EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
National Health (Growth Hormone Program) Special Arrangement Amendment Instrument 2012 (No.1)
PB 8 of 2012
Authority
Subsection 100(1) of the National Health Act 1953 (the Act) enables the Minister to make special arrangements for, or in relation to, providing that an adequate supply of pharmaceutical benefits will be available to persons:
(a) who are living in isolated areas; or
(b) who are receiving treatment in circumstances in which generally available pharmaceutical benefits are inadequate for that treatment; or
(c) if the pharmaceutical benefits covered by the arrangements can be more conveniently or efficiently supplied under the arrangements.
Subsection 100(2) provides that the Minister may vary or revoke a special arrangement made under subsection 100(1).
Subsection 100(3) provides that Part VII of the Act, and regulations and other legislative instruments made for the purposes of Part VII have effect subject to a special arrangement made under subsection 100(1). A section 100 arrangement may thus modify the operation of Part VII, the regulations and other relevant instruments.
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.
Changes to the Special Arrangement made by this Instrument
Schedule 1 to this instrument amends subsection 47(2) of the Special Arrangement and inserts a new subsection 47(2A). This amendment corrects a technical error in the Special Arrangement and reflects the correct administration of the Growth Hormone Program.
Subsection 47(2) provided that the dose that the Secretary determines to be the appropriate dose for the treatment of a person may be within 3% of a dose level mentioned in the relevant item of the table in subsection 47(1), if the form of the pharmaceutical benefit and the manufacturer’s pack is unable to accommodate the dose level mentioned in the item. In this situation, the Secretary was taken to have approved the dose level in the table in subsection 47(1).
It has since been found that a 3% variation is too restrictive for dose levels other than the maximum dose. This is because the form of the pharmaceutical benefit and the manufacturer’s pack have often resulted in the closest available dose being more than 3% higher or lower than the dose level mentioned in the relevant item in the table in subsection 47(1).
The changes made to subsection 47(2) have the effect that, if the form of the pharmaceutical benefit and the manufacturer’s pack are unable to accommodate the exact dose level mentioned in the relevant item of the table in subsection 47(1), and where the person is eligible for a dose level other than the maximum dose, the Secretary may determine the appropriate dose for that person to be the closest available dose to the dose level mentioned in the table. If the person is eligible for the maximum dose, the current 3% variation allowance will still apply.
The new subsection 47(2A) has the effect that, in either of these situations, the Secretary is taken to have approved the dose level in the table in subsection 47(1).
Schedule 2 to this instrument inserts 3 new pharmaceutical benefits with the listed drug ‘Somatropin’ and the brand ‘Saizen’ into Schedule 1 of the Special Arrangement on 1 March 2012. The changes made by this instrument reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 made under sections 84AF, 85, 85A and 101 of the Act, which commences on the same day.
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.
The amendment in Schedule 1 to this instrument is a minor and mechanical change and did not require any consultation.
Statement of Compatibility
This Legislative 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.
General
Sections 1 to 3 and Schedule 1 to this instrument are taken to have commenced on 1 December 2011, when the Special Arrangement commenced. The amendment in Schedule 1 has a beneficial impact as it allows patients to be approved for the closest available dose in the situation where the form and the manufacturer’s pack of the pharmaceutical benefit is unable to accommodate the patient’s required dose level. There are no rights disadvantaged or liabilities imposed on a person other than the Commonwealth by this amendment being retrospective.
Schedule 2 to this instrument commences on 1 March 2012.
This instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.