Policies and incentives for promoting innovation in antibiotic research
Elias Mossialos, Chantal M Morel, Suzanne Edwards, Julia Berenson, Marin Gemmill-Toyama, David Brogan
This study was commissioned and financed by theSwedish Government
World Health Organization 2010, on behalf of the European Observatory on Health Systems and Policies
Available online PDF [224p.] at: http://bit.ly/aEepeE
“……Bacterial resistance to currently available antibiotics is becoming increasingly frequent in both hospital and community settings. We are even starting to see resistance to entire antibiotic classes such as beta-lactams, quinolones, tetracyclines, glycopeptides and macrolides.
Resistance to antibiotics presents a major challenge in health care as resistant bacteria dramatically decrease the chances of treating infections effectively and increase the risk of complications and death (ReAct – Action on Antibiotic Resistance 2007). Within the European Union (EU) alone it is estimated that 2 million patients acquire nosocomial infections each year (European Academies Science Advisory Council 2007), over half of which are drug resistant (Vicente et al. 2006). Coupled with the lack of investment to discover new antibiotics, we are facing a potential health crisis. In response to this growing threat, in December 2009 the Council of the European Union called upon the European Commission (EC) 6 to:
within 24 months, develop a comprehensive action-plan, with concrete proposals concerning incentives to develop new effective antibiotics, including
ways to secure their rational use; and ensure that these proposals take account of the economic impact on the financial sustainability of healthcare systems.
Around the same time the
resistance.7 This book is intended to help shed light on some of the key policies and incentives proposed to tackle this problem…..”
Content:
Introduction
Chapter 1 Background on antibiotics
1.1 What are antibiotics?
1.2 Why antibiotics are important
1.3 Externalities of antibiotics and AR
Chapter 2 Background on AR
2.1 What is AR?
2.2 Severity of AR
2.2.1 AR trends in developed countries
2.2.2 AR trends in developing countries
2.3 Clinical and economic impact of AR
2.3.1 Clinical outcomes
2.3.2 Costs of resistance
Chapter 3 Causes of AR
3.1 Misuse of antibiotics
3.1.1 Physicians and health-care providers
3.1.2 Livestock and agriculture
3.2 Role of diagnostics in AR
3.3 Role of vaccines in AR
3.3.1 Examples from
3.3.2 Examples from the
3.4 Lack of new antibiotics
3.4.1 The antibiotic market
3.4.2 Areas of unmet need
Chapter 4 Reasons for limited innovation
4.1 Antibiotic restrictions deter pharmaceutical investment in R&D 49
4.2 Challenges in the antibiotics market – NPV
4.3 Regulatory environment
4.4 Estimated cost of drug development
4.5 Scientific challenges
Chapter 5 Health system responses to AR
5.1 Examples from
5.2 Examples from the
Chapter 6 Analysis of opportunities and incentives to stimulate R&D for antibiotics
6.1 Push incentives
6.1.1 Increasing access to research
6.1.2 Scientific personnel
6.1.3 Direct funding of research
6.1.4 Translational research
6.1.5 Tax incentives
6.1.6 PDPs
6.2 Pull incentives
6.2.1 Monetary prizes
6.2.2 Advance market commitments
6.2.3 Patent buyout
6.3 Lego-regulatory mechanisms
6.3.1 Clinical trials
6.3.2 Intellectual property mechanisms
6.3.3 Expedited regulatory review
6.3.4 Pricing and reimbursement
6.3.5 Liability protection
6.3.6 Antitrust laws
6.3.7 Sui generis rights
6.4 Combined push-pull incentive models
6.4.1 Orphan drug designation
6.4.2 Call options for antibiotics model
Chapter 7 Conclusions
7.1 Rationale for intervention in the antibiotics market
7.2 Preserving the effective life of existing and new antibiotics
7.3 Key concepts in incentive design
7.4 Conclusions on individual incentives
7.4.1 Direct public subsidy for basic research
Appendix A. EU Council conclusions on innovative incentives
Appendix B. US-EU joint declaration on creation of transatlantic taskforce on antimicrobial resistance
Appendix C. Global vaccine research
Appendix D. Possible funding mechanisms for a COA scheme
References
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