[co-author: Judy Rein]
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.
In Thursday’s report: EU suspends medical equipment tariffs, European guidance on IVDs and implantable devices, Belgian mask policy, European Insurance and Occupational Pensions Authority guidance, European Banking Authority guidelines on loan repayments, and a global guide to Intellectual Property regulatory changes.
Thursday, 9 April 2020
Following requests from numerous Member States, on 3 April the European Commission adopted Commission Decision (EU) 2020/491, which provides for relief from import duties and VAT for goods imported in the EU to combat the COVID-19 outbreak. Although the Decision does not include a specific list of covered products, it would likely cover items such as personal protective equipment (e.g., protective spectacles and visors, face shields, mouth-nose-protection equipment, protective garments and gloves), and other items to treat the pandemic, including testing kits, ventilators and other medical equipment. Read more here. (Authored by Lourdes Catrain)
On 3 April 2020, the European Commission issued a guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices ("IVD") in the COVID-19 context. The Guidance summarizes the legal requirements for placing these devices on the EU market and provides information, among others, on relevant EU harmonized standards, derogation procedures available at EU Member States' level, off-label use, registration of devices with competent authorities and the recent European Commission's proposal to postpone the application date of the Medical Devices Regulation ("MDR") by one year. Read more here. (Authored by EA Wright)
Given the challenges in maintaining the supplies of healthcare materials such as surgical masks and FFP2 and FFP3 face masks, the Belgian Task Force on shortages, a working group set up by the Belgian Federal Agency for Medicines and Health Products (AFMPS/FAGG) to remedy the shortage of protective and medical equipment in the context of the COVID-19 pandemic, has prepared a guidance on the reprocessing of these single-use products in collaboration with other stakeholders. The purpose of the guidance is to provide a reprocessing policy for single-used face masks in order to expand the availability of these products in Belgium. Read more here. (Authored by Hélène Boland)
The European Insurance and Occupational Pensions Authority (EIOPA) published recommendations on 20 March 2020, addressed to the EU insurance sector on supervisory flexibility regarding the deadline of supervisory and public disclosure by insurers, in light of the COVID-19 pandemic. In consideration of these recommendations, on 23 March 2020, the PRA published a statement on COVID-19 regulatory reporting amendments for UK insurers. It published a list of accepted delays relating to harmonised reporting under the Solvency II Directive (2009/138/EC) and PRA-owned reporting. The FCA has also issued a statement, on 21 March 2020, requesting all listed companies observe a moratorium on the publication of preliminary financial statements for at least two weeks. This was followed by a joint statement, on 26 March 2020, by the FCA, FRC and PRA confirming the moratorium can end on 5 April 2020 and an announcement allowing listed companies an extra 2 months to publish their audited annual financial reports. Read more here. (Authored by Steven McEwan)
On 3 April 2020, the European Banking Authority (EBA) published a final report containing guidelines on legislative and non-legislative moratoria on loan repayments as a result of the COVID-19 pandemic (EBA/GL/2020/02). These guidelines seek to clarify the six criteria to be met for any payment moratorium (whether legislative or non-legislative) (i) not to be classified as a forbearance and (ii) not to trigger the prudential framework applicable to credit impaired assets on bank balance sheets. Read more here. (Authored by Dr. Katlen Blöcker)
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 summarizes IP changes in China, the Community Plant Variety Office, EUIPO, EPO, France, Germany, Italy, Japan, Mexico, Singapore, Spain, the UK, U.S., and WIPO. Read more here. (Authored by Imogen Fowler)
Wednesday, 8 April 2020
- On 6 April 2020 the U.S. Food and Drug Administration (FDA) issued an immediately in effect guidance to help expand the availability of certain devices used in extracorporeal membrane oxygenation (ECMO) therapy. The guidance states that, to facilitate expanded availability of devices to perform ECMO therapy to treat COVID-19 patients, FDA does not intend to object to limited modifications to the indications and design of FDA-cleared or FDA-approved ECMO and cardiopulmonary bypass devices listed in the guidance document, during the declared public health emergency, without prior submission of a premarket notification or premarket approval application supplement where the modification does not create an undue risk (as discussed therein). The guidance recommends labeling and recognized standards for the design, evaluation, and validation of such modifications. In addition, FDA is interested in interacting with manufacturers of ECMO devices, or manufacturers of cardiopulmonary bypass devices seeking indications greater than 6 hour use to be used for ECMO, that are not currently legally marketed in the U.S. FDA intends to work interactively with these manufacturers through its emergency use authorization (EUA) process. (Authored by Ted Wilson)
