Producers and Distributors

Producers and Distributors
High Priority
• Engaging producers and distributors in dialogue regarding AS &
limitation on the use of new antimicrobials to preserve efficacy
• Linking set of required activities to licensing of new drugs (data
sharing, approved limitations )
• As a condition of licensure, producers would need to demonstrate
direct linkage to stewardship interventions.
• Relicensing (follow international standards) and promotion of
forgotten and last-resort antimicrobials
• International body to review and propose evidence based
antimicrobial stewardship intervention to suggest a framework
with the aim to develop evidence based guidelines
High Priority (2)
• International body to review and propose evidence
based antimicrobial stewardship intervention to
suggest a framework with the aim to develop
evidence based guidelines
• Vaccine utilization and development
• Incentivize the development and access to rapid
diagnostics useable also suitable in LICs
• Potential for linking for diagnostics as well as drugs
To be avoided
• Using pricing as a stewardship modality (eg
cost should not be used for rationing)
Supportive
• Need strong connections with targeted
diagnostics
• De-linking revenues from Research and
Development costs
• De-coupling revenues from manufacturing
costs
• Licensing and registration (including post
registration monitoring)
• Partnering with companies on establishing
training programs
Enablers to implementation
• Working with civil society and interested multisectoral groups
• Engage industry in full partnership
• Industry should be encouraged to provide clinical
data from drug trials (sharing clinical data)
• International guidelines on AM use
• Country specific governance issues (monitoring
and tracking distributors )
• Identifying key areas on the use of AMs
• Functioning effective health systems - generic
Barriers and Strategies
• Health sector fragmented from industry
• Evidence based research on appropriate use of AMs is not
sufficiently supported or widespread
• Lacking research in appropriate treatments and management
strategies
• Duration and dose studies
• Traceability for the supply chain
• Current models of pharmaceutical pricing and development
• Lack of surveillance and reporting of community acquired
resistance