Digital Commons Network^™

The Doha Round’S Public Health Legacy: Strategies For The Production And Diffusion Of Patented Medicines Under The Amended Trips Provisions, Jerome H. Reichman, Frederick M. Abbott

Faculty Scholarship

This entry into force of the World Trade Organization (WTO) TRIPS Agreement in 1995 transformed the international intellectual property system. The harmonization of basic intellectual property standards has operated to protect investment in innovation, limiting risks from unjustified 'free riding.' Yet these same harmonized IP standards sharply curtailed the traditional capacity of suppliers of public goods, such as health care and nutrition, to address the priority needs of less affluent members of society, particularly in (but not limited to) developing countries. In the Doha Declaration, the Waiver Decision of 30 August 2003 and the Article 31bis Protocol of Amendment, stakeholders …

Advancing The Rule Of Law: Report On The International Rule Of Law Symposium Convened By The American Bar Association November 9-10, 2005, Katharina Pistor

Faculty Scholarship

The American Bar Association hosted the first International Rule of Law Symposium in Washington, D.C. on November 9-10, 2005. The Symposium brought together representatives from all over the world who share a common interest in advancing the rule of law as a means to tackle major obstacles that hamper social and economic growth and development around the globe. Some were ministers and government officials, others entrepreneurs and business people, yet others represented non-governmental organizations or employees of multilateral donor organizations. The topics addressed at the Symposium were equally far reaching in scope, covering everything from poverty alleviation and improving public …

Medicine And Public Health: Crossing Legal Boundaries, Wendy K. Mariner

Faculty Scholarship

In 2006, New York City began a mandatory reporting system for laboratories to submit blood sugar (A1c) test results (primarily for diabetes) to the city's Department of Health and Mental Hygiene without the patient's consent. This article examines whether this new program is an innovative way to improve New Yorkers' health, an invasion of medical privacy, or usurpation of the physician's role. The registry is an example of public health initiatives in chronic diseases, which challenge the limits of laws governing medicine care and public health programs by blurring the historical boundaries between them.

Will Longer Antimicrobial Patents Improve Global Public Health?, Kevin Outterson, Julie Balach Samora, Karen Keller-Cuda

Faculty Scholarship

The problem of antimicrobial resistance has led some infectious disease experts and their professional societies to propose the use of transferable intellectual property rights (wildcard patents) and patent term extensions as methods to encourage antimicrobial R&D. We evaluate recent approvals of new antimicrobial classes and find the number of new introductions is higher than previously suggested. More importantly, creating new patent rights is shown to be an inefficient and possibly counterproductive response to antimicrobial resistance. Wildcard patents would operate as a more than US$40 billion annual tax on heart disease, hypertension, chronic obstructive pulmonary disease, asthma, and depression to inefficiently …

The Alfonse And Gaston Of Governmental Response To National Public Health Emergencies: Lessons Learned From Hurricane Katrina For The Federal Government And The States, Michael Greenberger

Faculty Scholarship

Hurricane Katrina renewed an old debate concerning which level of government should lead the response effort to catastrophic disasters. Traditionally, emergency response is handled at the most local level possible. Hurricane Katrina, however, and other catastrophes that may be labeled "Incidents of National Significance," are examples of emergencies of such magnitude that federal assets must be brought to bear to respond adequately to the situation. As such Incidents will almost always affect interstate commerce, Congress' commerce powers justify federal intervention in, and if necessary, supervision of the response. In such situations, the National Response Plan provides for extensive coordination between …

Choking Bioshield: The Department Of Homeland Security's Stranglehold On Biodefense Vaccine Development, Michael Greenberger

Faculty Scholarship

One of the bright milestones toward the development of a vibrant biodefense vaccine industry was the passage of the Project BioShield Act of 2004. That statute was designed "to provide protections and countermeasures against chemical, radiological, or nuclear agents that may be used in a terrorist attack against the United States". It encourages the development of effective countermeasures by establishing the Special Reserve Fund of $5.6 billion to be spent over ten years to assure pharmaceutical and biotechnology manufacturers that there is a ready market for their products through purchases by the government for the Strategic National Stockpile. The Act …

Identification Of Critical Determinants On Ace2 For Sars-Cov Entry And Development Of A Potent Entry Inhibitor, Dong P. Han, Adam Penn-Nicholson, Michael W. Cho

