II 

110TH CONGRESS 

1ST SESSION S. 569 

To accelerate efforts to develop vaccines for diseases primarily affecting 

developing countries and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

FEBRUARY 13, 2007 

Mr. LUGAR introduced the following bill; which was read twice and referred 

to the Committee on Foreign Relations 

A BILL 

To accelerate efforts to develop vaccines for diseases primarily affecting developing countries and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Vaccines for the Fu5 ture Act of 2007’’. 

6 SEC. 2. DEFINITIONS. 

7 In this Act: 

8 (1) AIDS.—The term ‘‘AIDS’’ has the meaning 

9 given the term in section 104A(g) of the Foreign As10 sistance Act of 1961 (22 U.S.C. 2151b–2). 

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1 (2) APPROPRIATE CONGRESSIONAL COMMIT2 TEES.—The term ‘‘appropriate congressional com3 mittees’’ means the Committee on Appropriations 

4 and the Committee on Foreign Relations of the Sen5 ate and the Committee on Appropriations and the 

6 Committee on Foreign Affairs of the House of Rep7 resentatives. 

8 (3) DEVELOPING COUNTRY.—The term ‘‘devel9 oping country’’ means a country that the World 

10 Bank determines to be a country with a lower mid11 dle income or less. 

12 (4) HIV/AIDS.—The term ‘‘HIV/AIDS’’ has 

13 the meaning given the term in section 104A(g) of 

14 the Foreign Assistance Act of 1961 (22 U.S.C. 

15 2151b–2). 

16 (5) GAVI ALLIANCE.—The term ‘‘GAVI Alli17 ance’’ means the public-private partnership launched 

18 in 2000 for the purpose of saving the lives of chil19 dren and protecting the health of all people through 

20 the widespread use of vaccines. 

21 (6) NEGLECTED DISEASE.—The term ‘‘ne22 glected disease’’ means— 

23 (A) HIV/AIDS; 

24 (B) malaria; 

25 (C) tuberculosis; or 

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1 (D) any infectious disease that, according 

2 to the World Health Organization, afflicts over 

3 1,000,000 people and causes more than 

4 250,000 deaths each year in developing coun5 tries. 

6 (7) WORLD BANK.—The term ‘‘World Bank’’ 

7 means the International Bank for Reconstruction 

8 and Development. 

9 SEC. 3. FINDINGS. 

10 Congress makes the following findings: 

11 (1) Immunization is an inexpensive and effec12 tive public health intervention that has had a pro13 found life-saving impact around the world. 

14 (2) During the 20th century, global immuniza15 tion efforts have successfully led to the eradication 

16 of smallpox and the elimination of polio from the 

17 Western Hemisphere, Europe, and most of Asia. 

18 Vaccines for diseases such as measles and tetanus 

19 have dramatically reduced childhood mortality world20 wide, and vaccines for diseases such as influenza, 

21 pneumonia, and hepatitis help prevent sickness and 

22 death of adults as well as children. 

23 (3) According to the World Health Organiza24 tion, combined, AIDS, tuberculosis, and malaria kill 

25 more than 5,000,000 people a year, most of whom 

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1 are in the developing world, yet there are no vac2 cines for these diseases. 

3 (4) Other, less well-known neglected diseases, 

4 such as pneumococcal disease, lymphatic filariasis, 

5 leptospirosis, leprosy, and onchocerciasis, result in 

6 severe health consequences for individuals afflicted 

7 with them, such as anemia, blindness, malnutrition 

8 and impaired childhood growth and development. In 

9 addition, these diseases result in lost productivity in 

10 developing countries costing in the billions of dollars. 

11 (5) Infants, children, and adolescents are 

12 among the populations hardest hit by AIDS, ma13 laria, and many other neglected diseases. Nearly 

14 11,000,000 children under age 5 die each year due 

15 to these diseases, primarily in developing countries. 

16 Existing and future vaccines that target children 

17 could prevent more than 2,500,000 of these illnesses 

18 and deaths. 

19 (6) The devastating impact of neglected dis20 eases in developing countries threatens the political 

21 and economic stability of these countries and con22 stitutes a threat to United States economic and se23 curity interests. 

24 (7) Of more than $100,000,000,000 spent on 

25 health research and development across the world, 

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1 only $6,000,000,000 is spent each year on diseases 

2 that are specific to developing countries, most of 

3 which is from public and philanthropic sources. 

4 (8) Despite the devastating impact these and 

5 other diseases have on developing countries, it is es6 timated that only 10 percent of the world’s research 

7 and development on health is targeted on diseases 

8 affecting 90 percent of the world’s population. 

9 (9) Because the developing country market is 

10 small and unpredictable, there is an insufficient pri11 vate sector investment in research for vaccines for 

12 neglected diseases that disproportionately affect pop13 ulations in developing countries. 

14 (10) Creating a broad range of economic incen15 tives to increase private sector research on neglected 

16 diseases is critical to the development of vaccines for 

17 neglected diseases. 

