REGIONAL COMMITTEE Fifty-eighth Session Colombo, Sri Lanka 6-10 September 2005
Provisional Agenda item 11 SEA/RC58/7 18 July 2005
INTERNATIONAL HEALTH REGUALATIONS (2005) The Tenth Meeting of Health Secretaries of countries in the SEA Region, held in Dhaka on 3-4 July 2005, deliberated, among other subjects, on the International Health Regulations (2005), which is also an Agenda item of the fifty-eighth session of the Regional Committee. The background document (SEA/HSM/Meet.10/4) prepared for the meeting is attached. The Meeting of Health Secretaries welcomed the adoption of the International Health Regulations (2005) by the Fifty-eighth World Health Assembly and expressed its appreciation to WHO for its support in the revision process. It emphasized the fact that Member States required technical and financial support in the implementation of the regulations in terms of capacity building, including strengthening of health systems and development of human resources. It called upon Member States to identify constraints and obstacles – administrative and legal – that may hinder timely adoption and implementation of the regulations; to promote intersectoral participation and involvement; and to strengthen intercountry and interregional cooperation for timely sharing of information and early diagnosis of priority communicable diseases. Furthermore, it requested Member States with advanced technical facilities to extend horizontal support to other countries. The meeting requested WHO to continue its technical support, convene a regional consultation, and to mobilize resources to support Member States to effectively implement the International Health Regulations (2005). The Agenda item is now submitted to the Regional Committee for its consideration.
WORLD HEALTH ORGANIZATION
REGIONAL OFFICE FOR SOUTH-EAST ASIA
Tenth Meeting of Health Secretaries of Countries of SEAR Dhaka, Bangladesh, 3-4 July 2005
SEA/HSM/Meet.10/4 8 June 2005
International Health Regulations (2005)
CONTENTS EXCUTIVE SUMMARY......................................................................................................... 1 1. BACKGROUND .............................................................................................................. 2 2. RATIONALE FOR REVISION OF INTERNATIONAL HEALTH REGULATIONS ............. 2 3. THE REVISION PROCESS ............................................................................................ 3 4. THE WHA RESOLUTION ............................................................................................... 4 5. IHR IMPLEMENTATION AND THE WAY FORWARD .................................................... 5 6. ISSUES FOR CONSIDERATION.................................................................................... 6 7. ROLE OF THE WHO REGIONAL OFFICE ..................................................................... 7 8. CONCLUSION................................................................................................................ 7
ACRONYMS AI CD CSR DG EB EC IGWG IHR MOH MS NFP PHEIC SARS SEAR SEARO WHA WHO avian influenza Communicable Diseases Communicable Diseases Surveillance and Response Director-General (WHO) Executive Board (WHO) Emergency Committee Inter-Governmental Working Group The International Health Regulations Ministry of Health Member State(s) National Focal Point (IHR) Public Health Emergency of International Concern severe acute respiratory syndrome South-East Asia Region Regional Office for South-East Asia World Health Assembly World Health Organization
EXCUTIVE SUMMARY The International Health Regulations (IHR), which are administered by WHO, have been in force since 1969. The IHR, which was revised in 1981, required Member States to notify only cholera, plague and yellow fever. These Regulations provided an essential and the only legal framework for sharing urgent epidemiological information on transboundary spread of infectious diseases. However, these Regulations were inadequate to address the evolving needs of combating disease outbreaks and other public health emergencies of international concern (PHEIC). This is particularly so in view of the growing threats from disease outbreaks related to the emergence of infectious pathogens which spread fast, facilitated by growing international travel and trade as well as potential that exists today for accidental or deliberate use of biological, chemical and radionuclear agents. Today, more than ever before, an outbreak or event in one country can constitute potential public health emergencies of international concern (PHEIC). Lessons from the recent pandemics of severe acute respiratory syndrome (SARS) and the outbreak of avian influenza (AI) in Asia are clear indications of this reality. In view of such mounting threats and the urgency to further strengthen global cooperation to