1.This Act may be cited as the
Vaccines for the Future Act of
2007
.
2.In this Act:
(1)The term AIDS has the meaning
given the term in section 104A(g) of the Foreign Assistance Act of 1961 (22
U.S.C. 2151b–2).
(2)Appropriate congressional
committeesThe term
appropriate congressional committees
means the Committee on
Appropriations and the Committee on Foreign Relations of the Senate and the
Committee on Appropriations and the Committee on Foreign Affairs of the House
of Representatives.
(3)The term developing country
means a country that the World Bank determines to be a country with a lower
middle income or less.
(4)The term HIV/AIDS
has the
meaning given the term in section 104A(g) of the Foreign Assistance Act of 1961
(22 U.S.C. 2151b–2).
(5)The term GAVI Alliance
means
the public-private partnership launched in 2000 for the purpose of saving the
lives of children and protecting the health of all people through the
widespread use of vaccines.
(6)The term neglected disease
means—
(A)HIV/AIDS;
(B)malaria;
(C)tuberculosis; or
(D)any infectious disease that, according to
the World Health Organization, afflicts over 1,000,000 people and causes more
than 250,000 deaths each year in developing countries.
(7)The term World Bank
means
the International Bank for Reconstruction and Development.
3.Congress makes the following
findings:
(1)Immunization is an inexpensive and
effective public health intervention that has had a profound life-saving impact
around the world.
(2)During the 20th century, global
immunization efforts have successfully led to the eradication of smallpox and
the elimination of polio from the Western Hemisphere, Europe, and most of Asia.
Vaccines for diseases such as measles and tetanus have dramatically reduced
childhood mortality worldwide, and vaccines for diseases such as influenza,
pneumonia, and hepatitis help prevent sickness and death of adults as well as
children.
(3)According to the World Health Organization,
combined, AIDS, tuberculosis, and malaria kill more than 5,000,000 people a
year, most of whom are in the developing world, yet there are no vaccines for
these diseases.
(4)Other, less well-known neglected diseases,
such as pneumococcal disease, lymphatic filariasis, leptospirosis, leprosy, and
onchocerciasis, result in severe health consequences for individuals afflicted
with them, such as anemia, blindness, malnutrition and impaired childhood
growth and development. In addition, these diseases result in lost productivity
in developing countries costing in the billions of dollars.
(5)Infants, children, and adolescents are
among the populations hardest hit by AIDS, malaria, and many other neglected
diseases. Nearly 11,000,000 children under age 5 die each year due to these
diseases, primarily in developing countries. Existing and future vaccines that
target children could prevent more than 2,500,000 of these illnesses and
deaths.
(6)The devastating impact of neglected
diseases in developing countries threatens the political and economic stability
of these countries and constitutes a threat to United States economic and
security interests.
(7)Of more than $100,000,000,000 spent on
health research and development across the world, only $6,000,000,000 is spent
each year on diseases that are specific to developing countries, most of which
is from public and philanthropic sources.
(8)Despite the devastating impact these and
other diseases have on developing countries, it is estimated that only 10
percent of the world's research and development on health is targeted on
diseases affecting 90 percent of the world's population.
(9)Because the developing country market is
small and unpredictable, there is an insufficient private sector investment in
research for vaccines for neglected diseases that disproportionately affect
populations in developing countries.
(10)Creating a broad range of economic
incentives to increase private sector research on neglected diseases is
critical to the development of vaccines for neglected diseases.
(11)In recognition of the need for more
economic incentives to encourage private sector investment in vaccines for
neglected diseases, an international group of health, technical, and economic
experts has developed a framework for an advance market commitment pilot
program for pneumococcal vaccines. Pneumococcal disease, a cause of pneumonia
and meningitis, kills 1,600,000 people every year, an estimated 1,000,000 of
whom are children under age 5. This pilot program will seek to stimulate
investments to develop and produce pneumococcal vaccines that could prevent
between 500,000 and 700,000 deaths by the year 2020.
(12)On February 9, 2007, 5 countries, Britain,
Canada, Italy, Norway, and Russia, together with the Bill and Melinda Gates
Foundation, pledged, under a plan called an Advance Market Commitment, to
purchase pneumococcal vaccines now under development. Together, these countries
and the Bill and Melinda Gates Foundation have committed $1,500,000,000 for
this program. Experts believe that this initiative could accelerate by a decade
the widespread use of such a vaccine in the developing world and could prevent
the deaths of an estimated 5,400,000 children by 2030.
4.Sense of Congress on support for neglected
diseasesIt is the sense of
Congress that—
(1)the President should continue to encourage
efforts to support the Global HIV Vaccine Enterprise, a virtual consortium of
scientists and organizations committed to accelerating the development of an
effective HIV vaccine;
(2)the United States should work with the
Global Fund to Fight AIDS, Tuberculosis and Malaria, the Joint United Nations
Programme on HIV/AIDS (UNAIDS
), the World Health Organization,
the International AIDS Vaccine Initiative, the GAVI Alliance, and the World
Bank to ensure that all countries heavily affected by the HIV/AIDS pandemic
have national AIDS vaccine plans;
(3)the United States should support and
encourage the carrying out of the agreements of the Group of 8 made at the 2005
Summit at Gleneagles, Scotland, to increase direct investment and create market
incentives, including through public-private partnerships and advance market
commitments, to complement public research in the development of vaccines,
microbicides, and drugs for HIV/AIDS, malaria, tuberculosis, and other
neglected diseases;
(4)the United States should support the
development of effective vaccines for infants, children, and adolescents as
early as is medically and ethically appropriate, in order to avoid significant
delays in the availability of pediatric vaccines at the cost of thousands of
lives;
(5)the United States should continue
supporting the work of the GAVI Alliance and the Global Fund for Children’s
Vaccines as appropriate and effective vehicles to purchase and distribute
vaccines for neglected diseases at an affordable price once such vaccines are
discovered in order to distribute them to the developing world;
(6)the United States should work with others
in the international community to address the multiple obstacles to the
development of vaccines for neglected diseases including scientific barriers,
insufficient economic incentives, protracted regulatory procedures, lack of
delivery systems for products once developed, liability risks, and intellectual
property rights; and
(7)the United States should contribute to the
pilot Advance Market Commitment for pneumococcal vaccines launched in Rome on
February 9, 2007, which could prevent some 500,000 to 700,000 child deaths by
the year 2020 and an estimated 5,400,000 child deaths by 2030.
