EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 61 OF 2011
NATIONAL HEALTH ACT 1953
AMENDMENT DETERMINATION UNDER SECTION 84AH OF THE NATIONAL HEALTH ACT 1953 (2011) (No.4)
Purpose
The purpose of this legislative instrument, made under section 84AH of the National Health Act 1953 (“the Act”), is to amend the legislative instrument titled Determination under section 84AH of the National Health Act 1953 (as amended) (“PB 58 of 2007”) to make changes to the pharmaceutical items that are determined to be exempt items.
Background
Part VII of the Act is the legislative basis of the Pharmaceutical Benefits Scheme (“PBS”) by which the Commonwealth provides reliable, timely and affordable access to a wide range of medicines for all Australians.
Drugs and medicinal preparations to which Part VII applies are declared as such by the Minister, by legislative instrument under subsection 85(2) of the Act. These are listed drugs (as defined in subsection 84(1)). The Minister may also determine by legislative instrument the form or forms of a listed drug by reference to strength, type of unit, size of unit or otherwise (subsection 85(3)) and the manner of administration of the form of the listed drug so determined (subsection 85(5)). If a drug has a declaration under subsection 85(2) in force in respect of it and determinations under subsections 85(3) and 85(5) in force in respect of it, then that declared drug in that determined form with that determined manner of administration is a pharmaceutical item. The Minister may also determine, by legislative instrument, brands of pharmaceutical items (subsection 85(6)).
Section 84AH empowers the Minister to determine, by legislative instrument, that a pharmaceutical item is an ‘exempt item’ if the pharmaceutical item satisfies the criteria in section 84AH. The criteria in section 84AH are as follows:
(a) that there is only one listed brand of the relevant pharmaceutical item; and
(b) there are no listed brands of other pharmaceutical items that are bioequivalent or biosimilar to the one listed brand of the relevant pharmaceutical item; and
(c) there is at least one other pharmaceutical item that has the same listed drug as the relevant pharmaceutical item; and
(d) the Minister is satisfied (having regard to advice, if any, from the Pharmaceutical Benefits Advisory Committee (“PBAC”)) that:
- the listed drug in the relevant pharmaceutical item represents suitable therapy for a particular patient population; and
- the relevant pharmaceutical item is suitable for use by a particular subgroup of that population because of either or both of the form and manner of administration; and
- no other pharmaceutical item that has that drug is suitable for use by the subgroup because of either or both of the form and manner of administration of the drug in that other item.
The effect of a pharmaceutical item being determined to be an exempt item is that the listed brand of that pharmaceutical item is excluded from statutory price reductions and price disclosure requirements under Division 3A and 3B of Part VII of the Act. The intention is to encourage the availability of certain pharmaceutical items with particular formulations of drugs that are used by a demographic subgroup (eg. children or geriatric patients) for whom other formulations of the drug are not suitable.
Changes to PB 58 of 2007 made by this instrument
This instrument makes the following changes to PB 58 of 2007:
- one pharmaceutical item (listed drug = fluconazole, form = Powder for oral suspension 50 mg in 5 mL, 35 mL, manner of administration = Oral) is added to the list of exempt items following advice from PBAC.
Consultation
This instrument affects pharmaceutical companies with medicines listed on the PBS. In relation to the introduction of the exempt items measure, which commenced on 1 August 2007, pharmaceutical companies have been consulted during both the policy development and implementation phases.
The Pharmaceutical Benefits Advisory Committee (PBAC) was also consulted in relation to issues relevant to this determination. The Pharmaceutical Benefits Advisory Committee (PBAC) is the independent expert body, established by section 100A of the Act, which makes recommendations to the Minister for Health and Ageing about which drugs and medicinal preparations should be available as pharmaceutical benefits and about other matters as required under the Act. Under subsection 101(4AB) of the Act PBAC provides advice to the Minister if it is satisfied of certain matters concerning suitability of pharmaceutical items for use by particular sub-groups. Consideration given by PBAC, under section 101(4AB), to the pharmaceutical items affected by the instrument, was considered by the delegate of the Minister who made the instrument.
General
The instrument commences on 1 September 2011.
This instrument constitutes a legislative instrument for the purpose of the Legislative Instruments Act 2003.
