Federal Register of Legislation - Australian Government

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Determinations/Health as made
This instrument amends the Commonwealth price (Pharmaceutical benefits supplied by approved pharmacists) Determination 2015 (PB 64 of 2015) to improve overall clarity and operation, update cross-references to other instruments and ensure consistency with current drafting practices.
Administered by: Health
Registered 29 Jan 2020
Tabling HistoryDate
Tabled HR04-Feb-2020
Tabled Senate04-Feb-2020
Date of repeal 15 May 2020
Repealed by Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003

EXPLANATORY STATEMENT

National Health Act 1953

National Health (Commonwealth Price) (Pharmaceutical Benefits Supplied by Approved Pharmacists) Consequential Amendments Determination 2020

 

Authority

Paragraph 98B(1)(a) of the National Health Act 1953 (the Act) provides that a function of the Pharmaceutical Benefits Remuneration Tribunal (the Tribunal) is to determine the manner in which the Commonwealth price for particular quantities or numbers of units for all or any pharmaceutical benefits is to be worked out for the purpose of payments to approved pharmacists for the supply of pharmaceutical benefits.

The Tribunal is an independent statutory body established under section 98A of the Act. The main functions of the Tribunal are to make a determination to give effect to the terms of agreement between the Commonwealth and the Pharmacy Guild of Australia in relation to the remuneration that is to be paid to pharmacists for dispensing pharmaceutical benefits and to perform other functions required by that agreement (currently the Sixth Community Pharmacy Agreement).

Purpose

The National Health (Commonwealth Price) (Pharmaceutical Benefits Supplied by Approved Pharmacists) Consequential Amendments Determination 2020 (the Amending Determination) provides for consequential amendments to the Commonwealth price (Pharmaceutical benefits supplied by approved pharmacists) Determination 2015 (PB 64 of 2015) (the Principal Determination). The purpose of these consequential amendments is to improve the overall clarity and operation of the Principal Determination, update cross-references to the National Health (Commonwealth Price and Conditions for Commonwealth Payments for Supply of Pharmaceutical Benefits) Determination 2019 (previously known as Determination – Conditions (PB 119 of 2008)) and ensure that the content of the Principal Determination reflects current drafting practices. The amendments do not alter the manner in which the Commonwealth price is currently calculated for the supply of PBS by approved pharmacists, the conditions subject to which relevant payments will be made or any applicable fees.

This instrument commences on 1 February 2020.

This instrument is a legislative instrument for the purposes of the Legislation Act 2003.

A provision by provision description of the Determination is contained in Attachment 1.

Consultation

The Department of Health undertook consultation with a number of stakeholders, including the Pharmacy Guild of Australia and Services Australia. The consultation period commenced on 15 November 2019 and closed on 29 November 2019. No objections were raised in relation to these amendments.

 


ATTACHMENT 1

 

Provision by provision description of the National Health (Commonwealth Price) (Pharmaceutical Benefits Supplied by Approved Pharmacists) Consequential Amendments Determination 2020

 

Section 1         Name

This section provides that the Determination is the National Health (Commonwealth Price) (Pharmaceutical Benefits Supplied by Approved Pharmacists) Consequential Amendments Determination 2020.

Section 2         Commencement

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

Section 3         Authority

This section provides that the Determination is made under paragraph 98B(1)(a) of the National Health Act 1953 (the Act).

Section 4         Schedules

This section provides that each instrument in the Schedule is amended or repealed as set out in the applicable items in that Schedule.

Schedule 1   Amendments

Commonwealth price (Pharmaceutical benefits supplied by approved pharmacists) Determination 2015 (PB 64 of 2015)

Items 1 Subsection 6(1) (paragraph (a) of the definition of dangerous drug), 2 Subsection 6(1) (definition of standard formula preparation) and 4 Subsection 11(2)

Items 1, 2 and 4 amend definitions and omit the references to Determination under paragraph 98C(1)(b) of the Act” and substitute with  references to “National Health (Commonwealth Price and Conditions for Commonwealth Payments for Supply of Pharmaceutical Benefits) Determination 2019”.

Item 3 Section 10

Item 3 repeals section 10 in the Principal Determination. This section has been relocated to the National Health (Commonwealth Price and Conditions for Commonwealth Payments for Supply of Pharmaceutical Benefits) Determination 2019. This will improve the overall clarity and operation of the Principal Determination and ensure the content reflects current drafting practices.

Item 5 Section 17 (heading)

Item 5 repeals the existing heading in section 17 and substitutes a new heading: ‘Pharmaceutical benefits that are to be supplied as complete packs’. This reflects the updated wording as used in the National Health (Commonwealth Price and Conditions for Commonwealth Payments for Supply of Pharmaceutical Benefits) Determination 2019.

