EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
National Health (Growth Hormone Program) Special Arrangement Amendment Instrument 2013 (No.1)
PB 27 of 2013
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 commence on the same day. This instrument amends Schedule 1 of the Special Arrangement to remove three pharmaceutical benefits with the listed drug ‘Somatropin’ and brand ‘Norditropin NordiFlex’.
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 May 2013.
This instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
National Health (Growth Hormone Program) Special Arrangement Amendment Instrument 2013 (No.1)
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.
Overview of the Legislative Instrument
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.
This instrument amends Schedule 1 of the Special Arrangement to the remove three pharmaceutical benefits with the listed drug ‘Somatropin’ and brand ‘Norditropin NordiFlex’.
Human rights implications
This legislative instrument engages Article 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR) by assisting with the progressive realisation by all appropriate means of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.
The PBS is a benefit scheme which assists with advancement of this human right by providing for subsidised access by patients to medicines. The recommendatory role of the Pharmaceutical Benefits Advisory Committee (PBAC) ensures that decisions about subsidised access to medicines on the PBS are evidence-based.
Conclusion
This Legislative Instrument is compatible with human rights because it advances the protection of human rights.
Mr Kim Bessell
Assistant Secretary
Pharmaceutical Access Branch
Principal Pharmacy Advisor
Pharmaceutical Benefits Division
Department of Health and Ageing