National Health (Weighted average disclosed price – October 2024 reduction day) Amendment Determination (No. 2) 2024

Administered by Department of Health, Disability and Ageing

Legislation au F2024L01214 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

INSTRUMENT NUMBER PB 107 of 2024

National Health Act 1953

National Health (Weighted average disclosed price – October 2024 reduction day) Amendment Determination (No. 2) 2024

Purpose and operation

The National Health (Weighted average disclosed price – October 2024 reduction day) determination 2024 (PB 67 of 2024) sets out the weighted average disclosed price (WADP) of a brand of a pharmaceutical item in accordance with the National Health (Pharmaceutical Benefits) Regulations 2017 (the Regulations).

The National Health (Weighted average disclosed price – October 2024 reduction day) Amendment Determination (No. 2) 2024 (the Instrument) amends the PB 67 of 2024 by revising WADPs in Schedule 1 for brands of pharmaceutical items containing:

  • tenofovir, tablet containing tenofovir disoproxil maleate 300 mg, oral, Tenofovir Disoproxil Mylan;
  • tenofovir, tablet containing tenofovir disoproxil maleate 300 mg, oral, Tenofovir Disoproxil Viatris; and
  • tenofovir, tablet containing tenofovir disoproxil phosphate 291 mg, oral, Tenofovir GH.

Amendments to the PB 67 of 2024 are being made following a review of determinations in response to matters raised by Responsible Persons, which revealed that Responsible Persons for brands of pharmaceutical items containing tenofovir had submitted incorrect data. Corrected data was resubmitted. New calculations for the WADPs set out in the Instrument were completed in accordance with the National Health Act 1953 (the Act) and the Regulations, revising the WADP for tenofovir.

Authority

The Instrument is made under subsection 99ADB(4) of the Act, which provides that the Minister may, by legislative instrument, determine the weighted average disclosed price of a brand of a pharmaceutical item (listed brand) in accordance with 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.

The PB 67 of 2024 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 2024 (2024 October cycle).

 

Reliance on subsection 33(3) of the Acts Interpretation Act 1901

Subsection 33(3) of the Acts Interpretation Act 1901 provides that where an Act confers a power to make, grant or issue an instrument of a legislative or administrative character (including rules, regulations or by-laws), the power shall be construed as including a power exercisable in the like manner and subject to the like conditions (if any) to repeal, rescind, revoke, amend or vary any such instrument.

Commencement

The Instrument commences on the day after registration.

Consultation

The Instrument affects Responsible Persons for certain brands of the drug and manner of administration tenofovir oral.

A review of all determinations made in the PB 67 of 2024 was conducted in accordance with the Price Disclosure Dispute Resolution Administrative Process, which provided Responsible Persons the opportunity to identify to the Department of Health and Aged Care any perceived issues with WADP determinations in the PB 67 of 2024. The Department conducted investigations to ensure the reductions were calculated correctly and that the reductions do not increase the risk of shortages in supply or unmet patient need. The reduction for two pharmaceutical items will change.

No additional consultation with experts was undertaken, as consultation with affected Responsible Persons drew on the knowledge of persons with relevant expertise.

 

General

 

This Instrument is a disallowable legislative instrument for the purposes of the Legislation Act 2003.

 

Details of the Instrument are set out in Attachment A.

 

The Instrument is compatible with the rights and freedoms recognised or declared under section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011. A full statement of compatibility with human rights is set out in Attachment B.

 

 

 

 

 

 

 

 

 

 

 

 

ATTACHMENT A

National Health (Weighted average disclosed price – October 2024 reduction day) Amendment Determination (No. 2) 2024

Section 1 – Name

 

This section provides that the name of the Instrument is the National Health (Weighted average disclosed price – October 2024 reduction day) Amendment Determination (No. 2) 2024. It further provides that it may be referenced as PB 107 of 2024.

 

Section 2 – Commencement

 

This section provides that the Instrument commences on the day after registration.

