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<title>O&apos;Neill Institute Papers</title>
<copyright>Copyright (c) 2013 Georgetown University Law Center All rights reserved.</copyright>
<link>http://scholarship.law.georgetown.edu/ois_papers</link>
<description>Recent documents in O&apos;Neill Institute Papers</description>
<language>en-us</language>
<lastBuildDate>Fri, 03 May 2013 01:36:40 PDT</lastBuildDate>
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<title>Countering the Problem of Falsified and Substandard Drugs</title>
<link>http://scholarship.law.georgetown.edu/ois_papers/51</link>
<guid isPermaLink="true">http://scholarship.law.georgetown.edu/ois_papers/51</guid>
<pubDate>Wed, 01 May 2013 12:51:06 PDT</pubDate>
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	<p>The adulteration and careless manufacture of medicines is an old problem, vastly aggravated by globalization. The US Food and Drug Administration commissioned the Institute of Medicine to investigate the global problem of falsified and substandard drugs, considering the causes and possible solutions to this international public health crisis. In its consensus report, the committee identified two main categories of drug quality failures of public health concern. Falsified drugs carry a false representation of identity or source; substandard drugs fail to meet the specifications set in the national pharmacopeia or the manufacturer’s dossier. In practice, these categories overlap, but they are sufficiently precise for public discourse.</p>
<p>It is difficult to measure the global market for falsified and substandard drugs, but there is good evidence that they are a problem in poor countries with weak drug regulatory systems. All classes of drugs are compromised, especially inexpensive antibacterial and antimalarial treatments. When fake antimicrobials contain sub-therapeutic doses of active ingredients, they encourage drug resistance, shortening the effective life of a drug and hastening the expense of new drug development. The trade in fake medicines erodes patient confidence in allopathic medicine and the public health system. The organized fraud that allows the drugs to circulate undermines all public institutions and conveys money and power to criminals.</p>
<p>Investment in drug manufacturing could improve drug quality in low- and middle-income countries, and development finance organizations are well positioned to make these investments. Changes to procurement practices could also help guarantee that honest manufacturers get the largest market share. Most of all, low- and middle-income countries need better regulatory systems. The first step to building these systems is developing a strategic plan for the agency improvement. Changes to the drug distribution system could protect the drugs supply. In the United States, licensing only wholesalers that meet National Association of Boards of Pharmacy accreditation standards would reduce the hazards of secondary wholesale, as would a congressionally mandated track-and-trace system. In developing countries, governments should use franchising, accreditation, low-interest loans, and task shifting to create an environment conducive to quality drug retail. There is also a need for sturdy and inexpensive detection technologies that can be used to detect fake medicines in the field. A WHO International Code of Practice on falsified and substandard drugs would facilitate international cooperation against falsified and substandard drugs.</p>

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<author>Gillian J. Buckley et al.</author>


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<title>Stemming the Global Trade in Falsified and Substandard Medicines</title>
<link>http://scholarship.law.georgetown.edu/ois_papers/50</link>
<guid isPermaLink="true">http://scholarship.law.georgetown.edu/ois_papers/50</guid>
<pubDate>Wed, 01 May 2013 12:15:56 PDT</pubDate>
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	<p>Drug safety and quality is an essential assumption of clinical medicine, but there is growing concern that this assumption is not always correct. Poor manufacturing and deliberate fraud occasionally compromises the drug supply in the United States, and the problem is far more common and serious in low- and middle-income countries with weak drug regulatory systems. An Institute of Medicine consensus committee report identified the causes and possible solutions to the problem of falsified and substandard drugs around the world.</p>
<p>The vocabulary people use to discuss the problem is itself a concern. The word counterfeit is often used innocuously to describe any drug that is not what it seems, but some NGOs and emerging manufacturing nations object to this term. These groups see hostility to generic pharmaceuticals in a discussion of counterfeit medicines. These groups see hostility to generic pharmaceuticals in a discussion of counterfeit medicines. Precisely speaking, a counterfeit drug infringes on a registered trademark, and trademark infringement in not necessarily a problem of public health consequence. Instead of talking broadly about counterfeit drugs, the WHO and other stakeholders should consider two main categories of drug quality problems. Falsified medicines misrepresent the product’s identity or source or both. Substandard drugs fail to meet the national specifications given in an accepted pharmacopeia or the manufacturer’s dossier. In practice, there is often considerable overlap between categories.</p>
<p>There is considerable uncertainty about the size of the falsified and substandard drug market. Improved pharmacovigilance, especially in developing countries, give a better picture of the scope of the problem. In the United States, tighter regulatory controls on the wholesale market and a mandatory drug tracking system would improve drug safety. In developing countries, development finance organizations should invest in small- and medium-sized pharmaceutical manufacturers, and governments should use tools such as franchising, accreditation, low-interest loans, and task shifting to encourage private sector investment in drug retail. Finally, the WHO should work with stakeholders such as the UNODC and the WCO to develop an international code of practice on falsified and substandard drugs.</p>

