[Senate Hearing 108-]
[From the U.S. Government Publishing Office]



 
      FOREIGN OPERATIONS, EXPORT FINANCING, AND RELATED PROGRAMS 
                  APPROPRIATIONS FOR FISCAL YEAR 2005

                              ----------                              


                         TUESDAY, MAY 18, 2004

                                       U.S. Senate,
           Subcommittee of the Committee on Appropriations,
                                                    Washington, DC.
    The subcommittee met at 10:35 a.m., in room SD-124, Dirksen 
Senate Office Building, Hon. Mike DeWine presiding.
    Present: Senators McConnell, DeWine, Leahy, Durbin, and 
Landrieu.

                          DEPARTMENT OF STATE

               Office of the U.S. Global AIDS Coordinator

STATEMENT OF HON. RANDALL L. TOBIAS, COORDINATOR

              OPENING STATEMENT OF SENATOR MICHAEL DE WINE

    Senator DeWine. Let me welcome all of you today. Senator 
McConnell asked that I preside and begin the hearing as he 
currently has another commitment, but he will be here shortly 
to join us.
    Today's subcommittee hearing on the fiscal year 2005 budget 
request for HIV/AIDS consists of two panels. Global HIV/AIDS 
Coordinator Randall Tobias will be the sole witness on the 
first panel, followed by DATA founding member Bono on the 
second.
    Senator Leahy and I will make brief opening remarks, 
followed by Ambassador Tobias. We will then proceed to 5-minute 
rounds of questions and answers. At approximately 11:20, about 
the time we may have a vote on the floor, we will move to our 
second panel.
    In the interest of time, I ask that our witnesses summarize 
their remarks and we will insert their full statements into the 
record. My colleagues should know that we will keep the record 
open for any written questions they wish to submit to our 
witnesses, and I request our witnesses to respond to these 
questions, of course, in a timely manner.
    Our hearing today is a chance for us to take a look at 
where we have been in terms of how our funding allocations have 
been spent in regard to AIDS and what the plans are for the 
future of the President's Global AIDS Initiative. We are 
privileged to have before us today on the first panel 
Ambassador Tobias, who serves as the Coordinator of this very 
important initiative. He will testify on the progress to date, 
as well as provide us with details on what lies ahead for the 
initiative.
    We have an historic opportunity with the funding that has 
been made available for the Global AIDS Initiative. I say that 
because the money, that money, can and should be used not only 
to fight HIV/AIDS, but also to lay a foundation for improved 
health systems in the developing world: health care systems for 
children, women, and families. The money that we put forward in 
regard to this fight against AIDS has the potential to yield 
tremendous dividends in other areas of public health.
    The fact is that in many of the countries that we will be 
spending and are spending this money for HIV/AIDS, many of 
these countries do not currently have a good health 
infrastructure. So it is really going to be impossible for us 
to deal with the AIDS problem without helping these countries 
build up that health infrastructure.
    So the two are going to be linked. One of the things that I 
want to explore with Ambassador Tobias today is how he sees us 
working with these countries to build up their health 
infrastructures.
    I think that is going to also, though, while it is a 
challenge, frankly it also has the benefit of providing extra 
dividends: that what we will end up with, we hope, in the 
future and what these countries and the people of these 
countries will end up with is not only fighting AIDS, but end 
up with the ability to do so much more in their health systems 
and end up with truly a good health system in many of these 
countries.
    What I hope to hear from Ambassador Tobias today are his 
plans on how to take advantage of the $15 billion in 
opportunities over the next 5 years. How can we make certain 
that we provide care and treatment to as many people as 
possible, treatment that includes the millions of children with 
HIV/AIDS and other infectious diseases like malaria and 
tuberculosis?
    Mr. Ambassador, having read your testimony, I know that you 
will speak to the issues of procuring low-cost antiretroviral 
medicines for adults. But what about the children? We need to 
ensure that children infected with HIV are not overlooked in 
the drug approval and procurement process. I would ask that in 
your comments you clarify what your office is doing to ensure 
safe pediatric formulations and how your office plans to 
increase the number of children receiving treatment.
    We know from experience that the core features of the 
prevention of mother-to-child transmission programs--voluntary 
counseling and testing, the establishment of pharmacies and 
drug distribution mechanisms, and the training of health care 
workers--all provide a sound foundation on which to build, on 
which to build expanded care and treatment. So I would like to 
hear from the Ambassador on his plans for the mother-to-child 
transmission program. What are your plans to increase the 
number of clinics capable of providing services to prevent the 
transmission of the virus from mother to child, especially 
since fewer than one percent of women have access to MTCT 
services in some of the most infected countries. What can we do 
to get more women treated before they give birth to HIV-
positive babies?
    Let me say again, we have $15 billion in opportunities to 
help build health care infrastructures, to increase the number 
of children, women and families receiving treatment and care, 
to invest in human capital development, and to put programs in 
place to take care of orphans and other vulnerable children.
    Let me again thank both of our witnesses for being here 
today, and also thank both of them for their great commitment 
to this cause. Ambassador Tobias, I look forward to hearing 
your vision on how we can take advantage of these opportunities 
and hearing what you have already done so far.
    Let me also say that I am pleased that Bono could join us 
and I look forward to hearing his thoughts on debt relief. We 
do not know anyone else who has really had the vision in this 
area and who has captured the attention of the public, not only 
in the United States but around the world, and we salute him 
for his great work as well.
    Let me at this point turn to Senator Leahy, the ranking 
member of this committee, who has also been just a great leader 
in this anti-AIDS work. Senator Leahy, thank you.

             OPENING STATEMENT OF SENATOR PATRICK J. LEAHY

    Senator Leahy. Thank you, Mr. Chairman.
    You know, it is interesting, some of the odd couplings in 
the Senate. Not only is Senator DeWine a close personal friend, 
but we have, coming from different parties and different 
philosophical spectrums, we have worked very closely on these 
issues.
    Ambassador Tobias, I am glad to see you. I enjoyed our chat 
outside before we came in and I really would welcome the 
opportunity to travel to parts of Africa with you. I am 
delighted that a long-time friend, Bono, is here. He is a close 
friend of the Leahy family. We have spent time together, each 
member of the family with him, and we think the world of him.
    I met just briefly the lady from Uganda before and we will 
be seeing more of her, of Agnes Nyamayarwo. And I probably--and 
I apologize. I have probably totally butchered the 
pronunciation of the name, and the poor reporter here is 
getting panicky at how to handle that, and I know you will do 
better. But I admire--as I told you privately before, I admire 
your courage, I really do, and you are in our thoughts and 
prayers.
    When you think of the statistics--Ambassador, we talked 
about that outside. We talked about these horrible statistics--
8,000 people will die of AIDS today. And as you said very 
rightly, the number is overwhelming, but each one has a name. 
And you have seen those, as has Bono and the others, as I. My 
wife is a registered nurse. We have been in some of these 
clinics. We have seen the people who are dying.
    During the hour and a half of this hearing, 513 will die, 
856 will become infected. That shows we have yet to confront 
this disease.
    I support President Bush's AIDS initiative. I have been 
impressed with the progress you have made in the very short 
time since you took on this responsibility. We are allocating 
far more to this crisis. The momentum is positive. But the 
President and Secretary Thompson and others in the 
administration, as well as some in Congress who defend the 
President's budget, say we are spending as much as can be 
effectively used to prevent the spread of HIV and treat those 
who are sick.
    I disagree. I think that is misinformed. In any of your 14, 
soon to be 15, focus countries, the medical facilities are 
grossly inadequate, health care workers are too few, often 
poorly trained, they are always underpaid. Private voluntary 
organizations are overwhelmed. Orphans are caring for other 
orphans. People are dying alone, often ostracized by their 
families.
    There is a huge unmet need to build the capacity in those 
countries to fight this pandemic. That is how it is in your 
focus countries, which are shown in white on this chart I have 
got over here.
    In the rest of the world, with half the HIV-infected 
people, we either have no programs or funding has been frozen 
at the fiscal year 2003 level due to a shortage of funds. So 
while the rate of infection soars in some non-focus countries, 
funding there is actually decreasing when you consider 
inflation and the growing number of victims and people at risk. 
This is a terrifying, terrifying chart.
    The President has proposed to cut funding for the Global 
Fund to Fight AIDS, TB, and Malaria from $547 million in 2004 
to $200 million in 2005, at a time when the Global Fund says it 
needs $3.6 billion, of which our share would be $1.2 billion. 
And when we ask the administration, why can we not have 
additional emergency funding to combat AIDS, we are told we do 
not need it, we cannot use it.
    It reminds you a little bit of the Department of Defense, 
which, despite overwhelming evidence of the contrary, insists 
we do not need more troops in Iraq.
    Mr. Tobias, we should be allocating $28 billion next year, 
not $2.8 billion. We are 20 years late, we are $20 billion 
short.
    Three other quick points. First, the generic drug issue, 
which has been the subject of a lot of press attention and has 
taken too long to resolve. Now that U.S. drug companies are 
finally interested in manufacturing fixed-dose combinations, 
the administration's opposition seems to have miraculously 
disappeared and the FDA will soon be reviewing the safety of 
these drugs. It makes you wonder.
    Second is your emphasis on faith-based groups and 
abstinence. Faith-based groups have a role to play and where 
abstinence programs work we should support them, but we risk 
millions of new infections if we apply an ideological lens to 
prevention rather than relying on methods that have been tested 
and proven and that deal with the world as it really is.
    Then third is your definition of ``high risk'' group. I 
heard, for example, that a 15-year-old girl in sub-Saharan 
Africa, where the percentage of HIV-positive females can be as 
high as 20 percent, could not receive condoms under your 
program because she is not high-risk. Yet today that girl is 
more likely to become infected and to die of AIDS than she is 
to live her life free of AIDS, more likely to have it than not. 
Now, I hope that girl does not have to expose herself to HIV 
before she can receive condoms or even information about them 
under your program.
    Mr. Tobias, I have been trying for more than 15 years to 
get more funding to combat AIDS. I believe we could and should 
be doing more. But I hear good things, particularly from my own 
staff, who traveled there, and the Global Health Council, which 
I admire greatly, notwithstanding the fact it is based in my 
home State of Vermont, I hear good things about the way you are 
taking on this challenge, that you are doing it with great 
energy and openness. I commend you for that.

                           PREPARED STATEMENT

    Just as Senator DeWine and I work together, we all have to 
work together. You know, when somebody is dying of AIDS we do 
not ask them what their politics are. We ask what we could do 
to stop it. Again, you look at that map; your heart has to cry 
out.
    Thank you.
    Thank you, Mr. Chairman.
    [The statement follows:]

             Prepared Statement of Senator Patrick J. Leahy

    Mr. Tobias, we appreciate you being here. We all know the 
statistics. 8,000 people will die of AIDS today. Just during the hour 
and a half of this hearing, 513 will die and another 856 will become 
infected. To me, that shows that, so far, we have failed miserably to 
confront this disease.
    I support President Bush's AIDS initiative, and I have been 
impressed with the progress you have made in the short time since you 
took on this responsibility. We are allocating far more than before to 
this crisis, and the momentum is positive. But the President, Secretary 
Thompson, and others in the administration, as well as some in Congress 
who defend the President's budget, say we are spending as much as can 
be effectively used to prevent the spread of HIV and treat those who 
are sick.
    That is either misinformed, or disingenuous. In any of your 14--
soon to be 15--focus countries, medical facilities are grossly 
inadequate, and health care workers are too few, often poorly trained, 
and always underpaid. Private voluntary organizations are overwhelmed. 
Orphans are caring for each other. People are dying alone, ostracized 
by their families. There is a huge, unmet need to build the capacity in 
those countries to fight this pandemic. That is how it is in your focus 
countries, which are shown in white on this chart. In the rest of the 
world--with half the HIV infected people--we either have no programs, 
or you have frozen funding at the fiscal year 2003 level due to a 
shortage of funds.
    So while the rate of infection soars in some non-focus countries, 
our funding there is actually decreasing, if you consider inflation and 
the growing number of victims and people at risk of infection. And the 
President proposes to cut funding for the Global Fund to Fight AIDS, TB 
and Malaria from $547 million in 2004 to $200 million in 2005, at a 
time when the Global Fund says it needs $3.6 billion, of which our 
share would be $1.2 billion. Yet what we hear from the administration, 
when we try to get additional emergency funding to combat AIDS, is that 
we don't need it. We can't use it. It reminds me of the Department of 
Defense, which despite overwhelming evidence to the contrary, insists 
that we don't need more troops in Iraq.
    Mr. Tobias, we should be allocating $28 billion next year, not $2.8 
billion. We are twenty years late and $20 billion short.
    Three other quick points:
    First, the generic drug issue, which has been the subject of a lot 
of press attention, has taken far too long to resolve. However, now 
that U.S. drug companies are finally interested in manufacturing fixed-
dose combinations, the administration's opposition seems to have 
miraculously disappeared and the FDA will soon be reviewing the safety 
of these drugs. It makes you wonder.
    Second is your emphasis on faith-based groups and abstinence. 
Faith-based groups have a role to play and, where abstinence programs 
work, we should support them. But we risk millions of new infections if 
we apply an ideological lens to prevention, rather than relying on 
methods that have been tested and proven, and that deal with the world 
as it really is.
    Third is your definition of ``high risk'' group. I heard, for 
example, that a 15-year-old girl in sub-Saharan Africa, where the 
percentage of HIV-positive females can be as high as 20 percent, could 
not receive condoms under your program because she is not ``high 
risk.''
    Yet, today that girl is more likely to become infected and to die 
of AIDS than she is to live her life free of AIDS. I hope that girl 
does not have to expose herself to HIV before she can receive condoms, 
or even information about condoms, under your program.
    Mr. Tobias, I have been trying for more than 15 years to get more 
funding to combat AIDS. I believe we could and should be doing much 
more. But I hear good things--including from my staff and from the 
Global Health Council in my own state of Vermont--about the way you are 
taking on this challenge, with great energy and openness. I commend you 
for that. We need to work together.

    Senator DeWine. Mr. Ambassador, thank you very much for 
joining us. We do have your written statement, which will be 
made a part of the record, and will you please proceed.

              SUMMARY STATEMENT OF HON. RANDALL L. TOBIAS

    Ambassador Tobias. Mr. Chairman, members of the 
subcommittee: I am very pleased to be here to testify this 
morning in support of the President's budget request and to 
report to you on the progress in implementing the President's 
emergency plan for AIDS relief. I appreciate the committee's 
indulgence in the fact that we were scheduled to do this 
earlier and I was suffering from laryngitis, which as you can 
probably tell I am not totally over yet; and then on another 
occasion the President asked me to go to South Africa to 
represent him at the inauguration of the president.
    But I am very pleased to be here today and particularly to 
be here with my friend Bono. It would be hard to find anybody 
who is working any harder on this issue than he is. As you have 
both said, this is a fight where we need everybody we can find 
to work together.
    With your permission, I will submit a longer written 
statement for the record and I would like to make a few opening 
comments.
    As you are aware and as you have made reference to, in his 
State of the Union Address last year, President Bush called for 
an unprecedented act of compassion to turn the tide against the 
ravages of HIV/AIDS with $15 billion over 5 years, more money 
than has ever been committed by any nation for any 
international health initiative: $5 billion directed at 100 
bilateral programs, $9 billion intended for new or expanded 
programs in 14--soon to be 15--focus countries; and $1 billion 
intended to support our principal multilateral partner, the 
Global Fund.
    The goals of this program are to help provide 
antiretroviral treatment to 2 million people in the focus 
countries, contribute to the prevention of 7 million new 
infections, and to help provide care for 10 million who are 
infected or affected, including the orphans and vulnerable 
children.
    Today I am pleased to report that we have made significant 
progress in beginning to implement the actions that will be 
necessary to achieve the goals of this initiative. On February 
23, a very short time after Congress appropriated fiscal year 
2004 funding for the first year of the plan, I announced the 
first release of funds for the focus country programs, totaling 
$350 million. This money is already being used in 
antiretroviral treatment programs, prevention programs, safe 
medical practices programs, and programs to provide care for 
orphans and vulnerable children. With just this first round of 
funding, an additional 50,000 people living with HIV/AIDS in 
the 14 focus countries will receive treatment, which will 
nearly double the number of people who are currently receiving 
treatment in sub-Saharan Africa. Prevention programs will reach 
about 500,000 additional people and about 60,000 additional 
orphans will receive help.
    For each of the focus countries, we have recently completed 
reviews of their annual operational plans to be addressed with 
the remaining 2004 appropriation. These plans represent the 
overall U.S. Government-supported HIV/AIDS programs in each of 
the focus countries.
    As a result of these reviews, Mr. Chairman, we are already 
moving beyond this first wave of funding, and we will be 
providing to this committee and other congressional committees 
very shortly the required notification for the obligation of 
approximately $300 million in the next tranche of funding from 
the Global AIDS Coordinator's Initiative and an additional $200 
million in funds appropriated to the Department of Health and 
Human Services and the U.S. Agency for International 
Development. That will bring to about $850 million the funds 
that we will have committed to new or expanded programs since 
the first of the year.
    While our short-term focus has been on putting funds to 
work in the field quickly and with accountability to ensure 
that those in need get help as quickly as possible, we are also 
working to ensure that host governments and local organizations 
are well prepared to fight this deadly disease. And similarly, 
we need to ensure that our own U.S. Government staffs in the 
field are properly sized in order to do this increased task 
that they are facing.
    But this is all only the first step. In fiscal year 2005 we 
have requested $1.45 billion for the Office of the AIDS 
Coordinator as part of the President's $2.8 billion total 
request. The President's request represents a $400 million 
increase over fiscal year 2004. An appropriation of $2.8 
billion will keep the emergency plan on path toward meeting the 
goals that have been set by the President and the Congress and 
is in keeping with our belief that as the emergency plan takes 
root and is scaled up additional resources are clearly going to 
be needed to effectively deliver assistance.
    Mr. Chairman, in February I also submitted to Congress a 
comprehensive integrated 5-year strategy. This strategy is 
driving everything that we are doing in the Office of the 
Global AIDS Coordinator. We have enlisted the help of the U.S. 
chief of mission in each country to bring together the local 
country team so that everybody is working in a coordinated 
effort, and I am very pleased with the way that effort is 
working.
    Within that framework, we are striving to coordinate and 
collaborate our efforts in order to respond as best we can to 
the priorities and the strategies of each of the host country 
governments, challenges which in many cases are different. In 
addition, we are increasingly coordinating our own worldwide 
response with those of our international partners--U.N. AIDS, 
the World Health Organization, the Global Fund--as well as 
nongovernmental and faith-based and community-based 
organizations and increasingly private sector companies who are 
stepping into the fray.
    Since my confirmation 7 months ago, I have had the 
opportunity to visit many of the countries in which we are 
focusing our efforts, including South Africa, Uganda, Kenya, 
Botswana, Zambia, Namibia, Rwanda, Ethiopia, and Mozambique. I 
will be leaving in a few days to visit Nigeria, Cote d'Ivoire, 
and Tanzania, and then going to Haiti and Guyana in the early 
summer.
    Finally, Mr. Chairman, I would like to say a few words 
about our policy to procure antiretroviral drugs under the 
emergency plan, a topic that has generated a significant amount 
of interest. I have consistently and repeatedly expressed our 
intent to provide, through the emergency plan, AIDS drugs that 
are acquired at the lowest possible cost, whether they are 
brand name products, generics, or copies of brand name 
products, regardless of their origin or who produces them, as 
long as we know that they are safe and effective and of high 
quality.
    As you know, this past Sunday Health and Human Services 
Secretary Thompson and I held a joint press conference in 
Geneva, where the World Health Assembly is currently taking 
place. Our purpose was to make two very important announcements 
that impact these issues.
    First, Secretary Thompson announced an expedited process 
for FDA review of AIDS drugs that combine already-approved 
individual HIV therapies into a single dose, known as fixed-
dose combination. The drugs that are approved under this 
expedited process will meet all FDA standards for safety, 
efficacy, and quality. This new FDA process will include the 
review of applications that may come from research-based 
companies that developed the individual therapies and now want 
to put them into fixed-dose combinations, or the applications 
may come from companies who are already manufacturing copies of 
those drugs for sale in the developing nations.
    For my part, I announced in Geneva that when a new 
combination drug for AIDS treatment receives a positive outcome 
under this expedited FDA review, then the Office of the Global 
AIDS Coordinator will recognize that positive result as 
evidence of the safety and efficacy of that drug, and thus the 
drug will be eligible for funding by the President's emergency 
plan so long as the various international patent agreements and 
local government policies allow for their purpose.
    Where it is necessary to do so, I will also use the 
authority that has been given to me by the Congress to waive 
buy-American requirements that might normally apply.
    Thanks to the generosity of the American people, as well as 
the growing number of donor nations, the donors to the Global 
Fund, and other multilateral sources, the human and physical 
capacity to deliver AIDS treatment is being scaled up to make 
it possible for millions more patients to follow those who are 
already receiving this life-extending therapy. As 
infrastructure is scaled up, drug availability will also need 
to be scaled up to an unprecedented level in order to fuel this 
newly expanded set of health care systems that can deliver this 
treatment capacity.
    It is in some ways in large part because of the President's 
emergency plan that the issue of drug safety needs to be 
addressed on an entirely new scale. With such a massive 
expansion of ARV treatment, the stakes have increased. If we do 
not apply appropriate scientific scrutiny to this vastly 
expanding flow of AIDS medicines, we will run the risk of 
causing the HIV virus to mutate and overcome specific drugs or 
even whole classes of drugs, and that is why getting it right 
at the outset is so important and requires great care.
    Our commitment from the beginning has been to move with 
urgency to help build the human and physical capacity that is 
needed to deliver this treatment and then to fund the purchase 
of AIDS drugs to be used in providing this treatment at the 
most cost-effective prices we can find, but only drugs that we 
can be assured are safe and effective.
    Patients in Africa deserve the same assurances of safety 
and efficacy that we would expect for our own families here in 
the United States. There should not be a double standard. But 
how to do that has presented some serious challenges. So with 
our colleagues at the World Health Organization and UNAIDS and 
the Southern African Development Community, the U.S. Government 
has been carefully examining this issue and considering 
alternatives.
    Many of the copies of the research-based AIDS drugs that 
are on the market today in developing countries may very well 
be totally safe and effective. The challenge stems in part from 
the fact that they have never been reviewed by any of the 
world's stringent regulatory authorities, and the same will 
likely be true of the additional copies of these drugs that 
will be coming to the market in the days ahead as new companies 
and particularly indigenous companies enter this market, 
something that we expect and indeed hope will happen.
    Many people and organizations have noted the World Health 
Organization's prequalification pilot program and have urged 
that we simply rely on that. We have the highest respect for 
the World Health Organization and for its program. However, the 
World Health Organization is not a regulatory authority and 
does not represent itself as such. And in my conversations with 
Dr. J.W. Lee, Director General of the World Health 
Organization, as recently as 2 days ago, he has been very 
supportive, and has said so publicly, of what we are doing with 
this new program.
    For drugs that are used in the United States, the already 
existing answer has been FDA approval, whether it is generic 
drugs or brand name drugs. Now we have a process that every 
drug company in the world who wants to participate in this 
program can submit for review to the FDA and do this very 
expeditiously.
    Today the most limiting----
    Senator DeWine. Mr. Ambassador, if you could wrap up.
    Ambassador Tobias. Okay.

