Policies and Incentives for Promoting Innovation in Antibiotic Research

by Mossialos, Elias; Morel, Chantal M.; Edwards, Suzanne; Berenson, Julia; Gemmill-Toyama, Marin

• ISBN13: 9789289042130
• ISBN10: 9289042133
• Edition: 1st
• Format: Paperback
• Copyright: 2010-11-30
• Publisher: World Health Organization

Summary

High levels of pathogen resistance are rendering current antibiotics obsolete. Coupled with insufficient investment in discovering new treatments, multidrug-resistant infections are an increasingly urgent public health concern. To curb the growth of antibiotic resistance and prevent major morbidity and mortality from multidrug-resistant bacterial infections, the overuse of antibiotics must be addressed and research and development for antibiotics with novel mechanisms of action actively promoted. This requires appropriately designed incentives for health and regulatory systems, in addition to economic incentives to attract academic interest and industry investment. This book, commissioned by the Swedish Government from the European Observatory on Health Systems and Policies, analyses many proposed policies and incentive mechanisms and sheds light on the key issues that will help policy-makers reach informed, concrete decisions on how to avert this potential public health crisis.

Author Biography

Elias Mossialos, Professor of Health Policy, LSE Health Chantal Morel, Research Fellow, LSE Health Suzanne Edwards, Research Associate, LSE Health Julia Berenson, Research Associate, LSE Health Marin Gemmill-Toyama, Research Fellow, LSE Health David Brogan, Resident Physician, Department of Orthopedic Surgery, Mayo Clinic, Rochester MN, United States

Table of Contents

List of tables, figures and boxes	p. vii
List of abbreviations	p. xi
Glossary	p. xiii
Foreword	p. ixx
Acknowledgements	p. xxi
10 key messages	p. xxiii
Introduction	p. 1
Background on antibiotics	p. 9
What are antibiotics?	p. 9
Why antibiotics are important	p. 10
Externalities of antibiotics and AR	p. 11
Background on AR	p. 15
What is AR?	p. 15
Severity of AR	p. 16
AR trends in developed countries	p. 16
AR trends in developing countries	p. 20
Clinical and economic impact of AR	p. 21
Clinical outcomes	p. 21
Costs of resistance	p. 23
Causes of AR	p. 27
Misuse of antibiotics	p. 27
Physicians and health-care providers	p. 28
Livestock and agriculture	p. 31
Role of diagnostics in AR	p. 32
Role of vaccines in AR	p. 36
Examples from Europe	p. 37
Examples from the United States	p. 37
Lack of new antibiotics	p. 37
The antibiotic market	p. 38
Areas of unmet need	p. 43
Reasons for limited innovation	p. 49
Antibiotic restrictions deter pharmaceutical investment in R&D	p. 49
Challenges in the antibiotics market-NPV	p. 50
Regulatory environment	p. 53
Estimated cost of drug development	p. 54
Scientific challenges	p. 57
Health system responses to AR	p. 59
Examples from Europe	p. 61
Examples from the United States	p. 63
Analysis of opportunities and incentives to stimulate R&D for antibiotics	p. 67
Push incentives	p. 67
Increasing access to research	p. 68
Scientific personnel	p. 71
Direct funding of research	p. 71
Translational research	p. 77
Tax incentives	p. 79
PDPs	p. 83
Pull incentives	p. 89
Monetary prizes	p. 89
Advance market commitments	p. 95
Patent buyout	p. 100
Lego-regulatory mechanisms	p. 100
Clinical trials	p. 101
Intellectual property mechanisms	p. 106
Expedited regulatory review	p. 117
Pricing and reimbursement	p. 121
Liability protection	p. 126
Antitrust laws	p. 127
Sui generis rights	p. 127
Combined push-pull incentive models	p. 128
Orphan drug designation	p. 128
Call options for antibiotics model	p. 129
Conclusions	p. 137
Rationale for intervention in the antibiotics market	p. 137
Preserving the effective life of existing and new antibiotics	p. 139
Key concepts in incentive design	p. 141
Conclusions on individual incentives	p. 147
Direct public subsidy for basic research	p. 147
EU Council conclusions on innovative incentives	p. 159
US-EU joint declaration on creation of transatlantic taskforce on antimicrobial resistance	p. 161
Global vaccine research	p. 175
Possible funding mechanisms for a COA scheme	p. 177
References	p. 179
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