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Report to the Chairman, Subcommittee on Foreign Operations, Export
Financing, and Related Programs, Committee on Appropriations, House of
Representatives:
July 2004:
GLOBAL HEALTH:
U.S. AIDS Coordinator Addressing Some Key Challenges to Expanding
Treatment, but Others Remain:
[Hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-04-784]:
GAO Highlights:
Highlights of GAO-04-784 a report to the Chairman, Subcommittee on
Foreign Operations, Export Financing, and Related Programs, House
Committee on Appropriations:
Why GAO Did This Study:
The President’s Emergency Plan for AIDS Relief (PEPFAR), announced
January 2003, aims to provide 2 million people with antiretroviral
(ARV) treatment in 14 of the world’s most severely affected countries.
In May 2003 legislation established the position of the U.S. Global
AIDS Coordinator in the State Department. GAO was asked to (1) identify
major challenges to U.S. efforts to expand ARV treatment in resource-
poor settings and (2) assess the Global AIDS Coordinator’s response to
these challenges.
What GAO Found:
GAO interviewed 28 field staff from the U.S. Agency for International
Development (USAID) and the Department of Health and Human Services
(HHS), who most frequently cited the following five challenges to
implementing and expanding ARV treatment in resource-poor settings:
(1) coordination difficulties among both U.S. and non-U.S. entities;
(2) U.S. government policy constraints; (3) shortages of qualified
host country health workers; (4) host government constraints; and (5)
weak infrastructure, including data collection and reporting systems
and drug supply systems (see figure). These challenges were also
highlighted by numerous experts GAO interviewed and in documents GAO
reviewed.
Major Challenges to Expanding ARV Treatment in Resource-poor Settings:
[See PDF for image]
[a] GAO asked all 28 respondents specific questions about
coordination; respondents raised the other four challenges when
answering open-ended questions.
[End of figure]
Although the Global AIDS Coordinator’s Office has begun to address
these challenges, resolving some challenges requires additional
effort, longer-term solutions, and the support of others involved in
providing ARV treatment. First, the Office has taken steps to improve
U.S. coordination and acknowledged the need to collaborate with
others, but it is too soon to tell whether these efforts will be
effective. Second, to address policy constraints, U.S. agencies are
working to enhance contracting capacity in the field and resolve
differences on procurement, foreign taxation of U.S. assistance, and
auditing of non-U.S. grantees. However, the office’s guidance did not
address key issues related to the use of PEPFAR funds to buy certain
ARV drugs. Third, the Office has proposed short-term solutions to the
health worker shortage, such as using U.S. and other international
volunteers for training and technical assistance; however, agency field
officials said that using such volunteers is not cost effective. The
office is discussing with other donors certain longer-term
interventions. Fourth, the Office has taken steps to encourage host
countries’ commitment to fight HIV/AIDS, but it is not addressing
systemic challenges outside its authority, such as poor delineation of
roles among government bodies. Finally, the office is taking steps to
improve data collection and reporting and better manage drug supplies.
What GAO Recommends:
GAO recommends that the Secretary of State direct the U.S. Global AIDS
Coordinator to monitor agencies’ efforts to coordinate with host
governments and other stakeholders; work with the USAID Administrator
and HHS Secretary to resolve contracting capacity constraints and any
negative effects from agency differences on procurement, foreign
taxation of U.S. assistance, and auditing of non-U.S. grantees; specify
the activities that PEPFAR can support in national treatment programs
that use ARV drugs not approved for purchase by the Coordinator’s
Office; and work with national governments and international partners
to address underlying economic and policy factors creating the crisis
in human resources for health care. State, HHS, and USAID concurred
with the report’s conclusion and said work is underway to address the
majority of challenges and issues raised.
www.gao.gov/cgi-bin/getrpt?GAO-04-784.
To view the full report, including the scope and methodology, click on
the link above. For more information, contact David Gootnick at (202)
512-3149 or gootnickd@gao.gov.
[End of section]
Contents:
Letter:
Results in Brief:
Background:
U.S. Government Faces Five Major Challenges to Expanding ARV Treatment
in Resource-poor Settings:
Coordinator's Office Has Taken Steps to Address Challenges, but
Continued Effort Is Needed:
Conclusions:
Recommendations for Executive Action:
Agency Comments and Our Evaluation:
Appendixes:
Appendix I: Objectives, Scope, and Methodology:
Appendix II: Structured Interview Questions:
Appendix III: U.S. and International HIV/AIDS Funding:
Appendix IV: The Structure of the Office of the U.S. Global AIDS
Coordinator:
Appendix V: PEPFAR Obligations as of March 31, 2004:
Appendix VI: Detailed Analysis of Challenges Identified in Structured
Interviews:
Appendix VII: Analysis of Difficulty of Coordination:
Appendix VIII: Joint Comments from the Department of State, HHS, and
USAID:
Appendix IX: GAO Contact and Staff Acknowledgments:
GAO Contact:
Staff Acknowledgments:
Tables:
Table 1: Guidance Issued by the Office of the U.S. Global AIDS
Coordinator to Field Staff on ARV Procurement and PEPFAR Deadlines:
Table 2: Difficulty Coordinating with Various Groups as Reported by
Respondents:
Table 3: Difficulty Coordinating on Various Issues as Reported by
Respondents:
Figures:
Figure 1: Progress toward PEPFAR Goals: Percentages Receiving Treatment
in Focus Countries as of February 2004:
Figure 2: Recent International and U.S. Milestones in Efforts to Combat
AIDS Worldwide:
Figure 3: U.S. Agencies Involved in PEPFAR:
Figure 4: Major Challenges to Expanding ARV Treatment in Resource-poor
Settings:
Figure 5: U.S. HIV/AIDS Funding in the 14 PEPFAR Focus Countries, Fiscal
Years 2003 and 2004:
Figure 6: World Bank, Global Fund, HHS/CDC, and USAID HIV/AIDS Funding
in the PEPFAR Focus Countries:
Figure 7: Office of the U.S. Global AIDS Coordinator Organization
Chart:
Figure 8: Coordination Challenges Identified by Respondents:
Figure 9: U.S. Policy Constraints Identified by Respondents:
Figure 10: Host Country Human Resource Challenges Identified by
Respondents:
Figure 11: Host Government Constraints Identified by Respondents:
Figure 12: Infrastructure and Logistics Challenges Identified by
Respondents:
Abbreviations:
AIDS: acquired immune deficiency syndrome:
ARV: antiretroviral:
ARVs: antiretroviral medications:
CDC: Centers for Disease Control and Prevention:
FDA: U.S. Food and Drug Administration:
FDC: Fixed-Dose Combination:
HHS: Department of Health and Human Services:
HIV: human immunodeficiency virus (that causes AIDS):
ICH: International Congress on Harmonization:
MSF: Medecins sans Frontieres (French NGO Doctors Without Borders):
NIH: National Institutes of Health:
NGO: nongovernmental organization:
PEPFAR: the President's Emergency Plan for AIDS Relief:
PMTCT: prevention of mother to child transmission:
TB: tuberculosis:
UN: United Nations:
UNAIDS: Joint United Nations Program on HIV/AIDS:
USAID: U.S. Agency for International Development:
WHO: World Health Organization:
Letter July 12, 2004:
The Honorable Jim Kolbe:
Chairman, Subcommittee on Foreign Operations, Export Financing, and
Related Programs:
Committee on Appropriations:
House of Representatives:
Dear Mr. Chairman:
In January 2003, the President announced an unprecedented 5-year
initiative to combat the global HIV/AIDS pandemic. The President's
Emergency Plan for AIDS Relief (PEPFAR), as authorized through the U.S.
Leadership Against HIV/AIDS, TB and Malaria Act of 2003 (the U.S.
Leadership Act),[Footnote 1] nearly triples the U.S. financial
commitment to addressing the disease and targets $9 billion in new
funding to dramatically expand prevention, treatment, and care efforts
in 14 of the world's most severely affected countries.[Footnote 2] The
administration's strategy establishes the goal of supplying
antiretroviral (ARV) treatment to 2 million HIV-infected people,
preventing 7 million new HIV infections, and providing care to 10
million people infected or affected by HIV/AIDS, including orphans. The
strategy also seeks to streamline the U.S. approach to global HIV/AIDS
treatment by coordinating and deploying U.S. agencies and resources
through a single entity, the Office of the U.S. Global AIDS Coordinator
(the Coordinator's Office), created in January 2004, within the
Department of State. The U.S. Agency for International Development
(USAID) and the Department of Health and Human Services (HHS) are
primarily responsible for implementing PEPFAR overseas.
Whereas previous U.S. programs focused mainly on preventing HIV/AIDS,
PEPFAR proposes that the U.S. government commit significantly greater
resources to providing treatment for those infected by the virus. In
this context, you requested that we (1) identify major challenges to
U.S. efforts to expand ARV treatment in resource-poor settings and (2)
assess the U.S. Global AIDS Coordinator's response to these challenges.
To identify challenges to U.S. efforts to expand ARV treatment, we
conducted 28 structured telephone interviews in December 2003 and
January 2004 with key staff from USAID and HHS' Centers for Disease
Control and Prevention (HHS/CDC) in the 14 targeted countries (we
conducted one USAID and one HHS/CDC interview in each
country).[Footnote 3] We coded the responses to our open-ended
interview questions using a set of analytical categories we
developed.[Footnote 4] We also reviewed numerous documents analyzing
treatment programs from U.S. government agencies, U.N. organizations,
and nongovernmental organizations (NGO), including reports by medical
experts and practitioners. We also interviewed U.S.-based officials
from USAID and HHS; representatives from multilateral organizations,
including the World Health Organization (WHO), the Joint United Nations
Program on HIV/AIDS (UNAIDS), the World Bank, and the Global Fund to
Fight AIDS, TB, and Malaria (Global Fund); and medical experts
experienced in treating people with HIV/AIDS in resource-poor settings.
To assess the U.S. Global AIDS Coordinator's approach to coordinating
the U.S. response to these challenges, we reviewed the February 2004
PEPFAR 5-year strategy, administration guidance, and information on the
emerging structure and initial activities of the Coordinator's Office.
We also interviewed officials from the Coordinator's Office, USAID, and
HHS. We conducted our work from July 2003 through May 2004, in
accordance with generally accepted government auditing standards. (See
app. I for further details of our scope and methodology and app. II for
our structured interview questions.)
Results in Brief:
U.S. government agencies face five major challenges in expanding ARV
treatment in resource-poor settings: (1) difficulties coordinating with
others involved in providing treatment, (2) U.S. government policy
constraints, (3) shortages of qualified health workers in host
countries, (4) host government limitations, and (5) weak
infrastructure. Specifically, our analysis of the structured interviews
and other documentation revealed the following:
* Nearly all agency field staff cited problems coordinating with non-
U.S. groups, and slightly fewer cited problems coordinating with other
U.S. government entities. Limited coordination has led to duplicate
efforts, confusion regarding standards, and heavy administrative
burdens.
* Field staff lacked clear guidelines for procuring ARV drugs, which
made it difficult to plan treatment programs, possibly inhibiting the
agencies' ability to support country HIV/AIDS treatment programs. Also,
inadequate contracting capacity in the field may create delays in
obtaining medical supplies and executing agreements with implementing
organizations. Further, differences among agencies regarding
procurement, foreign taxation of U.S. assistance, and auditing of non-
U.S. grantees may inhibit the agencies' joint efforts to expand ARV
treatment.
* Recipient countries faced critical shortages of qualified health
workers, including doctors, nurses, and administrators, needed to
expand ARV treatment.
* In some host governments, limited political commitment to addressing
HIV/AIDS, poor delineation of roles and responsibilities, and slow
decision-making processes hamper efforts to expand treatment.
* Many countries have weak systems for monitoring and evaluating health
care programs; inadequate systems for managing drug supplies; poor
linkages among programs providing HIV/AIDS services; and deteriorating
physical infrastructure, including labs, clinics, and roads needed to
access rural areas.
Although the Office of the U.S. Global AIDS Coordinator has begun to
address challenges in all areas, some challenges require additional
effort, longer-term solutions, and the support of others involved in
providing ARV treatment. Specifically:
* Coordination. The Coordinator's Office has created mechanisms for
enhancing coordination within the U.S. government and acknowledged the
importance of collaborating with others. However, it is too soon to
tell whether these mechanisms will be effective in resolving the
coordination challenges field staff identified, and the PEPFAR strategy
does not state whether the mechanisms will be monitored.
* U.S. government policy constraints. Agencies are exploring ways to
enhance contracting capacity in the field and address differences
regarding procurement, foreign taxation of U.S. assistance, and
auditing of non-U.S. grantees. While the Coordinator's Office did
provide guidance to U.S. field staff on ARV procurement, this guidance
did not address key issues--such as specifying activities PEPFAR can
support in countries that use ARV drugs not approved for purchase by
the Coordinator's Office--which may affect the U.S. government's
ability to rapidly expand treatment.
* Shortages of qualified health workers. To address these shortages,
the Coordinator's Office is focusing on short-term activities, such as
providing training and technical assistance through paid workers and
volunteers from the United States and other countries. However, U.S.
government officials said the use of international volunteers for some
activities is not cost effective. The Coordinator's Office is also
developing longer-term interventions, such as increasing health
workers' compensation, and is discussing with other donors ways to
implement these efforts. The Coordinator characterized the human
resource shortage as one of the most important challenges to addressing
HIV/AIDS.
* Host government constraints. The Coordinator has directed U.S.
ambassadors and their missions to encourage host countries' commitment
to fight HIV/AIDS by engaging heads of state, reaching out to community
and religious leaders, and conducting mass media campaigns. The
Coordinator's Office has not begun to work with host governments and
other groups involved in AIDS treatment to address other, systemic
constraints outside its authority, such as poor delineation of roles
among host government bodies or slow decision-making processes.
* Weak infrastructure. The Coordinator has assigned a team of experts
to assess the collection and analysis of data used to monitor and
evaluate treatment and work with other groups to synchronize data
reporting systems. The Coordinator is also taking steps to better
manage drug supplies. However, some field staff expressed differing
views on implementing a model called for in the U.S. Leadership Act and
proposed in the PEFFAR strategy to improve health care infrastructure
and treatment referrals. While the office is working to upgrade labs,
it has not addressed other physical impediments such as lack of space
at health facilities. The strategy does not address additional physical
impediments, such as poor roads, that are outside its direct authority.
To improve the U.S. Global AIDS Coordinator's ability to address key
challenges to expanding AIDS treatment in PEPFAR focus countries, we
are recommending that the Secretary of State direct the Coordinator to
(1) monitor implementing agencies' efforts to coordinate PEPFAR
activities with host governments and other stakeholders involved in ARV
treatment; (2) work with the Administrator of USAID and the Secretary
of HHS to resolve contracting capacity constraints and any negative
effects from agency differences on procurement, foreign taxation of
U.S. assistance, and auditing of non-U.S. grantees; (3) specify the
activities that PEPFAR can fund and support in national treatment
programs that use ARV drugs not approved for purchase by the
Coordinator's Office; and (4) work with national governments and
international partners to address the underlying economic and policy
factors creating the crisis in human resources for health care.
In providing written comments on a draft of this report, State, HHS,
and USAID concurred with the report's overall conclusion that while the
agencies have addressed a number of key challenges in providing
services, other challenges remain for the medium and long term (see
app. VIII for a reprint of their comments). Although the agencies did
not specifically comment on GAO's recommendations, they said work is
underway to address the majority of challenges and issues raised. They
also provided technical comments that we have incorporated where
appropriate.
Background:
About 40 million people globally were living with HIV/AIDS as of
December 2003, most of them in sub-Saharan Africa; few have access to
treatment. Propelled by recent advances in ARV treatment, PEPFAR is the
first U.S. program to seek to dramatically expand HIV/AIDS treatment in
resource-poor settings. PEPFAR builds on U.S. bilateral efforts begun
in June 2002 to prevent mother-to-child transmission of HIV during
pregnancy, labor and delivery, and breastfeeding. In May 2003, P.L.
108-25 established the position of the U.S. Global AIDS Coordinator to
lead the U.S. response to HIV/AIDS abroad; the Senate confirmed the
Coordinator in October 2003. The office received its initial
appropriation in January 2004.
AIDS Takes Heavy Toll, Particularly in Africa:
About two-thirds of those infected with HIV live in sub-Saharan Africa.
More than 50 percent of all HIV infections in the world, and nearly 70
percent of HIV infections in Africa and the Caribbean, occur in the 14
PEPFAR countries. According to WHO, less than 7 percent of the HIV-
infected people in need of ARV drugs were receiving them at the end of
2003. UNAIDS reports that about 3 million people died from AIDS in
2003, the vast majority of them in sub-Saharan Africa. The disease has
decimated the ranks of parents, health-care workers, teachers, and
other productive members of society in the region, severely straining
national economies and contributing to political instability.
Recent Advances Allow HIV/AIDS Treatment in Resource-poor Settings:
Propelled by recent advances in ARV treatment, PEPFAR is the first U.S.
program to seek to dramatically expand HIV/AIDS treatment in resource-
poor settings. In the 1990s, medical experts found that new forms of
treatment, involving a combination of three drugs, were effective in
suppressing the virus and thus slowing progression to illness and
death. According to medical experts, data from Brazil, Uganda, and
Haiti showed that patients in resource-poor settings adhere well to
this complex drug regimen. Adherence to ARV treatment is important: if
patients do not take the drugs properly or consistently, the virus in
their bodies may become resistant to the drugs and the drugs will cease
to be effective. The treatment must continue for life.