                           PREPARED STATEMENT

    Today the most limiting factor in providing treatment is 
not the drugs; it is the human and physical capacity in the 
health care system in Africa. But we are making progress on 
that and it is now time to get moving with the drugs.
    I pledge that the Office of the Global AIDS Coordinator 
will continue to move with urgency in all that we do, and I 
appreciate very much the opportunity to be here today.
    [The statement follows:]

              Prepared Statement of Hon. Randall L. Tobias

    Mr. Chairman, members of the subcommittee, I am pleased to appear 
before you to testify in support of the President's Budget request for 
fiscal year 2005 for global HIV/AIDS, and to report to you on our 
progress in implement the President's Emergency Plan For AIDS Relief.
    In his State of the Union address last year, President Bush called 
for an unprecedented act of compassion to turn the tide against the 
ravages of HIV/AIDS.
    The President committed $15 billion over five years to address the 
global HIV/AIDS pandemic--more money than ever before committed by any 
nation for any international health care initiative:
  --$5 billion intended to provide continuing support in the 
        approximately 100 nations where the U.S. Government currently 
        has bilateral, regional, and volunteer HIV/AIDS programs.
  --$9 billion intended for new or expanded programs to address HIV/
        AIDS in 14 of those countries that are among the world's most 
        affected--with a 15th country to be added shortly. The initial 
        14 countries account for approximately 50 percent of the 
        world's HIV/AIDS infections.
  --And finally, $1 billion intended to support our principal 
        multilateral partner in this effort, the Global Fund to Fight 
        AIDS, Tuberculosis and Malaria, which the United States helped 
        to found with the first contribution in May 2001.
    Today, I am pleased to report that we have made significant 
progress in beginning to achieve the President's, the Congress's, and 
the American public's goal of bringing prevention, treatment, and care 
to millions of adults and children courageously living with HIV/AIDS 
and replacing despair with hope.
    On February 23, just 4\1/2\ months after we launched the Office of 
the U.S. Global AIDS Coordinator, and less than a month after the 
Congress appropriated fiscal year 2004 funding for the first year of 
the President's Emergency Plan for AIDS Relief, I announced the first 
release of funds for focus country programs totaling $350 million.
    This money is being used by service providers who are bringing 
relief to suffering people in some of the countries hardest-hit by the 
HIV/AIDS pandemic to rapidly scale up programs that provide anti-
retroviral treatment; prevention programs, including those targeted at 
youth; safe medical practices programs; and programs to provide care 
for orphans and vulnerable children.
    These target areas were chosen because they are at the heart of the 
treatment, prevention and care goals of President Bush's Plan.
    The programs of these specific recipients were chosen because they 
have existing operations among the focus countries, have a proven track 
record, and have the capacity to rapidly scale up their operations and 
begin having an immediate impact.
    Our intent has been to move as quickly as possible to bring 
immediate relief to those who are suffering the devastation of HIV/
AIDS.
    By initially concentrating on scaling up existing programs that 
have proven experience and measurable track records, that's exactly 
what we have been able to do.
    With just this first round of funds, an additional 50,000 people 
living with HIV/AIDS in the 14 focus countries will begin to receive 
anti-retroviral treatment, which will nearly double the number of 
people who are currently receiving treatment in all of sub-Saharan 
Africa. Today, activities have been approved for anti-retroviral 
treatment in Kenya, Nigeria, and Zambia, and patients are receiving 
treatment in South Africa and Uganda because of the Emergency Plan.
    In addition, prevention through abstinence messages will reach 
about 500,000 additional young people in the Plan's 14 focus countries 
in Africa and the Caribbean through programs like World Relief and the 
American Red Cross's Together We Can.
    The first release of funding from the President's Emergency Plan 
will also provide resources to assist in the care of about 60,000 
additional orphans in the Plan's 14 focus countries in Africa and the 
Caribbean. These care services will include providing critical social 
services, scaling up basic community-care packages of preventive 
treatment and safe water, as well as HIV/AIDS prevention education.
    U.S. Government staff recently completed reviews of each of the 
focus country's annual operational plans to be addressed with the 
remaining fiscal year 2004 appropriation. These plans represent the 
overall U.S. Government-supported HIV/AIDS prevention, treatment, and 
care activities in each focus country.
    As a result of these reviews, Mr. Chairman, we will be providing to 
this Committee and other congressional committees the required 
notification for the obligation of approximately $300 million in the 
next tranche of funding from the Global HIV/AIDS Initiative account. In 
addition to that $300 million, another $200 million of funds 
appropriated to the U.S. Department of Health and Human Services and 
the U.S. Agency for International Development will be put to work in 
the field, bringing to approximately $850 million the funds already 
committed to new or expanded programs since the first of the year.
    As we make additional awards, the numbers of persons receiving 
treatment and care will increase substantially. I also expect our 
efforts to strengthen and expand safe blood transfusion and safe 
medical injection programs, as well as our efforts to strengthen human 
and organizational capacity through healthcare twinning and volunteers. 
And I also expect to place an additional focus on attracting new 
partners, including more faith-based and community-based organizations 
that can bring expanded capacity and innovative new thinking to this 
effort.
    Mr. Chairman, as I mentioned, our short-term focus has been putting 
funding to work in the field quickly and with accountability to ensure 
that those in need get help as quickly as possible. In addition to 
these important ideals and the achievement of our treatment, prevention 
and care goals, in the long term we are focused on strengthening 
indigenous capacity. We need to ensure that host governments and local 
organizations are well prepared to fight this deadly disease. 
Similarly, we need to ensure that our own U.S. Government staff in the 
field is properly sized to work closely with host governments over the 
next four years in accomplishing the goals of the Emergency Plan.
    But this is only the first step. In fiscal year 2005 we requested 
$1.45 billion for the Office of the Coordinator as part of the 
President's $2.8 billion request. With these funds we will continue to 
expand access to care, treatment and prevention and also take the next 
steps to build the necessary U.S. Government and host country capacity 
needed for this Initiative. To this end, we are working with HHS and 
USAID now to create a vehicle to help provide the necessary technical 
assistance to small indigenous non-governmental and faith-based 
organizations to become a more integral part of the solution to 
fighting HIV/AIDS in their country. We are also working with USAID, HHS 
and other relevant agencies to determine a long-term staffing plan.
    As I mentioned, the President's total Emergency Plan request for 
fiscal year 2005 is for $2.8 billion, a $400 million increase over the 
fiscal year 2004 appropriation--the first year of the Emergency Plan. 
This request is in keeping with our belief that as the Emergency Plan 
takes root and is scaled up, additional resources will be needed to 
effectively deliver assistance. An appropriation of $2.8 billion will 
keep the Emergency Plan on the path toward meeting the prevention, 
treatment and care goals set by the President and the Congress. The 
appropriation will also maintain U.S. leadership in the Global Fund to 
Fight AIDS, Tuberculosis and Malaria.
    Mr. Chairman, in addition to announcing the first round of funding 
and preparing to obligate the remaining fiscal year 2004 funds, I also 
submitted to this Committee and other appropriate Congressional 
committees in February a comprehensive, integrated, five-year strategy 
for the President's Emergency Plan for AIDS Relief.
    This Strategic Plan is guiding our efforts to deploy our resources 
to maximum effect:
  --We are concentrating on prevention, treatment and care, the focus 
        of the President's Emergency Plan.
  --In the 15 focus countries, over the five years of the Emergency 
        Plan:
    --We will help to provide anti-retroviral treatment for two million 
            people;
    --We will contribute to the prevention of 7 million new HIV 
            infections; and,
    --We will help provide care to 10 million people who are infected 
            or affected by the disease in the focus countries, 
            including orphans and vulnerable children.
  --We are not starting from scratch. Rather, we are capitalizing on 
        existing core strengths of the U.S. Government, including:
    --Established funding and disbursement mechanisms;
    --Two decades of expertise fighting HIV/AIDS in the United States 
            and worldwide;
    --Field presence and strong relationships with host governments in 
            over 100 countries; and,
    --Well-developed partnerships with non-governmental, faith-based 
            and international organizations that can deliver HIV/AIDS 
            programs.
    Starting with this foundation, we are implementing a new leadership 
model for those existing capabilities--a model that brings together, 
under the direction of the U.S. Global AIDS Coordinator, all of the 
programs and personnel of all agencies and departments of the U.S. 
Government engaged in this effort. This leadership model has been 
translated to the field, where the U.S. Chief of Mission in each 
country is leading an interagency process on-the-ground. In addition to 
the work that has been done to develop the programs for fiscal year 
2004 that we are or soon will be funding, in early fall each country 
team will submit to my office a unified five-year overarching strategic 
plan to define how the President's prevention, care and treatment goals 
will be achieved in that country.
    The Emergency Plan is built on four cornerstones, which guide my 
office:
    1. Rapidly expanding integrated prevention, care, and treatment in 
the focus countries by building on existing successful programs that 
are consistent with the principles of the Plan--as we have already 
begun with the $350 million announced in February.
    2. Identifying new partners, including faith-based and community-
based organizations, and building indigenous capacity to sustain a 
long-term and broad local response.
    3. Encouraging bold national leadership around the world, and 
engendering the creation of sound enabling policy environments in every 
country for combating HIV/AIDS and mitigating its consequences.
    4. Implementing strong strategic information systems that will 
provide vital feedback and input to direct our continued learning and 
identification of best practices.
    Within that framework, we are striving to coordinate and 
collaborate our efforts in order to respond to local needs and to be 
consistent with host government strategies and priorities.
    In addition, we intend to amplify our own worldwide response to 
HIV/AIDS by working with international partners, such as UNAIDS, the 
World Health Organization, and the Global Fund, as well as through non-
governmental organizations, faith- and community-based organizations, 
private-sector companies, and others who can assist us in engendering 
new leadership and resources to fight HIV/AIDS.
    Since my confirmation seven months ago, I have had the opportunity 
to visit many of the countries in which we are focusing our efforts, 
including South Africa, Uganda, Kenya, Botswana, Zambia, Namibia, 
Rwanda, Ethiopia, and Mozambique. I'll be leaving in a few days for a 
visit that will include Nigeria, Cote d'Ivoire and Tanzania.
    In these visits, I have witnessed how these countries have 
responded, in whatever way they can, to fellow community members in 
need. As we embark on this effort, it is inspiring to observe the 
remarkable self-help already under way in fighting HIV/AIDS by some of 
the most under-resourced communities in the world. With our support, we 
hope to broaden, deepen and sustain their efforts to combat the 
devastation of HIV/AIDS.
    That is why getting the first wave of funding released quickly 
after the appropriation was so critical, and I appreciate the 
Congress's assistance in ensuring that was able to happen. I again seek 
your support in ensuring that we are able to quickly move the 
additional resources about to be sent up so we can respond with the 
urgency these individuals in need require.
    Finally, Mr. Chairman, I would like to say a few words about our 
policy to procure anti-retroviral drugs under the Emergency Plan--a 
topic that has generated a significant amount of interest.
    I have consistently and repeatedly expressed our intent to provide, 
through the Emergency Plan, AIDS drugs that are acquired at the lowest 
possible cost, regardless of origin or who produces them, as long as we 
know they are safe, effective, and of high quality. These drugs may 
include brand name products, generics, or copies of brand name 
products.
    To define the terms here, when you or I go to our neighborhood 
pharmacy and have a prescription filled with a generic drug, we do so 
with the confidence that we are being given a drug that has undergone 
regulatory review to ensure that it is comparable to the version 
manufactured by the research-based company that originally created it, 
but no longer has the patent rights to the product. It is the same drug 
in dosage form, strength, route of administration, quality, performance 
characteristics, and intended use. Drugs that have not gone through 
such a process are more accurately described as copy drugs rather than 
generics, as they are sometimes called.
    This past Sunday, Health and Human Services Secretary Tommy 
Thompson and I held a joint press conference in Geneva where the World 
Health Assembly in currently taking place. Our purpose was to make two 
very important announcements that impact on these issues.
    First, Secretary Thompson announced an expedited process for FDA 
review of applications for HIV/AIDS drug products that combine already-
approved individual HIV/AIDS therapies into a single dosage. These 
combined therapies are known as fixed dose combinations or FDCs. Drugs 
that are approved by FDA under this process will meet all FDA standards 
for drug safety, efficacy, and quality.
    This new FDA process will include the review of applications from 
the research-based companies that developed the already-approved 
individual therapies and want to put them into fixed dose combinations, 
or from companies who are manufacturing copies of those drugs for sale 
in developing nations. There are no true generic versions of these AIDS 
drugs because they all remain under intellectual property protection 
here in the United States.
    For my part, I announced that when a new combination drug for AIDS 
treatment receives a positive outcome under this expedited FDA review, 
the Office of the Global AIDS Coordinator will recognize that result as 
evidence of the safety and efficacy of that drug. Thus the drug will be 
eligible to be a candidate for funding by the President's Emergency 
Plan, so long as international patent agreements and local government 
policies allow their purchase. Where it is necessary and appropriate to 
do so, I will also use my authority to waive the ``Buy American'' 
requirements that might normally apply.
    The issue of determining the safety and efficacy of the copy drugs 
is, in some ways, a positive problem to have. Many have argued over the 
years that bringing antiretroviral therapy to places like Africa on a 
large scale could never happen--that the problems were too complex. 
Well they were wrong. It is happening now--today.
    Because of the President's Emergency Plan For AIDS Relief, and with 
the partnerships between this initiative and those who are directly 
delivering treatment--the NGO's and faith-based organizations, the 
medical care-givers and the health-care delivery facilities of the 
governments of these nations themselves, just a few short months after 
launching the President's Emergency Plan, we have already increased by 
thousands the numbers of patients suffering from HIV/AIDS who are now 
on life-extending ARV treatment.
    Thanks to the generosity of the American people as well as a 
growing number of donor nations, the donors to the Global Fund and 
other multi-lateral sources, companies in the private sector, private 
foundations and others, as the human and physical capacity to deliver 
AIDS treatment is scaled up to make it possible, millions more patients 
will follow those who are already receiving this life extending 
therapy.
    Drug availability will also need to be scaled up to an 
unprecedented level in order to fuel this newly expanded treatment 
capacity. It is in large part because the President's Emergency Plan 
for AIDS Relief has made such a dramatic commitment to making drug 
treatment available that issues of safety need to be addressed on an 
entirely new scale. With such a massive expansion of ARV treatment, the 
stakes have increased.
    If we don't apply appropriate scientific scrutiny to this vastly 
expanded flow of AIDS medicines, we will run the risk of causing the 
HIV virus to mutate and overcome specific drugs or even whole classes 
of drugs. That could render our current drugs useless--and, incredibly, 
it could leave Africa even worse off than it is today. That's why 
getting this right at the outset is so important and requires great 
care.
    Our commitment, from the beginning, has been to move with urgency 
to help build the human and physical capacity that is needed to deliver 
this treatment, and then to fund the purchase of AIDS drugs to be used 
in providing this treatment, at the most cost effective prices we can 
find--but only drugs that we can be assured are safe and effective. 
Patients in Africa deserve the same assurances of safety and efficacy 
that we expect for our own families here in the United States. There 
should not be a double standard. But how to do that has presented some 
serious challenges. With our colleagues at the WHO, UNAIDS, the 
Southern African Development Community, and many others, the U.S. 
Government has been carefully examining this issue--and considering 
alternatives.
    Many of the copies of the research-based AIDS drugs that are on the 
market today in developing countries may well be safe and effective. 
The challenge stems in part from the fact that they have never been 
reviewed by any of the world's stringent regulatory authorities. And 
the same will likely be true of the additional copies of those drugs 
that will surely be coming on the market in the days to come, as new 
indigenous companies enter this market--something we expect and hope 
will happen.
    Many people and organizations have noted the World Health 
Organization's prequalification pilot program and have urged that we 
simply rely on it. We have the highest respect for the WHO and its 
program. However, the WHO is not a regulatory authority and does not 
represent itself as such.
    For drugs that are used in the United States, the already existing 
answer to ensuring safety and efficacy is simple: both research-based 
companies and generic companies submit their products to the U.S. Food 
and Drug Administration for review and approval. What FDA has announced 
is a process that will not only make it possible, but relatively fast 
and easy, for every manufacturer to now submit their AIDS drugs to that 
same scrutiny, including those that will only be made available in 
developing countries. If those drugs meet the appropriate standards--as 
we hope many or all will do--they can then be approved for potential 
funding by the President's Emergency Plan.
    I hope that FDA will receive applications as soon as possible from 
many companies that will want their drugs to be candidates for U.S. 
funding for use in the treatment programs of the President's Emergency 
Plan. If this process enables us to get safe and effective drugs at 
lower prices than we do now, that would indeed be a great success.
    Today the most limiting factor in providing treatment is not 
drugs--it is the human and physical capacity in the health care systems 
of Africa. The continent is desperately short of health care 
infrastructure and health care workers. Both are needed in order to 
deliver treatment broadly and effectively. We find that African leaders 
and African AIDS advocates are quite focused on addressing this 
limitation--because they know that all the drugs in the world won't do 
any good if they're stuck in warehouses with no place to go to actually 
be part of the delivery of treatment to those in need.
    But as we successfully attack that issue and Africa's capacity to 
deliver drug treatment grows, drug availability will become an 
increasingly significant constraint on treatment. We can't let that 
happen.
    For our part, I pledge that the Office of the Global AIDS 
Coordinator will continue to move with urgency in all that we do. 
President Bush has made clear to me that this is an emergency at the 
top of the list of America's priorities. We will act accordingly.
    Mr. Chairman, I am grateful for this Committee's resolve to defeat 
the HIV/AIDS pandemic. Your leadership and support has facilitated the 
speed with which we are responding to people in need, and that 
commitment will ensure our success--success that will be measured in 
lives saved, families held intact, and nations again moving forward 
without the shadow of this terrible pandemic.
    I would be pleased to respond to any questions you may have.

    Senator DeWine. Mr. Ambassador, let me turn to the 
prevention of mother-to-child transmission issue. Fiscal year 
2004 is actually the last year of this program. My 
understanding is that your plan is that beginning with fiscal 
year 2005 the budget does not provide any specific line item 
for this and that this program would be incorporated actually 
under your office.
    I wonder if you could tell us what you are anticipating for 
this program, how much you are looking at spending under your 
office, and what your plans are for the non-initiative 
countries for this program?
    Ambassador Tobias. Senator, the prevention of mother-to-
child transmission program has been very important, not only in 
treatment terms but also one could argue in orphan terms. I 
think you could make the case that the most effective orphan 
program we can have is keeping the mothers alive so that we do 
not have the orphans. The program to prevent mother-to-child 
transmission has been very effective. It is relatively 
inexpensive and it is a program that we will expand, not only 
in the countries in the program where it exists but well beyond 
that as we can.
    We are now going to something that is generally referred to 
as the mother-to-child transmission plus program, in that the 
mother-to-child transmission program per se really focused on 
protecting the health of the child and ensuring that when the 
baby was born the odds were improved that the baby would be 
infection-free. But what about the mother, what about the 
father, what about the siblings that are in that family? So the 
mother-to-child transmission plus program will begin to address 
those, too.
    This program, as you know, was started in the countries 
that became the focus countries. I think it gave us an 
important jump start on getting the emergency plan implemented. 
I would hope that we can find ways to take the lessons that we 
are learning in the focus countries and begin to expand those 
lessons into the so-called non-focus countries as we go forward 
and as funding permits.
    Senator DeWine. The plus program is certainly a wonderful 
idea and I think we all understand how important it is to keep 
the mother alive and keep the mother there for the children. I 
guess the concern would be that that prevents us--that focus 
might--you know, these are tough choices--might prevent us from 
moving forward into other communities and to other areas and 
expanding the mother-to-child program.
    What are the tradeoffs here? Let us be honest. What are we 
talking about?
    Ambassador Tobias. Well, you are exactly right with respect 
to the issue of tradeoffs. There are tradeoffs virtually 
everywhere we look.
    Senator DeWine. I mean, the mother-to-child program can be 
a fairly cheap program if you have got the infrastructure to 
implement it. It certainly is cheap as far as what the drugs 
cost if you can get the infrastructure going.
    Ambassador Tobias. I certainly do not anticipate that we 
are talking about an either-or situation here. I think that we 
need to, as you suggest, expand the mother-to-child 
transmission program, but with the building of increased 
infrastructure and the capabilities that we are putting in 
place I also believe that we can expand that into the mother-
to-child plus program also.
    Much of what we do will be driven by the policies that are 
established by the health officials and the government leaders 
in each of the countries in which we operate, and we need to 
pay close attention to that.
    Senator DeWine. Let me move to another area because I have 
one last question and my time is almost up. Let me move to the 
pediatric treatment, which I touched on in my opening 
statement. How does the President's 5-year strategy incorporate 
the special needs of children who are infected with HIV and 
require HIV treatment? What is the administration going to do 
to ensure that all HIV/AIDS drugs are available for pediatric 
use? And what is the administration going to do to ensure that 
both pediatric professionals and other HIV/AIDS workers have 
the necessary information and training to treat children 
infected with HIV/AIDS?
    Ambassador Tobias. I think you are very correct, Senator, 
that not only in this field but in other fields the amount of 
pediatric-specific research that has been done has been too 
little, and we clearly need more in this field. I will rely on 
the medical experts and the technical experts as to exactly how 
we need to address this, but we do need to expand the care to 
HIV-infected young people.
    But again, the best answer to that is the mother-to-child 
transmission program and things like that to keep that 
infection from going----
    Senator DeWine. No doubt about it, it is the most cost-
effective and we can save the most lives with the mother-to-
child. But still, every country I visited--and I visited a 
number of them--we have got kids out there who are dying and 
there are kids out there who could be saved if we could get the 
treatment to them, and we do not want to forget them.
    Senator Leahy.
    Senator Leahy. Thank you, Mr. Chairman.
    As you may have gathered by some of the demonstrators here 
this morning, there is some concern on the question of generic 
drugs. For months you had said: ``There is no process, no 
principles, no standards in place today,'' to assure the safety 
of generic fixed-dose combinations manufactured overseas. Now, 
many health experts and the World Health Organization disagreed 
with you.
    Now we have a new review process. How do you answer the 
fact that it appeared the review process came up after U.S. 
companies were interested in manufacturing their own fixed-dose 
combination drugs? And even then, how long is it going to take 
for this review process? I am just wondering if we have just 
one more unnecessary obstacle to getting these drugs out to the 
people who need them desperately.
    Ambassador Tobias. Well, Senator, first let me say that the 
World Health Organization does not present their 
prequalification program to be the equivalent of regulatory 
review. I would simply refer to the statement that has been 
released by Dr. J.W. Lee, the head of the World Health 
Organization, in total support of the program that we are 
putting in place to review these drugs.
    Senator Leahy. When will we have the drugs out there?
    Ambassador Tobias. The FDA tells me that if, for example, 
companies are applying today, which they could, that in some 
cases approval could be received in as little as 2 weeks. In 
some cases it could be 6 weeks or so, depending on the data. 
Then it will depend on the programs in individual countries. 
But we will be certainly ready to go.
    Senator Leahy. Would we have gone to a generic fixed-dose 
combination if American drug companies had not shown an 
interest in producing it themselves?
    Ambassador Tobias. Well, the announcement that I have read 
in the media, as you have, from the American companies, came 
after we announced this program, which we have been working on 
with the FDA for some time. I have said on a number of 
occasions that we are totally in favor of fixed-dose 
combinations. The issue has never been whether fixed-dose 
combinations are good or bad. I do not think there is any 
question with anybody that they are good because they make it 
easier for doctors to administer the program and patients to 
adhere.
    Senator Leahy. I am just trying to see what this is. This 
is today's New York Times and, for what it is worth: ``A WHO 
official familiar with both his agency's approval process and 
the outlines of the proposed American one said, `Although the 
United States has not exactly been in love with our 
prequalification process, they are now going to do exactly the 
same. If they want to create a parallel structure and do a good 
job, that is fine.' ''
    Let me ask you this--and I will put the whole article in 
the record. Over the next 5 years, you say you hope to prevent 
7 million new HIV/AIDS infections. We all agree that would be a 
great achievement. There are 5 million new ones each year. So 
even if you succeed, there will be at least 18 million new 
infected people by the end of 5 years, 2.5 times the number we 
have prevented.
    I raise this because in my opening statement you remember I 
mentioned the issue of absorptive capacity, what can we do. How 
did you come up with the number $2.8 billion for fiscal year 
2005? Could we not be doing a lot more? Because it seems to me 
we are in some ways chasing after the train. We are not keeping 
up with even the rate of infection, to say nothing about 
helping those who are direly in need.
    I am told by so many that we have the capacity, if the 
money was there, we have the capacity to do more. We have 
private organizations, private groups. The Gates Foundation did 
a lot more on this than the United States was willing to 
initially.
    [The information follows:]

            [From the New York Times, Tuesday, May 19, 2004]

              Views Mixed On U.S. Shift On Drugs For AIDS

                       (By Donald G. McNeil Jr.)

    AIDS activists and doctors who treat patients in poor countries 
greeted the Bush administration's shift in its policy on procuring AIDS 
drugs with mixed reviews yesterday.
    Many were delighted that the administration had decided to buy 
anti-AIDS cocktails that combine three drugs in one pill, and that it 
for the first time was willing to consider buying drugs from low-cost 
generic manufacturers, who are now the only companies making 3-in-1 
pills.
    ``I think it's fabulous,'' said Dr. Merle Sande, who treats 4,000 
AIDS patients in Uganda, most of whom cannot afford drugs. Most of 
those who can are on Triomune, a 3-in-1 pill from Cipla Ltd., an Indian 
company. Three-in-one drugs, he said, ``are exactly what we need out 
there.''
    At the same time, some activists expressed frustration that the 
White House had set up a new approval process overseen by the United 
States Food and Drug Administration when one overseen by the World 
Health Organization already existed.
    ``This just another roadblock,'' said William Haddad, an American 
generic manufacturer who now consults for Cipla. ``The W.H.O. process 
was a pain in the neck--it took us two years to get Triomune approved. 
Why do we have to bend over and let them kick us again?''
    Henry A. Waxman, a Democratic Los-Angeles area congressman who has 
harshly criticized the Bush administration's previous refusal to spend 
money on generic drugs said yesterday that he was ``disappointed that 
the plan does not involve cooperation with the World Health 
Organization.''
    ``We need to see the fine print before we can tell if the new 
process will actually improve access to these affordable, effective 
drugs,'' he said.
    Even though the administration indicated that it would waive the 
usual $500,000 fee for approving a drug and will let companies submit 
published data instead of starting new clinical trials, any new 
approval process involves reams of paperwork, legal expenses and time, 
critics said.
    The World Health Organization had no official reaction yet to the 
decision, a spokeswoman said.
    But a W.H.O. official familiar with both his agency's approval 
process and the outlines of the proposed American one, speaking on 
condition of anonymity, shrugged off the problem. ``Although the United 
States has not exactly been in love with our prequalification process, 
they are now going to do exactly the same,'' he said. ``If they want to 
create a parallel structure and do a good job, that's fine.''
    The official questioned how Tommy G. Thompson, the secretary of 
health and human services, could promise to approve new drugs in as 
little as two to six weeks unless it simply accepted all the data 
submitted to the W.H.O. ``For us, even if everything is perfect, it 
takes a minimum of three months,'' he said.
    Dr. Mark Goldenberger, director of the Food and Drug 
Administration's office that evaluates drugs for infectious diseases, 
said that ``two weeks would be at the extreme short end'' and would 
probably apply only to something like putting three already-approved 
drugs in one plastic blister pack, because all the agency would look at 
was the packaging.
    Asked if the F.D.A. would accept information gathered by W.H.O. 
inspectors, Jason Brodsky, an agency spokesman, said that there was not 
any agreement allowing it, ''but we would be willing to consider any 
information that we got from other countries in deciding whether or not 
we'd inspect.''
    On Sunday, as health ministers from around the world were gathering 
in Geneva for their annual meeting, the Bush administration made a 
surprise announcement that it would speed up its approval process for 
AIDS drugs to be bought for very poor countries and would consider 
generic drugs, 3-in-1 pills and letting different companies package 
their drugs together. The administration had been expected to face 
heavy criticism at the weeklong meeting for its previous reluctance to 
approve generic AIDS drugs.
    Some companies appeared to have been told of the administration's 
announcement in advance. Merck, Bristol-Myers Squibb and Gilead 
Sciences immediately issued a joint statement saying they planned to 
develop a 3-in-1 pill. GlaxoSmithKline and Boehringer Ingelheim said 
they were discussing packaging three of their drugs together.
    ``Obviously, they had inside information,'' complained Dr. Paul 
Zeitz, director of the Global AIDS Alliance, which pushes for cheaper 
AIDS drugs for the third world. ``That calls into question the honest 
broker role' of the U.S. government.''

    Ambassador Tobias. Senator, I think there is no question 
that the magnitude, the broad magnitude of this problem, goes 
well beyond the resources and the focus of the President's 
emergency plan. I do not think the emergency plan was intended 
to attack the entire problem. We need to get more resources and 
more participation from other people in the world.
    In 2003 the contributions of the U.S. Government for 
international HIV/AIDS totaled more than the rest of the 
world's governments combined. We are on a path so that in 2004 
our contributions may well be close to twice as much as the 
rest of the world combined. So we are doing a lot, but the rest 
of the world needs to do more.
    I think the issue is not where do these dollars fit in with 
the magnitude of the problem. It really is can we efficiently 
and effectively absorb the resources that we are bringing to 
bear and use them as well as possible, and I think reasonable 
people can disagree. But we are moving pretty quickly, and I 
think we will know more in the months ahead.
    Senator Leahy. My time is up, but I wonder if the chairman 
would allow me one more question here. And we should carry on 
that conversation.
    Ambassador Tobias. Yes, sir.
    Senator Leahy. Because I believe we could be doing a lot 
more than we are, and I believe we have set some artificial 
barriers to doing more.
    But I looked at an editorial today saying that the 
administration feels condoms are not effective in preventing 
the spread of HIV in the general population. I mentioned in my 
opening statement the 15-year-old African girl. ``On average, 
adolescents become sexually active at 16 to 17 years of age, 
some even younger. In some African countries, infections among 
women are rising fastest among those who are married. Sexual 
abuse and coercion within marriage is widespread.''
    I mean, how long do you have to wait to receive accurate 
information about the importance and effectiveness of condoms 
in preventing AIDS? You have taken--I understand this was taken 
off, this information was taken off the CDC and USAID web 
sites. How do we answer these questions?
    They say, in the editorial, it says: ``Randall Tobias, its 
AIDS Coordinator, has said numerous times that condoms are not 
effective at preventing the spread of AIDS in the general 
population.'' The editorial goes on to say: ``Mr. Tobias is 
wrong.''
    Here is your chance to respond.
    Ambassador Tobias. Senator, here is the report in my hand 
from the London School----
    Senator Leahy. School of Hygiene and Tropical Medicine.
    Ambassador Tobias [continuing]. The London School of 
Hygiene and Tropical Medicine, which allegedly does not exist. 
And it says exactly what I have said before, that in their 
study less than 7 percent of women used a condom in their last 
sex act with their main partner; less than 50 percent of women 
with casual partners used a condom.
    There is a new study from----
    Senator Leahy. Less than 50 percent do; does that mean 
that, say, 40 percent or so do?
    Ambassador Tobias. Well, this is again a study in a broad-
based population. But the point is--and let me make just one 
more reference. There is a new UNAIDS study out that was peer-
reviewed by the Population Council's peer review process, and 
just one quote from that: ``There are no clear examples that 
have emerged yet of a country that has turned back a 
generalized epidemic primarily by means of condom promotion.''
    Senator Leahy. Primarily, primarily.
    Ambassador Tobias. Yes.
    Senator Leahy. Do you believe they should be withheld----
    Ambassador Tobias. No.
    Senator Leahy [continuing]. From 15- or 16-year-olds?
    Ambassador Tobias. No, absolutely not. Our program is A, B, 
C.
    Senator Leahy. Absolutely not. A 15-year-old, it would not 
be withheld?
    Ambassador Tobias. The person that you described earlier, 
as I understood your description, would be someone that ought 
to have condoms available. I was in an area in northern Kenya 
recently where the incidence rate in 15- to 24-year-old girls 
is 24 percent and it is 4 percent in boys. But the evidence is 
that is not going to solve the problem, and we need to do a 
number of other things. That is why we are putting a lot of 
emphasis on the messages that Uganda has proven can be 
effective by getting young people to understand that if they 
delay the age at which they become sexually active and then if 
people who become sexually active reduce their number of 
partners, hopefully to one, those are the two factors that have 
been demonstrated to make a big difference.
    But condoms are an important part of our program.
    Senator Leahy. It would also help if that woman who reduces 
it to one, if her partner had reduced it to that one, too. 
Often that is not the case.
    Ambassador Tobias. Well, and that is where testing is so 
critically important. You are absolutely right.
    Senator Leahy. Thank you, Mr. Chairman.

