National Health (Pharmaceutical benefits supplied by private hospitals) Amendment Determination 2015 (No. 1) (PB 66 of 2015)

Administered by Department of Health, Disability and Ageing

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EXPLANATORY STATEMENT

National Health Act 1953

National Health (Pharmaceutical benefits supplied by private hospitals) Amendment Determination 2015 (No. 1)

PB 66 of 2015

Authority

Subsection 99(4) of the National Health Act 1953 (the Act) provides that an approved hospital authority is entitled to payment from the Commonwealth at such rates and subject to such conditions as the Minister determines, in respect of the supply of pharmaceutical benefits to patients receiving treatment in or at an approved hospital.  The National Health (Pharmaceutical benefits supplied by private hospitals) Determination 2010 (the Principal Determination) determines the rates and conditions of payments to private hospitals.  Another determination under subsection 99(4) determines the rates and conditions of payments to public hospitals.

Purpose

This Amendment Determination amends the Principal Determination to reflect the new Determination made by the Pharmaceutical Benefits Remuneration Tribunal under paragraph 98B(1)(a) of the Act, which will take effect from 1 July 2015.

The amendments are consequential and for consistency reflect similar changes to the Determination under paragraph 98B(1)(a) of the Act which include clarification of when rounding in a calculation applies and when the dangerous drug fee applies.  Additionally, the amendments change the date by which the wholesale cost for a container must be agreed between the Minister and the Pharmacy Guild of Australia to be more reflective of current practice.

Details of the amendments made by this Determination are set out in the Attachment.

Background

Part VII of the National Health Act 1953 (the Act) is the legislative basis of the Pharmaceutical Benefits Scheme (PBS) by which the Commonwealth provides reliable, timely, and affordable access to a wide range of medicines for all Australians.

Subsection 85(1) provides that benefits are to be provided by the Commonwealth in accordance with Part VII in respect of pharmaceutical benefits.

The Principal Determination sets out the rates of payment for the supply of pharmaceutical benefits by a private hospital approved under section 94 of the Act. 

Consultation

The changes to this Determination are consequential amendments as a result of amendments to the Determination under paragraph 98B(1)(a).  The changes to the 98B(1)(a) instrument are a direct result of the Sixth Community Pharmacy Agreement between the Pharmacy Guild of Australia and the Commonwealth. For this reason, no consultation on this determination was considered necessary.

This Determination commences on 1 July 2015.

This Determination is a legislative instrument for the purposes of the Legislative Instruments Act 2003.


ATTACHMENT

Details of the National Health (Pharmaceutical benefits supplied by private hospitals) Amendment Determination 2015 (No. 1) – PB 66 of 2015

 

Section 1 Name of Determination

This section provides that the title of the Determination is the National Health (Pharmaceutical benefits supplied by private hospitals) Amendment Determination 2015 (No.1) and that it may also be cited as PB 66 of 2015.

Section 2 Commencement

This section provides for the Determination to commence on 1 July 2015.

Section 3 Amendment of National Health (Pharmaceutical Benefits Supplied By Private Hospitals) Determination 2010

This section provides that Schedule 1 amends the National Health (Pharmaceutical benefits supplied by private hospitals) Determination 2010 made on 21 September 2010.

 

SCHEDULE 1 – AMENDMENTS

Section 1 – Section 6

This section amends the current wording to ensure that if the calculation of a price in the Determination includes a fraction of a cent, the result of the calculation will be rounded accordingly at the end of the calculation.

Section 2 – Section 7

This Section amends the current wording to clarify that where indicated in this Determination, the Commonwealth must pay a dangerous drug fee if a pharmaceutical benefit is a dangerous drug. 

Section 3 – Subsection 8(1)

This section includes a new reference at paragraph 8(1)(c) that where applicable, a single dangerous drug fee is to be paid when a repeat supply of a pharmaceutical benefit occurs.

Section 4 – Section 11

This section is amended to include references at paragraphs 11(1)(a)(iii), 11(1)(b)(iii) and 11(1)(c)(iv) to the dangerous drug fee being payable where applicable.

Section 5 – Subsection 13(3)

This section amends the date by which the wholesale cost for a container must be agreed between the Minister and the Pharmacy Guild of Australia from 1 May to 15 June each year.

Section 6 – Section 14, Step 1

This section amends Step 1 of the Method statement to include the dangerous drug fee, where applicable, within the calculation for the price of broken quantities for ready-prepared pharmaceutical benefits.

 

Statement of Compatibility with Human Rights

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

National Health (Pharmaceutical benefits supplied by private hospitals) Amendment Determination 2015 (No. 1) – PB 66 of 2015

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 Amendment Determination amends the Principal Determination to reflect the new Determination made under paragraph 98B(1)(a) of the Act, that will take effect from 1 July 2015.

The amendments are consequential and for consistency reflect similar changes to the Determination under paragraph 98B(1)(a) of the Act which include clarification of when rounding in a calculation applies, when the dangerous drug fee applies.  Additionally, the amendments amend the date by which the wholesale cost for a container must be agreed between the Minister and the Pharmacy Guild of Australia to be more reflective of current practice.   

