Order Code RL33219
CRS Report for Congress
Received through the CRS Web
U.S. and International Responses to the Global
Spread of Avian Flu: Issues for Congress
Updated April 4, 2006
Tiaji Salaam-Blyther, Coordinator
Analyst in Foreign Affairs
Foreign Affairs, Defense, and Trade Division
Congressional Research Service ˜ The Library of Congress

U.S. and International Responses to the Global Spread
of Avian Flu: Issues for Congress
Summary
Influenza A/H5N1 is the strain of influenza currently spreading throughout the
world. Although it is a bird flu, it has infected a relatively small number of people
— killing more than half of those infected. Some scientists are concerned that H5N1
may cause the next influenza pandemic. Flu pandemics have occurred cyclically,
between every 30 and 50 years. Since 1997, when the first human contracted H5N1
in Hong Kong, the virus has resurfaced and spread to nearly fifty countries in Asia,
Europe, the Middle East, and Africa — infecting more than 190 people. In February
2006, the virus spread from Asia and central Europe to western Europe. In March
2006, health experts confirmed new bird flu cases among more than 20 countries
across Europe, Asia, and Africa. Most of the countries were experiencing their first
H5N1 cases. The first human H5N1 fatalities outside of Asia occurred in 2006 when
Turkey and Iraq announced their first human deaths related to H5N1 infection in
January 2006 and February 2006, followed by Azerbaijan and Egypt in March 2006.
A global influenza pandemic could have a number of consequences. Global
competition for existing vaccines and treatments could ensue. Some governments
might restrict the export of vaccines or other health supplies to treat their own
population. Some countries might face a shortage of vaccines, antiviral medication,
or other medical equipment, because of limited global supply. Hospitality and airline
industries, and international trade could be negatively impacted. If global travel and
trade were to suddenly drop, there could be productivity losses and service
disruptions. Essential workers might become ill or stay home out of fear of
contracting the virus. Such workers could include law enforcement, medical
personnel, mass transit drivers and engineers, and other crucial emergency personnel.
Congress provided $31.3 million for international avian flu activities through
FY2005 emergency supplemental appropriations. FY2006 emergency supplemental
appropriations reserved $280 million for global H5N1 initiatives. The Administration
requests $215 million for global H5N1 containment activities in FY2007. Bills
introduced in the 109th Congress would increase U.S. resources allocated to the
global fight against avian flu; develop a “Pandemic Fund” to augment ongoing U.S.
and international avian flu and pandemic preparedness initiatives; increase funding
for preventing the spread among animals of the H5N1 virus; and strengthen
surveillance capacity within affected countries.
This report provides an up-to-date account of global H5N1-related human
infections and deaths, outlines U.S. government response to the global spread of
H5N1, and presents some foreign policy issues for Congress. This report will be
periodically updated. For more information on H5N1, U.S. domestic preparedness
efforts, agricultural issues, and the efforts of overseas governments to combat the
spread of avian influenza, please see CRS Report RL33349, International Efforts to
Control the Spread of the Avian Influenza (H5N1) Virus: Affected Countries’
Responses
, by Emma Chanlett-Avery; CRS Report RS21747, Avian Influenza:
Agricultural Issues
, by Jim Monke; and CRS Report RL33145 — Pandemic
Influenza: Domestic Preparedness Efforts
, by Sarah A. Lister.

Contents
Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Global Prevalence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Transmission . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Congressional Response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
U.S. Executive Branch Response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Department of State . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
U.S. Agency for International Development (USAID) . . . . . . . . . . . . . . . . . 7
U.S. Department of Health and Human Services (HHS) . . . . . . . . . . . . . . . . 8
Department of Agriculture (USDA) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Department of Defense (DoD) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
International Response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Overview of the Role of the World Health Organization . . . . . . . . . . . . . . 11
WHO’s Global Health Security . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
WHO Global Influenza Preparedness Plan . . . . . . . . . . . . . . . . . . . . . . . . . 12
International Health Regulations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Role of Other International Health Organizations
. . . . . . . . . . . . . . . . . . . 15
Issues for Congress . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Patent Protections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Global Data Sharing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Global Disease Surveillance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Global Pandemic Planning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Combating Bird Flu Among Animals in Affected Countries . . . . . . . . . . . 23
Cost of Culling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Global Economic Impacts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Global Biosafety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
List of Figures
Figure 1. Map of Human and Animal H5N1 Cases . . . . . . . . . . . . . . . . . . . . . . 29
List of Tables
Table 1. Human Cases of Avian Influenza A/H5N1 . . . . . . . . . . . . . . . . . . . . . . . 2
Table 2. WHO Pandemic Phases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Table 3. FY2005 and FY2006 Enacted Emergency Supplemental and
FY2007 Request for Global Avian Influenza Initiatives . . . . . . . . . . . . . . . 31
Table 4. International Partnership on Avian and Pandemic Influenza (IPAPI)
Core Principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

U.S. and International Responses to the
Global Spread of Avian Flu: Issues for
Congress
Background
Bird (or avian) flu outbreaks have occurred at various times around the world.1
Influenza A/H5N1 is the strain of bird flu currently spreading across the world.
Although it is a bird flu, the virus has infected some people and killed more than half
of those infected. Until 1997, there were no known human H5N1 cases. That year,
18 people in Hong Kong contracted the virus; of whom 6 died. To contain the virus,
1.5 million birds were killed. Since 2003, scientists have closely monitored resurgent
H5N1 outbreaks, which have infected poultry in a growing number of countries.
According to WHO, the hallmarks of a pandemic are: 1) a novel flu virus strain
emerges; 2) the strain causes human disease; and 3) person-to-person transmission
is sustained. The pandemic steps usually occur in six phases. Table 2 shows the
phases of a flu pandemic, as described by WHO. The current global H5N1 outbreak
is in pandemic alert phase three, which means a virus new to humans is causing
infections, but not spreading easily from one person to another.
Humans have no immunity against H5N1 since it is a bird flu and has not
commonly infected people. Some predict that if H5N1 were to become transmissible
among humans, an “influenza pandemic” (worldwide disease outbreak) could begin.
Skeptics argue that such predictions are exaggerated, because if the virus were able
to transform into a strain that is efficiently transmissible among people it would have
already done so. Still some health experts stress that governments should prepare for
some sort of pandemic. During the Spanish flu pandemic of 1918, it is estimated that
between 20 and 50 million people died, and between 200 million and 1 billion were
infected around the world. If a flu pandemic were to occur on the same scale as the
Spanish flu, some estimate that between 30 million and 384 million people could die
around the world,2 of which 1.9 million deaths could occur in the United States.3
1 For a list of past avian flu outbreaks see CRS Report RS21747, Avian Influenza:
Agricultural Issues
, by Jim Monke.
2 Osterholm, Michael, “Pandemic Influenza: A Harbinger of Things to Come.” Presentation
at the Woodrow Wilson International Center for Scholars, Sept. 19, 2005.
[http://www.wilsoncenter.org/index.cfm?fuseaction=news.item&news_id=145329]
3 HHS Pandemic Influenza Plan. [http://www.hhs.gov/pandemicflu/plan/].

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Global Prevalence
Since 1997, when the first human contracted H5N1 in Hong Kong, the virus has
resurfaced and spread to birds in nearly 50 countries across the world. In 2004, nine
Asian countries reported H5N1 poultry outbreaks. By August 2005, birds in
Mongolia had become infected with the virus. Two months later, domestic birds in
Russia and Kazakhstan had reportedly contracted H5N1 through contact with wild
waterfowl at shared water sources. By late October 2005, H5N1 had spread
westward, affecting six other regions in Russia, and infecting bird populations in
Romania, Croatia, and Turkey. In 2006, countries in western Europe, the Middle
East, and Africa reported H5N1 infection among poultry stocks for the first time.
Also, Turkey, Iraq, Azerbaijan, and Egypt reported the first H5N1 human cases
outside of Asia. Although Iraq has reported human H5N1 cases no birds have been
diagnosed with the virus. The table below shows the latest number of confirmed
human H5N1 cases as reported by WHO as of April 4, 2006.4 Figure 1 in the
Appendix maps the human H5N1 cases.
Table 1. Human Cases of Avian Influenza A/H5N1
Country
Human Cases
Deaths
Azerbaijan
7
5
Cambodia
5
5
China
16
11
Egypt
4
2
Indonesia
30
23
Iraq
2
2
Thailand
22
14
Turkey
12
4
Vietnam
93
42
Total
191
108
Source: World Health Organization: Cumulative Number of Confirmed Human Cases of Avian
I n f l u e n z a A / H 5 N 1 R e p o r t e d t o W H O . A p r i l 4 , 2 0 0 6 . S e e
[http://www.who.int/csr/disease/avian_influenza/en/].
4 WHO, Cumulative Number of Confirmed Human Cases of Avian Influenza A/H5N1, March
21, 2006. [http://www.who.int/csr/disease/avian_influenza/country/en/].

