8.6 Finalisation of restriction wording
The PBAC is required, as part of its advice to the Minister, to recommend the circumstances under which a medicine should be supplied under a new or amended PBS listing. These circumstances are referred to as a restriction. The wording of the restriction must be finalised before the Minister can approve the medicine for listing on the PBS.
The final restriction will generally be provided to the applicant in the PBAC Minutes, three weeks after the PBAC meeting.
When the restriction is complex, the PBAC Minutes will indicate the restriction wording is ‘to be finalised’. The department’s Restrictions Working Group may meet to discuss the wording to ensure it reflects the intention of the PBAC. The applicant may be approached for comment on the restriction by the department.
Departmental officers, working with the Restrictions Working Group and the PBAC out-of-session, continue development of the restriction within the intent of the PBAC recommendation. Where appropriate, clinical specialists may be consulted (refer to Section 6.8). One the restriction is drafted; Services Australia reviews the restriction and advises of any issues that may arise with administration. The completed draft is provided to the applicant for information purposes prior to entry into the PBS.
If the applicant does not agree with the finalised restriction, the listing will not proceed and the medicine will not be available on the PBS. Where the department and the applicant are unable to resolve differences about the restriction, the listing will not proceed. If the issues require PBAC consideration, the applicant will need to lodge a new submission (see Section 5). Refer to Appendix A for contact details.