EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM) SPECIAL ARRANGEMENT AMENDMENT (NURSE PRACTITIONER PRESCRIBING) INSTRUMENT 2026
PB 55 of 2026
Purpose
The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (Nurse Practitioner Prescribing) Instrument 2026 (PB 55 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 allow authorised nurse practitioners (NPs) and non-specialist medical practitioners to be authorised prescribers for special arrangement supplies of erythropoietin stimulating agents (ESAs) without specified additional requirements (such as a limitation to prescribing for continuing therapy only). ESAs are already listed on the Pharmaceutical Benefits Scheme (PBS) and are available for supply under the HSD Program but are not currently able to be prescribed by authorised NPs. Non-specialist medical practitioners can currently only prescribe ESAs where certain conditions are met (as specified in the Special Arrangement).
These amendments implement a recommendation made by the Pharmaceutical Benefits Advisory Committee (PBAC) at its meeting in July 2022, which supported allowing authorised NPs to prescribe ESAs for the treatment of chronic anaemia in patients with chronic kidney disease (for both initiation and continuing therapy). They also reflect the PBAC’s subsequent recommendation in March 2026 to allow non-specialist medical practitioners to prescribe ESAs on an equivalent basis with authorised NPs.
Schedule 1 to this Instrument also amends the Special Arrangement to allow persons receiving treatment by authorised NPs at or from public hospitals (other than as admitted patients), or in, at or from private hospitals, to be eligible patients for special arrangement supplies of azithromycin, doxorubicin - pegylated liposomal and rifabutin. Patients are currently eligible to receive PBS supplies of these medicines in specified circumstances under the Special Arrangement, but not where prescribed by authorised NPs independent of concurrent treatment provided by a medical practitioner.
These amendments address an unintended gap in the existing provisions of the Special Arrangement in terms of patients’ eligibility to receive special arrangement supplies of azithromycin, doxorubicin - pegylated liposomal and rifabutin where treated independently by authorised NPs in a hospital setting (noting that authorised NPs are authorised prescribers for these medicines under the relevant provisions of the Special Arrangement). They clarify patient eligibility for these medicines under the Special Arrangement consistent with the policy intent and thereby ensure consistent and lawful access to these HSD pharmaceutical benefits.
The National Health (Listing of Pharmaceutical Benefits) Instrument 2024 (Listing Instrument) determines the pharmaceutical benefits available for subsidised supply on the PBS through declarations of drugs and medicinal preparations, and determinations of forms, manners of administration and brands. Separate amendments to the Listing Instrument effective 1 May 2026 will reflect the addition of authorised NPs as an authorised prescriber type for the five listed ESAs (refer Attachment A for the specific medicines concerned). For completeness, the Listing Instrument already specifies authorised NPs as an authorised prescriber type for azithromycin, doxorubicin - pegylated liposomal and rifabutin as supplied under the Special Arrangement (the relevant amendments made by this Instrument concern patient, rather than prescriber, eligibility under the Special Arrangement).
Authority
Subsection 100(1) of the National Health Act 1953 (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
The amendments made by this Instrument accord with recommendations made by the PBAC.
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 PBAC.
The 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 the PBAC, and that would enable them to contribute meaningfully to the deliberations of the PBAC. In addition, an industry nominee has been appointed to the PBAC membership. When recommending the listing of a medicine on the PBS, the PBAC takes into account the medical conditions for which the medicine has been approved for use in Australia and its clinical effectiveness, safety and cost-effectiveness compared with other treatments.
Pharmaceutical companies were consulted throughout the process for changes to the listings on the PBS. This includes consultation through the PBAC process.
Further consultation for this Instrument was considered unnecessary due to the nature of the consultation that has already taken place in the respective decisions to amend the PBS listings of ESAs (per the relevant PBAC recommendation made in July 2022) and azithromycin, doxorubicin - pegylated liposomal and rifabutin (per the relevant PBAC recommendation made in November 2019) on the HSD Program for the addition of authorised NPs as an eligible prescriber type (as reflected by the changes outlined under ‘Purpose’).
Details of this Instrument are set out in the Attachment.
This Instrument commences on 1 May 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 (NURSE PRACTITIONER PRESCRIBING) INSTRUMENT 2026
Section 1 Name
This section provides that the name of the Instrument is the National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (Nurse Practitioner Prescribing) Instrument 2026 and may also be cited as PB 55 of 2026.
Section 2 Commencement
This section provides that this Instrument commences on 1 May 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 this Instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this 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 6
Item 1 inserts a new definition for an ‘erythropoietin stimulating agent’ into section 6 of the Special Arrangement.
