I 

110TH CONGRESS 

1ST SESSION H. R. 1391 

To accelerate efforts to develop vaccines for diseases primarily affecting 

developing countries, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

MARCH 7, 2007 

Mr. VISCLOSKY (for himself, Mr. RANGEL, Mr. KING of New York, Mr. 

MCGOVERN, Ms. CARSON, and Mr. MCNULTY) introduced the following 

bill; which was referred to the Committee on Energy and Commerce, and 

in addition to the Committees on Foreign Affairs and Financial Services, 

for a period to be subsequently determined by the Speaker, in each case 

for consideration of such provisions as fall within the jurisdiction of the 

committee concerned 

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: 


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

2 given the term in section 104A(g) of the Foreign As3 sistance Act of 1961 (22 U.S.C. 2151b–2). 

4 (2) APPROPRIATE CONGRESSIONAL COMMIT5 TEES.—The term ‘‘appropriate congressional com6 mittees’’ means the Committee on Appropriations 

7 and the Committee on Foreign Relations of the Sen8 ate and the Committee on Appropriations and the 

9 Committee on Foreign Affairs of the House of Rep10 resentatives. 

11 (3) DEVELOPING COUNTRY.—The term ‘‘devel12 oping country’’ means a country that the World 

13 Bank determines to be a country with a lower mid14 dle income or less. 

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

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

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

18 2151b–2). 

19 (5) GAVI ALLIANCE.—The term ‘‘GAVI Alli20 ance’’ means the public-private partnership launched 

21 in 2000 for the purpose of saving the lives of chil22 dren and protecting the health of all people through 

23 the widespread use of vaccines. 

24 (6) NEGLECTED DISEASE.—The term ‘‘ne25 glected disease’’ means— 


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1 (A) HIV/AIDS; 

2 (B) malaria; 

3 (C) tuberculosis; or 

4 (D) any infectious disease that, according 

5 to the World Health Organization, afflicts over 

6 1,000,000 people and causes more than 

7 250,000 deaths each year in developing coun8 tries. 

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

10 means the International Bank for Reconstruction 

11 and Development. 

12 SEC. 3. FINDINGS. 

13 Congress makes the following findings: 

14 (1) Immunization is an inexpensive and effec15 tive public health intervention that has had a pro16 found life-saving impact around the world. 

17 (2) During the 20th century, global immuniza18 tion efforts have successfully led to the eradication 

19 of smallpox and the elimination of polio from the 

20 Western Hemisphere, Europe, and most of Asia. 

21 Vaccines for diseases such as measles and tetanus 

22 have dramatically reduced childhood mortality world23 wide, and vaccines for diseases such as influenza, 

24 pneumonia, and hepatitis help prevent sickness and 

25 death of adults as well as children. 


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1 (3) According to the World Health Organiza2 tion, combined, AIDS, tuberculosis, and malaria kill 

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

4 are in the developing world, yet there are no vac5 cines for these diseases. 

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

7 such as pneumococcal disease, lymphatic filariasis, 

8 leptospirosis, leprosy, and onchocerciasis, result in 

9 severe health consequences for individuals afflicted 

10 with them, such as anemia, blindness, malnutrition 

11 and impaired childhood growth and development. In 

12 addition, these diseases result in lost productivity in 

13 developing countries costing in the billions of dollars. 

14 (5) Infants, children, and adolescents are 

15 among the populations hardest hit by AIDS, ma16 laria, and many other neglected diseases. Nearly 

17 11,000,000 children under age 5 die each year due 

18 to these diseases, primarily in developing countries. 

19 Existing and future vaccines that target children 

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

21 and deaths. 

22 (6) The devastating impact of neglected dis23 eases in developing countries threatens the political 

24 and economic stability of these countries and conVerDate Aug 31 2005 19:10 Mar 10, 2007 Jkt 059200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H1391.IH H1391

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1 stitutes a threat to United States economic and se2 curity interests. 

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

4 health research and development across the world, 

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

6 that are specific to developing countries, most of 

7 which is from public and philanthropic sources. 

8 (8) Despite the devastating impact these and 

9 other diseases have on developing countries, it is es10 timated that only 10 percent of the world’s research 

11 and development on health is targeted on diseases 

12 affecting 90 percent of the world’s population. 

13 (9) Because the developing country market is 

14 small and unpredictable, there is an insufficient pri15 vate sector investment in research for vaccines for 

16 neglected diseases that disproportionately affect pop17 ulations in developing countries. 

18 (10) Creating a broad range of economic incen19 tives to increase private sector research on neglected 

20 diseases is critical to the development of vaccines for 

21 neglected diseases. 