Since 2000, the price of ARV drugs has dropped considerably, from a
high of more than $10,000 per person per year to a few hundred dollars
or less per person annually, owing in part to the increased
availability of generic ARV drugs and public pressure. In addition,
some generic manufacturers[Footnote 5] have combined three drugs in one
pill--known as fixed-dose combinations, or FDCs[Footnote 6]--thereby
reducing the number of pills that patients must take at one time. While
major multilateral and other donors allow recipients of their funding
to purchase these FDCs, the Office of the U.S. Global AIDS Coordinator
currently funds only the purchase of drugs that have been:
approved by a "stringent regulatory authority,"[Footnote 7] citing
concerns about the quality of drugs that have not demonstrated safety
and efficacy to such an authority. Presently, only brand-name drugs
meet this standard.[Footnote 8] As a result, the Coordinator's Office
does not now fund the purchase of generic ARV drugs, including FDCs.
However, on May 16, 2004, the HHS Secretary announced an expedited
process for reviewing data submitted to the HHS/Food and Drug
Administration (HHS/FDA) on the safety, efficacy, and quality of
generic and other ARV drugs, including FDCs, intended for use under
PEPFAR.
To date, only more developed countries have offered ARV treatment on a
massive scale. The planned expansion of treatment to millions of people
in developing countries under PEPFAR coincides with international
efforts to increase the availability of treatment to HIV-infected
people in poor countries. These efforts include the launch of the
Global Fund in January 2002[Footnote 9] and a campaign by WHO,
announced in 2003 on December 1 (World AIDS Day), to provide access to
ARV treatment to 3 million people by the end of 2005, commonly referred
to as the "3 by 5" campaign. (See app. III for more information on
global, including U.S., HIV/AIDS funding.) PEPFAR's goal is to initiate
ARV treatment for nearly 2 million people in the 14 targeted countries
by 2008. As of February 2004, a total of 78,921 people, or about 4
percent of that goal, were receiving ARV treatment in these countries
(see fig. 1). On April 25, 2004, to synchronize international efforts,
the Global AIDS Coordinator and his counterparts from UNAIDS, the World
Bank, the Global Fund, and other bilateral donors voiced their support
for an international agreement to abide by the following principles:
(1) that there be one agreed-upon framework for coordinating HIV/AIDS
activities among all donors and other partners in each recipient
country; (2) that each recipient country have one national AIDS
coordinating authority; and (3) that each recipient country have one
system for monitoring and evaluating AIDS programs.
Figure 1: Progress toward PEPFAR Goals: Percentages Receiving Treatment
in Focus Countries as of February 2004:
[See PDF for image]
[End of figure]
PEPFAR Builds on Earlier U.S. Efforts to Combat HIV/AIDS Globally:
PEPFAR builds on U.S. bilateral efforts begun in June 2002 under
another presidential initiative that focused on preventing mother-to-
child transmission (PMTCT) of HIV during pregnancy, labor and delivery,
and breastfeeding. This $500 million initiative, formally known as the
International Mother and Child HIV Prevention Initiative, and more
commonly referred to as the PMTCT Initiative, focused on the same 14
countries as PEPFAR. According to administration officials, the
countries were selected based on the severity of their HIV/AIDS burden,
the extent to which they have a substantial U.S. government presence,
the effectiveness of their leadership, and foreign policy
considerations. The initiative focuses on treatment and care for HIV-
infected pregnant women and provides a short course of ARV treatment
that has been shown to be 50 percent effective in lowering the risk of
transmission of the virus in breast-feeding mothers.[Footnote 10] With
the establishment of the Coordinator's Office, PMTCT Initiative funding
and activities were included in PEPFAR. (See fig. 2 for a timeline of
international and U.S. efforts to combat HIV/AIDS worldwide.)
Figure 2: Recent International and U.S. Milestones in Efforts to Combat
AIDS Worldwide:
[See PDF for image]
[A] P.L. 108-7, Consolidated Appropriations Resolution, 2003.
[B] P.L. 108-199, Consolidated Appropriations Act, 2004.
[End of figure]
The agencies primarily responsible for implementing PEPFAR are the
State Department, where the U.S. Global AIDS Coordinator is based and
reports directly to the Secretary of State; USAID; and the Department
of Health and Human Services (HHS). The Coordinator plays an overall
coordinating role, and the State Department raises HIV/AIDS issues
through diplomatic channels and public relations campaigns. USAID
maintains overseas missions in 12 of the 14 PEPFAR focus countries,
with personnel trained in procurement and managing grants to foreign
entities; it works with NGOs and other entities. HHS's overseas
presence is focused on providing technical assistance and is more
recently initiated. HHS/CDC provides clinicians, epidemiologists, and
other medical experts who generally work directly with foreign
governments, health institutions, and other entities. Within HHS,
PEPFAR also draws on expertise from the National Institutes of Health/
National Institute of Allergy and Infectious Diseases, which is
involved in HIV/AIDS research in PEPFAR focus countries; the Health
Resources and Services Administration, which has experience expanding
HIV/AIDS and other health services in resource-poor settings in the
United States and is providing some assistance in several PEPFAR focus
countries; and the Office of the Secretary/Office of Global Health
Affairs, which plays a coordinating role on HIV/AIDS within
HHS.[Footnote 11] Other agencies involved in PEPFAR are the Department
of Defense, which works on HIV/AIDS issues with foreign militaries,
helps construct health facilities, and conducts some research and
program activities in PEPFAR focus countries; the Peace Corps; and the
Departments of Labor and Commerce, which are involved in HIV/AIDS-
related activities in the workplace and with the private sector,
respectively. (See fig. 3.)
Figure 3: U.S. Agencies Involved in PEPFAR:
[See PDF for image]
[End of figure]
Global AIDS Coordinator's Office Established, Implements Funding
Mechanisms:
In May 2003, the U.S. Leadership Act established the position of the
U.S. Global AIDS Coordinator "to operate internationally to carry out
prevention, care, treatment, support, capacity development, and other
activities for combating HIV/AIDS;" the Senate confirmed the
Coordinator in October 2003. (See app. IV for detailed information on
the structure of this office.) The Coordinator has been granted
authority to transfer and allocate the funds appropriated to his office
among the U.S. agencies implementing PEPFAR in the 14 focus countries
and additional bilateral HIV/AIDS programs in other countries. The U.S.
Leadership Act authorizing PEPFAR states that not less than 55 percent
of the amount appropriated pursuant to section 401 of the act is to be
spent on treatment and that at least three-quarters of that amount
should be spent on the purchase and distribution of ARV drugs for
fiscal years 2006 through 2008. Of the remaining 45 percent, 20 percent
should be spent on prevention, 15 percent on palliative care, and 10
percent on orphans and other vulnerable children.
Congress appropriated $488 million for the Coordinator's Office in
fiscal year 2004, and the President requested $1.45 billion for fiscal
year 2005. The office was formally established in January 2004. It
created three mechanisms, or funding "tracks," to allocate money: track
1, track 1.5, and track 2. Tracks 1 and 1.5 are one-time mechanisms
that rapidly allocated funds to expand ongoing activities through
Washington, D.C.-based multicountry awards and locally based country-
specific awards, respectively. Track 2 serves as an annual operational
plan for each country. A portion of the funds for tracks 1 and 1.5 were
obligated by a target date of January 20, 2004 and the remainder were
obligated by mid-February following congressional notification;
[Footnote 12] budgets for track 2 were submitted to the Coordinator's
Office for review on March 31, 2004, and approved on a rolling basis
through early May. Pending congressional review, the Coordinator's
Office expects that agencies will have begun to obligate these funds by
the end of June. PEPFAR activities are generally executed through
procurement contracts or through grant agreements or cooperative
agreements with implementing entities such as NGOs and ministries of
health (and/or national AIDS control programs).[Footnote 13] (See app.
V for additional information on initial obligations.)
U.S. Government Faces Five Major Challenges to Expanding ARV Treatment
in Resource-poor Settings:
In our structured interviews, we identified the following major
challenges to U.S. government agencies in expanding ARV treatment in
resource-poor settings: (1) difficulties coordinating with other groups
involved in combating HIV/AIDS; (2) U.S. government policy constraints;
(3) shortages of qualified health workers; (4) host government
constraints; and (5) weak infrastructure (see fig. 4). These challenges
were also highlighted by numerous government and nongovernment experts
whom we interviewed and in documents we reviewed. (See app. VI for
additional analysis of these challenges.)
Figure 4: Major Challenges to Expanding ARV Treatment in Resource-poor
Settings:
[See PDF for image]
[A] We asked all 28 respondents specific questions about coordination;
respondents raised the other four challenges when answering open-ended
questions. See app. I for a more detailed description of how we
identified these five main challenges.
[End of figure]
U.S. Government Faces Challenges Coordinating ARV Treatment Programs:
All of the field staff we interviewed in the 14 PEPFAR countries
identified problems coordinating with other groups. Nearly all cited
problems coordinating with non-U.S. government groups, and slightly
fewer cited problems coordinating with other U.S. government entities.
Consequences of the coordination problems cited by field staff include
duplicate efforts, confusion over standards, and heavy administrative
burdens.
Almost All Field Staff Cited Difficulty Coordinating with Non-U.S.
Groups:
Twenty-seven of 28 respondents cited challenges coordinating with non-
U.S. government groups, particularly with host governments and
multilateral organizations.
Just over three quarters (22 of 28) of the field staff we interviewed
provided examples of challenges to coordination between the U.S.
government and the host governments in the PEPFAR focus countries. One
of the most commonly cited challenges dealt with host governments'
perceptions. Field staff said that host government officials are often
skeptical of donors' intentions and may question the commitment of
donors and the sustainability of new treatment programs, especially
when they think that donors are promoting programs that run counter to
their national strategies. Similarly, an NGO official working with the
host government in one of the 14 PEPFAR focus countries reported that
when initial funding plans were created, U.S. field staff for the
country ignored existing government and NGO programs. The official said
that the plans for this country also did not incorporate any funding
for training, which was a stated government priority. In addition,
consulting the host government only after funding applications were
completed has increased government officials' skepticism regarding U.S.
intentions and programs in this country, according to U.S. field staff.
Field staff also noted that it is difficult to coordinate with host
governments owing to the governments' limited human resource capacity.
In addition, staff are often hindered by the governments' slow
bureaucratic practices and lack of understanding of U.S. and other
donors' programs and policies. Field staff commented that all of these
problems, paired with expedited PEPFAR timelines and consequently
compressed consultation time, could increase the challenges faced by
the United States in persuading host governments to support PEPFAR
plans for expanded treatment. Field staff generally reported the most
difficulty coordinating with host governments and multilateral
organizations (see app. VII).
Sixteen of 28 field staff identified coordination challenges with
multilateral organizations (such as the World Bank, the Global Fund,
WHO, and other U.N. organizations), with many citing perception issues.
Because of the influx of PEPFAR funding, the United States will
significantly increase its financial investment in treatment programs,
potentially causing other donors to see themselves as overshadowed.
Staff noted that before the United States instituted the PMTCT
Initiative, UNICEF was the main implementer of these programs.
According to field staff we interviewed, when the United States
expanded its own programs, UNICEF and other donors felt "steamrolled"
by programs that were quickly put in place by the United States with
little input from the donor community. Some U.S. staff said that PEPFAR
is replicating this unilateral approach. According to these staff, the
perception that the United States acts unilaterally is compounded by
the fact that, unlike many other donors, U.S. agencies are not allowed
to contribute money to other donors' programs or to pooled host
government funding "baskets" for the health and other sectors. The
staff noted that some donors therefore indicated that the United States
is willing to create duplicative programs. Staff frequently cited the
need for the United States to work with the WHO as both the PEPFAR
program and WHO's 3-by-5 campaign begin.[Footnote 14] Staff said that
such coordination is needed to minimize overlapping efforts, confusion
over standards, and the administrative burden on host governments and
other donors.
Finally, while some staff noted that they have not had enough time to
coordinate efforts, many said that all stakeholders need to harmonize
specific aspects of treatment programs--including treatment
guidelines, training schedules and materials, technical approaches,
educational and media campaigns, procurement policies, hiring and
payment policies, and the collection and reporting of data. The staff
indicated that without harmonization, unnecessary duplication and
confusion could occur as treatment programs are expanded.
Field Staff Cited Challenges Coordinating with Headquarters and Other
U.S. Agency Field Offices:
Twenty-four of 28 respondents cited challenges in coordinating with
other U.S. government agencies, their agency's headquarters, or the
Coordinator's Office in Washington, D.C. Twenty-two of the field staff
we interviewed told us that they face challenges coordinating with
headquarters, and 15 of 28 said that they face challenges coordinating
with other U.S. government agencies in the field. These challenges were
also cited in documents field staff prepared for the Global AIDS
Coordinator.
Field staff reported that headquarters did not coordinate with them
early in the process of developing activities for the PMTCT Initiative
and PEPFAR. For example, they expressed concern that headquarters
announced intended programs without first notifying staff in the field
or giving them the opportunity to discuss the PMTCT Initiative and
PEPFAR programs with host governments. Field staff stated that
government officials in these countries often regarded such
announcements as statements of commitment rather than intention,
resulting in overly optimistic expectations of the amounts of funding
they might receive from the United States. Also, headquarters' limited
coordination with field staff has made it more difficult for U.S.
officials in-country to work with host governments, increasing these
governments' perception that the United States is imposing programs on
them rather than seeking their commitment or concurrence, which could
impede U.S. efforts to expand ARV treatment.
In addition, when discussing coordination problems between the field
and headquarters, most field staff said that they were burdened by
administrative requirements, during both the PMTCT Initiative and the
initial stages of the PEPFAR planning. For example, eight respondents
stated that they rushed to complete multiple reporting requirements
that were often unclear or redundant. This point was also made in
several written communications from the field to the Coordinator's
Office. Three respondents stated that at the same time they were trying
to work with their agency counterparts in the field to complete
integrated reporting requests from the Coordinator's Office, they were
asked by headquarters to prepare duplicative, agency-specific reports,
which further compounded their burden. Five respondents indicated that
the time spent responding to these requests within the period allotted
has directly limited their ability to implement treatment programs.
Just over half (15 of 28) field staff also identified coordination
challenges among agencies in the field. Most staff that raised
interagency issues cited challenges arising from the different
agencies' roles--for example, HHS/CDC has traditionally provided
technical assistance directly to foreign governments through
cooperative agreements, while USAID has focused on development,
primarily by managing grant agreements implemented by NGOs. Staff
further stated that as the programs become more coordinated, challenges
could arise from agencies' differing administrative procedures. For
example, agencies may have different procurement or hiring policies;
agencies entering a program area may find themselves competing with
another agency previously dominant in that area; and field staff busy
with administrative tasks and program implementation may find little
time to communicate with their field counterparts.
U.S. Policy Constraints Limit Agencies' Ability to Rapidly Expand
Treatment Programs:
Twenty-five of the 28 structured interview respondents identified U.S.
policy constraints as a challenge that could limit the ability of the
agencies implementing PEPFAR to rapidly expand treatment programs. In
particular, unclear guidance on whether U.S. agencies can purchase
generic ARV drugs, including FDCs, makes it difficult for the PEPFAR
agencies to plan support for national treatment programs, some of which
use these drugs. In addition, field staff raised concerns that their
current contracting capacity will not be sufficient to manage the large
influx of funds expected under PEPFAR. Further, differing laws
governing the funds appropriated to these agencies--affecting
procurement standards and foreign taxation of U.S. assistance--and
varying grant requirements used by the agencies may challenge their
joint efforts to expand ARV treatment programs.
Unclear Guidance on ARV Procurement Complicates PEPFAR's Ability to
Support Country Treatment Programs:
Twenty-one respondents indicated that they had not received adequate
guidance on the procurement of ARV drugs, which makes it difficult for
the U.S. missions to plan their support of country programs. At least
four of the national programs in the PEPFAR focus countries are
currently purchasing generic ARV drugs with their own funds or with
funds from the Global Fund[Footnote 15] or other sources, and other
countries are considering purchasing them. In addition, in other PEPFAR
countries, NGOs such as Médecins sans Frontières (Doctors Without
Borders) are also purchasing generic ARV drugs. Given this situation,
and the fact that USAID and HHS/CDC have different procurement
standards, one USAID official in Africa stated that adhering to the
agency's current standards, which generally require that USAID-financed
pharmaceuticals be produced in and shipped from the United
States,[Footnote 16] will present a challenge as more governments
purchase generic FDCs to boost adherence. An HHS/CDC official in the
same country stated that the host government is buying these drugs with
Global Fund money and training doctors and pharmacists to support this
regimen. He said that it would complicate the country's ability to
expand treatment if the United States is not able to support such a
regimen.
In addition, in communications to the Global AIDS Coordinator in mid-to
late-2003, U.S. government officials in several PEPFAR focus countries
requested guidance regarding local procurement of ARV drugs. A
September 18, 2003, communication from Ethiopia observed that several
local companies are poised to produce generic ARV drugs, and an October
8, 2003, communication from Uganda stated that generic drugs are
available at much lower prices than brand-name drugs. The Uganda
communication also stated that procurement of nonlocal goods or
services (e.g., U.S. brand-name ARV drugs) to implement PEPFAR will
undermine PEPFAR's goal of enhancing local capacity to fight HIV/AIDS.
