The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time.
The Hogan Lovells Government Relations and Public Affairs group is tracking all of the latest developments in the U.S. Congress and relevant news stories. The standoff between Senate Majority Leader Chuck Schumer (D-NY) and Majority Leader Mitch McConnell has come to an end, and the Senate can start organizing its committees and getting to work on Biden's COVID-19 relief agenda. House Democrats are shifting the House activity calendar to speed up passing a relief reconciliation package by mid-March. President Joe Biden said he plans to purchase another 200 million doses of coronavirus vaccines from Pfizer and Moderna to have enough vaccine doses to fully vaccinate all 300 million adult Americans by the end of this Summer. Research related to the ongoing debate over in-person schooling remains inconclusive. Centers for Disease Control and Prevention (CDC) researchers found in a report issued on Tuesday that schools are not major transmission drivers. The Department of Health and Human Services (HHS) misused millions of dollars intended for vaccine research to pay for unrelated expenses since at least 2010, the U.S. Office of Special Counsel alleged in letters to President Biden and Congress Wednesday. Read about these developments here: 26 Jan.; 27 Jan. (Authored by Ivan Zapien)
In 2020, the U.S. Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) issued four warning letters and two untitled letters to pharmaceutical companies for promotional materials that allegedly misbranded prescription drug products in violation of the Federal Food, Drug, and Cosmetic Act (FDCA) and the agency’s regulations. This marks a decline from the ten OPDP letters sent in 2019, and a continuation of the trend of the agency issuing far fewer enforcement letters than it did in its heyday in 2010, when OPDP issued 51 letters. OPDP’s 2020 letters also showed a continued focus on drugs with serious and life-threatening risks, and on the presentation of warnings and other safety information relative to benefit claims. Another trend from OPDP's 2020 letters is that the agency appears to be increasingly monitoring drug promotion in online communications platforms. Acting OPDP director Katie Gray said in a CDER interview that the agency is "focusing on enforcement regarding prescription drug promotional materials making false or misleading claims about COVID-19 prevention or treatment." Read more here. (Authored by Heidi Gertner, Susan Lee, and Meredith Manning)
Hogan Lovells partners Alice Valder Curran, Jodi K. Scott, and Jon Layman convened with other industry leaders virtually at this year’s Biotech and Digital Medicine Showcase Investor Conference to discuss how the COVID-19 pandemic, U.S. presidential election, and other global changes in 2020 have caused seismic shifts in the regulatory and investment landscape for pharmaceutical, biotechnology, and medical device companies. Online here we have summarized the key takeways from their panel discussions of post-election drug development policy, the digital health care revolution, and value creation through seed financing.
On 15 January, the U.S. Department of Health and Human Services (HHS) published a notice and request for information (RFI) proposing to exempt 91 medical devices – for which the normal regulatory process was temporarily waived during the COVID-19 public health emergency – from the Food and Drug Administration (FDA) 510(k) notification requirement. The notice is immediately in effect for exemptions for seven of the devices, all of which are gloves. However, according to a January 20 memo from Biden Chief of Staff Ronald A. Klain, the proposal will not take effect with respect to the remaining 83 devices unless the Biden Administration decides to pursue it. Marketing submissions are still actively being filed and accepted by FDA for many of the types of devices covered by the notice. HHS will accept comments on the proposal, and on ways to improve the 510(k) premarket notification program more generally, until March 16. Read more online here. (Authored by Kelliann Payne)
The U.S. government response to COVID-19 has prompted numerous litigation claims from a diverse set of plaintiffs. Many of these claims relate to the federal Paycheck Protection Program (PPP), which was created by the federal CARES Act and distributed $660 billion in forgivable business loans. The PPP, which ended 8 August 2020 was administered by the Small Business Administration (SBA), although private sector banks processed applications, disbursed the loan proceeds, and were paid a processing fee for doing so. We have analyzed those claims online here. (Authored by Marc Gottridge)
