Law Commons^™

Intellectual Property As A Determinant Of Health, Ana Santos Rutschman

All Faculty Scholarship

Public health literature has long recognized the existence of determinants of health, a set of socio-economic conditions that affect health risks and health outcomes across the world. The World Health Organization defines these determinants as “forces and systems” consisting of “factors combin[ing] together to affect the health of individuals and communities.” Frameworks relying on determinants of health have been widely adopted by countries in the global South and North alike, as well as international institutional players, several of which are direct or indirect players in transnational intellectual property (IP) policymaking. Issues raised by the implementation of IP policies, however, are …

The Problem With Relying On Profit-Driven Models To Produce Pandemic Drugs, Ana Santos Rutschman

All Faculty Scholarship

The longstanding problems of relying on a market response to a pandemic are becoming readily apparent in the United States, which has quickly become the epicenter of the COVID-19 outbreak. The problems are particularly pronounced in pharmaceutical markets, where we are pinning our hopes for both cures and vaccines. In previous work we have shown how characteristics of healthcare markets in the United States create a divergence between the private incentives of for-profit companies and public health needs, leading to sub-optimal health outcomes in what is a uniquely market-driven healthcare system. In this Essay, written as the COVID-19 pandemic unfolds, …

Quarantine And The Federal Role In Epidemics, Wendy K. Mariner, Michael Ulrich

Faculty Scholarship

Every recent presidential administration has faced an infectious disease threat, and this trend is certain to continue. The states have primary responsibility for protecting the public’s health under their police powers, but modern travel makes diseases almost impossible to contain intrastate. How should the federal government respond in the future? The Ebola scare in the U.S. repeated a typical response—demands for quarantine. In January 2017, the Department of Health and Human Services and the Centers for Disease Control and Prevention issued final regulations on its authority to issue Federal Quarantine Orders. These regulations rely heavily on confining persons who may …

Ip Preparedness For Outbreak Diseases, Ana Santos Rutschman

All Faculty Scholarship

Outbreaks of infectious diseases will worsen, as illustrated by the recent back-to-back Ebola and Zika epidemics. The development of innovative drugs, especially in the form of vaccines, is key to minimizing future outbreaks, yet current intellectual property (IP) regimes are ineffective in supporting this goal.

IP scholarship has not adequately addressed the role of IP in the development of vaccines for outbreak diseases. This Article fills that void. Through case studies on the recent Ebola and Zika outbreaks, it provides the first descriptive analysis of the role of IP from the pre- to the post-outbreak stages, specifically identifying IP inefficiencies. …

The Ebola Virus Prevention And Human Rights Implications, Florence Shu-Acquaye

Faculty Scholarship

The Ebola virus and its now infamous 2014 West African outbreak have constituted the deadliest and most terrifying epidemic of recent memory.

A Global Vaccine Injury Compensation System, Sam F. Halabi, Saad B. Ommer

Faculty Publications

Vaccines are extremely safe and harm is rare. Worldwide, more than 30000 vaccine doses are delivered per second through routine immunization programs, which, in turn, prevent an estimated 2 million to 3 million deaths annually. Yet the specter of vaccine injury plays a central role in vaccine access and will continue to do so as vaccine technologies evolve.

Ebola And Human Rights: Post-9/11 Public Health And Safety In Epidemics, George J. Annas

Faculty Scholarship

In public health practice, the concepts of health and safety are often conflated. However, protecting and promoting health is radically different from protecting and promoting safety. Since 9/11, the distinctions between health and safety have changed and are in the process of merging. In our terrorism-obsessed world, public health has been increasingly militarized and enlisted, often without protest, into the service of protecting the safety of the public and the security of the nation. But safety and security are the proper purposes of law enforcement and the military, not of public health. More importantly, using public health to combat terrorism …

Law And Politics, An Emerging Epidemic: A Call For Evidence-Based Public Health Law, Michael Ulrich

Faculty Scholarship

As Jacobson v. Massachusetts recognized in 1905, the basis of public health law, and its ability to limit constitutional rights, is the use of scientific data and empirical evidence. Far too often, this important fact is lost. Fear, misinformation, and politics frequently take center stage and drive the implementation of public health law. In the recent Ebola scare, political leaders passed unnecessary and unconstitutional quarantine measures that defied scientific understanding of the disease and caused many to have their rights needlessly constrained. Looking at HIV criminalization and exemptions to childhood vaccine requirements, it becomes clear that the blame cannot be …

Tears In Heaven: Religiously And Culturally Sensitive Laws For Preventing The Next Pandemic, Eloisa Rodriguez-Dod, Aileen M. Marty, Elena Marty-Nelson

