Law Commons^™

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 …

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 …

The Pharmaceutical Industry, Aids And Justice, Jose López Guzman

Angela Aparisi Miralles

This article offers an approximation to the broad, and complicated, framework of relationships between the Third World and pharmaceutical companies. In the first part of this work, reference is made to the poverty of these countries, their lack of health education, the scarcity of basic hygiene, and of course, their greatly limited access to medicines, especially those for AIDS. The article then proceeds to the issue of the pharmaceutical companies’ degree of responsibility in the paucity of medicines in certain areas of the world. One factor that most limits access to medicines is price. Many sectors propose acting upon the …

What Happened To No-Fault? The Role Of Error Reporting In Healthcare Reform, Henry Y. Huang, Farzad Soleimani

Henry Y Huang

No-fault systems for compensating medical injuries offer theoretical advantages over tort-based malpractice litigation, but may not actually reduce medical error rates or costs in practice. Surveys of doctors in the United States, a tort-based system, and New Zealand, a no-fault system, show that physicians across both systems share similar concerns about error reporting. These results suggest that error reporting, instead of simple cost reduction, should play a central role in no-fault compensation systems, which would reduce mistakes, improve quality going forward, generate feedback to physicians, and provide the public with greater information about their healthcare providers.

Bureaucracy, Bacteria, And Blame: Risk Based Inspection Systems And The Modern Food Saftey Scheme, Educating Americans To Just Do It Well Done, Heather N. Sutton

Heather N. Sutton

This comment focuses on the recent implementation of the risk based inspection system (RBIS) by the United States Department of Agriculture. A discussion of food safety evolution and consideration of the impact of the system, pre-RBIS and post-RBIS, concludes that consumer savviness is not adequately taken into account and that education as to food safety and risk is the most efficient and necessary component to government efforts to address consumer health as related to food consumption.

The Trouble With Putting All Of Your Eggs In One Basket: Using A Property Rights Model To Resolve Disputes Over Cryopreserved Embryos, Bridget M. Fuselier

Bridget M Fuselier

“The Trouble With Putting All of Your Eggs in One Basket:

Using a Property Rights Model to Resolve Disputes Over Cryopreserved Embryos”

Bridget M. Fuselier

ABSTRACT

This article covers a very current and relevant topic in today’s legal environment. Previous articles have merely discussed competing models or coverage of the disputes in the case law. My article embarks upon a comprehensive look at the specific problem presented and then goes on to offer a specific model with proposed legislation to address these disputes in a fundamentally more efficient manner.

As evidenced by current efforts in a number of states, the …

People As Crops, Evelyn L. Wilson

Evelyn L. Wilson

In 1807, Congress passed a law prohibiting the importation of slaves. The South began to feel the effect of labor shortages and prices escalated. To meet this demand, farmers in the upper south states, especially Virginia, began the systematic breeding of slaves for sale to the southwest. Through the use of statements from Virginia statesmen and from some of Virginia’s former slaves, my paper discusses slave breeding, first as a consequence of slavery, as an added benefit to the labor obtained from the slave.

My father was born in Virginia, as was his father, as was his father, as was …

Can State Health Reform Initiatives Achieve Universal Coverage? California's Recent Failed Experiment, Susan A. Channick

Susan Channick

No abstract provided.

Dumping Emtala: Restoring The Fiduciary Ethic, Improving Community Care, And Increasing Efficiency Through The Membership Model, Joseph A. Gonzalez

Joseph A Gonzalez

The U.S. healthcare system is breaking. Hospital emergency departments ("EDs") disproportionately bear this burden. EMTALA, the federal law that mandates treatment in an emergency, is responsible. By forcing a hospital to provide medical treatment, despite a patient's inability to pay, EMTALA has altered treatment standards for the worse. In this note, I suggest that repealing EMTALA will allow the market to capture the treatment values that motivated EMTALA's passage. Permitting EDs to base treatment on a patient's pre-existing hospital membership encourages better treatment than EMTALA. A market driven ED will succeed where EMTALA has failed.

