Influenza Pandemic: Efforts to Forestall Onset Are Under Way; Identifying Countries at Greatest Risk Entails Challenges
Published: 2007-06-20T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: Since 2003, a global epidemic of avian influenza has raised concern about the risk of an influenza pandemic among humans, which could cause millions of deaths. The United States and its international partners have begun implementing a strategy to forestall (prevent or delay) a pandemic and prepare to cope should one occur. Disease experts generally agree that the risk of a pandemic strain emerging from avian influenza in a given country varies with (1) environmental factors, such as disease presence and certain high-risk farming practices, and (2) preparedness factors, such as a country's capacity to control outbreaks. This report describes (1) U.S. and international efforts to assess pandemic risk by country and prioritize countries for assistance and (2) steps that the United States and international partners have taken to improve the ability to forestall a pandemic. To address these objectives, we interviewed officials and analyzed data from U.S. agencies, international organizations, and nongovernmental experts. The U.S. and international agencies whose efforts we describe reviewed a draft of this report. In general, they concurred with our findings. Several provided technical comments, which we incorporated as appropriate.
section_title: What GAO Found
paragraphs: Assessments by U.S. agencies and international organizations have identified widespread risks of the emergence of pandemic influenza and the United States has identified priority countries for assistance, but information gaps limit the capacity for comprehensive comparisons of risk levels by country. Several assessments we examined, which have considered environmental or preparedness-related risks or both, illustrate these gaps. For example, a U.S. Agency for International Development (USAID) assessment categorized countries according to the level of environmental risk--considering factors such as disease presence and the likelihood of transmission from nearby countries, but factors such as limited understanding of the role of poultry trade or wild birds constrain the reliability of the conclusions. Further, USAID, the State Department, and the United Nations have administered questionnaires to assess country preparedness and World Bank-led missions have gathered detailed information in some countries, but these efforts do not provide a basis for making comprehensive global comparisons. Efforts to get better information are under way but will take time. The U.S. Homeland Security Council has designated priority countries for assistance, and agencies have further identified several countries as meriting the most extensive efforts, but officials acknowledge that these designations are based on limited information. The United States has played a prominent role in global efforts to improve avian and pandemic influenza preparedness, committing the greatest share of funds and creating a framework for managing its efforts. Through 2006, the United States had committed about $377 million, 27 percent of the $1.4 billion committed by all donors. USAID and the Department of Health and Human Services have provided most of these funds for a range of efforts, including stockpiles of protective equipment and training foreign health professionals in outbreak response. The State Department coordinates international efforts and the Homeland Security Council monitors progress. More than a third of U.S. and overall donor commitments have gone to individual countries, with more than 70 percent of those going to U.S. priority countries. The U.S. National Strategy for Pandemic Influenza Implementation Plan provides a framework for U.S. international efforts, assigning agencies specific action items and specifying performance measures and time frames for completion. The Homeland Security Council reported in December 2006 that all international actions due to be completed by November had been completed, and provided evidence of timely completion for the majority of those items.

section_title: Letter
paragraphs: Since the end of 2003, a global epidemic of avian influenza among poultry  has raised concern about the risk of a global influenza epidemic—a  pandemic—occurring among humans. Though initially confined to  Southeast Asia, since mid-2005, this epidemic has spread to the Middle  East, Europe, and Africa and has caused the deaths of more than 250  million poultry, either directly or as a result of culling programs designed  to stop its spread. While thus posing a serious threat to farmer livelihoods,  the H5N1 strain of influenza that is causing this epidemic has also  demonstrated the ability to infect and kill humans. From 2003 through  2006, more than 260 humans contracted the H5N1 strain and more than  half of them died. Nearly all of these cases resulted from contact with  infected poultry. However, if H5N1 develops the ability to pass easily  among humans, an influenza pandemic could ensue. In contrast to the  more moderate health threat presented by annual outbreaks of seasonal  influenza, pandemic influenza poses a grave threat to global public health.  Scientists estimate that the pandemic of 1918 to 1919 killed more than 50  million humans, including an estimated 675,000 Americans, although the  last two pandemics (in 1957 and 1968) were milder.
Disease experts caution that it is not possible to predict when or where  the next influenza pandemic will begin—or whether it will involve H5N1.  Nonetheless, concern that H5N1 may spark a pandemic has increased as  the virus has spread among countries with comparatively high levels of  environmental and preparedness-related risk—that is, countries where  the virus is already present, or is present in a neighboring country, and a  range of conditions, such as high-risk poultry farming practices, are  conducive to H5N1 spreading in poultry and infecting humans  (environmental risk) and    animal and human health systems are relatively unprepared to detect or  respond appropriately to this virus (preparedness risk).
The United Nations World Health Organization (WHO) has concluded that  the H5N1 epidemic in poultry has brought the world closer to an influenza  pandemic than at any time in the last 40 years. Concern about this threat  has prompted the United States and its international partners to launch  efforts aimed at improving global preparedness to both forestall (prevent  or at least delay) the onset of an influenza pandemic and cope with a  pandemic should one occur. As agreed with your offices, we focused on  U.S. and international efforts to forestall a pandemic. This report  addresses (1) the extent to which U.S. agencies and their international  partners have assessed the country-by-country risk of H5N1 sparking a  pandemic and prioritized countries for international assistance and (2) the  steps that U.S. agencies and their international partners have taken to  improve global preparedness to forestall a pandemic.
In related work, we are examining constraints on the use of vaccines and  antiviral drugs to help in forestalling a pandemic and efforts that are under  way to overcome these constraints. Our analysis of these issues will be  published in a separate report.
To address our objectives, we reviewed relevant Department of  Agriculture (USDA), Department of Health and Human Services (HHS),  Department of Defense (DOD), Department of State, and U.S. Agency for  International Development (USAID) planning, funding, and reporting  documents for avian and pandemic influenza programs and discussed  them with agency officials. We examined and analyzed documents such as  country risk and preparedness assessments, operational plans, and budget  spreadsheets. We also analyzed the U.S government’s strategy and plan for  addressing pandemic influenza and associated reports on progress  through December 2006. In addition, we studied relevant documents from  the United Nations (UN) and other international organizations, including  WHO, the United Nations Food and Agriculture Organization (FAO), the  World Bank, and the World Organization for Animal Health (OIE). Finally,  we consulted with nongovernmental and academic experts on avian and  pandemic influenza. We determined that the data provided to us were  sufficiently reliable for the purposes of this report. We conducted our  work from January 2006 through March 2007 in accordance with generally  accepted government auditing standards. Appendix I provides a detailed  description of our scope and methodology. A list of other GAO reports on  pandemic preparedness, influenza vaccine development, and related  topics is included at the end of this report.
subsections: section_title: Background
paragraphs: H5N1 has spread to infect poultry and wild birds over a wide geographic  area. After appearing in southeastern China and Hong Kong in 1996 and  1997, the virus reappeared in late 2003 and early 2004 in a number of other  Southeast Asian countries. In 2005 and 2006, it spread rapidly to countries  in other parts of Asia and to Europe and Africa. Through December 2006,  H5N1 had been detected in poultry and wild birds in nearly 60 countries.  Figure 1 shows the progression of the disease across countries and also  notes which of those countries have experienced human cases.
H5N1 has infected increasing numbers of humans. WHO confirmed only 4  cases of H5N1 infection among humans in 2003, and 3 of these occurred in  one country, Vietnam. In contrast, WHO confirmed 115 human cases in  2006, in nine different countries. Table 1 shows how the number and  distribution of human cases grew from 2003 through 2006. The largest  numbers of human cases occurred in Southeast Asian countries where the  virus is well established in wild and domestic birds.
Pandemics can occur when influenza strains emerge that have never  circulated among humans but can cause serious illness in them and can  pass easily from one person to the next. H5N1 has shown that it can cause  serious illness in humans, and could spark a pandemic if it evolves into a  strain that has the ability to pass easily from one human to the next.
