Law Commons^™

Restoring Health To Health Reform, Lawrence O. Gostin, Peter D. Jacobson

Georgetown Law Faculty Publications and Other Works

In this article, we discuss the public health provisions of the Patient Protection and Affordable Care Act (PPACA--P.L. 111-148). We first set forth a framework to identify the key reforms that are needed for a robust public health system. These include workforce and infrastructure investments. We then assess the PPACA against these criteria. We conclude that although the act would make significant investment in public health (especially in wellness and prevention programs), it does little to improve the existing structural deficiencies that the public health system must overcome if it is to be effective in improving the population’s health.

Redressing The Unconscionable Health Gap: A Global Plan For Justice, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Consider two children—one born in sub-Saharan Africa and the other in the United States. The African child is twenty-five times more likely to die in the first five years of life; if she lives to child-bearing age, she is a two hundred times more likely to die in labor; and overall, she will die thirty years earlier than the American child. The international community is deeply resistant to taking bold remedial action—more concerned with their geostrategic interests than the health of the poor. The scale of foreign aid is both insufficient and unsustainable and fails to address the key determinants …

Reducing Distracted Driving: Regulation And Education To Avert Traffic Injuries And Fatalities, Lawrence O. Gostin, Peter D. Jacobson

Georgetown Law Faculty Publications and Other Works

In this article, we consider the legal and policy implications of distracted driving (the tendency of people to use electronic devices while operating a motor vehicle). After reviewing the empirical evidence showing that distracted driving has serious adverse consequences, we discuss the legal basis for governmental interventions to reduce distracted driving. These interventions include laws restricting the use of electronic devices while driving, especially sending text messages. Since drivers have at best a reduced expectation of privacy, these restrictions should easily survive legal challenges. At the same time, it is important to consider the responsibility of automobile manufacturers to improve …

Health Care Reform In Transition: Incremental Insurance Reform Without An Individual Mandate, Lawrence O. Gostin, Elenora E. Connors

Georgetown Law Faculty Publications and Other Works

A major access problem exists in the private insurance market for individuals with preexisting conditions, who are either denied coverage or charged exorbitant premiums. In effect, individuals are denied coverage for exactly what they need, which jeopardizes their health and the financial security of their family. Before health reform passed, discussions surrounding incremental reform took place, including perhaps the most politically compelling – prohibiting insurers from denying coverage to those with preexisting health conditions. Insurance is based upon the principles of spreading risk of individuals across a population to ensure that everyone can afford medical care when he or she …

Health Care Reform — A Historic Moment In Us Social Policy, Lawrence O. Gostin, Elenora E. Connors

Georgetown Law Faculty Publications and Other Works

On March 23, 2010, President Obama signed into law the first U.S. comprehensive health care reform bill, the Patient Protection and Affordable Care Act (PPACA). After almost a century of failed attempts, the U.S. now has a national health care system which promises to increase access to care, increase consumer choice, and ban insurance discrimination for individuals with preexisting medical conditions. The PPACA is expected to expand insurance coverage to 32 million individuals by 2019 through a variety of measures. At a cost of $938 billion over 10 years, the PPACA is projected to reduce the deficit by $143 billion …

The President’S Global Health Initiative, Lawrence O. Gostin, Emily A. Mok

Georgetown Law Faculty Publications and Other Works

The U.S. Global Health Initiative (GHI) represents the Obama administration’s new strategy for international development assistance in health. With a pledge of $63 billion over six years, GHI aims to fund PEPFAR and a set of broader global health issues (e.g., maternal and child health, nutrition, and neglected tropical diseases). GHI is also being framed as “smart power” whereby health would serve as a critical tool for U.S. foreign policy.

However, as the U.S. enters a period of severe budgetary restraint and as domestic crises rise to the fore, the promise of global health reform could become illusory. The lack …

Implementing Public Health Regulations In Developing Countries: Lessons From The Oecd Countries, Lawrence O. Gostin, Emily A. Mok, Monica Das Gupta, Max Levin

Georgetown Law Faculty Publications and Other Works

The enforcement of public health standards is a common problem in many developing countries. Public health agencies lack sufficient resources and, too often, enforcement mechanisms rely on slow and erratic judicial systems. These limitations can make traditional public health regulations difficult to implement. In this article, we examine innovative approaches to the implementation of public health regulations that have emerged in recent years within OECD countries. These approaches aim to improve compliance with health standards, while reducing dependence on both the legal system and the administrative resources of public health agencies.

