National Health (Pharmaceutical Benefits) Regulations (Amendment)

Administered by Department of Health, Disability and Ageing

Legislation au F1996B02860 Regulations Not in force Legislative Instrument

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STATUTORY RULES

1965 No. 152

REGULATIONS UNDER THE NATIONAL HEALTH ACT 1953-1984.*

I, THE GOVERNOR-GENERAL in and over the Commonwealth of Australia, acting with the advice of the Federal Executive Council, hereby make the following Regulations under the National Health Act 1953-1964.

Dated this twenty-first day of October, 1965.

CASEY

Governor-General.

By His Excellency’s Command,

Minister of State for Social Services Acting for and on behalf of the Minister of State for Health.

 

Amendments of the National Health (Pharmaceutical Benefits) Regulations†

Commencement.

1. These Regulations shall come into operation on the first day of November, 1965.

Variation of determination of maximum number of repeats or maximum number or quantity of units.

2. Regulation 13 of the National Health (Pharmaceutical Benefits) Regulations is amended by adding at the end thereof the following sub-regulation:—

“(2.) Where an authority authorizing a medical practitioner to direct that the supply of a pharmaceutical benefit be repeated on a specified number of occasions is issued to the medical practitioner in pursuance of the last preceding sub-regulation, a number of copies of the authority equal to the number of occasions on which the supply of the pharmaceutical benefit may be repeated may also be issued to the medical practitioner.”.

Pharmaceutical benefits that may be prescribed only for specified persons, diseases, &c.

3. Regulation 14 of the National Health (Pharmaceutical Benefits) Regulations is amended—

(a) by omitting from sub-regulation (3.) the words “form and” and inserting in their stead the word “authority”; and

(b) by adding at the end thereof the following sub-regulation:—

“(4.) Where a medical practitioner making an application for authority under this regulation informs the Director-General that he intends to direct that the supply of the pharmaceutical benefit is to be repeated on a specified

* Notified in the Commonwealth Gazette on 26 October, 1965.

Statutory Rules 1960, No. 17, as amended by Statutory Rules 1960, Nos. 90 and 102; 1961, Nos. 59 and 137; 1962, Nos. 34, 101 and 114; 1963, Nos. 34, 69 and 107; 1964, Nos. 12, 57 and 135; and 1965, Nos. 17 and 51.

4889/65—Price 9d. 9/1.10.1965


number of occasions not greater than the maximum number of occasions on which the pharmaceutical benefit may be directed to be repeated under the determination for the time being in force for the purposes of paragraph (a) of subsection (5.) of section 85 of the Act, the Director-General may issue to the medical practitioner a number of copies of the numbered authority equal to that number of occasions.”.

Writing of prescriptions.

4. Regulation 19 of the National Health (Pharmaceutical Benefits) Regulations is amended—

(a) by inserting in sub-regulation (1.), after the word “prescription” (first occurring), the words “, not being a prescription written upon an authority issued in pursuance of regulation 13 or regulation 14 of these Regulations,”;

(b) by omitting from paragraph (a) of sub-regulation (1.) the words “six inches in length and four inches in breadth” and inserting in their stead the words “seven inches in length and five inches in breadth”;

(c) by inserting after sub-regulation (1.) the following sub-regulations:—

“(1a.) A prescription that is written upon an authority issued in pursuance of regulation 13 or regulation 14 of these Regulations is not duly written unless the medical practitioner concerned complies with the requirements of the last preceding sub-regulation except the requirement of paragraph (b) of that sub-regulation.”; and

(d) by omitting from sub-regulation (2.) the words “the last preceding sub-regulation” and inserting in their stead the words “sub-regulation (1.) or (1a.), as the case may be, of this regulation”.

Supply of Pharmaceutical benefits on prescriptions.