5.Public-Private Partnerships
(a)Congress makes the following
findings:
(1)Partnerships between governments and the
private sector (including foundations, universities, corporations,
community-based organizations, and other nongovernmental organizations) are
playing a critical role in the area of global health, particularly in the fight
against neglected diseases, including HIV/AIDS, tuberculosis, and
malaria.
(2)These public-private partnerships improve
the delivery of health services in developing countries and accelerate research
and development of vaccines and other preventive medical technologies essential
to combating infectious diseases that disproportionately kill people in
developing countries.
(3)These public-private partnerships maximize
the unique capabilities of each sector while combining financial and other
resources, scientific knowledge, and expertise toward common goals which cannot
be achieved by either sector alone.
(4)Public-private partnerships such as the
International AIDS Vaccine Initiative, PATH's Malaria Vaccine Initiative, and
the Global TB Drug Facility are playing cutting edge roles in the efforts to
develop vaccines for these diseases.
(5)Public-private partnerships serve as
incentives to the research and development of vaccines for neglected diseases
by providing biotechnology companies, which often have no experience in
developing countries, with technical assistance and on the ground support for
clinical trials of the vaccine through the various stages of
development.
(6)Sustaining existing public-private
partnerships and building new ones where needed are essential to the success of
the efforts by the United States and others in the international community to
find a cure for these and other neglected diseases.
(b)It is the sense of Congress that—
(1)the sustainment and promotion of
public-private partnerships must be a central element of the strategy pursued
by the United States to create effective incentives for the development of
vaccines and other preventive medical technologies for neglected diseases
debilitating the developing world; and
(2)the United States Government should take
steps to address the obstacles to the development of these technologies by
increasing investment in research and development and establishing market and
other incentives.
6.Comprehensive Strategy for Accelerating the
Development of Vaccines for Neglected Diseases
(a)The President shall establish a
comprehensive strategy to accelerate efforts to develop vaccines and
microbicides for neglected diseases such as HIV/AIDS, malaria, and
tuberculosis. Such strategy shall—
(1)expand public-private partnerships and seek
to leverage resources from other countries and the private sector;
(2)include the negotiation of advance market
commitments and other initiatives to create economic incentives for the
research, development, and manufacturing of vaccines and microbicides for
HIV/AIDS, tuberculosis, malaria, and other neglected diseases;
(3)address intellectual property issues
surrounding the development of vaccines and microbicides for neglected
diseases;
(4)maximize United States capabilities to
support clinical trials of vaccines and microbicides in developing
countries;
(5)address the issue of regulatory approval of
such vaccines and microbicides, whether through the Commissioner of the Food
and Drug Administration, or the World Health Organization, or another entity;
and
(6)expand the purchase and delivery of
existing vaccines.
(b)Not later than 180 days after the date of
enactment of this Act, the President shall submit to the appropriate
congressional committees a report setting forth the strategy described in
subsection (a) and the steps to implement such strategy.
7.Advance market commitments
(a)The purpose of this section is to improve
global health by creating a competitive market for future vaccines through
advance market commitments.
(b)
(1)The Secretary of the Treasury shall enter
into negotiations with the appropriate officials of the World Bank, the
International Development Association, and the GAVI Alliance, the member
nations of such entities, and other interested parties for the purpose of
establishing advance market commitments to purchase vaccines and microbicides
to combat neglected diseases.
(2)Not later than 180 days after the date of
the enactment of this Act, the Secretary shall submit to the appropriate
congressional committees a report on the status of the negotiations to create
advance market commitments under this section. This report may be submitted as
part of the report submitted under section 6(b).
(c)The Secretary of the Treasury shall work
with the entities referred to in subsection (b) to ensure that there is an
international framework for the establishment and implementation of advance
market commitments and that such commitments include—
(1)legally binding contracts for product
purchase that include a fair market price for a guaranteed number of treatments
to ensure that the market incentive is sufficient;
(2)clearly defined and transparent rules of
competition for qualified developers and suppliers of the product;
(3)clearly defined requirements for eligible
vaccines to ensure that they are safe and effective;
(4)dispute settlement mechanisms; and
(5)sufficient flexibility to enable the
contracts to be adjusted in accord with new information related to projected
market size and other factors while still maintaining the purchase commitment
at a fair price.
(d)Authorization of appropriations
(1)There are authorized to be appropriated
such sums as may be necessary for each of fiscal years 2009 through 2014 to
fund an advance market commitment pilot program for pneumococcal
vaccines.
(2)Amounts appropriated pursuant to this
subsection shall remain available until expended without fiscal year
limitation.