EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
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
PB 15 of 2026
Purpose
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 (PB 15 of 2026) (this Instrument) amends the National Health (Highly Specialised Drugs Program) Special Arrangement 2021 to make changes to the Special Arrangement relating to the Highly Specialised Drugs (HSD) Program.
Schedule 1 to this Instrument amends the National Health (Highly Specialised Drugs Program) Special Arrangement 2021 (Special Arrangement) to enable section 30 of the National Health (Pharmaceutical Benefits) Regulations 2017 (Regulations) to operate in relation to prescriptions written for supplies of pharmaceutical benefits including complex authority required (CAR) drugs. Section 30 of the Regulations permits the Minister (or delegates within Services Australia) to approve the writing of a prescription for an increased maximum quantity or number of units of a medicine or an increased maximum number of times a supply can be repeated, when needed for individual clinical reasons.
The Instrument also inserts provisions in the Special Arrangement to validate existing approvals of prescriptions written prior to 1 February 2026 that direct supply of an increased maximum quantity or number of units of an HSD pharmaceutical benefit containing a CAR drug, or an increased number of repeats, for the purpose of supplies made on or after 1 February 2026.
Authority
Subsection 100(1) of the Act enables the Minister to make special arrangements for the supply of pharmaceutical benefits.
Subsection 100(2) of the Act provides that the Minister may vary or revoke a special arrangement made under subsection 100(1).
Subsection 100(3) of the Act provides that Part VII of the Act, and instruments made for the purposes of Part VII have effect subject to a special arrangement made under subsection 100(1).
Consultation
An ongoing and formal process of consultation in relation to matters relevant to the Special Arrangement includes the involvement of interested parties through the membership of the Pharmaceutical Benefits Advisory Committee (PBAC).
PBAC is an independent expert body established by section 100A of the Act which makes recommendations to the Minister about which drugs and medicinal preparations should be available as pharmaceutical benefits. PBAC members are appointed following nomination by prescribed organisations and associations from consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and specialists, with at least one member selected from each of those interests or professions. Remaining members are persons whom the Minister is satisfied have qualifications and experience in a field relevant to the functions of PBAC, and that would enable them to contribute meaningfully to the deliberations of PBAC. In addition, an industry nominee has been appointed to the PBAC membership. When recommending the listing of a medicine on the Pharmaceutical Benefits Scheme (PBS), PBAC takes into account the medical conditions for which the medicine has been approved for use in Australia, its clinical effectiveness, safety and cost-effectiveness compared with other treatments.
Details of this Instrument are set out in the Attachment.
This Instrument commences on 1 February 2026.
This Instrument is a legislative instrument for the purposes of the Legislation Act 2003.
ATTACHMENT A
DETAILS OF 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
Section 1 Name of Instrument
This section provides that the name of the Instrument is 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 and may also be cited as PB 15 of 2026.
Section 2 Commencement
This section provides that this Instrument commences on 1 February 2026.
Section 3 Authority
This section states that this instrument is made under subsection 100(2) of the National Health Act 1953 (the Act).
Section 4 Schedules
This section provides that each instrument that is specified in a Schedule to the Instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to the Instrument has effect according to its terms.
Schedule 1 Amendments
National Health (Highly Specialised Drugs Program) Special Arrangement 2021 (PB 27 of 2021)
Item 1 – Section 22
This item repeals section 22 of the Special Arrangement.
Section 22 of the Special Arrangement previously provided that section 30 of the National Health (Pharmaceutical Benefits) Regulations 2017 (the Regulations) did not apply in relation to HSD pharmaceutical benefits containing a complex authority required (CAR) drug (an HSD CAR benefit).
The repeal of section 22 of the Special Arrangement means that, under section 30 of the Regulations, the Minister (or delegates within Services Australia) can authorise a prescriber to write a prescription for an HSD CAR benefit:
- directing the supply, on any one occasion, of a quantity or number of units of the pharmaceutical item in the HSD CAR benefit that is greater than the maximum quantity or number of units usually allowed (increased maximum quantity); or
- directing a number of repeats for the supply of the HSD CAR benefit that is greater than the number of repeats usually allowed (increased maximum repeats).
The Minister can already authorise prescribers to write prescriptions for an increased maximum quantity or increased maximum repeats for HSD pharmaceutical benefits that do not include CAR drugs.
Item 2 – At the end of Part 6
This item inserts new Division 3 at the end of Part 6 of the Special Arrangement. Part 6 contains application, savings and transitional rules for the Special Arrangement.
