COMMONWEALTH OF AUSTRALIA
NATIONAL HEALTH ACT 1953
PHARMACEUTICAL BENEFITS
DECLARATION UNDER SUB-SECTION 85(2AA)
No. PB3 of 1990
I, MARGARET NONA FORD, Principal Advisor, Health Care Access Division, Department of Community Services and Health and Delegate of the Minister of State for Community Services and Health, pursuant to sub-section 85(2AA) of the National Health Act 1953, hereby make the following Declaration:
1. This Declaration shall come into operation on 1 April 1990.
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
Ambenonium Chloride
Lauryl Dimethylamine Oxide with Octoxinol
Mithramycin
Neostigmine Methylsulphate
Papaveretum
Papaveretum with Hyoscine Hydrobromide
Phytomenadione
Dated this sixteenth day of March 1990.
MARGARET FORD
PRINCIPAL ADVISOR
HEALTH CARE ACCESS DIVISION
DEPARTMENT OF COMMUNITY SERVICES AND HEALTH
DELEGATE OF THE MINISTER OF STATE FOR COMMUNITY SERVICES AND HEALTH
Overview
The National Health Act 1953, enacted by the Australian Parliament, addresses various issues related to health services and public health initiatives. A specific legislative instrument, F2007B01042, was introduced to amend the Pharmaceutical Benefits under the Act. This instrument aims to address the gap in the availability of certain medications under the Pharmaceutical Benefits Scheme (PBS) by removing specific drugs and medicinal preparations from the list covered under Part VII of the Act. The policy objective is to ensure that the PBS remains sustainable and focuses on providing benefits for medications that offer the greatest therapeutic benefit to the community. This declaration by Margaret Nona Ford, the Principal Advisor for Health Care Access Division and Delegate of the Minister of State for Community Services and Health, specifies the drugs and medicinal preparations that are to be excluded from the PBS, effective from 1 April 1990.
Scope and Application
The Pharmaceutical Benefits Declaration under sub-section 85(2AA) of the National Health Act 1953 applies to specific drugs and medicinal preparations that are outlined in the Schedule of the Declaration. This legislative instrument specifically identifies substances such as Ambenonium Chloride, Lauryl Dimethylamine Oxide with Octoxinol, Mithramycin, Neostigmine Methylsulphate, Papaveretum, Papaveretum with Hyoscine Hydrobromide, and Phytomenadione, which are to cease being covered by Part VII of the National Health Act 1953. This cessation of coverage is effective from 1 April 1990, the date the Declaration comes into operation. The Act applies to these specified pharmaceutical products within the Commonwealth of Australia, impacting their eligibility for the Pharmaceutical Benefits Scheme (PBS). There are no stated exclusions, exemptions, or thresholds in this particular Declaration. However, the scope and application of the National Health Act 1953 may be extended or restricted through other subordinate instruments or legislative amendments, which would then further define the parameters of the Act's application.
Key Provisions
The key operative sections of the Declaration under sub-section 85(2AA) of the National Health Act 1953, as made by Margaret Nona Ford, Principal Advisor, Health Care Access Division, Department of Community Services and Health, include the commencement date and the specification of drugs and medicinal preparations that will cease to be covered under Part VII of the Act (sub-section 1 and 2). Specifically, the Declaration is set to come into operation on 1 April 1990, and it details that certain drugs and medicinal preparations listed in the Schedule will no longer be subject to the provisions of Part VII of the National Health Act 1953. These drugs include Ambenonium Chloride, Lauryl Dimethylamine Oxide with Octoxinol, Mithramycin, Neostigmine Methylsulphate, Papaveretum, Papaveretum with Hyoscine Hydrobromide, and Phytomenadione.
The obligations and requirements imposed by this Act primarily concern the cessation of certain drugs and medicinal preparations from being covered under Part VII of the National Health Act 1953. This means that from the date of operation of the Declaration, the specified drugs will no longer be eligible for benefits or subsidies under the Pharmaceutical Benefits Scheme (PBS). Consequently, healthcare providers and patients must be aware of this change and adjust their practices and prescriptions accordingly. The Declaration serves as an official notification to the public and stakeholders that these drugs are no longer part of the covered pharmaceutical list, thereby affecting procurement, reimbursement, and patient access to these medications.
There are no specific offences, penalties, or civil/criminal consequences outlined in the Declaration itself. However, non-compliance with the changes enacted by this Declaration could potentially lead to issues such as denied reimbursement claims for the specified drugs, which could result in financial burdens on healthcare providers and patients. Additionally, prescribing or dispensing these drugs without proper understanding of their altered status could lead to administrative or legal consequences if it is found that the practitioners were unaware of the changes mandated by the Act. The primary focus of the Declaration is to ensure transparency and compliance with the new legislative provisions regarding the covered pharmaceutical benefits.