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Contents - JLME - 2010 Volume 38: 3
Table of Contents
  1. Table Of Contents
Letter From The Editor
  1. Letter From The Editor
Symposium Articles
  1. Foreword Innovative Solutions to Closing the Health Gap Between Rich and Poor: A Special Symposium on Global Health Governance
  2. Seven Challenges in International Development Assistance for Health and Ways Forward
  3. Global Health Governance: Commission on Social Determinants of Health and the Imperative for Change
  4. Achieving Health Equity on a Global Scale through a Community-Based, Public Health Framework for Action
  5. Global Health Governance and the Challenge of Chronic, Non-Communicable Disease
  6. Implementing Public Health Regulations in Developing Countries: Lessons from the OECD Countries
  7. Basic Survival Needs and Access to Medicines - Coming to Grips with Trips: Conversion + Calculation
  8. Addressing Global Health Governance Challenges through a New Mechanism: The Proposal for a Committee C of the World Health Assembly
  9. Lessons from the Experience of U.N. Convention on the Rights of Persons with Disabilities: Addressing the Democratic Deficit in Global Health Governance
  10. A Framework Convention on Global Health: Social Justice Lite, or a Light on Social Justice?
  11. Why the West Is Perceived as Being Unworthy of Cooperation
  12. Examining the Global Health Arena: Strengths and Weaknesses of a Convention Approach to Global Health Challenges
  13. Mitigation/Adaptation and Health: Health Policymaking in the Global Response to Climate Change and Implications for Other Upstream Determinants
  14. A Global Framework Convention on Health: Would it Help Developing Countries to Fulfil Their Duties on the Right to Health? A South African Perspective
Independent Articles
  1. Developing a Policy for Sexual Assault Examinations on Incapacitated Patients and Patients Unable to Consent
  2. Medical Marijuana 2010: It's Time to Fix the Regulatory Vacuum
  3. Death, Brain Death, and the Limits of Science: Why the Whole-Brain Concept of Death Is a Flawed Public Policy
  4. Bridging the Divide between Genomic Science and Indigenous Peoples
Columns
  1. Currents in Contemporary Ethics - State Run Newborn Screening in the Genomic Era, or How to Avoid Drowning When Drinking from a Fire Hose
  2. Teaching Health Law -Teaching Social Justice and Health: Professionalism, Ethics, and Problem- Solving in the Medical-Legal Classroom
  3. Recent Case Developments in Health Law - False Claims Act: The Right Treatment for Off-Label Marketing?
Table of Contents
Table Of Contents
ASLME - [PDF] (Free Download)
451 Foreword Lawrence O. Gostin and Emily A. Mok 459 Seven Challenges in International Development Assistance for Health and Ways Forward Devi Sridhar This paper outlines seven challenges in development assistance for health, which in the current financial context, have become even more important to address. These include the following: (1) the proliferation of initiatives, focusing on specific diseases or issues, as well as (2 ) the lack of attention given to reforming the existing focal health institutions, the WHO and World Bank. (3) The lack of accountability of donors and their influence on priority- setting are part of the reason that there is "initiavitis," and resistance to creating a strong UN system. (4) Other than absolute quantity of aid, three other challenges linked to donors relate to the quality of aid financing particularly the pragmatic difficulties of financing horizontal interventions, (5) the marginal involvement of developing country governments as aid recipients, and (6) the heavy reliance on Northern-based organizations as managers of funds. (7) The final challenge discussed focuses on two unintended consequences of the recent linking of health and foreign policy for international development assistance. The paper then provides three suggestions for ways forward: creating new mechanisms to hold donors to account, developing national plans and strengthening national leadership in health, and South-South collaboration.
Letter From the Editor
Letter From The Editor
ASLME - [PDF]

Every issue of the Journal of Law, Medicine & Ethics that I send to the printer is, for me, bittersweet. My colleagues and I work on it nonstop for months, only to abruptly stop that work and send it away as our deadline nears, never wholly satisfied that we have created a perfect issue of the journal. I suspect most editors share some of these conflicting and melancholy feelings with their own publications.
Symposium Articles
Foreword Innovative Solutions to Closing the Health Gap Between Rich and Poor: A Special Symposium on Global Health Governance
Lawrence O. Gostin and Emily A. Mok - [PDF]

