Policy to encourage the development of antimicrobials

Antimicrobial resistance is a public health threat even in countries exercising aggressive antimicrobial stewardship. A market failure is also causing lackluster innovation in antimicrobial medicines development. At the heart of the issue are antimicrobial stewardship guidelines that, rightfully, reserve innovative antimicrobials for emergency situations that arise due to multidrug-resistant organisms. This suppresses revenues and research and development (R&D) investment incentives of manufacturers. The public policy makers and researchers have taken aim at the problem. The researchers have published strategies to encourage the production of innovative antimicrobials, while policy makers have taken legislative steps to address the issue. Most notably, the USA enacted the Generating Antibiotic Incentives Now (GAIN) act in 2012 and the EU created a commission to formally study possible policy solutions. The paper aims to discuss these issues.

In this paper, the authors describe incentives that drive pharmaceutical R&D and review the impact of a number of R&D stimulus policies in other pharmaceutical markets. The authors also discuss which policy levers are useful to boost R&D of new antimicrobials.

The authors find that a policy focused on extending intellectual property rights, as implemented in the GAIN act, are unlikely to be impactful. Instead, the authors see a need for the revision of the procurement policy to move away from paying per prescription and toward licenses and advanced market commitment models. Further, the authors note that the importance of steadfast public investment in basic biomedical research as it has been repeatedly shown to boost innovation.

The authors hope that the work can support the refinement of the GAIN act and the EU efforts.