PRESIDENT CLINTON UNVEILS MILLENNIUM INITIATIVE TO PROMOTE DELIVERY OF
EXISTING VACCINESIN DEVELOPING COUNTRIES AND ACCELERATE DEVELOPMENT OF NEW VACCINES
January 28, 2000
In his State of the Union address, President Clinton will call for
concerted international action to combat infectious diseases in
developing countries. These diseases cause almost half of all deaths
worldwide of people under age 45, killing over eight million children
each year and orphaning millions more.
The President committed the United States to addressing this terrible
problem in his September speech to the United Nations General Assembly.
Now the President is asking for foundations, pharmaceutical companies,
international agencies, and other governments to join us in this task,
and he is announcing these specific elements of his Millennium
A new financial commitment to purchase and deliver existing
vaccines in poor countries. As Vice President Gore told the U. N.
Security Council earlier this month, the Administration's FY 2001 budget
will include a proposed $50 million contribution to the vaccine purchase
fund of the Global Alliance for Vaccines and Immunization (GAVI).
Increased investments in health in developing countries. The
President is calling on the World Bank and other multilateral
development banks to dedicate an additional $400 million to $900 million
annually of their low-interest-rate loans to expand immunization,
prevent and treat infectious diseases, and build effective delivery
systems for other basic health services. These investments are as
central to economic progress as investments in education and physical
infrastructure, and they would build on the new focus on basic health
services that we have supported as part of the Highly Indebted Poor
Countries (HIPC) debt initiative. This proposed shift in existing
resources does not require additional U.S. budget expenditures.
A significant increase in basic research on diseases that affect
developing nations. The Administration's FY 2001 budget for the
National Institutes of Health includes a sharp step-up in research
critical to the development of vaccines for malaria, tuberculosis, and
A new tax credit for sales of vaccines for malaria, tuberculosis,
and HIV/AIDS to accelerate the invention and production of these
vaccines. Because developing countries often cannot afford to buy
vaccines, the market provides little incentive for pharmaceutical
companies to develop vaccines for diseases that disproportionately
affect those countries. This tax credit would provide such an
incentive, because every dollar paid by a qualifying organization to buy
a qualifying vaccine would be matched by a dollar of tax credits --
representing up to $1 billion of additional funding for future vaccine
purchases. The President is calling on other governments to make
similar purchase commitments, so that we can ensure a future market for
these critically needed vaccines.
Infectious Diseases Pose a Mounting Social and Economic Burden on
Developing Countries -- And a Threat to Our Health As Well.
More than eight million children die each year of centuries-old
diseases like malaria, tuberculosis, and respiratory and diarrheal
diseases. Deaths from the modern scourge of AIDS are climbing rapidly.
Altogether, as many children die of infectious diseases each year as the
total number of combatants who perished in World War I.
In an interconnected and highly mobile world, health crises in
other countries are a threat to everyone. We have seen this with
HIV/AIDS, with the resurfacing of tuberculosis, and with the outbreak
last year of West Nile encephalitis in New York. According to the
Global Health Council, during the past 50 years, at least five times as
many Americans have died from communicable diseases that have come from
the developing world than have died in military conflicts.
Vaccines Are One of the Most Cost-Effective Ways to Improve the
Well-Being and Productivity of the Poorest Countries -- And Medicines
and Other Basic Health Services Are a Necessary Complement.
It costs about $17 to immunize a child, but millions of children
die each year of diseases that could be prevented by existing vaccines.
Indeed, children in developing nations are 10 times more likely to die
of a vaccine-preventable disease than children in developed nations.
And these tragedies occur in spite of the enormous efforts of UNICEF and
others to vaccinate children, which save 3 million lives each year.
Highly effective vaccines do not yet exist for malaria, TB and
AIDS, which take over 5 million lives each year. But developed nations
have the scientific and technological capacity to make new vaccines
possible. For example, recent work on genetic sequencing, including the
human genome, will open vast possibilities.
Another health investment with very high returns is simple
preventive and curative services. Providing this basic health care
together with vaccines would save millions of lives each year.
A $50 Million Contribution to GAVI to Buy Vaccines For Children -- Which
Will Save Lives Now and Create Confidence that a Market for New Vaccines
Will Exist in the Future.
GAVI, the Global Alliance for Vaccines and Immunization, was formed
as a collaborative effort of UNICEF, the World Health Organization
(WHO), the World Bank, private foundations, bilateral aid agencies
(including the U.S. Agency for International Development), industry
representatives, and developing countries. GAVI established the "Global
Fund for Children's Vaccines" with an initial grant of $750 million over
5 years from the Bill and Melinda Gates Foundation. The formal launch
of GAVI, and the official announcement of the Gates gift, will occur
shortly in Davos, Switzerland.
A U.S. contribution will help to purchase vaccines for Hepatitis B,
Haemophilus Influenzae B (Hib), and Yellow Fever, along with related
safe delivery equipment such as auto-destruct syringes. To ensure that
GAVI's vaccine purchases complement, rather than replace, existing
vaccination efforts, they will be conditional on a country achieving 50
percent coverage of the DTP (diptheria-tetanus-pertussis) vaccine, which
is included along with measles and polio in the existing EPI (Expanded
Program for Immunization).
A U.S. contribution will hopefully catalyze significant
contributions from other countries and foundations. It will also add
crucial credibility to the international community's commitment to
provide a market for new vaccines when they are developed.