Health plays a fundamental role in our lives as individuals and as members of society. At the individual level, health is critical to a person's well-being and can affect his or her opportunities in the world. Health is also important to public welfare because a basic level of human functioning is a necessary condition for the development and stability of economic, social, and political structures within a society. International norms reinforce the special value of human health ranging from the constitutional mission of World Health Organization (WHO), to the human right to health, through the Millennium Development Goals (MDGs) - all of which oblige states to act in concert for the protection and promotion of health.
Seven Challenges in International Development Assistance for Health and Ways Forward
Devi Sridhar - [PDF]

Introduction Over the past 20 years, international development assistance for health has increased, albeit for some diseases more than others.1 However, the triple crises of food, fuel, and finance have raised questions regarding whether aid flows will continue to increase, or even be maintained in the coming future. Health and education are often the first victims of budget cuts in times of limited funding and competing priorities as they are viewed to be in the realm of "low politics" as opposed to security and military spending, which are seen as "high politics." 2 Cuts in overseas development aid will have a drastic impact on countries where external funding makes up a significant proportion of national health budgets. Although global health aid accounts for only 0.3% of total expenditures on health globally (6.5% in sub-Saharan Africa),3 in some countries like the Solomon Islands and Mozambique, for example, 82% and 66% of the national health budgets respectively come from external resources.4 WHO estimates that 23 countries have over 30% of their total health expenditures funded by donors.
Global Health Governance: Commission on Social Determinants of Health and the Imperative for Change
Ruth Bell, Sebastian Taylor, and Michael Marmot - [PDF]

I. Introduction On August 28, 2008, Michael Marmot, Chair of the Commission on Social Determinants of Health, formally handed over the Commission's Final Report to Margaret Chan, the Director-General of the World Health Organization, at the Palais des Nations in Geneva. It was a significant moment. Dr. Chan addressed a hall packed with representatives of the world's communications media in a speech that was remarkably direct. Dr. Chan reiterated the Commission's position that to improve health and health equity action needs to be taken not just across the health sector but across all social and economic policy areas, and stated, "Social deprivation is not a matter of fate. It is a marker of policy failure."
Achieving Health Equity on a Global Scale through a Community-Based, Public Health Framework for Action
Laura Anderko - [PDF]

As a worldwide economic crisis emerged at the end of 2008, international health agencies were quick to highlight its predictable impact on health in the poorest of communities. The World Health Organization (WHO) underscored the need for a multisectoral approach to the crisis, "seeking health gains through demonstrating the importance of health in all policies" and whether current investments in health addressed the broader social determinants of health.1 However, despite good intentions and decades of discussion addressing the need for transformative changes globally to reduce poverty and improve health equity, little progress has been made.
Global Health Governance and the Challenge of Chronic, Non-Communicable Disease
Roger S. Magnusson - [PDF]

Judging by their contribution to the global burden of death and disability, chronic, non-communicable diseases (NCDs) are the most serious health challenge facing the world today.1 The statistics tell a frightening story. Over 35 million people died from chronic diseases in 2005 - principally cardiovascular disease, cancer, and chronic respiratory disease. 2 Driven by population growth and population ageing, deaths from non-communicable diseases are expected to increase by 17% over the period 2005-2015,3 accounting for 69% of global deaths by 2030.4
Implementing Public Health Regulations in Developing Countries: Lessons from the OECD Countries
Emily A. Mok, Lawrence O. Gostin, Monica Das Gupta, and Max Levin - [PDF]

I. Introduction Public health agencies undertake a broad range of health promotion and injury and disease prevention activities in collaboration with an array of actors, such as the community, businesses, and non-profit organizations. These activities are "multisectoral" in nature and centered on public health agencies that oversee and engage with the other actors.1 Public health agencies can influence the hazardous activities in the private sector in a variety of ways, "ranging from prohibition and regulation to volunteerism, and from cooperation to cooption." 2 Hence, a public health agency that possesses the necessary administrative resources and authority is vital to the effective implementation of health policies and regulations.
Basic Survival Needs and Access to Medicines - Coming to Grips with Trips: Conversion + Calculation
Rudolf V. Van Puymbroeck - [PDF]

I. Introduction and Background 1. The Wider Problem of Access to Medicines When 47-year-old Simba Abalo, an unemployed retired soldier in Lome, Togo, found out that he had AIDS in September 2007, he was unable to receive government-supplied antiretroviral drugs: "CAMEG [the state's central medicines purchasing organization]," he said, "told me they were not taking any new cases for six months because they had run out of drugs."
Addressing Global Health Governance Challenges through a New Mechanism: The Proposal for a Committee C of the World Health Assembly
Ilona Kickbusch, Wolfgang Hein, and Gaudenz Silberschmidt - [PDF]

