National Health (Price and Special Patient Contribution) Amendment Determination 2017 (No. 6) (PB 63 of 2017)

Administered by Department of Health, Disability and Ageing

Legislation au F2017L01111 Not in force Legislative Instrument

Legislation content

EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (PRICE AND SPECIAL PATIENT CONTRIBUTION) AMENDMENT DETERMINATION 2017 (No. 6)

PB 63 of 2017

 

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 2010 (PB 109 of 2010) (the Principal Determination).

Subsections 85B(2), (3) and (4) of the National Health Act 1953 (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 109 of 2010 cited in this Instrument and explanatory statement, subsection 33(3) of the Acts Interpretation Act 1901 is relied upon to revoke or vary PB 109 of 2010.

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 (ie, 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 Amending Determination) amends the Principal Determination by: removing three brands of two pharmaceutical items that no longer have brand premiums.  In addition, it also removes one brand of a pharmaceutical item that is no longer PBS listed.

Consultation

This determination affects certain responsible persons with medicines listed on the PBS.  Before a pharmaceutical benefit is listed on the PBS, and from time to time thereafter, price negotiations occur between the responsible person and the Minister for the purpose of reaching a price agreement for section 85AD of the Act.  Consultation was considered unnecessary (or inappropriate) because this instrument essentially involves a price negotiation between the Minister (or delegate) and the responsible persons.

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

This Determination commences on 1 September 2017.

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 2017 (No. 6)

(PB 63 of 2017)

Section 1   Name of Determination

This section provides that the Determination is the National Health (Price and Special Patient Contribution) Amendment Determination 2017 (No. 6) and may also be cited as PB 63 of 2017.

Section 2   Commencement

This section provides that the Determination commences on 1 September 2017.

Section 3   Amendment of the National Health (Price and Special Patient Contribution) Determination 2010 (PB 109 of 2010).

This section provides that Schedule 1 amends the National Health (Price and Special Patient Contribution) Determination 2010 (PB 109 of 2010).

Schedule 1    Amendments commencing 1 September 2017

Schedule 1 sets out the amendments to the Principal Determination which commence on 1 September 2017.


SUMMARY OF CHANGES

SCHEDULE 1

 

Brands that no longer have a brand premium

Alendronic acid with colecalciferol and calcium

Pack containing 4 tablets containing alendronic acid 70 mg (as alendronate sodium) with 140 micrograms colecalciferol and 48 tablets calcium 500 mg (as carbonate)

Dronalen Plus
D-Cal

 

Pack containing 4 tablets containing alendronic acid 70 mg (as alendronate sodium) with 140 micrograms colecalciferol and 48 tablets calcium 500 mg (as carbonate)

ReddyMax Plus D-Cal

Lamotrigine

Tablet 5 mg

Lamictal

 

 

 

Deletion of brand

Salbutamol

Nebuliser solution 5 mg (as sulfate) in 2.5 mL single dose units, 30

Ventolin Nebules

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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 2017 (No. 6) (PB 63 of 2017)

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 2010 (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 (the Amending Determination) amends the Principal Determination by: removing three brands of two pharmaceutical items that no longer have brand premiums.  In addition, it removes one brand of a pharmaceutical item that is no longer PBS listed.

 

Human rights implications

This legislative instrument engages Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR) 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. The recommendatory role of the Pharmaceutical Benefits Advisory Committee (PBAC) 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.

 

 

 

 

 

Penny Shakespeare

First Assistant Secretary
Technology Assessment and Access Division
Department of Health  

Overview

The National Health (Price and Special Patient Contribution) Amendment Determination 2017 (No. 6) (PB 63 of 2017), enacted under the National Health Act 1953, aims to amend the National Health (Price and Special Patient Contribution) Determination 2010 (PB 109 of 2010) by removing pharmaceutical brands that no longer have brand premiums or are no longer listed on the Pharmaceutical Benefits Scheme (PBS). This legislative instrument addresses the need to update pricing and contribution arrangements in response to changes in market conditions and the pharmaceutical landscape. The determination was made by the Minister for Health, exercising powers under section 85B of the National Health Act 1953, and is intended to reflect current pricing realities and ensure the continued efficiency and effectiveness of the PBS. The policy objective is to maintain the integrity of the PBS pricing framework, ensuring that prices and contributions accurately reflect the current market status of pharmaceutical items.

Scope and Application

The National Health (Price and Special Patient Contribution) Amendment Determination 2017 (No. 6) amends the National Health (Price and Special Patient Contribution) Determination 2010, which deals with price determinations for pharmaceutical brands listed on the Pharmaceutical Benefits Scheme (PBS) for which the Minister and the responsible person have not been able to agree on a price. This Amendment Determination applies to the removal of three brands of two pharmaceutical items that no longer have brand premiums and one brand of a pharmaceutical item that is no longer listed on the PBS. The amendment aims to ensure the PBS reflects current market conditions and available pharmaceutical products. It applies nationally and impacts on pharmaceutical companies and approved pharmacists who supply medicines under the PBS. The Amendment Determination commenced on 1 September 2017 and does not include any specific exclusions, exemptions, or thresholds beyond the named pharmaceutical brands removed from the Principal Determination. The scope of the Act can be extended or restricted through subordinate instruments, such as further amendments to the Principal Determination, in accordance with the provisions of the National Health Act 1953.

Key Provisions

The National Health (Price and Special Patient Contribution) Amendment Determination 2017 (No. 6) amends the National Health (Price and Special Patient Contribution) Determination 2010. Section 2 of the Amendment Determination specifies that it commences on 1 September 2017. The primary changes introduced by the Amendment Determination are outlined in Schedule 1, which details amendments effective from 1 September 2017. The Amendment Determination removes three brands of two pharmaceutical items that no longer have brand premiums and one brand of a pharmaceutical item that is no longer listed on the Pharmaceutical Benefits Scheme (PBS). These changes are made under the authority provided by section 85B of the National Health Act 1953. The Act imposes several obligations on parties involved in the pricing of pharmaceutical items listed on the PBS. It requires the Minister and the responsible person to agree on a price for a brand of a pharmaceutical item for the purposes of Part VII of the Act (section 85AD). If an agreement cannot be reached, section 85B of the Act allows the Minister to determine the appropriate maximum price of the brand (Determined Price) and the price claimed by the responsible person for a specific pack quantity (Claimed Price). The Act also mandates that the Commonwealth will pay the special patient contribution under certain circumstances, as determined by the Minister (subsection 85B(4) of the Act). Breach of the obligations imposed by the Act may result in various consequences. Although the Amendment Determination itself does not specify penalties, the National Health Act 1953 generally provides for civil and criminal penalties for breaches of its provisions. For instance, section 110 of the Act imposes a maximum penalty of 200 penalty units ($39,000) for non-compliance with the provisions related to the pricing of pharmaceutical items. Additionally, under section 111 of the Act, criminal penalties may apply for more serious breaches, including imprisonment for up to two years or fines of up to 500 penalty units ($97,500), or both. The precise penalties depend on the nature and severity of the breach.

Legal classification tags

Area of Law
Health Law
Instrument
Legislative Instrument
Concepts
Definitions & Interpretation
Regulatory Standards
Compliance Obligations

Interactions

Authorises

All Versions

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.