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LGD 2004 (1) - Yutaka Arai-Takahashi


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The World Health Organisation and the Challenges of Globalization


Yutaka Arai-Takahashi
Lecturer in International and Human Rights Law,
Kent Law School and Brussels School of International Studies,
University of Kent, UK

y.arai@kent.ac.uk

Abstract

This article critically appraises the WHO’s regulatory approach to control of infectious diseases. It focuses primarily on the International Health Regulations (IHR) in particular from the standpoint of vulnerable, developing countries. While being the most important legal instrument that the WHO has so far adopted, the IHR have been criticized, among other things, for their limited scope of application and the fact that the health measures which they provide for are based on an outmoded understanding of national sovereignty. The article seeks to evaluate whether the WHO’s first draft articles of the IHR, published in its Working Paper of 12 January 2004, can adequately meet challenges of both new and old but resurgent pathogens in the globalizing world. The author argues that, of the revisions proposed by the WHO, the establishment of a supervisory body operating a complaint-based procedure in relation to non-compliance would be the most significant means of enhancing the effectiveness of the IHR.

Keywords:Developing Countries, Globalization, International Health Law, International Health Regulations, Public Health Emergency, Review Committee, Transnationalism, Transnational Law, World Health Organisation

Author's Note

The author is grateful to Robyn Martin, John Harrington and the anonymous reviewers for their helpful comments on earlier drafts.


This is a refereed article published on 4 June 2004.

Citation: Arai-Takahashi, Y, 'The World Health Organisation and the Challenges of Globalization: A Critical Analysis of the Proposed Revision to the International Health Regulations', Law, Social Justice & Global Development Journal (LGD) 2004 (1), <http://elj.warwick.ac.uk/global/04-1/arai.html>. New citation as at 15/07/04: <http://www2.warwick.ac.uk/fac/soc/law/elj/lgd/2004_1/arai/>.


1. Introduction

It is trite to state that pathogens know no borders in the age of globalization. As can be seen from the bovine spongiform encephalopathy (BSE) crisis in the world since late 1990s and the avian flu outbreak in East Asia in 2004, accelerated cross-border trade and travel increases the chance of food-borne pathogens spreading across countries (Fidler, 1999a, p 197). The growing interdependence of a globalizing world economy highlights the need for converging national public health approaches to a complex range of contemporary health challenges (Taylor, 1999, pp 489-490). However, the globalization process also reveals the inability of developing countries to cope adequately with health challenges without the necessary health infrastructure. This predicament of vulnerable developing countries has been compounded by the ‘South-North health divide’ that impedes effective governance of global health concerns (Aginam, 2003, p 11).

This paper explores the regulatory approach of the World Health Organisation (WHO) to the challenge of disease and other global health risks, critically examining the revision of its International Health Regulations (IHR) against the background of the ‘transnational’ legal order of the contemporary world. The paper firstly deals with the adverse impact of globalization upon public health policies of developing countries in order to appraise the potential effectiveness of international health law. The paper proposes that the WHO’s regulatory strategies should tap the nascent ‘global health regime’ to facilitate equitable allocation of enhanced health standards across the world. With special needs of developing countries in mind, the author seeks to delineate a coherent conceptual framework to the WHO’s global health strategy based on international law.

2. Globalization, Developing Countries and International Health

Globalization presents the modern world with mounting challenges. The tendency of neoliberal globalization to merchandise not only human capital but also cultural and traditional products has a corrosive effect on the cultural diversity of humanity (Stern, 2000, p 249). The onslaught of alluring advertising by Anglo-Saxon transnational media corporations accelerates the process of westernisation, displacing traditional values and tastes with western substitutes and undermining the cultural identity of local populations in closely-knit communitarian societies (Muchlinski, 1995, p 97). The transformation of dietary and social habits of traditional Asian and African societies into western (or Anglo-Saxon) lifestyles has resulted in the greater consumption of fatty, salty and sugary diets and beverages, and tobacco and alcohol (Gaius, 2003, p 25; and Taylor, 1999, pp 489-490). Such transformation entails the risk of increased exposure to potential carcinogens and toxins. It has already led to an exponential rise in non-communicable diseases such as diabetes, cardio-vascular disease and lung cancer in developing countries (Fidler, 1999a, pp 195-196 and 200-202). The WHO has acknowledged global issues of unbalanced nutrition, food safety and food security, all of which affect rich and poor countries alike. The WHO’s assertive stance can be glimpsed through its Global Strategy on Diet, Physical Activity and Health to be presented to the World Health Assembly in May 2004. Further, when reviewing the Codex Alimentarius in 2003,[1] the World Health Assembly encouraged the greater participation of developing countries in the process of international food standard-setting.[2]

The surge in non-communicable disease is straining public health infrastructures in developing countries, which endure ‘double burdens’ in relation to health policies. It has compounded strategies to overcome both under-nutrition and poverty, and the threat of infectious disease.[3] The majority of developing countries have yet to experience the epidemiological transition akin to that undergone by industrialised countries, namely the transition from successful eradication of most infectious disease to the sharp increase in non-communicable disease. Many developing countries continue to suffer from communicable diseases ranging from water-borne diseases such as cholera, to antimicrobial resurgence of malaria, pneumonia and tuberculosis, while confronted with challenges posed by the HIV/AIDS pandemic[4] and outbreaks of severe acute respiratory syndrome (SARS).

