COMMONWEALTH OF AUSTRALIA
NATIONAL HEALTH ACT 1953
PHARMACEUTICAL BENEFITS
DECLARATION UNDER SUB-SECTION 85(2AA)
No. PB5 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 August 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
Ampicillin Trihydrate with Purified Water B.P.
Chloral Hydrate
Chlorpromazine
Clopamide
Diloxanide Furoate
Fenoterol Hydrobromide
Lindane
“Locasol New Formula”
Primaquine Phosphate
Sulphafurazole
Testosterone Propionate
Tetracycline Hydrochloride with a buffering agent and Nystatin
Tetracycline Hydrochloride with Nystatin
Thiopropazate Hydrochloride
Dated this twenty-fifth day of July 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, was established to provide a framework for the administration of health services and benefits across the nation. This legislation aimed to address the gaps in health care access and affordability for Australian citizens. One significant aspect of the Act is the Pharmaceutical Benefits Scheme (PBS), which ensures that essential medications are accessible and affordable. The legislative instrument F2007B01057, titled "Pharmaceutical Benefits Declaration Under Sub-Section 85(2AA)", was introduced to amend the list of drugs and medicinal preparations covered under the PBS. This amendment was necessary to ensure that the scheme remains relevant and effective in meeting the changing health needs of the population. The policy objective of this instrument is to refine the scope of pharmaceutical benefits by excluding certain drugs from the PBS, thereby allowing for a more targeted and efficient allocation of resources towards medications that provide the greatest health benefit.
Scope and Application
The Pharmaceutical Benefits Declaration under sub-section 85(2AA) of the National Health Act 1953 specifies the cessation of coverage for certain drugs and medicinal preparations listed in the Schedule from the Pharmaceutical Benefits Scheme, effective from 1 August 1990. This legislative instrument applies to the drugs and medicinal preparations mentioned in the Schedule, which include Ampicillin Trihydrate with Purified Water B.P., Chloral Hydrate, Chlorpromazine, and others. This Act is a Commonwealth legislation, therefore it applies across the entire nation, impacting individuals and entities involved in the distribution, prescription, or procurement of these pharmaceutical products. The declaration effectively removes these specific items from the scope of Part VII of the National Health Act 1953, which governs the Pharmaceutical Benefits Scheme. While the Act itself is quite specific, the application and interpretation may be further refined or extended through subordinate instruments issued under the authority of the Act.
Key Provisions
This Declaration, effective from 1 August 1990, removes certain drugs and medicinal preparations from the scope of Part VII of the National Health Act 1953, which pertains to the Pharmaceutical Benefits Scheme (PBS). The drugs and preparations listed in the Schedule to this Declaration will no longer be covered under the PBS (Section 1 and 2). The Schedule includes specific drugs such as Ampicillin Trihydrate with Purified Water B.P., Chloral Hydrate, Chlorpromazine, and others, totalling fourteen items, that will no longer be subject to the provisions of the PBS (Schedule).
The primary obligation imposed by this Declaration is the removal of the listed drugs and medicinal preparations from the PBS, effectively ceasing their status as subsidised medications under the National Health Act 1953. This means that from the effective date, these drugs will no longer be eligible for the benefits provided by the PBS, such as reduced costs for patients or the Commonwealth government (Section 2). It is essential for healthcare providers, pharmacists, and patients to be aware of this change to avoid any misunderstandings regarding the coverage of these medications.
There are no explicit offences, penalties, or civil/criminal consequences stated in this Declaration for failing to comply with its provisions. However, non-compliance could potentially lead to legal and financial repercussions if patients or healthcare providers inadvertently rely on the continued PBS coverage of the drugs listed in the Schedule, leading to disputes or claims for reimbursement that are no longer valid under the Act. The primary consequence would be the financial burden on patients who might have to pay the full cost of these medications without any PBS subsidy (Section 2).