National Health (Price and Special Patient Contribution) Amendment Determination 2021 (No. 2) (PB 20 of 2021)

Administered by Department of Health, Disability and Ageing

Legislation au F2021L00153 Not in force Legislative Instrument

Legislation content

EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (PRICE AND SPECIAL PATIENT CONTRIBUTION) AMENDMENT DETERMINATION 2021 (No. 2)

PB 20 of 2021

 

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 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 (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 Amending Determination) amends the Principal Determination by removing three brands of three pharmaceutical items that will no longer have a premium.  These changes are taking affect on 1 March 2021.

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. If the Minister and the responsible person do not agree on a price, further consultation occurs with the responsible person, and thereafter the Minister determines the price that will be the approved ex-manufacturer price for the brand. The Minister also determines the corresponding price claimed by the responsible person which is used to calculate the special patient contribution that will apply to the brand. 

For candesartan, quinapril and sertraline brands, the responsible persons agreed to removal of the claimed price from these items.  These changes are taking affect from 1 March 2021.

As a result, further consultation with the responsible persons affected by this determination was unnecessary.

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

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

This Determination commences on 1 March 2021.

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 2021 (No. 2)

(PB 20 of 2021)

Section 1   Name of Determination

This section provides that the Determination is the National Health (Price and Special Patient Contribution) Amendment Determination 2021 (No. 2) and may also be cited as PB 20 of 2021.

Section 2   Commencement

This section provides that the Determination commences on 1 March 2021.

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 March 2021

Schedule 1 sets out the amendments to the Principal Determination which commence on 1 March 2021.


SUMMARY OF CHANGES

SCHEDULE 1

 

Brands that no longer have a brand premium

Candesartan

Tablet containing candesartan cilexetil 16 mg

Atacand

Quinapril

Tablet 5 mg (as hydrochloride)

Accupril

Sertraline

Tablet 100 mg (as hydrochloride)

Zoloft

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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 2021 (No. 2) (PB 20 of 2021)

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 determiations.  This instrument (the Amending Determination) amends the Principal Determination by removing three brands of three pharmaceutical items that will no longer have a  premium.  These changes are taking affect on 1 March 2021.

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 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.

 

 

 

Thea Connolly

 Assistant Secretary

Pricing and PBS Policy branch

Technology Assessment and Access Division

Department of Health  

Overview

The National Health (Price and Special Patient Contribution) Amendment Determination 2021 (No. 2) is a legislative instrument made under section 85B of the National Health Act 1953. This Act was enacted to regulate and improve health services across Australia, including the provision of pharmaceutical benefits. The primary issue it addresses is the determination of prices for pharmaceutical items listed on the Pharmaceutical Benefits Scheme (PBS) where an agreement between the Minister and the responsible person cannot be reached. The policy objective is to ensure that patients have access to necessary medications at affordable prices while balancing the interests of pharmaceutical companies. The determination also addresses the circumstances under which the Commonwealth will pay a special patient contribution, enabling patients who need higher-priced medications to access them without bearing the full cost. The determinations will take effect from 1 March 2021, removing brand premiums for certain pharmaceutical items, thereby making them more accessible to patients.

Scope and Application

The National Health (Price and Special Patient Contribution) Amendment Determination 2021 (No. 2) amends the National Health (Price and Special Patient Contribution) Determination 2010, which provides for the determination of prices in relation to brands of pharmaceutical items listed on the Pharmaceutical Benefits Scheme (PBS) where the Minister and the responsible person have been unable to agree on a price. This determination applies to the Commonwealth, responsible persons (manufacturers or importers of pharmaceutical items), and approved pharmacists. It specifies the appropriate maximum price for certain pharmaceutical brands, the claimed price by the responsible person, and the circumstances under which the Commonwealth will pay a special patient contribution. The Amendment Determination removes three brands of three pharmaceutical items that will no longer have a premium, effective from 1 March 2021. These changes were made following consultations with the responsible persons whose products are affected by this amendment, and no additional consultation with external experts was deemed necessary. This legislative instrument is compatible with human rights as it facilitates the enjoyment of the highest attainable standard of physical and mental health through subsidised access to medicines via the PBS.

Key Provisions

The National Health (Price and Special Patient Contribution) Amendment Determination 2021 (No. 2) (PB 20 of 2021) amends the National Health (Price and Special Patient Contribution) Determination 2010 (PB 109 of 2010) under section 85B of the National Health Act 1953. The primary changes introduced by this determination involve the removal of a premium on three brands of pharmaceutical items, effective from 1 March 2021. These brands are for candesartan, quinapril, and sertraline. The amendment involves removing the claimed price for these items, meaning that the special patient contribution for these brands will no longer apply, and patients will not incur an additional cost for these medications. The obligations imposed by this determination pertain primarily to the Minister for Health and the responsible persons (manufacturers or suppliers of the pharmaceutical items) involved. The Minister is responsible for determining the prices for pharmaceutical items where an agreement cannot be reached with the responsible person. The responsible persons must comply with the determined prices and ensure that their pricing aligns with the approved ex-manufacturer prices set by the Minister. The determination also places an obligation on pharmacists who dispense these medications to adhere to the Commonwealth prices set forth in the Act and to not charge patients the special patient contribution where the Commonwealth has determined to cover this amount. Breaching the provisions of the National Health Act 1953 or the determinations made under it can result in various legal consequences. For example, if a responsible person charges a price higher than the determined price for a pharmaceutical item, this could be considered an offence under the Act. Such an offence could lead to civil penalties, including fines, as stipulated in the Act. Additionally, if pharmacists charge patients an amount for the special patient contribution when the Commonwealth has determined to cover this cost, they could also face penalties. The exact penalties are not specified in the determination but are governed by the broader provisions of the National Health Act 1953, which may include substantial fines and other civil or administrative actions. The specific penalties would depend on the nature and severity of the breach, as well as any relevant regulations or guidelines in place.

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Area of Law
Health Law
Instrument
Legislative Instrument
Concepts
Commencement Provisions
Licensing & Registration
Reporting & Disclosure Obligations
Regulatory Standards
Catchwords
Pharmaceutical Benefits Scheme

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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.