Canada's obligations to global public health security under the revised International Health Regulations.

Summary

The aim of the World Health Organisation's recently revised International Health Regulations [IHR] is to establish a global alert and response network for outbreaks of infectious disease and other public health threats with the potential for international spread. The rationalized and modernized IHR are a set of obligations and procedures for broad-based domestic and international public health collaboration to contain known risks, respond to unexpected ones, and improve national and international readiness through long-term sustainable capacity building at all levels. However, in the absence of significant changes to existing policies, operations, and capacities both within and among nations, compliance with the requirements of the agreement will remain challenging for many countries. This article briefly surveys the historical origins and the principal requirements of the revised IHR, with a particular focus on four key obligations: (1) to create an integrated national surveillance system; (2) to ensure timely reporting; (3) to prevent the application of excessive restrictive measures; and (4) to contribute to capacity-building in the developing world. Strategies for meeting the challenge of these obligations are proposed, as are recommendations for Canadian policy leadership in laying the foundations for effective global public health security in the 21st century.

Introduction

In May 2005, Member States' delegates to the World Health Assembly [WHA] approved a series of major revisions to the World Health Organisation's [WHO] International Health Regulations [IHR]. (1) The approval of the IHR, the only binding international legal instrument for the control of infectious diseases (2), was a culmination of more than a decade of negotiations that were impelled to conclusion by the SARS experience, the expanding H5N1 crisis, and the threat of another global pandemic of human influenza. This article briefly surveys both the historical origins and some principal requirements of the revised IHR, and it seeks to open a constructive debate on how best to achieve compliance with four particular obligations, each of which raises difficult policy challenges in the Canadian context.

Revision of the IHR

The roots of the IHR stretch back to mid-19th century sanitary conventions among European trading powers devised to reduce the expense of preventing the spread of cholera, yellow fever, and plague. (3) That State Parties to the IHR, as the conventions were renamed in 1961, were still legally obligated to disclose only the incidence of those three diseases a century and a half later provides a good indication of how antiquated the regulations had become by the 1990s. Another was the increasingly wide variation in standards for inspection and hygiene measures, as well as conflicting or discriminatory applications of public health practice. (4) Of greatest concern, however, was that countries had begun, routinely and with impunity, to fail to adhere to the notification regulations and to WHO recommendations with regard to containment protocols. Affected states had become reluctant to give notice of an outbreak, and unaffected states had become increasingly prone to imposing scientifically unjustified (and economically damaging) measures in response to outbreaks. Examples of such non-compliance occurred in the 1990s with apparent outbreaks of plague in India and of cholera in Peru and East Africa, (5) and in 2003 during the SARS crisis. (6)

The 2005 revisions are intended to lift the IHR out of obsolescence and disregard by broadening the scope, enforceability, scientific rigour, and transparency of the regulations, and of the processes through which they will operate. Three specific principles guided the revision process: (1) all public health risks of urgent international concern should be reported to WHO; (2) stigmatisation and unnecessary constraints on international travel and trade should be avoided; and (3) a global system of surveillance and detection, combined with a pro-active response capacity under a WHO-led multilateral framework, should be developed. (7) All State Parties have approved the revisions, set to enter into force in June 2007. Significantly, the United States included in its formal agreement to the regulations a reservation that it will implement them "in line with U.S. principles of federalism." (8)

The primary objective of the regulations remains that of balancing security from the international spread of disease against unnecessary interference with world traffic and trade. Unchanged as well are the four basic state obligations: (1) notification to WHO of cases of certain diseases and transfer of epidemiological evidence thereof; (9) (2) provision of hygienic measures and health services at all ports; (3) issuance of international health and/or vaccination certificates; and (4) application of health measures to international traffic that are not more stringent than the measures described in the Regulations (unless a compelling scientific rationale is assessed as legitimate by WHO authorities).

In tandem or in response to the IHR revision process, numerous plans, goals, and guidelines for improving human and animal health surveillance and pandemic preparedness activities have been developed by public health authorities at all levels of government. (10) Growing awareness of the conflict between the need to boost transparent global detection systems and the substantial economic disincentive to report H5N1 outbreaks recently generated a call, (11) and then a formal recommendation by the WHO Executive Board, (12) to accelerate the process of compliance with key provisions of the revised IHR deemed relevant to pandemic influenza preparedness and response.