Faculty Scholarship

Severe acute respiratory syndrome (SARS) is caused by a novel coronavirus, SARS-CoV. Virus entry into cells is mediated through interactions between spike (S) glycoprotein and angiotensin-converting enzyme 2 (ACE2). Alanine scanning mutagenesis analysis was performed to identify determinants on ACE2 critical for SARS-CoV infection. Results indicated that charged amino acids between residues 22 and 57 were important, K26 and D30, in particular. Peptides representing various regions of ACE2 critical for virus infection were chemically synthesized and evaluated for antiviral activity. Two peptides (a.a. 22–44 and 22–57) exhibited a modest antiviral activity with IC(50) of about 50 μM and 6 μM, …

Social Contagion Of Violence, Jeffrey Fagan, Deanna L. Wilkinson, Garth Davies

Faculty Scholarship

Since 1968, violence and other crimes in New York City have followed a pattern of recurring epidemics. There have been three consecutive and contiguous cycles characterized by sharp increases in homicides and assaults to an elevated rate followed by equally steep declines to levels near the previous starting point. The most recent epidemic, from 1985-96, had the sharpest rise and steepest decline of the three epidemics. Popular explanations of the current epidemic fail to account for both the rise and fall of the decline, or for the repetitive pattern of these epidemics. In this article, we use public health data …

Foreword: Globe-Hopping Pharmaceuticals, Frances H. Miller

Faculty Scholarship

No abstract provided.

Bioterror And “Bioart”: A Plague O' Both Your Houses, George J. Annas

Faculty Scholarship

Since September 11, 2001, the threat of bioterrorism has caused Congress and the President to dramatically increase research funding for countermeasures, including funding for new biosecurity laboratories. The new kind of war against non-state actors who use terror to intimidate populations has also made the creation of new ethical and legal rules for researchers seem critical. New laws have been passed, and there have been proposals for new codes of ethics for bioterrorism-related research. Almost five years after September 11, however, the outcome of the development of new research rules remains uncertain.

Patent Buy-Outs For Global Disease Innovations For Low- And Middle-Income Countries, Kevin Outterson

Faculty Scholarship

Drug prices are uniquely susceptible to radical price reductions through generic competition. Patented pharmaceuticals may be priced at more than 30 times the marginal cost of production; the excess is the patent rent collected by the drug company while the patent and exclusive marketing periods remain. Patent rents are significant. AIDS drugs which sell for US$10,000 per person per year in the US are sold generically for less than US$200. If patented drugs could be sold at the marginal cost of production, cost effective treatments would become even more attractive, and other interventions would become affordable.

This Article proposes marginal …

The Role Of The Federal Government In Response To Catastrophic Health Emergencies: Lessons Learned From Hurricane Katrina, Michael Greenberger

Faculty Scholarship

In much of the recent thought devoted to the role of states in responding to catastrophic public health emergencies, as most clearly evidenced by the commentary surrounding the Centers for Disease Control and Prevention- sponsored Model State Emergency Health Powers Act (Model Act), there is a focus on state governments being viewed as the exclusive controlling governmental agent supervising the governmental response. Much of that thinking is premised on a view of limitations placed on Congress’ power to act in public health emergencies emanating from Commerce Clause restrictions in the Supreme Court decisions of U.S. v. Lopez, 514 U.S. 549 …

Removing Violent Parents From The Home: A Test Case For The Public Health Approach, Robin Fretwell Wilson

Faculty Scholarship

Few decisions are as determinative of a child’s well-being and long-term success as the decision to remove a child from his or her own home following an allegation of abuse by a parent. Using the public health lens Professor Marsha Garrison develops elsewhere in this Issue, this Comment examines one of the most critical questions Child Protective Services agencies face thousands of times a day: whether to remove a child who is a possible victim of abuse or neglect from his or her home. This evidence-based approach shows that the choice to remove the child rather than the alleged offender …

Removing Violent Parents From The Home: A Test Case For The Public Health Approach, Robin Fretwell Wilson

Faculty Scholarship

Child services caseworkers adhere to the belief that, in the absence of prosecution, the only remedy for protecting a child harmed by a parent is to remove the child from her home. The effect of this often is to leave the alleged perpetrator in the household with the victim's siblings. Using sexual violence as an example, this Comment contends the evidence of potential risk for the remaining children is so overwhelming that, as a matter of policy, an adult who violates one child should be removed from the household. Parents who commit incest rarely stop with one child. Ignoring such …

Jacobson V Massachusetts: It's Not Your Great-Great-Grandfather's Public Health Law, Wendy K. Mariner, George J. Annas, Leonard H. Glantz

Faculty Scholarship

Jacobson v Massachusetts, a 1905 US Supreme Court decision, raised questions about the power of state government to protect the public’s health and the Constitution’s protection of personal liberty. We examined conceptions about state power and personal liberty in Jacobson and later cases that expanded, superseded, or even ignored those ideas.

