National Health Act 1953 - Declaration under subsection 85(2AA) (No. PB 15 of 1998)

Overview

The National Health Act 1953 was enacted by the Parliament of Australia to provide a legislative framework for the administration of national health services, including the regulation of pharmaceutical benefits. This Act was introduced to address the need for a structured approach to the provision of health services and the regulation of pharmaceuticals in Australia. The Pharmaceutical Benefits Declaration under subsection 85(2AA) of the Act, made by David Trevor Graham, Assistant Secretary of the Pharmaceutical Benefits Branch and Delegate of the Minister for Health and Family Services, specifies certain drugs and medicinal preparations that are to cease being covered under Part VII of the Act. This legislative instrument, numbered PB 15 of 1998, came into operation on 1 August 1998 and includes the removal of specific drugs from the list of those eligible for pharmaceutical benefits. The policy objective underpinning this declaration is to refine the scope of pharmaceutical benefits provided under the National Health Act.

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, which cease to be subject to Part VII of the National Health Act. This Act governs the Pharmaceutical Benefits Scheme (PBS), which is a Commonwealth initiative aimed at making prescription medications more affordable for Australians. The Declaration issued by David Trevor Graham, the Assistant Secretary of the Pharmaceutical Benefits Branch, Department of Health and Family Services, and Delegate of the Minister for Health and Family Services, specifically removes certain drugs and preparations from the scope of the PBS. The changes outlined in the Declaration apply nationally, impacting the availability and subsidies for listed drugs across Australia. The exclusion of these drugs from the PBS means they will no longer be subject to the provisions regulating drug costs, availability, and eligibility for subsidies under the scheme. The legislative instrument operates under the authority granted by the National Health Act 1953, which is a Commonwealth Act, thereby extending its jurisdictional reach across all states and territories within Australia.

Key Provisions

The National Health Act 1953, specifically under subsection 85(2AA), allows for a declaration to be made by the Assistant Secretary of the Pharmaceutical Benefits Branch, who is acting as the Delegate of the Minister for Health and Family Services. This declaration (paragraph 1) takes effect from 1 August 1998 and removes certain drugs and medicinal preparations from the scope of Part VII of the Act. These drugs include Calcitonin (Pork), Choline Theophyllinate, Ethynodiol Diacetate with Ethinyloestradiol, Losartan Potassium, and Methenolone Acetate, all of which are listed in the attached Schedule to this declaration (paragraph 2). The obligations imposed by this Act primarily concern the process through which such a declaration is made. The Assistant Secretary must follow a defined procedure, which includes obtaining advice from the Pharmaceutical Benefits Advisory Committee as required by subsection 85(2AB) of the National Health Act 1953 (paragraph 1). This ensures that the decision to remove these drugs from the Pharmaceutical Benefits Scheme is informed and considered. Regarding consequences and penalties, the Act does not explicitly state any criminal or civil penalties for breaches within the context of this declaration. However, it is important to note that any non-compliance with the legislative process outlined in the Act could potentially lead to administrative or legal repercussions. While the Act itself does not specify maximum penalties, breaches of similar provisions in other sections of the National Health Act 1953 could result in substantial fines or other legal consequences depending on the severity and intent behind the breach. It is also worth considering that any decision to remove drugs from the Pharmaceutical Benefits Scheme without proper authority or process could lead to broader administrative actions or reviews.