Key Changes to the International Health Regulations

The revised IHR contain a number of important changes that distinguish it from its predecessor, three of which are noteworthy here: (1) the requirement that all State Parties meet specific standards and develop minimum capacities for their national surveillance and response systems; (2) the formalization of the WHO's authority to act during potential public health emergencies of international concern; and, (3) the expectation that the State Parties will assist each other, with the assistance of the WHO, in public health capacity-building and implementation of the IHR.

In a departure from the horizontal character of prior international law on infectious disease control, (13) the IHR impose on all State Parties the explicit obligation to develop, strengthen, and maintain domestic capacity to detect, report, and respond to public health events. An annex to the agreement outlines the obligations and core capacities for surveillance, reporting, and response at the local, intermediate, and national levels. Taken together, these requirements amount to a blueprint for a comprehensive, fully integrated and responsive national public health system. Moreover, every such system must be linked under the terms of the agreement to regional and global authorities through national operations centres, referred to as National IHR Focal Points [NFP]. The principal task of NFPs is to disseminate information about public health threats and response measures to, and consolidate input from, all relevant sectors of the administration, as well as to be accessible at all times for communication with the WHO.

The revised IHR also formalize WHO authority to act to protect global health during any possible "public health emergency of international concern" [PHEIC] by issuing recommendations and mobilizing multilateral interventions, most likely through the mechanism it coordinates known as the Global Outbreak Alert and Response Network [GOARN]. (14) To diminish reporting delays, WHO's information gathering authority is no longer limited to official state notifications or consultations, but now explicitly includes recourse to "scientific principles as well as the available scientific evidence and other relevant information." (15) Presumably, this includes information from non-state sources such as non-governmental organizations, media sources, individual health professionals, and web-based forums and networks such as the Global Public Health Information Network [GPHIN]. In the event of a suspected PHEIC, the agreement stipulates the ad hoc formation of a new body, the Emergency Committee, which is to be formed from a roster of experts named by States Parties. The Emergency Committee's main task is to appraise the available evidence and information and advise the WHO Director General, who now formally has the power (even without the consent of affected countries, provided a series of procedures is followed) to unilaterally issue travel and other temporary or standing recommendations in order to protect global health. The WHO Director General is also authorized under Article 10 of the IHR to share information with other States Parties when an affected State "does not accept the offer of collaboration" and "when justified by the magnitude of the public health risk". (16)

The new Regulations also explicitly impose obligations on all State Parties and the WHO to assist in the development of public health capacities in all countries, including the provision of technical cooperation and logistical support, as well as the mobilization of financial resources to facilitate implementation of the Regulations. The latter is particularly relevant for less-developed countries. (17) The agreement also imposes an ambitious 2009 deadline for the completion by each State Party of an assessment of existing national structures and resources, followed by the formulation and carrying out of "plans of action to ensure that these core capacities are present and functioning throughout their territories" (18) by 2012.

National Governance challenges to compliance with the IHR

With regard to the control of infectious diseases and other major risks to national and international health and security, the revised IHR will soon be both a key template for domestic organization of public health activities, as well as the primary framework for collaboration among states with regard to both preparedness and response. However, two broad considerations challenge the feasibility of implementing the regulations in their entirety. First, many countries (and most low and middle income countries) simply do not possess the expertise or the resources to develop or operate effective surveillance systems, and will require significant long-term investments to comply with the regulations within the stipulated time frames. Second, even where, if, and when such systems are created, many states (and perhaps particularly sub-national actors or peripheral authorities) will continue to face significant disincentives to report a potential PHEIC given the history of economic damages that result from international media coverage and disproportionate containment measures.

These broad considerations may furthermore be exacerbated by domestic political, legal, and operational factors and arrangements, which may themselves impede movements towards compliance with specific features of the IHR in many countries, particularly with regard to four key obligations: (1) creating an integrated national surveillance system; (2) ensuring timely reporting; (3) preventing the application of excessive restrictive measures; and, (4) contributing to public health capacity-building around the world.

