Law Commons^™

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 …

Filling In The Blanks On Reducing Tobacco Product Addictiveness In The Fctc Partial Guidelines For Articles 9 & 10, Eric N. Lindblom

Georgetown Law Faculty Publications and Other Works

The existing Partial Guidelines for Implementation of Articles 9 & 10 of the WHO Framework Convention for Tobacco Control includes a strategy for regulating tobacco products to reduce their attractiveness, but does not yet provide any guidance for reducing either the toxicity or the addictiveness of tobacco products. Section 1.2.1.2, “Addictiveness (dependence liability),” states only that: “This section has been left blank intentionally to indicate that guidance will be proposed at a later stage.” A related footnote says that the blanks will be filled “as new country experience, and scientific, medical and other evidence become available. . . [and] will …

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 …

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 …

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 …

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 …

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?

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 …