Law Commons^™

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 …

Influenza A(H1n1) And Pandemic Preparedness Under The Rule Of International Law, Lawrence O. Gostin

O'Neill Institute Papers

A novel strain of Influenza A (H1N1) spread rapidly through Mexico in April 2009 and now spans the globe. By the time WHO was notified and responded, geographical containment was not feasible, leading the agency to call for mitigation. The international outbreak of SARS in 2003 and the more recent Influenza A (H5N1) among birds with limited transmission to humans helped prepare the world for the current pandemic threat. SARS galvanized the WHO to revise the antiquated International Health Regulations (IHR) in 2005, which took effect June 15, 2007. Governments instituted preparedness plans in response to avian influenza.

Despite increased …

Health Insurance Exchanges: Legal Issues, Timothy S. Jost

O'Neill Institute Papers

Health insurance exchanges (HIE) are entities that organize the market for health insurance by connecting small businesses and individuals into larger pools that spread the risk for insurance companies, while facilitating the availability, choice and purchase of private health insurance for the uninsured. While there are legal issues that warrant consideration under a federal, state, or private exchange framework, those issues are not insurmountable barriers to implementation.

The Role Of Erisa Preemption In Health Reform: Opportunities And Limits, Peter D. Jacobson

O'Neill Institute Papers

The Employee Retirement Income Security Act (ERISA) is a federal law regulating the administration of private employer-sponsored benefits including health benefits (i.e., health insurance offered by an employer). In general, since the federal government has exercised its authority to preempt state regulation of the administration of private employer-sponsored health plans, states are blocked from enforcing laws interfering with ERISA.

As many states pursue health care reform experiments, ERISA preemption becomes relevant as a potential limit on the scope and type of reforms states are able to enact. The dominant trend in ERISA litigation has been to preempt state legislation and …

Privacy And Health Information Technology, Deven Mcgraw

O'Neill Institute Papers

The increased use of health information technology (health IT) is a common element of nearly every health reform proposal because it has the potential to decrease costs, improve health outcomes, coordinate care, and improve public health. However, it raises concerns about security and privacy of medical information.

This paper examines some of the “gaps” in privacy protections that arise out of the current federal health privacy standard, the Health Insurance Portability and Accountability (HIPAA) Privacy Rule, the main federal law which governs the use and disclosure of health information.

Additionally, it puts forth a range of possible solutions, accompanied by …

The Constitutionality Of Mandates To Purchase Health Insurance, Mark A. Hall

O'Neill Institute Papers

Health insurance mandates have been a component of many recent health care reform proposals. Because a federal requirement that individuals transfer money to a private party is unprecedented, a number of legal issues must be examined.

This paper analyzes whether Congress can legislate a health insurance mandate and the potential legal challenges that might arise, given such a mandate. The analysis of legal challenges to health insurance mandates applies to federal individual mandates, but can also apply to a federal mandate requiring employers to purchase health insurance for their employees. There are no Constitutional barriers for Congress to legislate a …

Executive Authority To Reform Health: Options And Limitations, Madhu Chugh

O'Neill Institute Papers

Presidential power has provoked increasingly vigorous debate since the turn of this century. In recent years, scholars and lawyers have been grappling with how Congress's dictates may limit the President's Commander-in-Chief power to detain enemy combatants at Guantanamo Bay, to fight wars abroad, and to conduct intelligence activities at home. But policymakers have not yet explored the many possibilities for invoking the President's "Take Care" power to change health care policy.

This paper explores the scope and limits of President Barack Obama's ability to invoke his executive authority to reform health care. Specifically, it identifies ways the Obama Administration can …

Insurance Discrimination On The Basis Of Health Status: An Overview Of Discrimination Practices, Federal Law And Federal Reform Options, Sara Rosenbaum

O'Neill Institute Papers

Actuarial underwriting, or discrimination based on an individual’s health status, is a business feature of the voluntary private insurance market. The term “discrimination” in this paper is not intended to convey the concept of unfair treatment, but rather how the insurance industry differentiates among individuals in designing and administering health insurance and employee health benefit products.

Discrimination can occur at the point of enrollment, coverage design, or decisions regarding scope of coverage. Several major federal laws aimed at regulating insurance discrimination based on health status focus at the point of enrollment. However, because of multiple exceptions and loopholes, these laws …

The Purchase Of Insurance Across State Lines In The Individual Insurance Market, Stephanie W. Kanwit

O'Neill Institute Papers

Proposals to allow the purchase of insurance across state lines (PASL) have gained some support in recent years. Health insurers have traditionally been allowed to sell a policy only within the state that approved and regulates that particular policy. PASL would allow insurers to sell a policy approved in one state to people residing in any state.