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Transmission
There is some debate over how H5N1 is spread. Some experts contend that
migratory virus-carrying wild bird species, notably water fowl, are a key H5N1
vector, or medium of transmission. H5N1 has been detected in migratory birds in
multiple countries, and in some instances, its spread has been temporally correlated
with seasonal migrations of certain wild species. In some countries, wild birds
comprise the sole known H5N1-positive animal population. Some wild species may
also be passive carriers of H5N1, harboring but not exhibiting disease symptoms or
ill effects from the virus.5 Other experts, however, maintain that cross-border trade
in infected poultry and poor agricultural practices, including the use of infected bird
feces in fertilizer and animal feed, may comprise equally or more important vectors.
Indications that may support such assertions include the initial detection of H5N1 on
commercial farms in caged poultry that are unable to mingle with wild fowl, and the
detection of H5N1 on farms located far from wetlands where migratory birds
seasonally dwell, or in regions where H5N1-linked wild fowl die-offs have not been
reported. In some countries, such as in Nigeria, there are some indications that wild
fowl may not be implicated in the transmission of H5N1.6
Congressional Response
Congress provided $31.3 million to support ongoing U.S. efforts to prevent and
contain the global spread of H5N1 through P.L. 109-13, FY2005 Emergency
Supplemental Appropriations. The act, which passed in May 2005, also provided
funds for domestic pandemic preparedness.7 Congress directed $25 million to the
U.S. Agency for International Development (USAID). Pursuant to the statute,
USAID transferred $15 million of the $25 million appropriation to CDC. The act also
permitted the Secretary of State to transfer part of the tsunami relief funds to federal
agencies for avian flu activities. Ultimately, an additional $6.3 million was
transferred to USAID for international avian influenza activities,8 bringing the total
for FY2005 emergency supplemental spending on international avian influenza
activities to $31.3 million.
5 See FAO, Wild birds and Avian Influenza, Sept. 2005, among other sources.
6 See Ellen Paul [Exec. Dir., Ornithological Council], “What We Don’t Know About Bird
Flu,” Washington Post, Dec. 27, 2005; BirdLife Int., “Are High Risk Farming Practices
Spreading Avian Flu?,” Jan. 18, 2006; and BirdLife Int., “Autumn Waterbird Migration
Ends Without Spread of H5N1 Bird Flu,” Aug. 12, 2005; David Brown, “Poultry, Not Wild
Birds, Most Often Carries Deadly Avian Flu to Africa,” Washington Post, Feb. 16, 2006;
and AFP, “Bird flu outbreak in Nigeria stirs fresh row over migrant birds,” Feb. 8, 2006.
7 For more information on the domestic response to H5N1, see CRS Report RL33145,
Pandemic Influenza: Domestic Preparedness Efforts, by Sarah A. Lister, and CRS Report
RS21747, Avian Influenza: Agricultural Issues, by Jim Monke.
8 FY2007 State Department Function 150 Budget Request. Of the $6.3 million, $1.8 million
went to Asia and the Near East region, $3.0 million to Europe and Eurasia, and $1.5 million
to sub-Saharan Africa.

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In FY2006, the President submitted a $7.1 billion emergency supplemental
request for avian flu and pandemic influenza preparedness. Appropriators attached
$3.8 billion in emergency supplemental funds for avian flu initiatives, which reserves
a portion for international efforts, to FY2006 Defense Appropriations.9 The Office
of Management and Budget (OMB) reports that $280 million was spent on global
avian flu initiatives through FY2006 emergency supplemental appropriations.
The President requests an additional $215 million for international avian flu
activities in FY2007. The Senate Budget Committee passed S.Con.Res. 83 on March
16, 2006, which provided $2.3 billion for pandemic influenza preparedness. Table
3 in the appendix outlines the Administration’s FY2007 request for international
avian flu initiatives, and enacted spending for those activities through FY2005 and
FY2006 emergency supplementals.
Some Members have argued that the Administration had proposed allocating
insufficient resources to the global fight against H5N1 and pandemic planning,
particularly in Africa. For example, during the House Foreign Operations
Subcommittee hearing on pandemic flu in March 2006, Chairman Jim Kolbe
suggested that the $55 million that USAID was requesting for global avian flu
initiatives might not be sufficient, and encouraged the agency to request additional
funds if necessary. The Chairman also questioned why such a small proportion of
the FY2007 requested funds were allocated to Africa (less than $10 million). A
number of Members have introduced legislation to increase U.S. resources allocated
to the global fight against avian flu. Some bills, such as H.R. 4062, Pandemic
Preparedness and Response Act
and its Senate companion, S. 1821, propose
developing a “Pandemic Fund”to augment ongoing U.S. and international avian flu
and pandemic preparedness initiatives. Other bills, such as H.R. 4476, Global
Network for Avian Influenza Surveillance Act
, and its Senate companion, S. 1912,
advocate greater support for initiatives that prevent the spread of H5N1 among
animals. A number of bills, such as H.R. 3369, Attacking Viral Influenza Across
Nations Act
, and its Senate companion, S. 969, suggest the U.S. strengthen
surveillance capacity within affected countries. Bills, such as H.R. 813, Flu
Protection Act
, and its Senate companion, S. 375, aim to boost influenza vaccine
supply. Additionally, other legislation, such as H.R. 4245, Influenza Preparedness
and Prevention Act
encourage greater international cooperation.
9 The FY2006 Defense, Disaster Assistance, and Avian Flu Preparedness Appropriations
conference report, H.Rept. 109-359, contains $3.8 billion for avian influenza initiatives.
$3.3 billion of the $3.8 billion is directed to the Department of Health and Human Services
(HHS) (of which $267 million is reserved for international initiatives, disease surveillance,
vaccine registries, research, and clinical trials). An additional $500 million is reserved for
international assistance, monitoring and tracking, and research and development, of which
$131.5 million is directed to USAID, $130 million to the Department of Defense, $71.5
million to the Department of Agriculture, $47.3 million to the Department of Homeland
Security, $20 million to FDA, $27 million to the Department of Veterans Affairs, $31
million to the Department of State, and $11.6 million to the Department of the Interior.

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U.S. Executive Branch Response
On November 1, 2005, the President released the National Strategy for
Pandemic Influenza.10 One day later, on November 2, 2005, the Administration
released the U.S. Department of Health and Human Services (HHS) Influenza Plan.
The HHS plan provided a detailed explanation of how the national strategy would be
implemented. Some were disappointed by the relatively small proportion of funds
reserved for international efforts. It has been argued that greater investment in
pandemic influenza preparedness abroad could enhance domestic pandemic
preparedness efforts. Of the $7.1 billion requested, $200 million is made available
for HHS to bolster international surveillance capacity; $131.5 million for USAID to
implement avian influenza containment efforts globally; an additional $18.5 million
for the State Department for avian flu and pandemic preparedness activities in
diplomatic arenas, $20 million for the potential evacuation of U.S. government
personnel and their dependents in the event of a pandemic; and $18.3 million for the
Department of Agriculture to provide technical assistance in international animal
surveillance.11
The U.S. Department of State is responsible for coordinating the U.S.
international response to the global spread of H5N1. Ambassador John Lange
replaced Ambassador Nancy Powell as the Senior Coordinator for Avian Influenza
and Infectious Diseases in March 2006. Ambassador Lange is responsible for
overseeing the work of the technical implementing agencies: HHS (and its relevant
agencies), USAID, the Department of Agriculture, and the Department of Defense.
Prior to 2005, U.S. agencies had been enhancing laboratory capabilities, training
health care providers, strengthening surveillance systems, and developing influenza
pandemic plans. Through the FY2005 emergency appropriations, Congress directed
U.S. agencies to revisit international influenza initiatives and ensure that there was
a coordinated response to the global spread of H5N1. USAID and HHS (including
its relevant agencies) undertook country planning visits to Vietnam, Cambodia, and
Laos. After the trip, the team outlined in a report12 a number of factors that have
complicated efforts to contain the spread of H5N1 in those countries, which included:
! Between 70% and 80% of poultry in the three countries are raised in
small backyard farms, hindering national governments’ ability to
ensure health standards.
10 For more information on U.S. government avian flu and pandemic preparedness see
[http://www.pandemicflu.gov]
11 FY2006 Emergency Request for Avian and Pandemic Influenza Preparedness.
[http://www.whitehouse.gov/omb/budget/amendments/supplemental_11_01_05.pdf]
12 Report from Country Planning Visits, “U.S. Government Emergency Response to Avian
Influenza: A Plan of Action for Vietnam, Laos, and Cambodia.” July 11-24, 2005. This
report was provided to CRS by USAID.

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! Between 50% and 80% of poultry die from other avian infections,
complicating efforts to identify unusual die-offs, and limiting
farmers’ likelihood of reporting bird deaths to authorities.
! Although culling is an essential element of controlling the spread of
H5N1, poorer countries can not afford to systematically compensate
farmers for lost stock, which also increases reluctance to report signs
of infection.
! Wild birds and domesticated ducks are H5N1 reservoirs.
! Low levels of awareness exist among local farmers.
! There is little pandemic preparedness activity in the countries toured.
! The capacity to monitor and respond effectively to animal outbreaks
is limited. Veterinary services are inadequate to deal with the scope,
severity, and rapid spread of H5N1 epidemics, which has resulted in
the disease becoming increasingly endemic among animal
populations in the region. The lack of human resources for disease
surveillance, diagnostics, and response also severely limits the
capacity of human health systems, and continued human infections
of avian influenza threaten to overburden already fragile public
health infrastructures.
The report also included an action plan, which outlined the activities that each
agency would implement. The agency-specific strategies are briefly described below.
Department of State
On September 14, 2005, President Bush announced the International Partnership
on Avian and Pandemic Influenza (IPAPI) at the U.N. General Assembly High-Level
Plenary Session. Through IPAPI, the U.S. government seeks to enhance public health
and surveillance capacity through diplomatic initiatives that promote transparency
and encourage reporting and rapid sharing of samples. IPAPI seeks to generate and
coordinate political momentum and action for addressing the threats of avian and
pandemic influenza based on a set of core principles. The principles are focused on
enhancing preparedness, prevention, response, and containment activities (see Table
4). The Partnership brings key nations and international organizations together to
improve global readiness by:
! elevating the issue of avian and pandemic influenza preparedness to
the national level;
! coordinating efforts among donor and affected nations;
! mobilizing and leveraging resources;
! increasing transparency in disease reporting and surveillance; and
! building capacity to identify, contain, and respond to pandemic
influenza.