The Hogan Lovells Government Relations and Public Affairs group is tracking all of the latest developments in the U.S. Congress and relevant news stories. On 21 Jan., President Biden invoked the Defense Protection Act to accelerate and expand the manufacturing and distribution of vaccines, increase testing to identify and isolate the virus, increase the manufacturing of personal protection equipment. Additional actions to battle the pandemic were signed with many more likely to be signed in Biden’s first two weeks of office. New Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky told Fox News on Sunday that the Biden Administration does not know the current number of COVID vaccines available for distribution. Walensky said that the Trump administration did not track that data, making it extremely difficult for states to plan their vaccination distribution. White House National Economic Council director Brian Deese hosted a call on 24 Jan. with 16 bipartisan senators to discuss Biden’s $1.9 trillion aid plan. Moderna is accelerating its testing on booster shots to vaccinate against the different variants and mutations in strains of COVID-19. The Biden White House announced it will resume regular briefings with public health experts focused on responding to the coronavirus pandemic, reviving an approach that had declined during the Trump administration. Dr. Deborah Birx, President Trump's coronavirus response coordinator, told CBS's Face the Nation that Trump received and presented different statistics than those she sent to the President. Read about these developments here: 21 Jan.; 22 Jan.; 25 Jan. (Authored by Ivan Zapien)
On 21 January, U.S. President Biden issued an Executive Order (EO) calling for increased federal emphasis on worker safety during the COVID-19 pandemic. In his Executive Order on Protecting Worker Health and Safety, President Biden announced that “it is the policy of my Administration to protect the health and safety of workers from COVID-19” and declared the “the Federal Government must take swift action to reduce the risk that workers may contract COVID-19 in the workplace,” including “issuing science-based guidance” on worker safety. The Executive Order does not create any immediate changes in companies’ obligations, but it calls for swift action by the Occupation Safety and Health Administration (OSHA) to issue updated guidance, consider issuing emergency workplace safety standards, and increase enforcement related to COVID-19. Read more here. (Authored by Brian Eyink)
The huge economic impact of the COVID-19 pandemic has long since been felt across numerous areas of the German economy. For many industries, the business climate has deteriorated massively. Stores remain closed, supply chains are affected, travelling is limited, revenues have significantly dropped and businesses have to impose reduced working hours (Kurzarbeit) or forced leave to reduce costs. Online here we have analyzed restructuring under plan proceedings in Germany. (Authored by Dr. Heiko Tschauner)
We describe online here the legal impact on Italian loan transactions of the current health emergency caused by COVID-19 in light of the latest legislative measures, including a suspension of interest and principal payments on loans to SMEs, the rescheduling of repayment plans, and a State guarantee for loans to larger corporates. SMEs also benefit from a mandatory hold of credit facilities, and there is a general suspension of insolvency proceedings, mandatory recapitalisations and subordination of shareholder loans. In accordance with the EU Commission's Temporary Framework on State aid of last March, financial support is not available for non-performing or otherwise impaired loans, and our observations relate to loans which were fully performing until COVID-19. (Authored by Carlo Massini)
Given the ongoing effects of the COVID-19 pandemic, many industries are bracing for an increase in bankruptcy filings and distressed M&A activity. It is important for directors to understand their fiduciary duties as a company's financial situation evolves and potentially deteriorates. Online here we seek to provide insights into a director's fiduciary duties when a company approaches or enters insolvency in the U.S., and endeavors to provide practical guidance for directors on the application of fiduciary duty best practices in the context of a bankruptcy sale process. (Authored by Ryan M. Philp)
Foreign direct investment (FDI) is an important part of the global economy: Organisation for Economic Co-operation and Development data indicates that there was US$1.426 billion of global FDI in 2019. In recent years, governments around the world have shown an increasing desire to scrutinize and, if considered necessary, intervene in transactions involving FDI, motivated by a number of geopolitical factors including rising protectionism, concern about cybersecurity threats, and more recently the need to protect critical industries in response to the COVID-19 pandemic. There are exceptions – notably, China, Chile, and the United Arab Emirates have all relaxed their FDI rules to encourage foreign investment. However, the general trend is for governments to seek to exercise greater control over flows of FDI into their jurisdictions. For M&A planning purposes, we analyzed online here some of the key considerations and provide a high level overview of the key features of a number of significant FDI regimes including the U.S., UK, France, Spain, Germany, Italy, and Australia. (Authored by Mark Jones)