Field Staff Concerned That Current Contracting Capacity Is Insufficient
to Manage PEPFAR Funds:
Almost half (13 of 28) of the structured interview respondents,
primarily from HHS/CDC, stated that contracting capacity in the field
is a problem. According to documents submitted to the Coordinator's
Office, U.S. government field staff in four countries expressed the
need for increased contracting capacity to process procurement of goods
and services, such as medical equipment, and increased capacity to
award and administer contracts, grant agreements, and cooperative
agreements with implementing organizations to allow rapid expansion of
treatment under PEPFAR. Further, a June 2003 communication summarizing
lessons learned from the PMTCT Initiative[Footnote 17] stated that HHS/
CDC, which uses the embassy contracting system, has experienced
considerable delays, funding level ceilings, and other difficulties in
processing contractual transactions. HHS/CDC uses the embassy
contracting system because it does not have contract officers in the
field. The communication stated that these difficulties raise concerns
that the embassy system will not be able to handle the number of
contracts and inflow of funds needed to expand treatment under PEPFAR.
Two HHS/CDC respondents cited embassy spending limits as a problem. One
HHS/CDC respondent explained that the embassy in his country can
process purchase orders for up to $100,000 but that orders exceeding
that amount require additional consultation in Washington, a process
that can take 4 to 6 months. He added that the $100,000 ceiling will be
reached quickly under PEPFAR[Footnote 18] and that the embassy
procurement system is designed for buying items like furniture rather
than evaluating, awarding, and managing long-term contracts or grant
agreements with implementing partners. Another HHS/CDC respondent
stated that it takes time to familiarize embassy personnel with the
specifications for certain medical equipment related to ARV treatment.
Moreover, he stated that if the equipment is specialized, it may have
only one supplier, causing additional delays for the embassy to justify
sole sourcing. When questioned about these examples, HHS/CDC contract
officers at headquarters stated that a time frame of several months is
not unusual and that the process could take just as long regardless of
whether it went through the embassy, HHS/CDC headquarters, or an HHS/
CDC field office.
Although HHS/CDC field staff articulated more concerns regarding
inadequate contracting capacity in the field, the PMTCT Initiative
summary stated that the current number of USAID contract officers in
the field will be insufficient to facilitate the number of contracts
and large amount of funds needed to meet PEPFAR treatment goals.
Another communication, dated December 5, 2003, spoke of "an urgent plea
for greater contracting officer support," and a third communication,
dated October 16, 2003, cited "a desperate need for contracting agents
in-country." In addition, a USAID respondent in one country and HHS/CDC
respondents in three countries stated that more staff in general are
needed in the field to expand treatment under PEPFAR.
The PMTCT Initiative summary and a communication from Botswana to the
Coordinator's Office offered several suggestions for addressing the
problem. These suggestions included changing the contracting system or
increasing the number of contract officers in the field and
strengthening USAID regional contracting offices with additional
personnel and capacity to travel to countries in their region. The
PMTCT Initiative summary also recommended that HHS/CDC and its parent
agency, HHS, work with the Department of State to review current
contracting mechanisms and develop strategies that will allow for
greater flexibility and capacity to program PEPFAR funds. According to
technical comments on a draft of this report that were submitted
jointly by the Coordinator's Office, HHS, and USAID, the funding
requests required of field staff for track 1.5 (rapid allocation of
funds to expand ongoing activities) and track 2 (annual operational
plans) specifically asked what additional contracting support field
staff would need, and some posts have been allotted staffing positions
to help fill these gaps.
Differing Laws and Regulations May Inhibit Agencies' Joint Efforts to
Expand Treatment Programs:
The agencies implementing PEPFAR are subject to varying laws and
regulations regarding procurement and foreign taxation of U.S.
government assistance, as well as differing grant requirements for
audits of grantees. These differences may cause confusion among NGOs--
particularly if they are not U.S. organizations--receiving grants from
several agencies to implement PEPFAR.
Agencies Have Different Procurement and Taxation Rules:
USAID and HHS agencies, such as HHS/CDC and the National Institutes of
Health (HHS/NIH), may require their grantees to use different
procurement standards owing to the agencies' different appropriations
legislation and operating procedures.[Footnote 19] In South Africa, for
example, according to USAID officials in that country, the mission
obligated all of its money for drug procurement under PEPFAR track 1.5
through the HHS/NIH; that agency's funds are governed by less
restrictive rules for overseas procurement, and HHS/NIH was therefore
able to allocate the money quickly to meet a January 2004 deadline. In
a January 2004 communication submitted to the Coordinator, officials in
that country raised questions regarding the application of different
procurement rules. Interview respondents in two other African countries
also raised these questions.
Similarly, the South African communication to the Coordinator raised
questions concerning the application of rules on foreign taxation
restrictions. Section 506 of the Foreign Operations, Export Financing
and Related Programs Appropriation Act for 2004 (the 2004 Foreign
Operations Appropriations Act) prohibits funds appropriated by the act
to be used to provide assistance for a foreign country under a new
bilateral assistance agreement unless the agreement exempts the
assistance from taxation.[Footnote 20] In addition, the provision
states that when a host country assesses taxes on U.S. assistance
provided under the act, an amount equal to 200 percent of the total
assessment shall be withheld from the fiscal year 2005 appropriations
for assistance to that country. Since this restriction applies only to
funds appropriated under the 2004 Foreign Operations Appropriations
Act, it does not affect funds appropriated to HHS agencies in their own
appropriations acts. According to the communication from the field and
interviews we conducted with the procurement and legal officials who
contributed to it, there could be confusion among agencies and grant
recipients over managing funds provided under different appropriations
laws, since some of the funds are subject to the taxation provision and
some are not.
In addition, there was initial confusion over what restrictions would
apply to money appropriated to the Coordinator's Office and transferred
to HHS agencies. Since funding for the Coordinator's Office was
appropriated under the 2004 Foreign Operations Appropriations Act,
certain restrictions apply to these funds, including the taxation
provisions discussed above and procurement restrictions in the Foreign
Assistance Act of 1961. Officials from the Coordinator's Office told us
that they recently determined that funds transferred to agencies from
that office would still be subject to their original appropriations
restrictions. In contrast, funds appropriated directly to HHS for
PEPFAR-related activities are not subject to these restrictions. We
spoke with the authors of the South African communication and an HHS/
CDC grantee, who raised concerns over managing funds that may be
subject to differing restrictions. They stated that grantees could be
confused by differing sets of rules. The grantee, a U.S. organization,
also noted that non-U.S. grantees often lack the resources to ascertain
what these rules require. According to HHS officials, the Coordinator's
intention is to set one policy for all U.S. government agencies
implementing PEPFAR.
Agency Requirements for Auditing Grantees Vary:
Agencies have varying grant requirements regarding the auditing of
foreign recipients of U.S. funds, possibly complicating the agencies'
oversight of organizations implementing PEPFAR. Office of Management
and Budget circular A-133 provides uniform auditing standards
applicable to all U.S. government agencies with respect to grants
awarded to U.S. entities. However, it does not apply to non-U.S.
entities that receive funds directly as grant recipients or indirectly
as subrecipients. U.S. government officials expect that many such
entities will implement PEPFAR. USAID officials noted that their agency
requires that any local (i.e., non-U.S.) grantee spending more than
$500,000 in U.S. government funds per year be audited annually, for
example, by a preapproved local audit firm in accordance with U.S.
government auditing standards. HHS/CDC's audit requirements for non-
U.S. grantees differ from USAID's in that audits must be performed by a
U.S.-based firm (which, according to USAID audit officials, could be
expensive).[Footnote 21] HHS/CDC's audit requirements for non-U.S.
grantees also state that audits must be performed according to
international accounting standards or standards approved by HHS/CDC.
The January communication from South Africa requested that these
differences be worked out quickly so that field staff can incorporate
appropriate language and cost implications in grant agreements
currently being negotiated with organizations that will be implementing
PEPFAR.
Insufficient Host Country Human Resources Hinder ARV Treatment
Expansion:
Insufficient host country human resources critically challenge U.S.
efforts to implement and expand AIDS treatment, according to agency
officials in 23 of our structured interviews as well as key documents
we reviewed. Inadequate training; high staff turnover, due in part to
low compensation; and national policies and regulations limiting the
use and hiring of doctors all contribute to human resource constraints
in the PEPFAR countries.
U.S. and Multilateral Sources Cited Host Country Worker Shortages:
U.S. field staff in 18 of 28 structured interviews identified shortages
of trained host country personnel, including doctors, nurses, and
administrators, as a major limitation to U.S. efforts to expand ARV
treatment. In addition, three officials working with the Coordinator's
Office identified the human resource shortage as a critical issue that
could impede the success of PEPFAR. Further, an assessment of four AIDS
treatment sites in Kenya by Family Health International and Management
Sciences for Health[Footnote 22] found that all sites were operating at
half the recommended staffing levels. Multilateral and bilateral
organizations have also reported on health personnel shortages. A joint
World Bank-WHO paper stated that in many poor countries, the number of
health workers is grossly insufficient for the widespread
implementation of a minimum of lifesaving interventions,[Footnote 23]
and a separate WHO paper stated that shortages of human resources are a
major constraint to expanding HIV/AIDS treatment and care.[Footnote 24]
For example, the size of the health workforce in Tanzania must triple
by 2015 to deliver health care, including HIV/AIDS treatment, to the
majority of the population, according to a report funded by the United
Kingdom Department for International Development.[Footnote 25] While
accurate data are difficult to obtain, WHO data indicate wide variances
in the numbers of doctors and nurses in the 14 countries. Even in
Botswana, one of the 14 countries reporting the highest number of
doctors per capita, field staff reported a shortage of trained doctors
who can provide ARV treatment.
The country's president cited human resource constraints as one of the
major challenges to introducing ARV treatment in Botswana.[Footnote 26]
Inadequate Training of Workers Hinders ARV Treatment Expansion:
Half of the field staff we interviewed said that in the countries where
they work, insufficient numbers of personnel are adequately trained to
facilitate expansion of ARV treatment. According to a USAID-funded
paper, low-quality nursing and medical training schools inhibit the
countries' ability to produce qualified providers.[Footnote 27] In
addition, an HHS/CDC official in one African country cited lack of
public health training as a key challenge to expanding AIDS treatment
in that country. A Coordinator's Office official and UNAIDS officials
stated that limited human capacity inhibits the ability of PEPFAR
countries to monitor and evaluate ARV treatment, and an advisor to a
national AIDS program in another African country stated that staff at
the national drug procurement center are not properly trained and that
as a result, the center has experienced shortages of health supplies.
Moreover, donor efforts to improve the skills of health workers through
training are not well coordinated, according to USAID and HHS/CDC
officials in the field. Lack of coordination results in duplicative
training materials or different messages, according to an HHS and WHO
official respectively. Further, the World Bank-WHO paper notes that
payment of high per diems by donors to ensure attendance at workshops
and seminars distracts managers and staff from their work. In addition,
the USAID-funded report stated that donors traditionally have focused
more on short-term rather than longer-term interventions such as
helping to develop and improve medical, nursing, and other technical
schools.
High Turnover Exacerbates Shortages:
According to agency field staff and multilateral and other U.S.
sources, high turnover of health services personnel is a significant
factor contributing to the shortage of health workers in PEPFAR
countries, hindering the delivery and expansion of ARV treatment. Seven
respondents cited high staff turnover as a challenge, and of these
seven, four cited low public sector pay as a factor leading to
turnover. Written documents from field staff also stated that low
public sector pay contributes to turnover. For example, the USAID-HHS/
CDC Fiscal Year 2004 PMTCT Initiative Implementation Plan for Rwanda
stated that rapid turnover of personnel, due to noncompetitive public
sector salaries, "burnout," and the loss of trained health-care workers
from the public sector, affects the health ministry's ability to
advance programs. Further, the document anticipated that personnel
issues will constitute a major challenge to expanding ARV treatment in
that country. A USAID-funded study reported that, in some cases, health
care providers leave the public sector to earn higher salaries in the
private sector or with NGOs.[Footnote 28] Similarly, the President of
Botswana said that the country's national ARV program lost skilled
health and other workers to NGOs and development partners, who pay
higher salaries than the government. Three U.S. field staff we spoke
with emphasized the need for donors to coordinate on common policies
regarding salaries for health workers. Likewise, a World Bank expert
and a WHO official suggested that donors should develop policies to
supplement salaries for public health workers to help alleviate the
shortages.
Worker emigration and death from AIDS among health workers also
contribute to staff shortages. World Bank and WHO reports noted that
low pay and poor working conditions contribute to the migration of
skilled health workers from resource-poor countries. WHO reported that
one-quarter to two-thirds of health care professionals interviewed in
some African countries expressed an intention to emigrate to other
countries.[Footnote 29] The report identified lack of training and
career opportunities, poor pay and working conditions, and political
conflicts and wars as the main factors leading to emigration. In
addition, according to a May 2004 WHO report, AIDS deaths have
dramatically increased among the health workforce throughout the
developing world.[Footnote 30]
National Policies and Regulations Limit Use and Hiring of Doctors:
Host governments' national policies and regulations regarding the use
and hiring of doctors limit the number of health services personnel
available to provide ARV treatment. For example, U.S. government
officials in one country said that a policy requiring that only doctors
treat AIDS patients represented the greatest obstacle to expanding
treatment. Documentation on the national ARV program in that country
recommended devolving responsibility to lower level staff, but
mentioned that labor issues could hinder this. In another country,
according to a U.S. official, hiring doctors in the public sector can
take 6 months to a year.
Host Government Constraints Inhibit Expansion of ARV Treatment:
Rapid expansion of treatment has been impeded by host government
constraints, including, in some countries, limited political commitment
to combating HIV/AIDS, poor delineation of roles among government
bodies responsible for addressing HIV/AIDS, and slow decision-making
processes, according to 19 of the structured interview respondents and
written communications to the Coordinator's Office from the field.
Limited Political Commitment Hampers Treatment Expansion:
Eleven of the 28 respondents cited lack of political commitment to
address HIV/AIDS as a major challenge. According to U.S. officials
working in one country, despite proclamations at the highest levels
that HIV/AIDS constitutes an emergency, it is not treated as such. They
noted that they have great difficulty getting a response from the
government, which tends to be slow and bureaucratic, and that the
health ministry has never been powerful or well funded. Similarly,
USAID officials in another country said that although there are strong
leaders at the health ministry's HIV/AIDS and TB division, weak
leadership at higher levels in the ministry has made it difficult to
advance programs. A joint U.S. government communication, dated
September 18, 2003, from a third country stressed the urgent need for
high-level political commitment to assure that ministries provide
sufficient oversight and staff for effective programming. Conversely,
staff in a fourth country stated that political will to address HIV/
AIDS has been demonstrated by the central government but not at the
local level, where much of the program implementation will occur.
Poor Delineation of Roles Impedes Expansion Efforts:
A quarter of the respondents (7 of 28) cited institutional constraints,
such as poor delineation of roles between government bodies responsible
for addressing HIV/AIDS, as an impediment to expanding treatment. For
example, a U.S. official in one country said that the lack of a clear
distinction and definition of roles and responsibilities within the
ministry of health and weak management structure constrained his
efforts to implement the PMTCT Initiative. A U.S. official in another
country reported difficulty working with the host government because
several different government entities have responsibility for HIV/AIDS,
with no clear reporting hierarchy. Further, HHS/CDC officials in a
third country voiced concern about friction between the health minister
and the AIDS minister regarding the control of money from the World
Bank. The HHS/CDC officials are concerned that the disagreement might
result in two separate coordinating mechanisms, causing duplication of
efforts.
Slow Decision-Making Processes Delay Rapid Expansion:
Four respondents from our structured interviews cited host governments'
slow decision-making processes as a key challenge to rapidly expanding
ARV treatment. For example, according to a U.S. government official in
one country, extensive consultation and discussion delayed programmatic
and management decisions, slowing implementation of the PMTCT
Initiative. Similarly, HHS/CDC officials in another country said that
country's tradition of consensus-based decision-making requires a great
deal of consultation and thus inhibits the country's ability to quickly
address situations such as the AIDS epidemic. According to the
officials, this slowness was the major challenge in implementing the
PMTCT Initiative in that country. However, the officials also stated
that consensus-based decision-making reduces opportunities for
corruption, a problem reported by U.S. officials in four countries as a
challenge to implementing programs. An HHS/CDC official in a third
country reported that decision making is slow because several levels of
officials have to approve even routine decisions.
Weak Infrastructure Hinders Expansion of Treatment:
HHS/CDC and USAID field staff in 16 of 28 structured interviews cited
weak infrastructure in host countries as an impediment to implementing
and expanding ARV treatment. Specifically, they noted weak systems for
gathering information needed to monitor and evaluate programs;
inadequate systems for managing the drug supply; poor linkages among
HIV/AIDS programs and between these programs and basic health care
infrastructure; and insufficient physical infrastructure, including
health facilities, roads, and water supply.
