National Health (Price and Special Patient Contribution) Amendment Determination 2019 (No. 11) (PB 100 of 2019)

Administered by Department of Health, Disability and Ageing

Legislation au F2019L01511 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (PRICE AND SPECIAL PATIENT CONTRIBUTION) AMENDMENT DETERMINATION 2019 (No. 11)

PB 100 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 two brands of two pharmaceutical items in addition to an administrative amendment to the form description of one brand of one pharmaceutical item.  It also  removes one brand of one pharmaceutical item that will no longer be PBS listed on 1 December 2019.

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.  In addition, for the delisting brand, 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 December 2019 as the product will be removed from the PBS at the request of the responsible person.

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

This Determination commences on 1 December 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. 11)

(PB 100 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. 11) and may also be cited as PB 100 of 2019.

Section 2   Commencement

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

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


SUMMARY OF CHANGES

SCHEDULE 1

Brands with a new brand premium

Fluticasone propionate with salmeterol

Pressurised inhalation containing fluticasone propionate 125 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation)

Seretide MDI 125/25

 

Pressurised inhalation containing fluticasone propionate 250 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation)

Seretide MDI 250/25

 

 

 

Brand with an administrative amendment to the form description

Triamcinolone with Neomycin, Gramicidin and Nystatin

Ear drops containing triamcinolone acetonide 0.9 mg with neomycin 2.25 mg (as sulfate), gramicidin 225 micrograms and nystatin 90,000 units per g, 7.5 mL

Kenacomb Otic

 

 

 

Deletion of brand

Trimethoprim with Sulfamethoxazole

Tablet 160 mg‑800 mg

Bactrim DS

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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. 11) (PB 100 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 determiations. This instrument (the Amending Determination) amends the Principal Determination by adding a new brand premium to two brands of two pharmaceutical items in addition to an administrative amendment to the form description of one brand of one pharmaceutical item.  It also  removes one brand of one pharmaceutical item that will no longer be PBS listed on    1 December 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. 11) (PB 100 of 2019) was enacted to address the need for amendments to the pricing and special patient contributions for certain pharmaceutical items listed on the Pharmaceutical Benefits Scheme (PBS). The National Health Act 1953 provides the legislative framework for the regulation of the PBS and the setting of prices for pharmaceutical items. This legislative instrument was made under section 85B of the National Health Act 1953, which allows the Minister for Health to determine prices and special patient contributions when an agreement cannot be reached between the Minister and the responsible person. The primary policy objective of this amendment is to ensure the ongoing availability of appropriate pharmaceutical treatments to patients by adjusting prices and contributions where necessary, reflecting changes in market conditions or the removal of certain pharmaceutical items from the PBS. This instrument amends the National Health (Price and Special Patient Contribution) Determination 2010 by introducing new brand premiums for two brands of pharmaceutical items, making an administrative amendment to the form description of another brand, and removing a brand from the PBS that will no longer be listed effective 1 December 2019. The changes are designed to reflect current market conditions and ensure that patients continue to have access to necessary medications while maintaining the financial sustainability of the PBS. The Determination will commence on 1 December 2019, aligning with the changes in the PBS listing and pricing.

Scope and Application

The National Health (Price and Special Patient Contribution) Amendment Determination 2019 (No. 11) is a legislative instrument made under section 85B of the National Health Act 1953, which amends the National Health (Price and Special Patient Contribution) Determination 2010. This amendment pertains to the Pharmaceutical Benefits Scheme (PBS), specifically concerning the pricing and special patient contributions for certain pharmaceutical brands. It applies to the Minister of Health and the responsible persons for pharmaceutical items listed on the PBS. The Amendment Determination introduces a new brand premium for two brands of pharmaceutical items, an administrative amendment to the form description of one brand, and removes one brand that will no longer be listed on the PBS from 1 December 2019. The instrument has a Commonwealth jurisdictional reach and is compatible with human rights as it assists in the progressive realisation of the right to the highest attainable standard of physical and mental health through the PBS. This instrument does not specify any exclusions or exemptions, and its application is not extended or restricted by subordinate instruments.

Key Provisions

The National Health (Price and Special Patient Contribution) Amendment Determination 2019 (No. 11) (PB 100 of 2019) 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 amendment primarily affects the prices and special patient contributions for certain brands of pharmaceutical items listed on the Pharmaceutical Benefits Scheme (PBS). Section 3 of the Amending Determination specifies the changes to the Principal Determination, which include adding a brand premium to two brands of pharmaceutical items, making an administrative amendment to the form description of one brand, and removing a brand that will no longer be PBS listed as of 1 December 2019. These amendments will come into effect on the specified date. The obligations imposed by this Act on the parties involved, particularly the Minister and the responsible persons, include engaging in price negotiations for pharmaceutical items listed on the PBS. When an agreement on price cannot be reached between the Minister and the responsible person, section 85B of the Act allows the Minister to determine the appropriate maximum price and the claimed price for the pharmaceutical item. The Minister is also tasked with determining the circumstances under which the Commonwealth will pay the special patient contribution. These provisions ensure that the pricing of pharmaceutical items on the PBS is managed fairly and that patients have access to necessary medications at an affordable price. Failure to comply with the provisions of the Act, or with the determinations made under it, can result in significant consequences. While the specific offences, penalties, or consequences for breach are not detailed in the text, it is clear that non-compliance could potentially lead to financial penalties or legal action. The Act provides a framework for ensuring that pharmaceutical prices are managed in a manner that is both fair to the Commonwealth and accessible to patients. The potential penalties or consequences underscore the importance of adhering to the provisions and determinations of the Act. In summary, the National Health (Price and Special Patient Contribution) Amendment Determination 2019 (No. 11) introduces specific amendments to the pricing and special patient contribution for certain pharmaceutical items on the PBS. It imposes obligations on the Minister and responsible persons to engage in price negotiations and to adhere to the determinations made under the Act. The potential consequences for non-compliance highlight the importance of following the provisions and determinations set out in the Act.

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