EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
National Health (Growth Hormone Program) Special Arrangement Amendment Instrument 2012 (No.2)
PB 66 of 2012
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 2011 (PB 88 of 2011) (the Special Arrangement) to make changes to the special arrangement relating to the Growth Hormone Program.
The Special Arrangement provides for the supply of pharmaceutical benefits with recombinant growth hormone (Somatropin) to eligible children and adolescents through the Growth Hormone Program. The Special Arrangement also sets out the dose of pharmaceutical benefit that may be approved for eligible patients.
The changes made by this instrument reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2010, which commences on the same day. This instrument amends Schedule 1 of the Special Arrangement to remove six pharmaceutical benefits with the listed drug ‘Somatropin’ and brands ‘Norditropin FlexPro’ and ‘Norditropin NordiFlex’ and replace with six pharmaceutical benefits with the same drug, manner of administration and brands but in forms with the added words ‘in pre-filled pen’. The forms for the pharmaceutical benefits being replaced are listed as ‘Solution for injection 5 mg (15 i.u.) in 1.5 mL cartridge (with preservative)’, ‘Solution for injection 10 mg (30 i.u.) in 1.5 mL cartridge (with preservative)’ and ‘Solution for injection 15 mg (45 i.u.) in 1.5 mL cartridge (with preservative)’.
This Instrument includes a transitional provision to provide that an application, approval, order, supply or claim for supply of one of the pharmaceutical benefits being removed, made before 1 September 2012 is taken to be an application, approval, order, supply or claim for supply of one of the replacement pharmaceutical benefits.
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 or as special pharmaceutical products. 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, 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 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.
Pharmaceutical companies were consulted throughout the process for additions and changes to listings on the PBS and for this Special Arrangement. This includes consultation through the PBAC process, and agreement to final listing details.
This Instrument commences on 1 September 2012.
This instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
Overview
The National Health (Growth Hormone Program) Special Arrangement Amendment Instrument 2012 (No. 2) was enacted to amend the National Health (Growth Hormone Program) Special Arrangement 2011, addressing the need to update the pharmaceutical benefits available under the Growth Hormone Program. Authorised by subsection 100(1) of the National Health Act 1953, the instrument amends the Special Arrangement to reflect changes in the National Health (Listing of Pharmaceutical Benefits) Instrument 2010, specifically updating the forms of recombinant growth hormone (Somatropin) available to eligible patients. The policy objective of these amendments is to ensure the continuity of supply of necessary pharmaceutical benefits while aligning with the most recent clinical recommendations and technological advancements in drug delivery methods. The instrument also includes transitional provisions to facilitate a smooth changeover from the old to the new pharmaceutical benefits, ensuring that any applications or supplies made before the amendment's commencement are treated as valid for the new forms.
Scope and Application
The National Health (Growth Hormone Program) Special Arrangement Amendment Instrument 2012 (No.2) applies to the supply of pharmaceutical benefits relating to recombinant growth hormone (Somatropin) for eligible children and adolescents through the Growth Hormone Program under the National Health Act 1953. It specifically pertains to the amendments of the National Health (Growth Hormone Program) Special Arrangement 2011, focusing on the replacement of certain pharmaceutical benefits for Somatropin with new forms described as ‘in pre-filled pen’. This amendment ensures continuity of supply and access to the specified drug forms under the program, thereby maintaining the health benefits provided to eligible patients. The instrument’s scope is limited to the changes in the listing of pharmaceutical benefits and does not extend to other areas of health care or pharmaceutical supply.
Geographically, this legislative instrument is applicable throughout Australia, as it is an amendment to an existing special arrangement under the National Health Act 1953, which operates on a Commonwealth level. It does not specify any exclusions or exemptions but provides a transitional arrangement to facilitate the smooth implementation of the changes by recognising applications, approvals, orders, supplies, or claims for the pharmaceutical benefits being replaced if made before 1 September 2012 as valid for the new forms. The amendment does not introduce new exclusions or thresholds but rather modifies existing provisions in line with updated pharmaceutical standards and practices.
Key Provisions
The National Health (Growth Hormone Program) Special Arrangement Amendment Instrument 2012 (No.2) (the Instrument) amends the National Health (Growth Hormone Program) Special Arrangement 2011 (the Special Arrangement) to update the supply of pharmaceutical benefits for the Growth Hormone Program (subsections 100(1) and 100(2) of the National Health Act 1953 (the Act)). Specifically, the Instrument removes six pharmaceutical benefits involving recombinant growth hormone (Somatropin) and replaces them with six new benefits that include the same drug, manner of administration, and brands, but in forms with the added words ‘in pre-filled pen’ (Schedule 1 of the Instrument). The forms being replaced are ‘Solution for injection 5 mg (15 i.u.) in 1.5 mL cartridge (with preservative)’, ‘Solution for injection 10 mg (30 i.u.) in 1.5 mL cartridge (with preservative)’ and ‘Solution for injection 15 mg (45 i.u.) in 1.5 mL cartridge (with preservative)’. The changes are intended to reflect amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2010, which commence on the same day.
The Act imposes several obligations on the parties and entities it governs, including the Minister for Health, the Pharmaceutical Benefits Advisory Committee (PBAC), and pharmaceutical companies. The Minister must make special arrangements for the supply of pharmaceutical benefits under subsection 100(1) of the Act, and has the power to vary or revoke such arrangements under subsection 100(2). The PBAC, an independent expert body established under section 100A of the Act, makes recommendations to the Minister about which drugs and medicinal preparations should be available as pharmaceutical benefits or as special pharmaceutical products. Pharmaceutical companies must consult with the PBAC throughout the process for additions and changes to listings on the Pharmaceutical Benefits Scheme (PBS), and agree to final listing details.
Failure to comply with the requirements of the Act and the Instrument may result in civil or criminal consequences. However, the Instrument does not specify any offences, penalties, or consequences for breach. It is likely that any breaches of the Act or the Instrument would be dealt with under the general provisions of the Act or other relevant legislation. The Instrument commences on 1 September 2012, and is a legislative instrument for the purposes of the Legislative Instruments Act 2003.