4.3 International health instruments: an overview*
Oxford Textbook of Public Health
International health instruments: an overview*
Allyn L.Taylor, Douglas W. Bettcher, Sev S. Fluss, Katherine DeLand, and Derek Yach
Sources of international public health law: the contribution of international, regional, and non-governmental organizations
Other United Nations bodies and organizations
Other international intergovernmental organizations
Regional intergovernmental organizations
International health instruments as they affect certain sectors of health
Communicable disease control
Infant feeding and nutrition
Narcotics and psychotropic substances
Nuclear safety and radiation protection
Pharmaceuticals, medical devices, and cosmetics
Refugees, detainees, and internally displaced people
Right to health
Trade and health
No definition of international health law is accepted worldwide. As the eminent scholar Frank Grad has observed:
Public health law does not come in a single, neat legislative package marked ‘public health law’. It consists of many different types of legislation which have little in common except for the benign purpose of advancing public health. (Grad 998)
This statement was undoubtedly written in the context of national health-care systems, but it is especially applicable to international public health law.
As Grad has observed, the field of international public health law encompasses increasingly complex concerns, including aspects of human reproduction, biomedical science and human reproduction/cloning, organ transplantation and xenotransplantation, infectious and non-communicable diseases, international trade and the control of safety of health services, food, and pharmaceuticals, and the control of addictive substances such as tobacco and narcotics. International public health law is linked with other areas of international concern. International labour law and occupational health and safety, environmental law and the control of toxic pollutants, arms control and the banning of weapons of mass destruction, nuclear safety and radiation protection, disabilities and human rights, and fertility and population growth are all related to public health (Grad 1998).
The breadth and depth of international health law at the beginning of the twenty-first century and its nexus with other realms of international concern is largely a result of globalization. Globalization is the process of increasing economic, political and social interdependence, and global integration that occurs as capital, traded goods, people, concepts, images, ideas, and values diffuse across state boundaries (Ruggie 1995). The roots of globalization can be traced back to the industrial revolution and the laissez-faire economic policies of the late nineteenth century. However, globalization at the beginning of the twenty-first century has assumed a magnitude and taken on patterns that are unprecedented in world history.
The global context of development has profound implications for public health and, concomitantly, the expansion of international health law as the lives of individuals are increasingly affected by transnational economic, social, scientific, and technological changes. As a result of the new globality, the domestic and international spheres of health policy are becoming more intertwined and inseparable. The domain of globalization includes many interconnected phenomena, risks, and opportunities that affect the sustained ability of health systems and the well being of populations of countries at all stages of development (Yach and Bettcher 1998a).
The development of binding global public health norms and commitments is becoming increasingly important as global interdependence accelerates and nations increasingly feel the need to co-operate to solve essential problems (Taylor 1992). Although international health law is still in a rudimentary stage of development relative to other fields of international concern, the health impact of globalization, both positive and negative, have become key global policy issues. Consequently, health development in the twenty-first century is likely to make wider use of international legal instruments to take advantage of the opportunities afforded by global change and to minimize the risks and threats associated with globalization.
At the same time, international health law remains very much concerned with the protection of human rights relating to physical and mental integrity (Abbing 1998). The domain of human rights in relation to health has expanded dramatically in the last 50 years, and tailored international instruments now address the rights of special populations, such as people with HIV/AIDS and disabilities, women, children, migrant workers, and refugees. International human rights law is also increasingly concerned with the human rights implications of advances in health technology, including human experimentation and biomedicine. It is well recognized, however, that human rights relating to health proclaimed in numerous instruments must be crystallized and operationalized if they are to affect national and international practice and that the human rights agenda of this century must move from the elaboration to the implementation of international norms.
This chapter focuses on international instruments ranging from binding treaties and conventions adopted under the auspices of international and regional organizations to non-binding instruments adopted under the auspices of such public international organizations as well as international non-governmental organizations and professional associations. It is concerned primarily with two complementary areas: the organizations under whose auspices international public health law and standards are developed, and international public health law and standards as they affect certain areas of health.
This chapter is not intended to be historical or comprehensive in perspective, rather it provides information on the current configuration of international public health law. Furthermore, space limitations prohibit systematic analysis of the effectiveness or efficacy of the instruments described. The reader is referred to the reference list at the end of this chapter for further information on international health law instruments. In addition, most of the organizations discussed in this chapter maintain websites where timely information on the instruments negotiated and adopted under their respective auspices can be obtained.
While it is not possible to discuss and clarify thoroughly the nature of the rules and process of international law within the confines of this chapter, it should be recognized that the rules of international law are very different in kind from those of municipal law as a consequence of the international legal system. Given the international political system of nation-states and the concept of state sovereignty, the sources of international law cannot be equivalent to those of municipal laws. Municipal rules generally derive from national constitutions, municipal statutes, executive regulations, and the decisions of municipal courts. Of course, some international organizations, such as the European Union, have established law-making structures that approach municipal-like sources, but, overall, formal international legislative and executive organs are fairly rare in the international system. Brownlie (1998), Higgens (1994), and Hiller (1994) provide thorough analyses of international law rules and processes.
It would have been impossible to write or conceive of this chapter without the pioneering work of four people. The late Norman Howard-Jones (1950, 1975), whose work on the early development of international public health law has almost biblical status for scholars in the field. Valentin Mikhailov (1984), whose legal treatise on the development of international health law has no real parallel in the English language. Michel Bélanger (1983, 1989) has made significant contributions to the field of international health law. Finally, Sev Fluss has made major and extensive contributions to the field of international health law are essential resources for all scholars in this field. This chapter draws upon Fluss’s contribution to the third edition of the Oxford Textbook of Public Health (1997b).
Sources of international public health law: the contribution of international, regional, and non-governmental organizations
Although the United Nations is not normally perceived as having a major role in health law, in fact, as shown in various sections of this chapter, numerous international conventions and non-binding instruments relevant to global public health have been adopted by or under the auspices of the United Nations. These include provisions dealing with discrimination in the field of health, rules governing the health and medical services to be provided to prisoners, mental health, medical ethics in certain contexts, measures to combat malnutrition, the rights of disabled people, the right to development (including the right to health), human rights and health, human rights in the population and reproductive health context, and various aspects of the protection of the human environment.
The legal foundation of the United Nations’ activities in international health is based on its Charter and, in particular, those sections that describe the objectives of the United Nations. Article 55 of the Charter describes the goals that the United Nations has pledged to promote among its members:
higher standards of living, full employment, and conditions of economic and social progress and development
solutions of international economic, social, health, and related problems, and international cultural and educational co-operation.
Acting within the framework of the United Nations Charter, the General Assembly, for example, has the legal capacity to discuss and study international health concerns. Article 13 of the United Nations Charter commands the General Assembly to ‘initiate studies and make recommendations … promoting international cooperation in the … health [field]’. The General Assembly also has the authority to make formal recommendations to the specialized agencies that those agencies are required to take into account. In addition, the General Assembly has the legal capacity to provide a forum for the negotiation of multilateral treaties. Article 13.1(a) empowers the General Assembly to ‘initiate studies and make recommendations … encouraging the progressive development of international law and its codification’. Although the General Assembly lacks express legislative powers, it has discharged its obligation to encourage the progressive development of international law and its codification by acting as a facilitator for the creation of international legislative rules through the traditional treaty-making process. The role of the General Assembly in international health law making is described by Taylor (1996).
As described in this chapter, a number of the specialized agencies, organs, and other bodies of the United Nations make a significant contribution to the development of international health law. The World Health Organization (WHO) is the United Nations specialized agency with the primary mandate to implement the aims of the Charter with respect to health.
Other United Nations bodies and organizations
Economic Commission for Europe
Established in 1947 as a United Nations organ, the Economic Commission for Europe was given the mandate of helping rebuild postwar Europe, develop economic activity, and strengthen economic relations between European countries and between them and other parts of the world. The Economic Commission for Europe has served as the forum for numerous conventions and other instruments relevant to the protection and promotion of human health including the following:
1979 Convention on Long-Range Transboundary Air Pollution and its protocols
1991 Convention on Environmental Impact Assessment in a Transboundary Context
1992 Convention on the Protection and Use of Transboundary Watercourses and International Lakes and its protocol
1992 Convention on Transboundary Effects of Industrial Accidents.
Food and Agricultural Organization
The Food and Agricultural Organization (FAO), the largest specialized agency within the United Nations system, was established in 1945 with the mandate to raise levels of nutrition and standards of living, to improve agricultural productivity, and to better the conditions of rural people. The Organization has developed a number of instruments directly and indirectly relevant to human health. The Food and Agricultural Organization collaborates with the WHO as a partner in the administration of the Codex Alimentarius Programme, which was initiated to promulgate food standards aimed at protecting consumer health and ensuring fair practices in the food trade. In collaboration with the United Nations Environment Programme, the Food and Agricultural Organization served as a forum for the adoption of the 1998 Convention on the Prior Informed Consent for Certain Hazardous Chemicals and Pesticides in International Trade, the most recent international instrument designed to promote health and environmental protection in international trade in chemicals and pesticides.
International Atomic Energy Agency
The International Atomic Energy Agency (IAEA) serves as the central intergovernmental forum for scientific and technical co-operation on nuclear issues and is the international inspectorate for the application of nuclear safeguards and verification measures covering non-military nuclear programmes. A related agency within the United Nations system, the International Atomic Energy Agency, currently has 128 member states. The International Atomic Energy Agency Statute was approved on 23 October 1956 by the Conference on the Statute of the International Atomic Energy Agency and entered into force on 29 July 1957.
The International Atomic Energy Agency has developed a number of conventions and codes dealing with nuclear safety. Those that have potential relevance to the protection of public health include the Convention on Early Notification of a Nuclear Accident (1986), the Convention on Assistance in the Case of a Nuclear Accident (1986), the Convention on Nuclear Safety (1994), and the Joint Convention on the Safety of Spent Fuel Management and on the Safety of Radioactive Waste Management (1997). Adede (1987) has written a definitive book on the 1986 Early Notification and Assistance Conventions.
The International Atomic Energy Agency, along with the Food and Agriculture Organization, the International Labour Organization, the Nuclear Energy Agency of the Organization for Economic Co-operation and Development, the Pan American Health Organization, and the WHO, jointly sponsored the recently updated International Basic Safety Standards for Protection Against Ionizing Radiation and for the Safety of Radiation Sources. Other relevant conventions and recommendations are discussed below in the sections dealing with nuclear safety and radiation protection in international public health law as it affects certain sectors of health.
International Labour Organization
The Geneva-based International Labour Organization (ILO) was founded in 1919 and is the only surviving entity created by the Treaty of Versailles. It became the first specialized agency of the United Nations in 1946. Articles 14 to 21 of the Constitution of the International Labour Organization (1919) enable that Organization to adopt conventions and recommendations. A substantial number of the 182 conventions and 190 recommendations developed under the auspices of the International Labour Organization as of 1999 have dealt with issues that are directly or indirectly related to human health. In fact, as early as October 1919, what was then known as the General Conference of the International Labour Organization adopted the Maternity Protection Convention, 1919 (this has since been superseded by the Maternity Protection Convention 1952). Other relevant conventions and recommendations are discussed below in the section dealing with occupational health in international public health law as it affects certain sectors of health.
International Maritime Organization
The London-based International Maritime Organization, originally established as the Intergovernmental Maritime Consultative Organization, is the United Nations specialized agency responsible for improving maritime safety and preventing pollution from ships. The International Maritime Organization has served as the platform for the development of numerous international instruments relevant to international public health, including:
1969 Convention on Civil Liability for Oil Pollution Damage
1972 Convention on the Prevention of Marine Pollution by Dumping of Wastes and Other Matter (London Ocean Dumping Convention)
1973 International Convention for the Prevention of Pollution from Ships, as modified by the Protocol of 1978
1990 International Convention on Oil Pollution, Preparedness, Response and Cooperation
1996 International Convention on Liability and Compensation for Damage in Connection with the Carriage of Hazardous and Noxious Substances by Sea.
United Nations Educational, Scientific and Cultural Organization
The Paris-based United Nation’s Educational, Scientific and Cultural Organization (UNESCO), established in 1945, has the primary constitutional directive of promoting collaboration among member states in education, science, and culture. With six regional offices, UNESCO is one of the largest specialized agencies of the United Nations.
The first article of UNESCO’s Constitution specifies that the purpose of the organization is to ‘contribute to peace and security by promoting collaboration among nations through education science and culture in order to further universal respect for justice, for the rule of law, and for the human rights and fundamental freedoms which are affirmed for the peoples of the world’.
Biomedical science has been a particular emphasis of UNESCO for more than 25 years. The Organization held its first of many symposiums on social and cultural changes brought about by scientific progress in the early 1970s and has monitored the human rights implications of advances in genetic science for over a decade. In 1997 UNESCO served as the forum for the adoption of the Universal Declaration on the Human Genome and Human Rights.
United Nations Environment Programme
The United Nations Environment Programme (UNEP), established by General Assembly Resolution 2997 of 15 December 1972 and with headquarters in Nairobi, is the outcome of the 1972 United Nations Conference on the Human Environment, the Stockholm Conference. UNEP, which operates as a quasi-autonomous subsidiary organ of the United Nations, has served as the forum of numerous multilateral environmental law instruments that have important implications for global public health. Some of the most significant are:
the 1987 Cairo Guidelines for the Environmentally Sound Management of Hazardous Wastes
the 1989 Code of Ethics on the International Trade in Chemicals
the 1989 Basel Convention on the Control of Transboundary Movements of Hazardous Wastes and their Disposal
the 1985 Vienna Convention for the Protection of the Ozone Layer and the 1987 Montreal Protocol thereto
in collaboration with the Food and Agricultural Organization, the 1998 Prior Informed Consent Convention.
UNEP also provided substantive support and technical expertise to the 1992 United Nations Framework Convention on Climate Change and the United Nations Convention to Combat Desertification in those Countries Experiencing Serious Drought and/or Desertification, particularly in Africa. In addition, it served as the framework for the negotiation of a number of regional seas agreements designed to protect the marine environment.
UNEP is in the process of organizing intergovernmental negotiations for the development of new treaties relevant to international public health, including a legally binding instrument for certain persistent organic pollutants. In addition, UNEP is currently developing new instruments within the framework of conventions formerly negotiated or developed under its auspices. The most significant of these are a Protocol on Biosafety to the 1992 Convention on Biological Diversity, and a Protocol on Liability and Compensation for Damage Resulting from Transboundary Movements of Hazardous Wastes and their Disposal to the 1989 Basel Convention on the Control of Transboundary Movements of Hazardous Wastes and their Disposal.
World Health Organization
The WHO is the primary multilateral organization charged with protecting and promoting global public health. With headquarters in Geneva, six regional offices and 191 member states, the WHO is the largest international health organization and one of the largest specialized agencies of the United Nations.
