National Health (Subsection 84C(7)) Amendment Determination 2014 (No. 1)

Administered by Department of Health, Disability and Ageing

Legislation au F2014L00964 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

National Health Act 1953

National Health (Subsection 84C(7)) Amendment Determination 2014 (No. 1)

PB 59 of 2014

Authority

Subsection 84C(7) of the National Health Act 1953 (the Act) provides that the Minister may determine the manner in which the price for all or any pharmaceutical benefits and repatriation pharmaceutical benefits is to be ascertained for the purpose of the Safety Net.  Paragraph 84C(8)(d) of the Act provides for the addition of fees or amounts as determined by the Minister in accordance with subsection 84C(9) of the Act which requires the agreement in writing of the Pharmacy Guild of Australia.

This price is determined in the National Health (Subsection 84C(7)) Determination 2010 made on 20 July 2010 (the Principal Determination), as being the sum of the Commonwealth price for a pharmaceutical benefit, calculated in accordance with the determination by the Pharmaceutical Benefits Remuneration Tribunal under paragraph 98B(1)(a) of the Act, and an additional amount for paragraph 84C(8)(d).

Purpose

The purpose of this Determination is to reflect the additional amount for ready-prepared pharmaceutical benefits and for extemporaneously-prepared pharmaceutical benefits, with effect from 1 August 2014.

Background

Part VII of 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.

Division 1A of Part VII of the Act provides for the Safety Net arrangements for the PBS and Repatriation Pharmaceutical Benefits Scheme (RPBS).  The Safety Net reduces the cost of medicines for individuals and families who require a large number of pharmaceutical benefits.

Section 84C of the Act provides that a person is eligible to receive a Safety Net concession card or entitlement card when expenditure on pharmaceutical benefits for the person or the person and their family during an entitlement period reaches a certain amount (the Safety Net amount).  A Safety Net concession card or entitlement card enables access to PBS or RPBS medicines at a reduced rate or free of charge for the remainder of the entitlement period.  An entitlement period for the Safety Net is a calendar year from 1 January to 31 December.

Section 84C also sets out the supplies and amounts which can be taken into account for the purpose of the Safety Net.  Where the Commonwealth price for a medicine is equal to or greater than the maximum amount the patient may be charged (the patient co-payment), the amount for Safety Net purposes is the amount charged as the patient co-payment.  Where the Commonwealth price for a pharmaceutical benefit is less than the patient co-payment, subsection 84C(4)(e) of the Act provides that the supply cannot be taken into account for Safety Net purposes unless the amount charged does not exceed the sum of the subsection 84C(7) price for the pharmaceutical benefit or repatriation pharmaceutical benefit and any charges (where applicable) for supplying the pharmaceutical benefit outside of normal trading hours and/or by delivery to premises other than the approved pharmacy.

Subsection 84C(7) of the Act provides that the Minister may determine the manner in which the price for all or any pharmaceutical benefits or repatriation pharmaceutical benefits (including those referred to in subsection 84C(4)(e)) is to be ascertained for the purpose of the Safety Net.  Subsection 87C(8) provides that the manner determined under subsection (7) shall accord with the requirements set out in subsection (8).

The price of a pharmaceutical benefit for subsection 84C(7) of the Act is determined in the Principal Determination to be the sum of the Commonwealth price, calculated in accordance with a determination under paragraph 98B(1)(a) of the Act, and an additional amount determined by the Minister for paragraph 84C(8)(d) of the Act.  A different amount applies for ready-prepared and extemporaneously-prepared pharmaceutical benefits.

The Principal Determination provides that the subsection 84C(7) price for a pharmaceutical benefit must not exceed the patient co-payment amount.  This means that the additional amount that can be included, in full or in part, only where price is up to a maximum of the patient copayment.

The additional amount for ready-prepared pharmaceutical benefits is indexed annually.  The additional amount for extemporaneously-prepared benefits is obtained by multiplying the additional amount for ready-prepared benefits by the ratio of the extemporaneously-prepared and ready-prepared dispensing fees determined under paragraph 98B(1)(a) of the Act.

The Commonwealth price (Pharmaceutical benefits supplied by approved pharmacists) Amendment Determination 2014 (No. 1), PB 44 of 2014, defines the ready-prepared dispensing fee and the extemporaneously-prepared dispensing fee to be $6.76 and $8.80, respectively, from 1 July 2014.

Amendments

This Determination revises the additional amount, for paragraph 84C(8)(d) of the Act, for ready-prepared pharmaceutical benefits from $1.13 to $1.15 and for extemporaneously-prepared pharmaceutical benefits from $1.48 to $1.50, with effect from 1 August 2014.

Consultation

Subsection 84C(9) of the Act provides that the Minister must not determine an additional amount unless the Pharmacy Guild of Australia has agreed in writing.

The Pharmacy Guild of Australia was consulted on this matter and agreed, in writing, to the revised values of the additional amounts for ready-prepared and extemporaneously-prepared pharmaceutical benefits.

The Determination commences on 1 August 2014.

