National Health (Price and Special Patient Contribution) Amendment Determination 2019 (No. 3) (PB 26 of 2019)

Administered by Department of Health, Disability and Ageing

Legislation au F2019L00466 Not in force Legislative Instrument

Legislation content

EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (PRICE AND SPECIAL PATIENT CONTRIBUTION) AMENDMENT DETERMINATION 2019 (No. 3)

PB 26 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 adding a new brand premium to one brand of a pharmaceutical item and also increases the brand premium to two other brands of two pharmaceutical items.  In addition, it also decreases the brand premium of one brand of pharmaceutical item as a result of an increase to the determination price for that brand.

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 April 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. 3)

(PB 26 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. 3) and may also be cited as PB 26 of 2019.

Section 2   Commencement

This section provides that the Determination commences on 1 April 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 April 2019

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


SUMMARY OF CHANGES

SCHEDULE 1

Brand with a new brand premium

Dipyridamole with aspirin

Capsule 200 mg (sustained release)- 25 mg

Asasantin SR

Brands with increased brand premiums

Levonorgestrel with Ethinylestradiol

Pack containing 21 tablets 150 micrograms- 30 micrograms and 7 inert tablets

Levlen ED

 

Pack containing 6 tablets 50 micrograms-30 micrograms, 5 tablets 75 micrograms-40 micrograms, 10 tablets 125 micrograms-30 micrograms and 7 inert tablets

Triquilar ED

Brand with a decreased brand premium

Salbutamol

Pressurised inhalation 100 micrograms (as sulfate) per dose, 200 doses (CFC-free formulation)

Ventolin CFC-free

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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. 3) (PB 26 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 adding a new brand premium to one brand of a pharmaceutical item and also increases the brand premium to two other brands of two pharmaceutical items.  In addition, it also decreases the brand premium of one brand of pharmaceutical item as a result of an increase to the determination price for that brand.

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. 3) (PB 26 of 2019) amends the National Health (Price and Special Patient Contribution) Determination 2010 (PB 109 of 2010) under the National Health Act 1953. This amendment was introduced to address the issue of determining appropriate prices and special patient contributions for pharmaceutical items listed on the Pharmaceutical Benefits Scheme (PBS) where agreement between the Minister and the responsible person could not be reached. This legislative instrument, made under section 85B of the National Health Act 1953, modifies the Principal Determination by adjusting brand premiums for specific pharmaceutical brands, either increasing, decreasing, or introducing a new premium, effective from 1 April 2019. The purpose of these amendments is to ensure that the prices and contributions reflect the most current and appropriate values, thereby maintaining the integrity and accessibility of the PBS for patients.

Scope and Application

The National Health (Price and Special Patient Contribution) Amendment Determination 2019 (No. 3) amends the National Health (Price and Special Patient Contribution) Determination 2010. This legislative instrument, made under section 85B of the National Health Act 1953, applies to pharmaceutical brands listed on the Pharmaceutical Benefits Scheme (PBS) where price agreements between the Minister and responsible persons are not reached. The Determination sets the maximum prices for these pharmaceutical items and the circumstances under which the Commonwealth will pay the special patient contribution. This amendment affects responsible persons who negotiate prices for their pharmaceutical items listed on the PBS. It does not apply to pharmaceutical brands for which price agreements have been successfully negotiated. The Amending Determination adds a new brand premium to one pharmaceutical brand and increases the brand premiums for two other brands, while also decreasing the brand premium for one brand due to an increase in the determined price. The Determination commenced on 1 April 2019 and it engages Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights by facilitating access to medicines and supporting the right to the highest attainable standard of physical and mental health.

Key Provisions

The National Health (Price and Special Patient Contribution) Amendment Determination 2019 (No. 3) (F2019L00466) amends the National Health (Price and Special Patient Contribution) Determination 2010 (the Principal Determination) (sections 3(1) and Schedule 1). The Principal Determination sets out prices for pharmaceutical items listed on the Pharmaceutical Benefits Scheme (PBS) when the Minister for Health and the responsible person cannot agree on a price. This amendment adds a new brand premium to Dipyridamole with aspirin (Asasantin SR), increases the brand premium for Levonorgestrel with Ethinylestradiol (Levlen ED) and Triquilar ED, and decreases the brand premium for Salbutamol (Ventolin CFC-free) (Schedule 1). The Determined Price and Claimed Price are set out in section 85B(2) and (3) of the National Health Act 1953. The Commonwealth may pay the special patient contribution under section 85B(4) of the Act. The Amending Determination imposes obligations on the relevant parties to adhere to the updated pricing and special patient contribution provisions. The Minister for Health must determine prices for pharmaceutical items when an agreement cannot be reached with the responsible person (section 85B(2) of the Act). The responsible persons must comply with the Determined Price and any special patient contribution provisions, including accurately invoicing the Commonwealth and adhering to charging limits (sections 98B, 99, and 87(2A) of the Act). The Act provides for penalties and consequences for non-compliance. Offences under the Act can result in fines, imprisonment, or both, depending on the severity of the breach (section 119 of the Act). For example, dishonestly claiming or receiving benefits under the Act can result in fines up to $22,200 or imprisonment for up to five years, or both (subsection 119(1) of the Act). Additionally, civil penalties may apply for breaches of the Act or the Regulations, with penalties varying based on the nature and extent of the breach (subsection 126A(2) of the Act).

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