4.2 Comparative national public health legislation*
Oxford Textbook of Public Health
Comparative national public health legislation*
Ruth Roemer and Milton I. Roemer
Functions of health laws
Environmental health and the law
Examples of environmental legislation
Issues in environmental legislation
Regulation of food and drugs
Examples of food and drug legislation
Issues in food and drug control
Licensure of health personnel
The example of nursing licensing laws
Legal issues in regulation of personnel
Regulation of health-care facilities
Examples of health-care facility regulation
Issues in health-care facility regulation
Social financing of health care
Control of communicable diseases
Examples of legislation to control communicable disease
Trends in communicable disease control
Legislation on HIV/AIDS
Issues in the control of the AIDS epidemic
Legislation on mental illness
Examples of mental hospital admission laws
Issues in mental hospital admission laws
Legal problems in human reproduction
Legislation on abortion
Issues in laws affecting human reproduction
Legislative approaches to health promotion
Prevention of motor vehicle accidents
Control of alcohol abuse
Control of the tobacco epidemic
Other health promotion legislation
Examples of health promotion legislation
Issues in health promotion legislation
Ethical issues in public health law
Public health law, like public health, concerns the health of populations as contrasted with the health of individuals. Thus, public health law concerns the legal aspects of providing preventive, curative, and rehabilitative services to populations, although public health law has an important impact on health protection and health care for individuals as well.
As the role of public health has expanded from its early function of preventing the spread of communicable diseases to encompass the development of resources, the organization and financing of the delivery of care, surveillance of the health-care system, health promotion, and overall protection of community health, so public health law and legislation have expanded to provide authorization, direction, and regulation of many fields of environmental and personal health services. As Grad has written, ‘The reach of public health law is as broad as the reach of public health itself. Public health and public health law expand to meet the needs of our society’ (Grad 1986).
This chapter begins by describing the functions of law and legislation in protecting the public health. Then several fields of public health law are examined, with comment on the general scope of law and legislation, methods of implementing law and policy, selected examples of legislation, and current legal issues.
In each field the review of the law is necessarily brief, and not all fields of public health law are covered. For further information, the reader is directed to the primary texts of the health laws of the world, published by the World Health Organization (WHO) in its quarterly journal, the International Digest of Health Legislation (now on the Internet), and to the many legal treatises, texts, journals, and reports of court decisions available in law libraries.
Perhaps a caveat or two are in order. Firstly, it should be noted that law and legislation can play a negative or a positive role with respect to public health. Some laws may be adverse to public health by imposing restrictions on health services based on the knowledge, social conditions, or fiscal constraints obtaining at the time that legislation was adopted. Such negative laws are illustrated by the criminal laws outlawing abortion that are being replaced by legalized abortion in most countries of the world (Cook 1989; Cook et al. 1999). Fortunately, laws also play a constructive role supportive of public health by authorizing measures to protect health, to increase access to health services, and to assure the quantity and quality of health care that a society needs. This chapter is replete with such examples.
Secondly, one should bear in mind that while law performs a technical function of expressing health policy and setting forth procedures for implementing it, the content of the law is determined by the nature and orientation of the political power in the country at any time and place. The element of political will is crucial to the enactment of health legislation. Legislation can serve as an instrument of change to improve health services and health protection but only if policy makers have the necessary political will.
Functions of health laws
Health laws perform various essential functions in protecting the health of populations.
Laws and legislation prohibit conduct that is injurious to the health of individuals and communities. Examples of this function are environmental health laws that prohibit the dumping of toxic chemicals in the environment, traditional public health legislation to prevent the spread of disease, laws to control drug abuse, laws regulating smoking in public places, and laws to regulate the quality of health care.
Health legislation authorizes programmes and services that promote the health of individuals and communities. Many diverse, categorical programmes authorized by law provide health services for specific people (mothers and children, the military, veterans, the mentally ill, the handicapped, the elderly), for specific diseases and conditions (heart disease, cancer, stroke, sexually transmitted diseases, mental illness and retardation, alcoholism and drug abuse, HIV/AIDS), and for specific services in various fields (environmental and occupational health, nutrition, mental health, dental health and ambulatory, hospital, and long-term care).
Legislation regulates the production of resources for health care. Laws authorize or provide financing for the construction of hospitals, health centres, and other health facilities. Legislation provides support for education of the health professions and occupations. Regulation of the production and importation and export of drugs, medical devices, and medical equipment and supplies is carried out under the authority of law. Financial support of research—the production of knowledge—may require legal action.
Legislation provides for the social financing of health care. This function is carried out by laws establishing systems of national health insurance or a national health service. It is also expressed in government grants for specific health programmes, in the imposition of special taxes for health purposes, and in tax exemption for non-profit health facilities.
Legislation authorizes surveillance over the quality of health care. Examples of this function are licensure laws establishing minimum standards for health personnel and facilities, legislation providing for peer review of the quality of care, and financing programmes that regulate the quantity and quality of care. The judicial system, in handling malpractice suits, also carries out this function.
In the process of performing these various functions, health law faces the challenge inherent in all law—that of balancing the interests of the individual and the interests of society. This over-riding issue faced by legislators, administrators, and judges is both legal and ethical. To what extent may individual rights be curtailed in order to promote the general welfare? The answer to this question is ‘It depends’. It depends on the importance of the governmental purpose, the degree of risk to the community, and the degree of intrusion on individual rights. It depends on the scientific and epidemiological evidence pertaining to the issue being legislated or litigated. It depends on the nature of the legal system and its protection of individual rights.
Environmental health and the law
Environmental sanitation was one of the earliest concerns of public health because of the basic need for a safe water supply and waste disposal in all societies. With the growth of industrialization, modern law to assure a healthful living and working environment has expanded to include control of air and water quality, regulation of domestic waste and industrial and agricultural effluents, management of solid waste disposal, control of marine pollution, regulation of radiation emissions, control of toxic substances in industry and the community, regulation of the use of pesticides in agriculture, and noise abatement. Each of these branches of environmental law is based on the need to protect the public health. In addition, other branches of environmental law, while not directed solely to protecting health, have an important impact on health and the quality of life. These include conservation of natural and environmental resources, land use control and regulations governing housing, and measures to meet population growth and power needs (Grad 1994).
Public health personnel are involved to varying degrees in each of these problems in environmental health. They may be called on to set standards for air and water quality, to treat water to make it potable, to add fluorides to a public water supply to prevent dental caries, to inspect factories for toxic chemicals, to enforce sanitation regulations in markets and restaurants, to develop solid waste disposal systems, and for other tasks. The size and complexity of environmental engineering, management, and control activities have caused principal responsibility for environmental regulation to be placed in non-health agencies with specialized scientific, engineering, and economic expertise in many countries, but public health personnel retain responsibility for managing the health component of environmental control. As they undertake their varied functions, public health environmentalists encounter legislation and regulations designed to control contaminants and prevent harm to the health of the community.
A number of mechanisms are used for environmental control. The most important of these is not a legal mechanism but rather economic measures that promote compliance with environmental standards. For example, an industry may find it cheaper to clean up its wastes than to pay the penalties for pollution. Or a government may find it advantageous to subsidize practices that will improve environmental quality.
Among the legal remedies used to implement environmental legislation are inspections and citations for violations of established standards of environmental quality, civil penalties for pollution, effluent charges, licensing of businesses and withdrawal of the license in the event of violation of standards, criminal prosecutions to punish violators, injunctions to prevent future harm, and seizure and forfeiture of property in cases of egregious pollution (Grad et al. 1971).
Examples of environmental legislation
Environmental health legislation may be either categorical or comprehensive. Categorical legislation deals with one type of problem, such as air or water quality or solid waste disposal. Comprehensive legislation is designed to provide integrated control of the many and often interrelated insults to the environment having an impact on health.
Choosing examples of categorical environmental legislation at random, one may cite as laws designed to protect health and safety in a specific field the 1996 legislation of Algeria and Djibouti promulgating water codes and specifying principles of water policy, including preservation of common resources, protecting the aquatic environment, and assuring the compatibility of water management and land use (Algeria 1996; Djibouti 1997). Virtually all countries have categorical legislation dealing with various specific aspects of environmental control to promote health.
Both industrialized and developing countries have also enacted comprehensive environmental legislation addressed to multiple aspects of the environment. In the United States, the National Environmental Policy Act of 1969 was designed to create a means for integrating and co-ordinating the many programmes affecting environmental protection (US 1969). An important provision of the legislation requires the filing of environmental impact statements before major federal projects with significant impact on the environment can be undertaken.
Impelled by the increasingly recognized threats to health from environmental pollution, many other countries have enacted comprehensive environmental legislation (for example, Sri Lanka 1981). An important provision of these laws is the requirement for an environmental assessment in advance of construction of a project to determine its effect on health and on physical and living conditions. The Canadian law establishing an environmental assessment process is designed to ensure that the environmental effects of projects receive careful consideration before responsible authorities take actions in connection with them, to encourage these authorities to take actions that promote sustainable development and thereby achieve or maintain a healthy environment and a healthy economy, and to ensure an opportunity for public participation in the environmental assessment process (Canada 1992). A statute of the Province of Ontario, Canada, allows any two people residing in Ontario who believe that an existing policy or regulation should be amended or repealed or that a new policy should be adopted to protect the environment apply to the Environmental Commissioner for review of that policy (Canada 1998).
As East European countries are making the transition from communism to capitalism, they have recognized that industrialization has been associated with serious degradation of the environment, and have consequently enacted broad environmental protection legislation. For example, Bulgaria’s 1991 law provides for monitoring the state of the environment, assessment of environmental impacts, and development of environmental policy based on the reduction of hazards to human health and the environment and its relation to damages suffered and benefits lost (Bulgaria 1993). The Hungarian legislation on environmental impact assessments requires a forecast and evaluation of the changes in environmental conditions resulting from the activity; an estimate of the probable environmental, health, economic, and social consequences of the changes in the environmental conditions; a definition of measures to prevent, reduce, or avert possible pollution and damage; the methods for measuring and analysing environmental impacts in the course of the activity and the method for subsequent monitoring of these impacts after the activity ceases; and a map of the impact areas (Hungary 1993).
Many developing countries have adopted statutes or regulations under their environmental protection acts specifying functions to be performed to protect the environment (for example, planning, standard setting, studies of industry and trade, pollution control) (Burkino Faso 1994; Belize 1996; Indonesia 1998; Morocco 1998), requirements for environmental impact statements (Malawi 1998), and the organization and operation of a secretariat responsible for the environment or an advisory body on environmental policy (Cameroon 1997; Madagascar 1998).