             OPENING STATEMENT OF SENATOR MITCH MC CONNELL

    Senator McConnell [presiding]. Thank you, Senator Leahy.
    The President's HIV/AIDS initiative is focused on 14 
countries in Africa and the Caribbean. Congress added an 
additional country in the fiscal year 2004 Foreign Operations 
bill. Have you identified the fifteenth focus country and what 
criteria are you using to select that country?
    Ambassador Tobias. Senator, we have not identified the 
country yet. I have gotten input from a variety of sources 
throughout the government and beyond. We identified 39 
candidate countries that anybody could think of. We put 
together a list of criteria looking at the infection rate, the 
health care system, the national leadership, which is a 
critically important issue, and how helpful the leadership 
could be and so forth.
    We are in the process of getting that down to a very short 
list and I am hoping that in a relatively short time we will be 
in a position to make that selection.
    Senator McConnell. Some have expressed concern that the 
administration is actually shortchanging countries that are not 
on the focus list of 15 and that more should be done to address 
rising infection rates in certain non-focus countries. Do you 
have any response to those criticisms? And are non-focus 
countries targeted for increases in bilateral assistance next 
year?
    Ambassador Tobias. Senator, one of the important principles 
of the President's program is focus. It is to try to keep this 
from being an inch wide--or an inch deep and a thousand miles 
wide and not really being able to make an impact.
    But we also need to recognize that this is not a disease 
that respects political boundaries. So we need to do what we 
can in the so-called non-focus countries. I am looking for some 
ways to shift at least some amount of resources into some of 
the non-focus countries that are being hit the hardest. But I 
think it is very important that we not lose sight of the focus 
aspect of this program, because the focus countries really 
represent 50 percent of the infections in the world and I think 
it is very important that we make a major impact there.
    Senator McConnell. I agree.
    The fiscal 2005 budget request for a contribution to the 
Global Fund to Fight AIDS, Tuberculosis, and Malaria is $200 
million. In the fiscal year 2004 Foreign Operations bill 
Congress provided not less than $400 million as a contribution 
to the Fund, which was $200 million above the request.
    Has the congressionally mandated increase leveraged 
additional contributions from other donors? How can we get, for 
example, donors like Russia--$20 million, Saudi Arabia--$10 
million, and Singapore--$1 million--to contribute more?
    Ambassador Tobias. Well, I think there are a number of ways 
we can do that. One of them is leadership. I have asked the 
President to mention this subject every time he has the 
opportunity. The Secretary of State is doing the same thing. I 
think the work that Bono is doing to draw attention to this and 
encourage the rest of the world to step up to this is extremely 
important, because we need to make this a program that gets 
broad support from all governments.
    Senator McConnell. Do you think Congress should provide 
$400 million for the Global Fund next year? And if we did that, 
do you anticipate U.S. contributions exceeding 33 percent of 
the total amount contributed to the fund?
    Ambassador Tobias. Mr. Chairman, the amount that the 
President has requested in his budget of $200 million is 
consistent with the original $15 billion proposal. This is one 
of those arguable tradeoff areas in the sense that the 
incremental difference between what the administration 
requested and what was appropriated to the Global Fund is money 
that might have been available for us to use to focus on the 
non-focus countries.
    So it is a matter of the tradeoffs of how we want to do 
that. The Global Fund is a very important part of our overall 
strategy.
    Senator McConnell. Is it being effective, yielding results 
out in the field?
    Ambassador Tobias. Well, it is new. It is only 2\1/2\ years 
old. They are experiencing the kinds of growing pains that 
would be expected. We are putting money into technical support 
in countries where the Global Fund is issuing grants in order 
to try to help those countries, first of all, be more effective 
in writing their grant proposals to the Global Fund, and then 
in utilizing and implementing the resources that come from the 
Global Fund.

                           PREPARED STATEMENT

    Senator McConnell. I have great hope for the Global Fund 
over time. But again, it is relatively new and it is just 
getting started.
    Thank you, Mr. Ambassador.
    [The statement follows:]

             Prepared Statement of Senator Mitch McConnell

    Today, HIV/AIDS is recognized as a significant transnational crisis 
that poses an immediate and growing threat to social, economic and 
political stability across the globe. While it may be expedient to 
frame the pandemic in geopolitical terms, it is far more difficult--
indeed horrific--to comprehend the devastation of the virus in 
personal, human terms.
    The statistics are staggering. As many as 46 million people live 
with HIV/AIDS today, and an estimated 20 million have already perished 
from complications of the virus. Last year alone, 5 million people 
became newly infected, and 3 million died from AIDS complications.
    This viral holocaust creates widows and orphans and destroys entire 
families. It is especially brutal to youth, and saps the hope and 
promise of future generations. If left unchecked in developing 
countries, it is conceivable that HIV/AIDS will destroy entire 
societies, economies and political systems.
    Under President Bush's leadership, America has significantly 
increased its contributions to combating this disease. Over a five year 
period, we will contribute a total of $15 billion to HIV/AIDS programs 
and activities. Fifteen countries, primarily in Africa and the 
Caribbean, are the main focus of this initiative, although funding will 
continue to some 100 countries where we have ongoing programs, and to 
the Global Fund to Fight AIDS, Tuberculosis and Malaria.
    There are no shortages to the challenges in successfully managing 
this disease. Some argue that we--and other nations--should spend more 
on HIV/AIDS, and that we shortchange the cause by not providing the $3 
billion authorized by Congress in the AIDS bill.
    Perhaps America should spend more, but that will ultimately be 
determined by fiscal constraints. I would point out, however, that last 
year's budget request for HIV/AIDS programs exceeded the total amount 
provided from fiscal years 1993 through 2001. Further, the President's 
plan gradually increases spending over the five year period so that 
beginning in fiscal year 2006, the budget request exceeds $3 billion 
and tops nearly $4 billion in fiscal year 2008.
    Funding alone is not enough. To stem the tide of HIV/AIDS, nations 
must have committed leadership, the most basic health care delivery 
systems, and the capacity to absorb substantial assistance targeted 
toward the health and welfare of all people--regardless of ethnic, 
tribal, political, gender, or religious affiliation.
    It will be an uphill battle. Of the 12 focus countries included in 
the Transparency International Corruption Perception Index 2003, only 
one--Botswana--is above a half-way mark of five. Nine countries rated 
below a three. In 2003, Freedom House scored only four focus counties 
as ``free''--seven were rated ``partly free'' and three ``not free''.
    ``A business as usual'' approach by focus countries will only 
translate into more lost lives and greater tragedy for millions of 
people. Many stand ready to help, including such faith-based 
organization as Lott-Carey International (LCI). I strongly encourage 
the Coordinator's office to use the experience and indigenous contacts 
that LCI and other groups bring to this effort.
    Let me close with brief comments on Burma and South Africa--
countries which represent the range of freedom in the developing world. 
In Burma, a military junta daily abuses and denies the rights of its 
citizenry, including access to even the most basic health care and 
medicines. While we may not accurately know the extent of the HIV/AIDS 
infection rate in Burma, we do know that the pandemic cannot be 
addressed by an illegitimate regime that places the welfare of the 
people far below the acquisition of Russian MiGs, nuclear reactors and 
money laundering.
    In South Africa, a country whose journey toward democracy has been 
nothing but inspirational, the lack of political will by the Mbeki 
government to address the HIV/AIDS pandemic head-on has wasted precious 
time in stemming the tide. South Africa's heroes are the health care 
workers at the grassroots level; the current government must be willing 
to partner with them--and available science--to combat the disease.
    It is my hope that in the future President Mbeki will be as 
vigilant on this issue as both our witnesses here today.

    Senator McConnell. Senator Durbin.

             OPENING STATEMENT OF SENATOR RICHARD J. DURBIN

    Senator Durbin. Mr. Ambassador, thank you very much.
    Sometimes I get the impression that different rooms on 
Capitol Hill are really living in different worlds. Last week 
we entertained people from the administration who, having told 
us in February they would need no additional funds for the war 
in Iraq, had a different point of view and came to tell us that 
they needed $25 billion and then, Assistant Secretary Wolfowitz 
said, maybe $50 billion on an emergency basis.
    The reasoning was hard to argue with. They said the war is 
not going well, our national interests are at stake, we cannot 
turn our back on our commitments, and we cannot turn our backs 
on people whose lives are at stake as well.
    I might say the same thing about the global AIDS epidemic. 
That war is not going well either, our national interests are 
at stake, we cannot turn our back on our commitments, there are 
people who have their lives at stake.
    As I look at the administration, I thought that the 
President's announcement a little over a year ago of a $15 
billion commitment was historic, receiving broad bipartisan 
support. His first budget request, the first of the 5 years was 
$2 billion. With the kind efforts of Senator DeWine and my 
colleagues, we raised that to $2.4 billion on the floor.
    Then came this year's budget request of $2.8 billion, still 
short of the mark of keeping up with the $15 billion 
commitment. With Senator Lugar and Senator DeWine and others, 
we brought this up to $3.3 billion in the budget resolution.
    But, going to a point that Chairman McConnell raised, how 
can we rationalize or justify such a dramatic decrease in our 
commitment to the Global Fund? You received a letter from Dr. 
Feicham on March 25 of this year and he made it clear that the 
amount that we are talking about appropriating for the Global 
Fund is dramatically inadequate. For this effort to reach its 
goal and to save lives across America, he believes $1.2 billion 
is needed from the United States.
    I think good evidence is there to support that position. 
Why do you feel that, instead of increasing our commitment to 
the war on AIDS, that we can start retrenching and pulling back 
in this next fiscal year?
    Ambassador Tobias. Well, Senator, the budget request for 
2005 is in fact the same amount that the administration 
requested in the previous year and that is reflected in the 
billion dollar component of the first $15 billion request. I am 
very supportive of the Global Fund, but I am also very 
supportive of the President's emergency plan. I want to be sure 
that we are not making tradeoffs that get in the way of our 
doing the things that we are demonstrating we can do of getting 
the money out and getting it to work very quickly.
    Dr. Feachem is talking about the broad need out there. I 
think we need to focus on the money we are getting out the door 
today and next month and in the next year.
    Senator Durbin. So do you think he is overstating his need 
for next year?
    Ambassador Tobias. No, I do not think he is overstating the 
need, but he may be overstating the ability to utilize those 
funds that quickly. But again, I want to make clear that the 
Global Fund is certainly a very important aspect of our overall 
strategy.
    Senator Durbin. I would say, Ambassador, that that is a 
fundamental error of this administration. I believe it is 
important for us to maintain our bilateral commitment to the 14 
nations, ultimately 15. But the Global Fund is serving a large 
part of the world that we are not addressing with bilateral 
assistance. I have seen that part of the world--India for 
example, desperate to see their Global Fund projects not only 
initially authorized, but carried on. When we fall so far short 
of what is needed, it is going to mean a cutback on fighting 
this epidemic in India.
    Let me also address the cutbacks in the budget relative to 
TB and malaria, a cutback of some $46 billion. I have been to 
India just a few weeks ago to see DOTS, the Direct Observed 
Therapy, and it is done on the cheap. I saw it in a shoe store 
in one of the poorest neighborhoods in New Delhi.
    How can we, in light of the fact that TB is such a killer 
and linked so many times to HIV/AIDS, how can we rationalize or 
justify cutting back in our commitment to TB and malaria?
    Ambassador Tobias. Well, TB and malaria are very important 
components of the program. Testing people who have HIV to 
determine whether or not they have TB and can be put into TB 
programs is a very important component of this. We do need to 
stay very focused on TB and malaria.
    Senator Durbin. We need more than focus; we need money. 
Focus is good; money is better. In this situation, a little bit 
of money goes a long, long way. Ten dollars for the therapy to 
deal with tuberculosis, and the observation of a shoe store 
owner of a person taking their medicine has created a health 
infrastructure which nobody knew could exist in this country, 
this vast country of India.
    I am just troubled by the fact that with such facility we 
talk about $25 billion more here and $50 billion more there, 
and when it comes to these issues of the war on AIDS and the 
war on tuberculosis, frankly, we are talking about a hollow 
army and a hollow commitment. I think we can do better. I think 
the President called on us to do better. But frankly, the 
President's rhetoric is not matched by his budget numbers, and 
people will die as a result of that.
    Ambassador Tobias. Well, we are very much on a path to meet 
the President's commitment of $15 billion over 5 years and we 
are implementing the needs in people and infrastructure in a 
very aggressive way. I think as we get more health care system 
improvement in place we are certainly going to be able to 
implement more quickly.
    Senator Durbin. My last point--thank you for your 
forbearance, Mr. Chairman--is that is an argument I 
categorically reject, and here is how it goes: We cannot give 
them the money; they do not have the health infrastructure. 
Well, how do you get the health infrastructure? You start 
training people to be doctors and nurses and medical 
professionals. You start setting up clinics.
    How are they going to do that? Is this supposed to spring 
just automatically? I think we have to invest in the 
infrastructure to deliver the drugs, to bring the people in, to 
monitor their activity, for public education. To say we are 
going to wait on the infrastructure before we send the money 
means basically we may not ever send the money.
    Ambassador Tobias. Well, we are not waiting on the 
infrastructure. That is exactly where the initial money is 
going, is to help build the health care systems and the 
infrastructure. The greater operating expense going forward is 
going to be the things that we put into that system.
    But there is no question that the magnitude of this problem 
is well beyond what this program is focused on and we need to 
get more help from everybody that we can find that will provide 
help.
    Senator Durbin. Thank you.
    Senator McConnell. Thank you, Mr. Tobias.
    Thank you, Senator Durbin. We are going to complete your 
appearance right now, Mr. Tobias. Any Senators who wish to 
submit questions in writing, may do so. We have a vote at 
11:30, so what I am going to do is to have a very short recess. 
We are going to catch the vote. We will come back and have the 
second panel as soon as I return, which will be shortly.
    Senator Leahy. Mr. Chairman.
    Senator McConnell. Senator Leahy.
    Senator Leahy. If I might, there will be questions for the 
record. I would just let Ambassador Tobias know that one 
question I will ask, and I really want a straight answer on 
this, is that we have been told that even though the 
administration's own experts have rated some of the faith-based 
organizations very, very low as to their abilities, they are 
getting preference for funding.
    I have some faith-based organizations I feel highly about. 
But what I feel most urgently is to do something to stop AIDS, 
and I do not want to think, with all the money we are doing, 
that it is being passed out as a political goodie. So look at 
my question. It is a very, very serious one.
    Senator McConnell. All right. We thank you, Mr. Tobias. We 
will take a brief recess and then resume the hearing shortly.
STATEMENT OF BONO, FOUNDER OF DATA, DEBT AIDS TRADE 
            AFRICA
ACCOMPANIED BY AGNES NYAMAYARWO, NURSE AND AIDS ACTIVIST, UGANDA

    Senator McConnell. This hearing will resume.
    Our second witness needs no introduction. In this town he 
is known as much for his music as he is for his work on behalf 
of HIV/AIDS and debt relief. He is an effective spokesman for 
these causes and his political skills are as good as any on 
this subcommittee, perhaps even better.
    So welcome, Bono. I understand that with you is Ms. Agnes 
Nyamayarwo, a nurse and AIDS activist from Uganda. I will leave 
the formal introduction of her to you, but I would request Ms. 
Nyamayarwo take a seat next to Bono, if you will. We want to 
give our colleagues an opportunity to ask questions to someone 
whose personal insights will undoubtedly be very, very helpful.
    Before you make a brief opening statement, let me take a 
moment to thank you for your eloquent description in Time 
magazine, Bono, of a woman we both admire and support, Burmese 
democracy leader Aung San Suu Kyi. Last week she, the National 
League for Democracy and ethnic nationalities made the 
courageous and correct decision to boycott the junta's sham 
constitutional convention in Rangoon.
    I unabashedly use this opportunity, while the spotlight 
shines on a high-profile activist such as yourself, to 
highlight her plight. At this critical moment she and the 
people of Burma need the world's attention and support. I am 
pleased that the United Nations, the European Union, Japan, 
Malaysia, and Thailand have expressed concern with the regime's 
unwillingness to move forward in a meaningful reconciliation 
process with the NLD and the ethnic minorities.
    The Burmese people should find encouragement from these 
remarks. As we approach the anniversary of Burma's 1990 
elections and last year's massacre, which almost took Suu's 
life, I would urge my colleagues in both the Senate and House 
to quickly renew import sanctions against the junta. Bono, I 
know you agree that we cannot fail Suu Kyi or freedom in Burma.
    Senator Leahy will be back shortly and I will allow him to 
make his comments then. I think what we will do is proceed, 
Bono, with your opening remarks.
    Bono. Thank you very much. Thank you very much, Chairman 
McConnell. It is an honor to be asked to share my thoughts 
today. I would like to thank friends Leahy, DeWine, and Durbin. 
When they come back I will. They have shown great leadership on 
this subject and, I have to say, patience in dealing with a 
rock star, and a rock star who asks for a seat at your 
distinguished table, then refuses to leave. And frankly, there 
is a lot of people who wish I had stayed in the studio, 
including my band.
    But you let me in the door. You let me in the door on debt 
relief. We have worked together on AIDS and the Millennium 
Challenge. And now I am going to abuse your hospitality by 
hanging around, talking loudly, when you really ought to be 
hearing from people who truly live the subject, like Jim Kim at 
the World Health Organization or a treatment advocate like 
Zackie Achmet in South Africa, or indeed a true heroine like 
Agnes here, whom many of you know.
    But I promise to talk briefly and politely. I think it is 
really brilliant to be here, and my testimony will be suitable 
for family audiences. Your children, your country, are safe, 
safe from my exuberant language.
    I have just come back from Philadelphia and it was an 
extraordinary day there yesterday with various religious groups 
and student activists. We are putting together a campaign to 
unite everybody all across the country, all across the United 
States, to unite the country under this issue of AIDS and 
extreme poverty.
    I think we are going to succeed. You listen to these people 
talk about America taking the lead on this and you would be 
very proud. I think they know--their message to me was: This is 
a critical time. And I think we all agree with that.
    We are making progress in the fight against AIDS. We are 
gaining speed, building momentum, but only as long as we keep 
our foot on the gas, because, Senator, as you know, we have a 
lot more road ahead. Our success so far should make us 
confident, but it cannot make us content. We are off to a great 
start. Only you here can make sure that it is not a false 
start. If we stop at AIDS, oddly enough, we will not beat AIDS, 
because we need to do more about the conditions, the extreme 
poverty in which AIDS thrives.
    But lest this sound like a burden or ``more money, more 
money,'' can I just say this is actually the exciting bit, 
because we can use this disease to knock poverty out. This is 
an incredible opportunity for America. I am not a Pollyanna on 
this stuff. I have seen it work. I have seen it save and 
transform lives.
    Just at this moment in the world, it just feels important, 
as a fan of America, to see America knocking poverty out and 
taking the lead on AIDS. I think it is a great, great message.
    So let me talk a little bit about the results that we are 
seeing, because a few years back I was here to talk about debt 
cancellation and I think it is important that I give you a 
report back on what we did with that money. I remember sitting 
in your office, Senator McConnell, and going through this, and 
you were listening to this. It was my first sort of foray here 
and you were very patient with me as I had my hand in your 
wallet.
    But I feel an obligation to explain to you all on this 
committee what we did with that money, because it is an 
astonishing thing, and I hope America is aware of what it did. 
There are 27 countries who had chronic debts owed to the United 
States from way back and they have been cancelled. With that 
money there has been astonishing results.
    Three times the amount of children, where Agnes is from, 
three times the amount of children going to school. What an 
astonishing thing. I have even had Senator Frist witness some 
of this stuff. Together we saw water holes built by moneys 
freed up by debt cancellation. When others said the money was 
going down a rat hole, in fact it was going down a water hole. 
A very, very proud moment for me and I hope for America.
    So more recently we have been working together on the 
Millennium Challenge, something we worked on with this 
administration and then across with support on both sides of 
the aisle. This is important stuff and I am not sure people 
have--it has really sank in what the Millennium Challenge was 
all about. It is important. It is a paradigm shift because it 
is rewarding countries that are fighting corruption and that 
are actually tackling poverty and the poverty of their people.
    Because wherever we go in America, that is the only issue 
we hear about that makes people cautious about development 
assistance. They want to know that the money is going to the 
people it is promised to. So corruption is absolutely essential 
that we deal with.
    The Millennium Challenge is this kind of new way of seeing 
aid as a reward for people who do the right thing. Where there 
is civil society, clear and transparent process, good 
governance, let us fast track those people. It is common sense 
and, by the way, it is going to be imitated around the world 
and it was invented here in this city. It is a new paradigm 
shift, deserves a lot of support.
    The President asked you for $2.5 billion for 2005 and I 
figure that is a little more persuasive than my asking you, but 
I will just urge you to support him on that. DATA, D-A-T-A, the 
organization I helped start, has found that the 16 well-
governed poor countries selected for the Millennium Challenge, 
are ready to use all of that funding on sound poverty reduction 
plans. They need only what you can give them, which is really a 
chance. So it is a good start, but only that, a start.
    We are not here today for a victory lap. We are here to 
pick up the pace, because AIDS, as Senator Durbin mentioned, is 
outrunning us. It is killing 6,500 Africans a day, 7,000 
Africans a day. Whoever you are talking to, the number is hard 
to stomach. 9,000 more Africans a day infected.
    The most incredible part about this is it is fully 
preventable and treatable, which is an incredible opportunity 
for America. As I say, at this moment of all moments, when 
people are not necessarily sure about us in the West that our 
intentions are benign even in Europe and America, there is a 
lot of suspicion about our intentions in the rest, in the wider 
world, this is an incredible opportunity because America has 
the power to make this stop. It is an achievable goal.
    There will soon be a day when AIDS is gone. There will be a 
vaccine, it will be gone. I think when the history books are 
written, would it not be nice to see the United States right 
out in front. Like going to the Moon: We did it first, there it 
is.
    The tough thing about this realization that we have the 
power to make it stop is that it means we have actually got to 
do something about it. For the first time in history, we have 
the know-how, we have the cash, we have the life-saving drugs. 
Do we have the political will?
    Ambassador Tobias does. As we heard, he sees the fire 
raging and he has got a fire brigade. That is a great thing. He 
needs your support, fully funding of around $2.5 billion for 
the bilateral programs. Every dollar counts.
    That is why the debate over generic medications is so 
frustrating, because when there is a fire raging you do not 
fight it with bottled spring water; you turn on the hose and 
put the fire out. There are safe generic drugs saving lives 
right now at a fraction of the price of their brand-named 
twins. Here is an advert for one sitting right beside me, 
someone who is a great advertisement for those generic drugs. 
And we have to ask the experts, like Medecin Sans Frontier, one 
of the first people to involve ARV's in the treatment of AIDS. 
They are doctors. They believe it is safe.
    I think what we talk about--President Bush when he spoke 
about AIDS he was very inspiring because he spoke about 
bicycles: We will get them on bicycles and motorcycles. This is 
exactly the tone, this is what we need. But the bicycles right 
now are wrapped in red tape, is the truth, and we need to cut 
through the red tape. We need the spirit of that announcement 
of $15 billion over 5 years in the actual follow-through.
    So we have this news in the last couple of days that could 
be great news, that we are considering generics and fast-
tracking a breakthrough on generics in 6 weeks. But this is, 6 
weeks of red tape, is very costly. That is 250,000 lives. So I 
would just caution us, this 6 weeks.
    So Americans want the biggest bang for their buck, that is 
true. They want to treat as many people as possible. Let us get 
together on that and make sure they get the biggest bang for 
their buck.
    Every dollar counts, but some dollars count for triple. By 
this I am talking about the Global Health Fund, an essential 
part of the fight and a vital partner to what the United States 
is doing. Every contribution America makes gets other countries 
to kick in more. Tony Blair says so, so does President Chirac, 
so does Paul Martin. I know because I have spoken to all these 
people recently. I make their lives miserable, too, you will be 
relieved to hear.
    But to date the United States has made one-third of the 
fund's contributions. I would urge you to maintain that 
commitment in the neighborhood of $1.2 billion for next year. 
Yes, the fund has growing pains, but the fact that it is 
growing in scale and in impact, not only on AIDS but on other 
killer diseases that worsen it like malaria and TB, is 
encouraging.
    Of course miracle drugs alone are no miracle cure. We 
cannot defeat AIDS unless we do more about the extreme poverty 
in which it spreads. Otherwise our efforts will come to naught. 
You cannot take a pill if you do not have water to swallow it, 
clean water that is. You cannot strengthen your immune system 
if there is no food in your belly. And you cannot teach kids to 
protect themselves if they do not go to school. That is why the 
Millennium Challenge and other key programs you fund through 
USAID are essential.
    More investment is needed, a lot more investment is needed. 
President Bush has asked for a lot more, over $21 billion in 
total for foreign ops in 2005. I think that is because he, like 
many of you, sees that a victory in this battle is vital to 
national security.
    Our issues, people tend to think of them as fringe, not 
central to the action here in Washington, D.C. If I can 
convince you of one thing, it is that at this time in the world 
these issues that you have gathered to talk about on this 
committee has a role to play in very central policymaking that 
will affect the way America is viewed everywhere in the world. 
It is where America meets the world, outside of commerce and 
the military.
    The Senate, in passing a bipartisan budget resolution, has 
gone a step further on these issues, and I applaud that. I 
trust the Senate will hold on to increases in the 
appropriations process. I do want to say thank you personally 
to the Senate for their leadership here and all of you sitting 
here. It is very, very, very important.
    Let me say this in closing. I know I spend a lot of time in 
this country and I am sure it is too much for your liking. But 
I also spend a lot of time in buses, truck stops, town halls, 
church halls, and I am not even running for office. But I have 
spent a lot of time in this country campaigning on these 
issues.
    You know what is amazing? Everywhere I go, people feel more 
American when you talk about these issues that affect people 
whom they have never met and who live far away. They feel more 
American. It is kind of extraordinary to me as an Irishman to 
observe this.
    I think that they are thinking big, as you always have. 
Sixty years ago there was another continent in trouble, my 
continent Europe in ruins after the Second World War. America 
liberated Europe, but not just liberated Europe; it rebuilt 
Europe. This was extraordinary. And it was not just out of the 
goodness of your heart, which it certainly was. It was very 
smart and strategic, because the money spent in the Marshall 
Plan was indeed wise money. It was a bulwark against Sovietism 
in the cold war.
    It was 1 percent of GDP over 4 years, I believe. I would 
argue that this stuff we are discussing today is a bulwark 
against the extremism of our age in the hot war. I believe 
there is an analogy.
    I believe brand USA, because all countries are brands in a 
certain sense, never shone brighter than after the Second World 
War, when a lot of people in my country and around the world 
just wanted to be American--wanted to wear your jeans, wanted 
to listen to your stereos, wanted to watch your movies. That 
was because this is an astonishing place, America.
    It cost money, that place in the world, I know, and I know 
how expensive the Marshall Plan was--point one. We are looking 
for numbers that I think are about half that to completely turn 
the world around at a time--on a positive thing, like a health 
crisis, making that a positive thing. So please bear with us.
    In turbulent times it is cheaper and smarter to make 
friends out of potential enemies than to defend yourself 
against them. A better world happens to be a safer one as well. 
I think it is a pretty good bargain.

