National Health Act 1953 - Declaration under subsection 85(2AA) (No. PB 11 of 1994)

Overview

The National Health Act 1953 was enacted by the Australian Parliament to provide a framework for the provision of health services, including the administration of the Pharmaceutical Benefits Scheme (PBS). This legislative instrument, titled "PHARMACEUTICAL BENEFITS DECLARATION UNDER SUBSECTION 85 (2AA)", was introduced to address the need for the Minister for Human Services and Health to remove certain drugs and medicinal preparations from the list of items covered under the PBS. The policy objective is to ensure that the PBS remains effective and sustainable by excluding medications that are either outdated, have safer alternatives, or do not meet the required efficacy standards. This particular declaration, made by David Trevor Graham on behalf of the Minister, removes several specified drugs from the PBS, effective from 1 August 1994. The enacting body is the Assistant Secretary of the Pharmaceutical Benefits Branch, Department of Human Services and Health, acting as the delegate of the Minister for Human Services and Health.

Scope and Application

The Pharmaceutical Benefits Declaration under subsection 85 (2AA) of the National Health Act 1953 applies to the cessation of certain drugs and medicinal preparations from the scope of Part VII of the Act. This legislative instrument specifies that particular medications, such as Colistin Sulfate with Neomycin Sulfate, Ferrous Aminoacetosulfate, Quinethazone, Perhexiline Maleate, and Somatrem, will no longer be subject to the provisions of the Pharmaceutical Benefits Scheme. This change came into effect on 1 August 1994. The declaration is made by the Assistant Secretary of the Pharmaceutical Benefits Branch, Department of Human Services and Health, who acts as the Delegate of the Minister for Human Services and Health, following advice from the Pharmaceutical Benefits Advisory Committee. The geographical reach of this Act is national, impacting all individuals and entities within Australia who are covered under the Pharmaceutical Benefits Scheme. The exclusion of these specific drugs from the scheme aims to refine the scope of the benefits provided under the National Health Act 1953, thereby affecting pharmaceutical entities, healthcare providers, and patients who rely on these medications.

Key Provisions

The main operative sections of this legislative instrument (subsection 85(2AA) and subsection 85(2AB) of the National Health Act 1953) require the Assistant Secretary, Pharmaceutical Benefits Branch, Department of Human Services and Health, to make a declaration regarding the cessation of certain drugs and medicinal preparations from being subject to Part VII of the National Health Act 1953. This declaration is made following consultation with the Pharmaceutical Benefits Advisory Committee. Section 1 specifies the commencement date of the declaration as 1 August 1994, while section 2 lists the specific drugs and medicinal preparations that will cease to be subject to the provisions of Part VII of the Act (subsection 85(2AA)). The listed drugs include Colistin Sulfate with Neomycin Sulfate, Ferrous Aminoacetosulfate, Quinethazone, Perhexiline Maleate, and Somatrem. The Act imposes certain obligations and requirements on the parties or entities it governs. The Assistant Secretary, Pharmaceutical Benefits Branch, must seek advice from the Pharmaceutical Benefits Advisory Committee before making any declaration under the Act. This ensures that the decision is informed and based on expert recommendations. Additionally, the declaration must specify the drugs and medicinal preparations that will be removed from the scope of Part VII of the Act, as outlined in the Schedule. The obligation to consult with the advisory committee and the requirement to detail the affected drugs in the Schedule are central to the process governed by the Act. There are no explicit offences, penalties, or civil/criminal consequences stated in this particular legislative instrument for breaches of the declaration or its provisions. The focus of this instrument is administrative and declarative, aiming to update the list of drugs and medicinal preparations subject to the National Health Act 1953. However, it is important to note that any failure to comply with the requirements of the Act or the advice of the Pharmaceutical Benefits Advisory Committee could potentially lead to legal challenges or administrative reviews. While this instrument itself does not prescribe specific penalties, the broader legal framework may impose consequences for non-compliance.