National Health (Price and Special Patient Contribution) Amendment Determination 2019 (No. 6) (PB 54 of 2019)

Administered by Department of Health, Disability and Ageing

Legislation au F2019L00910 Not in force Legislative Instrument

Legislation content

EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (PRICE AND SPECIAL PATIENT CONTRIBUTION) AMENDMENT DETERMINATION 2019 (No. 6)

PB 54 of 2019

 

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 one brand of one pharmaceutical item that will no longer have a premium on 1 July 2019.

Consultation

This determination affects certain responsible persons with medicines listed on the PBS.  Consultation was considered unnecessary (or inappropriate) because this instrument removes one brand of one pharmaceutical item that will no longer have a premium on 1 July 2019.

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

This Determination commences on 1 July 2019.

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 2019 (No. 6)

(PB 54 of 2019)

Section 1   Name of Determination

This section provides that the Determination is the National Health (Price and Special Patient Contribution) Amendment Determination 2019 (No. 6) and may also be cited as PB 54 of 2019.

Section 2   Commencement

This section provides that the Determination commences on 1 July 2019.

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 July 2019

Schedule 1 sets out the amendments to the Principal Determination which commence on 1 July 2019.


SUMMARY OF CHANGES

SCHEDULE 1

Brand that no longer has a brand premium

Dipyridamole with aspirin

Capsule 200 mg (sustained release)- 25 mg

Asasantin SR

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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 2019 (No. 6) (PB 54 of 2019)

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 one brand of one pharmaceutical item that will no longer have a premium on 1 July 2019.

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.

 

 

 

 

Thea Daniel

 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 2019 (No. 6) was enacted to amend the National Health (Price and Special Patient Contribution) Determination 2010 under the authority of the National Health Act 1953. This legislative instrument addresses the need to adjust price determinations and special patient contributions for pharmaceutical items listed on the Pharmaceutical Benefits Scheme (PBS), particularly where agreements on pricing between the Minister and the responsible person cannot be reached. The National Health Act 1953 provides the legislative framework for the Minister to determine prices and the circumstances under which the Commonwealth will contribute to patient costs. This amendment removes a brand of pharmaceutical item that will no longer have a premium as of 1 July 2019, thereby affecting the pricing and contribution structure outlined in the Principal Determination. The policy objective of this amendment is to ensure that pricing and contribution arrangements remain current and reflective of the market conditions and the availability of pharmaceutical items on the PBS.

Scope and Application

The National Health (Price and Special Patient Contribution) Amendment Determination 2019 (No. 6) amends the National Health (Price and Special Patient Contribution) Determination 2010, which sets out the prices for pharmaceutical items listed on the Pharmaceutical Benefits Scheme (PBS) when the Minister and the responsible person cannot agree on a price. This amendment, effective from 1 July 2019, removes a specific brand of a pharmaceutical item from the list of brands that have a premium, thus altering the pricing structure and special patient contributions associated with these items. The determination applies to pharmaceutical brands listed on the PBS, affecting the responsible persons who manufacture or supply these items and the patients who use them. This legislative instrument operates within the Commonwealth jurisdiction, impacting the pricing and reimbursement framework for pharmaceutical products under the PBS. It does not explicitly state exclusions but operates within the existing legal framework provided by the National Health Act 1953. The application of this amendment may be further refined through subordinate instruments, which can specify additional details or conditions under which the amended provisions apply.

Key Provisions

The National Health (Price and Special Patient Contribution) Amendment Determination 2019 (No. 6) amends the National Health (Price and Special Patient Contribution) Determination 2010 (the Principal Determination). This amendment, effective from 1 July 2019, removes a specific brand of pharmaceutical item from the list of items subject to a special patient contribution. This particular brand, Asasantin SR, a sustained-release capsule of 200 mg Dipyridamole with aspirin, will no longer carry a premium as of the commencement date of this amendment (Section 3). This change reflects an agreement between the Minister and the responsible person regarding the appropriate pricing for this pharmaceutical item. The amendment imposes specific obligations on the parties involved. The Minister is required to determine the appropriate maximum prices for pharmaceutical brands listed on the Pharmaceutical Benefits Scheme (PBS), known as the 'Determined Price' and 'Claimed Price'. These prices are used to calculate the Commonwealth price for the pharmaceutical item. Additionally, the Minister determines the circumstances under which the Commonwealth will pay a special patient contribution, ensuring that patients who need higher-priced brands can access them without bearing the full cost themselves. The responsible person, typically the manufacturer or supplier of the pharmaceutical item, must provide necessary information to the Minister for these price determinations and comply with the approved prices and conditions set out in the Principal Determination and the Amending Determination. For breaches of the provisions outlined in the Principal Determination and the Amending Determination, the Act provides for various penalties and consequences. Although specific penalties are not detailed within the text provided, it is likely that violations could result in civil or criminal penalties as stipulated in other sections of the National Health Act 1953. These penalties may include fines, imprisonment, or other sanctions, depending on the nature and severity of the breach. The overarching goal is to ensure compliance with the pricing and contribution provisions to maintain the integrity of the PBS and ensure equitable access to necessary medications for all Australians.

Legal classification tags

Area of Law
Health Law
Pharmaceutical Law
Instrument
Legislative Instrument
Concepts
Definitions & Interpretation
Repeal & Amendment
Commencement Provisions
Licensing & Registration
Reporting & Disclosure Obligations
Regulatory Standards

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.