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The State Department works closely with regional organizations, including the
Association of Southeast Asian Nations (ASEAN) and the Asia Pacific Economic
Cooperation (APEC) forum, to address avian influenza and the threat of an influenza
pandemic. The work includes efforts to encourage comprehensive national pandemic
preparedness plans that address the multi-sectoral impacts of an influenza
pandemic.13 The next IPAPI meeting is scheduled for June 2006.
In the FY2006 supplemental request, the President proposed that the State
Department receive $38.5 million in FY2006 for international response coordination;
diplomatic outreach; exchanges of U.S. and foreign medical personnel; and for avian
and pandemic influenza health support and protection of U.S. government employees
and families at U.S. missions overseas. About $20 million of those funds would be
reserved for the potential evacuation of U.S. government personnel and dependents
from overseas missions. OMB reports that in FY2006, $6 million of the funds were
spent on diplomatic support and international response coordination and $25 million
were spent on health support for embassy and evacuation contingency for overseas
missions. The Administration did not request additional funds in FY2007 for State
Department international avian flu activities.
U.S. Agency for International Development (USAID)
USAID coordinates its global H5N1 and influenza response with other U.S.
agencies. It also works closely with WHO, the Food and Agriculture Organization
of the United Nations (FAO), and other international governments and organizations
to support national influenza and H5N1 prevention efforts. USAID reports that it has
allocated $22.1 million to global avian flu prevention and containment during
FY2005 ($16.3 million of which was funded through the FY2005 emergency
appropriations).14 USAID has received $131.5 million from FY2006 emergency
supplemental appropriations for global avian flu efforts. The FY2007 budget request
allocates $55 million to USAID for continued avian flu and pandemic preparedness
initiatives abroad. Specifically, the agency has:
! strengthened disease surveillance, laboratory diagnosis, and rapid
containment of animal outbreaks in Cambodia, China, Indonesia,
Laos, and Vietnam;
! supported communication campaigns in Laos, Cambodia, Vietnam,
and Indonesia aimed at reducing animal handling practices that place
humans at risk;
13 The State Department also implements influenza pandemic preparedness initiatives
through the Office of International Health Affairs (OES/IHA), which works with agencies
throughout the U.S. government to facilitate policy-making regarding bioterrorism and
health security, environmental health, infectious diseases (e.g., SARS, Avian Influenza,
Pandemic Influenza, Polio), health in post-conflict situations, and surveillance and response.
[http://www.state.gov/g/oes/c1874.htm].
14 USAID Avian Flu Update #29, February 9-March 13, 2006.
[http://www.usaid.gov/our_work/global_health/home/News/news_items/actions.html].

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! distributed some 10,000 personal protective equipment (PPE) sets,
which include manual sprayers to assist in decontaminating hospital
rooms and equipment, Tyvek suits (protective coveralls used in
hazardous situations), gloves, boots, masks, and eye protection in
Cambodia, Thailand, Laos, Vietnam, and Indonesia;
! shipped 2,000 sets of PPE for first responders and animal cullers in
Nigeria;
! mobilized an emergency shipment of 2,000 PPE sets for first
responders within 48 hours of confirmation of H5N1 in Niger;
! deployed infectious disease and animal health experts to Iraq,
Turkey, Ukraine, Romania, Armenia, Azerbaijan, Georgia, Moldova,
and Nigeria to provide short-term technical assistance, assisted in the
rapid collection of animal samples and helped implement procedures
to strengthen surveillance and containment efforts in the countries;
! provided Ukraine PPE kits that two veterinary laboratories and
cullers and first responders from the Ministry of Emergencies are
using in their response and containment activities;
! granted WHO $300,000 for international coordination efforts and for
improving disease control and surveillance measures; and
! provided WHO an additional $250,000 for PPE.
U.S. Department of Health and Human Services (HHS)
CDC is the key agency at HHS responsible for implementing U.S. anti-influenza
activities around the world. The Coordinating Center for Infectious Diseases and the
Field Epidemiology Training Program — a CDC-sponsored activity — are also
critical components of HHS global pandemic preparedness initiatives. Activities
with foreign governments or populations include pandemic preparedness and
planning; training in avian influenza surveillance; laboratory safety and skills
instruction; epidemiology training; developing and training rapid response teams;
stockpiling support; and deployment of expert disease control teams.
A significant part of H5N1 and pandemic influenza planning is funded through
the Global Disease Detection (GDD) Initiative at CDC. GDD aims to recognize
infectious disease outbreaks faster, improve the ability to control and prevent
outbreaks, and detect emerging microbial threats. In FY2006, HHS enhanced its
international pandemic research activities. Research activities included assisting in
the development and testing of candidate vaccines and drugs produced by Vietnam
and other countries with endemic avian influenza; expanding the clinical trials
infrastructure and research in southeast Asia; conducting human-animal interface
studies, including disease surveillance among animals in the region; and expanding

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other research to accelerate the development of pandemic influenza vaccines, drugs,
and diagnostics.15
In 2005, CDC expanded its GDD activities by creating new sites, improving
early warning systems, researching new viral strains, and supporting international
organizations. CDC estimates that in FY2005, it spent approximately $21 million on
activities related to international influenza through both its Infectious Diseases
Control and GDD programs, of which $15 million was provided through emergency
appropriations. OMB reports that HHS spent $114 million on international avian flu
initiatives through FY2006 emergency supplemental appropriations. The
Administration requests $145 million for HHS global pandemic influenza and
preparedness initiatives in FY2007.
Department of Agriculture (USDA)
U.S. Department of Agriculture (and its related agencies)works closely with
other U.S. agencies on the ground, as well as other international organizations to help
nations take steps to address and control the spread of avian influenza. Dr. Ron
DeHaven, Administrator, Animal and Plant Health Inspection Service (APHIS) of
USDA stated that addressing avian flu at its source — in affected poultry abroad —
and participating in international eradication efforts provide the best opportunity to
reduce or eliminate the risk of an H5N1 pandemic.16 In that view, USDA and other
analysts consider the department’s efforts a critical element in the global fight against
the spread of H5N1.

Through FY2006 emergency supplemental appropriations, Congress directed
$91.3 million to USDA for avian flu and pandemic preparedness initiatives, of which
$18.3 million was reserved for international initiatives. The funds were allocated as
follows:
! $8.0 million for wildlife, poultry and swine surveillance and
diagnostics;
! $1.75 million for biosecurity enhancement through education and
information;
! $1.05 million for technical assistance through training and avian
movement control;
! $3.8 million for training and education related to industry changes
and food safety planning;
! $1.05 million for training and education regarding poultry
destruction and disposal methods;
! $0.6 million for testing and evaluation of vaccine formulations; and
! $2.1 million for in country expertise for longer term assistance.
1 5 HHS FY2007 budget request. [http://www.hhs.gov/budget/07budget/
2007BudgetInBrief.pdf]
16 USDA, Transcript of Technical Briefing regarding Avian Influenza. October 26, 2005.
[http://www.usda.gov/birdflu]

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The FY2007 Administration budget request includes $5 million for USDA
international avian flu initiatives.
Department of Defense (DoD)
The Department of Defense Global Emerging Infections System (GEIS) delivers
health care to American armed forces around the globe.17 GEIS has a network of
overseas medical research laboratories that track, prevent, and treat infectious
diseases around the world. The objective is to protect the U.S. military and
strengthen its ability to address the challenges related to a potential pandemic
influenza, including compromised military force health and readiness. GEIS is also
a critical partner in the WHO’s Global Outbreak Alert and Response Network
(GOARN) (described below). Key DoD-GEIS activities to combat the spread of
H5N1 and prepare for an influenza pandemic have included:
! providing a DoD staff veterinarian to serve as a member of the
WHO GOARN Team in Laos, and to conduct training workshops in
detecting and diagnosing avian flu cases;
! placing a U.S. Navy microbiologist at the Institute Pasteur in Ho Chi
Minh City, Vietnam, to hold training sessions on rapid diagnostic
test methodology;
! monitoring and preventing infectious disease emergence in southeast
Asia through its Armed Forces Research Institute of Medical
Sciences (AFRIMS).18
The Naval Medical Research Units (NAMRU) are another critical part of DoD’s
avian flu containment and pandemic preparedness efforts. NAMRU supports the
GEIS mission through four programs: emerging diseases, enteric diseases, parasitic
diseases, and virology. NAMRU are overseas research laboratories based in Egypt,
Indonesia, and Kenya, which collect and analyze viral samples. NAMRU has been
critical in U.S. government H5N1 surveillance efforts. DOD also maintains related
research activities in Southeast Asia and the Pacific Islands, and supports a satellite
laboratory in Phnom Penh, Cambodia, in collaboration with the Cambodian National
Institute of Public Health. Key activities include:
! bolstering local, national, and regional diagnostic and
epidemiological capacity;
! assisting in the development of new surveillance strategies, such as
the novel syndromic surveillance initiative Early Warning Outbreak
Recognition System (EWORS);
17 GEIS website, [http://www.geis.fhp.osd.mil/].
18 DoD, Global Emerging Infections System Annual Report Fiscal Year 2004.
[http://www.geis.fhp.osd.mil/GEIS/aboutGEIS/annualReports/GEIS_AR_04.pdf].

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! implementing a comprehensive influenza surveillance project in
Indonesia, which provides prevalence data and temporal, genotype
data of circulating strains;
! collaborating with CDC in its FY2005 and FY2006 global influenza
activities; and
! facilitating the transformation of outbreak response structures into
more effective, multidisciplinary, centrally directed ones.19
OMB reports that DoD spent $10 million in FY2006 on worldwide avian flu
surveillance and assistance to military partner nations. The Administration requests
$10 million for international avian flu efforts in FY2007.
International Response20
Overview of the Role of the World Health Organization
The World Health Organization, established in 1948, is the U.N. system’s
authority on international public health issues. It assists governments to improve
national health services and establish worldwide standards for foods, chemicals, and
biological and pharmaceutical products. WHO concentrates on preventive rather
than curative programs, including efforts to eradicate endemic and other widespread
diseases, stabilize population growth, and improve nutrition, sanitation, and maternal
and child care. WHO works through contracts with other agencies and private
voluntary organizations. The United States has been a member of WHO since its
inception.
WHO is a central actor in the global response to the outbreak of H5N1 avian
influenza. WHO seeks to mitigate the risks avian influenza and infectious diseases
pose to international public health, and to assure the availability of appropriate
containment mechanisms, particularly since global travel has become the primary
means of spreading disease around the world. With the exception of SARS and
HIV/AIDS, H5N1 is viewed by some as the most serious challenge facing WHO.
WHO’s Global Health Security
The Epidemic and Pandemic Alert and Response system is a critical part of
WHO’s global health security plan. Key aspects of the program include:
19 DoD, Global Emerging Infections System Annual Report Fiscal Year 2004.
[http://www.geis.fhp.osd.mil/GEIS/aboutGEIS/annualReports/GEIS_AR_04.pdf].
20 This section prepared by Rhoda Margesson and Tiaji Salaam-Blyther, Analysts in Foreign
Affairs.