Information Infrastructure Is Weak:
In 8 of the 28 structured interviews, HHS/CDC and USAID field staff
stated that the infrastructure needed for monitoring and evaluating
treatment programs is weak. For example, field staff in one country
stated that the national AIDS control program's indicators and data
collection methods are not sufficient to identify populations infected
with HIV, and staff in a second country said that that inadequate
feedback to those who administer services or collect data hampers the
improvement of programs. Staff from this country also stated that
agencies' differing methods of reporting activities make determining
data accuracy difficult. In addition, U.S. agency documents from PEPFAR
countries indicated the need for better data collection tools, feedback
of analysis and data to district and community facilities, behavior
change to increase the value placed on data, and monitoring of the
impact of programs as AIDS treatment expands.
A joint WHO-World Bank paper also emphasized the need to improve health
information systems at local, national and international
levels.[Footnote 31] Moreover, half or more of the structured interview
respondents indicated that they experienced moderate or greater
difficulties in harmonizing data collection methods and reporting
requirements with other stakeholders involved in AIDS treatment (see
app. VII). According to officials from the U.S. government, WHO, and
UNAIDS, there is general international consensus on what data should be
collected[Footnote 32] but less consensus regarding how the data should
be collected and reported.
Systems for Managing Drug Supply Are Inadequate:
Eight of 28 interview respondents said that the infrastructure needed
to manage and deliver drug supplies in their countries is inadequate,
complicating efforts to expand ARV treatment. Respondents in several
countries commented on, among other things, the difficulty of
maintaining a reliable supply of drugs and basic health commodities; a
lack of infrastructure for distributing and storing drugs and other
commodities and the absence of a sound commodity management information
system; and a protracted ARV shortage that could lead to drug
resistance in thousands of affected patients. In one country, fear of
being penalized has kept the government's agency for procuring drugs
and related items from sharing information on drug shortages, thereby
exacerbating the problem and inhibiting efforts to address it,
according to an advisor to the national AIDS program.
Poor Program and System Linkages Inhibit Treatment Expansion:
According to six interview respondents and written communications to
the Coordinator's Office from five countries, poor linkages among
programs providing HIV/AIDS services inhibit the expansion of these
services. For example, U.S. officials in one country stated that the
mechanism for referring patients from sites where they receive
counseling and testing to sites where they can receive treatment needs
to be improved. In addition, U.S. officials in three other countries
stressed the need to link PMTCT and ARV treatment programs to other
health services required by patients and their families, such as
nutrition and family planning.
Poor linkages between donor-supported HIV/AIDS programs and basic
health systems may also impair the ability of these systems to continue
ARV treatment once donor support is discontinued. According to an
expert directing two HIV/AIDS projects in four African countries,
unless ARV treatment is linked to investments in sustainable health
systems, HIV/AIDS programs can draw resources away from, and thus harm,
the overall health sector in recipient countries. For example, U.S.
officials in one African country stated that PEPFAR activities could
decrease the number of staff, quality of facilities, and availability
of drugs for basic health services that are not specifically focused on
combating HIV/AIDS.
Physical Infrastructure, Including Health Care Facilities, Is
Insufficient:
According to our interviews and the documents we reviewed, deteriorated
physical infrastructure also constitutes a challenge to expanding ARV
treatment programs. Many of the hospitals, clinics, and laboratories in
the PEPFAR focus countries--some of which have experienced years of
civil strife--are ill equipped to handle expansion of ARV treatment.
For example, U.S. officials working in one country said that inadequate
health care facilities, including lack of laboratories, hamper the
monitoring of ARV treatment. According to a U.S. government
communication from Ethiopia dated September 18, 2003, facilities must
be refurbished and equipment installed, among other needs, to support
the implementation of ARV treatment. A November 4, 2003 summary of a
joint U.S. agency discussion in Kenya stated that most health
facilities targeted for involvement in treatment activities have
physical infrastructure needs that should be addressed, including needs
for testing and counseling space, electricity, clean water, air
conditioning in pharmacy storerooms to maintain drug quality, and
improved laboratory space. Further, the USAID-HHS/CDC Fiscal Year 2004
PMTCT Initiative Implementation Plan for Uganda stated that there is
inadequate space for program staff and equipment at the ministry of
health and for HIV counseling and testing in prenatal clinics.
Multilateral and nongovernmental organizations have also identified
weak health care infrastructure as an impediment to expanding ARV
treatment. For example, when WHO ranked the overall health system
performance of its 191 member states in 2000, it ranked all 14 of the
PEPFAR focus countries in the bottom third.[Footnote 33] In many of
these countries, up to one-half of the population lacks access to basic
health care and many health facilities lack basic commodities, such as
syringes, as well as laboratories and safe drug storage facilities. In
addition, limited infrastructure, including roads, a clean water
supply, and electricity, presents barriers to expanding ARV treatment.
For example, field staff from one country said that deteriorated roads
and other basic physical infrastructure pose a major challenge to
delivering clinical and diagnostic services.
Coordinator's Office Has Taken Steps to Address Challenges, but
Continued Effort Is Needed:
The Office of the U.S. Global AIDS Coordinator has acknowledged each of
the five challenges to expanding ARV treatment programs and has taken
certain steps to address them, but some of these challenges require
additional effort, longer-term solutions, and the support of others
involved in providing ARV treatment. First, the Coordinator's Office
has devised means to improve coordination among U.S. agencies and with
host governments and other organizations; however, it is too soon to
tell whether they will be effective and the PEPFAR strategy does not
state whether the means will be monitored. Second, U.S. agencies are
exploring ways to address some U.S. government constraints, but the
Coordinator's Office guidance on ARV procurement leaves key problems
unresolved. Third, the Coordinator's Office proposed short-term
assistance to address health worker shortages, including the use of
paid workers and volunteers from the United States and other countries,
and the PEPFAR strategy proposes several longer-term interventions.
However, U.S. officials said that using international volunteers for
the short-term activities is not cost effective. Fourth, although the
Coordinator's Office has called for stronger commitment by host
governments, it has not addressed other, systemic constraints outside
its direct authority. Finally, the Coordinator's Office is taking steps
to strengthen systems for monitoring and evaluating progress toward
PEPFAR treatment goals and is seeking to involve the private sector in
improving the management and supply of drugs. However, some field staff
had differing views on implementing a "network model" proposed in the
strategy for improving basic health care infrastructure and
facilitating treatment referrals. In addition, the Coordinator's Office
has not addressed physical impediments such as lack of space for
counseling and testing.
Coordinator's Office Attempting to Enhance Coordination, but Too Early
to Judge Effectiveness:
The Office of the U.S. Global AIDS Coordinator has acknowledged the
importance of coordinating with national governments and other groups
and has created mechanisms, such as HIV/AIDS teams led by the
ambassador in each country, to enhance U.S. government coordination in
the field and with the host government. However, it is too soon to tell
whether these mechanisms will resolve the coordination challenges
identified by field staff, and the PEPFAR strategy does not state
whether the mechanisms will be monitored.
Recognizing that providing ARV treatment requires a sustained,
collaborative effort from international, national, and local
organizations, the PEPFAR strategy outlined an approach to leverage the
strengths of each entity while building local capacity. According to
the strategy, the Coordinator is expected to maximize U.S. technical
assistance, training, and research experience when expanding treatment
programs, while working with other stakeholders to leverage strengths
and fill program gaps. In tandem with the host governments in the 14
PEPFAR focus countries, the Coordinator is also expected to encourage
the development of a single in-country structure to facilitate
coordination among donors, the host government, NGOs, and other
stakeholders.[Footnote 34]
The increased coordination may also facilitate efforts to harmonize
proposal, reporting, surveillance, management, and evaluation
procedures to ensure that programs are comparable and complimentary and
to decrease the burden on host organizations and governments. The
strategy specifies that the Coordinator's Office will work with
technically expert partners, such as WHO, to determine the best
treatment options and ensure that there are sound management strategies
in place to support them. Finally, the Coordinator will encourage
stakeholders to work through local partners and promote programs that
support the countries' national strategies.
In addition, the Coordinator has worked to establish relationships with
international counterparts, meeting with the leadership of WHO, UNAIDS,
the World Bank, and the Global Fund. The Coordinator, together with the
HHS Secretary, also led a delegation of representatives from the
administration, the Congress, WHO, UNAIDS, the Global Fund, and
numerous private entities and NGOs to meet with leaders and view ARV
treatment and other HIV/AIDS-related programs in four African nations
in December 2003.
To ensure that U.S. efforts in the field are coordinated, and to
enhance relationships with the host government, the Coordinator has
directed that an HIV/AIDS team, led by the Ambassador, be set up in
each country. These teams may also have an official designated by the
Ambassador to serve as the day-to-day liaison. The teams are generally
comprised of representatives of each of the agencies working on HIV/
AIDS-related projects in a given country. According to the field staff
we interviewed, these teams have already been set up in most countries,
and some countries had already established HIV/AIDS teams that will now
focus on PEPFAR. Also, to improve coordination between headquarters and
the field, the Coordinator's Office sought input from field staff by
requesting written documents and by conducting an intensive series of
meetings with field staff over a 2-week period in November 2003.
However, it is too soon to tell whether these mechanisms will be
effective in resolving the coordination challenges field staff
identified.
Agencies Exploring Solutions to Some U.S. Government Constraints, but
ARV Procurement Problems Remain:
The Office of the U.S. Global AIDS Coordinator, together with the
agencies implementing PEPFAR, is exploring options for addressing U.S.
government constraints involving (1) contracting capacity in the field;
(2) differing laws and regulations governing funds appropriated to
implementing agencies, in particular, USAID and HHS/CDC, with respect
to procurement and foreign taxation of goods purchased with U.S.
assistance; and (3) differing agency requirements for auditing non-U.S.
grantees. In addition, the Coordinator's Office has provided guidance
to the field on ARV procurement. However, this guidance leaves key
issues unresolved.
PEPFAR Agencies Exploring Options to Enhance Contracting Capacity and
Address Differing Agency Laws, Regulations, and Requirements:
The Coordinator's Office and PEPFAR agencies are exploring ways to
enhance contracting capacity in the field and to address differing
laws, regulations, and audit requirements that may affect their joint
efforts to expand ARV treatment programs. While no specific options
have been proposed to date, the Coordinator's Office has directed USAID
to develop a request for proposals to design and implement a mechanism
for procuring, distributing, and managing the supply of drugs and other
items. All PEPFAR agencies and possibly other, non-U.S., stakeholders
would use this mechanism as well. As a joint mechanism, it may address
some of the contracting capacity needs raised by field staff, as well
as the differing agency regulations pertaining to procurement.
Guidelines on procurement released by the Coordinator's Office on March
24, 2004, note that U.S. agencies involved in PEPFAR have different
limitations on their ability to procure goods and services from outside
the United States and that the office is reviewing options for
addressing this issue. The guidelines state that the office will
provide additional guidance in the future, although no specific time
frame is given.
Regarding foreign taxation of goods bought with U.S. assistance, the
PEPFAR strategy states that tariffs and duties on pharmaceuticals are
"barriers" that can increase the cost of drugs in developing countries
and "work at cross purposes" with initiatives to improve access to
medicines. According to officials from the Coordinator's Office, legal
experts from the State Department and other PEPFAR agencies are
discussing how to address differing agency appropriations laws
regarding this issue. In addition, audit officials from USAID and HHS
are discussing how to address differing agency requirements for
auditing non-U.S. grantees.
Global AIDS Coordinator Provided Guidance to Field on ARV Procurement,
but Problems Remain:
The Coordinator's Office provided guidance to U.S. field staff on ARV
procurement, but this guidance did not resolve the following issues
regarding the use of PEPFAR funds to purchase these drugs: (1) The
policy of the Coordinator's Office on procuring ARVs may change in the
future. (2) The Coordinator's Office does not define how PEPFAR
activities and funding can support host country treatment sites that do
use generics. (3) In at least one country, the office's current ARV
procurement policy conflicts with PEPFAR's stated principle of
providing assistance in a manner consistent with host country plans and
policies.
Coordinator's Office Provided Guidance on ARV Procurement:
The Coordinator's Office issued guidance to field staff on ARV
procurement over a 5-month period (November 2003-March 2004) in an ad
hoc, question-and-answer format in response to inquiries from the field
(see table 1). This guidance was issued before, during, and after our
structured interviews. According to officials from the Coordinator's
Office, they also addressed questions from field staff during 2 weeks
of intensive meetings in Washington, D.C., in November 2003 and during
visits to the PEPFAR focus countries over the next several months.
However, the Coordinator's Office provided the most detailed guidance
more than 2 months after a January 19, 2004, deadline for obligating
initial funds and just one week before field staff in each country were
required to submit their operational plans for fiscal year 2004.
As noted previously, the Coordinator's current policy is to fund only
the purchase of drugs that have been approved by entities it defines as
stringent regulatory authorities, citing concerns about safety and
efficacy. The Coordinator's Office convened a meeting with
international regulators in March 2004 to develop principles for
evaluating the safety and efficacy of FDCs.[Footnote 35] In addition,
it has directed HHS/CDC to develop a request for proposals to assure
the quality of drugs and other products procured with PEPFAR funds. On
May 16, 2004, the HHS Secretary announced an expedited process for
reviewing data submitted to the HHS/FDA on the safety, efficacy, and
quality of generic and other ARV drugs, including FDCs, intended for
use under PEPFAR. Drugs approved under this process can then be
purchased with PEPFAR funds provided that international patent
agreements and local government policies allow their purchase,
according to the Coordinator's Office, HHS, and USAID.[Footnote 36]
Table 1: Guidance Issued by the Office of the U.S. Global AIDS
Coordinator to Field Staff on ARV Procurement and PEPFAR Deadlines:
Date: November 25, 2003;
Event: Guidance for completing track 2 plans;
Details:
* Stated that "Each mission must adhere to U.S. government policy in
procuring ARV drugs and other medicines.";
* Stated that "Separate guidance is available on current U.S.
government policy.";
* Did not state what U.S. government policy is or where separate
guidance on current policy could be found;
* Did not note that (as discussed earlier in this report) the agencies
implementing PEPFAR have different standards for procuring items to be
used abroad.
Date: December 16, 2003;
Event: Responses to questions on ARV procurement and other issues;
Details:
* Stated "no" in response to a question asking if a proposed
procurement mechanism under PEFAR would allow for the purchase of
generics;
* Stated that "specific guidance will be provided separately" in
response to a question asking if there is a definitive PEPFAR policy on
the procurement of generic drugs;
* Stated that a WHO prequalification process for drugs does not
constitute approval by a stringent regulatory authority.[A].
Date: January 19, 2004;
Event: Deadline for obligating funds under tracks 1 and 1.5.
Date: January 30, 2004;
Event: Updated guidance for completing track 2 plans;
Details:
* No change from November 25, 2003, guidance regarding ARV procurement.
Date: February 20, 2004;
Event: Responses to questions on ARV procurement and other issues;
Details:
* Stated that certain FDCs cannot be used "until there has been a
demonstration that these drugs are safe and effective.";
* Stated that the U.S. government is working with international
regulators to resolve safety and efficacy issues and that a complete
question-and-answer sheet on ARV procurement is being prepared.
Date: February 23, 2004;
Event: PEPFAR strategy issued;
Details:
* Leaves open the possibility that PEPFAR agencies could in the future
procure certain FDCs or other generics.
Date: March 24, 2004;
Event: Responses to questions on ARV procurement;
Details:
* Provided a definition of "stringent regulatory authority.";
* Provided a statement of USAID's procurement regulations, specifying
requirements related to source and origin, safety and efficacy, and
patents;
* Provided the anticipated timeframe for publishing requests for
proposals for procurement and quality assurance (second quarter of
2004) and awarding contracts (by the end of 2004).
Date: March 31, 2004;
Event: Deadline for submitting track 2 plans.
Note: The Coordinator's Office emailed this guidance to all field
staff.
[A] According to WHO, under this process, evaluators from both
industrialized and developing countries assess a manufacturer's data on
its product's safety, efficacy, and quality, as well as the
manufacturing processes and facilities. Through this process, WHO has
found some generic ARV drugs acceptable, in principle, for U.N.
agencies to procure.
[End of table]
Guidance from Coordinator's Office Does Not Resolve All Issues:
The ARV procurement guidance provided by the Coordinator's Office did
not resolve all issues regarding the use of PEPFAR funds to purchase
these drugs. While the guidance clearly stated that no PEPFAR funds
could be used to purchase drugs that have not been approved by entities
the office defines as stringent regulatory authorities, the PEPFAR
strategy leaves open the possibility that funds could in the future be
used to procure generic ARV drugs, including FDCs, provided they meet
safety and efficacy standards agreed to by the office. Moreover, the
strategy endorses the selection of products such as FDCs, which
combine several active ingredients. An April 8, 2004, press release
from HHS elaborates that combination therapies, including FDCs, are
considered by many to be essential to treating diseases like HIV/AIDS
as well as to limiting the development of drug resistance. The press
release states that, among other advantages, FDCs simplify dosing,
which could result in better patient adherence to therapy.
In addition, the ARV procurement guidance issued by the Coordinator's
Office does not define how PEPFAR activities and funding can support
host country treatment sites that do use generics. The March 24, 2004,
guidance acknowledged that many countries' treatment guidelines include
FDCs and other drugs that have not been approved by stringent
regulatory authorities. PEPFAR funds therefore cannot be used to
purchase these products or build logistical systems that support only
these products but can be used to "provide other support" to treatment
sites that use them.
