Commonwealth Numbered Regulations - Explanatory Statements

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NATIONAL HEALTH (PHARMACEUTICAL BENEFITS) AMENDMENT REGULATIONS 2003 (NO. 1) 2003 NO. 193

STATUTORY RULES 2003 No. 193

Issued by the authority of the Minister for Health and Ageing

National Health Act 1953

National Health (Pharmaceutical Benefits) Amendment Regulations 2003 (No. 1)

Subsection 140(1) 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 85A(2)(a) of the Act enables the Minister to determine the maximum quantity or number of units of a pharmaceutical benefit that may, in one prescription, be directed to be supplied on one occasion, either for all purposes or for particular purposes; and paragraph 85A(2)(b) of the Act enables the Minister to determine the maximum number of occasions on which the supply of a pharmaceutical benefit may, in one prescription, be directed to be repeated, either for all purposes or for particular purposes.

However, subsection 85A(3) of the Act provides that the regulations may make provision authorising the variation of the application, in relation to persons included in a class of persons, of a determination under paragraph 85A(2)(a) or (b) of the Act.

Under regulation 13 of the National Health (Pharmaceutical Benefits) Regulations 1960, a medical practitioner may apply for authorisation of a prescription for the supply of more than the maximum quantity and/or for more than the maximum number of repeats. This application may currently be made either in writing or by telephone.

Authorisation of these prescriptions is made in writing in the case of written applications, and orally at the time of the telephone call in the case of applications by telephone. Under paragraph 3E(f) of the Health Insurance Commission Regulations 1975, the exercise of powers of the Minister under regulation 13 is a function of the Health Insurance Commission (HIC).

The purpose of the Regulations is to provide a further method for the submission and authorisation of an application to exceed the maximum quantity and/or maximum number of repeats, namely, electronic communication between the medical practitioner and the HIC.

A medical practitioner who wishes to use this method would make the application by means of an electronic communication of a kind approved in writing by the Secretary. This would be done by logging on to the HIC's web browser and submitting the application by entering the prescription details in the format provided on the relevant page of the web browser.

Where a medical practitioner receives an electronic reply giving notice of authorisation of an application, the reply from the HIC's computer would include the authorisation number that has been allotted to the prescription. The medical practitioner would be required to mark the authorisation number on the prescription and retain a copy of the prescription for one year, in the same way as currently required for telephone authorisations.

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

Details of the Regulations are in the Attachment.

The Regulations commence on 1 August 2003.

Regulation 1 of the amending regulations provides that the name of the amending regulations is the National Health (Pharmaceutical Benefits) Amendment Regulations 2003 (No. 1).

Regulation 2 of the amending regulations provides that the amending regulations commence on 1 August 2003.

Regulation 3 of the amending regulations provides that the National Health (Pharmaceutical Benefits) Regulations 1960 be amended as set out in Schedule 1.

Item 1 of Schedule 1 amends paragraph 13(2)(b) as a consequence of item 2, which allows for electronic applications for authorisation of prescriptions for more than the maximum quantities or repeats.

Item 2 of Schedule 1 amends paragraph 13(3)(b) to provide that a medical practitioner may, as a further alternative to the existing methods of written or telephone application, submit an application for authorisation of a prescription for more than the maximum quantity or number of repeats by means of an electronic communication of a kind approved in writing by the Secretary.

Item 3 of Schedule 1 inserts paragraph 13(5)(c) to provide that, where the Minister gives authorisation of a prescription for more than the maximum quantity or number of repeats that was submitted by electronic communication, the authorisation will be given by electronic communication. Item 3 also amends paragraph 13(5)(b) to replace the word "verbally" with the more accurate term "orally" in respect of the method of authorisation of telephone applications.

Item 4 of Schedule 1 amends subregulation 13(6), as a consequence of proposed item 3, which enables authorisations to be given by the Minister by electronic communication under proposed paragraph 13(5)(c).

Item 5 of Schedule 1 amends paragraph 13(6)(a) to provide that the Minister must, when giving an authorisation by electronic communication, advise the medical practitioner of the authorisation number by electronic communication. The medical practitioner must, under paragraph 13(6)(b), mark this number on the prescription and retain a copy of the prescription for one year from the date of authorisation. The inclusion of the authorisation number on the prescription enables a pharmacist who receives the prescription for dispensing to recognise that the quantity or number of repeats included in the prescription has been duly authorised.

Item 6 of Schedule 1 inserts new subregulation 13(7) to define "electronic communication" for the purpose of regulation 13 as having the same meaning given by subsection 5(1) of the Electronic Transactions Act 1999, namely:

"(a)       a communication of information in the form of data, text or images by means of guided and/or unguided electromagnetic energy; or

(b)       a communication of information in the form of speech by means of guided and/or unguided electromagnetic energy, where the speech is processed at its destination by an automated voice recognition system."