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Lyme Disease: The Surprising Debate In The 2010 Virginia House Of Delegates, Gerald C. Canaan Ii, Karah L. Gunther

Richmond Public Interest Law Review

In most every General Assembly session, there are those bills that while on the surface appear fairly innocuous-quickly take on a life of their own, generating an audible buzz in and around the General Assembly Building. The 2010 Virginia General Assembly session was no different. Amidst hallway discussions concerning the budget, gun rights, and abortion, one could also hear the distinct murmur of a completely novel topic: Lyme disease. Often associated with a small, pesky insect known as the black-legged tick, until this year, Lyme disease had not been the subject of any controversial legislation proposed in the Commonwealth of …

"Substantially Limited:" The Reproductive Rights Of Women Living With Hiv/Aids, Lisa M. Keels

University of Baltimore Law Review

No abstract provided.

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 …

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 …

Implementing Public Health Regulations In Developing Countries: Lessons From The Oecd Countries, Lawrence O. Gostin, Emily A. Mok, Monica Das Gupta, Max Levin

Georgetown Law Faculty Publications and Other Works

The enforcement of public health standards is a common problem in many developing countries. Public health agencies lack sufficient resources and, too often, enforcement mechanisms rely on slow and erratic judicial systems. These limitations can make traditional public health regulations difficult to implement. In this article, we examine innovative approaches to the implementation of public health regulations that have emerged in recent years within OECD countries. These approaches aim to improve compliance with health standards, while reducing dependence on both the legal system and the administrative resources of public health agencies.

This article begins by discussing some traditional forms of …

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 …

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 …

National And Global Responsibilities For Health, Lawrence O. Gostin, Mark Heywood, Gorik Ooms, Anand Grover, John-Arne Røttingen, Wang Chenguang

Georgetown Law Faculty Publications and Other Works

Preventable and treatable injuries and diseases are overwhelming sub-Saharan Africa, the Indian subcontinent, and other impoverished areas of the world. Why are health outcomes among the world’s poor so dire after the first decade of the Millennium Development Goals (MDGs) and despite a quadrupling of international health assistance over the past two decades? We believe that this dynamic can change by establishing clearer understandings of, and forging consensus around and governance structures to support, national and global responsibilities to improve global health.

With the goal of a new post-MDG global health paradigm, we are establishing the Joint Action and Learning …

The Joint Action And Learning Initiative On National And Global Responsibilities For Health, Lawrence O. Gostin, Gorik Ooms, Mark Heywood, Just Haffeld, Sigrun Møgedal, John-Arne Røttingen, Eric A. Friedman, Harald Siem

Georgetown Law Faculty Publications and Other Works

A population’s health and wellbeing is primarily a national responsibility. Every state owes all of its inhabitants a comprehensive package of essential health goods and services under its obligations to respect, protect, and fulfill the human right to health. Yet health is also a global responsibility. Every state has a duty to ensure a safe and healthy world, with particular attention to the needs of the world’s poorest people. Improving health and reducing unconscionable health inequalities is both an international obligation under the human right to health and a matter of global social justice.

The mutual obligations of states to …

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 …

Phase Six Pandemic: A Call To Re-Evaluate Federal Quarantine Authority Before The Next Catastrophic Outbreak, John T. Clarkson

Georgia Law Review

At some point in the future, the United States will confront a deadly pandemic. One potential response to blunt the impact of an outbreak may be the use of a large-scale quarantine. The current statutory framework governing federal quarantine authority, however, is outdated and in need of revision. Any reform must acknowledge that the federal government may be best positioned to respond to national health threats and must simultaneously create limits on federal power to ensure a proper balance of power remains between the states and the federal government. This Note proposes that Congress focus its reform efforts on adding …

High Crimes, Not Misdemeanors: Deterring The Production Of Unsafe Food, Rena I. Steinzor

Faculty Scholarship

In the fall of 2008, Minnesota public health officials became alarmed by an unusually high number of illnesses and deaths caused by salmonella poisoning. Federal and state regulators and the news media eventually traced the outbreak back to products supplied by the Peanut Corporation of America (PCA). Employees shipped batches that tested positive for salmonella from a plant with a leaking roof, mold growing on ceilings and walls, rodent infestation, filthy processing receptacles, and feathers and feces in the air filtration system. Under an agreement with the Food and Drug Administration (FDA), Georgia state inspectors visited the PCA plant nine …

