National Health (Price and Special Patient Contribution) Amendment Determination 2022 (No. 9)

Administered by Department of Health, Disability and Ageing

Legislation au F2022L01755 Not in force Legislative Instrument

Legislation content

EXPLANATORY STATEMENT

 

NATIONAL HEALTH ACT 1953

 

National Health (Price and Special Patient Contribution) Amendment Determination 2022 (No. 9)

 

PB 127 of 2022

 

Authority

This legislative instrument, made under section 85B of the National Health Act 1953 (the Act), amends the National Health (Price and Special Patient Contribution) Determination 2022 (PB 98 of 2022) (the Principal Determination).

Subsections 85B(2), (3) and (4) of the Act provide for the Minister to determine, respectively, determined prices, claimed prices and the circumstances in which the Commonwealth will pay a special patient contribution. The Principal Determination contains determinations of these matters.

Variation and revocation

Unless there is an express power to revoke or vary PB 98 of 2022 cited in this instrument and explanatory statement, subsection 33(3) of the Acts Interpretation Act 1901 is relied upon to revoke or vary PB 98 of 2022.

Purpose

The Act provides for the Minister and the responsible person to agree a price that is taken to be the appropriate maximum price of a brand of a pharmaceutical item for the purposes of Part VII of the Act (section 85AD). Section 85B of the Act applies if the Minister and the responsible person have been unable to reach an agreement on a price for the pricing quantity. Whether or not an agreement is made for the pricing quantity, section 85B also applies if the responsible person is dissatisfied with the proportional ex-manufacturer prices that will apply to other pack quantities.   

Subsection 85B(2) provides that the Minister may determine, by reference to the pricing quantity of a brand of a pharmaceutical item, an amount that is taken to be the appropriate maximum price of the brand for the purposes of Part VII of the Act. This is termed the ‘Determined Price’ in this Determination.

Subsection 85B(3) provides that the Minister may determine, by reference to a pack quantity of a brand of the pharmaceutical item, an amount that is taken to be the price claimed by the responsible person for the pack quantity of the brand, for the purposes of Part VII of the Act. This is termed the ‘Claimed Price’ in this Determination.

The Determined Price is the approved ex-manufacturer price and is used as the basis for working out the Commonwealth price for the brand of the pharmaceutical item (section 98B of the Act); for pack quantities other than the pricing quantity, the proportional ex-manufacturer price is used as the basis. Approved pharmacists are entitled to payment from the Commonwealth equal to the Commonwealth price less the applicable patient co-payment (section 99 of the Act).

The difference between the responsible person’s Commonwealth price for a pack quantity (i.e, the price that would be the Commonwealth price if the responsible person’s claimed price had become the approved ex-manufacturer price or the proportional ex-manufacturer price for that pack quantity) and the Commonwealth price for the pack quantity is defined in subsection 85B(5) of the Act as the special patient contribution. An approved pharmacist may charge a patient an amount equal to the special patient contribution, in addition to any other amount that may be charged (subsection 87(2A) of the Act).

Subsection 85B(4) of the Act provides that the Minister may determine the circumstances in which the Commonwealth is to pay the special patient contribution for a brand. In such cases, the Commonwealth payment to the pharmacist is increased by the amount of the special patient contribution (subsection 99(2AA) of the Act) and the pharmacist may not charge the patient this amount (subsection 87(2A) of the Act). 

The purpose of making subsection 85B(4) determinations is to enable patients for whom the base-priced brands (the ones without a special patient contribution) are not suitable, to obtain the higher priced brand (the one with the special patient contribution) without the need to pay the higher price. In such cases the Commonwealth pays the special patient contribution.

This instrument (the Amendment Determination) amends the Principal Determination by removing one brand of one pharmaceutical item that is delisting from the PBS as requested by the responsible person.

The amendment provided by this instrument takes effect on 1 January 2023. 

Consultation

This Determination affects certain responsible persons with medicines listed on the PBS.

For the brand Rulide® in the 150 mg strength, the claimed price and brand premium will be removed for this brand consistent with the request made by the responsible person to delist this brand from the PBS for effect from 1 January 2023.

