Open AccessPatient Access in 14 High-Income Countries to New Antibacterials Approved by the US Food and Drug Administration, European Medicines Agency, Japanese Pharmaceuticals and Medical Devices Agency, or Health Canada, 2010–2020
Author(s) -
Kevin Outterson,
Ebiowei Samuel F Orubu,
John H. Rex,
Christine Årdal,
Muhammad H. Zaman
Publication year - 2021
Publication title -
clinical infectious diseases/clinical infectious diseases (online. university of chicago. press)
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.44
H-Index - 336
eISSN - 1537-6591
pISSN - 1058-4838
DOI - 10.1093/cid/ciab612
Subject(s) - revenue , agency (philosophy) , european union , business , marketing authorization , medicine , environmental health , finance , international trade , philosophy , epistemology , bioinformatics , biology
Inaccessibility of medicines in low- and middle-income countries is a frequent challenge. Yet it is typically assumed that high-income countries have complete access to the full arsenal of medicines. This study tests this assumption for new antibacterials, which are saved as a last resort in order to prevent the development of resistance, resulting in insufficient revenues to offset costs. Prior studies report only regulatory approval, missing the important lag that occurs between approval and commercial launch, although some antibiotics never launch in some countries.