EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (EFFICIENT FUNDING OF CHEMOTHERAPY) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2013 (No. 10)
PB 71 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 100(2) of the Act, is to amend the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011) (the Special Arrangement), to make changes relating to the efficient funding of chemotherapy.
The Special Arrangement achieves greater efficiency in payment for the supply of injected or infused chemotherapy medicines (“chemotherapy pharmaceutical benefits”) to eligible patients being treated for cancer, to reflect the 2010 budget measure entitled ‘Revised arrangements for the efficient funding of chemotherapy drugs’. This Special Arrangement also relates to the supply of medicines associated with the side-effects of cancer and cancer treatment (“related pharmaceutical benefits”) at certain public hospitals.
This instrument makes changes to the pharmaceutical benefits available under the Special Arrangement for the efficient funding of chemotherapy. These changes reflect changes made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the Act, which commence on the same day.
Item 3 of this instrument amends the entry in Schedule 1 Part 1 of the Special Arrangement, under the listed drug ‘Docetaxel’ in the form ‘Injection set containing 1 single use vial concentrate for I.V. infusion 80 mg (anhydrous) in 2 mL with solvent’ with manner of administration ‘Injection’, by removing the entry in relation to the brand ‘Taxotere’ .
Consultations
An ongoing and formal process of consultation in relation to matters relevant to the Special Arrangement includes the involvement of interested parties through the membership of the Pharmaceutical Benefits Advisory Committee (PBAC). PBAC is an independent expert body established by section 100A of the Act which makes recommendations to the Minister about which drugs and medicinal preparations should be available as pharmaceutical benefits.
PBAC members are appointed following nomination by prescribed organisations and associations 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 PBAC, and that would enable them to contribute meaningfully to the deliberations of PBAC. When recommending the listing of a medicine on the Pharmaceutical Benefits Scheme (PBS), 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.
This instrument commences on 1 November 2013.
This instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
Overview
The National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2013 (No. 10) was enacted to amend the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011, aiming to enhance the efficiency of funding for chemotherapy pharmaceutical benefits supplied to eligible cancer patients. This amendment was made under the authority provided by the National Health Act 1953, specifically subsections 100(1) and 100(2), which empower the Minister to establish special arrangements for the supply of pharmaceutical benefits and to modify or revoke these arrangements. The policy objective behind this amendment is to reflect changes in the budget measure from 2010, titled 'Revised arrangements for the efficient funding of chemotherapy drugs', ensuring that the funding arrangements align with the current legislative and medical standards.
Consultation and expert advice play a crucial role in shaping these arrangements, with the Pharmaceutical Benefits Advisory Committee (PBAC) being a key body involved. Established under section 100A of the National Health Act 1953, PBAC is composed of members from various relevant fields, including health economists, practising pharmacists, general practitioners, and clinical specialists. Their recommendations, based on clinical effectiveness, safety, and cost-effectiveness, are integral to the decision-making process regarding the listing of medicines on the Pharmaceutical Benefits Scheme (PBS). This amendment commenced on 1 November 2013 and is recognised as a legislative instrument under the Legislative Instruments Act 2003.
Scope and Application
The National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2013 (No. 10) applies to the efficient funding of chemotherapy and related pharmaceutical benefits within the framework of the National Health Act 1953. It specifically addresses the supply of injected or infused chemotherapy medicines and related pharmaceutical benefits to eligible patients being treated for cancer at certain public hospitals, amending the 2011 Special Arrangement to reflect changes made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. This amendment pertains to the pharmaceutical benefits available under the Special Arrangement and is implemented through the authority granted under subsections 100(1) and 100(2) of the Act. The changes reflect the 2010 budget measure aimed at enhancing the efficiency of funding for chemotherapy drugs, ensuring that the supply of these medicines aligns with updated listings and recommendations. The instrument excludes any brand of the drug Docetaxel in the specified form and administration manner, as amended in Item 3 of the Special Arrangement. The Act and its subordinate instruments extend to the Commonwealth jurisdiction, ensuring a consistent approach across Australia in the funding and supply of these critical pharmaceutical benefits.
Key Provisions
The key provisions of the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2013 (No. 10) relate primarily to the efficient funding of chemotherapy and associated pharmaceutical benefits. Under section 100(1) of the National Health Act 1953, the Minister is empowered to make special arrangements for the supply of pharmaceutical benefits, which includes the efficient funding of chemotherapy. This special arrangement aims to achieve greater efficiency in payment for the supply of injected or infused chemotherapy medicines to eligible patients being treated for cancer, as well as for medicines associated with the side-effects of cancer and cancer treatment at certain public hospitals. The instrument amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 by making changes to the pharmaceutical benefits available under the arrangement, reflecting changes made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012.
The Act imposes obligations on the parties involved in the supply and funding of chemotherapy medicines. It requires that the supply of chemotherapy pharmaceutical benefits and related pharmaceutical benefits be efficiently funded as per the special arrangement. The Pharmaceutical Benefits Advisory Committee (PBAC), established under section 100A of the Act, plays a crucial role in this process. PBAC is an independent expert body that recommends to the Minister about which drugs and medicinal preparations should be available as pharmaceutical benefits. The committee's recommendations take 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. By involving PBAC in the consultation process, the Act ensures that the decisions regarding the funding and supply of chemotherapy medicines are informed by expert advice.
Any breaches of the provisions set out in the National Health Act 1953 or the amendments made by the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2013 (No. 10) may lead to civil or criminal consequences. While the specific penalties are not detailed in the explanatory statement, breaches of the Act generally can result in penalties under various sections of the Act, including fines and imprisonment. The exact penalties would depend on the nature and severity of the breach, as well as the specific provisions of the Act that have been contravened. It is important for all parties involved in the supply and funding of chemotherapy medicines to comply with the requirements of the Act to avoid any legal repercussions.