Overview
The National Health Act 1953 was amended in 2011 through the legislative instrument titled Amendment Determination under section 84AH of the National Health Act 1953 (No.4). This instrument, made under section 84AH of the Act, aims to modify the determinations concerning pharmaceutical items that are exempt from certain statutory price reductions and price disclosure requirements. The purpose of this amendment is to ensure that specific pharmaceutical formulations, which are deemed suitable for particular patient sub-groups, remain accessible and affordable. The Pharmaceutical Benefits Advisory Committee (PBAC) provided advice during the development and implementation phases, highlighting the suitability of the pharmaceutical items for specific patient populations. This legislative change responds to the need for tailored pharmaceutical formulations that cater to the unique needs of certain demographic groups, ensuring continued availability and access to necessary medications.
This legislative instrument was enacted by the Minister for Health and Ageing, as per the authority granted under the National Health Act 1953. The overarching policy objective is to maintain the availability of certain pharmaceutical items with particular formulations, ensuring that these items remain accessible to specific patient populations for whom other formulations may not be suitable. The amendment is designed to encourage the continued provision of medications that are tailored to meet the needs of particular demographic subgroups, such as children or geriatric patients, ensuring that these groups have access to suitable therapeutic options.
Scope and Application
The F2011L01768 Amendment Determination under Section 84AH of the National Health Act 1953 (No.4) amends the legislative instrument titled Determination under Section 84AH of the National Health Act 1953 (as amended) (PB 58 of 2007) to alter the pharmaceutical items determined to be exempt items. This amendment applies to pharmaceutical companies with medicines listed on the Pharmaceutical Benefits Scheme (PBS), a scheme established under Part VII of the National Health Act 1953 to ensure reliable, timely, and affordable access to a wide range of medicines for Australians. The amendment specifically adds one pharmaceutical item, a listed drug of fluconazole in the form of Powder for oral suspension 50 mg in 5 mL, 35 mL, administered orally, to the list of exempt items following advice from the Pharmaceutical Benefits Advisory Committee (PBAC). The Minister for Health and Ageing made this determination under the authority granted by section 84AH of the Act, which allows for the exclusion of certain pharmaceutical items from statutory price reductions and price disclosure requirements if they meet specific criteria, including being the sole listed brand, having no bioequivalent or biosimilar listed brands, and being suitable for a particular patient subgroup due to its form and manner of administration. This amendment is effective from 1 September 2011 and constitutes a legislative instrument under the Legislative Instruments Act 2003.
Key Provisions
This legislative instrument amends the existing Determination under section 84AH of the National Health Act 1953 (PB 58 of 2007) by adding one pharmaceutical item to the list of exempt items. Specifically, the amendment adds fluconazole in the form of a Powder for oral suspension with a dosage of 50 mg in 5 mL, in a 35 mL container, administered orally. This change follows advice from the Pharmaceutical Benefits Advisory Committee (PBAC). The purpose of these amendments is to ensure that certain pharmaceutical items, particularly those with specific formulations suitable for certain patient subgroups, are exempt from statutory price reductions and price disclosure requirements. This is to encourage the availability of such items that are crucial for subgroups like children or geriatric patients, where other formulations might not be suitable.
The obligations imposed by the Act on the parties it governs are primarily related to compliance with the criteria for determining exempt items. Pharmaceutical companies must ensure that their listed drugs meet the specified criteria, including having only one listed brand, being bioequivalent or biosimilar to no other listed brands, and being suitable for a particular subgroup due to their form and manner of administration. Additionally, they must provide necessary information and advice to the Minister and PBAC to facilitate the determination process. The Minister, in turn, is required to consider the advice from PBAC and make determinations based on the suitability and necessity of the pharmaceutical items for specific patient populations.
For breaches of the provisions under the National Health Act 1953, the Act stipulates various offences and penalties. Offences may include non-compliance with the criteria for determining exempt items or providing misleading information to the Minister or PBAC. The consequences can range from civil penalties to criminal charges, depending on the severity of the breach. The maximum penalties for offences under the Act can include substantial fines and, in some cases, imprisonment. These provisions are designed to ensure that pharmaceutical companies and other entities comply with the legislative requirements to maintain the integrity and effectiveness of the Pharmaceutical Benefits Scheme.