5. Regulation 21 of the National Health (Pharmaceutical Benefits) Regulations is amended—

(a) by inserting after the words “a prescription for its supply” the words “(not being a prescription written upon an authority issued in pursuance of regulation 13 or regulation 14 of these Regulations)”; and

(b) by adding at the end thereof the following sub-regulation:—

“(2.) An approved pharmaceutical chemist or an approved medical practitioner is not authorized to supply a pharmaceutical benefit upon presentation of a prescription for its supply (being a prescription written upon an authority issued in pursuance of regulation 13 or regulation 14 of these Regulations) unless—

(a) the authority or a copy of the authority is surrendered to him;

(b) the writes on the authority or, if a copy of the authority is surrendered to him, that copy his name and the number of his approval under the Act;

(c) in the case of an approved pharmaceutical chemist—he allots to the prescription a number that will identify the prescription and writes that number on the authority or, if a copy of the authority is surrendered to him, on that copy;


(d) the prescription is duly written in accordance with these Regulations; and

(e) the prescription is dated within six months before the date of its presentation.”.

6. Regulation 23 of the National Health (Pharmaceutical Benefits) Regulations is repealed and the following regulation inserted in its stead:—

Supply of pharmaceutical benefit on first presentation of prescription.

“23. An approved pharmaceutical chemist or an approved medical practitioner is not authorized to supply a pharmaceutical benefit on the first presentation of a prescription (not being a prescription written upon an authority issued in pursuance of regulation 13 or regulation 14 of these Regulations) unless—

(a) he writes on the paper on which the prescription is written and on the duplicate of the prescription his name and the number of his approval under the Act; and

(b) in the case of an approved pharmaceutical chemist—he allots to the prescription a number which will identify the prescription and writes that number on the paper on which the prescription is written and on the duplicate of the prescription.”.

Repeat authorizations.

7. Regulation 26 of the National Health (Pharmaceutical Benefits) Regulations is amended—

(a) by inserting in sub-regulation (1.), after the word “prescription” (first occurring), the words “(not being a prescription written upon an authority issued in pursuance of regulation 13 or regulation 14 of these Regulations)”; and

(b) by omitting sub-regulation (2.) and inserting in its stead the following sub-regulation:—

“(2.) An approved pharmaceutical chemist is not authorized to supply a pharmaceutical benefit upon presentation of the duplicate of a prescription unless—

(a) there is surrendered to him a repeat authorization duly related to the duplicate prescription by a number or numbers and indicating that the pharmaceutical benefit to be supplied has not been supplied for the number of times directed in the prescription; and

(b) any numbered authority for the prescription issued under regulation 13 or regulation 14 of these Regulations is produced to him or, if the prescription does not authorize any further supply of the pharmaceutical benefit, is surrendered to him.”.

Receipts.

8. Regulation 31 of the National Health (Pharmaceutical Benefits) Regulations is amended—

(a) by omitting sub-regulation (1.) and inserting in its stead the following sub-regulations:—

“(1.) In this regulation, ‘the appropriate document’ means—

(a) where a pharmaceutical benefit is supplied to a person on the surrender of a prescription (not being a prescription written upon an authority


issued in pursuance of regulation 13 or regulation 14 of these Regulations) or a repeat authorization—that prescription or repeat authorization, as the case may be; or

(b) where a pharmaceutical benefit is supplied to a person on the surrender of a prescription written upon an authority issued in pursuance of regulation 13 or regulation 14 of these Regulations or on the surrender of a copy of such an authority—that authority or copy, as the case may be.

“(1a.) Subject to sub-regulation (3.) of this regulation, upon the supply to a person of a pharmaceutical benefit by an approved pharmaceutical chemist or an approved medical practitioner, that person shall sign, on the appropriate document, a receipt for that pharmaceutical benefit, showing the date of the supply and, if that person is not the person for whose treatment the prescription was written, his address.”; and

(b) by omitting from sub-regulation (3.) the words “the prescription or the repeat authorization” and inserting in their stead the words “the appropriate document”.

Retention of prescriptions, &c.

9. Regulation 32 of the National Health (Pharmaceutical Benefits) Regulations is amended by adding at the end thereof the following sub-regulation:—

“(2.) The last preceding sub-regulation does not apply in relation to a prescription written upon an authority issued in pursuance of regulation 13 or regulation 14 of these Regulations.”.

 

By Authority: A. J, Arthur, Commonwealth Government Printer, Canberra.

