Health Law and Policy Commons^™

The Fda, Preemption, And Public Safety: Antiregulatory Effects And Maddening Inconsistency, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Most people think of preemption as a technical constitutional doctrine, but it is pivotally important to health and safety, while also opening the door to broad judicial discretion. The Rehnquist and Roberts Courts’ pro-business/pro-preemption jurisprudence is distinctly antiregulatory, invalidating major state public health rules, such as in occupational safety, tobacco control, and motor vehicle safety. Apart from the antiregulatory effects, there is maddening inconsistency. Consider three relatively recent Supreme Court cases. In Riegel v. Medtronic, Inc. (2008), the Court held that federal law bars injured consumers from challenging the safety or effectiveness of FDA-approved medical devices. A year later, …

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 …

Food And Drug Administration Regulation Of Food Safety, Lawrence O. Gostin, Katie F. Stewart

Georgetown Law Faculty Publications and Other Works

Food-borne illness remains a major public health challenge in the United States, causing an estimated 48 million illness episodes and 3000 deaths annually. The FDA Food Safety Modernization Act (FSMA), enacted in 2011, gives the Food and Drug Administration (FDA) new tools to regulate food safety. The act emphasizes prevention, enhanced recall authority, and oversight of imported food.

The FSMA brings the FDA’s food safety regulation in line with core tenets of public health by focusing on preventing outbreaks, rather than reacting to them, and differentiating between foods and food producers based on the degree of risk they pose. The …

The Joint Action And Learning Initiative: Towards A Global Agreement On National And Global Responsibilities For Health, Lawrence O. Gostin, Eric A. Friedman, Gorik Ooms, Thomas Gebauer, Narendra Gupta, Devi Sridhar, Wang Chenguang, John-Arne Røttingen, David Sanders

O'Neill Institute Papers

A coalition of civil society organizations and academics is initiating a Joint Action and Learning Initiative on National and Global Responsibilities for Health (JALI) to research key conceptual questions involving health rights and responsibilities, with the goal of securing a global health agreement andsupporting civil society and community mobilization around the human right to health. The social mobilization is critical to creating the political space that would make such an agreement possible and to ensuring its implementation.

This agreement, such as a Framework Convention on Global Health, would inform post-Millennium Development Goal global health commitments, be grounded in the right …

Dangerous People Or Dangerous Weapons: Access To Firearms For Persons With Mental Illness, Lawrence O. Gostin, Katherine L. Record

Georgetown Law Faculty Publications and Other Works

The recent attempted assassination of Rep. Gabrielle Giffords has once again focused the nation’s attention on the danger of the wide availability of firearms.  The Supreme Court has ruled that gun restrictions may only be imposed on those deemed “prohibited persons” under the Gun Control Act of 1968.  Although some are easily identifiable (e.g., children, convicted felons), one widely inclusive group is not – the mentally ill.

The current system designed to bar the mentally ill from purchasing or possessing firearms is ineffectual due to a lack of reporting and the existence of loopholes.  What’s more, no state has developed …

Can Law Improve Prevention And Treatment Of Cancer?, Roger Magnusson, Lawrence O. Gostin, David Studdert

O'Neill Institute Papers

The December 2011 issue of Public Health (the Journal of the Royal Society for Public Health) contains a symposium entitled: Legislate, Regulate, Litigate? Legal approaches to the prevention and treatment of cancer. This symposium explores the possibilities for using law and regulation – both internationally and at the national level – as the policy instrument for preventing and improving the treatment of cancer and other leading non-communicable diseases (NCDs). In this editorial, we argue that there is an urgent need for more legal scholarship on cancer and other leading NCDs, as well as greater dialogue between lawyers, public health practitioners …

Biosafety Concerns Involving Genetically Modified Mosquitoes To Combat Malaria And Dengue In Developing Countries, Graciela R. Ostera, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Malaria and dengue are the most prevalent mosquito-borne infections worldwide. Because traditional vector control methods have proven to be insufficient to control mosquito populations in endemic areas, scientists are actively working in the design of new strategies, such as genetically modified (GM) mosquitoes, to reduce disease transmission. The replacement of natural populations with GM mosquitoes is becoming a tangible possibility, however, many fear that the release of these organisms into the environment could constitute a significant risk to biodiversity and may cause the unintended spread of GM organisms across national borders.

