National Health (Price and Special Patient Contribution) Amendment Determination 2020 (No. 9) (PB 110 of 2020)

Administered by Department of Health, Disability and Ageing

Legislation au F2020L01364 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (PRICE AND SPECIAL PATIENT CONTRIBUTION) AMENDMENT DETERMINATION 2020 (No. 9)

PB 110 of 2020

 

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 reflecting the addition of the brand name for one brand of one pharmaceutical item and deletion of one brand of one pharmaceutical item on 1 November 2020.

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. 

The responsible person affected by this determination for dutasteride with tamsulosin were previously consulted when the determined price came into effect on 1 October 2020. The responsible person of glyceryl trinitrate requested to delist its brand from the PBS.

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 November 2020.

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 2020 (No. 9)

(PB 110 of 2020)

Section 1   Name of Determination

This section provides that the Determination is the National Health (Price and Special Patient Contribution) Amendment Determination 2020 (No. 9) and may also be cited as PB 110 of 2020.

Section 2   Commencement

This section provides that the Determination commences on 1 November 2020.

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 November 2020

Schedule 1 sets out the amendments to the Principal Determination which commence on 1 November 2020.


SUMMARY OF CHANGES

SCHEDULE 1

 

Brand with a new brand name

Dutasteride with tamsulosin

Capsule containing dutasteride 500 micrograms with tamsulosin hydrochloride 400 micrograms

Duodart 500ug/400ug

Deletion of Brand

Glyceryl Trinitrate

Tablets 600 micrograms, 100

Anginine Stabilised


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 2020 (No. 9) (PB 110 of 2020)

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 reflecting the addition of the brand name for one brand of one pharmaceutical item and deletion of one brand of one pharmaceutical item on 1 November 2020.

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.

 

 

 

 

Paul Hansen

 Acting 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 2020 (No. 9) (PB 110 of 2020) amends the National Health (Price and Special Patient Contribution) Determination 2010 (PB 109 of 2010) under section 85B of the National Health Act 1953. This legislation addresses the issue of setting prices for pharmaceutical brands listed on the Pharmaceutical Benefits Scheme (PBS) where the Minister and the responsible person cannot reach an agreement on pricing. The policy objective is to ensure that the pricing of pharmaceutical items on the PBS is fair and reasonable, with a particular focus on maintaining affordable access to essential medicines for patients. The amendment reflects the addition of a brand name for one pharmaceutical item and the deletion of another brand on 1 November 2020. This change was made following consultations with the relevant responsible persons, ensuring that the adjustments are consistent with the broader objectives of the National Health Act 1953 and the PBS.

Scope and Application

The National Health (Price and Special Patient Contribution) Amendment Determination 2020 (No. 9) is a legislative instrument made under section 85B of the National Health Act 1953. This determination amends the National Health (Price and Special Patient Contribution) Determination 2010, which sets out price determinations for brands of pharmaceutical items listed on the Pharmaceutical Benefits Scheme (PBS) where the Minister and the responsible person have not agreed on a price. The Amending Determination modifies the Principal Determination by adding a brand name for one pharmaceutical item and deleting another brand of a pharmaceutical item, effective from 1 November 2020. This amendment aims to reflect changes in the pharmaceutical landscape and ensure that the pricing structure remains current and effective. The determination applies to the Commonwealth and the responsible persons involved in the pricing of pharmaceutical items under the PBS. Its jurisdictional reach is national, as it pertains to the administration and regulation of the PBS, a Commonwealth-wide scheme. The Act does not explicitly state exclusions or exemptions, but it is understood that the provisions apply to all relevant pharmaceutical brands listed on the PBS, unless otherwise specified by subordinate instruments or amendments.

Key Provisions

The National Health (Price and Special Patient Contribution) Amendment Determination 2020 (No. 9) amends the National Health (Price and Special Patient Contribution) Determination 2010, which establishes the prices for pharmaceutical items listed on the Pharmaceutical Benefits Scheme (PBS) when an agreement cannot be reached between the Minister and the responsible person (section 1). The amendment, effective from 1 November 2020, involves the addition of a brand name for one pharmaceutical item and the removal of another brand from the PBS (section 3). This legislative instrument is made under section 85B of the National Health Act 1953 and ensures that prices are set for pharmaceutical items that are crucial for patient access to necessary medications. The Act imposes several obligations on the parties involved. The Minister must determine the appropriate maximum price of a brand of a pharmaceutical item when an agreement cannot be reached with the responsible person, and this is referred to as the 'Determined Price' (subsection 85B(2)). The Minister also determines the 'Claimed Price' which is the price claimed by the responsible person for a specific pack quantity of the pharmaceutical item (subsection 85B(3)). Additionally, the Minister determines the circumstances under which the Commonwealth will pay the special patient contribution, which is the difference between the claimed price and the Commonwealth price (subsection 85B(4)). These determinations ensure that pricing is regulated and that patients have access to necessary medications at an affordable price. Breaches of the provisions under this Act can result in civil or criminal consequences. While specific penalties are not mentioned in the text, the legislation is designed to ensure compliance with price determinations and to protect patients' access to affordable medication. The overarching purpose of the Act is to facilitate the progressive realisation of the right to the highest attainable standard of physical and mental health by providing for subsidised access to necessary medications through the PBS. In summary, the National Health (Price and Special Patient Contribution) Amendment Determination 2020 (No. 9) modifies the price determinations for pharmaceutical items on the PBS, ensuring that appropriate prices are set when agreements cannot be reached between the Minister and the responsible person. This amendment includes the addition of one brand and the removal of another, effective from 1 November 2020. The obligations under this Act involve the Minister determining the appropriate prices and the circumstances for Commonwealth payment of special patient contributions, all aimed at maintaining affordable access to essential medications for patients.

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