HIV/AIDS Fiscal Year 2005 Budget Request

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 23rd, just 4½ months after we launched the Office of the U.S. Global AIDS Coordinator, and less than a month after the Congress appropriated FY 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 FY 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 4 years in accomplishing the goals of the Emergency Plan.

But this is only the first step. In FY 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 FY 2005 is for $2.8 billion, a $400 million increase over the FY 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 FY 2004 funds, I also submitted to this Committee and other appropriate Congressional committees in February a comprehensive, integrated, 5-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 5 years of the Emergency Plan:
  • We will help to provide anti-retroviral treatment for two million people;

  • We will contribute to the prevention of seven 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 United States 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 FY2004 that we are or soon will be funding, in early fall each country team will submit to my office a unified 5-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 anti-retroviral 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 U.S. 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 U.S., 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.