The definition lists five medicines—darbepoetin alfa, epoetin alfa, epoetin beta, epoetin lambda and methoxy polyethylene glycol‑epoetin beta—as erythropoietin stimulating agents (ESAs) for the purposes of provisions relating to (authorised prescribers and eligible patients for) special arrangement supplies of these HSD pharmaceutical benefits under the Special Arrangement. For clarity - before the commencement of this instrument, these five medicines were already covered by the definition of ‘HSD pharmaceutical benefit’. After the commencement of this instrument, these five medicines will continue to be covered by that definition.
The new definition of an ‘erythropoietin stimulating agent’ enables simplified reference to be made to the medicines included in this definition in providing for specified practitioners to be authorised prescribers for these medicines under the Special Arrangement. The definition similarly enables simplified reference to the relevant medicines to be made in providing for specified persons to be eligible patients for these medicines under the Special Arrangement.
Item 2 – Subsection 7(4) (heading)
Item 2 amends the heading of subsection 7(4) of the Special Arrangement by replacing the heading ‘Medical practitioners—medication for the treatment of hepatitis C, edaravone, lanreotide and octreotide’ with the heading ‘Medical practitioners—specified medications’.
This amendment has been made to simplify the heading of subsection 7(4) in view of additions to this subsection.
Item 3 – At the end of subsection 7(4)
Item 3 inserts a new paragraph (e) to subsection 7(4) of the Special Arrangement, to include ‘a benefit that has an erythropoietin stimulating agent’ in the list of HSD pharmaceutical benefits for which a medical practitioner is an authorised prescriber as specified in this subsection.
This amendment provides for any medical practitioner to be an authorised prescriber for an ESA (see Item 1) under the Special Arrangement irrespective of whether the ESA is being prescribed for continuing treatment for a patient, and without a requirement for the medical practitioner to obtain agreement from the patient’s treating specialist (or, alternatively, authorisation by an authority of the Commonwealth and an authority of the relevant State or Territory) as would otherwise be required under subsection 7(2) (or subsection 7(3)) of the Special Arrangement.
Item 4 – After subsection 7(6)
Item 4 inserts a new subsection (6A) within section 7 of the Special Arrangement, which relates to the definition of an ‘authorised prescriber’. New subsection 7(6A) specifies that an authorised nurse practitioner is an authorised prescriber for an HSD pharmaceutical benefit for a patient if the pharmaceutical benefit has an erythropoietin stimulating agent.
This amendment provides for authorised nurse practitioners (NPs) to be authorised prescribers for ESAs (see Item 1) under the Special Arrangement.
Item 5 – At the end of section 8
Item 5 inserts new subsections (8), (9), (10) and (11) at the end of section 8 of the Special Arrangement, which relates to the definition of an ‘eligible patient’.
New subsection 8(8) provides that a person is an eligible patient for an HSD pharmaceutical benefit that has the drug azithromycin, doxorubicin - pegylated liposomal or rifabutin if the person is receiving medical treatment by an authorised nurse practitioner at or from a public hospital. New subsection 8(8) also specifies that the person must be receiving that treatment as a non-admitted patient of, day admitted patient of or patient on discharge from the hospital, and must be, or be treated as, an ‘eligible person’ (as defined in the Health Insurance Act 1973). These requirements are consistent with existing requirements applying in respect of these pharmaceutical benefits under the Special Arrangement to persons receiving medical treatment at or from a public hospital by a medical practitioner.
New subsection 8(9) provides that a person is an eligible patient for an HSD pharmaceutical benefit that has the drug azithromycin, doxorubicin - pegylated liposomal or rifabutin if the person is receiving medical treatment by an authorised nurse practitioner in, at or from a private hospital. New subsection 8(9) also specifies that the person must be, or be treated as, an ‘eligible person’ (as defined in the Health Insurance Act 1973). This requirement is consistent with an existing requirement applying in respect of these pharmaceutical benefits under the Special Arrangement to persons receiving medical treatment in, at or from a private hospital by a medical practitioner.
New subsection 8(10) provides that a person is an eligible patient for an HSD pharmaceutical benefit that has an erythropoietin stimulating agent if the person is receiving medical treatment by an authorised nurse practitioner at or from a public hospital. New subsection 8(10) also specifies that the person must be receiving that treatment as a non-admitted patient of, day admitted patient of or patient on discharge from the hospital, and must be, or be treated as, an ‘eligible person’ (as defined in the Health Insurance Act 1973). These requirements are consistent with existing requirements applying in respect of these pharmaceutical benefits under the Special Arrangement to persons receiving medical treatment at or from a public hospital by a medical practitioner.
