During the latest political trilogue on 10 and 11 November, co-legislators confirmed that they had reached a preliminary political agreement on incentives for the development of priority antimicrobials. This includes the Council’s mandate as a baseline for the Voucher and the Parliament’s voluntary subscription model.
The emerging compromise points toward a hybrid incentives framework that blends the Council’s Transferable Exclusivity Voucher (TEV) with Parliament’s subscription approach.
We are now close to a preliminary compromise on antimicrobials. – Danish Presidency
According to the Danish Presidency, “the trilogues showed that we are progressing very well. We are now close to a preliminary compromise on antimicrobials.” Negotiators expect to finalise the structure at the 10 December ‘jumbo trilogue’. The full pharmaceutical package is hoped to be consolidated then.
New economic modelling reshapes the debate
The negotiation dynamics have also been influenced by new financial modelling published in April 2025 by the European Federation of Pharmaceutical Industries and Associations (EFPIA). Research carried out by Charles River Associates found that a transferable exclusivity voucher would cost Member States 45 percent less than previously estimated by the European Commission.
The analysis argues that safeguards built into the legislative proposal, restricting eligibility, tightening stewardship requirements, and narrowing transferability, “would avoid overcompensation,” lowering the average cost per TEV from €294m to €162m.
The report also places the economics of antimicrobial resistance (AMR) squarely in context. In France alone, AMR generates €264.3m in healthcare costs every year, compared to an estimated €28m cost per TEV under the updated model.
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Nathalie Moll, EFPIA’s Director-General, said in that statement: “AMR affects hundreds of thousands of people in Europe every year. We urgently need new thinking to kickstart R&D. The TEV is an affordable and balanced mechanism for unlocking antimicrobial innovation.”
TEVs should form part of a broader package of pull incentives. Including subscription models, precisely the combination now emerging from trilogue negotiations.
Roche invests into next-generation antibiotics
As the EU debates the future of AMR incentives, one of the clearest signs of scientific momentum comes from Roche, a Switzerland-headquartered global leader.
At a time when many major pharmaceutical companies have exited antibiotic development, Roche is making substantial long-term investments to rebuild the antibiotic pipeline.
According to the company, Roche “is providing just such a dedicated commitment to not one, but two teams of scientists”, one in Pharma Research and Early Development (pRED) in Basel, Switzerland, and one in Genentech Research and Early Development (gRED) in San Francisco. The company insist that “both are delivering exciting novel classes of antibiotics, which are currently in clinical development and research approaches to replenish the antibiotics pipeline.”
This is a tough business, and innovation does not move fast. – Michael Lobritz, Head of Infectious Diseases at Roche pRED
Michael Lobritz, Head of Infectious Diseases at Roche pRED, underscores the challenge: “This is a tough business, and innovation does not move fast… But we have a young portfolio, and the foundation of Roche’s commitment and support is a major driver behind our success.”
At the centre of this work is zosurabalpin, a first-in-class antibiotic targeting carbapenem-resistant Acinetobacter baumannii (CRAB). This is one of the most dangerous pathogens in modern hospitals.
In a July 2025 communication, the company confirmed that the molecule had advanced into Phase III trials. They called it “a novel antibiotic that could become the first in over 50 years to tackle a type of bacteria that has become resistant to most other treatments.”
The global Phase III study will enrol hundreds of patients across Europe, the Americas and Asia to treat life-threatening ventilator-associated pneumonia and sepsis caused by CRAB. As experts note, this is not just another drug in development. It is the first promising Gram-negative antibiotic class in half a century.
Final package expected to be adopted in December
Beyond AMR incentives, the broader pharmaceutical package continues progressing at both technical and political levels.
Negotiators were able to validate the sections of the compromise texts which had been agreed at the technical level, in all eight chapters. They also explored potential landing zones for the Bolar exemption, regulatory protection periods and access provisions.
“Political guidance was also given on the way forward with security of supply”, confirmed the Danish presidency spokesperson. The Danish Presidency believes that the foundation for the work needed on the technical level has been laid in order to present and agree on a final combined package at a ‘jumbo’ trilogue on the 10 of December.