International telework arrangements are deceptively complicated and layered with policy, regulatory, and tax implications. For example, in the wake of COVID-19, some countries issued guidance to alleviate permanent establishment (PE) concerns relative to temporary remote work arrangements driven by the pandemic. Online here we offer below five lessons learned from guiding international telework arrangements over the past year. (Authored by Bill Ferreira)
The Hogan Lovells Government Relations and Public Affairs group is tracking all of the latest developments in the U.S. Congress and relevant news stories. On Wednesday night, the Biden Administration issued a regulatory freeze on pending regulations. On Tuesday, Biden had designated Pennsylvania Health Secretary Dr. Rachel Levine to be his assistant secretary of Health and Human Services. Levine is a physician and professor of pediatrics and psychiatry at the Penn State College of Medicine and has been leading Pennsylvania’s response to the ongoing COVID-19 pandemic. Biden also announced that Vivek H. Murthy will return to be sworn in as surgeon general for the second time, and Andrea Palm as deputy secretary for legislation. Palm is Secretary-designee of the Wisconsin Department of Health Services. The Biden Administration will reverse President Trump's last-minute order to lift COVID-19 related travel restrictions, Jen Psaki, the incoming White House press secretary, tweeted. Read more about these developments online here. (Authored by Ivan Zapien)
The European Commission (EC) has published an inception impact assessment for a potential legislative proposal establishing a European Health Data Space. In its document, the European Commission identifies the problems currently faced by the current framework for cross-border exchanges of health data. To tackle these problems, three objectives with related policy options are provided. The inception impact assessment will be open for feedback until 3 February 2021. The European Commission’s legislative proposal will be prepared after an impact assessment is carried out. Although the use of digital health services and products have increased since the outbreak of the COVID-19 pandemic, the free movement and provision of these services and products remains very limited. Read more here. (Authored by Fabien Roy)
Last month the French Minister of Armed Forces formally blocked, for the first time ever, a foreign investment by a U.S. company. In addition, the French Minister of Economy and Finance announced a one year extension to interim rules on foreign investment introduced in response to COVID-19 that were due to expire on 31 December 2020 and recently expressed his intention to use investment control powers to block the proposed takeover of Carrefour SA by a Canadian company. These developments reflect a broader push by France to strengthen the enforcement of its investment screening regime. Foreign investors looking to invest in French target companies or assets are advised to consider early on whether they may be subject to notification obligations and/or exposed to government review under the French screening regime. Read more here. (Authored by Aline Doussin)
On 14 January, U.S. President Joe Biden unveiled the first step of an ambitious two-part package stimulus package with a total price tag of $1.9 trillion. Biden called on Congress to quickly approve $415 billion in emergency spending to scale up vaccinations, provide direct relief to families and businesses, and further support other efforts to combat the COVID-19 crisis. The “American Rescue Plan” would be the largest investment the federal government has made to address the public health efforts to combat the pandemic. The measure will more than double the money for vaccine procurement than what was passed in the December omnibus coronavirus relief bill. We have analyzed the proposal online here. (Authored by Ivan Zapien)
