Critical analysis of the EU's legislative proposal to incentivize investment in antimicrobial R&D and access

Antibiotics are fundamental to modern medicine, enabling routine surgery, chemotherapy, and treatment of common infections. However, innovation has stagnated, largely targeting known classes that are vulnerable to resistance. Antimicrobial resistance (AMR)-the ability of pathogens to withstand treatment-erodes therapeutic effectiveness and poses substantial health and economic burdens. Addressing AMR requires an integrated strategy that preserves existing agents and rebuilds the pipeline. Traditional incentives, like patents and regulatory exclusivities, do not mitigate the risks associated with development or guarantee returns in a market where antimicrobial R&D often has negative net value. What is needed is a tailored package across the lifecycle: push incentives to finance high-risk early discovery and preclinical work, and pull incentives like market entry rewards, subscription models, and, where appropriate, exclusivity vouchers, to support late-stage development, secure predictable revenues, and ensure timely access. Experiences from the UK and Sweden show that subscription payments can stabilize supply and even deliver innovation incentives by decoupling revenues from volume. One-off rewards, including transferable exclusivity vouchers (TEVs), can decouple sales from use, but raise concerns around predictability and conditionality. Ultimately, economic tools must be coupled with stewardship and equitable access, alongside a shift from pay-by-volume to pay-for-provision/access.