Friday, 1 May 2020

• On 29 April 2020, Belgium's Federal Agency for Medicines and Health Products (AFMPS) issued a new version of the Agency's alternative test protocol (ATP) for surgical face masks. The alternative test protocol allows masks that have not undergone a conformity assessment procedure in accordance with applicable standards to be placed on the Belgian market. The purpose is to facilitate their supply during the COVID-19 pandemic. The new version of the protocol provides specific criteria according to which the masks may be classified as either surgical face masks or comfort masks based on their test results. It also explains the correlation between the two parameters that the protocol takes into account to determine the performance of the mask. Read more here. (Authored by EA Wright)

• Businesses across the United States have been battered by the COVID-19 crisis and many companies have been the recipients of unprecedented levels of economic assistance and tax relief under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). We expect to see equally unprecedented government oversight and investigations into waste, fraud, and abuse in connection with the use of these funds. The potential for both legal and reputation harm for program participants is significant. Indeed, many companies have already found themselves on the front-page of the newspaper or in the crosshairs of investigators. Read more here. (Authored by Michael Bell)

• With an interim relief measure in the United States, the Paycheck Protection Program (PPP) and Health Care Enhancement Act, now signed into law, the jockeying over a CARES 2.0 stimulus package has begun. What follows is a thumbnail sketch of the players, issues, and timing of a possible legislative vehicle emerging in the near term that could be signed into law at some point in the coming weeks. Read more here. (Authored by Ivan Zapien)

• Many U.S. employers are eager to reopen their worksites and to resume more normal in-person operations. But resumption of business while the country continues to face the risk of COVID-19 infections presents significant legal and practical challenges. The nature of these challenges will differ based on the employer's geography and industry. This article describes key labor and employment considerations for U.S. employers in planning and executing a reopening strategy. Read more here. (Authored by George Ingham)

• The Hogan Lovells IP & Media Technology team is tracking the changes being made by intellectual property offices around the world in response to the coronavirus so we can keep you informed on the key developments. This latest report adds IP updates for Singapore. Read more here. (Authored by Imogen Fowler)

• Use our Global Guide to view global governmental, regulatory, and other legal responses to the coronavirus pandemic, compiled and regularly updated by our global team of cross-disciplinary lawyers. Review national responses on issues including government support and government restrictions, trade restrictions, tax reliefs, employment, privacy and data protection, insolvency, impact on supply chain, M&A and corporate, and litigation as well as infrastructure and energy projects, financial institutions, insurance, real estate, antitrust, and intellectual property. This short video will help you to navigate the content.

Thursday, 30 April 2020

• On 28 April 2020, Belgium's Federal Agency for Medicines and Health Products (AFMPS) announced that the measures to avoid shortages of medicinal products provided in the Decision of 1 April 2020 have been extended by one month, until 1 June 2020. Read more here. (Authored by EA Wright)

• The Hogan Lovells IP & Media Technology team is closely following the impact of COVID-19 on the operation of Courts around the world and what this means in practice for clients engaged in or contemplating litigation, with respect to upcoming hearings, deadlines, and limitation periods. We will keep you up to date on court guidance as it develops and share our expectations and experiences as we go through this challenging time. Our latest update for the Netherlands is online here. (Authored by Katie McConnell)

• The Hogan Lovells IP & Media Technology team is tracking the changes being made by intellectual property offices around the world in response to the coronavirus so we can keep you informed on the key developments. This latest report adds IP updates for the European Union. Read more here. (Authored by Imogen Fowler)

• Our Public Company Advisory practice has developed this quick-reference guide for U.S. public companies navigating the rapidly evolving regulatory landscape which continues to impact SEC filing and disclosure obligations, shareholder meetings, listing standards, capital raising, and other regulatory and governance matters. This guide briefly summarizes recent regulatory developments from the SEC, NYSE, and Nasdaq in response to the COVID-19 pandemic and certain other COVID-19-related developments. (Authored by John B. Beckman)

Wednesday, 29 April 2020

• On 24 April 2020, Europe's Medical Device Coordination Group (MDCG) published a new guidance (MDCG 2020-9) regarding regulatory requirements for ventilators and related accessories regulated under Directive 93/42/EEC (MDD). Such equipment is used to treat COVID-19 patients with acute and severe respiratory symptoms. The guidance document focuses on ventilators and related accessories that are currently regulated by the Medical Devices Directive (MDD) 93/42/EEC and intends to outline the different regulatory options for placing these devices on the EU market during the COVID-19 pandemic. Read more here. (Authored by Fabien Roy)

