EXPLANATORY STATEMENT

 

Select Legislative Instrument 2009 No. 287

 

National Health Act 1953

 

National Health Amendment Regulations 2009 (No. 2)

 

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’.

 

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 of the Principal Regulations are prescribed for the purposes of paragraph 9A(1)(a) of the Act.

 

The purpose of the Regulations is to prescribe “dressings, bandages, padding and ancillary items” for the purposes of paragraph 9A(1)(a) of the Act, by adding an item to Schedule 1 under Regulation 42 of the Principal Regulations.

 

The Regulations allow the Minister, on behalf of the Commonwealth, to make arrangements for the supply of dressings, bandages, padding and ancillary items to persons diagnosed with Epidermolysis Bullosa (EB) under the National Epidermolysis Bullosa Dressing Scheme (the Scheme), as an outcome of the 2009-10 Commonwealth Budget.

 

The Scheme has been developed to support people with EB, a debilitating genetic condition characterised by extremely fragile skin, requiring access to specialised bandages and dressings.

 

Details of the Regulations are set out in the Attachment.

 

The Scheme was an outcome of the 2009-2010 Commonwealth Budget as a commitment to supporting people with EB. Therefore, consultations specifically regarding the Regulations were not necessary. However, extensive stakeholder consultations were conducted during the development of the Scheme. Outcomes from these consultations were considered during the development of the Regulations, particularly for the interpretation of the products required by persons with EB.

 

Relevant support organisations were consulted on 1 July, 22 July and 3 August 2009 to discuss the needs of people with EB and the recommended treatment and services. The peak support organisation also provided a list of dressings required by people with EB which was also consulted in the development of the Regulations.

 

 

 

Experts from hospitals in Sydney, Melbourne, Adelaide and Perth were consulted on 26 June, 3 July, 24 July, 3 August and 6 August 2009 regarding the number of cases of EB in Australia and the types of EB that require constant dressings. The current treatment and services available to EB patients were also discussed.

 

Experts from the Australasian College of Dermatologists were consulted on 24 July, 29 July and 3 August 2009 regarding the number of cases of EB in Australia and the types of EB that require constant dressings.

 

An industry representative organisation was consulted on 20 August 2009 to inform the organisation of the Scheme and to seek feedback. The organisation was supportive of the Scheme and the implementation of the Scheme through an external provider.

 

Specialist nurses were consulted on 3 August and 13 August 2009 regarding the role of a nurse in the treatment of EB and the development of guidelines for the Scheme. The specialist nurses also discussed the needs of people with EB.

 

All stakeholders that were consulted during the development of the Scheme indicated great interest and support for the supply of dressings to people with EB by the Commonwealth.

 

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.

 

 

 

ATTACHMENT

 

Details of the National Health Amendment Regulations 2009 (No. 2)

 

Regulation 1 – Name of Regulations

This regulation provides that the title of the Regulations is the National Health Amendment Regulations 2009 (No. 2).

 

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]

This item inserts new item 17 into Schedule 1 to the Principal Regulations which prescribes “dressings, bandages, padding and ancillary items”.

 

The term:

 

• “dressings” covers applications directly applied to a blister or wound on the skin;

 

• “bandages” covers applications such as a strip of cloth or other material used to bind up a wound or hold a dressing in place;

 

• “padding” refers to cotton, foam and fabric padding which are used to prevent injury and further trauma to a blister or wound; and

 

• “ancillary items” encompasses products used as an accessory or subsidiary to dressings, bandages and padding in the treatment of blisters and wounds, specifically, cleaning wipes, surgical tape and sterilised needles. Topical treatments such as antiseptic, skin moisturisers and honey are not included under ancillary items and will not be supplied by the Commonwealth through the National Epidermolysis Bullosa Dressing Scheme (the Scheme).

 

It is intended that the Minister make arrangements for the supply of the dressings, bandages, padding and ancillary items prescribed in new item 17 of Schedule 1, only to persons diagnosed with Epidermolysis Bullosa through the Scheme. The conditions of access to the prescribed dressings, bandages, padding and ancillary are applied in the implementation of the Scheme. The supply of dressings, bandages, padding and ancillary items by the Commonwealth under paragraph 9A(1)(a) for purposes other than through the Scheme requires alternative arrangements by the Minister. The general supply of dressings, bandages, padding and ancillary items remain a state and territory responsibility through hospitals and health care facilities.