This article begins by discussing some traditional forms of …

International Assistance And Cooperation For Access To Essential Medicines, Emily A. Mok

Georgetown Law Faculty Publications and Other Works

Access to essential medicines is a critical problem that plagues many developing countries. With a daunting number of domestic constraints technologically, economically, and otherwise developing countries are faced with a steep uphill battle to meet the human rights obligation of providing essential medicines immediately. To meet these challenges, the international human rights obligations of international assistance and cooperation can play a key role to help developing countries fulfill the need for access to essential medicines. This article seeks to highlight and expand upon the current understanding of international assistance and cooperation for access to essential medicines through a review of …

The Joint Action And Learning Initiative On National And Global Responsibilities For Health, Lawrence O. Gostin, Gorik Ooms, Mark Heywood, Just Haffeld, Sigrun Møgedal, John-Arne Røttingen, Eric A. Friedman, Harald Siem

Georgetown Law Faculty Publications and Other Works

A population’s health and wellbeing is primarily a national responsibility. Every state owes all of its inhabitants a comprehensive package of essential health goods and services under its obligations to respect, protect, and fulfill the human right to health. Yet health is also a global responsibility. Every state has a duty to ensure a safe and healthy world, with particular attention to the needs of the world’s poorest people. Improving health and reducing unconscionable health inequalities is both an international obligation under the human right to health and a matter of global social justice.

The mutual obligations of states to …

Mapping The Issues: Public Health, Law And Ethics, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

The field of public health is typically regarded as a positivistic pursuit and, undoubtedly, our understanding of the etiology and response to disease is heavily influenced by scientific inquiry. Public health policies, however, are shaped not only by science but also by ethical values, legal norms, and political oversight. Public Health Law and Ethics: A Reader (expanded and updated 2nd ed., 2010) probes and seeks to illuminate this complex interplay, through a careful selection of government reports, scholarly articles, and court cases together with discussion and analysis of critical problems at the interface of law, ethics, and public health. The …

The National Individual Health Insurance Mandate: Ethics And The Constitution, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Within weeks, after signing the nation’s first comprehensive health insurance reform, twenty states filed lawsuits challenging the constitutionality of the Bill’s most politically charged feature—an individual purchase mandate. If anything, the tax penalty is too low compared with the cost of insurance, so it may not sufficiently incentivize healthy individuals. But it remains deeply controversial because it compels individuals to purchase coverage they choose not to have, raising the question whether Congress can lawfully and ethically require individuals to contract with, and transfer money to, a private party. To be sure, the individual mandate lacks a clear American precedent. (It …

Commandeering The People: Why The Individual Health Insurance Mandate Is Unconstitutional, Randy E. Barnett

Georgetown Law Faculty Publications and Other Works

The “Patient Protection and Affordable Care Act” includes what is called an “individual responsibility requirement” or mandate that all persons buy health insurance from a private company and a separate “penalty” enforcing this requirement. In this paper, I do not critique the individual mandate on originalist grounds. Instead, I explain why the individual mandate is unconstitutional under the existing doctrine by which the Supreme Court construes the Commerce and Necessary and Proper Clauses and the tax power. There are three principal claims.

First (Part II), since the New Deal, the Supreme Court has developed a doctrine allowing the regulation of …

National And Global Responsibilities For Health, Lawrence O. Gostin, Mark Heywood, Gorik Ooms, Anand Grover, John-Arne Røttingen, Wang Chenguang

Georgetown Law Faculty Publications and Other Works

Preventable and treatable injuries and diseases are overwhelming sub-Saharan Africa, the Indian subcontinent, and other impoverished areas of the world. Why are health outcomes among the world’s poor so dire after the first decade of the Millennium Development Goals (MDGs) and despite a quadrupling of international health assistance over the past two decades? We believe that this dynamic can change by establishing clearer understandings of, and forging consensus around and governance structures to support, national and global responsibilities to improve global health.