                           PREPARED STATEMENT

    The attention of the world might sometimes be somewhere 
else, but history is watching. It is taking notes and it is 
going to hold us to account, each of us. There is so much you 
can do with your power, with your leadership, to ensure that 
America here is on the right side of history. When the story of 
these times gets written, we want to say that we did all we 
could and it was more than anyone could have imagined.
    Thank you.
    [The statement follows:]

                       Prepared Statement of Bono

    Thank you, Chairman McConnell. It is an honour to be asked to share 
my thoughts today. Let me also thank some very good friends: Senators 
Leahy, DeWine, Durbin and so many others who have shown such leadership 
on these issues.
    And such patience in dealing with a rock star who asks for a seat 
at your distinguished table, then refuses to leave or to turn down the 
music he's blasting. Frankly there are a lot of people who wish I'd 
stay in the studio--including my band.
    You let me in the door on debt relief; we've worked together on 
AIDS and the Millennium Challenge; and now I'm going to abuse your 
hospitality by hanging round and talking loudly when you really ought 
to be hearing from someone who knows better--a medical doctor like Jim 
Kim at WHO, or a treatment advocate like Zackie Achmet of South Africa, 
or a true heroine like Agnes, here, whom many of you know.
    That said, I promise to talk briefly--and politely. Though I think 
it's really brilliant to be here my testimony will be suitable for 
family audiences. Your children, your country, are safe from my 
exuberant language.
    I've just returned from your nation's first capital--Philadelphia--
where my organisation, DATA, and an array of other groups launched a 
new effort we're calling ``The ONE Campaign.'' These organisations 
represent millions of Americans, from evangelicals to student 
activists. They came from all over the country. And they're speaking 
with one voice in the fight against AIDS and extreme poverty.
    What are they saying?
    They're saying--as I think we all agree--this is a critical moment.
    We're making progress in the fight against AIDS. Gaining speed. 
Building momentum. But only as long as we keep our foot on the gas. 
Senators, as you know, we've got a lot more road ahead.
    Our success so far should make us confident. But it can't make us 
content. We're off to a great start--but only you can make sure it's 
not a false start. If we stop at AIDS, we won't beat AIDS. We need to 
do more about the conditions--the extreme poverty--in which AIDS 
thrives.
    Now, I'm not a Pollyanna on this stuff; I've seen it work. I've 
seen it save and transform lives. So let me talk briefly about the 
results we're seeing.
    As I mentioned, I met many of you a few years back when we worked 
to cancel the debt that burdens the poorest countries. Today, 27 
countries--almost all in Africa--are investing that money in schools, 
vaccinations, and roads instead of in debt payments. In Uganda, I've 
stood with Senator Frist at a clean water well built thanks to debt 
relief. Debt money didn't go down a rathole--it went down a waterhole.
    More recently, we've all worked together on the Millennium 
Challenge. This is smart money, new aid in new ways, rewarding poor 
countries who are leading in the fight against corruption. Though it's 
only just up and running, it's already having an impact, encouraging 
countries to reform.
    The President has asked you for another $2.5 billion for 2005. I 
figure that's a little more persuasive than my asking you, so I'll just 
urge you to support him on that. DATA, the organization I helped start, 
has found that the 16 well-governed poor countries selected for MCA are 
ready to use all of that funding on sound poverty reduction plans. They 
need what only you can give them: a chance.
    All in all, then, we've made a good start. But only that. A start.
    We're not here today for a victory lap; we're here to pick up the 
pace. Because AIDS is outrunning us, Senators; it's killing 6,300 
Africans a day, infecting 8,800 more Africans a day; and the most 
incredible part is it's fully preventable, it's fully treatable.
    We actually have the power to make this stop. But the tough thing 
about that realization is that it means you've actually got to do 
something about it. For the first time in history, we have the brains, 
we have the cash, and we have the life-saving drugs. But do we have the 
political will?
    Ambassador Tobias does. As we heard, he sees the fire raging and he 
is leading a fire brigade, and that's a great thing. He needs your 
support, full funding of around $2.5 billion for bilateral programs.
    Every dollar counts. That's why the whole debate over generic 
medications is frankly frustrating. When there's a fire raging, you 
don't fight it with the finest spring water You turn on the hose and 
put the fire out. There are safe generic drugs saving lives right now 
at a fraction of the price of their brand-name twins.
    I know that Americans want to get the biggest bang for their buck: 
to treat as many people as possible. That's the whole point, right? If 
that's your goal, isn't the administration's position on generics 
untenable? Hopefully this is starting to change, we still need to hear 
the details.
    As I said, every dollar counts, and some dollars count for triple. 
I'm talking about your contributions to the Global Fund--an essential 
part of the fight and a vital partner to what the United States is 
doing. Every contribution America makes gets other countries to kick in 
more. Tony Blair says so. So does President Chirac. So does Paul 
Martin. I know because I've been making the rounds with the tin-cup in 
those countries too.
    To date, the United States has made one-third of the Fund's 
contributions--I urge you to maintain that commitment, in the 
neighbourhood of $1.2 billion for next year. Yes, the Fund has had 
growing pains, but the fact is it's growing--in scale and in impact: 
not only on AIDS but on the other killer diseases that worsen it, 
malaria and TB. Combined with bilateral, this is about $3.6 billion 
which is allowed under last year's law.
    Of course, miracle drugs alone are no miracle cure: we can't defeat 
AIDS unless we do more about the extreme poverty in which it spreads. 
Otherwise our efforts will come to naught. You can't take a pill if you 
don't have clean water to swallow it. You can't strengthen your immune 
system if there's no food in your belly. And you can't teach kids to 
protect themselves if they don't go to school.
    That's why the Millennium Challenge and other key programs you fund 
through USAID are essential. More investment is needed a lot more. 
President Bush has asked for a lot more--over $21 billion total--for 
Foreign Operations for 2005, because he, like many of you, I think, 
sees victory in this battle as vital to your national security. The 
Senate in passing a bipartisan budget resolution has gone a step 
further on these issues, and I applaud that. I trust the Senate will 
hold onto its minimum amounts and keep up the pressure for more.
    Let me say this in closing.
    Senators, I spend a lot of time in this country. Maybe too much for 
your liking. I spend a lot of time in buses. At truck stops. In town 
halls. In church halls. I do all this, and I'm not even running for 
office.
    But you know what's amazing? Everywhere I go, I see very much the 
same thing. I see the same compassion for people who live half a world 
away. I see the same concern about events beyond these borders. And, 
increasingly, I see the same conviction that we can and we must join 
together to stop the scourge of AIDS and poverty.
    Americans are thinking big. As you always have. You know, almost 60 
years ago, another continent was in danger of terminal decline--not 
Africa, but Europe. And Europe is strong today thanks in part to the 
Marshall Plan. It was great for Europe, but it was also great for 
America. Brand USA never shined brighter.
    Today we need the same audacity, imagination, and all-out 
commitment of a modern Marshall Plan. The Marshall Plan built a bulwark 
against Communism; today, for half the cost, we can build a bulwark 
against the extremism of our age.
    In turbulent times it's cheaper, and smarter, to make friends out 
of potential enemies than to defend yourself against them. A better 
world happens to be a safer one as well. That's a pretty good bargain.
    The attention of the world might sometimes be elsewhere, but 
history is watching. It's taking notes. And it's going to hold us to 
account, each of us. There is so much you can do, with your power, with 
your leadership, to ensure that America is on the right side of 
history. When the story of these times gets written, we want it to say 
that we did all we could, and it was more than anyone could have 
imagined.
    Thank you.

    Senator McConnell. Thank you very much, Bono.
    Ms. Nyamayarwo, I see that you have a piece of paper in 
front of you. Do you want to make a brief statement as well?

                 SUMMARY STATEMENT OF AGNES NYAMAYARWO

    Ms. Nyamayarwo. Thank you so much. I am happy to be in this 
house today. I want first of all to introduce myself. I am 
Agnes Nyamayarwo. I come from Uganda from an AIDS organization 
called TASO, the AIDS Support Organization in Uganda. I am a 
nurse and working as a volunteer with this organization.
    I have lived with HIV for 15 years. I want to share with 
you briefly what happened to my family with the AIDS epidemic. 
My husband died of AIDS in 1992. My youngest son died of AIDS 
at the age of 6\1/2\ because I passed the virus to him 
unknowingly. You can imagine as a parent giving a death 
sentence to a child. It is very painful.
    My other son, who was age 17, got overwhelmed by the 
problem of AIDS in the family and suffered depression and he 
disappeared from my family and up to today I have never seen 
him again, still searching for him.
    I have been very lucky. I have been on treatment, 
antiretroviral treatment. I started by taking generic drugs and 
now I am on the branded drugs from TASO, which is supported by 
the U.S. Government, and I am very grateful for that. Actually, 
I see that they work the same, because I was down and I started 
with generic drugs and they improved my life, and now that 
there are branded drugs I started taking branded drugs and they 
work exactly the same.
    Last year in July I met with President Bush and I told him 
I was in treatment and my life had improved, but my concern is 
the other people living with HIV in Uganda and in Africa who 
die every day. And every time I go back to the community, where 
we move around creating awareness about HIV/AIDS, I find so 
many people have died, so many people dying. That is very 
painful indeed.
    The President promised that he was going to give treatment 
to all people living with AIDS in Africa quickly and 
immediately. It is almost a year now. We have just got money to 
start on treatment on not even a quarter of the people in my 
organization. So it has given me hope, it has given us hope, 
all of us. But we are still asking for more.
    In my work with DATA I have been in about 10 States in 
America. It exposed me to many Americans and their response was 
excellent and they were willing to help. This has always given 
me a lot of hope, although every time I go back my people think 
I have carried medicines for them. But I tell them: I have 
hope; Americans are ready to help.
    Today I am here to request this house as you are going to 
make decisions on the programs to fund just to remember me, my 
family, and all the people living with HIV in Uganda and 
Africa, and the many orphans in Africa, and the young people 
who need the education, because the more they keep in school 
the more they delay to get infection, and the more they are 
educated the more they know about how they can avoid catching 
HIV. So good education is very, very important.
    Then we also have that problem of poverty. Even with the 
mother-to-child transmission, mothers are given the medicine to 
reduce the infection, but these mothers have to give the 
formula and they do not have the formula. They do not even have 
the money to buy it. Or if they have it, they may mix it with 
dirty water and these children end up dying of diarrhea. So 
clean water is also very, very important.
    I am still also asking you to really look at the trade with 
Africa. It is very important because one day maybe we shall be 
able to stand on our own. So please, help us fight AIDS and 
poverty in Africa.
    Thank you so much.
    Senator McConnell. Thank you very much.
    Even though this hearing is about HIV/AIDS, I do want to 
address once again, Bono, an issue that you and I are extremely 
interested in. For the record, do you support renewal of import 
sanctions against the Burmese junta, as Senator Leahy and I 
have proposed?
    Bono. I do not just support it; I applaud it as loudly as I 
can. Let me say, your leadership on this--there is no one 
leading support for Aung San Suu Kyi like you, and to have 
Senator Leahy by your side, and make sure that this is the 
support of all Americans is amazing.
    These toenail-pullers, these thugs, are also running this 
country like a business, so the place they will feel the pain 
is in business. Sanctions are crucial.
    Senator McConnell. One of my big frustrations, which I know 
you share, is that the only way sanctions are going to really 
have an impact is if they are multilateral. Is there anything 
we could do that we are not currently doing to convince the 
European Union that a tougher approach ought to be in place 
toward the generals in Rangoon?
    I had hoped that the attempted assassination of Suu Kyi 
last year might have gotten their attention, but apparently 
not. What thoughts do you have about how we get the Europeans 
fully engaged in the sanctions regime?
    Bono. I am deeply ashamed as a European of the pitiful lack 
of volume in support for her. I think Prime Minister Blair has 
been doing some good work, but we need more and we need the 
rest of Europe to pay attention. I will personally speak to 
Roman Prodi, who is the President of the European Union, about 
this and see at their next meeting if we can get a resolution.
    Senator McConnell. In your statement you indicated that 
America must have the political will to combat HIV/AIDS. How do 
you cultivate political will in countries that do not respect 
the basic rights of their citizens? In Burma, for example, 
where, instead of stopping HIV/AIDS and poverty, the junta may 
actually be spreading the disease and misery through rape, 
forced labor, and illicit narcotics?
    Bono. I think what is extraordinary about the Millennium 
Challenge Account, which I was talking about earlier, is that 
it provides assistance for countries who are doing the right 
thing by their people and tackling corruption, etcetera. I 
think with Burma we have a particular evil to deal with that 
needs a different and stronger response.
    So I would suggest sanctions. I think they should be 
punitive and I think those people should feel our mettle. They 
cannot walk over this woman, who is a true hero. In a way, with 
the Millennium Challenge we are trying to encourage the kind of 
leadership she represents. This is the future in the end for 
all of the issues that we are talking about today, is 
leadership. Leadership is everything.
    Even with AIDS, we talk about A, B, C. What is important is 
a balanced approach. But you know, the reason why abstinence 
and these kinds of programs, preventive programs, worked in 
Uganda was because of another letter ``L'', ``L'' for 
leadership and ``L'' for local, understanding the local. To me, 
Aung San Suu Kyi is great leadership.
    Senator McConnell. Ms. Nyamayarwo, in Cambodia sex workers 
refused to participate in a Gates Foundation-funded anti-HIV 
drug test because of concerns with potential long-term health 
impacts. How do we ensure that impacted groups, such as 
Cambodian sex workers, have the will themselves to participate 
in education and treatment programs?
    Ms. Nyamayarwo. Back in the country where I come from, they 
have been asking us about the sustainability of this treatment 
and that was--maybe that may have been the same reason why in 
Cambodia these people are not going in for this treatment. But 
as a person living with HIV I told them that for me if I live 
another 5 years for my children that is very important indeed, 
because they will have the guidance from me and the parental 
care.
    So I think maybe we need to, Uganda needs to go and share 
with those people what is happening in Uganda and what we 
people living with HIV in Uganda feel about this treatment.
    Senator McConnell. Thank you.
    Senator Leahy.
    Senator Leahy. Thank you, Mr. Chairman.
    Bono, you and I have been friends for many years. I think 
we also, on this Appropriations Committee, we also sit on the 
question of money for terrorism, and of course if somebody 
comes up and says this is for terrorism we can find enormous 
amounts of money.
    But I was struck by something you said in your statement, 
and I wrote it down: A better world is also a safer world. That 
really goes to the bottom line on everything you are trying to 
do. You have seen probably more than anybody this effect of 
AIDS and what is being done to combat it. You have traveled 
everywhere.
    You heard me ask Mr. Tobias about the potential of these 
countries to absorb more funds. Can they absorb more funds? And 
if they can, what would they spend it on? What should they 
spend it on?
    Bono. You know, we use this word ``absorptive capacity'' a 
lot, but the truth is there is a distributive capacity problem. 
I think what I object to sometimes was when it is characterized 
as, oh, Africa or whatever country in Africa or elsewhere, they 
just could not take the money, so it is kind of their fault. I 
object to that.
    I think what we should say is: Yes, there are difficulties 
spending the money effectively and efficiently, but we have to 
spend on building the capacity. That is what you do in an 
emergency, in a war. You have to build the infrastructure. And 
this is a war against AIDS.
    What is great about this war is we really are going to win. 
The only opposition is our own indifference.
    Senator Leahy. But you also have a chicken-egg sort of 
thing.
    Bono. Yes.
    Senator Leahy. You say building the capacity, but that can 
be done. There are models for doing that in parts of the world, 
bringing in everything from the roads to the training. We are 
not talking about building Johns Hopkins in every village that 
we see.
    Bono. No.
    Senator Leahy. But the basics are so absent. And I agree 
with you, we could be doing more.
    We are somewhat limited in time and I know you have to 
leave. An area that we are aware of, we do not talk enough 
about: What about AIDS orphans? What do we do to help the AIDS 
orphans?
    Bono. There is your chaos right there. Again, maybe 
sometimes it is obvious. It sounds grating to always describe, 
to describe the war against poverty as being connected to the 
war against terror, but I did not say that; Secretary of State 
Colin Powell said that. And it is very wise when a military man 
starts talking like that.
    There is a connection. We have a situation now--and I have 
seen it first-hand myself--where you have children bringing up 
children. And we should see Africa as not the front line in the 
war against terror, but it might be one day. You take a country 
like Nigeria, Nigeria is an oil-wealthy nation. It has 120 
million people. It is the whole of west Africa, essentially. In 
northern Nigeria every week a new village falls under sharia 
law and they are then--we have the madrassas, we have the 
schools that teach them to hate us.
    So these groups, they take advantage of the chaos, though 
in northern Nigeria the chaos is not as great as it is in 
southern, in some of the southern African countries. It is an 
example, the AIDS orphans is an example of the chaos waiting 
for order to be brought to it, either by them or by us. I am 
arguing that it is cheaper to prevent the fires than to put 
them out later.
    Senator Leahy. Oh, I agree with you.
    Mrs. Nyamayarwo, like you my wife was trained as a nurse, 
and I appreciate our conversations we had before this hearing. 
I do not know if I mentioned to you, we traveled to Uganda back 
in 1990. We visited a TASO center. We met HIV-positive 
volunteers there. In fact, most of the volunteers were HIV-
positive. We were so impressed by their courage, their 
selflessness, and the fact they were helping others even though 
they were living under a death sentence.
    In Uganda, if you could just take that one country, what 
has worked best in combatting AIDS? What could you use the 
most?
    Ms. Nyamayarwo. In Uganda it is not one thing, but first we 
have the good leadership of our president who has been open 
about HIV and AIDS and accepted to support us. The government 
has involved people living with HIV, and people living with HIV 
have got the heart to save other people's lives, like the 
volunteers in TASO. Myself, after losing my child to AIDS, I 
felt I should go out with those volunteers and talk to people, 
talk to parents, so that they do not go through what I went 
through, because it was very difficult for me, to try to save 
lives, go to schools and try to save the youth, to know more 
about HIV/AIDS.
    I think the education has been very, very important on this 
issue. That is why I feel that education is real great. Then 
there is one problem which still stands, is the poverty. The 
orphans remain vulnerable. It is going to be like a circle, re-
infection, because they do not have the support. Debt 
cancellation helps children to go to school just through 
primary. They cannot go to secondary schools, they cannot go to 
technical institutions. If all that is in place, I think we 
shall be able to really fight AIDS in Uganda.
    Senator McConnell. Thanks.
    Senator Leahy. Thank you very much.
    Senator McConnell. Because of the lateness of the hour, we 
are going to do one round of questioning and we will have to 
submit the others.
    Senator DeWine.
    Senator DeWine. Mr. Chairman, thank you very much.
    Mrs. Nyamayarwo, thank you very much for your very 
compelling testimony. We just very, very much appreciate it.
    Bono, thank you very much for being with us again. Again, 
very compelling testimony as well. You have really been at the 
forefront. If you look at the issues that matter, the 
Millennium Challenge, you have advocated for that. Debt relief, 
that matters so very much. AIDS. All three of those issues, you 
have been there. You have been a leader.
    Your testimony today I think has been so compelling because 
you have talked about AIDS from really a holistic point of 
view, that we cannot just look at AIDS separately; we have to 
look at it from the point of poverty, we have to look at it 
from the point of view of the whole medical system when we go 
into these countries that is connected to everything else.
    You truly understand this issue. You have done such a good 
job, I think, of focusing the public's attention on AIDS. I 
would just ask you, as you have gone around, not just in the 
United States, but in other countries, what works and what does 
not work when you are either addressing people in towns in the 
United States or when you are dealing with leaders in other 
countries? What is compelling and what is not compelling when 
you talk about this issue? What works and what does not work? 
And how are we doing with other countries, too?
    Bono. I think we need both bilateral and multilateral, is 
the truth. But we need them, we need everyone talking together. 
What does not work is when we play politics with people's 
lives. When everyone can get--when there is a parity of pain 
and sort of parity of applause--I think it is important there 
are people in other countries who are doing a lot more as a 
percentage of their GDP than the United States, and they get 
very upset when, just because the United States is giving more 
money--they say, well, hold on a second; we are spending a lot 
more as a percentage. So that does not work.
    I think some humility in saying we have different ways of 
doing things, but we want to work together and we are not 
trying to score points, that works. I think this is an 
opportunity to unite people in a way that there is very little 
else out there to. I think you have--what else are President 
Chirac, President Bush, and President Blair going to agree on?
    This is the one thing they can all hold hands on, and I 
think that might be a good symbol right now in the world. Maybe 
not holding hands, but--and I think seeing the historic side of 
things works. To tell--I know it is an absurd, an Irish rock 
star to do this, but to explain that when the dust settles and 
when the history books have been written, this entire era will 
be remembered for probably three things: the Internet, the war 
against terror, and what we did or did not do about this AIDS 
virus and what it did, what it did.
    It will be astonishing, like your children, like me, 
reading about the bubonic plague in the Middle Ages, which took 
a third of Europe. A third of Europe died from the bubonic 
plague, the Black Death. Now, imagine if China, say, had 
treatment at that time that could have saved those lives, but 
did not get it out there because, ah, it was a little difficult 
and it was expensive. How would we be reading about China now? 
That is the position we are in. That is where Europe and 
America is right now, and I think it is a great opportunity.
    Senator DeWine. Thank you very much.
    Thank you, Mr. Chairman.
    Senator McConnell. Thank you, Senator DeWine.
    Senator Durbin, you are it. After you finish the hearing is 
completed except for whatever questions that we may want to 
submit. So if you would proceed.
    Senator Durbin. That is a lot of pressure, Mr. Chairman.
    Senator McConnell. See how short you can be.
    Senator Durbin. Well, I thank you very much.
    I want to thank our witnesses for your patience in waiting 
for us to vote and come back and do other things in an 
extremely important session.
    Thank you for your leadership. I have told you, Bono, that 
you are a consummate pest on Capitol Hill and please keep up 
your good work, pestering us to be mindful of the rest of the 
world and what we are facing.
    It is no, I think, revelation that over the past several 
weeks we in America have been embarrassed and ashamed by some 
of the disclosures in the world press. The President has said 
and we have repeated that what happened in that prison is not 
indicative of American values. What I have found interesting in 
your tour of Wheaton College and other places in my State was 
that time and again you have said that you find us to be a good 
and caring people, and as a good and caring people there are 
things that we can do to prove that premise.
    I find the same thing when it comes to this commitment, 
when it comes to global AIDS. You really call on us to do our 
best and I think we should and we must.
    I would like to ask you specifically on this Global Fund 
issue. I am very concerned. If we do not increase the $200 
million commitment in this budget to a much higher level, I am 
fearful that ongoing projects may be cut back and new ones will 
not even be considered. What has been your impression of the 
work of Global Fund and if they had to retrench and fall back 
the impact it would have on this battle?
    Bono. There are some difficulties with the Global Fund 
right now, growing pains. I might suggest that some of those 
difficulties come out of an environment and a mood where they 
just do not want to make a mistake, because they know if they 
do make a mistake there is a lot at stake. I actually, I can 
understand their caution. They just do not want to screw up, 
and I think as a result things have moved a little slowly 
there.
    However, they have in Richard Feachem a really great 
leader. They have in their structure of the organization a 
really great design. And I think in a funny way it is a very 
American design. It is McKinsey Management. They have a 4 
percent overhead. They have auditors in place, PriceWaterhouse, 
Stokes Kennedy Crowell, all these people. Where the money is 
being spent on the ground, they have cut deals with them to 
make sure that these things are being effectively operated.
    Is there enough money out the door at the moment? No. But 
remember, they cannot--without having the cash in their bank, 
they cannot even have the discussion with the groups on the 
ground.
    The most important message to get out to Americans about 
the Global Health Fund is it is not a new bureaucracy. They are 
just supplying people in the regions who have effective 
programs with more money. They are scaling them up. It is 
really important. Some people do not understand that.
    So I think they are critical, they are extremely critical, 
because President Bush's brilliant AIDS initiative only applies 
to 16 countries. So this is the other side. This is the rest of 
the world. It has to work. It will work.
    I tried to say to them, you know, you are going to make 
mistakes; it is wonderful that you are so careful, but actually 
you are going to make mistakes; relax just a little bit about 
that.
    Senator Durbin. If I might ask you one last question. I do 
thank the committee for their patience here. People here in the 
audience earlier were removed with signs relative to drug 
companies and pharmaceutical companies and how much they are 
doing. I have heard you say something which is kind of self-
confessional about your own attitude in dealing and working 
with pharmaceutical companies and drug companies. Tell us now 
what you think is the appropriate approach to make certain that 
as quickly as possible affordable medications are in the hands 
of the poorest people in the world?
    Bono. Okay. Well, let me just say I fully, fully understand 
the frustration of my friends behind me who have their hopes 
raised when they hear of a $15 billion AIDS initiative and then 
have them dashed when they hear that none of the money is going 
to go to the cheapest drugs.
    What I would say to this issue is we need the 
pharmaceutical companies, is the truth. We need their brains, 
we need their know-how, we need their scientists. But there is 
an opportunity for them here to compete that they have not as 
yet made. They could really be heroes of the hour here. We need 
them.
    I want them involved, and I am not going to ask a business 
to behave like a philanthropy. I do not think we should do 
that. But make their profits. Sure, make their profits--just 
not on the greatest health crisis in 600 years, on the backs of 
poor people. I think they do a great business. I am happy for 
them to make profit on me, make profit on my friends, make 
profit on everyone in this room, in this country, but not on 
what is going on in the everyday lives of people like Agnes 
here.
    So I would say these drugs are a great advertisement for 
America. I told President Bush: Paint them red, white, and 
blue, you know, whatever. Get them out there. They are the best 
of the West.
    So that is my own position and I hope that is clear.
    Senator Durbin. Thank you, Agnes. Thank you, Bono.
    Thank you, Mr. Chairman.
    Senator McConnell. Thank you, Senator Durbin.
    Thank you, Bono. Thank you, Ms. Nyamayarwo. It is nice of 
you to be here and to tell your story. It was very helpful.