Issues in environmental legislation
Many issues face policy-makers and public health administrators in the field of environmental control. Each of these issues merits lengthy analysis, which is not possible here. However, a brief mention of the issues shows the magnitude and complexity of the problems in this field.
A priority for all countries, both industrialized and developing, is to balance the interest in a healthful environment and the need for employment and industrial development. This conflict is exemplified by Algeria in its law on environmental protection which provides: ‘National development implies the necessary equilibrium between the imperatives of economic growth and those on environmental protection and the preservation of the living conditions of the population’ (Algeria 1984).
The tension between the need for economic growth and the need to protect the quality of the living environment underlies all regulation of environmental pollution.
Management of environmental problems requires a high degree of scientific knowledge and technical sophistication in various specialized fields. At the same time, the interrelations among the various ambient elements (for example, the impact of water pollution on land use) requires an intersectoral approach involving both health and non-health agencies. These environmental health interfaces and interactions have implications for the geographical jurisdiction of environmental agencies, for the responsibilities of various levels of government, for the functions of environmental health personnel, and for the role of public health personnel in large environmental management agencies (Goldsmith 1970; Roemer et al. 1971).
In the operation of any environmental management system, agencies responsible for regulating substances harmful to health face the difficult question of what limits exist on the agency’s regulatory power in the light of scientific uncertainty. What are the powers of the agency if there are conflicting scientific opinions or if the evidence is based solely on epidemiological data (Grad 1994)? A case study of the court decision upholding the regulation by the United States Environmental Protection Agency restricting the amount of lead additives in gasoline provides important insights on the scope of judicial review and the role of the courts in cases of great technological complexity (Silver 1980).
The issue of how widely accepted a scientific process or theory must be to be admitted in evidence in a lawsuit arose in a case before the United States Supreme Court in 1993. The case involved not environmental issues but whether a drug prescribed for nausea during pregnancy caused birth defects. The decision has wide applicability to various kinds of cases involving scientific evidence (Daubert v. Merrell Dow Pharmaceuticals Inc. 1993).
The United States Supreme Court, by a vote of 7 to 2, rejected the test of ‘general acceptance’ of scientific evidence that has previously been applied and ruled that under modern rules of evidence adopted in the 1970s, particularly Rule 702 of the Federal Rules of Evidence, ‘general acceptance’ is not an absolute prerequisite to admissibility of scientific evidence. The Court’s opinion stated that trial judges serve as gatekeepers to ensure that all scientific evidence admitted is not only relevant but reliable. Pertinent evidence based on scientifically valid principles will satisfy these requirements. While publication in a peer-reviewed journal is not essential for admissibility of evidence, such publication is a relevant, but not a dispositive, factor for a judge to consider in determining whether a method or technique is valid. Also, the known or potential rate of error may be considered. Justice Blackmun justified the gatekeeper role by pointing out that there are ‘important differences between the quest for truth in the courtroom and the quest for truth in the laboratory. Scientific conclusions are subject to perpetual revision. Law, on the other hand, must resolve disputes finally and quickly.’
An innovative strategy used for obtaining scientific advice on complex and disputed questions in lawsuits is to establish a panel of scientists to study the question and advise judges and juries. Such a panel in federal class action lawsuits against silicone breast implant makers resulted in a finding that the breast implants did not cause the women’s illnesses (National Science Panel 1998).
Finally, an issue that is assuming increasing importance in the field of occupational and environmental health is worker and community involvement in assuring a healthful working and living environment. In the United States, worker and the community right-to-know laws impose on employers and manufacturers the duty to disclose hazards in the workplace or activities involving toxic exposures (Ashford and Caldart 1985). These laws are not a substitute for enforcement of environmental protection laws, but they are an important aid to better regulation of the environment. The principle is embodied in an international convention, the Convention Concerning Occupational Safety and Health and the Working Environment, adopted by the International Labour Organization in 1981. The International Labour Organization Convention requires employers and workers and their representatives to co-operate in protecting occupational safety and health. Measures taken by the employer to protect occupational safety and health must be disclosed to workers’ representatives, and the workers have a right to know all aspects of occupational safety and health associated with their work. The Convention also requires training of workers and their representatives in occupational safety and health (International Labour Organization 1981).
Regulation of food and drugs
Laws to prevent the adulteration of food and medicines originated centuries ago (Christoffel 1982). Today in industrialized countries, and to an increasing extent in developing countries, people are dependent on commercially produced food and manufactured drugs that they are unable to evaluate themselves. They must rely on governmental regulation of these goods.
Legislation related to nutritional quality and food safety regulates the hygienic standards for production and marketing of foods; control of equipment, utensils, and containers; hygiene and health of food handlers, storage, and vending places; methods of testing and inspection; requirements for labelling of contents and shelf-life; and advertising of foods. More specialized legislation deals with such matters as safety of food additives, including what additives are allowed, maximum permissible levels, and requirements for package labelling. These regulations include the requirement for iodization of salt to prevent goitre and in some countries labelling of foods for salt content to promote uniformity in definitions of low salt content.
Comprehensive drug control legislation, which exists generally in all industrialized countries and in many developing countries, provides authority to control the importation and production of drugs; the licensing of manufacturers, wholesalers, and distributors; drug registration; and the distribution, sale, labelling, advertising, and promotion of drugs. A national drug control programme regulates the quality, safety, and efficacy of prescription drugs and over-the-counter drugs and also shares in responsibility for control of narcotic drugs (Chapman 1976).
Enforcement of food and drug laws is carried out through inspections of the manufacturing process, recall or seizure of defective products, civil and criminal penalties for violations of established standards, and injunctions to prevent marketing of food and drugs found unsafe or unsanitary. Enforcement relies heavily on rule-making by the food and drug agency and on administrative hearings on violations of standards. Use of administrative law in this field so critical to health hastens the disposition of cases, provides expertise on the technical issues involved, and introduces flexibility in the process of adjudicating cases and designing sanctions.
Examples of food and drug legislation
In 1976, Norway became the first country in Western Europe to establish a national nutrition and food policy (Norway 1981–1982). Its objectives are to encourage healthful dietary habits, develop nutrition and food policy in accord with the recommendations of the World Food Conference, increase production and consumption of Norwegian food products, and improve self-sufficiency in food products. Numerous laws are implemented by various governmental agencies to these ends. The Food Control Coordinating Act of 1978 established a Food Control Board with representation from the various ministries and interests. The Inter-Ministerial Coordinating Committee on Nutrition (composed of leading civil servants in the Ministries of Fisheries, Consumer Affairs, and Government Administration; Trade, Industry, Church, and Education; Agriculture, the Environment, Health, and Social Affairs; and Foreign Affairs) is charged with defining tasks, preparing long-term plans, and implementing policies. The National Nutrition Council is composed of members who represent research and teaching in the fields of nutrition, diet, dietetics, food hygiene and technology, food production, and the food industry. The mandate of the Council is to advise the authorities, industrial organizations, large households, and food producers on nutrition and to disseminate information on diet. Implementation of the national nutrition policy thus depends on permanent interministerial bodies with well-staffed secretariats.
In addition, the national nutrition policy of Norway is elaborated through a health policy on nutrition which includes preventive work and training of personnel; agricultural, fisheries, and price policies that affect production and subsidies of foods; and a consumer and school policy to present an appropriate range of foods and develop sound attitudes towards diet and nutrition. The aim is to help the population consume more cereals, skimmed milk, fish, fruits, and vegetables, and less fat, sugar, and meat, and to substitute fish for some meat, starch for some sugar, and skimmed milk for most whole milk. The goals of the Norwegian nutrition policy are to motivate individuals to adopt a healthful diet, to improve food distribution in outlying districts, and to strengthen the rural economy by making farming more profitable and attractive (Klepp and Forster 1985).
Illustrative of comprehensive drug control programmes is the legislation of Australia, which regulates the manufacture, importation, sale, and distribution of drugs and also establishes a Pharmaceutical Benefits Scheme providing publicly financed prescribed drugs to the entire population (Roemer and Roemer 1976). About 90 per cent of all drugs prescribed in Australia are available on the approved list, and the patient generally pays only a flat $1 copayment, regardless of the cost of the prescription.
The Foods, Drugs and Devices, and Cosmetics Act of The Philippines provides for a comprehensive food and drug regulatory system governing various aspects of food and drug production and distribution, including standards and quality measures for these products, approval of new drugs, control of adulteration, labelling requirements, and licensing of manufacture, sale, and import and export of drugs (Philippines 1990). The 1995 decree of Bulgaria sets forth requirements relating to registration, clinical trials, manufacture, trade, import, and export of pharmaceuticals (Bulgaria 1996).
In contrast to comprehensive food and drug regulatory schemes are the numerous statutes dealing with specific issues in the field. For example, Indonesia requires all government hospitals and health centres to prescribe and use generic drugs for all patients and requires pharmacies to stock essential drugs, including generic drugs (Indonesia 1990). Increasing numbers of countries are enacting laws making the iodization of salt compulsory (Madagascar 1995; Côte d’Ivoire 1996; Morocco 1996; Tunisia 1996; Zaire 1996; Djibouti 1997; Philippines 1997). In the United States, voluntary labelling of the contents of foods, long unsatisfactory because of lack of uniformity and difficulty for consumers in interpreting the information, has been replaced by mandatory labelling (US 1991). Regulations of the Food and Drug Administration require nutrition labelling on most foods and specify the contents and format for nutrition information (US 1993c).
Issues in food and drug control
Control of such essential consumer products as food and drugs requires constant vigilance to monitor the safety and nutritional values of foods and the safety, efficacy, and quality of prescription and over-the-counter drugs. Public health agencies are concerned with surveillance of the production and marketing of both food and drugs, with labelling and advertising, and with provision of information to the consumers. Mandatory labelling of the sodium content of foods is a form of consumer education. Warning labels and package inserts in pharmaceuticals are an important part of patient education.
Drug regulation begins with establishing and implementing protocols for research on and testing of new drugs and proceeds to evaluate drugs for safety and efficacy. The process of evaluating animal and clinical data, and determining health risks from drug trials, may be quite protracted, so that regulatory agencies may be accused of unreasonable delays in approval of new drugs (‘drug lag’). In 1992, perhaps partially impelled by the needs of patients with AIDS, the American Food and Drug Administration adopted new regulations to accelerate approval of certain new drugs and biological products for serious or life-threatening conditions, with provisions for any necessary continued study of the drugs’ clinical benefits or with restrictions on use, if necessary (US 1993d).
