2018年-查塔姆研究所_New_Business_Models_for_Sustainable_Antibiotics_33页_2mb

Summary of "New Business Models for Sustainable Antibiotics"

Core Content

This paper, authored by Kevin Outterson and published by Chatham House in February 2014, explores the concept of antibiotic delinkage as a potential solution to the global challenge of antibiotic resistance. It emphasizes the need for a sustainable and global approach to antibiotic development and use, arguing that the current economic incentives for antibiotic R&D are flawed and contribute to the overuse and premature resistance of these critical drugs.

Main Viewpoints

• Antibiotics are a global resource that must be managed with the same care as fisheries, due to their non-renewable nature and the ecological impact of their overuse.
• Current market incentives for antibiotics are based on sales volume and price, which encourage overuse and discourage innovation.
• Antibiotic delinkage is a promising model that decouples the financial return of R&D from sales volume, aiming to align incentives with public health needs.
• Clinical failure from untreatable infections is not solely an economic issue but also reflects failures in infection control, evolution of resistance, and ecological mismanagement.

Key Information

The Problem

• Antibiotics are essential to modern medicine and global health.
• Resistance is an evolutionary response to antibiotic use, leading to clinical failure and unmanageable infections.
• The current R&D model fails to incentivize the development of high-quality, necessary antibiotics and instead encourages the production of undifferentiated drugs with limited clinical utility.

The Solution: Antibiotic Delinkage

• Delinkage aims to reform the financial incentives for antibiotic development by shifting the focus from sales volume to other forms of compensation.
• This model addresses three key issues:
  • Inadequate incentives for R&D investment;
  • Inadequate incentives to prevent overuse and resistance;
  • Inadequate incentives for global access to antibiotics.

Stakeholders and Support

• The concept of delinkage has been endorsed by industry stakeholders, including EFPIA, GSK, AstraZeneca, and US-based executives.
• It has also been supported by international organizations such as the WHO, UN, and civil society groups like Médecins Sans Frontières and Knowledge Ecology International.

The Four Stages of the Problem

The paper outlines a comprehensive framework that includes four stages leading to clinical failure:

1. Stage 1: Infection Control – Preventing infections through better hygiene and public health measures.
2. Stage 2: Stewardship and Conservation – Reducing inappropriate use to slow resistance.
3. Stage 3: Drug Development – Creating new antibiotics, but with current incentives, this often leads to overuse and resistance.
4. Stage 4: Clinical Failure – The ultimate consequence of uncontrolled resistance and lack of effective treatments.

These stages are interconnected, and effective coordination across them is essential to manage antibiotic resistance.

Challenges to Conventional Wisdom

The paper challenges several commonly held beliefs about antibiotic development:

1. A large number of antibiotics should be approved in the next decade – This is not necessarily the best approach, as it may accelerate resistance.
2. A large number of high-quality antibiotics should be approved in the next decade – Quality and necessity should be prioritized over quantity.
3. Antibiotic clinical trials should be simplified – Simplification may lead to the approval of drugs with limited clinical value, thereby increasing resistance.
4. Billions of dollars should be spent over the next decade to bring more antibiotics to the market – Alternative investments in prevention, diagnostics, and public health may be more effective.
5. Antibiotics are unprofitable due to short treatment courses – This overlooks the long-term value of antibiotics and the need for sustainable incentives.

Conclusion

The paper concludes that antibiotic delinkage models offer a way to address the ecological, economic, and public health challenges of antibiotic resistance. These models are still in development and require further research and collaboration across disciplines and regions. The ultimate goal is to prevent clinical failure and ensure global access to life-saving antibiotics, not just to increase the number of new drugs on the market.

Structure of the Paper

• About the Author: Kevin Outterson is a professor at Boston University School of Law and a member of the CDC’s antimicrobial resistance working group.
• Acknowledgments: The paper was developed as background for a Chatham House roundtable and received financial support from Boston University and the University of Iowa.
• Executive Summary: Highlights the importance of delinkage in creating sustainable antibiotic development and use.
• 1. Introduction: Introduces the concept of antibiotic delinkage and its relevance to global health.
• 2. Key Imperatives:
  • Understanding the multi-disciplinary nature of the problem;
  • Focusing on key pathogens;
  • Challenging conventional wisdom.
• 3. Antibiotic Delinkage Models: Explores various delinkage proposals in the literature.
• 4. Conclusion: Reiterates the importance of delinkage and the need for global cooperation.

Key Takeaways

• Antibiotic resistance is a global public health crisis.
• Delinkage is a critical concept for reforming antibiotic R&D incentives.
• Coordination across disciplines and regions is essential for effective management.
• Alternative investments in prevention and public health are equally important as new drug development.
• Sustainable business models must prioritize quality, conservation, and access.