EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (GROWTH HORMONE PROGRAM) SPECIAL ARRANGEMENT AMENDMENT (APRIL UPDATE) INSTRUMENT 2026
PB 38 of 2026
Purpose
This is the National Health (Growth Hormone Program) Special Arrangement Amendment (April Update) Instrument 2026 (this 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 (Growth Hormone Program) Special Arrangement 2025 (PB 112 of 2025) (the Special Arrangement).
The amendments made by this Instrument reflect amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2024 (PB 26 of 2024), which commence on the same day. The National Health (Listing of Pharmaceutical Benefits) Instrument 2024 (PB 26 of 2024), and amendments to that instrument, are made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the Act.
Schedule 1 to this Instrument provides for the addition of forms of the listed drug somatropin to the list of growth hormone pharmaceutical benefits for treatment of eligible adults under the Special Arrangement. These changes are summarised, by subject matter, in the Attachment.
Authority
Section 85A of the National Health Act 1953 (the Act) enables the Minister to determine the forms of pharmaceutical benefits or pharmaceutical items with respect to classes of persons.
Subsection 99(4) of the Act enables the Minister to determine the amount that approved hospital authorities may be paid by the Commonwealth for the supply of pharmaceutical benefits.
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 Pharmaceutical Benefits Advisory Committee (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.
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.
Pharmaceutical companies were consulted throughout the process of 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 had already taken place in the decision to list the medication outlined under ‘Purpose’.
General
Details of this Instrument are set out in the Attachment.
This Instrument commences on 1 April 2026.
This Instrument is a legislative instrument for the purposes of the Legislation Act 2003.
ATTACHMENT
DETAILS OF THE NATIONAL HEALTH (GROWTH HORMONE PROGRAM) SPECIAL ARRANGEMENT AMENDMENT (APRIL UPDATE) INSTRUMENT 2026
Section 1 Name of Instrument
This section provides the name of this Instrument is the National Health (Growth Hormone Program) Special Arrangement Amendment (April Update) Instrument 2026 and may also be cited as PB 38 of 2026.
Section 2 Commencement
This section provides that this Instrument commences on 1 April 2026.
Section 3 Authority
This section states that this Instrument is made under subsection 100(2) of the National Health Act 1953.
Section 4 Schedules
Section 4 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
The amendments in Schedule 1 involve the addition of forms of a listed drug to the list of growth hormone pharmaceutical benefits for treatment of eligible adults under the Special Arrangement. These changes are summarised below.
SUMMARY OF CHANGES TO THE NATIONAL HEALTH (GROWTH HORMONE PROGRAM) SPECIAL ARRANGEMENT 2025 MADE BY THIS INSTRUMENT
Form Addition – Pharmaceutical benefits for treatment of adults
Listed Drug | Form |
Somatropin | Solution for injection 6 mg (18 i.u.) in 1.03 mL cartridge (with preservative) |
| Solution for injection 12 mg (36 i.u.) in 1.5 mL cartridge (with preservative) |
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
National Health (Growth Hormone Program) Special Arrangement
Amendment (April Update) Instrument 2026
(PB 38 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 (Growth Hormone Program) Special Arrangement 2025 (PB 112 of 2025) (the Special Arrangement).
The purpose of the Special Arrangement is to ensure that an adequate supply of pharmaceutical benefits is available for patients who require treatment with growth hormone. Restrictions on the provision of this treatment mean that these pharmaceutical benefits can more conveniently or efficiently be supplied under a special arrangement.
Human Rights Implications
The Instrument engages Articles 2, 9 and 12 (as detailed below) of the International Covenant on Economic Social and Cultural Rights (ICESCR), by assisting with the progressive realisation by all appropriate means of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health. It also engages Article 24 of the Convention on the Rights of the Child (Convention).
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 PBAC ensures that decisions about subsidised access to medicines on the PBS are evidence based.
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 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.
Convention on the Rights of the Child
Article 24(1) of the Convention relevantly provides for the right of the child to the highest attainable standard of health and ensuring no child is deprived of his or her right to access to such health care services. Article 24(2)(b) goes on to provide that States Parties to the Convention shall take appropriate measures to ensure the provision of necessary medical assistance and health care to all children with emphasis on the development of primary health care.
Analysis
This Instrument advances the right to health and the right to social security by ensuring that the amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2024 (the Listing Instrument), that affect the growth hormone pharmaceutical benefits that may be supplied under the Special Arrangement, are made concurrently. This Instrument provides for the addition of forms of the listed drug somatropin to the list of growth hormone pharmaceutical benefits for treatment of eligible adults under the Special Arrangement.
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
The Special Arrangement promotes the rights to health and social security by ensuring continued access to PBS subsidised growth hormone medicines.
Rebecca Richardson
Assistant Secretary
PBS Listing, Pricing and Policy Branch
Technology Assessment and Access Division
Department of Health, Disability and Ageing