Do policies that allow access to unregistered antimicrobials address the unmet need? Australia as a case study of a high-income country with universal healthcare

The study aimed to determine the average time for new antibacterials to gain registration in Australia and quantify the use of unregistered antimicrobials in Australian clinical practice between 2018 and 2023. Between 2018 and 2023, 36-131 applications were made to access unapproved antimicrobials, with 26.6% of cases involving critically ill patients. The most frequently accessed unregistered antimicrobials were levofloxacin, pyrazinamide, tetracycline, and pristinamycin. Policy reform and economic incentives are needed to support the registration of antimicrobials for untreatable infections and ensure supply sustainability.