National Health (Weighted average disclosed price – April 2020 reduction day) Amendment Determination 2020 (PB 13 of 2020)

Administered by Department of Health, Disability and Ageing

Legislation au F2020L00244 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

INSTRUMENT NUMBER PB 13 OF 2020

 

NATIONAL HEALTH ACT 1953

 

National Health (Weighted average disclosed price – April 2020 reduction day)
Amendment Determination 2020

Authority

This legislative instrument is made pursuant to subsection 99ADB(4) of the National Health Act 1953 (the Act), which provides that the Minister may, by legislative instrument, determine the weighted average disclosed price (WADP) of a brand of a pharmaceutical item (listed brand) in accordance with the National Health (Pharmaceutical Benefits) Regulations 2017 (the Regulations).

Subsection 99ADB(7) of the Act further provides that a subsection 99ADB(4) determination for a listed brand may include the adjusted approved ex-manufacturer price (AAEMP) for the listed brand.

Purpose

This legislative instrument amends the National Health (Weighted average disclosed price – April 2020 reduction day) Determination 2019 (PB 103 of 2019) (the Principal Instrument) by:

  • amending the WADPs for brands of pharmaceutical items containing:
    • abacavir with lamivudine for oral administration (abacavir with lamivudine);
    • ezetimibe for oral administration (ezetimibe); and
    • olmesartan for oral administration (olmesartan); and
    • tobramycin for administration by inhalation (tobramycin inhalation);
  • removing from Schedule 1 WADPs and inserting in Schedule 2 for brands of pharmaceutical items containing:
    • ezetimibe with simvastatin for oral administration (ezetimibe with simvastatin);
    • olmesartan with hydrochlorothiazide for oral administration (olmesartan with hydrochlorothiazide);
    • pegfilgrastim for administration by injection (pegfilgrastim);
    • rasagiline for oral administration (rasgiline); and
    • tobramycin for administration of inhalation by mouth (tobramycin inhalation by mouth).
  • inserting WADPs for the first new brand of new pharmaceutical items containing:
    • isotretinoin for oral administration (isotretinoin);
    • levodopa with carbidopa for oral administration (levodopa with carbidopa); and
    • tacrolimus for oral administration (tacrolimus).

The Principal Instrument was made pursuant to subsection 99ADB(4) and paragraph 99ADH(1)(aa) of the Act for brands of pharmaceutical items with a data collection period ending 30 September 2019 (2020 April cycle).

 

 

Amendments

Revision of WADP determinations for Brands of Pharmaceutical Items

Amendments are being made following consideration of matters raised by responsible persons concerning the determinations in the Principal Instrument for brands of pharmaceutical items containing abacavir with lamivudine, ezetimibe, ezetimibe with simvastatin, olmesartan, olmesartan with hydrochlorothiazide, pegfilgrastim, rasgiline, rosuvastatin and tobramycin.

A review of determinations in response to matters raised by responsible persons revealed that incorrect data had been submitted by some responsible persons for all of the drugs cited above. Corrected data was submitted. New calculations for the WADPs set out in this amending determination were completed in accordance with the Act and Regulations.

Insertion of WADP determinations for New Brands of New Pharmaceutical Items

A WADP is required to be determined for new brands of pharmaceutical items listing between 30 September 2019 and 31 March 2020 that have no other existing brand of the same pharmaceutical item (including a single brand pharmaceutical item where the brand or pharmaceutical item changes, or where all existing brands change).

There are three brands of three new pharmaceutical items that are included in this amending instrument, as follows:

  • the ADVAGRAF XL® brand of ‘tacrolimus, capsule 3 mg (once daily prolonged release)’;
  • the Oratane® brand of ‘isotretinoin, capsule 30 mg, oral’; and
  • the Sinemet CR Prolonged-Release Tablets® brand of ‘levodopa with carbidopa, tablet (prolonged release) 200 mg-50 mg’.

Basis for amendments

Subsection 33(3) of the Acts Interpretation Act 1901 is relied upon to vary or revoke the determination made under subsection 99ADB(4) for the medicines affected by this amending instrument.

Consultation

This instrument affects companies that are responsible persons for all brands of all pharmaceutical items containing abacavir with lamivudine, ezetimibe, ezetimibe with simvastatin, olmesartan, olmesartan with hydrochlorothiazide, pegfilgrastim, rasgiline, and tobramycin.

