National Health (Weighted average disclosed price – October 2021 reduction day) Amendment Determination 2021

Administered by Department of Health, Disability and Ageing

Legislation au F2021L01195 Not in force Legislative Instrument

Legislation content

EXPLANATORY STATEMENT

 

INSTRUMENT NUMBER PB 86 OF 2021

 

NATIONAL HEALTH ACT 1953

 

National Health (Weighted average disclosed price – October 2021 reduction day) Amendment Determination 2021


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 – October 2021 reduction day) Determination 2021 (PB 72 of 2021) (the Principal Instrument) by:

  • removing from Schedule 1 and inserting in Schedule 2 WADPs for brands of pharmaceutical items containing:
    • pegfilgrastim, injection 6 mg in 0.6 mL single use pre-filled syringe, injection;
    • clonidine, tablet containing clonidine hydrochloride 100 micrograms, oral and;
    • clonidine, tablet containing clonidine hydrochloride 150 micrograms, oral.
  • inserting WADPs for brands of new pharmaceutical items that listed after publication of the Principle Instrument:
    • aciclovir, eye ointment 30 mg per g, 4.5 g, application to the eye;
    • adrenaline (epinephrine), injection:
      • I.M. injection 500 micrograms in 0.3 mL single dose syringe auto-injector;
      • Solution for injection 1 mg (as tartrate) in 1 mL (1 in 1,000);
    • hydromorphone, oral solution containing hydromorphone hydrochloride 1 mg per mL, 473 ml, oral;
    • imipramine, tablet containing imipramine hydrochloride 10 mg USP, oral;
    • infliximab, injection:
      • Solution for injection 120 mg in 1 mL pre-filled pen;
      • Solution for injection 120 mg in 1 mL pre-filled syringe;
    • paraffin, eye drops containing liquid paraffin, glycerol, tyloxapol, poloxamer-188, trometamol hydrochloride, trometamol, cetalkonium chloride, 10 mL (preservative free), application to the eye; and
    • tenofovir with emtricitabine, tablet containing tenofovir disoproxil succinate 301 mg with emtricitabine 200 mg, oral.

 

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 31 March 2021 (2021 October 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 clonidine and pegfilgrastim.

A review of determinations in response to matters raised by Responsible Persons revealed that:

  • Responsible Persons for brands of clonidine had submitted incorrect data. Corrected data was resubmitted. New calculations for the WADPs set out in this amending determination were completed in accordance with the Act and Regulations, moving this drug from Schedule 1 to Schedule 2; and
  • pegfilgrastim will not take a scheduled reduction due to the correct threshold for its calculations being 30 per cent, moving the drug from Schedule 1 to Schedule 2.

Insertion of WADP determinations for new brands of new pharmaceutical items

WADPs need to be determined for new pharmaceutical items that listed on the F2 formulary between 1 April 2021 and 30 September 2021. Examples are s19A temporary listings (adrenaline (epinephrine), imipramine), new forms of drugs (aciclovir, adrenaline (epinephrine), infliximab, paraffin, tenofovir with emtricitabine), and formerly exempt items (hydromorphone).

There are nine new pharmaceutical items that are included in this amending instrument, as follows:

  • aciclovir, eye ointment 30 mg per g, 4.5 g, application to the eye;
  • adrenaline (epinephrine), injection:
    • I.M. injection 500 micrograms in 0.3 mL single dose syringe auto-injector;
    • solution for injection 1 mg (as tartrate) in 1 mL (1 in 1,000);
  • hydromorphone, oral solution containing hydromorphone hydrochloride 1 mg per mL, 473 ml, oral;
  • imipramine, tablet containing imipramine hydrochloride 10 mg USP, oral;
  • infliximab, injection:
    • solution for injection 120 mg in 1 mL pre-filled pen;
    • solution for injection 120 mg in 1 mL pre-filled syringe;
  • paraffin, eye drops containing liquid paraffin, glycerol, tyloxapol, poloxamer-188, trometamol hydrochloride, trometamol, cetalkonium chloride, 10 mL (preservative free), application to the eye; and
  • tenofovir with emtricitabine, tablet containing tenofovir disoproxil succinate 301 mg with emtricitabine 200 mg, oral.