Although the WHO is not the only international agency involved in health matters, it has a unique mandate to address global public health based on responsibilities assigned by relevant international instruments. Article 1 of the WHO’s Constitution proclaims the fundamental objective of the ‘attainment by all peoples of the highest possible level of health’.
The foundation of the WHO’s unique obligation to promote global health is its affiliation with the United Nations system as a specialized agency. The structure of the relationships between the United Nations and the WHO is grounded in the United Nations Charter and, in particular, those sections that describe the objectives of the United Nations. Article 55 of the Charter describes the goals that the United Nations has pledged to promote among its members, including ‘(b) solutions of international, economic, social, health and related problems; and international cultural and educational co-operation’. As the specialized agency with the primary constitutional directive to act as the ‘directing and co-ordinating authority on international health work’, the WHO has the cardinal responsibility to implement the aims of the Charter with respect to health.
The first steps towards the creation of the WHO were taken at the United Nations Conference on International Organization, held in San Francisco from 25 April to 26 June 1945. During that conference, two delegations proposed convening an international health conference, with the objective of creating such an organization. Thereafter, the Economic and Social Council of the United Nations agreed to convene an international conference of members of the United Nations, with a view to establishing a single international health organization to replace pre-existing international health organizations, in particular the Health Organization of the League of Nations, the Paris-based International Office of Public Hygiene, and the United Nations Relief and Rehabilitation Administration. The ensuing conference was held in New York from 19 June to 22 July 1946, and the WHO’s Constitution was signed on the final day, entering into force on 7 April 1948. Further details of the origins of WHO have been described by Fluss and Gutteridge (1993).
The WHO’s Constitution confers authority upon the Organization to develop conventions under Article 19, regulations under Article 21, and recommendations under Article 23. The WHO has the legal authority under Article 19 to seek member state adoption of conventions or agreements with respect to any matter within the competence of the Organization. Historically, the WHO has not utilized its constitutional authority to develop binding international conventions (Taylor 1992). However, as described in the section on tobacco control below, the World Health Assembly (the supreme governing body of WHO) has recently activated Article 19 to authorize the negotiation of the WHO’s first international convention, a proposed WHO framework convention on tobacco control.
The WHO also has the authority to adopt international regulations under Article 21 of its Constitution, which lays down that such regulations may concern:
sanitary and quarantine requirements and other procedures designed to prevent the international spread of disease
nomenclatures with respect to diseases, causes of death, and public health practices
standards with respect to diagnostic procedures for international use
standards with respect to the safety, purity, and potency of biological, pharmaceutical, and similar products moving in international commerce
advertising and labelling of biological, pharmaceutical, and similar products moving in international commerce.
Article 23 confers further authority on the Assembly to make recommendations with respect to any matter within the Organization’s competence. The WHO regularly formulates and adopts technical recommendations and guidelines that command attention because of the Organization’s established reputation for technical expertise. Article 62 requires member states to report annually on action taken with respect to such recommendations, as well as with respect to conventions, agreements, and regulations, although this constitutional provision has never strictly been applied.
World Trade Organization
The Geneva-based World Trade Organization (WTO), formed at the conclusion of the Uruguay Round of the General Agreement on Tariffs and Trade (GATT) in 1994, is the primary international institution governing international trade: approximately 90 per cent of world trade is conducted pursuant to its rules. The initial Round of GATT (1947) called for the formation of the International Trade Organization to administer the multilateral agreement, but that organization was never formally established. The organizational features of GATT (1947) were therefore rudimentary, and it functioned primarily as a forum for negotiation. With the conclusion of the Uruguay Round in 1994, the GATT contracting parties took a major step towards strengthening the international trade regime by establishing and formalizing the institutional status of the World Trade Organization, strengthening the trade dispute mechanisms, and broadening the World Trade Organization’s jurisdiction.
The Uruguay Round brought about an overhaul of the international trade regime through the conclusion of a number of agreements addressing contemporary trade issues. The World Trade Organization Agreement has four annexes that contain the agreements reached in the Uruguay Round. The agreement was amended and incorporated into the new World Trade Organization agreement, including the case law and interpretive decisions. Now known as GATT (1994), the amended agreement, other agreements addressing non-tariff barriers to trade, trade in services, and a long list of understandings, declarations, decisions, and other texts are contained in the first Annex. Other World Trade Organization agreements covering trade in intellectual property as well as dispute settlement rules are contained in the second and third Annexes. These three sets of multilateral agreements were accepted by member states as a ‘single package’ during the Uruguay Round and therefore impose binding obligations on all member states. The fourth Annex, which contains the plurilateral agreements, are binding only on the World Trade Organization members who have accepted them.
The principal aim of the World Trade Organization is the reduction of barriers to trade. The general principles of the World Trade Organization include a commitment to achieving free trade and fair competition; limits on and eventual elimination of tariff and non-tariff barriers to trade; non-discriminatory treatment of all trading partners; the non-discriminatory treatment of domestically produced and foreign products; predictability by ensuring that trade barriers are not erected arbitrarily; negotiated elimination of trade barriers; the settlement of trade disputes; and opposition to retaliatory trade sanctions.
As described below, a number of the new World Trade Organization agreements have important implications for the protection and promotion of global public health. The most significant of these agreements are GATT (1994), the General Agreement on Trade in Services, the Agreement on the Application of Sanitary and Phytosanitary Measures, the Agreement on Technical Barriers to Trade, and the Trade-Related Aspects of Intellectual Property Rights Agreement.
Other international intergovernmental organizations
Organization for Economic Co-operation and Development
The forerunner of the Paris-based Organization for Economic Co-operation and Development (OECD) was the Organization for European Economic Co-operation, which was formed to administer American and Canadian aid under the Marshall Plan for reconstruction of Europe after the Second World War. Since it took over from the Organization for European Economic Co-operation in 1961, the OECD’s mission has been to build strong economies in its member countries, improve efficiency, expand free trade, and contribute to development in industrialized as well as developing countries.
Article 5 of the December 1960 Convention on the OECD empowers it to make recommendations to its members. A substantial number of texts dealing with the environment and pharmaceutical and chemical safety have been developed under OECD auspices. Other areas of OECD concern which have relevance to global public health are biotechnology, food, agriculture, and fisheries, biodiversity, nuclear energy, and ageing.
Regional intergovernmental organizations
Benelux Economic Union and Nordic Council
The health-related texts adopted by the Committee of Ministers of the Benelux Economic Union relate to food safety, while those formulated by the five-member Nordic Council (Nordic Committee on Medicines) relate to the registration of pharmaceuticals.
Council of Europe
Article 1, Statute of 5 May 1949, of the 41-member Council of Europe states that the Council’s aim is to ‘achieve a greater unity between members for the purpose of safeguarding and realising the ideals and principles which are their common heritage and facilitating their economic and social progress’. This aim is to be pursued ‘through the organs of the Council by discussion of questions of common concern and by agreements and common action in economic, social, cultural, scientific, legal and administrative matters and in the maintenance and further realisation of human rights and fundamental freedoms’. There is no explicit reference to health matters in this statute, but the Committee of Ministers has given a remit to various committees to deal with health issues.
In addition, 18 states of the Council of Europe are also members of the Partial Agreement in the Social and Public Health Field, concluded in 1959 and revised in 1996. The aim of the Partial Agreement public health activities is to protect consumers from contemporary health risks. Committees of experts provide the scientific basis for national and international regulations concerning products that have a direct or indirect impact on the human food chain (control of foodstuffs, nutrition, food safety, consumer health, food contact materials, flavouring substances), pesticides, pharmaceuticals, and cosmetics.
The Committee of Ministers has adopted many resolutions and recommendations dealing with matters related directly or indirectly to human health which are used by member states as the basis for corresponding national laws and regulations. They have addressed issues such as organ transplantation, protection of health and medical data, blood, and blood products, certain aspects of health care, genetic screening and testing, ethical, legal, and policy aspects of AIDS, food safety, pesticides, health professionals, mental health, and pharmaceuticals. Other instruments likely to have an impact on public health, at least in the member states of the Council of Europe, have been or are being developed under the auspices of the Steering Committee on Public Health.
Reference should also be made to the Convention on the Protection of Human Rights and Dignity with Regard to the Application of Biology and Medicine: the Convention on Human Rights and Biomedicine, opened for signature on 4 April 1997. A protocol to the Convention on the Prohibition of Cloning Human Beings was opened for signature on 12 January 1998 and came into force in December 1999. In addition, the Council of Europe is in the process of preparing further protocols to the Convention on Human Rights and Biomedicine which will address organ transplantation, biomedical research, the protection of the human embryo and fetus, and problems relating to human genetics.
The Brussels-based European Union has a mandate under various articles of the Treaty of Rome, the Single European Act, the Maastricht Treaty, and the Treaty of Amsterdam. Bélanger (1985) has analysed the enabling provisions of the Treaty of Rome, the Single European Act, and the Maastricht Treaty from the standpoint of their relevance to the protection of public health in the European Community.
Of particular relevance to contemporary public health protection in the European Union is the Treaty of Amsterdam, signed by the European Union’s political leaders on 2 October 1997 and entered into force 1 May 1999. The Treaty introduced major reforms for promoting high standards of public health. The Treaty of Amsterdam amended the Treaty Establishing the European Union by authorizing the organization to adopt measures directly aimed at ensuring a high level of human health protection. Pursuant to the new Article 152 of the Treaty Establishing the European Union, areas of co-operation between member states include not only diseases and major health scourges, but also all causes of danger to human health, as well as the general objective of improving health. The single Article 152 contained in Title XIII of the Treaty establishing the European Union comprises the following provisions.
A high level of human health protection shall be ensured in the definition and implementation of all Community policies and activities.
Community action, which shall complement national policies, shall be directed towards improving public health, preventing human illness and diseases, and obviating sources of danger to human health. Such action shall cover the fight against the major health scourges, by promoting research into their causes, their transmission, and their prevention, as well as health information and education.
The Community shall complement the Member States’ action in reducing drugs-related health damage, including information and prevention.
The Community shall encourage cooperation between the Member States in the areas referred to in this Article and, if necessary, lend support to their action.
Member States shall, in liaison with the Commission, coordinate among themselves their policies and programmes in the areas referred to in paragraph 1. The Commission may, in close contact with the Member States, take any useful initiative to promote such coordination.
The Community and the Member States shall foster cooperation with third countries and the competent international organisations in the sphere of public health.
The Council, acting in accordance with the procedure referred to in Article 251 and after consulting the Economic and Social Committee and the Committee of the Regions, shall contribute to the achievement of the objectives referred to in this Article through adopting:
measures setting high standards of quality and safety of organs and substances of human origin, blood and blood derivatives; these measures shall not prevent any Member State from maintaining or introducing more stringent protective measures;
by way of derogation from Article 37, measures in the veterinary and phytosanitary fields which have as their direct objective the protection of public health;
incentive measures designed to protect and improve human health, excluding any harmonisation of the laws and regulations of the Member States.
The Council, acting by a qualified majority on a proposal from the Commission, may also adopt recommendations for the purposes set out in this Article.
Community action in the field of public health shall fully respect the responsibilities of the Member States for the organisation and delivery of health services and medical care. In particular, measures referred to in paragraph 4(a) shall not affect national provisions on the donation or medical use of organs and blood.
Other provisions of the Treaty of Amsterdam also have important implications for public health. For example, Title VI of the Treaty Establishing the European Union, as amended by the Treaty of Amsterdam, contains new measures to combat drug trafficking in the region. The Treaty of Amsterdam also includes formal recognition of human rights, including a new Article 13 to the Treaty on the European Union which provides for measures to combat disability discrimination. Furthermore, the Treaty of Amsterdam promotes the consolidation of environmental policy, emphasizing sustainable development, the consideration of environmental aspects in all sectoral policies, and the simplification of Community decision making.
A series of resolutions and other instruments relating to public health have been adopted by the Council of the European Union or other Community institutions. Of particular interest is Resolution 94/C 165/01 on the Framework for Community Action in the Field of Public Health, adopted by the Council of the European Union (2 June 1994). This Resolution recommended the establishment of a Community framework to enhance co-operation and co-ordination between member states for the protection of public health. It further emphasized that priority should be given to the establishment of Community programmes in cancer, drug dependence, AIDS, and other communicable diseases, and health promotion, education, and training, as well as disease surveillance and the collection of reliable and comparable health data. Following on this Resolution, a number of new programmes have been established within the identified priority areas as well as others. Included are programmes on health monitoring (1997 to 2001), pursuant to Decision No. 1400/97/EC of the European Parliament and of the Council of the European Union (30 June 1997); health promotion, information, education, and training (1996 to 2000), pursuant to Decision No. 654/96/EC of the European Parliament and of the Council of the European Union (29 March 1996); and the prevention of drug dependence (1996– 2000), pursuant to Decision No. 102/97/EC of the European Parliament and of the Council of the European Union (16 December 1996).
In June 1999, the Council of the European Union adopted Resolution 1999/C 200/01 on the future of organizational action in the field of public health. Following on the entry into force of the Treaty of Amsterdam on 1 May 1999, this Resolution recommended review of the internal organization and working methods of the European Union to achieve better co-ordination of its public health policies. It also recommended key challenges that should be addressed within a programme of action in the field of public health, including emerging and re-emerging threats to health; major health scourges; genetic, behavioural, and environmental determinants of health; growing health inequalities; quality assurance; demographic changes and the impact of ageing; social, economic, and political factors; and advances in research and the proliferation of new technologies, in particular biotechnology.
European Free Trade Association
The European Free Trade Association, which now has four members (Iceland, Liechtenstein, Norway, and Switzerland), has been active in the field of pharmaceuticals, having been responsible for the Convention on the Mutual Recognition of Inspections in respect to the Manufacture of Pharmaceutical Products (better known as the Pharmaceutical Inspection Convention) and for the Scheme for the Mutual Recognition of Evaluation Reports on Pharmaceutical Products (better known as the PER Scheme). Many countries that are not members of the European Free Trade Association have adhered to this Convention, originally signed in October 1970.
Organization of African Unity
The Organization of African Unity, with headquarters in Addis Ababa, Ethiopia, was established on 25 May 1963, and the Charter of the Organization was signed on that occasion by 32 independent African states. The purposes of the Organization include promoting the unity and solidarity of the African States; defending the sovereignty of members; eradicating all forms of colonialism; promoting international co-operation having due regard for the Charter of the United Nations and the Universal Declaration of Human Rights; and co-ordinating and harmonizing member states’ economic, diplomatic, educational, health, welfare, scientific, and defence policies.
