Law Commons^™

Safeguarding The Pandemic Agreement From Disinformation, Alexandra Finch, Kevin A. Klock, Lawrence O. Gostin, Sam F. Halabi, Sarah A. Wetter

Georgetown Law Faculty Publications and Other Works

Complicating the negotiation of a global pandemic treaty has been a sustained disinformation campaign worldwide to undermine the agreement by making and amplifying spurious assertions about what it intends to accomplish and how it will do so. Central to the disinformation campaign are erroneous claims about national sovereignty and forcible takings of pandemic countermeasures. Further, legitimate and unfounded unease concern weakened intellectual property (IP) and speech rights. Having followed the negotiations and provided technical assistance to the World Health Organization's (WHO's) leadership, we set the record straight in several key areas.

Financing The Future Of Who, Lawrence O. Gostin, Kevin A. Klock, Helen Clark, Fatimatou Zahra Diop, Dayanath Jayasuriya, Jemilah Mahmood, Attiya Waris

Georgetown Law Faculty Publications and Other Works

WHO's resources have consistently lagged behind its constitutional mandate. There is a deep misalignment between what governments and the public expect WHO to do and what the organisation is resourced to do. WHO is challenged by low levels of political will to increase its financing, strained government treasuries, and a battle over control of priorities. WHO's Executive Board has charged the Working Group on Sustainable Financing with identifying a viable plan for sustainable financing before the World Health Assembly in May. There is no time to lose. WHO's resourcing strategy must match its mission with assured financial support from member …

No Future But A Shared Future, Lawrence O. Gostin, Kevin A. Klock, Sam F. Halabi, Katie Gottschalk, Katherine Ginsbach

Georgetown Law Faculty Publications and Other Works

The COVID-19 pandemic revealed the fractured and inadequate state of national and global health law and institutions, revealing deeply embedded inequalities. In response to a World Health Assembly resolution proposing a special session to consider the benefits of developing a WHO convention or other international instrument on pandemic preparedness and response, the O’Neill Institute for National and Global Health Law and the Foundation for the National Institutes of Health (FNIH) convened 30 of the world’s leading authorities on global health law, financing, biomedical science, implementation, and emergency response along with leaders from prominent international organizations deeply engaged in responding to …

Going Global, Acting Local: How An International Pandemic Convention Can Support Regional And Community Response, Kevin A. Klock, Lawrence O. Gostin, Sam F. Halabi

Georgetown Law Faculty Publications and Other Works

A WHO pandemic convention could set in place an overarching framework needed for strengthening global health security. As the World Health Assembly (WHA) debated the merits of such an agreement, a critically important regional instrument – the Treaty for the Establishment of the African Medicines Agency (AMA Treaty) – entered into force on 5 November 2021. The new agency will, among other things, ensure there is a “common framework” for addressing “emerging issues and pandemics in the event of a public health emergency on the continent with cross border or regional implications.”

An improved worldwide health security strategy is essential …

9 Steps To End Covid-19 And Prevent The Next Pandemic: Essential Outcomes From The World Health Assembly, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

A year ago, the World Health Assembly (WHA) met virtually for the first time since the creation of the World Health Organization (WHO) in 1948. Last year’s WHA adopted a resolution asking states to intensify action to fight COVID-19. Yet a year on, there have been 3.7 million deaths reported, with the real number estimated as more than 7 million. From May 24-31, 2021, the 74th WHA (WHA74) was again held virtually amidst this historic pandemic. The WHA created a member states working group on strengthening WHO preparedness for and response to health emergencies to make recommendations to next year’s …

The Coronavirus Pandemic 1 Year On—What Went Wrong?, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

January 30, 2021, marked the first anniversary of the declaration by the World Health Organization (WHO) of COVID-19 as a public health emergency of international concern (PHEIC). Thus far, the world has been no match for SARS-CoV-2, with more than 100 million cases and 2.5 million deaths. The US has been among the world’s poorest performers in addressing the pandemic, with more than 500 000 deaths.

Vaccines offer the best chance of returning to normal, but circulating variants pose a major obstacle, particularly the emergence of variants that are more transmissible and are developing partial resistance to vaccines against …

Mandating Covid-19 Vaccines, Lawrence O. Gostin, Daniel A. Salmon, Heidi J. Larson

Georgetown Law Faculty Publications and Other Works

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines hold promise to control the pandemic, and help restore normal social and economic life. The Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for 2 mRNA vaccines and will likely issue full biologics licenses in the coming months. Anticipating vaccine scarcity, the Advisory Committee on Immunization Practice (ACIP) published guidance on vaccine priorities.