- To help combat the threat posed by the COVID-19 outbreak, the European Commission last week announced the publication of new guidance aimed at assisting manufacturers to increase production of essential medical equipment. The new guidance focuses on three key product areas – 3D printing for products in a medical context, personal protective equipment (such as masks and gloves) (PPE) and hydro-alcoholic cleansers and disinfectants for the hands. This forms part of an EU-wide push to enable European industry to step up manufacturing and availability of PPE and medical equipment in the face of supply chain disruption and enhanced demand. Read more about the new guidance here. (Authored by Valerie Kenyon and Zen Cho)
- The Spanish Ministry of Health has implemented new measures to facilitate the manufacture and marketing of face masks and white coats classified as medical devices for the duration of the public health emergency. As is widely known, there are currently a large number of patients in Spain who are hospitalized, many of them in Intensive Care Units. It is therefore essential to have the maximum number of medical devices available in order to take care of those affected by the pandemic and help them recover. Learn more about Order SND/326/2020, of 6 April in this article. (Authored by Santiago Garrido and Álvaro Abad)
Tuesday, 7 April 2020
- As part of the CARES Act, U.S. President Trump signed into law a long-awaited overhaul of the regulatory system for Over-the-Counter (OTC) drugs. This “OTC drug monograph reform” has been a priority of the Food and Drug Administration (FDA) for several years, as the agency has struggled to effectively implement an antiquated system for regulating over 800 active ingredients in more than 300,000 OTC drug products marketed in the U.S. Connecting the OTC reform provisions with the emergency relief nature of the bill, FDA Commissioner Stephen M. Hahn, M.D. stated, “The FDA is committed to using these new tools to promote innovation and improve the safety and effectiveness of OTC monograph drugs – including products like hand sanitizers and acetaminophen, which are so critical to the public health emergency we face right now.” OTC drug companies will want to review this OTC monograph reform legislation closely, and begin preparing immediately for the innovation opportunities, as well as the regulatory and competitive risks, created by the new law, which we have analyzed here. (Authored by David Horowitz and Heidi Gertner)
Monday, 6 April 2020
- The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the first diagnostic test that can detect antibodies to the SARS-CoV-2 virus that causes COVID-19 disease. On 1 April 2020 the agency granted an EUA to Cellex Inc.’s serology test, which can detect the presence of coronavirus antibodies, and provides results in 15 minutes. This testing capacity may prove vital to tracking the spread and extent of the viral infection in the population. Although the EUA scope indicates that the test cannot be used as the sole basis for diagnosis, the diagnostic may be helpful in identifying who has already been infected even if they did not show symptoms, as immunoglobulin M (IgM) and immunoglobulin G (IgG) generated by the virus can be detected in the blood post-infection. The EUA limits use of the test to laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform moderate and high complexity tests. (Authored by Randy Prebula)
- On 5 April 2020, the U.S. Food and Drug Administration (FDA) issued a guidance outlining relaxed enforcement to help expand the availability and remote capabilities of infusion pumps and their accessories during the COVID-19 public health emergency for patients requiring continuous infusion therapy. FDA does not intend to object to limited modifications to the indications, functionality, hardware, software, design, or materials of FDA-cleared devices used to support patients who require continuous infusion therapy, without prior submission of a premarket notification (510(k)). The agency also does not intend to object to the distribution and use of infusion pump accessories beyond their indicated shelf life and/or duration of use. The guidance lists the relevant devices, outlines modifications that would not pose undue risk under this policy, sets forth standards for designing, evaluating, and validating acceptable modifications, and makes recommendations for performance testing and labeling. The guidance also opens up a new Emergency Use Authorization (EUA) pathway for infusion pumps allowing manufacturers of devices which have not previously been cleared by FDA to enter the US market, indicating that FDA is interested in working with manufacturers, including those who have not previously been engaged in medical device manufacturing, to increase the availability of infusion devices. The agency has a dedicated email, CDRH-COVID19-InfusionPumps@fda.hhs.gov, to communicate with manufacturers seeking EUAs for these devices. (Authored by Lina Kontos)