Any federal legislation to enact PASL in an individual insurance market would have to address two main legal considerations: 1) the McCarran-Ferguson Act, which allows the states to retain their regulatory authority over insurance, and 2) a constitutional prohibition against the commandeering of …

A Broader Liberty: Js Mill, Paternalism, And The Public’S Health, Lawrence O. Gostin, Kieran G. Gostin

O'Neill Institute Papers

Is the ‘harm principle’, famously propounded by JS Mill and widely adopted in bioethics, an appropriate principle to guide public health regulation? The harm principle limits liberty-limiting interventions to only those instances where the person poses a significant risk of harm to others. However, much of public health regulation is not primarily directed to avert risk to others, but to safeguard the health and safety of the individual him or herself. Think about regulations regarding seatbelts, motorcycle helmets, or the fluoridation of water as illustrations of pervasive public health regulations that are primarily intended to safeguard the individual’s own health …

Science, Politics, And Values: The Politicization Of Professional Practice Guidelines, Lawrence O. Gostin, John D. Kraemer

O'Neill Institute Papers

The Connecticut Attorney General’s recent allegations that the Infectious Disease Society of America violated antitrust law through its treatment guidelines for Lyme disease were neither based in sound science or appropriate legal judgment. Strong scientific evidence favors IDSA’s position that chronic infection with the etiologic agent of Lyme disease does not occur in the absence of objective signs of ongoing infection and that long-term antibiotic use to treat dubious infection, recommended in the quasi-scientific guidelines put forth by the International Lyme and Associated Diseases Society (ILADS), are of no benefit. In siding with ILADS and other chronic Lyme disease advocates, …

President’S Emergency Plan For Aids Relief: Health Development At The Crossroads, Lawrence O. Gostin

O'Neill Institute Papers

The President’s Emergency Plan for AIDS Relief (PEPFAR) was the largest commitment by any nation to combat a single disease in human history, authorizing up to $15 billion over 5 years. On July 30, 2008, President Bush signed into law the historic reauthorization of PEPFAR, dramatically increasing the financial commitment by authorizing up to $48 billion over 5 years, including $5 billion for Malaria and $4 billion for Tuberculosis. PEPFAR’s global targets are inspiring: treat 3 million people; prevent 12 million new HIV infections, and care for 12 million people, including 5 million orphans and vulnerable children. But, PEPFAR has …

Male Circumcision As An Hiv Prevention Strategy In Sub-Saharan Africa: Socio-Legal Barriers, Lawrence O. Gostin

O'Neill Institute Papers

UNAIDS and WHO recommend safe, voluntary male circumcision as an additional, important strategy for the prevention of heterosexually-acquired HIV in men in areas with high HIV prevalence and low levels of male circumcision. Comprehensive male circumcision services should include HIV testing and counseling, partner reduction, and male and female condom use. Yet, male circumcision can have deep symbolic meaning that could pose barriers to implementation. In some parts of the world, it is a traditional practice with religious or cultural significance, in others it is a common hygiene intervention, and in yet others it is unfamiliar or foreign. Consequently, the …

The Deregulatory State, Lawrence O. Gostin

O'Neill Institute Papers

Public health can be achieved only through collective action, not through individual endeavor. Collective goods are essential conditions for health, but can be secured only through a well-regulated society. Yet, successive governments have eroded health and safety protections, with serious consequences. Think about the death of miners, lead in children’s toys, industrial solvents in toothpaste, salmonella in peanut butter, e-coli in spinach, and unsafe or ineffective pharmaceuticals such as COX-2 inhibitors or non-statin cholesterol medications.

Conservatives have waged a campaign against the administrative state that has created and reinforced deep-seated concerns about over-bearing government, particularly at the national level. The …

Global Health Law Governance, Lawrence O. Gostin

O'Neill Institute Papers

The field of public health law traditionally focuses on law at the national and sub-national level. National legal systems, however, are inadequate to deal with major threats to humans. Despite the inadequacies of national governance, there are fundamental questions that need resolution in the field of global health law: Why should governments care about the health of people far away? Are profound health disparities just and, if not, is there a corresponding obligation to redress the injustice? Can international law effectively bind governments, foundations, and corporations to act for the global good? This article, based on a lecture at Emory …

Global Health Law: A Definition And Grand Challenges, Lawrence O. Gostin, Allyn L. Taylor

O'Neill Institute Papers

It has been only recently that scholars have engaged in a serious discussion of "public health law." This academic discourse examines the role of the state and civil society in health promotion and disease prevention within the country. There is an important emerging literature on the international dimensions of health, but no similar systematic definition and exposition of a field we call "global health law." In this article we aim to fill this gap by defining global health law and characterizing the grand challenges. Given the rapid and expanding globalization that is a defining feature of today's world, the need …

Global Health Law: Health In A Global Community, Lawrence O. Gostin

O'Neill Institute Papers

The examination of public health law traditionally focuses on constitutions, statutes, regulations, and common law at the national and sub-national level. However, the determinants of health (e.g., pathogens, air, food, water, even lifestyle choices) do not originate solely within national borders. Health threats inexorably spread to neighboring countries, regions, and even continents. Peoples’ lives are profoundly affected by commerce, politics, science, and technology from all over the world. Global integration and interdependence occur “as capital, traded goods, persons, concepts, images, ideas, and values diffuse across state boundaries.” It is for this reason that law and policy need to be transnational, …

A Theory And Definition Of Public Health Law, Lawrence O. Gostin

O'Neill Institute Papers

The literature, both academic and judicial, on the intersection of law and health is pervasive. The subject of law and health is widely taught, practiced, and analyzed. The fields that characterize these branches of study are called health law, health care law, law and medicine, forensic medicine, and public health law. Do these names imply different disciplines, each with a coherent theory, structure, and method that sets it apart? Notably absent from the extant literature is a theory of the discipline of public health law, an exploration of its doctrinal boundaries, and an assessment of its analytical methodology.

