8.3 Restriction wording
The PBAC is required, as part of its advice to the minister, to recommend any restriction on the circumstances for prescribing that should apply to a new listing. The wording of the restriction must be finalised before listing on the PBS Schedule can be recommended to the minister.
The final restriction will generally be provided to the sponsor in the PBAC Minutes. In some cases, where refinement of the wording is requested by the PBAC, the PBAC Minutes state that the restriction is ‘to be finalised’.
Where the PBAC has not finalised the restriction , the Department of Health’s Restrictions Working Group may meet to discuss the wording to ensure it reflects the intention of the PBAC. Departmental officers, working with the Restrictions Working Group and the PBAC out of session, prepare a draft version of the restriction. Where appropriate, clinical specialists may be consulted (refer to Section 6.8).The draft is provided to the Department of Human Services to check for issues with administration. The completed draft is provided to the sponsor for comment.
In these instances, the sponsor is required to agree to the wording of the restriction in writing before the listing can be recommended to the minister. This can be via company email to the PBAC Secretariat. The PBAC ratifies the restriction at the next opportunity. This is usually during the next meeting.
8.3.1 Restriction wording timeframes
When a final restriction is available, a copy of the restriction wording that will be recommended to the Minister for Health is provided to the sponsors with the ratified PBAC Minutes three weeks after the PBAC meeting.
When the PBAC Minutes indicate the restriction wording is ‘to be finalised’, the restriction will be forwarded to the sponsor for comments. The sponsor is able to comment on and discuss the restriction with the department. If the sponsor agrees to the restriction wording, the sponsor should forward agreement by company email to the PBAC Secretariat. Refer to Appendix A for contact details.
In the event that the sponsor does not agree with the restriction wording in the PBAC Minutes or the draft restriction provided by OHTA officers, the listing will not proceed. Where the department and the sponsor are unable to resolve differences about the restriction wording, these restriction wording issues may need to be referred to the PBAC through a new submission (see Section 5). Refer to Appendix A for contact details.