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Contents - JLME - 2007 Volume 35: 4
Table of Contents
  1. Table of Contents
Letter From The Editor
  1. Letter From The Editor
Symposium Articles
  1. Global Health Law, Ethics, and Policy
  2. The Duty of States to Assist Other States in Need: Ethics, Human Rights, and International Law
  3. The Proliferation of Human Rights in Global Health Governance
  4. Advancing Health Rights in a Globalized World: Responding to Globalization through a Collective Human Right to Public Health
  5. Addressing the Global Tragedy of Needless Pain: Rethinking the United Nations Single Convention on Narcotic Drugs
  6. Mapping the Scope and Opportunities for Public Health Law in Liberal Democracies
  7. An Exploration of Conceptual and Temporal Fallacies in International Health Law and Promotion of Global Public Health Preparedness
  8. Limited Liability and the Public's Health
  9. Detention and the Evolving Threat of Tuberculosis: Evidence, Ethics, and Law
  10. Through the Quarantine Looking Glass: Drug-Resistant Tuberculosis and Public Health Governance, Law, and Ethics
  11. Nanotechnology in Global Medicine and Human Biosecurity: Private Interests, Policy Dilemmas, and the Calibration of Public Health Law
  12. What is Fair? Choice, Fairness, and Transparency in Access to Prescription Medicines in the United States and Australia
  13. Looking Ahead: Addressing Ethical Challenges in Public Health Practice
  14. The Ethics of Restrictive Licensing for Handguns: Comparing the United States and Canadian Approaches to Handgun Regulation
  15. The Ancillary-Care Responsibilities of Researchers: Reasonable But Not Great Expectations
Independent Articles
  1. Ethical Implications of Physician Involvement in Lawsuits on Behalf of the Tobacco Industry
  2. Jewish Perspectives on the Use of Preimplantation Genetic Diagnosis
  3. Luck, Genes, and Equality
  4. Ethics at Phase 0: Clarifying the Issues
Columns
  1. Currents in Contemporary Ethics
  2. Teaching Health Law
  3. The Ethical Health Lawyer
  4. Reviews in Medical Ethics
  5. Recent Developments in Health Law
Table of Contents
Table of Contents
ASLME - [PDF] (Free Download)
Table of Contents
Letter From the Editor
Letter From The Editor
ASLME - [PDF]

Global Health Law, Ethics, and Policy
Symposium Articles
Global Health Law, Ethics, and Policy
Lawrence O. Gostin, James G. Hodge, Jr. - [PDF]

Global Health Law, Ethics, and Policy
The Duty of States to Assist Other States in Need: Ethics, Human Rights, and International Law
Lawrence O. Gostin, Robert Archer - [PDF]

In this article, Gostin and Archer explore the varied lenses through which governments are obligated to address humanitarian needs. States' responsibilities to help others derive from domestic law, political commitments, ethical values, national interests, and international law. What is needed, however, is clarity and detailed standards so that States can operationalize this responsibility, making it real for developing countries. Transnational cooperation needs to be more effective and consistent to provide assistance for the world's poorest and least healthy people.
The Proliferation of Human Rights in Global Health Governance
Lance Gable - [PDF]

Human rights play an integral role in the global governance of health. Recently, both structural and normative aspects of human rights have proliferated across multiple levels and within multiple contexts around the world. Human rights proliferation is likely to have a positive impact on the gover-nance of health because it can expand the avenues through which a human rights framework or human rights norms may be used to address and improve health.
Advancing Health Rights in a Globalized World: Responding to Globalization through a Collective Human Right to Public Health
Benjamin Mason Meier - [PDF]

The right to health was codified in Article 12 of the International Covenant on Economic, Social and Cultural Rights as an individual right, focusing on individual health services at the expense of public health systems. This article assesses the ways in which the individual human right to health has evolved to meet collective threats to the public's health. Despite its repeated expansions, the individual right to health remains normatively incapable of addressing the injurious societal ramifications of economic globalization, advancing individual rights to alleviate collective inequalities in underlying determinants of health. By examining modern changes to underlying determinants of health, this article concludes that responding to globalized health threats necessitates a collective right to public health.
Addressing the Global Tragedy of Needless Pain: Rethinking the United Nations Single Convention on Narcotic Drugs
Allyn L. Taylor - [PDF]

The lack of medical availability of effective pain medica-tion is an enduring and expanding global health calamity. Despite important medical advances, pain remains severe-ly 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.
Mapping the Scope and Opportunities for Public Health Law in Liberal Democracies
Roger S. Magnusson - [PDF]

The two questions, "What is public health law"? and "How can law improve the public's health"? are perennial ones for public health law scholars. This paper proposes a framework for conceptualizing discussion and debate about the scope and opportunities for public health law within liberal democracies. Part 2 of the paper draws selectively on this framework in order to highlight some areas where law's potential role deserves greater acknowl-edgment and exploration.
An Exploration of Conceptual and Temporal Fallacies in International Health Law and Promotion of Global Public Health Preparedness
Dhrubajyoti Bhattacharya - [PDF]