We Must Shift Existing International Resources Toward Building Health
Infrastructure in Poor Countries That Can Deliver Vaccines and Medicines
and Provide Essential Basic Health Services.
The World Bank and other multilateral development banks (MDBs, such
as the African Development Fund) lend money on highly favorable terms to
the world's poorest countries. Today, roughly $1 billion to $1-1/2
billion of this so-called "concessional funding" is devoted to health
care each year. The Administration proposes to increase that amount by
$400 million to $900 million per year, with a focus on:
prevention of diseases using basic measures such as information and
condoms for AIDS, treated bed nets for malaria, and stronger systems for
treatment of diseases, including common respiratory and diarrheal
more effective provision of basic health care.
The Administration is exploring ways to use the HIPC debt reform to
support this part of the Millennium Initiative. One possibility is to
make an increase in vaccination rates one of the performance targets
monitored in the HIPC progress reports. This could be accompanied by
debtor countries' agreements to include specific improvements in vaccine
delivery systems as priority uses of debt relief proceeds. We also
expect that all Poverty Reduction Strategy Papers that are prepared for
HIPC candidates will discuss the adequacy of budget resources and
suggested policy reforms devoted to basic health care.
This re-direction of resources supports the Administration's
overall strategy for global development, which emphasizes poverty
reduction and gives a central role to "global public goods" -- like
health or the environment -- in which positive actions taken in one
country benefit other countries as well. To meet this objective, these
funds should not come from spending on other basic social programs, such
as education and health care.
This aspect of the Millennium Initiative does not require a new
budgetary commitment by the United States (or other donor countries).
However, the U.S. ability to influence the direction of MDB lending and
the use of HIPC proceeds depends crucially on meeting our existing
commitments to these aid programs. We will work with other G-8 finance
and development ministries to refine this proposal.
A conservative estimate suggests that if basic health care
including immunization were made broadly available, up to 2 million
children's lives could be saved each year.
Higher Funding for Basic Scientific Research Through the National
Institutes of Health (NIH) and Elsewhere Will Hasten the Development of
Vaccines for Malaria, TB, and AIDS.
The Administration's FY 2001 budget for NIH includes a significant
increase in research critical to creating vaccines for these diseases.
For malaria and TB, this increase will build on recent advances in the
genetic sequencing of these diseases, which have set the stage for major
breakthroughs in vaccine development.
Funding for NIH malaria vaccine research will increase more than 10
percent over the FY 2000 level. Future research will range from
pre-clinical studies aimed at improving our understanding of the malaria
parasite, through the development of vaccine candidates, to clinical
trials judging vaccine efficacy and safety. NIH will also expand its
collaboration with scientists in malaria-endemic regions, especially in
Africa, to strengthen those regions' capacity for conducting clinical
trials of malaria vaccines in the future.
NIH research on a tuberculosis vaccine will receive over 40 percent
more funding than in FY 2000 and more than double the FY 1999 level.
NIH will focus on studying the body's defense mechanisms against TB, and
developing and studying vaccine candidates. Through its Tuberculosis
Research Unit, NIH supports an international multi-disciplinary team to
translate advances in basic research into new tools for fighting TB.
NIH funding for AIDS vaccine research will increase substantially
in FY 2001 and will have more than doubled since FY 1997. These
additional resources will allow NIH to accelerate basic research on
developing vaccine candidates and to significantly expand testing of
potential vaccine candidates in both developing and developed countries.
The new Vaccine Research Center on the NIH campus, which will be
occupied this summer, will receive a sizeable increase in funding for
the development and pre-clinical testing of HIV vaccine candidates.
The Administration is providing strong support for the
path-breaking research on infectious diseases being conducted by U.S.
military scientists, including the opening (in October 1999) of the
Walter Reed Army Institute of Research/Naval Medical Research Center.
Working in close collaboration with scientists worldwide, military
scientists have developed and tested successful vaccines against
Japanese encephalitis and hepatitis A -- and they are working to create
vaccines and medicines to protect service people, travelers, and
millions of others from malaria, HIV/AIDS, and other infectious
A New Tax Credit Would Effectively Provide Up to $1 Billion for Future
Vaccine Purchases, Speeding the Invention and Production of New
Current tax law provides substantial incentives for pharmaceutical
research and development, including the research and experimentation
(R&E) tax credit, the orphan drug tax credit, and an enhanced deduction
for charitable contributions of certain products. Nonetheless,
pharmaceutical companies may be reluctant to invest in developing
vaccines for diseases that primarily afflict people in poor countries,
because little or no paying market exists in those countries.
Under the proposal, the seller of a qualified vaccine could claim a
tax credit equal to 100 percent of the amount paid by a qualifying
organization that received a "credit allocation" by the U.S. Agency for
International Development (AID). The tax credit would match the
qualified organizations' expenditures dollar-for-dollar, thereby
doubling their purchasing power. A qualifying vaccine would be a new
vaccine that received FDA approval for use against malaria,
tuberculosis, HIV/AIDS, or any infectious disease that causes over 1
million deaths annually worldwide.
For 2002 through 2010, AID could designate up to $1 billion of
vaccine sales as eligible for the credit. This tax credit would be
limited to new vaccines developed to fight these terrible diseases. The
credit would provide a specific and credible commitment to purchase
future vaccines at reasonable prices. Together with similar commitments
from foundations and other governments, it would provide a critical and
powerful incentive to accelerate vaccine research and development.