H5N1 may evolve into such a strain gradually, through accumulation of a  number of small mutations, or suddenly, through the introduction of  genetic material from another influenza virus. Influenza A viruses, which  cause both avian influenza outbreaks and human influenza pandemics,  occur naturally in wild birds and can also infect pigs, humans, and other  mammals. The various subtypes, including H5N1, mutate as they  reproduce in their avian or mammal hosts. These small mutations  continually produce new strains with slightly different characteristics.  More rarely, when an animal or human is infected with two different  subtypes, an entirely new subtype can emerge. Scientists believe that the  1957 and 1968 pandemics began when subtypes circulating in birds and  humans simultaneously infected and combined into new subtypes in other  host animals, most likely pigs.
subsections: section_title: Pandemic Risk Varies with Environmental Conditions and Preparedness
paragraphs: Disease experts caution that there are significant gaps in our  understanding of the H5N1 virus in wild and domestic birds and in  humans, and it is not possible to quantify the pandemic risk presented by  this strain. However, they generally agree that the level of risk that H5N1  will spark a pandemic varies with (1) environmental factors, defined as the  extent to which a country or region has already become infected with the  virus—or may become infected from a neighboring country—and provides  conditions in which the virus can spread in poultry and infect humans, and  (2) preparedness factors, defined as the extent to which the country or  region is prepared to detect the virus in poultry and humans and respond  appropriately.
Taking both environmental and preparedness factors into consideration,  the risk of a pandemic emerging from the current H5N1 epidemic in  poultry is considered higher in countries or regions where  the virus is well-established among domestic poultry;  there is substantial risk that wild birds or unregulated trade in poultry and  other birds will introduce the virus from neighboring infected countries;  large numbers of poultry are raised in heavily populated areas;    high-risk agricultural practices (such as allowing poultry unrestricted  access to family homes and selling them in “wet markets”) are common;  local authorities have little ability to detect, diagnose, and report H5N1  cases or outbreaks in either poultry or humans; or  local authorities have little ability to respond (apply control measures) and  contain outbreaks when they occur.
In such conditions, outbreaks among humans or poultry are more likely to  occur and to persist for prolonged periods before they are detected or  investigated. This increases the potential for mutations, and thus the  emergence of a pandemic strain.
section_title: Different Systems and Approaches Are Used to Control Influenza in Animals and Humans
paragraphs: The global community maintains separate systems for addressing  influenza and other infectious diseases in animals and humans. At the  country level, agricultural agencies are responsible for addressing disease  threats to animals, while public health agencies are responsible for  addressing disease threats to humans. International organizations support  and coordinate these national efforts. In particular, OIE and FAO share  lead responsibility for addressing infectious disease threats to animal  health, while WHO leads efforts to safeguard humans. National agencies  with technical expertise, such as USDA and HHS, assist in these efforts.
The animal and human health systems have traditionally approached  influenza in different ways. The animal health system has emphasized  measures to protect flocks from exposure to influenza—for example, by  reducing contact with wild birds—and, when outbreaks nonetheless  occur, taking action to contain them and eradicate threatening strains.  Outbreak control measures include (1) identifying and isolating infected  zones, (2) “stamping out” the virus by culling (killing) all poultry within  these zones, and (3) cleaning and disinfecting facilities before  reintroducing poultry. Vaccines that prevent clinical illness in poultry— and decrease the risk of transmission to both other poultry and humans— are available. However, these vaccines do not completely prevent  influenza viruses from infecting and replicating in apparently healthy  poultry and veterinary authorities recommend their use only in  conjunction with other disease control measures. No effective antiviral  drugs are available for poultry and thus animal health agencies do not  recommend their use.
The human health system’s approach to both seasonal and pandemic  influenza has traditionally emphasized development and application of  vaccines to limit spread and protect individuals. However, while vaccines  are likely to play a key role in mitigating the impact of the next pandemic,  they are likely to play little role in forestalling its onset, barring major  changes in technology. Prior to a strain being identified, the  pharmaceutical industry cannot currently produce vaccines that are  certain to be effective against it. Rather, when a new strain is identified, 6  months or more are required to develop and reach full production capacity  for new vaccines. Therefore, a pandemic will likely be well under way  before a vaccine that is specifically formulated to counteract the pandemic  strain becomes available. Antiviral drugs are also used to treat and  prevent seasonal influenza in humans and could be used in the event of a  pandemic to contain or slow the spread of the virus. In contrast to the  approach used with poultry, the human public health community has not  generally attempted to contain an initial outbreak of a pandemic-potential  strain or to eradicate it while it is still confined to a limited area.
section_title: The United States and International Partners Have Adopted an Overall Response Strategy
paragraphs: The U.S. government has developed a national strategy for addressing the  threats presented by H5N1, and has also worked with its international  partners to develop an overall global strategy that is compatible with the  U.S. approach. In November 2005 the Homeland Security Council  published an interagency National Strategy for Pandemic Influenza,  followed in May 2006 by an Implementation Plan that assigns  responsibilities to specific U.S. agencies. The U.S. strategy, in addition to  outlining U.S. plans for coping with a pandemic within its own territory,  states that the United States will work to “stop, slow, or otherwise limit” a  pandemic beginning outside its own territory. The strategy has three  pillars that provide a framework for its implementation: (1) preparedness  and communications, (2) surveillance and detection, and (3) response and  containment. The United States has also worked with UN agencies, OIE,  and other governments to develop an overall international strategy. Figure  2 shows key steps in the development of this international strategy in  relation to the spread of the H5N1 virus. These steps included the  appointment of a UN System Influenza Coordinator and periodic global  conferences to review progress and refine the strategy. The most recent  global conference was held in Bamako, Mali, in early December 2006.
At the global level, according to the UN coordinator, the overall strategic  goal of avian and pandemic influenza-related efforts is to create conditions  that enable all countries to (1) control avian influenza in poultry, and thus  reduce the risk that it poses for humans; (2) watch for sustained human-to- human transmission of the disease (through improved surveillance) and be  ready to contain it; and (3) if containment is not successful, mitigate the  impact of a pandemic. To guide efforts to improve capacity for performing  these tasks, the UN System Influenza Coordinator has identified seven  broad objectives. Four of these focus in large measure on improving  capacity to forestall a pandemic:Improve animal health practices and the performance of veterinary  services.
Sustain livelihoods of poorer farmers whose animals may be affected by  illness or by control measures, including culling programs.
Strengthen public health services in their ability to protect against newly  emerging infections.
Provide public information to encourage behavioral changes that will  reduce pandemic risks.
section_title: Information Gaps Hinder Assessments of Comparative Risk and Identification of Priority Countries
paragraphs: Although U.S. and international assessments have identified serious and  widespread environmental and preparedness-related risks in many  countries, gaps in the available information on both types of risk have  hindered comprehensive, well-informed comparisons of risk levels by  country. Assessment efforts that we examined, carried out by U.S. and  international agencies from late 2005 through late 2006, illustrate these  gaps. Efforts to assemble more comprehensive information are under  way, but will take time to produce results. Despite these limitations, the  Homeland Security Council has used available information to designate  about 20 priority countries for U.S. assistance, and U.S. officials have  determined that the United States should focus, in particular, on certain of  these countries where pandemic risk levels appear comparatively high,  including Indonesia, Nigeria, and Egypt.
subsections: section_title: USAID Environmental Risk Assessment Illustrated Information Shortfalls
paragraphs: A global analysis based on environmental factors that USAID originally  conducted during 2005 identified areas at greater risk for outbreaks but  revealed gaps in available information. USAID considered two factors in  its analysis: (1) the extent to which H5N1 was already present in animals  and (2) the likelihood that the virus will be introduced from another  country through factors such as trade in poultry and other birds and bird  migration. USAID undertook this assessment to inform its decisions about  spending priorities in the initial phase of heightened concern about human  pandemic risk from H5N1, when very little risk information was available,  according to USAID officials. USAID used OIE data on reported animal  cases. For countries that had not yet reported cases, USAID estimated the  risk of introduction based on proximity to affected countries and available  information on poultry trade and bird migration patterns. USAID  concluded that the countries at highest risk for new or recurring H5N1  outbreaks, or both, were those in Southeast Asia where the disease was  well-established, with widespread and recurring infections in animals  since 2003 (see fig. 3). Countries that were comparatively distant from  those that had already reported cases were deemed at lowest risk.
