Incentivising innovation in antibiotic drug discovery and development: progress, challenges and next steps

Political momentum and funding for combatting antimicrobial resistance (AMR) continues to build. Numerous major international and national initiatives aimed at financially incentivising the research and development (R&D) of antibiotics have been implemented. However, it remains unclear how to effectively strengthen the current set of incentive programmes to further accelerate antibiotic innovation. Based on a literature review and expert input, this study first identifies and assesses the major international, European Union, US and UK antibiotic R&D funding programmes. These programmes are then evaluated across market and public health criteria necessary for comprehensively improving the antibiotic market. The current set of incentive programmes are an important initial step to improving the economic feasibility of antibiotic development. However, there appears to be a lack of global coordination across all initiatives, which risks duplicating efforts, leaving funding gaps in the value chain and overlooking important AMR goals. This study finds that incentive programmes are overly committed to early-stage push funding of basic science and preclinical research, while there is limited late-stage push funding of clinical development. Moreover, there are almost no pull incentives to facilitate transition of antibiotic products from early clinical phases to commercialisation, focus developer concentration on the highest priority antibiotics and attract large pharmaceutical companies to invest in the market. Finally, it seems that antibiotic sustainability and patient access requirements are poorly integrated into the array of incentive mechanisms.

[1]  J. O'Neill,et al.  Tackling drug-resistant infections globally: final report and recommendations , 2016 .

[2]  Prateek Shrivastava,et al.  World health organization releases global priority list of antibiotic-resistant bacteria to guide research, discovery, and development of new antibiotics , 2018 .

[3]  J. Powers,et al.  Repairing the Broken Market for Antibiotic Innovation , 2015, Health affairs.

[4]  John H Rex,et al.  Antibiotic Reimbursement in a Model Delinked from Sales: A Benchmark-Based Worldwide Approach , 2016, The Lancet. Infectious diseases.

[5]  Elias Mossialos,et al.  A critical analysis of the review on antimicrobial resistance report and the infectious disease financing facility , 2016, Globalization and Health.

[6]  H. Goossens,et al.  The Innovative Medicines Initiative's New Drugs for Bad Bugs programme: European public-private partnerships for the development of new strategies to tackle antibiotic resistance. , 2016, The Journal of antimicrobial chemotherapy.

[7]  Elias Mossialos,et al.  Targeting innovation in antibiotic drug discovery and development: The need for a One Health – One Europe – One World Framework [Internet] , 2016 .

[8]  J. Frère,et al.  Treatment of health-care-associated infections caused by Gram-negative bacteria: a consensus statement. , 2008, The Lancet. Infectious diseases.

[9]  Wendy R. Sanhai,et al.  A comprehensive regulatory framework to address the unmet need for new antibacterial treatments. , 2013, The Lancet. Infectious diseases.

[10]  A. Towse,et al.  Incentives for New Drugs to Tackle Anti-Microbial Resistance , 2017 .

[11]  M. Eichberg Public funding of clinical-stage antibiotic development in the United States and European Union. , 2015, Health security.

[12]  Elias Mossialos,et al.  Policies and Incentives for Promoting Innovation in Antibiotic Research , 2010 .

[13]  H. Goossens,et al.  Public funding for research on antibacterial resistance in the JPIAMR countries, the European Commission, and related European Union agencies: a systematic observational analysis , 2016, The Lancet. Infectious diseases.

[14]  D. Monnet Antibiotic development and the changing role of the pharmaceutical industry , 2005 .

[15]  John K Billington The ABCs of the US Broad Spectrum Antimicrobials Program: Antibiotics, Biosecurity, and Congress. , 2015, Health security.

[16]  M. Mendelson,et al.  A Global Antimicrobial Conservation Fund for Low- and Middle-Income Countries. , 2016, International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases.

[17]  Elias Mossialos,et al.  Strategies for achieving global collective action on antimicrobial resistance , 2015, Bulletin of the World Health Organization.

[18]  M. Cooper,et al.  Antibiotics in the clinical pipeline in 2013 , 2013, The Journal of Antibiotics.

[19]  Innovative Medicines Initiative and antibiotic resistance. , 2015, The Lancet. Infectious diseases.

[20]  B. Spellberg The future of antibiotics , 2014, Critical Care.

[21]  F. Franceschi,et al.  Accelerating global innovation to address antibacterial resistance: introducing CARB-X , 2016, Nature Reviews Drug Discovery.

[22]  A. Kesselheim,et al.  Improving antibiotic markets for long-term sustainability. , 2010, Yale journal of health policy, law, and ethics.

[23]  Elias Mossialos,et al.  A systematic review and critical assessment of incentive strategies for discovery and development of novel antibiotics , 2015, The Journal of Antibiotics.

[24]  Elias Mossialos,et al.  Incentives for new antibiotics: the Options Market for Antibiotics (OMA) model , 2013, Globalization and Health.

[25]  S. Solomon,et al.  Antibiotic resistance threats in the United States: stepping back from the brink. , 2014, American family physician.