                     ADDITIONAL COMMITTEE QUESTIONS

    There will be some additional questions which will be 
submitted for your response in the record.
    [The following questions were not asked at the hearing, but 
were submitted to the Department for response subsequent to the 
hearing:]

             Questions Submitted by Senator Mitch McConnell

    Question. Voices for Humanity (VFH), a Kentucky-based non-profit, 
is slated to receive funding from USAID for a pilot project on HIV/AIDS 
education in Nigeria using cutting edge information technology. I 
strongly encourage you to follow VFH's efforts in Nigeria.
    What importance do you place in using cutting edge information 
technology to educate and inform illiterate or semi-literate 
populations?
    Answer. The unprecedented goals set by the President's Emergency 
Plan for AIDS Relief--to provide treatment to 2 million persons living 
with HIV, to prevent 7 million new HIV infections, and to provide care 
to 10 million people infected and affected by HIV/AIDS, including 
orphans and vulnerable children, will require that we actively seek new 
approaches to addressing HIV/AIDS, including through the use of cutting 
edge information technologies to reach as many people as possible.
    The Emergency Plan not only brings hope through the commitment of 
extraordinary resources, but, as important, the opportunity to find new 
and more effective ways to fight the HIV/AIDS pandemic--our approach 
will not be ``business as usual.'' We are committed to implementing 
programs that are responsive to local needs--countries and communities 
are at different stages of HIV/AIDS response and have unique drivers of 
HIV, distinctive social and cultural patterns, and different political 
and economic conditions. Effective interventions must be informed by 
local circumstances and coordinated with local efforts.
    The Office of the U.S. Global AIDS Coordinator has met with 
representatives of Voices for Humanity to be briefed on their project 
in Nigeria and will be meeting with them again as the project is 
implemented.
    Question. Faith-based organizations, such as Lott Carey 
International (LCI), have decades of experience working overseas and 
have cultivated broad contacts among indigenous organizations and 
groups.
    A. What are your goals and objective for utilizing faith-based 
organizations in combating HIV/AIDS?
    B. Do you have a recruitment plan or strategy to increase 
participation of these groups?
    C. How many faith-based organizations currently receive funding for 
HIV/AIDS activities--from USAID and your office?
    Faith-based and other organizations interested in combating HIV/
AIDS have contacted the Subcommittee to complain that the process for 
securing funding under this initiative is NOT user friendly.
    D. Are you aware of these difficulties, and what steps can you take 
to ensure that the funding process is less bureaucratically cumbersome?
    Answer. In implementing the President's Emergency Plan for AIDS 
Relief, we have sought to fund a broad range of innovative new 
partners, including faith-based and community-based organizations, to 
bring not only expanded capacity but also innovative new thinking to 
our efforts. Faith-based organizations not only bring expanded capacity 
and innovative new thinking to our efforts, but they are also among the 
first responders to the international HIV/AIDS pandemic, delivering 
much needed care and support for fellow human beings in need. Their 
reach, authority, and legitimacy--like other organizations--identifies 
them as crucial partners in the fight against HIV/AIDS, and we are 
committed to encouraging and strengthening such partners.
    Our intent in the initial, first round of grants under the 
Emergency Plan has been to move as quickly as possible to bring 
immediate relief to those who are suffering the devastation of HIV/
AIDS. The Office of the Global AIDS Coordinator chose programs in the 
first round because they have existing operations among the focus 
countries of the Emergency Plan, have a proven track record, and have 
the capacity to rapidly scale up their operations and begin having an 
immediate impact.
    By initially concentrating on scaling up existing programs that 
have proven experience and measurable track records, an additional 
175,000 people living with HIV/AIDS in the 14 initial focus countries 
will begin to receive anti-retroviral treatment. Prevention through 
abstinence messages will reach about 500,000 additional young people, 
and assistance in the care of about 60,000 additional orphans will soon 
commence in those same countries.
    As of March 30, 2004, we have partnered or sub-partnered with some 
45 faith-based organizations. Grants to these organizations total 
$57,528,298 thus far, and we are committed to expanding our work with 
both new and current faith-based organizations as Emergency Plan 
implementation progresses.
    We recognize that the windows for applications in our initial 
rounds of funding have been relatively quick, and anticipate that 
future rounds will allow more time for applicants to prepare and submit 
funding proposals.
    Question. Repressive regimes that commit widespread human rights--
such as the Burmese junta's policies of rape, forced labor, and use of 
child soldiers--have a direct and substantial impact on the general 
health of the population.
    A. What programs or projects can the Coordinator's office support 
to better understand--and mitigate--the impact widespread human rights 
violations have on populations, including the failure to prioritize 
HIV/AIDS prevention and treatment in places such as Burma, China and 
Russia?
    B. How can ``political will'' be cultivated in repressive countries 
to address the HIV/AIDS pandemic, or to ensure the treatment is 
provided on an equitable basis and not only to supporters of a regime, 
for example?
    Answer. The Emergency Plan for AIDS Relief Emergency Plan is the 
largest commitment ever by a single nation toward an international 
health care initiative. The vision of the President's Plan embraces a 
multifaceted global approach to combating the HIV/AIDS pandemic. Within 
this global framework, leadership is a fundamental lever to ensure that 
governments respect human rights and appropriately prioritize HIV/AIDS 
prevention, treatment, and care.
    The mission of the U.S. Office of the Global AIDS Coordinator is to 
work with leaders throughout the world to combat HIV/AIDS, promoting 
integrated prevention, treatment, and care interventions. While we are 
proceeding with an urgent focus on 15 countries that are among the most 
afflicted nations of the world, we continue to pursue on going 
bilateral programs in more than 100 countries, including Burma, China, 
and Russia. Our Five-Year Strategy for the Emergency Plan, released in 
February, articulates our goals, including a commitment to encourage 
bold leadership nationally at every level to fight HIV/AIDS.
    Under the Emergency Plan, USAID's fiscal year 2004 budget for its 
South East Asia Regional HIV/AIDS programs includes an additional $1 
million for programs in Burma, primarily in Shan and Karen States, 
which border China and Thailand. We are committed to ensuring that our 
assistance is consistent with our primary objectives of supporting 
democracy and improved human rights in Burma. No assistance is being 
provided directly to the regime. Our support is channeled though 
established international non-governmental organizations, such as 
Medicins Sans Frontiers, renowned for their resistance to government 
interference. In conjunction with the President's Plan, HHS recently 
launched its Global AIDS Program (GAP) in China, the offices of which 
HHS Secretary Tommy G. Thompson helped inaugurate in October 2003. In 
an unmistakable demonstration of leadership, U.S. Ambassador to China 
Clark Randt led the Embassy delegation and attended a ceremony at the 
rural village with the first recorded case of AIDS in China. In March 
1998, the United States and Russia began collaborating to control the 
spread of HIV and other sexually transmitted diseases. Since then, the 
United States and Russia have steadily advanced joint programs for HIV/
AIDS prevention and capacity building. At their bilateral summit 
meeting in September 2003, Presidents Bush and Putin committed to 
reinforce this joint cooperation and coordination. At the just held G-8 
Summit in Sea Island, they reaffirmed the U.S.-Russian HIV/AIDS 
Cooperation initiative with focus on: prevention, treatment, and care; 
surveillance and epidemiology; basic and applied research, including 
vaccine development; bilateral policy coordination in Eurasia and with 
the Global Fund for AIDS, Tuberculosis, and Malaria; and involving 
senior officials in support of public-private partnerships to combat 
AIDS. Such leadership at the highest levels underscores the President's 
commitment to ensure that all governments pursue appropriate national 
strategies to confront the HIV/AIDS pandemic as the global health 
emergency it is.
    Regarding political will, as noted above, the Emergency Plan places 
a high value on leadership to persuade all governments to address the 
HIV/AIDS pandemic and to ensure that HIV/AIDS services are provided on 
an equitable basis to all comers based on clinical eligibility, 
particularly with repressive government. We are committed to encourage 
our partners, including multilateral organizations and other host 
governments, to coordinate at all levels to strengthen response 
efforts, to embrace best practices, to adhere to principles of sound 
management, and to harmonize monitoring and evaluation efforts to 
ensure the most effective and efficient use of resources.
    In the global battle against HIV/AIDS, it is imperative that the 
many actors coordinate their efforts and make maximum use of increasing 
but still limited resources. To this end, in April, the United States, 
through the Office of the Global AIDS Coordinator, was instrumental in 
achieving donor government approval for a set of principles dubbed the 
``Three Ones'' by UNAIDS. These basic principles, aimed at coordinating 
national responses to HIV/AIDS and applicable to all stakeholders 
involved in country-level HIV/AIDS, are: one agreed HIV/AIDS Action 
Framework that provides the basis for coordinating the work of all 
partners; one National AIDS Coordinating Authority, with a broad based 
multi-sector mandate; and one agreed country level monitoring and 
evaluation system.
    The ``Three Ones'' Principles provide a constructive framework for 
coordination while permitting individual donors to fulfill their own 
program goals and mandates and disburse money to partners in their own 
ways, without having any one government or organization claim exclusive 
ownership of the coordinating authority. For the Emergency Plan, our 
focus worldwide is anchored in care, treatment, and prevention 
available to all comers based on clinical eligibility.
    Question. On March 9, 2004, Director of Central Intelligence George 
Tenet testified that HIV/AIDS continues to endanger social and 
political stability, and warned that the virus is gaining a foothold in 
the Middle East and North Africa, ``where governments may be lulled 
into overconfidence by the protective effects of social and cultural 
conservatism''.
    Do you agree with the Tenet's assessment that HIV/AIDS is gaining a 
foothold in the Middle East and North Africa?
    Answer. As it has around the globe, AIDS is certainly gaining a 
foothold in the region. Although the Middle East as a region has one of 
the lowest rates of HIV/AIDS infection (an estimated 0.3 percent) of 
its adult population, even this rate is higher than East Asia and the 
Pacific region, and by UNAIDS' estimates the Middle East and Near Asia 
has the second-highest rate of increase of HIV after the former Soviet 
Union and Eastern Europe. While not a health and social crisis 
presently, HIV/AIDS is a growing and potentially serious problem in the 
region.
    Drug use is on the rise in the Middle East, and in some countries 
such as Bahrain and Iran, injecting drug use is the primary cause of 
HIV infection. Prevailing social attitudes, cultural norms and 
religious tradition limit discussion of premarital sex, homosexuality, 
and adultery, all sexual behaviors that contribute to the spread of 
HIV/AIDS. Civil society, which in many other regions actively combats 
the disease, has not yet taken up the HIV/AIDS problem in the region. 
Unsafe medical practices are also a mode of HIV/AIDS transmission in 
countries such as Algeria and Iraq.
    The underlying vulnerability of the region, therefore, is 
significant, especially given rapidly changing social norms in many 
countries and exposure to high-risk behaviors for HIV/AIDS 
transmission. Poverty and pronounced gender inequality in the region 
are also drivers of the epidemic.
    While not calling for large-scale interventions or program 
investments, the HIV/AIDS situation in the region needs to be closely 
monitored. Middle Eastern and North African governments need to be 
urged to assess the vulnerability of their own countries and respond 
appropriately. Leadership by religious and political leaders at all 
levels at this early stage of the epidemic is the most effective means 
to ensure that its potential destructiveness is not realized.
    Question. AIDS orphans generally do not have access to education in 
Africa, which often requires the payment of a school fee.
    Do school fees create obstacles to stemming the spread of the 
disease by excluding vulnerable segments of the population to both the 
traditional ABC's and ``Abstain, Be Faithful, use Condoms''?
    Answer. Many children in Africa, particularly those impacted by 
HIV/AIDS, are unable to attend school because their families do not 
have the resources to pay school fees. This is particularly an issue 
for children orphaned due to HIV/AIDS. As part of a comprehensive 
assistance package for children affected by AIDS, school fees are 
sometimes included. However, it is important to note that school fees 
are often only one of several barriers to accessing education, and the 
right intervention can only be determined at the local level.
    Basic education is the linchpin for success in many of the U.S. 
Government's development activities, including family planning, child 
health and HIV/AIDS. In order to be successful in the fight against 
HIV/AIDS, it is essential that we wrap all of our development programs 
around HIV/AIDS programs. We have been working around the world to 
integrate AIDS prevention messages into all of the other sectors, 
including education.
    Question. Given Rotary International's superb work in combating 
polio internationally, do you have any plans to use Rotary--and its 
networks--to tackle HIV/AIDS, malaria or TB issues?
    Answer. In implementing the President's Emergency Plan for AIDS 
Relief, we have sought to fund a broad range of innovative new partners 
to bring not only expanded capacity but also innovative new thinking to 
our efforts. We would welcome the opportunity to consider partnering 
with Rotary International in our efforts, especially in countries such 
as Kenya with strong local clubs. Health and Human Services Secretary 
Tommy G. Thompson traveled with the Chairman of the Rotary 
International Foundation, Jim Lacy, to India, Pakistan and Afghanistan 
in April 2004, and encouraged him to fund ways for the Foundation and 
individual Rotary chapters to engage with the President's Emergency 
Plan.
    Question. The 2002-2003 outbreak of SARS in Asia highlighted 
deficiencies in mounting a concerted international response to a 
rapidly spreading disease. In a recent GAO report, delays in the 
initial response were attributed to China's reluctance to share 
information on SARS or to invite specialists to investigate the 
outbreak in a timely manner.
    A. With respect to HIV/AIDS, are there particular countries that 
are less than willing to provide information or access to international 
medical specialists to help stem the spread of the disease?
    B. Given that SARS underscored weaknesses in many Asian 
governments' disease surveillance systems and public health 
capacities--to say nothing of communications systems and effective 
leadership--how confident should we be that these same governments are 
capable of monitoring HIV/AIDS?
    Answer. In Asia, as with other regions of the developing world, 
there has been a perceived reluctance on the part of some countries to 
share specific information, including numbers of HIV/AIDS cases, issues 
relating to safe blood supplies, and other information relating to the 
treatment and care of HIV/AIDS patients. There are a number of 
political, cultural, economic, and security reasons that influence some 
East and Southeast Asian countries to withhold valuable information 
during health and environmental crises and fail to seek appropriate 
outside assistance. In recent years, the world has increasingly 
acknowledged the dire threat that HIV/AIDS poses, not only as a health 
crisis, but also as a threat to economic growth, an overwhelming burden 
on health care infrastructure, and the potential for undermining 
national stability. Recently, there have been positive developments in 
Asia demonstrating a new level of political will to meet the challenges 
imposed by the pandemic. In addition, the inadequate response to the 
SARS epidemic served as an important lesson, particularly for China, on 
the consequences of inaction during a health crisis. Since the Severe 
Acute Respiratory Syndrome (SARS) emergency, China has significantly 
strengthened its political will to openly address the HIV/AIDS 
pandemic. China has formed the State Council Working Group on HIV/AIDS, 
which includes 21 ministries and has increasingly sought information on 
the most effective way to respond to HIV/AIDS, including dialogue on 
technical assistance to support the health care sector and health 
infrastructure.
    With regard to monitoring for HIV/AIDS, along with an increased 
level of political will to effectively address HIV/AIDS, many Asian 
countries now recognize the importance of significantly improving data 
quality. For example, in China, the Global AIDS Program of the U.S. 
Department of Health and Human Services has a surveillance component as 
part of its technical assistance project in China. This will help the 
country develop systems to monitor rates of infection and the impact of 
prevention programs. The Chinese government is supportive of this type 
of technical assistance, and continues to work with donor countries and 
nongovernmental organizations to develop more effective strategies in 
the fight against HIV/AIDS.
    Question. What weight do you put on efforts to combat malaria--
which kills over 1 million people a year--and what is the role of your 
office in anti-malarial efforts of the U.S. Government?
    Answer. As you suggest, opportunistic infections, such as 
tuberculosis (TB) and malaria, play a fundamental role in the overall 
health of HIV infected individuals. Malaria is the most common life-
threatening infection in the world. It is endemic in more than 90 
countries, and a child dies every 30 seconds from it, mostly in Africa. 
Causing more than one million deaths and 500 million infections 
annually, malaria impedes economic development in Africa, Asia, and the 
Americas. Because of the annual loss of economic growth caused by 
malaria, gross domestic product in endemic African countries is up to 
20 percent lower than it would have been if there were no malaria in 
the last 15 years.
    The Emergency Plan for AIDS Relief, will coordinate and integrate 
anti-malarial efforts into HIV/AIDS prevention, care and treatment. 
This is especially critical in the context of providing HIV care to 
pregnant women. Moreover, the Office of the U.S. Global AIDS 
Coordinator is committed to coordinating with the global anti-malarial 
activities of both the U.S. Agency for International Development and 
the U.S. Department of Health and Human Services.

                                 ______
                                 
            Questions Submitted by Senator Patrick J. Leahy

    Question. Do you agree that any faith-based organization that 
receives U.S. funds, if it provides information about condoms the 
information must be ``medically accurate and include the public health 
benefits and failure rates of such use?'' Do grant agreements with 
faith-based groups require them to adhere to this requirement, as 
Senator Frist and I recommended in a colloquy on the Senate floor? How 
do you plan to monitor adherence to the law?
    I am told that funding for USAID's commodity fund to purchase 
condoms has remained stagnant for several years, despite the steady 
increase in HIV infections. Do you plan to spend more on condoms in 
fiscal year 2005 than last year, or less?
    Answer. In the Acquisition and Assistance Policy Directive dated 
February 26, 2004, the U.S. Agency for International Development 
mandates that information provided by any organization receiving 
funding--including faith-based groups--must be medically accurate. 
Specifically, the following wording is now included as a standard 
provision of all new agreements, as well as older agreements that add 
new funding:

    ``Information provided about the use of condoms as part of projects 
or activities that are funded under this agreement shall be medically 
accurate and shall include the public health benefits and failure rates 
of such use.''

    Organizations not in compliance could be considered in violation of 
the terms of their agreement.
    The Commodity Fund was established in fiscal year 2002 to remove 
financial constraints to the availability of condoms for missions who 
wish to make them available as part of their AIDS prevention programs. 
The amount allocated for this purpose increased in 2003, and then 
remained constant in 2004. Funding decisions have not yet been made for 
fiscal year 2005, but the importance of this resource is acknowledged. 
Total condom shipments--paid by central and field resources--have 
increased significantly from 233 million units in calendar year 2002 to 
550 million units expected by final shipment in 2004.
    Question. The Administration declined to apply the Mexico City 
Policy to HIV/AIDS funds, but there is still confusion in the field 
about this. Can you clarify for U.S. officials and foreign NGOs that 
there is no legal impediment to supporting a foreign NGO for AIDS 
prevention or treatment efforts, even if that organization would be 
barred under Mexico City from receiving family planning funds?
    Answer. As you note, the Mexico City Policy applies only to 
assistance for family planning activities by foreign non-governmental 
organizations, not to assistance for HIV/AIDS funding or other health 
activities that do not involve assistance for family planning. The 
President's extension last year of the Mexico City Policy to State 
Department programs expressly did not apply to HIV/AIDS assistance. Any 
group, subject to other relevant provisions of U.S. law, will be 
eligible to apply for HIV/AIDS funding under the President's Emergency 
Plan.
    Question. The Statement of Managers accompanying the Fiscal Year 
2004 Foreign Operations Act requires you to report back to us by April 
1 (60 days after enactment) on how much the Administration will spend 
this year on AIDS prevention activities and what amount of that will go 
towards ``abstinence until marriage'' programs. As far as I know, the 
report has not been submitted, or am I mistaken? When will we get it?
    A provision in the United States Leadership Against HIV/AIDS, 
Tuberculosis and Malaria Act of 2003 requires that at least one-third 
of all global HIV/AIDS prevention funds be set aside for ``abstinence-
until-marriage'' programs. When Senator Feinstein offered an amendment 
to the Fiscal Year 2004 Foreign Operations Appropriations bill to 
clarify the congressional intent of the provision, you wrote a letter 
to Senator McConnell that was read on the Senate floor expressing 
opposition on the grounds that it would have restricted the 
administration's flexibility and undermined your ability to implement 
the full variety of abstinence until marriage approaches.
    How exactly do you define an ``abstinence-until-marriage'' program? 
Was this definition available during debate on the Fiscal Year 2004 
Foreign Operations Appropriations bill? If not, why were you so sure 
that Senator Feinstein's amendment would have undermined your ability 
to fund the full variety of abstinence until marriage approaches?
    If a program is successful in leading to increased abstinence with 
a comprehensive message that places a priority, rather than exclusive, 
emphasis on abstinence, would it be eligible for funds under the one-
third earmark?
    Based on your experience, is it appropriate to devote one-third of 
prevention funds to abstinence until marriage programs? If so, what 
empirical evidence do you base that on?
    Answer. First, the Office of the U.S. Global AIDS Coordinator 
apologizes for the delay in submitting the report in question to 
Congress. The Office is working on completing the report and submitting 
it to Congress within the next several weeks.
    Under the Emergency Plan for AIDS Relief, the ``ABC'' model 
(Abstinence, Be Faithful, and, when appropriate, correctly and 
consistently use of Condoms) will support behavior change for the 
prevention of the spread of HIV. The Emergency Plan will balance and 
target the application of A, B, and C interventions according to the 
needs and specific circumstances of different populations and 
individuals.
    The success of the ABC model in countries such as Uganda, Zambia, 
and Ethiopia, among others, has demonstrated that promoting behavior 
change and healthy lifestyles, including abstinence and delayed sexual 
initiation, faithfulness and fidelity in marriage and other committed 
relationships, reduction in the number of partners, consistent and 
correct use of condoms, and avoidance of substance abuse, has been and 
can be successful in preventing the spread of HIV/AIDS.
    Abstinence-until-marriage programs, as part of a comprehensive 
prevention approach, should appeal to the specific needs of specific 
groups. For example, in many countries the average age of marriage is 
17 or 18. Once married, a message underlining the importance of 
faithfulness is more appropriate than an abstinence-only approach that 
would be appropriate for unmarried, single, school-age youth. Reliable 
data exists to show that youth can and do respond to abstinence-until-
marriage messages and programs, and that delaying sexual activity and 
being faithful to one partner is not only protective for young people 
but can also have widespread impact on the growth of the HIV/AIDS 
pandemic.
    As such, under the Emergency Plan for AIDS Relief, abstinence-
until-marriage programs will include two goals:
  --Encouraging individuals to be abstinent from sexual activity 
        outside of marriage as a way to be protected from exposure to 
        HIV and other sexually transmitted infections (STIs). These 
        activities or programs will promote the following:
    --Importance of abstinence in reducing HIV transmission among 
            unmarried individuals;
    --Decision of unmarried individuals to delay sexual activity until 
            marriage;
    --Development of skills in unmarried individuals for practicing 
            abstinence; and
    --Adoption of social and community norms that support delaying sex 
            until marriage and that denounce forced sexual activity 
            among unmarried individuals.
  --Encouraging individuals to practice fidelity in sexual 
        relationships, including marriage, as a way to reduce risk of 
        exposure to HIV. These activities or programs will promote the 
        following:
    --Importance of faithfulness in reducing the transmission of HIV 
            among individuals in long-term sexual partnerships, 
            including marriage;
    --Elimination of casual sexual partnerships;
    --Development of skills for sustaining marital fidelity, including 
            the ability to voluntarily seek counseling and testing to 
            know the serostatus of persons in relationship;
    --Endorsement of social and community norms supportive of 
            refraining from sex outside of marriage, partner reduction, 
            and marital fidelity using strategies that respect and 
            respond to local customs and norms; and,
    --Diffusion of social and community norms that denounce forced 
            sexual activity in marriage or long-term partnerships.
    Question. The President's Emergency Global AIDS Plan does not 
ensure that additional funds will be available for developing safe and 
effective microbicides. The plan appears to leave this to the 
discretion of HHS and NIH. Yet NIH spends barely 2 percent of its HIV/
AIDS research budget on microbicides.
    Given that married women who get infected from their husbands 
urgently need options like microbicides, what if anything do you plan 
to do to mobilize more funds for this research?
    Answer. Microbicides, once successfully developed, will help reduce 
the transmission of HIV/AIDS. Under the Emergency Plan, the National 
Institutes of Health (NIH) within the U.S. Department of Health and 
Human Services (HHS) is pursuing a comprehensive program for 
discovering, developing, testing, and evaluating microbicides for HIV 
prevention. HHS/NIH is the major federal sponsor of microbicide 
research and development. The Emergency Plan provides opportunities for 
HHS/NIH to expand its HIV Prevention Trials Network, a worldwide 
network of clinical trial sites established to evaluate the high 
priority area of safety and efficacy of non-vaccine HIV prevention 
interventions such as microbicides. As we use the tools available today 
to bring immediate relief to the millions suffering from consequences 
of HIV/AIDS, we will continue to pursue strategies, such as 
microbicides, that will allow us to make greater strides against this 
disease in the future.
    We appreciate the concerns voiced by many about the vulnerabilities 
of women and girls to HIV/AIDS, including women coerced or forced to 
have sex, and who have few options for negotiating sex with their male 
partners. There is increasing recognition that women and girls 
represent nearly half of all HIV infections worldwide and that the 
disease disproportionately affects them in many ways. HHS/NIH supports 
an extensive AIDS research portfolio on women and girls. The President 
preceded his announcement of the Emergency Plan by his announcement in 
June 2002 of his $500 million International Mother-and-Child HIV 
Prevention Initiative for Africa and the Caribbean. That initiative, 
now part of the Emergency Plan, is intended to treat one million women 
annually and reduce mother-to-child transmission of HIV by 40 percent 
within five years or less in target countries.
    Several U.S. Government agencies, including the U.S. Agency for 
International Development (USAID) and the U.S. Department of Health and 
Human Services (HHS), are working with women's organizations, public 
health groups, and others to define mechanisms to address even better 
the gender dimensions of the HIV/AIDS pandemic. For example, USAID is 
supporting policy changes, research and interventions that address 
issues related to gender and HIV/AIDS and seeks to reduce women and 
girls' vulnerabilities to HIV/AIDS. Such activities include public 
outreach materials and peer-education programs directed toward men and 
boys to address cultural norms about violence and sexual promiscuity; 
promotion of abstinence and fidelity; research on issues related to 
women's vulnerability, including cross-generational sex, stigma, and 
gender-based violence; and identifying and training women's grassroots 
organizations to participate in policy making processes regarding HIV/
AIDS.
    Question. We have reports of preferential treatment in the 
allocation of U.S. funds to ``faith-based'' organizations. We have 
heard that in several instances, organizations with little or no 
experience in public health; with ideological or religious objections 
to offering information about safer sex and condoms; and whose 
proposals for funding received low scores under review by technical 
experts, nevertheless were given preference for funding over other 
organizations with strong technical capability and long-term 
experience. Can we get copies of the recent proposals and scores 
evaluating organizations that are receiving funding?
    What specific guidelines are there to ensure that scientific, 
medical, and public health expertise is put above religious or 
ideological preferences in the granting of contracts?
    Answer. In implementing the President's Emergency Plan for AIDS 
Relief, we have sought to fund a broad range of innovative partners, 
including host government agencies, non-governmental organizations, 
faith-based organizations, networks of persons living with HIV/AIDS and 
their families, and U.S. institutions, to bring not only expanded 
capacity but also innovative new thinking to our efforts. The Office of 
the Global AIDS Coordinator has provide general guidance to U.S. 
Government agencies in the field to foster partnerships with a broad 
array of organizations, including organizations that minimize 
administrative and other costs that do not directly contribute to 
prevention, treatment and care for persons in needs. Guidance has also 
been provided that a partnering organization should not be required, as 
a condition of receiving assistance, to endorse or use a multi-sectoral 
approach to combating HIV/AIDS, or to endorse, use, or participate in a 
prevention method or treatment program to which the organization has a 
religious or moral objection. Neither should any organization advocate 
against any other component of the U.S. Government's programs. In 
reviewing funding proposals, criteria for the eligibility of 
applications include that organizations have a track record of 
experience in directly providing or assisting in providing treatment, 
care and prevention in the focus countries of the Emergency Plan.
    Faith-based organizations were among the first responders to the 
international HIV/AIDS pandemic, and deliver much needed care and 
support for fellow human beings in need. Their reach, authority, and 
legitimacy--like other organizations--identify them as crucial partners 
in the fight against HIV/AIDS; we are committed to encouraging and 
strengthening such partners. No organization, secular or faith-based, 
however, has received preferential treatment in funding on the basis of 
its affiliation or background.
    Our intent in the initial, first round of grants under the 
Emergency Plan has been to move as quickly as possible to bring 
immediate relief to those who are suffering the devastation of HIV/
AIDS. The Office of the Global AIDS Coordinator chose programs for 
funding in the first round because their recipients have existing 
operations among the focus countries of the Emergency Plan, have a 
proven track record, and have the capacity to rapidly scale up their 
operations and begin having an immediate impact.
    By initially concentrating on scaling up existing programs that 
have proven experience and measurable track records, an additional 
175,000 people living with HIV/AIDS in the 14 initial focus countries 
will begin to receive anti-retroviral treatment. Prevention through 
abstinence messages will reach about 500,000 additional young people, 
and assistance in the care of about 60,000 additional orphans will soon 
commence in those same programs.
    Regarding copies of proposals and evaluation scores, the Office of 
the U.S. Global AIDS Coordinator did not contract directly for these 
proposals, but rather worked through our partner U.S. Government 
agencies--the U.S. Agency for International Development and the U.S. 
Department of Health and Human Services. Each has advised that federal 
executive guidelines establish that absent a Committee request (and the 
strict protections that are imposed pursuant to such release), 
proposals or evaluation materials are not released to Members of 
Congress as a matter of course when they contain (1) proprietary 
business confidential or ``competitively useful'' information and (2) 
protectable deliberative process and privacy information that might be 
publicly disclosed pursuant to such release. Please see, by reference, 
Federal Acquisition Regulation 5.403 and . Both HHS and USAID, however, have 
expressed their willingness to release, on an expedited basis, the 
requested Request for Applications (RFA), which include the evaluation 
criteria, and any actual awards that have been made, such awards being 
appropriately redacted to reflect business proprietary or privacy 
concerns.
    Question. Our law requires recipients of U.S. funds to have a 
policy opposing prostitution and sex trafficking. However, Senator 
Frist and I made clear in a colloquy that this requirement would be 
satisfied if the grant agreement for United States funding states that 
the grantee opposes prostitution and sex trafficking, rather than by 
requiring the grantee to have an explicit policy to that effect. Is 
that colloquy being followed, both with respect to United States and 
foreign organizations?
    Answer. As you note, Section 301(f) of the United States Leadership 
Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003 (Public Law 
108-25) states that ``No funds made available to carry out this Act, or 
any amendment made by this Act, may be used to provide assistance to 
any group or organization that does not have a policy explicitly 
opposing prostitution and sex trafficking.'' Also of note is Section 
301(e), which expressly prohibits funds from being used to promote or 
advocate the legalization or practice of prostitution or sex 
trafficking; yet does allow for the provision of HIV/AIDS prevention, 
treatment and care services to victims of prostitution or sex 
trafficking.
    Proper implementation of these two provisions is critical, and the 
Office of the U.S. Global AIDS Coordinator intends to implement the law 
consistent with the U.S. Government's opposition to prostitution and 
related activities, especially those that contribute to trafficking in 
persons. To this end, Congress's views, including the legislative 
history, report language and floor statements, have been informative 
and helpful.
    To ensure that the relevant provisions of Public Law 108-25 are 
met, both the U.S. Department of Health and Human Services (HHS) and 
the U.S. Agency for International Development (USAID) require that 
primary grantees affirmatively certify their compliance with the 
applicable restrictions regarding prostitution and related activities 
prior to the receipt of any federal funds.
    In addition, under the Emergency Plan, HHS and USAID are including 
the limitation on funds expressed in Section 301(e) in HIV/AIDS funded 
grants and requiring that primary recipients include the funding 
limitation in all subagreements. USAID is applying this same process 
for all HIV/AIDS funded contracts.
    Regarding the implementation of Section 301(f), the Office of Legal 
Counsel (OLC) in the U.S. Department of Justice is considering the 
constitutional implications of the funding restrictions of Public Law 
108-25, particularly Section 301(f). In provisional advice, OLC 
determined that Section 301(f) can only be constitutionally applied to 
foreign organizations when they are engaged in activities outside of 
the United States.
    Currently, HHS and USAID are including the Section 301(f) 
limitation in their international HIV/AIDS funded grants, cooperative 
agreements, contracts and subagreements with foreign organizations. If 
a U.S. organization is the primary recipient of funds, they must 
include the Section 301(f) limitation in any subagreement with a 
foreign organization, as well as ensure, through contract, 
certification, audit, and/or any other necessary means, that the 
foreign organization complies with the limitation.
    In addition, the Fiscal Year 2004 Foreign Operations, Export 
Financing and Related Programs Appropriations Act amends Section 301(f) 
of Public Law 108-25 by exempting the Global Fund to Fight AIDS, 
Tuberculosis and Malaria (Global Fund), the World Health Organization 
(WHO), the International AIDS Vaccine Initiative (IAVI) and United 
Nations agencies from that section. Awards to these organizations 
include the limitation on funds expressed in Section 301(e).
    Question. Ambassador Tobias, you have said that the fact that less 
than 7 percent of women used a condom in their last sex act with their 
main partner and that less than 50 percent of women have used a condom 
with casual parters shows that condom are not effective. Would you also 
say that the low abstinence rates that exist in many countries show 
that abstinence promotion is not effective in the general population 
and should therefore be abandoned?
    Answer. Under the President's Emergency Plan for AIDS Relief, 
policy decisions will be evidence-based and will build on the best 
practices established in the fight against HIV/AIDS. I am committed to 
bringing the resources of sound science to bear in selecting and 
developing interventions that achieve real results. Determining which 
approach is best will depend upon numerous variables, including local 
needs and circumstances. The Office of the U.S. Global AIDS Coordinator 
will promote the proper application of the ABC approach through 
population-specific interventions that emphasize abstinence for youth, 
including the delay of sexual debut, fidelity for sexually active 
couples, and correct and consistent use of condoms by persons engaging 
in behaviors that put them at increased risk for HIV transmission. The 
success of the ABC model in countries such as Uganda, Zambia, and 
Ethiopia, among others, has demonstrated that promoting behavior change 
and healthy lifestyles, including abstinence and delayed sexual 
initiation, faithfulness and fidelity in marriage and other committed 
relationships, reduction in the number of partners, and consistent and 
correct use of condoms, has been and can be successful in preventing 
the spread of HIV/AIDS. Under the Emergency Plan, abstinence-until-
marriage programs will have two goals: (1) Encouraging individuals to 
be abstinent from sexual activity outside of marriage, and (2) 
Encouraging individuals to practice fidelity in sexual relationships, 
including marriage, as ways to reduce risk of exposure to HIV and other 
sexually transmitted infections (STIs).
    Abstinence from sexual intercourse or maintaining a mutually 
faithful long-term relationship between partners known to be uninfected 
is the surest way to avoid transmission of HIV and other sexually 
transmitted infections (STIs). Outside of those conditions, condoms 
have been an important and successful intervention in many places, 
particularly when made available in commercial and other casual sexual 
encounters, areas of high prevalence, or amongst those who do not know 
their serostatus. While no barrier method is 100 percent effective, 
correct and consistent use of latex condoms can reduce the risk of 
transmission of HIV by about 90 percent. The body of research on the 
effectiveness of latex condoms in reducing sexual transmission of HIV 
is both comprehensive and conclusive--if they are used correctly and 
consistently. Certainly, in many of the Emergency Plan focus countries, 
gender inequities and other issues may impact whether or not people can 
and will use condoms. However, part of our role in these countries will 
be to facilitate a shift in cultural norms around HIV prevention 
behaviors--abstinence, being faithful, and when necessary correct and 
consistent condom use. When cultural norms shift and prevention 
mechanism is available, great changes can occur. For example, Thailand 
slowed its explosive HIV epidemic by promoting ``100 percent condom'' 
use in brothels but at the same time discouraging men from visiting 
prostitutes. As a result of this policy and an accompanying public 
information campaign, as well as improved STI treatment services, 
condom use among sex workers increased to more than 90 percent, 
reported visits to sex workers by men declined by about half, HIV 
infection rates among military recruits decreased by about half, and 
the cases of five other STIs decreased by nearly 80 percent among 
brothel workers. Given the evidence around condom effectiveness, condom 
use programs the Emergency Plan supports will be leveraged across a 
range of situations in which those persons at increased risk for 
becoming infected by or for transmitting HIV will have access to them, 
and will include communication components to encourage responsible 
behavior.