Tuesday, 28 April 2020

• It appears that Spain has taken definitive steps to face the current situation of shortage of Personal Protective Equipment (PPE), not only for face masks, but also for a wider range of products, making it necessary to expand the list of standards considered as equivalent for the acceptance of PPE. In this sense, the Spanish Ministry of Industry, Trade and Tourism, in development of the Commission Recommendation (EU) 2020/403 of 13 March 2020 on conformity assessment and market surveillance procedures within the context of COVID-19 (Commission Recommendation (EU) 2020/403), has set the following scenarios where both CE marked and non-CE marked PPE based on equivalent standards may be acceptable in Spain. Read more here. (Authored by Santiago Garrido de las Heras)

• The European Union has extended the export restrictions on certain items of PPE for a further period of 30 days. On 24 April, the European Commission (Commission) extended the export controls on PPE until 26 May 2020, through Commission Implementing Regulation (EU) 2020/568 (you may find the regulation here). According to the existing measures, which were initially adopted on 15 March (see our client alert here), an export authorization is required for the export of certain categories of PPE from the EU, whether EU-originating or not. Face shields and gloves are no longer subject to the restrictions, which have been limited to the categories of PPE items outlined in our latest update, which is available online here. (Authored by Lourdes Catrain)

• In order to mitigate the economic impacts of the COVID-19 pandemic on companies and the market, plethora of financial measures was introduced at the EU level, German federal level, and German states levels. Through this overview, we would like to give you a first insight into the scope of the different financial support products. Our detailed analysis is now online here. (Authored by Dr. Katlen Blöcker)

• The Hogan Lovells IP & Media Technology team is closely following the impact of COVID-19 on the operation of Courts around the world and what this means in practice for clients engaged in or contemplating litigation, with respect to upcoming hearings, deadlines, and limitation periods. We will keep you up to date on court guidance as it develops and share our expectations and experiences as we go through this challenging time. Our latest update for Japan is online here. (Authored by Katie McConnell)

Monday, 27 April 2020

• On 23 April 2020 the U.S. Food and Drug Administration (FDA) issued an immediately in effect Enforcement Policy Guidance to expand the availability and capacity of non-invasive fetal and maternal monitoring devices that measure or detect fetal heart rate, maternal heart rate, and/or uterine activity, which are used to support patient monitoring in a home setting, and which may be used to support patient monitoring during the COVID-19 public health emergency. FDA states that it does not intend to enforce the requirement for 510(k) clearance for limited modifications made to the indications, functionality, hardware and /or software of certain FDA-cleared non-invasive fetal and maternal monitoring devices which are specifically listed in the guidance. FDA provides specific examples of what the agency believes would or would not create an undue risk to health, and thus would or would not be considered to fall within the scope of FDA’s enforcement discretion policy. FDA indicates that manufacturers are still required to comply with certain Quality Systems Regulations under 21 CFR Part 820, such as performing verification and validation activities and documenting design changes to the device master record. (Authored by Seth Olson)

• In March, FDA issued guidance documents, first revised on 27 March, temporarily relaxing certain regulatory requirements for the production of alcohol-based hand sanitizers, to respond to the increased demand for hand sanitizer products during the novel coronavirus crisis. Recently, FDA issued additional minor updates to these documents. Notably, FDA provides that fuel or technical grade ethanol should only be used if it meets food (or pharmaceutical) grade standards and has been screened for certain impurities. The agency invites companies wishing to use or supply fuel or technical grade ethanol that does not meet food-grade requirements to submit specified data to FDA for its review. FDA also addresses several other topics, including the use of other technical grade ingredients, and the form of and packaging for the hand sanitizer. FDA maintains that ethanol used in hand sanitizers under the policy must be denatured using specified denaturants listed in the guidance, but continues to provide that companies may submit information on additional denaturants to the agency for consideration. FDA appears, however, to have ruled out acetone as a potential denaturant. Read more here. (Authored by Martin Hahn)

• The Hogan Lovells IP & Media Technology team is tracking the changes being made by intellectual property offices around the world in response to the coronavirus so we can keep you informed on the key developments. This latest report adds IP updates for Japan. Read more here. (Authored by Imogen Fowler)

• Andrew Skipper is the Head of Hogan Lovells Africa Practice. Since taking on this role six years ago, he has met and formed close relationships with some of Africa's most influential leaders, both on and off the continent. Join Andrew in open conversation with his guests, asking questions and gaining insights as only he can. The first in this our series of interviews is with Emma Wade-Smith OBE, Her Majesty’s Trade Commissioner for Africa, who shares her thoughts on coronavirus, gender lens, and why the UK is 100% committed to Africa. Listen online here.

Daily reports for the week of 20 - 24 April are online here.

Daily reports for the week of 13 - 17 April are online here.

Daily reports for the week of 6 - 10 April are online here.

Daily reports for the week of 30 March - 3 April are online here.

Daily reports for the week of 23 - 27 March are online here.