The instrument is built around several interlocking statutory concepts, most of which derive their content from cross-references to the National Health Act 1953, the Listing Instrument, or other delegated legislation.
Botulinum toxin pharmaceutical benefit: This is defined exhaustively by Schedule 1. Only four specific listed brands are captured: Botox (botulinum toxin type A purified neurotoxin complex, lyophilised powder for injection 100 units), Dysport in two presentations (Clostridium botulinum type A toxin-haemagglutinin complex, lyophilised powder for I.M. injection 300 units and 500 units), and Xeomin (incobotulinumtoxinA, lyophilised powder for injection 100 units). Each has been declared by the Minister under section 85(2) of the Act, with the form, manner of administration and brand determined under subsections 85(3), (5) and (6) respectively. No other botulinum toxin products fall within the ambit of this instrument.
Special arrangement supply: This is the core transactional concept, defined in section 9(1). Six cumulative conditions must be satisfied. The recipient must be an eligible patient. The supply must be made by an approved hospital authority. A valid prescription must be provided either prior to supply or within seven days after administration. The benefit must be directly administered to the patient by an eligible medical practitioner. Where the Minister has determined a maximum quantity under paragraph 85A(2)(a) of the Act, the prescription must direct supply of no more than that quantity. Any conditions attached to writing such a prescription under subsection 85A(2A) must also be satisfied. The note to the subsection makes explicit that the supplier cannot physically hand the product to the patient.
Eligible medical practitioner: Section 7 adopts a purposive test hinging on the circumstances codes embedded in the Listing Instrument (as in force on 1 October 2025). A medical practitioner is eligible for a particular patient and a particular botulinum toxin pharmaceutical benefit if, under paragraph 85(7)(b) of the Act, a prescription for that benefit may be written in circumstances that include one or more sets of circumstances relating to a patient or a medical practitioner, and at least one of those sets of circumstances exists in relation to the particular patient and practitioner. The relevant circumstances codes are found in the table in Part 1 of Schedule 4 to the Listing Instrument, cross-referenced against the pharmaceutical benefit in Part 1 of Schedule 1 to that instrument. This definition ensures that only practitioners whose prescribing rights align with the patient’s clinical indication and registration status can administer the product under the program.
Eligible patient: Section 8 imposes a three-limb test. First, the person must be entitled to receive pharmaceutical benefits under section 86 of the Act. Second, the person must fall within the PBS prescribing circumstances determined under paragraph 85(7)(b), again by reference to the Listing Instrument circumstances codes. Third, the person must be receiving treatment in one of three specified settings: in or at a private hospital; in or at a public hospital as a non-admitted patient, a day-admitted patient, or an in-patient admitted for less than 24 hours; or by an eligible medical practitioner at a business address for which the practitioner holds a provider number under the Health Insurance Regulations 2018. Patients admitted to a public hospital for 24 hours or longer are excluded, reflecting the principle that such patients are already funded through public hospital arrangements rather than through this special PBS pathway.
Dispensed price: The definition bifurcates by hospital type. For public hospital supplies, the dispensed price is calculated under section 13 and consists only of the approved ex-manufacturer price or proportional ex-manufacturer price for the relevant pack quantities and broken quantities, without any mark-ups. For private hospital supplies, section 15 incorporates those same ex-manufacturer price elements plus, for ready-prepared pharmaceutical benefits, a tiered mark-up under section 16 and the ready-prepared dispensing fee. The ready-prepared dispensing fee takes its meaning from the Commonwealth price (Pharmaceutical benefits supplied by approved pharmacists) Determination 2020.
Same benefit rule: Section 11 contains a bespoke rule for determining when two botulinum toxin prescriptions written on the same day are taken to be for the same pharmaceutical benefit, which is relevant to the application of paragraph 40(3)(a) of the National Health (Pharmaceutical Benefits) Regulations 2017. Prescriptions are treated as being for the same benefit only if they relate to treatment of one of ten specified conditions (for example, moderate to severe spasticity of the upper limb, urinary incontinence, chronic migraine) or if they share the same circumstances code under the Listing Instrument.