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! The Alert and Response Operations: systematically track the
development of diseases, share and disseminate information, and
coordinate rapid outbreak response and logistics.
! The Global Outbreak Alert and Response Network (GOARN):
provides an operational framework and aims to create a standardized
international outbreak response system through 112 institutions and
networks of people and technical resources.21
! The Global Public Health Intelligence Network (GPHIN): tracks
Internet communications through a customized search engine, which
effectively picked up telecommunicated alerts in China during the
SARS outbreak. WHO also uses the system to clarify or refute
information that may create disruption or panic.
WHO Global Influenza Preparedness Plan22
In September 2005, U.N. Secretary-General Kofi Annan appointed Dr. David
Nabarro as the Senior U.N. System Coordinator for Human and Avian influenza. Dr.
Nabarro, seconded from the WHO, is responsible for coordinating the avian
influenza containment efforts of various U.N. agencies. Dr. Nabarro is also tasked
with encouraging global support and implementation of the WHO Global Influenza
Preparedness Plan. The plan outlines WHO goals and actions, as well as
recommended actions for individual nations at each pandemic phase. The plan
contains an annex of recommendations to nations for “non-pharmaceutical public
health interventions,” such as isolation, quarantine and travel restrictions. The annex
stresses the use of voluntary rather than compulsory measures. Additionally, it
stresses that nations implement infection-specific responses, noting the lack of
demonstrated utility of certain practices. For example, certain SARS control
measures, such as temperature screening at airports, would not be expected to
effectively control influenza spread.23

WHO has requested $150 million to establish a global stockpile of influenza
vaccines and treatments. WHO officials underscore that wealthy and poor countries
must develop pandemic preparedness plans collectively to reduce national and
international viral transmission. The organization envisions using the stockpile to
arrest a potential pandemic by containing the virus at the first sign of an outbreak. In
the event of an outbreak, WHO asserts that a pandemic could potentially be averted
21 For more information on the Global Outbreak Alert and Response Network, see
[http://www.who.int/csr/outbreaknetwork].
2 2 The WHO influenza pandemic preparedness Home Page is at
[http://www.who.int/csr/disease/influenza/pandemic/en/index.html].
23 See WHO, Department of Communicable Disease Surveillance and Response Global
Influenza Programme, “Responding to the Avian Influenza Pandemic Threat: Recommended
Strategic Actions,” WHO/CDS/CSR/GIP2005.8.

CRS-13
if antiviral drugs were quickly distributed in a poor country without access to them.24
To date, countries have pledged between $20 million and $30 million to fund the
stockpile. Roche, the patent holder of Tamiflu, announced that it would donate three
million courses of the drug to WHO25. The company estimates that the three million
courses would be ready before mid-2006. On January 17, 2006, WHO announced
that Roche would donate an additional two million treatment courses of Tamiflu for
use in developing countries — bringing the total of donated courses to five million.26
Similarly, the U.N. General Assembly has established an emergency fund —
Central Emergency Response Fund (CERF) — to provide quick initial funding
during the early stages of emergencies and to minimize extra costs related to funding
delays. CERF was formerly launched in March 2006. The U.N. aims to have a $500
million revolving budget that could be used within three to four days of the start of
an emergency. To date, the United Nations has received $225 million for the fund.27
International Health Regulations
An outbreak of infectious diseases raises many public health questions including
the application of international law, particularly as it affects three main areas —
International Health Regulations (IHR); public health measures and civil and political
rights; and principles of state responsibility.28 This section will focus on the IHR
because of its relevance to WHO.
On May 23, 2005, the World Health Assembly revised the IHR, adding novel
influenza strains (those with pandemic potential) and SARS to the list of “notifiable
diseases” that WHO urges countries to report. In addition, the revised IHR include
a provision requiring notification of “events of international concern.” This
mechanism could strengthen WHO’s ability to address emerging diseases, because
it requires member States to report unusual health events whether or not they are
attributable to a known pathogen. The updated IHR also include expanded
requirements for disease surveillance and control activities at points of international
travel (airports, border crossings, etc.), and urge developed countries to assist
24 WHO, “Donation of three million treatments of oseltamivir to WHO will help early
response to an emerging influenza pandemic.” August 24, 2005.
[http://www.who.int/mediacentre/news/releases/2005/pr36/en/index.html].
25 Roche, “Roche donates 3 million treatments of antiviral Tamiflu to the WHO for use in
an influenza pandemic.” August 24, 2005. [http://www.roche.com/med-cor-2005-08-24]
26 WHO, “Additional two million treatment courses of oseltamivir donated to WHO to help
countries which cannot afford the treatment.” January 17, 2006. [http://www.who.int/
mediacentre/news/notes/2006/np01/en/index.html]
27 United Nations, “CERF launch promises immediate impact.” March 10, 2006.
[http://www.irinnews.org]
28 The American Society of International Law, SARS and International Law, April 2003, see
[http://www.asil.org/insights].

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developing countries to gain the capacities needed to meet the new disease control
guidelines.29
The revised IHR are to replace the existing IHR (adopted in 1969) on June 15,
2007, when the revised regulations come into force. Considered an international
legal instrument, the revised IHR will be binding on all WHO member States who
have not stated a reservation or rejected them altogether, and on non-member States
that have notified the Director-General of WHO that they agree to be bound by the
revised IHR.30 Between now and June 2007, WHO and Member States may take
concrete steps towards implementation of the revised IHR and to improve their
capacity to respond to international health risks and emergencies.31 The revised IHR
do not include an enforcement mechanism. However, for states to respond
appropriately and avoid potentially harmful consequences, much of the
encouragement to comply will likely come from international pressure, as the SARS
outbreak demonstrated.
At the Executive Board’s semi-annual session, from January 23-28, 2006, the
Board discussed a number of issues, including how to reduce the risk of a global
influenza pandemic. During the 117th Session, the Board discussed strategies to
encourage countries to immediately voluntarily comply with provisions of the revised
IHR related to a possible flu pandemic. Member countries, such as Canada, are
reportedly among those who advocate for the revised IHR to be adopted earlier than
2007.32 Dr. Lee Jong-wook, WHO Director General, argued that the recent spread
of the virus to Turkey has demonstrated that immediate voluntary compliance with
selected provisions of the revised IHR are urgent.33 During the session, the 32 Board
Members backed and released WHO Pandemic Influenza Draft Protocol for Rapid
Response and Containment.
The draft protocol must be ratified by the General
Assembly in May 2006. The protocol seeks to “facilitate rapid detection and
assessment of potential ‘signals’ that the virus is improving its transmissibility, and
to guide implementation of effective response interventions before an emerging
pandemic virus has spread beyond an initial outbreak zone.”34 Former Ambassador
29 The revised International Health Regulations, approved by the World Health Assembly
on May 23, 2005, are available at [http://www.who.int/csr/ihr/en/].
30 If a State makes a reservation that is compatible with the “object and purpose of IHR
(2005)” and at least one-third of other States have not objected to the reservation within six
months of notification, the revised IHR will enter into force for that State, subject to its
reservation. WHO, “Frequently Asked Questions About IHR.”
[http://www.who.int/csr/ihr/howtheywork/faq].
31 WHO, “Frequently Asked Questions About IHR.” [http://www.who.int/csr/ihr/
howtheywork/faq].
32 Nebehay, Stephanie, “WHO backs early adoption of bird flu rules.” Reuters, January 26,
2006. [http://www.alertnet.org/thenews/newsdesk/L26248393.htm]
33 WHO, “Report by the Director-General to the Executive Board at the 117TH Session.
January 23, 2006. [http://www.who.int/dg/lee/speeches/2006/eb_117/en/index.html]
34 WHO, “WHO Pandemic Influenza Draft Protocol for Rapid Response and Containment.”
January 27, 2006. [http://www.who.int/csr/disease/avian_influenza/guidelines/

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Nancy Powell stated at a House Foreign Operations subcommittee hearing that the
U.S. is working with countries to help them comply with the IHR. Ambassador
Powell pointed out that in the Caucuses there is a lack of boxes used for sending viral
samples to WHO, and a lack of information on how to adhere to the IHR. Various
U.S. government agencies are reportedly working with countries to demonstrate how
to safely handle and transport viral samples to WHO.
Role of Other International Health Organizations
The U.N. Food and Agriculture Organization coordinates global surveillance
and response activities for animal influenza strains with pandemic potential, such as
H5N1.35 To accomplish its mission, FAO works closely with the World Organization
for Animal Health, known by its French acronym, OIE.36 Rapid detection of avian
influenza outbreaks is key to controlling the disease both in poultry and in people,
and is therefore key to preventing and controlling a potential influenza pandemic.
FAO, OIE, and WHO work closely to prevent and respond to the threat of an avian
influenza pandemic. FAO has spent $7.5 million on H5N1 initiatives since 2004.
USAID is granting the U.N. organization $6 million, and the German government has
pledged $20 million for 2005 and 2006 activities.37 FAO is requesting an additional
$175 million from the international community, due to the rapid global spread of
H5N1.
The World Bank provides low-interest loans to countries heavily affected by
H5N1. Additionally, the Bank coordinates efforts between countries, and encourages
them to develop pandemic plans that connect sectors, such as health and rural
development. In September 2005, representatives from the WHO, FAO, OIE and the
World Bank met with health experts from the United Nations, European Commission
and H5N1-affected countries to discuss the global spread of H5N1, to emphasize the
importance of pandemic planning, and to prepare a coordinated response. On
November 4, 2005, the World Bank announced that it would provide $500 million
in loans to poor southeast Asian countries that are struggling to combat avian
influenza. The funds will be used to supplement government resources, strengthen
veterinary systems, and assist in culling and animal vaccination programs.38
Although the World Bank has agreed to provide $500 million in loans to affected
countries, the Bank estimates that $1 billion could be needed over the next three
34 (...continued)
RapidResponse_27%2001.pdf]
35 See FAO avian influenza home page at [http://www.fao.org/ag/againfo/subjects/en/
health/diseases-cards/special_avian.html].
36 See OIE avian flu home page at [http://www.oie.int/eng/AVIAN_INFLUENZA/
home.htm].
37 Interview with FAO official, October 31, 2005.
38 World Bank Press Release, “New Global Program to Deal with Avian Flu.” November
4, 2005. [http://www.worldbank.org]