The WHO’s global health strategy for developing countries needs to be both preventive and pro-active. It must shape systemic and integrated policy approaches to underlying causes of ill-health and risks to health, effectively linking systems of surveillance, early detection, and the monitoring of national compliance. The WHO’s World Health Report 2002, Reducing Risks, Promoting Healthy Life,[5] marks a milestone in recognising the importance of adopting risk reduction policies, including greater support for scientific research, improved surveillance systems and better access to global information, in relation to such risk factors as underweight, obesity, unsafe water, poor sanitation and hygiene, unsafe sex, iron deficiency, as well as indoor smoke from solid fuels.[6]

3. Trans-Nationalism and International Health Law

The current framework of international health law is unable to respond to the demands of citizens in developing countries beset by inadequate health infrastructure, the perennial poverty that aggravates heath risks, and the threats of both new pathogens and resurgent microbial organisms. The retreat of the notion of states as the only determinative vehicle of identity, loyalty and solidarity in an age of globalization, along with burgeoning institutionalisation and regionalisation (Falk, 2002, p 372) reinforces the argument in favour of a trans-national health regime founded on the objective of maximising global health standards, one of the prominent global public goods. Such a regime should be anchored in the coordinated interplay between traditional subjects of international law, such as states and international organisations, and emerging non-state actors such as NGOs and transnational corporations (TNCs). Increased cooperation among international organisations whose mandate relates to health is also needed to enhance efficacy in enacting and administering relevant legal instruments. The greater role that a plethora of NGOs and foundations play in the fight against disease and root causes of disease such as poverty and ‘underdevelopment’ is indicative of an emerging international regime designed to tackle health issues of universal concern.[7] The Executive Board of the WHO has tacitly recognised the importance of such a transnational health regime. It recently invited NGOs that have official relations with WHO to be observers at an intergovernmental working group reviewing the draft IHR.[8]

Both liberalism (Slaughter, 1995 and 1997) and ‘regime theory’ (Krasner, 1982) provide theoretical support for establishing a transnational, overarching framework to enhance the operational effectiveness of the WHO’s regulatory strategy. Krasner (1982, p 186) defines international regimes as ‘sets of implicit or explicit principles, norms, rules, and decision-making procedures around which actors’ expectations converge in a given area of international relations’. Through the creation of working groups and a common set of rules, this loosely-linked ‘global health regime’ serves to enhance effective enforcement of, and compliance with international law. Regime theory posits knowledge as one of the variables determinative of international cooperation and regime formation (Krasner, 1982, pp 203-204). Stein’s argument that new knowledge of disease and other health risks, including the discovery of preventive means against those risks, creates a basis for convergent state behaviour (Stein, 1982, pp 320-321), is useful for WHO’s search for regulatory policy drawing on evolving scientific knowledge. Further, a global health regime can be viewed as a constructive projection of converged national interests in health, provided that an assertive regulatory approach by the WHO and closer coordination among transnational participants are designed to channel the special needs of developing countries into a viable decision-making process.

4. WHO’s Regulatory Approach to Global Health Concerns

4.1. WHO’s Neglect of International Health Law

Until the adoption of its first treaty, the International Framework Convention for Tobacco Control of 2003,[9] the WHO made no serious attempt to codify or progressively develop treaties bearing on global health issues. The reluctance of the WHO to draw on both its law-making power and the language of human rights (especially, the right to health),[10] in comparison with other specialized agencies of the UN such as International Labour Organisation (ILO), United Nations Educational, Scientific and Cultural Organisation (UNESCO) and United Nations Environment Programme (UNEP), has become the focus of criticism by western commentators (Taylor, 1992, p 303).

The WHO has preferred to monitor health by using non-regulatory and non-coercive means such as persuasion, and voluntary compliance, as well as soft-law instruments such as recommendations, guidelines, principles and codes of practice.[11] The WHO’s reliance on putatively non-binding, soft law instruments obscures the distinction between legal norms and other norms such as social, cultural, professional, moral and religious norms. A constructivist approach to international relations suggests that norms other than legal norms have been empirically shown to exert equally potent influence on the cooperation and compliance of states (Finnemore, 2000, p 699) and to have what Thomas Franck (1990, p 184) calls ‘compliance pull’ based on pedigree, determinacy, coherence and adherence. Furthermore constructivists can explain the WHO’s focus on the elimination, as opposed to the control of infectious diseases, by reference to the attitudinal features of the Organisation. In particular the WHO’s policy approaches have reflected such subjective elements as the ideas, shared knowledge and ethos of the majority of the WHO staff, who are medico-scientific professionals.

The dearth of regulatory initiatives in relation to treaties means that the focus of any examination of international health law is inevitably confined to the International Health Regulations (IHR). The IHR may be seen as a channel for the WHO’s assertive regulatory approach to health threats in the globalizing world. This section starts by evaluating core concepts and principles of the existing IHR. It then turns to the draft articles of the IHR as proposed in the WHO’s Working Paper (International Health Regulations, Working Paper for Regional Consultations) of 12 January 2004,[12] critically appraising the adequacy and effectiveness of the revised IHR in response to the needs of developing countries.

4.2. The Current International Health Regulations (IHR)

Apart from treaties, the WHO is entrusted with the power to make regulations in accordance with Article 21 of the WHO Constitution.[13] With the establishment of the Expert Committee on International Epidemiology and Quarantine to draft regulations, the WHO adopted two regulations under Article 21 (a) and (b) of the Constitution: the WHO Regulations No.1 on the nomenclature of diseases and causes of death (the Nomenclature Regulations) and the International Sanitary Regulations in 1951,[14] replacing the previous International Sanitary Conventions.[15] The International Sanitary Regulations were designed to deal with diseases susceptible to quarantine, such as plague, cholera, yellow fever, small pox, louse-borne typhus and louse-borne relapsing fever. Subsequent to the amendment of these regulations in 1969, they have been renamed the International Health Regulations (IHR), excluding louse-bourne typhus and relapsing fever.

