National Health Amendment Regulations 2011 (No. 1)

Administered by Department of Health, Disability and Ageing

Legislation au F2011L01912 Regulations Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

Select Legislative Instrument 2011 No. 169

 

National Health Act 1953

 

National Health Amendment Regulations 2011 (No. 1)

 

Section 140 of the National Health Act 1953 (the Act) provides, in part, 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 for Health and Ageing (the Minister) may, on behalf of the Commonwealth Government, arrange for the supply by the Commonwealth of ‘such medical or surgical aids, equipment or appliances as are prescribed to persons who require them’.  ‘Prescribed’ means prescribed under the Regulations to the Act.

 

Subsection 9A(3) of the Act provides that the Minister may impose such conditions as the Minister thinks fit on the use or possession of aids, equipment or appliances supplied, or to be supplied, under subsection 9A(1) of the Act. 

 

Regulation 42 of the National Health Regulations 1954 (the Principal Regulations) provides that the medical or surgical aids, equipment and appliances specified in Schedule 1 to the Principal Regulations are prescribed for the purposes of paragraph 9A(1)(a) of the Act.

 

The purpose of the Regulations is to amend current eligibility restrictions for access to syringes and needles through the National Diabetes Services Scheme (NDSS) for the purposes of paragraph 9A(1)(a) of the Act.

 

The Regulations ensure that NDSS registrants who are prescribed injectable non insulin blood glucose lowering medications, are able to access subsidised syringes and needles for the delivery of their medication. This implements an outcome of the 2011-12 Commonwealth Budget.

 

The relevant items in the Principal Regulations may not cover insulin pump consumables, which were added to the NDSS in 2004.  The Principal Regulations therefore are amended to cover insulin pump consumables more clearly.

 

The NDSS aims to ensure that people with diabetes have timely, reliable and affordable access to products and services that help them effectively self-manage their condition.

 

Details of the Regulations are set out in the Attachment.

 

The Act specifies no conditions that need to be met before the power to make the  Regulations may be exercised.

 

The Regulations are a legislative instrument for the purposes of the Legislative Instrument Act 2003.

 

The Regulations commence on the day after they are registered on the Federal Register of Legislative Instruments.

 

Consultation

 

Pharmaceutical company Eli Lilly listed a new injectable non insulin blood glucose lowering medication on the Pharmaceutical Benefits Scheme from 1 August 2010.  Eli Lilly then applied to the Department of Health and Ageing to extend National Diabetes Services Scheme (NDSS) eligibility criteria to allow people with diabetes who are registered on the NDSS, access to syringes and needles to administer this new medication.  Eli Lilly has been consulted during this process and kept informed of updates in their application process.

 

Diabetes Australia Ltd (DAL) administers the NDSS on behalf of the Department of Health and Ageing.  DAL has been consulted regarding amendments that need to be made to the NDSS IT system to allow access to syringes and needles for NDSS registrants with type 2 diabetes who are prescribed injectable non-insulin blood glucose lowering medications.

 

 


ATTACHMENT

 

Details of the National Health Amendment Regulations 2011 (No. 1)

 

Regulation 1 – Name of Regulations

This regulation provides that the title of the Regulations is the National Health Amendment Regulations 2011 (No. 1).

 

Regulation 2 – Commencement

This regulation provides for the Regulations to commence on the day after they are registered.

 

Regulation 3 – Amendment of the National Health Regulations 1954

This regulation provides that the National Health Regulations 1954 (the Principal Regulations) are amended as set out in Schedule 1.

 

Schedule 1 – Amendments

 

Item [1] – Subregulation 2(1), before the definition of approved form

This item defines Act as the National Health Act 1953 as a consequence of the change in item [3].

 

Item [2] – Subregulation 2(1), after the definition of approved form

This item defines ‘insulin pump consumables’ as the equipment manufactured for use with an insulin pump.  This equipment includes cannulae, tubing, insulin reservoirs and insulin cartridges, other than insulin cartridges that contain insulin when the cartridges are supplied.  This definition is needed to limit ‘insulin pump consumables’ to the products currently supplied under this category through the National Diabetes Services Scheme (the NDSS).  There are many products that could be described as insulin pump consumables which are not supplied through the NDSS.

 

Item [3] – Subregulation 2(1), definition of the Act

This item removes the terminology the Act and replaces it with Act in reference to the National Health Act 1953.  This change was recommended by the Office of Legislative Drafting and Publishing as a minor technical correction to the wording of the Regulations.

 

Item [4] – Schedule 1, after item 17

This item inserts an item to prescribe needles for the delivery of injectable blood glucose lowering medications other than insulin.  It also adds an item to prescribe insulin pump consumables as it was identified that the items in the Principal Regulations may not cover insulin pump consumables, which were added to the NDSS in 2004 following a new policy proposal.

