Health Law and Policy Commons^™

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 …

The Historic Role Of Boards Of Health In Local Innovation: New York City’S Soda Portion Case, Lawrence O. Gostin, Belinda H. Reeve, Marice Ashe

Georgetown Law Faculty Publications and Other Works

Childhood and adult obesity pose major risks for cancer, diabetes, and cardiovascular disease, with the poor and racial minorities suffering from disproportionately high burdens of obesity and chronic disease. With current policies failing, cities and states have moved forward with creative prevention measures–-with boards of health driving policy innovation in many local jurisdictions. The New York City Board of Board of Health’s (NYCBH) soda portion limit pushed the boundaries of innovation, but was struck down on June 26, 2014 by New York State’s highest court, which held that the Board trespassed on the City Council’s authority.

The Court’s decision ignored …

Virus Sharing, Genetic Sequencing, And Global Health Security, Lawrence O. Gostin, Alexandra Phelan, Michael A. Stoto, John D. Kraemer, K. Srinath Reddy

Georgetown Law Faculty Publications and Other Works

The WHO’s Pandemic Influenza Preparedness (PIP) Framework was a milestone global agreement designed to promote the international sharing of biological samples to develop vaccines, while that ensuring poorer countries would have access to those vaccines. Since the PIP Framework was negotiated, scientists have developed the capacity to use genetic sequencing data (GSD) to develop synthetic viruses rapidly for product development of life-saving technologies in a time-sensitive global emergency—threatening to unravel the Framework. Access to GSD may also have major implications for biosecurity, biosafety, and intellectual property (IP).

By rendering the physical transfer of viruses antiquated, GSD may also undermine the …

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 …

The Aca’S Contraceptive Mandate: Religious Freedom, Women’S Health, And Corporate Personhood, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

On June 30 2014 the Supreme Court decided Burwell v Hobby Lobby Stores, Inc, in a deeply divided judgment that engaged religious freedom, women’s health, and corporate personhood. Three closely held for-profit organizations challenged the Affordable Care Act’s contraceptive mandate, objecting to four contraceptive methods that they believe acted as abortifacients, in violation of their Christian beliefs.

The Court held that the contraceptive mandate violated the Religious Freedom Restoration Act of 1993, ruling that the Act’s protections extended to closely held corporations, with the mandate substantially burdening their religious freedoms. The Court acknowledged the federal government’s compelling interest in …

Healthy Living Needs Global Governance, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

It may seem counter-intuitive, but the same factors that drive the spread of infectious diseases also contribute to the dominance of non-communicable diseases (NCDs) in the global burden of disease—urbanization, global markets and harmonized cultures. NCDs have overtaken infectious diseases as the leading cause of morbidity and premature mortality worldwide, with deaths concentrated among the poor due to the growing availability and affordability of highly-processed, unhealthy foods, alcohol and tobacco.

The global response to NCDs has been slow and fractured, with the World Health Organization dedicating scant funding and the United Nations waiting until September 2011 to hold a high-level …

E-Cigarettes, Vaping, And Youth, Lawrence O. Gostin, Aliza Y. Glasner

Georgetown Law Faculty Publications and Other Works

E-cigarettes, a relatively new product, storming the tobacco industry are causing a massive stir among public health advocates. While e-cigarettes have the potential to serve as an effective harm reduction tool for existing smokers, they also may present an equally tempting pathway to first time smoking, particularly among youth. Many fear that e-cigarettes will revive the popular smoking culture that has taken decades to dismantle.

In April 2014, the FDA issued proposed rules to “deem” or extend its authority over tobacco products to regulate electronic cigarettes, cigars, pipe tobacco, nicotine gels, waterpipe (hookah) tobacco, and orally ingested dissolvable tobacco products. …

Global Rules For Global Health: Why We Need An Independent, Impartial Who, Devi Sridhar, Julio Frenk, Lawrence O. Gostin, Suerie Moon

Georgetown Law Faculty Publications and Other Works

Over the past few years the World Health Organization (WHO) has been undergoing a significant reform process. The immediate trigger was a budget crisis in 2010 that spurred massive lay-offs at the global agency. But at a more fundamental level, deeper systematic changes in global health governance have made reform imperative. While WHO reform draws relatively little attention outside diplomatic circles in Geneva, at stake are critical issues that will impact public health everywhere. This article’s key messages are:

• Recent outbreaks of MERS highlight the need for a global response to infectious disease
• The WHO has had a crucial role …

Limiting What We Can Eat: A Bridge Too Far?, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Innovative mayors across America are seeking to shape personal decisions about diet and physical activity, taking a page from tobacco control. But attempts to limit personal choices of what to eat have drawn the ire of vocal critics and sometimes the rebuke of judges, with former New York City mayor Michael Bloomberg’s limit on soda portions becoming a key flash point. The public broadly accepts state power to control infectious diseases, but often draws a line at limiting dietary choices. The author wants to dispel some of the well-worn arguments in the obesity wars.