Faculty Publications

In February 2016, the World Health Organization (WHO) declared a “public health emergency of international concern” due to the increased clusters of microcephaly, Guillain-Barré Syndrome, and other neurological disorders in areas affected by the Zika virus. That declaration came in the wake of the West Africa Ebola crisis. Back to back declarations by WHO of the highest threat level for an international public health emergency underscores how quickly pathogens can now spread and cause devastation across borders. It also highlights the need to implement lessons learned from each pandemic crisis without delay. These crises demonstrate that laws to curtail the …

Strengthening The Detection Of And Early Response To Public Health Emergencies: Lessons From The West African Ebola Epidemic, Mark J. Siedner, Lawrence O. Gostin, Hilarie H. Cranmer, John D. Kraemer

Georgetown Law Faculty Publications and Other Works

Background

In the year since the World Health Organization (WHO) notified of an Ebola outbreak in West Africa, more than 24,000 cases have been reported and over 10,000 individuals have died. Moreover, countless non-Ebola deaths have occurred as a result of health system closings and an international aid effort in the $USD billions has been invested in control efforts. While the international response to the West African Ebola virus disease epidemic eventually exemplified the great potential of the global public health community, the protracted early response also revealed critical gaps, which likely resulted in exacerbation of the epidemic. It is …

Ebola, Quarantine, And Flawed Cdc Policy, Robert Gatter

All Faculty Scholarship

The CDC’s Interim Guidance for Monitoring and Movements of Persons with Potential Ebola Virus Exposure is deeply flawed because it disregards the science of Ebola transmission. It recommends that officials quarantine individuals exposed to the virus but who do not have any symptoms of illness, ignoring the fact that only those with Ebola symptoms can communicate the virus to others. Consequently, any quarantine order based on the Guidelines is surely unconstitutional and illegal under most states’ public health statutes — as exemplified by the State of Maine’s failed petition to quarantine Nurse Kaci Hickox in October 2014. This article examines …

An O'Neill Institute Briefing Paper: Ebola, The World Health Organization, And Beyond: Toward A Framework For Global Health Security, Lawrence O. Gostin, Eric A. Friedman, Daniel Hougendobler

Georgetown Law Faculty Publications and Other Works

The West African Ebola epidemic has demonstrated that the world remains ill-prepared to respond to infectious disease outbreaks. A host of institutions are now reviewing what went wrong, and new institutions are being considered, including an African Centers for Disease Control and Prevention and World Bank-initiated Pandemic Emergency Facility. The World Health Organization itself failed in one of its core functions by allowing a preventable infectious disease to spiral out of control in the world’s poorest region. The 68th World Health Assembly (WHA), held in May 2015, provided an opportunity for the Organization to reflect on what went wrong and …

Under Containment: Preempting State Ebola Quarantine Regulations, Eang L. Ngov

Faculty Scholarship

No abstract provided.

A Retrospective And Prospective Analysis Of The West African Ebola Virus Disease Epidemic: Robust National Health Systems At The Foundation And An Empowered Who At The Apex, Lawrence O. Gostin, Eric A. Friedman

Georgetown Law Faculty Publications and Other Works

The West African Ebola epidemic is a pivotal moment for the global health system. Just as the depth of the crisis ultimately spurred an unprecedented response, the failures of leadership demand innovative reforms. This analysis offers a template for these reforms, responding to the profound harms posed by fragile national health systems, delays in the international response, deficient resource mobilization, ill-defined responsibilities, and insufficient coordination. The scope of the reforms must address the failures evident in the Ebola response, as well as entrenched weaknesses that enabled the epidemic to reach its heights, transforming the existing inchoate, organically developed global health …

Legal Preparedness And Ebola Vaccines, Sam F. Halabi, John T. Monahan

Faculty Publications

On Dec 9, 2014, US Secretary of Health and Human Services Sylvia Burwell issued a declaration under the US Public Readiness and Emergency Preparedness Act to provide immunity from legal claims in the USA related to manufacturing, testing, development, distribution, and administration of three candidate Ebola vaccines except in instances of willful misconduct. Although progress in combating Ebola in west Africa has shifted public attention away from vaccine development and deployment, we should not forget that the management of legal liabilities related to vaccines has been an important subject of discussion between national governments, international organizations, vaccine manufacturers, and other …

Sharing The Burden Of Ebola Vaccine Related Adverse Events, Sam F. Halabi, John Monahan

Faculty Publications

Based upon past experience with other vaccines, the proposed administration of Ebola vaccines (once testing has been completed) will inevitably result in at least some adverse events that will give rise to legal liabilities of only crudely estimable magnitude at this time. Manufacturers, beneficiary governments (e.g., Guinea, Liberia, Sierra Leone), supporting governments (e.g. U.S., U.K.), individuals suffering adverse events, and populations benefiting from widespread vaccination against the Ebola virus all have a shared interest in recognizing, understanding, and managing potential liability as effectively as possible within the framework of a global public health response. There are multiple options available to …

Epic Failure Of Ebola And Global Health Security, David P. Fidler

Articles by Maurer Faculty

No abstract provided.

