UK, EU, & US Regulatory Incentives for Antibiotic Development
Author:
Basia Grodyńska
Associate Consultant
Co-Author:
Erik Doevendans
Technical Head (NL) & Principal Consultant
Introduction
The rapid rise of antimicrobial resistance makes treating potentially life-threatening bacterial infections more difficult. Furthermore, as most routine surgical procedures, from appendectomies to joint replacements to coronary bypasses, rely on antibiotic prophylaxis to prevent life-threatening postoperative infections, without reliably effective antimicrobials, these procedures will pose unacceptable risks.
This whitepaper examines global regulatory initiatives designed to stimulate antibiotic development. Governments and organizations worldwide recognize the need for innovative strategies to overcome scientific, regulatory, and financial barriers hindering antibiotic R&D. The paper highlights push and pull incentives, funding mechanisms, and specific regulatory incentives in the UK, EU, and US, including subscription models, transferable exclusivity vouchers, and the GAIN Act. It also addresses challenges in clinical trials, the potential of novel approaches such as bacteriophages and microbiome-targeted therapies, and the need for sustainable market conditions to develop new antimicrobials.