Law Commons^™

Improving The Population’S Health: The Affordable Care Act And The Importance Of Integration, Lorian E. Hardcastle, Katherine L. Record, Peter D. Jacobson, Lawrence O. Gostin

O'Neill Institute Papers

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, …

Mandatory Hpv Vaccination And Political Debate, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Vaccinations are among the most cost-effective and widely used public health interventions, but have provoked popular resistance, with compulsion framed as an unwarranted state interference. When the FDA approved a human papillomavirus (HPV) vaccine in 2006, conservative religious groups strongly opposed a mandate, arguing it would condone pre-marital sex, undermine parental rights, and violate bodily integrity. Yet, Governor Rick Perry signed an executive order in 2007 making Texas the first state to enact a mandate — later revoked by the legislature.

Mandatory HPV vaccination reached the heights of presidential politics in a recent Republican debate. Calling the vaccine a "very …

The Fda, Preemption, And Public Safety: Antiregulatory Effects And Maddening Inconsistency, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Most people think of preemption as a technical constitutional doctrine, but it is pivotally important to health and safety, while also opening the door to broad judicial discretion. The Rehnquist and Roberts Courts’ pro-business/pro-preemption jurisprudence is distinctly antiregulatory, invalidating major state public health rules, such as in occupational safety, tobacco control, and motor vehicle safety. Apart from the antiregulatory effects, there is maddening inconsistency. Consider three relatively recent Supreme Court cases. In Riegel v. Medtronic, Inc. (2008), the Court held that federal law bars injured consumers from challenging the safety or effectiveness of FDA-approved medical devices. A year later, …

Who’S Pandemic Influenza Preparedness Framework: A Milestone In Global Governance For Health, Lawrence O. Gostin, David P. Fidler

Georgetown Law Faculty Publications and Other Works

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 …

Food And Drug Administration Regulation Of Food Safety, Lawrence O. Gostin, Katie F. Stewart

Georgetown Law Faculty Publications and Other Works

Food-borne illness remains a major public health challenge in the United States, causing an estimated 48 million illness episodes and 3000 deaths annually. The FDA Food Safety Modernization Act (FSMA), enacted in 2011, gives the Food and Drug Administration (FDA) new tools to regulate food safety. The act emphasizes prevention, enhanced recall authority, and oversight of imported food.

The FSMA brings the FDA’s food safety regulation in line with core tenets of public health by focusing on preventing outbreaks, rather than reacting to them, and differentiating between foods and food producers based on the degree of risk they pose. The …

The Joint Action And Learning Initiative: Towards A Global Agreement On National And Global Responsibilities For Health, Lawrence O. Gostin, Eric A. Friedman, Gorik Ooms, Thomas Gebauer, Narendra Gupta, Devi Sridhar, Wang Chenguang, John-Arne Røttingen, David Sanders

O'Neill Institute Papers

A coalition of civil society organizations and academics is initiating a Joint Action and Learning Initiative on National and Global Responsibilities for Health (JALI) to research key conceptual questions involving health rights and responsibilities, with the goal of securing a global health agreement andsupporting civil society and community mobilization around the human right to health. The social mobilization is critical to creating the political space that would make such an agreement possible and to ensuring its implementation.

This agreement, such as a Framework Convention on Global Health, would inform post-Millennium Development Goal global health commitments, be grounded in the right …

Dangerous People Or Dangerous Weapons: Access To Firearms For Persons With Mental Illness, Lawrence O. Gostin, Katherine L. Record

Georgetown Law Faculty Publications and Other Works

The recent attempted assassination of Rep. Gabrielle Giffords has once again focused the nation’s attention on the danger of the wide availability of firearms. The Supreme Court has ruled that gun restrictions may only be imposed on those deemed “prohibited persons” under the Gun Control Act of 1968. Although some are easily identifiable (e.g., children, convicted felons), one widely inclusive group is not – the mentally ill.