On 14 January, the U.S. Food and Drug Administration (FDA) issued a final guidance entitled, “Enforcement Policy for Coagulation Systems for Measurement of Viscoelastic Properties During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.” Hypercoagulability has been observed in patients with COVID-19, and coagulation systems for measurement of whole blood viscoelastic properties can help identify changes in coagulation status and are used routinely to aid in the assessment of hemostasis following certain surgical procedures and in the assessment of bleeding and thrombosis following a traumatic injury or event. Accordingly, the new FDA guidance purports to foster the continued availability of safe and effective medical devices while being flexible regarding certain modifications made to coagulation systems for measurement of whole blood viscoelastic properties to include use in hospital patient health care settings in response to COVID-19. The guidance describes the devices that are within the scope of the guidance, and explains that, for the duration of the PHE, FDA does not intend to object to limited modifications to the indications, functionality, hardware, or software of the devices within the scope of the guidance without prior submission of a 510(k), where the modification does not create an undue risk to the patient. FDA recommends that devices modified as described in the guidance include certain labeling elements to help ensure that such devices do not create undue risk to the patient and to help users understand the device modifications under the policy. (Authored by Randy Prebula)
The Hogan Lovells Government Relations and Public Affairs group is tracking all of the latest developments in the U.S. Congress and relevant news stories. Dr. David Kessler, former FDA commissioner, will lead the White House's COVID-19 vaccination drive under the Biden Administration. A new report says that while the Trump Administration announced it was releasing a stockpile of COVID-19 vaccine initially held for second shots to accelerate lagging vaccination efforts nationwide, no such reserve existed. The Small Business Administration (SBA) announced Wednesday that it would re-open the Paycheck Protection Program (PPP) loan portal to PPP-eligible lenders with $1 billion or less in assets for First and Second Draw applications on Friday, January 15, at 9 am ET. Read about these developments here: 14 Jan.; 15 Jan.; and 16 Jan. (Authored by Ivan Zapien)
The UK Supreme Court has dismissed insurers’ appeals and substantially allowed the FCA’s appeal in the conclusion of the FCA test case litigation. The result of the Supreme Court ruling is that all insuring clauses in issue before the Supreme Court will provide cover for COVID-19 business interruption losses and trends clauses cannot be deployed to cut down that cover in the calculation of amounts payable, meaning significantly greater coverage of claims than following the High Court ruling. With the conclusion of the litigation, the focus will now shift to the adjustment and settlement of claims. Online here we take a look at some key practical and legal considerations for the UK insurance market, including issues to watch going forward. (Authored by Lydia Savill)
Many Southeast Asian countries have adopted a strict new norm in response to the COVID-19 pandemic and with it the markets and economies have stabilized. The news of global vaccine approvals and its subsequent roll-out in the first half of the year looks set to bolster business. Online here we analyzed the most important topics making an impact on doing business in Southeast Asia in 2021, including strengthening trade, growing foreign investment, and technological advancements. (Authored by Chalid Heyder)
The impact of the COVID-19 pandemic has seen a sharp increase in online activity, in both the public and private sectors, among consumers and business alike. In this publication we highlight key developments from 2020 that have occurred for domain names, and take a look at what the year ahead is likely to bring. (Authored by David Taylor)
On 11 January 2021, the European Commission published a Notice which provides the conditions under which remote audits under Regulation 2017/745 of 5 April 2017 on medical devices (MDR) and Regulation 2017/746 of the of 5 April 2017 on in vitro diagnostic medical devices (IVDR) may be performed. The European Commission recalls that this is a temporary extraordinary measure motivated by the unprecedented circumstances that the medical devices industry is experiencing due to COVID-19. The possibility of conducting remote audits will, therefore, be assessed on a case-by-case basis and will only be allowed until on-site audits are again possible. Read more here. (Authored by Fabien Roy)
On January 6, 2021, the U.S. Department of Health and Human Services (HHS) ordered the Food and Drug Administration (FDA) to “cease further collection efforts” related to the Over-the-Counter (OTC) Drug Monograph User Fee Program, issuing a Withdrawal Notice for FDA’s December 29, 2020 Federal Register Notice on user fee rates. The December 29 Notice had sparked concern from distilleries and breweries that entered the market under FDA’s March 2020 temporary guidance, which encouraged firms that were not traditional drug manufacturers to make hand sanitizer for consumer use under certain conditions specified in the guidance. On January 8, HHS issued another notice (“Exemption Notice”) stating that distilleries and other small businesses that supplied hand sanitizer for the first time during the COVID-19 public health emergency cannot not be subject to OTC user fees. Read more here. (Authored by David Horowitz)