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<author>Lawrence O. Gostin et al.</author>


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<title>Tackling the Global NCD Crisis: Innovations in Law and Governance</title>
<link>http://scholarship.law.georgetown.edu/ois_papers/49</link>
<guid isPermaLink="true">http://scholarship.law.georgetown.edu/ois_papers/49</guid>
<pubDate>Mon, 22 Apr 2013 08:35:59 PDT</pubDate>
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	<p>35 million people die annually of non-communicable diseases (NCDs), 80% of them in low- and middle-income countries—representing a marked epidemiological transition from infectious to chronic diseases and from richer to poorer countries. The total number of NCDs is projected to rise by 17% over the coming decade, absent significant interventions. The NCD epidemic poses unique governance challenges: the causes are multifactorial, the affected populations diffuse, and effective responses require sustained multi-sectorial cooperation. The authors propose a range of regulatory options available at the domestic level, including stricter food labeling laws, regulation of food advertisements, tax incentives for healthy lifestyle choices, changes to the built environment, and direct regulation of food and drink producers. Given the realities of globalization, such interventions require global cooperation. In 2011, the UN General Assembly held a High-level meeting on NCDs, setting a global target of a 25% reduction in premature mortality from NCDs by 2025. Yet concrete plans and resource commitments for reaching this goal are not yet in the offing, and the window is rapidly closing for achieving these targets through prevention--as opposed to treatment, which is more costly. Innovative global governance for health is urgently needed to engage private industry and civil society in the global response to the NCD crisis.</p>

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<author>Bryan P. Thomas et al.</author>


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<title>Tobacco Endgame Strategies: Challenges in Ethics and Law</title>
<link>http://scholarship.law.georgetown.edu/ois_papers/48</link>
<guid isPermaLink="true">http://scholarship.law.georgetown.edu/ois_papers/48</guid>
<pubDate>Wed, 17 Apr 2013 12:25:46 PDT</pubDate>
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	<p>There are complex legal and ethical tradeoffs involved in using intensified regulation to bring smoking prevalence to near-zero levels. The authors explore these tradeoffs through a lens of health justice, paying particular attention to the potential impact on vulnerable populations. The ethical tradeoffs explored include the charge that heavy regulation is paternalistic; the potentially regressive impact of heavily taxing a product consumed disproportionately by the poor; the simple loss of enjoyment to heavily addicted smokers; the health risks posed by, for example, regulating nicotine content in cigarettes—where doing so leads to increased consumption. Turning to legalistic concerns, the authors explore whether endgame strategies constitute a form of ‘regulatory taking’; whether endgame strategies can be squared with global trade/investment laws; whether free speech rights are infringed by aggressive restrictions on the advertisement and marketing of cigarettes.</p>

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<author>Bryan P. Thomas et al.</author>


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<title>A Systematic Plan for Firearms Law Reform</title>
<link>http://scholarship.law.georgetown.edu/ois_papers/47</link>
<guid isPermaLink="true">http://scholarship.law.georgetown.edu/ois_papers/47</guid>
<pubDate>Mon, 25 Feb 2013 12:50:41 PST</pubDate>
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	<p>Tragedy after tragedy has drawn the nation’s attention towards gun violence. Yet the murder of 20 school children in Newtown, CT has done more to drive the national dialogue on gun control than any preceding mass shooting, not to mention the endemic murderous violence that plagues city streets day in and out. President Obama has responded by calling on Congress to (1) close background check loopholes; (2) ban assault weapons and high-capacity magazines; and (3) improve mental health services. All of these measures are necessary to curb gun violence.  Yet, in a nation with more firearms per capita than anywhere in the world, they are not sufficient. Violence is depicted and even glorified in the media; law enforcement lacks the ability to track stolen or illegally traded arms; and the National Instant Criminal Background Check System is vastly deficient (and not always consulted before a sale). The public health threat of firearms—whether through inner-city violence, mass murders, suicides, or inadvertent firearm discharges—is tremendous, and reasonable firearm restrictions are both critical and in high public demand. Yet Congress has stalled comprehensive gun safety legislation for years (e.g., mandatory trigger locks, fingerprint and tracking technology, training requirements, limits on mass sales). Moreover, President Obama’s renewed call for change does not touch on these strategies. In short, federal, state, and city officials lack the basic tools needed to detect, prevent, and punish firearm related crime. Before Newtown becomes another sound bite, it must inspire the greatest bipartisan courage to at least stem the mass shootings and street killings that our newly found individual right to bear arms has made so prevalent.</p>