Associated with the drug approval process is the determination of national policy governing the import and export of therapeutic drugs. The multiple national standards on acceptability of different drugs affects the availability of drugs in international trade—an increasingly critical problem in a shrinking world (Cook 1987). Fortunately, in 1975 the WHO established the Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce. It regularly disseminates information on drugs and drug quality as certified by the competent authority of the exporting country that the product is safe for distribution or sale in the exporting country; furthermore, the plant at which the product is manufactured is subject to inspection showing that the manufacturer conforms to requirements for good practice in manufacture and quality control as recommended by the WHO (World Health Assembly 1989). Use of international standards is designed to alleviate problems related to variance in standards among countries.
Another issue addressed in national legislation is advertising of pharmaceuticals. Some countries restrict advertising of pharmaceuticals to professional journals and publications, allowing advertising in the mass media of only over-the-counter drugs (Bulgaria 1996; Iceland 1998; Niger 1998). Colombia, seeking to limit advertising of pharmaceuticals to established facts and to avoid exaggeration of benefits, partial truths, and fraud, provides that all advertising of pharmaceuticals is subject to prior authorization by the National Institute for Food and Drug Surveillance (Colombia 1998b).
A major problem on which there is great variation in the laws of different jurisdictions is that relating to product liability and compensation for adverse effects of drugs. The tension existing between the interest of the pharmaceutical industry in marketing new drugs, the interests of the consumer in compensation for damages suffered, and the interest of society in promoting development of pharmaceutical products and assuring their availability has led to varying solutions. These have included, to take the example of the United States, decisions holding the manufacturers strictly liable, with damages assessed according to their share of the market where the supplier of the drug could not be identified (Sindell v. Abbott Laboratories 1980), decisions holding a manufacturer liable only for failure to follow state-of-the-art manufacturing practices (Brown v. Superior Court 1988), and, in the case of vaccines, development of a no-fault federally funded compensation system for untoward outcomes of childhood immunizations (US 1986).
Finally, an increasingly important issue relates to regulation of drug prices. The high cost of drugs has led to the use of generic drugs and repeal of laws banning substitution of generic equivalents for brand name drugs prescribed by the doctor (DeMarco 1975). Another strategy for controlling drug costs in health-care programmes is development of a drug formulary or a list of essential drugs for which reimbursement is provided.
Licensure of health personnel
Licensing or registration laws for doctors were designed originally to protect the public against quacks, charlatans, and incompetent practitioners. Over the years the function of licensing laws for a wide variety of health professionals has expanded to specify minimum qualifications for practice, to regulate educational programmes, to define the scope of practice for each profession, and to set forth requirements for continued competence. Some licensing laws are mandatory, such as medical and dental practice acts, requiring all who practice the profession to be licensed and making it illegal to practice without a license. Voluntary or permissive licensing laws protect only the title and prohibit unlicenced personnel from holding themselves out as licensed personnel but do not require licensure in order to practice the profession. As professions grow in strength, voluntary licensure tends to be replaced by mandatory licensure.
While licensing or registration laws have been criticized as protecting the professions rather than the public and as creating monopolies of the licensed professions, all countries have a governmental system for regulating the qualifications of medical, dental, and a varying number of other health personnel. In some countries licensure may be granted without further examination on completion of an approved educational programme. In others a separate examination may be required after completion of the approved educational programme. In recent years, recognition of the capacity of licensing laws to do more than specify minimum qualifications for practice—to influence the geographic location of doctors, dentists, and others, to affect the proportions of generalists and specialists, to influence the pattern of practice, and to promote the continued competence of practitioners—has given them a new importance for the health professions.
Implementation of licensing laws is carried out by licensing boards composed originally largely of members of the profession to be licensed. In response to the demand for greater public accountability, members of other professions, consumers, and representatives of governmental agencies have been added to the boards in many countries.
The example of nursing licensing laws
To present some insight on the role of licensing laws in regulating the qualifications and functions of health personnel the example of nursing licensure is useful. Nursing practice acts generally provide for personal and educational qualifications of nurses, prescribe the content of nursing curricula, including practical experience, define the scope of nursing practice, specify grounds and procedures for disciplinary action, and provide for renewal of licenses.
As nursing education has been expanded and technology in health care improved, it became clear in the United States and in other countries that nurses were being underutilized. Although they were equipped by enriched training for new nursing roles, the licensing laws generally barred nurses from undertaking ‘diagnosis and treatment’, which were defined as medical functions. Beginning in 1971 the American states adopted various legislative strategies to authorize an expanded role for nurses (Bullough 1975). These included the following.
Authorization by the medical and nursing licensing boards of expanded functions for nurses.
Authorization by the medical and nursing licensing boards of amended definitions of professional nursing to include autonomous functions for nurses (New York 1972). (In 1972 the State of New York revised its definition of professional nursing as follows: ‘The practice of the profession of nursing as a registered professional nurse is defined as diagnosing and treating human responses to actual or potential health problems through such services as case-finding, health teaching, health counseling, and provision of care supportive to or restorative of life and well-being and executing medical regimens prescribed by a licensed or otherwise legally authorized physician or dentist. A nursing regimen shall be consistent with and shall not vary any existing medical regimen.’ Furthermore, in Sermchief v. Gonzales (Missouri Supreme Court 1983), the Missouri Supreme Court upheld the authority of nurses to perform diagnostic and treatment functions in family planning services under a modernized nursing practice act prescribing a broad spectrum of nursing functions qualified by the phrase ‘including but not limited to’.)
Authorization by the medical and nursing licensing boards of standardized procedures and protocols to authorize expanded nursing functions.
Authorization by the medical and nursing licensing boards to allow individual doctors to delegate to nurses the right to diagnose and treat.
These legislative changes made in nursing practice acts in state after state expanded the contribution of nurses to patient care and made the profession of nursing more interesting and rewarding.
Legal barriers to extension of the nurse’s role in developing countries are particularly grave because the nurse is often the only health professional available in rural areas to provide primary health care. Yet often the medical and pharmacy acts bar the nurse from diagnosing and treating and from prescribing medications. The nursing practice acts restrict not only the scope of nursing practice but also the training that nurses receive (WHO Study Group 1986). In order to alter this negative impact of the law, countries have enacted new statutes to reorient nursing education and to authorize functions for nurses that were formerly the exclusive province of the doctor. For example, in 1977 Senegal issued a decree adapting its nursing education to the needs of the country so that nurses will be prepared to serve the rural population (Senegal 1978). Also in 1977 the Ministry of Health of Israel authorized nurses to carry out certain kinds of medical activity, such as drawing blood for tests, immunizations, and suturing wounds (WHO Study Group 1986). In 1982 Dominica authorized its family nurse practitioners to prescribe drugs from the Dominica Nurse Practitioner Formulary (Dominica 1983). In 1998 Luxembourg issued regulations defining the preventive, curative, and palliative functions of the nurse (Luxembourg 1998).
Legal issues in regulation of personnel
The issue of scope of practice of health personnel recurs periodically as new types of health workers are introduced in a country, such as pharmacy technicians or acupuncturists, and as strengthened preparation of existing categories of personnel warrants expanded functions. A newly recognized need is the requirement for management personnel specialized in health-care administration (Morocco 1998a). In fact, an overriding issue in this field is how allied and auxiliary personnel should be credentialed, whether by a governmental mechanism, such as licensure or some form of officially required registration, or by a voluntary mechanism, such as certification by a professional association.
Another concern is to assure equitable and rational geographic and specialty distribution of health professionals. Some countries, such as Norway and Mexico, require doctors to contribute a period of service in an underserved area as a condition of licensure. Other countries, such as the United States, use governmental funding for medical education as leverage for specialty distribution and as an economic incentive for settlement in rural areas.
The development of distance learning and telemedicine for the training of personnel and the provision of medical care in remote areas have led to new programmes and legislation (Tunisia 1998).
The problem of assuring continuing competence has challenged many countries. Various strategies have been adopted, including voluntary and mandatory educational programmes, periodic re-examinations, and further clinical training. But no consensus has been reached on the best way to achieve the objective of updated knowledge and skills.
With the introduction of private medical practice in East European countries and Vietnam, new legislation specifies the conditions and rules governing private practice. Bulgaria, for example, requires medical specialists wishing to practice privately in their consulting rooms to register with the municipal council. Their scope of practice is limited: private practitioners are not authorized to perform abortions, to administer required immunizations, or to treat communicable diseases, which must be treated in a public health establishment (Bulgaria 1992). Vietnam requires that applicants seeking to open a private medical or dental practice, test laboratory, anaesthetic surgery establishment, convalescent or rehabilitation facility, maternity home, or birth control centre have at least 5 years of continuous practice at relevant consulting and treatment establishments (Vietnam 1996). Similar experience is prescribed for applicants seeking to open traditional medical clinics and traditional pharmacies. Traditional medical practices are required to keep medical records, observe public health sterilization and bacteria-killing regulations of the Ministry of Public Health, and refer patients with complications or who do not improve after long treatment to state-run medical establishments (Vietnam 1996).
Not only licensing laws but various other regulatory mechanisms affect the qualifications and functions of health personnel. These include the educational system, the policies of professional associations, the regulation of work settings, the requirements of payment programmes, and judicial decisions in malpractice suits and other legal cases. While licensing laws impinge directly on the qualifications and functions of health personnel, indirect influences through the methods of providing and paying for care can also shape the ‘health’ human resources component of a national health system.
Regulation of health-care facilities
Various mechanisms regulate the quality of the care provided by hospitals, health centres, and long-term care facilities—hospital licensing laws, requirements of the financing system, court decisions, actions of voluntary accrediting bodies, standards of professional associations for specialty training, and rules of the facilities themselves. Legislation sets minimum standards that facilities must meet in order to operate. Legislation also governs the planning, construction, and distribution of facilities.
The cornerstone of this multifaceted regulatory system is hospital licensure. Hospital licensing laws are important because such a large proportion of care—and care for serious illness—is provided in hospitals and because the costs of hospital and long-term care represent such a large proportion of health-care expenditures. As Somers has written, ‘it is difficult to exaggerate the importance of the hospital in contemporary society’ (Somers 1969).
Originally, hospital licensing laws were concerned solely with the physical conditions in the hospital—safety, sanitation, and space. But over the years health facility legislation has expanded to cover many types of health facility and to prescribe requirements to assure not only the safety of patients but also the quality of their care (Lander 1980). Government sets standards for both public and private institutions. The public purpose of health facilities and the public interest in their use are the basis for public regulation of private institutions. For non-governmental agencies and the private market, legislation may regulate performance to protect public health, may provide support, and may define inter-relationships of private institutions with government.
