National Health Act 1953 - Declaration under subsection 85(2AA) (No. PB 11 of 2004)

Overview

The National Health Act 1953, enacted by the Parliament of Australia, was introduced to provide for the administration of national health schemes and the regulation of pharmaceuticals, medical services, and other health-related matters. One of its key provisions is the ability to regulate and control the pharmaceutical benefits scheme, ensuring that only approved drugs and medicinal preparations are available to the public. This legislative instrument, F2007B01102, was developed to address the need to periodically review and amend the list of approved drugs under the Pharmaceutical Benefits Scheme (PBS). The policy objective is to ensure that the PBS remains effective and safe for the public by removing from the scheme any drugs that no longer meet safety, efficacy, or cost-effectiveness criteria. This particular declaration, made under subsection 85(2AA) of the Act, removes certain specified drugs and medicinal preparations from the PBS, effective from 1 August 2004.

Scope and Application

The Pharmaceutical Benefits Declaration under subsection 85(2AA) of the National Health Act 1953 applies to the cessation of Pharmaceutical Benefits Scheme (PBS) listings for specific drugs and medicinal preparations, which are outlined in the Schedule of this legislative instrument. The Act impacts the entities and individuals involved in the supply, prescribing, and dispensing of these medications, ensuring compliance with the updated provisions. This Declaration, which came into effect on 1 August 2004, specifies that the listed drugs and medicinal preparations, including Cisapride Monohydrate, Dexamethasone with Framycetin Sulfate and Gramicidin, and others, will no longer be subject to the benefits outlined in Part VII of the National Health Act 1953. The geographic reach of this legislation is national, as it pertains to the Commonwealth's regulation of pharmaceutical benefits across Australia. Notably, the application of the Act is limited to the cessation of PBS listings for the specified drugs and does not extend to other drugs or medicinal preparations not listed in the Schedule. This legislative instrument operates under the authority of the Minister for Health and Ageing, with the Assistant Secretary of the Pharmaceutical Benefits Branch having obtained advice from the Pharmaceutical Benefits Advisory Committee before making the Declaration.

Key Provisions

The main operative sections of this legislation, specifically subsection 85(2AA) of the National Health Act 1953, permit the Minister for Health and Ageing to declare certain drugs and medicinal preparations as no longer eligible for coverage under Part VII of the Act. This is enacted through a Declaration by the Assistant Secretary, Pharmaceutical Benefits Branch, Department of Health and Ageing, who acts as the Minister's delegate. The Declaration, numbered PB 11 of 2004, specifies the drugs and medicinal preparations that are to cease being covered under the Pharmaceutical Benefits Scheme (PBS), effective from 1 August 2004. The obligations imposed by this Act are primarily on the Assistant Secretary, who must follow due process by obtaining the advice of the Pharmaceutical Benefits Advisory Committee as mandated under subsection 85(2AB) of the Act. This ensures that the decision to delist certain medications is well-informed and based on expert recommendations. The Declaration itself serves as a formal announcement and is effective from the specified commencement date, which is 1 August 2004, as outlined in the second point of the Declaration. Breaching the provisions of this Declaration could lead to various consequences. While specific offences and penalties are not detailed in this legislative instrument, the broader legislative context of the National Health Act 1953 may provide for civil or criminal penalties for non-compliance with pharmaceutical regulations. These could include fines, imprisonment, or other sanctions as deemed appropriate by the relevant authorities. The exact penalties would depend on the nature and severity of the breach, as well as other applicable laws and regulations.