EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM)
SPECIAL ARRANGEMENT AMENDMENT (MEDICATION CHARTS FOR COMPLEX AUTHORITY REQUIRED (CAR) AND RITUXIMAB PHARMACEUTICAL BENEFITS) INSTRUMENT 2026
PB 14 of 2026
Purpose
The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (Medication Charts for Complex Authority Required (CAR) and rituximab Pharmaceutical Benefits) Instrument 2026 (PB 14 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 subparagraph 39(a)(ii) of the National Health (Pharmaceutical Benefits) Regulations 2017 (Regulations) to operate in relation to medication chart prescriptions written for supplies of HSD pharmaceutical benefits including complex authority required (CAR) drugs or rituximab. Subparagraph 39(a)(ii) of the Regulations permits medication chart prescriptions to be written for the supply of a pharmaceutical benefit in accordance with section 41 of the Regulations.
The Instrument also includes an application provision which ensures the supply of a HSD pharmaceutical benefit that has a CAR drug or rituximab, that was made on the basis of a medication chart prescription written before, on or after the commencement of this instrument, will be a valid supply if the supply occurs after the commencement of this instrument.
Authority
Subsection 100(1) of the National Health Act (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.
Key stakeholders, within the Department of Health, Disability and Ageing (Department) (including policy and system sections), were consulted to ensure that medication chart prescribing for CAR drugs and rituximab was clinically appropriate. There were no issues raised by these stakeholders.
The following external stakeholders were also consulted:
• The Australian Commission on Safety and Quality in Health Care;
• Services Australia was also consulted throughout this process to ensure that current IT systems would continue to be able to accommodate the relevant PBS authorities process. They provided comprehensive feedback, however there were no concerns included in their response; and
• A Departmental Medical Officer was consulted to ascertain whether he could see a clinical rationale for the current ‘carve out’ of CAR drugs and rituximab from medication chart prescribing. The advice was that he could see no clinical reason for the ‘carve-out’ and that other HSD pharmaceutical benefits can already be prescribed using medication charts.
Consultations were conducted by phone, email or meetings (a mix of virtual and face-to-face).
All stakeholders consulted agreed that a PBS prescriber should be permitted to use a medication chart to prescribe a PBS subsidised benefit for CAR drugs and rituximab.
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 (MEDICATION CHARTS FOR COMPLEX AUTHORITY REQUIRED (CAR) AND RITUXIMAB PHARMACEUTICAL BENEFITS) 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 (Medication Charts for Complex Authority Required (CAR) and rituximab Pharmaceutical Benefits) Instrument 2026 and may also be cited as PB 14 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 – Subsection 18(1)
This item repeals subsection 18 (1) of the Special Arrangement.
Subsection 18(1) of the Special Arrangement previously provided that subparagraph 39(a)(ii) of the Regulations does not apply to a prescription for a special arrangement supply of a HSD pharmaceutical benefit that has a CAR drug or rituximab. As such, medication chart prescriptions were not to be written for HSD pharmaceutical benefits that have CAR drugs or rituximab.
The repeal of subsection 18(1) of the Special Arrangement means that, under subparagraph 39(a)(ii) of the Regulations, a PBS prescriber will be permitted to use a medication chart prescription to prescribe a PBS subsidised HSD benefit for CAR drugs and rituximab.
Item 2 – Application of amendment
This item applies the amendments made by item 1 to the special arrangement supply of an HSD pharmaceutical benefit that has a CAR drug or rituximab that is made on or after the commencement of item 1, if the supply is made on the basis of a medication chart prescription that was written before, on or after the commencement of item 1.
This will mean that if a medication chart prescription is written for the supply of a HSD pharmaceutical benefit that has a CAR drug or rituximab before the commencement of item 1, but the supply of the drugs does not occur until after the commencement of item 1, it will still be a valid supply of a pharmaceutical benefit. This may be particularly relevant (but not limited) to situations where the patient does not fill their prescription on the same day it is written due to either an inability to access a pharmacy or a shortage of the relevant drug.
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 (Medication Charts for Complex Authority Required (CAR) and rituximab Pharmaceutical Benefits) Instrument 2026
(PB 14 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 CAR drugs or rituximab to be prescribed with medication chart prescriptions for supply under the Special Arrangement. Other HSD pharmaceutical benefits can already be prescribed using medication charts.
The Instrument also includes a provision that ensures the supply of a HSD pharmaceutical benefit containing CAR drugs or rituximab is valid if it was supplied on the basis of a medication chart prescription written before, on or after the amendments to the Special Arrangement commence, provided the supply occurs after the amendments commence.
The National Health (Listing of Pharmaceutical Benefits) Instrument 2024 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