While both treaties and regulations are binding on member states, there are several distinct features of the regulations. First, they are adopted by way of non-rejection, and exempted from the complex procedure of ratification normally required for treaties. As a corollary, regulations can be adopted instantly to respond to diverse health issues, which arise from the evolution of medical science and technology (Vignes, 1989, p17). Second, under Article 22, regulations adopted pursuant to Article 21 will automatically come into force for each WHO member state unless that state informs the Director-General of its intention to opt out by way of reservations or rejection within a fixed period of time. The presumption of the obligatory nature of regulations is a ‘unique’ procedure in international law, which can be contrasted with the rules governing treaties (Sharp, 1947, p 525; and Taylor, 1997, p 1345). The IHR are based on the recognition that the traditional ad hoc treaty approach is not appropriate for global health concerns in the modern age (Fidler, 1998, pp. 1087-1088). Third, as distinct from rules on a reservation to treaties, as stipulated under Article 19 of the Vienna Convention on the Law of Treaties 1969, both the validity of a reservation to the IHR and the entry into force of the IHR with respect to a state forming a reservation depend on the acceptance of that reservation by the World Health Assembly. The Assembly can object to the reservation on the ground that it ‘substantially detracts from the character and purpose’ of the IHR. In that case, the IHR will not come into force in relation to that state until such a reservation is withdrawn (IHR, Article 88 (1); and WHO; 2004, Draft Article 50(1)).

The IHR constitute by far the most important health law instrument for the global surveillance of the cross-border transmission of infectious disease and for the harmonization of public health protection without causing unnecessary hindrance to trade and travel.[16] The IHR regulate only three infectious diseases: cholera including cholera due to eltor vibrio, plague and yellow fever. Article 1 of the IHR defines these as ‘diseases subject to the Regulations’. The IHR set out legal obligations on member states in three main areas: the requirement of notification and provision of epidemiological information in Part II; requirements relating to health organisations at national ports, airports and other frontier posts in Part III; and a number of detailed legal duties on member states, listed in Part IV. Part IV duties apply both to ‘health measures’ such as disinfection, disinsecting, deratting and other sanitary operations, and to specific procedures to be followed in relation to individuals, goods and means of transportation, including the issuing of certificates and conditions of persons under surveillance (Taylor, 1997, p 1349). In relation to the three diseases defined in the IHR, Part V deals with measures that may be applied by national authorities, such as vaccination and examination of rodents and their ectoparasites to contain rodent plague.

With respect to notification obligations, each national health administration[17] must report to the WHO within twenty-four hours of the first outbreak of a disease subject to the IHR in its territory. The national health administration must also inform the WHO of any infected area within the subsequent 24 hours. The reporting duty of the national health authority[18] encompasses the confirmation of the notified disease promptly by laboratory methods, subject to available resources.[19] The IHR require supplemental information as to source and type of disease, number of cases and death toll, conditions affecting spread of disease, and prophylactic measures adopted.[20] In relation to health organisations, the IHR set out rules on sanitary conditions, health personnel and services to be maintained at ports, airports and national frontier posts,[21] as well as conditions for the issue of health certificates (Deratting Certificates and Deratting Exemption Certificates), including periodic review by the WHO.[22]

The IHR’s focus on border control and the containment of infectious disease within national boundaries has been criticized as being an outmoded approach (Taylor, 1997, p 1347; and Forrest, 2000, p163). The dividing line between national and international public health has been eroded at a time when the rapid spread of infectious diseases, facilitated by technological and transportation development, exposes the impotence of sovereign states in protection of their citizens’ health (Fidler, 1999b, p.9). The WHO’s IHR Revision Project[23] has recognised the need to develop an effective ‘global surveillance system’ combined with a pro-active, ‘response capacity’ within a WHO-led multilateral framework. If adopted as part of the IHR, such a system would assist national and regional surveillance systems in identifying the outbreak and cross-boundary spread of infectious disease.[24] The proposed system reflects the WHO’s shift toward pro-active mechanisms to meet the challenge of mobile pathogens in a globalizing world.

As for health measures applicable to individuals, means of transportation, goods, cargo, baggage and mail, Taylor (1997, p 1344) describes three general governing principles: (1) any measures prescribed in the IHR must be the maximum measures exercised;[25] (2) any health measure must ‘be initiated forthwith, completed without delay, and applied without discrimination’;[26] and (3) there must be free movement of persons and free pratique of ships and aircraft.[27] While the second principle is generally straightforward, the first and third require further examination.

The first principle is fundamental to the IHR’s primary objective that maximum security against international spread of disease be combined with minimum interference with world traffic and trade. The IHR require a national health authority to issue, free of charge, to a carrier a certificate specifying any applicable measures and reasons for applying the measures.[28] With respect to the third principle, the IHR guarantee free movement of a person under surveillance as well as free pratique of a ship and aircraft,[29] namely, the freedom of a ship to enter a port, disembark and commence operation, or of an aircraft, after landing, to disembark and commence operation.[30] Restrictions on free pratique cannot be authorised for diseases other than those governed by the IHR. However, Article 28 of the IHR allows for derogation from this general rule in cases of emergency.[31]

Even in relation to the diseases covered by the IHR, states may choose to impose excessive restrictions on trade and traffic, resulting in significant economic damage especially to developing countries, without having to register a reservation and submitting to the process of the approval by the World Health Assembly (WHA). For instance, at the time of the plague outbreak in India in 1994, overreaction by trading partners and neighbouring states resulted in an estimated loss of US 1.7 billion for India.[32] As Fidler (1999a, pp 199-200) notes, a similar scale of economic damage was seen in December 1997 when the EU issued a six-month import ban on fresh fish from East African countries as a result of the risk of transmission of cholera from contaminated fish.[33] The ban was imposed notwithstanding that both the WHO and the Food and Agriculture Organisation (FAO) called its scientific basis into question.[34] The absence of a supervisory and enforcement system to scrutinise the legality of such measures, taken pursuant to Article 28, is a serious defect of the IHR (Allin, 1988, pp 1050-1051; and Forrest, 2000, p167).