 

Section 3 – Authority

 

This section provides that the Instrument is made under subsection 99ADB(4) of the National Health Act 1953.

 

Section 4 – Schedule

 

This section provides that each Instrument that is specified in a Schedule to the Instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Instrument has effect according to its terms.

 

Schedule 1 – Amendments

 

National Health (Weighted average disclosed price – October 2024 reduction day) Determination 2024 (PB 67 of 2024)

 

Item 1 – Schedule 1 (table items 497 to 499, column 3)

Item 1 omits “$29.02” from table items 497, 498 and 499 in column 3 of the table in Schedule 1 of the National Health (Weighted average disclosed price – October 2024 reduction day) Determination 2024 (PB 67 of 2024) and substitutes it with “$53.38.”

This replaces the previous weighted average disclosed prices (WADPs) for tenofovir with WADPs based on new calculations.

ATTACHMENT B

Statement of Compatibility with Human Rights

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

 

National Health (Weighted average disclosed price – October 2024 reduction day) Amendment Determination (No. 2) 2024

 

This disallowable legislative instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.

Overview of the Legislative Instrument

The National Health (Weighted average disclosed price – October 2024 reduction day) Determination 2024 (PB 67 of 2024) sets out the weighted average disclosed price (WADP) of a brand of a pharmaceutical item in accordance with the National Health (Pharmaceutical Benefits) Regulations 2017 (the Regulations).

The purpose of the National Health (Weighted average disclosed price – October 2024 reduction day) Amendment Determination (No. 2) 2024 (the Instrument) is to update the WADP for the listed drug, tenofovir.

Human rights implications

The Instrument engages Article 12(1) of the International Covenant on Economic, Social and Cultural Rights (ICESCR) by assisting with the progressive realisation by all appropriate means of the right to the enjoyment of the highest attainable standard of physical and mental health.

Pharmaceutical Benefits Scheme

Part VII of the National Health Act 1953 (the Act) is the legislative basis for the Pharmaceutical Benefits Scheme (PBS) by which the Commonwealth provides reliable, timely, and affordable access to a wide range of medicines for all Australians.

This is a positive and supportive step towards attaining the highest standard of health for all Australians, and therefore supporting the right contained in Article 12 of the ICESCR.

Price disclosure policies

The Instrument sets out new WADPs based on most recent calculations for tenofovir. This provides for appropriate and effective reductions, consistent with the intent of the price disclosure policies, for prices for pharmaceutical benefits on 1 October 2024 under the statutory provisions for price disclosure.

Price disclosure provides for the ‘approved ex-manufacturer price’ of a ‘brand of a pharmaceutical item’ to be reduced on a reduction day in certain specified circumstances. The reduction is based on sales revenue, incentives and volume data collected from responsible persons (drug companies) and occurs in accordance with the Act and the Regulations This ensures better value for money for these medicines. These reductions may also result in patients accessing these medicines at lower prices, further promoting the above right.

Conclusion

The Instrument is compatible with human rights as it further promotes the realisation of relevant rights under Article 12 of the ICESCR.

 

 

Nikolai Tsyganov

Assistant Secretary

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Department of Health and Aged Care

Overview

The National Health (Weighted average disclosed price – October 2024 reduction day) Amendment Determination (No. 2) 2024 amends the earlier determination concerning the weighted average disclosed price (WADP) of pharmaceutical items, specifically for tenofovir brands. Enacted under the National Health Act 1953, this amendment was introduced to address inaccuracies in the originally disclosed WADPs for certain tenofovir brands, which had resulted from incorrect data submissions by Responsible Persons. The amendment ensures that the WADPs reflect accurate calculations, thereby maintaining the integrity and effectiveness of the price disclosure policies under the National Health (Pharmaceutical Benefits) Regulations 2017. The policy objective is to achieve appropriate reductions in pharmaceutical prices on the specified reduction day, thereby providing better value for money and potentially lowering costs for patients. The Instrument is made under the authority of subsection 99ADB(4) of the National Health Act 1953, allowing the Minister to determine the WADP of pharmaceutical brands in line with the Regulations. It also relies on subsection 33(3) of the Acts Interpretation Act 1901, which allows for the amendment or variation of legislative instruments. This amendment ensures the proper administration of the Pharmaceutical Benefits Scheme, providing reliable, timely, and affordable access to essential medicines for all Australians. The Instrument commenced on the day after its registration, and it is a disallowable legislative instrument under the Legislation Act 2003.

