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Thursday, 12 August 2004
Page: 26380


Senator HILL (Minister for Defence) (5:19 PM) —I guess the short answer is that it was something that was sought, and the Australian negotiators saw no downside in it. I remind the honourable senator that the review mechanism is available only in cases where the PBAC recommends that a drug not be added to the PBS. It gives an unsuccessful applicant an opportunity, but they would have to identify grounds for review and those grounds must relate to issues raised in the rejection of the drug for PBS listing by the PBAC.

Reviews will be conducted by an independent expert, who will make comments back to the PBAC. The review process will not have the power to overturn the listing decisions of the PBAC. The PBAC will remain the gatekeeper to the PBS. In fact, it is possible to argue that the review mechanism provides increased transparency, which is perhaps a good thing in the PBS listing decision-making process. I have certainly heard senators in this place argue for greater transparency within that process. The review mechanism has been developed in consultation with the PBAC, the pharmaceutical industry and other stakeholders. The review mechanism in no way affects the fundamental architecture of the PBS—that is, the listing and pricing mechanisms for the PBS remain unchanged.