Global Health And The Law, Lawrence O. Gostin, Devi Sridhar

Georgetown Law Faculty Publications and Other Works

The last two decades have brought revolutionary changes in global health, driven by popular concern over AIDS, novel influenzas, and maternal mortality. Given the rapid globalization that is a defining feature of today’s world, the need for a robust system of global health law has never been greater. Global health law has been defined as the legal norms, processes, and institutions designed primarily to attain the highest possible standard of physical and mental health for the world’s population. Global health law is not an organized legal system, with a unified treaty monitoring body, such as the World Trade Organization. There …

Legal And Ethical Responsibilities Following Brain Death: The Mcmath And Muñoz Cases, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

What are the legal and ethical implications of continuing to treat a brain dead patient? And may a hospital refuse to provide such treatment? These ethical and legal problems are raised in two recent cases. In the first Marlise Muñoz, a pregnant woman declared brain dead, was kept on life support against her family’s wishes due to the treating hospital’s interpretation of a Texas fetal protection law. In the other a hospital refused to treat Jahi McMath, a brain dead girl, despite her family's entreaties. The cases, at first, appear similar because in each case the hospital was refusing to …

An Assessment Of Mayor Bloomberg’S Public Health Legacy, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

As New York City Mayor Michael Bloomberg’s last term was coming to an end, Professor Gostin wrote an article for the Hasting Center Report addressing Bloomberg’s public health legacy. Rodger Citron has edited that article into a question and answer format and also asked Professor Gostin to elaborate on a number of points made in that article.

Libertarian Patriarchalism: Nudges, Procedural Roadblocks, And Reproductive Choice, Govind Persad

Georgetown Law Faculty Publications and Other Works

Cass Sunstein and Richard Thaler's proposal that social and legal institutions should steer individuals toward some options and away from others-a stance they dub "libertarian paternalism"-has provoked much high-level discussion in both academic and policy settings. Sunstein and Thaler believe that steering, or "nudging," individuals is easier to justify than the bans or mandates that traditional paternalism involves.

This Article considers the connection between libertarian paternalism and the regulation of reproductive choice. I first discuss the use of nudges to discourage women from exercising their right to choose an abortion, or from becoming or remaining pregnant. I then argue that …

The Increasing Weight Of Regulation: Countries Combat The Global Obesity Epidemic, Allyn L. Taylor, Emily W. Parento, Laura A. Schmidt

Georgetown Law Faculty Publications and Other Works

Obesity is a global epidemic, exacting an enormous human and economic toll. In the absence of a comprehensive global governance strategy, states have increasingly employed a wide array of legal strategies targeting the drivers of obesity. This article identifies recent global trends in obesity-related legislation and makes the normative case for an updated global governance strategy.

National governments have responded to the epidemic both by strengthening traditional interventions and by developing novel legislative strategies. This response consists of nine important trends: (1) strengthened and tailored tax measures; (2) broader use of counter-advertising and health campaigns; (3) expanded food labeling; (4) …

Future Oversight Of Recombinant Dna Research: Recommendations Of An Institute Of Medicine Committee, Lawrence O. Gostin, Bruce M. Altevogt, Andrew M. Pope

Georgetown Law Faculty Publications and Other Works

The National Institutes of Health (NIH) established the Recombinant DNA Advisory Committee (RAC) in 1974 in response to public concerns about the safety of manipulating genetic material through recombinant DNA. The accumulation of 40 years of experience with gene transfer research has led to a better understanding of the risks. Yet, as gene transfer research has matured, the complexity of the overall regulatory environment has remained. Gene transfer research continues to be subjected to multiple layers of review: the Food and Drug Administration (FDA), institutional review boards, institutional biosafety committees, and the RAC. It is within the context of overlapping …

