The Daily Report is a compilation of COVID-19 (coronavirus) news briefs from around the world to help life sciences and health care companies stay current in this challenging time.

Friday, 17 April 2020

  • The U.S. FDA’s Emergency Use Authorizations continue in multiple areas, including molecular and serology testing, respirators and respirator/PPE reprocessing systems, ventilatory support devices, and extracorporeal blood purification systems. Recently issued EUAs include: (1) the TransAeris Diaphragmatic Pacing Stimulator System and the Lungpacer Diaphragm Pacing Therapy System to assist in weaning patients at high risk of weaning failure off of breathing assistance machines requiring patient intubation; (2) two new serology test EUAs to detect for the presence of coronavirus antibodies (for Ortho-Clinical Diagnostics, Inc. for its VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and Chembio Diagnostic Systems, Inc. for its DPP COVID-19 IgM/IgG System); (3) multiple molecular tests for viral detection; and, (4) three rapidly deployable ventilators which automate compression of resuscitator bags to provide mechanical ventilation. (Authored by Gerard J. Prud'homme and Lina Kontos)

  • On 14 April 2020, the U.S. Department of Health and Human Services (HHS) General Counsel issued an advisory opinion on the 10 March 2020 Public Readiness and Emergency Preparedness Act (PREP Act) Declaration related to COVID-19, in response to numerous requests for guidance from manufacturers, distributors, and health care providers. Although the Opinion is not binding law and does not answer every question about the Declaration, it does provide insight into the intended scope of the Declaration. There are three key elements necessary to obtain PREP Act immunity, all of which are addressed in the Opinion and are discussed here. (Authored by Allison Pugsley)

  • On Friday, 27 March, President Trump signed into law H.R. 748, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) to address the catastrophic impact of COVID-19 on the U.S. economy. Division B provides over US$339 billion in an emergency supplemental appropriations package, more than 80% of which is for state and local governments and communities. SBA and Treasury jointly issued additional interim regulations (the Second SBA Regulations) on 14 April 2020. SBA/Treasury FAQs clarify that, notwithstanding recent guidance, borrowers and lenders previously acting on the basis of the Initial SBA Regulations as of April 2 are permitted to rely on the laws, rules, and guidance available at the time of the relevant application. Borrowers whose previously submitted loan applications have not yet been processed may, however, revise their applications based on clarifications reflected in the SBA/Treasury FAQs. Read more here. (Authored by David Winter)

  • In response to the economic effects of the COVID-19 pandemic and market uncertainty, 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. Our note summarizes our understanding of the key EU, German federal and German states’ financial and state aid measures. Developments in this area are fast-changing. In many cases the legislation, guidance or other materials relating to these measures is limited in detail. This means that in some instances questions remain about the scope of some of these measures. Read more here. (Authored by Dr. Katlen Blocker)

  • 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 Patent Office (EPO) and the U.K. Read more here. (Authored by Imogen Fowler)

 

Thursday, 16 April 2020

  • On 14 April 2020, the Belgian Federal Agency for Medicines and Health Products (AFMPS), published a news flash warning physicians of the risk of hemolysis associated with the use of hydroxychloroquine in patients with glucose-6-phosphate dehydrogenase (G6PD). The warning was published after the AFMPS received a report of an adverse reaction to a Belgian patient in the context of COVID-19 treatment. The AFMPS news flash provides recommendations to prevent the occurrence of similar adverse events in the future during treatment of COVID-19. Read more here.  The AFMPS has also announced that it has abolished measures introducing quotas for the supply of paracetamol-based medicinal products. The measures had previously been imposed on pharmaceutical companies and wholesaler-distributors to prevent shortages of these medicinal products during the COVID-19 pandemic. Read more here. (Authored by EA Wright)

  • The Italian Government adopted Law Decree No. 18 of 17 March 2020 (the so called "Cura Italia Decree") which provides a number of measures to strengthen the Italian health care system and provide economic support for families, workers and businesses as a consequence of the epidemiological emergency, and Law Decree No. 23 of 8 April 2020 (the so-called "Liquidity Decree"), which provides measures concerning access to credit and tax compliance for businesses, special powers in strategic sectors, as well as the extension of administrative and procedural terms; some of these measures have an impact on the health insurance sector both directly and indirectly. Read more here. (Authored by Silvia Lolli)

 

Wednesday, 15 April 2020

  • EU competition law update: European Commission is available to provide "comfort letters" for specific cooperation efforts. The Commission has published a Communication which covers cooperation regarding the supply of essential products such as medicines and medical products. The Communication explains the criteria that the Commission will follow when assessing the legality of cooperation efforts between companies, and the temporary process that has been set up to provide guidance to companies, including through "comfort letters." Read more here. (Authored by Sabrina Borocci)

