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.