22 (11) In recognition of the need for more eco23 nomic incentives to encourage private sector invest24 ment in vaccines for neglected diseases, an inter25 national group of health, technical, and economic exVerDate Aug 31 2005 19:10 Mar 10, 2007 Jkt 059200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H1391.IH H1391

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1 perts has developed a framework for an advance 

2 market commitment pilot program for pneumococcal 

3 vaccines. Pneumococcal disease, a cause of pneu4 monia and meningitis, kills 1,600,000 people every 

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

6 under age 5. This pilot program will seek to stimu7 late investments to develop and produce pneumo8 coccal vaccines that could prevent between 500,000 

9 and 700,000 deaths by the year 2020. 

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

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

12 the Bill and Melinda Gates Foundation, pledged, 

13 under a plan called an Advance Market Commit14 ment, to purchase pneumococcal vaccines now under 

15 development. Together, these countries and the Bill 

16 and Melinda Gates Foundation have committed 

17 $1,500,000,000 for this program. Experts believe 

18 that this initiative could accelerate by a decade the 

19 widespread use of such a vaccine in the developing 

20 world and could prevent the deaths of an estimated 

21 5,400,000 children by 2030. 

22 SEC. 4. SENSE OF CONGRESS ON SUPPORT FOR NE23 GLECTED DISEASES. 

24 It is the sense of Congress that— 


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1 (1) the President should continue to encourage 

2 efforts to support the Global HIV Vaccine Enter3 prise, a virtual consortium of scientists and organi4 zations committed to accelerating the development of 

5 an effective HIV vaccine; 

6 (2) the United States should work with the 

7 Global Fund to Fight AIDS, Tuberculosis and Ma8 laria, the Joint United Nations Programme on HIV/ 

9 AIDS (‘‘UNAIDS’’), the World Health Organiza10 tion, the International AIDS Vaccine Initiative, the 

11 GAVI Alliance, and the World Bank to ensure that 

12 all countries heavily affected by the HIV/AIDS pan13 demic have national AIDS vaccine plans; 

14 (3) the United States should support and en15 courage the carrying out of the agreements of the 

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

17 Scotland, to increase direct investment and create 

18 market incentives, including through public-private 

19 partnerships and advance market commitments, to 

20 complement public research in the development of 

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

22 malaria, tuberculosis, and other neglected diseases; 

23 (4) the United States should support the devel24 opment of effective vaccines for infants, children, 

25 and adolescents as early as is medically and ethically 


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1 appropriate, in order to avoid significant delays in 

2 the availability of pediatric vaccines at the cost of 

3 thousands of lives; 

4 (5) the United States should continue sup5 porting the work of the GAVI Alliance and the Glob6 al Fund for Children’s Vaccines as appropriate and 

7 effective vehicles to purchase and distribute vaccines 

8 for neglected diseases at an affordable price once 

9 such vaccines are discovered in order to distribute 

10 them to the developing world; 

11 (6) the United States should work with others 

12 in the international community to address the mul13 tiple obstacles to the development of vaccines for ne14 glected diseases including scientific barriers, insuffi15 cient economic incentives, protracted regulatory pro16 cedures, lack of delivery systems for products once 

17 developed, liability risks, and intellectual property 

18 rights; and 

19 (7) the United States should contribute to the 

20 pilot Advance Market Commitment for pneumococcal 

21 vaccines launched in Rome on February 9, 2007, 

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

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

24 child deaths by 2030. 


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1 SEC. 5. PUBLIC-PRIVATE PARTNERSHIPS. 

2 (a) FINDINGS.—Congress makes the following find3 ings: 

4 (1) Partnerships between governments and the 

5 private sector (including foundations, universities, 

6 corporations, community-based organizations, and 

7 other nongovernmental organizations) are playing a 

8 critical role in the area of global health, particularly 

9 in the fight against neglected diseases, including 

10 HIV/AIDS, tuberculosis, and malaria. 

11 (2) These public-private partnerships improve 

12 the delivery of health services in developing countries 

13 and accelerate research and development of vaccines 

14 and other preventive medical technologies essential 

15 to combating infectious diseases that disproportion16 ately kill people in developing countries. 

17 (3) These public-private partnerships maximize 

18 the unique capabilities of each sector while com19 bining financial and other resources, scientific 

20 knowledge, and expertise toward common goals 

21 which cannot be achieved by either sector alone. 

22 (4) Public-private partnerships such as the 

23 International AIDS Vaccine Initiative, PATH’s Ma24 laria Vaccine Initiative, and the Global TB Drug 

25 Facility are playing cutting edge roles in the efforts 

26 to develop vaccines for these diseases. 


