Giuseppe
Emeritus
Preview - Report of the Review Committee on the Functioning of the International Health Regulations (2005) and on Pandemic Influenza A (H1N1) 2009 (WHO, March 11 2011)
[Source: World Health Organization, full PDF document (LINK). Edited.]
7 March 2011
Preview - Report of the Review Committee on the Functioning of the International Health Regulations (2005) and on Pandemic Influenza A (H1N1) 2009
For discussion at the meeting of the Review Committee, 28 March 2011
INTRODUCTION
In January 2010, at its 126th session, WHO?s Executive Board welcomed 1 the Director-General?s proposal to convene a Review Committee provided for in Chapter III of Part IX of the International Health Regulations 2005 (IHR). The Director-General?s proposal included a request for the Committee to review the experience gained in the global response to the influenza A (H1N1) 2009 pandemic, in order to inform the review of the functioning of the Regulations; to help assess and, where appropriate, to modify the ongoing response; and to strengthen preparedness for future pandemics.
The Committee?s remit follows:
The assessment of the global response to the pandemic H1N1 will be conducted by the International Health Regulations Review Committee, a committee of experts with a broad mix of scientific expertise and practical experience in public health. The members are some of the leading experts in the world in their respective fields.
The International Health Regulations (IHR) is an international legal agreement that is binding on 194 States? Parties across the globe, including all of the Member States of WHO. The basic purpose of the IHR is to help the international community prevent and respond to acute public health risks that have the potential to cross borders and threaten people worldwide. In January 2010, the WHO Executive Board requested a proposal from the Director-General on how to assess the international response to the pandemic influenza, and then approved her suggestion to convene the IHR Review Committee to review both the pandemic response and the functioning of the IHR.
The pandemic H1N1 is the first Public Health Emergency of International Concern to occur since the revised IHR came into force. The IHR played a central role in the global response to the pandemic and so review of the IHR and review of the 22 global handling of the pandemic influenza are closely related.
The IHR facilitate coordinated international action by requiring countries to report certain disease outbreaks and public health events to WHO so that global reporting of important public health events is timely and open.
The IHR were first implemented (i.e. ?entered into force?) worldwide in 2007 and the Health Assembly determined that a first review of its functioning is to take place by the Sixty-third World Health Assembly in May 2010.
Objectives
The review has three key objectives:
METHOD OF WORK
The Review Committee conducted a major portion of its work through plenary meetings at WHO?s headquarters in Geneva. For transparency, these meetings were open to the media. The Committee heard testimony from individuals representing States Parties, National IHR Focal Points, Intergovernmental organizations, nongovernmental organizations, United Nations agencies, industry, health professionals, experts, members of the media, chairs of relevant committees and the WHO Secretariat.
The full Committee and its working groups also met for deliberative sessions in Geneva, open only to members of the Committee and its immediate support staff. Further consultations took place among the support staff, the chair and working groups of the Committee by means of telephone conferences and e-mail exchange.
While operating independently, the Review Committee frequently sought information from WHO?s Secretariat, asking for clarification of issues that arose during the information-gathering and report-writing periods. WHO staff provided written responses to many questions posed by the Committee and spoke informally with Committee members. WHO provided the Committee with unfettered access to internal documents and Committee members signed non-disclosure agreements in order to review confidential legal documents.
The WHO Secretariat developed a series of briefing notes for the Committee, providing background on issues such as: the IHR; pandemic preparedness; pandemic phases; pandemic severity; pandemic vaccine; antiviral drugs; virological monitoring; disease monitoring; laboratory response; public health measures; and the Open-ended Working Group of Member States on Pandemic Influenza Preparedness: Sharing of Influenza Viruses and Access to Vaccines and Other Benefits. The Committee had access to a series of studies that evaluated the functioning of Annex 2 of the IHR (i.e. the decision instrument for States Parties? assessment and notification of public health events) as well as progress reports on the implementation of the IHR. At the Committee?s request, the WHO Secretariat devised a matrix of the key public health functions of the IHR and identified a broad range of non-pandemic events that had been notified to WHO since the IHR came into force. The Committee selected 18 events and directed the Secretariat to prepare a summary of each event to facilitate its assessment of the public health functions of the IHR.