The Hogan Lovells Government Relations and Public Affairs group is tracking all of the latest developments in the U.S. Congress and relevant news stories. The House voted 292-197 to impeach President Trump for a second time on a charge of inciting insurrection over the 6 Jan. siege on the U.S. Capitol that left five people, including a Capitol Police officer, dead. Moncef Slaoui, the chief adviser to Operation Warp Speed, on Wednesday submitted his resignation effective next month according to CNBC. The Trump Administration abruptly halted its current guidance on administrating the COVID-19 vaccine in order to speed up inoculations. It also told states to start vaccinating anyone 65 and older or high-risk medical conditions despite vaccinations for essential employees not yet being completed. The Administration says it will provide the Biden transition team access to meetings regarding the government's coronavirus vaccine development efforts. Read about these developments here: 12 Jan. and 13 Jan. (Authored by Ivan Zapien)
As we enter a new decade with various uncertainties, there is only one thing that is certain: the adoption of new technologies will continue as individuals and companies embrace and become more reliant on different forms of new technology. Particularly in 2020, amid the COVID-19 pandemic and moving things "virtual," there has been a growing need for technology capabilities to evolve and adapt to new working styles in order to keep up with increasing demand. This guide aims to provide an overview of the different regulatory landscapes of setting up a technology start-up in Asia-Pacific. Focusing on the hot spots: Hong Kong, Singapore, Japan, Vietnam, and Taiwan, we aim to highlight what start-ups should be thinking about when making a decision of where to establish their company, and what sort of government incentives are available. (Authored by Wataru Kamoto)
The Hogan Lovells Government Relations and Public Affairs group is tracking all of the latest developments in the U.S. Congress and relevant news stories. On 14 Jan., President-elect Joe Biden will unveil his sweeping coronavirus vaccination plan. Soon-to-be Senate Majority Leader Chuck Schumer (D-NY), Sen. Patty Murray (D-WA), and 44 other Democrats sent a letter to Health and Human Services Director Secretary Alex Azar calling for plans to correct "significant" failures in vaccine rollout, including guidance and support for states. Hospitals are throwing out portions of Pfizer’s COVID-19 vaccine because the syringes distributed to them by Operation Warp Speed aren’t efficient enough to extract all the doses, according to hospitals. Germany’s BioNTech, which developed the first COVID-19 vaccination on the market with American partner Pfizer, says it expects to produce 2 billion doses in 2021 with ramped-up manufacturing. The White House Coronavirus Task Force is warning that there may be a new fast-spreading U.S. variant of the coronavirus. Now that Democrats will have a Senate majority, President-elect Biden is confident that he can usher two packages through Congress. One would send to individuals the full $2,000 coronavirus stimulus payment and the other would consist of a $3 trillion tax and infrastructure package. Read about these developments here: 7 Jan.; 8 Jan.; and 11 Jan. (Authored by Ivan Zapien)
As of January 1, 2021, COVID-19 leave is no longer mandated under the U.S. Families First Coronavirus Relief Act (FFCRA), although covered employers who voluntarily provide paid leave outlined in the FFCRA may take advantage of the FFCRA tax credit through 31 March, 2021. In the Consolidated Appropriations Act, 2021 (CAA), which became law on December 27, 2020, Congress allowed the FFCRA leave mandate to sunset effective December 31, 2020. However, Congress retained the FFCRA tax credit through the first quarter of 2021. This means that covered employers may voluntarily provide FFCRA leave to eligible employees through March 31, 2021, in which case they can recover the costs of the leave through the FFCRA’s fully refundable tax credit. Read more here. (Authored by George W. Ingham). Notwithstanding this change in federal law, District of Columbia employers should be aware of their continuing obligations to provide leave to eligible employees for COVID-19 related reasons at least through the first quarter of 2021. Read more about that here. (Authored by Patricia R. Ambrose).