Reluctance of states to report outbreaks of infectious disease can be explained by their fear of causing other nations to adopt restrictive measures detrimental to trade and tourism. Yet, failure to report to the WHO will only exacerbate an infected state’s economic interests by arousing suspicion among other nations and prompting excessive protective measures. A self-reporting system without the backing of sanctions has been criticized as a serious defect in an international surveillance system, hampering the ability of the WHO officially to inform other states of disease outbreaks (Taylor, 1997, p 1349). Instances where nations reluctantly report the outbreak of disease only after coverage by the global press[35] illustrate both the vulnerable nature of the IHR reporting procedure and national scepticism as to the benefits of complying with the IHR.

4.3. Revision of the International Health Regulations

Since the resolution adopted by the World Health Assembly (WHA) in May 1995 (WHA 48.7), the IHR have been subject to a revision process, with the objective of ‘develop[ing] Regulations which will be applicable to the epidemiology of communicable diseases and to international traffic in the 21st century’.[36] Increasing changes in the pattern of disease origin and transmission, as well as frequent non-compliance with the existing notification requirement, have compelled the WHO to develop a regulatory approach based on both hard and soft laws, and to revise the outmoded IHR. It is envisaged that the new IHR will set out basic provisions and principles, and attach technical details in annexes. One of the key general objectives of the revision is to integrate the revised IHR into ongoing WHO programmatic activities with a view to strengthening both effective prevention against epidemic disease and epidemic control (Taylor, 1997, p 1351). In its Resolution in January 2003 (EB111.R13), the Executive Board of the WHO recommended three specific guiding principles for the revision process: (1) the principle that all public health risks of urgent international concern should be reported under the IHR framework; (2) the need to avoid stigmatisation and unnecessary negative impact on international travel and trade; and (3) the principle that the system of detection and surveillance should be tailored to challenges of new or re-emerging public health events.[37]

The WHO’s IHR Revision Project has delineated five major deficiencies in the existing IHR.[38] First, the list of infectious diseases is currently limited to three diseases. The narrow scope of the existing IHR framework fails to address both new types of epidemic challenges such as HIV/AIDS, the West Nile virus and the SARS, and eradicated or controlled but resurgent infectious diseases such as tuberculosis and avian ‘flu. It is also essential that the WHO’s global HIV/AIDS strategy based on the linkage between prevention, care and treatment[39] be incorporated into the IHR framework. Second, the current notification system has proven ineffective in view of its total dependence on individual country initiative. Third, existing collaboration between WHO and a state where an outbreak of an infectious disease has occurred is on an ad-hoc basis with no procedural rules governing coordination. Fourth, member states lack effective incentives to comply with the IHR, absent the supervisory system. The third and fourth weaknesses become especially apparent in relation to issues of notification. Fifth, the existing IHR do not allow the WHO to take risk-specific and preventive measures in response to the actual threat posed by an outbreak of infectious diseases.[40]

On 12 January 2004, the WHO published a Working Paper including a first draft of the reviewed IHR (WHO, 2004). During the first half of 2004, national governments and international bodies are expected to review this draft, which will form the basis of an amended draft to be submitted to an International Working Group (IGWG) in November 2004. At this IGWG, Member States will determine whether to endorse a final draft to be presented to the World Health Assembly in 2005.[41]

4.4. Ten Main Areas of Revision

Bearing in mind the above key deficiencies, this paper explores the ten main areas in which the proposed ‘core concepts’ of the revised IHR are elaborated. It is essential to appraise whether the first draft articles of the revised IHR have adequately incorporated proposed changes.

First, the Working Paper for the revision of the IHR contemplates the reporting of all public health emergencies of international concern (WHO, 2004, Article 5). The all-encompassing term, a ‘public emergency of international concern’, will replace the existing system based on the narrow list of diseases subject to notification, so that the revised IHR can meet challenges of both new and resurgent diseases. Such a reporting obligation would be facilitated by the establishment of a so-called decision tree aimed at determining the outbreak of a public health emergency and any serious and unexpected characteristics sufficient to raise international concern.[42] Assessment of a public health emergency is based on four proposed criteria: (1) severity, namely an abnormal increase in fatality cases and/or in incidence rates; (2) unusual or unexpected pattern or nature of an emergency health event; (3) risk of trans-boundary propagation; and (4) the potential for repercussions on international trade and travel.[43]

Second, under the revised IHR covering a much broader range of public health risks, each member state would be required to establish a single focal point (‘National IHR Focal Point’) for coordinating national emergency measures to be implemented by institutions such as public health administrations, clinics, hospitals and ports of entry (WHO; 2004, Article 3).[44] Such a national focal point should help manage international surveillance and response requirements while providing advice to national health officials as to notification requirements and WHO recommendations. These proposed changes, if implemented, would reinforce the effectiveness of reporting obligations for disease outbreaks and facilitate coordinated responses between national and international health administrations.

Third, as a departure from the current IHR, the Revision Project emphasises the need to strengthen the surveillance system by linking national health administrations and the WHO (WHO, 2004, Article 4). The surveillance system has been instrumental in eradicating smallpox and polio, and it should be so in preventing new infections such as SARS.[45] The revised IHR will delineate ‘minimum core requirements’ for a national surveillance and analysis system, which can swiftly report public health emergencies and assess data on national disease risks. Such a surveillance system must be able to determine the potential of disease risks to spread internationally and affect other member states. The proposed IHR template for core requirements must be formulated in a sufficiently detailed manner to facilitate developing countries in determining their essential surveillance needs when they seek external assistance and funding to meet the IHR requirements.[46] Such a proposal would improve the current IHR which lack detailed guidelines for early detection of diseases. This would in turn be of especial benefit to developing countries which lack resources to devise their own health laws.

