In the July-August 2024 issue of the Global Regulatory Developments Journal, I and my colleagues, Greg Levine, Katherine Wang, Julie Kvedar, Ling Xu and Helen Ryan, of Ropes & Gray's global life sciences & healthcare practice, address the global public policy and legislative developments on antimicrobial resistance (AMR).
AMR is recognised as the most serious global public health threat of this century. While resistance is a natural biological phenomenon, it is accelerated and influenced by several factors such as misuse of medicines, poor infection control practices, and increasing cross-border movements.
AMR puts many of our modern medical advances at risk. It makes infections harder to treat and renders many medical procedures and treatments much riskier. In addition to death and disability, AMR has significant economic costs.
While the public health need for new antimicrobial drugs is pressing, market incentives to develop such drugs have not historically matched this urgent need. Antibiotic resistance in bacteria poses an especially urgent problem. There are few replacements or alternative products in development. Various new pharmacotherapeutic approaches are currently being investigated to address antibiotic resistance through novel targets for emerging antimicrobial treatments.
This article considers the varying approaches to addressing AMR across the key geographical regions of the world, including the United States, Europe, and China. In particular, the article explores different jurisdictions' efforts to incentivise antimicrobial research and development, including:
- 'Push' incentives, such as grants, subsidies, and tax incentives; and
- 'Pull' incentives, such as advance market commitments, exclusivity or patent extensions, market entry rewards, and tradeable vouchers.
The article also addresses the impact of these efforts on the life sciences industry and potential future directions for tackling AMR.
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