Geneva, 5 May 2025 – At the 25th meeting of the World Health Organization (WHO) Expert Committee on the Selection and Use of Essential Medicines, the Global Antibiotic Research & Development Partnership (GARDP) has called for revisions to the definitions underpinning the WHO’s AWaRe (Access, Watch, Reserve) antibiotics classification system.

In its intervention at the meeting, GARDP emphasized that the AWaRe framework is a powerful global tool for guiding antibiotic stewardship, and suggested adjustments of its current definitions—particularly for Reserve antibiotics—to better reflect clinical realities.

“The current definition of Reserve antibiotics is based solely on activity against multidrug-resistant pathogens,” said Dr Manica Balasegaram, Executive Director of GARDP. “We must move toward a more granular definition that enables better alignment with clinical realities and supports a more accurate identification of patients who truly need last-resort treatments.”

Key Recommendations from GARDP:

• Replace “Multidrug-Resistant (MDR)” with “Difficult-to-Treat Resistance (DTR)”: GARDP proposes redefining Reserve antibiotics based on the presence of DTR, which better captures resistance to all first-line safe and effective therapies. This shift would support more accurate identification of patients who truly need last-resort treatments and enable better alignment with clinical decision-making.
• Factor in access and availability: In many low- and middle-income countries (LMICs), low use of Reserve antibiotics reflects lack of access rather than appropriate use. GARDP recommends using a DTR Index, which considers what antibiotics are actually available in a given setting, to guide classification and improve stewardship efforts.
• Reassess the criteria for Essential Reserve Antibiotics: Currently, inclusion in the Essential Medicines List (EML) Reserve category is limited to antibiotics that are active against pathogens on the WHO’s Bacterial Priority Pathogens List (BPPL)—a list designed for research prioritization, not clinical need. This approach excludes vital antibiotics needed to treat DTR infections that could also be classified as Reserve antibiotics.

“The AWaRe framework must evolve to remain effective,” said Dr Balasegaram. “GARDP’s recommendations aim to make it more responsive to real-world treatment challenges and the needs of patients, while also being more useful for stewardship, access and surveillance globally. We urge the EML Expert Committee to support these recommendations and prioritize their implementation.”

Antimicrobial resistance (AMR) is already one of the world’s biggest killers, with 4.71 million deaths associated with drug-resistant infections each year. But now, according to the recent findings of the Global Burden of Antimicrobial Resistance (GRAM) study, AMR has now reached an alarming tipping point. AMR-related mortality has remained relatively stable in recent decades, but a sharp rise is expected, with the number of AMR-related deaths increasing by more than 70% by 2050.

The primary reasons behind this sudden surge are the rise and spread of difficult-to-treat Gram-negative infections and a lack of access to effective antibiotics across the globe. Recent research, carried out by GARDP, suggests that a significant number of multidrug-resistant infections in low- and middle-income countries are not being treated appropriately, because of large gaps in access. According to the GRAM study, more than 50 million deaths could be prevented by 2050 through improvements to access.

GARDP stands ready to build on its close collaboration with WHO and work with national health authorities and stakeholders to ensure antibiotic classification systems support responsible use while enabling equitable access to life-saving treatments.

GARDP

We are a not-for-profit global health organization driven to protect people from the rise and spread of drug-resistant infections, one of the biggest threats to us all. By forging the public and private partnerships that matter, we develop and make accessible antibiotic treatments for people who need them. Vital support for our work comes from the governments of Canada, Germany, Japan, Monaco, the Netherlands, Switzerland, the United Kingdom, the Canton of Geneva, the European Union, as well as the Gates Foundation, Global Health EDCTP3, GSK, the RIGHT Foundation, the South African Medical Research Council (SAMRC) and Wellcome. We are GARDP, the Global Antibiotic Research & Development Partnership. www.gardp.org