Further, in at least one country, the office's current policy, which in
effect does not allow the purchase of generics, conflicts with PEPFAR's
stated principle of providing assistance in a manner consistent with
host country plans and policies. An inquiry from Kenya cited by the
Coordinator's Office in its February 20, 2004, response states that the
country's first line treatment, at both government and faith-based or
private sector facilities, relies on FDCs "for reasons of economics,
pill burden, and other factors." The inquiry urgently requested
clarification from the Coordinator's Office, stating that a decision on
whether FDCs and other generics can be purchased will profoundly affect
the extent to which the Kenya mission "must develop parallel rather
than integrated systems" and the level of resources needed to reach
treatment targets under PEPFAR. Other major donors such as the Global
Fund--to which the United States is one of the largest contributors and
for which the HHS Secretary currently serves as the Chairman of the
Board--allow their funds to be used for purchasing generic ARV drugs,
including FDCs.
Coordinator's Office Focusing on Short-and Long-term Interventions to
Alleviate Shortage of Health Workers:
The Coordinator's Office will focus on both short-and long-term
interventions to address host country human resource shortages, which
it has identified as a critical limitation to implementing its
treatment goals. In the short term, the office will focus on rapidly
expanding and mobilizing health care personnel through interventions
that include the use of paid workers, international volunteers,
training, and technical assistance to meet treatment goals under
PEPFAR. However, in June 2003, U.S. government officials documented
their concerns about the use of international volunteers for some of
these activities. The PEPFAR strategy also identified longer-term
interventions[Footnote 37] that should be considered by host
governments and other donors, and the Coordinator's Office is
initiating discussions with these groups to explore options for
implementing longer-term interventions.
Coordinator's Office Proposed Several Short-term Solutions; U.S. Field
Staff Have Raised Concerns over Use of International Volunteers:
The Coordinator's Office will respond to immediate needs to increase
manpower through several short-term interventions, including the use of
international volunteer health professionals, but field staff expressed
concern that this intervention will generate other problems. In
addition to using volunteers, U.S. efforts will focus on training
existing providers in case management for ARV treatment and providing
technical assistance through arrangements that include "twinning"--
pairing health facilities in the PEPFAR focus countries with
organizations in the United States and other countries--to provide
training and technical assistance, according to the PEPFAR
strategy.[Footnote 38] The Coordinator's Office will also support host
country efforts to depend less on the scarce supply of skilled health
workers by extending responsibility for patient treatment to nurses,
counselors, and health volunteers, as well as exploring options to
involve traditional healers, birth attendants, and family members in
treatment and care. The Coordinator characterized the human resource
shortage as the second most important issue after political leadership
in addressing HIV/AIDS. Accordingly, Coordinator's Office officials
stated that all contracts and contract renewals include language on
developing local human resource capacity.
However, USAID and HHS/CDC field officials informed the Coordinator's
Office of potential problems associated with using international
volunteers to address health worker shortages and training.
Specifically, the use of such volunteers for short overseas tours
creates heavy administrative burdens, may not be sustainable over the
long term, and is not cost effective, according to a June 2003
communication summarizing lessons learned from the PMTCT Initiative.
The communication recommended that tours be for a minimum of one year.
In addition, regarding twinning, a USAID official in one country stated
that the ministry of health raised concerns over the time involved in
training international volunteers and that twinning will not address
issues such as attracting and enrolling nurses who will stay in the
country, particularly in rural areas. Despite its attention to training
and technical assistance, the strategy does not discuss the extent to
which the Coordinator's Office will collaborate with other donors on
training to minimize duplicative sessions and workplace disruptions
when staff attend training.
PEPFAR Strategy Identifies Longer-term Interventions:
The PEPFAR strategy outlines longer-term interventions to stem the
critical human resource shortage in the 14 countries, emphasizing
actions that host governments can take on their own or in discussion
with other donors. These include increasing the quality and number of
graduates from medical and related professional schools, improving
retention of the health sector workforce through salary increases and
other incentives, and establishing bilateral and international
agreements to resolve salary differentials. The June 2003 communication
emphasized the need for guidance on the extent to which U.S. agencies
will supplement the salaries of government health-care workers in
PEPFAR focus countries in order to retain qualified employees and
implement activities under PEPFAR.
According to an official in the Coordinator's Office, the office is
developing a policy statement on the use of PEPFAR resources for
salaries. This official stated that the Coordinator's Office plans to
work with other donors, including the World Bank, to support long-term
interventions such as supplementing salaries and building and
strengthening professional schools. The Coordinator's Office is engaged
in frequent meetings with the 3-by-5 team at WHO and has met with
officials at the World Bank and UNAIDS to discuss a coordinated
approach to human capacity development. An interagency group formed
under the PMTCT Initiative is also contributing to these efforts.
According to an expert at the World Bank, donors should help finance
host countries' efforts to address human resource issues. Because
PEPFAR will play a central role in its focus countries, a WHO official
stated that other donors will look to the United States to address
long-term interventions to issues faced by host country governments. An
October 2003 document from U.S. field staff in one African country also
raised the importance of U.S. government support for salaries for
government workers in the national health system, adding that the
national government cannot afford to pay for significant numbers of new
staff.
Coordinator's Office Focuses on Enhancing Leadership and Political
Commitment:
The Coordinator's Office called on U.S. officials, including
ambassadors, to advocate for bold leadership to fight HIV/AIDS and
identified mechanisms for fostering political commitment and reaching
out to all groups involved in combating the disease in recipient
countries. The Coordinator's Office has not begun to work with other
stakeholders to address other, more systemic host government
constraints that U.S. field staff identified.
Recognizing that containment of HIV/AIDS requires bold leadership and
political commitment, the PEPFAR strategy calls for high-level
officials in Washington and American ambassadors abroad to encourage
commitment from heads of state and other government leaders. The
strategy emphasizes that American embassy staff must be informed and
engaged on the issue of HIV/AIDS in their host countries and asks them
to raise the issue in host government forums. On November 26, 2003, the
Global AIDS Coordinator sent a communication to embassies in the PEPFAR
focus countries that summarized points for building support at the
country level. For example, the communication requested that all chiefs
of mission brief host government leaders on PEPFAR in order to build
their support for the program and establish a process whereby U.S.
field staff, along with host government officials and other
stakeholders, can rapidly begin to design and implement PEPFAR.
However, these efforts were hindered by the fast pace of PEPFAR, which,
as previously discussed, made it difficult for field staff to consult
with host governments.
The PEPFAR strategy looks to a broad range of community leaders and
private institutions to generate leadership and fight the stigma
associated with HIV/AIDS.[Footnote 39] It calls for using public-
private partnerships at local, national, regional, and international
levels to strengthen global and in-country responses to HIV/AIDS. For
example, the strategy states that the United States will engage
community leaders such as mayors, tribal authorities, elders, and
traditional healers to promote correct and consistent information about
the epidemic and to combat stigma and harmful cultural practices. In
addition, it commits to working with faith-based leaders and joint
national and international business and labor coalitions to facilitate
efforts to improve and expand programs in the workplace and take
advantage of marketing, communications, and logistical skills to
improve the reach and effectiveness of AIDS programs. The strategy also
calls on U.S. officials to advocate for a greater global response
through multilateral forums such as UNAIDS, international conferences,
and participation in the Global Fund.
Neither the PEPFAR strategy nor the Coordinator's Office addresses
other host government constraints raised by our interview respondents,
including the poor delineation of roles between government bodies
responsible for combating HIV/AIDS and slow decision-making processes,
that are outside the Coordinator's control and will take additional
time to resolve.
Coordinator's Office Aims to Strengthen Infrastructure for Information
and Drug Supply; Some Field Staff Had Differing Views on Implementing
Proposed Health Care Model:
The Coordinator's Office has taken several steps to improve the
infrastructure needed to support expansion of ARV treatment; however,
some field staff expressed differing views on implementing a proposed
tiered system of health care. In response to the PEPFAR strategy's
emphasis on results-driven interventions, the Coordinator's Office is
working to strengthen systems to monitor and evaluate progress toward
treatment goals. In addition, the Coordinator's Office seeks to improve
countries' abilities to manage the drug supply in the short run by,
among other things, calling on the private sector to help with
distribution. The new procurement mechanism (see p. 34) is also meant
to address these issues. Consistent with the U.S. Leadership Act
authorizing PEPFAR, the strategy proposes the use of a "network model"
of health care facilities to provide a high volume and level of
services in central medical centers and more basic services in outlying
areas to enhance access to ARV treatment. However, some field staff
expressed differing views on this model. Neither the strategy nor the
Coordinator's Office addresses certain physical infrastructure
impediments raised in documents submitted to the Coordinator or by our
interview respondents.
Coordinator's Office Attempting to Improve Data Collection and
Reporting:
To support the effective gathering and reporting of information to
monitor and evaluate progress toward PEPFAR goals, the Coordinator's
Office will support training to improve and expand recipient countries'
surveillance and laboratory capacity. The office will provide
assistance to countries for improved information gathering and
reporting to measure progress in reaching program goals. These
indicators measure the numbers of facilities supported, practicing
professionals and community workers trained, and clients reached. The
Coordinator's Office worked with officials from HHS, the U.S. Census
Bureau, USAID, other U.S. agencies, UNAIDS, WHO, and the Global Fund,
to assess new data needs and minimize duplicative data collection. The
Coordinator's Office developed HIV/AIDS-specific coding categories to
gather information for a number of activities, including (1) preventing
HIV transmission from mothers to babies, (2) other HIV prevention
activities, (3) treatment, (4) care, and (5) assessing laboratory
infrastructure needs. For example, to gather information for ARV
treatment, the Coordinator's Office developed a facility checklist to
assess delivery of treatment, including eligibility criteria for
patients, clinical monitoring and lab tests offered, standard operating
procedures and protocols, and record keeping.
The Coordinator's Office is working with the Global Fund and other
organizations to synchronize systems for monitoring and evaluating HIV/
AIDS programs. According to the office, U.S. officials have met with
officials from UNAIDS, the World Bank, the Global Fund, and WHO to
discuss developing common indicators and guidelines for paper-based or
electronic tracking. To assist U.S. field staff in planning and
monitoring treatment programs and report on PEPFAR progress, the office
has established the following indicators for monitoring and evaluating
ARV treatment: the number of facilities, programs, or both, including a
separate breakout of the number of faith-based facilities or programs;
the number of clients served; the number of new clients served; the
number of clients continuously receiving treatment and related services
for more than 12 months; and the number of people trained. To measure
progress toward the overall PEPFAR goal of providing ARV treatment to 2
million people by the end of 2008, field staff in each of the focus
countries will report semiannually to the Coordinator's Office on the
number of people receiving ARV drugs through PEPFAR.
According to the Coordinator's Office, data will be collected and
stored in an electronic repository that is expected to be operational
in September 2004. Twice a year, U.S. field staff will electronically
transmit data measuring the progress of PEPFAR activities to the
Coordinator's Office. According to the office officials, the office
will put the information in a database that field staff and
multilateral organization can access.
Because fully equipped laboratories are necessary for monitoring ARV
treatment to limit the development of resistant strains of the virus,
the Coordinator's Office will fund assessments of existing laboratory
infrastructure and will fund upgrades of laboratories, as needed. In
addition, the Coordinator's Office will support the development,
adaptation, and translation of training materials for specimen
collection, storage, shipment, testing, and record keeping.
PEPFAR Strategy Has Identified Short-term Actions for Managing the Drug
Supply:
The PEPFAR strategy recognizes that the sharp increase in the volume of
products to be provided under the program and from other sources such
as the Global Fund may challenge existing national supply systems.
Accordingly, as noted on p. 34, the Coordinator's Office is developing
a request for proposals to design and implement a joint procurement
mechanism to better manage the supply of drugs and other products. The
strategy calls for training personnel in health logistics systems and
supporting efforts to minimize drug diversion, counterfeiting and
waste. It also states that the United States will collaborate with
other donors to minimize distribution gaps. To accomplish its
objectives in the short run, the Coordinator's Office will call on the
private sector to perform some logistics functions, such as building up
distribution and information management systems and improving storage
conditions. For example, PEPFAR agencies will provide technical
assistance and fund training to strengthen procurement and distribution
systems. By increasing the number of people trained in procurement and
distribution, PEPFAR seeks to improve local capacity to negotiate,
purchase, manage, and supply goods. However, the implementation of this
objective may face the same human resource constraints noted
previously, due to the limited number of available workers.
PEPFAR Proposes "Network Model" to Address Basic Health Infrastructure;
Some Field Staff Had Differing Views on Implementing this Model:
Consistent with the U.S. Leadership Act authorizing PEPFAR, the PEPFAR
strategy proposes a tiered model for providing treatment; however, some
field staff expressed differing views on implementing this model.
According to the strategy, this "network model" integrates prevention,
treatment, and care activities through a layered system of central
facilities that support satellite centers and mobile units to reach the
most rural areas. It comprises central medical facilities, regional and
district-level facilities, and community clinics.
A September 18, 2003 communication to the Coordinator from U.S. field
staff in Ethiopia stated that the model is appropriate in that country,
and that current HHS/CDC and USAID planning for PEPFAR in Ethiopia uses
the model. In addition, an October 28, 2003 communication from
Mozambique stated that the country has developed an integrated health
network with levels of supervision and referral that correspond to the
model. However, field staff in Uganda, the country often cited by U.S.
government headquarters officials as having a successful model, stated
in a written communication to the Coordinator dated October 8, 2003,
that the model is not fully operational in Uganda owing to the same
host country constraints that many resource-poor countries face.
According to the communication, weak or nonexistent infrastructure,
limited human and financial resources, and poor training constrain the
model at all levels.
Certain Physical Impediments Are Not Addressed:
Although the PEPFAR strategy acknowledges that many of the affected
countries lack the necessary health infrastructure needed for effective
HIV/AIDS treatment, it does not address certain physical impediments
raised by U.S. government field staff, such as inadequate space for HIV
counseling and testing in prenatal clinics and other medical
facilities. While the strategy recognizes that lack of basic amenities
such as clean water is a barrier to successful treatment, it does not
discuss how to address this issue. In addition, it does not discuss the
impact of deteriorating roads, which affect the delivery of drugs and
other commodities. Clean water, passable roads, and other basic
infrastructure are outside the direct authority of the Coordinator's
Office.
Conclusions:
The Office of the U.S. Global AIDS Coordinator faces five key
challenges as it leads U.S. efforts to significantly expand ARV
treatment in the 14 PEPFAR focus countries. Certain key challenges,
such as the shortage of trained health workers, limited commitment of
some host governments, and weak infrastructure require long-term
solutions and the support of host governments, donors, and other
organizations providing ARV treatment. Other challenges are within the
control of the U.S. government, and the Coordinator's Office has begun
to (1) take steps to facilitate host government participation in
planning PEPFAR activities and (2) explore ways to enhance U.S.
contracting capacity in the field and address differing laws,
regulations, and requirements applicable to the agencies implementing
PEPFAR. In addition, HHS, with the support of the Coordinator's Office,
recently announced an expedited review process for generic and other
ARV drugs, including FDCs, which could be procured with PEPFAR funds.
However, the Coordinator's Office has not specified the activities that
PEPFAR can fund and support in national treatment programs that use ARV
drugs not approved for purchase by the office. Given the importance of
these challenges to expanding ARV treatment, it is critical that the
Coordinator's Office ensure that the issues reach full and timely
resolution.
Recommendations for Executive Action:
To improve the U.S. Global AIDS Coordinator's ability to address
challenges in expanding AIDS treatment in PEPFAR focus countries, we
recommend that the Secretary of State direct the Coordinator to:
* monitor implementing agencies' efforts to coordinate PEPFAR
activities with stakeholders involved in ARV treatment, including
taking adequate steps to actively solicit the input of host government
officials and respond to their input;
* collaborate with the Administrator of USAID and the Secretary of HHS
to address contracting capacity constraints in the field and resolve
any negative effects resulting from the differing laws governing the
funds appropriated to these agencies in the areas of procurement and
foreign taxation of U.S. assistance, as well as differing requirements
for auditing non-U.S. grantees;
* specify the activities that PEPFAR can fund and support in national
treatment programs that use ARV drugs not approved for purchase by the
Coordinator's Office; and:
* work with national governments and international partners to address
the underlying economic and policy factors creating the crisis in human
resources for health care.
Agency Comments and Our Evaluation:
The State Department, HHS, and USAID provided combined written comments
on a draft of this report (see app. VIII for a reprint of their
comments). The agencies concurred with the report's overall conclusion
that while they have addressed a number of key challenges in providing
services, other challenges remain for the medium and long term. The
agencies did not specifically comment on GAO's recommendations;
however, they noted that program efforts and activities have progressed
beyond what the report describes, and work is underway to address the
majority of challenges and issues raised. Some of these efforts reflect
our recommendations. The agencies also provided technical comments that
we have incorporated as appropriate. Our draft report contained the
first 3 recommendations. We added the fourth recommendation in light of
additional information State, HHS, and USAID provided when they
commented on a draft of this report. This information reemphasized the
need for these agencies to engage in efforts to address the critical
shortage of health workers in recipient countries.
We are sending copies of this report to the U.S. Global AIDS
Coordinator, the Secretary of HHS, the Administrator of USAID, and
interested congressional committees. Copies of this report will also be
made available to other interested parties on request. In addition,
this report will be made available at no charge on the GAO web site at
[Hyperlink, http://www.gao.gov].