In February 2007, Indonesia withheld sharing H5N1 viral samples in order to compel the World Health Organization and Member States to guarantee future access to vaccines for States disproportionately burdened by infectious dis-eases. This article explores conceptual and temporal falla-cies in the International Health Regulations (2005) and the Doha Declaration on the TRIPS Agreement and Public Health, as relates to global public health preparedness. Recommendations include adopting laws to facilitate non-pharmaceutical interventions; securing the rights of affected populations; and fostering inter-State collaborations to pro-mote intra-State public health capacity building
Limited Liability and the Public's Health
Lainie Rutkow, Stephen P. Teret - [PDF]

Corporations, through their products and behaviors, exert a strong effect on the well-being of populations. Industries including firearms, motor vehicles, tobacco, and alcohol pro-duce and market products negatively impact public health. All of these industries are composed of corporations, which are legal fictions designed to provide limited exposure to liability, through a variety of mechanisms, for their investors and direc-tors. This means that when actions are taken on behalf of a corporate entity, the individuals responsible generally will not face personal liability for the negative results of those actions. To illustrate this point, this article considers corporate prod-ucts or practices that have caused harm in varied settings, and analyzes the role that limited liability played in these cases. In addition, the article identifies ways to modify or eliminate some of the principles and practices that accompany limited liability.
Detention and the Evolving Threat of Tuberculosis: Evidence, Ethics, and Law
Richard Coker, Marianna Thomas, Karen Lock, Robyn Martin - [PDF]

The issue of detention as a public health control measure has attracted attention recently. This is because the threat of strains of tuberculosis that are resistant to a wider range of drugs has been identified, and there is renewed concern that public health is threatened. This paper considers whether involuntary detention is justified where voluntary measures have failed or where a patient poses a danger, albeit uncertain, to the public. We discuss the need for strengthening evidence-based assessments of public health risk and suggest that we should reflect more profoundly on the philosophical founda-tions upon which our policies and practices are grounded.
Through the Quarantine Looking Glass: Drug-Resistant Tuberculosis and Public Health Governance, Law, and Ethics
David P. Fidler, Lawrence O. Gostin, Howard Markel - [PDF]

The incident in May-June 2007 involving a U.S. citizen travel-ing internationally while infected with drug-resistant tuber-culosis involved the U.S. federal government's application of its quarantine and isolation powers. The incident and the isolation order raised numerous important issues for public health governance, law, and ethics. This article explores many of these issues by examining how the exercise of quarantine powers provides a powerful lens through which to understand how societies respond to and attempt to govern threats posed by dangerous, contagious pathogens. The article considers historical aspects of governmental power to quarantine and isolate individuals and groups; analyzes the current state of quarantine and isolation law in the United States in light of the recent incident with drug-resistant tuberculosis; and explores global aspects of public health governance and law highlighted by this incident.
Nanotechnology in Global Medicine and Human Biosecurity: Private Interests, Policy Dilemmas, and the Calibration of Public Health Law
Thomas A. Faunce - [PDF]

This paper considers how best to approach dilemmas posed to global health and biosecurity policy by increasing advances in practical applications of nanotechnology. The type of nano-technology policy dilemmas discussed include: (1) expenditure of public funds, (2) public-funded research priorities, (3) pub-lic confidence in government and science and, finally, (4) pub-lic safety. The article examines the value in this context of a legal obligation that the development of relevant public health law be calibrated against less corporate-influenced norms issuing from bioethics and international human rights.
What is Fair? Choice, Fairness, and Transparency in Access to Prescription Medicines in the United States and Australia
Ruth Lopert, Sara Rosenbaum - [PDF]

The importance of prescription drugs to modern medical practice, coupled with their increasing costs, has strengthened imperatives for national health policies that ensure safety and quality, facilitate affordable access, and promote rational use. Australia has made universal and affordable prescription drug coverage a priority for decades, within a policy framework that emphasizes equity and increasing transparency in cover-age design and payment decisions. By contrast, the U.S. lacks such a national policy. Furthermore, federal Medicare reforms aimed at making appropriate drug coverage affordable and accessible employs two icons of the U.S. perception of fairness - the right to choose and the right to challenge coverage design limits - that mask the limited nature of the assistance. As the U.S. seeks to impose its values and priorities on other nations through the negotiation of bilateral and regional trade agreements, it becomes important to consider the two national experiences, in order to avoid trading illusory notions of fairness for true population equity.
Looking Ahead: Addressing Ethical Challenges in Public Health Practice
Nancy M. Baum, Sarah E. Gollust, Susan D. Goold, Peter D. Jacobson - [PDF]