We identified three constraints on the reliability of these USAID  categorizations. First, global surveillance of the disease among domestic  animals has serious shortfalls. While OIE and FAO collaborate to obtain  and confirm information on suspected H5N1 cases, surveillance capacity  remains weak in many countries. Second, estimates of risk for disease  transmission from one country to another, as well as among regions within  countries, are difficult to make because of uncertainties about how factors  such as trade in poultry and other birds and wild bird migration affect the  movement of the disease. Specifically, illegal trade in birds is largely  undocumented and movement of the virus through the wild bird  population is poorly understood. Finally, these categorizations did not  take other elements of environmental risk, such as high-risk agricultural  practices, into account.
section_title: USAID, State Department, and UN Data Collection Efforts Have Found Widespread Preparedness Weaknesses but Have Not Resulted in Clear Country Comparisons
paragraphs: USAID, the State Department, and the UN System Influenza Coordinator  have each administered questionnaires to assess country-by-country avian  and pandemic influenza preparedness. These efforts identified widespread  preparedness weaknesses and provided information for planning  improvement efforts in individual countries. However, the results did not  provide information that was sufficiently detailed or complete to permit  clear categorization of countries by level of preparedness.
subsections: section_title: USAID and State Department Data Collection on Country Preparedness
paragraphs: During 2005, USAID and the State Department collected country-level data  that indicated widespread weaknesses in countries’ ability to detect and  respond to avian and pandemic influenza, but did not provide enough  information to place the examined countries in preparedness categories.  USAID and the State Department sent separate questionnaires to their  respective missions around the world to obtain a quick overview of avian  and pandemic influenza preparedness by country. The two agencies  requested information on key areas of concern, including surveillance,  response, and communications capacity, and stockpiles of drugs and other  supplies. These efforts identified widespread preparedness shortfalls. Our  analysis of a selection of the USAID and State Department results found,  for example, that many of the countries had not prepared stockpiles of  antiviral drugs or did not have plans for compensating farmers in the event  that culling becomes necessary. Missions in African countries reported the  greatest overall shortfalls. (See app. V for our analysis of the USAID and  State Department preparedness responses.)
USAID disease experts used this information to rate each country  according to a numerical “preparedness index,” but decided against using  the results of the exercise to help establish U.S. assistance priorities.  According to USAID headquarters officials, the information submitted by  its missions provided insights on preparedness strengths and weaknesses  in the examined countries but was not sufficiently complete or detailed to  allow them to rate countries on a numerical scale. The officials noted that  they had difficulty interpreting the largely qualitative information provided  by their field missions and, in some instances, found that the responses did  not match their experience in the relevant countries. In addition, the  USAID exercise did not include developed countries or developing  countries where the agency does not maintain a presence. The State  Department did not use the information it had collected to categorize  countries by preparedness level.
section_title: UN Data Collection and Analysis on Country Preparedness
paragraphs: The UN System Influenza Coordinator, in collaboration with the World  Bank, has completed two data collection and analysis efforts that provided  useful information on country preparedness. However, this information  was not sufficiently complete or comprehensive to allow clear country  comparisons. These efforts, which surveyed UN mission staff in countries,  were conducted before the June and December 2006 global conferences  on avian and pandemic influenza preparedness, to inform discussion at the  conferences. In collaboration with the World Bank, UN staff have used the  information, in addition to information from government officials and the  public domain, to summarize each country’s status with regard to seven  “success factors.” The staff also analyzed the aggregate results for all  countries and for specific regions.
Similar to the USAID effort, this exercise identified widespread  shortcomings in country-level preparedness. For example, the UN found  that about one-third of the countries lacked the capacity to diagnose avian  influenza in humans. Figure 4 presents the UN’s summary for a  representative country, Bangladesh. The information indicates, for  example, that programs were in place to strengthen Bangladesh’s  surveillance and reporting for avian influenza in both animals and humans,  but capacity to detect outbreaks was still constrained.
Like USAID, the UN data-gathering effort encountered obstacles that  preclude placing countries in preparedness categories. As shown in figure  4, for example, the UN mission in Bangladesh could not provide a clear  response concerning the country’s planning for farmer compensation in  the event that poultry culling becomes necessary. In addition, the UN  sought information from its mission staff in about 200 countries, but  obtained information on 141 of these in its first round of data gathering  and 80 in its second. The UN cautioned that there had been no  independent validation of the information obtained on individual  countries, and that the information could not be used to compare  countries to one another or to make a comprehensive evaluation of  preparedness levels.
section_title: World Bank-Led Missions Have Provided Additional Information for Some Countries but Have Not Provided Basis for Comprehensive Comparisons
paragraphs: The World Bank has conducted more in-depth assessments of both  environmental and preparedness-related risk factors in some countries  (those that have expressed interest in World Bank assistance), but they do  not provide a basis for making complete or comprehensive global  comparisons.
The World Bank has developed guidance for its staff to apply in generating  the information needed to design avian and pandemic influenza  preparedness improvement projects in individual countries. The guidance  instructs bank staff charged with preparing assistance projects to examine  and take into account both environmental and preparedness-related risk  factors. In preparing their projects, bank staff often work with officials  from other organizations with technical expertise, including U.S. agencies,  WHO, and FAO, and conduct fieldwork in the countries requesting bank  assistance. As of December 2006, the World Bank reported that it had  completed or was conducting assessments of national needs in more than  30 countries.
The following are examples of preparedness shortfalls in the human and  animal sectors identified by World Bank teams:    District-level staff responsible for human disease surveillance typically are  not qualified in epidemiology and lack the equipment needed to report  health events in a timely manner.
Public health laboratories are not capable of diagnosing influenza in  humans.
The human health care system has insufficient professional staff and lacks  essential drugs and needed equipment.
Veterinary services are inadequately equipped and trained to deal with  large-scale outbreaks.
Most available laboratory facilities are outdated, with laboratory staff  needing substantial training.
Although the World Bank’s assessment efforts generate information that is  useful in designing country-specific programs, they do not provide a basis  for making complete or comprehensive global comparisons of pandemic  risk levels. The World Bank performs such studies only in countries that  request bank assistance, and incorporates its findings into project  documents as needed. That is, bank staff members cite assessment  findings to support particular points in individual project plans. The  World Bank does not assess risk in countries that have not requested bank  assistance, nor does it publish its assessment results in independent  documents that employ a common format, and thus could be readily  employed to make country-by-country comparisons.
section_title: Efforts to Assemble More Comprehensive Information on Country Preparedness Are Under Way but Will Take Time to Produce Results
paragraphs: U.S. government and international agencies have initiated several data- gathering and analysis efforts to provide more complete information on  country preparedness levels. However, these efforts will take time to  produce substantial results.
First, HHS’s Centers for Disease Control and Prevention (CDC) is  developing an assessment protocol or “scorecard” that the United States  could employ to obtain systematic, and therefore comparable, information  on pandemic preparedness levels by country. CDC officials explained that  no such assessment tool currently exists. CDC officials are developing  indicators that could be applied to rate core capabilities in key areas, such  as differentiating among influenza strains and identifying clusters of  human illness that may signal emergence of a pandemic strain. According  to CDC officials, creating such a system would provide the United States  with a basis for comparing preparedness in different countries, identifying  response capabilities within countries that are particularly weak, and— over time—gauging the impact of U.S. efforts to address these  shortcomings. CDC officials said that they hoped to begin testing these  indicators before the end of 2007. They stated that their efforts have so far  been limited to human public health functions, but they have discussed  with USDA and USAID opportunities to incorporate animal health  functions into this format once the prototype has been worked out for  human health capabilities.
Second, the UN System Influenza Coordinator’s staff has indicated that it  is working with the World Bank to improve the quality of the UN’s country  preparedness questionnaire and increase the response rate. The goal is for  their periodic efforts to assess global and country-level preparedness to  generate more useful information. The impact of these efforts will not be  clear until the staff publishes the results of its third survey prior to the  next major global conference on avian and pandemic influenza, which is  scheduled to take place in New Delhi in December 2007.