The treaty establishing the African Economic Union (Abuja, Nigeria, 3 June 1991) under the auspices of the Organization of African Unity includes Article 73 (Health), under which member states ‘agree to promote and increase cooperation among themselves in the field of health’. To this end, they are to ‘cooperate in developing primary health care, promoting medical research, particularly in the field of African traditional medicine and pharmacopoeia’. The Organization of African Unity adopted a Resolution on Bioethics (AHG/Res. 254 (XXXII)) in July 1996 and also served as the forum for the adoption of the Bamako Convention on the Ban of the Import into Africa and the Control of Transboundary Movement of Hazardous Wastes within Africa (30 January 1991).
Organization of American States
The Organization of American States, comprising 35 states from the region of the Americas and located in Washington, DC, is not typically thought of as having a strong mandate in international health law. Although the Organization of American States Charter does not specifically mention health as one of the purposes of the Organization, instruments developed under the auspices of the Organization of American States address regional public health concerns. Article 10(1) of the Additional Protocol to the Inter-American Convention on Human Rights in the Area of Economic, Social and Cultural Rights provides that ‘[e]veryone shall have the right to health, understood to mean the enjoyment of the highest level of physical, mental and social well-being’. Recent Organization of American States instruments with an important health component include the 1994 Inter-American Convention to Prevent and Punish Torture, the 1996 Inter-American Convention on the Prevention, Punishment and Eradication of Violence Against Women, and the 1998 Draft Inter-American Convention on the Elimination of All Forms of Discrimination Against People with Disabilities. The role of the Organization of American States in regional standard-setting is analysed by Gorove et al. (1999).
Pan American Health Organization
The Pan American Health Organization (PAHO), which serves as the WHO Regional Office for the Americas, administers the Pan American Sanitary Code, signed at Havana on 14 November 1924. Based in Washington, DC, in 1950 PAHO was recognized as a specialized Inter-American organization pursuant to the Charter of the Organization of American States.
The Constitution of PAHO specifies that the fundamental purposes of the Organization ‘shall be to promote and coordinate efforts of the countries of the Western Hemisphere’ to ‘combat disease, lengthen life, and promote the physical and mental health of the people’. The ‘objects’ in the current version of the Pan American Sanitary Code include the prevention of the international spread of communicable infections of human beings, the promotion of co-operative measures for the prevention of the introduction and spread of disease into and from the territories of the signatory governments, the standardization of the collection of morbidity and mortality statistics by the signatory governments, and the stimulation of the mutual interchange of information that may be of value in improving the public health and combatting the diseases of humans (PAHO 1991).
Reference should be made to Resolution CSP25.R15 adopted by the Pan American Sanitary Conference in 1998, instructing PAHO to ‘begin a study of the feasibility of preparing a regional convention against tobacco use’ and to ‘submit a progress report in 1999’. The legal authority of PAHO to adopt and promote conventions and the relationship of a regional convention on tobacco control to the proposed WHO Framework Convention on Tobacco Control is examined in the feasibility study commissioned by PAHO pursuant to Resolution CSP25.R15 (Gorove et al. 1999).
The principal non-governmental organizations whose statements and declarations have exerted an impact on national health law include the Council for International Organizations of Medical Sciences based in Geneva, the World Medical Association based in Ferney-Voltaire, France, the Commonwealth Medical Association based in London, the World Psychiatric Association, and various other organizations focusing on particular issues in the field of health care and/or bioethics. Recent products of these organizations include the Commonwealth Medical Association’s Guiding Principles on Medical Ethics in Human Rights (1995) and the Declaration on the Role of Medical Ethics and Woman’s Right to Health, including Sexual and Reproductive Health (1997). The following resolutions and statements were recently adopted by the General Assembly of the World Medical Association:
Statement on Family Planning and the Right of a Woman to Contraception (1996)
Statement on Professional Responsibility for Standards of Medical Care (1996)
Resolution on Cloning (1997)
Statement on Health Hazards of Tobacco Products (1997)
Proposal for a United Nations Rapporteur on the Independence and Integrity of Health Professionals (1997)
Resolution on Economic Embargoes and Health (1997)
Declaration of Ottawa on the Right of the Child for Health Care (1998)
Resolution on Medical Care for Refugees (1998)
Declaration on Nuclear Weapons (1998).
International health instruments as they affect certain sectors of health
The United Nations General Assembly has been active in the field of ageing and has adopted numerous programmes and resolutions in this field. Resolutions adopted during the last decade include:
1999 Resolution on the International Year of Older Persons
1998 Resolution on the International Year of Older Persons: Towards a Society for All Ages
1992 Proclamation on Ageing
1991 Resolution on the Implementation of the International Plan of Action on Ageing and Related Activities.
In 1996, the United Nations undertook a major reform of the intergovernmental organizational framework for addressing AIDS. A new Joint United Nations Programme on HIV/AIDS (UNAIDS) based in Geneva, commenced in January 1996. UNAIDS supersedes the WHO Global Program on AIDS, which itself replaced the WHO Special Programme on AIDS.
The new organization, UNAIDS, is a partnership effort of six institutional cosponsors: the United Nations International Children’s Emergency Fund (UNICEF), the United Nations Development Program, the United Nations Population Fund, UNESCO, the WHO, and the International Bank for Reconstruction and Development (World Bank).
The United Nations and its organs have adopted a series of international instruments on HIV/AIDS and HIV/AIDS-related discrimination, including Resolution 1999/49 on the Protection of Human Rights in the Context of HIV and AIDS, adopted by the Commission on Human Rights on 27 April 1999 and the Resolution on Discrimination in the Context of HIV or AIDS, adopted on 24 August 1995 by the United Nations Sub-Commission on Prevention of Discrimination and Protection of Minorities. In addition, the International Guidelines on HIV/AIDS and Human Rights were jointly issued by the Office of the United Nations High Commissioner for Human Rights and UNAIDS (UN 1998c). The guidelines are designed to provide an international framework for discussion of human rights and public health considerations in the context of HIV/AIDS at the national, regional, and international level. See Gostin and Lazzarini (1997) for a discussion of international human rights in the context of HIV/AIDS.
At the regional level, a substantial number of instruments relating to HIV/AIDS and HIV/AIDS-related discrimination have been adopted in Europe, starting with the Parliamentary Assembly of the Council of Europe Resolution 812 (1983) which, among other things, drew attention to various human rights issues raised by HIV/AIDS, including the dangers of discrimination against homosexuals and the need for respect for privacy of AIDS-related information.
The European Community has developed numerous texts establishing a regional strategy to address HIV/AIDS, including the European Parliament and Council Decision No. 1729/95 on the extension on the Europe against AIDS programme (19 June 1995) and Decision No. 647/96 (29 March 1996) on a programme of Community action on the prevention of AIDS and certain other communicable diseases within the framework for action in the field of public health (1996 to 2000). To facilitate global co-ordination, the Council of the European Union adopted Regulation No. 550/97 (24 March 1997) on HIV/AIDS-related operations in developing countries. The Organization of African Unity Declaration on the AIDS Epidemic of 19 June 1995 also established a regional approach to address the issue.
Since 1987 the WHO has developed a series of statements, recommendations, and the like, which have influenced the current configuration of HIV/AIDS legislation. Resolution WHA 41.24, adopted by the 41st World Health Assembly in May 1988, is an early instrument in the field. This Resolution specifically addressed the need to ‘protect the human rights and dignity of HIV-infected people and people with AIDS…and to avoid discriminatory action against and stigmatization of them in the provision of services, employment and travel’.
Significant international and regional documents in this field appear in a listing generated by UNAIDS (1999). UNAIDS has also recently produced a guide to United Nations human rights machinery (1997). See the section on blood and blood products below for a discussion of blood safety in the context of AIDS.
Dramatic advances in biomedical science during the past decade have triggered numerous initiatives at the international, regional, and non-governmental level, particularly in relation to human rights and human experimentation. Instruments that address bioethics and human experimentation are described below in the section on human experimentation.
Despite the extensive international activity in this area, there is still no legally binding global instrument that addresses the global implications of advances in genetic science. In November 1997, the UNESCO General Conference adopted the Universal Declaration on the Human Genome and Human Rights, the first global instrument to address a broad range of human rights and public health implications of advances in genetic science. The seven chapters of the Declaration cover such topics as human rights, research on the human genome, and co-operation between industrialized and developing countries. The Universal Declaration on the Human Genome and Human Rights was endorsed by the General Assembly in Resolution 53/152 of 9 December 1998.
At the regional level, the Council of Europe has developed the first legally binding regional instrument designed to preserve human rights through a series of principles and prohibitions against the misuses of biological and medical advances. The Council of Europe’s Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine was opened for signature on 4 April 1997 and entered into force on 1 December 1999. Article 2 of the Convention proclaims that ‘The interests and welfare of the human being shall prevail over the sole interest of society or science’. Substantive articles of the Convention address human rights in relation to genetic science, including free and informed consent, non-discrimination, scientific research, genetic counselling, and medical privacy. Notably, Article 13 of the Convention prescribes that interventions seeking to modify the human genome may only be undertaken for preventive, diagnostic, and therapeutic purposes and not to introduce modifications in the genome of any descendants. On 1 December 1999 a protocol to the Convention on the Prohibition of Cloning Human Beings entered into force. The Council of Europe has also developed a Draft Additional Protocol on the Transplantation of Organs and Human Tissues of Human Origin to the 1997 Convention on Human Rights and Biomedicine. The Draft Protocol was examined by the Steering Committee on Bioethics during its 15th meeting (7–10 December 1998) and authorized for publication for consultation purposes by the Committee of Ministers at its 658th meeting (2–3 February 1999). The Council of Europe is preparing additional protocols to the Convention on Human Rights and Biomedicine relating to organ transplantation, biomedical research, the protection of the human embryo and fetus, and problems relating to human genetics. The Council of Europe has recently issued a report on the Convention on Human Rights and Biomedicine (1998b).
On 8 July 1996, the Organization of African Unity adopted a Resolution on Bioethics (AHG/Res. 254 XXX.II). Finally, a Resolution on Bioethics and its Implications Worldwide for Human Rights Protection was adopted by consensus by the 93rd Inter-Parliamentary Conference of Inter-Parliamentary Union on 1 April 1995.
The WHO plays an important role in the ethical and public health discourse relating to biomedicine and has published guidelines on ethical issues in medical genetics and genetic services (WHO 1998d).
Fluss (1995, 1997a,b, 1998a) has recently examined the contributions of international law and international organizations to the field of bioethics and human rights. International human rights and bioethics is also examined by Le Bris et al. (1998) and Schwartz (1997). In addition, Taylor (1999) has analysed international standard setting in this field and UNESCO’s Universal Declaration on the Human Genome and Human Rights.
Recent advances in genetics have also led to the development of resolutions and declarations at the non-governmental level. Reference should be made to the 1994 Declaration of Ixtapa adopted by the Council for International Organizations of Medical Sciences; the 1996 Statement on the Principled Conduct of Genetics Research adopted by the Human Genome Organisation; the 1996 Draft International Convention on the Human Genome prepared by the International Bar Association; and the 1992 Declaration on the Human Genome Project adopted by the World Medical Association.
Following the successful cloning of a sheep, numerous initiatives related to research on cloning and human health have been put forth. These include the Council of Europe’s Additional Protocol on the Prohibition of Cloning Human Beings to the Convention on Human Rights and Biomedicine (1997), the World Medical Association Resolution on Cloning (1997), and the World Health Assembly Resolution 50.37 on Cloning in Human Reproduction (1997) and Resolution 51.10 on Ethical, Scientific and Social Implications of Cloning in Human Health (1998). The WHO has recently examined the implications of cloning for human health (WHO 1998e) and has developed draft guiding principles in this field (WHO 1999a).
Many international instruments exist in the area of blood safety. As early as May 1975, the 28th World Health Assembly adopted Resolution WHA 28.72 (Utilization and Supply of Human Blood and Blood Products), under which member states were urged, among other things, ‘to enact effective legislation governing the operation of blood services and to take other actions necessary to protect and promote the health of blood donors and of recipients of blood and blood products’ WHO 1994b). The WHO published Requirements for the Collection, Processing and Quality Control of Blood, Blood Components and Plasma Derivatives and the Consensus Statement on Screening of Blood Donations for Infectious Agents Transmissible through Blood Transfusion was developed by what was known as the Global Blood Safety Initiative and issued by the WHO in 1991.
Numerous instruments addressing blood safety have been adopted in Europe. In 1998 the Council of the European Union adopted Recommendation 98/463 on the suitability of blood and plasma donors and the screening of donated blood in the European Community. This Recommendation established standards for screening of blood donors, the screening of donations, and the recording of appropriate data to ensure the safety of blood and plasma donations and the transfusion process. Resolution 96/C 164/01 and Resolution 96/C 374/01, adopted by the Council of the European Union on 2 June 1995 and 12 November 1996 respectively, affirm the need to develop a strategy to promote self-sufficiency and safety of blood supplies in the European Community.
The Council of Europe has also developed and adopted a number of instruments dealing with the safety of blood and blood supplies. The Council of Europe Guide to the preparation, use and quality assurance of blood components (1999b) was adopted in 1995 as a technical appendix to Council of Europe Recommendation R (95) 15 on the preparation, use, and quality assurance of blood components and forms the basis for many national guidelines. Recommendation R (95) 14 addresses the protection of health of blood donors and recipients in blood transfusions. A recent Council of Europe publication reviews the history of blood transfusion in Europe and the legal framework in which it has developed (1998a).
The 1998 Convention on the Prior Informed Consent for Certain Hazardous Chemicals and Pesticides in International Trade, adopted under the auspices of UNEP and the Food and Agricultural Organization, is the most recent international instrument designed to promote health and environmental protection in international trade in chemicals and pesticides. The Prior Informed Consent Convention codifies a voluntary programme on chemicals operated by Food and Agricultural Organization and UNEP since 1989, based on the amended London Guidelines for the Exchange of Chemical Information in International Trade and the International Code of Conduct on the Distribution and Use of Pesticides (Prabhu 1993).
The Convention on the Prior Informed Consent for Certain Hazardous Chemicals and Pesticides in International Trade covers pesticides and industrial chemicals that have been banned or severely restricted for health and environmental reasons by participating parties. Currently, 29 chemicals are included in the Prior Informed Consent Convention procedure. This Convention allows governments that import banned or severely restricted chemicals to make informed regulatory decisions about future imports and allows the global community to monitor and control trade in toxic substances. It also mandates that export of a chemical can only take place with the prior informed consent of the importing party. It specifically excludes certain groups of chemicals, such as narcotic drugs, radio-active materials, wastes, chemical weapons, pharmaceuticals, foods, and food additives.
There have also been recent developments in the international regime governing the transboundary movement of hazardous wastes pursuant to the 1989 Basel Convention on the Transboundary Movements of Hazardous Wastes and their Disposal. The Basel Convention establishes a notice and consent system for the transboundary movement of hazardous wastes. Subject to certain agreements, States Parties are generally prohibited from trading in wastes covered by the Convention with non-Parties. In September 1995, the Third Conference of the Parties adopted an amendment to the Convention that, when ratified by three-quarters of the Parties, will greatly restrict hazardous wastes exports from developed to developing countries. In addition, the Basel Protocol on Liability and Compensation was adopted on 10 December 1999. Reference should also be made to the Bamako Convention, developed under the auspices of the Organization of African Unity.
