National Health (Subsection 84C(7)) Amendment Determination 2013 (No. 1)

Administered by Department of Health, Disability and Ageing

Legislation au F2013L01408 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

National Health Act 1953

National Health (Subsection 84C(7)) Amendment Determination 2013 (No. 1)

PB 48 of 2013

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 2013.

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 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 2013 (No. 1), PB 48 of 2013, defines the ready-prepared dispensing fee and the extemporaneously-prepared dispensing fee to be $6.63 and $8.67, respectively, from 1 July 2013.

Amendments

This Determination revises the additional amount, for paragraph 84C(8)(d) of the Act, for ready-prepared pharmaceutical benefits from $1.11 to $1.13 and for extemporaneously-prepared pharmaceutical benefits from $1.45 to $1.48, with effect from 1 August 2013.

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 2013.

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 2013 (No. 1)

PB 48 of 2013

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 $1.11 to $1.13 and for extemporaneously-prepared pharmaceutical benefits from $1.45 to $1.48, with effect from 1 August 2013.

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.

 

 

Steve Dunlop

A/g Assistant Secretary

Pharmaceutical Access Branch

Department of Health and Ageing

 

Overview

The National Health (Subsection 84C(7)) Amendment Determination 2013 (No. 1) was enacted to amend the National Health (Subsection 84C(7)) Determination 2010, which provides the methodology for determining the price of pharmaceutical benefits for the purpose of the Safety Net under the National Health Act 1953. The Safety Net is a scheme that reduces the cost of medicines for individuals and families who require a significant number of pharmaceutical benefits. This legislative instrument was introduced to adjust the additional amount used in the calculation of the price of pharmaceutical benefits, ensuring that the patient payment does not exceed the patient co-payment amount. The amendment was made in consultation with the Pharmacy Guild of Australia, which agreed to the revised values in writing. The policy objective of this determination is to maintain favourable conditions of work and ensure remuneration for workers with fair wages, engaging Article 7 of the International Covenant on Economic, Social and Cultural Rights. This determination was enacted by the Australian Government and it reflects the additional amount for ready-prepared and extemporaneously-prepared pharmaceutical benefits, effective from 1 August 2013. The determination revises the additional amount for ready-prepared pharmaceutical benefits from $1.11 to $1.13 and for extemporaneously-prepared pharmaceutical benefits from $1.45 to $1.48. 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 co-payment amount. It is included in full or in part such that the patient payment is not more than the co-payment amount. This legislative instrument is compatible with human rights because it advances the protection of human rights by ensuring fair remuneration for workers.

Scope and Application

The National Health (Subsection 84C(7)) Amendment Determination 2013 (No. 1) amends the National Health (Subsection 84C(7)) Determination 2010, which sets the manner in which prices for pharmaceutical benefits under the Pharmaceutical Benefits Scheme (PBS) are ascertained for the purpose of the Safety Net. The amendment adjusts the additional amounts for ready-prepared and extemporaneously-prepared pharmaceutical benefits, effective from 1 August 2013. These additional amounts, also known as the Safety Net Recording Fee, are part of the price charged to patients for pharmaceutical benefits where the Commonwealth price is less than the patient co-payment amount. The purpose of this adjustment is to reflect the annual indexation of these fees. The determination applies to approved pharmacists supplying pharmaceutical benefits, and it ensures that the patient payment does not exceed the co-payment amount. This legislative instrument is compatible with human rights, as it supports the provision of favourable conditions of work and fair remuneration for workers, in line with Article 7 of the International Covenant on Economic, Social and Cultural Rights.

Key Provisions

The main operative sections of this legislative instrument are subsections 84C(7) and 84C(8)(d) of the National Health Act 1953. Subsection 84C(7) empowers the Minister to determine the manner in which the price for pharmaceutical benefits and repatriation pharmaceutical benefits is ascertained for the purpose of the Safety Net. Subsection 84C(8)(d) provides for the addition of fees or amounts as determined by the Minister, which must be agreed upon in writing by the Pharmacy Guild of Australia. The National Health (Subsection 84C(7)) Amendment Determination 2013 (No. 1) revises the additional amounts for ready-prepared and extemporaneously-prepared pharmaceutical benefits, effective from 1 August 2013. The obligations and requirements imposed by the Act on the parties or entities it governs include the necessity for the Minister to consult with the Pharmacy Guild of Australia before determining any additional fees or amounts. The determination of the additional amount must be in accordance with the requirements set out in subsection 84C(8). The Pharmacy Guild of Australia has agreed, in writing, to the revised values of the additional amounts for both ready-prepared and extemporaneously-prepared pharmaceutical benefits. The Minister is required to ensure that the price of pharmaceutical benefits does not exceed the patient co-payment amount. The Pharmaceutical Benefits Remuneration Tribunal calculates the Commonwealth price, which is used in determining the subsection 84C(7) price. The National Health (Subsection 84C(7)) Amendment Determination 2013 (No. 1) does not explicitly outline specific offences, penalties, or civil/criminal consequences for breaches of the Act. However, it is implied that any non-compliance with the requirements for determining the price of pharmaceutical benefits and the additional amounts could result in legal consequences. The National Health Act 1953 may impose penalties for non-compliance with its provisions, which could include fines or other legal actions. The penalties for breaches of the Act would be determined in accordance with the relevant provisions of the Act and any other applicable laws. The compatibility statement confirms that this legislative instrument is compatible with human rights, ensuring that the provisions do not infringe upon any recognised human rights.

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