CRS-16
years.39 The $1 billion does not include the cost of financing human or animal
vaccine development, purchasing antiviral medicine, or compensating farmers for
loss of income.
On January 17-18, 2006, the World Bank, the European Commission, and the
Chinese government co-hosted the “International Pledging Conference on Avian and
Human Influenza.” The conference’s stated goal was to raise between $1.2-$1.4
billion from the global community to combat avian flu in developing and middle-
income countries.40 Representatives from approximately 100 countries and 20
international organizations attended, ultimately pledging $1.9 billion in avian flu
assistance.
Details on how the money will be spent are scant; however, David Nabarro, the
U.N. bird flu coordinator, stressed that “there will be very clear procedures for the
monies being applied to particular programs.” Among the donors, the World Bank
reportedly promised $500 million, the U.S. pledged $334 million, Japan offered $159
million, EU member states donated $138 million, and the European Commission, the
EU’s executive body, pledged $121 million. Although China is struggling to contain
the spread of H5N1, it pledged $10 million.41 It is anticipated that $635.2 million
would go to East Asia and the Pacific, $224.6 million to Eastern Europe and Central
Asia, $147.1 million to Africa, $110.1 million to the Middle East and Africa, $76.0
million to South Asia, and $9.2 million to Latin America and the Caribbean.42
The World Bank has already begun plans for distributing the $1.9 billion raised.
In February 2006, the World Bank announced that it would provide the Kyrgyz
Republic $4 million, the first of the $500 million in avian flu assistance grants. The
grant is intended to support national efforts to strengthen veterinary services, enhance
information dissemination, and improve disease surveillance.43 The World Bank also
announced in February that it is planning to provide $50 million in emergency funds
to Nigeria for culling and farmer compensation, as well as vaccination assistance.44
39 UN News Service, “Bird flu: UN-sponsored conference draws up six-point action plan.”
November 9, 2005. [http://www.un.org/apps/news/]
40 “Avian and Human Influenza: Financing Needs and Gaps,” World Bank, January 12,
2006, pp. 10-11. [http://siteresources.worldbank.org/PROJECTS/Resources/40940-
1136754783560/AHIFinancingGAPSFINAL.pdf]
41 Information in this paragraph was compiled from the Wall Street Journal, “Donors Pledge
$1.9 billion to Fight Avian Flu in Developing Nations.
” January 19, 2006.
[http://www.wsj.com]
42 BBC, “$1.9bn pledged for bird flu fight.” January 18, 2006. [http://news.bbc.co.uk/go/pr/
fr/-/1/hi/world/asia-pacific/4622982.stm]
43 World Bank press release, “First World Bank Avian Flu Grant to Kyrgyz Republic.”
February 9, 2006. [http://www.worldbank.org]
44 World Bank press release, “Emergency Aid for Nigeria to Combat Avian Flu.” February
24, 2006. [http://www.worldbank.org]

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Issues for Congress
Some experts point out that in order to effectively contain the spread of H5N1
and prepare for pandemic influenza, the U.S. government would need to develop a
plan that integrates domestic and international policy. Some of the policy responses
may originate domestically, but resonate globally. For example, issues related to
U.S. drug policy, such as vaccine technology and intellectual property rights could
impact access to antiviral drugs and vaccines in countries where H5N1 is endemic
— particularly since some of the most affected countries do not have the capacity
to produce or purchase sufficient quantities of the drugs.45 One article in the Journal
of Public Health Policy pointed out that “almost 40% of the world’s supply of
interpandemic influenza vaccines is used in countries that do not produce their own
vaccines.”46 Below are some issues that particularly impact the most affected
countries in Asia, and other parts of the world.
Patent Protections
Intellectual property rights has become an increasingly contentious issue in
global health, particularly since companies began threatening to ignore patents for
HIV/AIDS treatments. In an effort to expand global access to flu drugs, the United
Nations had been encouraging Roche — the patent holder of Tamiflu — to license
other companies to produce generic versions of the drug. Roche announced on
October 21, 2005 that U.S. pharmaceutical companies could manufacture a generic
version of Tamiflu.47 Legislation introduced in the first session of the 109th Congress
aims to permit the United States to invoke a compulsory license and export generic
versions of the drug to non-producing countries.48 Some speculate that Roche has
been increasing efforts to license its products in other countries, in part because an
Indian pharmaceutical company, Cipla, has threatened to manufacture a generic
version of the drug — in spite of Roche’s patent rights. Underscoring that Tamiflu
is too expensive for many of the least developed countries, a Cipla representative said
that the company would sell the generic version of Tamiflu “at a humanitarian price”
in developing nations, and not in the United States or Europe.49 Two Indian
pharmaceutical companies are reportedly negotiating with Roche to produce generic
45 For more information on these issues see CRS Report RL33145, Pandemic Influenza:
Domestic Preparedness Efforts
, by Sarah Lister.
46 Fedson, David, “Preparing for Pandemic Vaccination: An International Policy Agenda for
Vaccine Development.” Journal of Public Health Policy 2005, Volume 26, Issue 1, April
2005. p.11.
47 Alonso-Zaldivar, Ricardo, “Roche agrees to generic version of Tamiflu drug.” Baltimore
Sun
, October 21, 2005. [http://www.baltimoresun.com].
48 H.R. 4392, To provide for the importation of pharmaceutical products under a
compulsory license as provided for under the World Trade Organization.

49 McNeil Jr., Donald, “Indian Company to Make Generic Version of Flu Drug Tamiflu.”
New York Times. October 14, 2005. [http://www.nytimes.com].

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versions of Tamiflu.50 Roche also reached an agreement with a Chinese
pharmaceutical company to make the drug.51
Health experts predict that patent protections will continue to be a contentious
issue as poorer countries seek to protect themselves against virulent diseases. Some
analysts contend that Congress faces an issue of whether to help countries where
H5N1 is endemic gain greater access to generic versions of Tamiflu and other
antivirals if licensed drugs are not accessible.52 Supporters assert that the precedent
for greater access to generics by poorer countries had already been established on
December 6, 2005, when World Trade Organization (WTO) members approved
changes to the intellectual property agreement making permanent a decision on
patents and public health.53 The General Council decision means that for the first
time a core WTO agreement will be amended. The decision directly transforms the
August 30, 2003 waiver to Section 31(f) of the Trade-Related Aspects of Intellectual
Property Rights (TRIPS).54 The waiver permits a country without manufacturing
capacity to obtain cheaper generic versions of patented medicines from countries
under compulsory licenses. The waiver enables the country to receive generic
versions of drugs in situations of “national emergency or other circumstances of
extreme urgency.”55 A separate statement describes members’ “shared
understanding” on how the decision is interpreted and implemented. Particularly, the
statement points out that the decision will be used in good faith in order to deal with
public health problems and not for industrial or commercial policy objectives.56
Although the waiver was seen as a tool to enable largely poorer countries to import
generic versions of licensed drugs, one piece of legislation proposes that the U.S.
Trade Representative inform WTO that the United States declares itself an “eligible
importing member” to import pharmaceutical products, largely because Roche is
unable to meet the “public health needs” of the United States.57
50 Jack, Andrew, “India drugs groups in Tamiflu talks.” Financial Times. December 12,
2005. [http://news.ft.com/home/us/]
51 Wright, Tom, “Roche to Let Chinese Producer Make Flu Drug.” New York Times.
December 13, 2005. [http://nytimes.com]
52 For more information on influenza and patent issues, see CRS Report RL33159, Influenza
Antiviral Drugs and Patent Law Issues.

53 WTO, “Members OK amendment to make health flexibility permanent.” December 6,
2005. [http://www.wto.org/english/news_e/pres05_e/pr426_e.htm]
54 Article 31(f) of the TRIPS Agreement says that production under compulsory licensing
must be predominantly for the domestic market. The concern was that this could limit the
ability of countries that cannot make pharmaceutical products from importing cheaper
generics from countries where pharmaceuticals are patented.
55 For more information on this issue see CRS Report RS21609, The WTO, Intellectual
Property Rights, and the Access to Medicines of Controversy
, by Ian F. Fergusson.
56 WTO, “Members OK amendment to make health flexibility permanent.” December 6,
2005. [http://www.wto.org/english/news_e/pres05_e/pr426_e.htm]
57 H.R. 4392, To provide for the importation of pharmaceutical products under a
compulsory license as provided for under the World Trade Organization.