Data show 95% efficacy for vaccines granted an EUA, but even highly effective vaccines cannot curb the pandemic without high population coverage and maintenance of other mitigation strategies. Recent data from 1,676 adults surveyed November 30-December …

The Value Proposition Of The Global Health Security Index, Sanjana J. Ravi, Kelsey Lane Warmbrod, Lucia Mullen, Diane Meyer, Elizabeth Cameron, Jessica Bell, Priya Bapat, Michael Paterra, Catherine Machalaba, Indira Nath, Lawrence O. Gostin, Wilmot James, Dylan George, Simo Nikkari, Ernesto Gozzer, Oyewale Tomori, Issa Makumbi, Jennifer B. Nuzzo

Georgetown Law Faculty Publications and Other Works

Infectious disease outbreaks pose major threats to human health and security. Countries with robust capacities for preventing, detecting and responding to outbreaks can avert many of the social, political, economic and health system costs of such crises. The Global Health Security Index (GHS Index)—the first comprehensive assessment and benchmarking of health security and related capabilities across 195 countries—recently found that no country is sufficiently prepared for epidemics or pandemics. The GHS Index can help health security stakeholders identify areas of weakness, as well as opportunities to collaborate across sectors, collectively strengthen health systems and achieve shared public health goals. Some …

An Analysis Of International Health Regulations Emergency Committees And Public Health Emergency Of International Concern Designations, Lucia Mullen, Christina Potter, Lawrence O. Gostin, Anita Cicero, Jennifer B. Nuzzo

Georgetown Law Faculty Publications and Other Works

Nine public health events have been assessed for the potential declaration of a Public Health Emergency of International Concern (PHEIC). According to the World Health Organization (WHO) International Health Regulations (IHR), a PHEIC is defined as an extraordinary event that constitutes a public health risk to other states through international spread and requires a coordinated international response. The WHO Director-General convenes Emergency Committees (ECs) to provide their advice on whether an event constitutes a PHEIC. The EC rationales have been continuously criticised for being non-transparent and contradictory to the IHR. This first comprehensive analysis of EC rationale provides recommendations to …

Imagining Global Health With Justice: Transformative Ideas For Health And Wellbeing While Leaving No One Behind, Lawrence O. Gostin, Eric A. Friedman

Georgetown Law Faculty Publications and Other Works

The disproportionate impact of COVID-19 on communities of color in the United States and immense vulnerabilities in lower-income countries has revealed a global health reality that is often overshadowed by decades of progress in overall global health, with new lows in child and maternal deaths every year, more people with HIV receiving access to lifesaving anti-retroviral therapy, and rising life expectancies. That reality is one of vast national and global inequalities, with the lived experiences of members of marginalized populations far removed from laudatory health headlines.

Here, we propose an ambitious agenda to bridge the gap between progress in global …

Regulating Medicines In A Globalized World With Increased Recognition And Reliance Among Regulators: A National Academies Report, Lawrence O. Gostin, Alastair J. Wood, Patricia A. Cuff

Georgetown Law Faculty Publications and Other Works

Research and development of pharmaceuticals are now complex global endeavors, with drug companies operating worldwide using global supply chains. Pharmaceutical companies source their products from many countries, conduct trials in multiple sites, and market essential drugs and vaccines globally. Yet oversight of drug safety and effectiveness is primarily the responsibility of national regulators of variable capacities. National agencies often undertake product reviews without recognizing that similar reviews are occurring elsewhere, sometimes simultaneously. The result is duplication and redundancy, which benefits neither national nor global public health. Supported by the US Food and Drug Administration (FDA), the National Academies of Sciences, …

The World Health Organization In Global Health Law, Benjamin Mason Meier, Allyn Taylor, Mark Eccleston-Turner, Roojin Habibi, Sharifah Sekalala, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

The World Health Organization (WHO) has sought to bring the world together to respond to a shared threat. This column seeks to examine the central importance of WHO in developing and implementing global health law. Recognizing that global health law requires global governance, the column begins by situating WHO’s role at the forefront of global health governance. WHO’s leadership in global governance for health is supported by an expansive mandate to serve as a forum for the codification of international law, which WHO has exercised sporadically through the evolving development of the International Health Regulations (IHR). Yet, where the IHR …