                                 ______
                                 
           Questions Submitted by Senator Barbara A. Mikulski

    Question. PEPFAR only covers 14 countries in Africa and the 
Caribbean. Other regions such as Eastern Europe, Latin America and Asia 
are left behind. Reports indicate that although Africa and the 
Caribbean have the largest rates of infection presently, however if 
left unaddressed, countries like China and India, with their large 
populations will easily overtake Africa in number of infections. For 
example, estimates show that by 2010, the number of HIV infections in 
India is predicted to rise from 4 million to 20-25 million, the current 
number of infections on the entire continent of Africa.
    How are we looking to the future and addressing the emerging 
threats in other parts of the world?
    Answer. The vision of the President's Emergency Plan is to turn the 
tide of HIV/AIDS. Recognizing that HIV is a virus that knows no 
borders, the Emergency Plan continues to support strengthened 
programming across the world in order to achieve this vision. The 
President's Emergency Plan includes nearly $5 billion to support on-
going bilateral HIV/AIDS programs in approximately 100 countries 
worldwide.
    Question. In 2003, 58 percent of the 26.6 million people living 
with HIV/AIDS in sub-Saharan Africa were women. Young women between the 
ages of 15-24 in Africa and the Caribbean are 2.5 times more likely to 
have HIV than young men and teenage women are 5 times as likely. The 
vast majority of these women are identified as having only one mode of 
exposure to HIV--sex with their husbands.
    Given that most sexually transmitted HIV infections in females 
occur either inside marriage or in relationships women believe to be 
monogamous, what targeted and appropriate prevention policy do we have 
that addresses this most vulnerable segment of the population?
    Answer. I share your concerns about the vulnerabilities of young 
women to HIV/AIDS. Targeted and appropriate prevention strategies to 
address the vulnerability of women to exposure to HIV are integral to 
the President's Emergency Plan. The U.S. Five Year Global HIV/AIDS 
Strategy includes not only preventing seven million infections in some 
of the most afflicted countries in the world, but also continues 
bilateral, regional and multilateral efforts to prevent new infections.
    Limitations in human resources and sites able to provide PMTCT are 
major impediments to implementing national PMTCT programs. The 
President's Mother and Child Initiative, now folded into the Emergency 
Plan.focused on the need to develop capacity to effectively scale-up 
programs. Through the President's International Mother and Child HIV 
Prevention Initiative and the Emergency Plan for AIDS Relief, the U.S. 
Government provided $143 million for PMTCT activities and programs from 
October 1, 2002, to March 31, 2004. As a result, 14,700 health workers 
received training in the provision of PMTCT services and 900 health 
facilities received financial and technical support, which enabled the 
provision of a minimum package of PMTCT care, including (1) voluntary 
counseling and testing for pregnant women, (2) anti-retroviral 
prophylaxis to HIV-infected women to prevent HIV transmission, (3) 
counseling and support for safe infant-feeding practices, and (4) 
voluntary family planning counseling and referral. The focus on 
training and developing sites for PMTCT lays the foundation for 
scaling-up national programs, thus making a substantial step towards 
the Emergency Plan goal of averting seven million new HIV infections. 
Moreover, reaching women during pregnancy provides a critical 
opportunity for those who test negative to receive counseling to avoid 
infection.
    PMTCT centers also foster and build healthy families by offering 
counseling and testing for expectant fathers. For example, the U.S. 
Government and the Elisabeth Glaser Pediatric AIDS Foundation support 
the Masaka Health Center in Rwanda. It has developed unique program to 
encourage couples to participate jointly in pre-natal care and 
subsequently HIV testing. A personalized written invitation is prepared 
in the local language (Kinyarwanda) for all women who participate in 
pre-natal care at the center and agree to be tested for HIV after 
counseling. They are invited to return with their partner the following 
weekend for a special session. This approach has resulted in a 74 
percent HIV testing rate for male partners at Masaka, as compared to 13 
percent for 12 other sites in the same program. Based on the success of 
this approach, the Foundation intends to introduce this concept to its 
other sites as part of an overall initiative to increase partner 
testing.
    Under the Emergency Plan, we also foster approaches that recognize 
father/husband have a role to play as far as violence and HIV 
prevention are concerned. In Soweto, South Africa a PMTCT unit employed 
six counselors in 2003, one of whom one was an HIV-positive male who 
lost his baby son to HIV/AIDS. This counselor helped men talk about 
their disease and its consequences.
    The Emergency Plan also supports activities to stimulate male 
involvement in HIV/AIDS prevention efforts. On March 27, 2004, a 
Solidarity Center in South Africa supported by the Emergency Plan 
organized a ``Men as Partners'' and voluntary counseling and testing 
(VCT) day for various workers unions in the community. The daylong 
program was designed to get men involved in preventing HIV transmission 
and violence against women.
    Increasingly, young women and men who are sexually active are 
committing to a monogamous relationship. The President's Emergency Plan 
Strategy supports comprehensive and effective prevention approaches 
that reflect the complex influences on young people's decision-making 
and the need to address the broader social factors that shape their 
behaviors. Internationally, a number of programs have proven successful 
in increasing abstinence until marriage, delaying first sex, reducing 
the number of partners, and achieving ``secondary abstinence'' among 
sexually experienced youth.
    The Emergency Plan recognizes several categories of activities as 
part of its rapid scale-up of prevention programs for young adults:
    Scale up skills-based HIV education, especially for younger youth 
and girls.--We need to reach young people early, before they begin 
having sex, with skills-based HIV education that provides focused 
messages about the benefits of abstinence until marriage and other safe 
behaviors. Best practices suggest that curricula that target specific 
risk factors for early sexual activity in the local context, delivered 
through interactive methods that help young people clarify values, 
build communication skills and personalize risk are most effective. 
Ideally, programs go beyond sexuality to build on young people's assets 
of character and encourage them to stay in school and plan for their 
futures.
    Broad social discourse on safer norms and behaviors.--Communities 
need to mobilize to address the norms, attitudes, values, and behaviors 
that increase vulnerability to HIV, including multiple casual sex 
partners and cross-generational and transactional sex. The Emergency 
Plan supports groups that seek to generate public discussion about 
harmful social and sexual behaviors through a variety of media and 
other activities, at both the community and national levels.
    Reinforcement of the role of parents and other protective 
factors.--Parents are potentially the most powerful protective factors 
in young people's lives; they have great potential to guide youth 
toward healthy and responsible decision-making and safer behaviors. In 
Emergency Plan countries, where many youth have lost their parents to 
AIDS, other adult caregivers and mentors also have an important role to 
play in providing guidance to youth. The Emergency Plan will support 
efforts to reach out to parents and other adult caregivers to educate 
and involve them in issues relating to youth and HIV and to empower 
them by improving their communication skills in the areas of sexuality 
as well as broader limit-setting and mentoring.
    Address sexual coercion and exploitation of young people.--
Adolescents need a safe environment where they can grow and develop 
without fear of forced or unwanted sex, which often precludes the 
option of abstinence. The Emergency Plan supports psychosocial and 
other assistance for victims of sexual abuse. The Emergency Plan also 
supports efforts to target men with messages that challenge norms about 
masculinity and emphasize the need to stop sexual violence and 
coercion.
    In sum, the President's Plan recognizes that prevention is a 
continuum in which all members of the community the young and the 
mature, girls and women, and boys and men must be meaningfully engaged 
to prevent the spread of HIV/AIDS.
    Question. There are currently 14 million people co-infected with TB 
and HIV. TB is the leading killer worldwide of people who die of AIDS, 
responsible for one third of all AIDS deaths. Fewer than half of those 
with HIV who are sick with TB in the 14 countries targeted in PEPFAR 
have access to TB treatment.
    How does the PEPFAR initiative address the issue of TB co-
infection?
    Answer. The Office of the U.S. Global AIDS Coordinator is committed 
to the appropriate coordination, integration and support of 
tuberculosis (TB) and HIV/AIDS services and programs. As you are aware, 
opportunistic infections, such as TB and malaria, play a fundamental 
role in the overall health of HIV infected individuals. TB is 
frequently the first manifestation of HIV/AIDS disease, the reason many 
people first present themselves for medical care, and the leading 
killer of people with HIV/AIDS.
    Since both tuberculosis treatment and HIV/AIDS treatment require 
longitudinal care and follow-up, successful TB programs provide 
excellent platforms upon which to build capacity for HIV/AIDS 
treatment. The Emergency Plan for AIDS Relief will support TB treatment 
for those who are HIV-infected and develop HIV treatment capacity in TB 
programs. In addition, interventions that increase the number of 
persons diagnosed and treated for HIV/AIDS will increase the need for 
TB treatment and care. Therefore, action is required to build or 
maintain necessary tuberculosis treatment capacity. For example, 
laboratories, clinical staff, community networks, and management 
structures used for TB control can be upgraded to accommodate HIV/AIDS 
treatment. Finally, because the prevalence of HIV infection is high 
among persons with tuberculosis, TB programs will be important sites 
for HIV testing in the focus countries, and the Emergency Plan will 
work toward ensuring the availability of TB testing in HIV testing, 
treatment and care sites.
    Question. The Global Fund to Fight AIDS, TB and Malaria 
specifically addresses co-infection issues has seen a cut in funding. 
How can you justify this?
    Answer. The President's Emergency Plan for AIDS Relief made a 
pledge of $200 million each year for the five-year period of 2004-2008. 
Our fiscal year 2005 request therefore remains the same as our request 
in fiscal year 2004. We were the first donor to make such a long-term 
pledge of support to the Global Fund, which together with our previous 
donations to the Fund still represents nearly 40 percent of all pledges 
and contributions through 2008.
    The American people can be extremely proud of our record of support 
for the Global Fund, which is an integral part of the Emergency Plan 
for AIDS Relief. When the United States contributes to a project of the 
Global Fund, it means that our dollars are leveraged in these grants by 
a factor of two, since the United States thus far has provided one-
third of all Fund monies. The Fund has so far committed $2.1 billion to 
224 grants in 121 countries and three territories. So it is in our 
interests, as well as the interest of all people struggling against 
HIV/AIDS, malaria and tuberculosis, to see to it that the Global Fund 
is an effective partner in the fight against these diseases.
    The Global Fund nevertheless is a relatively new organization, 
particularly in comparison to the 20 years of bilateral HIV/AIDS 
programs carried out by the United States and other bilateral donors. 
As of May 15, 2004, the Global Fund had disbursed approximately $311 
million since the Global Fund's Board approved its first round of 
funding in January 2002. This compares to the first $350 million under 
the President's Emergency Plan sent to our focus countries only three 
weeks after the program first received its funding.
    This is not to criticize the Global Fund for being slow--indeed, 
the United States is one of the donors that has been urging the Global 
Fund to move carefully to ensure accountability and avoid waste. It 
does highlight, however, the potential effectiveness of bilateral 
assistance where donors already have an in-country presence.
    We need both multilateral and bilateral avenues of assistance; 
neither the Global Fund nor bilateral donors can do it all. Other 
bilateral donors also need to step up with greater technical assistance 
to Global Fund projects, without which those projects will founder.
    In addition, the United States believes that in order for funds to 
be effectively and efficiently disbursed, Country Coordinating 
Mechanisms (CCMs) and Local Fund Agents (LFAs) must actively engage in 
overseeing the implementation of grant activities. The United States 
would like to see, in particular, a stronger representation of the 
private sector, non-governmental organizations, and people living with 
the diseases on CCMs, largely chaired now by government ministries. 
Engaging a broader representation of various stakeholders will help 
reduce potential acts of corruption and will allow for a wider 
distribution of funds to serve more individuals in need.
    The Global Fund has already announced, in advance of the June Board 
meeting, that Round Four proposals approved by the Technical Review 
Panel will not exceed the cash already on-hand, so that, at least 
through this Round, no funding gap exists. And we, along with other 
donors, believe that as a new organization, the Global Fund should not 
press its current capacity too far, and our position is that Round Five 
should not occur until late 2005 and Round Six no earlier than the 
following year. The Fund's first projects will not come up for review 
and possible renewal until August 2004, and we will have a better sense 
at that time of its performance record and future needs.
    Question. On April 6, 2004, the Global Fund to Fight AIDS, TB and 
Malaria, the World Bank, UNICEF and the Clinton Foundation brokered a 
deal to announce that high quality AIDS medicines would be available 
for prices 50 percent less than currently available.
    Will the President's initiative take advantage of these of these 
options?
    Answer. It has always been our policy to provide, through the 
Emergency Plan, drugs that are acquired at the lowest possible cost, 
regardless of origin or who produces them, as long as we know they are 
safe, effective, and of high quality. These drugs could include brand-
name products, generics or copies of brand-name products.
    Our commitment from the beginning has been to move with urgency to 
help build the human and physical capacity needed to deliver this 
treatment, and to fund the purchase of HIV/AIDS drugs to provide this 
treatment at the most cost-effective prices we can find--but only drugs 
we can assure ourselves are safe and effective. The people we are 
serving deserve the same assurances of safety and efficacy that we 
expect for our own families here in the United States. There should not 
be a double standard for quality and safety.
    On May 16, Health and Human Services (HHS) Secretary Tommy G. 
Thompson and U.S. Global AIDS Coordinator Ambassador Randall L. Tobias 
held a joint press conference in Geneva, Switzerland, in advance of the 
World Health Assembly. Secretary Thompson and Ambassador Tobias made 
two very important announcements on these issues.
    First, Secretary Thompson announced an expedited process for HHS, 
through its Food and Drug Administration (FDA), to review applications 
for HIV/AIDS drug products that combine already-approved individual 
HIV/AIDS therapies into a single dosage, often referred to as ``fixed-
dose combinations'' (FDCs), and for co-packaged products, often 
referred to as ``blister packs.'' Drugs approved by HHS/FDA under this 
process will meet all normal HHS/FDA standards for drug safety, 
efficacy, and quality.
    This new HHS/FDA process will include the review of applications 
from research-based companies that have developed already-approved 
individual therapies, or from companies that are manufacturing copies 
of those drugs for sale in developing nations. There are no true 
generic versions of these HIV/AIDS drugs because they all remain under 
intellectual property protection here in the United States. The steps 
taken by HHS/FDA could encourage the development of new and better 
therapies to help win the war against HIV/AIDS.
    Second, Ambassador Tobias announced that when a new combination 
drug for HIV/AIDS treatment receives a positive outcome under this 
expedited HHS/FDA review, the Office of the U.S. Global AIDS 
Coordinator will recognize that evaluation as evidence of the safety 
and efficacy of that drug. Thus the drug will be eligible to be a 
candidate for funding by the Emergency Plan for AIDS Relief, so long as 
international patent agreements and local government policies allow 
their purchase. Where it is necessary and appropriate to do so, 
Ambassador Tobias will also use his authority to waive the ``Buy 
American'' requirements that might normally apply.
    We hope HHS/FDA will receive applications as soon as possible from 
many companies that will want their drugs to be candidates for use in 
the treatment programs of the President's Emergency Plan.
    Because of the President's Emergency Plan for AIDS Relief, and with 
the partnerships between the Emergency Plan and those individuals and 
organizations who are delivering treatment on the ground, we expect to 
increase the number of HIV-infected persons who are receiving treatment 
in our 14 focus countries by approximately 175,000. Today, patients are 
receiving treatment in Kenya and Uganda because of the Emergency Plan, 
and I expect that as we and others scale up our efforts, millions of 
more people will follow those who are already receiving this life-
extending therapy.
    Finally, we note that the most limiting factor in providing HIV/
AIDS treatment is not drugs--it is the human and physical capacity in 
the health care systems in the countries we are seeking to assist. Many 
countries are desperately short of health care infrastructure and 
health care workers. Both are needed to deliver treatment broadly and 
effectively. We are focused on addressing this limitation as well.