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WTO members voted against delineating which drugs should be included in the
waiver agreement. Consequently, there is not consensus on which drugs are
considered critical in protecting public health. Advocates argue that in the event of
a pandemic, the new WTO amendment should apply to antiviral drugs and H5N1
vaccines for use in animals. Opponents are concerned that some might abuse and
undermine the agreement by reselling the drugs and vaccines for profit. In the event
of a pandemic, Congress might be faced with the decision on whether to support or
oppose the export of generic antivirals. Additionally, increased pressure might be
placed on Congress to encourage USDA to share with other countries some of its
H5N1 vaccine for use in animals.
Global Data Sharing
In spite of Tamiflu stockpiling efforts, it is unknown if the medicine will be
broadly useful in treating human H5N1 victims in a pandemic scenario. Some health
experts were reportedly alarmed when two patients in Vietnam who were infected
with H5N1 and aggressively treated with Tamiflu later died. Some are beginning to
question if the recommended dosage should be changed, as doctors reportedly
adhered to the recommended regimen when treating the two patients.58 Health
experts point out that more information is needed on patients who have already been
treated for H5N1 with Tamiflu. Data from the subjects would help in determining
if the drug remains effective in fighting H5N1 and if changes to dosage regimens are
required.
Those pressing for greater international data sharing point to new research that
might counter previous findings on the limited effectiveness of amantadine. The
New York Times reported in September 2005 that researchers found that amantadine
was no longer effective against H5N1. WHO reportedly spent $1.3 million to
stockpile the drug when it was used during the 1997 H5N1 outbreak. The Times
article asserted that in 2005, laboratory research found that all human viral samples
of H5N1 were resistant.59 Before 2000, almost no influenza virus was resistant to the
drug. Some experts speculated that viral resistence occurred in part, because China
reportedly used amantadine, intended solely for humans, on animals. (See “Affected
Countries’ Response” section). However, the Wall Street Journal quoted Dr. Shu
Yuelong, the Director of China’s national influenza laboratory, as stating that
preliminary evidence indicates that amantadine might be effective in treating avian
influenza in people.60 Dr. Shu reported that all of the viral samples that have been
isolated from patients in China were sensitive to amantadine. Those findings
conflicted with previous research on virus samples that were taken from patients in
Indonesia and found to be resistant to the drug. The new research has reportedly
58 Chang, Alicia, “Bird Flu Victims Die After Drug Resistence.” Washington Post.
December 21, 2005. [http://www.washingtonpost.com]
59 Rosenthal, Elisabeth, “Two Studies Find Flu Treatments Fall Far Short.” September 22,
2005. [http://www.nytimes.com].
60 Zamiska, Nicholas, “Scientists Says Bird-Flu Virus Appears to Be Stable in China; No
Signs that Avian Strain Is Easily passed by People; Old Drug Shows Promise.” December
12, 2005.

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prompted WHO and other officials to consider whether amantadine might eventually
play a role in fighting H5N1. The article underscores that there are currently too few
samples to draw any firm conclusions.
Some believe that some countries are intentionally withholding viral samples
of H5N1 cases. One article stated that countries with human H5N1 cases do not want
to send viral samples to the WHO or other industrialized countries, because they fear
the samples will be used to develop up-to-date vaccines which they will not have
access to.61 Others have speculated that China is withholding its samples, because
it is trying to produce an H5N1 vaccine.62
Some analysts propose that the United States and other countries should vote
to provide WHO with enforcement mechanisms. Supporters argue that WHO should
be able to force countries to share viral samples. Others contend that Congress
should provide greater support and resources to WHO, particularly for strengthening
global laboratory and testing capabilities. Skeptics point out that WHO has not
provided transparent, detailed data on the adequacy of funds or how funds are spent.
Global Disease Surveillance
A number of analysts have argued that due to insufficient investment in disease
surveillance and health care in many of the countries where H5N1 is endemic, a
pandemic may progress before it is discovered. In this view, ill-equipped
surveillance systems will be slow to determine the source of a pandemic, evaluate the
rate of viral transmission, ascertain whether H5N1 has become efficiently
transmissible among humans, or rate the effectiveness of anti-flu initiatives. Senate
Majority Leader Bill Frist has proposed $1 billion for a real-time international threat
detection system.63
USAID and other U.S. government officials suspect that the lack of documented
human cases of H5N1 in Laos has more to do with inadequate surveillance and
reporting systems than an absence of infection.64 The New York Times reported that
Laos has 69 veterinarians in the entire country, and all but two of them were trained
in other Communist countries before the collapse of the former Soviet Union.
Additionally, Laos reportedly has no veterinary school.65 Some health experts
believe that H5N1transmission could already be underway in Laos, since surrounding
countries have already had human and animal outbreaks. Key U.S. agencies and
61 Globe and Mail, “Chinese officials haven’t shared samples of H5N1: experts.” November
18, 2005. [http://www.theglobeandmail.com].
62 China Daily, “China: Bird flu vaccine for human use developed.” November 15, 2005.
[http://www.chinadaily.com.cn/english/doc/2005-11/15/content_494593_3.htm].
63 Honorable Bill Frist website, “First Addresses National Press Club on Avian Flu —
Pandemic: The Economy Killer.” December 8, 2005. The Senate passed S. 2170 on
December 22, 2005.
64 Interview with USAID official, October 11, 2005.
65 Bradsher, Keith, “Health Officials Call for Long-Term Spending on Bird Flu.” January
17, 2006. [http://www.nytimes.com]

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international organizations have determined that Laos is a country that needs critical
prevention, monitoring, and surveillance support in order to prevent full-blown
human-to-human transmission of H5N1 that could emerge and sweep across the
region without warning.66 U.N. officials argue that Laos exemplifies the sort of long-
term assistance that other poorer countries will require, such as training in veterinary
services and surveillance systems, provision of surveillance and testing equipment,
and support for farmer compensation.67
Some experts have expressed increasing concern about the capacity of poorer
countries that have not yet had H5N1 cases to effectively contain the spread of the
virus and plan for pandemic influenza, particularly in sub-Saharan Africa. FAO is
particularly wary of the virus spreading across Africa, as the surveillance capacities
and veterinary services in those countries are limited. According to Reuters, a WHO
representative declared that an H5N1 outbreak would likely be initially missed in
Africa, as bird nutrition is poor and high mortality among poultry is common.
Concurrently, human cluster cases are likely to be missed due to poor surveillance
systems. South Africa is reportedly the only country in sub-Saharan Africa to have
drawn up a pandemic preparedness plan.68 Some experts fear that an unabated H5N1
outbreak in Africa could make the bird flu endemic there. “If the virus were to
become endemic in Africa, it could increase the risk that the virus would evolve
through mutation or reassortment into a strain that could be transmitted to and
between humans.”69
The press reported on December 20, 2005 that a bird suspected of having
contracted H5N1 in Ethiopia, tested negative of the virus.70 Experts are concerned
that birds in Ethiopia and other countries in the Rift Valley, including Kenya,
Tanzania, and Uganda, are at particular risk of avian flu infection due to the large
numbers of migratory birds that fly to the region during the European winter. Those
concerned about insufficient surveillance and diagnostic equipment and expertise,
point out that Ethiopia had to use health experts and equipment from Egypt to
determine what caused a rash of bird deaths in December 2005. USAID with support
from the U.S. Navy Medical Research Unit (NAMRU) in Cairo reportedly provided
$15,000 in emergency funding to analyze the viral samples of dead pigeons found in
Addis Ababa and the Eastern Somali region for H5N1 infection. Additionally,
USAID has reportedly reprogrammed $600,000 from existing surveillance funds for
66 Ibid.
67 Bradsher, Keith, “Health Officials Call for Long-Term Spending on Bird Flu.” January
17, 2006. [http://www.nytimes.com]
68 Reuters, “Bird Flu in Africa Could Swamp Health Systems: WHO.” November 27, 2005.
[http://www.nlm.nih.gov/medlineplus/news/fullstory_27731.html]
69 “UN agency says risk of bird flu spreading to Middle East, Africa rises markedly.” U.N.
News Center, October 19, 2005.
[http://www0.un.org/apps/news/story.asp?NewsID=16037&Cr=bird&Cr1=flu]
70 Reuters Foundation, “ETHIOPIA: Birds Test Negative for avian flu.” December 20,
2005. [http://www.alertnet.org]

CRS-22
bird flu initiatives in Ethiopia.71 The funds are to help provide technical assistance
to the Ministries of Agriculture and Health, develop laboratory and communications
capacity, and procure Personal Protective Equipment for first responders.
Many of the countries in which H5N1 is endemic have complained that they can
not afford to implement the strategies recommended by the international community.
Furthermore they are hesitant to divert their limited budgets — already struggling to
contend with AIDS, child and maternal health, tuberculosis, and other health
challenges — to something that might not occur. Advocates of greater assistance to
the region, point out that countries with more resources for pandemic planning than
neighboring poorer countries have also acknowledged difficulties in responding to
the H5N1 threat. A news report cited a South Korean health worker who stated that
his country is ill-equipped to respond to a pandemic citing insufficient supplies of
medication, hospital beds, and ventilators.72
On December 22, 2005, the Senate passed S. 2170, which would help
developing countries bolster their disease surveillance programs, and establish
fellowships for citizens of those countries to study epidemiology and public health
in the United States. Additionally, some in Congress have advocated for greater U.S.
spending on fighting the global spread of H5N1 avian flu. Press reports quoted
Representatives Henry Hyde and Tom Lantos, Chairman and Ranking Member of the
House International Relations Committee respectively, stating concern about the
level of funding the Administration proposes to provide for global efforts in
FY200673. Advocates assert that the Administration requests for international H5N1
initiatives will not sufficiently address the significant needs of countries with H5N1-
endemic stocks. Particularly, experts add that the threat of an H5N1 or other
influenza pandemic illuminates the neglect that health care systems in many
southeast Asian countries have faced over the last couple of decades. Proponents
argue that if the United States would increase its funding to support global health
care systems the global community could benefit from efficient outbreak reporting
and control measures, accurate diagnoses, enhanced case management, and improved
disease surveillance and monitoring.
Global Pandemic Planning
Some experts caution that pandemic preparedness plans must extend beyond
procuring and stockpiling antiviral drugs and vaccines. In this view, governments
must also develop detailed vaccine and treatment distribution plans. Particular
attention has been paid to H5N1-affected countries that have communication and
infrastructure barriers, especially between urban and rural areas (where many of the
backyard poultry farms exist). Many Asian countries have significant income and
71 USAID, H5N1 Avian Influenza (AI) Most Recent Developments and Actions. November
26 - December 19, 2005.
72 Grudgings, Stuart, “Rich-poor divide hobbles Asia’s bird flu plans.” Reuters, September
13, 2005. [http://www.reuters.com]
73 GovEXEC.com, “House panel calls plan for tracking avian influenza ‘inadequate’.”
December 7, 2005. [http://govexec.com/dailyfed/1205/120705cdpm2.htm]