combat such threats, it was imperative to review the existing legal framework to address these evolving needs. Cognizant of these global challenges and needs, Member States requested WHO to facilitate the revision process of the International Health Regulations. Accordingly, WHO established a Secretariat to expedite the revision process which produced a draft document for comments by all Member States and interested stakeholders. This draft was thoroughly reviewed through broad participation of all Member States, including through national, regional and global meetings which deliberated on the proposed changes in the articles and related annexes. After two meetings of the Intergovernmental Working Group (IGWG) in November 2004 and February 2005 and the resumed second IGWG meeting in May 2005, prior to the Fifty-eighth World Health Assembly, Member States have been able to achieve a consensus on the revised IHR document. With regard to the IHR revision process in the WHO SEA Region, Member States had been actively engaged in the whole revision process. National IHR focal points had been assigned and had played key roles in the revision process. National level workshops involving all relevant sectors and three regional consultations were conducted. Through these systematic and participatory consultative meetings, Member States of the Region made significant contributions to the IHR revision process and had achieved a sense of ownership of the revised IHR. After two meetings of the Intergovernmental Working Group (IGWG) and the resumed second IGWG meeting held on 12-13 May 2005 in Geneva, the revision process was completed to the satisfaction of all Member States and the revised draft submitted for consideration by the Fifty-eighth World Health Assembly. After intense deliberations in committee A, the revised Regulations were adopted by the Health Assembly on 21 May 2005. Henceforth the revised regulations are to be referred to as “International Health Regulations (2005)” This working paper is prepared (a) to provide background and rationale for the revision of the IHR document, (b) to brief Member States on the revision process and the salient features of the International Health Regulations (2005), including the expected role of Member States and the WHO Regional Office, and (c) to stimulate discussion on the implementation of IHR (2005) in terms of the challenges and opportunities ahead for the Member States of the Region.
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1.
BACKGROUND The last three decades have witnessed the emergence of at least 30 hitherto unrecognized infectious diseases, ranging from AIDS, nipah, ebola and SARS. On the other hand, diseases like malaria, cholera, meningitis, influenza and tuberculosis have re-emerged on an unprecedented scale1. Many of these infectious diseases cause epidemics, and often pandemics, that challenge the health systems in countries with limited resources. Outbreaks of infectious diseases can emerge in one country and eventually spread fast across geopolitical divide; and hence warrant urgent actions to scale up global effort to combat emerging infectious diseases.2,3 Today, as never before, infectious diseases pose threats to national and global health security and socioeconomic development. The recent emergence and fast spread of SARS to 29 countries showed this growing threat from emerging diseases. Likewise, the recent outbreak of avian influenza is yet another reminder of this growing threat. Several factors, including overcrowding and population growth, rapid globalization, growing antimicrobial resistance, and the emergence of new strains contribute to disease outbreaks. Moreover, the impact of the changing ecology, encounters of humans to disease vectors and reservoirs, mass production and marketing of processed food stuff over vast geographic area contribute to the emergence and fast spread of infectious diseases.4 In view of these challenges and evolving needs, it is imperative to strengthen capacity for early recognition, confirmation, notification and containment of outbreaks. It is also essential to improve the capacity to track, assess and verify rumours of outbreaks.5 To achieve these, there is a need to have a legal framework for improving partnerships for effective collaboration and networking among various stakeholders. Historically, international law has been important in facilitating such collaboration to control infectious diseases. While this role has never been more important and urgent, such legal instruments have to be revised to address the evolving challenges and enhance partnerships for combating outbreaks of infectious diseases.6 The International Health Regulations provide the only such legally binding framework and single code of practices to prevent transboundary spread of disease outbreaks.
2.