The current system designed to bar the mentally ill from purchasing or possessing firearms is ineffectual due to a lack of reporting and the existence of loopholes. What’s more, no state has developed …

Can Law Improve Prevention And Treatment Of Cancer?, Roger Magnusson, Lawrence O. Gostin, David Studdert

O'Neill Institute Papers

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 …

Restoring Health To Health Reform: Integrating Medicine And Public Health To Advance The Population's Wellbeing, Lawrence O. Gostin, Peter D. Jacobson, Katherine L. Record, Lorian E. Hardcastle

Georgetown Law Faculty Publications and Other Works

The Patient Protection and Affordable Care Act is a major achievement in improving access to health care services. However, evidence indicates that the nation could achieve greater improvements in health outcomes, at a lower cost, by shifting its focus to public health. By focusing nearly exclusively on health care, policy makers have chronically starved public health of adequate and stable funding and political support. The lack of support for public health is exacerbated by the fact that health care and public health are generally conceptualized, organized, and funded as two separate systems. In order to maximize gains in health status …

Turning Citizens Into Subjects: Why The Health Insurance Mandate Is Unconstitutional, Randy E. Barnett

Georgetown Law Faculty Publications and Other Works

In 2010 something happened in this country that has never happened before: Congress required that every person enter into a contractual relationship with a private company. While the author realizes that writers make lots of factual claims that readers are wise to be skeptical about, he proves that an economic mandate like this one is unprecedented. If this mandate had ever happened before, everyone reading this passage would know all the contracts the federal government requires them to make, upon pain of a penalty enforced by the Internal Revenue Service (IRS). No reader, however, can recite any such mandate and …

Ethical Allocation Of Preexposure Hiv Prophylaxis, Lawrence O. Gostin, Susan C. Kim

Georgetown Law Faculty Publications and Other Works

Civil society-led movements transformed global AIDS action from deep skepticism about extending anti-retroviral (ARV) treatment in low and middle-income countries to an historic scaling up of treatment towards universal access. The AIDS movement, however, is at an inflection point due to the interplay of key health and economic determinants—the global financial downturn, tight foreign aid budgets, and intense resource competition. Policy makers will now have to consider implementation of a new intervention—pre-exposure prophylaxis (PrEP), which could mean a diversion of ARVs from treatment to prevention. The principle underlying PrEP is that ARVs could prevent HIV infection among people who are …

Biosafety Concerns Involving Genetically Modified Mosquitoes To Combat Malaria And Dengue In Developing Countries, Graciela R. Ostera, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Malaria and dengue are the most prevalent mosquito-borne infections worldwide. Because traditional vector control methods have proven to be insufficient to control mosquito populations in endemic areas, scientists are actively working in the design of new strategies, such as genetically modified (GM) mosquitoes, to reduce disease transmission. The replacement of natural populations with GM mosquitoes is becoming a tangible possibility, however, many fear that the release of these organisms into the environment could constitute a significant risk to biodiversity and may cause the unintended spread of GM organisms across national borders.

The Cartagena Protocol on Biosafety, an international agreement originally …

Reforming The World Health Organization, Devi Sridhar, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Director-General Margaret Chan recently called the WHO overextended and unable to respond with speed and agility to today’s global health challenges. Given the importance of global health cooperation, few would dispute that a stronger, more effective WHO would benefit all. In this commentary, we offer 5 proposals for re-establishing WHO’s leadership.

(1) Give Real Voice to Multiple Stakeholders
The WHO would be more effective by giving real voice and representation to key stakeholders, including philanthropies, businesses, public/private partnerships, and civil society. Meaningful stakeholder engagement would instill confidence, and spark investment, in the agency.

(2) Improve Transparency, Performance and Accountability
Stakeholders …

The Who Global Code Of Practice On The International Recruitment Of Health Personnel: The Evolution Of Global Health Diplomacy, Allyn L. Taylor, Ibadat S. Dhillon

Georgetown Law Faculty Publications and Other Works

The May 2010 adoption of the World Health Organization Global Code of Practice on the International Recruitment of Health Personnel created a global architecture, including ethical norms and institutional and legal arrangements, to guide international cooperation and serve as a platform for continuing dialogue on the critical problem of health worker migration. Highlighting the contribution of non-binding instruments to global health governance, this article describes the Code negotiation process from its early stages to the formal adoption of the final text of the Code. Detailed are the vigorous negotiations amongst key stakeholders, including the active role of non-governmental organizations. The …

Health Insurance Reform And Intimations Of Citizenship, Nan D. Hunter

Georgetown Law Faculty Publications and Other Works

This article considers the implications of the Patient Protection and Affordable Care Act (PPACA) for social meanings of civic belonging in American society and for possible new forms of individual engagement with the health care system. Once fully implemented, PPACA will have many of the governance characteristics of other social insurance systems, in that it will define membership in a collective undertaking, establish a mechanism for collective security against a shared risk, and channel, incentivize and penalize specific behaviors. The article considers the extent to which PPACA has the potential to also produce new narratives and understandings of social solidarity …

Is Health Care Reform Unconstitutional?, David Cole

Georgetown Law Faculty Publications and Other Works

No abstract provided.