OBJECTIVES: In Australia, drugs are only publicly subsidised and listed on the Pharmaceutical Benefits Scheme (PBS) if the Pharmaceutical Benefits Advisory Committee (PBAC) has determined that the drug is cost effective. This process is in addition to the regulatory process including the Australian Drug Evaluation Committee (ADEC). Critics of the current scheme have commented that requirements of the PBAC have become more onerous in recent years and that the listing of important new drugs is being delayed. We sought to analyse all published recommendations of the PBAC meetings from December 1999 to June 2003 to determine if there is a relationship between the date of a drug's regulatory approval, its PBAC recommendation and subsequent listing on the PBS. METHODS: There were 4 dates associated with each application: ADEC meeting date, PBAC meeting date, projected PBS listing date (the first date an approved drug could be PBS listed) and actual PBS listing date. We used a logistic regression model to identify variables associated with successful PBS listing, including the year of the PBAC meeting, submission type, form of economic analysis and requested listing restrictions. A second analysis was performed with the outcome variable being 'approval within 5 months of meeting date', to overcome any bias against 2003 applications that had a shorter follow-up period. RESULTS: The analysis showed 'Year of PBAC meeting' was statistically significant for successful PBS listing. The other variables were not statistically significant. Using 1999 as the reference year, the odds ratios were as follows: 2000 = 0.6889, 2001 = 0.5500, 2002 = 0.3917, 2003 = 0.1000. Using the modified dependent variable (approval within 5 months) similar results to the above analysis were produced - the OR for variable Year remained statistically significant. CONCLUSIONS: The analysis of factors associated with PBS listing showed that there was a significant downward trend over the years in successful applications. This trend did not appear to be associated with the other factors listed.