Third, in 2006 OIE published an evaluation tool that can be used to assess  the capacity of national veterinary services. While it has established  standards for national veterinary services, the organization had not  previously developed a tool that could be used to determine the extent to  which national systems meet these standards. With assistance from the  United States and other donors, OIE reports that it has trained over 70  people in how to apply its evaluation tool and has initiated assessments of  veterinary services in 15 countries. A senior OIE official indicated that the  organization intends to complete assessments of over 100 countries over  the next 3 years.
Finally, under the terms of a 2005 revision of the International Health  Regulations, WHO member countries have agreed to establish  international standards for “core capacity” in disease surveillance and  response systems and to assess the extent to which their national systems  meet these standards. However, guidance on how to conduct such  assessments is still being developed. Such assessments would provide  consistent information on preparedness in all participating countries.  WHO is required to support implementation of these regulations in several  ways, including supporting assessments of national capacity. The UN  System Influenza Coordinator has identified development of national  systems that comply with the new international standards as a key  objective of global efforts to improve pandemic preparedness, and WHO  has begun developing assessment tools. However, while the regulations  enter into force in June 2007, member states are not required to assess  their national capacities until 2009 and are not required to come into  compliance with the revised regulations until 2012.
section_title: The United States Has Prioritized Countries Based on Available Information
paragraphs: The United States has prioritized countries for U.S. assistance, with the  Homeland Security Council identifying about 20 “priority countries,” and  agency officials have determined that the United States should focus in  particular on certain of these countries where pandemic risk levels appear  comparatively high.
In May 2006, the Homeland Security Council categorized countries, using  the limited information available on environmental and preparedness- related risks from U.S. and international agencies, and also taking U.S.  foreign policy concerns into account. The council differentiated among  countries primarily according to available information on H5N1’s presence  in these countries or their proximity to countries that have reported the  disease. According to agency officials and planning documents, more  detailed information on environmental risk factors and country  preparedness would have provided a more satisfactory basis for  differentiating among countries, but such information was not available.
In May 2006 the council grouped 131 countries into four risk categories:    At-risk countries: Unaffected countries with insufficient medical, public  health, or veterinary capacity to prevent, detect, or contain influenza with  pandemic potential.
High-risk countries: At-risk countries located in proximity to affected  countries, or in which a wildlife case of influenza with pandemic potential  has been detected.
Affected countries: At-risk countries experiencing widespread and  recurring or isolated cases in humans or domestic animals of influenza  with human pandemic potential.
Priority countries: High-risk or affected countries meriting special  attention because of the severity of their outbreaks, their strategic  importance, their regional role, or foreign policy priorities.
Through this process, the Homeland Security Council initially identified 19  U.S. priority countries. They include countries in Southeast Asia where  H5N1 has become well-established (such as Indonesia) as well as  countries that    have experienced severe outbreaks (such as Egypt);    have not yet experienced major outbreaks, but U.S. foreign policy  considerations mandate their identification as a priority (such as  Afghanistan); or    are playing an important regional role in responding to the H5N1 threat  (such as Thailand).
The council has updated the country categorizations, according to State  Department officials, and there have been slight changes since the original  list was completed. According to these officials, the council had  designated 21 countries as priority countries as of March 2007.
In addition, U.S. agency officials stated that certain of these priority  countries have emerged as being of especially high concern, and the State  Department is coordinating preparation of interagency operating plans for  U.S. assistance to these countries. Based on ongoing evaluation of both  environmental and preparedness-related factors, agency officials stated  that Indonesia, Egypt, Nigeria, and a small number of Southeast Asian  countries present comparatively high levels of pandemic risk and thus  merit greatest attention. According to the State Department, a plan for  Indonesia has been completed and plans are being prepared for Egypt,  Nigeria, and three additional Southeast Asian countries, as well as for U.S.  assistance to international organizations such as WHO. According to State  Department officials, each plan will provide information on a country’s  avian and pandemic influenza preparedness strengths and weaknesses and  lay out a U.S. interagency strategy for addressing them, taking into  account the actions of the host governments and other donors. The  country plans are to be laid out according to the three pillars of the U.S.  National Strategy for Pandemic Influenza: preparedness and  communications, surveillance and detection, and response and  containment.
section_title: The United States Has Played a Prominent Role in Global Efforts to Improve Preparedness
paragraphs: The United States has played a prominent role in global efforts to improve  avian and pandemic influenza preparedness, committing more funds than  any other donor country and creating a framework for monitoring its  efforts. According to data assembled by the World Bank, U.S.  commitments amounted to about 27 percent of overall donor assistance as  of December 2006. U.S. agencies and other donors are supporting efforts  to improve preparedness at the country-specific, regional, and global  levels, and the bulk of the country-specific assistance has gone to U.S.  priority countries. USAID and HHS have provided most of the U.S. funds,  while the State Department coordinates the United States’ international  efforts. The U.S. National Strategy for Pandemic Influenza  Implementation Plan establishes a framework for U.S. efforts to improve  international (and domestic) preparedness, listing specific action items,  assigning agencies responsibility for completing them, and specifying  performance measures and time frames for determining whether they have  been completed. The Homeland Security Council is responsible for  monitoring the plan’s implementation. The council reported in December  2006 that all action items due to be completed by November had been  completed, and provided evidence of timely completion for the majority of  the items.
subsections: section_title: The United States Has Been a Leader in Financing Efforts to Improve Global Preparedness
paragraphs: As shown in figure 5, the United States has been a leader in financing  efforts to improve preparedness for pandemic influenza around the  world. Through December 2006, the United States had committed about  $377 million to improve global preparedness for avian and pandemic  influenza. This amounted to about 27 percent of the $1.4 billion  committed by all donors combined; exceeded the amounts other  individual donors, including the World Bank, the Asian Development  Bank, and Japan, had committed; and was also greater than combined  commitments by the European Commission and European Union member  countries. In terms of pledged amounts, the United States has pledged  $434 million, behind the World Bank and the Asian Development Bank,  which offer loans and grant assistance.
section_title: The United States and Other Donors Are Funding Efforts at Country, Regional, and Global Levels
paragraphs: The United States and other donors are supporting efforts to improve  preparedness at the country-specific, regional, and global levels (see fig.  6). According to the World Bank, more than one-third of U.S. and total  global commitments have gone to assist individual countries. Substantial  shares of U.S. and global commitments also have been directed to  regionally focused programs, with primary emphasis on the Asia-Pacific  region, and to relevant global organizations, with primary emphasis on  WHO and FAO (see app. VI for additional detail). More than half of U.S.  funding in the “other” category has been used to stockpile  nonpharmaceutical equipment, such as protective suits for workers  involved in addressing outbreaks in birds or humans. The other category  also includes support for research, wild bird surveillance, and a variety of  other purposes.
section_title: Most Country-Specific Commitments Have Gone to U.S. Priority Countries
paragraphs: The bulk of U.S. and other donors’ country-specific commitments have  been to countries that the United States has designated as priorities, with  funding concentrated among certain of these countries (see fig. 7). Of the  top 15 recipients of committed international funds, 11 are U.S. priority  countries. According to data compiled by the World Bank, about 72  percent of U.S. country-specific commitments and about 76 percent of  overall donor country-specific commitments through December 2006 were  to U.S. priority countries.
As figure 7 shows, Vietnam and Indonesia have been the leading recipients  of country-specific commitments from the United States and from other  donors. Indonesia, which U.S. officials have indicated is their highest- priority country, has received the largest share of U.S. country-specific  commitments (about 18 percent), followed by Vietnam and Cambodia.
section_title: USAID and HHS Implement Most U.S.- Funded Activities
paragraphs: USAID, HHS, USDA, DOD, and the State Department carry out U.S.  international avian and pandemic influenza assistance programs, with  USAID and HHS playing the largest roles. According to funding data  provided by these agencies, USAID accounts for 51 percent of U.S.  planned spending, with funds going to provide technical assistance,  equipment, and financing for both animal and human health-related  activities. HHS accounts for about 40 percent of the total, with the focus  on technical assistance and financing to improve human disease detection  and response capacity. USDA provides technical assistance and conducts  training and research programs, and DOD stockpiles protective equipment.  The State Department leads the federal government’s international  engagement on avian and pandemic influenza and coordinates U.S.  international assistance activities through an interagency working group.  Figure 8 shows planned funding levels by agency.
section_title: U.S. Implementation Plan Establishes a Framework for U.S. Action
paragraphs: The U.S. National Strategy for Pandemic Influenza Implementation  Plan, adopted in May 2006, provides a framework for monitoring U.S.  efforts to improve both domestic and international preparedness. The plan  assigns agencies responsibility for completing specific action items under  the three pillars of the overall U.S. strategy (preparedness and  communications, surveillance and detection, and response and  containment) and, in most cases, specifies performance measures and  time frames for determining whether they have been completed. The  Homeland Security Council is responsible for monitoring the plan’s  implementation.