The Legal Ecology Of Resistance: The Role Of Antibiotic Resistance In Pharmaceutical Innovation, Kevin Outterson

Faculty Scholarship

Antibiotic effectiveness is a common pool resource that can be prematurely depleted through resistance. Some experts warn that we may face a global ecological collapse in antibiotic effectiveness. Conventional wisdom argues for more intellectual property rights to speed the creation of new antibiotics. Recent theoretical literature suggests that conservation-based approaches may yield superior results. This Article describes a novel typology for organizing these emerging theories, and provides an early empirical test of these models, using proprietary data on the sales of vancomycin, an important hospital antibiotic for the last three decades.

The results challenge the assumptions in several models, and …

Fighting Antibiotic Resistance: Marrying New Financial Incentives To Meeting Public Health Goals, Aaron S. Kesselheim, Kevin Outterson

Faculty Scholarship

The world faces a worsening public health crisis: A growing number of bacteria are resistant to available antibiotics. Yet there are few new antibiotics in the development pipeline to take the place of these increasingly ineffective drugs. We review a number of proposals intended to bolster drug development, including such financial incentives for pharmaceutical manufacturers as extending the effective patent life for new antibiotics. However, such strategies directly conflict with the clear need to reduce unnecessary antibiotic prescriptions and could actually increase prescription use. As an alternative, we recommend a two-prong, "integrated" strategy. This would increase reimbursement for the appropriate, …

Negotiating Equitable Access To Influenza Vaccines: Global Health Diplomacy And The Controversies Surrounding Avian Influenza H5n1 And Pandemic Influenza H1n1, David P. Fidler

Articles by Maurer Faculty

No abstract provided.

Canadian Food Law Update, Patricia L. Farnese

Journal of Food Law & Policy

Provided below is an overview of developments in Canadian food law and policy in 2009. This update primarily analyzes the regulatory and policy developments and litigation activities by the federal government. This focus reflects the significance of federal activities in the food policy realm. In 2009, regulatory and policy developments continue to be dominated by the 2008 Listeriosis outbreak in ready-to-eat, deli meats. Other noted activities include Canada's ongoing efforts to minimize the effects of infectious diseases related to meat production, Canada's request for a WTO panel to consider the effects of American Country of Origin Labelling, and an initiative …

Health Care Law, Kathleen M. Mccauley, Kristi L. Vanderlaan

University of Richmond Law Review

No abstract provided.

The International Response To Climate Change: An Agenda For Global Health, Lindsay F. Wiley, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

As the international community negotiates a successor to the Kyoto Protocol of the United Nations Framework Convention on Climate Change (UNFCCC), there is new reason to hope that meaningful action might be taken to prevent devastating climate change. Even the more ambitious mitigation targets currently under negotiation, however, will not be sufficient to avoid a profound effect on the public's health in coming decades, with the world's poorest, most vulnerable populations bearing the disproportionate burden. The influence of historic and current emissions will be so substantial that it is imperative to reduce global emissions while at the same time preparing …

Healthy Planet, Healthy People: Integrating Global Health Into The International Response To Climate Change, Lindsay F. Wiley

Georgetown Law Faculty Publications and Other Works

The potentially groundbreaking negotiations currently underway on the international response to climate change and national implementation of commitments under the United Nations Framework Convention on Climate Change (UNFCCC) include a number of hotly contested issues: (1) what degree of climate change is acceptable as a basis for emissions targets, (2) to what extent and in what ways climate change mitigation should incorporate emissions reductions or increased sinks for developing countries, (3) whether the legal regime governing mitigation can take advantage of the huge mitigation potential of changed practices in the land use and agricultural sectors, (4) how adaptation should be …

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 …

Improving Legal Competencies For Obesity Prevention And Control, Wendy Collins Perdue