Other instruments in this field currently under development include a Biosafety Protocol to the 1992 Convention on Biological Diversity, which entered into force on 29 December 1993. The Convention on Biological Diversity is the first international instrument to address conservation of biological diversity and the equitable sharing of its benefits. Responding to the mandate of Article 19.3 of the treaty, in November 1995 the Second Conference of the Parties to the Convention initiated negotiation of a protocol to address any threat to the conservation and sustainable use of biodiversity posed by living, genetically modified organisms. The core function of the proposed protocol will be to enable importing nations to learn in advance of the possible entry of genetically modified organisms and thereby have the opportunity to prohibit importation.
Intergovernmental negotiations concluded in December 2000 on the development of a Draft Protocol to the Convention on Long-range Transboundary Air Pollution on Persistent Organic Pollutants. UNEP defines persistent organic pollutants as ‘chemical substances that persist in the environment, bioaccumulate through the food web, and pose a risk of causing adverse effects on human health and the environment’.
Other existing instruments that exert an impact on national legislation in this area are the 1985 Vienna Convention for the Protection of the Ozone Layer and the 1987 Montreal Protocol on Substances that Deplete the Ozone Layer, both developed under the auspices of UNEP. The Montreal Protocol mandates that ratifying nations gradually reduce their consumption and production of certain ozone-depleting chemicals. The international ozone regime established by the Vienna Convention, widely considered a success story in international law making, is described at length by Benedick (1998).
Another highly significant instrument is the 1992 United Nations Framework Convention on Climate Change. The Climate Change Convention obligates all States Parties to develop inventories of their emissions (carbon dioxide, methane, nitrous oxide, and others) and includes a pledge by industrialized countries to aim to reduce their emissions to 1991 levels by the year 2000. The Climate Change Convention, however, did not impose a legally binding cap on greenhouse gas emissions. In December 1997, States Parties adopted the Kyoto Protocol to the Climate Change Convention, which establishes caps on the emissions of greenhouse gases from industrialized nations. The Kyoto Protocol also establishes market-based approaches for implementing these caps.
Concern for the health of children is expressed in numerous international instruments. The 1966 Covenant on Economic, Social and Cultural Rights provides for measures to be undertaken by States Parties to achieve full realization of the right to health, including in Article 12.2(a) ‘the provision for the reduction of the stillbirth-rate and of infant mortality and for the healthy development of the child’.
Certain conventions developed under the auspices of the International Labour Organization relate to the protection of children from harmful work, the establishment of minimum ages to begin employment, and required conditions of employment. In 1999 the International Labour Organization General Conference adopted the Convention Concerning the Prohibition and Immediate Action for the Elimination of the Worst Forms of Child Labour. This convention seeks to eliminate and prohibit the worst forms of child labour, including slavery and all practices similar to slavery such as the compulsory recruitment of children into armed forces.
The most significant international instrument addressing children’s health rights is the Convention on the Rights of the Child adopted by the United Nations General Assembly in Resolution 44/25 of 20 November 1989 and entered into force on 2 September 1990. Article 24 of the Convention, which addresses the children’s health rights, is examined by Pais (1997), UNICEF (1998), and van Buren (1995).
Another important instrument is the World Declaration and Plan of Action, adopted at the 1990 World Summit for Children, which includes targeted reductions in infant and child mortality as well as targeted increases in access to basic services for health to be achieved in children’s health by the year 2000.
At the regional level, the Additional Protocol to the American Convention on Human Rights in the Area of Economic Social and Cultural Rights (Protocol of San Salvador) contains several provisions relevant to children’s health rights. Article 15(3)(c) provides that States Parties undertake to ‘adopt special measures for the protection of adolescents in order to ensure the full development of their physical, intellectual, and moral capacities’. Garcia-Mendez (1998) has recently examined children’s rights in Latin America, and the Council of Europe (1996a,b) has published reports on children’s rights, including health rights, in Europe.
At the non-governmental level, the 1998 World Medical Association Declaration of Ottawa on the Rights of the Child to Health Care addresses a broad range of child health-care issues, including quality of care, informed consent and self-determination, confidentiality of medical data, child abuse, and health education.
Communicable disease control
Upon its establishment in 1948, the WHO inherited from its predecessor health organizations the responsibility for management of the international legal regime for the control of the international spread of disease. This regime was based on a series of international agreements and conventions dating from 1892. The revision and consolidation of these international sanitary conventions and agreements was undertaken by the WHO, starting in 1948. Regulations were first adopted by the Fourth World Health Assembly in 1951 as WHO Regulations No. 2, the International Sanitary Regulations (1951 Regulations).
The 1951 Regulations have been subject to a number of revisions, resulting generally from global improvements in knowledge and control of epidemic diseases. The 1951 Regulations were renamed the International Health Regulations in 1969. Last revised in 1981, the International Health Regulations are binding international law for all member states of the WHO (except Australia), subject to limited reservations by certain counties.
Fluss (1997b), retired chief of health legislation at the WHO, citing the WHO’s former Legal Counsel, Frank Gutteridge, has observed that:
The inconsistency of the earlier regime under the succession of conventions and agreements was apparent: none of these entirely replaced each other, they did not take account of new methods available for the control of the diseases they covered, and they were not framed to deal adequately with the greatly increased volume and speed of international traffic. For years, it has been pointed out that the need for the health control of international traffic could be obviated if the transmission of disease was stopped or reduced in the places where it principally occurred. However, this is a solution which cannot be obtained by an international instrument but only by improvement of the health conditions of the peoples of WHO’s member states. Any attempt to control diseases by the imposition of barriers at frontiers is by definition fortuitous, since frontiers are political and do not necessarily constitute a natural barrier to the spread of infection. To obtain effective control of the international spread of diseases required sound epidemiological services with reliable disease surveillance and the frank and rapid exchange of information among national epidemiological services.
Although a considerable improvement over earlier conventions and agreements, the International Health Regulations have come under detailed scrutiny by scholars and practitioners. Recent critical commentary on the efficacy of the current version of the International Health Regulations has included recommendations to enhance co-ordination with the World Trade Organization on trade-related aspects of infectious diseases (Plotkin and Kimball 1997) and to develop an effective monitoring institution for the International Health Regulations (Taylor 1997). Following the WHO’s adoption of a framework convention-protocol approach for global tobacco control, another commentator recommended applying a parallel international regulatory strategy for infectious disease control (Fidler 1999).
The WHO is revising the International Health Regulations into a working global alert system to adapt to changes in disease epidemiology and control and to substantial increases in the volume of international traffic (Gostin 1998). The WHO Secretariat expects that the revised International Health Regulations will be submitted for consideration for adoption at the May 2002 World Health Assembly. The WHO is consulting with the Members of the Committee on Sanitary and Phytosanitary Measures of the World Trade Organization to explore mechanisms that can minimize any conflict in the application of measures under the International Health Regulations and the Committee on Sanitary and Phytosanitary Measures Agreement (WHO 1999b). Both the Committee on Sanitary and Phytosanitary Measures Agreement and the International Health Regulations are concerned with minimizing interference with international trade and traffic because of unwarranted health measures.
In the administration of the regulations, the WHO has produced a number of publications for the use of its member states and others. The regulations are available in an ‘annotated’ edition which includes, in addition to the text of the articles, the format of international certificates of vaccination and other health documents required in international travel, as well as information and interpretations of the provisions. Information on the incidence of disease, including communicable diseases under surveillance, is published in the Weekly Epidemiological Record.
A number of provisions to protect the rights of disabled people are established in various United Nations and regional instruments. At the global level, the United Nations General Assembly Declaration on the Rights of Disabled Persons (1975) is an important early instrument in the field. In 1993, the General Assembly adopted the Standard Rules on the Equalization of Opportunities for Persons with Disabilities. Although they are non-binding, the Standard Rules reflect a political commitment on behalf of states to take action for the equalization of opportunities for people with disabilities and provide a basis for technical co-operation among states, the United Nations, and other international organizations.
The past decade has seen a rapid expansion in international standard setting in the field of disability by regional organizations. One of the most significant advances in international disability law is the Draft Inter-American Convention on the Elimination of All Forms of Discrimination Against Persons with Disabilities (1998), developed under the auspices of the Organization of American States. Although subject to a number of significant exceptions or exclusions, Article 3 of the Draft Convention mandates that States Parties adopt broad-based measures to eliminate discrimination against people with disabilities by both public and private entities. See also Article 18 of the Additional Protocol to the American Convention on Human Rights in the Area of Economic, Social and Cultural Rights (Protocol of San Salvador).
The Treaty of Amsterdam (1998) establishes significant measures to address the human rights of people with disabilities. It amends the Treaty on European Union to create a new Article 13 that prohibits discrimination on the basis of disability. The Intergovernmental Conference that negotiated the Treaty of Amsterdam sought an even stronger guarantee of the protection of the fundamental human rights of people with disabilities by including a declaration in the Final Act that states that the Community’s institutions must take account of the needs of people with disabilities when adopting measures to approximate member states’ legislation.
Important secondary sources on international disability law and policy include Leo et al. (1996), Cabrit (1996), and Despouy (1991).
The vast field of international environmental law is not typically thought of as part of international public health law. But, as Kiss (1998) has noted:
Admittedly, the convergence between human health and the environment was not obvious to everyone, at least not at the beginning. It should not be forgotten that the prime objective of the protection of the environment was the safeguard of nature, understood essentially as wild nature. The discovery of the problems of pollution affecting the oceans, continental waters and the atmosphere, now considered as natural resources—thus as elements perceived as being in a relationship with man—has broadened the horizons and fields of action for environmental protection.
Modern environmental hazards, including pollution of the seas, watercourses, lakes, and continental waters, air pollution, solid and hazardous waste accumulation and transfer, chemical and radiation hazards, climate change, transboundary air pollution, stratospheric ozone depletion, deforestation, and land degradation, to name a few, are widely recognized as having critical implications for global public health. In recent decades, the United Nations and its agencies, including the International Maritime Organization and UNEP, have taken the lead in bringing international environmental concerns to the attention of the world community and fostering global and regional co-operation through numerous binding and non-binding international instruments.
The conceptual link between the human health and environmental protection has been strengthened by the gradual recognition and integration of ‘sustainable development’ within the global environmental agenda. In 1987, the World Commission on Environment and Development defined ‘sustainable development’ as development that meets the needs of the present without compromising the ability of future generations to meet their own needs. UNEP, in Governing Council Decision 15/2 of May 1989, added that sustainable development requires ‘the maintenance, rational use and enhancement of the natural resource base that underpins ecological resilience and economic growth and ‘implies progress towards international equity’. The significance of sustainable development to international health law is aptly stated by Kiss (1998).
A decisive step was taken at the end of the 1980s with the fusion between environment and development, given that health problems have long been considered as constituting an aspect of development. Principle One of the Declaration adopted at the United Nations Conference on Environment and Development (Rio de Janeiro, 3–14 June 1992), in affirming that human beings are at the centre of concerns for sustainable development—a concept that expresses the integration of environment and development—thus seals the alliance between preoccupations and measures concerning, on the one hand, human health and, on the other, the environment.
Although some aspects of international environmental law are addressed in other parts of this chapter, this formidable field and its relation to public health cannot be fully covered here. For recognized scholarship in international and regional environmental law see Birnie and Boyle (2001), Weiss (1989, 1993), Weiss et al. (1992), Kiss and Shelton (1991), and Sands (1991).
The WHO collaborates with Food and Agricultural Organization in the administration of the Codex Alimentarius Programme, which was initiated to promulgate food standards to protect consumers’ health and ensure fair practices in the food trade. The standards prescribe requirements pertaining to food hygiene, food additives, food contaminants, food labelling, and so forth. The Codex Alimentarius consists of standards, recommended codes of practice, and guidelines. A Codex standard sets out the required qualities of food commodities, as sold, in objective terms. The Codex Alimentarius Commission recommends the standards to the governments of the member states of the Food and Agricultural Organization and the WHO. Codex Codes of Practice and Codex Guidelines are advisory instruments, covering such matters as good manufacturing practices and nutrition labelling. These are sent to governments as recommendations. The legal basis for the Codex Alimentarius operations and the procedures it is required to follow are published in the procedural manual, which is currently in its 10th edition (FAO/WHO 1999).
The Codex Alimentarius standards have recently been incorporated as binding standards in the international legal regime for food trade. Expanding international trade in food has markedly increased the risk for cross-border transmission of infectious diseases and has led to rapid expansion in international food safety standard setting (Kaferstein and Abdussalam 1998). The Uruguay Round of Multilateral Trade Negotiations (1994) led to a number of multilateral agreements that entered into force in 1995 and incorporated agriculture, for the first time, under the operational rules of the multilateral trading system. Of particular importance for the trade in food are the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) and the Agreement on Technical Barriers to Trade (TBT Agreement) (Miyagishima and Kaferstein 1998).
The World Trade Organization agreements provide detailed rules and standards for determining what phytosanitary and sanitary measures are permitted, based upon risk assessment and scientific support, including the Codex Alimentarius. The TBT Agreement, which deals with aspects of food labelling and claims relating to health and nutrition, is designed to encourage the development of international standards, technical regulations, and conformity assessment systems to facilitate trade. Standards established by the Codex Alimentarius are specifically recognized in Technical Regulations and Standards provisions contained in Article 2 of the TBT Agreement.
The Sanitary and Phytosanitary Measures Agreement is designed to promote free trade by ensuring that measures taken by countries to protect human, animal, or plant life or health are based on scientific evidence and are not used as pretexts to protect domestic markets from international competition. Central to the Sanitary and Phytosanitary Measures Agreement is the required use of established international standards, guidelines, or recommendations rather than domestic standards to promote international harmonization of measures. Regarding food safety, the Sanitary and Phytosanitary Measures Agreement specifically incorporates the standards, guidelines, and recommendations established by the Codex Alimentarius Commission.
The adoption of the Codex Alimentarius standards as norms for the purposes of the Sanitary and Phytosanitary Measures and TBT Agreements is of considerable significance: the Codex Alimentarius standards have become a central component of the legal framework within which world food trade is facilitated (FAO/WHO 1999). The implications of the World Trade Organization regime for food safety have recently been examined by Charnovitz (1997, 1998).
The Rome Declaration on World Food Security, adopted at the 1996 World Food Summit organized by the Food and Agricultural Organization reaffirms the ‘right of everyone to safe and nutritious food, consistent with the right to adequate food and the fundamental right of everyone to be free from hunger’. Article 21 of the World Food Summit Plan of Action sets forth strategies and goals, amongst others, to improve the safety of the food supply.