Implementation of hospital licensing laws is carried out through rule-making by governmental agencies, inspections of facilities, consultations to remedy deficiencies, administrative hearings, injunctions, denial of reimbursement, license suspension, and, if all else fails, through closure of the facility.
Examples of health-care facility regulation
In the United States hospital licensing laws are fairly recent, having been enacted in 1946 following the Second World War in response to the Hill–Burton Hospital Survey and Construction Act, which required states to specify minimum standards for facilities receiving federal subsidies.
Beginning in 1968 a number of states amended their hospital licensing laws to enact what were termed comprehensive laws encompassing both physical and patient care standards. For example, the modernized facility licensing law of New York State, enacted in 1969 (New York 1985), contains detailed provisions governing construction, financial reporting, and patient care. The law specifies, among other matters, requirements for ambulatory care, calls for a comprehensive evaluation of patients on a periodic basis, requires continuity of care when patients are referred outside the hospital, mandates full-time medical staffing in emergency rooms, specifies rules for surgical consultation, and requires general hospitals to admit patients in need of immediate hospital admission without advance enquiry as to their ability to pay. Thus, the provisions of modernized facility licensing laws have moved far beyond bricks and mortar.
In Bolivia, regulations issued in 1982 specify that establishments that provide health services (hospitals, clinics, laboratories, medical posts, and consulting rooms) must be licensed by the Ministry of Social Welfare and Public Health and conform to the requirements of the National Health Plan (Bolivia 1983). The services that various types of hospitals are required to provide are set forth. A Commission on Health Establishments is created, with power to review applications for planning and construction of health establishments in urban and rural areas. Such applications must include a study of the population to be served, classification of the population by age, sex, and occupation, foreseeable population changes in the next 20 years, health conditions in the area, numbers and kinds of health personnel available in the area, co-ordination with other health establishments, and conditions of funding (Bolivia 1983).
In Senegal, the law on hospital reform classifies public health hospitals as first, second, and third levels, assures patients free choice of practitioner and hospital, specifies that all shall have equitable access to care, and requires hospitals to take part in public health activities (Senegal 1998).
Issues in health-care facility regulation
A critical issue in health facility regulation is the authorized supply of beds, whether in public or private facilities and whether subsidized by public funds or not. Since the supply of beds is a major determinant of hospital utilization rates, under conditions of widespread insurance, the control of this supply is extremely important in the overall issue of health-care cost containment (Roemer and Shain 1959).
Implementation of requirements for facility licensure is a prominent issue facing governmental agencies responsible for standards in health-care facilities. Frequent inspections and time-consuming consultations require trained staff, often in short supply. Although licensing statutes provide legal mechanisms for enforcement, less onerous strategies are generally preferred. Particularly in the field of long-term care, where often the need is to upgrade the quality of care, attaching standards of the facility to the financing mechanism is increasingly preferred as an effective sanction.
Even when implemented, the standards specified in a licensing law may be minimal standards rather than the most up-to-date requirements for patient care. To take account of the need to encourage higher standards than those required by the hospital licensing law, a voluntary accreditation system has long been established in the United States. The Joint Commission on Accreditation of Health Care Organizations periodically surveys hospitals and other health-care establishments and accredits those that meet its exigent standards.
Social financing of health care
Health services to individuals and communities may be financed in several different ways. Aside from expenditures by individuals and families for their personal benefit, there are several mechanisms for collective economic support. These are through charitable donations, general tax revenues, voluntary (non-governmental) insurance, mandatory or social insurance, and foreign aid.
Social insurance—also called social security—has been adopted by an increasing number of countries throughout the world (Social Security Administration 1997). Starting in Germany in 1883, in order to finance personal health services for low-wage industrial workers, this mechanism has spread to coverage of other types of person for a variety of benefits over the years.
The types of person covered have increased to those with higher earnings and having different types of occupation, such as in agriculture, transport, commerce, and other fields. The types of monetary benefit have also been increased from personal health services to maternity, old age, disability and death, work injury, unemployment, and family allowances.
As of 1997, the number of countries with designated types of social insurance programme were as follows (Social Security Administration 1997).
Old-age, disability, death
Sickness and maternity
Benefits for these risks consist of money for periods of time that vary among countries. Furthermore, among the 111 countries that provide for sickness and maternity, 93 also pay for the costs of medical care and/or hospital admission (Social Security Administration 1997, Table 1, p. xlv).
The patterns by which health services are delivered to beneficiaries differ among countries. In the industrialized countries, such as Germany and France, where these programmes have operated for the longest time, health services are usually delivered by private medical practitioners and allied personnel who are paid on a fee-for-service basis. In developing countries, where these programmes are younger, health services are usually delivered through more structured patterns, under which health personnel work on salaries in hospitals and health centres. This pattern prevails in Colombia, Peru, and most Latin American countries (Roemer 1991).
In some countries both of these patterns may operate in parallel. A beneficiary may seek service in an organized facility or seek care from a private practitioner who is paid by the insurance, usually along with a copayment by the patient. Such dual-choice policies exist in the health systems of most Latin American countries, as well as in the systems of Middle Eastern and Asian countries, such as Egypt, Iraq, and Malaysia (Roemer 1991).
The worldwide trend has been towards extension of social security protection for health services to larger proportions of national populations. In several countries, the extension has been to cover total national populations. This has occurred by evolution, as in the United Kingdom (Roemer 1991) or by revolution as in the former Soviet Union (Roemer 1991). By either route, when coverage has become universal, the financial support usually changes from social security to general tax revenues. With the latter arrangement, health expenditures are subject to greater planning and supervision.
Recent legislation in developing countries has extended coverage for health care by various means. In a country with an entrepreneurial health system as in The Philippines, the national health insurance programme seeks to provide all citizens of The Philippines with financial access to health services and to assure beneficiaries free choice of health provider, who is paid according to a fixed fee schedule (Philippines 1998). In Colombia, the Primary Health Care Plan of the General Health and Social Security System provides personal preventive services and community health promotion measures free of charge (Colombia 1998a). For treatment, beneficiaries may choose between public and private health care (Social Security Administration 1997).
The use of collectivized financing has gradually contributed to greater national expenditures for personal health services. The changing demographic composition of the population, with larger proportions of elderly people, is linked to effective reductions of mortality in the younger years. Also influential have been advanced technology, higher rates of health-care utilization at all ages, and prevention, which have enabled people to live longer even with disabilities. The rising proportion of national wealth, measured by gross national product per capita, being devoted to national health systems has also been associated with greater proportions of health expenditures being derived from public compared with private sectors of national economies (Roemer 1991).
Control of communicable diseases
Prevention of the spread of communicable diseases was one of the earliest functions of public health. In this effort, two types of law have been employed: laws to assure a sanitary environment (discussed above) and laws to regulate human conduct to control the spread of disease.
Turning off the Broad Street pump through which cholera was spread was an ideal public health measure because it cut off the source of the disease and benefited the whole population served by that water supply. In 1854, John Snow demonstrated that the distribution of deaths from cholera in London was from water in the River Thames that flowed to consumers through the Broad Street pump (Rosen 1958). Such a solution, however, is not always available. Therefore, other measures to prevent epidemics have been adopted. Such laws authorize public health officials to ascertain the incidence of communicable disease, to regulate the conduct of those who are infected, and to require measures to prevent its spread. Because these actions involve some restriction of the rights of individuals, the law in this field seeks to balance the need of society for protection against disease and the rights of the individual to privacy and liberty.
Traditional methods of preventing and controlling communicable disease have evoked statutory responses. To assist epidemiological investigation of the incidence of communicable diseases, laws mandating reporting to public health officials of specified communicable diseases by doctors, school authorities, and laboratories have been passed. To prevent and control communicable disease, the law provides for compulsory examination of individuals who are in a position to spread disease (for example, food handlers), and of individuals in whom communicable disease presents special hazards (for example, schoolchildren, applicants for a marriage license, pregnant women). A health officer also generally has power—although it is rarely exercised—to order a person suspected of being infected with a contagious disease to submit to a physical examination (Grad 1990). Similarly, rarely used today is the health officer’s power to isolate and quarantine an infected individual, although the power continues on the statute books. The most important legal measure for control of communicable diseases is certainly compulsory immunization.
Statutes authorizing these measures for controlling communicable diseases generally provide a civil or criminal penalty for violators, but much preferred are other strategies for implementation of the laws, such as exclusion from school or work. Compliance with a specified immunization schedule may be required for school attendance, as in Ontario, Canada (Canada 1984a,b). Compulsory examinations may be required for a marriage license or to obtain a certain job, as in the United States (Grad 1990).
Examples of legislation to control communicable disease
In 1986 Finland enacted a comprehensive ordinance concerned with the prevention of communicable diseases through vaccination, distribution of antibody preparations and medicines, the provision of measures related to individuals and their environment that are intended to prevent the development or spread of communicable disease, early diagnosis, screening, and treatment, and medical rehabilitation. The duties of the National Board of Health, county councils, communes, hospitals, pathology laboratories, and Institute of Public Health are set forth in this comprehensive regulatory system to control communicable diseases (Finland 1987).
In 1988, Malaysia amended and consolidated into a single, comprehensive statute its various laws on the prevention and control of infectious diseases (Malaysia 1990). The statute provides for the declaration of an infected area, examination of vehicles arriving in Malaysia, required notification of infectious diseases to the health authorities, power of health officers to require treatment, immunization, isolation, observation, or surveillance, or any other measure necessary to control the disease, obligation of infected people not to spread the disease, and other matters (Malaysia 1990).
Trends in communicable disease control
Immunization and other measures to control communicable diseases are so well accepted that the principal problems in this field are spin-offs from effective immunization: the high cost of vaccines, the question of how to compensate those patients who suffer an untoward outcome of immunization, and providing treatment for tuberculosis in developing countries, now that leprosy is being eradicated (Lamb 1994), and in all countries in a time of AIDS (Bayer et al. 1992). These problems are handled in different fashions by the health and legal systems of each country.
Tension between protection of the public health and protection of the civil liberties of individuals is a feature of all communicable disease control. This tension was heightened as measures were developed to control the AIDS epidemic (discussed below). Prompted by this tension, a legal scholar in the United States re-examined the balance between collective and individual rights and found current public health laws in the United States inadequate for dealing with the issues (Gostin 1986). In order to provide health-care officials and agencies with the tools to balance individual rights against public health necessities, Gostin recommended revising American public health legislation to provide clearly stated criteria for defining ‘public health necessity’ to guide public health officials in the exercise of their powers, to assure strong protections of confidentiality in the collection and storage of public health information, and to authorize a graded series of less restrictive measures than currently exist, such as a community health order that can be adjusted to the particular risk to the public health presented by each case.
