National Health (Price and Special Patient Contribution) Amendment Determination 2018 (No. 10) (PB 115 of 2018)

Administered by Department of Health, Disability and Ageing

Legislation au F2018L01811 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (PRICE AND SPECIAL PATIENT CONTRIBUTION) AMENDMENT DETERMINATION 2018 (No. 10)

PB 115 of 2018

 

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 a pharmaceutical item that is no longer PBS listed.

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 January 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 2018 (No. 10)

(PB 115 of 2018)

Section 1   Name of Determination

This section provides that the Determination is the National Health (Price and Special Patient Contribution) Amendment Determination 2018 (No. 10) and may also be cited as PB 115 of 2018.

Section 2   Commencement

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

Schedule 1 set out the amendments to the Principal Determination which commence on 1 January 2019.


SUMMARY OF CHANGES

SCHEDULE 1

Deletion of brand

Nifedipine

Talbet 20 mg

Adalat 20

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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 2018 (No. 10) (PB 115 of 2018)

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 a pharmaceutical item that is no longer PBS listed.

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.

 

 

 

 

Lisa La Rance

 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 2018 (No. 10), also known as PB 115 of 2018, was enacted under section 85B of the National Health Act 1953. This determination amends the National Health (Price and Special Patient Contribution) Determination 2010 to address the issue of determining prices and special patient contributions for pharmaceutical items listed on the Pharmaceutical Benefits Scheme (PBS) where an agreement between the Minister and the responsible person could not be reached. The objective of this legislative instrument is to ensure appropriate pricing and patient contributions for pharmaceuticals, while facilitating access to necessary medications under the PBS. Enacted by the Minister for Health under the authority of the National Health Act, the policy aims to support the progressive realisation of the right to the highest attainable standard of physical and mental health, as recognised in the International Covenant on Economic, Social and Cultural Rights. The amendment specifically removes a brand of pharmaceutical item that is no longer listed on the PBS, reflecting the most current and relevant pricing arrangements.

Scope and Application

The National Health (Price and Special Patient Contribution) Amendment Determination 2018 (No. 10) 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 relates to price determinations for brands of pharmaceutical items listed on the Pharmaceutical Benefits Scheme (PBS) where the Minister and the responsible person have not reached an agreement on a price. This determination also specifies the circumstances under which the Commonwealth will pay the special patient contribution resulting from these price determinations. The primary application of this amendment is to remove one brand of pharmaceutical item, Nifedipine Talbet 20 mg, from the PBS listing as it is no longer listed. The amendment applies nationally and affects responsible persons with medicines listed on the PBS, particularly those engaged in price negotiations with the Minister. This legislative instrument is compatible with human rights as it supports the progressive realisation of the right to the highest attainable standard of physical and mental health by ensuring access to medicines through the PBS. The Act applies to responsible persons involved in the pricing of pharmaceutical items listed on the PBS, encompassing entities and individuals engaged in the pharmaceutical industry and healthcare sector. The jurisdiction of this Act is national, extending across all states and territories of Australia. There are no stated exclusions or exemptions in this determination, but it is noted that the Minister may determine prices and special patient contributions under the Act. The application of the Act may be extended or restricted through subordinate instruments, which are detailed in the Principal Determination. The Amending Determination commences on 1 January 2019, and it operates to refine and update the pricing framework for pharmaceutical items under the PBS, ensuring that the scheme remains current and effective in providing access to necessary medications.

Key Provisions

The main operative sections of the National Health (Price and Special Patient Contribution) Amendment Determination 2018 (No. 10) (the Amending Determination) are sections 1 to 3, which provide the name of the Determination, its commencement date, and the amendments it makes to the National Health (Price and Special Patient Contribution) Determination 2010 (the Principal Determination). The primary change made by this Amending Determination is the removal of a brand of pharmaceutical item that is no longer listed on the Pharmaceutical Benefits Scheme (PBS). This action is detailed in Schedule 1, which outlines the amendments to the Principal Determination and specifies that these changes take effect from 1 January 2019. The Principal Determination, which the Amending Determination alters, is concerned with the determination of prices and special patient contributions for pharmaceutical items under the National Health Act 1953. The obligations and requirements imposed by the Act on the parties it governs include the process of price determination for pharmaceutical items listed on the PBS. Specifically, section 85B of the National Health Act 1953 empowers the Minister to determine the appropriate maximum price (the Determined Price) and the claimed price (the Claimed Price) of a pharmaceutical item when an agreement cannot be reached between the Minister and the responsible person. Furthermore, the Act requires that the Commonwealth price for the brand of the pharmaceutical item be calculated based on the Determined Price, and that approved pharmacists be paid by the Commonwealth an amount equivalent to the Commonwealth price minus the applicable patient co-payment. In cases where the Commonwealth decides to pay the special patient contribution, the pharmacist is prohibited from charging this amount to the patient. Breaches of the provisions set out in the National Health Act 1953 and the associated determinations may lead to various civil and criminal consequences. While the specific penalties for non-compliance are not detailed in the explanatory statement, it is known that violations of health-related legislation can attract significant fines and, in some cases, imprisonment. The severity of the penalties would depend on the nature and extent of the breach, as well as the intent behind it. For instance, wilfully misleading or providing false information during price negotiations could potentially result in criminal charges under relevant Australian legislation.

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