 

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 clonidine and pegfilgrastim.

All of the affected Responsible Persons were consulted about the amendments. 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 – October 2021 reduction day) Amendment Determination 2021 (F2021L01195) amends the National Health (Weighted average disclosed price – October 2021 reduction day) Determination 2021, made under the National Health Act 1953. This amendment was introduced to address discrepancies in the weighted average disclosed prices (WADP) for specific pharmaceutical items, as well as to include new pharmaceutical items listed after the publication of the Principal Instrument. The Act, enacted by the Parliament of Australia, aims to regulate the pricing of pharmaceutical benefits listed on the Pharmaceutical Benefits Scheme (PBS). The policy objective of this amendment is to ensure accurate and fair pricing for pharmaceutical items, reflecting corrected data and newly listed items on the PBS. The determinations for clonidine and pegfilgrastim were revised due to incorrect data submissions and recalculations, respectively. Additionally, new WADPs were established for nine pharmaceutical items that were listed on the F2 formulary between 1 April 2021 and 30 September 2021. These amendments are based on subsection 33(3) of the Acts Interpretation Act 1901, and the Responsible Persons for the affected pharmaceutical items were consulted during the amendment process. The amendment commences on the day after it is registered on the Federal Register of Legislation and is considered a legislative instrument under the Legislation Act 2003.

Scope and Application

This legislative instrument amends the National Health (Weighted average disclosed price – October 2021 reduction day) Determination 2021 by revising the weighted average disclosed prices (WADP) for brands of pharmaceutical items containing clonidine and pegfilgrastim, moving them from Schedule 1 to Schedule 2 of the Principal Instrument. The amendments are made following the consideration of matters raised by Responsible Persons concerning the determinations in the Principal Instrument for these brands. The responsible persons for the brands of clonidine had submitted incorrect data, which was corrected and used to recalculate the WADPs. For pegfilgrastim, the correct threshold for its calculations was found to be 30 per cent, leading to its move from Schedule 1 to Schedule 2. Additionally, the instrument inserts WADPs for nine new pharmaceutical items that were listed on the F2 formulary between 1 April 2021 and 30 September 2021, including temporary listings, new forms of drugs, and formerly exempt items. The amendments apply to companies that are Responsible Persons for these pharmaceutical items, all of whom were consulted about the changes. The instrument commences on the day after it is registered on the Federal Register of Legislation and is a legislative instrument for the purposes of the Legislation Act 2003.

Key Provisions

The National Health (Weighted Average Disclosed Price – October 2021 Reduction Day) Amendment Determination 2021 (F2021L01195) amends the National Health (Weighted Average Disclosed Price – October 2021 Reduction Day) Determination 2021 (PB 72 of 2021) by altering the weighted average disclosed prices (WADP) for certain pharmaceutical brands. Specifically, it removes WADPs for brands of pegfilgrastim and clonidine from Schedule 1 and places them in Schedule 2 (sections 3 and 4). Additionally, it introduces WADPs for nine new pharmaceutical items listed on the F2 formulary between 1 April 2021 and 30 September 2021, including aciclovir eye ointment, various forms of adrenaline (epinephrine), hydromorphone oral solution, imipramine tablets, infliximab injection, paraffin eye drops, and tenofovir with emtricitabine tablets (sections 3 and 5). These changes are made in response to data corrections and the inclusion of new pharmaceutical items. The Act imposes obligations on Responsible Persons, who are companies responsible for brands of pharmaceutical items. These obligations include the submission of accurate data to the Minister for the calculation of WADPs. The Amendment Determination highlights that corrections were made to data submitted for clonidine, which necessitated recalculations and adjustments to the WADPs (section 6). Furthermore, Responsible Persons must ensure that new pharmaceutical items listed on the F2 formulary are included in the WADP determinations (section 5). For breaches of the obligations under the Act and Regulations, there may be civil and criminal consequences. Although specific penalties are not detailed in the Amendment Determination, the National Health Act 1953 and the National Health (Pharmaceutical Benefits) Regulations 2017 provide for penalties that could include fines and, in serious cases, criminal charges. These penalties are intended to ensure compliance with the provisions of the Act, particularly regarding the accurate reporting and calculation of WADPs (sections 99ADB and 99ADH).

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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.