Introduction In January 2010 the Director General of the World Health Organization (WHO) called for an "informal consultation on the future of financing for WHO" and in her opening remarks expressed the need to make the WHO fit for purpose given the unique health challenges of the 21st century
Lessons from the Experience of U.N. Convention on the Rights of Persons with Disabilities: Addressing the Democratic Deficit in Global Health Governance
Janet E. Lord, David Suozzi, and Allyn L. Taylor - [PDF]

Introduction The United Nations Convention on the Rights of Persons with Disabilities (the CRPD or the Convention), adopted on December 13, 2006, and entered into force on May 3, 2008, constitutes a key landmark in the emerging field of global health law and a critical milestone in the development of international law on the rights of persons with disabilities.1 At the time of its adoption, the U.N. High Commissioner for Human Rights heralded the CRPD as a rejection of the understanding of persons with disabilities "as objects of charity, medical treatment and social protection" and an embrace of disabled people as "subjects of rights."
A Framework Convention on Global Health: Social Justice Lite, or a Light on Social Justice?
Scott Burris and Evan D. Anderson - [PDF]

I. Introduction A decade ago, Jonathan Mann made a powerful case that human rights could provide a vocabulary and mode of analysis for understanding and advancing health.1 He made the case well, and put the idea into inspired practice, but the idea was neither new nor his alone. The idea that social justice - and henceforth in this article we will use that term loosely (and with obvious imprecision) to embrace goods like human rights, social equality, and distributive justice - was intrinsically important to health resonated with the social epidemiology already gathering force (not to mention an enduring theme running through the history of public health work).
Why the West Is Perceived as Being Unworthy of Cooperation
Gorik Ooms - [PDF]

Natural selection generated a natural sense of justice. This natural sense of justice created a set of natural rights; rights humans accorded to each other in virtue of being members of the same tribe. Sharing the responsibility for natural rights between all members of the same tribe allowed humans to take advantage of all opportunities for cooperation. Human rights are the present day political emanation of natural rights. Theoretically, human rights are accorded by all humans to all humans in virtue of being humans; however, the idea that the corresponding responsibility is now shared among all humans is not broadly accepted.
Examining the Global Health Arena: Strengths and Weaknesses of a Convention Approach to Global Health Challenges
Just Balstad Haffeld, Harald Siem, and John-Arne Rottingen - [PDF]

Introduction Global health is a concept which in recent years has evoked a lot of interest from both academics, politicians, celebrities, and the media. The term "global health" implies a globally shared responsibility to provide health as a public good through an expansive number of initiatives. This emerging era of consciousness about our international interdependence, regardless of a problem's geographic location or type of disease, may be a good moment for exploring the strengths and weaknesses of an international law approach to global health challenges: a global health convention.
Mitigation/Adaptation and Health: Health Policymaking in the Global Response to Climate Change and Implications for Other Upstream Determinants
Lindsay F. Wiley - [PDF]

I. Introduction In coming decades, enhanced global health governance will be crucial to achieving international health and development objectives in the face of a number of challenges;1 this article focuses on one of them. Climate change, which is now widely recognized as the defining challenge of the 21st century,2 will make the work of ensuring the conditions in which people can be healthy more difficult in a myriad of ways.3 Scientists from both the health and climate communities have been highlighting the significant interaction between climate and health for decades and have made significant strides in integrating health and environmental research.
A Global Framework Convention on Health: Would it Help Developing Countries to Fulfil Their Duties on the Right to Health? A South African Perspective
Mark Heywood and John Shija - [PDF]

It is arguable that the delivery of global health has reached an impasse. This is evident not only in unresolved debates that are raging about where to allocate health aid or how to sustain and expand funding for AIDS treatment,1 but also in challenges facing national health systems that are incapable of purely domestic resolution. But there is some irony and much opportunity in this situation. Not only have the last 20 years seen an unprecedented growth in funding for health, mainly through funding for AIDS, but there has also been a range of initiatives and ideas2 that have generated better knowledge not only of the determinants of health,3 but also of how to attain it.4 Scientists, public health experts, and activists have created a store of intellectual knowledge, technology, and ideas, which, if properly and fairly deployed, might provide the opportunity to re-launch tangible progress towards the progressive realization of the right to health on a global scale.
Independent Articles
Developing a Policy for Sexual Assault Examinations on Incapacitated Patients and Patients Unable to Consent
Mary E. Carr and Alda L. Moettus - [PDF]