The Committee sought to document WHO?s role and management in response to the pandemic and to evaluate the effectiveness of the IHR. This required a thorough investigation of events and decisions in the course of the pandemic, an examination of criticisms of the Organization and an assessment of its achievements. The goal from the outset has been to identify the best ways to protect the world in the next public health emergency. Throughout its deliberations, the Committee has aimed to be thorough, systematic, open and objective. The final report will provide a full description of the evidence presented to the Committee in interviews and documents, and the Committee?s assessment and interpretation of that evidence.
ORGANIZATION OF THE FINAL REPORT
The final report will have three main components. The first section describes the development and functions of the IHR. It also assesses pandemic preparedness in the context of earlier infectious outbreaks, such as severe acute respiratory syndrome (SARS) and avian influenza A (H5N1), and how these historic events shaped the global response to the pandemic in 2009.
The second section includes a chronology of the events of the pandemic. It provides a snapshot of decision-making in the early days of the outbreak.
Section three assesses the public health functions of the IHR in relationship to the pandemic and other events. It describes the global response to the pandemic and evaluates how WHO and the IHR performed in light of the first Public Health Emergency of International Concern, as defined by the IHR.
BACKGROUND AND CONTEXT
The IHR establish a regime for the routine protection of public health and provide for the management of disease threats, both in countries and at their borders. They also provide a framework for coordinated and proportionate responses to significant emerging disease threats. Such threats may range from public health events affecting one or more countries to events of global public health significance. The provisions of the IHR are legally binding on States Parties and WHO. The IHR introduced a number of key innovations, including the replacement of a list of notifiable diseases with a decision instrument (Annex 2), to assist countries to determine whether an event may constitute a Public Health Emergency of International Concern. The 2009 pandemic was the first major test of the IHR.
A review of the functioning of the IHR and how successfully WHO performed in response to the pandemic requires an understanding of the context of the pandemic. The Review Committee identified five factors that framed the events and help explain what happened in the pandemic response. Expressed simply, they are:
Influenza pandemics will continue to occur, if history and science are any guide. In this sense, influenza is grossly predictable. However, exactly when, where and how severe the next influenza pandemic will be, no one can predict. Because pandemics occur infrequently, there is a tendency to over-interpret the patterns of the past. For example, it may be tempting when considering the pandemics of 1918, 1957, 1968 and 2009 to conclude that successive pandemics tend to decline in severity. However, four observations are too few to support this conclusion. Research, especially on genetic markers of the virus and on host factors, may eventually increase the accuracy of predictions, but at present, lack of certainty is an inescapable reality when it comes to influenza. One key implication is the importance of flexibility to accommodate unexpected and changing conditions. The ability to take action in the face of uncertainty and to adapt rapidly to new circumstances are hallmarks of sound public health practice and emergency management.
The response to the emergence of pandemic influenza A (H1N1) 2009 was the result of a decade of pandemic planning, largely centred on the threat of an avian influenza A (H5N1) pandemic. However, H5N1 and H1N1 have markedly different characteristics. H5N1 infection in humans results in about 60% mortality among confirmed cases, yet it is only sporadically transmitted to humans and even less often between humans. When thinking about a potential H5N1 pandemic, large numbers of fatalities could be assumed because the virus had proved itself to be highly lethal. Since H5N1 was not easily transmissible from human to human, suppression of an outbreak through the use of antiviral drugs and other measures could be thought feasible. WHO?s web site has described the prospect of severe disease in a possible pandemic, which was understandable in the context of expectations about H5N1. But the reality of H1N1 was quite different. Because H1N1 caused illness that did not require hospitalization in the vast majority of cases, the question of severity of the pandemic and how to characterize it became a key challenge. As the H1N1 virus spread to several countries within days, the possibility of rapid containment, a tenet of planning in WHO?s multi-stage response, was never really feasible.
Another reality that shaped the response to the pandemic is the nature of WHO itself. WHO has a dual character and mission: as a moral voice for global health, and as a servant of its Member States. As the directing and coordinating authority on international health within the United Nations system, WHO is well-positioned to be a champion for health as a human right. Its policy and technical leadership can help countries cope with an array of public health concerns. At the same time, WHO is a servant of its 193 Member States, which meet every year at the World Health Assembly in Geneva to set policy for the Organization, approve the Organization?s budget and plans, and, through the Assembly?s Executive Board, elect the Director-General every five years. WHO?s scientific and technical aspirations for global health are constantly conditioned by the multiplicity of views, needs and preferences of its Member States.