Scope and Application

The National Health (Weighted average disclosed price – October 2024 reduction day) Amendment Determination (No. 2) 2024 applies to pharmaceutical companies responsible for submitting data on the prices of pharmaceutical items, specifically focusing on the brands of tenofovir listed in the Schedule. This legislative instrument operates under the authority of the National Health Act 1953 and the National Health (Pharmaceutical Benefits) Regulations 2017. It amends the previously determined weighted average disclosed prices (WADP) for certain tenofovir products, reflecting corrected data submitted by the Responsible Persons. The amendments are intended to ensure accurate price disclosures for pharmaceutical items listed in the Pharmaceutical Benefits Scheme (PBS), thereby maintaining the integrity and effectiveness of price reductions for these items. The Instrument applies on a national level across Australia, as it is issued under the Commonwealth's legislative framework. No specific exclusions or exemptions are mentioned in the text, although the adjustments made are confined to the particular brands of tenofovir identified. The Instrument is compatible with human rights, particularly the right to health, by promoting access to affordable medicines through effective price disclosure policies.

Key Provisions

The National Health (Weighted average disclosed price – October 2024 reduction day) Amendment Determination (No. 2) 2024 amends the National Health (Weighted average disclosed price – October 2024 reduction day) Determination 2024 to revise the weighted average disclosed prices (WADP) for brands of pharmaceutical items containing tenofovir. This amendment is necessitated by the need to correct previously submitted data by Responsible Persons, which led to inaccurate WADPs being recorded. The updated WADPs are based on corrected data and recalculations in accordance with the National Health Act 1953 and the National Health (Pharmaceutical Benefits) Regulations 2017. The new prices for tenofovir are set to be $53.38, replacing the earlier figure of $29.02. The Amendment Determination imposes obligations on Responsible Persons, who are generally the manufacturers or importers of pharmaceutical items, to submit accurate data regarding the prices of pharmaceutical items. These Responsible Persons must ensure that the data submitted for WADP calculations is correct and reflects the actual market prices of the pharmaceutical items. The amendments require Responsible Persons to resubmit corrected data and to comply with the recalculated WADPs set out in the Amendment Determination. This ensures that the prices reflected in the Pharmaceutical Benefits Scheme (PBS) are accurate and reflect the true market value, thereby maintaining the integrity of the scheme. Any breach of the obligations under the National Health Act 1953 and the Regulations, such as failing to submit accurate data or complying with the revised WADPs, may lead to civil or administrative consequences. While specific penalties are not detailed in the explanatory statement, breaches of the Act or Regulations can typically result in financial penalties or other administrative actions. Additionally, ongoing non-compliance may result in further investigations by the Department of Health and Aged Care, potentially leading to more severe consequences including fines or other legal actions. The precise penalties would depend on the nature and severity of the breach, as well as any relevant provisions in the Act or Regulations. The determination also highlights the importance of the Price Disclosure Dispute Resolution Administrative Process, which allows Responsible Persons to identify and address any issues with WADP determinations. This process ensures that the reductions are calculated correctly and do not negatively impact the supply of essential medicines or patient access. The Department of Health and Aged Care conducts investigations to verify the accuracy of the reductions, ensuring they are fair and do not compromise the availability of necessary pharmaceutical items. The amendments made under this process reflect a commitment to maintaining the integrity and effectiveness of the PBS.

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