This instrument also affects the responsible persons for ADVAGRAF XL, Oratane, and Sinemet CR Prolonged-Release Tablets.

All of the affected responsible persons were consulted about the amendments. While some responsible persons requested clarification of the impact of this instrument, all concerns raised have been addressed.No additional consultation with experts was undertaken, as consultation with affected responsible persons drew on the knowledge of persons with relevant expertise.

This instrument commences on the day after it is registered on the Federal Register of Legislation. This instrument is a legislative instrument for the purposes of the Legislation Act 2003.


 

Overview

The National Health (Weighted average disclosed price – April 2020 reduction day) Amendment Determination 2020, enacted by the Australian Government under the authority of the National Health Act 1953, addresses inaccuracies in the previously determined weighted average disclosed prices (WADP) for specific pharmaceutical items. This amendment was necessary following revelations that incorrect data had been submitted by responsible persons for these medications, leading to an adjustment of the WADPs in accordance with the Act and the National Health (Pharmaceutical Benefits) Regulations 2017. The policy objective of this amendment is to ensure that the WADPs accurately reflect the true market prices of the specified pharmaceutical items, thereby maintaining the integrity of the Pharmaceutical Benefits Scheme (PBS). All affected responsible persons were consulted, and their concerns were adequately addressed, ensuring the accuracy and fairness of the WADPs for these medications. This amendment also includes the determination of WADPs for new pharmaceutical items that have been listed between 30 September 2019 and 31 March 2020, which were not covered by the previous determination. This ensures that new brands of pharmaceutical items are appropriately included in the PBS pricing structure. The amendment aims to provide a transparent and equitable pricing mechanism for pharmaceutical items within the PBS, ensuring that consumers have access to affordable medications. The determination commences on the day after it is registered on the Federal Register of Legislation, aligning with the legislative framework established under the Legislation Act 2003.

Scope and Application

The National Health (Weighted average disclosed price – April 2020 reduction day) Amendment Determination 2020 applies to specific brands of pharmaceutical items, including abacavir with lamivudine, ezetimibe, ezetimibe with simvastatin, olmesartan, olmesartan with hydrochlorothiazide, pegfilgrastim, rasagiline, tobramycin, isotretinoin, levodopa with carbidopa, and tacrolimus. It is applicable to entities known as "responsible persons" who are responsible for the brands of pharmaceutical items listed within the instrument. These entities are required to adhere to the revised weighted average disclosed prices (WADP) stipulated in this amendment. The amendment affects the pharmaceutical industry, specifically the manufacturers and suppliers of the listed brands, and pertains to the pricing of these pharmaceutical items. The geographic reach of this amendment is national, as it is made pursuant to the National Health Act 1953, which is a Commonwealth Act. There are no stated exclusions or exemptions in this amendment; however, it does extend the application of the principal instrument by amending and inserting new WADPs for the specified brands. The amendment is effective from the day after it is registered on the Federal Register of Legislation and is a legislative instrument under the Legislation Act 2003.

Key Provisions

The National Health (Weighted average disclosed price – April 2020 reduction day) Amendment Determination 2020 (F2020L00244) primarily amends the weighted average disclosed price (WADP) for certain brands of pharmaceutical items, as stipulated in section 99ADB(4) of the National Health Act 1953. Specifically, the amendment addresses brands containing abacavir with lamivudine, ezetimibe, olmesartan, and tobramycin for oral administration, as well as tobramycin for inhalation (paragraphs 2 and 3). Additionally, the determination introduces new WADPs for pharmaceutical items that were not previously listed, such as those containing isotretinoin, levodopa with carbidopa, and tacrolimus, as per sections 2 and 3. The Act imposes specific obligations on responsible persons, who are defined in the National Health (Pharmaceutical Benefits) Regulations 2017. These individuals or entities must ensure the accuracy of the data submitted for determining the WADPs. This includes submitting corrected data when necessary, as was the case for the drugs in question. The amendments reflect the corrected data, which was submitted in accordance with the requirements set forth in the Act and Regulations. Failure to comply with the obligations set forth in the Act and Regulations may result in civil or criminal penalties. Although specific penalties are not detailed in the text, breaches of the Act can generally lead to enforcement actions, fines, or other sanctions. It is important to note that the exact consequences would depend on the nature and severity of the breach, as well as any additional guidance provided by relevant authorities.

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Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.