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