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.

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 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.

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.

National health information privacy: regulations under the Health Insurance Portability and Accountability Act.

Health information privacy is important in US society, but existing federal and state law does not offer adequate protection. The Department of Health and Human Services, under powers granted by the Health Insurance Portability and Accountability Act of 1996, recently issued a final rule providing systematic, nationwide health information privacy protection. The rule is extensive in its scope, applying to health plans, health care clearinghouses, and health care providers (hospitals, clinics, and health departments) who conduct financial transactions electronically ("covered entities"). The rule applies to personally identifiable information in any form, whether communicated electronically, on paper, or orally. The rule does not preempt state law that affords more stringent privacy protection; thus, the health care industry will have to comply with multiple layers of federal and state law. The rule affords patients rights to education about privacy safeguards, access to their medical records, and a process for correction of records. It also requires the patient's permission for disclosures of personal information. While privacy is an important value, it may conflict with public responsibilities to use data for social goods. The rule has special provisions for disclosure of health information for research, public health, law enforcement, and commercial marketing. The privacy debate will continue in Congress and within the president's administration. The primary focus will be on the costs and burdens on health care providers, the ability of health care professionals to use and share full medical information when treating patients, the provision of patient care in a timely and efficient manner, and parents' access to information about the health of their children.

Health promotion and the First Amendment: government control of the informational environment.

Government efforts to protect public health often include controlling health information. The government may proscribe messages conveyed by commercial entities (e.g., false or misleading), recommend messages from commercial entities (e.g., warnings and safety instructions), and convey health messages (e.g., health communication campaigns). Through well-developed, albeit evolving, case law, government control of private speech has been constrained to avoid impinging on such values as free expression, truthfulness, and autonomous decision making. No simple legal framework has been developed for the government's own health messages to mediate between the legitimate goals of health protection and these other values. Nevertheless, government recommendations on matters of health raise difficult social and ethical questions and involve important societal trade-offs. Accordingly, this article proposes legal and ethical principles relating to government control of the health information environment.

Health information: reconciling personal privacy with the public good of human health.

The success of the health care system depends on the accuracy, correctness and trustworthiness of the information, and the privacy rights of individuals to control the disclosure of personal information. A national policy on health informational privacy should be guided by ethical principles that respect individual autonomy while recognizing the important collective interests in the use of health information. At present there are no adequate laws or constitutional principles to help guide a rational privacy policy. The laws are scattered and fragmented across the states. Constitutional law is highly general, without important specific safeguards. Finally, a case study is provided showing the important trade-offs that exist between public health and privacy. For a model public health law, see www.critpath.org/msphpa/privacy.

A proposed national policy on health care workers living with HIV/AIDS and other blood-borne pathogens.

In 1991, scientific uncertainty about the risk of transmission of human immunodeficiency virus or hepatitis B virus (hepatitis B e antigen [HBeAg]-positive) led the Centers for Disease Control and Prevention to recommend that infected health care workers (HCWs) be reviewed by an expert panel and inform patients of their serologic status before engaging in exposure-prone procedures. The data demonstrate that risks of transmission in the health care setting are exceedingly low, suggesting that the national policy should be reformed. Implementation of the current national policy at the local level poses significant human rights burdens on HCWs, but does not improve patient safety. A new national policy should focus on the management of the workplace environment and injury prevention by creating a program to prevent blood-borne pathogen transmission; by encouraging infected HCWs to promote their own health and well-being; by discontinuing expert review panels and special restrictions for exposure-prone procedures, which stigmatize HCWs; by discontinuing mandatory disclosure of a HCW's infection status in low-level risk procedures; and by imposing practice restrictions to avert significant risks to patients. Inclusion of these principles would achieve high levels of patient safety without discrimination and invasion of privacy. JAMA. 2000;284:1965-1970.