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 …

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: 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, …

The Duty Of Treatment: Human Rights And The Hiv/Aids Pandemic, Noah B. Novogrodsky

Noah B Novogrodsky

This article argues that the treatment of HIV and AIDS is spawning a juridical, advocacy and enforcement revolution. The intersection of AIDS and human rights was once characterized almost exclusively by anti-discrimination and destigmatization efforts. Today, human rights advocates are demanding life-saving treatment and convincing courts and legislatures to make states pay for it. Using a comparative Constitutional law methodology that places domestic courts at the center of the struggle for HIV treatment, this article shows how the provision of AIDS medications is reframing the right to health and the implementation of socio-economic rights. First, it locates an emerging right …

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 …

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 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; …

The Impact Of Government-Mandated Public Access To Biomedical Research: An Analysis Of The New Nih Depository Requirements, Kristopher A. Nelson

Kristopher A Nelson

On December 26, 2007, President Bush signed the Consolidated Appropriations Act of 2008. The bill, which became Public Law 110-161, contained a new requirement that manuscripts developed through funding by the National Institutes of Health (NIH) be made available to the public, free of charge, within one year after publication. This new mandatory requirement struck a compromise position between the existing pay-to-access model of private journal publishers and the potential free-for-all of the public domain. But did it go far enough? Should Congress have adopted a more aggressive policy of opening access to research? Alternatively, did Congress go too far, …

Paging King Solomon: Towards Allowing Organ Donation From Anencephalic Infants, Fazal Khan

Fazal Khan

The article, Paging King Solomon: Towards Allowing Organ Donation from Anencephalic Infants, argues that organ donation from anencephalic infants is ethically and legally justifiable. Anencephaly is a medical condition characterized by a lack of brain development above the brainstem, so such children often lack a cerebrum, cerebellum and a skull. With an intact brainstem, these children can maintain heart and lung function. Without higher brain functioning though, these children are not capable of human consciousness and they typically have very short life spans measured in days or weeks. The way in which an anencephalic infant dies typically destroys the suitability …

On Breaking Patents: Separating Strands Of Fact From Fiction Under Trips, Cynthia M. Ho

Cynthia M Ho

This article provides the first comprehensive analysis of when compulsory licensing of patents is permissible as a matter of international law under the Agreement of Trade-Related Aspects of Intellectual Property (TRIPS). Thailand’s recent compulsory licenses of patents on a variety of medications provide a convenient vehicle to analyze the limits of compulsory licensing under TRIPS. Thailand’s actions are unique; most countries hesitate to issue compulsory licenses in the wake of legal uncertainties regarding TRIPS requirements as well as political pressure. This article capitalizes on the many issues involved in Thailand’s licenses to provide an authoritative interpretation of the scope of …

Optimal Federalism Across Institutions: Theory And Applications From Environmental Policies And Health Care, Dale B. Thompson

Dale Thompson

This article presents a framework to analyze federalism based on enactment, implementation, and enforcement institutions. The framework provides a mechanism to determine whether a particular public policy should be conducted at a state or federal level, by examining economies and diseconomies of scale inherent in each of these institutions. This article then applies the framework in a comparison of environmental policies for wetlands and endangered species, and in an analysis of a health care policy. These applications can then serve as guides to legislators and judges in analyzing federalism concerns.

The Kidney Donor Scholarship Act: How College Scholarships Can Provide Financial Incentives For Kidney Donation While Preserving Altruistic Meaning, Jake Linford

Jake Linford

In the United States, lives are lost on a daily basis due to a significant shortfall in the availability of kidneys for transplantation. The current debate over possible solutions has primarily taken place at two theoretical poles—open markets and pure altruism. This article provides a timely and original response, bridging the gulf between the poles by proposing an educational scholarship to encourage kidney donation, and presenting data which indicates that the scholarship incentive may well increase the availability of transplantable kidneys in a way that preserves altruistic donation and mitigates potentially coercive market pressures. In making this case, this article …

The Ghost In Our Genes: Ehical And Legal Implications Of Epigenetics, Gary E. Marchant, Mark A. Rothstein, Yu Cai

Gary E. Marchant

Epigenetics is one of the most scientifically important, and legally and ethically significant, cutting-edge subjects of scientific discovery. Epigenetics link environmental and genetic influences on the traits and characteristics of an individual, and new discoveries reveal that a large range of environmental, dietary, behavioral, and medical experiences can significantly affect the future development and health of an individual and their offspring. This article describes and analyzes the ethical and legal implications of these new scientific findings.