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 Pharmaceutical Benefits Scheme (PBS) is a benefit scheme which assists with advancement of this human right by providing for subsidised access by patients to medicines.

Conclusion

This legislative instrument is compatible with human rights because it advances the protection of human rights.

 

 

Julianne Quaine

Assistant Secretary

Pharmaceutical Access Branch

Pharmaceutical Benefits Division

Department of Health

Overview

The National Health (Pharmaceutical benefits supplied by private hospitals) Amendment Determination 2015 (No. 1), also known as PB 66 of 2015, was introduced to amend the National Health (Pharmaceutical benefits supplied by private hospitals) Determination 2010 in order to reflect new determinations made by the Pharmaceutical Benefits Remuneration Tribunal under the National Health Act 1953. This Amendment Determination was enacted by the Parliament of Australia to ensure that the rates and conditions of payments to private hospitals align with the latest changes to the Determination. The primary policy objective of this amendment is to enhance the consistency and clarity of the Pharmaceutical Benefits Scheme (PBS), which provides Australians with access to affordable medications, by updating the calculation of pharmaceutical benefits, clarifying the application of the dangerous drug fee, and adjusting the timeline for agreeing on wholesale costs for pharmaceutical containers. This Amendment Determination, which commenced on 1 July 2015, is a legislative instrument under the Legislative Instruments Act 2003 and 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 reliable access to affordable medications through the PBS. The amendments made by this Determination are consequential, reflecting the changes in the Sixth Community Pharmacy Agreement between the Pharmacy Guild of Australia and the Commonwealth, and no further consultation was deemed necessary.

Scope and Application

The National Health (Pharmaceutical benefits supplied by private hospitals) Amendment Determination 2015 (No. 1) amends the National Health (Pharmaceutical benefits supplied by private hospitals) Determination 2010 to reflect the new Determination made by the Pharmaceutical Benefits Remuneration Tribunal under paragraph 98B(1)(a) of the National Health Act 1953, which will take effect from 1 July 2015. This Amendment Determination applies to approved private hospitals that supply pharmaceutical benefits to patients receiving treatment within their facilities, thereby ensuring they receive payment from the Commonwealth at rates and conditions determined by the Minister. The changes made are consequential, reflecting similar amendments to the Determination under paragraph 98B(1)(a) of the Act, including clarifications on when rounding in a calculation applies and when the dangerous drug fee applies. Additionally, the amendments change the date by which the wholesale cost for a container must be agreed between the Minister and the Pharmacy Guild of Australia to better align with current practices. The Determination is applicable nationally, as it pertains to private hospitals across Australia that supply pharmaceutical benefits, and it complements the broader framework of the Pharmaceutical Benefits Scheme established under the National Health Act 1953.

Key Provisions

The main operative sections of the National Health (Pharmaceutical benefits supplied by private hospitals) Amendment Determination 2015 (No. 1) (sections 1-6) provide for the amendment of the National Health (Pharmaceutical benefits supplied by private hospitals) Determination 2010 to reflect the changes made by the Pharmaceutical Benefits Remuneration Tribunal under paragraph 98B(1)(a) of the Act. The amendments include clarifications on rounding in calculations, the application of the dangerous drug fee, and the date by which the wholesale cost for a container must be agreed upon between the Minister and the Pharmacy Guild of Australia. Section 1 of the Determination provides for the title and citation of the Amendment Determination, while Section 2 establishes the commencement date of 1 July 2015. Section 3 specifies the amendment to the Principal Determination, which is detailed in Schedule 1. The amendments in Schedule 1 clarify rounding in calculations, the circumstances under which a dangerous drug fee is payable, and the date for agreeing on the wholesale cost for a container. The Amendment Determination imposes obligations on parties governed by the National Health Act 1953, including private hospitals approved under section 94 of the Act. These obligations include adhering to the specified rates and conditions of payments for the supply of pharmaceutical benefits, as amended by this Determination. Approved hospitals must ensure that their calculations for pharmaceutical benefits, including any rounding, comply with the new provisions. Furthermore, hospitals must be aware of when a dangerous drug fee is applicable and ensure that such fees are included in their calculations. Additionally, the Minister and the Pharmacy Guild of Australia must agree on the wholesale cost for a container by 15 June each year to ensure that the pricing for pharmaceutical benefits supplied by private hospitals remains current and accurate. The Amendment Determination does not explicitly state specific offences or penalties for breaches; however, any failure to comply with the legislative requirements could potentially lead to financial repercussions. Under the National Health Act 1953, the Commonwealth has the authority to withhold or recover payments from hospitals that do not adhere to the stipulated rates and conditions of payments. While the exact penalties for non-compliance are not detailed in this Amendment Determination, it is implied that any failure to comply with the legislative requirements could result in financial penalties, including the withholding or recovery of payments made to the hospital for pharmaceutical benefits supplied to patients. The potential consequences of non-compliance underscore the importance of adhering to the legislative obligations set forth by the Amendment Determination.

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