EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (EFFICIENT FUNDING OF CHEMOTHERAPY) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2012 (No. 7)
PB 65 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 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 to the special arrangement 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 titled ‘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 section 100 special arrangement for the efficient funding of chemotherapy. These changes reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (the main listing instrument) made under sections 84AF, 85, 85A, 88 and 101 of the Act, which commence on the same day.
This Instrument:
- removes 1 pharmaceutical item with the listed drug ‘Docetaxel’; and
- adds a circumstance for 2 pharmaceutical benefits with the listed drug ‘Docetaxel’ and brand ‘Docetaxel Sandoz’.
A provision by provision description of this Instrument is contained in the Attachment.
Consultations
An ongoing and formal process of consultation in relation to matters relevant to this instrument 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 September 2012.
This Instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
ATTACHMENT
PROVISION BY PROVISION DESCRIPTION OF THE NATIONAL HEALTH (EFFICIENT FUNDING OF CHEMOTHERAPY) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2012 (No. 7)
Section 1 Name of Instrument
This section provides that this Instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2012 (No. 7) and that it may also be cited as PB 65 of 2012.
Section 2 Commencement
This section provides that this Instrument commences on 1 September 2012.
Section 3 Amendments to PB 79 of 2011
This section provides that Schedule 1 amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011) (the Special Arrangement).
Schedule 1
Item 1 amends the entry in Schedule 1 Part 1 of the Special Arrangement for ‘Docetaxel’ by removing a pharmaceutical benefit, which is the listed drug ‘Docetaxel’ in the form ‘Injection set containing 1 single use vial concentrate for I.V. infusion 20 mg (anhydrous) in 0.5 mL with solvent ’ with the manner of administration ‘Injection’ and brand ‘Taxotere’.
Item 2 amends the entry in Schedule 1 Part 1 of the Special Arrangement for ‘Docetaxel’ in the form ‘Solution concentrate for I.V. infusion 20 mg in 2 mL’ with manner of administration ‘Injection’ and brand ‘Docetaxel Sandoz’ by adding the circumstances code ‘C3892’.
Item 3 amends the entry in Schedule 1 Part 1 of the Special Arrangement for ‘Docetaxel’ in the form ‘Solution concentrate for I.V. infusion 80 mg in 8 mL’ with manner of administration ‘Injection’ and brand ‘Docetaxel Sandoz’ by adding the circumstances code ‘C3892’.
Overview
The National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2012 (No. 7) was enacted to amend the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011. This amendment was introduced to address the need for more efficient funding of chemotherapy drugs and related pharmaceutical benefits under the National Health Act 1953. The instrument was enacted by the Australian Government and aims to reflect the 2010 budget measure titled 'Revised arrangements for the efficient funding of chemotherapy drugs'. This amendment instrument ensures that changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 are incorporated into the special arrangement, thereby streamlining the funding of chemotherapy drugs and related treatments for cancer patients.
The instrument removes one pharmaceutical item with the listed drug 'Docetaxel' and adds circumstances for two pharmaceutical benefits with the listed drug 'Docetaxel' and the brand 'Docetaxel Sandoz'. This amendment is designed to maintain the efficiency of funding chemotherapy drugs and associated treatments. The changes to the special arrangement are informed by recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), which ensures that the recommendations take into account the clinical effectiveness, safety, and cost-effectiveness of the drugs being considered. The National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2012 (No. 7) commenced on 1 September 2012 and is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
Scope and Application
The National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2012 (No. 7) amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 to make changes to the special arrangement relating to the efficient funding of chemotherapy. The instrument applies to the supply of injected or infused chemotherapy medicines to eligible patients being treated for cancer and related pharmaceutical benefits supplied at certain public hospitals. It reflects changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2010. The amendment instrument removes a pharmaceutical benefit for the listed drug ‘Docetaxel’ and adds a circumstance code for two pharmaceutical benefits with the listed drug ‘Docetaxel’ and brand ‘Docetaxel Sandoz’. The instrument is made under subsections 100(1) and 100(2) of the National Health Act 1953, which provides that the Minister may make special arrangements for the supply of pharmaceutical benefits and vary or revoke a special arrangement. The instrument is subject to the National Health Act and instruments made for the purposes of Part VII of the Act. It is a legislative instrument for the purposes of the Legislative Instruments Act 2003 and commences on 1 September 2012.
Key Provisions
The main sections of the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2012 (No. 7) focus on altering the special arrangement related to the efficient funding of chemotherapy under the National Health Act 1953. Specifically, section 3 of the Instrument amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011) to modify the pharmaceutical benefits for the drug Docetaxel. Section 1 identifies this Instrument as the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2012 (No. 7) and its alternative citation, PB 65 of 2012, while section 2 sets the commencement date as 1 September 2012. The Instrument introduces changes by removing the listed drug Docetaxel in a specific form and adding circumstances codes for two other forms of Docetaxel under the brand Docetaxel Sandoz.
The obligations imposed by this Act on the parties involved primarily revolve around the efficient funding and supply of chemotherapy medicines to eligible patients being treated for cancer. It mandates the removal of a specific pharmaceutical benefit for Docetaxel and the addition of circumstances codes for two other forms of the drug. The Act also ensures that these changes are in line with the broader amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2010, which also took effect on the same day. This alignment is critical for maintaining consistency and efficiency in the funding and supply of chemotherapy drugs.
Failure to comply with the provisions of this Act may lead to civil or criminal consequences, although specific offences and penalties are not detailed in the provided text. Typically, breaches of legislative instruments related to health funding and pharmaceutical benefits could result in penalties under the relevant acts, including fines and other sanctions. The precise penalties would depend on the nature and severity of the breach, as well as any additional provisions or regulations that apply.
The changes brought about by this Instrument are designed to reflect the 2010 budget measure titled ‘Revised arrangements for the efficient funding of chemotherapy drugs’ and to ensure that the supply of chemotherapy and related pharmaceutical benefits remains efficient and effective. By involving the Pharmaceutical Benefits Advisory Committee (PBAC) in the consultation process, the Act ensures that expert recommendations and stakeholder interests are considered in making these amendments.