Governing For Health As The World Grows Older: Healthy Lifespans In Aging Societies, Lawrence O. Gostin, Anna Garsia

Georgetown Law Faculty Publications and Other Works

So much of global health governance focuses intensely on a brief moment in the human lifespan—from a safe birth to infant and child survival. Yet, with all the attention to this early window of life (infancy to age five), the opposite end of the life spectrum is comparatively neglected. The Millennium Development Goals (MDGs) do not mention a healthy lifespan or a healthy old age. This inadequate attention to the older years of the life appears to be a glaring omission given the universal challenges posed by aging societies. Aging is a demographic fact in almost all countries, but it …

Public Health Emergencies: What Counts?, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Vaccines and drugs to prevent and treat Ebola Virus Disease that have never been tested in humans, and in scarce supply raise profound ethical challenges. What if good evidence emerged demonstrating safety and efficacy of drugs? What would be an ethical method of allocating scarce beneficial resources? The apparent preference given to foreign aid workers over West Africans provoked a firestorm. In addition to discussing the ethical allocation of scarce drugs, this article also asks a more fundamental question: Why did it take nearly 40 years after the first Ebola outbreak in 1976 to launch clinical trials?

The Global Health Security Agenda In An Age Of Biosecurity, Lawrence O. Gostin, Alexandra Phelan

Georgetown Law Faculty Publications and Other Works

Historically, the Oval Office has been a leader in global health assistance. From the President’s Emergency Plan for AIDS Relief (PEPFAR) and the President’s Malaria Initiative (PMI) under the Bush Administration, to the Global Health Initiative launched by President Obama in 2009. However, unlike PEPFAR and PMI, the Global Health Initiative met an untimely end with the launch of a bold new global health measure by the Obama Administration: the Global Health Security Agenda (GHS Agenda). The GHS Agenda aims to “accelerate progress toward a world safe and secure from infectious disease threats” through a US-led diplomatic collaboration with 30 …

Towards A Framework Convention On Global Health, Lawrence O. Gostin, Eric A. Friedman, Kent Buse, Attiya Waris, Moses Mulumba, Mayowa Joel, Lola Dare, Ames Dhai, Devi Sridhar

Georgetown Law Faculty Publications and Other Works

A global health treaty, a Framework Convention on Global Health (FCGH)–grounded in the right to health, with the central goal of reducing immense domestic and global health inequities–could serve as a robust global governance instrument to underpin the United Nations post-2015 Millennium Development Goals (MDGs). It would ensure for all people the three essential conditions for a healthy life–public health, health care, and the positive social determinants of health–while advancing good governance, responding to drivers of health disadvantages for marginalized populations, elevating health in other legal regimes, and enhancing people's ability to claim their rights.

The legally binding nature of …

How Nfib V. Sebelius Affects The Constitutional Gestalt, Lawrence B. Solum

Georgetown Law Faculty Publications and Other Works

The thesis of this essay is that the most important legal effects of the Supreme Court's decision in NFIB v. Sebelius are likely to be indirect. Sebelius marks a possible shift in what we can call the “constitutional gestalt” regarding the meaning and implications of the so-called “New Deal Settlement.” Before Sebelius, the consensus understanding was that New Deal and Warren Court cases had established a constitutional regime of plenary and virtually unlimited national legislative power under the Commerce Clause (which might be subject to narrow and limited carve outs protective of the core of state sovereignty).

After Sebelius …

Advancing The Right To Health Through Global Organizations: The Potential Role Of A Framework Convention On Global Health, Eric A. Friedman, Lawrence O. Gostin, Kent Buse

Georgetown Law Faculty Publications and Other Works

Organizations, partnerships, and alliances form the building blocks of global governance. Global health organizations thus have the potential to play a formative role in determining the extent to which people are able to realize their right to health.

This article examines how major global health organizations, such as WHO, the Global Fund to Fight AIDS, TB and Malaria, UNAIDS, and GAVI approach human rights concerns, including equality, accountability, and inclusive participation. We argue that organizational support for the right to health must transition from ad hoc and partial to permanent and comprehensive.

