It may apply.

The fact that a product is a generic drug does not exempt it from the scope of the Ordinance. While the existence of competition tends to reduce the need for individual negotiation, it does not preclude the Committee from taking action.

A generic drug can have a significant budgetary impact due to the volume purchased, the number of patients treated, or the duration of treatment. Negotiations may also address supply reliability, delivery schedules, staggered purchasing, demand predictability, or a product portfolio.

Therefore, the analysis should not be limited to patent status or unit cost. It is necessary to examine who is making the purchase, the volume purchased by the SUS, the aggregate impact, and the economic and operational conditions subject to negotiation.