Social and Behavioral Sciences Commons^™

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 …

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 …

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) …

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 …

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?

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 …

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 …

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 …

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 …

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 …

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 ( …

It Doesn't Pass The Sell Test: Focusing On "The Facts Of The Individual Case" In Involuntary Medication Inquiries, Susan A. Mcmahon

Georgetown Law Faculty Publications and Other Works

Criminal defendants who are incompetent to stand trial have a significant liberty interest in refusing the antipsychotic medication that could restore their competency. The Supreme Court cautioned that instances of intrusion upon that right “may be rare,” and, in Sell v. United States, it laid out what it believed to be stringent criteria for when a defendant could be medicated against his will. Yet, since Sell, trial courts have ordered over sixty-three percent of defendants involuntarily medicated. These individuals did not pose a danger to themselves or others, and they were rarely accused of crimes that involved damage …

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 …

Emergency Preparedness And Public Health: The Lessons Of Hurricane Sandy, Tia Powell, Dan Hanfling, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

When Hurricane Sandy hit downtown Manhattan, three neighboring hospitals each made different decisions about when to evacuate. Across the metro region, more than five hospitals and over 20 nursing and assisted living facilities were evacuated, making this the central public health challenge of this calamitous event. It is a familiar story—a super storm comes ashore, infrastructure is overwhelmed, and healthcare facilities evacuate patients, with major delays in returning to normal functioning. Afterwards, policy makers evaluate lessons learned for the next disaster, but similar missteps are often repeated.

Although not identical, it is instructive to compare Hurricane Katrina with the still …

Ethical Challenges Of Preexposure Prophylaxis For Hiv, Jonathan S. Jay, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

On July 16, 2012, emtricitabine/tenofovir (Truvada) became the first drug approved by the US Food and Drug Administration for preexposure prophylaxis (PrEP) of human immunodeficiency virus (HIV) for adults at high risk. While PrEP appears highly effective with consistent adherence, effective implementation poses ethical challenges for the medical and public health community. For PrEP users, it is necessary to maintain adherence, safe sex practices, and routine HIV testing and medical monitoring, to maximize benefits and reduce risks. On a population level, comparative cost-effectiveness should guide priority-setting, while safety measures must address drug resistance concerns without burdening patients' access. Equitable distribution …

An O’Neill Institute Briefing Paper: The Supreme Court’S Landmark Decision On The Affordable Care Act: Healthcare Reform’S Ultimate Fate Remains Uncertain, Emily W. Parento, Lawrence O. Gostin

O'Neill Institute Papers

The Supreme Court’s decision on the constitutionality of the Patient Protection and Affordable Care Act (ACA) is a landmark on the path toward ensuring universal access to health care in the United States. In a 5-4 decision written by Chief Justice Roberts, the Court upheld the law in its entirety with the sole exception that Congress may not revoke existing state Medicaid funding to penalize states that decline to participate in the Medicaid expansion under the ACA. In this O’Neill Institute Briefing, we explain and analyze the Court’s decision, focusing on the individual purchase mandate and the Medicaid expansion, while …

Global Health Justice: A Perspective From The Global South On A Framework Convention On Global Health, Lawrence O. Gostin, Ames Dhai

Georgetown Law Faculty Publications and Other Works

A global coalition of civil society and academics recently launched the Joint Action and Learning Initiative on National and Global Responsibilities for Health (JALI), which is developing a post-Millennium Development Goal (MDG) framework for global health. JALI’s mission is the achievement of a global health treaty based on the right to health—a Framework Convention on Global Health (FCGH). The FCGH proposes establishing fair terms of international co-operation, with agreed-upon mutually binding obligations to create enduring health system capacities, meet basic survival needs, and reduce unconscionable inequalities in global health. States that bear a disproportionate burden of disease have the least …

Pillars For Progress On The Right To Health: Harnessing The Potential Of Human Rights Through A Framework Convention On Global Health, Eric A. Friedman, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Ever more constitutions incorporate the right to health, courts continue to expand their right to health jurisprudence, and communities and civil society increasingly turn to the right to health in their advocacy. Yet the right remains far from being realized. Even with steady progress on numerous fronts of global health, vast inequities at the global and national levels persist, and are responsible for millions of deaths annually. We propose a four-part approach to accelerating progress towards fulfilling the right to health: 1) national legal and policy reform, incorporating right to health obligations and principles including equity, participation, and accountability in …

