COMMONWEALTH OF AUSTRALIA
National Health Act 1953
PHARMACEUTICAL BENEFITS
DECLARATION UNDER SUBSECTION 85 (2AA)
No. PB 3 of 1992
I, ALAN WILLIAM STEVENS, Acting Principal Advisor, Health Care Access Division, Department of Health, Housing and Community Services and Delegate of the Minister of State for Health, Housing and Community Services, having in accordance with subsection 85 (2AB) of the National Health Act 1953 obtained the advice of the Pharmaceutical Benefits Advisory Committee, pursuant to subsection 85 (2AA) of the National Health Act 1953, hereby make the following Declaration:
1. This Declaration shall come into operation on 1 April 1992.
2. The drugs and medicinal preparations specified 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
Aluminium Hydroxide and Magnesium Carbonate Co-dried Gel
Chloramphenicol Palmitate
Lypressin
Methyltestosterone
Quinidine Sulphate
Semisodium Valproate
Thiethylperazine Maleate
Tolazamide
Coal Tar, Prepared B.P. 1973
Raspberry Syrup B.P.
Sulphurated Potash B.P.C. 1973
Dated this twelfth day of March 1992.
A. STEVENS
Acting Principal Advisor
Health Care Access Division
Department of Health, Housing and Community Services
Delegate of the Minister of State for Health, Housing and Community Services
Overview
The National Health Act 1953 was enacted to establish a framework for the provision of health services in Australia and to facilitate the administration of the Pharmaceutical Benefits Scheme (PBS). This Act was introduced to address the need for a coordinated and accessible system of healthcare services and subsidies for pharmaceuticals, aiming to make essential medicines affordable and accessible to the public. The Commonwealth Parliament enacted this legislation, with the overarching policy objective of ensuring that the Australian population has equitable access to necessary health services and medications. This legislative instrument, specifically the Pharmaceutical Benefits Declaration under subsection 85 (2AA) made by Alan William Stevens on 12 March 1992, serves to update the list of pharmaceutical benefits by removing certain drugs and medicinal preparations from the scope of Part VII of the Act, thereby refining the list of subsidised medications available under the PBS.
Scope and Application
The National Health Act 1953 applies to the regulation of pharmaceutical benefits in Australia, with its scope extending to drugs and medicinal preparations listed in the Schedule to the Act. This specific legislative instrument, Declaration under Subsection 85(2AA), pertains to the cessation of certain drugs and medicinal preparations from being covered under Part VII of the National Health Act 1953, effective from 1 April 1992. The listed drugs, such as Aluminium Hydroxide and Magnesium Carbonate Co-dried Gel and Chloramphenicol Palmitate, are removed from the pharmaceutical benefits scheme. The Act applies nationally across the Commonwealth of Australia, affecting entities and individuals who rely on the Pharmaceutical Benefits Scheme for drug subsidies. There are no stated exclusions or exemptions within this instrument, and the scope of the Act may be further extended or restricted through subordinate instruments, as per the provisions of the National Health Act 1953.
Key Provisions
The National Health Act 1953, under subsection 85(2AA), allows for a declaration to be made by the Acting Principal Advisor of the Health Care Access Division, in this case Alan William Stevens, to modify the list of drugs and medicinal preparations that are subject to the Pharmaceutical Benefits scheme. This particular declaration (sections 1 and 2) specifies that certain drugs and preparations listed in the Schedule will no longer be covered under Part VII of the National Health Act 1953, effective from 1 April 1992. The listed items include Aluminium Hydroxide and Magnesium Carbonate Co-dried Gel, Chloramphenicol Palmitate, and several others, as detailed in the Schedule.
The obligations imposed by this declaration on the relevant parties are primarily to cease the coverage and benefits for the specified drugs and preparations under the Pharmaceutical Benefits scheme. This means that from the date of operation, these drugs will no longer be subject to the benefits provided under the scheme, which could include reduced costs for consumers or exclusion from the list of reimbursable medications by health practitioners. The declaration is binding and must be adhered to by all entities governed by the National Health Act 1953.
In terms of consequences for non-compliance, while the legislation does not explicitly state offences or penalties for breaching this specific declaration, general contraventions of the National Health Act 1953 can result in significant penalties. For instance, under section 125 of the Act, any person who contravenes a provision of the Act can be subject to a penalty of up to $22,200 for individuals and $111,000 for bodies corporate, depending on the severity and intent of the breach. These penalties underscore the importance of compliance with the declared changes to the Pharmaceutical Benefits scheme.