Recent experiences in Canada illustrate these implementation challenges, both broad and specific. Canadian experience also demonstrates that compliance will be an issue in high and low-income countries alike, and that IHR-related reforms require improvements in "germ governance" (19) as much as they require improved scientific and epidemiological expertise and systems of information and communication technologies. Indeed, as SARS demonstrated, in the absence of unambiguous legislation and/or detailed formal protocols coordinating the roles and responsibilities of the multitude of actors involved in preparing and responding to complex public health events, the national public health systems of even the most highly-developed countries are likely to be tested and found wanting by actual crises.

The difficulty Canada has faced in developing an integrated national public health surveillance system is a salient and illustrative case in point. Despite being an explicit policy goal for more than a decade, as well as being identified as a priority objective by a multitude of national and provincial reports, inquiries and commissions, such a system remains unrealized. (20) Surveillance within provinces and across the country is thus characterized not only by disparities in scope, sensitivity, funding sustainability, and qualified staffing levels, but also by the fragmentation of related clinical, laboratory, and training activities, by conflicting epidemiological and reporting standards, and by incompatible data collection and information technology platforms. (21) The irony is that Canada is recognized as a leader in international health surveillance through its central role in the development of GPHIN. Our view is that problems within Canada have been the result of a lack of effective intergovernmental collaboration in public health. Thus more hierarchical approaches--with the federal government adopting more aggressive leadership, balanced against increased commitments to fund public health improvements and offset the costs of responding to crises--ought to be adopted in order to accelerate the pace and quality of reforms. (22)

Although the IHR rightly propose integrated national surveillance systems as the keystone for both prevention and mitigation of public health crises, timely interpretation and reporting of the information collected by such systems is just as crucial to responding to crises and containing threats. Here again, however, Canadian experience illustrates the challenges many states may face. Local and regional authorities across the country, for example, are under no legal obligation to notify their federal or international counterparts of possible public health emergencies, nor must they release related epidemiological data. (23) This is due to a lack of both legislation and formal data sharing agreements among the provinces, as well as between the provinces and Health Canada. Although we understand that intergovernmental efforts are presently being made to redress this and related policy gaps, at the time of this writing, the outcomes of those efforts remain uncertain. Provincial public health officials, therefore, remain susceptible to considerable political pressure to delay notification and data/sample transfers, pending confirmation of results, in light of the economic harm that follow such revelations. This directly conflicts both with the terms of the revised IHR and with the goal of preventing and mitigating emergencies, and supports the incorporation into law and practice (as proposed in a diversity of countries, from New Zealand to India (24)) of a common standard for decision-making during public health crises. A template for such a standard is provided in an annex to the revised IHR agreement itself, in the form of an algorithm for identifying a potential PHEIC (see Figure 1).

The IHR are best understood as an attempt to establish international norms with regard to the range of related and sequential but also looped activities related to public health practice (detection, analysis, verification, communication, intervention, and back again). It is noteworthy, however, that much of this practice (particularly for developed countries such as Canada) will occur in response to crises in other countries (particularly developing countries) rather than to endogenous threats. As discussed above, the historical record of such responses is at best mixed: even where technical public health advice and emergency response support has been offered or provided, affected states or regions have not uncommonly been simultaneously subject to disproportionate isolation (expressed by the blocking of trade and travel on the people and products of such places without scientific rationale). (25) Worse still is that such disproportionate external responses to disease outbreaks may in turn drive disproportionate internal responses in poorer countries, including the imposition of containment measures with low regard for human rights, as authorities overeagerly seek to avoid the devastating effects of prolonged international sanctions against their citizens and products.