18 (11) In recognition of the need for more eco19 nomic incentives to encourage private sector invest20 ment in vaccines for neglected diseases, an inter21 national group of health, technical, and economic ex22 perts has developed a framework for an advance 

23 market commitment pilot program for pneumococcal 

24 vaccines. Pneumococcal disease, a cause of pneu25 monia and meningitis, kills 1,600,000 people every 

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1 year, an estimated 1,000,000 of whom are children 

2 under age 5. This pilot program will seek to stimu3 late investments to develop and produce pneumo4 coccal vaccines that could prevent between 500,000 

5 and 700,000 deaths by the year 2020. 

6 (12) On February 9, 2007, 5 countries, Britain, 

7 Canada, Italy, Norway, and Russia, together with 

8 the Bill and Melinda Gates Foundation, pledged, 

9 under a plan called an Advance Market Commit10 ment, to purchase pneumococcal vaccines now under 

11 development. Together, these countries and the Bill 

12 and Melinda Gates Foundation have committed 

13 $1,500,000,000 for this program. Experts believe 

14 that this initiative could accelerate by a decade the 

15 widespread use of such a vaccine in the developing 

16 world and could prevent the deaths of an estimated 

17 5,400,000 children by 2030. 

18 SEC. 4. SENSE OF CONGRESS ON SUPPORT FOR NE19 GLECTED DISEASES. 

20 It is the sense of Congress that— 

21 (1) the President should continue to encourage 

22 efforts to support the Global HIV Vaccine Enter23 prise, a virtual consortium of scientists and organi24 zations committed to accelerating the development of 

25 an effective HIV vaccine; 

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1 (2) the United States should work with the 

2 Global Fund to Fight AIDS, Tuberculosis and Ma3 laria, the Joint United Nations Programme on HIV/ 

4 AIDS (‘‘UNAIDS’’), the World Health Organiza5 tion, the International AIDS Vaccine Initiative, the 

6 GAVI Alliance, and the World Bank to ensure that 

7 all countries heavily affected by the HIV/AIDS pan8 demic have national AIDS vaccine plans; 

9 (3) the United States should support and en10 courage the carrying out of the agreements of the 

11 Group of 8 made at the 2005 Summit at Gleneagles, 

12 Scotland, to increase direct investment and create 

13 market incentives, including through public-private 

14 partnerships and advance market commitments, to 

15 complement public research in the development of 

16 vaccines, microbicides, and drugs for HIV/AIDS, 

17 malaria, tuberculosis, and other neglected diseases; 

18 (4) the United States should support the devel19 opment of effective vaccines for infants, children, 

20 and adolescents as early as is medically and ethically 

21 appropriate, in order to avoid significant delays in 

22 the availability of pediatric vaccines at the cost of 

23 thousands of lives; 

24 (5) the United States should continue sup25 porting the work of the GAVI Alliance and the Globmstockstill on PROD1PC66 with BILLS

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1 al Fund for Children’s Vaccines as appropriate and 

2 effective vehicles to purchase and distribute vaccines 

3 for neglected diseases at an affordable price once 

4 such vaccines are discovered in order to distribute 

5 them to the developing world; 

6 (6) the United States should work with others 

7 in the international community to address the mul8 tiple obstacles to the development of vaccines for ne9 glected diseases including scientific barriers, insuffi10 cient economic incentives, protracted regulatory pro11 cedures, lack of delivery systems for products once 

12 developed, liability risks, and intellectual property 

13 rights; and 

14 (7) the United States should contribute to the 

15 pilot Advance Market Commitment for pneumococcal 

16 vaccines launched in Rome on February 9, 2007, 

17 which could prevent some 500,000 to 700,000 child 

18 deaths by the year 2020 and an estimated 5,400,000 

19 child deaths by 2030. 

20 SEC. 5. PUBLIC-PRIVATE PARTNERSHIPS. 

21 (a) FINDINGS.—Congress makes the following find22 ings: 

23 (1) Partnerships between governments and the 

24 private sector (including foundations, universities, 

25 corporations, community-based organizations, and 

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1 other nongovernmental organizations) are playing a 

2 critical role in the area of global health, particularly 

3 in the fight against neglected diseases, including 

4 HIV/AIDS, tuberculosis, and malaria. 

5 (2) These public-private partnerships improve 

6 the delivery of health services in developing countries 

7 and accelerate research and development of vaccines 

8 and other preventive medical technologies essential 

9 to combating infectious diseases that disproportion10 ately kill people in developing countries. 

11 (3) These public-private partnerships maximize 

12 the unique capabilities of each sector while com13 bining financial and other resources, scientific 

14 knowledge, and expertise toward common goals 

15 which cannot be achieved by either sector alone. 

16 (4) Public-private partnerships such as the 

17 International AIDS Vaccine Initiative, PATH’s Ma18 laria Vaccine Initiative, and the Global TB Drug 

19 Facility are playing cutting edge roles in the efforts 

20 to develop vaccines for these diseases. 