Item 6 Section 17

Item 6 amends section 17 by omitting “of the determination under paragraph 98C(1)(b) of the Act as a pharmaceutical benefit the complete pack of which shall be supplied regardless of any lesser quantity ordered” and substituting it with “to the National Health (Commonwealth Price and Conditions for Commonwealth Payments for Supply of Pharmaceutical Benefits) Determination 2019 (about benefits to be supplied as complete packs)”.

Item 7 Paragraph 23(a)

Item 7 amends paragraph 23(a) by omitting “a drug that is unstable or packed sterile, mentioned in Schedule 2 to the Determination under paragraph 98C(1)(b) of the National Health Act 1953”, and substituting it with “described in Schedule 2 to the National Health (Commonwealth Price and Conditions for Commonwealth Payments for Supply of Pharmaceutical Benefits) Determination 2019 (about unstable or sterile ingredients)”.

Item 6 Section 17

Item 6 amends section 17 by omitting “of the determination under paragraph 98C(1)(b) of the Act as a pharmaceutical benefit the complete pack of which shall be supplied regardless of any lesser quantity ordered” and substituting it with “to the National Health (Commonwealth Price and Conditions for Commonwealth Payments for Supply of Pharmaceutical Benefits) Determination 2019 (about benefits to be supplied as complete packs)”.

Item 7 Paragraph 23(a)

Item 7 amends paragraph 23(a) by omitting “a drug that is unstable or packed sterile, mentioned in Schedule 2 to the Determination under paragraph 98C(1)(b) of the National Health Act 1953”, and substituting it with “described in Schedule 2 to the National Health (Commonwealth Price and Conditions for Commonwealth Payments for Supply of Pharmaceutical Benefits) Determination 2019 (about unstable or sterile ingredients)”.

Item 8 Subsection 32(1)

Item 8 amends section 32 of the Principal Determination. It repeals subsection 32(1) and replaces it with a statement on how the Commonwealth price for the supply by an approved pharmacist of an extemporaneously-prepared pharmaceutical benefit for which there is no standard formula, preparation may be worked out by the pharmacist under section 19 of the Determination, provided the supply of the benefit is made where the pharmacist elected to work out the Commonwealth price in a way consistent with subsections (1A) and (1B) of section 32.

Subsections 32(1A) and (1B) outline that the pharmacist may make the election in writing to the Chief Executive Medicare, and that the election is in force for the period specified in the election (which must be at least 3 months), unless revoked before the end of the period.

These amendments replicate the effects of section 9 of the Determination under paragraph 98C(1)(b) of the National Health Act 1953 (No. PB 119 of 2008) and subsection 32(4) of the Principal Determination.

Item 9 Subsection 32(4)

Item 10 repeals subsection 32(4) of the Principal Determination, as the effect of that subsection is replicated in the amendments outlined in item 8.

 

 

 

 

 

 


 

 

Statement of Compatibility with Human Rights

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

National Health (Commonwealth Price) (Pharmaceutical Benefits Supplied by Approved Pharmacists) Consequential Amendments Determination 2020

This Determination 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 Determination

The National Health (Commonwealth Price) (Pharmaceutical Benefits Supplied by Approved Pharmacists) Consequential Amendments Determination 2020 (the Determination) amends the Commonwealth price (Pharmaceutical benefits supplied by approved pharmacists) Determination 2015 (the Principal Determination).

The Determination provides for consequential amendments which improve the overall clarity and operation of the Principal Determination, update cross-references to the National Health (Commonwealth Price and Conditions for Commonwealth Payments for Supply of Pharmaceutical Benefits) Determination 2019 and ensures the content of the Principal Determination reflects current drafting practices.

Human rights implications

The Determination aims to improve the overall clarity and operation of the Principal Determination. These changes do not engage any of the applicable rights or freedoms and do not raise any human rights issues.

More broadly, the Pharmaceutical Benefits Scheme (PBS) is a statutory benefit scheme which assists with providing subsidised access to medicines for people in the community. It engages Article 12 of the ICESCR, as it is a positive step towards attaining the highest standard of health for all Australians. Efficient operational arrangements for the PBS support effective administration of the scheme. In addition, it also assists in 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 Determination has no net effect on the Articles engaged by the Principal Determination.

The Tribunal is an independent statutory body established under section 98A of the National Health Act 1953. The main functions of the Tribunal are to make a determination to give effect to the terms of agreement between the Commonwealth and the Pharmacy Guild of Australia in relation to the remuneration that is to be paid to pharmacists for dispensing pharmaceutical benefits and to perform other functions required by that agreement (currently the Sixth Community Pharmacy Agreement).

Conclusion

The Determination is compatible with human rights, as they apply to Australia, as it does not raise any human rights issues and does not impinge on any rights or freedoms.

 

 

Abbeygail Beaumont

Chairperson

Pharmaceutical Benefits Remuneration Tribunal