Eide has extensively examined the relationship between nutrition and human rights (Eide et al. 1984, 1996).
It is not possible within the confines of this chapter to describe fully the food safety instruments developed by the European Community, primarily in the form of directives. However, Council Directive EC/222 (23 April 1990), as amended, on the deliberate release into the environment of genetically modified organisms is particularly noteworthy. Part C of the Directive establishes a Community procedure enabling the competent authority of a member state to give consent to placing products consisting of genetically modified organisms on the market.
There have been major developments in international standards for trade in health services in the past 5 years. With the conclusion of the Uruguay Round of Trade Negotiations and the establishment of the World Trade Organization, the World Trade Organization Member States adopted the General Agreement on Trade in Services (GATS), which has significant implications for health services. GATS is the first multilateral agreement to provide legally enforceable rights to trade in all services, subject to certain exceptions, including services provided in the exercise of governmental authority.
Although still relatively modest, trade in health-care services is growing rapidly and has considerable potential as a foreign-exchange earner for developing countries (Kinnon 1998; UNCTAD/WHO 1998). GATS also has potentially wide-ranging ramifications for international health services, as it addresses every possible means of supplying a service, including the right to set up a commercial presence. Health services sectors addressed by GATS include foreign direct investment in the health sector; health-care services for those who travel abroad for treatment: telemedicine; services provided abroad by expatriate health personnel; and medical training of foreign students. The World Trade Organization has recently published a document analysing the health services implications of GATS (WTO 1998b). Bettcher et al. (2000) have also recently examined the implications of the World Trade Organization regime for trade in health services.
Of all the topics covered in this chapter, human experimentation may well be the area that has attracted the largest number of international efforts to address the ethical and legal dimensions. Perhaps the best-known formulation is that of the International Covenant on Civil and Political Rights (1966), Article 7 of which proscribes that ‘no one shall be subjected without his free consent to medical or scientific experimentation’.
The 1947 Nuremberg Code, which was enumerated as part of a judgment at the trial of Nazi doctors in post-Second World War Germany, was the first international code to establish ethical standards for human experimentation. The principles of the Nuremberg Code have been embodied in many subsequent codes governing medical ethics and biomedical research. Numerous intergovernmental and non-governmental organizations have addressed issues surrounding medical and scientific experimentation, notably the World Medical Association in the Declaration of Helsinki (1989), the Council for International Organizations of Medical Sciences and the WHO in the International Guidelines for Ethical Review of Epidemiological Studies, and the WHO in the Guidelines for Good Clinical Practice for Trials on Pharmaceutical Products. The Declaration of Helsinki has recently been examined by Fluss (1999a).
Reflecting developments in biomedical research and bioethics over the past decade or so, recent international, regional, and non-governmental instruments have focused on human experimentation in the context of genetics research. Such instruments include UNESCO’s 1997 Declaration on Human Rights and the Human Genome, the Council for International Organizations of Medical Sciences’ 1993 International Ethical Guidelines for Biomedical Research Involving Human Subjects, and the Council of Europe’s draft Protocol on Biomedical Research to the Convention on Human Rights and Biomedicine. The WHO has also addressed human experimentation in the Proposed International Guidelines on Ethical Issues in Medical Genetics and Genetic Services (WHO 1997b).
Human experimentation is also addressed in the field of humanitarian law and prohibited by numerous provisions of the 1949 Geneva Convention and the 1977 Protocols:
Convention (I) for the Amelioration of the Condition of the Wounded and Sick in Armed Forces in the Field
Convention (II) for the Amelioration of the Condition of the Wounded, Sick and Shipwrecked Members of Armed Forces at Sea
Convention (III) Relative to the Treatment of Prisoners of War
Convention (IV) Relative to the Protection of Civilian Persons in Time of War
Protocol Additional to the Geneva Conventions of 12 August 1949, and relating to the Protection of Victims of International Armed Conflicts (Protocol I)
Protocol Additional to the Geneva Conventions of 12 August 1948, and relating to the Protection of Victims of Non-International Armed Conflicts (Protocol II).
Many concepts and ideas that have arisen in the framework of human experimentation have been widely accepted in other areas of human health. Specifically, reference should be made to the 1978 Belmont Report, prepared by the United States National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research, which consists of a set of ethical principles and guidelines for the protection of human subjects of research. These principles, well described by Gillon (1994), have been formulated and applied in different contexts. For example, Last (1992) has formulated them as follows in the context of public health, rather than biomedical research:
respect for autonomy means concern about human dignity and freedom, the fundamental rights of the individual
non-maleficence is the principle of not harming, derived from the ancient maxim primum non nocere (first do no harm); this may have had greater force in former times when medical care was often hazardous, but it remains relevant today
beneficence is the principle of doing good, which members of the professions related to public health practice often believe to be the main function of health care
justice in the ethical sense means natural justice, distributive justice—fairness, equality, and impartiality.
The Nuremberg Code and its significance for the contemporary framework for international standards on medical ethics and human experimentation has been examined in a collection of essays edited by Annas and Grodin (1992). In addition, reference should be made to a symposium edited by Dickens et al. (1991) and to Fluss (1998b) for national and international ethical guidelines for research on human populations.
Infant feeding and nutrition
In 1981 the World Health Assembly adopted the International Code of Marketing of Breast-milk Substitutes in the form of a recommendation under Article 23 of the WHO Constitution. The aim of the code is to contribute to the provision of safe and adequate nutrition for infants by protecting and promoting breast feeding and by ensuring the proper use of breast-milk substitutes when these are necessary, on the basis of adequate information and through appropriate marketing and distribution.
The Convention on the Rights of the Child (1989) recognizes the role of breast feeding in infant nutrition. Article 24(e) of the Convention specifies that State Parties shall take appropriate measures to ‘ensure that all segments of society, in particular parents and children, are informed, have access to education and are supported in the use of basic knowledge of child health and nutrition, the advantages of breast feeding, hygiene and environmental sanitation and the prevention of accidents’. UNICEF has sought to operationalize the International Code of Marketing Breast-milk Substitutes by promoting it as a practical mechanism to fulfil State obligations under Article 24(e) with respect to State Parties that have ratified the Convention on the Rights of the Child (UNICEF 1997). In 1991, WHO and UNICEF launched the Baby-Friendly Hospital Initiative, a global advocacy campaign to encourage hospitals to adhere to measures to promote breast feeding.
The 1992 World Declaration on Nutrition and Plan of Action for Nutrition, products of the International Conference on Nutrition, reaffirmed the role of breast feeding in infant nutrition. Article 30 of the Plan of Action, adopted by 159 states, sets forth a detailed list of measures to promote breast feeding.
Difficulties in implementing the International Code of Marketing Breast-milk Substitutes and in promoting breast feeding are widely recognized (IGBM 1997). According to the WHO’s Global Data Bank on Breast-Feeding, which covers 94 countries and 65 per cent of the world’s infant population, only 35 per cent of infants worldwide are exclusively breast-fed at some point between birth and 4 months (WHO 1997a).
Shubber has recently published a comprehensive book on the International Code of Marketing Breast-milk Substitutes (1998).
Perhaps the most important recent text at the global level is the Principles for the Protection of People with Mental Illness and the Improvement of Mental Health Care, adopted by United Nation General Assembly Resolution 46/119 of 17 December 1991. One of the Principles (23) provides that ‘States should implement these Principles through appropriate legislative, judicial, administrative, educational and other measures’. At the European level, an important instrument in the field is Recommendation R (83) 2 of the Committee of Ministers of the Council of Europe (adopted on 22 February 1983) ‘concerning the legal protection of persons suffering from mental disorder placed as involuntary patients’. On 12 April 1994, the Parliamentary Assembly of the Council of Europe adopted Resolution 1235 (1994) on psychiatry and human rights which affirms, ‘the time has come for the member states of the Council of Europe to adopt legal measures guaranteeing respect for human rights of psychiatric patients’.
The WHO has developed guidelines intended to assist countries in the development of mental health legislation and other measures to protect the human rights of people with mental disabilities. These documents include Guidelines for the Promotion of the Rights of Persons with Mental Disorders (WHO 1995a) and Mental Health Care Law: Ten Basic Principles (WHO 1996a).
At the non-governmental level, provisions that may be useful in the development of mental health legislation are also contained in the Declaration of Madrid, approved by the General Assembly of the World Psychiatric Association on 25 August 1996.
Narcotics and psychotropic substances
There is a complex international regime governing narcotic and psychotropic substances. The three major global treaties in the field are the 1961 United Nations Single Convention on Narcotic Drugs and the 1972 Protocol amending that Convention; the 1971 United Nations Convention on Psychotropic Substances; and the 1988 United Nations Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances. The International Narcotics Control Board, an independent and quasi-judicial control organ established by the 1961 Single Convention on Narcotic Drugs, is the primary implementing agency of the United Nations narcotics conventions.
The three major United Nations drug control treaties are complementary. The 1961 Single Convention on Narcotic Drugs and the 1971 Convention on Psychotropic Substances are intended to ensure the availability of narcotic drugs and psychotropic substances for medicinal and scientific purposes and to prevent their distribution through illicit channels. These two treaties also include general provisions on illicit trafficking and drug abuse. The 1988 Convention Against the Illicit Traffic in Narcotic and Psychotropic Substances provides for comprehensive measures against drug trafficking, including the establishment of internationally recognized criminal offenses relating to drug trafficking and money laundering that are to be criminalized under the domestic laws of the parties to the Convention. It also provides a framework for international co-operation through, amongst other measures, extradition of drug traffickers, controlled deliveries, and transfer of proceedings. The Convention further requires that States Parties enact broad-based domestic laws providing for the confiscation of drug proceeds or instrumentalities used, intended to be used, or derived from the drug trafficking activities. In 1998 the United Nations published an official commentary on the 1988 Convention to assist states in interpreting and implementing the Convention (UN 1998a). The 1988 Convention and its implementation by States Parties is reviewed by Gurule (1998).
To assist States in giving effect to the United Nations drug control conventions, the United Nations International Drug Control Programme in Vienna has developed relevant model legislation on matters ranging from the classification of narcotic drugs to drug trafficking and international co-operation for civil and common law systems (UNDCP 1999).
In Resolution 51/64 of 12 December 1996, the General Assembly called for a special session to consider the fight against illicit narcotic drugs and psychotropic substances and related activities, and to propose new strategies, methods, practical activities, and specific measures to strengthen international co-operation in addressing the problem. At the General Assembly’s 20th special session on countering the world drug problem, held on 8 to 10 June 1998, states adopted, without a vote, a Political Declaration, a Declaration on the Guiding Principles of Drug Demand Reduction, and a Resolution on Measures to Enhance International Cooperation to counter the world drug problem.
The WHO plays an important role in the implementation of United Nations psychotropic and drugs conventions by providing expertise in updating the list of drugs of abuse under the 1961 and Single Convention on Narcotic Drugs and the 1971 Convention on Psychotropic Substances.
Recent initiatives in Europe in this field include Decision 102/97/EC of the European Parliament and of the Council of the European Union (16 December 1996) adopting a programme of Community action on the prevention of drug dependence within the framework for action for public health (1996 to 2000); and Regulation 2046/97 of the Council of the European Union on North–South co-operation in the campaign against drugs and drug addiction.
Nuclear safety and radiation protection
Modern nuclear technology creates public health risks for all states: every state is potentially affected by the risk of radio-active contamination and the long-term health hazards resulting from radiation exposure. It is not possible within the confines of this chapter to discuss in full the numerous international and regional conventions and texts addressing nuclear energy and safeguards.
Both the United Nations and the International Atomic Energy Agency are primary actors in nuclear safety and radiation protection. The 1968 Treaty on the Non-Proliferation of Nuclear Weapons is intended to prevent the spread of nuclear weapons and weapons technology, to foster the peaceful uses of nuclear energy, and to further the goal of achieving general and complete disarmament. The treaty establishes a safeguards system under the responsibility of the International Atomic Energy Agency, which also plays a central role under the instrument in areas of technology and transfer for peaceful purposes. The Non-Proliferation of Nuclear Weapons Treaty, which was originally given a 25-year lifespan, was extended indefinitely in 1995 by the International Atomic Energy Agency Non-Proliferation of Nuclear Weapons Treaty Review and Extension Conference.
The central provision of the Non-Proliferation of Nuclear Weapons Treaty is Article III, which requires bilateral ‘full scope safeguards’ agreements with the International Atomic Energy Agency by all nuclear facilities of non-nuclear weapons states that are Non-Proliferation of Nuclear Weapons Treaty parties, and International Atomic Energy Agency safeguards in nuclear exports by any of its Parties. As of December 1998, 222 International Atomic Energy Agency safeguard agreements were in force with 138 states. In May 1997, the Board of Governors of the International Atomic Energy Agency approved an agreement to strengthen safeguards on peaceful nuclear activities. The new measures are designed to help the International Atomic Energy Agency detect undeclared nuclear activities, as well as to assist it in determining whether declared ones are being used for nuclear explosive purposes. The agreement, referred to as the Model Protocol, is in the form of a protocol to existing safeguards agreements between the International Atomic Energy Agency and individual states.
Article VII of the Non-Proliferation of Nuclear Weapons Treaty preserves the ‘right of any group of States to conclude regional treaties in order to assure the total absence of nuclear weapons in their respective territories’. Recent regional initiatives to develop nuclear-free zones include the 1996 Treaty on the Nuclear-Weapon Free Zone in Africa (Pelindaba Treaty) adopted 11 April 1996, and the Treaty on the Southeast Asia Nuclear-Weapon-Free Zone (Bangkok Treaty) adopted 14 December 1995 and entered into force on 27 March 1997. The Treaty of Tiateloloco, or the Treaty of the Prohibition of Nuclear Weapons in Latin America, was concluded in 1967 and therefore predates the Non-Proliferation of Nuclear Weapons Treaty. However, it is an example of a regional agreement envisioned by Article VII.
The most recent United Nations instrument in this field is the Comprehensive Test Ban Treaty of 1996. This Treaty, which has not yet entered into force, requires States Parties to prohibit and prevent nuclear weapon test explosions or any other nuclear explosions. To facilitate compliance, the Comprehensive Test Ban Treaty established an international organization, the Comprehensive Nuclear Test-Ban Treaty Organization, and a multifaceted verification regime.
A series of treaties designed to moderate the ultrahazarous risks of nuclear energy through international regulation, transboundary co-operation, and liability for damage have been developed and adopted under the auspices of the International Atomic Energy Agency, including the following:
1963 Vienna Convention on Civil Liability for Nuclear Damage
1980 Convention on Physical Protection of Nuclear Material
1986 Convention on Early Notification of a Nuclear Accident
1986 Convention on Assistance in the Case of a Nuclear Accident
1994 Convention on Physical Protection of Nuclear Material
1994 Convention on Nuclear Safety
1997 Joint Convention on the Safety of Spent Fuel Management and on the Safety of Radioactive Waste Management.
In addition, in September 1997, governments took a significant step in improving the liability regime for nuclear damage by adopting a protocol to the 1962 Vienna Convention on Civil Liability for Nuclear Damage and a Convention on Supplementary Compensation for Nuclear Damage.