21 (5) Public-private partnerships serve as incen22 tives to the research and development of vaccines for 

23 neglected diseases by providing biotechnology compa24 nies, which often have no experience in developing 

25 countries, with technical assistance and on the 

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1 ground support for clinical trials of the vaccine 

2 through the various stages of development. 

3 (6) Sustaining existing public-private partner4 ships and building new ones where needed are essen5 tial to the success of the efforts by the United States 

6 and others in the international community to find a 

7 cure for these and other neglected diseases. 

8 (b) SENSE OF CONGRESS.—It is the sense of Con9 gress that— 

10 (1) the sustainment and promotion of public11 private partnerships must be a central element of 

12 the strategy pursued by the United States to create 

13 effective incentives for the development of vaccines 

14 and other preventive medical technologies for ne15 glected diseases debilitating the developing world; 

16 and 

17 (2) the United States Government should take 

18 steps to address the obstacles to the development of 

19 these technologies by increasing investment in re20 search and development and establishing market and 

21 other incentives. 

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1 SEC. 6. COMPREHENSIVE STRATEGY FOR ACCELERATING 

2 THE DEVELOPMENT OF VACCINES FOR NE3 GLECTED DISEASES. 

4 (a) REQUIREMENT FOR STRATEGY.—The President 

5 shall establish a comprehensive strategy to accelerate ef6 forts to develop vaccines and microbicides for neglected 

7 diseases such as HIV/AIDS, malaria, and tuberculosis. 

8 Such strategy shall— 

9 (1) expand public-private partnerships and seek 

10 to leverage resources from other countries and the 

11 private sector; 

12 (2) include the negotiation of advance market 

13 commitments and other initiatives to create eco14 nomic incentives for the research, development, and 

15 manufacturing of vaccines and microbicides for HIV/ 

16 AIDS, tuberculosis, malaria, and other neglected 

17 diseases; 

18 (3) address intellectual property issues sur19 rounding the development of vaccines and 

20 microbicides for neglected diseases; 

21 (4) maximize United States capabilities to sup22 port clinical trials of vaccines and microbicides in 

23 developing countries; 

24 (5) address the issue of regulatory approval of 

25 such vaccines and microbicides, whether through the 

26 Commissioner of the Food and Drug Administration, 

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1 or the World Health Organization, or another entity; 

2 and 

3 (6) expand the purchase and delivery of existing 

4 vaccines. 

5 (b) REPORT.—Not later than 180 days after the date 

6 of enactment of this Act, the President shall submit to 

7 the appropriate congressional committees a report setting 

8 forth the strategy described in subsection (a) and the steps 

9 to implement such strategy. 

10 SEC. 7. ADVANCE MARKET COMMITMENTS. 

11 (a) PURPOSE.—The purpose of this section is to im12 prove global health by creating a competitive market for 

13 future vaccines through advance market commitments. 

14 (b) AUTHORITY TO NEGOTIATE.— 

15 (1) IN GENERAL.—The Secretary of the Treas16 ury shall enter into negotiations with the appro17 priate officials of the World Bank, the International 

18 Development Association, and the GAVI Alliance, 

19 the member nations of such entities, and other inter20 ested parties for the purpose of establishing advance 

21 market commitments to purchase vaccines and 

22 microbicides to combat neglected diseases. 

23 (2) REPORT.—Not later than 180 days after 

24 the date of the enactment of this Act, the Secretary 

25 shall submit to the appropriate congressional commstockstill on PROD1PC66 with BILLS

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1 mittees a report on the status of the negotiations to 

2 create advance market commitments under this sec3 tion. This report may be submitted as part of the re4 port submitted under section 6(b). 

5 (c) REQUIREMENTS.—The Secretary of the Treasury 

6 shall work with the entities referred to in subsection (b) 

7 to ensure that there is an international framework for the 

8 establishment and implementation of advance market 

9 commitments and that such commitments include— 

10 (1) legally binding contracts for product pur11 chase that include a fair market price for a guaran12 teed number of treatments to ensure that the mar13 ket incentive is sufficient; 

14 (2) clearly defined and transparent rules of 

15 competition for qualified developers and suppliers of 

16 the product; 

17 (3) clearly defined requirements for eligible vac18 cines to ensure that they are safe and effective; 

19 (4) dispute settlement mechanisms; and 

20 (5) sufficient flexibility to enable the contracts 

21 to be adjusted in accord with new information re22 lated to projected market size and other factors 

23 while still maintaining the purchase commitment at 

24 a fair price. 

25 (d) AUTHORIZATION OF APPROPRIATIONS.— 

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1 (1) IN GENERAL.—There are authorized to be 

2 appropriated such sums as may be necessary for 

3 each of fiscal years 2009 through 2014 to fund an 

4 advance market commitment pilot program for pneu5 mococcal vaccines. 

6 (2) AVAILABILITY.—Amounts appropriated pur7 suant to this subsection shall remain available until 

8 expended without fiscal year limitation. 

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