Sexual assault cases are challenging for both the patient and provider, particularly given the emotional and logistic overlays in the majority of these cases. In this article we offer sexual assault programs information and areas for consideration when developing a policy addressing sexual assault examinations on patients who are either incapacitated or otherwise unable to consent to examination. This information is based on our experience in creating and implementing such a policy for our program. We also offer the written policy and associated consent form that we designed (see Figures 1 and 2).
Medical Marijuana 2010: It's Time to Fix the Regulatory Vacuum
Peter J. Cohen - [PDF]

Washington, D.C.'s City Council has recently taken the first step towards legalizing the use of "medical marijuana" in accordance with the provisions of the Legalization of Marijuana for Medical Treatment Initiative of 1998 (Initiative 59).2 This action was not overruled by the United States Congress within the 30-day deadline imposed by the District of Columbia's Home Rule Statute. The Council is now crafting regulations3 that will govern the therapeutic and palliative use of this drug with the goal of avoiding some of the problems faced by the other states that have legalized medical marijuana; however, the proposed rules do not establish criteria for legitimate medical practice when medical marijuana is recommended (discussed infra). If the enabling regulations are passed by the D.C. Council and not rejected by the Congress, the District of Columbia will join over one-quarter of the states in legalizing medical marijuana (Table I). On the other hand, if the D.C. Council fails to act favorably on the final regulations (or if Congress nullifies the Council's approval), then the effective legalization of medical marijuana will die and not be reconsidered until next year.
Death, Brain Death, and the Limits of Science: Why the Whole-Brain Concept of Death Is a Flawed Public Policy
Mike Nair-Collins - [PDF]

The 1981 Uniform Determination of Death Act (UDDA)1 states: An individual that has sustained either (1) irreversible cessation of circulatory and respiratory functions, or (2) irreversible cessation of all functions of the entire brain, including the brain stem, is dead.
Bridging the Divide between Genomic Science and Indigenous Peoples
Bette Jacobs, Jason Roffenbender, Jeff Collmann, Kate Cherry, LeManuel Lee Bitsoi, Kim Bassett, and Charles H. Evans, Jr. - [PDF]

The new science of genomics endeavors to chart the genomes of individuals around the world, with the dual goals of understanding the role genetic factors play in human health and solving problems of disease and disability. From the perspective of indigenous peoples and developing countries, the promises and perils of genomic science appear against a backdrop of global health disparity and political vulnerability. These conditions pose a dilemma for many communities when attempting to decide about participating in genomic research or any other biomedical research. Genomic research offers the possibility of improved technologies for managing the acute and chronic diseases that plague their members.
Columns
Currents in Contemporary Ethics - State Run Newborn Screening in the Genomic Era, or How to Avoid Drowning When Drinking from a Fire Hose
Ellen Wright Clayton - [PDF]

Parents, providers, policy makers, and the public need to talk about the implications of advances in genomic technologies for state run newborn metabolic screening programs. Technologies, such as highly multiplex testing and whole genome sequencing, are raising old issues with new urgency and are posing new challenges that threaten to overwhelm newborn screening programs.
Teaching Health Law -Teaching Social Justice and Health: Professionalism, Ethics, and Problem- Solving in the Medical-Legal Classroom
Elizabeth Tobin Tyler - [PDF]

Our course on social justice and health began as an experiment between Roger Williams University School of Law and the Warren Alpert Medical School of Brown University. As a course for both law and medical students, it broke relatively new ground by focusing on the intersection between law and the social determinants of health and the ways in which lawyers and doctors might partner to address social and health disparities. The course blends professionalism, ethics, and problem-solving by using case studies that raise practical challenges at the intersection of poverty, law, and health. This kind of collaborative, interdisciplinary teaching presents many challenges and rewards, which I discuss in this essay.
Recent Case Developments in Health Law - False Claims Act: The Right Treatment for Off-Label Marketing?
Sally Wang - [PDF]

Introduction The False Claims Act (FCA), 31 U.S.C. 3729, a post-Civil War law inspired by cases of defense contracting fraud, was revitalized in 1986.1 Since then it has been used to sue both manufacturers and providers of pharmaceuticals. In some cases, these suits were meant to target off-label marketing of pharmaceuticals. In 2009, the 11th Circuit rendered a decision in Hopper v. Solvay Pharmaceuticals that dramatically limits the ability of private plaintiff whistleblowers to bring qui tam suits under the FCA for such marketing. In June 2010, the Supreme Court denied certiorari, making the Circuit court decision final.