Thursday, 25 February 2021

• Companies in the life sciences and health care industry navigated unparalleled challenges in 2020. The COVID-19 pandemic forced the development and adoption of new technologies and innovations resulting in massive investments into virtual health solutions, telehealth products, and related cybersecurity measures. It also spurred new debate over drug and medical device regulatory standards, as many regulators permitted emergency use authorizations and granted temporary waivers for compliance obligations. In the transactional space, companies found new ways to collaborate virtually, as the need for cooperation grew. In the 2021 edition of our Life Sciences and Health Care Horizons publication, our global team identifies a number of evolving trends that are shaping the future of the industry. With perspectives from around the world in Asia-Pacific, Europe, Latin America and the U.S., we help you tackle specific legal challenges and report on the extraordinary progress and opportunities for the future of human health.

• The U.S. Food and Drug Administration (FDA) has issued new guidance for COVID-19 test developers to evaluate the impact of emerging and future viral mutations on COVID-19 tests. The SARS-CoV-2 virus has mutated over time, creating multiple variants of the virus with different genetic sequences. Mutations can potentially change a test’s performance and cause false negative results. The guidance is informative for all test developers, but the scope of the guidance document likely does not cover LDTs unless the developer is seeking or maintaining an EUA for their LDT. The guidance makes recommendations for development of COVID-19 molecular, antigen, and serology tests. FDA’s recommendations for molecular test developers fall into three areas: test design, monitoring, and labeling. We analyzed the guidance online here. (Authored by Blake Wilson)

• 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. Johnson & Johnson's coronavirus vaccine candidate is safe and effective at preventing moderate-to-severe cases of COVID-19, according to an analysis of trial data the FDA published Wednesday. The Biden Administration plans to send states, pharmacies, and community health centers 3 million to 4 million doses of Johnson & Johnson's coronavirus vaccine should the FDA authorize it for use. On Wednesday, President Biden signed an executive order to review global supply chains to avoid the shortages of critical goods during the pandemic. The order will require 100-day reviews of the global producers and shippers for several industries including pharmaceuticals and their active ingredients. A new COVID-19 variant is spreading through New York City and researchers say it has a mutation that may weaken the effectiveness of vaccines. The Senate Health and Finance committees held California Attorney General Xavier Becerra's confirmation hearing as Biden's Health and Human Services Secretary nominee. Read about these developments online here: 23 Feb. and 24 Feb. (Authored by Ivan Zapien)

Tuesday, 23 February 2021

• 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 U.S. surpassed 500,000 deaths from COVID-19 on Monday, in a pandemic that has lasted almost a year. The House Budget Committee met this afternoon to start marking up the $1.9 trillion American Rescue Plan Act of 2021. The committee aims for the House to have a floor vote to pass the legislation by Friday or Saturday. President Biden on Monday announced policy changes to the Paycheck Protection Program (PPP), a business loan program established under the Trump administration when Congress passed the CARES Act last year. The Food and Drug Administration (FDA) released new guidance Monday for modifying COVID-19 vaccines and tests to target virus variants first discovered in Britain, South Africa and Brazil. President Biden announced Friday that he has selected Chiquita Brooks-LaSure, a longtime health policy staffer, as Administrator of the Centers for Medicare and Medicaid Services (CMS). Read about these developments here: 18 Feb, 19 Feb, and 22 Feb. (Authored by Ivan Zapien)

• The UK Women and Equalities Select Committee launched an inquiry into the impact of COVID-19 on people with protected characteristics in March 2020. On 9 February this year, the Committee published a report on the economic impact of the pandemic on women in particular. Much of the report focuses on the effect of government policies such as the Coronavirus Job Retention Scheme and the need for investment in childcare and changes to social security policy. However, the report also calls for government action that will affect employers. Read more online here. (Authored by Stefan Martin)