New section 51 will apply to supplies of HSD CAR benefits made on or after 1 February 2026, where:
- the prescription on which the supply is made was written before 1 February 2026; and
- the prescription directs an increased maximum quantity of the pharmaceutical item in an HSD CAR benefit.
New section 52 will apply to supplies of HSD CAR benefits made on or after 1 February 2026, where:
- the prescription on which the supply is made was written before 1 February 2026; and
- the prescription directs an increased maximum number of repeats of an HSD CAR benefit.
Prior to 1 February 2026, the Minister could not validly authorise a prescription for the supply of an HSD CAR benefit to be written for an increased maximum quantity or an increased maximum number of repeats.
For supplies made on or after 1 February 2026, sections 51 and 52 will together have the effect that the Minister is taken to have validly authorised the prescription under subsection 30(2) of the Regulations and allotted the required number to the prescription, and the prescription is valid for the purposes of supply of the HSD pharmaceutical benefit.
ATTACHMENT B
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
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
(PB 15 of 2026)
This Instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.
Overview of the Instrument
The purpose of this Instrument, made under subsection 100(2) of the National Health Act 1953 (the Act), is to amend the National Health (Highly Specialised Drugs Program) Special Arrangement 2021 (PB 27 of 2021) (the Special Arrangement), to make changes to the Special Arrangement relating to the Highly Specialised Drugs (HSD) Program.
The pharmaceutical benefits supplied under the Special Arrangement are for the treatment of chronic conditions which, because of their clinical use or other special features, may only be supplied to patients receiving specialised treatment.
Human Rights Implications
This Instrument engages Articles 9 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR), specifically the rights to social security and health.
The Right to Social Security
The right to social security is contained in Article 9 of the ICESCR. It requires that a country must, within its maximum available resources, ensure access to a social security scheme that provides a minimum essential level of benefits to all individuals and families that will enable them to acquire at least essential health care. Countries are obliged to demonstrate that every effort has been made to use all resources that are at their disposal in an effort to satisfy, as a matter of priority, this minimum obligation.
The UN Committee on Economic Social and Cultural Rights reports that there is a strong presumption that retrogressive measures taken in relation to the right to social security are prohibited under ICESCR. In this context, a retrogressive measure would be one taken without adequate justification that had the effect of reducing existing levels of social security benefits, or of denying benefits to persons or groups previously entitled to them. However, it is legitimate for a government to re-direct its limited resources in ways that it considers to be more effective at meeting the general health needs of all society, particularly the needs of the more disadvantaged members of society.
The Right to Health
The right to the enjoyment of the highest attainable standard of physical and mental health is contained in Article 12(1) of the ICESCR. The UN Committee on Economic, Social and Cultural Rights (the Committee) has stated that the right to health is not a right for each individual to be healthy, but is a right to a system of health protection which provides equality of opportunity for people to enjoy the highest attainable level of health.
The Committee reports that the ‘highest attainable standard of health’ takes into account the country’s available resources. This right may be understood as a right of access to a variety of public health and health care facilities, goods, services, programs, and conditions necessary for the realisation of the highest attainable standard of health.
Analysis
This Instrument advances the right to health and the right to social security by enabling HSD pharmaceutical benefits containing Complex Authority Required (CAR) drugs to be prescribed for supply under the Special Arrangement at an increased maximum quantity or number of units, or increased number of repeats, if authorised by the Minister. Other HSD pharmaceutical benefits can already be prescribed for supply at an increased maximum quantity or number of units, or increased number of repeats, where authorised by the Minister.
The Instrument also includes provisions that validate purported authorisations of prescriptions for an increased maximum quantity or number of units or increased number of repeats of HSD pharmaceutical benefits containing CAR drugs written before 1 February 2026. For supplies made on or after 1 February 2026, the Minister will be taken to have validly authorised the prescription, and the prescription is therefore valid for the purposes of supply of the HSD pharmaceutical benefit.
The National Health (Listing of Pharmaceutical Benefits) Instrument 2024 (the Listing Instrument) determines the pharmaceutical benefits that are on the Pharmaceutical Benefits Scheme (PBS) through declarations of drugs and medicinal preparations, and determinations of forms, manners of administration and brands. The PBS is a benefit scheme which assists with advancement of these human rights by providing for subsidised access by patients to medicines. The recommendatory role of the Pharmaceutical Benefits Advisory Committee (PBAC) ensures that decisions about subsidised access to medicines on the PBS are evidence-based.
Conclusion
This Instrument is compatible with human rights because it advances the protection of human rights.
Maryka Gaudio
Acting Assistant Secretary
Community Access Programs Branch
Technology Assessment and Access Division
Department of Health, Disability and Ageing