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<author>Katherine L. Record et al.</author>


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<title>The Power to Block the Affordable Care Act: What Are the Limits?</title>
<link>http://scholarship.law.georgetown.edu/ois_papers/46</link>
<guid isPermaLink="true">http://scholarship.law.georgetown.edu/ois_papers/46</guid>
<pubDate>Tue, 04 Dec 2012 10:00:45 PST</pubDate>
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	<p>Though Supreme Court upheld most parts of the Affordable Care Act (ACA), Congress’ goals in enacting it could still be frustrated by non-implementation. During his campaign for president, Governor Romney promised “to issue Obamacare waivers to all fifty states.” While such blanket waivers would likely violate the Constitution’s Take Care Clause, the ACA does permit other waivers. To be lawful, however, they must meet certain requirements designed to enhance access and lower cost. A president who opposes the ACA might be able to limit its implementation by refusing to issue premium subsidies in federally operated insurance exchanges, and this might be deemed a reasonable interpretation of the ACA because of a drafting error Congress made. Additionally, a president who opposes the individual mandate might be able to limit its effectiveness by directing the IRS not to make collecting the mandate’s tax penalty a high priority, and it is unclear whether the courts would accept the constitutionality of such an approach.</p>
<p>Although President Obama won the election, Congress could choose not to fund key parts of the ACA, but it lacks the votes to repeal the Act. Many parts of the ACA, including the health insurance exchanges and high-risk pools for people with pre-existing conditions, were directly funded and, therefore, would require an act of Congress to de-fund. Other components, however, including many relating to health workforce expansion, quality improvement, and some prevention programs were not directly funded, so they could be starved of money through Congressional inaction.</p>

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<author>John D. Kraemer et al.</author>


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<title>Emergency Preparedness and Public Health: The Lessons of Hurricane Sandy</title>
<link>http://scholarship.law.georgetown.edu/ois_papers/45</link>
<guid isPermaLink="true">http://scholarship.law.georgetown.edu/ois_papers/45</guid>
<pubDate>Tue, 04 Dec 2012 07:41:04 PST</pubDate>
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	<p>When Hurricane Sandy hit downtown Manhattan, three neighboring hospitals each made different decisions about when to evacuate. Across the metro region, more than five hospitals and over 20 nursing and assisted living facilities were evacuated, making this the central public health challenge of this calamitous event. It is a familiar story—a super storm comes ashore, infrastructure is overwhelmed, and healthcare facilities evacuate patients, with major delays in returning to normal functioning. Afterwards, policy makers evaluate lessons learned for the next disaster, but similar missteps are often repeated.</p>
<p>Although not identical, it is instructive to compare Hurricane Katrina with the still unfolding events of Sandy. Unlike in Katrina, New York hospitals had more detailed emergency plans. What seemed to be missing, however, were clear and consistent criteria to guide evacuation decisions. Evacuation decisions are complex—a decision to evacuate prematurely places patients at risk, while waiting too long can have devastating consequences. Public officials, in collaboration with facilities, should decide whether to shelter in place or risk transfer of fragile patients. Governors should consider early emergency declarations, including request for a formal “public health emergency declaration”, to reduce legal concerns and regulatory constraints. Federal, state, and municipal authorities can better prepare for the next disaster and have a duty to do so.</p>

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<author>Tia Powell et al.</author>