CRS-23
infrastructure gaps between rural and urban areas. In the rural areas, there are often
few hospitals and treatment centers. Equipment can be outdated or lacking.
Veterinary and animal health services can be limited. Additionally, in many cases
rural governments operate independently from urban governments, which tend to
receive larger portions of national resources. Farmers in rural areas may not adhere
to government H5N1 initiatives, exacerbating the problem. One infectious disease
expert in Hong Kong asserted that the communication problem is particularly acute
in China. “I trust and believe the central government has very good intentions, but
unfortunately, it is a very big country. At the district, regional levels, the failure to
communicate continues.”74
Pandemic planners are warning that no country has the surge capacity to meet
national demands for consumer products and medical services for the full term of an
influenza pandemic (an estimated six months to a year). The United States, and other
industrialized nations, rely on a range of critical products from H5N1-affected
countries, such as medical supplies, military parts, and sanitation equipment. These
supply chains are replenished “just-in-time” to minimize costs. If an outbreak were
to occur, hospitals, food and water systems, and the military could all be vulnerable
to interrupted supply due to absenteeism, border closures, and other supply chain
disruptions. Therefore, the private sector, as well as national and international trade
organizations have been urged to participate in pandemic planning.
Some analysts argue that resources allocated to containing the spread of H5N1
have been insufficient in part, because many countries have funded the response
primarily through the ministries of agriculture and health. Some experts point out
that an influenza pandemic will likely impact the animal and health sectors, as well
as trade, security, hospitality, and labor. Consequently, they say, governments should
develop pandemic plans that utilize the resources of other ministries that are often
better funded, such as ministries of trade, tourism, and commerce. Some analysts
note that U.S. officials, such as the U.S. Trade Representative and the Secretary of
Commerce should be engaged in U.S. international pandemic influenza planning
efforts. Others would like Congress to encourage public-private partnerships that
augment U.S. international avian flu and pandemic preparedness efforts.
Combating Bird Flu Among Animals in Affected Countries
Most countries have used mass culling to prevent viral spread when avian
influenza outbreaks are detected. However, some countries have not been able to
rely on this process as a primary containment measure, because the governments
might not have been able to compensate farmers for slaughtering their stocks.
Scientists have also found that mass culling is sometimes not feasible when wild
birds are involved in transmission. Some health experts assert that there should be
more research on more affordable methods of preventing pandemics at their source
— in the animals that carry the virus. Strategies such as implementing cleaning days
(when all live markets are simultaneously emptied and cleaned), and separating ducks
and chickens in live poultry markets may decrease viral transmission among animals.
74 Grudgings, Stuart, “Rich-poor divide hobbles Asia’s bird flu plans.” Reuters. September
13, 2005. [http://www.reuters.com]

CRS-24
Some countries (including China) propose using vaccination to control avian
influenza in poultry. Skeptics warn that animal vaccination is a risky strategy, as it
is often difficult to distinguish infected from vaccinated animals, complicating efforts
to track the disease. Additionally, vaccination campaigns, if not carried out properly,
could result in entrenchment of the disease rather than eradication, further threatening
public health. 75
Cost of Culling. It has been suggested that a global fund should be
established to compensate farmers for culling their poultry in countries whose
governments can not afford to compensate the farmers. The WHO has already
expressed concern that some farmers in poorer countries may not cull their poultry,
because their livelihoods depend on poultry farming. For example, Indonesia has
carried out only a limited culling drive, because it lacks the funds to compensate
farmers.76 Farmers in some parts of Romania reportedly failed to cull their birds
despite government orders to do so. In some affected countries, public and animal
health authorities are reluctant to destroy their population’s dominant protein source
and income. A number of bills, such as H.R. 4062 and its counterpart S. 1821, have
been introduced that support the concept of a “Pandemic Fund”, which could include
funds for farmer compensation.
The World Bank announced that it would provide $500 million in loans to poor
countries struggling to fund national avian flu and pandemic preparedness plans —
a portion of which could be used to support poor farmers.77 However, the Bank noted
that $1 billion could be needed over the next three years to help countries contain the
spread of H5N1. The Asia Development Bank (ADB) also announced that it is
prepared to provide at least $470 million to support Asian anti-H5N1 and pandemic
preparedness efforts.78
Some have suggested that the United States target some foreign aid funds to
help the affected governments — including Vietnam, Indonesia, Cambodia, and Laos
— cover the cost of compensating individuals and companies for the destruction of
their birds. In this view, such assistance could help the image of the United States in
the region by demonstrating American concern and could minimize reluctance to
slaughter infected flocks. Others would like to see increased assistance to prevent the
spread of H5N1 among animals.
75 Ilaria Capua and Stafano Manganon, “Vaccination for Avian Influenza in Asia,” Vaccine,
Vol. 22, 2004, pp. 4137-4138.
76 Perry, Michael, “Poor Asian farmers are weak link in bird flu fight.” Reuters. September
19, 2005. [http://www.alertnet.org/thenews/newsdesk/SYD28137.htm]
77 World Bank, “New Global Program to Deal with Avian Flu.” November 4, 2005.
[http://www.worldbank.org]
78 ADB, “ADB Support for Asia’s Fight Against Avian Flu Could Reach $470 Million.”
November 9, 2005. [http://www.adb.org/Documents/News/2005/nr2005173.asp]

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Global Economic Impacts
The International Monetary Fund recently released a report which outlined the
potential global economic and financial impact of an avian flu pandemic. The report
outlines some possible effects of a severe pandemic. According to the report,
government finances might sharply deteriorate due to increased expenditure on health
and public safety. Concurrently, IMF asserts that governments could experience a
decrease in revenues as businesses and consumers avoid purchases, firms scale back
production as employee attendance drops, and borders close. There could also be
disruptions in payment systems leading to less revenue flow to national treasuries,
the report predicts. Governments might also be indirectly affected if poultry
businesses demand compensation, or if tourism, transport, retail, and insurance
industries become bankrupt. Ultimately, the IMF document predicts that a severe
avian flu pandemic could trigger a “sharp but short-lived impact” on the global
economy. However, the report asserts that financially stable economies might be
better equipped to contend with sharp fluctuations in GDP from quarter to quarter.
The IMF document reported that countries previously affected by SARS, some
countries that had recently dealt with avian flu outbreaks, and several countries with
large, complex financial systems generally had more advanced preparations.79
Many economists assert that health and non-health related sectors could be
severely affected by a global influenza pandemic, though it would be difficult to
predict the costs of those effects. For example, Canadian and Asian hospitality and
tourism sectors were considerably impacted during the SARS outbreak. In 2002 and
2003, SARS cost the Asia-Pacific region about $40 billion.80 Additionally, flights
to the region fell by about 45%, crippling the airline and hotel industries. Canada
estimated that it lost approximately $1.2 billion, with about $763 million spent on the
health-care system.81 In the event of a flu pandemic, researchers expect Britain,
Greece, Spain, Italy, and other countries that rely heavily on tourism, to be most
affected economically. One economist estimated that a flu pandemic could force
Britain’s GDP to fall by 8% or $168 billion (about 95 billion pounds), and result in
the loss of almost 1 million jobs (about 3% of all employment). 82
The World Bank estimates that a global influenza pandemic could cost the
global economy about $200 billion in one quarter or $800 billion over a year (about
2% of the global GDP). The Bank based its estimate on the economic losses induced
by the SARS pandemic, which caused GDP to fall by 2% in Asia over a three month
79 IMF, The Global Economic Impact of an Avian Flu Pandemic and the Role of the IMF.
February 28, 2006. [http://www.imf.org/external/pubs/ft/afp/2006/eng/022806.htm]
80 Osterholm, Michael, “Preparing for the Next Pandemic.” Foreign Affairs, July/August
2005. [http://www.foreignaffairs.org].
81 Ibid. Country-specific SARS-related information, including costs and fatalities can be
found in CRS Report RL32072, Severe Acute Respiratory Syndrome (SARS): The
International Response
, by Rhoda Margesson and Tiaji Salaam.
82 Nordland, Rod and George Wehrfritz, “A Costly Disease: Europe and the rest of the world
braces for the economic fallout of a possible bird-flu pandemic.” October 24, 2005.
[http://msnbc.msn.com/id/9711926/site/newsweek/]

CRS-26
period in 2003. However, the Bank underscored that it is virtually impossible to
accurately determine how much a global influenza pandemic would cost the world,
because experts assume that the immediate shock during a flu epidemic could be
larger and last longer than SARS. The 1918 pandemic, for example, came in three
waves, and spread over two years.83 Some economists have advised the United States
to identify source countries for key imports and develop a detailed plan that would
ensure continuity.
Economists point out that an Asian economy crippled by an influenza pandemic
could impact the U.S. economy, even if a significant number of Americans was not
sickened or killed by H5N1. According to U.S. Trade Representative (USTR) Robert
Portman, South Korea and Malaysia are the 7th and 10th largest trading partners for
the United States, respectively. The United States earned $72 billion and $40 billion
from South Korea and Malaysia, respectively, in 2004. Both countries have had
H5N1 cases among their flocks.84 Additionally, U.S. exports to China, one of the
most threatened countries, grew 76 percent between 2000 and 2003, while sales to
the rest of the world declined by 9 percent. China is now the sixth largest market for
U.S. exports and America’s third largest trading partner overall — surpassing Japan
in 2003.85 In 2004, U.S. exports to China grew to $33 billion, more than double the
level in 2001.86 Therefore, any pandemic related disruption of bilateral trade could
have a large impact. Alternatively, some economists predict that U.S. poultry exports
could increase as countries move to ban imported birds from countries with H5N1-
endemic stocks.
CLSA Asia-Pacific Markets, the Asian investment banking arm of Crédit
Agricole of France, estimates that H5N1 has already cost the region between $8
billion and $12 billion, citing the prolonged poultry ban by the European Union from
eight Asian countries and the death or destruction of some 140 million chickens and
other poultry. The Prime Minister of Thailand stated that the avian flu has already
cost his country some $1.09 billion, in addition to the $55.78 million the government
paid to farmers for a mass chicken cull.87
Some analysts caution that Congress should be prepared to respond to the impact
that potential fluctuations in supply and demand from key Asian markets might have
on the U.S. economy. Particularly, some would like Congress to direct the U.S. Trade
83 World Bank East Asia and Pacific Region, “Spread of Avian Flu Could Affect Next
Year’s Economic Outlook.” November 2005.
[http://siteresources.worldbank.org/INTEAPHALFYEARLYUPDATE/Resources/EAP-
Brief-avian-flu.pdf]
84 U.S. Trade Representative Robert Portman discussion at the US-ASEAN Business
Council Second Annual Asia Forum, November 1, 2005.
85 USTR website, “America’s Trade with China.” April 21, 2004. [http://www.ustr.gov]
86 USTR website, “Real Results in U.S. Trade with China.” September 9, 2004.
[http://www.ustr.gov]
87 Bullion, Alan, “Threats on the Wing.” The World Today, August/September 2005. Also
see, Bradsher, Keith, “Some Asian Bankers Worry About the Economic Toll From Bird
Flu.” New York Times. April 5, 2005. [http://www.nytimes.com]

