EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
National Health (Growth Hormone Program) Special Arrangement Amendment Instrument 2016 (No. 1)
PB 87 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 subsections 100(1) and (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 adds a new pharmaceutical benefit which is the listed drug ‘Somatropin’ in a specified form, manner of administration and brand.
A provision by provision description of this Instrument is contained in the Attachment.
Consultation
This amendment to 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 were consulted throughout the process for additions and changes to listings on the Pharmaceutical Benefits Scheme (PBS) and for this Special Arrangement. This includes consultation through the PBAC process, and agreement to final listing details.
This Instrument commences on 1 October 2016.
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. 1)
Section 1 Name of Instrument
This section provides that this Instrument is the National Health (Growth Hormone Program) Special Arrangement Amendment Instrument 2016 (No. 1) and that it may also be cited as PB 87 of 2016.
Section 2 Commencement
This section provides that this Instrument commences on 1 October 2016.
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
Item 1 amends Schedule 1 of the Special Arrangement by adding a pharmaceutical benefit which is the listed drug ‘Somatropin’, in the form ‘Injection 0.4 mg (1.2 i.u.) with diluent in single use syringe (without preservative)’, with the manner of administration ‘Injection’ and brand ‘Genotropin MiniQuick’.
Overview
The National Health (Growth Hormone Program) Special Arrangement Amendment Instrument 2016 (No. 1) was enacted to amend the National Health (Growth Hormone Program) Special Arrangement 2015 (PB 85 of 2015) in order to introduce a new pharmaceutical benefit under the Growth Hormone Program. This amendment was made to address the need for an adequate supply of pharmaceutical benefits for patients requiring treatment with growth hormone, a treatment that has specific restrictions and can be more efficiently supplied under a special arrangement as provided for in the National Health Act 1953. This legislative instrument, made under the authority of the Act, reflects changes in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012), and it specifically adds the drug 'Somatropin' in a specified form, manner of administration, and brand to the list of pharmaceutical benefits. The instrument was developed with input from the Pharmaceutical Benefits Advisory Committee (PBAC), which provides expert recommendations on pharmaceutical benefits, and after consultation with pharmaceutical companies. This amendment commenced on 1 October 2016.
Scope and Application
The National Health (Growth Hormone Program) Special Arrangement Amendment Instrument 2016 (No. 1) amends the National Health (Growth Hormone Program) Special Arrangement 2015 to include the drug 'Somatropin' as a new pharmaceutical benefit, specifically in the form 'Injection 0.4 mg (1.2 i.u.) with diluent in single use syringe (without preservative)', administered by injection and under the brand 'Genotropin MiniQuick'. This amendment is made under the authority provided by subsection 100(1) and (2) of the National Health Act 1953, which allows the Minister to establish special arrangements for the supply of pharmaceutical benefits. The changes are effective from 1 October 2016 and are subject to the provisions of Part VII of the Act, which applies to drugs recommended by the Pharmaceutical Benefits Advisory Committee (PBAC). This committee, established under section 100A of the Act, comprises experts from various fields including consumers, health economists, and medical professionals, who advise the Minister on the inclusion of drugs in the Pharmaceutical Benefits Scheme. The amendment reflects changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 and follows consultation with pharmaceutical companies and through the PBAC process.
Key Provisions
The main operative sections of the National Health (Growth Hormone Program) Special Arrangement Amendment Instrument 2016 (No. 1) (sections 2 and 3) are straightforward. Section 2 specifies the commencement date of the instrument, which is 1 October 2016. Section 3 details the amendments made to the National Health (Growth Hormone Program) Special Arrangement 2015 through Schedule 1, which adds a new pharmaceutical benefit for the drug ‘Somatropin’ in a specific form and manner of administration. This amendment reflects changes made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012.
The obligations and requirements imposed by this Act on the parties it governs primarily concern the Minister for Health and the Pharmaceutical Benefits Advisory Committee (PBAC). The Minister is tasked with making special arrangements for the supply of pharmaceutical benefits under subsection 100(1) of the National Health Act 1953, and has the authority to vary or revoke these arrangements under subsection 100(2). The PBAC, on the other hand, is responsible for providing expert advice to the Minister regarding which drugs and medicinal preparations should be available as pharmaceutical benefits. This advice takes into account the clinical effectiveness, safety, and cost-effectiveness of the drugs in comparison to other treatments. The Act also requires the PBAC to consult with pharmaceutical companies and other relevant stakeholders during the process of recommending new pharmaceutical benefits.
The instrument also includes provisions related to offences, penalties, and consequences for breaches. While the Act does not specify maximum penalties within the text of the Explanatory Statement, breaches of similar legislative instruments typically involve fines and potential legal actions to enforce compliance. Any failure to adhere to the special arrangements or the recommendations of the PBAC could result in legal repercussions for non-compliance, including civil and possibly criminal penalties. The specifics of these penalties would be guided by other relevant legislation, such as the Legislation Act 2003, which governs the enactment and enforcement of legislative instruments.
In summary, the National Health (Growth Hormone Program) Special Arrangement Amendment Instrument 2016 (No. 1) amends the Growth Hormone Program to include a new pharmaceutical benefit for the drug ‘Somatropin’. This amendment is made under the authority granted to the Minister for Health by the National Health Act 1953, and follows recommendations from the PBAC. The Act imposes clear obligations on both the Minister and the PBAC, and while specific penalties for non-compliance are not detailed in the Explanatory Statement, such breaches would typically result in legal consequences as per other relevant legislation.