National Health Act 1953 - Declaration under subsection 85(2AA) (No. PB 1 of 2004)

Administered by Department of Health, Disability and Ageing

Legislation au F2007B01029 Not in force Legislative Instrument

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COMMONWEALTH OF AUSTRALIA

National Health Act 1953

PHARMACEUTICAL BENEFITS

DECLARATION UNDER SUBSECTION 85(2AA)

No. PB 1 of 2004

 

 

I, JOAN CORBETT, Assistant Secretary, Pharmaceutical Benefits Branch, Department of Health and Ageing and Delegate of the Minister for Health and Ageing, having in accordance with subsection 85(2AB) of the National Health Act 1953 obtained the advice of the Pharmaceutical Benefits Advisory Committee, pursuant to subsection 85(2AA) of the National Health Act 1953 hereby make the following Declaration:

 

1. This Declaration commences on 1 February 2004.

 

2. The drugs and medicinal preparations specified in the Schedule to this Declaration shall cease to be drugs and medicinal preparations to which Part VII of the National Health Act 1953 applies.

 

THE SCHEDULE

 

Benzydamine Hydrochloride with Chlorhexidine Gluconate

Menotrophin standardised using Chorionic Gonadotrophin

 

 

Dated this fourteenth day of January 2004.

 

 

 

 

JOAN CORBETT

Assistant Secretary

Pharmaceutical Benefits Branch

Department of Health and Ageing

Delegate of the Minister for Health and Ageing

 

Overview

The National Health Act 1953 was enacted to provide a framework for the administration of health services and the provision of benefits under the Medicare scheme in Australia. This legislation was introduced to address the need for a coordinated national approach to health services and pharmaceutical benefits. The Act was enacted by the Parliament of Australia, aiming to ensure that Australians have access to necessary health services and medications in a structured and equitable manner. The policy objective behind the Act is to establish a universal health care system that provides accessible and affordable health care to all Australians. The Pharmaceutical Benefits Declaration under subsection 85(2AA) of the Act, issued in 2004, serves to update the list of pharmaceutical benefits by removing certain drugs and medicinal preparations from the scope of Part VII of the Act, thereby ensuring that the benefits provided are both relevant and effective.

Scope and Application

The Pharmaceutical Benefits Declaration under Subsection 85(2AA) of the National Health Act 1953 applies to specific drugs and medicinal preparations listed in the Schedule, effectively removing their eligibility for benefits under Part VII of the Act. This legislative instrument is issued by the Assistant Secretary, Pharmaceutical Benefits Branch, Department of Health and Ageing, acting as the delegate of the Minister for Health and Ageing, following consultation with the Pharmaceutical Benefits Advisory Committee. The Declaration specifies that the listed drugs, including Benzydamine Hydrochloride with Chlorhexidine Gluconate and Menotrophin standardised using Chorionic Gonadotrophin, will no longer be covered by the Pharmaceutical Benefits Scheme as of the commencement date of 1 February 2004. The scope of this Act is confined to the Commonwealth of Australia and directly affects entities and individuals involved in the provision and receipt of these pharmaceutical benefits. The Declaration does not apply to any other drugs or medicinal preparations not listed in the Schedule. Any further application or restriction of the Act may be made through subordinate instruments, but this Declaration itself does not extend beyond its stated terms.

Key Provisions

The key operative sections of this legislative instrument, No. PB 1 of 2004, are sections 1 and 2. Section 1 states that this declaration commences on 1 February 2004, which means that the provisions outlined in the declaration will take effect from that date. Section 2 specifies that the drugs and medicinal preparations listed in the schedule to this declaration will cease to be subject to Part VII of the National Health Act 1953, which governs the pharmaceutical benefits scheme. The listed drugs are Benzydamine Hydrochloride with Chlorhexidine Gluconate and Menotrophin standardised using Chorionic Gonadotrophin. This effectively removes these medications from the Pharmaceutical Benefits Scheme (PBS), meaning they will no longer be subsidized by the government for patients. The obligations and requirements imposed by this Act on the relevant parties primarily involve compliance with the declaration. For the Department of Health and Ageing, as represented by Joan Corbett, it entails making the declaration in accordance with the advice from the Pharmaceutical Benefits Advisory Committee, as required by subsection 85(2AB) of the National Health Act 1953. For the public, it means that from the commencement date of the declaration, the specified drugs will no longer be eligible for government subsidies under the PBS. Health practitioners and patients need to be aware of this change and adjust their practices and prescriptions accordingly. The Act does not explicitly detail offences or penalties for breaches within its text, but general compliance with the National Health Act 1953 would apply. If there were any unauthorised use or provision of the listed drugs under the PBS after the declaration's effective date, this could potentially be subject to penalties under the broader provisions of the National Health Act 1953. For example, any attempt to obtain or provide these drugs under the PBS could be viewed as contravening the Act, leading to civil or criminal penalties as determined by relevant authorities. However, specific penalties would depend on the broader context and any subsequent legal proceedings.

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Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.