Overview

The Statutory Rules 1965 No. 152, made under the National Health Act 1953-1964, address the need for amendments to the National Health (Pharmaceutical Benefits) Regulations to enhance the efficiency and oversight of pharmaceutical benefits administration. Enacted by the Governor-General in Council, these Regulations seek to refine the regulatory framework concerning the supply, prescription, and record-keeping of pharmaceutical benefits. The policy objective appears to be ensuring that the administration of pharmaceutical benefits is conducted in a manner that is both effective and compliant with legislative requirements, thereby supporting the overarching goals of the National Health Act. These Regulations introduce several amendments, such as modifying the process for issuing authorities for pharmaceutical benefits that may be prescribed only for specified persons or diseases, adjusting the dimensions of prescriptions, and setting specific requirements for prescriptions written on certain authorities. Additionally, they clarify the conditions under which pharmaceutical benefits can be supplied upon presentation of a prescription or a repeat authorization. By doing so, the Regulations aim to streamline the supply chain of pharmaceutical benefits while maintaining stringent controls to prevent misuse or oversupply.

Scope and Application

The National Health (Pharmaceutical Benefits) Regulations, made under the National Health Act 1953-1984, apply to pharmaceutical benefits within the Commonwealth of Australia and govern the process by which these benefits are prescribed, supplied, and reimbursed. These regulations specifically pertain to medical practitioners, approved pharmaceutical chemists, and the prescriptions they issue for pharmaceutical benefits. The Regulations are applicable nationally, extending their reach to all states and territories within Australia. The Regulations include provisions for the variation of determinations concerning the maximum number of repeats or quantity of units for pharmaceutical benefits, and outline the requirements for the writing and submission of prescriptions, including the specific dimensions and details that must be present. Notably, the Regulations detail the circumstances under which pharmaceutical benefits can be supplied, including the requirement for certain prescriptions to be accompanied by specific authorities or copies thereof. Additionally, the Regulations specify the conditions under which receipts must be provided and the retention periods for prescriptions and related documents. These regulations do not specify any exclusions or exemptions but they may be further refined or extended through subordinate instruments as deemed necessary by the relevant authorities.

Key Provisions

The Statutory Rules 1965 No. 152 under the National Health Act 1953-1964, which came into operation on 1 November 1965, primarily amend the National Health (Pharmaceutical Benefits) Regulations. Key sections include amendments to the maximum number of repeats for pharmaceutical benefits, the prescription writing requirements, and the supply of pharmaceutical benefits on prescriptions. For example, Regulation 13(2) allows a medical practitioner to receive multiple copies of an authority if the pharmaceutical benefit can be repeated a specified number of times. Regulation 14(4) provides that the Director-General may issue multiple copies of an authority if a medical practitioner intends to direct repeated supplies within the allowed limit. Regulation 19 modifies the size and content requirements for prescriptions, while Regulation 21 outlines conditions for supplying pharmaceutical benefits on prescriptions, including the need for the authority or a copy to be surrendered and the prescription to be dated within six months. The Regulations impose several obligations on parties involved, including medical practitioners, approved pharmaceutical chemists, and approved medical practitioners. Medical practitioners must comply with the requirements for issuing and using authorities for repeated pharmaceutical supplies. Approved pharmaceutical chemists and approved medical practitioners must ensure that prescriptions are properly written and that appropriate documents are signed by the recipients. These professionals must also ensure that repeat authorizations are correctly related to duplicate prescriptions and that they only supply pharmaceutical benefits in accordance with the regulations. Additionally, the Regulations mandate the retention of prescriptions and other related documents for a specified period, although this requirement is waived for prescriptions issued under certain authorities. The Statutory Rules 152 also establish penalties and consequences for non-compliance. While the specific penalties are not detailed within the text, breaches of the regulations could lead to legal actions under the National Health Act 1953-1964, potentially resulting in fines or other civil or criminal consequences. The exact penalties would depend on the nature and severity of the breach, as well as any applicable provisions within the overarching Act. It is crucial for all parties to adhere to the regulations to avoid these potential repercussions.

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