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Table of COntents Making Markets for Vaccines Preface vii Acknowledgments ix Policy highlights x Summary A legacy of our generation 1 Chapter 1 We need to invest more in vaccines 6 Vaccines are important for global health 8 Millions die of vaccine-preventable diseases 9 More investment needed in vaccines for diseases concentrated in developing countries 10 Pharmaceutical development is a risky investment decision 11 The small market for vaccines for developing countries 13 Chapter 2 Promoting private investment in vaccine development 16 Drug development depends on both public and private investment 18 Possible incentives for commercial investment 21 Options for fi nancing R&D for neglected diseases of developing countries 22 The potential benefi ts of an advance market commitment 25 Chapter 3 A market not a prize 28 A practical advance market commitment 30 Commitments for late-stage and early-stage products 30 A sample advance market commitment for malaria 32 Advance market commitments for rotavirus and pneumococcus 34 Risks and benefi ts of an advance market commitment 36 An advance market commitment is only a partial solution 38 Chapter 4 Design choices 40 Legal issues: the contract structure 42 Eligibility requirements 44 Co-payment and the case against quantity guarantee 45 The guaranteed price 46 Two-stage pricing 46 Allowing second entrants but avoiding "me too" copies 47 Should we improve the terms over time? 47 Chapter 5 $3 billion per disease 48 Determining the size of the market needed 50 Is the commitment the right size? 52 Chapter 6 Meeting industry requirements 54 A range of industry requirements 56 The industry is diverse 56 Key industry requirements 57 Chapter 7 How sponsors can do it 58 Possible government sponsors 60 The World Bank 61 Foundations 62 The Global Alliance on Vaccines and Immunization and Vaccine Fund 63 Would sponsors pay twice? 64 Regulatory and procurement systems 67 The need for long-term contracting 68 Regulatory and procurement implications of advance market commitments 68 Where to read more 70 Notes 71 References 74 Appendix A Abbreviations 79 Appendix B Objectives of the Working Group 80 Appendix C Profi les of Working Group members 81 Appendix D Individuals consulted 87 Appendix E A tool to estimate cost effectiveness of an advance market commitment 89 Appendix F Contract term sheet for Framework Agreement 90 Schedule A to term sheet for Framework Agreement (Malaria) 102 Schedule B to draft term sheet for Framework Agreement (Malaria) 103 Appendix G Draft term sheet for Guarantee and Supply Agreement 104 Schedule A to draft term sheet for Guarantee and Supply Agreement 112 Schedule B to draft term sheet for Guarantee and Supply Agreement 112 Schedule C to draft term sheet for Guarantee and Supply Agreement 113
Library of Congress Subject Headings for this publication:
Vaccines industry -- Developing countries.
Vaccines -- Research -- Economic aspects -- Developing countries.
Pharmaceutical industry -- Developing countries.
Pharmaceuticals -- Developing countries.