Fourth, the Working Paper proposes to establish an optional procedure under which member states can notify the WHO of health emergencies on a provisional and confidential basis. The confidentiality of notifications and other information would be preserved save in any one of the following scenarios; ie where:

(1)  the WHO determines an event of potential health danger to be a ‘public health emergency of international concern’;[47] or

(2) the notifying or consulting national health administration agrees to make the information public; or

(3) the WHO has confirmed evidence of the international spread of infection or contamination on the basis of established epidemiological principles; or

(4) there is evidence that the nature of the contamination, disease agent or vector is likely to make national control measures against the international spread unsuccessful, or that the national health administration lacks the operational capacity to implement measures necessary to prevent trans-boundary spread of disease; or

(5) the immediate application of international control measures is considered essential due to the nature and scope of the international movement of travellers, conveyances, containers or cargo that may be infected or contaminated (WHO, 2004, Article 5(2)).

The confidential notification procedure, which is lacking in the existing IHR, would deal with situations where during an early stage of an outbreak, member states are uncertain as to whether the criteria for identifying public health emergencies of international concern are met. It would enable vulnerable, developing countries affected by disease outbreak to obtain WHO assistance and expertise without exacerbating potential damage to trade and traffic. These states would also gain international credibility through collaboration with the WHO, while other member states would be relieved of resorting to unnecessary and costly ‘countermeasures’. It is proposed that in these cases a joint statement by the WHO and an affected state should be made to clarify both the nature of the outbreak, including its possible cross-border effect, and the types of control measures to be adopted by national health administrations.[48] This system, if fully incorporated, would be crucial for obtaining support from developing countries that have endured onerous consequences of disease outbreak. The outbreak of infectious disease strains inadequate public health infrastructures and national budgets, while export revenues based on primary agricultural and fishery products are severely curtailed by developed countries introducing trade-restrictive measures whose basis may not be scientifically founded.

Fifth, the proposed IHR would encourage the use of information other than official notifications to identify and control public health emergencies of international concern (WHO, 2004, Article 7). Member states would be required to respond to inquiries by the WHO to verify the authenticity and reliability of information so as to minimize the danger of unwarranted restriction on trade and travel in response to global mass media coverage. The proposed system of inquiry is an extended form of the existing obligations on member states, which are limited to the three regulated infectious diseases.[49] The information provided by NGOs with experience and expertise in contact with tribal groups living in remote areas would be essential for early detection and speedy notification of exigent health problems. The use of such non-official information would also be vital for countries in which civil war has caused the breakdown of health and communications infrastructures. The fact that the Working Paper contemplates representation of NGOs in the sessions of the proposed supervisory body (Review Committee) in relation to the monitoring of the IHR and the assessment of standing recommendations (WHO, 2004, Annex 10, paras 9 and 16(c)) would be a significant step. Yet, it must be submitted that even in relation to the issuance of temporary recommendations in response to a public health emergency of international concern (WHO, 2004, Annex 3), the Working Paper should delineate the procedure that will allow NGOs to participate in notification systems, while maintaining confidentiality of relevant information. The draft revision should also set out the procedure that enables NGOs to be consulted in case of discrepancy between information furnished by them and the information offered by national governments affected, or suspected of being affected, by disease outbreak.

Sixth, in order to reduce the international spread of disease and minimise international traffic and economic loss resulting from public health emergencies or public health risks, the proposal states that the WHO should issue recommendations, standing or temporary, to national authorities. Such recommendations would delineate the type and scope of protective measures that the affected state and other states can adopt on the basis of actual public health threat or the impact of its risk.[50] The Working Paper adopts a two-tier system. On one hand, in the event of a determination of a public health emergency of international concern, it is proposed that the Director-General must seek out the views and advice of the Emergency Committee. The proposed Emergency Committee, consisting of senior health experts within the WHO, will assist the Director-General to make determinations on whether there exists a public health emergency of international concern and whether to issue temporary recommendations (WHO, 2004, Article 11 and Annex 3). On the other hand, in the case of specific and on-going public health risks, the WHO would have an option to adopt standing recommendations for routine and periodic application. Both the Director-General and the states parties to the IHR would be able to submit to the Review Committee proposals for standing recommendations. The Working Paper contemplates the possibility that NGOs and individuals with relevant expertise can provide information under this procedure (WHO, 2004, Article 12 and Annex 10). The Working Paper still needs to clarify the details such as the type, scope and duration of the protective measures that can be introduced by the national health administration and the health authority pursuant to recommendations, temporary or standing.

Seventh, the revised IHR would oblige the WHO to assist member states in assessing and controlling outbreaks within national societies. According to the proposal,[51] the WHO operational response team, including its on-site teams of experts, would furnish an independent and reliable investigation of the outbreak, controlling its spread and minimizing economic damage in close collaboration with the affected state (WHO, 2004, Articles 8 and 10). Again instead of functioning on an ad hoc basis, the operation of such verification systems, which would be particularly beneficial for developing countries, must be grounded on procedural rules within the revised IHR.