With the goal of a new post-MDG global health paradigm, we are establishing the Joint Action and Learning …

Rights Talk And Patient Subjectivity: The Role Of Autonomy, Equality And Participation Norms, Nan D. Hunter

Georgetown Law Faculty Publications and Other Works

Patients themselves have transformed the role of the patient in the health care system, making it far more complex than it ever has been before. As a result, the conceptual root of our contemporary understandings of “patient” is an assumption of autonomous subjectivity, i.e., of an individual aware of and capable of acting on her choices for medical care. The Symposium on Patient-Centered Health Law and Ethics of which this Article is a part considers the most recent stage in this evolution of meanings: the concept of patient-centeredness, with its implication of provider deference to the patient’s perspective. Throughout the …

Pharmaceutical Patent Litigation Settlements: Implications For Competition And Innovation, John R. Thomas

Georgetown Law Faculty Publications and Other Works

Although brand-name pharmaceutical companies routinely procure patents on their innovative medications, such rights are not self-enforcing. Brand-name firms that wish to enforce their patents against generic competitors must commence litigation in the federal courts. Such litigation ordinarily terminates in either a judgment of infringement, which typically blocks generic competition until such time as the patent expires, or a judgment that the patent is invalid or not infringed, which typically opens the market to generic entry. As with other sorts of commercial litigation, however, the parties to pharmaceutical patent litigation may choose to settle their case. Certain of these settlements have …

The O’Neill Institute For National And Global Health Law: Discovering Innovative Solutions For The Most Pressing Health Problems Facing The Nation And The World, Lawrence O. Gostin, Oscar A. Cabrera, Susan C. Kim

Georgetown Law Faculty Publications and Other Works

The connection between health and an individual’s ability to function in society, as well as the importance of health to a society’s economic, political, and social wellbeing necessitates finding innovative solutions to the world’s most pressing health problems. The O’Neill Institute for National and Global Health Law at Georgetown University seeks to demonstrate the role that academia can play in addressing complex national and global health problems in a comprehensive, evidence-based, intellectually-rigorous, and nonpartisan manner. The O’Neill Institute currently has three research programs: global health law, national health law, and the center for disease prevention and outcomes. Projects within these …

The Unconscionable Health Gap: A Global Plan For Justice, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

International norms recognize the special value of health. The WHO Constitution states that “the enjoyment of the highest attainable standard of health” is a fundamental human right. The right to health, moreover, is a treaty obligation with clear obligations. Despite robust international norms, unconscionable health disparities exist between the world’s rich and poor, causing enormous suffering. The WHO urges “closing the health gap in a generation” through action on the social determinants of health. As the Marmot Commission observed: “the social conditions in which people are born, live, and work are the single most important determinant of good or ill …

Adaptation To The Health Consequences Of Climate Change As A Potential Influence On Public Health Law And Policy: From Preparedness To Resilience, Lindsay F. Wiley

Georgetown Law Faculty Publications and Other Works

Because the health effects of climate change are likely to be significant and far-reaching, a key component of climate change adaptation will be our public health infrastructure. Perhaps counter-intuitively, recent emphasis in public health law on preparedness for extraordinary events may be to the detriment of our ability to cope with the health impacts of climate change. While existing emergency preparedness law will necessarily be an important backdrop for health-focused climate change adaptation efforts (especially with regard to natural disasters and infectious disease outbreaks), the focus on emergency preparedness in recent years does not necessarily situate us well for handling …

The Right To Bear Arms: A Uniquely American Entitlement, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

In District of Columbia v. Heller the Supreme Court held that individuals have a constitutional right to own firearms, notably to keep a loaded handgun at home for self-protection. The historic shift announced by Heller was the recognition of a personal right, rather than a collective right tied to state militias. In McDonald v. Chicago, the Supreme Court – in a familiar 5-4 ideological split – held that the 2nd Amendment applies not only to the federal government, but also to state and local gun control laws. In his dissent, Justice Stevens predicted that “the consequences could prove far more …

The United States' Engagement In Global Tobacco Control: Proposals For Comprehensive Funding And Strategies, Thomas J. Bollyky, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Tobacco use kills more people annually than HIV/AIDS, tuberculosis, and malaria combined. Unless action is taken, tobacco-related diseases will kill hundreds of millions more in coming decades, mostly in low- and middle-income countries. Beyond its effects on morbidity and mortality, tobacco use has dramatic social and economic consequences, consuming healthcare budgets, robbing families of their primary wage earners, and hindering economic development. Tobacco consumption is shifting from industrialized to developing countries, spurred by rising incomes, trade liberalization, and intensive marketing.

Although Congress empowered the U.S. Food and Drug Administration to regulate tobacco domestically, the United States has failed to lead …