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<title>Child Abuse Reporting: Rethinking Child Protection</title>
<link>http://scholarship.law.georgetown.edu/ois_papers/44</link>
<guid isPermaLink="true">http://scholarship.law.georgetown.edu/ois_papers/44</guid>
<pubDate>Tue, 07 Aug 2012 07:59:07 PDT</pubDate>
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	<p>The general public has been bewildered by the magnitude of sex abuse cases and the widespread failure by pillars of the community to notify appropriate authorities. The crime of sexually abusing children is punishable in all jurisdictions and this article examines the duty to report suspected cases by individuals in positions of trust over young people, such as in the church or university sports. The Federal Child Abuse Prevention and Treatment Act (CAPTA) defines child maltreatment as an act or failure to act on the part of a parent or caregiver that results in death, serious physical or emotional harm, sexual abuse, or exploitation, and establishes minimum federal standards. Each state has its own definitions of maltreatment and every state identifies persons who are required to report child abuse. As such, state law is highly variable in defining who has a mandatory duty to report, and clergy and other individuals in close supervision of children (e.g., athletic coaches, scout leaders, volunteers in religious programs, and university officials) may necessarily hold such duty.</p>
<p>The article outlines why there are strong moral reasons the law should require all adults in close supervision of children to report any individual who they have good reason to believe has abused a child and moreover outlines how to ensure prompt reporting of abuse, while still ensuring that respected individuals are not falsely accused.</p>

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<author>Susan C. Kim et al.</author>


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<title>Ethical Challenges of Preexposure Prophylaxis for HIV</title>
<link>http://scholarship.law.georgetown.edu/ois_papers/43</link>
<guid isPermaLink="true">http://scholarship.law.georgetown.edu/ois_papers/43</guid>
<pubDate>Mon, 06 Aug 2012 07:01:26 PDT</pubDate>
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	<p>On July 16, 2012, emtricitabine/tenofovir (Truvada) became the first drug approved by the US Food and Drug Administration for preexposure prophylaxis (PrEP) of human immunodeficiency virus (HIV) for adults at high risk. While PrEP appears highly effective with consistent adherence, effective implementation poses ethical challenges for the medical and public health community. For PrEP users, it is necessary to maintain adherence, safe sex practices, and routine HIV testing and medical monitoring, to maximize benefits and reduce risks. On a population level, comparative cost-effectiveness should guide priority-setting, while safety measures must address drug resistance concerns without burdening patients' access. Equitable distribution will require addressing the needs of underserved populations, women (for whom efficacy data are mixed) and people living in developing countries with high HIV incidence; meanwhile, it is necessary to consider the fair use of drugs for treatment vs. prevention and the appropriate design of new HIV prevention studies.</p>

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<author>Jonathan S. Jay et al.</author>


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<title>An O’Neill Institute Briefing Paper: The Supreme Court’s Landmark Decision on the Affordable Care Act: Healthcare Reform’s Ultimate Fate Remains Uncertain</title>
<link>http://scholarship.law.georgetown.edu/ois_papers/42</link>
<guid isPermaLink="true">http://scholarship.law.georgetown.edu/ois_papers/42</guid>
<pubDate>Wed, 11 Jul 2012 09:55:55 PDT</pubDate>
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	<p>The Supreme Court’s decision on the constitutionality of the Patient Protection and Affordable Care Act (ACA) is a landmark on the path toward ensuring universal access to health care in the United States. In a 5-4 decision written by Chief Justice Roberts, the Court upheld the law in its entirety with the sole exception that Congress may not revoke existing state Medicaid funding to penalize states that decline to participate in the Medicaid expansion under the ACA. In this O’Neill Institute Briefing, we explain and analyze the Court’s decision, focusing on the individual purchase mandate and the Medicaid expansion, while also explaining the fundamental shifts in constitutional interpretations that may affect public health, safety and environmental protection in the future.</p>
<p>The precise significance of the individual mandate to the proper functioning of the ACA remains to be seen, primarily because the penalties are small relative to the cost of insurance. The IRS also has little enforcement authority if individuals elect not to purchase insurance. The mandate remains the only mechanism for the ACA’s financial sustainability.</p>
<p>The importance of the Medicaid expansion cannot be overstated, as it is the sole means by which poor Americans will gain coverage. If states decline to participate there may be a social justice disaster in which disparities in access to health insurance in some states actually <em>widen</em> under the ACA as middle-class and well-off Americans gain access to insurance while the poor are left behind.</p>
<p>Justice Roberts sided with the Court’s conservative wing to espouse a narrow view of Congress’ ability to regulate under the Commerce Clause, which could create challenges as future Congresses seek to address national public health problems. Even so, we conclude that the Court’s decision leaves the United States immensely better off in that future debates will likely center around <em>how</em> to ensure access to health care for all, not whether to do so–that debate is over, and the nation should push forward on the path toward universal coverage.</p>

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<author>Emily W. Parento et al.</author>