 

Item [5] – Schedule 1, after the table

This item inserts a note after the table referring readers to subregulation 2(1) for the definition of insulin pump consumables.

Overview

The National Health Amendment Regulations 2011 (No. 1) were enacted to address the problem of limited access to syringes and needles for certain diabetic patients enrolled in the National Diabetes Services Scheme (NDSS). This legislative instrument amends the National Health Regulations 1954 to expand the eligibility criteria for accessing subsidised syringes and needles, particularly for NDSS registrants who are prescribed injectable non-insulin blood glucose lowering medications. The objective of these amendments is to ensure that people with diabetes have timely and affordable access to products that help them effectively self-manage their condition, in line with the broader goals of the NDSS. The regulations were introduced by the Commonwealth Parliament and aim to implement outcomes from the 2011-12 Commonwealth Budget. These amendments also clarify the inclusion of insulin pump consumables, which were added to the NDSS in 2004, thereby ensuring these items are explicitly covered under the scheme.

Scope and Application

The National Health Amendment Regulations 2011 (No. 1) are a legislative instrument made under Section 140 of the National Health Act 1953, aimed at extending eligibility for certain medical aids, equipment, and appliances under the National Diabetes Services Scheme (NDSS). These Regulations are applicable to individuals who are registered with the NDSS and require specific medical aids for managing diabetes, particularly focusing on those prescribed injectable non-insulin blood glucose-lowering medications. The Regulations ensure that NDSS registrants have access to subsidised syringes and needles for administering their medication, thus implementing an outcome of the 2011-12 Commonwealth Budget. Additionally, the Regulations clarify and expand the scope to include insulin pump consumables, ensuring they are prescribed and available for those who use insulin pumps. These amendments extend to the entire Commonwealth of Australia and do not specify any exclusions or exemptions other than those implied by the existing eligibility criteria of the NDSS. The Regulations are designed to amend the National Health Regulations 1954, providing a more precise definition of 'insulin pump consumables' to include items such as cannulae, tubing, insulin reservoirs, and insulin cartridges, excluding cartridges that contain insulin. The changes were made following consultation with relevant stakeholders, including pharmaceutical companies like Eli Lilly and Diabetes Australia Ltd, which administers the NDSS on behalf of the Department of Health and Ageing. The Regulations, once registered on the Federal Register of Legislative Instruments, will commence on the day following their registration. This legislative update ensures that the NDSS continues to provide timely and reliable access to necessary medical aids and equipment for the management of diabetes in Australia.

Key Provisions

The National Health Amendment Regulations 2011 (No. 1) (the Regulations) amend the National Health Regulations 1954 (the Principal Regulations) to expand access to subsidised syringes and needles for registrants of the National Diabetes Services Scheme (NDSS) who are prescribed injectable non-insulin blood glucose lowering medications (sections 2 and 4). The Regulations also provide a clearer definition of 'insulin pump consumables' to ensure that these items, which include cannulae, tubing, insulin reservoirs, and insulin cartridges, are covered under the scheme (section 4). These amendments are designed to align with the objectives of the NDSS, which is to ensure that individuals with diabetes have reliable and affordable access to products and services that aid in the self-management of their condition. The Regulations impose several obligations on the parties involved. Firstly, the Minister for Health and Ageing, on behalf of the Commonwealth Government, must arrange for the supply of prescribed medical or surgical aids, equipment, or appliances to eligible individuals (section 9A(1)(a) of the Act). The Minister may also impose conditions on the use or possession of these supplies (section 9A(3) of the Act). Secondly, Diabetes Australia Ltd, as the administrator of the NDSS, must ensure that its IT systems are updated to allow access to syringes and needles for eligible NDSS registrants with type 2 diabetes who are prescribed injectable non-insulin blood glucose lowering medications (section 4). Finally, pharmaceutical companies, such as Eli Lilly, must apply to the Department of Health and Ageing to extend the eligibility criteria for the NDSS and keep abreast of updates in their application process (Consultation section). Failure to comply with the Regulations may result in various consequences. The Act does not specify any conditions that must be met before the Regulations can be made. However, any breaches of the Regulations could potentially lead to legal actions or administrative penalties, depending on the severity and nature of the breach. For instance, if a registrant misuses the supplies provided under the scheme, they could face civil or criminal penalties as outlined in the Act or other relevant legislation. The maximum penalties for such offences are not specified in the Regulations but would typically depend on the specific breach and the relevant statutory provisions. It is essential for all parties involved to adhere to the Regulations to ensure the effective and efficient operation of the NDSS.

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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.