CRS-27
Representative to prepare a report that comprehensively analyzes the potential
economic gains and losses to the U.S. economy in a pandemic scenario due to
changes in Asia’s economy. Experts point out that the Congressional Budget Office
(CBO) report A Potential Influenza Pandemic: Possible Macroeconomic Effects and
Policy Issues
focuses on possible supply and demand changes in the U.S. economy
if an H5N1 pandemic were to reach the United States.88 The Wall Street Journal
reported that the U.S. poultry industry currently exports about 15% of its chicken
meat annually, earning $2.2 billion in 2004. The article asserted that some poultry-
industry executives are concerned that importing countries might reject poultry from
states that have vaccinated the animals.89 Consequently, many executives in the
poultry industry are opposed to vaccinating chickens intended for export. Some
would like Congress to require USDA to present clear guidelines on how and when
poultry would have to be vaccinated.
Global Biosafety
In October 2005, scientists reported that the 1918 influenza pandemic that had
killed between 20 million and 50 million people worldwide may have emerged from
an avian flu strain. Health experts have debated whether the genetic sequence of the
1918 influenza should be published. Some were concerned that the information
could be used to construct a biological weapon. However, other scientists argued that
sharing such important findings is critical to efficiently identifying dangerous viruses,
and to finding ways to disable them. Ultimately, the genetic sequence was
published.90 Dr. Anthony Fauci, Director of the National Institute of Allergy and
Infectious Diseases, and Dr. Julie Gerberding, Director of the CDC, said in a joint
statement, “The new studies could have an immediate impact by helping scientists
focus on detecting changes in the evolving H5N1 virus that might make widespread
transmission among humans more likely.” Furthermore, the HHS National Science
Advisory Board for Biosecurity “voted unanimously that the benefits [to making the
results public] outweighed the risk that it would be used in a nefarious manner.”91
However, the Administration acknowledged that the influenza virus could be used
as a biological weapon and added the virus to the Select Agent list on October 20,
2005.92 Congress authorized the Select Agent program in the late 1990s to track the
88 CBO, A Potential Influenza Pandemic: Possible Macroeconomic Effects and Policy
Issues.
December 8, 2005. [http://www.cbo.gov/ftpdocs/69xx/doc6946/12-08-BirdFlu.pdf]
89 Kilman, Scott, “Vaccine Remains Sticking Point in U.S. Defense Against Bird Flu.”
December 12, 2005. [http://www.wsj.com]. Basic screening tests for bird flu used by many
importing countries leave ambiguous whether a bird testing positive is infected with H5N1
or has been vaccinated against it.
90 Kolata, Gina, “Experts Unlock Clues to Spread of 1918 Flu Virus.” New York Times,
October 6, 2005. [http://www.nytimes.com]
91 Ibid.
92 CDC, “Possession, Use, and Transfer of Select Agents and Toxins — Reconstructed
Replication Competent Forms of the 1918 Pandemic Influenza Virus Containing Any
Portion of the Coding Regions of All Eight Gene Segments.” 70 Federal Register 61407,
October 20, 2005.

CRS-28
movement of certain bacteria and viruses that could potentially be used as bioterrorist
weapons.93
Health specialists caution that lab safety must be a top priority as other countries
begin to develop their own research and vaccine capacities. Some are closely
watching Taiwan in its effort to build its own influenza vaccine factory.94 Japan,
already accomplished in viral research, is reportedly helping Vietnam build a
biosafety lab to work with the influenza virus.95 If global influenza vaccine
production is to increase, disease experts caution that some form of oversight must
first be established. Some scientists advocate the development of an international
influenza research facility. Supporters envision a global laboratory that could rapidly
identify influenza threats, and produce appropriate vaccines. It also could, they say,
streamline existing flu monitoring systems. Opponents of this idea believe that
current technology, such as the WHO’s Internet-based FluNet, is fully capable of
obtaining the same goal. Furthermore, critics believe that scientists might lose
interest in sharing viral samples, if they believe their analytical and research
capacities will be taken away.96
S. 1873, The Biodefense and Pandemic Vaccine and Drug Development Act,
would address production of pandemic products. The bill would authorize funding
for surge capacity of manufacturing vaccines. It would also authorize funding for
research and development of flu vaccines, counter measures, and pandemic products.
93 For more information, see the CDC Select Agent Program page at
[http://www.cdc.gov/od/sap] and CRS Report RL31719, An Overview of the U.S. Public
Health System in the Context of Emergency Preparedness
, by Sarah A. Lister.
94 Altman, Lawrence and Keith Bradsher, “Vaccine Alone Won’t Stem Avian Flu, Experts
Warn.” New York Times. August 8, 2005. [http://www.nytimes.com]
95 Interview with State Department staff, October 18, 2005.
96 Abbott, Alison, “The flu HQ.” Nature, Volume 414, November 1, 2001.
[http://www.nature.com]


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Appendix
Figure 1. Map of Human and Animal H5N1 Cases

CRS-30
Table 2. WHO Pandemic Phases
Phase
Description
Overarching Public Health Goals
Interpandemic Period
Phase 1
No new influenza virus strains have
Strengthen global influenza pandemic
been detected in humans. A virus
preparedness at the global, regional and
strain that has caused human infection
national levels.
may be present in animals. If so, the
risk of human infection is considered
to be low.
Phase 2
No new influenza virus strains have
Minimize the risk of transmission to
been detected in humans. However, a
humans; detect and report such
circulating animal influenza virus
transmission rapidly if it occurs.
strain poses a substantial risk of
human disease.
Pandemic Alert Period
Phase 3
Human infection(s) with a new strain,
Ensure rapid characterization of the new
but no human-to-human spread, or at
virus strain, and early detection,
most rare instances of spread to a
notification and response to additional
close contact.
cases.
Phase 4
Small cluster(s) with limited human-
Contain the new virus within limited foci
to-human transmission, but spread is
or delay spread to gain time to
highly localized, suggesting that the
implement preparedness measures,
virus is not well adapted to humans.
including vaccine development.
Phase 5
Larger cluster(s), but human to human
Maximize efforts to contain or delay
spread still localized, suggesting that
spread, to possibly avert a pandemic,
the virus is becoming increasingly
and to gain time to implement pandemic
better adapted to humans, but may not
response measures.
yet be fully transmissible (substantial
pandemic risk).
Pandemic Period
Phase 6
Pandemic: increased and sustained
Minimize the impact of the pandemic.
transmission in the general population
Source: World Health Organization.

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Table 3. FY2005 and FY2006 Enacted Emergency Supplemental
and FY2007 Request for Global Avian Influenza Initiatives
($ millions)
AGENCY
FY2005
FY2006
FY2007 Request
Emergency
Emergency
Appropriations
Appropriations
Enacted
Enacted
Department of Health and
15.0a
114.0
145.0b
Human Services
Department of Agriculture
18.0
5.0b
Department of Defense
10.0
10.0b
Department of State
6.0
0.0
USAID
16.3
132.0
55.0b
GRAND TOTAL
31.3c
280.0
215.0
Source: Prepared by CRS from FY2005 and FY2006 Emergency Supplemental appropriations,
FY2007 budget requests per agency or department, and interviews with CDC Washington officials.
a. CDC Washington officials indicate that it spent $6 million on international avian flu activities
through FY2005 appropriations. This figure is in addition to the $15 million provided through
the FY2005 emergency supplemental.
b. U.S. Office of Management and Budget (OMB).
c. The FY2005 emergency supplemental permits the Secretary of State to transfer up to $656 million
to various U.S. agencies for avian flu activities. USAID received $31.3 million of those funds,
of which $15 million was transferred to HHS. See Congressional Response section and
Department of State 2007 Budget Request at [http://www.state.gov/s/d/rm/rls/iab/2007/pdf/].

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Table 4. International Partnership on Avian and Pandemic
Influenza (IPAPI) Core Principles
1. International
cooperation to protect the lives and health of our people;
2.
Timely and sustained high-level global political leadership to combat avian and
pandemic influenza;
3. Transparency in reporting of influenza cases in humans and in animals caused
by strains that have pandemic potential, to increase understanding, preparedness
and, especially to ensure rapid and timely response to potential outbreaks;
4.
Immediate sharing of epidemiological data and samples with the World Health
Organization (WHO) and the international community to detect and characterize
the nature and evolution of any outbreaks as quickly as possible, by utilizing,
where appropriate, existing networks and mechanisms;
5.
Rapid reaction to address the first signs of accelerated transmission of H5N1 and
other highly pathogenic influenza strains so that appropriate international and
national resources can be brought to bear;
6. Prevent and contain an incipient epidemic through capacity building and in-
country collaboration with international partners;
7. Work in a manner complementary to and supportive of expanded cooperation
with and appropriate support of key multilateral organizations (WHO, Food and
Agriculture Organization, World Organization for Animal Health);
8.
Timely coordination of bilateral and multilateral resource allocations; dedication
of domestic resources (human and financial); improvements in public
awareness; and development of economic and trade contingency plans;
9.
Increased coordination and harmonization of preparedness, prevention, response
and containment activities among nations, complementing domestic and
regional preparedness initiatives and encouraging where appropriate the
development of strategic regional initiatives;
10. Actions based on the best available science.
Source: State Department Press Release, “U.S. Launches International Partnership on Avian and
Pandemic Influenza.” September 22, 2005. [http://www.state.gov/r/pa/prs/ps/2005/53865.htm]