对新型抗菌药物进行补充性国家激励的必要性白皮书

The need for European countries tocomplement EU-level pull incentives with Report June2026 The research was initiated and funded by GSK and developed by CRA. NP-GBL-NA-WCNT-260001 Table of Contents Executive Summary ............................................................................................................ 3 1.1European commitments to address the antibiotic pipeline crisis ............................................... 71.2Overview of different types of incentives addressing AMR........................................................ 81.3The need for complementary incentives in Europe ................................................................... 92.Current progress across Europe ............................................................................... 11 2.1An overview of progress at the European level ....................................................................... 112.2An overview of progress at the country level ........................................................................... 123.A national policy agenda to incentivise new antibiotics and sustain access ......... 18 3.1Opportunities for optimising the incentive mix in Europe......................................................... 183.2Key recommendations ............................................................................................................. 21 Executive Summary European commitments to address the antibiotic pipeline crisis Antimicrobial resistance (AMR) poses an escalating threat to global health, economies, and health-system resilience.1Resistant infections already cause more than 35,000 deaths annually in Europe andcost billions in healthcare and productivity losses.2The urgent need for new antibiotics to be developedis widely acknowledged; at the same time, the antibiotic market fails to provide adequate incentives forinnovation. Although the clinical need for new antimicrobials is well established, the current R&D Recent progress at the EU level—such as the transferable exclusivity voucher (TEV), the proposedvoluntary subscription model for the joint procurement of antimicrobials and the Health Emergency Preparedness and Response Authority (HERA) pilot revenue-guarantee model—represents pivotalsteps toward creating a predictable incentive framework in Europe.4However, ensuring that these EU- The need for complementary incentives in Europe Despiterenewed political commitment and momentum behind the development of EU-levelmechanisms,Europe’s response remains fragmented;national engagement,uneven.6Recentevidence shows that while some countries, including the United Kingdom and Italy, are contributing their fair share to global antimicrobial incentives, most others are falling behind in proportionateinvestment and policy implementation.7EU-level pull incentives, such as the proposed TEV, are Accessible from:https://globalamrhub.org/wp-content/uploads/2024/10/g7progress_2024_hub_who.pdfAccessed on:28/10/20254CRA (2022). “A framework for assessing the potential net benefits realised through transferable exclusivity extension(TEE) as an incentive for development of novel antimicrobials”.Accessible from:https://www.efpia.eu/media/676634/cra-efpia- high-priorityantimicrobials.However,these instruments alone cannot secure equitable access,sustained commercial viability, or alignment of national markets with global innovation goals.8 To ensure that Europe meets its collective responsibility and benefits from robust antibiotic pipelines,countries need to complement EU-level initiatives with national policy measures that (1) reflect their fair This white paper seeks to answer two key questions: •What the role and need for complementary policy changes at the national level?•What are the options for countries to ensure they contribute their fair share and deliver access An overview of progress at country level At a national level, progress has been positive but uneven, with a handful of countries leading the wayin developing are credible pull incentives and addressing access. A 2025 study revealed that amongthe G7 and EU27 countries, only the United Kingdom and Italy are currently contributing to their fair Different approaches are being proposed to stimulate antibiotic innovation and ensure sustainableaccess. Several countries, including Sweden, Germany, and France, have implemented incentives fornovel antimicrobials that fall short of their fair-share obligations. In contrast, many other countries havenot yet introduced any incentives for novel antimicrobials, although policy discussions are underway in 8CRA (2022). “A framework for assessing the potential net benefits realised through transferable exclusivity extension(TEE) as an incentive for development of novel antimicrobials”.Accessible from:https://www.efpia.eu/media/676634/cra-efpia-a-framework-for-assessing-the-costs-and-benefits-of-tee-final-report.pdfAccessed on: 06/11/20259Årdal, C., Baraldi, E., Bettiol, E