Public health and constitutional law have evolved to better protect both health and human rights. States’ sovereign power to make laws of all kinds has not changed in the past century. What has changed is the Court’s recognition of the importance of individual liberty and how it limits …

Law And Public Health: Beyond Emergency Preparedness, Wendy K. Mariner

Faculty Scholarship

This Article examines three questions: What is public health? What is public health law? What roles can lawyers play in public health? It first describes the breadth of public health, highlighting six trends shaping its future: social determinants of health; synergy between medicine and public health; shifts in focus from external (e.g., environmental and social) to internal (behavioral) risks to health; federalization of public health law; globalization of health risks and responses; and bioterrorism. Because the domains of law that apply to public health are equally broad, the Article next offers a conceptual framework for identifying the types of laws …

Lifting The Pall Of Orthodoxy: The Need For Hearing A Multitude Of Tongues In And Beyond The Sexual Education Curricula At Public High Schools, Carlo A. Pedrioli

Faculty Scholarship

When public high schools promote heterosexuality at the cost of denying sexual minority youth the opportunity to learn about minority sexualities, these schools contribute to the disastrous situation in which many sexual minority high school students find themselves. This approach, which many public high schools take, is unnecessarily destructive and warrants prompt change. Instead of helping to perpetuate many of the challenges that sexual minority students face in high school, public high schools can and need to help address these challenges. To establish the case for such a position, this article begins by presenting the plight of many sexual minority …

Tragedy & Remedy: Reparations For Disparities In Black Health, Kevin Outterson

Faculty Scholarship

The Tragedy of American health care is the stubborn persistence of disparities in Black health, one hundred and forty years after Emancipation, and more than four decades after the passage of Title VI. Formal legal equality has not translated into actual health equality. This Tragedy is deeper and older than mere legal forms; it has been supported by powerful social institutions, including some governments, charities, market participants, religions, ideologies, and cultures. Black health disparities interact with other vestiges of slavery such as disparities in wealth, education, employment and housing. They have permeated the American health experience. Efforts to eliminate Black …

The Vanishing Public Domain: Antibiotic Resistance, Pharmaceutical Innovation And Global Public Health, Kevin Outterson

Faculty Scholarship

Penicillin and other antibiotics were the original wonder drugs and laid the foundation of the modern pharmaceutical industry. Human health significantly improved with the introduction of antibiotics. By 1967, the US Surgeon General declared victory over infectious diseases in the US. But pride goes before a fall. The evolutionary pressure of antibiotic use selects for resistant strains with the least fitness cost. Effective drugs should be used. But when they are used, no matter how carefully, evolutionary pressure for resistance is created. The problem is not limited to antibiotics. Variants of the human immunodeficiency (AIDS) virus develop resistance to anti-retroviral …

The Threat Of Smallpox: Eradicated But Not Erased: A Review Of The Fiscal, Logistical And Legal Obstacles Impacting The Phase I Vaccination Program, Holly L. Myers, Elin Gursky, Georges C. Benjamin, Christopher Gozdor, Michael Greenberger

Faculty Scholarship

Fears that terrorists may have the capabilities and intent to disseminate a variety of biologic agents has once again brought smallpox into the American consciousness. On December 13, 2002, recognizing that the global discontinuation of routine smallpox vaccination over two decades ago had left most Americans unprotected and vulnerable to the ravaging effects of the virus, the President announced a precautionary measure to begin vaccinating teams of emergency responders. The program commenced January 24, 2003. In the ensuing months, public health departments scrambled to meet the goal of vaccinating approximately 500,000 first responders, a protected phalanx that could quickly and …

Development Of A Safe Neutralization Assay For Sars-Cov And Characterization Of S-Glycoprotein, Dong P. Han, Hyung G. Kim, Young B. Kim, Michael W. Cho