RATIONALE FOR REVISION OF INTERNATIONAL HEALTH REGULATIONS The International Sanitary Regulations (ISR)7, providing framework on quarantine measures, was adopted in 1951. These Regulations were revised and became the International Health Regulations (IHRs) in 1969. This is the only legally binding
WHO. Emerging Infectious Diseases; 1997; WHD97.1 WHO. Revision of the International Health Regulations: Severe Acute Respiratory Syndrome (SARS). 2003; A56/48 WHO. Consultation of priority public health interventions before and during an influenza pandemic, Geneva, 16-18 March 2004 4 Halstead S.B. Human factors in emerging infectious diseases. EMJH. 1996; (2):1:21-29 (http://www.emro.who.int/publications) 5 Grein WT, Kamara OK, Rodier G, et al. Rumors of disease in the global village: outbreak verification. WHO Perspectives 6 Fidler DP. Emerging Trends in International Law Concerning Global Infectious Disease Control. Emerg Inf Dis; 2003 (vol 9):3:285-290. 7 Bailey J. Guide to hygiene and sanitation in aviation. WHO, 1977. 2 3
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international instrument covering measures for preventing transboundary spread of infectious diseases. Initially, only six diseases were included in the list of diseases for notification. In 1981, the Regulations were revised to include notification only for plague, yellow fever and cholera. Even for these three diseases, IHR lacked mechanisms for collaboration and the provisions to take risk-specific measures directed at actual outbreaks. With increasing risk from more and more disease outbreaks, including disease risks not covered by the Regulations as well as threats from other public health emergencies of international concern (PHEIC), there was a definite need to revise the existing Regulations. The threats from emerging and re-emerging infectious diseases as well as other potential public health emergencies of international concern, including those from accidental or deliberate use of biological, chemical and radionuclear agents in the context of growing international travel and trade, clearly demonstrated that the existing Regulations had become outdated and inadequate to address these challenges and threats. In view of these evolving needs and potential public health emergencies of international concern, the Forty-eighth World Health Assembly called for a revision of the existing Regulations8. Based on this, and pursuant to resolution WHA56.28 to complete technical work required to facilitate the revision of the IHR document, WHO jointly with its Member States embarked on the process of revision.
3.
THE REVISION PROCESS All WHO regional offices facilitated consultation on the revision process and deliberated on the proposed draft IHR document circulated by the IHR revision team of WHO headquarters. At the regional level, three consultations were held for the purpose. The first regional consultation was followed by national-level workshops with the participation of all stakeholders such as ministries of agriculture, ministries of transport, customs and airports authorities, attorney general’s offices, ministries of defence and so on. Based on the outcome of national and regional-level consultations and inputs from Member States, the Secretariat produced a revised draft in September 2004 and circulated it to the countries. This revised version was the basis for the discussions at the first meeting of IGWG on the Revision of IHR, held from 1 to 12 November 2004 in Geneva. As a consensus could not be reached on a number of articles at the meeting, it was agreed that a second meeting of IGWG be convened from 21 to 26 February 2005, to further deliberate on the document. The second meeting of IGWG achieved much success as agreement was reached on most of the articles as well as all annexes. However, due to time constraints the meeting was not able to complete its work. Hence, it was decided to resume the second IGWG meeting on 12-13 May 2005, just prior to the Fifty-eighth Health Assembly. There were a number of key issues which were extensively discussed at the various consultative meetings that deserve special mention. These stood in the way of progress of the first as well as the second meeting of IGWG. However, the resumed second meeting of IGWG was able to resolve these issues to the mutual satisfaction of Member States. These issues and how they were resolved at IGWG, are stated below
8
WHA 48.7. 1995
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in view of the importance of some of these issues to Member States, including to some from this Region: (1) Definition of PHEIC: whether to have specific references to the origin of events either accidental or deliberate use (subsequently changed to “unexpected and unusual public health events”) and of biological, chemical and radionuclear agents (subsequently changed to “toxic, infectious or otherwise hazardous, not only those that may be occurring naturally or otherwise”). (2) Originally “The decision Instrument “did not contain a disease list, but ultimately it was agreed that it should be supplemented by disease lists, while retaining adequate flexibility to expand them, if and when the need arose. (3) Scope of the Regulations and role of WHO: The issue was whether the scope of IHR should be limited to cover PHEIC of biological origin only and leave the rest to other concerned agencies. In the end, it was agreed that there is a definite role for WHO to play in the instances of all PHEICs, irrespective of the origin and source and should be covered by the revised IHR. (4) Representation of affected countries in the emergency committee: This was an