The social and economic consequences of the COVID-19 pandemic continue to create shock waves throughout the world. When implementing emergency measures to address the pandemic, many governments have tried – and are still trying – to balance the risk to lives from the pandemic against the risk to livelihoods from the restrictions imposed on business in an attempt to contain the virus. In a number of jurisdictions, temporary and permanent changes have been made to insolvency and restructuring laws with the aim of giving struggling but ultimately viable companies a breathing space in which to restructure and recover. Read more here. (Authored by Scott Harris)
In this analysis of 2020's data protection milestones, we focus on Spain-specific decisions, guidelines, legal reports, etc. issued or enacted by the Spanish Data Protection Agency (AEPD), regional authorities, and Spanish courts. This analysis does not discuss the more significant news that occurred at the higher EU level (among others, the Schrems II decision and its consequences, the European Data Protection Board new guidelines, etc.). COVID-19 has undoubtedly been the star topic of this 2020, and the AEPD has issued several resources (reports, FAQs, guidelines, etc.), which we summarized here. (Authored by Gonzalo F. Gallego)
In an end-of-year interview with Medtech Insight, Hogan Lovells partners Mike Heyl and Jodi Scott look back at the the work of the U.S. Food and Drug Administration (FDA) in 2020 and predict what the regulatory future may hold. They discuss topics such as the impact on product launches from the pandemic over the next year and how their firm has responded to the crisis. The fate of medical products given emergency use authorization (EUA) after the U.S. public health emergency ends, and FDA’s harmonization efforts around its Quality System Regulation (QSR) are two hot-button topics the medtech industry should keep a sharp eye on in 2021, Heyl and Scott explained.
Our employment team's latest analysis addresses some of the key questions that UK employers are asking about their obligations to employees when dealing with the current COVID-19 outbreak. FAQ addressed include whether employers can require medical evidence that someone is sick or self-isolating; who is entitled to sick pay; whether employees are entitled to time off if their child's school closes; parameters surrounding annual leave rules; contact tracing regulations; disclosure laws; and more. (Authored by Stefan Martin)
The Hogan Lovells Government Relations and Public Affairs group is tracking all of the latest developments in the U.S. Congress and relevant news stories. Democrats achieved an effective Senate majority on Tuesday as Rev. Raphael Warnock defeated Sen. Kelly Loeffler (R) and Jon Ossoff defeated Sen. David Perdue (R). The Trump Administration says it is accelerating a plan to get vaccines into pharmacies after facing a slow rate of immunizations. In a statement on Monday, FDA Commissioner Stephen Hahn and Peter Marks, director of the agency’s Center for Biologics Evaluation and Research, responded that it was “premature” to start altering coronavirus vaccine doses to speed up the distribution process. In a new FAQ sheet, the Centers for Disease Control and Prevention (CDC) says that the COVID-19 vaccine cannot make you sick with COVID because it does not contain the live virus. The CDC did warn that it can take several weeks for a person's body to build up immunity after being vaccinated. This means it is possible to still get COVID-19 just before or after being vaccinated. Read about these developments online here: 5 Jan. and 6 Jan. (Authored by Ivan Zapien)
The Hogan Lovells Government Relations and Public Affairs group is tracking all of the latest developments in the U.S. Congress and relevant news stories. The House of Representatives met Sunday to swear in new members of Congress and elect Nancy Pelosi (D-CA) (216-206) to be the Speaker of the House for the fourth time. The Trump Administration has only been able to vaccinate 4.2 million U.S. citizens by the end of December, far below the 20 million promised. The Trump Administration is continuing discussions with Moderna about the possibility of speeding up the COVID-19 vaccination process by giving people only half the recommended dose, a top adviser said Sunday. Due to the COVID-19 pandemic, and to limit the large gatherings of crowds, the