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<title>Global Health Justice: A Perspective from the Global South on a Framework Convention on Global Health</title>
<link>http://scholarship.law.georgetown.edu/ois_papers/41</link>
<guid isPermaLink="true">http://scholarship.law.georgetown.edu/ois_papers/41</guid>
<pubDate>Thu, 05 Jul 2012 11:14:26 PDT</pubDate>
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	<p>A global coalition of civil society and academics recently launched the Joint Action and Learning Initiative on National and Global Responsibilities for Health (JALI), which is developing a post-Millennium Development Goal (MDG) framework for global health. JALI’s mission is the achievement of a global health treaty based on the right to health—a Framework Convention on Global Health (FCGH). The FCGH proposes establishing fair terms of international co-operation, with agreed-upon mutually binding obligations to create enduring health system capacities, meet basic survival needs, and reduce unconscionable inequalities in global health. States that bear a disproportionate burden of disease have the least capacity to do anything about it. The richer states are deeply resistant to expending the political capital and economic resources. When they do act, it is often more out of narrow self-interest or humanitarian instinct than a full sense of ethical or legal obligation. The result is a spiraling deterioration of health in the poorest regions, with manifest global consequences and systemic effects on trade, international relations, and security.</p>
<p>The very concept of global health justice as conceived by JALI and the FCGH is to have the global campaign led by civil society, with the major conceptualization and advocacy coming from the Global South. This paper presents the African, particularly South African, perspective on global health justice.</p>

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<author>Lawrence O. Gostin et al.</author>


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<title>Pillars for Progress on the Right to Health: Harnessing the Potential of Human Rights Through a Framework Convention on Global Health</title>
<link>http://scholarship.law.georgetown.edu/ois_papers/40</link>
<guid isPermaLink="true">http://scholarship.law.georgetown.edu/ois_papers/40</guid>
<pubDate>Mon, 18 Jun 2012 06:24:37 PDT</pubDate>
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	<p>Ever more constitutions incorporate the right to health, courts continue to expand their right to health jurisprudence, and communities and civil society increasingly turn to the right to health in their advocacy. Yet the right remains far from being realized. Even with steady progress on numerous fronts of global health, vast inequities at the global and national levels persist, and are responsible for millions of deaths annually. We propose a four-part approach to accelerating progress towards fulfilling the right to health: 1) national legal and policy reform, incorporating right to health obligations and principles including equity, participation, and accountability in designing, implementing, and monitoring the health sector, as well as an all-of-government approach in advancing the public's health; 2) litigation, using creative legal strategies, enhanced training, and promotion of progressive judgments to increase courts' effectiveness in advancing the right to health; 3) civil society and community engagement, empowering communities to understand and claim this right and building the capacity of right to health organizations; and 4) innovative global governance for health, strengthening World Health Organization leadership on health and human rights, further clarifying the international right to health, ensuring sustained and scalable development assistance, and conforming other international legal regimes (e.g., trade, intellectual property, and finance) to health and human rights norms. We offer specific steps to advance each of these areas, including how a new global health treaty, a Framework Convention on Global Health, could help construct these four pillars.</p>

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<author>Eric A. Friedman et al.</author>


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<title>A Framework Convention on Global Health: Health for All, Justice for All</title>
<link>http://scholarship.law.georgetown.edu/ois_papers/39</link>
<guid isPermaLink="true">http://scholarship.law.georgetown.edu/ois_papers/39</guid>
<pubDate>Fri, 01 Jun 2012 13:03:37 PDT</pubDate>
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	<p>Health inequalities represent perhaps the most consequential global health challenge and yet they persist despite increased funding and innovative programs. The United Nations is revising the Millennium Development Goals (MDGs) that will shape the world for many years to come. What would a transformative post-MDG framework for global health justice look like? A global coalition of civil society and academics—the Joint Action and Learning Initiative on National and Global Responsibilities for Health (JALI)—has formed an international campaign to advocate for a Framework Convention on Global Health (FCGH). Recently endorsed by the UN Secretary-General, the FCGH would reimagine global governance for health, offering a new post-MDG vision. This Special Communication describes the key modalities of an FCGH to illustrate how it would improve health and reduce inequalities. The modalities would include defining national responsibilities for the population’s health; defining international responsibilities for reliable, sustainable funding; setting global health priorities; coordinating fragmented activities; reshaping global governance for health; and providing strong global health leadership through the World Health Organization.</p>

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<author>Lawrence O. Gostin</author>


