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 ...
On February 1, 2021, the Federal Trade Commission (FTC) announced its revised annual threshold that determines whether companies may be required to notify federal antitrust authorities about a proposed merger or acquisition due to the size and value of the transaction. For the first time since 2010 and a reflection of the state of the economy, the annual threshold has been reduced rather than raised, from $94 million in 2020 to $92 million for 2021 ...
The Electronic Communications Code was subject to a wholesale re-write in 2017, with the intention of facilitating the faster roll-out of the UK’s digital communications infrastructure. Three years on, the government has commenced a consultation on proposals to revise aspects of the Code to ensure it is fit for purpose ...
On Jan. 19, 2021, the two recent final rules issued by the Department of Health and Human Services Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) regarding changes to the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (Stark Law) regulations (respectively the OIG Rule and the CMS Rule, collectively the Final Rules) became effective ...
The Government of the UAE made another milestone announcement on 30 January 2021, announcing a procedure for the granting of citizenship to foreign nationals in a bid to retain talent in critical sectors and to expand and diversify the economy. Nationality and citizenship in the UAE are governed by Federal Law No. 17 of 1972 Concerning Nationality and Passports, as amended by Federal Law No. 10 of 1975 and Federal Decree-Law No ...
Bradley’s Government Enforcement and Investigations Practice Group is pleased to present the False Claims Act: 2020 Year in Review, our annual review of significant False Claims Act (FCA) cases, developments and trends. Despite the pandemic and the smallest recoveries for the Department of Justice in over a decade, FCA enforcement remains robust. As always, the healthcare industry remains the most frequent subject of FCA cases and investigation ...
Aron Beezley of Bradley Arant Boult Cummings LLP outlines the Justice Department's noteworthy procurement fraud recoveries for fiscal year 2020. The Department of Justice (DOJ) recently announced1 that it obtained more than $2.2 billion in False Claims Act (FCA) settlements and judgments in the fiscal year ending September 29, 2020 ...
The information listed below is categorized by topic for your convenience and includes content from the previous week. Bradley is actively monitoring and engaging with relevant federal, state or local entities on issues related to the coronavirus. Please contact one of the authors if you have any questions. Click on a link below to view the full article, alert, blog, webinar recording or interview ...
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 ...
In recent years, Russia has focused on regulating its IT area. In particular, this has been needed due to the increasing number of cases, when prohibited information has been distributed on various large Internet resources, such as a social network. However, according to Russian government agencies, despite the risks of possible sanctions, many foreign companies still do not respond quickly enough to government requests, or ignore the demands to remove prohibited information ...
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 ...
On January 22, 2021, the Federal Official Gazette published Resolution No. 55, by means of which the National Mining Agency (“ANM”) amends Resolutions No. 28/2020 and 46/2020, which deal with the suspension of deadlines of certain procedural and material acts under its competence, and the extension of the terms of mineral titles, due to the current COVID-19 pandemic ...
Northern Ireland Mark Blair Partnerships between the public and private sectors have had a big impact in Northern Ireland, and could potentially achieve more. Shoosmiths collaborated with Insider on a series of virtual roundtables across our regions to discuss how processes could be improved, where funding could come from and what successful collaboration could achieve. To read the report from the Northern Ireland debate, please click below ...
A new Angolan Public Procurement Law (“PPL”) has been approved recently. Law 41/20 of 23 December revokes Law 9/16 of 16 June and will enter into force on 22 January 2021. The new law will apply to all public procurement procedures beginning after that date and to the performance of subsequent contracts ...
On January 25, 2021, President Biden signed the Ensuring the Future Is Made in All of America by All of America’s Workers (Made in America) Executive Order, which not only directs that federal government purchases and procurement go to American businesses and workers, but also calls out the Jones Act for specifically endorsing the nation’s vessels, ports, and merchant crews ...
Hong Kong’s Legislative Council’s Panel on Financial Affairs discussed tax concessions for carried interest in its meeting on 4 January 2021, following the publication of a discussion paper by the Financial Services and the Treasury Bureau (FSTB). The FSTB’s paper sets out proposals to offer a zero percent concessionary tax rate for eligible carried interest distributed by eligible private equity funds operating in Hong Kong ...
To boost the economy post-Brexit the government is committed to establishing up to 10 freeports across the UK. In our latest freeport bitesize article, we look at some of the planning implications of which bidders and bid participants should be aware. Back in August 2019 the UK Government announced plans to create ten new freeports that would be free of “unnecessary checks and paperwork, and include customs and tax benefits” ...
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 ...
On January 1, 2020, Congress overrode President Trump’s veto to pass the National Defense Authorization Act (H.R. 6395 – 116th Congress (2019-20)), which includes the Anti-Money Laundering Act of 2020 (the “AML Act”). The AML Act revises the Bank Secrecy Act to bolster the government’s power to identify and regulate suspicious banking activity ...
The Government Accountability Office (GAO) recently issued to Congress its annual bid protest report. As discussed below, this year's report is noteworthy for multiple reasons, including that it shows that protesters received some form of relief from the procuring agency in more than half of the protests filed with the GAO in FY 2020, and the GAO's use of Alternative Dispute Resolution (ADR) increased by 210% in FY 2020 ...
The Biden administration implemented a regulatory rule freeze affecting all federal agency rules that had not gone into effect as of Jan. 20, 2021. At its core, the regulatory rule freeze requires all pending final rules to be delayed at least 60 days in order for the Biden administration to review and opine on the necessity and scope of affected rules. During this delay period, the administration may review, revise, and possibly rescind federal administrative rules ...
The U.S. Department of Justice (DOJ) has just released its annual statistical overview[1] of False Claims Act (FCA) and other fraud actions for Fiscal Year 2020 (FY2020)[2], and the numbers tell a mixed story. The total of just over $2.2 billion in settlements and judgments represents a decline of more than one-quarter in recoveries from FY2019,[3] likely reflecting workforce, logistical, and judicial impacts of the COVID-19 pandemic ...
The EU-UK Trade and Cooperation Agreement has effectively brought an end to state aid and a new regime of subsidy control has come into effect ...
The majority of people with a mobile phone or access to the internet have received unsolicited emails or calls from telemarketers (cold marketing). While the practice of cold marketing is decades-old, the recent awareness in data protection and privacy has affected this concept in recent times, particularly in relation to access to the data of consumers ...