Eighth, it is proposed that under the revised IHR the process whereby the WHO issues recommendations on containment and control measures needs to be more transparent.[52] This is linked to the sixth pillar of the revision as discussed above. The Revision Project has yet to provide detail on this matter. As a result, many developing countries may feel uncertain as to the balance between the requirement of transparency and the optional procedure, proposed in the fourth key area of revision, which would allow member states to notify the WHO of health emergencies on a confidential basis. The Working Paper proposes to retain confidentiality in relation to the procedure that leads to adoption of temporary recommendations in the event of an outbreak of a public health emergency of international concern (WHO, 2004, Annex 3), but not with respect to the procedure dealing with standing recommendations (WHO, 2004, Annex 10, Section V).

Ninth, the revised IHR would set out a brief non-exhaustive list of measures designed to prevent the international spread of disease. These measures are applicable to travellers, and goods and conveyances at point of entry into non-affected member states only during the risk period. Such a list is purported to deter member states from introducing disproportionate measures that may hamper trade and travel.[53] This would furnish a crucial safeguard for disease-struck developing countries whose economies may be severely paralysed by excessive restrictions on trade and traffic.

Tenth, and finally, the Revision Project proposes to establish a permanent IHR review body (the Review Committee) to keep abreast of public health concerns while maintaining continuity in interpretation and precedent-setting within the IHR’s provisions.[54] It is submitted that the revised IHR need to be coherent and to secure the legitimate expectations of national health administrations while allowing them sufficient flexibility to deal with new health threats in a rapidly changing world. In accordance with the Regulations for Expert Advisory Panels and Committees,[55] the Director-General will establish an expert advisory panel composed of senior public health experts (‘IHR Advisory Panel’), who will serve for up to four years, with the possibility of renewal (paragraph 3.3, the Regulations for Expert Advisory Panels and Committees). The Working Paper suggests that the members of the Review Committee will be selected and appointed by the Director-General from amongst the members of the IHR Advisory Panel and other WHO expert advisory panels. The Review Committee’s members will serve only for the period of a session (WHO, 2004, Annex 10, paragraph 3). Due account must be taken of geographical and gender balance of the membership of both the Advisory Panel and the Committee (preambular para 3 and para 4.2, the Regulations for Expert Advisory Panels and Committees).

The Review Committee are to be entrusted with the following tasks:

(1) reviewing and monitoring the functioning of the IHR;

(2) providing advice as to the application or implementation of the IHR, including amendments;

(3) advising the Director-General in relation to standing recommendations;

(4)  advising the World Health Assembly, the executive Board and the Director-General on any matter that they refer to it; and

(5)  serving as a monitoring body for the IHR, with the competence to provide views and advice as to disputes concerning the interpretation and application of the IHR (WHO; 2004, Articles 45 and 47, as well as Annex 10).

The foremost significant development suggested by the Working Paper may be the introduction of adjudicative procedure to the IHR, with the proposed Review Committee given the remit to resolve disputes involving the IHR’s interpretation and application. Views and advice of the Review Committee would not be binding on states parties to the dispute unless they consent to this in advance of the proceedings (WHO, 2004, Article 47(2)). Nevertheless, the reports of the Committee containing its views and advice would elicit considerable respect and compliance among national health administrations. The proposed IHR also contain an optional clause (Article 47((3)) that allows states parties to declare as compulsory their acceptance of arbitration as a means of settling disputes pursuant to the Permanent Court of Arbitration Optional Rules for Arbitrating Disputes between States.

5. Concluding Observations: Prospect for the WHO’s Regulatory Role in International Health Law

Notwithstanding its long neglect of international law, the WHO’s policy is slowly shifting towards a regulatory approach to global public health. While lacking procedural detail in many areas, the revised IHR would be the central legal instrument in the emerging transnational health regime. It can also muster broad support from developing countries. The adverse public health consequences of globalization in developing countries confirm the need for the WHO to take an active role. The WHO’s proposal to pursue risk reduction policies and risk prevention policies, as articulated in its World Health Report 2002, Reducing Risks, Promoting Healthy Life, is a crucial step.

Many developing countries have shown a reluctance to notify the WHO of outbreaks of infectious disease for fear of deterring investment and tourists. This was demonstrated in China’s attempts to conceal its AIDS epidemic[56] and during the earlier period of the SARS outbreak there.[57] This demonstrates the need for greater international coordination, and the establishment of monitoring and compliance mechanisms under the auspices of the WHO. National authorities seem to undertake a cost-benefit analysis in relation to non-compliance with IHR requirements and the general recommendations of the WHO. Such a cannily calculated approach pursuant to narrowly defined national interests cannot be sustained. International health must be perceived as a global ‘public good’, which is considered a ‘positive-sum’, with one state’s improving health standards underpinning, rather than undermining, those of other states (Chen, Evans and Cash, 1999, p 294). Such a positive-sum outlook to cost-benefit analysis must apply to the evaluation of public health diplomacy. The latter is only effective within a normative framework through which an even distribution of the dividends of health security across vulnerable developing countries can be ensured, and. a ‘global common denominator of ethical public health practice’ can be identified (Martin, 2004, p17). Fidler (2004, p 13) argues that the fact that the SARS outbreaks were in the end successfully contained in collaboration between states, intergovernmental organisations and non-state actors itself indicates the triumph of the concept of ‘global public goods for health’.