Under Article III.A.6 of its Statute, the International Atomic Energy Agency is authorized to establish or adopt standards of safety in collaboration with the competent organs of the United Nations and the specialized agencies concerned. The Board of Governors of the International Atomic Energy Agency first approved basic radiation standards in 1962 and issued revised versions of those standards in 1967 and 1982. In a jointly sponsored 1994 project with the WHO, PAHO, the Food and Agricultural Organization, the International Labour Organization, and the OECD–Nuclear Energy Agency, the International Atomic Energy Agency approved the International Basic Safety Standards for Protection Against Ionizing Radiation and for Safety of Radiation Sources (IAEA 1995). The Standards are supplemented by many International Atomic Energy Agency guides and supporting documents.
The development of new international standards for radiation safety has been described by González (1994) as ‘the product of unprecedented co-operation’. It provides an almost paradigmatic example of how authoritative non-governmental bodies (and specifically the International Commission on Radiological Protection and the International Commission on Radiation Units and Measurements) influence United Nations entities in a process whose international endpoint is safety standards and whose general national endpoint is national legislation. The development of international safety standards for the management of radio-active wastes has been described by Warnecke and Saire (1994). In addition, the eminent scholar Paul Szasz (1970, 1991, 1992, 1994) has examined the role of the International Atomic Energy Agency and international instruments on nuclear safety and liability.
The numerous nuclear safety instruments adopted in the European region include European Council Directive 97/43/Euratom of 30 June 1997 on health protection of individuals against the dangers of ionizing radiation in relation to medical exposures and repealing Directive 84/466/Euratom; European Council Directive 89/618/Euratom of 27 November 1989 on informing the general public about health protection measures to be applied and steps to be taken in the event of a radiological emergency; and European Council Resolution of 8 June 1999 on the limitation of exposure of the general public to electromagnetic fields.
The key role in the development of international law in the field of occupational health has been played by the International Labour Organization. Conventions that have exerted a substantial influence on national legislation in this field as well as new conventions with relevance to occupational health include the following:
Radiation Protection Convention 1960 (No. 115)
Benzene Convention 1971 (No. 136)
Occupational Cancer Convention 1974 (No. 139)
Working Environment (Air Pollution, Noise and Vibration) Convention 1977 (No. 148)
Occupational Safety and Health Convention 1981 (No. 155)
Occupational Health Services Convention 1985 (No. 161)
Asbestos Convention 1986 (No. 162)
Chemicals Convention 1990 (No. 170)
Night Work Convention 1990 (No. 171)
Prevention of Major Industrial Accidents Convention 1993 (No. 174)
Part-Time Work Convention 1994 (No. 175)
Safety and Health in Mines Convention 1995 (No. 176)
Home Work Convention 1996 (No. 177)
Worst Forms of Child Labour Convention 1999 (No. 182).
In addition, there are many European Community directives on various aspects of occupational health.
A series of international instruments deal with various aspects of organ transplantation, with particular reference to measures to combat commerce in human organs. The first such measure dates from 1970, when the Committee on Morals and Ethics of the (international) Transplantation Society adopted a statement on the subject. In September 1985 the Council of the Transplantation Society proposed a series of guidelines for the distribution and use of organs from cadavers and living unrelated donors. In May 1978 the Committee of Ministers of the Council of Europe adopted Resolution R (78) 29 on ‘harmonisation of legislations of member states relating to removal, grafting and transplantation of human substances’ (sic). Numerous key issues in organ transplantation were addressed in the Final Text adopted by a Conference of European Health Ministers held in Paris on 16 to 17 November 1987, under the auspices of the then French Minister of Health and Family Affairs. Other important instruments are the Committee of Ministers 1997 Recommendation R (97) 16 on liver transplantation from living related donors and 1998 Recommendation R (98) 2 on the provision of haematopoietic progenitor cells.
The Council of Europe has prepared a Draft Additional Protocol on the Transplantation of Organs and Human Tissues of Human Origin to the 1997 Convention on Human Rights and Biomedicine. The Draft Protocol was examined by the Steering Committee on Bioethics during its 15th meeting (7 to 10 December 1998) and authorized for publication for consultation purposes by the Committee of Ministers at its 658th meeting (2 to 3 February 1999). This instrument is designed to define and safeguard the rights of organ and tissue donors, both living and deceased, and the rights of people receiving implants of organs and tissues of human origin. Article 2 limits the scope of the proposed treaty by specifically excluding organs and tissues removed from animals, blood and derivatives, reproductive organs and tissue, and embryonic and fetal organs and tissues (including embryonic stem cells). The transplantation of embryonic and fetal organs and tissues will be addressed in another draft protocol to the Convention being prepared on the protection of the human embryo and fetus.
Another regional initiative was the adoption of a Unified Arab Draft Law on Human Organ Transplants by the 12th session of the Council of Arab Ministers of Health (Khartoum, 14 to 16 March 1987).
The WHO has also been active in this field. The Guiding Principles of Human Organ Transplantation, which were adopted by the 44th World Health Assembly in May 1991 and other related activities, as well as relevant national legislation, have been published by the WHO (1991). In 1996, the WHO established a Task Force on Organ Transplantation to identify the medical, social, economic, ethical, and related issues involved in human organ transplantation. The work of the WHO Task Force is reviewed by Dickens (1998).
International efforts are also being made to address the ethical, legal, and public health dimensions of the rapidly moving field of xenotransplantation. Xenotransplantation involves the grafting of cell tissues or organs from non-human species into humans. The emphasis of the discussion on xenotransplantation has shifted from the rights and welfare of non-human source animals to deepening concern about the public health risk of transmission of disease (Daar 1999). In September 1997, for example, the Committee of Ministers of the Council of Europe adopted Recommendation R (97) 15 calling upon governments of member states to establish mechanisms for the registration and regulation of certain aspects of xenotransplantation to minimize the risk of transmission of diseases and infections. In 1999, the Parliamentary Assembly of the Council of Europe, in Recommendation 1399, called for the Committee of Ministers to work toward the development in all member states of a legally binding moratorium on clinical xenotransplantation and to consider the feasibility of elaborating a new protocol to the Convention on Human Rights and Biomedicine on xenotransplantation.
In 1997, a WHO meeting of global experts established a uniform set of recommendations on xenotransplantation consisting of technical and ethical guidelines to minimize the risk of infection, safeguard human dignity and human rights, and ensure animal welfare (WHO 1998f).
There have been major developments in the formulation of international standards in patients’ rights over the past decade, particularly in Europe. Emerging threats to the confidentiality of personal medical data resulting from the development of sophisticated biotechnology and medical information systems have hastened the elaboration of instruments designed to protect personal privacy and confidential medical information. For example, the Committee of Ministers Recommendation R (97) 5 to Member States on the protection of medical data, 13 February 1997, sets forth detailed standards for the collection, processing and confidentiality of medical data.
Other significant developments include the adoption of a Declaration on the Promotion of Patients’ Rights in Europe, endorsed by a WHO European Consultation on the Rights of Patients (Amsterdam, 28 to 30 March 1994), which has been published by the WHO (1994a, 1995b). The Amsterdam Declaration on the Promotion of Patients’ Rights recognizes the right of every citizen to respect, dignity, integrity, privacy, informed consent, confidentiality, care, and treatment. The Statement on the Promotion of Patients’ Rights was adopted by the European Forum of Medical Associations and the WHO in Stockholm 1 to 2 February 1996, and the 1996 Statement on Professional Responsibility for Standards of Medical Care was adopted by the World Medical Association.
In addition, in an April 1999 meeting organized by the WHO, the Nordic Council of Minsters, and the Nordic School of Public Health, a new European network on patients’ rights was launched by patients’ organizations, health professionals, and ministries of health in the 38 countries of the WHO European Region.
Fluss (1994a), Chapman (1997), and Zielinski (1994) have examined international patients’ rights issues.
Pharmaceuticals, medical devices, and cosmetics
A very large number of international texts deal with pharmaceuticals, medical devices, and cosmetics. The WHO has been active in the development of guidance to be used at the country level in the formulation of national laws and regulations dealing with medicinal drugs. The WHO Department of Essential Drugs and Medicines Policy develops and promotes international standards for safety, quality, and efficacy of biological and pharmaceutical products, and it disseminates drug regulatory information. In addition, the WHO Drug Action Programme supports countries in implementing policies and programmes to achieve the objectives of the revised drug strategy.
The Ethical Criteria for Medicinal Drug Promotion were endorsed by the World Health Assembly in a resolution adopted in May 1988, and in 1995 the WHO prepared Guidelines for Good Clinical Practice for trials on pharmaceutical products. In addition, the ninth WHO Model List of Essential Drugs was published in 1997 and work is in progress on the development of a WHO Model Formulary for Essential Drugs. In addition, the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce is subscribed to by some 140 member States.
The WHO has also been actively involved in the so-called ICH process (i.e. the convening of a series of International Conferences on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), which provides a forum for regulatory authorities and experts from the pharmaceutical industry of the European Union, Japan, and the United States to address scientific and technical aspects of the marketing authorization of pharmaceutical products (Idänpään-Heikkilä 1994).
WHO publications, the quarterly WHO Drug Information, and the monthly WHO Pharmaceuticals Newsletter, provide current information on drug development, drug regulation, and drug regulatory decisions. A recent WHO report set forth international guidelines and other recommendations to assist national drug regulatory authorities in the quality control of pharmaceutical products (WHO 1996b). The WHO has recently published a study on the impact of the World Trade Organization Trade-Related Aspects of Intellectual Property Rights Agreement on global access to drugs (WHO 1998a). Bettcher et al. have examined the implications of Trade-Related Aspects of Intellectual Property Rights Agreement on access to medical technologies and pharmaceuticals in developing countries (Bettcher et al. 2000). Tarabusi and Vickery (1998) have analysed globalization in the pharmaceutical industry.
Many directives dealing with pharmaceuticals have been developed under the auspices of the European Union, while the Council of Europe has developed a significant number of essentially non-binding recommendations dealing with pharmaceuticals. As mentioned previously, the European Free Trade Association is the intergovernmental organization responsible for the Pharmaceutical Inspection Convention, as well as subsidiary texts (including a scheme for the mutual recognition of evaluation reports on pharmaceutical products). A set of guidelines on good clinical trial practice is among the texts developed under the auspices of the Nordic Council (Nordic Committee on Medicines).
Significant European Union instruments include the Council Directive concerning medical devices (14 June 1993), the Council Resolution on the mutual recognition of the validity of medical prescriptions in member states (20 December 1995), the Council Resolution on medical plant preparations (20 December 1995), and the Council Resolution on generic medicinal products (20 December 1995). Recently, the European Commission has proposed the codification of a new European Parliament and Council Regulation on orphan medicinal products, drugs used for the diagnosis or treatment of diseases that occur in less than 5 per 10 000. The impact of new European authorization procedures has been analysed by Matthews and Wilson (1998).
Council of Europe resolutions in this field include Resolution AP (99) 1 on the classification of medicines which are obtainable only on medical prescription (superseding AP (95) 1); Resolution AP (96) 1 on the declaration of excipients present in pharmaceutical products (superseding Resolution AP (91) 1); Resolution AP (99) 2 on warning phrases for certain categories of medicines (superseding Resolution AP (92) 1); and Resolution AP (99) 1 on the classification of medicines which are obtainable only on medical prescription. In the field of cosmetics, the Council of Europe has published books addressing good manufacturing practices in cosmetics products (Council of Europe 1995, 1999a).
Refugees, detainees, and internally displaced people
A number of provisions designed to safeguard the health of people in detention or imprisonment are contained in various United Nations instruments, including the Standard Minimum Rules for the Treatment of Prisoners (1957, 1977); the Basic Principles for the Treatment of Prisoners (1990) (this text, adopted by the General Assembly, states that ‘prisoners shall have access to the health services available in the country [of detention] without discrimination on the grounds of their legal situation’); the Body of Principles for the Protection of All Persons under Any Form of Detention or Imprisonment (1988); the United Nations Rules for the Protection of Juveniles Deprived of their Liberty (1990); and the Principles of Medical Ethics relevant to the Role of Health Personnel, Particularly Physicians, in the Protection of Prisoners and Detainees against Torture, and Other Cruel, Inhuman or Degrading Treatment or Punishment (1982). The United Nations Center for Social Development and Humanitarian Affairs has compiled international standards and norms in criminal justice (1992).
At the European level, in 1998 the Council of Europe Committee of Ministers adopted Recommendation R (98) 7 to member states concerning the ethical and organizational aspects of health care in prison. In addition, Tomasevski (1992) has described various other European standards.
The core international instruments addressing refugees and access to health care are the 1951 United Nations Convention Relating to the Status of Refugees and its 1967 Protocol, which expanded the geographic and temporal coverage of the Convention. These instruments are described by Helton (1994). Langren (1999) has examined the protections of the United Nations Convention in relation to regional and bilateral treaties in the field. Amnesty International produced a manual on United Nations human rights mechanisms and refugees (Amnesty International 1997). At the non-governmental level, the Resolution on Medical Care for Refugees, adopted by the World Medical Association in 1998. The rights of refugees and international law are examined in a recent compilation of essays edited by Nicholson and Twomey (1999).
The protection of internally displaced people has recently risen to the fore of the global human rights agenda. Internally displaced people are described by the United Nations High Commissioner for Refugees as people who have been forced to flee their homes suddenly in large numbers, as a result of conflict, internal strife, systematic violations of human rights, or natural or manmade disasters; and who are in the territory of their own country. The estimated 25 million internally displaced people worldwide, also called ‘internal’ refugees, have traditionally fallen outside the legal foundation for humanitarian assistance and the mandates of refugee and relief organizations because they have not crossed a border (Cohen 1994).
Resolutions of the United Nations General Assembly and the Security Council have increasingly moved towards establishing an entitlement of humanitarian assistance for internally displaced people whose governments are unable or unwilling to provide assistance. In Resolution 45/100 of 1990, the General Assembly affirmed the importance of humanitarian assistance and access and endorsed the establishment of relief corridors to provide assistance to people in need. The role of the Security Council in implementing humanitarian assistance for internally displaced people is described by Henkin (1994).
