Expanding Access to Novel Antibacterial Therapeutics in Low- and Middle-Income Countries: Leveraging Donor-Funded Pooled Procurement

Abstract

Antibiotics are one of the most significant advances of modern medicine, however, bacteria continue to evolve faster than new antibacterials are being developed. In 2019, 1.27 million deaths were directly attributable to bacterial antimicrobial resistance (AMR) globally—more than either HIV or malaria that year—with the highest death rates occurring in low- and middle-income countries (LMICs) (Murray et al., 2022). Because of limited returns on investment, multinational pharmaceutical companies have largely abandoned antibacterial development. This void has been filled by smaller product developers vastly located in the United States and Europe who have limited resources and experience in seeking licensure and commercialization in LMICs, where the need is greatest (WHO, 2021). When these smaller developers only seek regulatory approval in the high-income countries where they are located, they often cannot sell enough of their product to avoid bankruptcy because of the low volume of patients with susceptible infections there (Alm & Gallant, 2020). Building on the current body of literature, this study assessed the factors necessary to leverage an existing donor-funded pooled procurement strategy to expand its scope to include novel antibacterial therapeutics, with the goal of expanding access to these products in LMICs. Market access expansion would bring new products to patients where they are needed most while also ensuring financial viability for developers of novel antibacterials who struggle to retain financial solvency. A qualitative case study gathering expertise from individuals familiar with current procurement practices for novel antibacterials and donor-funded global procurement strategies for other infectious disease therapeutics elucidated that the Global Drug Facility (GDF) is the entity best positioned to expand scope to include novel antibacterials for AMR. An eight-stage action plan was developed to provide recommended actions, resource needs, measures of success, and an anticipated timeline over the next decade for GDF and a consortium of technical partners to implement the scope expansion. By pairing a market-driven access expansion initiative with a pragmatic approach to support financial sustainability of product developers, these critical medicines can be available for patients globally, and the AMR pipeline can support the demand for new antibacterials for decades to come.