Legislation on HIV/AIDS
As with other communicable diseases, the epidemic of HIV/AIDS presents the classical public health problem of a conflict between the welfare of the community and the rights of the individual, but with significant differences. Like other sexually transmitted and communicable diseases, HIV/AIDS calls for measures to prevent its spread and also for protection of the privacy and other civil rights of people with the disease. But HIV/AIDS presents grave and different problems because as yet there is no cure and no vaccine for prevention. Also, the incidence of HIV/AIDS is concentrated in some countries in people who engage in certain high-risk activities (homosexual activity and intravenous drug use)—groups that are particularly vulnerable to discrimination.
Legislation has been a significant component of the response to the HIV/AIDS epidemic (Gostin and Curran 1987; WHO 1997). An early response to the epidemic was to require testing of all blood and blood products provided by blood donors and confidential reporting of results. A most effective measure to protect the blood supply was the public health strategy, often adopted without the necessity of legislation, of establishing alternate testing sites (that is, other than blood collection centres) enabling people seeking information on their antibody status to have confidential or entirely anonymous testing without endangering the blood supply.
Most jurisdictions having legislation on HIV/AIDS require reporting of cases of AIDS to a health agency. Some statutes classify AIDS as a sexually transmitted disease, as in the State of Idaho (United States), Chile, Guatemala, Iceland, and Sweden. Such an approach permits the testing of prostitutes and tracing of contacts to advise testing and provide counselling. In order to improve tracking of the epidemic, increasing numbers of jurisdictions require reporting of HIV positivity either by confidential names-based reporting or by a unique identifier (usually a number). Despite concern that names-based reporting will deter testing and treatment, experience with confidential names-based reporting of HIV shows that it has not deterred testing (Nakashima et al. 1998). Much of the HIV/AIDS legislation contains specific requirements to safeguard the confidentiality of information, and stringent systems have been put in place to prevent any breach of confidentiality.
Protection of the confidentiality of test results has conflicted with the need to protect other members of society. In order to cope with this problem, some laws provide for very limited disclosure of identifying information, for example, to a health-care professional engaged in the care of a patient with HIV/AIDS and to a medical facility that will receive blood, organs, semen, or breast milk from an HIV-positive individual. Some jurisdictions authorize a doctor to disclose positive HIV antibody status to an individual’s spouse or sexual partner when the doctor has reason to believe that the individual will not inform the spouse or sexual partner.
A controversial legal issue concerns the recalcitrant patient or seropositive person who does not respond to education, counselling, medical direction, and community pressures to stop infecting others but knowingly exposes others to HIV infection. Legal remedies may exist in the general civil and criminal law. Regulations in the United Kingdom authorize an order by a justice of the peace to detain the patient if the justice is satisfied that the patient will not take proper precautions to prevent the spread of the disease (UK 1989).
Vast numbers of diverse laws relating to HIV/AIDS have been enacted worldwide. Fortunately, this legislation is readily available in a directory compiled and periodically updated by the WHO’s Health Legislation Unit with the support of the Joint United Nations Programme on HIV/AIDS (WHO 1997). Organized by country, these laws cover a wide range of issues, including, among others, establishment of national committees to control HIV/AIDS or sexually transmitted diseases generally; screening of blood donors and maintenance of the safety of the blood supply; preventive measures and health education; testing for HIV and confidentiality of test results; required notification to public health authorities of cases of HIV and AIDS; provision of pharmaceuticals and medical care to patients with HIV/AIDS; and prohibition of discrimination against people with HIV/AIDS with respect to work, housing, education, and other matters.
As an example of recent legislation, the law of the Dominican Republic requires screening of blood donations, bans testing for HIV for work-related purposes, mandates sex education throughout schools and colleges, provides for public information messages, and requires hotels and motels to provide condoms in a conspicuous place without the customer having to ask for them (Dominican Republic 1998). Vietnam’s legislation calls for measures for the prevention and control of drug abuse and prostitution as part of the campaign for HIV/AIDS prevention and control (Vietnam 1998). The law of Latvia specifies the functions of the National Centre for AIDS comprised of a service for epidemiological surveillance and a service for the diagnosis, treatment, and medical observation of AIDS (Latvia 1996).
An important support for national efforts to combat the AIDS epidemic is legislation of the European Community to implement a programme to assist the developing countries in their efforts to minimize the spread of HIV/AIDS and to help them cope with its impact on health and social and economic development (European Community 1997). The programme, for which specific aims and guiding principles are set forth, is to be directed primarily at the poorest and least developed countries and the most disadvantaged sections of developing countries. The measures to be taken include information and education for target groups; improved protection of the blood supply; increasing women’s power of decision-making with respect to sexuality and reproductive health; strengthening health services, particularly primary health care; improving training for health personnel; combating discrimination against, and the social and economic exclusion of, people with HIV/AIDS; and combating the stigma attached to those living with the virus through public health information campaigns and the setting up of an appropriate legislative framework.
Issues in the control of the AIDS epidemic
The most controversial issue in the law governing AIDS is the extent to which screening for AIDS—the systematic application of the ELISA test and confirmatory supplemental tests to specific populations—should be undertaken. While some countries have mandated tests for particular groups, such as prisoners, prostitutes, or immigrants, or even, in some jurisdictions, intravenous drug users or applicants for a marriage license, the weight of authority favours voluntary testing accompanied by counselling for several reasons.
It encourages behaviour changes and notification of sexual contacts and people with whom needles have been shared.
It facilitates protection of privacy and therefore does not drive those who believe they may be infected to go ‘underground’.
In a low-prevalence population a test with a high degree of sensitivity and specificity, as the serological tests for HIV antibodies are, will produce a large proportion of false-positive responses, causing great anxiety, providing misleading information, and requiring confirmatory tests.
In any testing system a certain number of false negatives will occur in the window of time before infection is manifested, which give a false sense of security and inhibit behaviour changes.
Therefore, the United Nations Global AIDS Program strongly favours voluntary testing, counselling, and protection of confidentiality. Mandatory testing without informed consent has no place in an AIDS prevention and control programme, the WHO states, because it violates the rights and dignity of individuals and is counterproductive to control of the epidemic (WHO 1992).
Advances in therapy may, however, increase the urgency of expanding testing. For example, the finding that zidovudine reduces the chance that an infected woman will pass the HIV virus to her fetus from 25 to 8 per cent led the United States Centers for Disease Control and Prevention (CDC) to recommend that all pregnant women be tested voluntarily early in pregnancy, with infected women offered zidovudine therapy (CDC 1998).
Another issue concerns precautions to prevent the transmission of HIV to health-care workers. The increasing prevalence of HIV increases the risk that health-care workers will be exposed to blood from patients infected with HIV. The CDC has issued an authoritative document emphasizing the need for health-care workers to consider all patients as potentially infected and to adhere rigorously to infection-control precautions. The response to the risk to health-care workers must be universal precautions (CDC 1987). In late 1991, the United States Occupational Safety and Health Administration adopted standards mandating universal precautions to protect workers from blood-borne diseases, including the requirement that the employer make available the hepatitis B vaccine and vaccination series to all employees who have occupational exposure, and postexposure prophylaxis and follow-up to all employees who have had an exposure incident. These detailed standards provide legal force in the United States to the recommendations of the CDC (US Department of Labor 1991). In a landmark decision in 1998, the United States Supreme Court held that a dentist may not discriminate against a person with asymptomatic HIV infection. The Americans with Disabilities Act prohibits discrimination against a person who suffers a disability that impairs a major life function. The Court held that the patient in this case suffered a disability that impairs the major life function of the ability to bear children (Bragdon v. Abbott 1998). The Court also rejected the dentist’s claim that courts should defer to his assessment of the risk posed by HIV-positive patients. Instead, the Court ruled, deference should be given to the opinion of public health authorities, which the dentist could seek to rebut, because they are the ones best trained to assess risk. Subsequent lower court proceedings found the dentist unable to rebut public health’s conclusion that HIV-positive patients could be safely treated in dentists’ offices.
From the beginning of the AIDS epidemic the issues of privacy, confidentiality, and protection against discrimination have been prominent concerns. But, as Dr Stephen Joseph, Commissioner of Health of New York City 1986 to 1990, points out, AIDS constitutes a public health emergency which carries within it extraordinary civil liberties issues; it is not a civil liberties emergency which carries within it extraordinary public health issues (Joseph 1992). For this reason, the AIDS epidemic raises a double ethicolegal imperative: to prohibit and punish discrimination in employment, housing, health insurance, public accommodations, governmental services, and schooling solely because the person has AIDS or is believed to be seropositive and, at the same time, to expand and intensify the response to the public health emergency created by the epidemic.
Legislation on mental illness
If one were to select a single sector of health services to see the field of health law in microcosm, one should examine health services for the mentally ill. This sector illustrates with particular sharpness the conflict between health needs and legal rights, between protection of the patient and protection of society, and ways to resolve these conflicts.
The scope of legislation affecting the mentally ill is very broad. It includes laws governing admissions to mental hospitals, standards for mental health facilities and care of patients, organization of community mental health programmes, legal protection of the person and property of the mentally ill, the doctrines of the right to treatment and right to treatment in the least restrictive alternative setting, legal aspects of deinstitutionalization, and mental illness and the criminal defendant (Curran and Harding 1978). The discussion here is restricted to mental hospital admission laws.
With the advent of tranquillizers, the development of the concept of the open hospital and the therapeutic community, and increased awareness of the civil rights of patients, many jurisdictions have amended their centuries-old statutes governing criteria for hospital admission of the mentally ill. Definitions of who is mentally ill have moved away from vague standards, such as ‘in need of care and treatment’, to more precise standards, such as ‘dangerous to others’, ‘dangerous to self’, and ‘gravely disabled’. In addition to changes in the grounds for admission, the procedures for admission have been modified to assure prompt and non-traumatic admission to mental hospitals when needed, to require periodic review of the need for continued hospital treatment, and to assure prompt discharge as soon as the patient is ready.