Faculty Scholarship

The etiological agent of severe acute respiratory syndrome (SARS) has been identified as a novel coronavirus SARS-CoV. Similar to other coronaviruses, spike (S)-glycoprotein of the virus interacts with a cellular receptor and mediates membrane fusion to allow viral entry into susceptible target cells. Accordingly, S-protein plays an important role in virus infection cycle and is the primary target of neutralizing antibodies. To begin to understand its biochemical and immunological properties, we expressed both full-length and ectodomain of the protein in various primate cells. Our results show that the protein has an electrophoretic mobility of about 160–170 kDa. The protein is …

The Jekyll And Hyde Story Of International Trade: The Supreme Court In Phrma V. Walsh And The Trips Agreement, Srividhya Ragavan

Faculty Scholarship

The paper analyses the international impact of the approval by the United States Supreme Court to use indirect price control mechanisms to tackle public health and Medicaid issues. It traces similarities in policies implemented by the United States and those it opposed within developing nations. For example, the recent use by the developed nations of compulsory licensing and price control mechanisms, which they opposed as violating TRIPS when used by developing nations, underlines a poverty penalty suffered by developing nation signatories of TRIPS. In effect, TRIPS exempts developed nations from fulfilling obligations developing nations were forced to fulfill and thus …

Toward A Climate Change Strategy For Pennsylvania, John C. Dernbach

Faculty Scholarship

No abstract provided.

Toward An Indigenous Jurisprudence Of Rape, Sarah Deer

Faculty Scholarship

This article sets forth some preliminary issues and perspectives for the development of indigenous models of rape jurisprudence. Part I examines the reasons for and importance of developing an indigenous jurisprudence of rape. Part II addresses tribal jurisdiction issues, particularly the current limitations on tribal authority. Part III provides a historical context for the issue, including examples of the role of colonization in the responses to sexual violence. Part IV shares some visions for the development of a contemporary jurisprudence of rape for indigenous nations.

Finding Cures For Tropical Diseases: Is Open Source An Answer?, Stephen M. Maurer, Arti K. Rai, Andrej Sali

Faculty Scholarship

No abstract provided.

Parks As Gyms? Recreational Paradigms And Public Health In The National Parks, Jay D. Wexler

Faculty Scholarship

When scholars and policymakers think about the relationship between public health and environmental law and policy, they likely think first about controlling pollution and other toxic substances. As other articles have amply demonstrated, water pollution, air pollution, and other environmental toxins can have significant deleterious effects on the public's health. Scholars rightly pay serious attention to these relationships, and policymakers wisely devise methods and strategies to ameliorate the public health risks posed by these polluting substances.

Although pollution control might be the most obvious and important intersection between environmental policy and public health, legal and policy decisions regarding the management …

Blinded By Bioterrorism: Public Health And Liberty In The 21st Century, George J. Annas

Faculty Scholarship

In Blindness, Nobel Prize laureate Jos6 Saramago chronicles the quarantining of the first victims of a plague of blindness.1 We meet many people who become blind in Saramago's novel, including an opthamologist, a one-eyed man with an eye patch, and a man born blind. Saramago reminds us that we are all blind in one way or another, and that there are many things about ourselves and our society that we can't or won't see. The quarantine itself turns out to be isolating, inhumane, and degrading; the interred blind being portrayed by themselves and others as pigs, dogs, and "lame crabs." …

The Right To Health And The Nevirapine Case In South Africa, George J. Annas

Faculty Scholarship

Thanks to activists in South Africa, the right to health as a human right has returned to the international stage, just as it was being displaced by economists who see health through the prism of a globalized economy and by politicians who see it as an issue of national security or charity. The current post-apartheid debate in South Africa is not about race but about health, and in this context, the court victory by AIDS activists in the nevirapine case has been termed not only, as stated in one British newspaper, “the greatest defeat for [President Thabo] Mbeki's government” but …

Puppy Love: Bioterrorism, Civil Rights, And Public Health, George J. Annas

Faculty Scholarship

Florida has been the state humorists most like to make fun of since the 2000 presidential election, especially when it comes to politics. And humorists are almost the only commentators who can be counted on to tell us the truth about the state of American politics today. When Californians decided to recall their Governor, for example, Conan O'Brien observed: "Yesterday Arnold Schwarzenegger announced he would run for governor of California. The announcement was good news for Florida residents, who now live in the second-flakiest state in the country."' And when more than 200 people filed to run for Governor, Jay …

Learning From The President’S Council On Sustainable Development: The Need For A Real National Strategy, John C. Dernbach

Faculty Scholarship

No abstract provided.