[FIGURE 1 OMITTED]

Preventing the application of excessive internal and external restrictive measures thus emerges as a key element of the revised regulations. It is one that Canada may have difficulty ensuring, however, given three realities: the immediacy of media attention to outbreaks, the resultant public demand for decisive government intervention (which may lead to the imposition of measures more for visibility than for proven or expected public health efficacy), and the fact that Article 43 of the agreement leaves it to each State Party to define for itself acceptable levels of "risk to human health." (26) Along with the uncertainty inherent to the early phases of many infectious disease outbreaks, these realities combine to introduce a flexibility in defending restrictive measures that may well continue to see applied by state authorities what most public health officials would consider to be disproportionate (and possibly economically damaging) interventions. (27) We limit our consideration here of this complex impasse to drawing attention to the Bellagio Statement of Principles, (28) which contains some thoughtful guidance for further policy development on this and related issues. Formulated by a leading group of philosophers, the Statement provides concrete principles and checklists for ensuring that the needs and rights of disadvantaged groups--"almost always the worst affected by epidemics" (29)--are accounted for during pandemic planning and response activities, and Canada would do well to incorporate such concern not only in its domestic policy, but also in its foreign and official development assistance policies and programs. (30)

The importance of such outward-looking policies, and in making certain that they cohere with domestic public health policy and practice, cannot be overstated. The notion that the boundaries of public health coincide with those of the nation state is a dangerously outmoded one, and perhaps the most fundamental challenge posed by the IHR lies in ensuring that wealthy countries, such as Canada, live up to their obligations to contribute to public health capacity-building in the developing world. If public health systems are not up to the standard mandated by the regulations anywhere, and the situation is particularly dire in those places where the most threatening pathogens are emerging, then mutual vulnerability applies and isolationism is no longer an option. (31) Functioning national public health systems linked in a global surveillance and response system thus emerges as a type of public good in which Canadians have very good reason to invest. Although international aid for health in general has recently been on the increase, substantial new long-term commitments to core capacity amelioration are needed to overcome the obstacles (of limited public health infrastructure and funding specifically, and of poor governance more generally) currently facing the countries most at risk from newly emerging infectious diseases. (32) Canadian public health authorities have emerged as leaders on the international stage following SARS and in preparation for another global influenza pandemic. They were also instrumental in the negotiations that led to the revision of the IHR. (33) The challenges for such authorities now lie, first, in convincing Canadians and their elected officials that investments in domestic pandemic preparedness must be accompanied by similar investments overseas, and second, in ensuring that such investments do not compete or conflict with existing local public health priorities and programmes.

Conclusion

The revised IHR constitute a major advance in international health law and a crucial step towards the establishment of a global surveillance system. (34) Animating the IHR is the implicit principle that state sovereignty can in some circumstances be subordinated to protect the (global) common good. From a public health perspective, such a principle may seem rather unremarkable. From an international relations perspective, however, and as it aims to affect the practice of global public health surveillance and response, making such a principle fully functional could mark a revolutionary power shift away from State Parties and towards the WHO in collaboration with non-state partners. (35) Thus far, the revised IHR have precipitated or contributed to public health reform initiatives in a number of countries, although the legal, ethical, and governance challenges posed by the requirements remain far from resolved. (36) Canadian experience demonstrates that a number of key obligations under the agreement will be difficult to fulfil, even under favourable conditions, and that the revised regulations as a whole will require detailed and careful interpretation and implementation within every country according to local priorities and existing resources.

Christopher McDougall, Ph.D. candidate, Department of Health Policy Management and Evaluation, University of Toronto, and Kumanan Wilson, Associate Professor, Departments of Medicine and Health Policy Management and Evaluation, University of Toronto, Toronto, Ontario.

This research was supported by grants from the Canadian Institutes of Health Research and the Public Health Agency of Canada. Dr. Wilson is a Canadian Institutes of Health Research New Investigator.

1. World Health Organization, Third Report of Committee A: Revision of the International Health Regulations, (2005) 58th WHA, Agenda Item 13.1.

2. Lawrence O. Gostin, "International infectious disease law: revision of the World Health Organization's International Health Regulations" (2004) 291:21 JAMA 2623.

3. S. Carvalho & M. Zacher, "The International Health Regulations in Historical Perspective" in Andrew T. Price-Smith, ed., Plagues and Politics: Infectious Diseases and International Policy (New York: Palgrave Macmillan, 2001) 235.

4. Lawrence Gostin, "The International Health Regulations and beyond" (2004) 4 Lancet Infectious Diseases 606.

5. Richard A. Cash & Vascant Narasimhan, "Impediments to global surveillance of infectious diseases: consequences of open reporting in a global economy" (2000) 78 Bulletin of the World Health Organization 1358.