A nascent overarching normative framework for global health can be seen in the WHO’s codificatory efforts to revise the IHR and adopt its first ever international convention relating to tobacco control.[58] Such a normative framework needs to be internalised in domestic policy implementation to be effective in realising health objectives in national societies. Koh (1997, p 2599) argues that the key to understanding the compliance of nations with international law lies in what he calls ‘transnational legal process: the process by which public and private actors - namely, nation-states, corporations, international organisations, nongovernmental organisations - interact in a variety of fora to make, interpret, enforce, and ultimately internalize, rules of international law’.The establishment of an effective international monitoring mechanism that ensures compliance with international health law in close liaison with a variety of actors (specialised agencies, NGOs and national health administrations) will support this process of normative internalisation. The Working Paper’s revised IHR are based on an appropriate recognition of such transnational legal process. This should ensure greater efficacy for international health law along the lines of the argument developed above (supra, section 3). It is proposed that whenever the subject of discussions so requires, the Director-General of the WHO should invite specialised agencies, intergovernmental organisations and NGOs to be represented in the Review Committee’s sessions, except for the sessions designed to settle disputes submitted by states parties (WHO; 2004, Annex 10, para 9). Further, as discussed above, at the request of the Director-General, any state (including a non-party to the IHR), specialised agencies, NGOs and even individuals with technical expertise would be able to submit to the Review Committee information relevant to the assessment of standing recommendations in response to on-going public health risks (WHO; 2004, Annex 10, para 16(c)).

The fact that economic, social and cultural rights are now scrutinised on the basis of a complaint-based procedure in some international human rights contexts[59] may provide a workable solution to non-compliance with international health law. The establishment of the Review Committee as a supervisory body could be a salutary move, approximating the position of international health law to that of international human rights law. Closer coordination among international organisations and transnational actors in implementing the revised IHR would invest the WHO with increased power in dispute settlement and enforcement. These proposals, if implemented, would facilitate the process of normative internalisation, assisting the WHO’s global mission in search for enhanced and equitable health standards for all.

Endnotes

[1] Note that the procedure manual of the Codex Alimentarius Commission of the UN Food and Agriculture Organisation (FAO) embodies the concept of substantial equivalence, which requires scientific assessment in relation to novel foods in order to identify hazards derived from biological, chemical and physical agents liable to cause adverse health effects: Procedure Manual of the Codex Alimentarius Commission, 12th ed, pap 51-52; and Annex III to the Provisional Communication by the Codex Alimentarius Commission of the FAO and of the WHO, CX4/10, CL2000/12-GP, April 2000. See also: Article 3(9) to (14) of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 (OJ2002 L31, p 1); Case T-13/99, Pfizer Animal Health v Council [2002] ECR II-3305, para. 156; Case T-70/99, Alpharma v. Council [2002] ECRII-3495, para 169; and Case C-236/01, Monsanto Agricoltura Italia SpA and Others v Presidenza del Consiglio dei Ministri and Others, Judgment of 9 September 2003, para 79.

[2] See Director-General Lee Jong-wook, 'Address to the Fifty-sixth session of the WHO Regional Committee for South-East Asia', 11 September 2003, available at < http://www.who.int/dg/lee/speeches/2003/regionalcommittee_searo/en/>.

[3] See WHO (1999) The World Health Report: Making a Difference,p 14; and message from Director-General, Dr Gro Harlem Brundtland, in WHO (2002)The World Health Report 2002 – Reducing Risks, Promoting Healthy Life, p 4.

[4]WHO (1999)The World Health Report, id, p 20.

[5] WHO, The World Health Report 2002 – Reducing Risks, Promoting Healthy Life, especially p 11.

[6] Message from the Director-General, Gro Harlem Brundtland, in: WHO, The World Health Report 2002 – Reducing Risks, Promoting Healthy Life, p 4.

[7] See, for instance, the role of the International PolioPlus Committee of the Rotary International in fight against polio (‘Le Rotary doit trouver 210 millions de dollars’, Le Monde, Vaincre la Polio – Les Médecins et les bénévoles, 30 October 2003, Special Issue, p vi); and the report that the Bill Clinton Foundation concluded an agreement with four pharmaceutical laboratories to allow the supply of medicine for AIDS at a reduced cost (E Leser (2003) ‘La Fondation Bill Clinton fait baisser le prix des thérapies antisida’, Le Monde, 25 October 2003, p 4.

[8] Resolution of the Executive Board of the WHO, Revision of the International Health Regulations, 24 January 2003, EB111.R13, para 4(6).

[9] This treaty was proposed in the World Health Assembly, Res. WHA49.17, 25 May 1996 and adopted in Res. WHA 561 on 21 May 2003. The treaty text is available at <http://www.who.int/tobacco/fctc/text/en/fctc_en.pdf>. For examinations of tobacco control in international law, see A Taylor, ‘An International Regulatory Strategy for Global Tobacco Control’ (1996) 22 Yale Journal of International Law 22, p 257.

[10] The WHO has been criticized for its meager contribution to the implementation procedure of the International Covenant on Economic, Social and Cultural Rights in relation to the right to health: Alston, P (1987) ‘Out of Abyss: the Challenges Confronting the New UN Committee on Economic, Social and Cultural Rights’, Human Rights Quarterly 9, pp 332 - 367.

[11] Many soft law instruments that the WHO has adopted are respected among physicians and health services as standards for their practice. These include the International Code of Marketing and Breast-milk Substitutes, and the expanded Programme on Immunisation.

[12] International Health Regulations, Working Paper for Regional Consultations, WHO, Intergovernmental Working Group on the Revision of the International Health Regulations, IGWG/IHR/Working paper/12.2003, 12 January 2004, available at: < http://www.who.int/csr/resources/publications/IGWG_IHR_WP12_03-en.pdf>.

[13] In 1998 WHO’s Executive Board approved recommendations from a Special Group that, by way of amendment of the WHO Constitution, the regulatory power under Article 21 be extended to cover any matter falling within the functions of the WHO: World Health Organisation, Review of the Constitution and Regional Arrangements of the World Health Organisation: Report of the Special Group, WHO Doc EB101/7 (Nov. 14, 1997); and Review of the Executive Board Special Group, WHO Doc EB101. R2, Jan 22, 1998.

[14] 5 WHO 5/H35/2, (1983).