WHO?s internal response capacities to health emergencies are geared towards relatively short term, geographically focal events, a type that WHO confronts many times each year. By contrast, the pandemic required a worldwide response lasting one to two years. Before the pandemic, SARS was the only global emergency in recent decades that provided WHO with a foretaste of the demands that a pandemic might entail. However, SARS lasted but a few months and affected only about two dozen countries.
CONCLUSIONS AND RECOMMENDATIONS
With this background and context, the Review Committee offers three overarching conclusions:
Summary conclusion 1
Summary conclusion 1
The IHR helped make the world better prepared to cope with public health emergencies. The core national and local capacities called for in the IHR are not yet fully operational and are not now on a path to timely implementation worldwide.
Development of the IHR required more than a decade of complex deliberations. While the IHR are not perfect, they significantly advance the protection of global health. The Committee has focused its recommendations on how ongoing implementation of the IHR can be strengthened. The IHR seek to balance the sovereignty of individual States Parties with the common good of the international community, and take account of economic and social interests as well as the protection of health. The Committee?s recommendations acknowledge these inherent tensions and focus on actions that can enhance the shared goal of global public health security.
The Committee commends the following provisions of the IHR:
The most important structural shortcoming of the IHR is the lack of enforceable sanctions. For example, if a country fails to explain why it has adopted more restrictive traffic and trade measures than those recommended by WHO, no legal consequences follow.
To remedy a number of these problems, the Committee recommends the following:
Summary conclusion 2
WHO performed well in many ways during the pandemic, confronted systemic difficulties and demonstrated some shortcomings. The Committee found no evidence of malfeasance. As noted in testimony by States Parties, WHO provided welcome leadership in coordinating the global response throughout the pandemic. WHO?s epidemic intelligence functions have strengthened in recent years as a result of the Event Management System, increases in Regional Office capacity, and the Global Outbreak Alert and Response Network.
The Committee commends the following actions by WHO and other partners:
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[Source: World Health Organization, full PDF document (LINK). Edited.]
7 March 2011
Preview - Report of the Review Committee on the Functioning of the International Health Regulations (2005) and on Pandemic Influenza A (H1N1) 2009
For discussion at the meeting of the Review Committee, 28 March 2011
INTRODUCTION
In January 2010, at its 126th session, WHO?s Executive Board welcomed 1 the Director-General?s proposal to convene a Review Committee provided for in Chapter III of Part IX of the International Health Regulations 2005 (IHR). The Director-General?s proposal included a request for the Committee to review the experience gained in the global response to the influenza A (H1N1) 2009 pandemic, in order to inform the review of the functioning of the Regulations; to help assess and, where appropriate, to modify the ongoing response; and to strengthen preparedness for future pandemics.
The Committee?s remit follows:
The assessment of the global response to the pandemic H1N1 will be conducted by the International Health Regulations Review Committee, a committee of experts with a broad mix of scientific expertise and practical experience in public health. The members are some of the leading experts in the world in their respective fields.
The International Health Regulations (IHR) is an international legal agreement that is binding on 194 States? Parties across the globe, including all of the Member States of WHO. The basic purpose of the IHR is to help the international community prevent and respond to acute public health risks that have the potential to cross borders and threaten people worldwide. In January 2010, the WHO Executive Board requested a proposal from the Director-General on how to assess the international response to the pandemic influenza, and then approved her suggestion to convene the IHR Review Committee to review both the pandemic response and the functioning of the IHR.
The pandemic H1N1 is the first Public Health Emergency of International Concern to occur since the revised IHR came into force. The IHR played a central role in the global response to the pandemic and so review of the IHR and review of the 22 global handling of the pandemic influenza are closely related.
The IHR facilitate coordinated international action by requiring countries to report certain disease outbreaks and public health events to WHO so that global reporting of important public health events is timely and open.
The IHR were first implemented (i.e. ?entered into force?) worldwide in 2007 and the Health Assembly determined that a first review of its functioning is to take place by the Sixty-third World Health Assembly in May 2010.
Objectives
The review has three key objectives:
- Assess the functioning of the International Health Regulations (2005);
- Assess the ongoing global response to the pandemic H1N1 (including the role of WHO); and
- Identify lessons learnt important for strengthening preparedness and response for future pandemics and public health emergencies.
