EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
National Health (Growth Hormone Program) Special Arrangement Amendment Instrument 2016 (No. 2)
PB 116 of 2016
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).
Purpose
The purpose of this Legislative Instrument, made under subsection 100(2) of the Act, is to amend the National Health (Growth Hormone Program) Special Arrangement 2015 (PB 85 of 2015) (the Special Arrangement) to make changes relating to the Growth Hormone Program.
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.
This Instrument reflects changes made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012), which commence on the same day.
This Instrument removes a form of the listed drug ‘Somatropin’, as requested by the supplier.
A provision by provision description of this Instrument is contained in the Attachment.
Consultation
The Special Arrangement was made having regard to advice provided by the Pharmaceutical Benefits Advisory Committee (PBAC), an independent expert body established by section 100A of the Act, which makes recommendations to the Minister for Health about which drugs and medicinal preparations should be available as pharmaceutical benefits. Part VII of the Act only applies to drugs or medicinal preparations recommended by the PBAC. When making recommendations, 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.
PBAC members are selected from consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and specialists, with at least one member selected from each of these 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.
Pharmaceutical companies are consulted throughout the process for additions and changes to listings on the Pharmaceutical Benefits Scheme (PBS), including consultation through the PBAC process and agreement to final listing details.
This Instrument commences on 1 January 2017.
This Instrument is a legislative instrument for the purposes of the Legislation Act 2003.
ATTACHMENT
PROVISION BY PROVISION DESCRIPTION OF THE NATIONAL HEALTH (GROWTH HORMONE PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2016 (No. 2)
Section 1 Name of Instrument
This section provides that this Instrument is the National Health (Growth Hormone Program) Special Arrangement Amendment Instrument 2016 (No. 2), and that it may also be cited as PB 116 of 2016.
Section 2 Commencement
This section provides that this Instrument commences on 1 January 2017.
Section 3 Amendment of PB 85 of 2015
This section provides that Schedule 1 amends the National Health (Growth Hormone Program) Special Arrangement 2015 (PB 85 of 2015) (the Special Arrangement).
Schedule 1 Amendments
Item 1 amends Schedule 1 of the Special Arrangement by removing a form of the listed drug ‘Somatropin’, being the form ‘Injection 8 mg (24 i.u.) vial with 1.37 mL diluent cartridge (with preservative) (for use with one.click auto-injector)’, with the manner of administration of ‘Injection’, brand of ‘Saizen 8 mg click.easy’ and Section 100 only code of ‘D(100)’.
Overview
The National Health (Growth Hormone Program) Special Arrangement Amendment Instrument 2016 (No. 2) was enacted to amend the National Health (Growth Hormone Program) Special Arrangement 2015. This legislative instrument aims to adjust the provisions of the Growth Hormone Program, ensuring an adequate supply of pharmaceutical benefits for patients requiring growth hormone treatment, thereby facilitating a more convenient and efficient supply of these treatments under special arrangements. The National Health Act 1953, enacted by the Australian Parliament, provides the legislative framework for the Minister for Health to make special arrangements for the supply of pharmaceutical benefits, subject to certain conditions and the recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC). The policy objective of this amendment is to align the Growth Hormone Program with the latest changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, ensuring the continuity and efficiency of pharmaceutical benefits provision for patients.
Scope and Application
The National Health (Growth Hormone Program) Special Arrangement Amendment Instrument 2016 (No. 2) amends the National Health (Growth Hormone Program) Special Arrangement 2015 to make changes relating to the Growth Hormone Program. This instrument applies to the supply of pharmaceutical benefits, specifically growth hormone treatments, and is made under the authority of the National Health Act 1953. The amendments are primarily concerned with the removal of a specific form of the drug ‘Somatropin’ from the Growth Hormone Program, following consultation with the relevant parties. This instrument applies to all entities and individuals involved in the supply and administration of pharmaceutical benefits under the Act, particularly those involved in the Growth Hormone Program. The changes implemented by this instrument have a national reach, affecting the provision of pharmaceutical benefits across Australia. There are no specific exclusions or exemptions stated in the instrument, and it does not alter any thresholds for eligibility or participation in the Growth Hormone Program. The application of the Act and any special arrangements, including this amendment, can be further refined through subordinate instruments made under the authority of the Act.
Key Provisions
The main operative sections of this Legislative Instrument include the amendments to the National Health (Growth Hormone Program) Special Arrangement 2015 (referred to in Section 3 of the Instrument). This amendment involves the removal of a specific form of the drug 'Somatropin' from the list of pharmaceutical benefits provided under the Growth Hormone Program, as detailed in Schedule 1 of the Instrument (Section 1, Item 1). This change is made in response to a request from the drug supplier and reflects updates to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (Section 1, Item 1). The Instrument comes into effect on 1 January 2017 (Section 2).
The Act imposes specific obligations on the parties involved in the provision of pharmaceutical benefits under the Growth Hormone Program. The Minister for Health is responsible for making and varying special arrangements under subsection 100(1) of the National Health Act 1953, and ensuring these arrangements align with the recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC) (subsection 100A). The PBAC, an independent expert body, is tasked with advising the Minister on which drugs should be included in the Pharmaceutical Benefits Scheme (PBS) based on their clinical effectiveness, safety, and cost-effectiveness. Pharmaceutical companies must engage in consultation processes with the PBAC and agree to the final listing details before drugs can be included in the PBS (Section 100A).
There are no explicit offences, penalties, or civil/criminal consequences outlined in this Legislative Instrument. However, the Act provides that Part VII of the National Health Act 1953, and any instruments made for the purposes of Part VII, have effect subject to any special arrangements made under subsection 100(1) (subsection 100(3)). The Act also empowers the Minister to vary or revoke a special arrangement under subsection 100(2). These provisions suggest that while the Instrument itself does not directly impose penalties, any failure to comply with the terms of the special arrangement could potentially lead to actions under the overarching provisions of the Act, such as revocation or variation of the arrangement.