Although United Nations resolutions have moved in the direction of recognizing the rights of the internally displaced, no specific treaties currently exist in this field. To clarify the international structure for the protection of internally displaced people, the Commission on Human Rights, in Resolution 50/195 of 22 December 1995, and the United Nations General Assembly in Resolution 1996/52 of 19 April 1996, requested the preparation of an appropriate framework for the protection and assistance of the internally displaced. In 1998, the Representative of the Secretary-General of the United Nations completed the Guiding Principles on Internal Displacement, a non-binding document designed to provide information and guidance on international human rights law and international humanitarian law relevant to internally displaced people (United Nations 1998b). Principle 7(2) proclaims that authorities undertaking displacements ‘shall ensure, to the greatest practicable extent … that such displacements are effected in satisfactory conditions of safety, nutrition, health and hygiene’. Principle 19 addresses the rights of wounded, sick, and disabled internally displaced people to medical care, the special health needs of women, and the prevention of contagious and infectious diseases, including HIV/AIDS.
The Programme of Action of the International Conference on Population and Development, adopted in Cairo on 13 September 1994, contains a formulation of reproductive rights and reproductive health. Principle 8 of that formulation states:
Everyone has the right to the enjoyment of the highest attainable standard of physical and mental health. States should take all appropriate measures to ensure, on a basis of equality of men and women, universal access to health-care services, including those related to reproductive health care, which includes family planning and sexual health. Reproductive health-care programmes should provide the widest range of services without any form of coercion. All couples and individuals have the basic right to decide freely and responsibly the number and spacing of their children and to have the information, education and means to do so. (UN 1994b)
The Beijing Declaration, produced by the Fourth World Conference on Women in September 1995, also addresses reproductive rights. Article 17 of the Declaration provides ‘The explicit recognition and reaffirmation of the right of all women to control all aspects of their health, in particular, their own fertility, is basic to their empowerment’. In addition, Article 12(1) of the Convention on the Elimination of all Forms of Discrimination Against Women guarantees women equal access to health care services, including family planning services and advice. Article 12(2) further provides that States Parties must ensure appropriate health services in connection with pregnancy, confinement, and the postnatal period.
The United Nations (1996) and the United Nations Population Fund (1997) have examined global reproductive rights and reproductive health (1996). In addition, Tomasevski (1994), and Issacs and Freedman (1992) provide an examination of international law and policy on reproductive rights.
The Council of Europe Convention on Human Rights and Biomedicine is the first treaty to address some of the implications of genetic advances for reproductive rights. Article 14 of the Convention prohibits the use of techniques of medically assisted procreation for the purpose of choosing a future child’s sex, except where serious hereditary sex-related disease is to be avoided. In addition, the Council of Europe is developing an additional protocol to the Convention Human Rights and Biomedicine on the human embryo and fetus.
At the non-governmental level, instruments relating to reproductive rights are contained in the 1997 Declaration on the Role of Medical Ethics and a Woman’s Right to Health, Including Sexual and Reproductive Health, produced by the Commonwealth Medical Association; the 1997 Recommendations on Ethical Aspects of Sexual and Reproductive Rights adopted by the International Federation of Gynecology and Obstetrics; the 1995 Statement on Ethical Aspects of Embryonic Reduction adopted by the 47th World Medical Assembly; the 1994 Recommendation on Donation of Genetic Material for Human Reproduction adopted by the International Federation of Gynecology and Obstetrics (FIGO) Committee for the Study of Ethical Aspects of Human Reproduction; and the 1996 International Planned Parenthood Federation Charter on Sexual and Reproductive Rights.
Fluss (1994b, 1997b) has reviewed some of the international instruments and texts that have addressed legal and ethical issues of reproductive rights. The WHO, in collaboration with the United Nations Development Programme, the United Nations Population Fund, and the World Bank Special Programme on Research, Development and Research Training in Human Reproduction, has also addressed the ethical aspects of fertility regulation methods.
Right to health
There are numerous provisions for health and health-related matters in international human rights instruments (Mann et al. 1994; Fluss 1999b). The principal international legal basis for the right to heath is found in the core instruments of international human rights law, the International Bill of Rights. The International Bill of Rights consists of the Universal Declaration of Human Rights (1948), the International Covenant on Economic, Social and Cultural Rights (1966), and the International Covenant on Civil and Political Rights (1966).
Article 25 of the Universal Declaration of Human Rights (1948) proclaims that:
Everyone has the right to a standard of living adequate for the health and well-being of himself and of his family, including food, clothing, housing and medical care and necessary social services, and the right to security in the event of unemployment, sickness, disability, widowhood, old age or other lack of livelihood in circumstances beyond his control.
The Universal Declaration does not guarantee a right to health per se, but a right to health incident to an adequate standard of living. To evidence the legal obligation necessary to advance the rights proclaimed in the Universal Declaration, the United Nations promulgated two treaties, the International Covenant on Civil and Political Rights (1966) (ICCPR) and the International Covenant on Economic Social and Cultural Rights (1966) (ICESCR). As Henkin has observed, these two treaties ‘legislate essentially what the Universal Declaration had declared’ (Henkin 1990).
The Universal Declaration of Human Rights provides the normative basis for the most significant United Nations instrument guaranteeing a right to health, the ICESCR. Article 12.1 of the Covenant provides for ‘the right of everyone to the enjoyment of the highest attainable standard of physical and mental health’. The ICESCR also provides, among other things, that each nation to the maximum extent of its resources, ‘undertakes to take steps’ to achieve the ‘highest attainable standards of physical and mental health’ for all individuals, without discrimination.
Article 12(2) of the Covenant identifies measures to be undertaken by member states to ‘achieve the full realization of this right’, including those necessary for:
the provision for the reduction of the still-birth rate and infant mortality and for the health development of the child
the improvement of all aspects of environmental and industrial hygiene
the prevention, treatment, and control of epidemic, endemic, occupational, and other diseases
the creation of conditions which would assure to all medical service and medical attention in the event of sickness.
Following the International Bill of Rights, the General Assembly and other organs of the United Nations have produced numerous declarations and treaties addressing the international right to health of particularly vulnerable populations, including women, children, and disabled and mentally impaired people. These instruments are discussed in elsewhere in this chapter.
The Vienna Declaration and Programme of Action, adopted by the World Conference on Human Rights (14 to 25 June 1993), includes passages that address health and health-related issues. The following passage is particularly noteworthy (UN 1993).
Everyone has the right to enjoy the benefits of scientific progress and its applications. The World Conference on Human Rights notes that certain advances, notably in the biomedical and life sciences as well as information technology, may have potentially adverse consequences for the integrity, dignity and human rights of the individual, and calls for international cooperation to ensure that human rights and dignity are fully respected in this area of universal concern.
The United Nations regularly publishes compilations of all international (universal and regional) instruments in the field of human rights. Many of the relevant texts are also reproduced in Brownlie (1992). Amnesty International (1999) and Fluss (1999b) have recently published extensive bibliographies on select aspects of health and human rights.
With respect to regional instruments, Brownlie (1992) points out that the European Convention on Human Rights (1950) is essentially concerned with political and civil rights, and it was in 1961 that the European Social Charter was adopted to ‘develop and protect social and economic rights’. The European Social Charter (Revised) entered into force on 7 January 1999. Item 11 of Part I of the new Charter states that ‘everyone has the right to benefit from any measures enabling him to enjoy the highest possible standard of health attainable’ and, in item 13, that ‘anyone without adequate resources has the right to social and medical assistance’. Of particular importance is Article 11 (the right to protection of health).
With a view to ensuring the effective exercise of the right to protection of health, the Contracting Parties undertake, either directly or in co-operation with public or private organizations, to take appropriate measures designed amongst others:
to remove as far as possible the causes of ill-health;
to provide advisory and educational facilities for the promotion of health and the encouragement of individual responsibility in matters of health;
to prevent as far as possible epidemic, endemic and other diseases.
The Charter includes provisions on the right to safe and healthy working conditions (Article 3), the right of children and young people to protection (Article 7), the right to social and medical assistance (Article 13), the right of employed women to protection of maternity (Article 8), and the right of physically or mentally disabled people to independence, social integration, and participation in the life of the community (Article 15).
In the Western Hemisphere, the principal human rights instrument is the American Declaration of the Rights and Duties of Man (1948), Article XI of which reads: ‘Every person has the right to the preservation of his health through sanitary and social measures relating to food, clothing, housing and medical care, to the extent permitted by public and community resources’.
There are no specific health provisions in the American Convention on Human Rights (1969), although its Additional Protocol in the Area of Economic, Social, and Cultural Rights (1988) includes a section on the right to health (Article 10).
Everyone shall have the right to health, understood to mean the enjoyment of the highest level of physical, mental and social well-being;
In order to ensure the exercise of the right to health, the States Parties agree to recognize health as a public good and, particularly, to adopt the following measures to ensure that right;
primary health care, i.e. essential health care made available to all individuals and families in the community;
extension of the benefits of health services to all individuals subject to the State’s jurisdiction;
universal immunization against the principal infectious diseases;
prevention and treatment of endemic, occupational and other diseases;
education of the population on the prevention and treatment of health problems; and
satisfaction of the health needs of the highest risk groups and of those whose poverty makes them the most vulnerable.
Other articles deal with the right to a healthy environment (Article 11), the right to food (Article 12), and the protection of the handicapped (Article 18).
The African Charter on Human and Peoples’ Rights (1981) includes the following Article 16.
Every individual shall have the right to enjoy the best attainable state of physical and mental health.
States Parties to the present Charter shall take the necessary measures to protect the health of their people and the ensure that they receive medical attention when they are sick.
The preamble to the WHO’s Constitution, the first international expression of a right to health, defines health as a ‘state of complete, physical, mental and social well-being and not merely the absence of disease or infirmity’. The preamble further declares that ‘[t]he enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being without distinction of race, religion, political belief, economic or social condition’.
Although there has been a proliferation of international and regional instruments proclaiming the right to health, none of these instruments has elaborated with legal specificity the scope of obligations and individual entitlements with respect to the right to health (Taylor 1992; Molinari 1998). Alston (1994) has put forward proposals on how the economic, social, and cultural rights set forth in the international covenant that addresses these rights could potentially become more effective.
The right to health is commonly viewed as implying a right to health services. Marmor (1991) suggests that ‘almost all of the twentieth century debate over the right to health in fact has addressed issues concerning not health per se but the distribution of access to medical care’. Others suggest that a requirement to provide healthy living conditions is extremely vague and impossible to satisfy fully and that the rights relating to health set out in the international instruments are expressed in terms too general for them to be invoked as international rules before a domestic judge (von Wartburg 1979; Auby 1981; Hersch 1986). Giesen (1994) analyses the implications of the right to health care (see also Leary 1994; Mann et. al. 1994).
The WHO definition has not gone without other criticism. Daniels (1983) has suggested that the inclusion of the reference to social well being amounts to the ‘over-medicalization’ of the domain of social philosophy.
To restore to the WHO definition the integrity of its purpose, the member states of WHO defined the concept and vision of Health for All, when the 30th World Health Assembly declared that the main social target of governments and the WHO in the coming decades should be ‘the attainment by all citizens of the world by year 2000 of a level of health that would permit them to lead a socially and economically productive life’. In the interpretation of this goal by governments and the WHO, the intention is that there is a health baseline below which no individuals in any country should find themselves, and that all peoples in all countries should have a level of health that would enable them to work productively and participate actively in the social life of the community in which they live.
Health for All was conceived as a process leading to progressive improvement in the health of people, not as a single finite target. It combines a set of strategies, plans of action, and managerial processes, with evaluation and monitoring, using indicators developed for this purpose (WHO 1981). The Global Strategy for Health for All by the Year 2000 relied on the concept of country-wide health systems based on primary health care as described in the report of the International Conference on Primary Health Care (WHO 1978). It proposed concerted action in the health and related socio-economic sectors following the principles of the Declaration of Alma-Ata, adopted in 1978 by the International Conference on Primary Health Care, which was jointly sponsored and organized by the WHO and UNICEF. The Declaration of Alma-Ata stated that primary health care was the key to attaining Health for All as part of overall development, and that the approach to attaining health development could be interpreted differently according to the social, economic, and health characteristics of each country.
In May 1995 the World Health Assembly, in Resolution WHA 48.16, requested the Director-General of the WHO to take the necessary steps to develop a new holistic global health policy.
Emerging from a 3-year consultative process, the 51st World Health Assembly, in May 1998, adopted a World Health Declaration stating that ‘changes in the world health situation require that we give effect to the Health for All Policy for the 21st century’. The Health for All Policy for the 21st century notes that although the twenty-first century brings with it new threats and new opportunities, new approaches to overcome them are also becoming available. The globalization of trade, travel, technology, and communication could yield substantial benefits, provided serious adverse effects are addressed. In particular, global environmental hazards, and the globalization and mass marketing of harmful commodities, such as tobacco, require urgent attention.
The foundational role of certain values is emphasized in the updated Health for All policy. These core values are recognition that the enjoyment of the highest attainable standard of health is a fundamental human right (‘the right to health’), continued and strengthened application of ethics to health policy, research, and service provision, implementation of equity-oriented policies and strategies that emphasize solidarity, and incorporation of a gender perspective into health policies and strategies. This policy approach emphasizes that these values are interlinked and should be incorporated into all aspects of health policy and strategy. The new policy for Health For All in the 21st Century succeeds the Health for All strategy launched in 1977, and will come into action fully within WHO member states and regions in 2002 to 2003. Health for All in the 21st Century is described by Antezana et al. (1998) and Yach (1996, 1997a, b).
In 1999 the WHO set in motion a process to begin multilateral negotiations on a new treaty to circumscribe the global rise and spread of the tobacco pandemic. If adopted and brought into force, the WHO Framework Convention on Tobacco Control will be the first legally binding convention developed under the auspices of the WHO.
In response to the globalization of the tobacco pandemic, in 1995 the 48th World Health Assembly adopted Resolution WHA 48.11 which, among other things, requested the Director-General to report to the 49th World Health Assembly on the feasibility of developing an international instrument for tobacco control. Reference should be made to the feasibility study commissioned by the WHO calling for the development of a framework convention-protocol approach to tobacco control (Taylor and Roemer 1996). On 30 November 1995, the Director-General submitted his report calling for the development of a framework convention-protocol approach to global tobacco control. In 1996, the 49th World Health Assembly, in Resolution WHA 49.17, requested the Director-General to initiate the development of a WHO Framework Convention on Tobacco Control.
In Resolution WHA 52.18 of May 1999, the 52nd World Health Assembly authorized a process leading to formal negotiations of the Convention and called upon member states to adopt the Framework Convention on Tobacco Control no later than May 2003. This Resolution established a Framework Convention on Tobacco Control Working Group to develop proposed draft elements of the Convention and complete its work by May 2000. It further established an intergovernmental negotiating body, which met for the first time in October 2000, to draft and negotiate the framework convention and possible related protocols.
The globalization of the tobacco pandemic and global control strategies is extensively described in Chapter 10.1. Reference should also be made to a number of recent articles that analyse the transnationalization of the tobacco pandemic and the potential role of the WHO Framework Convention on Tobacco Control and related protocols (Taylor 1996; Yach and Bettcher 1998b, 2000; Bodansky 1999; Joosens 1999; World Bank 1999; Taylor and Bettcher 2000).