Law Faculty Publications

Our purpose is to offer action options that will help to improve the legal competencies of public health practitioners and policy decision makers with respect to drafting, interpreting, implementing, and enforcing laws and regulations that are relevant to the effective prevention and control of obesity. The accompanying assessment paper provided a foundation for this agenda by first establishing that legal competence for obesity prevention and control is important for both health professionals, who with proper training can effectively interject health considerations into decision- making processes, and non-health professionals involved with relevant policy and legal work, who with proper training can …

Book Review Of “Populations, Public Health, And The Law,” Wendy E. Parmet (Georgetown University Press, Washington, D.C., 2009), Elizabeth Weeks Leonard

Scholarly Works

Wendy Parmet's new book, Populations, Public Health, and the Law, is a provocative, milestone contribution to the growing body of public health law scholarship. This article reviews this scholarly work.

Pandemic Preparedness: A Return To The Rule Of Law, Wendy K. Mariner, George J. Annas, Wendy E. Parmet

Faculty Scholarship

Current discussions of pandemic influenza and emergency preparedness would do well to heed the lessons of US Airways flight 1549, which landed in the Hudson River in January 2009. This article examines what past emergencies teach us about how to prevent or control epidemics and argues that it is time for a return to the rule of law in pandemic preparedness. The most important resource in emergency preparedness is a healthy, resilient population, which depends importantly on sustainable systems of medical care and public health. Preparedness thus requires more money than law. After September 11, 2001, however, federal emergency preparedness …

Sustainable Commerce: Public Health Law And Environmental Law Provide Tools For Industry And Government To Construct Globally-Competitive Green Economies, T. Rick Irvin, Peter A. Appel

Scholarly Works

This Article examines the legal mechanics underlying the sustainable commerce private/public governance paradigm whereby industry and government create sustainable commerce initiatives which coordinately grow local/state economies and employment, enhance local/state competitiveness in the global marketplace, and at the same time substantially improve local/state public health and environmental infrastructure. This includes an examination of the legal foundation for state/local sustainable commerce initiatives drawn from existing public health and environmental law and a review of two specific local/state sustainable commerce initiatives which have followed this paradigm with impressive results over a two-to-four year timeframe. Part II of this Article examines how public …

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, …

Health Care-Associated Infections: Is There An End In Sight?, Lisa Sprague

National Health Policy Forum

Health care–associated infections (HAIs) have emerged as a significant concern in policy as well as clinical circles. An HAI is an infection acquired during treatment for another condition. Some of the HAI-causing bacteria have become drug-resistant; methicillin-resistant Staphylococcus aureus, or MRSA, is a familiar example. Tied to perhaps 100,000 deaths and $20 billion in health care costs each year, HAIs have given rise to state laws, legislative proposals at the federal level, public-private initiatives, and work at the hospital system and individual hospital level. However, much remains to be done. This issue brief reviews the prevalence of HAIs and the …

Prizes For Innovation Of New Medicines And Vaccines, James Love, Tim Hubbard

Annals of Health Law and Life Sciences

This article argues that prizes can help stimulate medical innovation, control costs and ensure greater access to new medicines and vaccines. The authors explore four increasingly ambitious prize options to reward medical innovation, each addressing flaws in the current patent system. The first option promotes innovation through a large prize fund linked to the impact on health outcomes; the second option rewards the sharing of knowledge, data, and technology with open source dividends; the third option awards prizes for interim benchmarks and discrete technical problems; and the final option removes the exclusive right to use patented inventions in upstream research …

Diseases Endemic In Developing Countries: How To Incentive Innovation, Ann Weilbaecher

Annals of Health Law and Life Sciences

This comment addresses the inadequacies of research and development for diseases endemic in developing countries and explores how the patent system can inhibit innovation for new drugs for neglected diseases. The author analyzes four strategies to encourage innovation, including open source initiatives, patent pools, prizes, and wild card patent extensions, and examines how these alternative systems may spur innovation while balancing cost concerns held by drug manufacturers and purchasers. The author concludes that a combination of solutions may provide the best framework for the creation of essential medicines for neglected diseases.

Weighing Medical Judgments: Explaining Evidentiary Preferences For Treating Physician Opinions In Erisa Cases After Black & Decker Disability Plan V. Nord, Roy F. Harmon Iii, A.G. Harmon

Scholarly Articles

No abstract provided.