6. Lawrence O. Gostin, Ronald Bayer & Amy L. Fairchild, "Ethical and legal challenges posed by severe acute respiratory syndrome: implications for the control of severe infectious disease threats" (2003) 290 JAMA 3229.

7. World Health Organization, International Health Regulations Revision Project, Global crises, global solutions: managing public health emergencies of international concern through the revised International Health Regulations. (Geneva, Switzerland: World Health Organization, 2002).

8. United States, Department of Health and Human Services, News Release, "United States Officially Accepts New International Health Regulations"(13 December 2006), online: Department of Health and Human Services <http://www.dhhs.gov/news/press/2006pres/20061213.html>.

9. The revised IHR mandate that State Parties immediately notify WHO of cases of smallpox, polio, SARS, and novel strains of human influenza, as well as any event that potentially poses a public health emergency of international concern. In a bid to improve cooperation, however, the revised IHR do not impel the WHO to make such notifications automatically and immediately available to all other States Parties.

10. Canada, Public Health Agency of Canada, The Canadian Pandemic Plan for the Health Sector (Ottawa, Ont: PHAC, 2006), online: Public Health Agency of Canada <http://www.phac-aspc.gc.ca/cpip-pclcpi/>; U.S., Department of State, Bureau of Public Affairs, Avian Influenza: International Partnership To Meet A Global Threat (3 November 2005), online: Department of State <http://www.state.gov/documents/organization/56061.pdf>; EC, Commission, Communication on Pandemic Influenza Preparedness and Response Planning in the European Community (28 November 2005), online: EC <http://eur-lex.europa.eu/LexUriServ/site/en/com/2005/com2005_0607en01.pdf>; World Health Organisation, Global Influenza Preparedness Plan (2005), online: WHO <http://www.who.int/csr/resources/publications/influenza/WHO_CDS_CSR_GIP_2005_5/en/index.html>; Pan American Health Organization, World Health Organization, PAHO Strategic and Operational Plan for Responding to Pandemic Influenza (Draft, 23 September 2005), online: PAHO <http://www.paho.org/English/AD/DPC/CD/vir-flu-PAHO-Plan-9-05.pdf>; World Organization for Animal Health, Ensuring Good Governance to Address Emerging and Re-emerging Animal Disease Threats (2006), online: OIE <http://www.oie.int/downld/Prep_conf_Avian_inf/A_Pilot%20programme.pdf>; Food and Agricultural Organization & World Organization for Animal Health, A Global Strategy for the Progressive Control of Highly Pathogenic Avian Influenza (2005), online: FAO <http://www.fao.org/ag/againfo/subjects/documents/ai/HPAIGlobalStrategy31Oct05.pdf>; World Bank, East Asia Update: Countering Global Shocks (2005), online: World Bank <http://siteresources.worldbank.org/INTEAPHALFYEARLYUPDATE/Resources/EAP-Brief-final.pdf>; G8 Summit, Evian 2003, Health: A G8 Action Plan, online: G8 Russia <http://en.g8russia.ru/g8/history/evian2003/15/>.

11. Hannah Brown, "Countries call for accelerated adoption of IHR", online: (2005) The Lancet.com <http://www.thelancet.com/collections/avian_flu/report2>.

12. World Health Organization, Executive Board, Application of the International Health Regulations (26 January 2006) 117th Session, Agenda Item 4.2, online: WHO <http://www.who.int/gb/ebwha/pdf_files/EB117/B117_R7-en.pdf>.

13. David P. Fidler, "Emerging trends in international law concerning global infectious disease control" (2003) 9:3 Emerging Infectious Diseases 285.

14. GOARN is described by WHO as "a technical collaboration of existing institutions and networks who pool human and technical resources for the rapid identification, confirmation and response to outbreaks of international importance." See also World Health Organization, A framework for global outbreak alert and response (2001), online: WHO <http://www.who.int/csr/resources/publications/surveillance/WHO_CDS_CSR_20002/en>.