Many of the old commitment laws, as they were called, resemble criminal proceedings. They require a petition to the court, notice of hearing, representation by counsel, a hearing before a judge, often with a jury trial, testimony by witnesses, and even sometimes a written opinion by the judge as to the necessity for hospital admission. These laws, it was found, provided only the illusion of due process and actually were adverse to the health needs of patients in many cases for prompt and non-traumatic hospital admission (Association of the Bar of the City of New York 1962). Modern statutes have replaced this legalistic procedure with new administrative mechanisms for protecting both the health needs and the legal rights of mental patients. At the same time, since an individual’s liberty is at stake in an involuntary admission to a mental hospital, the role of the courts in overseeing the propriety of retaining an individual in a hospital has been strengthened.
Examples of mental hospital admission laws
The first country to enact a modernized mental health law was the United Kingdom, which adopted legislation along lines recommended by the Royal Commission on the Law Relating to Mental Illness and Mental Deficiency in 1957. Previously in England and Wales, involuntary patients were admitted to mental hospitals on an order from a justice of the peace based on one medical certificate from a medical practitioner. This procedure was viewed as providing inadequate safeguards because the magistrate could not form any sound independent opinion on the patient’s mental condition and because the judicial order associated mental hospital admission with the courts and with punishment of crime (Maclay 1960).
The Mental Health Act of 1959, applicable to England and Wales, abolished the judicial order and made compulsory admission, when necessary, a medical matter requiring two medical opinions, including one from a doctor with special experience (UK 1959). The doctors recommending compulsory detention must specify the grounds for their opinions and state whether alternative methods of dealing with the patient are available and, if so, why they are not appropriate and hospital admission is necessary. The hospital must confirm the need for hospital admission, and on the basis of these three certifications the hospital is authorized to retain the patient for specified time limits. Most importantly, an administrative agency to which patients and their families have access—the Mental Health Review Tribunal—is established in each hospital region, with power to review the appropriateness of hospital admission and to discharge the patient.
In 1983, 24 years after passage of the Mental Health Act, amendments to the law were adopted to strengthen protection of the civil rights of mental patients (UK 1983). These amendments require consent to treatment, assurance of patient rights (such as the right to visitors, to pocket money, and so on), and establishment of a Board of Visitors to provide surveillance of the quality of care in mental hospitals.
In the climate of opinion created by new methods of treatment of the mentally ill and new public attitudes towards mental illness, New York State revised its mental hospital admission law after an extensive study which found great variations, inequities, and injustices in the involuntary admission of patients to mental hospitals. The measures intended to protect the rights of patients had become a rubber stamp by the judges of the decisions of doctors (Association of the Bar of the City of New York 1962).
Accordingly, in 1964 the New York State Legislature unanimously passed a new Mental Hygiene Law (New York 1978). It abolished civil judicial certification of an involuntary patient to a mental hospital and provided that the initial admission of an involuntary patient to a mental hospital is a medical matter, on the application of a near relative or other interested person and on the recommendations of two doctors, with the concurrence of the admitting hospital. Immediate and periodic legal reviews of the propriety of hospital admission are required. The rights of the patient are protected by an arm of the court, the Mental Health Information Service, which faces towards the patient and his family to inform them of the patient’s rights and alternatives, and towards the court to inform it of the patient’s condition and alternative treatment resources.
A key feature of both the British and the New York laws is the functioning of a protective structure to provide representation of the patient’s interests and needs. Both the British Mental Health Review Tribunal and the New York Mental Health Information Service, however, apply only to institutionalized people.
As deinstitutionalization has increased, so have the numbers of the mentally disabled in the community and many of them have become homeless. Recognition has gtrn of the need for similar protection of non-institutionalized mentally disabled people (Association of the Bar of the City of New York 1988). Simon Rosenzweig, who was one of the architects of the New York Mental Hygiene Law of 1964, proposed establishing an ongoing continuing legal service for the mentally disabled in the community. Such a service would differ from the service for institutionalized patients in that it would be concerned principally with entitlements to welfare, housing, treatment (including complaints as to treatment modes), access to ambulatory mental health centres, and so on. Rosenzweig envisaged a form of ‘outpatient commitment’, now quite common, to assure mental health care in the community and comport with constitutional rights to due process (McCafferty and Dooley 1990; Rosenzweig 1990).
Israel has enacted a law providing for an order for compulsory ambulatory treatment as an alternative to hospital admission or as a follow-up to hospital admission for patients meeting the requirements for involuntary hospital admission. The statute provides a right of appeal from an order for ambulatory treatment just as a right of appeal exists from an order for hospital admission (Israel 1992).
Issues in mental hospital admission laws
Modernized mental hospital admission laws reflect the revolution that has occurred in the care of the mentally ill. But not all problems have been resolved. What standard of proof should be required for involuntary hospital admission? Does the patient have a right to treatment or a right to refuse a particular kind of treatment? What safeguards are afforded for minors deemed in need of mental hospital admission (Parham v. J.R. et al.1979)? Probably in no field of health law is the conflict between the rights of the individual to liberty and confidential treatment and the right of society to protection from harm so sharp as in the field of mental illness.
To some extent, legislation can provide a solution for this dilemma. For example, the statute of Qatar contains a detailed patient’s bill of rights protecting the patient’s right to know about his or her illness, to give informed consent before any treatment, to refuse treatment, to have information about his or her case treated as confidential, to inspect his or her chart in the presence of the doctor, and to receive a reasonable continuity of care (Qatar 1989). The law of Albania provides restrictions on the use of physical restraints on mental patients (Albania 1997). But in the long run, resolution of this conflict in various contexts will depend on further advances in psychiatric diagnosis and treatment, and on imaginative legal strategies to protect the individual and society.
Legal problems in human reproduction
A priority for public health concerns the protection of the health of mothers and children. In all countries emphasis has been placed on prenatal and maternity care and on breast feeding, immunization, and well-baby care. A new dimension was added to maternal and child health efforts with the recognition of the importance of birth control and abortion to prevent unwanted pregnancy and assure proper child spacing. Deaths from illegal abortion were the largest single cause of maternal mortality in many countries and still are in some. According to the WHO, 20 million unsafe abortions each year result in 78 000 maternal deaths and hundreds of thousands of disabilities in women, with the majority occurring in developing countries (Cook et al. 1999).
To tackle the enormous toll in preventable maternal deaths from dangerous illegal abortion, a number of countries turned in the mid-twentieth century to legislation to shift abortion from the illegal to the legal sector of medical practice (Cook and Dickens 1988). To promote family planning programmes, laws were enacted removing barriers to access to birth control and providing educational and financial support for contraceptive services (for example, France, Germany, Italy, Morocco, and Spain) (Paxman 1980; Isaacs 1981; Mason et al. 1987). Laws also authorized voluntary sterilization, as in Japan, Panama, the Scandinavian countries, and Singapore (Isaacs 1981; Stepan et al. 1981). Statutes mandating sex education in schools were adopted (Roemer and Paxman 1985). Also, as another aspect of the woman’s choice in reproductive matters, the law has been called on to authorize means to reduce infertility and has addressed alternative or assisted means of reproduction (Annas and Elias 1983; Andrews 1984; Annas 1984; Warnock Committee 1984; Swiss Institute of Comparative Law 1986).
These legal changes were not achieved without opposition. A minority of the population in a number of countries opposed legalized abortion and even attempted to restrict contraceptive and sex education programmes. Despite their efforts, advances in the technology of contraception, and changed social attitudes concerning sexual behaviour and the rights of women, have impelled modernization of the laws governing human reproduction.
Legislation on abortion
Abortion at the request of the woman or on a wide range of indications has been legalized in the most countries of the world, including China, India, Japan, the United States, and the former Soviet Union. It is allowed in the first 3 months of pregnancy in Austria, France, Germany, Denmark, and Italy. Abortion is authorized on social or sociomedical grounds in Barbados, Belize, the Scandinavian countries, and the United Kingdom, and it was legal in most of the countries of Eastern Europe before the end of the communist regimes. Many countries allow abortion on medical grounds, as in Algeria, Israel, and Switzerland. South Africa allows abortion on request of the woman during the first 12 weeks of pregnancy; from the 13th to the 20th week abortion is allowed if a doctor believes that the pregnancy poses a risk to the physical or mental health of the woman, there is a risk of a defective fetus, the pregnancy is the result of a sex crime, or the continued pregnancy would significantly affect the social or economic circumstances of the woman; after the 20th week abortion is allowed if two doctors or a doctor and a registered midwife determine that continued pregnancy would endanger the life of the woman, result in severe malformation of the fetus, or risk injury to the fetus (South Africa 1997).
In Colombia, Guatemala, Honduras, Nicaragua, Turkey, and Venezuela abortion is allowed only to save the life of the woman. Abortion is prohibited in Chile, the Dominican Republic, Haiti, Panama, Paraguay, The Philippines, and Suriname. The reality in many countries where abortion is illegal or restricted is that it is nevertheless widely practised, often by doctors, and with acceptance by the public (David 1984; Mason et al. 1985; Cook and Dickens 1988; David and Pick de Weiss 1992; Cook et al. 1999).
Henshaw has analysed recent trends in abortion laws, from 1988 to 1993, in non-communist industrialized countries, the formerly communist countries of Eastern Europe, and developing countries (Henshaw 1994). Little change occurred in almost all the non-communist industrialized countries, which had fairly liberal laws. Three of these countries—Canada, France, and the United Kingdom—made minor changes liberalizing their laws. Belgium replaced its extremely restrictive law with one allowing women in a state of ‘distress’ to end their pregnancies during the first trimester. In Ireland, a decision of the Supreme Court held that, although the law prohibits abortion without exception, the procedure is permissible when the pregnant woman’s life is endangered by physical health conditions or threat of suicide.
Before 1988 most of the formerly communist countries of Eastern Europe allowed abortion on request or for social indications. With the end of the communist regimes, three countries that had severe restrictions on abortion—Albania, Mongolia, and Romania—immediately authorized abortion on request. Bulgaria and Hungary liberalized their laws further. However, in Poland, the liberal 1956 law was repealed in 1993 by a law allowing abortions only in public hospitals on grounds of threat to life or health of the pregnant woman, serious and irremediable malformation of the fetus, and pregnancy resulting from rape or incest (David 1993). The Polish law was amended in 1996 and 1997 to allow abortion within the first 12 weeks of pregnancy only on the grounds of risk to the woman’s physical or mental health or in pregnancy resulting from sex crimes (Cook et al. 1999). It is a crime punishable by imprisonment for up to 3 years to carry out a pregnancy termination in violation of the law or to encourage a woman to terminate her pregnancy in violation of the law (Poland 1997). Two other ex-communist countries—the Czech Republic and Serbia—restrict abortions by imposing fairly substantial fees (Henshaw 1994).