METHOD OF WORK
The Review Committee conducted a major portion of its work through plenary meetings at WHO?s headquarters in Geneva. For transparency, these meetings were open to the media. The Committee heard testimony from individuals representing States Parties, National IHR Focal Points, Intergovernmental organizations, nongovernmental organizations, United Nations agencies, industry, health professionals, experts, members of the media, chairs of relevant committees and the WHO Secretariat.
The full Committee and its working groups also met for deliberative sessions in Geneva, open only to members of the Committee and its immediate support staff. Further consultations took place among the support staff, the chair and working groups of the Committee by means of telephone conferences and e-mail exchange.
While operating independently, the Review Committee frequently sought information from WHO?s Secretariat, asking for clarification of issues that arose during the information-gathering and report-writing periods. WHO staff provided written responses to many questions posed by the Committee and spoke informally with Committee members. WHO provided the Committee with unfettered access to internal documents and Committee members signed non-disclosure agreements in order to review confidential legal documents.
The WHO Secretariat developed a series of briefing notes for the Committee, providing background on issues such as: the IHR; pandemic preparedness; pandemic phases; pandemic severity; pandemic vaccine; antiviral drugs; virological monitoring; disease monitoring; laboratory response; public health measures; and the Open-ended Working Group of Member States on Pandemic Influenza Preparedness: Sharing of Influenza Viruses and Access to Vaccines and Other Benefits. The Committee had access to a series of studies that evaluated the functioning of Annex 2 of the IHR (i.e. the decision instrument for States Parties? assessment and notification of public health events) as well as progress reports on the implementation of the IHR. At the Committee?s request, the WHO Secretariat devised a matrix of the key public health functions of the IHR and identified a broad range of non-pandemic events that had been notified to WHO since the IHR came into force. The Committee selected 18 events and directed the Secretariat to prepare a summary of each event to facilitate its assessment of the public health functions of the IHR.
The Committee sought to document WHO?s role and management in response to the pandemic and to evaluate the effectiveness of the IHR. This required a thorough investigation of events and decisions in the course of the pandemic, an examination of criticisms of the Organization and an assessment of its achievements. The goal from the outset has been to identify the best ways to protect the world in the next public health emergency. Throughout its deliberations, the Committee has aimed to be thorough, systematic, open and objective. The final report will provide a full description of the evidence presented to the Committee in interviews and documents, and the Committee?s assessment and interpretation of that evidence.
ORGANIZATION OF THE FINAL REPORT
The final report will have three main components. The first section describes the development and functions of the IHR. It also assesses pandemic preparedness in the context of earlier infectious outbreaks, such as severe acute respiratory syndrome (SARS) and avian influenza A (H5N1), and how these historic events shaped the global response to the pandemic in 2009.
The second section includes a chronology of the events of the pandemic. It provides a snapshot of decision-making in the early days of the outbreak.
Section three assesses the public health functions of the IHR in relationship to the pandemic and other events. It describes the global response to the pandemic and evaluates how WHO and the IHR performed in light of the first Public Health Emergency of International Concern, as defined by the IHR.
BACKGROUND AND CONTEXT
The IHR establish a regime for the routine protection of public health and provide for the management of disease threats, both in countries and at their borders. They also provide a framework for coordinated and proportionate responses to significant emerging disease threats. Such threats may range from public health events affecting one or more countries to events of global public health significance. The provisions of the IHR are legally binding on States Parties and WHO. The IHR introduced a number of key innovations, including the replacement of a list of notifiable diseases with a decision instrument (Annex 2), to assist countries to determine whether an event may constitute a Public Health Emergency of International Concern. The 2009 pandemic was the first major test of the IHR.
A review of the functioning of the IHR and how successfully WHO performed in response to the pandemic requires an understanding of the context of the pandemic. The Review Committee identified five factors that framed the events and help explain what happened in the pandemic response. Expressed simply, they are:
- the core values of public health;
- the unpredictable nature of influenza;
- the threat of avian influenza A (H5N1) and how it shaped general pandemic preparedness;
- WHO?s dual role as a moral voice for health in the world and as a servant of its Member States;
- the limitations of systems that were designed to respond to a geographically focal, short-term emergency, rather than a global, sustained, long-term event.
