National Health (Subsection 84C(7)) Amendment Determination 2017 (No. 1) (PB 52 of 2017)

Administered by Department of Health, Disability and Ageing

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EXPLANATORY STATEMENT

National Health Act 1953

National Health (Subsection 84C(7)) Amendment Determination 2017 (No. 1)

PB 52 of 2017

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 July 2017.

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 the price is up to a maximum of the patient copayment.

Amendments

A component of the Sixth Community Pharmacy Agreement (Sixth Agreement) is the Safety Net Additional Fee indexed annually by Wage Cost Index 9 (WCI9) on 1 July. The fee for 2015/16 was set as part of the Sixth Agreement negotiations and indexation will begin to be applied from 1 July 2017.

This Determination revises the additional amount, for paragraph 84C(8)(d) of the Act, for ready prepared pharmaceutical benefits from $1.19 to $1.21 and for extemporaneously prepared pharmaceutical benefits from $1.55 to $1.57, with effect from 1 July 2017.

Consultation

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

The Guild 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 July 2017.

This Determination is a legislative instrument for the purposes of the Legislation 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 2017 (No. 1)

PB 52 of 2017

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 the execution of the Sixth Pharmacy Community Agreement.  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 benefits.  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 $1.19 to $1.21 and for extemporaneously prepared pharmaceutical benefits from $1.55 to $1.57, with effect from 1 July 2017.

Human rights implications

This legislative instrument engages Article 2, 7 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR). The legislative instrument assists with the provision favourable conditions of work to ensure remuneration for workers with fair wages. 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 Pharmaceutical Benefits Scheme (PBS) is a benefit scheme which assists with providing subsidised access for people to medicines. This is a positive step towards attaining the highest standard of health for all Australians. Efficient operational arrangements for PBS support effective administration of the scheme.

Conclusion

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

 

 

Julianne Quaine

Assistant Secretary

Pharmaceutical Access Branch

Department of Health

 

Overview

The National Health (Subsection 84C(7)) Amendment Determination 2017 (No. 1) was enacted to amend the National Health (Subsection 84C(7)) Determination 2010, specifically to adjust the additional amounts used in the calculation of the price of pharmaceutical benefits for the purpose of the Pharmaceutical Benefits Scheme (PBS) Safety Net. This legislation was introduced to reflect changes in the Safety Net Recording Fee as part of the Sixth Community Pharmacy Agreement, which was indexed annually by the Wage Cost Index 9 (WCI9). The primary purpose of this amendment is to ensure that the additional fees for ready prepared and extemporaneously prepared pharmaceutical benefits are updated to $1.21 and $1.57, respectively, effective from 1 July 2017. The determination was made under subsection 84C(7) of the National Health Act 1953, and it aligns with the requirement for the Pharmacy Guild of Australia's written agreement, which was duly obtained. The overall aim is to maintain the affordability of medications for individuals and families who utilise the PBS Safety Net.

Scope and Application

The National Health (Subsection 84C(7)) Amendment Determination 2017 (No. 1) 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 benefits under the National Health Act 1953. This amendment reflects the additional amounts for ready prepared pharmaceutical benefits and extemporaneously prepared pharmaceutical benefits, with effect from 1 July 2017. The purpose of these amendments is to give effect to the execution of the Sixth Pharmacy Community Agreement, which includes an indexed annual fee for the Safety Net Additional Fee from 1 July 2017. The additional amount for ready prepared pharmaceutical benefits has been increased from $1.19 to $1.21, and for extemporaneously prepared pharmaceutical benefits, it has been increased from $1.55 to $1.57. This adjustment is made in accordance with subsection 84C(7) of the Act and requires the agreement of the Pharmacy Guild of Australia in writing, as mandated by subsection 84C(9) of the Act. This legislative instrument is compatible with human rights, engaging Article 2, 7, and 12 of the International Covenant on Economic, Social and Cultural Rights by assisting in providing favourable conditions of work and supporting the progressive realisation of the highest attainable standard of health for all Australians.

Key Provisions

The key sections of the National Health (Subsection 84C(7)) Amendment Determination 2017 (No. 1) primarily involve the adjustment of the additional amount used in the calculation of the price of pharmaceutical benefits for the Safety Net under the National Health Act 1953 (the Act). Specifically, section 84C(7) of the Act allows the Minister to determine the manner in which the price for pharmaceutical benefits is ascertained for the purpose of the Safety Net, while subsection 84C(8) provides the criteria that must be met in making such determinations. Section 84C(9) mandates that any additional amount determined by the Minister must have the written agreement of the Pharmacy Guild of Australia. The Amendment Determination modifies these provisions to increase the additional amount for ready prepared pharmaceutical benefits from $1.19 to $1.21 and for extemporaneously prepared pharmaceutical benefits from $1.55 to $1.57, effective from 1 July 2017. The obligations imposed by this Act on the relevant parties include ensuring that the price of pharmaceutical benefits for Safety Net purposes does not exceed the patient co-payment amount. Pharmacists, who are required to supply pharmaceutical benefits and record patient payments for Safety Net purposes, must comply with the new pricing structure set out in the Amendment Determination. The Pharmacy Guild of Australia, having agreed in writing to the revised values, must also ensure its members are informed of and comply with the updated additional amounts. Furthermore, the Minister, who has the authority to determine the price for pharmaceutical benefits, must ensure that any determinations are consistent with the criteria outlined in subsection 84C(8) of the Act. Breach of the provisions under this Amendment Determination may result in civil or criminal consequences. While the specific offences and penalties are not detailed in the explanatory statement, it is implied that non-compliance with the Act's provisions, such as charging prices exceeding the patient co-payment amount or failing to record payments correctly, could lead to penalties. Such penalties might include fines or other sanctions imposed by the relevant authorities to enforce compliance with the Safety Net provisions. The maximum penalties, if applicable, would be determined in accordance with the broader legislative framework governing the National Health Act 1953 and related regulations.

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