The Affordable Care Act (ACA) and other federal initiatives are fostering the emergence of a coherent vision for chronic disease prevention that has never before existed in the United States. This investment in population health and prevention comes not a moment too soon. Health care costs are proving very difficult to control and are rising at an unsustainable rate, driven in part by sky-rocketing chronic disease rates.

This article looks at how a health system can engage in prevention activities beyond the clinical setting and makes a strong case that these interventions will result in documented cost savings. We first examine an individually targeted strategy that helps patients obtain health insurance coverage. This strategy furthers a hospital's goal of receiving reimbursement for care while also having the social benefit of increasing patients’ economic stability.

The federal regulations that govern biomedical research, most notably those enshrined in the Common Rule, are a product of their time. Born in the aftermath of wartime atrocities committed by Nazi doctors, and influenced by domestic research scandals like the Willowbrook and Tuskegee studies, the regulations express a protectionist ethos aimed at safeguarding subjects of human experimentation from the potential harms of research participation. Requirements for informed consent, risk minimization, equitable subject selection, and peer review of proposed research rest on the presumption that the research enterprise owes subjects a duty of protection.

Congress has consistently failed to solve some serious problems with the cost, effectiveness, and safety of pharmaceuticals. In part, this failure results from the pharmaceutical industry convincing legislators to define policy problems in ways that protect industry profits. By targeting campaign contributions to influential legislators and by providing them with selective information, the industry manages to displace the public’s voice in developing pharmaceutical policy.

The most common response to the challenge of protecting health through law is to focus on protecting the rights of vulnerable individuals and to enhance their access to health care. Each one of us is vulnerable or potentially vulnerable because of the fragile, existential nature of the human condition. Catastrophic and unexpected events could instantaneously transform us from a state of total independence and potential vulnerability to one of extreme vulnerability and complete dependence. Some legal provisions have the potential to provide a modicum of protection when we find ourselves in those situations (for example, through legislation, effective emergency health services can be created to reduce the impact of our potential vulnerability). There are also legal provisions that contribute to beneficial social circumstances; for example, legislation enabling universal access to medical care, and operationalizing respect for the individual’s right to health care, as advocated for by other authors in this issue.

Law can greatly facilitate responses to public health emergencies, including naturally-occurring infectious disease outbreaks and intentional or accidental exposures to chemical, biological, radiological, or nuclear (CBRN) agents. At the federal level, the Secretary of the Department of Health and Human Services (HHS), as the lead for federal public health and medical responses to public health emergencies and incidents, has a range of authorities to support federal, state, tribal, local, and territorial responses. For example, under the Public Health Service (PHS) Act, the Secretary may provide temporary assistance to States to meet health emergency needs or deploy medicine and supplies from the Strategic National Stockpile. The Secretary also may determine that a disease or disorder presents a public health emergency, which may be the first step in triggering other critical legal authorities for response.

Since the 2001 anthrax attacks, one focus of public health preparedness has been on developing, distributing, and rapidly dispensing medical countermeasures (MCMs) for CBRN emergencies and pandemics.

Access to human biospecimens is widely regarded as essential to the progress of medical research, and in particular, to the success of “personalized medicine.” Understanding the influence of genetic variation on human health and disease requires that researchers conduct genetic and other studies on thousands of human specimens. Over the past decade, human “biobanks” — vast collections of human biospecimens — have proliferated both in the United States and internationally. These biobanks are subject to a heterogeneous mix of standards that govern the collection and use of biospecimens.

Across the nation, local, state, territorial, and tribal governments are engaged in successful efforts to protect and promote the health of their citizens by supporting healthy eating and active living initiatives. The ten essential services define a role for public health at multiple levels of influence (see Table 1). These functions provide a framework for obesity prevention that is consistent with the systems approach presented by the Institute of Medicine in “Accelerating Progress in Obesity Prevention.”

Governmental public health authorities can contribute to public health efforts to address obesity by monitoring prevalence of obesity and association risk factors, investigating the contributing factors, informing the public, and work with the citizens in their jurisdiction to develop solutions that fit the needs and sensibilities of the people.

This article argues that the misalignment of private profit-maximizing objectives with public health needs causes institutional corruption in the pharmaceutical sector and systematically leads firms to act contrary to public heath. The article analyzes how financial incentives generate a business model promoting harmful practices and explores several means of realigning financial incentives in order to foster therapeutic innovation and promote the rational use of medicines.

Making decisions is an important component of everyday living, and issues surrounding autonomy and self-determination are crucial for persons with intellectual disabilities. Adults with intellectual disabilities are characterized by the limitations in their intellectual functioning and in their adaptive behavior, which compromises three skill types (conceptual skills, social skills, and practical skills), and this starts before the age of 18. Though persons with intellectual disabilities are characterized by having these limitations, they are thought to face significant decisionmaking challenges due to their disability. Moving away from this generalization, Article 12 (Equal recognition before the law) of the United Nations (UN) Convention on the Rights of Persons with Disabilities (herewith called “the Convention”) addresses this issue of decision-making for persons with disabilities, recognizing the right to legal capacity.

The World Health Organization (WHO) has in the last decade identified mental health as a priority for global health promotion and international development, to be targeted through promulgation of evidence-based medical practices, health systems reform, and respect for human rights. Yet these overlapping strategies are marked by tensions as the historical primacy of expert-led initiatives is increasingly subject to challenge by new social movements — in particular, disabled persons’ organizations (DPOs). These tensions come into focus upon situating the WHO’s contributions to the analysis of global mental health in light of the negotiation and early stages of implementation of the Convention on the Rights of Persons with Disabilities (CRPD), particularly as it applies to persons with mental disabilities.

For at least the past 15 years, food safety stakeholders across all levels of government have recognized the critical role that state and local agencies play in our nation's food safety system. State and local agencies are the first responders to foodborne outbreaks and have primary responsibility for keeping their residents safe from foodborne disease through effective surveillance and rapid response to outbreaks. They also conduct the vast majority of food safety inspections across the nation's restaurants, grocery stores, and other food service and food retail establishments.

Recent efforts among industry and government officials alike have focused on creating a more integrated, prevention-oriented food safety system. The Food Safety Modernization Act, the first major overhaul of the nation's food safety laws since the 1930s, now mandates that most sectors of the food industry put preventive controls in place, changing the emphasis of what the FDA does from response to prevention.

Human rights are basic, inalienable, interdependent, and universally recognized rights that are sine qua non for existence and growth of any human to be his best. These human rights are to be enjoyed by all human beings (individually or collectively) by virtue of being human, irrespective of their limitations or disabilities; due to the stated reason, the rights of disabled people as a “group right” are recognized as a third-generation human right.

The U.S. Department of Health and Human Services (HHS) has proposed substantial changes to the current regulatory system governing human subjects research in its Advanced Notice of Proposed Rulemaking (ANPRM), entitled “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators.” Some of the most significant proposed changes concern the use of biospecimens in research. Because research involving biological materials begins with an initial interaction with an individual, such research falls squarely within the human subjects research regulatory framework known as the “Common Rule,” which applies to research conducted or funded by the HHS and the other signatory agencies and departments. However, as described in detail below, much biospecimen research may fall within exemptions and exceptions under the Common Rule and, thus, may be conducted without consent. The ANPRM proposes requiring written consent for research use of biospecimens, even if the biospecimens were initially collected for a purpose other than research or have been stripped of identifiers.

Worksites are an important setting to promote healthy behaviors as 143 million adults are employed full-time and spend 8-10 hours per day at the workplace. Participation in health promotion programs have been shown to have a “dose response” relationship with health care costs, meaning health care costs decrease as employee involvement in health promotion activities in the workplace increase. Also from the employer perspective, it is important to note that obesity is a risk factor for many other chronic conditions, diabetes, heart disease, and cancer and is known to be related to increase injuries and health care costs. Motivating employees to participate in a number of wellness activities may provide benefits not only for obesity prevention but other desired outcomes such as: risk reduction, risk avoidance, reduced health costs, and improved productivity measures. Employers should be concerned as forecasts suggest that by 2030, 42% of the adult population will be obese. In fact, among employers, the costs of medical expenses and absenteeism increase as employees become more obese. The cost burden of obesity (BMI 30 or greater) ranges from $462-$2,027 among men and $1,372-$2,164 among women in comparison to normal-weight employees. However, halting this trend over the next few decades by maintaining (vs. increasing) current prevalence of obesity could potentially save billions in medical care expenditures related to obesity. Employers can be part of the solution by offering workplace wellness programs and facilitating opportunities for physical activity, access to healthier foods and beverages, and incentives for disease management and prevention to help prevent weight gain among their employees.

The federal government indirectly subsidizes the pharmaceutical industry by funding basic research, various tax credits and deductions, patent rules, grants of market exclusivity, and other means, in order to spur drug development, promote public health, and improve medical care. But today, the pharmaceutical industry often neglects these goals and sometimes even undermines them, due to what Lawrence Lessig refers to as institutional corruption — that is, widespread or systemic practices, usually legal, that undermine an institution’s objectives or integrity. A key source of institutional corruption is improper dependence by the institution or its key actors on the actions of third parties that have fundamentally different interests. It is the health care system’s improper dependency on pharmaceutical firms that allows them to displace some public policy goals and to compromise the attainment of others.

State and international laws have often been instruments of oppression against Indigenous peoples, enabling and casting a veil of legitimacy over state actions that dispossess, assimilate, and discriminate. In the contemporary setting such law has, at times, come to be harnessed to support or protect Indigenous interests, including addressing Indigenous health deficits and associated injustices.

Institutional corruption is a normative concept of growing importance that embodies the systemic dependencies and informal practices that distort an institution’s societal mission. An extensive range of studies and lawsuits already documents strategies by which pharmaceutical companies hide, ignore, or misrepresent evidence about new drugs; distort the medical literature; and misrepresent products to prescribing physicians. We focus on the consequences for patients: millions of adverse reactions. After defining institutional corruption, we focus on evidence that it lies behind the epidemic of harms and the paucity of benefits.

In this paper we review selected international legal instruments, the effect, if any, that they have had on global health, and how these instruments might have contributed to the realization of health rights. We consider a number of instruments from the international health law field as well as two from the field of international environmental law.1 The latter two, in addition to the considerable link between health and climate/environment, are considered with the purpose of drawing more generalized lessons about what contributes to the success or failure of an international legal instrument; the lessons are then applied to our analysis of the health law instruments that are the primary focus of our paper.

Physical inactivity is one of the leading “actual” causes of preventable premature mortality due in large part to its role in obesity and associated morbidities. Currently, less than half (47%) of U.S. adults meet recommendations for aerobic physical activity. For children the numbers are also low, 29% of high school students reported meeting the goal of 60 minutes of daily physical activity over the last week. There has also been a decline in the proportion of children walking or biking to school from 48% in 1969 to 13% in 2009. As a result, promoting physical activity both as recreational exercise and as a part of day-to-day utilitarian travel by foot or bicycle has emerged as a central goal of national and international efforts, often as part of obesity prevention and control efforts.

Drug overdose has recently surpassed motor vehicle accidents to become the leading cause of unintentional injury death in the United States. The epidemic is largely driven by opioids such as oxycodone, hydrocodone, and methadone, which kill more Americans than heroin and cocaine combined. The demographics of overdose have changed over the past few decades as well: according to the latest data, the average overdose victim is now a non-Hispanic white man aged 45-54.

These deaths — over 16,000 per year — are almost entirely preventable. Opioid overdose kills by slowly depressing respiration, a process that can take several hours. It can be quickly and effectively reversed by the timely administration of naloxone, an opioid antagonist that works by displacing opioids from the brain receptors to which they attach, reversing their depressant effect. Naloxone, also known as Narcan, has many benefits and minimal risks. Although it is a prescription drug, it is not a controlled substance and has no abuse potential.