National Health Act 1953 – Determination under subsection 99(4) Amendment Determination 2015 (No. 1) (PB 67 of 2015)

Administered by Department of Health, Disability and Ageing

Legislation au F2015L01066 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

National Health Act 1953 – Determination under subsection 99(4) Amendment Determination 2015 (No.1)

PB 67 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 Act 1953 - Determination under subsection 99(4) (the Principal Determination) determines the rates and conditions of payments to public hospitals.  Another determination under subsection 99(4) determines the rates and conditions of payments to private hospitals.

Purpose

This Amendment Determination amends the Principal Determination to reflect the 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 reflect the change to the date that the basic wholesale price for a drug or container is ascertained. The amendments also include a correction of the name of the Department of Health.

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 public hospital authority 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 Act 1953 – Determination under subsection 99(4) Amendment Determination 2015 (No. 1)

 

Section 1 - Name of Determination

This section provides that the name of the determination is the National Health Act 1953 – Determination under subsection 99(4) Amendment Determination 2015 (No. 1) and that it may also be cited as PB 67 of 2015.

Section 2 - Commencement

This section provides that the determination commences on 1 July 2015.

Section 3 - Amendment of National Health Act 1953 – Determination under subsection 99(4)

This section provides that Schedule 1 amends the National Health Act 1953 – Determination under subsection 99(4) which commenced on 1 October 2006.

 

SCHEDULE 1 – AMENDMENTS

Item [1] - Paragraph 3

This item substitutes the definition of ‘the Secretary’ to correctly reflect the change of Department name from the Department of Health and Ageing to the Department of Health.

Item [2] - Paragraph 27

The item removes the date reference of 1 May and replaces it with 15 June as the date for the basic wholesale price of a drug to be ascertained in each year. This change is made to be consistent with current practice and changes made to the Determination made under 98B(1)(a).

Item [3] - Paragraph 29

The item removes the date reference of 1 May and replaces it with 15 June as the date for the basic wholesale price of a drug to be ascertained in each year. This change is made to be consistent with current practice and changes made to the Determination made under 98B(1)(a).

Statement of Compatibility with Human Rights

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

National Health Act 1953 – Determination under subsection 99(4) Amendment Determination 2015 (No. 1)

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

The changes include amending the reference to the name of the Department in the Definition section and also amend and date references to ensure consistency with current practice and other changes to the Determination made under paragraph 98B(1)(a) which take effect on 1 July 2015.

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

 

 

 

Overview

The National Health Act 1953 – Determination under subsection 99(4) Amendment Determination 2015 (No. 1) was enacted to amend the rates and conditions of payments to public hospitals for the supply of pharmaceutical benefits, aligning with changes made by the Pharmaceutical Benefits Remuneration Tribunal effective from 1 July 2015. This determination, issued by the Commonwealth under subsection 99(4) of the Act, responds to the need for updating the Pharmaceutical Benefits Scheme (PBS) to ensure accurate and consistent application of payment rates. The objective is to reflect the new determination made under paragraph 98B(1)(a) of the Act and correct administrative details such as the name of the Department of Health. This amendment was deemed necessary as a result of the Sixth Community Pharmacy Agreement between the Pharmacy Guild of Australia and the Commonwealth, and no consultation was required as these changes were consequential. The legislative instrument 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 and timely access to affordable medicines through the PBS. This determination ensures that the provisions of the National Health Act 1953 continue to support the healthcare needs of Australians, reflecting updated practices and maintaining the integrity of the PBS.

Scope and Application

The National Health Act 1953 – Determination under subsection 99(4) Amendment Determination 2015 (No. 1) applies to approved hospital authorities, both public and private, that supply pharmaceutical benefits to patients receiving treatment. This legislative instrument amends the Principal Determination to reflect changes made by the Pharmaceutical Benefits Remuneration Tribunal, effective from 1 July 2015. The amendments include updating the date for ascertaining the basic wholesale price of drugs and correcting the name of the relevant Department of Health. The Amendment Determination has a national reach, as it pertains to the Pharmaceutical Benefits Scheme (PBS), which is administered by the Commonwealth to ensure affordable access to a range of medicines for all Australians. There are no stated exclusions, exemptions, or thresholds in this Determination, and its application is not extended or restricted through subordinate instruments. This legislative instrument 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 access to affordable medicines through the PBS.

Key Provisions

The primary sections of the National Health Act 1953 – Determination under subsection 99(4) Amendment Determination 2015 (No. 1) are outlined in the attached Schedule 1. Section 3 of the Amendment Determination specifies the changes to the Principal Determination under subsection 99(4), which was originally established to determine the rates and conditions of payment to public hospitals for the supply of pharmaceutical benefits (section 99(4)). The amendments primarily involve updates to the definitions and the dates for ascertaining the basic wholesale price of drugs, reflecting changes in practice and decisions by the Pharmaceutical Benefits Remuneration Tribunal (item [1], [2] and [3]). These amendments are intended to align with the new Determination under paragraph 98B(1)(a) of the Act, which takes effect from 1 July 2015. The obligations imposed by the Act on public hospital authorities are primarily financial. They are entitled to receive payments from the Commonwealth for the supply of pharmaceutical benefits to patients, as outlined in section 99(4). The Amendment Determination refines the terms of these payments, ensuring that public hospitals receive appropriate compensation for their services in supplying pharmaceuticals. The changes in the Amendment Determination, such as the updated dates for ascertaining the basic wholesale price of drugs, ensure that these payments are calculated accurately and consistently with other relevant practices (items [2] and [3]). In terms of consequences for non-compliance, the Amendment Determination itself does not explicitly outline specific offences, penalties, or civil/criminal consequences for breaches. However, the National Health Act 1953 generally provides for enforcement mechanisms, including potential penalties for non-compliance with regulations and provisions governing the supply of pharmaceutical benefits. The Pharmaceutical Benefits Scheme (PBS) ensures that any breaches could result in financial penalties or other legal consequences as stipulated by the overarching legislation. The precise penalties would be determined based on the nature and severity of the breach, in accordance with the broader legislative framework under which the Act operates.

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