In addition to the WHO framework convention process, a whole series of resolutions have been adopted by successive World Health Assemblies aimed at combatting smoking and other forms of tobacco consumption. These have been described in detail by Roemer (1993). Furthermore, a resolution adopted in October 1992 by the International Civil Aviation Organization addresses smoking restrictions on international passenger aircraft.
There have been various regional initiatives in tobacco control, including certain recommendations adopted under the auspices of the Council of Europe and a series of European Community directives as well as other instruments. Of particular importance is the 1998 Directive 98/43 of the European Parliament and the Council of the European Union on the approximation of the laws, regulations, and administrative provisions of the member states relating to the advertising and sponsorship of tobacco products. This Directive establishes measures gradually to phase out all direct tobacco advertising and promotion in the European Community. Mention should also be made of a series of resolutions on smoking and health issues adopted by the health ministers of the Arab States of the Gulf Area.
Trade and health
The conclusion of the Uruguay Round, marked by the Final Act (GATT 1994), transformed the General Agreement on Tariffs and Trade to a permanent organization, the World Trade Organization. The Multilateral Agreements establishing the World Trade Organization have been compared to a tricycle: ‘a driver (World Trade Organization), two large wheels (the thirteen multilateral agreements on trade in goods and the General Agreement on Trade in Services), and a smaller one, the Agreement on Trade-Related Aspects of Intellectual Property’ (Berrod and Gippini 1995). These agreements constitute a single undertaking (i.e. a single binding treaty), which must be accepted by members of the World Trade Organization. The World Trade Organization agreements represent a motor of trade liberalization in the global trading system, and a major force behind the globalization of trade in goods and services, information, and investment. Moreover, the global transformation of the world’s trading order intersects with global public health in several areas (Kinnon 1995).
With respect to public health, Article XX(b) under the General Exceptions of the General Agreement on Tariffs and Trade (1947), allows ‘each contracting party to set its human animal or plant life or health standards’ if these restrictions do not represent an ‘unjustifiable discrimination or a disguised restriction on international trade’. Under the single package of Multilateral Trade Agreements, Article XX (b) is part of GATT 1994, and in other multilateral agreements, for instance the Technical Barriers to Trade Agreement and the Agreement on Trade-Related Aspects of Intellectual Property similar provisions for the protection of human health and safety are included.
In several disputes on trade issues, Article XX(b) has been enlisted as a justification for restricting or barring trade. In 1990, Thailand referred to Article XX(b) in order to defend its import restrictions on cigarettes. The GATT dispute settlement Panel Report entitled ‘Thailand—Restrictions on Importation of and Internal Taxes on Cigarettes’ decided that ‘GATT consistent measures could be taken to control both the supply of and demand for cigarettes, as long as they were applied to both domestic and imported cigarettes’ without discrimination. In other words, comprehensive tobacco control measures, including excise tax increases and advertising bans, were permissible as long as they do not discriminate unduly between foreign and domestic products. The relationship between international trade law and tobacco control is described by Taylor et al. (2000).
Article XX(b) has also been referred to in other dispute settlement cases. For instance in 1991, under the old GATT dispute settlement procedure, Mexico complained that the United States could not embargo imports of tuna products from Mexico just because Mexican regulations on the method by which tuna was produced did not satisfy United States regulations. The United States Marine Mammal Protection Act sets standards within its jurisdiction for dolphin protection for fishing fleets catching yellowfin tuna. The GATT dispute settlement panel report found that trade action could not be taken by one country to enforce its own domestic regulations in another country, even if such measures were take to protect animal health. In the end, Mexico did not choose to pursue the case and the panel report was not adopted. Similarly, the United States prohibited imports of shrimp into the United States that were caught in a way which endangered sea turtles. The report released by the Appellate Body of World Trade Organization in October, 1998, stated that one World Trade Organization member could not ‘impose its domestic environmental regulations on another member as long as certain safeguards are met’. This report has also not been formally adopted. Such restrictions on the imposition of extraterritorial public health measures/standards, as exemplified by these two cases, would, presumably, also apply to the protection of human public health.
The protection of human health has also been the subject of the World Trade Organization Dispute Settlement Body case on ‘European Community Measures Concerning Meat and Meat Products (Hormones)’. In May 1996 the Dispute Settlement Body of the World Trade Organization established a panel on the request of the United States to investigate European Community measures regarding the hormone ban on United States bovine meat and meat products (WTO 1999d). Both the panel and the Appellate Body found that the hormones measures taken by the European Community violated the Agreement on Sanitary and Phytosanitary Measures (SPS Agreement) (WTO 1999e). Although this decision has not been readily accepted by the European Community, it clearly demonstrates the interface between global trade agreements and the protection of public health.
The globalization of food production and distribution, in conjunction with liberalization of world markets, has led to a ballooning of global food trade to US$266 billion in 1994, which represents an increase of 300 per cent over 20 years. With the growth of world food trade, the risks of infectious disease dissemination have increased accordingly. Therefore, the protection of human health is intimately linked to global trade in food and feedstuffs. International standards on food trade are discussed in the section on food safety in this chapter.
Another multilateral trade agreement with significant implications for public health is the Agreement on Trade-Related Aspects of Intellectual Property. This Agreement establishes minimum standards for governing the scope, availability, and use of intellectual property, including medical technologies and pharmaceuticals. The Trade-Related Aspects of Intellectual Property Agreement extends patent protection, including both product and process patenting, to a minimum of 20 years from the filing date. Under the Trade-Related Aspects of Intellectual Property Agreement, all members of World Trade Organization are given 1 year to fulfil their obligations under the agreement, developing countries are provided an additional 4-year grace period, plus an additional 5 years for countries that had not previously provided for patent protection. Least developed countries are provided a transitional period of 10 years. Discord has already erupted between some developed and developing countries over patent protection of pharmaceuticals, particularly in the context of HIV/AIDS, and other aspects of the Trade-Related Aspects of Intellectual Property Agreement. In a recent World Trade Organization Dispute Settlement Panel, India-Patent Protection for Pharmaceutical and Agricultural Chemical Products, the United States complained that India was in breach of its obligations under the Trade-Related Aspects of Intellectual Property Agreement. The panel concurred with the United States, concluding that India had failed to ensure adequate mechanisms for ensuring product patents for pharmaceutical and agricultural chemical interventions (WTO 1997b).
It is not possible within the confines of this chapter to cover the vast fields of arms control, peace, and security. Discussion is limited to contemporary international efforts to control the proliferation of particular types of weapons systems recognized as uniquely catastrophic for human health. In particular, global efforts to control nuclear weapons, biological weapons, chemical weapons, landmines, and excessively injurious conventional weapons is reviewed.
By eroding the traditional distinction between combatants and civilians, weapons of mass destruction, including biological, chemical, and nuclear weapons, have emerged as a significant public heath concern. International instruments relevant to nuclear non-proliferation are discussed in the section on nuclear safety and radiation protection above.
The most significant contemporary instrument relating to biological weapons is the 1972 Convention on the Prohibition of the Development, Prevention, and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction. The so-called Biological Weapons Convention prohibits the development or acquisition of biological agents or toxins, as well as weapons carrying them and means of their production, stockpiling, transfer, or delivery, except for prophylactic, protective, or other peaceful purposes. Biological weapons, which are agents designed to cause disease and death in humans, animals, and plants, span a wide range of potential infection causing organisms, promoted through various vectors and modes of dispersal. In 1994 an Ad Hoc Group was created to consider possible ways of strengthening the Convention. In 1996 the Ad Hoc Group was called upon to develop a verification protocol to the Biological Weapons Convention within 5 years in order to strengthen implementation of the Convention. The public health implications of biological weapons and efforts to regulate them are examined by Gould and Connell (1997).
Another class of weapons of mass destruction of significant public health concern are chemical weapons. Chemical weapons are poisonous or toxic compounds that are designed to kill or disable by direct effect on body organs and systems. Recognizing that existing treaties did not provide adequate safeguards to prevent the proliferation of chemical weapons, in January 1993 130 nations signed Chemical Weapons Convention. As of March 2000, 131 had ratified or acceded to the treaty. The Chemical Weapons Convention bans production, possession, or transfer of chemical weapons and requires destruction of existing weapons within 10 years after the treaty enters into force. An inspection/verification regime is included in the Convention’s provisions.
International initiatives have recently focused on the control of antipersonnel landmines. Landmines are a unique weapons system in that they are victim-activated and may continue to cause death and injury decades after being sown. In December 1997 122 States signed the Convention on the Prohibition of the Use, Stockpiling, Production and Transfer of Anti-Personnel Mines and their Destruction (the Ottawa Treaty). This instrument, which is significant for being the first treaty to ban an entire class of weapons already in widespread use, is examined by Thakur and Maley (1999).
A key instrument in the field of conventional weapons is the 1980 Convention on Prohibitions or Restrictions on the Use of Certain Conventional Weapons which May Have Been Deemed to be Excessively Injurious or to have Indiscriminate Effects (CCW), which entered into force on 2 December 1983. The CCW does not contain any prohibitions on the use of specific weapons. Rather, provisions on the prohibition or restrictions on the use of certain weapons are elaborated in protocols to the Convention. Article 4(3) of the CCW proscribes that only states that have expressed their consent to be bound by at least two of these Protocols at the time of deposition of its instrument of ratification, acceptance or approval, or of accession may be bound by the Convention. The Conventional Weapons Convention and the first three protocols were adopted by States Parties, by consensus, on 10 October 1980. Protocols to the Convention include: the 1980 Protocol on Non-Detectable Fragments (Protocol I) (entered into force 2 December 1983); the 1980 Protocol on Prohibitions or Restrictions on the Use of Mines, Booby-Traps and Other Devices as amended on 3 May 1996 (Protocol II) (entered into force, as amended, 3 December 1998); the 1980 Protocol on the Prohibitions or Restrictions on the use of Incendiary Weapons (Protocol III) (entered into force 2 December 1983); and the 1995 Protocol on Blinding Laser Weapons (Protocol IV) (entered into force 30 July 1998).
While the core instruments of international human rights law (the Universal Declaration, and the International Covenants on Civil and Political Rights and on Economic Social and Cultural Rights) declare that all people are entitled to human rights and fundamental freedoms without discrimination, international organizations have not, until recently, paid significant attention to issues of human rights affecting women, including health rights. The United Nations Commission on the Status of Women, a body established under the United Nations Charter in 1947, was until 1982 the only public international body devoted entirely to the pursuit of women’s human rights.
A major accomplishment of the Commission on the Status of Women is the development of the Convention on the Elimination of All Forms of Discrimination Against Women (CEDAW), adopted by the General Assembly in 1979 and ratified by 130 states in December 1993. Article 12(1) of CEDAW provides that ‘States Parties shall take all appropriate measures to eliminate discrimination against women in the field of health care in order to ensure, on a basis of equality of men and women, access to health care services, including those related to family planning’. The Committee on the Elimination of Discrimination Against Women, the body charged with monitoring the implementation CEDAW, has recently produced an extensive interpretation of Article 12 along with recommendations to governments (CEDAW 1999). On 6 October 1999 the General Assembly adopted an Optional Protocol to the Convention which creates a communications procedure to allow individuals and groups to submit complaints to the Committee against State Parties to the Protocol for grave or systematic violation of rights established by the Convention. The Optional Protocol has not yet entered into force.
Reference should also be made to the Beijing Declaration and Platform for Action adopted by the Fourth World Conference on Women, held in Beijing in September 1995 for an elaboration of women’s health rights. In 1996 the General Assembly, in Resolution 50/203, specifically endorsed the Beijing Declaration and the Platform for Action, and called upon bodies of the United Nations system to implement the Platform for Action.
Violence against women in both the public and private spheres has recently attracted a number of international initiatives. Both CEDAW and the World Conference on Women Platform for Action recognize the right of women to be free from violence. The Committee on the Elimination of Discrimination Against Women in its General Recommendation 19 defines gender-based violence as ‘violence directed against a women because she is a woman or that affects women disproportionately, as discrimination’. Such violence includes acts that inflict physical, mental and sexual harm or suffering, threats of such acts, coercion, and other deprivations of liberty (Llic and Corti 1997). Reference should also be made to the 1996 Inter-American Convention on the Prevention, Punishment and Eradication of Violence Against Women (Convention of Belem do Para), developed under the auspices of the Organization of American States.
Scholarly contributions in the field include Alfredsson and Tomasevski (1995), Cook (1994), and Schuler (1995).
To mark the 40th anniversary of the establishment of the WHO, the editors of the International Digest of Health Legislation organized a Round Table on the Future of International Health Law, which was published by the WHO in 1989. This consisted of lead contributions from Bélanger and Mikhailov as well as comments from five experts in the field.
In his contribution, Mikhailov was singularly forward-looking, expressing the view that international health law is a rapidly evolving branch of international law and commenting that:
Although this may be unrealistic at the present time, and indeed even ridiculous, I for my part am convinced that the day will come when international health law will contain rules aimed at eliminating … tobacco use … which cause(s) enormous damage to health. Efforts to combat these scourges are being carried out in certain countries with varying degrees of success. One could in fact envisage that these efforts be made global in character and that an international law framework be developed. This would be difficult to achieve at the present time but could become a reality one day. Certain actions could indeed be carried out forthwith, examples being the development of conventions prohibiting advertising for tobacco products.
This was written 10 years before the 191 member states of 52nd World Health Assembly adopted, by consensus and without objection, a resolution to set in motion a process leading to the adoption of a WHO framework convention on tobacco control.
Grad (1998) has observed:
The reach of public health law is as broad as the reach of the public health itself. Public health and public health law expand to meet the needs of our society. The scope and the reach of public health law have expanded enormously during the past fifty years and continue to expand today.
This chapter illustrates that the scope and depth of international health law has evolved dramatically in the last several decades and now encompasses increasingly complex concerns such as biotechnology, organ transplantation, and global trade in food, medicine, and health services. In addition, international health law now incorporates various other legal subjects, including environmental protection, arms control, and population control. The rapid development of binding international law and non-binding standards and guidelines endorsed and adopted by the world community provide a framework for global co-operation and co-ordination in an increasingly interdependent world.
Health development in the twenty-first century is likely to include expanded use of international norms, standards, and instruments. As the world becomes more interdependent, innovative global health development strategies are needed to address the increasingly complex and interrelated health problems. Globalization makes multilateral collective action, through the further development and refinement of international norms and standards, imperative to protect and promote world health.
Health development in the twenty-first century must take advantage of the opportunities afforded by global change and, at the same time, minimize the risks and threats associated with globalization so that the dramatic improvements in the health of the world’s population achieved in the twentieth century can be maintained and advanced in the twenty-first.
*The views expressed herein are those of the authors and do not necessarily reflect the views of the World Health Organization.
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