In Europe alone, Antimicrobial Resistance or AMR results in 35,000 deaths annually, with healthcare costs and productivity losses estimated at €1.5 billion each year. Without urgent action, these figures are expected to rise.

Developing new antimicrobials is essential to tackle AMR, as existing treatments lose effectiveness over time. However, the antimicrobial R&D pipeline remains fragile and severely underfunded due to scientific and economic challenges. Unlike other types of drugs, antimicrobials should be used sparingly to limit resistance, which leads to low revenue and frequent bankruptcies in the sector. 

According to the World Health Organization (WHO), currently there are only 32 traditional antibiotics in clinical development targeting the WHO list of priority pathogens. This falls short of what is needed to effectively combat AMR. The lack of funding and investment has forced many AMR scientists out of the field in search of more sustainable opportunities.

The EU is addressing the challenge of an insufficient pipeline through the revision of its pharmaceutical legislation, taking a leading position in the fight against AMR. The proposed transferable exclusivity voucher (TEV), currently under discussion in the Council, is a targeted “pull” incentive designed to encourage companies to develop new antimicrobials. TEVs would allow companies that successfully developed a priority antimicrobial to transfer 12 months additional data exclusivity to another product, providing a predictable return on investment and decoupling rewards from sales volume.

Concerns of overcompensation or predictability for health care systems are addressed in the design of the TEV, which is limited to products under regulatory data protection, and there are limitations on the number of vouchers that can be awarded. Strict eligibility criteria and a range of conditionalities further safeguard its application. Moreover, the cost of the TEV scheme, which is minimal compared to the cost of inaction, would only represent a fraction of the total pharmaceutical spending in EU member states.

The European Commission estimates each TEV could be worth around €400 million, covering part of the EU's "fair share" of a global pull incentive, projected at approximately €1.4 billion, contributing to a worldwide effort to drive investment in new antimicrobials. Complementary access models under consideration by the Commission, along with initiatives in certain EU countries, could further support the EU in meeting its fair share.

 The international community is also stepping up. At the recent United Nations General Assembly (UNGA) High-Level Meeting on AMR, world leaders committed to taking decisive action to combat antimicrobial resistance as a top health priority, formalised in the political declaration on AMR. UN Member States also acknowledged the need for “appropriate incentives, including push and pull incentives, in the development of new health products and technologies”.

To address the lack of innovation in antimicrobial R&D, several countries are pioneering new models. In the UK, the subscription model for antimicrobials offers fixed annual payments to companies for essential antimicrobials. This approach creates a predictable revenue stream, critical for sustained investment in antimicrobial R&D.  In the U.S., the proposed Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act would bolster the antimicrobial pipeline through long-term contracts and fixed payments, ensuring the financial viability of critical new medicines independent of sales volume. Canada’s pilot project and Japan’s revenue guarantee program are also generating momentum, by creating predictable returns that encourage innovation in this vital area.

As discussions on the EU’s pharmaceutical legislation progress, policymakers have a unique opportunity to establish a predictable mechanism for urgent and much-needed sustainable antimicrobial R&D. By seizing this moment, Europe can play a leading role in the global response to AMR, delivering vital treatments for patients and securing substantial economic benefits. EFPIA is committed to working with stakeholders to help Europe strengthen its leadership in the fight against AMR.