15. Supra note 1 at 14.

16. Ibid. at 13.

17. Unfortunately, this obligation is largely exhortative, since it is not accompanied by any specific targets, detailed program guidance, or enforceable minimum contribution levels, and no checklists for IHR-related official development assistance comparable to those for national public health capacities were included in the final version of the agreement. The agreement also lacks provisions regarding compensation to affected states for compliance with the requirements, which might have further minimized the incentive not to report.

18. Supra note 1 at 42, annex 1, item 2.

19. David P. Fidler, "Germs, governance, and global public health in the wake of SARS" (2004) 113:6 The Journal of Clinical Investigation 799.

20. Canada, Health Canada, National Advisory Committee on SARS and Public Health, Learning from SARS: Renewal of Public Health in Canada (Ottawa, Ont.: Health Canada, October 2003) at especially ch. 5 (Chair: Dr, David Naylor), online: Public Health Agency of Canada <http://www.phac-aspc.gc.ca/publicat/sars-sras/naylor/>; Kumanan Wilson, "The Role of Federalism in Health Surveillance. A Case Study of the National Health Surveillance 'Infostructure'" in D. Adams, ed., Federalism, Democracy, and Health Policy in Canada (Kingston, Ont.: McGill-Queen's University Press, 2001) at 207.

21. R. Deber, C.W. McDougall & K. Wilson, "Financing and Delivering Public Health in Canada's Provinces and Territories: Approaches, Issues, and Options: A research paper prepared for the Public Health Agency of Canada" (2006).

22. K. Wilson, "The complexities of multi-level governance in public health" (2004) 95:6 Canadian Journal of Public Health 409.

23. For more detailed analysis of varying legislative regimes for information handling across Canada, see Professor Elaine Gibson's article, "Public Health Information, Federalism and Politics," in this volume.

24. Institute of Intergovernmental Relations, Queen's University, "Proceedings of the Workshop on the State of National Governance Relative to the New International Health Regulations" (Ottawa, Ont.: September 20-21, 2006), online: Institute of Intergovernmental Relations <http://www.iigr.ca/iigr.php/confcrcnccs/IHRworkshop.html>.

25. Barbara von Tigerstrom, "The revised international health regulations and restraint of national health measures" (2005) 13 Health L.J. 35.

26. Ibid. at 58.

27. Ibid.

28. Berman Institute of Bioethics, The Bellagio Meeting on Social Justice and Influenza Bellagio, Statement of Principles (July 2006), online: Berman Institute of Bioethics <http://www.hopkinsmedicine.org/bioethics/bellagio/Bellagio_Statement.pdf>.

29. Ibid. at 1.

30. See also: Joint Centre for Bioethics, Pandemic Influenza Working Group, Stand on guard for thee: ethical considerations in preparedness planning for pandemic influenza (Toronto, Ont.: University of Toronto Joint Centre for Bioethics, 2005), online: University of Toronto <http://www.utoronto.ca/jcb/home/documents/pandemic.pdf>.

31. Obijiofor Aginam, "International law and communicable diseases" (2002) 80:12 Bulletin of the World Health Organization 946.

32. Laurie Garrett, "The Challenge of Global Health" (2007) 86 Foreign Affairs 14.

33. Supra note 24.

34. Michael G. Baker & David P. Fidler, "Global public health surveillance under new international health regulations" (2006) 12:7 Emerging Infectious Diseases 1058.

35. David P. Fidler & Lawrence O. Gostin, "The new International Health Regulations: an historic development for international law and public health" (2006) 34:1 J.L. Med. & Ethics 85.

36. Kumanan Wilson et al., "The new International Health Regulations and the federalism dilemma" (2006) 3:1 PLoS Medicine e1; Nancy E. Kass, "Public health ethics: from foundations and frameworks to justice and global public health" (2004) 32:2 J.L. Med. & Ethics 232; Yukata Arai-Takahashi, "The World Health Organization and the Challenges of Globalization: A Critical Analysis of the Proposed Revision to the International Health Regulations", online: (2004) Law, Social Justice & Global Development Journal (LGD) 1, <http://www2.warwick.ac.uk/fac/soc/law/elj/lgd/2004_1/arai/>.