According to the Department of Health and Aged Care, "The PBAC is able to set its own meeting agenda."
The Pharmaceutical Benefits Advisory Committee can make certain adjustments to its agenda, such as the order of items.
However, the department's claim suggests the committee has the power to override regulations and defer its evaluation of submissions.
This is incorrect.
The committee has no legal authority to defer the health department's evaluation and its consideration of submissions lodged by sponsors that are consistent with regulatory requirements.
Former PBAC chair Professor Andrew Wilson AO consistently stated its processes as submission-driven. It was a legally accurate description.
What is included in the PBAC agenda reflects the complex regulatory arrangements governing the committee's operation.
Many agenda items reflect the interoperability of these regulatory arrangements.
The cost-recovery regulations - The National Health (Pharmaceutical and Vaccines--Cost Recovery) Regulations 2022 - interact with others, including the resubmission pathways.
Former health minister Greg Hunt imposed the resubmission pathways via regulation. These regulations legally require the PBAC to nominate one of four re-entry pathways for submissions that are not recommended: standard, early re-entry, early resolution, or facilitated resolution.
The PBAC cannot 'set its agenda' to disregard this regulatory requirement, as the health department claims.
The resubmission pathways are also included in the cost-recovery regulations.
These regulations significantly dictate the PBAC's agenda, giving the committee minimal discretion in what it considers.
If a sponsor submits consistent with the regulations, it must be evaluated and included on the committee's agenda.
In response to a question, the health department said, "There is no obligation for the PBAC to consider a submission at the meeting date specified in the submission."
Who said anything about a date in the submission?
What matters is the notice of intent, which in regulation relates to a specific meeting, and an invoice that references the submission's consideration at the same meeting.
It is odd, to say the least, to claim that a regulated invoice process that includes references to specific PBAC meetings does not impose any obligation.
Of course, the health department has form on talking around the legality of programs. Its officials denied the unlawful arrangements of the former Opiate Dependence Treatment Program. This arrangement removed the protection of PBS co-payments and the safety net without any legislative instrument.
All stakeholders need to question how this 45-submission gap will be reconciled.
Are we meant to believe that the process, which apparently can only accommodate 32 submissions at the March PBAC meeting, will be able to manage what could be 80, 90 or 100 in July?
The obvious risk is that the short-term prioritisation of some submissions, which means deprioritising almost two-thirds, becomes an intractable part of decision-making.