The Cartagena Protocol on Biosafety, an international agreement originally …

Restoring Health To Health Reform: Integrating Medicine And Public Health To Advance The Population's Wellbeing, Lawrence O. Gostin, Peter D. Jacobson, Katherine L. Record, Lorian E. Hardcastle

Georgetown Law Faculty Publications and Other Works

The Patient Protection and Affordable Care Act is a major achievement in improving access to health care services.  However, evidence indicates that the nation could achieve greater improvements in health outcomes, at a lower cost, by shifting its focus to public health.  By focusing nearly exclusively on health care, policy makers have chronically starved public health of adequate and stable funding and political support.  The lack of support for public health is exacerbated by the fact that health care and public health are generally conceptualized, organized, and funded as two separate systems.  In order to maximize gains in health status …

Is Health Care Reform Unconstitutional?, David Cole

Georgetown Law Faculty Publications and Other Works

No abstract provided.

Reforming The World Health Organization, Devi Sridhar, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Director-General Margaret Chan recently called the WHO overextended and unable to respond with speed and agility to today’s global health challenges. Given the importance of global health cooperation, few would dispute that a stronger, more effective WHO would benefit all. In this commentary, we offer 5 proposals for re-establishing WHO’s leadership.
 
(1) Give Real Voice to Multiple Stakeholders
The WHO would be more effective by giving real voice and representation to key stakeholders, including philanthropies, businesses, public/private partnerships, and civil society. Meaningful stakeholder engagement would instill confidence, and spark investment, in the agency.
 
(2) Improve Transparency, Performance and Accountability
Stakeholders …

Ethical Allocation Of Preexposure Hiv Prophylaxis, Lawrence O. Gostin, Susan C. Kim

Georgetown Law Faculty Publications and Other Works

Civil society-led movements transformed global AIDS action from deep skepticism about extending anti-retroviral (ARV) treatment in low and middle-income countries to an historic scaling up of treatment towards universal access. The AIDS movement, however, is at an inflection point due to the interplay of key health and economic determinants—the global financial downturn, tight foreign aid budgets, and intense resource competition. Policy makers will now have to consider implementation of a new intervention—pre-exposure prophylaxis (PrEP), which could mean a diversion of ARVs from treatment to prevention. The principle underlying PrEP is that ARVs could prevent HIV infection among people who are …

Health Insurance Reform And Intimations Of Citizenship, Nan D. Hunter

Georgetown Law Faculty Publications and Other Works

This article considers the implications of the Patient Protection and Affordable Care Act (PPACA) for social meanings of civic belonging in American society and for possible new forms of individual engagement with the health care system. Once fully implemented, PPACA will have many of the governance characteristics of other social insurance systems, in that it will define membership in a collective undertaking, establish a mechanism for collective security against a shared risk, and channel, incentivize and penalize specific behaviors. The article considers the extent to which PPACA has the potential to also produce new narratives and understandings of social solidarity …

The Who Global Code Of Practice On The International Recruitment Of Health Personnel: The Evolution Of Global Health Diplomacy, Allyn L. Taylor, Ibadat S. Dhillon

Georgetown Law Faculty Publications and Other Works

The May 2010 adoption of the World Health Organization Global Code of Practice on the International Recruitment of Health Personnel created a global architecture, including ethical norms and institutional and legal arrangements, to guide international cooperation and serve as a platform for continuing dialogue on the critical problem of health worker migration. Highlighting the contribution of non-binding instruments to global health governance, this article describes the Code negotiation process from its early stages to the formal adoption of the final text of the Code. Detailed are the vigorous negotiations amongst key stakeholders, including the active role of non-governmental organizations. The …

Turning Citizens Into Subjects: Why The Health Insurance Mandate Is Unconstitutional, Randy E. Barnett

Georgetown Law Faculty Publications and Other Works

In 2010 something happened in this country that has never happened before: Congress required that every person enter into a contractual relationship with a private company. While the author realizes that writers make lots of factual claims that readers are wise to be skeptical about, he proves that an economic mandate like this one is unprecedented. If this mandate had ever happened before, everyone reading this passage would know all the contracts the federal government requires them to make, upon pain of a penalty enforced by the Internal Revenue Service (IRS). No reader, however, can recite any such mandate and …

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 …

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 …

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 …

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 …

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 …

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.

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …