National Health Act 1953 - Declaration under subsection 85(2AA) (No. PB 7 of 1989)

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COMMONWEALTH OF AUSTRALIA

NATIONAL HEALTH ACT 1953

PHARMACEUTICAL BENEFITS

DECLARATION UNDER SUB-SECTION 85(2AA)

 

No. PB7 of 1989

 

 

I, IAN JAMES McNEIL, First Assistant Secretary, Health Benefits Division, Department of Community Services and Health and Delegate of the Minister of State for Community Services and Health, pursuant to sub-section 85(2AA) of the National Health Act 1953, hereby make the following Declaration:

 

 

1. This Declaration shall come into operation on 1 August 1989.

 

2. The drugs and medicinal preparations contained 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

 

Ethyloestrenol

Morphine Sulphate with Tacrine Hydrochloride

Staphylococcus Toxoid

 

 

Dated this 20th day of July 1989.

 

 

 

 

IAN McNEIL

FIRST ASSISTANT SECRETARY

HEALTH BENEFITS DIVISION

DELEGATE OF THE MINISTER OF STATE FOR COMMUNITY SERVICES AND HEALTH

 

Overview

The National Health Act 1953 was enacted to provide a framework for the administration of health services and the provision of health benefits in Australia. This legislation was introduced to address the need for a cohesive and structured approach to healthcare funding and delivery. The problem or gap that the Act aimed to address was the lack of a unified system for the administration of health services and the need for a national scheme to provide access to essential health benefits. The Act was enacted by the Commonwealth Parliament and its policy objective is to ensure that all Australians have access to necessary health services and benefits. This legislative instrument, a declaration under subsection 85(2AA) of the National Health Act 1953, specifically pertains to the removal of certain drugs and medicinal preparations from the scope of Part VII of the Act, which deals with the Pharmaceutical Benefits Scheme. The declaration, made by Ian James McNeil on behalf of the Minister, specifies the cessation of coverage for these particular drugs and medicinal preparations, effective from 1 August 1989.

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 of the Declaration, removing them from the coverage provided by Part VII of the National Health Act. This legislative instrument affects entities and individuals involved in the provision and supply of these pharmaceutical products by excluding them from the Pharmaceutical Benefits Scheme (PBS). The Declaration, which came into effect on 1 August 1989, has a national jurisdictional reach, impacting the entire Commonwealth of Australia. The exclusion of certain drugs, such as Ethyloestrenol, Morphine Sulphate with Tacrine Hydrochloride, and Staphylococcus Toxoid, from the PBS means that they will no longer be eligible for the subsidies and benefits provided under the scheme. This exclusion is specific to the items listed in the Schedule and does not extend to other pharmaceutical products not mentioned. The application and effect of this Declaration can be further detailed or modified through subordinate instruments, which may provide additional specifications or exceptions as needed.

Key Provisions

The National Health Act 1953, under its section 85(2AA), allows for the declaration that certain drugs and medicinal preparations will no longer be subject to the provisions of Part VII, which deals with the Pharmaceutical Benefits Scheme (PBS). This particular declaration, numbered PB7 of 1989, specifies that as of 1 August 1989, the drugs listed in the Schedule will cease to be covered by the PBS (subsections 1 and 2). The drugs mentioned in the Schedule are Ethyloestrenol, Morphine Sulphate with Tacrine Hydrochloride, and Staphylococcus Toxoid. The declaration imposes a clear requirement on the entities and parties governed by the Act. Specifically, it mandates that the listed drugs will no longer be eligible for reimbursement under the PBS. This means that from the effective date, any prescriptions for these drugs will not be covered by the scheme, and patients will be responsible for the full cost of these medications. Healthcare providers, pharmacies, and patients must be aware of this change to avoid any financial surprises or misunderstandings regarding the coverage of these drugs. Failure to comply with the provisions of the National Health Act 1953, including the provisions set out in this declaration, can result in significant consequences. Although the declaration itself does not explicitly outline penalties for non-compliance, breaches of the Act generally can lead to both civil and criminal liabilities. For example, knowingly supplying a drug that should be covered by the PBS but is listed in such a declaration could lead to fines or other penalties under the relevant sections of the Act. The maximum penalties for such offences can be severe, reflecting the importance of adhering to the legislative requirements.

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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.