Discovering A Gold Mine Of U.S. Government Information: Exploring The Hathitrust Catalog And Its Rich Veins, Bert Chapman

Libraries Faculty and Staff Presentations

The Hathitrust Catalog provides researchers at member institutions with exponentially expanded access to historical U.S. Government information resources. This presentation describes how researchers can use this resource to conduct substantive research using government information resources on public policy issues such as Internal Revenue Service program problems, infectious diseases such as Ebola, and U.S. foreign relations with the former Soviet Union/Russian Federation.

The President’S National Security Agenda Curtailing Ebola, Safeguarding The Future, Lawrence O. Gostin, Henry A. Waxman, William Foege

Georgetown Law Faculty Publications and Other Works

A clear lesson of the Ebola epidemic in West Africa is the need for strong public health systems globally, including in the United States. Ebola has highlighted the dangers of weak public health systems, from the immense shortage of health workers in West Africa to the budget cuts at the U.S. Centers for Disease Control and Prevention. In response to Ebola and the broader threat of infectious disease, President Obama has proposed a $6.2 billion supplemental funding request to Congress. The supplemental would surge resources for containing and treating Ebola in West Africa -- including a reserve of funds to …

Is The United States Prepared For Ebola?, Lawrence O. Gostin, James G. Hodge Jr., Scott Burris

Georgetown Law Faculty Publications and Other Works

The West African Ebola epidemic is a humanitarian crisis and a threat to international security. It is not surprising that isolated cases have emerged in Europe and North America, but a large outbreak in the United States, with its advanced health system, is unlikely. Yet the handling of the first domestically diagnosed Ebola case in Dallas, Texas, raised concerns about national public health preparedness. What were the critical health system vulnerabilities revealed in Dallas, and how can the country respond more effectively to novel diseases in a globalized world?

Ebola: A Crisis In Global Health Leadership, Lawrence O. Gostin, Eric A. Friedman

Georgetown Law Faculty Publications and Other Works

At the core of the present Ebola crisis in West Africa is a lack of global health leadership. WHO should be the global health leader, following its constitutional charge, yet it is significantly under-resourced, having a direct effect on its rapid response capacity. The Organization's response to this crisis has been constantly behind, from low funding appeals to its delay in declaring this outbreak to be a Public Health Emergency of International Concern under the binding International Health Regulations (2005) (IHR). The IHR themselves have proven insufficient, as countries have failed to cooperate in building the public health capacities that …

Public Health In The Age Of Ebola In West Africa, Michael T. Osterholm, Kristine A. Moore, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

The Ebola epidemic, with its fast-growing toll and real potential for spreading into much of Africa, including major cities, has the makings of a “Black Swan” event. Such events, using the term coined by Nassim Nicholas Taleb, are: 1) unpredictable, outside the realm of regular expectations; 2) have a major impact, and; 3) are rationalized after the fact as being explainable and predictable.

We have learned from this outbreak the potential for an infectious disease to be politically, economically, and socially destabilizing, and that what kills us may be very different from what frightens us or substantially affects our social …

The Ebola Epidemic: A Public Health Emergency Of International Concern, Lawrence O. Gostin, Daniel Lucey, Alexandra Phelan

Georgetown Law Faculty Publications and Other Works

On August 8, 2014, the World Health Organization (WHO) Director-General Margaret Chan declared the West Africa Ebola crises a “public health emergency of international concern,” triggering powers under the 2005 International Health Regulations (IHR).

The most affected West African states have attempted classic public health measures with varied success, including quarantine and isolation, social distancing, risk communication, and travel restrictions. These have involved a trade off between population health and human rights; sometimes to the disadvantage of both. At the same time, the countries’ health systems and human resources are fragile, impeding an effective response.

Beyond the public health and …

Ebola: Towards An International Health Systems Fund, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

The current outbreak of Ebola virus disease (EVD) in West Africa is spiraling out of control, but it never had to happen. What can the international community do now to bring the epidemic under control, and how can we prevent the next one?

The counties most affected by Ebola (Guinea, Liberia, and Sierra Leone), rank among the lowest in global development, lacking essential public health infrastructure. If the affected countries had adequate public health systems, they probably would have contained Ebola within rural settings, avoiding the first outbreak in major urban areas.

More than 130 health workers have died from …