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1 (5) Public-private partnerships serve as incen2 tives to the research and development of vaccines for 

3 neglected diseases by providing biotechnology compa4 nies, which often have no experience in developing 

5 countries, with technical assistance and on the 

6 ground support for clinical trials of the vaccine 

7 through the various stages of development. 

8 (6) Sustaining existing public-private partner9 ships and building new ones where needed are essen10 tial to the success of the efforts by the United States 

11 and others in the international community to find a 

12 cure for these and other neglected diseases. 

13 (b) SENSE OF CONGRESS.—It is the sense of Con14 gress that— 

15 (1) the sustainment and promotion of public16 private partnerships must be a central element of 

17 the strategy pursued by the United States to create 

18 effective incentives for the development of vaccines 

19 and other preventive medical technologies for ne20 glected diseases debilitating the developing world; 

21 and 

22 (2) the United States Government should take 

23 steps to address the obstacles to the development of 

24 these technologies by increasing investment in reVerDate Aug 31 2005 19:10 Mar 10, 2007 Jkt 059200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H1391.IH H1391

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1 search and development and establishing market and 

2 other incentives. 

3 SEC. 6. COMPREHENSIVE STRATEGY FOR ACCELERATING 

4 THE DEVELOPMENT OF VACCINES FOR NE5 GLECTED DISEASES. 

6 (a) REQUIREMENT FOR STRATEGY.—The President 

7 shall establish a comprehensive strategy to accelerate ef8 forts to develop vaccines and microbicides for neglected 

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

10 Such strategy shall— 

11 (1) expand public-private partnerships and seek 

12 to leverage resources from other countries and the 

13 private sector; 

14 (2) include the negotiation of advance market 

15 commitments and other initiatives to create eco16 nomic incentives for the research, development, and 

17 manufacturing of vaccines and microbicides for HIV/ 

18 AIDS, tuberculosis, malaria, and other neglected 

19 diseases; 

20 (3) address intellectual property issues sur21 rounding the development of vaccines and 

22 microbicides for neglected diseases; 

23 (4) maximize United States capabilities to sup24 port clinical trials of vaccines and microbicides in 

25 developing countries; 


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1 (5) address the issue of regulatory approval of 

2 such vaccines and microbicides, whether through the 

3 Commissioner of the Food and Drug Administration, 

4 or the World Health Organization, or another entity; 

5 and 

6 (6) expand the purchase and delivery of existing 

7 vaccines. 

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

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

10 the appropriate congressional committees a report setting 

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

12 to implement such strategy. 

13 SEC. 7. ADVANCE MARKET COMMITMENTS. 

14 (a) PURPOSE.—The purpose of this section is to im15 prove global health by creating a competitive market for 

16 future vaccines through advance market commitments. 

17 (b) AUTHORITY TO NEGOTIATE.— 

18 (1) IN GENERAL.—The Secretary of the Treas19 ury shall enter into negotiations with the appro20 priate officials of the World Bank, the International 

21 Development Association, and the GAVI Alliance, 

22 the member nations of such entities, and other inter23 ested parties for the purpose of establishing advance 

24 market commitments to purchase vaccines and 

25 microbicides to combat neglected diseases. 


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

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

3 shall submit to the appropriate congressional com4 mittees a report on the status of the negotiations to 

5 create advance market commitments under this sec6 tion. This report may be submitted as part of the re7 port submitted under section 6(b). 

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

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

10 to ensure that there is an international framework for the 

11 establishment and implementation of advance market 

12 commitments and that such commitments include— 

13 (1) legally binding contracts for product pur14 chase that include a fair market price for a guaran15 teed number of treatments to ensure that the mar16 ket incentive is sufficient; 

17 (2) clearly defined and transparent rules of 

18 competition for qualified developers and suppliers of 

19 the product; 

20 (3) clearly defined requirements for eligible vac21 cines to ensure that they are safe and effective; 

22 (4) dispute settlement mechanisms; and 

23 (5) sufficient flexibility to enable the contracts 

24 to be adjusted in accord with new information re25 lated to projected market size and other factors 


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1 while still maintaining the purchase commitment at 

2 a fair price. 

3 (d) AUTHORIZATION OF APPROPRIATIONS.— 

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

5 appropriated such sums as may be necessary for 

6 each of fiscal years 2009 through 2014 to fund an 

7 advance market commitment pilot program for pneu8 mococcal vaccines. 

9 (2) AVAILABILITY.—Amounts appropriated pur10 suant to this subsection shall remain available until 

11 expended without fiscal year limitation. 

Æ 


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