If you or your staff have any questions about this report, please
contact me at (202) 512-3149. Other GAO contacts and staff
acknowledgments are listed in appendix IX.
Sincerely yours,
Signed by:
David Gootnick,
Director, International Affairs and Trade:
[End of section]
Appendixes:
Appendix I: Objectives, Scope, and Methodology:
The Chairman of the Subcommittee on Foreign Operations, Export
Financing, and Related Programs of the House Committee on
Appropriations asked us to (1) identify major challenges to U.S.
efforts to expand antiretroviral (ARV) treatment in resource-poor
settings and (2) assess the U.S. Global AIDS Coordinator's response to
these challenges. Our work focused on the 14 countries targeted under
the President's Emergency Plan for AIDS Relief (PEPFAR): Botswana, Côte
d'Ivoire, Ethiopia, Guyana, Haiti, Kenya, Mozambique, Namibia, Nigeria,
Rwanda, South Africa, Tanzania, Uganda, and Zambia.[Footnote 40]
Methodology for Identifying Challenges to Expanding ARV Treatment:
To identify challenges to U.S. efforts to expand ARV treatment, we
conducted 28 structured telephone interviews in December 2003 and
January 2004 with key staff from the U.S. Agency for International
Development (USAID) and the Department of Health and Human Services'
Centers for Disease Control and Prevention (HHS/CDC) responsible for
implementing HIV/AIDS programs in the 14 targeted countries.[Footnote
41] To ensure balance, we conducted one USAID and one HHS/CDC interview
in each country. We coded the responses to our open-ended interview
questions using a set of internally developed analytical categories.
Our structured interview document contained 16 questions on the
implementation and expansion of HIV/AIDS treatment programs, including
program activities and coordination and management challenges (see app.
II). To develop the questions and further assess challenges, we
reviewed numerous documents analyzing treatment programs from U.S.
government agencies, U.N. organizations, and nongovernmental
organizations (NGO), including reports by medical experts and
practitioners. We also interviewed U.S.-based officials from USAID and
HHS; representatives from multilateral organizations, including the
World Health Organization (WHO), the United Nations Joint Program on
HIV/AIDS (UNAIDS), the World Bank, and the Global Fund to Fight AIDS,
TB, and Malaria (Global Fund); and medical experts experienced in
treating people with HIV/AIDS in resource-poor settings. We traveled to
Geneva, Switzerland, to meet with WHO, Global Fund, and UNAIDS
representatives, and to Paris, France, to meet with program experts
from Médecins sans Frontières (Doctors Without Borders), an NGO
providing ARV and other AIDS treatment in resource-poor countries. Most
of the structured interview questions were open ended; two were closed
ended (see app. II for a list of the questions). Experts reviewed
initial versions of our open-and close-ended questions and four of our
initial respondents pretested the questions. We refined our questions
based on their input.
To summarize the open-ended responses, we systematically coded a set of
key questions[Footnote 42] on challenges to coordination and program
expansion from our structured interviews. We grouped the responses into
five major challenge categories. As in any exercise of this type, the
categories developed can vary when produced by different analysts. To
address this, two GAO analysts reviewed the responses to the key
questions from five interviews and independently proposed categories,
separately identifying major challenges and then agreeing on a common
set of challenges. They independently analyzed and differentiated
responses into subcategories within each major challenge area and then
agreed on a common set of subcategories. We refined these subcategories
during the coding exercise that followed. Interview responses falling
into a specific subcategory often derived from a variety of questions
in our analysis; there was not a one-to-one correspondence between
questions and categories.
We then analyzed applicable statements from each of the 28 interviews
and placed them into one or more of the resulting subcategories. Four
GAO analysts each examined 7 of the 28 interviews. One analyst made
some adjustments in placements to ensure consistency in coding and then
compiled the resulting placements into a single master document. The
analyst then summarized and tallied the number of respondents providing
information in each subcategory.[Footnote 43] Two GAO analysts then
independently reviewed the interview analysis document. All
disagreements regarding the placement of responses into subcategories
were discussed and reconciled. Figure 4 presents the numbers of
respondents citing challenges in each of the five major categories, and
figures 8 through 12 present the breakout of each major challenge into
subcategories. These figures show subcategories containing information
from 3 or more respondents; we also cite in footnotes other information
provided by only 1 or 2 respondents.
We explicitly prompted respondents with questions on coordination
issues. We identified the other four major challenges during our
analysis of the responses to the coded questions. As a result, the
number of respondents providing information on coordination challenges
is higher than the number providing information on the other four
challenges.
We conducted a separate analysis of the two closed-ended questions,
which asked respondents to rank the degree of difficulty coordinating
with various groups (question 12.b), and coordinating with all parties
on specific activities (question 13.b). (See app. VII.)
Finally, to expand on the structured interviews, we reviewed relevant
U.S. laws, regulations, and policies governing procurement,
contracting, taxation, and auditing; documents that field
representatives prepared for the Coordinator's Office; and documents
from multilateral organizations and NGOs. We also interviewed U.S.-
based officials from the Coordinator's Office, USAID, and HHS.
Methodology for Assessing the U.S. Response:
To assess the Global AIDS Coordinator's response to these challenges,
we reviewed The President's Emergency Plan for AIDS Relief: U.S. Five
Year Global HIV/AIDS Strategy (February 2004);[Footnote 44]
administration guidance, including several communications to the field
on ARV procurement; and information on the emerging structure and
initial activities of the Coordinator's Office. We also interviewed
officials from the Coordinator's Office, USAID, and HHS.
We conducted our work from July 2003 through May 2004, in accordance
with generally accepted government auditing standards.
[End of section]
Appendix II: Structured Interview Questions:
COUNTRY:
Respondent's(s'):
* name(s):
* titles(s):
* email(s):
* phone number(s):
Respondent's(s) agency:
Date of interview:
Name(s) of interviewer(s):
Introduction:
The following questions are to assist the U.S. General Accounting
Office to gather information on how USAID missions and HHS/CDC field
offices coordinate the implementation and scale up of ARV treatment
programs in the field. Specifically, we are looking to understand how
your agency coordinates with other U.S. government agencies and other
key stakeholders (multilateral, other bilateral, host government,
nongovernmental) to identify the challenges to these coordination
efforts, and to obtain lessons learned that can inform the President's
Emergency Plan for AIDS Relief.
Background:
For questions 2-5, please refer to appropriate documents. Where asked,
please indicate the name of the document(s) you used to answer these
questions.
1; We are interested in the PMTCT, PMTCT Plus, and other ARV programs.
Which of these programs does your mission/field office support?
ARV treatment:
PMTCT Plus:
PMTCT (over last 12 months):
2.a; Approximately how many people are currently receiving these
services in your country?
ARV treatment:
PMTCT Plus:
PMTCT (over last 12 months):
PMTCT (total, to date):
2.b; Please indicate whether the numbers in the PMTCT Plus column are
included in the ARV treatment column:
ARV treatment:
PMTCT Plus: Yes? No?
PMTCT (over last 12 months):
PMTCT (total, to date):
2.c; Please provide the name of the document(s) you used to obtain the
data for each of these services:
ARV treatment:
PMTCT Plus:
PMTCT (over last 12 months):
PMTCT (total, to date):
2.d; Please indicate if the available data are inadequate to answer
the question for any of these services:
ARV treatment:
PMTCT Plus:
PMTCT (over last 12 months):
PMTCT (total, to date):
3.a; Of the number in 2.a., how many are being supported by U.S.
government programs?
ARV treatment:
PMTCT Plus:
PMTCT (over last 12 months):
PMTCT (total, to date):
3.b; Please provide the name of the document(s) you used to obtain the
data for each of these services:
ARV treatment:
PMTCT Plus:
PMTCT (over last 12 months):
PMTCT (total, to date):
3.c; Please indicate if the available data are inadequate to answer
the question for any of these services:
ARV treatment:
PMTCT Plus:
PMTCT (over last 12 months):
PMTCT (total, to date):
4.a; Over the next 6-12 months, how many people in your country do you
realistically expect to start treatment?
ARV treatment:
PMTCT Plus:
PMTCT (over last 12 months):
4.b; Please provide the name of the document(s) you used to obtain the
data for each of these services:
ARV treatment:
PMTCT Plus:
PMTCT (over last 12 months):
4.c; Please indicate if the available data are inadequate to answer the
question for any of these services:
ARV treatment:
PMTCT Plus:
PMTCT (over last 12 months):
5.a; Of the number in 4.a., how many will be supported by U.S.
government programs?
ARV treatment:
PMTCT Plus:
PMTCT (over last 12 months):
5.b; Please provide the name of the document(s) you used to obtain the
data for each of these services:
ARV treatment:
PMTCT Plus:
PMTCT (over last 12 months):
5.c; Please indicate if the available data are inadequate to answer
the question for any of these services:
ARV treatment:
PMTCT Plus:
PMTCT (over last 12 months):
6.a. Please look at the list of program activities related to PMTCT,
PMTCT Plus, and ARV treatment that we sent to you. In which of these
program activities is your mission/field office involved? Indicate
which of these activities are directly funded by your mission/field
office.
Voluntary counseling and testing.
Rapid testing.
Targeting of at-risk groups.
Safe motherhood programs.
Mother/child health programs.
Family planning assistance.
Education programs.
Community outreach.
Short course zidovudine (AZT).
Single dose nevirapine.
Continuous ARV treatment.
Treatment for partners.
Treatment of opportunistic infections.
TB diagnosis and treatment.
Diagnosis and treatment of STIs.
Lab support.
Palliative care.
Surveillance.
Monitoring and evaluation.
Training (of doctors, nurses, healthcare workers and administrators).
Other (please describe).
6.b. I'm going to read out a list of items and services related to ARV
treatment. Does your mission/field office procure any of them?
hiring/contracting of services.
ARV drugs.
other drugs (for opportunistic infections).
diagnostics (e.g., test kits, including rapid test kits).
lab equipment and commodities (e.g., reagents).
vehicles.
computers or other office equipment.
other (please specify) .
6.c. What types of program activities (listed in 6.a.) and procurement
activities (just discussed) is your mission/field office best suited to
perform?
6.d. With which of these activities do you face the greatest challenges
to implementation?
6.e. What do you see as a feasible solution to these challenges?
7. How do you program resources according to congressional earmarks?
Given the earmarks in the authorizing legislation for the President's
Emergency Plan for AIDS Relief (55% for treatment, of which 75% is to
be spent on ARV drugs), do you have to make major changes in your
programs to accommodate these earmarks?
Coordinating with other USG agencies:
8.a. Has a point of contact for the President's Emergency Plan for
AIDS Relief been designated in your country? If so, is this contact at
the U.S. Embassy? If not, at which agency?
8.b. What other U.S. government agencies does your mission/field office
work or coordinate with on VCT, PMTCT, PMTCT Plus, and/or other ARV
treatment programs? Please identify the program activities that these
agencies perform.
8.c. How does your mission/field office currently coordinate with
these agencies? (Please tell us about all formal and informal
coordination mechanisms, such as regular meetings, procedures for
information sharing, MOUs, TORs, informal contacts, etc.)
8.d. Are there any plans to change the method of coordination?
9. Please describe the key challenges your mission/field office has
faced coordinating with other U.S. agencies on VCT, PMTCT, PMTCT Plus,
and/or other ARV treatment. Please provide examples of the consequences
of these challenges.
Coordination with non-U.S. organizations (host government, multilateral
and nongovernmental organizations, other bilateral donors):
10.a. How does your mission/field office interface with the host
government in your country on the programs listed in 6.a.? The
procurement activities listed in 6.b.?
10.b. What are the key challenges your mission/field office has faced
in working with the host government? Please provide examples of the
consequences of these challenges.
11.a. With what other non-U.S. organizations does your mission/field
office currently coordinate on the programs listed in 6.a.? The
procurement activities listed in 6.c.?
11.b. Through what mechanisms? Are there any established mechanisms to
ensure coordination?
12.a. Please describe the key challenges your mission/field office has
faced coordinating with non-U.S. organizations on VCT, PMTCT, PMTCT
Plus, and/or other ARV treatment. Please provide examples of the
consequences of these challenges.
12.b. Based on your experience at your current post, please rate the
extent to which you experience difficulties coordinating with the
following partners:
Coordinating with other U.S. agencies;
Very great extent:
Great extent:
Moderate extent:
Some or little extent:
No extent:
No basis to judge:
Coordinating with host government;
Very great extent:
Great extent:
Moderate extent:
Some or little extent:
No extent:
No basis to judge:
Coordinating with multilateral organizations (World Bank, Global Fund,
UN organizations);
Very great extent:
Great extent:
Moderate extent:
Some or little extent:
No extent:
No basis to judge:
Coordination with other bilateral donors;
Very great extent:
Great extent:
Moderate extent:
Some or little extent:
No extent:
No basis to judge:
Coordinating with NGOs and/or the private sector;
Very great extent:
Great extent:
Moderate extent:
Some or little extent:
No extent:
No basis to judge:
12.c. If you have not already addressed this issue in question 12.a.,
with which type of partner do you experience the most coordination
challenges? Please explain.
13.a. Based on our research to date, we have identified certain
function-related coordination challenges that may arise among
stakeholders in a given country:
* harmonization of treatment protocols:
* harmonization of procurement policies:
* harmonization of monitoring and evaluation indicators:
* harmonization of data collection methods:
* harmonization of data reporting requirements:
* harmonization of feedback to those who administer services and/or
collect data:
Are there any other functional areas that you think raise or may raise
significant coordination challenges?
13.b. Based on your experience at your current post, please rate the
extent to which you experience difficulties coordinating with other
partners in the following areas:
Harmonization of treatment protocols;
Very great extent:
Great extent:
Moderate extent:
Some or little extent:
No extent:
No basis to judge:
Harmonization of procurement policies;
Very great extent:
Great extent:
Moderate extent:
Some or little extent:
No extent:
No basis to judge:
Harmonization of monitoring and evaluation indicators (i.e., the data
collected);
Very great extent:
Great extent:
Moderate extent:
Some or little extent:
No extent:
No basis to judge:
Harmonization of data collection methods;
Very great extent:
Great extent:
Moderate extent:
Some or little extent:
No extent:
No basis to judge:
Harmonization of data reporting requirements;
Very great extent:
Great extent:
Moderate extent:
Some or little extent:
No extent:
No basis to judge:
Coordinating provision of feedback to those who administer services
and/or collect data;
Very great extent:
Great extent:
Moderate extent:
Some or little extent:
No extent:
No basis to judge:
13.c. If you have not already addressed this issue in question 12.a. or
13.a., with which area do you experience the most coordination
challenges? Please explain.
14.a. What activities did your mission/field office initiate with
funding from the PMTCT Initiative?
14.b. What were the key challenges you faced on the PMTCT Initiative
and what were the lessons learned that can inform the implementation
of PEPFAR?
15. Could you please tell us about a successful ARV treatment program
in the country where you serve? What factors contribute to its success?
Could you please provide contacts (phone, email address) with whom we
can follow up, if necessary?:
16. What changes--if any--would you suggest be made to facilitate
interagency and international coordination in scaling up ARV
treatment?
[End of section]
Appendix III: U.S. and International HIV/AIDS Funding:
With the advent of PEPFAR, U.S. proposed funding for HIV/AIDS-related
activities in the 14 focus countries increased substantially, as shown
in figure 5.
Figure 5: U.S. HIV/AIDS Funding in the 14 PEPFAR Focus Countries,
Fiscal Years 2003 and 2004:
[See PDF for image]
Note: This information is provided solely for background purposes;
therefore, we did not assess the reliability of these data.
[A] These figures represent USAID and HHS/CDC combined spending limits
for HIV/AIDS activities in each of the countries in fiscal year 2003.
Other U.S. agencies, including the Departments of Agriculture, Defense,
Labor, and State, allocated additional, smaller amounts of funds for
HIV/AIDS activities in fiscal year 2003 that may have been spent in the
PEPFAR focus countries. The National Institutes of Health obligated a
total of $78 million in fiscal year 2003 to the 14 countries for HIV/
AIDS research, and estimated fiscal year 2004 obligations to the 14
countries at $86 million.
[B] These figures represent planned allocations determined by the
Office of the U.S. Global AIDS Coordinator for each of the 14 countries
for fiscal year 2004. The allocations include funds from USAID, HHS,
and the Coordinator's Office and will be used by USAID, HHS, the
Department of Defense, State Department, and the Peace Corps to carry
out PEPFAR activities.
Figure 6: World Bank, Global Fund, HHS/CDC, and USAID HIV/AIDS Funding
in the PEPFAR Focus Countries:
[See PDF for image]
Note: This information is provided solely for background purposes;
therefore, we did not assess the reliability of these data.
[A] World Bank projects in the PEPFAR countries are for approximately
5-year periods. Three projects began in 2001, one project began in
2002, four projects began in 2003, and one is scheduled to begin in
2004. As of December 2003, 16 percent of the total funds obligated had
been disbursed. Obligations refer to the total amount committed for the
duration of the project in that country. Disbursed amounts refer to the
amount of funds withdrawn by the country from the World Bank.
[B] The Global Fund figures are 2-year approved funding amounts. The
Fund approved most of these amounts in 2003, two in 2002, and three in
2004. As of April 2004, there were a total of 32 HIV/AIDS-related
grants for the 14 countries, 7 of which had not yet been signed.
Seventeen percent of the total grant funds approved had been disbursed.