Among developing countries, Malaysia replaced a restrictive law with one modelled on the British statute allowing abortion if continuing a pregnancy involves more risk to the woman’s physical or mental health than terminating it. Other developing countries that made minor changes liberalizing their laws are Botswana, Pakistan, Peru, and the Sudan (Henshaw 1994). In Indonesia, a family health law of 1992 provides that, in emergency cases, to save the life of a pregnant woman ‘certain medical procedures’ may be performed—a provision, according to the Indonesian Family Planning Association, designed to assure safe services and act as a compromise with those opposed to abortion (David 1993). Developing countries that increased their restrictions on abortion are Argentina, Chile, and Singapore (Henshaw 1994).
Issues in laws affecting human reproduction
The worldwide turnabout in the law governing birth control and abortion that has occurred in the last two decades has brought significant public health benefits to women and their families. Deaths from illegal abortion of desperate women faced with unwanted pregnancies have been prevented. Infant mortality and morbidity have been combated by improved spacing of pregnancies (Maine and McNamara 1985). Many adolescents have been able to defer child-bearing to a time more appropriate for parenting (Roemer 1985; Paxman and Zuckerman 1987). The development of medical abortion, with approval of mifepristone (RU-486) in several countries, provides a new option for pregnancy termination (Cook et al. 1999). A most significant advance in women’s health—and in human rights—occurred with the enactment in Egypt and Ghana of statutes making it a crime to perform female circumcision (Ghana 1996; Egypt 1997).
Still, many problems remain. In many countries where abortion is still illegal or restricted, desperate women faced with unwanted pregnancies are driven to unsafe illegal abortions. Geographic access to family planning and abortion services is uneven. Financial access is a serious problem where universal financing of health services is not available. The shortage of abortion providers is a barrier to access to service. Required authorization by a spouse or a parent blocks or delays services. Further work is needed to prevent teenage pregnancy by improved sex education in the schools and improved access to contraceptive services and abortion. Constant vigilance is necessary to prevent restrictions in law or practice on the right of women to choose to terminate unwanted pregnancies. Finally, an unknown element in this field is the impact of the epidemic of AIDS on the use of condoms and on the option of abortion for seropositive women.
Legislative approaches to health promotion
The historical role of public health of preventing disease and disability received a new impetus in 1974 with the publication in Canada of the Lalonde Report, A New Perspective on the Health of Canadians (Lalonde 1974). This report launched a worldwide effort for health promotion, examining and improving the judgements that must be made by individuals in respect of their own living habits, by society in respect of the values it holds, and by governments in respect of both the funds they allocate to the preservation of health and the restrictions they impose on the population for whose well being they are responsible (Lalonde 1974).
How does health promotion differ from the time-honoured function of public health, the function of health education? Hotritz (1981) defines health education as consisting of any combination of learning experiences designed to facilitate voluntary adaptations of behaviour conducive to health. In contrast, health promotion is the process of advocating health to enhance the probability that personal, private, and public support of positive health practices will become a societal norm.
In this effort to establish societal norms that contribute to healthful lifestyles, legislation has proved to be an essential component. This does not denigrate the role of education, which is important to engender the motivation to change behaviour. That motivation, however, can be encouraged by societal norms and expectations which, in turn, are promoted by governmental policy expressed in legislation.
Prevention of motor vehicle accidents
The fields in which legislation can be directed to promoting health are many and varied. A high priority has been given to laws to prevent the enormous toll in death and disability from motor vehicle accidents. These include laws setting standards for fitness to drive, mandating the use of child passenger restraint systems, seat belts, and motor cycle crash helmets, and requiring manufacturers of vehicles to instal air bags. With the technological innovation of blood alcohol measurement, stringent laws make the presence of a given level of alcohol in the blood a conclusive presumption of drunk driving entailing mandatory fines, jail sentences, license restriction, and rehabilitation programmes (California Vehicle Code 1985).
Control of alcohol abuse
Drunk driving laws are just one kind of law to control alcohol abuse. There are two major types of legislation: control of the availability of alcoholic beverages, and influencing drinking practices.
In the category of controlling the availability of alcohol are laws to control places of sale, hours of sale, and sales to minors, and to provide controls through taxation and prices (Moser 1980; Addiction Research Foundation 1981; Institute f Medicine 1982). While the evidence on the effectiveness of some of these measures is equivocal, it is generally agreed that decreasing the availability of alcohol is important. The experience of the Province of Ontario, Canada, showed that lowering the drinking age increased alcohol-related traffic accidents and admissions of teenagers to alcoholism and rehabilitation facilities (Addiction Research Foundation 1981; Single 1984). Increase in price of alcohol relative to income has been associated with a decline in consumption (Moser 1980).
In the category of regulating drinking practices are control of advertising, punishing public drunkenness, control of drinking and driving, education and information about alcohol, taxation policy, and counselling, treatment, and rehabilitation (Porter et al. 1986). Again, although evidence on the effectiveness of these measures is conflicting, there are indications that drinking practices can be affected by legislation, combined with education, provided the laws are enforced.
A notable advance in alcohol control policy is the 1985 law in the United States providing for mandatory label information on alcoholic beverages stating that women should not drink alcoholic beverages during pregnancy because of the risk of birth defects and that consumption of alcoholic beverages impairs the ability to drive a car or operate machinery, and may cause health problems (US 1993b). Most importantly, the pioneering 1991 French law bans all advertising of alcoholic beverages (France 1991).
Control of the tobacco epidemic
Tobacco use is the largest single avoidable cause of ill health and premature mortality in the world, accounting for an estimated 3 million deaths a year from smoking-related diseases. In response to the worldwide smoking epidemic, governments have intensified their efforts to control smoking by legislation, combined with education and smoking cessation programmes.
Two broad categories of laws have been enacted: laws to bring about changes in the production, manufacture, promotion, and sale of tobacco—laws to control the supply (or ‘production’) side—and laws to achieve changes in practices among smokers—laws to control the ‘demand’ (or ‘consumption’) side (Roemer 1993).
In the category of bringing about changes in the production, manufacture, promotion, and sale of tobacco are:
control of advertising, sales promotion, and sponsorship of tobacco products
requirements for health warnings and statement of tar and nicotine contents on cigarette packages and other tobacco products
control of harmful substances in tobacco, such as tar, nicotine, and additives
restrictions on sales to adults
economic strategies relating to subsidies, crop substitution, and trade policies.
While all these measures contribute to a decline in tobacco consumption, the most important is control of advertising and sponsorship. The tobacco industry spends more than US$2 billion a year globally to lure consumers to its products, not counting the cost of indirect advertising through sponsorship of sports and cultural events by tobacco companies. Through advertising, the industry conveys the message, especially to young people, that smoking is associated with success, pleasure, relaxation, sports, freedom, beauty in nature, sophistication, virility, and sexuality. Moreover, the substantial revenues received by newspapers and magazines from advertising of tobacco products have a chilling effect on their editorial policies and deter publication of articles on smoking and health.
By 1991, 27 countries in the world had banned all advertising of cigarettes and 77 had enacted partial bans, some limiting the contents of advertisements to facts, barring the depiction of adolescents or children associated with sports, or restricting the amount of space devoted to advertising, and some imposing moderate partial bans prohibiting use of the electronic media for advertising of tobacco products or restricting the hours during which cigarettes may be advertised on television. Experience in the Scandinavian countries, particularly Finland and Norway, showed that total bans on advertising combined with strong antismoking policies lowered smoking rates markedly, particularly among young people (WHO 1987). A study of tobacco-promotion policies and consumption trends in 33 countries, commissioned by the New Zealand Toxic Substances Board, found that, when countries were grouped according to the degree of governmental restriction on tobacco promotion, the greater the degree of restriction, the greater the average annual fall in tobacco consumption (New Zealand Toxic Substances Board 1989). The alarming uptake in smoking by children and adolescents led Canada, Australia, New Zealand, and France to ban all advertising and promotion of tobacco products (Canada 1988; New Zealand 1990; Australia 1991; France 1991; Roemer 1993).
In the category of legislation to change smoking behaviour are:
tax and price policies
restricting smoking in public places
restricting smoking in the workplace
preventing young people from smoking (by prohibiting sales to minors and restricting sales of cigarettes from vending machines)
mandating health education.
Experience in Canada, Hong Kong, the State of California (United States), and the United Kingdom has shown that raising taxes on tobacco decreases sales (Roemer 1993). An important report from Finland confirms the need for substantial and repeated increases in taxes and prices of tobacco products if consumption is to be significantly reduced (National Board of Health of Finland 1985).
Compelling scientific evidence on the dangers of environmental tobacco smoke led the United States Environmental Protection Agency to classify environmental tobacco smoke as a group A human carcinogen, a classification used only when there is sufficient evidence from epidemiological studies to support a causal association between exposure to the agents and cancer (US Environmental Protection Agency 1993). Because of the Environmental Protection Agency’s findings on the respiratory health effects of passive smoking, restrictions on smoking in public places and the workplace are of prime importance. Such legislation has been enacted at the national level of government, and it has also been successfully implemented when enacted by states and cities (Roemer 1988, 1993). These laws contribute to the creation of a non-smoking environment and the view that smoking is socially unacceptable. It is generally agreed that social acceptability is the ground on which the battle against the smoking epidemic will be decided.
In the United States, new impetus was given to tobacco control efforts by the following revelations in the mid-1990s (Hilts 1994a,b,c,d,e,f and g; Glantz et al. 1995, 1996):
that the Philip Morris Company knew that tobacco was addictive 5 years before the United States Surgeon General declared tobacco an addictive substance
that the tobacco industry abruptly terminated research to develop a ‘safe’ cigarette and concealed its findings on the addictiveness of tobacco
that the Btrn and Williamson Tobacco Company grew a genetically engineered tobacco in Brazil that more than doubles the amount of nicotine delivered, used it in five brands of cigarettes, including three brands labelled ‘light’, and has 3 million tons of it in warehouses in the United States.
In 1996, after a 2-year investigation, the United States Food and Drug Administration issued a determination that nicotine in cigarettes and smokeless tobacco is a drug and that these products are nicotine delivery devices subject to regulation by the Food and Drug Administration (US 1996). On 23 August 1996 President Clinton approved the Food and Drug Administration’s regulations designed to reduce teenage consumption of tobacco by reducing easy access to and appeal of tobacco products (Federal Register 1996). In March 2000, the United States Supreme Court, by a vote of 5 to 4, held invalid these regulations on the ground that the Food and Drug Administration lacks jurisdiction to regulate tobacco. The dissent by Justice Stephen G. Breyer states: ‘The upshot is that the court today holds that a regulatory statute aimed at unsafe drugs and devices does not authorize regulation of a drug (nicotine) and a device (a cigarette) that the court itself finds unsafe’ (Food and Drug Administration v. Btrn and Williamson Tobacco Corp. 2000).