                                 ______
                                 
            Questions Submitted by Senator Richard J. Durbin

    Question. Mr. Ambassador, I would like to get clarification on the 
Administration's position on contributions to the Global Fund for 2005.
    The President's 2005 budget provides only $200 million for the 
Global Fund in 2005. This is less than half of the $547 million 
Congress provided in 2004 and far less than the most conservative 
estimate of Global Fund need from the United States for 2005 of $1.2 
billion. The Global Fund is a critical partner in the 14 countries that 
are part of the President's Emergency Plan for AIDS Relief (PEPFAR) and 
is needed in all the other countries that PEPFAR won't reach (the 
Global Fund currently has grants in 122 countries). The Global Fund is 
currently the most important new funder of TB and malaria, as well as 
AIDS programs, globally.
    (1) Mr. Ambassador, can you justify the President's $200 million 
request for the Global Fund in 2005, explaining why this amount is 
sufficient when it represents only 37 percent of what was appropriated 
for the Global Fund for 2004, only 24 percent of what the Global Fund 
has already raised for 2005, and only 6 percent of what the Global Fund 
will need in 2005 if it approves two rounds for that year?
    (2) Why has the Administration proposed such severe cuts to the 
Global Fund?
    (3) How can we provide leadership to the Fund while providing only 
$200 million, only six percent? $200 million isn't even a third of 
what's needed to keep existing programs running--that would be around 
$530m.
    (4) How will the Global Fund be able to renew existing grant awards 
from Rounds 1-3 and be able to award grants in Rounds 5 and 6 to the 
many countries left out of your 14 country initiative, yet equally 
needy?
    (5) Will you support funding the Global Fund at a level of $1.2 
billion to meet its 2005 need?
    Answer. The President's Emergency Plan for AIDS Relief made a $200 
million per year commitment of pledges for the five-year period of 
2004-2008. Our fiscal year 2005 request therefore remains the same as 
our request in fiscal year 2004. We were the first donor to make such a 
long-term pledge of support to the Global Fund, which together with our 
previous donations to the Fund still represents nearly 40 percent of 
all pledges and contributions through 2008.
    The American people can be extremely proud of our record of support 
for the Global Fund, which is an integral part of the Emergency Plan 
for AIDS Relief. As you note, we cannot make every country a focus 
country, and there are other nations equally needy. When the United 
States contributes to a project of the Global Fund, it means that our 
dollars are leveraged in these grants by a factor of two, since the 
United States thus far has provided one-third of all Fund monies. The 
Fund has so far committed $2.1 billion to 224 grants in 121 countries 
and three territories. So it is in our interests, as well as the 
interest of all people struggling against HIV/AIDS, malaria and 
tuberculosis, to see to it that the Global Fund is an effective partner 
in the fight against these diseases.
    The Global Fund nevertheless is a relatively new organization, 
particularly in comparison to the 20 years of bilateral HIV/AIDS 
programs carried out by the United States and other bilateral donors. 
Like all new organizations, it is quite understandably undergoing some 
growing pains. As of May 15, 2004, the Global Fund had disbursed 
approximately $311 million to Principal Recipients since the Global 
Fund's Board approved its first round of funding in January 2002. This 
compares to the first $350 million under the President's Emergency Plan 
sent to our focus countries only three weeks after the program first 
received its funding.
    This is not to criticize the Global Fund for being slow--indeed, 
the United States is one of the donors that has been urging the Global 
Fund to move carefully to ensure accountability and avoid waste. It 
does highlight, however, the potential effectiveness of bilateral 
assistance where donors already have an in-country presence.
    We need both multilateral and bilateral avenues of assistance; 
neither the Global Fund nor bilateral donors can do it all. Other 
bilateral donors also need to step up with greater technical assistance 
to Global Fund projects, since without which those projects will 
founder.
    In addition, the United States believes that to disburse funds 
effectively and efficiently, Country Coordinating Mechanisms (CCMs) and 
Local Fund Agents (LFAs) must get actively engaged in overseeing the 
implementation of grant activities. The United States in particular 
would like to see a stronger representation of the private sector, non-
governmental organizations, and people living with the diseases on 
CCMs, which are largely (approximately 85 percent) chaired by 
government ministries. Engaging a broader representation of various 
stakeholders will help reduce potential acts of corruption, and will 
allow for a wider distribution of funds so that more individuals in 
need can be served.
    The Global Fund has already announced, in advance of the June Board 
meeting, that the two-year budgets of Round Four proposals recommended 
by the independent Technical Review Panel will not exceed the cash 
already on-hand, so that, at least through this Round, no funding gap 
exists. And we, along with other donors, believe that as a new 
organization, it might be best for the Global Fund not to press its 
current capacity too far, and our position is that Round Five should 
not occur until late 2005 and Round Six no earlier than the following 
year. The Global Fund's first projects will not come up for review and 
possible renewal until August 2004, and we will have a better sense at 
that time of its performance record and future financial needs.
    Question. Ambassador Tobias, tuberculosis is the greatest curable 
infectious killer on the planet and the biggest killer of people with 
HIV. Treating TB in people with HIV can extend their lives from weeks 
to years. I am very concerned that the President's 2005 budget actually 
cuts TB and malaria funding by some $46 million. And the President's 
AIDS initiative fails to focus on expanding TB treatment as the most 
important thing we can do right now to keep people with AIDS alive and 
the best way to identify those with AIDS who are candidates for anti-
retroviral drugs.
    I was just in India where TB is a currently far greater problem 
than HIV--though AIDS is rapidly catching up--and a new WHO report has 
shown that parts of the former Soviet Union and Eastern Europe have 
rates of dangerous drug resistant TB 10 TIMES the global average! TB 
rates have skyrocketed in Africa in conjunction with HIV, and yet only 
one in three people with HIV in Africa who are sick with TB even have 
access to basic life-saving TB treatment. We are missing the boat on 
this issue--at our own risk! The cuts in TB funding are short-sighted 
and I think TB efforts should be expanded.
    (6) Make it a priority to expand access to TB treatment for all HIV 
patients with TB and link TB programs to voluntary counseling and 
testing for HIV.
    (7) Push to expand overall funding to fight TB to our fair share of 
the global effort? (The United States is currently investing about $175 
million in TB from all sources, including our contribution to the 
Global Fund.)
    (8) Consider appointing a high-level person in your office to be 
the point person for TB efforts?
    Answer. The Office of the U.S. Global AIDS Coordinator is committed 
to the appropriate coordination, integration and support of 
tuberculosis (TB) and HIV/AIDS services and programs across the U.S. 
Government. As you are aware, opportunistic infections, such as TB and 
malaria, are great risks to the overall health of HIV-infected 
individuals. TB is frequently the first manifestation of HIV/AIDS 
disease, the reason many people first present themselves for medical 
care, and the leading killer of people with HIV/AIDS.
    Since both tuberculosis treatment and HIV/AIDS treatment require 
longitudinal care and follow-up, successful TB programs provide 
excellent platforms upon which to build capacity for HIV/AIDS 
treatment. The Emergency Plan will improve referral for TB patients to 
HIV testing and care, support TB treatment for those who are HIV-
infected and develop HIV treatment capacity in TB programs. In 
addition, interventions that increase the number of persons diagnosed 
and treated for HIV/AIDS will increase the need for TB treatment and 
care. Therefore, action is required to build or maintain necessary 
tuberculosis treatment capacity. For example, laboratories, clinical 
staff, community networks, and management structures used for TB 
control can be upgraded to accommodate HIV/AIDS treatment. Finally, 
because the prevalence of HIV infection is high among persons with 
tuberculosis, TB programs will be important sites for HIV testing in 
the focus countries as well as ensuring that TB testing is available in 
HIV testing, treatment and care sites.
    Finally, the Office of the U.S. Global AIDS Coordinator will take 
into consideration your suggestion for identifying an individual within 
the Office of the Coordinator to have specific responsibilities related 
to coordinating TB and HIV/AIDS efforts.
    Question. Ambassador Tobias, in September 2002, the National 
Intelligence Council released a report that identified India, China, 
Nigeria, Ethiopia and Russia, countries with large populations and of 
strategic interest to the US, as the ``next wave'' where HIV is 
spreading rapidly. India already contains one-third of the global TB 
burden, and because AIDS fuels TB, TB rates will also skyrocket as AIDS 
spreads.
    (9) Congress mandated a 15th country be included as a part of the 
President's AIDS Initiative. The PEPFAR strategy report stated that 
this 15th country will be named shortly. When will you make a decision? 
Do you know what country this will be?
    (10) What consideration is being given to including India as the 
15th country, given the large number of HIV cases already present, the 
growing HIV problem that is likely to become a more generalized 
epidemic and India's strategic importance?
    India also has a remarkable TB program that has expanded over 40 
fold in the last 5 years, and treated 3 million patients and trained 
300,000 health workers. I would suggest that India's TB program has 
important lessons for scale-up of AIDS treatment programs in India and 
globally and we should support it and use it as a model.
    Answer. Consultations regarding the selection of a 15th country 
have been underway. As a first step, the U.S. Global AIDS Coordinator 
has consulted with senior officials within the Administration, 
including at the U.S. Agency for International Development (USAID), the 
U.S. Department of Health and Human Services (HHS), and the U.S. 
Department of State, about possible candidate countries for the 15th 
focus country. From this consultative process, the Coordinator's Office 
has identified the following list of 39 countries by one or more of the 
agencies named above as a potential candidate for the 15th focus 
country.
 emergency plan for aids relief 15th focus country--initial candidate 
                               countries
    Albania, Armenia, Azerbaijan, Bangladesh, Belarus, Bolivia, Brazil, 
Burma, Cambodia, China, Croatia, Egypt, El Salvador, Estonia, Georgia, 
Guatemala, Honduras, India, Indonesia, Jordan, Kazakhstan, Kyrgystan, 
Latvia, Lithuania, Macedonia, Mexico, Moldova, Nepal, Nicaragua, Peru, 
Philippines, Romania, Russia, Tajikistan, Thailand, Turkmenistan, 
Ukraine, Uzbekistan, and Vietnam.
    Currently, these countries are being considered in the context of 
the 10 standards listed below. These considerations provide a basis for 
comparative analysis and discussion regarding the potential candidates. 
It is important to note that these do not represent weighted criteria 
against which Ambassador Tobias will quantitatively evaluate to 
recommend one to the President. We do not expect that any one country 
will excel in all areas; instead, Ambassador Tobias and his staff are 
evaluating each country for its collective strengths and weaknesses.
  --Severity and Magnitude of the Epidemic.--The prevalence rate, the 
        rate of increase in HIV infection, and the total number of 
        people living with HIV/AIDS.
  --Commitment of Host-Country Government.--The basis of leadership's 
        willingness to address HIV/AIDS and stigma and its desire to 
        partner in an amplified response.
  --Host-Country commitment of resource potential.--The degree to which 
        the host government has the capacity and the determination to 
        make trade-offs among national priorities and resources to 
        combat HIV/AIDS.
  --Enabling Environment.--The level of corruption, stigma, free press, 
        state of government bureaucracies and the strength of bilateral 
        partnerships, all of which help determine whether we can use 
        Emergency Plan resources effectively.
  --U.S. Government In-country Presence.--Whether the country has a 
        strong U.S. Government bilateral in-country presence through 
        USAID and/or HHS.
  --Applicability of Emergency Plan Approaches.--Whether modes of 
        transmission of HIV/AIDS in the host country are receptive to 
        Emergency Plan interventions.
  --Potential Impact of Emergency Plan Interventions.--How many people 
        we can reach and the effect of intervention on the trajectory 
        of disease.
  --Gaps in Response.--Whether the U.S. Government's technical 
        expertise, training, development and strengthening of health 
        care systems and infrastructure would fill gaps in the current 
        response.
  --Existence of Other Partners.--Whether non-governmental 
        organizations and other partners have a substantial in-country 
        presence and can facilitate rapid expansion of services and the 
        efficient use of funds.
  --U.S. Strategic Interests.--The Emergency Plan is ultimately a 
        humanitarian endeavor. At the same time, applicability of U.S. 
        strategic interests could further the sustainability of 
        programming, engender new sources of support, and offer 
        increased opportunities for partnerships.
    With regard to India, it is among the potential candidates for the 
15th focus country. As you know, India has the second-largest 
population of HIV-infected persons in the world, second only to South 
Africa. Regardless of its selection as a 15th focus country, an 
amplified response is necessary to stem the potential for a generalized 
epidemic that would greatly increase India's HIV/AIDS burden. India has 
a well-developed national strategic plan to address HIV/AIDS and a 
comparatively large pool of health professionals to assist in its 
implementation.
    In addition, the Emergency Plan for AIDS Relief includes nearly $5 
billion to support on-going bilateral HIV/AIDS programs in 
approximately 100 countries worldwide, including India. USAID and HHS 
are highly engaged and active in the HIV/AIDS response in India. India 
is a participating country in HHS' Global AIDS Program through which 
the Department allocated $2.3 million for HIV/AIDS programs in India in 
fiscal year 2002, and $3.6 million in fiscal year 2003. USAID allocated 
$12.2 million to HIV/AIDS prevention and care activities in India in 
fiscal year 2002, and $13.5 million in fiscal year 2003. Additionally, 
both the U.S. Departments of Defense and Labor have HIV/AIDS programs 
underway in India. Numerous other donors, including governments, the 
private sector, multilateral organizations, and foundations, also fund 
HIV/AIDS programs in India.
    With regard to using India's tuberculosis program as a model for 
HIV/AIDS treatment, the President's Emergency Plan for AIDS Relief is 
focused on identifying and promoting evidence-based best practices in 
combating HIV/AIDS. The Directly Observed Therapy Short-Course (DOTS) 
treatment that has been so effective in India has served as a model for 
HIV/AIDS treatment programs in Haiti and elsewhere. One of the most 
important lessons drawn from the DOTS program is its use of community 
health workers to expand access to treatment. The network model of 
treatment and care promoted by the President's Emergency Plan 
implements this lesson by using community health workers to expand 
access to HIV/AIDS treatment in rural areas where consistent access to 
medical health professionals is limited.
    The President's Emergency Plan for AIDS Relief also recognizes the 
importance of local context in implementing effective HIV/AIDS 
treatment programs. India's human resource capacity is significantly 
greater than that of many focus countries of the President's Emergency 
Plan, as is the reach of its health care infrastructure. These 
advantages play a significant role in India's tuberculosis treatment 
success, but represent limiting factors in access to treatment in the 
focus countries. Thus, the Emergency Plan, while actively implementing 
best practices identified from the success of DOTS therapy, focuses 
significant resources in building human capacity and strengthening 
health infrastructure in the focus countries to support expanded 
treatment programs.
    Question. In a press release of April 13, 2004, USAID announced the 
first round of grants made under PEPFAR with fiscal year 2004 funding. 
Five grants were announced for projects in just some of the 14 
countries eligible for PEPFAR funding, totaling less than $35 million. 
Only three of these grants--totaling just $18 million were directed to 
orphans and vulnerable children (OVC) programs. Not one of these grants 
exceeded $7 million, even though all were for efforts in multiple 
countries.
    Given the magnitude of the orphan problem, and the grave 
consequences it has for the children, their families and communities, 
and for their countries, these efforts seems far too tentative and too 
limited, far smaller than the effort anticipated by Congress in 
allocating 10 percent of fiscal year 2004 HIV/AIDS funds for OVC 
programs.
    I am concerned that our financial support to date is too limited to 
effectively address the needs of rapidly growing numbers of orphans and 
other children affected by AIDS.
    (11) Can you tell me how much of the fiscal year 2004 appropriation 
for HIV/AIDS has in fact been committed to date for this purpose and 
how much will be committed in fiscal year 2005?
    (12) Can you assure me that fully 10 percent of the 2005 
appropriations will be dedicated to this critical problem and that 
funding for OVC programs will expand significantly from what appears to 
be a slow and tentative beginning?
    Answer. Each of the identified focus countries has submitted a 
Country Operational Plan (COP) for approval to Office of the U.S. 
Global AIDS Coordinator. Each COP describes the activities the U.S. 
Government will undertake for the remainder of fiscal year 2004 in that 
country. Once these plans are approved, the amount of fiscal year 2004 
resources committed for activities to address orphans and vulnerable 
children will be available, and the Global AIDS Coordinator will be 
pleased to share the information with your office.
    The United States Leadership Against HIV/AIDS, Tuberculosis, and 
Malaria Act of 2003 (Public Law 108-25) provides that for fiscal years 
2006 through 2008 not less than 10 percent of the amounts appropriated 
for bilateral HIV/AIDS assistance be expended for assistance for 
orphans and vulnerable children affected by HIV/AIDS. The Office of the 
U.S. Global AIDS Coordinator is committed to meeting this funding 
requirement through a broad-range of activities targeted at the needs 
of orphans and vulnerable children. In addition, USAID has recognized 
the importance of funding programs to support children affected by HIV/
AIDS for the past few years. USAID's programs in this area are 
beginning to grow significantly under the Emergency Plan. Grants for 
orphans and vulnerable children were some of the first announced under 
the Emergency Plan. These grants will provide resources to assist in 
the care of about 60,000 additional orphans in the Emergency Plan's 14 
focus countries in Africa and the Caribbean. Approaches to care will 
include providing critical, basic social services, scaling up basic 
community-care packages of preventive treatment and safe water, as well 
as HIV/AIDS prevention education.
    Prior to the implementation of the Emergency Plan, USAID was 
funding over 125 programs in 27 countries to specifically respond to 
the unique issues facing children affected by HIV/AIDS. In addition, 
USAID funds a consortium of groups who are working together as the 
``Hope for Africa's Children Initiative.''
    Question. Scale-Up: The HIV/AIDS pandemic has had an enormous 
impact on the world's youth. To date, 13-14 million children have been 
orphaned by AIDS, and that number is expected to reach more than 25 
million by 2010. The virtual ``tsunami'' of orphans in sub-Saharan 
Africa will spread to new countries in Africa and to Asia as death 
rates from AIDS rise in those regions.
    (13) Within PEPFAR and other programs, what are you currently doing 
to scale-up efforts as regards AIDS treatment, health care and getting 
these children in school?
    Answer. Under the Emergency Plan for AIDS Relief, activities 
targeted at orphans and vulnerable children will be aimed at improving 
the lives of children and families affected by HIV/AIDS. The emphasis 
is on strengthening communities and families to meet the needs of 
orphans and vulnerable children affected by HIV/AIDS, supporting 
community-based responses, helping children and adolescents meet their 
own needs, and creating a supportive social environment. Program 
activities could include the following:
  --Training caregivers;
  --Increasing access to education;
  --Economic support;
  --Targeted food and nutrition support;
  --Legal aid;
  --Support of institutional responses;
  --Medical, psychological, or emotional care; and,
  --Other social and material support.
    Question. Yesterday Secretary Thompson announced a major shift in 
AIDS policy relating to anti-retroviral (ARV) drugs. It is good news 
that the administration has created a policy that will be more 
streamlined than the usual HHS/FDA process for approval of anti-
retroviral (ARV) generic and combination drugs. But it also seems to be 
creating a parallel process to that which the World Health Organization 
has set up to pre-qualify generic and combination ARV drugs.
    I am concerned that this policy undermines the authority of the 
World Health Organization, which did such an admirable job combating 
SARS and that we need now to be strong in fighting AIDS. It also seems 
a slap in the face to our European allies whose regulatory authorities 
are the underpinning of the WHO's pre-qualification process.
    (14) Are you at all concerned at the message this sends to our 
partners abroad about the level of respect we are prepared to give 
them?
    (15) How will you ensure that the WHO retains its role and has the 
resources to expand its provision of technical assistance?
    Answer. It has always been our policy to provide, through the 
Emergency Plan, drugs that are acquired at the lowest possible cost, 
regardless of origin or who produces them, as long as we know they are 
safe, effective, and of high quality. These drugs could include brand-
name products, generics or copies of brand-name products.
    Our commitment from the beginning has been to move with urgency to 
help build the human and physical capacity needed to deliver this 
treatment, and to fund the purchase of HIV/AIDS drugs to provide this 
treatment at the most cost-effective prices we can find--but only drugs 
we can assure ourselves are safe and effective. The people we are 
serving deserve the same assurances of safety and efficacy that we 
expect for our own families here in the United States. There should not 
be a double standard for quality and safety.
    On May 16, Health and Human Services (HHS) Secretary Tommy G. 
Thompson and U.S. Global AIDS Coordinator Ambassador Randall L. Tobias 
held a joint press conference in Geneva, Switzerland, in advance of the 
World Health Assembly. Secretary Thompson and Ambassador Tobias made 
two very important announcements that impact on these issues.
    First, Secretary Thompson announced an expedited process for HHS, 
through its Food and Drug Administration (FDA), to review applications 
for HIV/AIDS drug products that combine already-approved individual 
HIV/AIDS therapies into a single dosage, often referred to as ``fixed-
dose combinations'' (FDCs), and for co-packaged products, often 
referred to as ``blister packs.'' Drugs approved by HHS/FDA under this 
process will meet all normal HHS/FDA standards for drug safety, 
efficacy, and quality.
    This new HHS/FDA process will include the review of applications 
from research-based companies that have developed already-approved 
individual therapies, or from companies that are manufacturing copies 
of those drugs for sale in developing nations. There are no true 
generic versions of these HIV/AIDS drugs because they all remain under 
intellectual property protection here in the United States. The steps 
taken by the HHS/FDA could encourage the development of new and better 
therapies to help win the war against HIV/AIDS.
    Second, Ambassador Tobias announced that when a new combination 
drug for HIV/AIDS treatment receives a positive outcome under this 
expedited HHS/FDA review, the Office of the U.S. Global AIDS 
Coordinator will recognize that evaluation as evidence of the safety 
and efficacy of that drug. Thus the drug will be eligible to be a 
candidate for funding by the Emergency Plan for AIDS Relief, so long as 
international patent agreements and local government policies allow 
their purchase. Where it is necessary and appropriate to do so, 
Ambassador Tobias will also use his authority to waive the ``Buy 
American'' requirements that might normally apply.
    We hope HHS/FDA will receive applications as soon as possible from 
many companies that will want their drugs to be candidates for use in 
the treatment programs of the President's Emergency Plan.
    With regard to the World Health Organization (WHO), we have the 
highest respect for the WHO and its prequalification pilot program. 
However, the WHO is not a regulatory authority. We must be assured the 
drugs we provide meet acceptable safety and efficacy standards and are 
of high quality. Under the Emergency Plan, we intend to support 
programs that will have a sustainable positive impact on health. If the 
medications in question have not been adequately evaluated, have had 
problems with safety or cause resistance issues in the future, the 
patients we serve and the international community we appropriately hold 
us accountable. We will continue to work with the WHO and the 
international community on this important area.
    Because of the President's Emergency Plan for AIDS Relief, and with 
the partnerships between the Emergency Plan and those individuals and 
organizations that are delivering treatment on the ground, we expect to 
increase the number of HIV-infected persons who are receiving treatment 
by approximately 175,000. Today, patients are receiving treatment in 
Kenya and Uganda because of the Emergency Plan, and we expect that as 
we and others scale up our efforts, millions of more people will follow 
those who are already receiving this life extending therapy.
    Finally, we note that the most limiting factor in providing HIV/
AIDS treatment is not drugs--it is the human and physical capacity in 
the health care systems in the countries we are seeking to assist. Many 
countries are desperately short of health care infrastructure and 
health care workers. Both are needed to deliver treatment broadly and 
effectively. We are focused on addressing this limitation as well.
    Question. Ambassador Tobias, while we know that your PEPFAR mandate 
keeps you focused on ramping up treatment and current preventive tools 
as quickly as possible in the countries hit hardest by the epidemic, 
the unfortunate truth is that treatment is unlikely to keep up with the 
growth of the epidemic. The President's plan calls for putting two 
million people on much-needed treatment by 2008, yet millions more will 
have been infected by then--5 million a year, according to UNAIDS.
    (16) What role do you see your office playing to catalyze efforts 
underway to develop and distribute a preventive vaccine?
    (17) What synergies do you see between the medical infrastructure 
needed for providing testing and treatment, and ongoing clinical trials 
in the developing world?
    (18) How can PEPFAR programs lay the groundwork for future delivery 
of vaccines and other preventive technologies like microbicides?
    Answer. I am strongly supportive of the need for research and 
development on new technologies for preventing HIV transmission, such 
as a preventive HIV vaccine, microbicides, and improved means to 
prevent mother-to-child HIV transmission (PMTCT). The U.S. Government, 
through the U.S. Department of Health and Human Services (HHS), the 
U.S. Department of Defense, and the U.S. Agency for International 
Development, has been substantially engaged in biomedical and 
behavioral research efforts in these areas for the past 20 years. 
Findings from HHS/National Institutes of Health (NIH) sponsored 
research provide the crucial scientific basis for HIV/AIDS treatment 
regimens, prevention interventions, and standards of care. My office 
intends to continue to support and promote research through leadership 
in continuing to advocate for such research, and to assure that it is 
well-coordinated with the goals of the President's Emergency Plan for 
AIDS Relief.
    In the field, there are a number of ways our new and expanded 
programs for HIV/AIDS prevention, care, and treatment will help to 
promote this important research into new prevention technologies. 
First, the core of our treatment and care activities will be 
implemented through the ``Network Model''. This model supports Central 
Medical Centers and other community settings where prevention research 
can take place in a quality health care setting, including the 
provision of anti-retroviral therapy and other HIV/AIDS prevention, 
care, and treatment (including PMTCT). Expanding these services through 
the Emergency Plan will provide an increased number of settings where 
HIV/AIDS prevention research can be supported. Second, the emphasis on 
``institutional twinning'' (defined as matching hospitals; clinics; 
schools of medicine, nursing, pharmacy, public administration, and 
management; and other institutions in the United States and other 
countries with counterparts in the 14 focus countries for the purposes 
of training and exchanging information and best practices) primarily 
focused on improving the capacity to provide HIV prevention, care, and 
treatment, will serve to expand strong relationships among institutions 
that also conduct research. Third, the capacity-building supported 
through the Emergency Plan that develops infrastructure and trains 
staff will have a spillover effect in ways that will promote research, 
such as training health care workers, establishing public health 
communications infrastructure, and improving clinical and laboratory 
capacity.
    It is not a coincidence that it has been the same developing 
countries that, with assistance from the U.S. Government, first 
participated in extensive clinical and vaccine research efforts that 
also have been the most successful in fighting the HIV/AIDS epidemic, 
especially by translating knowledge gained from clinical research into 
medical practice (e.g., Thailand, Uganda, Senegal, and Brazil). A 
robust clinical research infrastructure can be a foundation for 
building excellent clinical care and making the best use of the 
investments of the Emergency Plan for AIDS Relief.
    In addition to catalyzing research into new preventive 
technologies, the Emergency Plan also will lay the groundwork that will 
accelerate the ability to implement any new technologies that are found 
to be safe and effective. For instance, if a safe and effective HIV 
vaccine is identified, high-risk HIV-uninfected persons will be an 
appropriate target group for implementation. Such persons could be 
identified through the network of HIV testing sites built up through 
Emergency Plan investments. Likewise, if a safe and effective HIV 
microbicide is identified, it could be promoted widely through the same 
behavior change programs we are expanding to meet the HIV prevention 
goals of the Emergency Plan, and supplies of microbicide could be 
distributed through the same supply-chain management systems 
strengthened through Emergency Plan investments.