In its international component, the Implementation Plan identifies 84  action items. It designates HHS as the lead or co-lead agency for 34 of  these, the State Department for 25, USAID for 19, USDA for 19, and DOD  for 11. Table 2 shows the distribution of planned funding by agency  within each of the three pillars in the strategy. Appendix VII provides  information on obligations by agency and pillar.
Within the preparedness and communications pillar, the Implementation  Plan assigns U.S. agencies responsibility for action items that focus on     (1) planning for a pandemic; (2) communicating expectations and  responsibilities; (3) producing and stockpiling vaccines, antiviral drugs,  and other medical material; (4) establishing distribution plans for such  supplies; and (5) advancing scientific knowledge about influenza viruses.  For example, action item 4.1.5.2 assigns HHS and USAID lead  responsibility for setting up stockpiles of protective equipment and  essential commodities (other than vaccines and antiviral drugs) with  action to be completed within 9 months—that is, by February 2007 (see  fig. 9). Through fiscal year 2006, USAID reported spending about              $56 million to create a stockpile of personal protective equipment (PPE)  kits and other nonmedical commodities to facilitate outbreak investigation  and response. The USAID stockpile consisted of 1.5 million PPE kits to  be used by personnel investigating or responding to outbreaks, 100  laboratory kits, and 15,000 decontamination kits. As of October 2006,  USAID reported having deployed approximately 193,000 PPE kits for  immediate or near-term use in more than 60 countries (see app. VIII).
To improve global surveillance and detection capacity, the  Implementation Plan assigns U.S. agencies responsibility for action items  that focus on   (1) ensuring rapid reporting of outbreaks and (2) using  surveillance to limit their spread. For example, action item 4.2.2.4 assigns  HHS lead responsiblity for training foreign health professionals to detect  and respond to infectious diseases such as avian influenza with action to  be completed within 12 months—that is, by May 2007 (see fig. 10). In  2006, HHS established or augmented five regional global disease detection  and response centers located in Egypt ($4.4 million), Guatemala ($2  million), Kenya ($4.5 million), Thailand ($6.5 million), and China ($3.9  million) to enhance global disease surveillance and response capacity.  Among other things, these centers provide training in field epidemiology  and laboratory applications. For example, in July 2006, the Thailand center  conducted a workshop aimed at teaching public health officials what to do  when investigating a respiratory disease outbreak that may signal the start  of a pandemic. More than 100 participants from 14 countries participated  in this workshop, which was cosponsored by WHO and Thai authorities.
To improve global response and containment capacity, the  Implementation Plan assigns U.S. agencies responsibility for action items  that focus on (1) containing outbreaks; (2) leveraging international  medical and health surge capacity; (3) sustaining infrastructure, essential  services, and the economy; and (4) ensuring effective risk communication.  Action item 4.3.1.5, for example, assigns USDA and USAID lead  responsibility for supporting operational deployment of response teams  when outbreaks occur in poultry (see fig. 11). In 2006, USDA and USAID  supported the creation of a crisis management center at FAO to  coordinate and respond to avian influenza outbreaks globally. According  to FAO, the center is able to dispatch its experts to any location in the  world in under 48 hours. USAID and USDA have provided approximately  $5 million in support to the center. USDA detailed three veterinary  specialists to the center for headquarters operations as well as an official  to serve as its deputy director. USDA is also providing experts to respond  to outbreaks. USAID has directed its support toward enhancing  coordination with WHO on rapid deployment of joint animal health/human  health teams and facilitating operations in underresourced African  countries.
The Homeland Security Council’s first progress report on U.S. pandemic  influenza-related efforts reported that agencies had completed all of the 22  international action items scheduled for completion by November 2006. In  December 2006, the council issued a compendium of the action items in  the Implementation Plan, with updates on the corresponding  performance measures. The council reported that all 22 of the  international action items in the Implementation Plan that agencies were  to complete by November 2006 had been completed. (The 84 action items  in the international section of the Implementation Plan have time frames  for completion that range from 3 months to 2 years.)
The Homeland Security Council’s report did not clearly indicate the basis  for determining completion in a number of cases, generally because the  report did not fully reflect agency efforts or the wording of the  performance measure made it difficult for agency staff to respond. Our  review of the progress report found that for 14 of the 22 action items, the  report directly addressed the specified performance measures and  indicated that these measures had been addressed within the specified  time frames. However, for 8 of the action items, the information in the  progress report did not directly address the performance measure or did  not indicate that the completion deadline had been met. Based on  interviews and information we obtained from the responsible agencies, we  determined that the lack of clarity in these cases was primarily because of  omission of key facts on agency activities or agency difficulties in  reporting on poorly worded performance measures. For example, 1  action item directed DOD to prepare to limit the spread of a pandemic- potential strain by controlling official military travel between affected  areas and the United States. The performance measure was designation  of military facilities that could serve as points of entry from affected areas.  The council’s report described the department’s preparedness for  controlling travelers’ movements but did not state that DOD had identified  facilities that could serve as points of entry. Our review of DOD  documents indicated that the department had designated such facilities. A  second action item assigned the State Department lead responsibility for  developing plans to communicate U.S. avian and pandemic influenza  objectives to key stakeholders. The performance measure was the  “number and range of target audiences reached” and the impact of  relevant efforts on the public. The council’s report provided a rough  estimate of the number of people reached through U.S. government  communication efforts to date. However, State Department officials told  us that the performance measure was difficult to address because they did  not have the means to accurately estimate the effective reach or impact of  their efforts.
section_title: Concluding Observations
paragraphs: Difficulties in obtaining and applying accurate and complete information  present an overarching challenge to U.S. efforts to identify countries at  greatest risk and effectively target resources against the threat presented  by the H5N1 virus. In particular, although country preparedness is a  primary consideration in determining relative risk levels, U.S.  determinations on priority countries have relied primarily on information  about environmental risks, which is itself incomplete. While the United  States, the UN, and the World Bank, as well as WHO and OIE, are refining  and expanding their efforts to gather useful information, substantial gaps  remain in our understanding of both environmental and preparedness- related risks in countries around the world.
With strong leadership from the United States, the international  community has launched diverse efforts to increase global preparedness  to forestall an influenza pandemic. These efforts constitute a substantial  response to the threat presented by H5N1. They reflect significant  international cooperation, and the U.S. National Strategy for Pandemic  Influenza Implementation Plan provides a useful framework for  managing U.S. agencies’ participation in these efforts. The Homeland  Security Council’s first update on U.S. efforts and UN reports on donor  efforts in general suggest that U.S. and global efforts to improve  preparedness are producing results, but challenges remain in accurately  measuring their impact. Many countries remain relatively unprepared to  recognize or respond to highly pathogenic influenza in poultry or humans,  and sustained efforts will be required to overcome these challenges.
section_title: Agency Comments and Our Evaluation
paragraphs: USAID, HHS, and USDA provided written comments on a draft of this  report. These comments are reproduced in appendixes II, III and IV. In  addition, Treasury provided oral comments. HHS and Treasury also  provided technical comments, as did the Department of State, DOD, WHO,  the World Bank, and the United Nations System Influenza Coordinator.  The Coordinator’s comments included comments from FAO and OIE, and  the latter organization also provided us with technical comments  independently. These agencies generally concurred with our findings, and  we incorporated their technical comments in the report as appropriate.