Biden Inauguration won’t get a traditional inaugural parade down Pennsylvania Avenue after he takes the oath of office, but he will get a presidential escort to the White House. Drug manufacturer Moderna will increase its vaccine production from 500 million doses to 600 million for the U.S. for 2021, and the company said it hopes ultimately to produce one billion doses in total this year, the company announced on Monday. On Monday, UK Prime Minister Boris Johnson announced that England is closing all schools and imposing a strict national lockdown. Scottish officials also announced a host of new lockdown measures as the United Kingdom continues to grapple with a new, more infectious strain of COVID-19. Read about these developments online here. (Authored by Ivan Zapien)
California's landmark privacy law and looming changes to strengthen those rules are poised to keep companies busy in 2021, while state legislatures and Congress are expected to jumpstart efforts derailed by the COVID-19 pandemic to rein in how businesses use and share personal information. How the transition to a Democratic Biden administration impacts the Federal Trade Commission's privacy and data security enforcement efforts and the future health of transatlantic data flows will also bear watching, experts say. Online here, attorneys including Hogan Lovells partner Peter Marta flag some of the major cybersecurity and privacy policy issues they will be tracking in the new year. They say they'll be watching to see if these more targeted efforts gain any traction in 2021, especially as the rollout of COVID-19 vaccines continue to fuel thorny data collection issues.
The Hogan Lovells Government Relations and Public Affairs group is tracking all of the latest developments in the U.S. Congress and relevant news stories. On 22 December, U.S. President Trump threatened to turn a month’s worth of negotiations and passage of the COVID-19 and FY-2021 omnibus appropriations bills upside down by announcing that he would veto the bill unless Congress increased the individuals’ stimulus check from $600 to $2000. House Democrats, who have been advocating for more COVID-19 relief were more than happy to oblige the president’s request. On 24 December, the House attempted to pass a standalone bill increasing the amount to $2,000 by unanimous consent, but Republicans rejected the legislation, which sent the fate of the bill and a government shutdown pending unless Republicans or the President backed down first. The President on Sunday abruptly signed the measure, but not before allowing unemployment benefits for approximately 12 million Americans to lapse. House Democrats still plan to move forward with a formal vote on 28 Dec. to increase the stimulus checks to $2000. Read about these and other updates here: 22 Dec. and 23 Dec. (Authored by Ivan Zapien)
Germany has enacted a new corporate restructuring law, the centerpiece of which will be the so-called stabilization and restructuring framework (SRF). The German Parliament (the Bundestag) passed the law on 17 December 2020. On 18 December 2020, the law was also accepted by the Federal Council (the Bundesrat). It will come into force on 1 January 2021. Prior to the pandemic, the German Insolvency Code has also been modified, in particular with regard to the insolvency grounds, the duty to file for insolvency, and the debtor-in-possession proceedings. Notably, for companies affected by the COVID-19 pandemic, the duty to file for insolvency is suspended in January 2021 for both mandatory insolvency grounds. We have summarized the most important modifications online here. (Authored by Dr. Heiko Tschauner)
In response to the economic effects of the COVID-19 pandemic and market uncertainty, a plethora of financing measures was introduced at EU level, German federal level, and German states levels. In their joint effect, these measures are aimed at shielding enterprises from the crisis, by offering different liquidity programs for overbridging temporary, crisis-evoked liquidity shortages. This analysis summarizes our understanding of the key EU, German federal, and German states’ financial and state aid measures. Developments in this area are fast-changing, and our publication includes updates to our initial version published on 1 April 2020, which relate, among other things, to the criteria of KfW-Sonderprogramm 2020 and the relevant financing products available on German state levels. (Authored by Dr. Katlen Bloecker)