• The new classification rules for software-based medical devices (SaMDs) in Australia and personalized medical devices introduced by the Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019 commences this week, on 25 February 2021. Due to the COVID-19 pandemic, the implementation of a number of medical device reforms have been delayed to commence on 25 November 2021. This includes the re-classification rules of a number of medical devices such as active medical devices for therapy with diagnostic functions, active implantable medical devices, medical devices used in direct contact with the heart, central circulatory or central nervous systems and medical devices that administer medicines or biologicals by inhalation or consist of substances introduced into the body via a body orifice or applied to the skin. Read more online here. (Authored by Mandi Jacobson)

Thursday, 18 February 2021

• 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 Health and Human Services Department (HHS) signed a $54.2 contract for special syringes made by Retractable Technologies that are designed to extract six doses of Pfizer's COVID-19 vaccine doses from the initially labeled five-dose vials. The National Governors Association’s Executive Committee on Monday publicly called for better federal-state coordination on coronavirus vaccine distribution. The Centers for Disease Control and Prevention (CDC) is working with labs to expand efforts to sequence the genomes of coronavirus samples across the country as the U.S. continues to get ahead of and track new COVID-19 variants. Read about these developments here: 16 Feb.; and 17 Feb. (Authored by Ivan Zapien)

• The tension over COVID-19 vaccine supplies has thrust the thorny issue of interpreting “endeavors” clauses back onto center stage. But what are they, why are they used and what are the differences between “reasonable endeavors," “best endeavors,” and “all reasonable endeavors”? Online here, we shed much-needed light on these routinely used phrases and explain when to use them and how to minimize the risk of contracts failing to adequately protect you. (Authored by Sanjay Dave)

• In the latest episode of our "Talking the Cure" podcast, we talk with Fabien Roy and Jonas Albert about the current "surge" of digital health innovations in Europe, receiving the CE-Mark, getting reimbursed for their products, and what that means for start-ups as well as established companies. 

Tuesday, 16 February 2021

• House committees drafted and passed their portions of the $1.9 trillion COVID-19 relief package that Democrats are preparing to pass through budget reconciliation. The reconciliation process will allow Democrats to pass the relief package with just a simple majority vote in the Senate, instead of the 60 votes required for most legislation. Democrats are aiming to give President Biden a relief bill by mid-March to prevent 1.4 million American workers from losing their unemployment benefits. Read more online here. (Authored by Anna Weinstein)

• On 2 February, Hogan Lovells partners Melissa Bianchi, David Horowitz, and George Ingham presented a webinar to the Biotechnical Innovation Organization (BIO) on “What Biotech Employers Need to Know about COVID Vaccines and Returning to the Office.” Online here are the top 10 considerations discussed in the webinar, and a full video recording containing additional details is available here.

• 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. Vice President Harris, speaking to Axios, charged that the Trump administration left the incoming Biden Administration with "no stockpile" of coronavirus vaccines. A new study by U.S scientists has discovered seven coronavirus variants with nearly identical mutations that have originated in the United States. On Monday, World Health Organization (WHO) Director-General Tedros Adhanom Ghebreyesus announced that the health organization has granted the Oxford/AstraZeneca coronavirus vaccine an emergency use listing, paving the way for its more widespread global rollout. The Centers for Disease Control and Prevention (CDC) released new guidance on Friday saying that teachers and school staff could return to campuses even if they haven't been vaccinated, but does not mandate that schools reopen. Read about these developments online here: 13 Feb.; 14 Feb.; and 15 Feb. (Authored by Ivan Zapien)

• The IoT sector has exploded over the past few years, and, even taking into account the globally inhibitive effects of COVID-19, this growth shows few long-term signs of abating. The buoyant, fast-paced IoT industry was the subject of a webinar, involving a panel of four partners from Hogan Lovells: Valerie Kenyon, Christelle Coslin, Matthias Schweiger, and Salomé Cisnal de Ugarte. Each gave their take on the state of play of IoT across the EU and explored the liability issues that potentially are coming down the line for IoT products. In this article, we follow up on that webinar by setting out some of the key discussion points from the session. You can find a link to the recording of the webinar here.