USAID briefly reviewed progress in improving global preparedness, citing,  for example, reductions in outbreaks among poultry and humans in  Vietnam and Thailand. The agency observed, however, that the practices  employed in small-scale “backyard farms” continue to present a major  challenge to efforts to control the spread of H5N1. USAID will therefore be  paying particular attention to this challenge in the coming months.
While acknowledging the information gaps that limit capacity for  comparing country-level risks, HHS emphasized its support for targeting  resources according to the Homeland Security Council’s country  prioritization decisions. In this context, HHS stressed the importance of  improved information sharing among countries, as called for under the  revised International Health Regulations, and noted the particular  importance of sharing influenza virus samples and surveillance data. In  addition, HHS commented that limited human-to-human transmission of  H5N1 could not be ruled out in some clusters of cases in Indonesia, and  explained certain differences in the roles played by HHS, USDA and  USAID under the response and containment pillar of the U.S. National  Strategy for Pandemic Influenza. In response, we clarified the  information in the background section of this report on human-to-human  transmission and our presentation on the roles played by the HHS, USDA,  and USAID in responding to poultry and human outbreaks. In its technical  comments, HHS elaborated upon our concluding observation regarding  the need for sustained effort to overcome challenges in improving global  preparedness.  We added a footnote to our concluding observations to  summarize the HHS comments in this area.
USDA stated that the report provides a comprehensive evaluation of  pandemic influenza and global efforts needed to improve avian and  pandemic influenza preparedness.  USDA also stated that it found the  report accurate in its description of USDA’s role and involvement in global  efforts to improve preparedness.
In oral comments, Treasury stated that it has been actively engaged in the  U.S. government’s efforts to respond to avian influenza and increase  readiness to address a potential influenza pandemic, both internationally  and within the United States. To coordinate the department’s activities,  Treasury created an informal avian influenza working group that includes  staff from its domestic and internationally focused offices. Among other  things, the working group ensures that Treasury is fully engaged in all  Homeland Security Council-led initiatives against avian and pandemic  influenza. Treasury also stated that, in coordination with U.S. executive  directors at the various international financial institutions (including the  World Bank), it has encouraged and supported these institutions in their  efforts to develop adequate responses to the threat of an influenza  pandemic. However, Treasury stated that its efforts in this area have been  constrained by U.S. legislation that requires the United States to vote  against multilateral development bank programs in cases where Burma  might receive support. According to Treasury, this has occurred two times  with respect to Asian Development Bank regionally-focused projects.   While these matters were largely outside the scope of our report, we  modified the text to acknowledge Treasury efforts to encourage and  support international financial institution efforts against avian and  pandemic influenza.
Treasury also stated that, building on experiences drawn from the 2003  severe acute respiratory syndrome outbreak, the international financial  institutions (including the World Bank) have responded to the H5N1  epidemic by providing financing, and also by helping countries develop  national strategies, providing relevant technical assistance and training,  serving as focal points for donor and regional coordination, tracking and  reporting on donor commitments, preparing impact analyses, and hosting  international conferences. Treasury further noted that in addition to  providing financing for individual countries, the multilateral development  banks have provided financial and technical support to international and  regional technical organizations working in this area, including WHO and  FAO.
We are sending copies of this report to the Secretaries of Agriculture,  Defense, Health and Human Services, State, and the Treasury; the  Administrator of the U.S. Agency for International Development;  appropriate congressional committees; and other interested parties. We  will also make copies available to others upon request. In addition, the  report will be available at no charge on GAO’s Web site at  http://www.gao.gov.
If you or your staff have any questions, please contact David Gootnick at  (202) 512-3149 or gootnickd@gao.gov or Marcia Crosse at (202) 512-7114  or crossem@gao.gov. Contact points for our Offices of Congressional  Relations and Public Affairs may be found on the last page of this report.  Key contributors to this report are listed in appendix IX.
section_title: Appendix I: Scope and Methodology
paragraphs: We provided relevant background information on the spread of the H5N1  virus, factors that may affect the comparative risk that this virus presents  in different countries, methods that health systems traditionally employ to  respond to influenza in animals and humans, and the overall strategy that  the United States and its international partners have developed to respond  to the threats presented by H5N1. To describe how H5N1 has spread  internationally, we used country-specific data on cases among humans  assembled by the United Nations World Health Organization (WHO), and  on cases and outbreaks in humans and in wild and domestic birds  assembled by the United Nations (UN) World Food Program. World Food  Program officials told us their data on human cases were provided by  WHO, while their data on cases in birds were provided by the World  Organization for Animal Health (OIE) and the UN Food and Agriculture  Organization (FAO). WHO, OIE, and FAO have cautioned that global  surveillance is imperfect, and some human and animal cases and  outbreaks may go unrecorded. However, these organizations work with a  wide variety of global partners, including national governments, to identify  and verify outbreaks of this disease. We determined that these data on  human and animal outbreaks were sufficiently reliable for the purposes of  this report, which were to convey a general sense of the manner in which  the disease has spread across international boundaries and the extent to  which it has infected humans. However, these data should not be relied  upon to precisely identify countries where the disease has occurred or to  indicate with absolute certainty the number of human cases that have  occurred.
To identify and describe factors that affect the level of risk that H5N1  presents in different countries and the methods that animal and health  systems generally employ against influenza, we interviewed officials and  consulted documents produced by avian and human disease experts in  relevant U.S. government agencies, international organizations, academic  institutions, and nongovernmental organizations. To describe the overall  strategy that the United States and its international partners have  developed to respond to the H5N1 epidemic, we interviewed and  examined relevant documents from U.S. and UN agencies, including the  U.S. National Strategy for Pandemic Influenza and strategy statements  and progress reports produced by the UN System Influenza Coordinator  and the World Bank.
To examine the extent to which U.S. and international agencies have been  able to assess the pandemic risk that H5N1 presents in individual  countries and prioritize them for international assistance, we reviewed  and analyzed assessments of environmental risk and preparedness.
Specifically, we reviewed assessments prepared by the U.S. Agency for  International Development (USAID), the Department of State, the UN, and  the World Bank and spoke with cognizant officials at these agencies and  organizations about how they were conducted. These assessments  evaluated country-level pandemic risk deriving from environmental  conditions, country preparedness for responding to avian and pandemic  influenza, or both. We analyzed a sample of 17 country-specific avian  influenza preparedness assessments compiled by USAID and the State  Department to provide summary information on capacity in several  regions. (See app. V for a detailed description of the scope and  methodology for our analysis of sampled USAID and State Department  assessments.) We also reviewed the U.S. Homeland Security Council  Country Prioritization Matrix as of May 3, 2006, which designates country  priority levels for U.S. actions to address the avian and pandemic influenza  threat. We discussed this priority ranking with officials from the State  Department and USAID. We requested a meeting with officials from the  council, but the council declined, stating that we could obtain needed  information from other agencies and departments. In addition, we  reviewed analyses of environmental risk factors prepared by U.S.  intelligence community analysts during 2006 and early 2007 and discussed  these analyses with U.S. agency officials. We also reviewed assessments of  risks in particular countries prepared by a U.S. intelligence agency.
To determine the actions U.S. agencies and their international partners  took to address these risks, we examined funding, planning, and reporting  documents and spoke with cognizant officials. To determine the overall  level of financial support that the donor community is providing for efforts  to improve global avian and pandemic influenza preparedness, we  examined World Bank and UN documents detailing donor pledges and  commitments resulting from the international pledging conferences on  avian and pandemic influenza, including funding levels by donor, by  recipient, and by purpose. We also reviewed World Bank and UN  documents describing recipient countries, regions, and organizations.
To describe the international activities of the U.S. government, we  reviewed the National Strategy for Pandemic Influenza and the National  Strategy for Pandemic Influenza Implementation Plan. We reviewed  pertinent planning, reporting, and funding documents for U.S.  international avian influenza control and pandemic preparedness  assistance programs. We also consulted cognizant officials from USAID  and from the Departments of Agriculture (USDA), Health and Human  Services (HHS), Defense (DOD), and State about their efforts. We  reviewed the international action items tasked to these U.S. agencies and  assessed by the Homeland Security Council in its 6-month status report  issued on December 18, 2006. We independently compared the  performance measures associated with each action item with the agency  responses to it. Finally, we visited the WHO, OIE, and FAO headquarters in  Geneva, Paris, and Rome, respectively.