A Framework Convention On Global Health: Health For All, Justice For All, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Health inequalities represent perhaps the most consequential global health challenge and yet they persist despite increased funding and innovative programs. The United Nations is revising the Millennium Development Goals (MDGs) that will shape the world for many years to come. What would a transformative post-MDG framework for global health justice look like? A global coalition of civil society and academics—the Joint Action and Learning Initiative on National and Global Responsibilities for Health (JALI)—has formed an international campaign to advocate for a Framework Convention on Global Health (FCGH). Recently endorsed by the UN Secretary-General, the FCGH would reimagine global governance for …

Healthcare Reform Hangs In The Balance, Lawrence O. Gostin

O'Neill Institute Papers

In this timely new briefing, Professor Lawrence O. Gostin, University Professor and Faculty Director, O’Neill Institute for National and Global Health Law, Georgetown University writes:

Prior to Tuesday’s arguments, I believed that the Supreme Court would uphold the health insurance purchase mandate by a comfortable margin. But now I believe that health care reform hangs in the balance. Here are the key arguments on which the future of President Obama’s health care reform depends: a greater freedom, cost-shifting, the health care market, acts versus omissions, limiting principles, the population-base approach, and what is necessary and proper. If the Court strikes …

Why The Affordable Care Act's Individual Purchase Mandate Is Both Constitutional And Indispensable To The Public Welfare, Lawrence O. Gostin

O'Neill Institute Papers

Integral to the Affordable Care Act's (ACA’s) conceptual design is the individual purchase mandate, which requires most individuals to pay an annual tax penalty if they do not have health insurance by 2014. Despite the vociferous opposition, the mandate is the most “market-friendly” financing device because it relies on the private sector. Ironically, less market-oriented reforms such as a single-payer system clearly would have been constitutional.

It is common sense for everyone to purchase health insurance and thus gain security against the potentially catastrophic costs of treating a serious illness or injury. However, Congress’ method of ensuring that everyone has …

Improving The Population’S Health: The Affordable Care Act And The Importance Of Integration, Lorian E. Hardcastle, Katherine L. Record, Peter D. Jacobson, Lawrence O. Gostin

O'Neill Institute Papers

Heath care and public health are typically conceptualized as separate, albeit overlapping, systems. Health care’s goal is the improvement of individual patient outcomes through the provision of medical services. In contrast, public health is devoted to improving health outcomes in the population as a whole through health promotion and disease prevention. Health care services receive the bulk of funding and political support, while public health is chronically starved of resources. In order to reduce morbidity and mortality, policymakers must shift their attention to public health services and to the improved integration of health care and public health. In other words, …

Mandatory Hpv Vaccination And Political Debate, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Vaccinations are among the most cost-effective and widely used public health interventions, but have provoked popular resistance, with compulsion framed as an unwarranted state interference. When the FDA approved a human papillomavirus (HPV) vaccine in 2006, conservative religious groups strongly opposed a mandate, arguing it would condone pre-marital sex, undermine parental rights, and violate bodily integrity. Yet, Governor Rick Perry signed an executive order in 2007 making Texas the first state to enact a mandate — later revoked by the legislature.

Mandatory HPV vaccination reached the heights of presidential politics in a recent Republican debate. Calling the vaccine a "very …

Who’S Pandemic Influenza Preparedness Framework: A Milestone In Global Governance For Health, Lawrence O. Gostin, David P. Fidler

Georgetown Law Faculty Publications and Other Works

In May 2008, the World Health Organization (WHO) adopted the Pandemic Influenza Preparedness Framework for the Sharing of Influenza Viruses and Access to Vaccines and Other Benefits (PIP Framework). The PIP Framework’s adoption ended years of difficult negotiations, which began after Indonesia refused to share samples of avian influenza A (H5N1) with WHO in late 2006. Indonesia justified its actions on the need to create more equitable access for developing countries to benefits, such as vaccines and antivirals, derived from research and development on shared influenza virus samples. The global health community feared that failure to share influenza virus samples …