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<title>Bridging International Law and Rights-Based Litigation: Mapping Health-Related Rights Through the Development of the Global Health and Human Rights Database</title>
<link>http://scholarship.law.georgetown.edu/ois_papers/38</link>
<guid isPermaLink="true">http://scholarship.law.georgetown.edu/ois_papers/38</guid>
<pubDate>Thu, 03 May 2012 13:00:52 PDT</pubDate>
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	<p>The O'Neill Institute for National and Global Health Law at Georgetown University, the World Health Organization, and the Lawyers Collective have come together to develop a searchable Global Health and Human Rights Database that maps the intersection of health and human rights in judgments, international and regional instruments, and national constitutions. Where states long remained unaccountable for violations of health-related human rights, litigation has arisen as a central mechanism in an expanding movement to create rights-based accountability. Facilitated by the incorporation of international human rights standards in national law, this judicial enforcement has supported the implementation of rights-based claims, giving meaning to states' longstanding obligations to realize the highest attainable standard of health. Yet despite these advancements, there has been insufficient awareness of the international and domestic legal instruments enshrining health-related rights and little understanding of the scope and content of litigation upholding these rights. As this accountability movement evolves, the Global Health and Human Rights Database seeks to chart this burgeoning landscape of international instruments, national constitutions, and judgments for health-related rights. Employing international legal research to document and catalogue these three interconnected aspects of human rights for the public's health, the Database's categorization by human rights, health topics, and regional scope provides a comprehensive means of understanding health and human rights law. Through these categorizations, the Global Health and Human Rights Database serves as a basis for analogous legal reasoning across states to serve as precedents for future cases, for comparative legal analysis of similar health claims in different country contexts, and for empirical research to clarify the impact of human rights judgments on public health outcomes.</p>

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<author>Benjamin Mason Meier et al.</author>


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<title>Why the Affordable Care Act&apos;s Individual Purchase Mandate is Both Constitutional and Indispensable to the Public Welfare</title>
<link>http://scholarship.law.georgetown.edu/ois_papers/37</link>
<guid isPermaLink="true">http://scholarship.law.georgetown.edu/ois_papers/37</guid>
<pubDate>Fri, 30 Mar 2012 06:36:33 PDT</pubDate>
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	<p>Integral to the Affordable Care Act's (ACA’s) conceptual design is the individual purchase mandate, which requires most individuals to pay an annual tax penalty if they do not have health insurance by 2014. Despite the vociferous opposition, the mandate is the most “market-friendly” financing device because it relies on the private sector. Ironically, less market-oriented reforms such as a single-payer system clearly would have been constitutional.</p>
<p>It is common sense for everyone to purchase health insurance and thus gain security against the potentially catastrophic costs of treating a serious illness or injury. However, Congress’ method of ensuring that everyone has health insurance is actually novel. It appears that Congress has never before mandated that individuals enter into a contract with a private company. Although some scholars have pointed to precedents—such as the requirement that everyone pay into the Medicare system—these appear distinguishable—in the case of Medicare, for example, it is a public program, albeit with private aspects.</p>
<p>The very idea that Congress could exercise this unprecedented power has provoked mostly (but not only) conservatives to recite a parade of horribles, ranging from mandatory purchase of things that are good for individuals (buy broccoli, a fitness club membership) or good for society (buy electric cars to stimulate environmentally friendly industry sales). Fundamentally, critics believe that individuals have the right to be left alone—to opt out of commerce (buy no insurance) and self-insure or simply accept the consequences if they fall ill.</p>

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<author>Lawrence O. Gostin</author>


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<title>Healthcare Reform Hangs in the Balance</title>
<link>http://scholarship.law.georgetown.edu/ois_papers/36</link>
<guid isPermaLink="true">http://scholarship.law.georgetown.edu/ois_papers/36</guid>
<pubDate>Fri, 30 Mar 2012 06:29:58 PDT</pubDate>
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	<p>In this timely new briefing, Professor Lawrence O. Gostin, University Professor and Faculty Director, O’Neill Institute for National and Global Health Law, Georgetown University writes:</p>
<p><strong> </strong>Prior to Tuesday’s arguments, I believed that the Supreme Court would uphold the health insurance purchase mandate by a comfortable margin. But now I believe that health care reform hangs in the balance. Here are the key arguments on which the future of President Obama’s health care reform depends: a greater freedom, cost-shifting, the health care market, acts versus omissions, limiting principles, the population-base approach, and what is necessary and proper. If the Court strikes down the individual mandate, everyone’s premiums for health insurance could rise inexorably. Is that what a decent society would want or accept?</p>

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<author>Lawrence O. Gostin</author>