Influenza pandemics will continue to occur, if history and science are any guide. In this sense, influenza is grossly predictable. However, exactly when, where and how severe the next influenza pandemic will be, no one can predict. Because pandemics occur infrequently, there is a tendency to over-interpret the patterns of the past. For example, it may be tempting when considering the pandemics of 1918, 1957, 1968 and 2009 to conclude that successive pandemics tend to decline in severity. However, four observations are too few to support this conclusion. Research, especially on genetic markers of the virus and on host factors, may eventually increase the accuracy of predictions, but at present, lack of certainty is an inescapable reality when it comes to influenza. One key implication is the importance of flexibility to accommodate unexpected and changing conditions. The ability to take action in the face of uncertainty and to adapt rapidly to new circumstances are hallmarks of sound public health practice and emergency management.
The response to the emergence of pandemic influenza A (H1N1) 2009 was the result of a decade of pandemic planning, largely centred on the threat of an avian influenza A (H5N1) pandemic. However, H5N1 and H1N1 have markedly different characteristics. H5N1 infection in humans results in about 60% mortality among confirmed cases, yet it is only sporadically transmitted to humans and even less often between humans. When thinking about a potential H5N1 pandemic, large numbers of fatalities could be assumed because the virus had proved itself to be highly lethal. Since H5N1 was not easily transmissible from human to human, suppression of an outbreak through the use of antiviral drugs and other measures could be thought feasible. WHO?s web site has described the prospect of severe disease in a possible pandemic, which was understandable in the context of expectations about H5N1. But the reality of H1N1 was quite different. Because H1N1 caused illness that did not require hospitalization in the vast majority of cases, the question of severity of the pandemic and how to characterize it became a key challenge. As the H1N1 virus spread to several countries within days, the possibility of rapid containment, a tenet of planning in WHO?s multi-stage response, was never really feasible.
Another reality that shaped the response to the pandemic is the nature of WHO itself. WHO has a dual character and mission: as a moral voice for global health, and as a servant of its Member States. As the directing and coordinating authority on international health within the United Nations system, WHO is well-positioned to be a champion for health as a human right. Its policy and technical leadership can help countries cope with an array of public health concerns. At the same time, WHO is a servant of its 193 Member States, which meet every year at the World Health Assembly in Geneva to set policy for the Organization, approve the Organization?s budget and plans, and, through the Assembly?s Executive Board, elect the Director-General every five years. WHO?s scientific and technical aspirations for global health are constantly conditioned by the multiplicity of views, needs and preferences of its Member States.
WHO?s internal response capacities to health emergencies are geared towards relatively short term, geographically focal events, a type that WHO confronts many times each year. By contrast, the pandemic required a worldwide response lasting one to two years. Before the pandemic, SARS was the only global emergency in recent decades that provided WHO with a foretaste of the demands that a pandemic might entail. However, SARS lasted but a few months and affected only about two dozen countries.
CONCLUSIONS AND RECOMMENDATIONS
With this background and context, the Review Committee offers three overarching conclusions:
Summary conclusion 1
- The IHR helped make the world better prepared to cope with public health emergencies. The core national and local capacities called for in the IHR are not yet fully operational and are not now on a path to timely implementation worldwide.
- WHO performed well in many ways during the pandemic, confronted systemic difficulties and demonstrated some shortcomings. The Committee found no evidence of malfeasance.
- The world is ill-prepared to respond to a severe influenza pandemic or to any similarly global, sustained and threatening public health emergency. Beyond implementation of core public health capacities called for in the IHR, global preparedness can be advanced through research, strengthened health-care delivery systems, economic development in low- and middle-income countries and improved health status.
Summary conclusion 1
The IHR helped make the world better prepared to cope with public health emergencies. The core national and local capacities called for in the IHR are not yet fully operational and are not now on a path to timely implementation worldwide.
Development of the IHR required more than a decade of complex deliberations. While the IHR are not perfect, they significantly advance the protection of global health. The Committee has focused its recommendations on how ongoing implementation of the IHR can be strengthened. The IHR seek to balance the sovereignty of individual States Parties with the common good of the international community, and take account of economic and social interests as well as the protection of health. The Committee?s recommendations acknowledge these inherent tensions and focus on actions that can enhance the shared goal of global public health security.
The Committee commends the following provisions of the IHR:
- The IHR oblige WHO to obtain expert advice on the declaration and discontinuation of a Public Health Emergency of International Concern.