The Hogan Lovells Government Relations and Public Affairs group is tracking all of the latest developments in the U.S. Congress and relevant news stories. After months of not reaching an agreement on a coronavirus stimulus package, congressional leaders announced Sunday evening they have agreed to a roughly $900 billion COVID-19 relief package. The aid is being attached to a $1.4 trillion FY-2021 appropriations omnibus bill and also includes additional sought-after provisions on tax extenders, surprise billing, and $45 billion in transportation-related provisions. The House and Senate planned on passing the bill Monday evening, but Congress will also have to pass a seven-day stopgap bill to keep the government open for another week while they complete the administrative and paperwork. Operation Warp Speed’s chief scientific advisor Moncef Slaoui told reporters that they are considering trials to test if a lower dose of Moderna’s coronavirus vaccine will be as effective as the two microgram shots given three weeks apart, allowing the U.S. to extend its supply to more Americans. A growing number of countries are banning travelers from the U.K. to preemptively block the spread of a new strain of the coronavirus. The Food and Drug Administration (FDA) issued an emergency use authorization for Moderna’s vaccine for emergency use on 18 December. Read about these and other updates here: 17 Dec.; 18 Dec.; and 21 Dec. (Authored by Ivan Zapien)
On 16 December, the U.S. Equal Employment Opportunity Commission (EEOC) updated its COVID-19 guidance to address COVID-19 vaccines in the workplace. The EEOC’s guidance implies that a mandatory workplace vaccination program is lawful under the Americans with Disabilities Act (ADA) and the other laws the EEOC administers provided that the employer provides disability and religious exemptions. Nonetheless, employers must consider a number of practical and legal considerations in deciding whether and how to implement a mandatory program in the workplace. Read more online here. (Authored by Michael E. DeLarco, George W. Ingham, Amy Folsom Kett & Zachary Siegel)
In our latest episode of the "A Perspective Podcast," Andrew Skipper speaks with Nigerian media entrepreneur, journalist, political activist and motivational speaker, Adebola Williams. He is the Group CEO of Red for Africa, Africa's largest portfolio of youth-focused media brands which include Red Media Africa, Statecraft Inc, The Future Awards Africa and YNaija.com. Listen online here as they discuss Adebola’s involvement in African elections, the power of social media – both positive and negative – as well as and the importance of promoting the right messages to propel "Brand Africa" forward. He also paints a picture of his role in inspiring youth advocacy as a GenU Global Champion and why mobilizing Africa's youth can help shape a more progressive future. He goes on to share his views about the opportunities presented by COVID-19 for Africa, and the message he believes can inspire younger audiences to create the “ new paradigm” demanded by the Africa Union.
Compiled by Aaron Armstrong
New Orange & Purple Book laws increase transparency of patent information for drugs, biologics
CMS finalizes “reasonable and necessary” definition, expedited breakthrough device coverage process
COVID-19 Report for Life Sciences and Health Care Companies (14 - 17 December 2020)
Five highlights from FDA’s new AI device regulation Action Plan
STeP’ing up: FDA advances expedited device review program, set to begin in March
2020 final price reporting developments: stimulus legislation, 340B contract pharmacy Advisory Opinion
HHS forces FDA to withdraw notice for OTC user fees and creates new exemptions
Comment period ending for proposal to automatically sunset HHS/FDA/CMS regulations
MDRP: CMS Final Rule on value-based purchasing, line extension definition, PBM accumulator programs
HHS proposes changes to key provisions of the HIPAA Privacy Rule
FDA continues to escalate enforcement for undeclared allergen recalls
U.S. policy on the regulation of genetically engineered animals evolves with steps by FDA and USDA
OMB releases Fall 2020 Unified Agenda of Regulatory Actions
The effect of the Brexit Deal on data protection
Biden’s China policy: No details, but several clues on approach
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