Ethical challenges in public health can have a significant impact on the health of communities if they impede efficien-cies and best practices. Competing needs for resources and a plurality of values can challenge public health policymak-ers and practitioners to make fair and effective decisions for their communities. In this paper, the authors offer an analytic framework designed to assist policymakers and practitioners in managing the ethical tensions they face in daily practice. Their framework is built upon the following set of six consid-erations: determining population-level utility of the proposed action; demonstrating evidence of need and effectiveness of actions; establishing fairness of goals and proposed imple-mentation strategies; ensuring accountability; and, assessing expected efficiencies and costs associated with the proposed action. Together, these considerations create a structured guide to assist decision-makers in identifying potential ethi-cal challenges and in assessing the moral considerations that underlie public health practice - and possibly even, if the conditions are met, reduce the creation of ethical tension. Although the authors, empirical experiences provide the basis for the framework advanced here, their approach remains to be tested and evaluated by public health practitioners.
The Ethics of Restrictive Licensing for Handguns: Comparing the United States and Canadian Approaches to Handgun Regulation
Jon S. Vernick, James G. Hodge, Jr., Daniel W. Webster - [PDF]

The United States and Canada regulate firearms, particularly handguns, quite differently. With only a few state and local exceptions, the U.S. approach emphasizes the ability of most individuals to purchase, possess, and carry handguns. By comparison, Canada has a form of restrictive licensing for handguns that places a premium on community safety. The authors first review the potential individual and community level harms and benefits associated with these differing fire-arm policies. Using this information, they explore the ethical dimensions of the U.S. and Canadian approaches through three major themes of autonomy, prevention of harms, and social justice. The authors conclude that the Canadian approach is consistent with respect for the autonomy of per-sons, fosters the prevention of harms, and more appropriately furthers social justice.
The Ancillary-Care Responsibilities of Researchers: Reasonable But Not Great Expectations
Roger Brownsword - [PDF]

This paper argues that, in a community of rights, the prima facie responsibilities of researchers to attend to the ancil-lary-care needs of their participants would be determined by a four-stage test (relating to placement, capacity, reasonable imposition, and fair demand). This test, it is suggested, sets a standard (and an example) for common law courts that are invited to recognize the ancillary-care responsibilities of researchers, whether as a matter of contract or tort law.
Independent Articles
Ethical Implications of Physician Involvement in Lawsuits on Behalf of the Tobacco Industry
Jess Alderman - [PDF]

The statements of physicians who serve as expert witnesses for the tobacco industry reveal subtle but significant problems. Some expert testimony obfuscates the important issues, and some initially reasonable statements later evolve into extreme positions during cross-examination. Such statements fall into a "gray area" of professional ethics, potentially misleading juries and adversely affecting professional integrity. Medical associations can and should strongly enforce professional standards that do not tolerate tobacco industry influence on physician expert witnesses.
Jewish Perspectives on the Use of Preimplantation Genetic Diagnosis
Mark Popovsky - [PDF]

This article presents an analysis of the ethical considerations raised by preimplantation genetic diagnosis (PGD) from a Jewish perspective. It weighs the Jewish imperatives to pursue good health against a number of harms that may follow from the expanded use of PGD technology, including increased medical risk to the mother, the destruction of embryos and possible emotional harm to the child born from this proce-dure. It pays special attention to the potential harms that may befall those in society who do not have access to PGD or who choose not to employ it.
Luck, Genes, and Equality
Dov Fox - [PDF]

This essay considers principles of distributive justice for access to reproductive biotechnologies which make it possible to enhance the traits of human offspring. The author provides prima facie reason to think that redistributive principles apply to genetic goods and proceed to evaluate the way in which four distributive patterns - egalitarianism, luck egalitarianism, prioritarianism, and sufficientarianism - would implement a just distribution of genetic goods. He argues that the currency of genetic redistribution consists in natural primary goods like health, vision, and rationality as these goods contribute to the biological component of basic capabilities, like being healthy, seeing properly, and being able to reason. The author develops a mixed sufficiency/priority approach to genetic enhancement, and defends this approach against objections.
Ethics at Phase 0: Clarifying the Issues
Jonathan Kimmelman - [PDF]

The Food and Drug Administration (FDA) and the European Agency for the Evaluation of Medicinal Products (EMEA) recently issued documents encouraging sponsors to consider microdose testing before launching Phase I trials, and many commentators predict that such methodologies will be applied more routinely in drug development. However, exploratory testing has provoked several ethical criticisms. Skeptics ques-tion the value and validity of microdose trials, and whether they present a reasonable balance of risks and benefits for subjects. Another major criticism is that such studies serve mainly commercial ends. The present article explores these and other ethical concerns for studies conducted in the oncol-ogy setting. It concludes that microdosing is not inconsistent with prevailing practices in Phase I research, and that in prin-ciple, such studies could strengthen the ethical basis for Phase I trials by providing them better evidentiary justification.
Columns
Currents in Contemporary Ethics
Yann Joly, Gillian Nycum - [PDF]

Currents in Contemporary Ethics
Teaching Health Law
Charity Scott - [PDF]

Teaching Health Law
The Ethical Health Lawyer
Christie L. Hager - [PDF]

The Ethical Health Lawyer
Reviews in Medical Ethics
Andrea Ott - [PDF]

Reviews in Medical Ethics
Recent Developments in Health Law
Matthew Gordon, Rachel E. Caplan and Rebecca Entigar Nauta - [PDF]

Recent Developments in Health Law