- The IHR strongly encourage countries to provide each other with technical cooperation and logistical support for capacity building.
- The IHR encourage establishment of systematic approaches to surveillance, early warning systems and response in Member States.
- The IHR required the establishment of National IHR Focal Points to create a clear two way channel of communication between WHO and Member States.
- The IHR led a number of countries to strengthen surveillance, risk assessment, response capacity and reporting procedures for public health risks.
- The IHR introduced a decision instrument (Annex 2) for public health action that has proved more flexible and useful than the list of notifiable diseases it replaced.
- The IHR require countries to share information relevant to public health risks.
- The IHR require States Parties that implement additional health measures significantly interfering with international traffic and trade to inform WHO about these measures, and to provide the public health rationale and relevant scientific information for them.
The most important structural shortcoming of the IHR is the lack of enforceable sanctions. For example, if a country fails to explain why it has adopted more restrictive traffic and trade measures than those recommended by WHO, no legal consequences follow.
To remedy a number of these problems, the Committee recommends the following:
- Recommendation 1
- Accelerate implementation of core capacities required by the IHR. WHO and States Parties should refine and update their strategies for implementing the capacity-building requirements of the IHR, focusing first on those countries that will have difficulty meeting the 2012 deadline for core capacities.
- One possible way to support and accelerate implementation would be for WHO to enlist appropriate agencies and organizations that would be willing to provide technical assistance to help interested countries assess their needs and make the business case for investment. Making the case for investment in IHR capacity building and subsequent resource mobilization would increase the likelihood that more States Parties could come into compliance with the IHR.
- Recommendation 2
- Enhance the WHO Event Information Site. WHO should enhance its Event Information Site to make it an authoritative resource for disseminating reliable, up-to-date and readily accessible international epidemic information. States Parties should be able to rely on the Event Information Site as a primary source for such information.
- Recommendation 3
- Reinforce evidence-based decisions on traffic and trade. When States Parties implement traffic and trade measures more restrictive than those recommended by WHO, IHR Article 43 provides that the States Parties shall inform WHO of their actions. WHO should energetically seek to obtain the public health rationale and relevant scientific information, share it with other States Parties, and, where appropriate, request reconsideration, as stipulated under Article 43. WHO should convene an expert panel to review and assess the effectiveness and impact of border measures taken during the pandemic to support evidence-based guidance for future events.
- Recommendation 4
- Ensure necessary authority and resources for all National IHR Focal Points. States Parties should ensure that designated National IHR Focal Points have the authority, resources, procedures, knowledge and training to communicate with all levels of their governments and on behalf of their governments as necessary.
Summary conclusion 2
WHO performed well in many ways during the pandemic, confronted systemic difficulties and demonstrated some shortcomings. The Committee found no evidence of malfeasance. As noted in testimony by States Parties, WHO provided welcome leadership in coordinating the global response throughout the pandemic. WHO?s epidemic intelligence functions have strengthened in recent years as a result of the Event Management System, increases in Regional Office capacity, and the Global Outbreak Alert and Response Network.
The Committee commends the following actions by WHO and other partners:
- Development of influenza preparedness and response guidance to help inform national plans. Pandemic preparedness plans were in place in 74% of countries when the pandemic began.
- Effective partnering and interagency coordination (with the United Nations Children?s Fund and the United Nations Office for Project Services), including close cooperation with the animal health sector (the World Organisation for Animal Health, and the Food and Agriculture Organization) on technical and policy issues.
- Rapid field deployment and early guidance and assistance to affected countries.
- Timely detection, identification, initial characterization and monitoring of the pandemic (H1N1) 2009 virus through the Global Influenza Surveillance Network.
- Selection of the pandemic vaccine virus and development of the first-candidate vaccine reassortant virus within 32 days of declaration of the Public Health Emergency of International Concern.
- Vaccine seed strains and control reagents made available within a few weeks.
- Early policy recommendations on target groups and dosage of vaccines by the WHO Strategic Advisory Group of Experts (SAGE).
- Weekly collation, analysis and reporting of global epidemiological, virological and clinical surveillance data.
- Prompt appointment of an Emergency Committee with well-qualified individuals, which was convened within 48 hours of activation of IHR provisions.