Loco Labels And Marketing Madness: Improving How Consumers Interpret Information In The American Food Economy, Margaret Sova Mccabe

Margaret Sova McCabe

America's current food labeling scheme, as illustrated by the example of salt, is flawed when examined from the consumer and public health perspective. While the Food, Drug, and Cosmetic Act has sound scientific standards, those standards as currently applied to labels do not efficiently signal health information to consumers. Without better information on labels, consumers will continue to make poor choices at the grocery store. However, there are promising new ways to label. Both the United Kingdom and the domestic supermarket chain Hannaford’s have implemented simple health labeling on food packaging or grocery shelves to improve the amount and location …

State Actors Beating Children: A Call For Judicial Relief, Deana Ann Pollard Sacks

Deana A Pollard

Controversy over public school corporal punishment is at an all-time high. On August 20, 2008, the Human Rights Watch/ACLU brought public attention to the issue by releasing its report on corporal punishment of children in American public schools. Lawsuits challenging this state action on constitutional grounds continue to be filed, as advocates seeking to ban school paddling refuse to accept that beating students is constitutionally permissible, despite their repeated losses in the federal courts, and the Supreme Court’s refusal to consider the issue again on June 23, 2008. Ignoring the uproar, nearly half of the United States continue to employ …

The Emergent Logic Of Health Law, Maxwell Gregg Bloche

Maxwell Gregg Bloche

The American health care system is on a glide path toward ruin. Health spending has become the fiscal equivalent of global warming, and the number of uninsured Americans is approaching 50 million. Can law help to divert our country from this path? There are reasons for deep skepticism. Law governs the provision and financing of medical care in fragmented and incoherent fashion. Commentators from diverse perspectives bemoan this chaos, casting it as an obstacle to change. I contend in this article that pessimism about health law’s prospects is unjustified, but that a new understanding of health law’s disarray is urgently …

Plain Language Patents, Robin C. Feldman

Robin C Feldman

Law is a process of Bounded Adaptation. The law that exists at any given moment is constantly driven to adapt to changing circumstances within the framework of what has gone before. The boundaries of that framework are policed by the necessity of articulating an interpretation in a way that gains general acceptance. It is the need to effectively articulate a common logic that mitigates the distortion of personal perspective.

This process of Bounded Adaptation cannot proceed effectively without an adequately structured dialogue that will promote the flow of information and analysis. Nowhere is this dialogue more challenging than at the …

Rulemaking Without Rules: An Empirical Study Of Direct Final Rulemaking, Michael Kolber

Michael Kolber

In an effort to improve efficiency, several administrative agencies have adopted a procedure known as “direct final rulemaking” (DFR). Some academics have debated whether DFR violates the Administrative Procedure Act, but none have studied how DFR has functioned in practice. This paper, which examines the first decade of DFR at the Food and Drug Administration (FDA), is the first of this kind. The results are surprising, and suggest DFR deserves more study than it has received. Intended for noncontroversial rules that are expected to receive no significant comments in a notice-and-comment rulemaking, FDA has often used direct final rulemaking for …

Everything Old Is New Again: The Re-Emerging Public Health Right, Elizabeth A. Weeks

Elizabeth A. Weeks

This Article offers a contemporary examination of traditional public health objectives to address social problems not amenable to individual resolution. Taking the tradition a step further, it defines a “public health right” that may justify certain government actions that otherwise appear to impair individual rights. For example, lawmakers are considering whether current regulations on prescription drugs should be loosened to allow terminally ill patients to access drugs before they have been tested and approved for the general public. This Article concludes that expanding access to experimental drugs would violate the public health right to scientific knowledge and new drug development. …

Punishing Pharmaceutical Companies For Unlawful Promotion Of Approved Drugs: Why The False Claims Act Is The Wrong Rx, Vicki W. Girard

Vicki W Girard

This article criticizes the shift in focus from correction and compliance to punishment of pharmaceutical companies allegedly violating the Food, Drug, & Cosmetic Act (FD&C Act) prohibitions on unlawful drug promotion. Traditionally, the Food and Drug Administration (FDA) has addressed unlawful promotional activities under the misbranding and new drug provisions of the FD&C Act. Recently though, the Justice Department (DOJ) has expanded the purview of the False Claims Act to include the same allegedly unlawful behavior on the theory that unlawful promotion “induces” physicians to prescribe drugs that result in the filing of false claims for reimbursement. Unchecked and unchallenged, …