Therapeutic Guidelines: Oral and Dental

will be prevented or delayed in reaching the Australian market.The Australian pharmaceutical market is a competitive one and 'if a company decides not to launch a particular product in Australia, then competitors' products come in'. 4 If there is no competitor then it is possible that a sole manufacturer may decide not to introduce a new product to the Australian market.It is a commercial decision.If cost recovery fees alone swing the manufacturer's net present value calculation of a new drug from a decision to submit (to the Therapeutic Goods Administration (TGA) and subsequently to PBAC) to 'not submit', then the case for registration and PBS listing is likely to have been marginal in the first place.Another concern is that cost recovery may compromise the independence of the PBAC, because it will be paid by the drug companies.This fear appears to be unfounded because the PBAC has no direct pecuniary interest in the process.All the income from cost recovery fees goes into consolidated revenue rather than to the PBAC itself.Neither the Department of Health and Ageing nor the PBAC would actually see any of the 'cost recovery' funds.Historically the PBAC has shown itself to be