[C] Obligations are binding agreements that will result in immediate or
future outlays. Other U.S. agencies, including the Departments of
Agriculture, Defense, Labor, and State, may have obligated additional,
smaller amounts of funds to the PEPFAR countries for HIV/AIDS-related
activities. HHS/NIH obligated a total of $78 million to the 14
countries for HIV/AIDS research in fiscal year 2003.
[End of figure]
[End of section]
Appendix IV: The Structure of the Office of the U.S. Global AIDS
Coordinator:
The Office of the U.S. Global AIDS Coordinator was organized to manage
U.S. policies and programs to combat the global AIDS epidemic and to
support administrative, communications, and diplomatic efforts. To
accomplish this mission, the office has eight specialized units (see
fig. 7).
Figure 7: Office of the U.S. Global AIDS Coordinator Organization
Chart:
[See PDF for image]
Note: in addition to the areas shown here, the Coordinator's Office
also includes staff focused on strategic policy and planning, issue
support and analysis, several administrative assistants, and 6
unallocated FTEs.
[A] FTE = full-time-equivalent position, equal to one person working
full time, two people working half time, and so on.
[End of figure]
* Management Services--provides administrative support to the office,
including human resources, information management, and operational
budget.
* Communications--plans and implements all communications support for
PEPFAR activities while promoting the involvement of public and private
organizations.
* Diplomatic Liaison--prepares strategic plans, conducts activities to
promote international involvement, and coordinates international
response on HIV/AIDS by working with non-U.S. stakeholders.
* Training and Human Resources--oversees human capacity and development
activities and develops, implements, and monitors training programs.
* Program Services--develops and monitors the 14 countries' PEPFAR
implementation plans and provides technical and clinical support to the
focus countries and for all other activities conducted by the Global
AIDS Coordinator.
* Monitoring, Evaluation, and Strategic Information--evaluates
progress toward PEPFAR goals and the impact of PEPFAR activities; works
with the international community to harmonize information collection
and serves as the liaison to both the research community and the
research and information divisions of implementing agencies.
* Government Relations--responds to congressional requests for
information, communicates policy to the Congress, and prepares
congressional reports and compliance documents.
* Budget and Appropriations--develops the annual program budget for the
Coordinator's Office and serves as the liaison to the White House,
administrative departments and agencies, and the field on program
budget issues, including disbursement, tracking, and reporting.
As of June 25, 2004, 69 percent of the positions shown in figure 7 were
staffed. Positions within the Coordinator's Office are filled with a
combination of permanent hires and individuals on reimbursable and
nonreimbursable detail from other sections of the State Department or
other agencies.
[End of section]
Appendix V: PEPFAR Obligations as of March 31, 2004:
The Office of the U.S. Global AIDS Coordinator reported that, together
with USAID and HHS, it had obligated a total of $346.9 million in
PEPFAR funds as of March 31, 2004.[Footnote 45] These funds were
obligated by means of tracks 1 and 1.5 through many awards to
implementing entities in the 14 focus countries for activities related
to HIV/AIDS treatment, prevention, and care, as follows.
* Track 1 provided rapid funding to organizations such as U.S.-based
NGOs that can respond quickly in more than one country. As of March 31,
2004, the Coordinator's Office had awarded a total of $114.7
million[Footnote 46] in five areas: (1) modifying behavior by
encouraging abstinence and faithfulness ($4.9 million obligated by
USAID);[Footnote 47] (2) providing care for AIDS orphans and vulnerable
children ($4.7 million obligated by USAID); (3) providing ARV therapy
for those infected with HIV ($92 million obligated by HHS); and (4)
preventing HIV transmission through safe medical injection ($13.1
million obligated by USAID and HHS).
* Track 1.5 provided rapid funding to programs run by organizations in
individual countries. USAID and HHS obligated a total of $232 million
under track 1.5 for all 14 countries combined as of March 31, 2004.
Like track 1 funding, this funding was to continue and expand ongoing
activities. When allocating funding under track 1.5, U.S. missions were
encouraged to consider programs that build on the PMTCT Initiative, in
particular those that expand treatment to cover mothers and their
partners.
Track 2 provides funding for each country's first annual operational
plan. The Coordinator will assess annual funding levels in consultation
with the U.S. agencies and Chiefs of Mission in each country and
release funds after approving each country's plan. According to
guidance provided by the Coordinator's Office, these assessments are
meant to ensure that U.S. agencies in each country are leveraging their
strengths and coordinating their efforts. As of May 31, 2004, the
Coordinator's Office had approved 14 countries' operational plans
totaling $589,401,340.
[End of section]
Appendix VI: Detailed Analysis of Challenges Identified in Structured
Interviews:
Figures 8 through 12 provide more information on the challenges that 28
respondents in the field identified during the structured interviews.
To generate these figures, we separately analyzed responses in each of
the five main challenge categories and placed them in specific
subcategories within each challenge category. We then tallied the
number of respondents in each of the subcategories to generate figures
8 through 12. Many respondents reported challenges in more than one
category or subcategory.
Figure 8: Coordination Challenges Identified by Respondents:
[See PDF for image]
Note: All 28 respondents identified coordination challenges. As noted
on pp. 14 and 15, 27 respondents reported challenges coordinating with
non-U.S. government groups as a whole (including host governments,
among all stakeholders, and with other stakeholders) and 24 reported
challenges coordinating with other U.S. agencies in the field and/or
headquarters.
[A] The majority of responses falling into this category referred to
harmonization of policies and activities among all or most groups
involved in HIV/AIDS program expansion.
[B] Other stakeholders include multilateral organizations, bilateral
organizations, NGOs, and the private sector.
[End of figure]
Figure 9: U.S. Policy Constraints Identified by Respondents:
[See PDF for image]
Note: Twenty-five respondents identified challenges regarding U.S.
policy constraints. In addition to the five constraints shown, two or
fewer respondents cited the following constraints: agencies have
different auditing requirements for non-U.S. grantees; PEPFAR needs to
invest in building sustainable capacity to address HIV/AIDS rather than
investing in short-term projects; and PEPFAR's focus is less well
defined than that of the PMTCT Initiative.
[A] These issues include conforming to spending percentages in the
PEPFAR authorizing legislation; HHS and USAID operating under different
laws and regulations; and whether PEPFAR resources can be channeled
through U.N. agencies.
[End of figure]
Figure 10: Host Country Human Resource Challenges Identified by
Respondents:
[See PDF for image]
Note: Twenty-three respondents identified challenges regarding host
country human resources. In addition to the three challenges shown, two
or fewer respondents cited the following challenges: lack of staff
motivation, host government policies regarding the use and hiring of
doctors, and difficult personalities.
[End of figure]
Figure 11: Host Government Constraints Identified by Respondents:
[See PDF for image]
Note: Nineteen respondents identified challenges regarding host
government constraints.
[End of figure]
Figure 12: Infrastructure and Logistics Challenges Identified by
Respondents:
[See PDF for image]
Note: Sixteen respondents identified challenges regarding
infrastructure and logistics.
[End of figure]
[End of section]
Appendix VII: Analysis of Difficulty of Coordination:
Our structured interview analysis contained two closed-ended questions
that asked respondents to rank the difficulty of (1) coordinating with
various groups and (2) coordinating with all parties on specific
activities (see questions 12.b and 13.b in app. II).
When asked to rank the difficulty of coordinating with various groups,
15 respondents indicated that they experienced at least moderate
difficulty coordinating with the host government in the country where
they serve, and 13 reported the same level of difficulty coordinating
with multilateral entities, such as the World Bank and U.N.
organizations (see table 2). By comparison, only 2 respondents stated
they had at least moderate difficulty coordinating with other U.S.
government entities. The majority of respondents reported only a
minimal degree of difficulty ("some or little extent" or "no extent")
coordinating with other bilateral donors, NGOs, and the private sector.
Respondents said that the difficulty coordinating with nongovernmental
and private organizations was that they are so numerous and not all are
known.
Question 12.b: Based on your experience at your current post, please
rate the extent to which you experience difficulties coordinating with
the following partners: A:
Table 2: Difficulty Coordinating with Various Groups as Reported by
Respondents:
Coordination with other U.S. agencies;
Very Great Extent: 1;
Great Extent: -;
Moderate Extent: 1;
Some or Little Extent: 17;
No Extent: 8;
No Basis to Judge: -;
Moderate or Greater: Extent: 2.
Coordination with host government;
Very Great Extent: -;
Great Extent: -;
Moderate Extent: 15;
Some or Little Extent: 9;
No Extent: 2;
No Basis to Judge: 1;
Moderate or Greater: Extent: 15.
Coordination with multilateral organizations (World Bank, Global Fund,
UN organizations);
Very Great Extent: -;
Great Extent: -;
Moderate Extent: 13;
Some or Little Extent: 11;
No Extent: 2;
No Basis to Judge: 1;
Moderate or Greater: Extent: 13.
Coordination with other bilateral organizations;
Very Great Extent: -;
Great Extent: -;
Moderate Extent: 3;
Some or Little Extent: 18;
No Extent: 4;
No Basis to Judge: 2;
Moderate or Greater: Extent: 3.
Coordination with NGOs and/or the private sector;
Very Great Extent: - ;
Great Extent: -;
Moderate Extent: 4;
Some or Little Extent: 16;
No Extent: 6;
No Basis to Judge: 1;
Moderate or Greater: Extent: 4.
Source: GAO.
[A] Twenty-seven of the 28 respondents answered this question.
[End of table]
Regarding coordination on specific activities, 16 respondents reported
moderate or greater difficulty coordinating provision of feedback to
those who administer services or collect data, and 15 reported a
similar degree of difficulty in coordinating procurement policies and
data reporting requirements (see table 3). Half of the 26 respondents
who answered this question reported moderate or greater difficulty
coordinating data collection methods. The majority reported little or
no difficulty coordinating treatment protocols or data to be
collected.
Question 13.b: Based on your experience at your current post, please
rate the extent to which you experience difficulties coordinating with
other partners in the following areas: A:
Table 3: Difficulty Coordinating on Various Issues as Reported by
Respondents:
Harmonization of treatment protocols;
Very Great Extent (1): 1;
Great Extent (2): 2;
Moderate Extent (3): 5;
Some or Little Extent (4): 5;
No Extent (5): 10;
No Basis to Judge (6): 3;
Moderate or greater: 8.
Harmonization of procurement policies;
Very Great Extent (1): 1;
Great Extent (2): 5;
Moderate Extent (3): 9;
Some or Little Extent (4): 3;
No Extent (5): 3;
No Basis to Judge (6): 5;
Moderate or greater: 15.
Harmonization of monitoring and evaluation indicators (i.e., the data
collected);
Very Great Extent (1): 2;
Great Extent (2): 1;
Moderate Extent (3): 7;
Some or Little Extent (4): 13;
No Extent (5): 3;
No Basis to Judge (6): -;
Moderate or greater: 10.
Harmonization of data collection methods;
Very Great Extent (1): 2;
Great Extent (2): -;
Moderate Extent (3): 11;
Some or Little Extent (4): 10;
No Extent (5): 3;
No Basis to Judge (6): -;
Moderate or greater: 13.
Harmonization of data reporting requirements;
Very Great Extent (1): 4;
Great Extent (2): 3;
Moderate Extent (3): 8;
Some or Little Extent (4): 9;
No Extent (5): 2;
No Basis to Judge (6): -;
Moderate or greater: 15.
Coordinating provision of feedback to those who administer services
and-or collect data;
Very Great Extent (1): 3;
Great Extent (2): 3;
Moderate Extent (3): 10;
Some or Little Extent (4): 8;
No Extent (5): 1;
No Basis to Judge (6): 1;
Moderate or greater: 16.
Source: GAO.
[A] Twenty-six of the 28 respondents answered this question.
[End of table]
[End of section]
Appendix VIII: Joint Comments from the Department of State, HHS, and
USAID:
June 25, 2004:
Dear Mr. Gootnick:
On behalf of the Departments of State, Health and Human Services (HHS)
and the United States Agency for International Development (USAID), we
appreciate the opportunity to comment on the draft General Accounting
Office (GAO) report, U.S. AIDS Coordinator Addressing Some Key
Challenges to Expanding Treatment But Others Remain (GAO-04-784).
In the past few months, we have quickly launched President Bush's
historic Emergency Plan for AIDS Relief to bring prevention, treatment
and care to millions of people living with HIV/AIDS. We concur with the
overall conclusion reached by the report that while we have addressed a
number of key challenges in providing services, a number of challenges
remain for the medium and long-term. However, we do note that the GAO
report was commissioned and interviews were conducted in the first few
months of implementation. Program efforts and activities have
progressed far beyond what the report describes, and work is underway
to address the majority of challenges and issues raised.
Your report rightly describes the urgency of action inherent in
President Bush's announcement of the Emergency Plan in January 2003,
With the unwavering support of the American people, Congress passed the
United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria
Act of 2003 in May of 2003, which authorized activities to be carried
out under the President's Emergency Plan, And, less than five months
after passage of the bill, President Bush nominated and the Senate
confirmed Randall L. Tobias as the first U.S. Global AIDS Coordinator
to lead an expanded and coordinated U.S. response to the international
HIV/AIDS pandemic.
In the nine months since Senate confirmation on October 3, 2003,
Ambassador Tobias has rapidly marshaled the resources of the United
States Government to begin implementing the Emergency Plan. He started
his work
predicated on two fundamental concepts heralded by President Bush:
focus and innovation, Given the vast development, health and other
related challenges present in the focus countries of the Emergency
Plan, Ambassador Tobias has been steadfast in his commitment to
implementing a focused initiative --focused on integrating HIV/AIDS
prevention, care, and treatment, and focused on rapidly achieving
results in a select number of countries that represent nearly half of
the global pandemic in order to demonstrate that a program of this
scope and scale is not only feasible but successful, He has also been
determined to seek innovation in our AIDS response and not simply to
conduct "business as usual," From bringing in new partners, such as
faith-and community-based organizations, to implementing a new
leadership model for coordinating U.S. Government programs and
personnel, the Emergency Plan for AIDS Relief is creating opportunities
to find new and more effective ways to turn the tide of HIV/AIDS.
In fact, the progress made to date in addressing many of the concerns
raised in the draft report reflects some early achievements already
secured by the Emergency Plan, On February 23, 2004, less than one
month after the Congress appropriated fiscal year 2004 funding,
Ambassador Tobias announced the first release of funds for focus
country programs, totaling $350 million, Subsequently, U.S. Government
Missions have developed and Ambassador Tobias has approved annual
operational plans for HIV/AIDS prevention, treatment and care
activities in each of the focus countries, Pending Congressional
approval, an additional $515 million will begin flowing to the focus
countries at the end of June 2004, By the end of the program's first
year, over 200,000 people are expected to be on ARV treatment and over
1,1 million people infected or affected by HIV/AIDS will benefit from
care services.
Progress is especially visible regarding the purchase of anti-
retroviral (ARV) drugs under the Emergency Plan, The Office of the U.S.
Global AIDS Coordinator has consistently and repeatedly expressed its
policy to provide, through the Emergency Plan, HIV/AIDS drugs at the
lowest possible cost, regardless of origin or who produces them, as
long as the drugs are determined to be safe, effective, and of high
quality, These drugs may include brand name products, generics, or
copies of brand name products. At the present time, there are no true
generic versions of these HIV/AIDS drugs because they all remain under
intellectual property protection here in the United States.
On May 16, 2004, HHS Secretary Tommy G, Thompson announced the HHS Food
and Drug Administration's (FDA) expedited process for the review of
applications for HIV/AIDS drug products that combine already-approved
individual HIV/AIDS therapies into a single dosage (also known as
fixed-dose combinations or "FDC"s), as well as new co-packaging of
existing therapies. (Please obtain HHS/FDA draft guidance on the new
review process at http://www.fda.gov/oc/initiatives/hiv/
hivguidance.html, or call 301-827-4573.):
At the same time, Ambassador Tobias announced that when a new
combination drug for HIV/AIDS treatment receives a positive outcome
under this expedited FDA review, the Office of the U.S. Global AIDS
Coordinator will recognize that result as evidence of the safety and
efficacy of that drug. The drug will then become an eligible candidate
for purchase with funding from the President's Emergency Plan, so long
as international patent agreements and local government policies allow
their purchase, The expedited HHS/FDA review process, combined with the
work of local drug regulatory authorities in the affected countries,
will provide a mechanism to ensure that companies who provide drugs for
the President's Emergency Plan meet and maintain safety, efficacy, and
quality standards, Also, Ambassador Tobias expressed his intent to use
his authority to waive any "Buy American" requirements that might
normally apply in certain situations to these drugs. We are confident
that this process will bring safe and effective drugs to millions of
Emergency Plan patients.
Less than one month after this announcement, senior officials from the
U.S. Government initiated outreach efforts to pharmaceutical companies
in Africa and Asia that have products that could enter the HHS/FDA's
review process. In addition, USAID posted recently on the Internet a
special notice for industry comments on the Draft Statement of Work for
a contract to establish a safe, secure, reliable, and sustainable
supply chain and to procure pharmaceuticals and other products needed
to provide care and treatment of persons with HIV/AIDS and related
infections. USAID plans to formally release the request for proposal
(RFP) soon and award the contract later this year for interagency use.
