Thursday, 3 December 2020

• On 24 November, 2020, the U.S. Food and Drug Administration (FDA) posted two Serology Templates with updated recommendations on the content and data for Emergency Use Authorization (EUA) requests or Pre-EUA submissions. The key updates and recommendations for the Serology Template for Test Developers and Home Specimen Collection Serology Template for Fingerstick Dried Blood Spot are summarized below. The Serology Template for Test Developers will replace the prior two individual templates used by  commercial manufacturers and laboratories. The updated template includes revised recommendations on clinical performance data stratified by time of symptom onset as well as guidelines on data to support semi-quantitative tests, which include: Limit of Blank (LoB), Limit of Detection (LoD), Limit of Quantitation (LoQ), Linearity, Precision, Interference, and Recovery, as applicable. Compared to the prior template used by laboratories, the new template includes additional recommendations on Point of Care tests. The template also provides updated recommendations on software validation information to be provided for devices with no prior FDA review. The Home Specimen Collection Serology Template for Fingerstick Dried Blood Spot provides guidance for developing prescription use only, home collection devices which can be used by an individual to self-collect fingerstick dried blood spot specimens for further SARS-VoC-2 antibody test. The recommended performance evaluation includes Usability, Clinical Performance, Home Collection Sample Stability, Analytical Robustness, along with labeling. (Authored by Eriko S. Yoshimaru)

• 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. Congressional interest in a coronavirus relief legislation has been revived after months of the stalled negotiations. On Tuesday, a bipartisan group of senators held a press conference to introduce a broad coronavirus aid framework, which would provide $908 billion in aid and also provide liability protection for businesses. Meanwhile, Senate Leader Mitch McConnell on Tuesday circulated a revised version of his targeted coronavirus relief package among his caucus. The Centers for Disease Control and Prevention (CDC) is suggesting that Americans postpone holiday travel after a busy Thanksgiving weekend that will likely result in a surge of new coronavirus cases. The CDC's Advisory Committee on Immunization Practices (ACIP) voted on Tuesday to recommend that health care workers and long-term care facility residents should receive a coronavirus vaccine first when it is available. On Wednesday, the CDC updated its guidance to shorten its recommended quarantine times for people who have been exposed to the virus from 14 days to ten days if the individual is not exhibiting any symptoms and has not been tested. Also on Wednesday, the U.K. became the first country to authorize the Pfizer-BioNTech coronavirus vaccine for emergency use.  Read about these and other updates here: 1 Dec.; and 2 Dec. (Authored by Ivan Zapien)

• On 12 November 2020, the European Commission’s Sub-Working Group on Borderline Products published a technical document concerning product claims related to leave-on hydro alcoholic hand gels within the context of COVID-19 pandemic. This technical document provides a list of product claims which would not support the classification of leave-on hydro alcoholic hand gels as cosmetic products. The guidance is intended to serve as a tool for national competent authorities and national courts. Read more online here. (Authored by EA Wright)

Tuesday, 1 December 2020

• Leaders of our Life Sciences and Health Care team recently met for a panel discussion of the impacts on the industry of the 2020 U.S. election. This was the first event in a series of conversations, with other webinars scheduled for 1 December and 16 December. We are excited to share online here the following highlights from the webinar, and we look forward to future discussions as we forecast and help clients prepare for what’s to come in 2021 under a new presidential administration.

• 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 Sunday, White House Coronavirus Task Force coordinator Dr. Deborah Birx warned Americans to “assume that you’re infected” with COVID-19 if you traveled or gathered for Thanksgiving and advised being tested about five to 10 days later. Both Dr. Birx and the nation’s top infectious disease expert, Dr. Anthony Fauci, are warning about a “surge upon a surge” before the Christmas and New Year’s holidays, noting that travel restrictions and recommendations are likely to stay in place. A bipartisan group of senators is attempting to restart stalled coronavirus stimulus talks during the lame duck. Members of the White House Coronavirus Task Force covered the Sunday talk shows to promise a rapid rollout of coronavirus vaccines to millions of Americans by year-end. But distribution will have to overcome several hurdles in the health care system and mistrust in the virus, especially in the country’s underserved rural states. Moderna filed today for a Food and Drug Administration (FDA) emergency use authorization (EUA) of its experimental coronavirus vaccine. The biotech company said the vaccine was 94.1 percent effective against COVID-19 and 100 percent effective at preventing severe COVID-19 in an analysis of a stage three trial. Read about these and other updates here: 30 Nov. (Authored by Ivan Zapien)

• The first wave of COVID-19 lockdowns this year led to a significant increase in online scams. Whilst in “normal times” individuals might identify these scams as being “too good to be true”, isolation coupled with financial fears meant that people were more susceptible to fraudulent offerings. With a second wave of lockdowns sweeping across Europe this winter, we anticipate another uptick in these types of frauds. Here we explore the ways in which the joined-up IP and Financial Services Litigation and Investigations team at Hogan Lovells can assist businesses to protect themselves against fraudsters.

• The Hong Kong government is proposing much-anticipated legislation for the introduction of a corporate rescue procedure and insolvent trading regime. Hong Kong has, for years, struggled to introduce a statutory corporate rescue procedure (CRP), having previously made unsuccessful attempts in 2000-2001, 2008-2009, and 2014. Now – with COVID-19 severely impacting the economy – the government has finally tabled the Companies (Corporate Rescue) Bill.  Read more online here.

• The Spanish government last week approved a new reform of the legal regime that establishes a screening regime for certain foreign direct investments ("FDI") in Spain, through the enactment of Royal Decree-Law 34/2020, of 17 November, on urgent measures to support business solvency and the energy sector as well as on tax matters. The Fourth Final Provision of Royal Decree-Law 8/2020 of 17 March regarding extraordinary urgent measures to deal with the economic and social impact caused by the COVID-19 crisis amended the Spanish Act 19/2003 of 4 July on the legal regime of capital movements and economic transactions abroad (the "Act 19/2003").  Read more online here.

• On 17 November 2020, the European Commission (EC) published an inception impact assessment for a revision of the Tissue Directive and the Blood Directive. With this proposal, the European Commission aims to tackle existing shortcomings and gaps in the current legislation. Three policy options are proposed in the impact assessment. Following an evaluation of the existing BTC legislation, the EC identified certain gaps and shortcomings. According to the EC, these challenges have been emphasized due to the COVID-19 pandemic. The key differences among the three scenarios concern the body in charge of establishing the technical requirements, and the degree of enforcement at EU and national level. The European Commission’s potential legislative proposal is expected by the fourth quarter of 2021. Read more here. (Authored by Fabien Roy)

Compiled by Aaron Armstrong