Thursday, 11 February 2021

• 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, the House Ways and Means Committee advanced the portion of House Democrats’ coronavirus relief package that would expand federal unemployment benefits. A new Centers for Disease Control and Prevention (CDC) study finds wearing a cloth mask over a medical procedure mask or wearing a mask fitted properly can cut COVID-19 transmission by up to 96.5 percent. The Food and Drug Administration (FDA) has authorized the emergency use of a second Covid-19 antibody treatment from Eli Lilly. President Biden said Tuesday he agrees with a proposal from House Democrats to begin phasing out the next round of direct coronavirus relief payments to Americans who make more than $75,000. Community health centers will receive coronavirus vaccines directly from the federal government next week, the White House announced Tuesday. Read about these developments here: 9 Feb. and 10 Feb. (Authored by Ivan Zapien)

Tuesday, 9 February 2021

• The U.S. Department of Health and Human Services (HHS) issued its fifth amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) related to COVID-19, adding categories of qualified persons authorized to prescribe, dispense, and administer COVID-19 vaccines that are FDA-authorized, approved, or licensed in an effort to help states and U.S. territories "meet the demand for vaccines and protect their communities as quickly as possible." In turn, where the applicable requirements have been met (and subject to certain limitations), these additional “qualified persons,” as covered persons under the PREP Act,  will be afforded liability protections in accordance with the PREP Act and the terms of the amended Declaration. Most notably, the Fifth Amendment: Authorizes any health care provider who holds an active licensed or certification in a state to prescribe, dispense, and/or administer COVID-19 vaccines in any other state or U.S. territory; Authorizes any physician, registered nurse, or practical nurse whose license or certification expired within the past five years to prescribe, dispense and/or administer COVID-19 vaccines in any state or U.S. territory so long as the license or certification was active and in good standing prior to the date it went inactive; Requires any health care professional described above to complete Centers for Disease Control and Prevention (CDC) COVID-19 Vaccine Training and, for health care providers who are not currently practicing or whose license or certification is expired, requires an on-site observation period by a currently-practicing health care professional; and Preempts any State law that would otherwise prohibit a member of any of the classes of “qualified persons” specified in the Declaration from administering a covered countermeasure. (Authored by Lauren Colton and David Horowitz)

• On 4 February 2021, the U.S. Federal Trade Commission (FTC) announced that the antitrust agencies will temporarily suspend grants of early terminations of the waiting periods for pre-merger filings made pursuant to the Hart-Scott-Rodino Antitrust Improvements Act of 1976 Act (HSR Act). The FTC and the Antitrust Division of the Department of Justice (DOJ) will use this time to review “the processes and procedures used to grant” early terminations to HSR filings. The FTC cites the pandemic, leadership transition, and “unprecedented volume” of filings as necessitating suspension of grants of early termination. The current suspension comes nearly a year after the FTC temporarily suspended grants of early termination in March 2020 to facilitate the transition to an electronic filing system for the submission of premerger notification filings in response to the COVID-19 pandemic. Read more online here. (Authored by Michele Harrington)

• 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. House committees continue to work on the next COVID-19 relief package, which must pass before 14 March 1to prevent many Americans from losing their increased unemployment benefits. House Speaker Nancy Pelosi says she is hoping to have the bill finished for a floor vote the week of 22 Feb. U.S. House Ways & Means Chairman Richard E. Neal (D-MA) announced the Committee will consider nine legislative proposals under the budget reconciliation instructions this week. Proposals include $1,400 in individual stimulus payments and extends the temporary federal unemployment and benefits through 29 August, 2021, and increases the weekly benefit from $300 to $400. The White House said it will use the Defense Production Act to make more Covid-19 tests and vaccines more available to Americans in the coming months.  Read about these developments here: 4 Feb., 5 Feb., and 8 Feb. (Authored by Ivan Zapien)