 

No additional consultation with experts was undertaken regarding this Determination because consultation with affected responsible persons, which informed the making of this Determination, drew on the knowledge of persons with relevant expertise.

 

A provision by provision description of the Determination is contained in the Attachment.

This Determination commences on 1 January 2023.

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


ATTACHMENT 

 

PROVISION BY PROVISION DESCRIPTION OF THE NATIONAL HEALTH (PRICE AND SPECIAL PATIENT CONTRIBUTION) AMENDMENT DETERMINATION 2022 (No. 9)

(PB 127 of 2022)

Section 1   Name of Determination

This section provides that the Determination is the National Health (Price and Special Patient Contribution) Amendment Determination 2022 (No. 9) and may also be cited as
PB 127 of 2022.

Section 2   Commencement

This section provides that the Determination commences on 1 January 2023.

Section 3   Amendment of the National Health (Price and Special Patient Contribution) Determination 2022 (PB 98 of 2022).

This section provides that Schedule 1 amends the National Health (Price and Special Patient Contribution) Determination 2022 (PB 98 of 2022).

Schedule 1 Amendments commencing 1 January 2023

Schedule 1 sets out the amendments to the Principal Determination which commence on
1 January 2023.

 

Deletion of brand

Roxithromycin

Tablet 150 mg

Rulide

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Statement of Compatibility with Human Rights

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

National Health (Price and Special Patient Contribution) Amendment Determination 2022 (No. 9) (PB 127 of 2022)

This 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

This legislative instrument, made under section 85B of the National Health Act 1953 (the Act), amends the National Health (Price and Special Patient Contribution) Determination 2022 (the Principal Determination), which provides for price determinations in relation to brands of pharmaceutical items listed on the Pharmaceutical Benefits Scheme (PBS) for which the Minister and the responsible person have not been able to make a price agreement. It also provides for the circumstances in which the Commonwealth will pay the special patient contribution resulting from these price determinations. This instrument amends the principal determination by removing one brand of one pharmaceutical item that is delisting from the PBS as requested by the responsible person. This change takes effect on 1 January 2023. 

Human rights implications

This legislative instrument engages Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights by assisting with the progressive realisation by all appropriate means of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.

The PBS is a benefit scheme which assists with advancement of this human right by providing for subsidised access by patients to medicines. Deletion of the above listed brand, by way of this determination, is unlikely to result in negative financial impact on patient access, therefore ensuring their rights to social security are maintained. Five premium-free brands remain PBS listed for roxithromycin tablet 150 mg following the deletion of the brand, Rulide®. Eligible Australians may continue to access any one of the remaining brands for this pharmaceutical item at subsidised prices as they are flagged for substitution by pharmacists against the respective delisting brand.

All brands subsidised by the PBS are evaluated by the Therapeutic Goods Administration for quality and safety and determined to be bioequivalent, which means they are clinically equivalent and work in the same way. The recommendatory role of the Pharmaceutical Benefits Advisory Committee ensures that decisions about subsidised access to medicines on the PBS are evidence-based. 

Conclusion

This legislative instrument is compatible with human rights because it advances the protection of human rights.

Nikolai Tsyganov

 Acting Assistant Secretary

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Department of Health and Aged Care 

 

Overview

The National Health (Price and Special Patient Contribution) Amendment Determination 2022 (No. 9), enacted under section 85B of the National Health Act 1953, addresses the issue of setting prices for pharmaceutical items listed on the Pharmaceutical Benefits Scheme (PBS) where an agreement between the Minister and the responsible person cannot be reached. This Amendment Determination specifically removes one brand of a pharmaceutical item from the PBS as requested by the responsible person. The purpose of this amendment is to ensure that the PBS continues to provide access to affordable medications by adjusting the list of pharmaceutical items in response to market changes and requests from responsible parties. This legislative instrument, which is a legislative instrument under the Legislation Act 2003, is set to take effect on 1 January 2023. The amendment aims to maintain the balance between ensuring access to necessary medications and responding to the market dynamics and requests from pharmaceutical companies.