                                 ______
                                 
            Questions Submitted by Senator Mary L. Landrieu

    Question. (1) Domestic Violence.--Women make up 58 percent of the 
HIV/AIDS population in Africa. This higher number can be attributed to 
cultural vices within Africa about the reluctance permit women to take 
drugs to prevent mother-to-child transmissions and a high rate of 
domestic violence where men refuse to let women negotiate condom use, 
according to Human Rights Watch.
    What efforts are you pursuing to overcome the cultural obstacles to 
effectively treat and prevent HIV/AIDS? What efforts are you 
undertaking to curb domestic violence so that women may have a stake in 
both their physical safety from abuse and their medical well-being?
    Answer. Stigma and discrimination against persons living with HIV 
and AIDS, real or perceived, does present a significant obstacle to 
combating HIV/AIDS. It strengthens existing social inequalities and 
cultural prejudices, especially those related to gender, sexual 
orientation, economic status, and race. Stigma and denial also create 
barriers to our integrated multifaceted prevention, treatment, and care 
strategy.
    Under the Emergency Plan for AIDS Relief, we will act boldly to 
address stigma and denial through three operational strategies: (1) 
Engage local and national political, community, and religious leaders, 
and popular entertainers to speak out boldly against HIV/AIDS-related 
stigma and violence against women, and to promote messages that address 
gender inequality, encourage men to behave responsibly, promote HIV 
testing, and support those found to be HIV-positive to seek treatment; 
(2) Identify and build the capacity of new partners from a variety of 
sectors to highlight the harm of stigma and denial and promote the 
benefits of greater HIV/AIDS openness; and (3) Promote hope by 
highlighting the many important contributions of people living with 
HIV/AIDS, providing anti-retroviral treatment to those who are 
medically eligible, and involving those who are HIV-positive in 
meaningful roles in all aspects of HIV/AIDS programming.
    With regard to domestic violence, evidence from Uganda, Tanzania, 
and Zambia shows that violence against women is both a cause and 
consequence of rising rates of HIV infection--a cause because rape and 
sexual violence pose a major risk factor for women, and a consequence 
because studies have shown that HIV-positive women are more likely to 
suffer violence at the hands of a partner than those who are not 
infected. For many women, fear of sexual coercion and violence often 
precludes the option of abstinence or holds them hostage to their 
husband's or partner's infidelity. The Emergency Plan will work closely 
with communities, donors, and other stakeholders to reduce stigma, 
protect women from sexual violence related to HIV, promote gender 
equality, and build family skills through conflict resolution. The 
Emergency Plan will also support interventions to eradicate 
prostitution, sexual trafficking, rape, assault, and sexual 
exploitation of women and children.
    Question. (2) Orphans.--Ambassador Tobias, as you may know, I am 
the Chair of the Congressional Coalition on Adoption, and I will be 
traveling next week to Uganda with a focus on orphans and Uganda's 
efforts to curb the HIV/AIDS epidemic. Last year's legislation to 
combat the international HIV/AIDS epidemic included language to 
allocate 10 percent of U.S. funding to assist children orphaned by 
AIDS. The United Nations estimates we could have 20 million AIDS 
orphans by 2010.
    Could you outline how you office plans to use its funds to benefit 
orphans? What efforts are you taking to make it possible for these 
children to be adopted?
    Answer. The United States Leadership Against HIV/AIDS, 
Tuberculosis, and Malaria Act of 2003 (Public Law 108-25) provides that 
for fiscal years 2006 through 2008 not less than 10 percent of the 
amounts appropriated for bilateral HIV/AIDS assistance be expended for 
assistance for orphans and vulnerable children affected by HIV/AIDS. 
The Office of the U.S. Global AIDS Coordinator is committed to meeting 
this funding requirement through a broad-range of activities targeted 
at the needs of orphans and vulnerable children. The Emergency Plan for 
AIDS Relief, will aim activities at improving the lives of orphans and 
vulnerable children affected by HIV/AIDS and their families. The 
emphasis is on strengthening communities and families to meet the needs 
of orphans and vulnerable children affected by HIV/AIDS, supporting 
community-based responses, helping children and adolescents meet their 
own needs, and creating a supportive social environment. Program 
activities could include the following:
  --Training caregivers;
  --Increasing access to education;
  --Economic support;
  --Targeted food and nutrition support;
  --Legal aid;
  --Support of institutional responses;
  --Medical, psychological, or emotional care; and,
  --Other social and material support.
    U.S. policy is to encourage extended families to care for children 
who have lost their parents. If families are not available, the 
Emergency Plan will often provide support to communities to care for 
children orphaned by AIDS. For example, several programs in the focus 
countries are supporting the integration or re-integration of orphans 
and vulnerable children into their communities of origin, as well as 
identifying foster families in local communities to care for affected 
children.
    Programs that are part of the Emergency Plan for AIDS Relief are 
coordinated with polices and strategies of host governments and are 
responsive to local needs. Countries and communities are at different 
stages of HIV/AIDS response and have unique drivers of HIV, distinctive 
social and cultural patterns, and different political and economic 
conditions. Local circumstances must inform effective interventions, 
and the Emergency Plan will coordinate with local efforts.
    Question. (3) I mentioned, I will be traveling to Uganda next week, 
and Uganda has been praised for its ABC Plan, Abstinence, Be Faithful, 
and Condoms. Even with their successes, they still have a long way to 
go.
    Could you please name some of the countries taking proactive steps 
to fight HIV/AIDS? As I mentioned, even those countries taking the 
right steps have a long way to go, and will need long-term assistance 
to from the United States. Are there any efforts set up a graduation 
plan whereby countries will stop receiving U.S. assistance for meeting 
certain milestones? I worry we often set the bar too low for 
graduation. I see that in Eastern Europe we are curbing assistance 
because they are ``graduating'' toward democracies and market 
economies. What steps are being taken to make sure countries don't 
graduate too soon from HIV/AIDS assistance?
    Answer. All of the focus countries of the Emergency Plan for AIDS 
Relief are taking proactive steps to address the HIV/AIDS pandemic in 
their country. Examples include beginning anti-retroviral treatment 
pilot programs (Mozambique, Guyana), scaling up anti-retroviral 
treatment sites (Haiti, Namibia, South Africa, Uganda), increasing HIV 
testing and counseling opportunities through the expanded use of 
community health workers (Namibia), enhancing HIV surveillance, 
laboratory support, and blood-safety efforts (Tanzania), distributing 
culturally relevant HIV-prevention messages (Botswana) and working to 
effectively integrate or re-integrate orphans and vulnerable children 
into local communities (Haiti, Rwanda). However, as you suggest, these 
countries are facing many difficult challenges in fully addressing 
their HIV/AIDS epidemic. These challenges must be addressed before any 
of these countries are positioned to respond on their own.
    As you know, the Emergency Plan for AIDS Relief is a $15 billion, 
five-year initiative targeted to reaching the following goals across 
the 15 focus countries:
  --Providing treatment to 2 million HIV-infected adults and children;
  --Preventing 7 million new HIV infections; and,
  --Providing care to 10 million people infected and affected by HIV/
        AIDS, including orphans and vulnerable children.
    By developing and strengthening integrated HIV/AIDS prevention, 
treatment, and care, the Emergency Plan is focused on building local 
capacity to provide long-term, widespread, essential HIV/AIDS services 
to the maximum number of those in need. Key strategies include creating 
and/or enhancing the human and physical infrastructure needed to 
deliver care; supporting the host government and local, indigenous-led 
organizations in their response to their nation's epidemic; ensuring a 
continuous and secure supply of high-quality products to patients who 
need them at all levels of the health system; and coordinating with 
other donors to eliminate duplication of efforts and fill gaps. As the 
five-year initiative comes to a close, assessments will be made about 
the continuing need for U.S. Government bilateral support, especially 
in light of the host government's HIV/AIDS activities and the impact of 
the Global Fund to Fight AIDS, Tuberculosis, and Malaria.
    Question. (4) African Capacity to Make Its Own Drugs--
Independence.--The Bible tells us that if you give a man a fish he will 
eat for a day. If you teach a man to fish he will eat for a lifetime. 
Africa has very little capacity to treat this pandemic with its own 
resources. All drugs are imported and there have been reports of price 
gauging or the purchasing of dummy drugs.
    What efforts is your office undertaking to increase Africa's 
capacity to make its own drugs, to create a pharmaceutical 
infrastructure within Africa that can go from manufacturer to clinic to 
patient? This should reduce the cost for drugs.
    Answer. Ensuring procurement of high quality pharmaceutical 
products is absolutely essential for the HIV/AIDS programs under the 
Emergency Plan. The U.S. Department of Health and Human Services (HHS) 
recently announced an expedited process for U.S. Food and Drug 
Administration (FDA) review of applications for HIV/AIDS drug products 
that combine already-approved individual HIV/AIDS therapies into a 
single dosage--many of these products are currently made in the 
developing countries, including South Africa. The Office of the U.S. 
Global AIDS Coordinator also announced that when a new combination drug 
for HIV/AIDS treatment receives a positive outcome under this expedited 
HHS/FDA review, it will recognize that tentative approval as evidence 
of the safety and efficacy of that drug. Thus the drug will be eligible 
to be a candidate for funding by the Emergency Plan, so long as 
international patent agreements and local government policies allow its 
purchase. Where necessary and appropriate to do so, the U.S. Global 
AIDS Coordinator will also use his authority to waive the ``Buy 
American'' requirements that might normally apply. Second, HHS plans to 
announce a solicitation for a contract to provide technical assistance 
to regulatory authorities and pharmaceutical quality assurance. The 
U.S. Government will seek a contractor to perform specified tasks 
related to the quality assurance of HIV/AIDS-related pharmaceutical 
products. Final products purchased by the supply management system will 
meet appropriate standards for quality, safety and effectiveness. This 
activity will also be able to support provision of direct technical 
assistance to increase the capacity for quality assurance in-country 
and strengthen quality-testing procedures.
    Question. (5) Tulane/West Africa Health Organization.--Congress has 
expressed its support for a West African AIDS Initiative involving the 
Economic Community of West African States (ECOWAS), the West African 
Health Organization (WAHO) and American schools of public health 
(TULANE). The objective of such an initiative would be to develop and 
implement a coordinated effort to provide AIDS education, prevention 
and treatment in the West African states. As in all African countries, 
the ECOWAS nations struggle with overwhelming rates of infection for 
HIV/AIDS, a situation that poses grave potential crises in the loss of 
human life among the people of Africa. What are your views on such an 
initiative involving the West African Health Organization, supported by 
ECOWAS and American schools of public health?
    Answer. The scope and urgent timing for expansion of training 
programs places a high priority in recruiting all available, 
experienced institutions for the effort in fighting the global HIV/AIDS 
pandemic, including outstanding implementing partners like Tulane that 
are interested and willing to establish twinning relationships with 
local institutions in the 15 focus countries of the President's 
Emergency Plan. Tulane is already highly involved, and its involvement 
was recently and substantially scaled up, through the HHS University 
Technical Assistance Program (UTAP). We expect to depend greatly on the 
steadily expanding work of all such outstanding partners over the 
course of this Initiative.
    Questions. (6) Ambassador Tobias, would you explain how you plan to 
ship the anti-retrovirals and other drugs needed to treat HIV/AIDS, TB 
and malaria to Africa? Do you intend to use containerized shipping?
    (7) In light of this, to what extent do you expect the drugs to 
experience degradation in quality as a result of high temperatures and 
humidity during oceanic shipment and port clearance?
    (8) What is the effect of such degradation on resistance to anti-
retrovirals among the patient population?
    (9) Would you agree that production of these drugs in Africa could 
address this problem of degradation if accompanied by stringent quality 
controls?
    Answer. On behalf of the U.S. Global AIDS Coordinator, the U.S. 
Agency for International Development (USAID) plans to announce for 
public comment imminently a request for proposal for a supply-chain 
management contract. The purpose of this contract is 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. This contract will ask 
for a consortium to perform a number of tasks, including procurement, 
in-country assistance, logistical management information system, as 
well as freight forwarding. We anticipate the contractor will ensure 
timely, accurate, safe, and cost-effective freight-forwarding services 
for all products, and we will expect it to make efforts to minimize any 
product degradation. The contractor will conduct periodic reviews of 
freight-forwarding practices, and identify special or reoccurring 
delivery problems and devise timely and cost-effective solutions for 
them. In addition, the contractor will establish quality-assurance 
procedures to ensure that required storage and handling standards for 
products shipped are met, to guarantee that a safe, effective, and 
high-quality product reaches the patient. To make certain of that, we 
anticipate the contractor will devise and carry out random testing of 
production lots purchased by the system and released for shipment. The 
contractor will make efforts to purchase products that require minimal 
shipping times, as long as it meets the Emergency Plan's goal of 
procuring pharmaceuticals at the lowest possible cost while 
guaranteeing safety, quality and effectiveness.
    Question. (10) Finally, in last year's appropriations report 
language, the managers encouraged you to consider a pilot program, 
including public-private partnerships and faith-based organizations, 
aimed at increasing sustainability through indigenous production of 
drugs in Africa. What steps, if any, have you taken to explore the 
possibility of producing the required drugs in Africa while respecting 
intellectual property rights?
    Answer. Ensuring procurement of high quality pharmaceutical 
products is absolutely essential for the HIV/AIDS programs under the 
Emergency Plan. The U.S. Department of Health and Human Services (HHS) 
recently announced an expedited process for U.S. Food and Drug 
Administration (FDA) review of applications for HIV/AIDS drug products 
that combine already-approved individual HIV/AIDS therapies into a 
single dosage--many of these products are currently made in the 
developing countries, including South Africa. The Office of the U.S. 
Global AIDS Coordinator also announced that when a new combination drug 
for HIV/AIDS treatment receives a positive outcome under this expedited 
HHS/FDA review, it will recognize that tentative approval as evidence 
of the safety and efficacy of that drug. Thus the drug will be eligible 
to be a candidate for funding by the Emergency Plan, so long as 
international patent agreements and local government policies allow its 
purchase. Where necessary and appropriate to do so, the U.S. Global 
AIDS Coordinator will also use his authority to waive the ``Buy 
American'' requirements that might normally apply. Secondly, HHS plans 
to announce a solicitation for a contract to provide technical 
assistance to regulatory authorities and pharmaceutical quality 
assurance. The U.S. Government will seek a contractor to perform 
specified tasks related to the quality assurance of HIV/AIDS-related 
pharmaceutical products. Final products purchased by the supply 
management system will meet appropriate standards for quality, safety 
and effectiveness. This activity will also be able to support provision 
of direct technical assistance to increase the capacity for quality 
assurance in-country and strengthen quality-testing procedures.
    Question. (11) Fixed-Dose Combinations and Pediatric Treatment.--
Children are not small adults when it comes to medicines and HIV/AIDS 
is no exception. Many AIDS medicines, particularly fixed dose 
combinations and other non-brand medicines have yet to be tested for 
use by children. With 2.5 million children infected with HIV around the 
world, it is essential that children are not an afterthought in our 
care and treatment activities.
    A. Will the new HHS/FDA review process require that fixed-dose 
combinations (FDCs), both generic and brand, be available for pediatric 
use?
    B. How does the President's five year strategy address the special 
needs of children who require HIV treatment?
    C. What is the Administration doing to ensure that both medical 
professionals and others have the necessary information, equipment and 
training to treat children with HIV/AIDS?
    Answer. The announcement on May 16 by U.S. Health and Human 
Services Secretary Tommy G. Thompson and U.S. Global AIDS Coordinator 
Ambassador Randall L. Tobias included two important components that 
address these issues.
    First, Secretary Thompson announced an expedited process for the 
U.S. Department of Health and Human Services (HHS), through its Food 
and Drug Administration (FDA), to review of applications for HIV/AIDS 
drug products that combine already-approved individual HIV/AIDS 
therapies into a single dosage, often referred to as ``fixed-dose 
combinations (FDCs),'' and for co-packaged products, often referred to 
as blister packs. Drugs HHS/FDA approves under this process will meet 
all normal HHS/FDA standards for drug safety, efficacy, and quality.
    This new HHS/FDA process will include the review of applications 
from research-based companies that have developed already-approved 
individual therapies, or from companies that are manufacturing copies 
of those drugs for sale in developing nations. There are no true 
generic versions of these HIV/AIDS drugs because they all remain under 
intellectual property protection here in the United States. The steps 
taken by HHS/FDA could encourage the development of new and better 
therapies to help win the war against HIV/AIDS.
    Second, Ambassador Tobias announced that when a new combination 
drug for HIV/AIDS treatment receives a positive outcome under this 
expedited HHS/FDA review, the Office of the U.S. Global AIDS 
Coordinator will recognize that evaluation as evidence of the safety 
and efficacy of that drug. Thus the drug will be eligible to be a 
candidate for funding by the Emergency Plan for AIDS Relief, so long as 
international patent agreements and local government policies allow its 
purchase.
    We hope HHS/FDA will receive applications as soon as possible from 
many companies that will want their drugs, including drugs for treating 
children, to be candidates for use in the treatment programs of the 
President's Emergency Plan.
    With regard to how the President's Emergency Plan will further 
address the special needs of children who require HIV treatment, you 
might recall that before the President announced the Emergency Plan in 
his January 2003 State of the Union address, in June 2002 he announced 
his $500 million International Mother-and-Child HIV Prevention 
Initiative for Africa and the Caribbean. After more than a year of 
implementation, that initiative is now part of the Emergency Plan, and 
is intended to treat one million women annually and reduce mother-to-
child transmission of HIV by 40 percent within five years or less in 
target countries.
     With regard to ensuring that both medical professionals and others 
have the necessary information, equipment, and training to treat 
children with HIV/AIDS, under the Emergency Plan we are committed to 
developing sustainable HIV/AIDS healthcare networks. We recognize the 
limits of health resources and capacity in many, particularly rural, 
communities. To more effectively address that shortfall, we will build 
on and strengthen systems of HIV/AIDS healthcare based on the 
``network'' model. Prevention, treatment, and care protocols will be 
developed, enhanced, and promoted in concert with local governments and 
Ministries of Health. With interventions emphasizing technical 
assistance and training of healthcare professionals, healthcare 
workers, community-based groups, and faith-based organizations, we will 
build local capacity to provide long-term, widespread, essential HIV/
AIDS care to the maximum number of those in need.
    Question. (12) Prevention of Mother-to-Child Transmission (MTCT).--
The President's Global HIV/AIDS strategy recognizes that by giving a 
simple dose of anti-retroviral drugs to pregnant women and to the 
infant shortly after delivery, we can reduce mother-to-child 
transmission of HIV by almost 50 percent. For fiscal year 2005, MTCT 
activities will be integrated and financed through the Global HIV/AIDS 
Initiative.
    A. Out of your $1.4 billion request, how much are you requesting 
for MTCT?
    B. Will funding for MTCT be considered as part of the 55 percent 
target for treatment programs? If so, will you track spending and 
numbers of people covered separately for these MTCT activities?
    C. In countries hardest hit by the pandemic, less than 1 percent of 
women have access to MTCT services. Do you have any plans to scale up 
existing MTCT programs? If so, how will this be implemented?
    D. How will the Administration expand MTCT services to people who 
do not have access?
    Answer. Ambassador Tobias will make fiscal year 2005 funding 
decisions based upon the submission of a unified annual Country 
Operational Plan (COP) from each of the 15 focus countries. This plan 
maximizes the core competencies and comparative advantages of all U.S. 
Government departments and agencies with in-country HIV/AIDS activities 
and allocates resources according to those core competencies and 
comparative advantages. The COPs for fiscal year 2005 will further 
illuminate how each focus country will harness those core competencies 
to reach the overall five-year Emergency Plan goals and how the 
allocation of resources among departments and agencies in the annual 
operational plan will contribute to reaching those goals. After 
Ambassador Tobias has approved the COPs, the Office of the U.S. Global 
AIDS Coordinator will be able to determine how much of fiscal year 2005 
funding to allocate to the prevention of mother-to-child transmission 
(PMTCT) activities.
    Regarding program classification, the Emergency Plan will consider 
traditional PMTCT activities as prevention activities and tracked 
accordingly. Under the Emergency Plan, the package of care for 
preventing mother-to-child transmission will include counseling and 
testing for pregnant women; anti-retroviral prophylaxis to prevent 
mother-to-child transmission; counseling and support for safe infant 
feeding practices; and voluntary family planning counseling or 
referral. The Emergency Plan will consider PMTCT-plus (HIV anti-
retroviral treatment for HIV-infected mothers and other members of the 
child's immediate family) treatment activities.
    As you note, the President's International Mother and Child HIV 
Prevention Initiative (MTCT Initiative) has become a major pillar of 
the President's Emergency Plan for AIDS Relief. During the initial 
phase of the MTCT Initiative's programming, anti-retroviral treatment 
was not broadly available, and our emphasis was on saving those babies 
at-risk for HIV infection during childbirth and early infancy. Now, the 
Emergency Plan is scaling up ARV treatment programs to provide ongoing 
ARV therapy to communities at large.
    Building on the significant work already accomplished under the 
MTCT Initiative in 14 of the 15 focus countries, the Emergency Plan is:
  --Scaling up existing PMTCT programs by rapidly mobilizing resources;
  --Providing technical assistance and expanded training for health 
        care providers (including family planning providers, 
        traditional birth attendants, and others) on appropriate 
        antenatal care, safe labor and delivery practices, 
        breastfeeding, malaria prevention and treatment, and voluntary 
        family planning;
  --Strengthening the referral links among health care providers;
  --Ensuring effective supply-chain management of the range of PMTCT-
        related products and equipment; and,
  --Expanding PMTCT programs to include HIV anti-retroviral treatment 
        for HIV-infected mothers and other members of the child's 
        immediate family (commonly known as ``PMTCT-plus'').
    In addition, two key strategic principles of the Emergency Plan are 
the development and strengthening of integrated HIV/AIDS prevention, 
treatment, and care and the development of sustainable HIV/AIDS health 
care networks. With interventions that emphasize technical assistance 
and training of health care professionals, health care workers, 
community-based groups, and faith-based organizations, the Emergency 
Plan is committed to building local capacity to provide long-term, 
widespread, essential HIV/AIDS care to the maximum number of those in 
need.
    Question. (13) HHS/FDA Process for Review of Fixed Dose Combination 
(FDC) Products.--Two days ago, Secretary Thompson announced that HHS/
FDA will establish an expedited review process for products that 
combine individual HIV/AIDS therapies into a single pill, also known as 
fixed-dose combination drugs. For the Administration's global AIDS 
initiative to be successful, it is critically important that we are 
able to purchase high-quality drugs at the most affordable price. If we 
move quickly, we can serve larger numbers of children and adults who 
are in need of AIDS drugs.
    A. How soon do you expect this new system to be in place, and when 
do you think we'll have FDCs approved for use in resource-poor nations?
    B. Some countries only allow for the purchase of brand or generic 
drugs. For example, in South Africa you can only buy brand drugs. Do 
you think this new process will provide momentum for countries to allow 
for the purchase of both brand and generic drugs? What are we doing in 
this area?
    C. I understand that you will also be creating a competitive 
procurement process to purchase medications. When will this process be 
in place? Do you have estimates for how much drugs might cost under 
this system?
    Answer. Guidance proposed by the U.S. Department of Health and 
Human Services (HHS) through its Food and Drug Administration (FDA) to 
implement the rapid review process of fixed-dose combination and co-
packaged HIV/AIDS drugs has outlined four scenarios for reviewing 
different FDC and co-packaged products. Some of the scenarios could 
permit approval in as little as two to six weeks after submission of a 
high-quality application. For companies that make products for which 
another firm owns the U.S. patent rights, HHS/FDA could issue a 
tentative approval when it finds the product meets the agency's normal 
safety and efficacy standards.
    To obtain approval of new products, manufacturers could cite 
existing clinical data to demonstrate the safety and effectiveness of 
the individual drugs in the new combined product--and new data to show 
effectiveness of the new combination could be developed quickly. HHS/
FDA has pledged to work with companies to help them develop that data 
rapidly if they do not already have access to such data. HHS/FDA is 
also evaluating whether it can waive or reduce user fees, normally 
charged to companies making new drug applications, for products 
reviewed under this rapid review process.
    With regard to the creation of a competitive procurement process to 
purchase HIV/AIDS medications under the Emergency Plan, as described in 
the answer to questions 6-9 above, USAID plans to announce for public 
comment imminently a request for proposal for a supply-chain Management 
contract. The purpose of this contract is to establish a safe, secure, 
reliable, and sustainable supply chain for the Emergency Plan and to 
procure pharmaceuticals and other products needed to provide care and 
treatment of persons with HIV/AIDS and related infections at the lowest 
possible cost with guaranteed safety, quality and effectiveness. This 
contract will include procurement, in-country assistance, logistical 
management information system, as well as freight forwarding.
    Question. (14) a. Given that other disease treatment programs 
involving inexpensive drugs and treatments are still major health 
problems in Africa due to the lack of a human resource infrastructure 
(malaria being a very good example), why do you believe that the more 
complex to deliver anti-retroviral programs for HIV/AIDS will succeed? 
What needs to be in place for this effort to be successful?
    Answer. A lack of human resources for health (HRH) is holding back 
health interventions in Africa for malaria and other health problems, 
even though the interventions for malaria and other are technically 
much cheaper and simpler than anti-retroviral treatment. The Emergency 
Plan needs several things to be successful:
    A. Better data on the current health workforce in place in 
countries (both employed and unemployed), a better understanding of the 
underlying reasons for the dismal current status, morale and 
performance of HRH, and concerted short- and medium-term actions by the 
U.S. Government in collaboration with national governments and other 
donors to address those causes;
    B. Short-term actions to rapidly prepare and deploy more health 
care workers to meet the requirements for emergency delivery of needed 
care [local health care workers (nationals) must be the bulwark of the 
response, but expatriate volunteers placed through institutional 
twinning arrangements can be important in assisting in emergency care 
and in the initial phase of building sustainable capacity for ongoing 
training in more complex interventions such as anti-retroviral 
treatment]; and
    C. Medium-term actions to begin increasing the numbers of health 
care workers available to the expanding HIV/AIDS needs (while not 
damaging other important efforts such as those against malaria), and to 
better use scarce resources, such as doctors, nurses, pharmacists, and 
other cadres through realigning certain tasks to less intensively-
trained staff (such as community health workers).
    Each of these activities are underway as part of the Emergency 
Plan; all will likely need to be done in nearly all countries in a 
concerted fashion if the Emergency Plan is to ultimately succeed. If 
done properly with careful design and implementation, the Emergency 
Plan could begin a reversal of the serious decline in HRH seen in sub-
Saharan Africa and the Caribbean over the past two decades.
    Question. (14) b. Does USAID have an estimate of the additional 
trained individuals required to implement retro-viral programs? Have 
you analyzed the need for retraining current tertiary service delivery 
personnel for the HIV/AIDS initiatives?
    Answer. The U.S. Global AIDS Coordinator's Office, in collaboration 
with USAID and other partners, does have preliminary estimates of the 
additional trained personnel needed, based on the targets proposed in 
the first-year plans. However, those estimates are based on crudely 
estimated numbers of providers already trained and in place. Moreover, 
they are lacking essential data such as the current attrition rate from 
HIV/AIDS care programs, either from brain drain, retirement, HIV/AIDS 
infection itself, or other reasons. A critical step over the next few 
months and first full year of the Emergency Plan is to establish a 
reliable database with estimates of: (1) the currently qualified 
workforce, and (2) the workforce required to meet the Emergency Plan 
goals for each year of the Emergency Plan. Retraining current tertiary 
service delivery personnel is usually the quickest route to rapidly 
initiating anti-retroviral treatment programs, and is part of every 
country's program.
    Question. (14) c. There is only a handful of institutions in the 
United States that have a history of supporting African health training 
institutions. For example, Tulane University and its School of Public 
Health and Tropical Medicine have played a very significant role in 
terms of the number of African health professionals trained over the 
years. Are these institutions actively involved in the HIV/AIDS human 
resource development and training efforts?
    Answer. The scope and urgent timing for expansion of training 
programs places a high priority in recruiting all available, 
experienced institutions for the effort in combating HIV/AIDS, 
including outstanding implementing partners like Tulane that are 
interested and willing to establish twinning relationships with local 
institutions in the 15 focus countries of the President's Emergency 
Plan. Tulane is already highly involved, and their involvement was 
recently substantially scaled up, through the HHS University Technical 
Assistance Program (UTAP). We expect to depend greatly on the steadily 
expanding work of all such outstanding partners over the course of the 
Emergency Plan.
    Question. (14) d. Is the Agency exploring the use of information 
technology as a means of getting the message for HIV/AIDS training to 
the local institutions as efficiently as possible?
    Answer. The Office of the U.S. Global AIDS Coordinator is 
interested in the most cost-effective, sustainable approaches to 
meeting the goals of the Emergency Plan. We try to match the 
technological approach to the specific needs and context of the 
training situation, rather than the other way around. In that context, 
we do expect (and will pay for) information technology for training as 
well as to support the strengthening of networks for bi-directional 
communication that enhances the quality of health care. We expect 
exciting models for a mixture of e-learning, telemedicine, and enhanced 
monitoring and evaluation to emerge from our U.S. Government staff's 
efforts at problem-solving and building sustainable capacity in the 
coming years.
    Question. (14) e. To what extent are capacity building efforts 
among appropriate African educational and research institutions being 
involved to create an environment that can sustain the President's 
initiatives?
    Answer. The dual principles of cost-effectiveness and 
sustainability require us to conduct training predominantly through 
African educational and training institutions. The Emergency Plan will 
look for African (or Caribbean) institutions to be implementers at 
every opportunity, especially to have them work with their peers in 
other of the 15 focus countries. In the many contexts in which 
technical assistance from United States or third-country providers 
might be needed to initiate programs, a requirement of all grants will 
be to force international grantees to have a plan to develop capacity 
such that they can turn their activities over to local, in-country 
organizations.

                         CONCLUSION OF HEARINGS

    Senator McConnell. Thank you all very much for being here. 
That concludes our hearing.
    [Whereupon, at 12:36 p.m., Tuesday, May 18, the hearings 
were concluded, and the subcommittee was recessed, to reconvene 
subject to the call of the Chair.]
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