Although the regulatory costs outlined in Table 18 above were calculated for six specified options for the purpose of inclusion in the RIS, there is a logical grouping of options, resulting in four scenarios (see Table 2 for summary of scenarios). The average annual regulatory burden estimates (RBE) for each scenario is given in Table 19. In accordance with OBPR requirements, the costs outlined in Table 19 have been calculated for a 10-year period and presented as an average annual amount. It is worth noting that there are assumptions and limitations underpinning the regulatory impact analysis, and the conclusions of the analysis should be regarded as indicative rather than definitive. Assumptions have been made based on general information, ARTG data on existing products, stakeholder feedback, and data provided by the broader Department of Health (specifically the Medical (MBS) and pharmaceutical benefits (PBS) divisions).
Table 19: Average annual regulatory costs (from business as usual) by sector for all scenarios.
Change in costs ($million)
Total change in cost
Options 2 and 5 (Schedules 2 and 3 reduced pack size and new label warning)
(0.05 + 0.13)
Options 3 and 5 (Schedule 2 to Schedule 3, reduced pack size and new warning label)
(6.95 + 0.13)
(3.19 + 0)
Option 4 and 6 (Schedules 2, 3 to Schedule 4)
(2.53 + 0.24)
(7.71 + 1.97)
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.