Scope and Application

The National Health (Price and Special Patient Contribution) Amendment Determination 2022 (No. 9) amends the National Health (Price and Special Patient Contribution) Determination 2022, which sets out the price determinations for brands of pharmaceutical items listed on the Pharmaceutical Benefits Scheme (PBS) where the Minister and the responsible person have not reached an agreement on the price. The amendment removes one brand of a pharmaceutical item from the PBS at the request of the responsible person. This legislative instrument applies to the responsible persons, such as pharmaceutical companies, involved in the pricing of pharmaceutical items listed on the PBS and to the patients who access these medicines through the scheme. The amendment takes effect on 1 January 2023, and no additional consultation was deemed necessary as the responsible parties were already consulted in the process. The changes made by this determination are unlikely to have a negative impact on patient access to affordable medicines, ensuring their rights to social security are maintained. The amendment is made under section 85B of the National Health Act 1953 and is a legislative instrument for the purposes of the Legislation Act 2003. The 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. It engages Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights by assisting with the progressive realisation of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health. The PBS provides subsidised access by patients to medicines, and the deletion of the brand Rulide® from the PBS is unlikely to result in a negative financial impact on patient access, thus maintaining their rights to social security. The remaining five premium-free brands for roxithromycin tablet 150 mg continue to be listed on the PBS and are flagged for substitution by pharmacists against the respective delisted brand, ensuring eligible Australians can still access these medicines at subsidised prices. The Therapeutic Goods Administration evaluates all brands subsidised by the PBS for quality and safety, and the Pharmaceutical Benefits Advisory Committee ensures that decisions about subsidised access to medicines on the PBS are evidence-based.

Key Provisions

The National Health (Price and Special Patient Contribution) Amendment Determination 2022 (No. 9) (PB 127 of 2022) amends the National Health (Price and Special Patient Contribution) Determination 2022 (PB 98 of 2022). This amendment is particularly concerned with the removal of one brand of a pharmaceutical item from the Pharmaceutical Benefits Scheme (PBS). Specifically, the brand Roxithromycin Tablet 150 mg, marketed as Rulide®, is being delisted from the PBS as per the request from the responsible person. This change takes effect from 1 January 2023. The primary sections of this amendment are Section 1, which names the Determination; Section 2, which sets the commencement date of 1 January 2023; and Section 3, which details the amendments to the Principal Determination through Schedule 1. The amendments in Schedule 1 remove the specified brand from the PBS list of covered items. The Amendment Determination imposes specific obligations on the entities governed by it, primarily concerning the Pharmaceutical Benefits Scheme (PBS). The Minister, under the National Health Act 1953, has the authority to determine the appropriate maximum price of a brand of a pharmaceutical item and the price claimed by the responsible person for a pack quantity, as well as the circumstances under which the Commonwealth will pay a special patient contribution. The responsible persons, who are typically pharmaceutical companies or manufacturers, must comply with these determinations when providing their pharmaceutical items under the PBS. This includes ensuring that the prices and contributions are correctly applied and that any changes are communicated appropriately. The pharmacists, as approved providers under the scheme, must also adhere to these price determinations and patient contribution policies when dispensing medications. Failure to comply with the provisions of the Amendment Determination can result in various consequences, both civil and criminal. The specific offences and penalties are not detailed in the text, but under the National Health Act 1953, breaches can lead to enforcement actions. These actions might include fines, legal proceedings, or other administrative measures to ensure compliance. The severity of the penalties can vary based on the nature and extent of the breach, but they are designed to uphold the integrity of the PBS and protect patient access to affordable medications. The determination process and the legislative instrument itself are designed to ensure that the PBS continues to provide access to necessary medications while maintaining the financial sustainability of the scheme. By removing a brand from the PBS, the Amendment Determination aims to streamline the available options and ensure that patients can still access equivalent, bioequivalent medications at subsidised prices. This approach helps in preserving the human rights related to health and social security by ensuring continued access to essential medicines.

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