However, as the draft report suggests, the most limiting factor in many
of the focus countries is not necessarily drugs - it is the need for
institutional strengthening of human and physical capacity in the
health care systems. Many of the focus countries are desperately short
of health care workers and health care infrastructure, Both are needed
to deliver treatment broadly, effectively, and in a sustainable manner.
The focus on health care systems provides a base from which to rapidly
expand essential services. Health care systems in the target countries,
and indeed in much of the world, are currently organized around the
concept of a "network
model" comprising central medical facilities, district-level
hospitals, and local health clinics, supplemented by private, often
faith-based, facilities. This network concept of public and private
health care institutions currently provides the backbone design of
health care delivery systems, and many of the focus countries-Nigeria,
Uganda, and Haiti, for example -have planned their HIV/AIDS national
strategies with networked health care systems as the foundation.
The current capacity of these existing health systems to deliver HIV/
AIDS prevention, treatment, and care is limited, however, particularly
in rural areas. The Emergency Plan, in accordance with national health
and HIV/AIDS strategies and with the intent to build long-term
sustainability, will strengthen linkages between central facilities and
international and private support to build the human and physical
capacity of different network components and reinforce network-wide
linkages in order to deliver quality HIV/AIDS care more effectively to
those who need them most.
Because the use of medical volunteers can be highly cost effective in
certain situations, the Office of the U.S. Global AIDS Coordinator
requested the Institute of Medicine (IOM) conduct a study of
alternative mechanisms to mobilize the quantity and qualities of
relevant U.S. technical experts and expert networks needed to support
the Emergency Plan. The study will examine short and long-term options
for mobilizing, preparing, sending, managing, and compensating
volunteer U.S. health professionals who would serve in the focus
countries. The IOM is expected to complete this study by November 2004.
Further, efforts under the Emergency Plan will support the concept of
"twinning" as a long-term solution to promote sustainability and
capacity building by forming relationships that can provide technical
assistance over many years.
The World Health Organization is completely supportive of the concept
of twinning, as are many European donor governments who have gathered
together under the umbrella of the Ensemble pour une Solidarite
Therapeutique Hospitaliere en Reseau (Esther) initiative, with which
the Emergency Plan will work closely.
Additionally, the Office is developing a longer-term training and
capacity-building strategy that includes strengthening training
systems and local training institutions, and improving human resource
policies and planning at the national level, In the meantime, the
Emergency Plan is supporting training efforts in all of the focus
countries, from doctors to community health workers, as well as
indigenous trainers to expand the available pool of qualified health
care workers.
To address immediate health care infrastructure needs, the Emergency
Plan is upgrading and enhancing key health care structures to deliver
HIV care across the focus countries. Mobile units will expand the reach
of counseling and testing activities as well as increase the
distribution network for the provision and monitoring of ARV
medications.
As the report indicates, there are some key rules and regulations that
affect the U.S. Government agencies and departments that are
implementing the Emergency Plan in differing ways. The Office of the
U.S. Global AIDS Coordinator has begun working with experts in each of
the involved agencies and departments to fully define the operational
challenges that exist and to identify a wide-range of solutions, Later
this summer, the Coordinator's office will convene two meetings of
expert field and headquarters staff to address and solve specific,
immediate operational, management and administrative obstacles, such as
contracting constraints, procurement mechanisms, staffing
configurations, and auditing issues, These issues were raised as
tantamount to successful program implementation during the three-day
consultation with U.S. Embassy and agency field staff from the 14 focus
countries that the Office of the Global AIDS Coordinator convened in
Johannesburg, South Africa in early June.
As the Emergency Plan for AIDS Relief is an integral part of the global
response to the HIV/AIDS pandemic, coordination is key to filling gaps
and minimizing duplication, As such, all participating U.S. Government
agencies are working closely together under the leadership of the
Office of the U.S. Global AIDS Coordinator, There is a strong
commitment to inter-agency collaboration, and the Ambassadorial
leadership of in-country teams is proving to be a dynamic catalyst for
coordination and effectiveness, These efforts are part of the annual
program monitoring and evaluation process Ambassador Tobias is leading
to ensure Emergency Plan accountability and effectiveness, In pursuit
of this aim, the Inspector Generals from the participating agencies are
cooperating with each other and the Office of the U.S. Global AIDS
Coordinator, especially as all foresee the need for field audits as the
initiative proceeds.
While implementation efforts have been rapid, the U.S. Government is
striving to coordinate and collaborate our efforts to respond to local
needs and to be consistent with host government strategies and
priorities. It is important to recognize, however, that legislative and
policy constraints will affect the range of activities the Emergency
Plan pursues under a country's national strategy, Thus, coordination
with host governments and other partners, especially with international
partners, such as UNAIDS, the World Health Organization, and the
Global Fund to Fight HIV/AIDS, Tuberculosis and Malaria, as well as
non-governmental organizations, faith-and community-based
organizations, private-sector companies, and others, is key to address
needs outside of the scope of the Emergency Plan.
In conclusion the U.S. Government is making overwhelming progress under
the President's Emergency Plan for AIDS Relief to bring hope and care
to millions around the world, Much remains to be done, However, in
leading the world's response, we believe we can restore lives, preserve
families, and help nations progress forward.
Sincerely,
Signed by:
Christopher Burnham:
Assistant Secretary for Resource Management and Chief Financial
Officer:
U.S. Department of State:
Signed by:
Dara Corrigan:
Acting Principal Deputy Inspector General:
Department of Health and Human Services:
John Marshall:
Assistant Administrator:
Bureau for Management:
U.S Agency for International Development:
Mr. David Gootnick, Director,
International Affairs and Trade,
U.S. General Accounting Office,
441 G Street NW,
Washington, D.C. 20548.
[End of section]
Appendix IX: GAO Contact and Staff Acknowledgments:
GAO Contact:
Cheryl Goodman, (202) 512-6571:
Staff Acknowledgments:
In addition to the person named above, Kate Blumenreich, Martin de
Alteriis, David Dornisch, Kay Halpern, Reid Lowe, Rebecca L. Medina,
Mary Moutsos, and Tom Zingale made key contributions to this report.
(320205):
FOOTNOTES
[1] P.L. 108-25.
[2] The President's announcement targeted 14 countries: Botswana, Côte
d'Ivoire, Ethiopia, Guyana, Haiti, Kenya, Mozambique, Namibia, Nigeria,
Rwanda, South Africa, Tanzania, Uganda, and Zambia; the President
announced a 15th country, Vietnam, on June 23, 2004. In addition to
these focus countries, the Coordinator's Office will oversee HIV/AIDS
activities in 96 other countries.
[3] In the two countries where there is no USAID mission (Botswana and
côte d'Ivoire), we interviewed the official in charge of USAID's
Southern Africa Regional HIV/AIDS program and the head of health issues
for USAID's Western Africa Regional Office, respectively.
[4] These staff spoke with us with the understanding that individual
respondents and the countries where they serve would not be named in
our report. The challenges identified include those experienced by U.S.
officials during an earlier program that used ARV drugs to prevent HIV
transmission from mothers to infants.
[5] There is one brand-name FDC that combines three drugs in one pill;
however, HHS treatment guidelines do not recommend this drug
combination because it is ineffective.
[6] Fixed-dose combinations of ARV drugs are single pills that contain
more than one ARV medication. Reducing the number of pills that must be
taken at any one time is intended to simplify the regimen and thus
promote adherence and decrease the risk of resistance.
[7] In guidelines to field staff, the Coordinator's Office defines
stringent regulatory authority as a drug regulatory body that closely
resembles the HHS/FDA in standards utilized in its operations. The
Coordinator's Office considers as stringent regulatory authorities
regulatory agencies in countries that participate in the International
Conference on Harmonization (ICH). The ICH is an agreement between the
European Union, Japan, and the United States to harmonize regulatory
requirements for the testing, application, and approval of
pharmaceutical medications; it is a joint initiative between government
regulators and industry manufacturers. The Coordinator's Office also
considers Canada's drug regulatory body to be a stringent regulatory
authority and states that other countries may be considered on a case-
by-case basis to have a stringent regulatory body if the countries have
implemented ICH guidelines and resemble the HHS/FDA in operation.
[8] According to technical comments on a draft of this report that were
submitted jointly by the Coordinator's Office, HHS, and USAID, patents
and/or exclusivity protect most of these brand-name drugs in the United
States and overseas.
[9] The Global Fund is a multilateral, non-profit, public-private
mechanism to rapidly disburse grants to augment existing spending on
the prevention and treatment of HIV/AIDS, tuberculosis, and malaria
while maintaining sufficient oversight of financial transactions and
program effectiveness. See U.S. General Accounting Office, Global
Health: Global Fund to Fight AIDS, TB and Malaria Has Advanced in Key
Areas, but Difficult Challenges Remain, GAO-03-601 (Washington, D.C.:
May 7, 2003).
[10] Intrapartum and Neo-Natal Single Dose Nevirapine Compared with
Zivovudine for Prevention of Mother-to-Child Transmission of HIV-1 in
Kampala, Uganda: HIVNET 012 Randomized Trials, The Lancet, September 4,
1999.
[11] These HHS agencies, together with the HHS/CDC, received money
through PEPFAR in fiscal year 2004. Other HHS agencies, such as the
Food and Drug Administration, the Administration for Children and
Families, the Indian Health Service, the Office of the Assistant
Secretary for Planning and Evaluation, and other institutes of the
National Institutes of Health, have not received PEPFAR funds but are
providing planning and other input to PEPFAR.
[12] Budget officials in the Coordinator's Office said that only those
funds already appropriated to agencies were obligated by this target
date. After Congress appropriated funds for PEPFAR on January 23, 2004,
agencies obligated the remaining track 1 and 1.5 funds, according to
officials in the Coordinator's office, HHS, and USAID.
[13] According to the Federal Grant and Cooperative Agreement Act of
1977, 31 U.S.C. 6301-6308, procurement contracts are used to acquire
goods or services "for the direct benefit or use of the United States
Government"; grant agreements are used to transfer funds to a recipient
"to carry out a public purpose of support or stimulation authorized by
a law of the United States" in which "substantial involvement is not
expected" by the U.S. agency providing the grant; and cooperative
agreements are similar to grant agreements except that "substantial
involvement is expected between the agency and the recipient."
[14] This may be due to the fact that the 3-by-5 campaign is the
largest and most recent international ARV treatment initiative.
[15] The United States is one of the largest contributors to the Global
Fund, and the U.S. Secretary of Health and Human Services currently
chairs the Fund.
[16] These requirements may be waived if, among other factors,
information is available to attest to the safety, efficacy, and quality
of the product or if the product meets the standards of the HHS/FDA or
other controlling U.S. authority.
[17] The communication included input from USAID and HHS/CDC field
staff in 13 of the 14 PEPFAR focus countries as well as U.S.-based
officials from these and other agencies.
[18] According to procurement officers at HHS/CDC headquarters,
embassies can write contracts for up to $250,000; contract agreements
typically cover a longer period of time and more complex transactions
than purchase orders.
[19] For example, according to a USAID legal official, for USAID and
its grantees, the agency's source, origin, and nationality rules
implement provisions of the Foreign Assistance Act of 1961, as amended,
and other statutory provisions generally requiring the purchase of U.S.
goods, regardless of whether the goods are purchased or used overseas.
HHS/CDC, on the other hand, does not have similar agency regulations or
implementing procedures other than those stated in the Buy American Act
(U.S.C. 10a-10d). However, this act applies to supplies acquired for
use in the United States. Since PEPFAR supplies will be used outside
the United States, HHS/CDC has stated that the Buy American Act would
not apply to its PEPFAR grantees who acquire supplies for use overseas.
[20] For example, taxation would include value added taxes and customs
duties. In addition, under the legislation, the Secretary of State
"shall expeditiously seek to negotiate amendments to existing bilateral
agreements as necessary to conform with this requirement."
[21] The HHS/CDC audit requirements also state that the U.S.-based firm
conducting the audit has international branches and current licensure/
authority in the country where the audit is being conducted.
[22] These organizations are USAID contractors working overseas.
[23] WHO and World Bank, High-Level Forum on the Health Millennium
Development Goals: Improving Health Workforce Performance, Issues for
Discussion, Session 4 (Geneva, Switzerland: 2003).
[24] WHO, Workshop on Human Resources and Service Delivery Aspects of
Scaling Up ARV Treatment in Resource-limited Settings: A Preliminary
Discussion Paper (draft, October 2003).
[25] Christoph Kurowski, Kaspar Wyss, Salim Abdulla, N'Diekhor Yémadji,
and Anne Mills, Human Resources for Health: Requirements and
Availability in the Context of Scaling Up Priority Interventions in Low
Income Countries: Case Studies from Tanzania and Chad, January 2003.
The purpose of the study was to explore the role and importance of
human resources for the expansion of health services in low-income
countries. The study was conducted under the auspices of the London
School of Hygiene and Tropical Medicine, Health Economics and Financing
Programme.
[26] In remarks before a Center for Strategic and International Studies
forum on "Botswana's Strategy to Combat HIV/AIDS: Lessons for Africa,
and President Bush's Emergency Plan for AIDS Relief," November 12,
2003, Washington, D.C.
[27] USAID, Academy for Educational Development, Support for Analysis
and Research in Africa (SARA), Jenny Huddort, Oscar F. Picazo, and
Sambe Duale, The Health Sector Human Resource Crisis in Africa: An
Issues Paper (Washington, D.C.: 2003).
[28] Ibid. Another USAID-funded report, on the Zambian HIV/AIDS
workforce, cited an average annual salary for a doctor in Zambia of
$7,525 in the public sector, $9,240 at an NGO, and $17,050 in the
private sector (see USAID, Initiatives, Inc., and University Research
Co. LLC, Jenny Hoddart, Rebecca Furth, Dr. Joyce Lyons, HIV/AIDS
Workforce Study (Washington, D.C.: 2003)).
[29] WHO, Recruitment of Health Workers from the Developing World:
Report by the Secretariat (Geneva, Switzerland: 2004).
[30] WHO, The World Health Report 2004: Changing History (Geneva,
Switzerland: 2004).
[31] WHO and World Bank, High-Level Forum on The Health Millennium
Development Goals, Monitoring the Health MDGS, Issues for Discussion:
Session 3 (2003).
[32] For example, the data collected for treatment programs include the
number of treatment facilities or programs and the number of people
being treated. (See pp. 43-44 for a more detailed discussion of these
indicators.)
[33] WHO, World Health Report 2000 Health Systems: Improving
Performance (Geneva, Switzerland: 2000), annex table 10.
[34] In many countries, such structures have been set up to facilitate
the development and implementation of Global Fund and World Bank
programs. The structures have had varying degrees of success.
[35] The Coordinator's Office, together with WHO, UNAIDS, and
regulatory agencies from 23 countries, held a conference in Gaborone,
Botswana, on March 29-30, 2004, to specify principles to be applied
when considering the use of FDCs.
[36] Neither the technical nor official comments on a draft of this
report that were submitted jointly by the State Department, HHS, and
USAID address whether the process supercedes the Coordinator's
previously stated policy of purchasing only drugs approved by stringent
regulatory authorities that include bodies other than the HHS/FDA.
[37] The Coordinator's Office defines short-term interventions as those
that generally take less than a year to implement, and long-term
interventions as those spanning PEPFAR's 5-year time frame and beyond.
[38] The Coordinator's Office expects to make an award by September 30,
2004, in response to a request for applications for twinning
activities, according to technical comments on a draft of this report
that were submitted jointly by the Coordinator's Office, HHS, and
USAID. Multiple missions had visited or were in the process of visiting
countries to provide technical assistance for human capacity
development.
[39] For example, many people who think they may be infected are too
ashamed and afraid to be tested for the disease, fearing social
isolation, rejection, or violence.
[40] The President announced a 15th country, Vietnam, on June 23, 2004.
[41] These staff spoke with us with the understanding that individual
respondents and the countries where they serve would not be named in
our report. The challenges identified include those experienced by U.S.
officials during an earlier program that used ARV drugs to prevent HIV
transmission from mothers to infants.
[42] The key questions were 6.d, 6.e, 9, 10.b, 12.a, 12.b, 12.c, 13.a,
13.b, 13.c, 14.b, and 16.
[43] We do not provide the number of responses here; individual
respondents often provided several responses that fell into the same
subcategory.
[44] The Office of the U.S. Global AIDS Coordinator prepared this
report in collaboration with the Departments of State (including the
U.S. Agency for International Development), Defense, Commerce, Labor,
Health and Human Services (including the Centers for Disease Control
and Prevention, the Food and Drug Administration, the Health Resources
and Services Administration, the National Institutes of Health, and the
Office of Global Health Affairs); and the Peace Corps.
[45] This information is provided solely for background purposes;
therefore, we did not assess the reliability of these data.
[46] Track 1 also provided $1 million to HHS and USAID for strategic
information activities, including gathering and assessing data for
monitoring and evaluating PEPFAR.
[47] According to a budget official in the Coordinator's Office, most
of the transferred funds were obligated through contracts or grant
agreements with organizations that deliver services.
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Web site: www.gao.gov/fraudnet/fraudnet.htm E-mail: fraudnet@gao.gov
Automated answering system: (800) 424-5454 or (202) 512-7470:
Public Affairs:
Jeff Nelligan, managing director, NelliganJ@gao.gov (202) 512-4800 U.S.
General Accounting Office, 441 G Street NW, Room 7149 Washington, D.C.
20548: