Legal priorities for prevention of non-communicable diseases: innovations from WHO's Eastern Mediterranean region.

OBJECTIVES: Non-communicable diseases (NCDs) are the leading cause of death globally and in the World Health Organization's (WHO) Eastern Mediterranean region (EMR). This paper reports on a research collaboration between the WHO's Eastern Mediterranean Office (EMRO) and the O'Neill Institute for National and Global Health Law at Georgetown University that aims to identify (1) regionally relevant, cost-effective and affordable legal interventions to prevent NCDs, and (2) methods to strengthen implementation and enforcement. STUDY DESIGN: Comparative analysis of >200 international, regional and domestic interventions addressing key NCD risk factors, including tobacco, alcohol, diet and physical inactivity. METHODS: Researchers searched legal and policy databases including the WHO Nutrition, Obesity and Physical Activity Database and drew upon academic commentary and 'grey' literature. Measures included evidence of impact; evidence of cost-effectiveness; and monitoring and enforcement mechanisms. RESULTS: Researchers identified many examples of legal interventions effectively reducing NCD risk factors. Key enabling factors for effective NCD-related laws include regulatory capacity; governance mechanisms promoting multisectoral collaboration and accountability; and tailoring interventions to local legal, economic and social contexts. CONCLUSIONS: In the EMR, and globally, law can be a cost-effective and affordable means of curbing underlying drivers of the NCD pandemic, such as rampant junk food marketing. Building upon this research, together with international and regional experts, EMRO has identified 10 priority interventions in the areas of tobacco control, unhealthy diets and NCD governance. The EMRO/O'Neill Institute partnership will develop guidance tools and capacity building initiatives to support Member States to harness the power of law to achieve population health improvements.

The normative authority of the World Health Organization.

The World Health Organization (WHO) was born after the devastation of World War II, as a normative agency endowed with unprecedented constitutional powers. But even as it has achieved stunning successes, such as the eradication of smallpox, it has failed to live up to the exalted expectations of the postwar health and human rights movement - exemplified most recently by its inadequate response to the Ebola epidemic. Our aim is to offer innovative ideas for restoring the Organization to its leadership position by exercising its normative authority, even as it faces a crowded and often chaotic global health architecture. Before doing so, it will be helpful to summarize the main tensions the Organization faces in today's global health landscape.

Health worker shortages and global justice

The world is experiencing a serious human resource shortage in the health sector, which the World Health Assembly calls 'a crisis in health'. This Report systematically explains the human services crisis, particularly in the world's poorest countries. The Report considers the complex mix of factors that cause the global shortage of health workers. We demonstrate why no single country, acting alone, can solve the human resources crisis. In short, a country's health workforce is not determined only by decisions of its national government. Policy choices in one country often have consequences for the health workforce in other countries. We give particular attention to the policy positions of rich countries that contribute to the extreme shortages in much poorer countries. We recommend a range of policy interventions that rich countries, particularly the United States, should make to alleviate workforce shortages domestically and globally. Our recommendations are based on the best-available evidence as to what interventions are most likely to be successful in addressing the causes and consequences of the shortage. They are also predicated on a normative analysis of the legal rights and obligations, as well as moral interests and claims, of governments, health workers, and users of health services.

Public health measures to control tuberculosis in low-income countries: ethics and human rights considerations.

In low-income countries, tuberculosis (TB) control measures should be guided by ethical concerns and human rights obligations. Control programs should consider the principles of necessity, reasonableness and effectiveness of means, proportionality, distributive justice, and transparency. Certain measures-detention, infection control, and treatment to prevent transmission-raise particular concerns. While isolation is appropriate under certain circumstances, quarantine is never an acceptable control measure for TB, and any detention must be limited by necessity and conducted humanely. States have a duty to implement hospital infection control to the extent of their available resources and to provide treatment to health care workers (HCWs) infected on the job. HCWs, in turn, have an obligation to provide care unless conditions are unreasonably and unforeseeably unsafe. Finally, states have an obligation to provide adequate access to treatment, as a means of preventing transmission, as broadly as possible and in a non-discriminatory fashion. Along with treatment, states should provide support to increase treatment adherence and retention with respect for patient privacy and autonomy. Compulsory treatment is almost never acceptable. Governments should take care to respect human rights and ethical obligations as they execute TB control programs.

A global assessment of the role of law in the HIV/AIDS pandemic.

This article examines the dynamic role of law as a tool, and potential barrier, to public health interventions designed to ameliorate the negative impacts of human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS) globally. Law impacts the lives of persons living with (and at risk of) HIV/AIDS in many ways. Laws may: (1) help to ensure that public health authorities are empowered to provide effective prevention and treatment programmes; (2) effectuate the human rights to life, health, work, education and property ownership of persons living with, or at risk of, HIV/AIDS; and (3) protect persons living with HIV/AIDS from social risks, stigma and other harms by respecting privacy and prohibiting unwarranted discrimination. However, laws can also create legal barriers in many countries that impede effective HIV/AIDS interventions by penalizing those with HIV/AIDS through criminal sanctions or other policies. As a result, it is recommended globally that laws should facilitate the prevention and treatment of HIV/AIDS consistent with scientific and public health practices and with a human rights framework. Effective use of existing laws that promote the public's health, and reforms of laws which impede it, contribute to improved individual and communal health outcomes concerning HIV/AIDS.

