National Health (Highly Specialised Drugs Program) Special Arrangement 2021
Summary
National Health HSD Special Arrangement 2021, In Force
What changed
The National Health (Highly Specialised Drugs Program) Special Arrangement 2021 establishes the regulatory framework for supplying Highly Specialised Drugs (HSD) pharmaceutical benefits under the National Health Act 1953. The instrument defines key terms including 'authorised prescriber' and 'eligible patient', sets out requirements for supplies from HSD hospital authorities to patients receiving hospital treatment, and establishes governance provisions for approved hospital authorities including numbering allotments.
Affected parties—including pharmaceutical companies, HSD hospital authorities, healthcare providers, and patients—must adhere to the special arrangement's supply, prescribing, and eligibility requirements. The instrument creates compliance obligations for approved hospital authorities supplying HSD pharmaceutical benefits and establishes the administrative framework through which these specialised drugs reach eligible patients receiving hospital-based treatment.
What to do next
- Healthcare providers must comply with HSD pharmaceutical benefits supply requirements
- HSD hospital authorities must follow prescribed supply procedures
- Authorised prescribers must meet eligibility criteria under the arrangement
Archived snapshot
Apr 16, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
- Interactions
National Health (Highly Specialised Drugs Program) Special Arrangement 2021
In force Administered by
- Department of Health, Disability and Ageing
This item is authorised by the following title:
- National Health Act 1953 Latest version View as made version F2026C00321 C61 01 April 2026
View document Legislative instrument Filter active Table of contents
- Volume 1
- Part 1—Preliminary
- Division 1—General
- 1 Name
- 3 Authority
- 5 Simplified outline of this instrument
- 6 Definitions
- 7 Definition of authorised prescriber
- 8 Definition of eligible patient
- Division 2—Supplies of HSD pharmaceutical benefits from hospitals
- 9 Supplies of HSD pharmaceutical benefits by approved hospital authorities to patients receiving treatment from hospitals
- Division 3—HSD hospital authorities
- 10 HSD hospital authorities
- 11 References to approved suppliers and approved hospital authorities
- 12 Numbers allotted to HSD hospital authorities
- Part 2—Special arrangement supplies of HSD pharmaceutical benefits
- Division 1—Preliminary
- 13 Definition of special arrangement supply
- Division 2—Prescribing of HSD pharmaceutical benefits
- 15 Prescription circumstances—general (Act s 85(7)(a) and (b))
- 16 Prescription circumstances—authority required procedures
- 18 When medication chart prescriptions not to be written
- 19 Prescriptions not to direct repeated supplies for visitors to Australia
- 20 Maximum quantity or number of units (Act s 85A(2)(a))
- 21 Maximum number of repeats (Act s 85A(2)(b))
- 23 Records to be kept—prescriptions for HSD pharmaceutical benefits that have eculizumab for the treatment of atypical haemolytic uraemic syndrome
- Division 3—Supplying HSD pharmaceutical benefits
- 24 Special patient contribution for certain HSD pharmaceutical benefits
- 25 Conditions for approved pharmacists
- 26 Supplies need not be directly to persons
- 27 Repeated supplies of pharmaceutical benefits
- Part 3—Payment for special arrangement supplies of HSD pharmaceutical benefits
- Division 1—Supplies by approved hospital authorities for public hospitals
- 28 Rates of payment for approved hospital authorities for public hospitals (Act s 99(4))
- 29 Dispensed price for approved hospital authorities for public hospitals
- Division 2—Supplies by other approved suppliers
- 30 Entitlement to, and amount of, payment for approved pharmacists and approved medical practitioners
- 30A Paragraph 99AAAB(1)(b) of the Act does not apply to certain HSD pharmaceutical benefits
- 31 Rates of payment for approved hospital authorities for private hospitals (Act s 99(4))
- 32 Dispensed price for approved suppliers other than approved hospital authorities for public hospitals
- 33 Mark-up for ready-prepared pharmaceutical benefits
- 34 Dispensing fee
- Part 3A—Supply to CTG registered patients by CTG suppliers
- 34A Application of this Part
- 34B Application of the CTG Special Arrangement—co-payment and payment etc.
- Part 4—Claims for payment for special arrangement supplies of HSD pharmaceutical benefits
- 35 Rules for providing information about supplies—definition of under co-payment data
- 35A Claim for payment if an eligible patient is a CTG registered patient
- Part 5—Miscellaneous
- 36 Compliance and audit arrangements
- 37 Value for safety net purposes for supplies
- Part 6—Application, saving and transitional provisions
- Division 1—Provisions relating to this instrument as made
- 38 HSD hospital authorities
- Division 2—Provisions relating to the National Health Legislation Amendment (Opioid Dependence Treatment and Maximum Dispensed Quantities) Instrument 2023
- 39 Purpose of this Division
- 40 Definitions
- 41 Definition of special arrangement supply
- 42 Prescriptions directing supply for dispensing over time
- 43 Prescriptions directing supply of buprenorphine for injection
- 44 Prescriptions directing supply of methadone
- 45 First supply on or after 1 July 2023 deemed to be supply on first presentation
- 46 Supply on first presentation of prescription (Regulations s 44)
- 47 Repeat authorisations (Regulations s 52)
- 48 Prescriptions written in electronic form—additional procedures for giving information (Claims Rules s 7) and keeping documents
- 49 Information to be given using Claims Transmission System (Claims Rules Sch 1)
- 50 Pre-commencement benefits
- Division 3—Provisions relating to the National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (Increases in Maximum Quantity and Number of Repeats for Complex Authority required (CAR) Medicines) Instrument 2026
- 51 Prescriptions directing increased maximum quantities or numbers of units of HSD pharmaceutical benefits that have a CAR drug
- 52 Prescriptions directing increased maximum number of repeats of HSD pharmaceutical benefits that have a CAR drug
- Schedule 1—HSD pharmaceutical benefits and related information
- 1 Highly specialised drugs and HSD pharmaceutical benefits
- Schedule 2—Maximum quantities and repeats for certain HSD pharmaceutical benefits
- 1 Maximum quantity or number of units and maximum number of repeats
- Schedule 3—Circumstances and purposes
- 1 Circumstances and purposes
- Volume 2
- Schedule 3—Circumstances and purposes
- Endnotes
- Endnote 1—About the endnotes
- Endnote 2—Abbreviation key
- Endnote 3—Legislation history
- Endnote 4—Amendment history
Named provisions
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