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<title>Affordable Care Act Litigation: The Supreme Court and the Future of Health Care Reform</title>
<link>http://scholarship.law.georgetown.edu/ois_papers/35</link>
<guid isPermaLink="true">http://scholarship.law.georgetown.edu/ois_papers/35</guid>
<pubDate>Fri, 30 Mar 2012 06:28:02 PDT</pubDate>
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	<p>In <em>Florida v. HHS</em>, a lawsuit brought on behalf of 26 states  challenging the constitutionality of the Patient Protection and  Affordable Care Act (ACA), the Supreme Court will determine the future  direction of health care reform in the United States.  During the  unprecedented 5-1/2 hours of oral arguments, the Court will hear 4  issues: the individual purchase mandate, severability, the Medicaid  expansion and the Anti-Injunction Act.</p>
<p>The states challenging the ACA maintain that the purchase mandate  uniquely penalizes individuals for failing to purchase insurance.   Uninsured individuals, however, rarely do nothing. Instead, they  self-insure, rely on family, and cost-shift to hospitals, the insured,  and tax payers.  Because most uninsured people will eventually require  uncompensated care, they impose costs on everyone through higher taxes  and insurance premiums.  Further, although the ACA’s mandate is unusual,  it is not unprecedented. Mandatory worker contributions to Medicare,  for example, are a compelled purchase of health insurance.  The  necessary and proper clause, which permits Congress to pass laws  rationally related to the exercise of federal powers, may be the best  argument in favor of the mandate because the mandate is necessary for  the other insurance market reforms to work.</p>
<p>If the Court were to strike down the mandate, it would then have to  determine whether the mandate is severable from the rest of the ACA.   Although the ACA did not explicitly state that if part of the act were  deemed unconstitutional the rest would survive, most ACA reforms are  severable because they are unrelated to the mandate, such as funding for  public health and community health centers.  The more difficult  question is whether the mandate is so intertwined with the ACA’s still  unimplemented market reforms that the Court must strike them down.</p>
<p>The Court will also review the constitutionality of expanding  Medicaid to all individuals with household incomes below 138% of the  federal poverty level.  The states argue that Medicaid expansion is  unduly coercive because they could lose all Medicaid funding and not  just the funding related to the expansion.  The Court, however, is  unlikely to uphold the coercion theory because state participation in  Medicaid has always been optional and some states have openly discussed  exercising their option to discontinue the program.</p>
<p>Finally, the Court will hear technical arguments concerning the  Anti-Injunction Act (AIA), which prohibits lawsuits “for the purpose of  restraining the assessment or collection of any tax.”  The Court is  unlikely to invoke the AIA because neither the administration nor the  states contend that it applies.</p>
<p>The ACA will achieve near universal coverage, something that seemed  unimaginable just a short time ago.  Health reform envisages a social  contract in which everyone shares the cost, recognizing that virtually  everyone will become ill one day. The ACA and its individual mandate are  not unjustified limits on freedom, but rather are vital to a decent  society.</p>

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<author>Lawrence O. Gostin et al.</author>


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<title>Can law improve prevention and treatment of cancer?</title>
<link>http://scholarship.law.georgetown.edu/ois_papers/34</link>
<guid isPermaLink="true">http://scholarship.law.georgetown.edu/ois_papers/34</guid>
<pubDate>Thu, 01 Dec 2011 08:06:58 PST</pubDate>
<description>
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	<p>The  December 2011 issue of Public Health (the Journal of the Royal Society  for Public Health) contains a symposium entitled: Legislate, Regulate,  Litigate? Legal approaches to the prevention and treatment of cancer.   This symposium explores the possibilities for using law and regulation –  both internationally and at the national level – as the policy  instrument for preventing and improving the treatment of cancer and  other leading non-communicable diseases (NCDs).  In this editorial, we  argue that there is an urgent need for more legal scholarship on cancer  and other leading NCDs, as well as greater dialogue between lawyers,  public health practitioners and policy-makers about priorities for law  reform, and feasible legal strategies for reducing the prevalence of  leading risk factors.  The editorial discusses two important challenges  that frequently stand in the way of a more effective use of law in this  area.  The first is the tendency to dismiss risk factors for NCDs as  purely a matter of individual 'personal responsibility'; the second is  the fact that effective regulatory responses to risks for cancer and  NCDs will in many cases provoke conflict with the tobacco, alcohol and  food industries. After briefly identifying some of the strategies that  law can deploy in the prevention of NCDs, we briefly introduce each of  the ten papers that make up the symposium.</p>