Thursday, 4 February 2021

• 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, President Biden told House Democrats that he is willing to compromise on the individual stimulus payments’ income eligibility limits but remained firm on the checks’ size being $1,400. CDC Director Rochelle Walensky maintained Wednesday that vaccinating teachers is not required to reopen schools safely, citing data from her agency finding in-person classes safe when paired with other precautions. Sen. Joe Manchin (D-WV), a centrist swing vote, said that he would vote for the Democrats’ budget resolution assuring that the Democrats will be able to pass a COVID-19 relief package with just 50 votes. On Tuesday, the Biden Administration announced that it will begin providing COVID-19 vaccines directly to pharmacies nationwide. Read about these developments here: 2 Feb. and 3 Feb. (Authored by Ivan Zapien)

• The Woolard Review recognizes that the unsecured credit market in the UK has been rapidly evolving, both in light of innovative new products and broader economic changes as a result of COVID-19. The Review concludes that more needs to be done to ensure a healthy, sustainable market. It discusses a number of key emerging issues and sets out 26 recommendations for how the FCA should take these forward. The industry is likely to have mixed reactions to the Review, with many reserving judgment until there is more clarity on how it will impact the regulatory regime and how exactly this will affect lenders. Read more online here. (Authored by James Black)

Tuesday, 2 February 2021

• The COVID-19 pandemic has resulted in an unprecedented disruption to the U.S. Food and Drug Administration (FDA) inspection program. With the vast majority of its inspectional activities on hold due to the pandemic, FDA has been forced to pilot new inspectional initiatives, including increased use of records requests under 21 USC 374(a)(4) and increased reliance other health authorities’ inspections under the Mutual Reliance Initiative (MRI). FDA has published a summary report on the agency’s Pandemic Recovery and Preparedness Plan (PREPP) initiative, which is aimed at strengthening FDA’s ongoing COVID-19 response and building the agency’s resilience to respond to future emergencies, including by identifying several “broad cross-cutting ‘Action Areas’ that reflect ongoing and potential prospective actions.” Notably, these action areas include “continu[ing] to evolve and optimize inspectional operations, building on the COVID-19 experience as a catalyst” and “strengthen[ing] supply chain surveillance for regulated products,” suggesting that several of FDA’s COVID-related inspection pilot projects will continue into the future. Read more online here. (Authored by Jim Johnson)

• 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. A group of 10 GOP senators unveiled an estimated $618 billion coronavirus relief proposal on Monday ahead of a meeting with President Biden to discuss relief legislation. Monday evening, Senator Susan Collins (R-ME) and the Republican Senators emerged from the longer-than-expected meeting, saying there was a "good exchange of views" as they discussed the differences between the packages. Collins said they didn't come together on a single package but did agree to follow up at the staff level as they work further among themselves and with President Biden and Vice President Harris on a COVID-19 relief package. The nonpartisan Congressional Budget Office (CBO) projects that the U.S. economy will return to its pre-pandemic size by mid-2021. The Biden Administration is funding the mass production of a rapid, over-the-counter COVID-19 test. A top FDA official said Friday that the agency will try to have a "streamlined" FDA process for authorizing any updates required for COVID-19 vaccines to adapt to the threat of new variants. Johnson & Johnson announced that results from its clinical trials show that it provides strong protection against COVID-19. Read about these developments here: 28 Jan.; 29 Jan.; and 1 Feb. (Authored by Ivan Zapien)

• This month has seen the rollout of the Oxford/AstraZeneca COVID-19 vaccine in the UK and Prime Minister, Boris Johnson, forecasts that "tens of millions" of COVID-19 vaccinations will be administered over the next three months. But how can such a large-scale rapid rollout of vaccines be accurately monitored, and effectively delivered, especially when a program like that is completely unprecedented? Online here IPMT Associate Hannah Schofield explores how Blockchain could have helped with supply chain issues.

Compiled by Aaron Armstrong