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


Statement of Compatibility with Human Rights

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

National Health (Subsection 84C(7)) Amendment Determination 2014 (No. 1)

PB 59 of 2014

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

The purpose of this legislative instrument, made under subsection 84C(7) of the National Health Act 1953 (the Act), is to give effect to an annual indexation adjustment to a remuneration payment.  It amends the National Health (Subsection 84C(7)) Determination 2010 to adjust the additional amount (also known as the Safety Net Recording Fee) used in the calculation of the price of pharmaceutical benefit.  The supply of pharmaceutical benefits by approved pharmacists includes recording patient payments for Safety Net purposes.  The additional amount forms part of the price that can be charged to the patient for a pharmaceutical benefit where the Commonwealth price is less than the patient copayment amount.  It is included in full or in part such that the patient payment is not more than the co-payment amount.

The legislative instrument increases the additional amount for ready-prepared pharmaceutical benefits from $1.13 to $1.15 and for extemporaneously-prepared pharmaceutical benefits from $1.48 to $1.50, with effect from 1 August 2014.

Human rights implications

This legislative instrument engages Article 7 of the International Covenant on Economic, Social and Cultural Rights (ICESCR) by assisting with the provision favourable conditions of work to ensure remuneration for workers with fair wages. 

Conclusion

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

 

 

Kim Bessell

Assistant Secretary

Pharmaceutical Access Branch

Department of Health

 

Overview

The National Health (Subsection 84C(7)) Amendment Determination 2014 (No. 1) is an amendment to the National Health Act 1953, which was enacted to address the need for adjustments to the pharmaceutical benefit pricing structure under the Pharmaceutical Benefits Scheme (PBS). This particular amendment aims to update the additional amounts for ready-prepared and extemporaneously-prepared pharmaceutical benefits, effective from 1 August 2014. The determination was made by the Minister for Health under subsection 84C(7) of the Act, with the agreement of the Pharmacy Guild of Australia as required by subsection 84C(9). The primary purpose of this amendment is to reflect the updated additional amounts in the calculation of the price of pharmaceutical benefits, ensuring that the prices remain within the patient co-payment limits set by the Safety Net provisions of the PBS. The determination was introduced to maintain the integrity of the PBS by ensuring that the prices charged for pharmaceutical benefits are accurately reflected, particularly for those who rely on Safety Net concessions. This adjustment is intended to keep the PBS affordable and accessible, while also ensuring fair remuneration for the pharmacists and pharmacies involved in dispensing these benefits. The determination also aligns with the human rights framework by promoting favourable conditions of work and fair wages, as recognised under Article 7 of the International Covenant on Economic, Social and Cultural Rights.

Scope and Application

The National Health (Subsection 84C(7)) Amendment Determination 2014 (No. 1) amends the National Health (Subsection 84C(7)) Determination 2010 to adjust the additional amount used in the calculation of the price of pharmaceutical benefits for the Pharmaceutical Benefits Scheme (PBS) Safety Net. This Determination applies to approved pharmacists who supply pharmaceutical benefits under the PBS, particularly in the context of the Safety Net, which is designed to reduce the cost of medicines for individuals and families who require a large number of pharmaceutical benefits. The amendment specifically affects the additional amount charged for ready-prepared and extemporaneously-prepared pharmaceutical benefits, increasing these amounts to $1.15 and $1.50 respectively, effective from 1 August 2014. This adjustment ensures that the price charged to patients for pharmaceutical benefits does not exceed the patient co-payment amount. The Determination is applicable nationally, aligning with the overarching objectives of the National Health Act 1953, and requires the agreement of the Pharmacy Guild of Australia, as stipulated in subsection 84C(9) of the Act.

Key Provisions

The main operative sections of the National Health (Subsection 84C(7)) Amendment Determination 2014 (No. 1) primarily revise the additional amounts for ready-prepared and extemporaneously-prepared pharmaceutical benefits. Specifically, Section 84C(7) of the National Health Act 1953 allows the Minister to determine the manner in which the price for pharmaceutical benefits is to be ascertained for the purpose of the Safety Net. The amendment to this section, effective from 1 August 2014, increases the additional amount for ready-prepared pharmaceutical benefits from $1.13 to $1.15, and for extemporaneously-prepared pharmaceutical benefits from $1.48 to $1.50. These adjustments are intended to reflect changes in the costs associated with the preparation and supply of these pharmaceutical benefits. The Act imposes specific obligations on the parties involved, particularly the Minister and the Pharmacy Guild of Australia. The Minister must determine the manner in which pharmaceutical benefit prices are ascertained, ensuring that the additional amounts do not exceed the patient co-payment amount. The Pharmacy Guild of Australia is required to agree in writing to any changes in these additional amounts, as stipulated under Section 84C(9) of the Act. This requirement ensures that the amendments are made with the consent of the relevant professional body, reflecting a collaborative approach to policy adjustments. There are no explicit offences, penalties, or civil/criminal consequences for breach mentioned in the text. However, the legislative framework within which this Determination operates is part of a broader legal structure that includes penalties for non-compliance with the National Health Act 1953 and related regulations. For instance, Section 116 of the Act provides that a person who contravenes a provision of the Act, or any regulation or direction under the Act, is liable to a penalty not exceeding 50 penalty units. This penalty reflects the seriousness with which the law treats non-compliance within the health and pharmaceutical sectors.

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