The powerful evidence on the addictiveness of tobacco and the revelation of the industry’s deception about the risk of smoking and the addictiveness of tobacco over the years have fuelled the wave of litigation that has been launched against the industry in the United States. Suits by state attorneys general to recover the costs of caring for patients with tobacco-induced diseases were settled in a series of stunning agreements. In 1997, Mississippi settled its suit for $3.3 billion to be paid over 25 years, Florida settled next for $11.3 billion, then Texas in 1998 for $15.3 billion, and Minnesota for $6.1 billion (Bloch et al. 1998). In November 1998, a multistate national settlement for $206 billion to be paid over 25 years was entered into with 46 states. It bars outdoor tobacco advertising nationally but also bars future claims against the industry that might be brought by state and local officials and gives the industry credit on its payments to the states if Congress enacts a tobacco tax in the next 4 years and turns the money over to the states (Torry 1998). Litigation continues, strengthened by industry documents showing that the tobacco companies lied to the public about the addictiveness and risks of smoking. On 7 July 1999 a jury in a class-action suit in Florida (the Engle case) returned a unanimous verdict holding all the defendant tobacco companies liable for the negligence and fraud of the industry. Although appeals will undoubtedly be taken, this decision makes the industry potentially liable for billions of dollars in damages (Weinstein and Levin 1999).
Most important for the control of the tobacco epidemic worldwide is the action of the WHO to develop an international regulatory authority to promote tobacco control. In 1996 the World Health Assembly adopted a resolution to initiate a Framework Convention on Tobacco Control to encourage the countries of the world to move towards comprehensive tobacco control policies (WHO 1996). (For further discussion of the Framework Convention on Tobacco Control see Chapter 4.3 and Chapter 10.1.)
In 1999 the World Health Assembly put in place the structures and process to move towards adoption of the Framework Convention, with May 2003 as the target date for adoption (WHO 1999). The WHO’s leadership is designed to promote international co-operation and to energize national governments, regional associations, and non-governmental organizations to combat the largest single cause of preventable mortality and morbidity in the world.
Other health promotion legislation
To promote healthful nutrition, legislation may regulate the quantitative declaration of calories, fats, cholesterol, sodium, sugars, and other nutrients to promote safe and wholesome food, as discussed earlier. Legislation may also establish supplemental feeding programmes, such as school lunches and nutritional supplements for low-income pregnant women and infants, require use of unsaturated fats in commercially produced foods, subsidize the production of foods rich in unsaturated fats in order to lower the price, assist farmers to change cattle feed in order to produce beef low in saturated fats, and provide scientific, technical, and other assistance to agriculture and the food industry to enable them to shift as painlessly as possible to production of foods compatible with the ‘prudent diet’ (Terris 1983). These are ideal public health measures because they benefit whole populations and do not require individual behavioural change.
Another ideal measure is fluoridation of public water supplies to prevent dental decay. Community water fluoridation improves the oral health of an entire population regardless of socio-economic level, education, individual motivation, or the availability of dental personnel (Murray 1986).
Many of the problems discussed in connection with health promotion are manifestations of stress. Certainly, smoking and alcoholism are largely responses to stress. Stress is also produced by adverse environmental and life situations, such as poor working conditions, poor housing, and unemployment. Stress has so many causes that one needs to address specific problems to ascertain what legislation can do to alleviate them.
The list of health problems associated with stress is long and daunting. It includes drug abuse, depression, suicide, mental illness generally, child abuse, and family violence. Societal responses to these difficult problems lie in social institutions and programmes that can be assisted by legislation.
Examples of health promotion legislation
One could select many examples of legislation to promote health, such as legislation to assure product safety to prevent accidents in the home, laws to prevent road accidents, or laws to reduce alcohol consumption. The Norwegian national nutrition and food policy, discussed above, expresses an important policy to promote health. Two examples of laws to control the smoking epidemic are useful here.
In 1992, Thailand enacted two laws—the Tobacco Products Control Act and the Non-Smokers’ Health Protection Act—to provide a comprehensive or multifaceted tobacco control policy. On the ‘supply’ side, the Thai Tobacco Products Control Act bans all advertising of tobacco products, requires health warnings on cigarette packages, bans the sale of tobacco products to people under 18, bans sales from vending machines, distribution of free samples, exchanges, and gifts of tobacco products, and bans manufacture and advertising of non-tobacco goods in imitation of tobacco products. Manufacturers and importers are required to report the contents of tobacco products to the Ministry of Public Health, which has authority to prohibit their sale or import if they fail to comply with prescribed standards. On the ‘demand’ side, the Thai Non-Smokers’ Health Protection Act is designed to protect the health of non-smokers. It bans smoking in public places, authorizing designation of smoking areas in some public places (Health Systems Research Institute of Thailand 1995; Chitanondh 2000).
A single-purpose statute with a far-reaching impact is the 1987 Belgian Ctrn Decree banning smoking in all indoor places to which the public is admitted, including post offices, hospitals, schools, universities, homes for the elderly, theatres, concert halls, and sports arenas (Belgium 1987). In premises where the service to the public consists of furnishing food or drink, smoking may be allowed in a clearly defined part of the premises, but such permission may be denied if the premises are in buildings where students are taught, lodged, or cared for.
Issues in health promotion legislation
A number of general issues or recurring questions plague the field of legislation for health promotion.
How should the interest in social control and individual liberty be reconciled?
What types of legislative control are acceptable and effective?
How do various legislative approaches affect different socio-economic groups, and are they consistent with our notions of equity?
What legislative measures are effective in motivating individuals to change their behaviour? How do we evaluate them?
Who should bear the costs of risk-taking behaviour?
Are environmental measures available that lessen or eliminate the need for behavioural change?
What strategies for implementation of legislation are useful?
What is the responsibility of government for the people’s health vis-à-vis powerful commercial interests?
How should one legislate in the face of scientific uncertainty?
Ethical issues in public health law
Ethics is a set of philosophical beliefs and practices concerned with questions of justice, fairness, equity, rights, allocation of resources, and costs. Law is a system of principles and rules devised by organized society for the purpose of controlling human conduct. Law may be described as a vital process or group of processes by which people living together in a society meet their common problems and solve them to promote the common good (Christoffel 1982; Wing 1985). Law and ethics converge because both are concerned with rights and duties.
Public health is concerned with ethics because, as Beauchamp (1985) points out, public health is concerned not only with explaining the occurrence of disease but also with ameliorating it, and public health is concerned with integrative goals expressing the commitment of the whole people to face the threat of death and diseases.
A well-known ethicist in the field of health in the United States, Daniel Callahan, has stated that the most significant development in the field of bioethics in the decade from 1970 to 1980 was the development of a closer interface between ethics and regulation (Callahan 1980). Formerly, ethics was discussed in terms of individual choice and personal morality. But we have come to examine ethical issues in terms of their legislative, regulatory, and judicial implications.
For example, Hutt, an eminent American expert in the field of food and drug regulation, has stated that all regulation of food and drugs and of the environment as a whole has emerged from our collective sense of societal ethic. He specifies the following five moral imperatives of government for its regulatory process (Hutt 1980):
to protect the public from harm
to preserve maximum individual choice
to guarantee meaningful public participation in the decision-making process
to promote consistent and dependable rules applicable to everyone
to provide prompt decisions on all issues that arise in a regulatory context.
While ethical issues pervade much of governmental regulation of health services, in a few fields ethical issues predominate. These may be described as:
clinical decision-making on life and death issues involving providing medical treatment to severely disabled neonates and continuing life-support measures for terminally ill and comatose patients
regulation of clinical experimentation
equitable allocation of all resources for health care, including scarce resources, such as equipment for kidney dialysis and organ transplants
control of non-coital methods of human reproduction, such as in vitro fertilization and surrogate motherhood
policies concerning genetic testing and use of genetic information.
A voluminous literature is available on each of these topics and on many others involving ethical issues (Ladimer and Newman 1963; Walters 1975; Reich 1978; Annas and Elias 1983; Capron 1983, 1984; Andrews 1984; Annas 1984; Warnock Committee 1984; Bankowski and Bryant 1985; Bankowski et al. 1989). It is not possible here to do justice to the complexities involved in any one of these issues. Sensitive and difficult questions are involved, such as the best interests of the child and the family, the length of life and the quality of life, assuring individual integrity and autonomy, protecting confidentiality, equitable distribution of resources, competition for scarce resources, and societal values in individual choice and collective conduct.
The development of law governing ethical issues has provided guidelines to doctors and has nartred their sphere for making ethical judgements (Grad 1978). In fact, one of the most significant contributions of the law to this field is its capacity to create procedures and processes to resolve ethical questions in medicine and public health. Ethics committees of hospitals, ombudspeople to resolve disputes, patient advocates, review tribunals to monitor involuntary admissions to mental hospitals, protocols to govern care of the terminally ill, and manuals of procedures developed by the medical and nursing professions are all feasible mechanisms promoted and assisted by the law for resolving ethical issues in health care.
For the principal public health problem in the world—the threat of nuclear war—international law is crucial. No better illustration of the role of law in solving ethical problems can be found than efforts to achieve international agreements to stop the production and deployment of nuclear armaments and eventually to reduce conventional weapons of war. If peace in the world can be secured through international law, then other ethical problems in public health can surely follow.
Laws can generally be inspired by a sense of justice and right. Law provides the rules that all in society must abide by. Health law provides the regulatory system for patients, providers, and governments in the sphere of health protection and health services.
While the law may, in some instances, stand as a barrier to innovations in health service, in the main it has proved responsive to new scientific discoveries and to changed social and economic conditions. Where existing policies are inequitable or outmoded, the law has the capacity to serve as an instrument for change. If the outlines for change are uncertain, the law can facilitate the development of mechanisms for defining and achieving solutions.
Working in co-operation with public health experts, the health lawyer can assist and clarify the definition of sound health policy and can promote its implementation for the benefit of individuals and society.
*The authors are deeply indebted to Mr S.S. Fluss, former Chief of Health Legislation at the WHO, Geneva, and Editor of the International Digest of Health Legislation, for information and insights generously provided over the years on health legislation of countries throughout the world.
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