New subsection 8(11) provides that a person is an eligible patient for an HSD pharmaceutical benefit that has an erythropoietin stimulating agent if the person is receiving medical treatment by an authorised nurse practitioner in, at or from a private hospital. New subsection 8(11) also specifies that the person must be, or be treated as, an ‘eligible person’ (as defined in the Health Insurance Act 1973). This requirement is consistent with an existing requirement applying in respect of these pharmaceutical benefits under the Special Arrangement to persons receiving medical treatment in, at or from a private hospital by a medical practitioner.
These amendments provide for patients receiving medical treatment by authorised NPs at or from a public hospital (other than as admitted patients), or in, at or from a private hospital, to be eligible patients for the purposes of receiving ESAs (see Item 1), azithromycin, doxorubicin - pegylated liposomal and rifabutin under the Special Arrangement, provided a patient is, or is to be treated as, an ‘eligible person’ within the meaning of the Health Insurance Act 1973 (per existing requirements under the Special Arrangement). For clarity, this means that patients who are prescribed these HSD pharmaceutical benefits by an authorised NP in the hospital setting will be eligible patients in respect of these medicines under the Special Arrangement irrespective of whether they are receiving concurrent treatment by a medical practitioner.
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 (Nurse Practitioner Prescribing) Instrument 2026
(PB 55 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 (Act), is to amend the National Health (Highly Specialised Drugs Program) Special Arrangement 2021 (PB 27 of 2021) (Special Arrangement), to make changes to the Special Arrangement relating to the Highly Specialised Drugs (HSD) Program.
Schedule 1 to this Instrument amends the Special Arrangement to allow authorised nurse practitioners (NPs) and non-specialist medical practitioners to be authorised prescribers for special arrangement supplies of erythropoietin stimulating agents (ESAs) without specified additional requirements (such as a limitation to prescribing for continuing therapy only). These amendments implement recommendations made by the Pharmaceutical Benefits Advisory Committee (PBAC) in July 2022 and March 2026.
Schedule 1 to this Instrument also amends the Special Arrangement to allow persons receiving treatment by authorised NPs at or from public hospitals (other than as admitted patients), or in, at or from private hospitals, to be eligible patients for special arrangement supplies of azithromycin, doxorubicin - pegylated liposomal and rifabutin. These amendments address an unintended gap in the existing provisions of the Special Arrangement in terms of patients’ eligibility to receive special arrangement supplies of these medicines where treated independently by authorised NPs in a hospital setting. In so doing, they clarify patient eligibility for these medicines under the Special Arrangement consistent with the policy intent.
Separate amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2024 (Listing Instrument) effective 1 May 2026 will reflect the addition of authorised NPs as an authorised prescriber type for the five listed ESAs, noting that the Listing Instrument already specifies authorised NPs as an authorised prescriber type for azithromycin, doxorubicin - pegylated liposomal and rifabutin as supplied under the Special Arrangement.
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 (the Committee) reports that there is a strong presumption that retrogressive measures taken in relation to the right to social security are prohibited under the 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 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
The Pharmaceutical Benefits Scheme (PBS) is a benefit scheme which assists with the advancement of the rights to health and social security by providing for subsidised access by patients to medicines. The PBS provides timely, reliable and affordable access to necessary medicines for Australians. The recommendatory role of the PBAC ensures that decisions about subsidised access to medicines on the PBS are evidence-based.
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. In most cases, medical practitioners are required to undertake specific training or be affiliated with a specialised hospital unit to prescribe these medicines.
This Instrument advances the right to health and the right to social security by enabling ESAs to be prescribed by a medical practitioner or an authorised NP without specified additional requirements (such as a limitation to prescribing for continuing therapy only) for supply under the Special Arrangement to eligible patients receiving medical treatment at or from a public hospital (other than as admitted patients), or in, at or from a private hospital. This expands the cohort of practitioners eligible to prescribe these medicines for the treatment of chronic anaemia in patients with chronic kidney disease (and in the case of non-specialist medical practitioners, removes limitations on the circumstances in which they are able to prescribe them) for subsidised supply under the HSD Program. These changes are likely to improve access to PBS-subsidised ESAs for vulnerable populations including patients in regional, rural and remote areas.
The Instrument also includes amendments that explicitly articulate the eligibility of patients receiving medical treatment by an authorised NP at or from a public hospital (other than as admitted patients), or in, at or from a private hospital, to access PBS-subsidised azithromycin, doxorubicin - pegylated liposomal and rifabutin for the treatment of conditions secondary to Human Immunodeficiency Virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS) in specified circumstances under the Special Arrangement.
Conclusion
This Instrument is compatible with human rights because it advances the protection of human rights.
Sarah Norris
Assistant Secretary
Community Access Programs Branch
Technology Assessment and Access Division
Department of Health, Disability and Ageing