[Congressional Record Volume 153, Number 27 (Tuesday, February 13, 2007)]
[Senate]
[Pages S1911-S1913]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. LUGAR:
  S. 569. A bill to accelerate efforts to develop vaccines for diseases 
primarily affecting developing countries and for other purposes; to the 
Committee on Foreign Relations.
  Mr. LUGAR. Mr. President, I rise to introduce the Vaccines for the 
Future Act of 2007.
  This legislation seeks to accelerate the development of vaccines for 
HIV/AIDS, malaria, tuberculosis and other diseases that are major 
killers of people living in developing countries. HIV/AIDS, malaria, 
and tuberculosis are devastating sub-Saharan Africa where, combined, 
they claim as many as 5 million lives a year. Yet there are no vaccines 
for these diseases.
  Vaccines are one of the most effective public health measures of the 
20th century. With U.S. leadership, the global community has eradicated 
smallpox, and we are close to eradicating polio. Vaccines for diseases 
such as measles and tetanus have dramatically reduced childhood 
mortality worldwide. These public health victories benefit every 
country.
  Vaccines for diseases such as AIDS, tuberculosis, malaria, and for 
other, less well-known diseases would save millions of lives. 
Partnerships between governments, private foundations, and businesses 
have made significant strides toward the development of vaccines, but 
much more needs to be done.
  One of the biggest challenges is that drug companies do not have a 
strong financial incentive to invest in the development of vaccines for 
these diseases because there is no reliable market for them. In other 
words, vaccine manufacturers are reluctant to commit the hundreds of 
millions of dollars necessary to create a new vaccine with no obvious 
way to recoup their investment. What is needed is the promise of market 
demand to encourage industry to develop the vaccines for these 
diseases.
  Five countries--Britain, Italy, Norway, Russia, and Canada--along 
with the Bill and Melinda Gates Foundation, have developed such a 
market solution. On February 9, 2007, in Rome, they pledged $1.5 
billion for an initiative called an Advance Market Commitment, AMC, 
aimed at encouraging pharmaceutical companies to develop vaccines for 
diseases caused by the pneumococcus bacterium, such as pneumonia and 
meningitis. These diseases claim the lives of an estimated 1 million 
children per year, most of whom live in the developing world. Through 
this AMC, these countries and the Gates Foundation have pledged to 
purchase pneumococcal vaccines that will work in poor countries.
  Although a vaccine for pneumococcal disease exists in the United 
States and other developed countries, this version is not effective 
against the strains prevalent in developing countries. By committing to 
purchase large quantities of a successful vaccine beforehand, the 
Advance Market Commitment aims to bridge the gap between the vaccine 
makers' research costs and the future sales needed to cover the costs 
of their investment. Experts are hopeful that this initiative could 
accelerate by a decade the widespread use of a pneumococcal vaccine 
specific to the developing world and could prevent the deaths of an 
estimated 5.4 million children by 2030.
  In 2005, the United States, at the G8 Summit in Gleneagles, Scotland, 
agreed to encourage the development of vaccines for diseases affecting 
the developing world and endorsed the Advance Market Commitment 
concept. I believe that, with continued strong U.S. leadership, we can 
save many more lives in this new century. Because of the promise that 
vaccines hold, I am introducing the ``Vaccines for the Future Act of 
2007.'' My bill would authorize the United States to contribute to the 
Advance Market Commitment for pneumococcal vaccines. Equally important, 
it would require the administration to develop a comprehensive strategy 
and make a commitment to speed development, testing, and distribution 
of life-saving vaccines for other diseases, including AIDS, malaria, 
and tuberculosis, through innovative financial incentives like the AMC.
  I am hopeful that my fellow Senators will join me in supporting this 
legislation.
  I ask unanimous consent that the text of the bill be printed in the 
Record.
  There being no objection, the text of the bill was ordered to be 
printed in the Record, as follows:

                                 S. 569

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Vaccines for the Future Act 
     of 2007''.

     SEC. 2. DEFINITIONS.

       In this Act:
       (1) AIDS.--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 committees.--The 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) Developing country.--The term ``developing country'' 
     means a country that the World Bank determines to be a 
     country with a lower middle income or less.
       (4) HIV/AIDS.--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) GAVI alliance.--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) Neglected disease.--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) World bank.--The term ``World Bank'' means the 
     International Bank for Reconstruction and Development.

     SEC. 3. FINDINGS.

       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

[[Page S1913]]

     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.

     SEC. 4. SENSE OF CONGRESS ON SUPPORT FOR NEGLECTED DISEASES.

       It 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.

     SEC. 5. PUBLIC-PRIVATE PARTNERSHIPS.

       (a) Findings.--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) Sense of Congress.--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.

     SEC. 6. COMPREHENSIVE STRATEGY FOR ACCELERATING THE 
                   DEVELOPMENT OF VACCINES FOR NEGLECTED DISEASES.

       (a) Requirement for Strategy.--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) Report.--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.

     SEC. 7. ADVANCE MARKET COMMITMENTS.

       (a) Purpose.--The purpose of this section is to improve 
     global health by creating a competitive market for future 
     vaccines through advance market commitments.
       (b) Authority to Negotiate.--
       (1) In general.--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) Report.--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) Requirements.--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) In general.--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) Availability.--Amounts appropriated pursuant to this 
     subsection shall remain available until expended without 
     fiscal year limitation.
                                 ______