issue proposed by the SEA Region (Thailand) and generated considerable debate as some felt that this contravened the existing procedures of selection of expert panel members. In the end, it was agreed that the Director-General may appoint experts, in consultation with the affected countries, whereby the experts may be drawn from the list of nominations received from the Member States for this purpose. (5) Information sharing during suspected intentional release: A number of Member
states had expressed concern on this issue and noted that sharing specimens or epidemiological information during an intentional release may be constrained by a criminal investigation and/or national security requirements. Ultimately, this issue was resolved amicably as Member States felt that such information sharing is vital for effective implementation of the revised IHR. (6) Use of information from sources other than from national authorities concerned when initiating the process of rumour verification: Member States agreed that such information may be used taking into consideration all the relevant factors, including the sensitivities of the countries concerned. (7) Verification procedures for PHEIC including team deployment: It was agreed that due consideration should be given to national sensitivities and respect for sovereignty of the countries concerned. (8) Strengthening core capacities in countries: A number of Member States have requested WHO to assess the resources needed to achieve the desired level of capacity and to assist in the mobilization of specific funds during the implementation phase of the revised Regulations.
4.
THE WORLD HEALTH ASSEMBLY RESOLUTION Following successful completion of the revision process, by agreeing to all the outstanding issues, the resumed second meeting of IGWG submitted the draft revised IHR document to the Fifty-eighth World Health Assembly for its consideration.
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At the Health Assembly, after extensive debate on the document in Committee A, the revised IHR document was submitted to the plenary for adoption, along with the draft resolution. The World Health Assembly adopted resolution WHA58.3 together with the document “International Health Regulations”, which thereafter should be referred to as the “International Health Regulations (2005)”. The purpose and scope of these Regulations are: “to prevent, protect against, control and provide a public health response to the international spread of disease in ways that are commensurate with and restricted to public health risks, and which avoid unnecessary interference with international traffic and trade”. Resolution WHA58.3 calls upon Member States and the Director-General to implement fully the International Health Regulations (2005) in accordance with the purpose and scope set out in Article 2 and the Principles embodied in Article 3. The resolution urges Member States to build, strengthen and maintain capacities required under the International Health Regulations (2005) and to mobilize resources for that purpose. In addition, the resolution urges Member States to collaborate actively with each other and WHO in accordance with the relevant provision of the International Health Regulations (2005) so as to ensure their effective implementation. Member States are also urged to take appropriate measures, pending the entry into force of the International Health Regulations (2005) for furthering their purpose and eventual implementation, including development of necessary public health, capacities and legal and administrative provisions. Resolution WHA58.3 calls upon the Director-General of WHO to give prompt notification of the adoption of the International Health Regulations (2005) to Member States and associate members of WHO and also other parties to relevant international sanitary agreements or regulations. The resolution also requests the Director-General, inter alia, to build and strengthen the capacities of WHO to perform fully and effectively the functions entrusted to it under International Health Regulations (2005), as appropriate, including through provision of facilities of technical cooperation and logistical approach. In addition, it requests the Director-General to collaborate with state parties to the extent possible in the mobilization of financial resources to provide support to developing countries in building, strengthening and maintaining the capacities required under the International Health Regulations (2005).
5.