 

Tuesday, 14 April 2020

  • On 8 April 2020, the Office of Assistant Secretary for Health (OASH), in the U.S. Department of Health and Human Services (HHS) issued Guidance for Licensed Pharmacists, COVID-19 Test, and Immunity Under the PREP Act (Guidance). The Guidance clarifies that immunity from liability under the PREP Act extends to licensed pharmacists who order and administer COVID-19 tests, including serology tests, authorized by FDA. Apart from providing specifics regarding the scope of PREP Act coverage with respect to pharmacy activity, more generally, the Guidance offers insight into how HHS interprets PREP Act coverage under the HHS Declaration for Medical Countermeasures Against COVID-19, of March 17, 2020 (COVID-19 Declaration). Further, the Guidance demonstrates how obtaining an official statement, such as a guidance document, from a government agency responsible for public health and/or incident response, can help bolster PREP Act liability protection. Read more here. (Authored by David Horowitz)

  • Also on 8 April, the U.S. Department of Health and Human Services’ (HHS) Office for Human Research Protections (OHRP) issued guidance discussing how HHS human subjects protection regulations (45 CFR part 46) apply to actions taken by institutions and investigators in response to the COVID-19 pandemic. OHRP emphasizes that it will consider the specific circumstances that institutions/investigators are experiencing during the pandemic and will take into account when actions are necessary to protect public health, while still appropriately protecting research subjects. OHRP also emphasizes that it will exercise flexibility in its decision making. The new guidance contains critical updates related to the privacy of COVID-19 test results, IRB approval for study changes, and reporting standards for the suspension or termination of research. Read more here. (Authored by Robert Church)

  • As the world responds to COVID-19, physicians and patients increasingly turn to telemedicine solutions as a central facet of health care. And as global regulation strains to keep pace with growing telemedicine demands, clinicians who seek to practice remotely across borders encounter a blurry legal patchwork from country to country. We offer some guideposts related to: the regulation of telemedicine and remote second opinions (RSOs); defining the "practice of medicine" and "telemedicine"; RSOs and doctor-to-doctor consultations internationally; physician licensure and registration requirements for international telemedicine; organizational licensure and marketing international telemedicine; and patient consent & data privacy. Read online here. (Authored by William Ferreira)

  • On 11 April 2020, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) to Advanced Sterilization Products (ASP) for the STERRAD Sterilization Cycles that has the potential to decontaminate approximately 4 million N95 or N95-equivalent respirators per day in the U.S. for single-user reuse by health care workers in hospital settings. FDA said this authorization will help increase the availability of respirators so health care workers on the front lines can be better protected and provide the best care to patients with COVID-19. Read more here. (Authored by Ted Wilson)

Monday, 13 April 2020

  • As a result of the COVID-19 outbreak and the associated quarantine and travel restrictions, the ability of notified bodies to conduct mandatory on-site audits under medical devices legislation has been significantly affected. The European Commission's Medical Device Coordination Group (MDCG) has, therefore, prepared a guidance which outlines the temporary extraordinary measures to be followed by notified bodies during the pandemic to permit the continued certification of medical devices and assist in the prevention of potential medical device shortages. The guidance is immediately applicable. Read more here. (Authored by Fabien Roy)

  • FDA expanded the category of emergency use authorizations (EUAs) over the weekend to permit authorization of two Extracorporeal Blood Purification Devices which may be effective in treating certain patients with confirmed COVID-19 by removing various pro-inflammatory cytokines from their blood to ameliorate cytokine storm. The devices from CytoSorbents and a joint application from Terumo BCT and Maker Therapeutics were authorized for use in treatment of persons aged 18 years of age and older with confirmed Coronavirus Disease 2019 (COVID-19) admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure to reduce pro-inflammatory cytokines levels. (Authored by Lina Kontos)
  • Also on 9 April, the FDA also granted an EUA to STERIS Corporation for the STERIS V-PRO 1 Plus, maX and maX2 Low Temperature Sterilization Systems using the STERIS N95 Decontamination Cycle (non-lumen cycle), which uses vaporized hydrogen peroxide to decontaminate compatible N95 or N95-equivalent respirators. This EUA is estimated to support decontamination of approximately 750,000 N95 respirators per day in the U.S. (Authored by Ted Wilson)

  • The Hogan Lovells litigation 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. Our latest global litigation update, online here, provides critical notices regarding upcoming hearings, deadlines, and limitation periods for the Court of Justice of the European Union (CJEU), as well as courts in China, France, Germany, Italy, Japan, Mexico, the Netherlands, Spain, the UK, and the U.S. (Authored by Katie McConnell)

 

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.