To assess the reliability of the pledges and commitments data that national  governments and other donors submitted to the World Bank, we spoke  with World Bank officials responsible for maintaining these data and  reviewed supporting documentation. The pledges and commitments data  are self-reported by individual donor countries in response to a standard  request template. The World Bank staff responsible for this data collection  provided countries with standard definitions of key terms, such as  pledges, commitments, and in-kind and cash payments. However, because  countries’ data reporting systems vary substantially, World Bank staff  conduct ongoing discussions with donor countries to establish the  correspondence between those systems and the World Bank terms. World  Bank staff also stated that the pledges and commitments totals provided  by countries may include funding not strictly related to pandemic  influenza and may therefore be somewhat overstated. Therefore, based on  our review, we use these data to identify general levels of pledges and  commitments made by particular countries or organizations; they should  not be relied upon to support precise comparisons of funding by donor or  recipient. Overall, we concluded that the World Bank pledges and  commitments data were sufficiently reliable for the purposes of this  report.
To obtain data on U.S. agency funding for international avian and  pandemic influenza preparedness by agency and by the three pillars of the  overall U.S. pandemic strategy, we requested separate submissions from  each of the five U.S. agencies, showing planned, obligated, and expended  funds by pillar. Two of the five agencies (USAID and USDA) maintained  funding data by pillar prior to our requesting these data. Two others (DOD  and the State Department) found it relatively easy to comply with our  request, since all of their reported activities fell within the preparedness  and communications pillar. However, providing this information was  comparatively complex for HHS. The various units within that agency (for  example, the Centers for Disease Control and Prevention and the National  Institutes of Health) support a wide variety of relevant programs, many of  which involve more than one pillar. In addition, HHS can utilize other  sources of funding in addition to influenza-specific appropriations for  many of these programs. To respond to our request, the HHS Office of  Global Health Affairs collected data from relevant HHS units. The Director  of the Office of Global Health Affairs reviewed the final HHS submission  for accuracy before reporting back to GAO. The pillar-specific totals HHS  was able to provide were for planned funds and for obligated funds. Thus,  the funding information by agency that we provide is for these two  categories of funding data and not for expenditures.
We identified a number of limitations in the data that the agencies  provided. First, the data are not from consistent periods. USDA and USAID  provided information on planned funding levels and obligations through  December 2006. HHS, DOD, and the State Department provided data  through September 2006. In addition, DOD and the State Department  received funding for international avian and pandemic influenza activities  through appropriations in 2006 only; whereas, USAID, HHS, and USDA  received funding through 2005 and 2006 appropriations. Second, the  distribution of funds among the pillars is somewhat imprecise. When  programs addressed more than one pillar, agency officials employed their  professional judgment to decide which pillar was most significant. This  limitation was most pronounced in the HHS data. While HHS decided how  to allocate most of its funds, the agency did not specify a pillar for about  $15 million of its planned funds. This total included about $5 million to  expand staffing levels in key global, regional, and country-level facilities,  including the WHO regional offices for Africa and the Western Pacific and  surveillance and response facilities in Thailand and Egypt, and about      $10 million for HHS headquarters management of its influenza-related  initiatives.
Third, the total planned and obligated amounts are also somewhat  imprecise. Some of the agency funds come from programs that are not  dedicated specifically to avian or pandemic influenza. In such cases,  agency officials used professional judgment to decide what portion of the  funds should be designated as supporting avian or pandemic influenza  preparedness.
Despite these limitations, we determined that these data were sufficiently  reliable for the purpose of this report, which was to provide information  on general levels of agency planned and obligated funding by pillar.  However, we rounded the funding information that the agencies provided  to the nearest million dollars.
We conducted our work from January 2006 through March 2007 in  accordance with generally accepted government auditing standards.
section_title: Appendix II: Comments from the U.S. Agency for International Development
section_title: Appendix III: Comments from the Department of Health and Human Services
paragraphs: The following are GAO’s comments on the Department of Health and  Human Services letter dated June 11, 2007.
subsections: section_title: GAO Comment
paragraphs: 1.  HHS said that it is inaccurate to state, without qualification, that H5N1  has never circulated among humans; limited human-to-human  transmission cannot be ruled out in a few clusters of cases in  Indonesia. We agreed with the need to qualify this statement. We  revised the background section of this report to acknowledge that  limited human-to-human transmission cannot be ruled out in these  cases.
section_title: Appendix IV: Comments from the Department of Agriculture
section_title: Appendix V: Analysis of Selected USAID and State Department Rapid Assessments of Avian Influenza Preparedness
paragraphs: This appendix presents the results of our analysis of avian influenza  preparedness information submitted by USAID and State Department field  staff from 17 of more than 100 countries surveyed by USAID and State  Department headquarters during late 2005. These characterizations reflect  our analysis of information gathered through assessment efforts at that  time. For some countries, the assessments may not reflect current  capabilities. As figure 12 shows, the field staff charged with providing  information identified widespread shortcomings in national preparedness.  However, the figure also shows that field staff often could not obtain  sufficient information to provide clear or definitive information on every  topic.
The preparedness and communications section of the figure suggests that  most of the countries in our sample were aware of the need to position  themselves for effective action, 16 of the 17 were reported to have made at  least limited progress in preparing a national plan for responding to the  threats presented by avian influenza, and 14 of 15 countries for which data  were available were reported to have established national task forces to  address these threats. However, the remainder of the figure suggests that  there were at the time of the assessments widespread weaknesses in the  elements of preparedness. For example, only 9 of the 17 countries were  reported to have made at least limited efforts to educate the public about  avian influenza. Only 4 of the 12 countries for which data were available  were reported to have made at least limited progress toward preparing  stockpiles of both antiviral drugs and PPE kits that could be used by those  responding to poultry or human outbreaks. Most of the countries were  found to be conducting at least limited surveillance for avian influenza.  However, many countries were found to have gaps in their capacity to  carry out key outbreak response activities. For example, only 4 of the 15  countries for which data were available were reported to have plans for  compensating farmers in the event that culling became necessary.
The USAID and State Department officials who provided this information  reported shortcomings in each of the 17 countries we reviewed. The  officials identified multiple shortcomings in Cambodia, Indonesia, and  Vietnam, where H5N1 is well-established. In addition, the figure illustrates  why there is particular concern about weak capacity in Africa. USAID and  State Department officials recorded negative responses in most categories  for the 2 of the 3 African countries in the table (Djibouti and Uganda).  Additionally, officials recoded limited or negative responses for 11 of 15  categories for Nigeria—the remaining African country in our analysis.
The figure also demonstrates the data-gathering and analysis difficulties  that field and headquarters staff experienced in completing this exercise.  The information provided by field staff was insufficient to allow us to  arrive at definitive entries for about 15 percent (39 of 255) of the cells in  the figure. Field staff had particular difficulty in providing clear  information on response and containment measures, such as stockpile  distribution and culling plans and quarantine capacity. Staff in some  countries (for example, Vietnam) were able to provide comparatively clear  information on all or nearly all issues, while others (for example, India)  were unable to provide sufficient information on several matters.
subsections: section_title: Scope and Methodology
paragraphs: The study population for our analysis included rapid country avian  influenza preparedness assessment reports prepared by USAID and State  Department overseas missions from October to November 2005. USAID  maintains country-specific missions in 80 developing countries and  regional offices in 6 such countries, and these missions provided USAID  headquarters with information on more than 100 countries. The State  Department maintains diplomatic missions in about 180 countries and  territories. From the population of USAID missions, we drew a  nonprobability sample of 17 countries. Of these countries, 14 had reports  from USAID and the State Department, 3 had USAID reports only, and 1  had a State Department report only. State Department assessments were  missing from the following countries: India, Pakistan, and Indonesia.  USAID did not perform a country assessment on Thailand.
