National Health Act 1953 - Declaration under subsection 85(2AA) (No. PB 14 of 1995)

Overview

The National Health Act 1953 was enacted to provide for the promotion of health, the prevention, treatment and control of disease, and the provision of medical and related services. The Pharmaceutical Benefits Declaration under subsection 85(2AA) was introduced to address the need for regulating the inclusion and exclusion of certain drugs and medicinal preparations from the list of items covered under the Pharmaceutical Benefits Scheme (PBS). This legislative instrument was issued by David Trevor Graham, Assistant Secretary of the Pharmaceutical Benefits Branch, Department of Human Services and Health, and Delegate of the Minister for Human Services and Health, following advice from the Pharmaceutical Benefits Advisory Committee. The policy objective of this declaration was to ensure that only those drugs and preparations that meet the required standards and criteria are included in the PBS, thereby maintaining the scheme's integrity and ensuring its sustainability. This declaration specifically excludes the listed drugs and preparations from the coverage under Part VII of the National Health Act 1953, effective from 1 November 1995.

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 being covered under Part VII of the Act. Specifically, the Declaration, issued by David Trevor Graham, Assistant Secretary of the Pharmaceutical Benefits Branch, Department of Human Services and Health, removes the specified substances from the list of pharmaceutical benefits covered under the Act. This applies to a range of medicinal preparations including "Albumaid XPXT", Chlorhexidine Gluconate, Clioquinol, Colistin Sulfomethate Sodium, Hydrocortisone with Cinchocaine Hydrochloride, Sodium Citro-Tartrate, Surgical Cement, Surgical Cement Solvent, and Urea. The geographic reach of this Act is national, extending throughout the Commonwealth of Australia, and its application is inclusive of all persons and entities that may have an interest in or reliance upon the pharmaceutical benefits outlined in the Act. There are no stated exclusions, exemptions, or thresholds within this Declaration, and its effect is solely limited to the cessation of the listed drugs and medicinal preparations from the scope of Part VII of the National Health Act 1953. This Declaration came into operation on 1 November 1995.

Key Provisions

The key provisions of this legislative instrument, declared under the National Health Act 1953, involve the cessation of certain drugs and medicinal preparations from being subject to Part VII of the Act. Specifically, section 1 of the Declaration states that it comes into operation on 1 November 1995. Section 2 then lists the drugs and medicinal preparations, such as "Albumaid XPXT," "Chlorhexidine Gluconate," and others, that will no longer be subject to Part VII of the Act as of this date. This effectively removes these items from the Pharmaceutical Benefits Scheme, meaning they will no longer be subsidised under the Act. The obligations imposed by this Declaration are primarily on the Pharmaceutical Benefits Advisory Committee, which is tasked with providing advice to the Assistant Secretary, Pharmaceutical Benefits Branch, Department of Human Services and Health. This advice is critical in determining which drugs and preparations should be removed from the scheme. The Assistant Secretary, as the Delegate of the Minister for Human Services and Health, must then make the Declaration based on this advice, ensuring that the specified drugs and preparations are no longer subject to the Act's provisions. There are no explicit offences or penalties outlined in this Declaration for breaching its provisions. However, any failure to comply with the terms of the Declaration could potentially lead to legal consequences under the broader National Health Act 1953. For example, if a party were to continue to claim benefits for the listed drugs after they were removed from the Pharmaceutical Benefits Scheme, they could face penalties under the Act, which may include fines or other civil consequences. The exact penalties would depend on the specific breach and the provisions of the National Health Act 1953 that are contravened.