National Health Regulations (Amendment)

Administered by Department of Health, Disability and Ageing

Legislation au F1996B03236 Regulations Not in force Legislative Instrument

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EXPLANATORY STATEMENT

STATUTORY RULES 1987 NO 76

ISSUED BY AUTHORITY OF THE MINISTER FOR HEALTH

NATIONAL ACT 1953

NATIONAL HEALTH REGULATIONS (AMENDMENT)

Section 140 of the National Health Act 1953 (“the Act”) provides that the Governor-General may make regulations, not inconsistent with the Act, prescribing all matters which by the Act are required or permitted to be prescribed, or which are necessary or convenient to be prescribed for carrying out or giving effect to the Act.

Paragraph 9A(1)(a) of the Act provides that the Minister may, on behalf of the Commonwealth, arrange for the supply by the Commonwealth of such medical or surgical aids, equipment and appliances as are prescribed to persons who require them. Regulation 27 of the National Health Regulations prescribes for purposes of paragraph 9A(1)(a) the medical or surgical aids, equipment and appliances that are specified in Schedule 1 to those Regulations.


It is intended that the Australian Diabetes Foundation be given a grant to act as agent for the Minister to supply persons suffering from diabetes with insulin syringes and needles, and testing materials for diabetes. The Regulations provide authority for this by including the following additional items in Schedule 1 to the National Health Regulations:

15 Insulin syringes and needles

16 Equipment used for testing and monitoring the diabetic condition.

The Regulations came into operation on the date of their notification in the Gazette.

Overview

The National Health Regulations (Amendment) Statutory Rules 1987 No. 76, issued under the authority of the Minister for Health, amends the National Health Regulations to address a specific need in the healthcare provision for Australians suffering from diabetes. Enacted under the National Health Act 1953, the primary legislative framework governing health matters in Australia, this amendment was introduced to enhance the accessibility of essential medical supplies for diabetic patients. The policy objective is to facilitate the provision of insulin syringes and needles, as well as equipment used for testing and monitoring diabetes, through grants to the Australian Diabetes Foundation, which will act as an agent for the Minister. This initiative aims to ensure that individuals with diabetes have reliable access to necessary medical aids and equipment, thereby improving their health outcomes and quality of life.

Scope and Application

The National Health Regulations (Amendment) Statutory Rules 1987 No. 76, issued under the authority of the Minister for Health, serve to amend the National Health Regulations and thereby extend the scope of the National Health Act 1953. The Act, applicable across the Commonwealth of Australia, empowers the Minister to arrange for the supply of specified medical and surgical aids, equipment, and appliances to individuals in need, as stipulated in section 140 and paragraph 9A(1)(a). The recent amendment introduces insulin syringes and needles, along with equipment used for testing and monitoring diabetes, into the regulated list of supplies, enhancing support for persons suffering from diabetes. These regulations, which came into effect on the date of their notification in the Gazette, are designed to facilitate the Australian Diabetes Foundation acting as an agent for the Minister to distribute these essential items. This amendment does not alter the jurisdictional reach or the substantive exclusions or thresholds outlined in the existing legislation but rather refines the application to include specific diabetes-related medical supplies.

Key Provisions

The main operative sections of the National Health Regulations (Amendment) (Statutory Rules 1996 No. 3236) focus on the expansion of the list of medical and surgical aids, equipment, and appliances prescribed under the National Health Act 1953. Specifically, section 140 of the Act empowers the Governor-General to make regulations regarding the matters required or permitted by the Act. Regulation 27, as amended, now includes insulin syringes and needles (item 15) and equipment used for testing and monitoring the diabetic condition (item 16) in Schedule 1. These additions allow for the Australian Diabetes Foundation to be appointed as an agent to supply these items to individuals suffering from diabetes on behalf of the Commonwealth. The Act imposes certain obligations on the parties involved. The Minister for Health, under section 9A(1)(a), must ensure that the prescribed medical and surgical aids, equipment, and appliances are supplied to those in need. The Australian Diabetes Foundation, as the appointed agent, must comply with all regulations and ensure the timely and efficient distribution of insulin syringes and needles, and diabetes testing materials. The individuals receiving these supplies are expected to use them for their intended medical purposes as prescribed. Failure to comply with the regulations can result in civil or criminal penalties. Under the National Health Act 1953, breaches may lead to fines, imprisonment, or both, depending on the severity of the offence. For instance, supplying or distributing items without proper authorisation could result in a fine of up to $22,200 for individuals or $111,000 for corporations, along with potential imprisonment for up to two years. Additionally, the Minister may take enforcement actions against any party that fails to meet their obligations, including revocation of the grant or supply authority. These penalties underscore the importance of adhering to the regulatory framework established by the Act.

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Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.