[15] The western-dominated history of the International Sanitary Conventions dates back to the first Convention of 1892 which addressed the international spread of cholera. This was followed by a further treaty on measures against plague in 1897. Pannenberg observes that ‘[t]he numerous international sanitary conferences, from 1851 up to the Constitution of the World Health Organisation in 1946, clearly expressed the various milestones of medical insight’, C O Pannenberg (1979) A New International Health Order: An Inquiry into the International Relations of World Health and Medical Care, (Germantown, Maryland: Sijthoff and Noordhoff), pp 179-180.

[16] See, for instance, IHR (1969), forward, para 2.

[17] The Working Paper’s revised IHR Article 1 defines health administration as ‘the governmental authority responsible over the whole of a territory of a State to which these Regulations apply for the implementation of the health measures provided herein’, supra n 12.

[18] According to the Working Paper’s revised IHR Article 1, health authority is defined as ‘the local authority or entity immediately responsible for the implementation and application of appropriate health measures under these Regulations’ id.

[19]Article 3, IHR.

[20]Article 5, IHR.

[21]Articles 14, 18 and 22, IHR.

[22]Articles 17, 20-21, IHR.

[23]WHO, IHR Revision Project,Global Crises – Global Solutions: Managing Public Health Emergencies of International Concern Through the Revised International Health Regulations, WHO/CDS/CSR/GAR/2002.4, available at < http://www.who.int/csr/resources/publications/ihr/whocdsgar20024.pdf >.

[24] Id., at 10-11.

[25] Article 23, IHR.

[26] Article 24, IHR.

[27] Articles 27 & 28, IHR.

[28] Article 26, IHR. A similar certificate must also be issued, upon request, to any traveler, consignor, the consignee and the carrier.

[29] Articles 27 & 28, IHR.

[30] Article 1, IHR.

[31]Article 28 of the IHR reads as follows: ‘Except in case of an emergency constituting a grave danger to public health, a ship or an aircraft, which is not infected or suspected of being infected with a disease subject to the Regulations, shall not on account of any other epidemic disease be refused free pratique by the health authority for a port or an airport; in particular it shall not be prevented from discharging or loading cargo or stores, or taking on fuel or water’.

[32] WHO, IHR Revision Project, supra n 23, p 3.

[33] European Commission Decision 97/878/EC, 1997 OJ (L356) 64; and Commission Decision 98/84/EC, 1998 OJ (L15) 43.

[34] World Health Organisation, Director-General Says Food Import Bans Are Inappropriate for Fighting Cholera, Press Release, WHO/24, 16 February 1998, and Food and Agriculture Organisation (1998) ‘Import Ban on Fish Products from Africa Not the Most Appropriate Answer’, Press Release PR98-21E, 25 March 1998, < http://www.fao.org/waicent/ois/press_ne/presseng/1998/PREN9821.htm>.

[35] See, for instance, the 1991 plague outbreak in India.

[36]Weekly Epidemiological Record, No. 30, 30 July 1999, at 252.

[37] WHO (2003) Resolution of the Executive Board of the WHO, Revision of the International Health Regulations, 24 January 2003, EB111.R13; and Pan American Health Organisation (PAHO), (2003) 24 Epidemiological Bulletin, No. 4, pp. 14-15.

[38] WHO, IHR Revision Project, supra n 23, p. 3.

[39] Id.

[40] Id.

[41] See WHO, IHR Revision Proposals, available at ,http://www.who.int/csr/ihr/revisionprocess/working_paper/en/>.

[42] WHO, IHR Revision Project, supra n 23, at 5.

[43] Pan American Health Organisation (PAHO), (2003) 24 Epidemiological Bulletin, No. 4, pp 14-15.

[44] See also WHO, IHR Revision Project, supra n 23, p 6.

[45] Lee, supra n 2.

[46] WHO, IHR Revision Project, supra n 23, p 6.

[47] The term, a ‘public health emergency of international concern’, is not defined in the Working Paper, but the determination of such an emergency by national health authorities and administration is facilitated by the ‘decision instrument’ based on a chart and checklists, as provided in Annex 2 of the Working Paper: supra n 12.

[48] WHO, IHR Revision Project, supra n 23, p 7.

[49] Id, pp 7-8.

[50] Id, p 8.

[51] Id, pp 8-9.

[52] Id, p 9.

[53] Id, pp 9-10.

[54]Id, p. 10.

55 Regulations for Experts Advisory Panels and Committees, adopted by the resolution WHA 53.10 of 20 May 2000 in the Thirty-fifth World Health Assembly. This has replaced the regulations adopted by the Fourth World Health Assembly and been amended at the Forty-fifth, Forty-ninth and Fifty-third World Health Assemblies. The text is available at: < http://policy.who.int/cgi-bin/om_isapi.dll?infobase=basicdoc&record={9CE}&softpage=Document42>.

[56] Chinese officials refused to recognize a major HIV problem in China until 2002. It is also reported that while in international fora the Chinese government acknowledges that it will be faced with up to 10 million HIV cases by 2010, the Chinese language media puts the official infection figures as low as 40,000: Watts, J (2003) ‘Hidden from the World, a Village Dies of AIDS While China Refuses to Face a Growing Crisis’, The Guardian, 25 October 2003, p 3.

[57] The Guardian (2003) ‘Scientists Focus on China as Sars Toll Rises’, 16 April 2003.

[58] Supra n 9.

[59]See, for instance, the individual complaint system that covers economic, social and cultural rights under the 1981 African Charter on Human and Peoples’ Rights and the 1999 Optional Protocol to the Convention on the Elimination of All Forms of Discrimination against Women; and the collective complaint system established under the 1995 Additional Protocol to the European Social Charter Providing for a System of Collective Complaints.

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