- To facilitate an adequate supply of clinical electronic thermometers in the context of the public health emergency, on 4 April 2020 the U.S. Food and Drug Administration (FDA) issued an immediately in effect guidance relaxing enforcement of these Class II medical devices, including both contact and non-contact electronic thermometers. FDA does not intend to object to the distribution and use of clinical electronic thermometers that are not currently 510(k) cleared and without compliance with a number of specific regulatory requirements where such devices do not create an undue risk. The guidance sets forth minimum performance and labeling standards relevant to the enforcement policy. This policy is only in effect for the duration of the public health emergency and does not apply to previously cleared clinical thermometers. (Authored by Ted Wilson and Lina Kontos)
- In light of the medical device industry’s critical role in the response to the COVID-19 epidemic, the U.S. Food and Drug Administration (FDA) released two communications on 4 April 2020. An updated letter to industry informs medical device companies that the Center for Devices and Radiological Health (CDRH) is extending provisions previously set forth on 23 March. The conversion of in-person meetings to teleconferences is extended through 31 May 2020. Additionally, for marketing applications on hold as of 16 March 2020, where the response due date is on or before 30 June 2020, CDRH has further extended response due dates by 90 days for Premarket Notifications (510(k)s), Premarket Approval (PMA) applications (original and supplements), Humanitarian Device Exemption (HDE) applications (original and supplements) and De Novo classification requests. The extension is automatic; no extension requests need to be submitted. The agency also released recommendations for medical device manufacturers to reduce the risk of exposure to SARS-CoV-2, the virus that causes COVID-19, among manufacturing personnel, including measures such as worker hygiene, cleaning and disinfecting, production line modification to minimize face-to-face contact, and cleanroom process controls. (Authored by Ted Wilson)
- COVID-19 litigation tracker - keep up to date with Courts around the world: Hogan Lovells is closely following the impact of COVID-19 on the operation of Courts around the world and what this means in practice for life sciences and health care companies engaged in or contemplating litigation, with respect to upcoming hearings, deadlines, and limitation periods. The litigation tracker updates are provided by the Hogan Lovells IP & Media Technology team, which remains fully operational and working remotely to support clients and continue to provide our high-quality services. 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. To follow our litigation tracker, click here. (Authored by Katie McConnell and Imogen Ireland)
- COVID-19 and emergency inventions: As the spread of COVID-19 accelerates across the globe, everyone wants to find a way to tackle the pandemic, from Governments asking manufacturers to urgently make vital equipment to inventors creating innovative solutions. In Italy, for example, inventors have created a 3D printable valve that can turn a snorkelling mask into a portable ventilator and in Israel the Government has approved the import of generic versions of a patented HIV antiviral drug for use in treating COVID-19. Patent systems around the world include a number of unique and rarely used provisions designed to ensure sufficient access to certain inventions in times of crisis, often subject to appropriately balancing the impact on rights holders. In this article we look at the laws that inventors, rights holders, and those wanting to use a patented invention should be aware of in the rush to meet the medical and technological challenges raised by COVID-19. (Authored by Katie McConnell)
- On 19 March 2020, the Ministry of Health, Labour and Welfare of Japan (MHLW) issued a notice announcing a waiver of the statutorily-required waiting period after submitting a request for clinical trial to the MHLW in respect of treatments related to COVID-19. Typically, any person or legal entity that submits a request for clinical trial to the MHLW must wait 30 days from the date of request before starting a clinical trial, in order for the MHLW to investigate health and sanitary issues that may occur in connection with the proposed trial (Article 80-2, Paragraph 3 of the Pharmaceuticals and Medical Devices Act). However, the new circular notice enables pharmaceutical companies, medical device companies, or doctors to start clinical trials for drugs or medical devices that are considered necessary to prevent and/or treat COVID-19 without the 30 day waiting period. This is intended to facilitate clinical trials for COVID-19 related drugs and medical devices in Japan. It is reported that some clinical trials of medicines intended potentially to treat COVID-19 have already started, or will start soon, and it is possible that they may benefit from this new policy. Read more here. (Authored by Dr. Frederick Ch'en)
- As the COVID-19 outbreak has evolved into a worldwide economic shutdown, businesses are reevaluating their operating plans in order to remain viable. This is particularly true for joint venture (JV) businesses, which are owned and jointly controlled by two or more partners or equity holders. Read more here. (Authored by Mark Kurtenbach)
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.