IHR IMPLEMENTATION AND THE WAY FORWARD The International Health Regulations (2005) were adopted by the Fifty-eighth World Health Assembly in accordance with the Article 21 of the Constitution of WHO. These Regulations shall enter into force 24 months from the date of notification of the adoption by the Director-General, subject to any rejection or reservation that a Member State may have made as provided for in Article 22 of the Constitution of WHO, the duration for which, in this case, shall be 18 months from the date of notification of adoption by the Director-General. However, under certain specific circumstances, a state party may be given a further extension of 12 months for these Regulations to enter into force in respect of this/these specific country/countries.
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In view of the foregoing provisions with regard to entry into force of these Regulations, it is amply clear that the time available for both Member States and WHO for adequate preparation for implementation of International Health Regulations (2005), is very limited. There are many challenges ahead such as development of core capacity, health system development including human resources development, strengthening of health information system, upgradation of the existing health infrastructure at entry points such as ground crossings, ports and airports etc. in addition to domestic legislative and administrative arrangements, before Member States become fully capable of implementing these Regulations. All these are needed to be done within a short period of 2-3 years. And these activities are to be carried out concurrently with many other ongoing important health activities that are being undertaken in a routine manner. This obviously puts tremendous strain on the resources available for the health sector in many Member States, in terms of financial resources as well as health infrastructure. On the other hand, the challenges posed by emerging and re-emerging infectious diseases such as avian influenza, SARS, nipah virus etc. make the implementation of the International Health Regulations (2005) that much more urgent. It is obvious that these challenges cannot be faced by the health sector alone. Therefore, intersectoral participation is of paramount importance. Innovative approaches such as intercountry and horizontal cooperation between Member States of the Region need to be promoted. In addition, all efforts need to be made by Member States, with technical assistance from WHO and other international partners, to mobilize financial resources required to address these problems.
6.
ISSUES FOR CONSIDERATION Analysis of existing core capacity Most of the countries in the Region lack the necessary core capacity for effective implementation of IHR 2005. This relates to human resources, health facilities at seaports and airports and ground/sea crossing as well as other health systems including laboratory services. However, in order to assess the current status vis-à-vis the above requirements, a situation analysis/assessment will need to be conducted in the countries.
Determination of major constraints/obstacles It is anticipated that there may be constraints/obstacles other than those related to development of core capacity, such as various domestic, legislative and administrative arrangements that may need to be made in order for the countries to be fully capable of implementing IHR (2005). Therefore, the countries may wish to conduct national workshops, meetings and consultations to identify these issues and constraints.
Financial resources Shortage of necessary financial resources may be another issue that could impede effective implementation of IHR 2005. Therefore, Member States may need to consider
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the availability of adequate financial resources within the countries as well as plan for mobilizing external donor funding that may be available for the purpose.
7.
ROLE OF THE WHO REGIONAL OFFICE • Convene a regional consultation of national IHR focal points and other relevant stakeholders for the purpose of preparing a regional strategy and plan of action for implementation of IHR 2005, based on the global strategy for implementation of IHR 2005, to be formulated by WHO headquarters. Explore the possibility of mobilizing extrabudgetary funds for the purpose of building core capacity for the implementation of IHR at the Regional Office, country offices as well as Member States in the Region. Endeavour to provide all possible technical support and assistance to Member States in addressing those issues that are identified, including those referred to under Section 6 of this working paper by the Member States as being constraints for effective implementation of IHR 2005.
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8.
CONCLUSION In view of the limited time available to prepare for implementation of the International Health Regulations (2005) in terms of strengthening of core capacity at the regional level, country offices as well as in the countries, all efforts need to be concentrated on facilitating this process in an expeditious manner. Closer cooperation between WHO headquarters, the Regional Office and country offices is of paramount importance. This would involve exploring innovative approaches for resource mobilization by WHO headquarters and the Regional Office, intercountry and horizontal cooperation, and advocacy and political commitment by Member States of the Region.