A broader liberty: J.S. Mill, paternalism and the public's health.

Is the 'harm principle', famously propounded by J.S. Mill and widely adopted in bioethics, an appropriate principle to guide public health regulation? The harm principle limits liberty-limiting interventions to those instances where the person poses a significant risk of harm to others. However, much of public health regulation is not primarily directed to avert risk to others, but to safeguard the health and safety of the individual him- or herself. Regulations regarding seatbelts, motorcycle helmets and the fluoridation of water are examples of pervasive public health regulations that are primarily intended to safeguard the individual's own health or safety. Even laws designed to reduce smoking are justified, at least in substantial part, by the reduction of risk to the smoker. Certainly, scholars argue that there are 'other-regarding' aspects to these types of laws, but there is little doubt that there are strong paternalistic features to these, and many other public health laws, such as bans on trans fat in foods. This article directly and forcefully questions the Millian principle, making the case for hard paternalism. When seen from a population-based perspective that counts the number of lives saved, paternalism becomes a plausible justification for interventions that do not pose a truly significant burden on individual liberty, but go a long way towards safeguarding the health and well-being of the populace.

Large-scale quarantine following biological terrorism in the United States: scientific examination, logistic and legal limits, and possible consequences.

Concern for potential bioterrorist attacks causing mass casualties has increased recently. Particular attention has been paid to scenarios in which a biological agent capable of person-to-person transmission, such as smallpox, is intentionally released among civilians. Multiple public health interventions are possible to effect disease containment in this context. One disease control measure that has been regularly proposed in various settings is the imposition of large-scale or geographic quarantine on the potentially exposed population. Although large-scale quarantine has not been implemented in recent US history, it has been used on a small scale in biological hoaxes, and it has been invoked in federally sponsored bioterrorism exercises. This article reviews the scientific principles that are relevant to the likely effectiveness of quarantine, the logistic barriers to its implementation, legal issues that a large-scale quarantine raises, and possible adverse consequences that might result from quarantine action. Imposition of large-scale quarantine-compulsory sequestration of groups of possibly exposed persons or human confinement within certain geographic areas to prevent spread of contagious disease-should not be considered a primary public health strategy in most imaginable circumstances. In the majority of contexts, other less extreme public health actions are likely to be more effective and create fewer unintended adverse consequences than quarantine. Actions and areas for future research, policy development, and response planning efforts are provided.

Informed consent for population-based research involving genetics.

Bridging the gap between gene discovery and our ability to use genetic information to benefit health requires population-based knowledge about the contribution of common gene variants and gene-environment interactions to the risk of disease. The risks and benefits associated with population-based research involving genetics, especially lower-penetrance gene variants, can differ in nature from those associated with family-based research. In response to the urgent need for appropriate guidelines, the Centers for Disease Control and Prevention formed a multidisciplinary group to develop an informed consent approach for integrating genetic variation into population-based research. The group used expert opinion and federal regulations, the National Bioethics Advisory Commission's report on research involving human biological materials, existing consent forms, and literature on informed consent to create suggested language for informed consent documents and a supplemental brochure. This language reflects the premise that the probability and magnitude of harm, as well as possible personal benefits, are directly related to the meaning of the results for the health of the participant and that appropriate disclosures and processes for obtaining consent should be based on an assessment at the outset of the likelihood that the results will generate information that could lead directly to an evidence-based intervention. This informed consent approach is proposed to promote discussion about how best to enable potential participants to make informed decisions about population-based research involving genetics and to suggest issues for consideration by research sponsors, institutional review boards, and investigators.

Public health law reform.

Public health law reform is necessary because existing statutes are outdated, contain multiple layers of regulation, and are inconsistent. A model law would define the mission and functions of public health agen cies, provide a full range of flexible powers, specify clear criteria and procedures for activities, and provide protections for privacy and against discrimination. The law reform process provides an opportunity for public health agencies to draw attention to their resource needs and achievements and to form ties with constituency groups and enduring relations with the legislative branch of government. Ultimately, the law should become a catalyst, rather than an impediment, to reinvigorating the public health system.

Informational privacy and the public's health: the Model State Public Health Privacy Act.

Protecting public health requires the acquisition, use, and storage of extensive health-related information about individuals. The electronic accumulation and exchange of personal data promises significant public health benefits but also threatens individual privacy; breaches of privacy can lead to individual discrimination in employment, insurance, and government programs. Individuals concerned about privacy invasions may avoid clinical or public health tests, treatments, or research. Although individual privacy protections are critical, comprehensive federal privacy protections do not adequately protect public health data, and existing state privacy laws are inconsistent and fragmented. The Model State Public Health Privacy Act provides strong privacy safeguards for public health data while preserving the ability of state and local public health departments to act for the common good.