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<author>Roger Magnusson et al.</author>


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<title>Improving the Population’s Health: The Affordable Care Act and the Importance of Integration</title>
<link>http://scholarship.law.georgetown.edu/ois_papers/33</link>
<guid isPermaLink="true">http://scholarship.law.georgetown.edu/ois_papers/33</guid>
<pubDate>Fri, 23 Sep 2011 08:11:23 PDT</pubDate>
<description>
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	<p>Heath care and public health are typically conceptualized as separate,  albeit overlapping, systems. Health care’s goal is the improvement of  individual patient outcomes through the provision of medical services.  In contrast, public health is devoted to improving health outcomes in  the population as a whole through health promotion and disease  prevention. Health care services receive the bulk of funding and  political support, while public health is chronically starved of  resources. In order to reduce morbidity and mortality, policymakers must  shift their attention to public health services and to the improved  integration of health care and public health. In other words, health  care and public health should be treated as two parts of a single  integrated health system (which we refer to as the health system  throughout this article). Furthermore, in order to maximize improvements  in health status, policymakers must consider the impact of all  governmental policies on health (a Health in All Policies Approach).</p>
<p>The Patient Protection and Affordable Care Act of 2010 (ACA or the Act)1 reflects the dominance of health care over public health. As its name suggests, the statute’s primary goal is to improve access to health care services through insurance system reforms. In contrast, politicians neglected the goal of improving the population’s health in this monumental overhaul of our health system. Although the ACA does little to mandate health system integration, various opportunities exist within the Act’s implementation for decision makers to improve coordination between health care and public health.</p>
<p>In the first part of this article, we argue that the key purpose of health reform should be the improvement of health. Evidence indicates that public health efforts — health promotion and disease prevention — contribute more to reductions in morbidity and mortality than improved access to health care services. We then argue that optimal gains in health status will occur through effective and efficient integration of public health and health care services. In the third part of the article, we explore the ACA’s contribution to the goal of improving the population’s health. Specifically, we critically analyze the extent to which the Act facilitates integration between public health and health care. Drawing from the health policy literature, we discuss strategies for advancing integration, with a view to guiding the Act’s implementation and future health care debates. We conclude by advocating for a broad approach to integration — a Health in All Policies Approach — which would integrate health considerations into all areas of government policy.</p>

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</description>

<author>Lorian E. Hardcastle et al.</author>


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<title>WHO’s Pandemic Influenza Preparedness Framework: A Milestone in Global Governance for Health</title>
<link>http://scholarship.law.georgetown.edu/ois_papers/32</link>
<guid isPermaLink="true">http://scholarship.law.georgetown.edu/ois_papers/32</guid>
<pubDate>Thu, 04 Aug 2011 06:59:47 PDT</pubDate>
<description>
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	<p>In May 2008, the World Health Organization (WHO) adopted the Pandemic Influenza Preparedness Framework for the Sharing of Influenza Viruses and Access to Vaccines and Other Benefits (PIP Framework). The PIP Framework’s adoption ended years of difficult negotiations, which began after Indonesia refused to share samples of avian influenza A (H5N1) with WHO in late 2006. Indonesia justified its actions on the need to create more equitable access for developing countries to benefits, such as vaccines and antivirals, derived from research and development on shared influenza virus samples. The global health community feared that failure to share influenza virus samples would jeopardize surveillance and response efforts against the threat of pandemic influenza.</p>
<p>The PIP Framework seeks to improve pandemic influenza preparedness by addressing virus and benefit sharing on an equal footing and establishing mechanisms to achieve more equitable access to benefits. To facilitate virus sharing, the PIP Framework encourages WHO member states to share influenza virus specimens. It also creates a virus tracking mechanism that features two standard material transfer agreements to increase transparency concerning the use of shared viruses. This mechanism represents the Framework’s most significant contribution to strengthening pandemic influenza surveillance and response.</p>
<p>The Framework’s benefit-sharing system contains many components, but its most notable accomplishment for increasing equitable access to benefits is the pharmaceutical industry’s agreement to provide monetary and in-kind contributions. The PIP Framework is a landmark for global governance for health because it is the first international agreement facilitating influenza virus and benefit sharing. However, the Framework is not legally binding, avoids intellectual property issues that complicated the negotiations, does not include commitments from developed countries to donate portions of influenza vaccines they purchase, and faces implementation challenges in an increasingly difficult global health environment.</p>

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<author>Lawrence O. Gostin et al.</author>


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