Drawing on the literature and our knowledge of …

Realizing The Right To Health Through A Framework Convention On Global Health?, Eric A. Friedman, Jashodhara Dasgupta, Alicia E. Yamin, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

This article introduces a special issue of Health and Human Rights (volume 15, issue 1) that features articles exploring potential elements of and key questions and issues surrounding the Framework Convention on Global Health (FCGH). The FCGH is a proposed global health treaty that would be grounded in the right to health, with the aim of closing domestic and global health inequities. It would set standards and ensure financing for health care and public health services, while also addressing social determinants of health. The FCGH would raise the priority of health in other sectors, ensure effective private sector regulation, and …

Stemming The Global Trade In Falsified And Substandard Medicines, Lawrence O. Gostin, Gillian J. Buckley, Patrick W. Kelley

Georgetown Law Faculty Publications and Other Works

Drug safety and quality is an essential assumption of clinical medicine, but there is growing concern that this assumption is not always correct. Poor manufacturing and deliberate fraud occasionally compromises the drug supply in the United States, and the problem is far more common and serious in low- and middle-income countries with weak drug regulatory systems. An Institute of Medicine consensus committee report identified the causes and possible solutions to the problem of falsified and substandard drugs around the world.

The vocabulary people use to discuss the problem is itself a concern. The word counterfeit is often used innocuously to …

Tackling The Global Ncd Crisis: Innovations In Law And Governance, Bryan P. Thomas, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

35 million people die annually of non-communicable diseases (NCDs), 80% of them in low- and middle-income countries—representing a marked epidemiological transition from infectious to chronic diseases and from richer to poorer countries. The total number of NCDs is projected to rise by 17% over the coming decade, absent significant interventions. The NCD epidemic poses unique governance challenges: the causes are multifactorial, the affected populations diffuse, and effective responses require sustained multi-sectorial cooperation. The authors propose a range of regulatory options available at the domestic level, including stricter food labeling laws, regulation of food advertisements, tax incentives for healthy lifestyle choices, …

Tobacco Endgame Strategies: Challenges In Ethics And Law, Bryan P. Thomas, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

There are complex legal and ethical tradeoffs involved in using intensified regulation to bring smoking prevalence to near-zero levels. The authors explore these tradeoffs through a lens of health justice, paying particular attention to the potential impact on vulnerable populations. The ethical tradeoffs explored include the charge that heavy regulation is paternalistic; the potentially regressive impact of heavily taxing a product consumed disproportionately by the poor; the simple loss of enjoyment to heavily addicted smokers; the health risks posed by, for example, regulating nicotine content in cigarettes—where doing so leads to increased consumption. Turning to legalistic concerns, the authors explore …

Better Health, But Less Justice: Widening Health Disparities After National Federation Of Independent Business V. Sebelius, Emily W. Parento, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

At the time it was enacted in 2010, the Patient Protection and Affordable Care Act (ACA) was widely applauded by health activists, as it meant that the United States would at last join the overwhelming majority of industrialized countries in providing its population with guaranteed access to affordable health care. Roughly half of the increase in access to health insurance was to come from the expansion of Medicaid eligibility to all U.S. citizens and legal residents with income below 138% of the Federal Poverty Level. However, the Supreme Court’s 2012 ruling in National Federation of Independent Business v. Sebelius ( …

Towards A Framework Convention On Global Health: A Transformative Agenda For Global Health Justice, Lawrence O. Gostin, Eric A. Friedman

Georgetown Law Faculty Publications and Other Works

International law has responded weakly to the inequities in health care, public health, and the broader determinates of health that collectively cause the greatest loss of lives and human potential every year. Approximately one-third of global deaths can be attributed to enduring and unconscionable inequities. Despite significant progress in improving global health over the past several decades, these inequities persist. Current global governance for health is inadequate to the task of resolving these inequities, from lack of accountability and enforcement to inadequate funding and the absence of leadership required to respond to the threats to health that arise from other …

Bloomberg’S Health Legacy: Urban Innovator Or Meddling Nanny?, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Michael Bloomberg leaves the mayoralty of New York City, with his health legacy is bitterly contested. The public health community views him as an urban innovator—a rare political and business leader willing to fight for a built environment conducive to healthier, safer lifestyles. To his distractors, however, Bloomberg epitomizes a meddling nanny—an elitist dictating to largely poor and working class people about how they ought to lead their lives. His policies have sparked intense public, corporate, and political ire—critical of sweeping mayoral power to socially engineer the city and its inhabitants.

Here, I seek to show how Bloomberg has fundamentally …