EXPLANATORY STATEMENT
Select Legislative Instrument 2007 No. 160
Subject- National Health Act 1953
National Health (Pharmaceutical Benefits) Amendment Regulations 2007
(No. 1)
Subsection 140(1) 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 required or permitted by the Act to be prescribed, or which are necessary or convenient to be prescribed for carrying out or giving effect to the Act.
Paragraph 105(b) of the Act provides that the regulations may make provision for or in relation to the writing of prescriptions.
Part VII, Division 2 of the Act provides, among other things, for the process by which a prescription for the supply of a pharmaceutical benefit may be authorised, prescribed and dispensed.
The Regulations help implement a streamlined approval process for certain prescriptions.
The pharmaceutical benefits which may be prescribed are listed in instruments made by the Minister under Part VII of the Act. Under those instruments, some prescriptions may only be issued with the prior approval of the Medicare Australia CEO. Currently, this is achieved by one of three methods:
- delivering or posting the prescription to the Medicare Australia CEO;
- submitting details of the prescription by telephone; or
- submitting an on-line form.
In the case of approvals obtained by telephone or on-line, the Medicare Australia CEO issues an "authority approval number", which must be noted on the prescription. In the case of prescriptions that are delivered or posted to the CEO, the CEO signs his or her authorisation of the prescription on it.
From 1 July 2007, some of the prescriptions which require authority will be able to be authorised without the need for prior submission to the Medicare Australia CEO. This will be achieved by the prescriber noting on the prescription a "streamlined authority code", which will apply to particular pharmaceutical benefits, prescribed in particular circumstances. Where this is done, the prescription will be able to be issued immediately, without the need to seek a specific approval from the Medicare Australia CEO.
The pharmaceutical benefits to which the streamlined authority process will apply will be identified in the instruments made by the Minister under Part VII of the Act.
Regulation 19 of the National Health (Pharmaceutical Benefits) Regulations 1960 (the Principal Regulations) sets out how a prescriber must write a prescription, including an authority prescription, and the required contents of a prescription. The term ‘authority prescription’ is defined in the Principal Regulations to include a prescription that is written in circumstances specified by the Minister for Health and Ageing in an instrument made under the Act.
The Regulations specify that, unless an authority prescription is being posted or delivered to the Medicare Australia CEO for authorisation, prescribers must write an authority approval number or a streamlined authority code on the prescription as the case requires.
A parallel process operates with the Department of Veterans’ Affairs (DVA), where prior approval is required from DVA to prescribe specified items for patients with veterans’ entitlements. The streamlined authority process will also operate for streamlined authority items that are common to both the Pharmaceutical Benefits Scheme and the Repatriations Pharmaceutical Benefits Scheme. However, the streamlined authority process does not apply to authority required items that are listed on the Repatriation Schedule of Pharmaceutical Benefits only.
Details of the Regulations are set out in the Attachment.
The Act specifies no conditions which need to be satisfied before the power to make the Regulations may be exercised.
The Regulations are a legislative instrument for the purposes of the Legislative Instruments Act 2003.
The Regulations commence on 1 July 2007 to coincide with the commencement of the streamlined authority process.
ATTACHMENT
Details of the National Health (Pharmaceutical Benefits) Amendment Regulations 2007 (No. 1)
Regulation 1 – Name of Regulations
This regulation provides that the title of the Regulations is the National Health (Pharmaceutical Benefits) Amendment Regulations 2007 (No. 1)
Regulation 2 – Commencement
This regulation provides for the Regulations to commence on 1 July 2007, to coincide with the commencement of the streamlined authority process.
Regulation 3 – Amendment of National Health (Pharmaceutical Benefits) Regulations 1960
Provides that Schedule 1 to the Regulations amends the National Health (Pharmaceutical Benefits) Regulations 1960.
Schedule 1 – Amendment
Item [1]: After paragraph 19(1)(aa)
A new paragraph 19(1)(b) is inserted.
Subparagraph 19(1)(b)(i) provides for the requirement to write on an authority prescription an authority approval number issued by the Medicare Australia CEO, unless the prescription is to be posted or delivered to the Medicare Australia CEO. This will continue to be the rule for authority prescriptions which are not the subject of the new streamlined authority process and which are therefore required to be submitted to the Medicare Australia CEO for prior approval.
Subparagraph 19(1)(b)(ii) provides for the writing of an authority prescription in accordance with the streamlined authority process. In this circumstance a streamlined authority code (which will be published in instruments made by the Minister under Part VII of the National Health Act 1953) will have to be recorded on the prescription.