- Efficient distribution of more than 3 million treatment courses of antiviral drugs to 72 countries.
- Establishment of a mechanism to help countries monitor their development of IHR core capacities.
- The absence of a consistent, measurable and understandable depiction of severity of the pandemic. Even if the definition of a pandemic depends exclusively on spread, its degree of severity affects policy choices, personal decisions and the public interest. What is needed is a proper assessment of severity at national and sub-national levels. These data would inform WHO's analysis of the global situation as it evolves, allowing WHO to provide timely information to Member States. The Committee does, however, recognize that characterization of severity is complex and difficult to operationalize.
- Inadequately dispelling confusion about the definition of a pandemic. One online WHO document described pandemics as causing ?enormous numbers of deaths and illness?, while the official definition of a pandemic was based only on the degree of spread. When, without notice or explanation, WHO altered some of its online documents to be more consistent with its intended definition of a pandemic, the Organization invited suspicion of a surreptitious shift in definition rather than an effort to make its descriptions of a pandemic more precise and consistent. Reluctance to acknowledge its part in allowing misunderstanding of the intended definition fuelled suspicion of the Organization.
- A pandemic phase structure that was needlessly complex. The multi-phase structure contains more stages than differentiated responses. Defined phases leading to a pandemic are more useful for planning purposes than for operational management.
- Weekly requests for specific data were overwhelming to some countries, particularly those with limited epidemiological and laboratory capacity. Country officials were not always convinced the data they submitted were being analysed and used, particularly as the epidemic progressed. Continued counting of cases yielded less useful information than would have been provided by rates of hospitalization, complications and death in countries affected early on in the pandemic.
- The decision to keep confidential the identities of Emergency 298 Committee members. Although confidentiality represented an understandable effort to protect the members from external pressures, this paradoxically fed suspicions that the Organization had something to hide. While the decision was consistent with WHO practices for other expert committees, whose identities are normally divulged only at the end of what is often a one-day consultation, this practice was not well-suited to a Committee whose service would extend over many months.
- Lack of a sufficiently robust, systematic and open set of procedures for disclosing, recognizing and managing conflicts of interest among expert advisers. In particular, potential conflicts of interest among Emergency Committee members were not managed in a timely fashion by WHO. Five members of the Emergency Committee and an Adviser to the Emergency Committee declared potential conflicts of interest. None of these were determined sufficiently important to merit the members? exclusion from the Emergency Committee. The relationships in question were published, along with the names of the members of the Emergency Committee, when the pandemic was declared over on 10 August 2010. Before this information was published, however, assumptions about potential ties between Emergency Committee members and industry led some to suspect wrongdoing. The Review Committee recognizes that WHO is taking steps to improve its management of conflicts of interest, even as this review has proceeded.
- At a critical point of decision-making about the pandemic (moving from Phase 4 to 5), conferring with only a subset of the Emergency Committee rather than inviting input from the full Emergency Committee.
- The decision to diminish proactive communication with the media after declaring Phase 6 (for example, by discontinuing routine press conferences focused on the evolving pandemic) was ill-advised.
- Failure to acknowledge legitimate reasons for some criticism, in particular, inconsistent descriptions of a pandemic, or the lack of timely disclosure of relationships potentially constituting a conflict of interest among experts who advised on plans and response to the pandemic. In such instances, WHO may have inadvertently contributed to confusion and suspicion.
- Responding with insufficient vigour to criticisms that questioned the integrity of the Organization.
- Despite the ultimate deployment of 78 million doses of pandemic influenza vaccine to 77 countries, numerous systemic difficulties impeded WHO?s ability to achieve a timely distribution of donated vaccines. Negotiations over legal agreements with manufacturers were protracted and in some cases unsuccessful. Excessive complexity in donor and recipient agreements hindered timely execution. Obtaining regulatory approvals, dealing with liability concerns over vaccine used in recipient countries, assuring maintenance of the cold chain throughout vaccine distribution and securing plans for local vaccine administration added to the delays. These difficulties proved daunting in the midst of a pandemic; some could have been reduced by more concerted preparation and arrangements in advance of a pandemic.
- Lack of timely guidance in all official languages of WHO.
- Lack of a cohesive, overarching set of procedures and priorities for publishing consistent and timely technical guidance resulted in a multiplicity of technical units within the Organization individually generating an unmanageable 344 number of documents.
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