To select our sample, we took a variety of factors into account. To ensure  geographic diversity, we included countries from four regions: Asia,  Africa, Eurasia and the Near East, and the Americas. Based on influenza  experts’ opinions and congressional interest, we chose to oversample  Asian countries and not represent North America or Europe. We sought to  include countries in a variety of situations with regard to the presence of  H5N1 in animals or humans, concentrations of poultry and humans living  in proximity to each other, exposure to migratory patterns that could  allow wild birds to transmit H5N1 into the country, political stability, and  strength of the public health infrastructure. We did not include China in  our table of countries because the relevant reports were classified.
USAID and the State Department conducted their assessments by sending  out sets of questions to personnel at their respective missions. The  questions asked in the two instruments differed in their wording, and as a  consequence, our first step in developing our analysis was to identify a set  of broader dimensions, or indicators, encompassing data from both sets of  assessments. Through a review of these two sets of questions, as well as  survey questions recently developed by WHO and the World Bank to  assess country preparedness, we identified a set of 15 qualitative  indicators covering a wide array of issues within the topic areas of  preparedness and communications, surveillance and detection, and  response and containment. These indicators then became the dimensions  along which we analyzed the data contained in the USAID and State  Department assessments.
We reviewed USAID rapid country assessments and State Department  cables assessing the level of country preparedness for avian influenza. The  analysis of the 17 USAID and State Department assessments was  performed by two GAO analysts, reviewing the reports separately and  recording answers, with justifications, in workpapers. To enhance inter- rater reliability in our analysis of the USAID and State Department  assessments, we developed a code book to reflect the specific  characteristics needed for a country to be classified in one of three  categories for each indicator: yes, no, or limited. Subsequently, the two  analysts compared their answers and justifications, reconciled their  analyses when they diverged, and modified the code book as needed to  ensure consistent coding across indicators and countries. A methodologist  performed a final check on the consistency and accuracy of the analysis.
The USAID and State Department instruments had a number of  limitations. First, the information provided in these assessments is limited  by the rapidly evolving dynamic of the H5N1 virus and ongoing efforts to  improve capacity. As a consequence the information provided in them is  already dated and should be understood as a snapshot of the countries  assessed at a particular point in time (fall 2005), rather than directly  reflecting the current status of country capacities. Second, the purpose of  these assessments was to rapidly assess country capacities in this evolving  environment, and as a result, the instruments developed were limited in  the design of the questions asked, restricted primarily to open-ended  questions that could be interpreted and answered in multiple ways. Third,  the instruments were limited in the manner in which they were  implemented. In particular, the data reported reflect the individualized  data-gathering and assessment efforts of the point of contact at USAID or  the State Department rather than a standardized approach to data  gathering and assessment.
Fourth, while many respondents addressed the indicators we identified for  analysis, because the questions were open-ended, there is inconsistency in  the depth and coverage of responses. Furthermore, in some cases, the  response to a question was simply “yes” or “no” without any details. When  this occurred, we recorded the answer the respondent gave. Fifth, some  indicators had only one source of information (they were addressed in one  report but left blank in another), and we could not compare them for  consistency. Sixth, in some instances, respondents did not answer  questions sufficiently for us to make determinations or left them blank. We  could not determine the level of these indicators based on available data  and rated them as missing and left them blank in those cases. Despite  these limitations, we determined that the data contained in these  statements were sufficient for the purpose of our report, which was to  provide information broadly demonstrating the limited capacities of  countries at a particular point in time with implications for the challenges  posed in subsequent periods.
section_title: Appendix VI: Assistance to Regional and Global Organizations
paragraphs: According to data submitted to the World Bank by the United States and  other donors, Asia-Pacific regional initiatives have received the largest  share of regionally focused funding from international donors, including  the United States (see table 3). Approximately 67 percent of committed  funds have gone to programs in this region. For example, donors reported  providing the Association of Southeast Asian Nations about $50 million in  committed funds, including about $47 million from Japan to procure  antiviral drugs, PPE kits, and influenza test kits. Examples of support in  other regions include HHS’s provision of $3.3 million in committed funds  to support the Gorgas Institute, a laboratory network in Panama, and the  European Commission’s provision of about $28 million to the African  Union.
According to data submitted to the World Bank, WHO and FAO have  received the greatest shares of overall funding committed to global  organizations (see fig. 13). Of the $240 million in reported overall donor  commitments for global organizations, the WHO and FAO shares  constituted about 35 percent and 27 percent, respectively. U.S. agencies  are supporting WHO and FAO with funds, staff, equipment, and technical  assistance to improve these organizations’ capacity to support countries.  For example, HHS has provided funding to all six WHO regional offices.  Some of this assistance is directed at improving collaboration on human  and animal components of the response. OIE, the UN Children’s Fund,  and the UN System Influenza Coordinator (among others) share the  remaining $91 million, with the Children’s Fund accounting for more than  half of this amount—about $49 million from Japan, provided primarily to  enhance communications on avian and pandemic influenza risks.
section_title: Appendix VII: U.S. Agency Obligations Funding by Pillar
paragraphs: In response to our request, HHS, USAID, DOD, USDA, and the State  Department reported having obligated about 64 percent of their planned  funding for international avian and pandemic influenza-related assistance.  However, the data are not from consistent time periods. HHS, DOD, and  State Department data represent obligations through the end of fiscal year  2006 (that is, through the end of September 2006). USAID and USDA  provided data on their obligations through December 2006. (See table 4.)
section_title: Appendix VIII: Distribution of USAID Personal Protective Equipment Kits
paragraphs: Figure 14 shows USAID’s distribution of PPE kits by country as of the end  of fiscal year 2006. As the figure shows, Indonesia accounted for the  majority of these kits. According to a USAID official, approximately  193,000 PPE kits were distributed for immediate use in surveillance and  response activities in more than 60 countries. Additionally, USAID had  begun to create long-term stockpiles of PPE, laboratory, and  decontamination kits in 20 countries.
section_title: Appendix IX: GAO Contacts and Staff Acknowledgments
subsections: section_title: Staff Acknowledgements
paragraphs: Key contributors to this report were Celia Thomas, Assistant Director;   Thomas Conahan, Assistant Director; Michael McAtee; Robert Copeland;  R. Gifford Howland; Syeda Uddin; David Fox; Jasleen Modi; David  Dornisch; Etana Finkler, Debbie Chung, Monica Brym, and Jena Sinkfield.
section_title: Related GAO Products
paragraphs: Financial Market Preparedness: Significant Progress Has Been Made,  but Pandemic Planning and Other Challenges Remain. GAO-07-399.  Washington, D.C.: March 29, 2007.
Influenza Pandemic: DOD Has Taken Important Actions to Prepare, but  Accountability, Funding, and Communications Need to be Clearer and  Focused Departmentwide. GAO-06-1042. Washington, D.C.: September 21,  2006.
Influenza Vaccine: Shortages in 2004–05 Season Underscore Need for  Better Preparation. GAO-05-984. Washington, D.C.: September 30, 2005.
Influenza Pandemic: Challenges in Preparedness and Response. GAO-05- 863T. Washington, D.C.: June 30, 2005.
Influenza Pandemic: Challenges Remain in Preparedness. GAO-05-760T.  Washington, D.C.: May 26, 2005.
Flu Vaccine: Recent Supply Shortages Underscore Ongoing Challenges.  GAO-05-177T. Washington, D.C.: November 18, 2004.
Infectious Disease Preparedness: Federal Challenges in Responding to  Influenza Outbreaks. GAO-04-1100T. Washington, D.C.: September 28,  2004.
Public Health Preparedness: Response Capacity Improving, but Much  Remains to Be Accomplished. GAO-04-458T. Washington, D.C.:       February 12, 2004.
Global Health: Challenges in Improving Infectious Disease Surveillance  Systems. GAO-01-722. Washington, D.C.: August 31, 2001.
Flu Vaccine: Steps Are Needed to Better Prepare for Possible Future  Shortages. GAO-01-786T. Washington, D.C.: May 30, 2001.
Flu Vaccine: Supply Problems Heighten Need to Ensure Access for High- Risk People. GAO-01-624. Washington, D.C.: May 15, 2001.
Influenza Pandemic: Plan Needed for Federal and State Response.   GAO-01-4. Washington, D.C.: October 27, 2000.