Public health …

The International Migration And Recruitment Of Nurses: Human Rights And Global Justice, Lawrence O. Gostin

O'Neill Institute Papers

The international migration of health workers – physicians, nurses, midwives, and pharmacists – leaves the world’s poorest countries with severe human resource shortages, seriously jeopardizing the achievement of the U.N. health Millennium Development Goals (MDGs). Advocates for global health call active recruitment in low-income countries a crime. Despite the pronounced international concern, there is little research and few solutions. This commentary focuses on the international recruitment of internationally educated nurses (IENs) from the perspective of human rights and global justice. It explains the complex reasons for nurse shortages in rich and poor countries; the duties of source and host countries; …

Ensuring Effective Pain Treatment: A National And Global Perspective, Allyn L. Taylor, Lawrence O. Gostin, Katrina A. Pagonis

O'Neill Institute Papers

Medical availability of effective pain medication is vitally important domestically and globally. Medical advances have substantially improved the technical capacity to control pain and diminish its consequences. Worldwide, millions of persons with chronic, acute, and terminal conditions have found relief from excruciating pain through medical intervention. However, richer countries have disproportionately benefited from improvements in access to and use of pain medication. The tragedy is that for most of the world's population, particularly persons in poorer countries, effective pain control is entirely unavailable.

The Duty Of States To Assist Other States In Need: Ethics, Human Rights, And International Law, Lawrence O. Gostin, Robert Archer

O'Neill Institute Papers

This article deals with a foreign policy question of extraordinary importance: What responsibilities do States have to provide economic and technical assistance to other states that have high levels of need affecting the health and life of their citizens? The question is important for a variety of reasons. There exist massive inequalities in health globally, with the result that poorer countries shoulder a disproportionate burden of disease and premature death. While poor countries have by far the greatest ongoing health needs, they also have the least capacity to meet those needs. In addition to the pervasive and debilitating effects of …

Addressing The Global Tragedy Of Needless Pain: Rethinking The United Nations Single Convention On Narcotic Drugs, Allyn L. Taylor

O'Neill Institute Papers

The lack of medical availability of effective pain medication is an enduring and expanding global health calamity. Despite important medical advances, pain remains severely under-treated worldwide, particularly in developing countries. This article contributes to the discussion of this global health crisis by considering international legal and institutional mechanisms to promote wider accessibility to critical narcotic drugs for pain relief.

Climate Change, Human Health, And The Post-Cautionary Principle, Lisa Heinzerling

O'Neill Institute Papers

In this Article, I suggest two different but related ways of reframing the public discourse on climate change. First, I propose that we move further in the direction of characterizing climate change as a public health threat and not only as an environmental threat. Second, I argue that we should stop thinking of responses to climate change in terms of the precautionary principle, which counsels action even in the absence of scientific consensus about a threat. We should speak instead in terms of a ?post-cautionary? principle for a post-cautionary world, in which some very bad effects of climate change are …

The Difficult Case Of Direct-To-Consumer Drug Advertising, David C. Vladeck

O'Neill Institute Papers

This article will appear in a symposium to pay tribute to Professor Steven H. Shiffrin, one of the leading First Amendment theorists of our time. The author was asked to focus on Professor Shiffrin’s contribution to the development of the commercial speech doctrine. To reflect on the wisdom of Professor Shiffrin’s refusal to rely on general First Amendment theories, the article focuses on the difficult First Amendment problem of regulating direct-to-consumer (DTC) advertising of prescription drugs. In his famous dissent in Virginia Pharmacy Board, then-Justice Rehnquist forecast that, as a consequence of the Court’s ruling, drug companies would soon advertise …

A Critical Examination Of The Fda’S Efforts To Preempt Failure-To-Warn Claims, David A. Kessler, David C. Vladeck

O'Neill Institute Papers

This article explores the legality and wisdom of the FDA’s effort to persuade courts to find most failure-to-warn claims preempted. The article first analyzes the FDA’s justifications for reversing its long-held views to the contrary and explains why the FDA’s position cannot be reconciled with its governing statute. The article then examines why the FDA’s position, if ultimately adopted by the courts, would undermine the incentives drug manufacturers have to change labeling to respond to newly-discovered risks. The background possibility of failure-to-warn litigation provides important incentives for drug companies to ensure that drug labels reflect accurate and up-to-date safety information. …