ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2022
Patient 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.
Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers.
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Who cites it
33 citing papers in PubMed.
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- Barriers to accessing newer antibiotics in countries with high burden of bacterial antimicrobial resistant infections-a qualitative study.The Lancet regional health. Western Pacific · 2026Article
- Mind the governance gap: a one health scoping review of national AMR performance indicators.npj antimicrobials and resistance · 2026Article
- Illuminating the mechanism: gene expression responses to antimicrobial photodynamic therapy.BMC genomics · 2026Review
- Silent Waterborne Carriers of Carbapenem-Resistant Gram-Negative Bacilli and Antimicrobial Resistance Genes in Rio de Janeiro's Aquatic Ecosystems.Antibiotics (Basel, Switzerland) · 2026Article
- Bridging the fair share gap for antibacterial innovation: an observational analysis of antibacterial revenues in the G7 and EU27.EClinicalMedicine · 2025Article
- "Dusting Off the Cobwebs": Rethinking How We Use New Antibiotics.Antibiotics (Basel, Switzerland) · 2025Review
- The evolving epidemiology of Carbapenemase-producing Enterobacterales in Canadian acute care facilities, 2010-2023.Antimicrobial resistance and infection control · 2025Article
- Not all disinfectants are created equal: the importance of mechanistic understanding to drive research forward.Future microbiology · 2025Article
- Variations in the Medical Device Authorization and Reimbursement Landscape: A Case Study of 2 Cardiovascular Devices Across 4 Countries.Circulation. Cardiovascular quality and outcomes · 2025Article
- Review
- Country of origin and prices of systemic antibiotics in Vietnam: a multicentre retrospective study.JAC-antimicrobial resistance · 2025Article
- 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.JAC-antimicrobial resistance · 2025Article
- Canadian impact of CLSI aminoglycoside breakpoint changes for selected gram-negative bacteria.Antimicrobial stewardship & healthcare epidemiology : ASHE · 2025Article
- China's position and competitiveness in the global antibiotic value chain: implications for global health.Globalization and health · 2024Article
- The influence of marine fungal meroterpenoid meroantarctine A toward HaCaT keratinocytes infected with Staphylococcus aureus.The Journal of antibiotics · 2024Article
- Differences in Patient Access to Newly Approved Antibacterial Drugs in EU/EEA Countries.Antibiotics (Basel, Switzerland) · 2024Review
- Advancing global antibiotic research, development and access.Nature medicine · 2024Review
- Multi-year analysis of the global preclinical antibacterial pipeline: trends and gaps.Antimicrobial agents and chemotherapy · 2024Review
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundInaccessibility 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.
methodsWe identified all antibacterials approved and launched in the G7 and 7 other high-income countries in Europe for the decade beginning 1 January 2010, using quantitative methods to explore associations.
resultsEighteen new antibacterials were identified. The majority were accessible in only 3 countries (United States, United Kingdom, and Sweden), with the remaining 11 high-income countries having access to less than half of them. European marketing authorization did not lead to automatic European access, as 14 of the antibacterials were approved by the European Medicines Agency but many fewer were commercially launched. There was no significant difference in access between "innovative" and "noninnovative" antibacterials. Median annual sales in the first launched market (generally the United States) for these 18 antibiotics were low, $16.2M.
conclusionsPatient access to new antibacterials is limited in some high-income countries including Canada, Japan, France, Germany, Italy, and Spain. With low expected sales, companies may have decided to delay or forego commercialization due to expectations of insufficient profitability.
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