Insurance (UK Ltd) & Ors [2021] UKSC 1, clarified whether a variety of insurance policy wordings cover business interruption losses resulting from the COVID-19 pandemic and public health measures taken by UK authorities in response to the pandemic from March 2020 ...
Brief notes on Commission Regulation 2021/111 of 29 January 2021 Following the differences that came to light with AstraZeneca at the end of last week, the European Commission approved Implementing Regulation (EU) 2021/111 of 29 January 2021, which came into force on Saturday, 30 January. The Regulation prohibits the unauthorised exportation of vaccines against SARS-CoV-2 outside the European Union ...
A change in administrations from Republican to Democratic usually ushers in increased enforcement, regulation and strategic initiatives. Most of the Trump regulations and initiatives will likely be scrapped where possible. They will be replaced by rules and guidance documents that have been held in abeyance during the previous administration, as well as numerous new initiatives ...
Welcome to the Life Sciences & Healthcare Newsletter, a publication prepared by our multidisciplinary team dedicated to the Healthcare industry, under the coordination of partners Lior Pinsky and Renata Fialho de Oliveira. INSURANCE ANS establishes operating rules for electronic administrative proceedings, effective as of end of March 2021 Andrea Piccolo Brandão In accordance with Decree No. 8,539, of Oct. 08, 2015 ("Dec ...
Not surprisingly, COVID-19 business interruption insurance disputes dominated media headlines for most of 2020. Nonetheless, there were a number of other insurance rulings that will undoubtedly shape the coverage landscape. Policyholders enjoyed a number of significant wins including significant victories related to COVID-19 business interruption cases. The start of a new year gives us an opportunity to highlight some of 2020’s most notable coverage decisions ...
Two federal cases in the Northern District of Ohio recently reached very different conclusions on whether the state’s COVID-19 shutdowns of restaurants permit valid claims for business interruption insurance coverage. Reviewing essentially the same facts and policy provisions, one court found for the insurer, holding no coverage to exist. The other found for the policyholder, awarding coverage. The opposite results will no doubt lead to further upcoming appellate activity in Ohio ...
In a scenario that has played out across the country for nearly a year now, a group of restaurants based in Ohio were ordered by government authorities to close their on-site dining operations to abate the spread of the coronavirus. However, when the restaurants sought insurance coverage for their loss of business income, their insurer, Zurich American Insurance Company, denied coverage. Last week, the U.S ...
The Supreme Court has handed down its much anticipated decision relating to the coverage of business interruption insurance claims made following the COVID-19 pandemic. A key question was whether the Supreme Court ruling would finally provide the clarity that the expedited test case sought to achieve for both policyholders and insurers. The good news for all is that the Supreme Court has indeed provided much more clarity in relation to most issues ...
How does one resolve a dispute involving thousands of individual items where it is impractical to deal separately with each one? A recent decision in the Technology and Construction Court provides some guidance - but raises further questions. The case is Standard Life Assurance Limited v Gleeds (UK)(a firm) and Others (December 2020, TCC). Standard Life had engaged Costain as its main contractor for the development of a large residential and retail development in Berkshire ...
The Unemployment Insurance Fund (“UIF”) has shed some light on what will happen to existing and outstanding COVID-19 Temporary Employer-Employee Relief Scheme (“TERS”) applications and payments, particularly over the festive season. We discuss the must-knows for employers below ...
When the scope of the COVID-19 pandemic became apparent in March 2020, an avalanche of articles appeared in which many insurers took the position that there was no coverage for losses associated with the SARS-CoV-2 virus due either to a lack of physical loss or damage to property necessary to trigger coverage under most commercial property policies, or to the effect of virus exclusions found in many such policies ...
