Pharmaceutical Benefits Regulations (Amendment)

Legislation au C1948L00155 Regulations Not in force Legislative Instrument

Legislation content

STATUTORY RULES.

1948. No. .

 

REGULATIONS UNDER THE PHARMACEUTICAL BENEFITS ACT 1947.*

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 Pharmaceutical Benefits Act 1947.

Dated this first day of December, 1948.

W. J. McKell

Governor-General.

By His Excellencys Command.

N.E. McKenna

Minister of State for Health.

 

Amendment of the Pharmaceutical Benefits Regulations.†

Commencement.

1. These Regulations shall be deemed to have come into operation on the tenth day of May, 1948.

Fifth Schedule.

2. The Fifth Schedule to the Pharmaceutical Benefits Regulations is amended—

(a) by omitting from the table in paragraph 4 the word Clare (under the heading South Australia) and inserting in its stead the word Cleve;

(b) by adding at the end of paragraph 10 the words in respect of each such drug contained in that prescription;

(c) by adding at the end of Table A the following letters and figures:—

“SG 98

318

SG 99

265

SG 100

212

SG 101

159

SG 102

106

SG 103

53”;

(d) by inserting in Column 4 of Table B, opposite Prescription Code CP4 (second occurring), the letter S;

(e) by inserting in Column 4 of that Table, opposite Prescription Code GE l (first occurring), the letter W;

 

* Notified in the Commonwealth Gazette on      1948.

† Statutory Rules 1948, No. 56.

4988.—Price 3d. 9/9.11.1948.


(f) by omitting from that Table the following item:—

GL1 | 1 fl. oz. | C2 | S;

(g) by inserting in Column 4 of that Table, opposite Prescription Code LO7D, the letter W;

(h) by omitting from Column 4 of that Table, opposite Prescription Code MS33 (second occurring), the letter W and inserting in its stead the letters N, W;

(i) by omitting from Column 3 of that Table, opposite Prescription Code MS34 (first occurring), the letter and figure C3 and inserting in their stead the letter and figure D1;

(j) by omitting from Column 4 of that Table, opposite Prescription Code MS34 (first occurring), the letters N, Q, S, W;

(k) by omitting from Column 4 of that Table, opposite Prescription Code PA1 (first occurring), the letter N and inserting in its stead the letters N, W;

(l)  by inserting in Column 4 of that Table, opposite Prescription Code PG6, the letters N, W”;

(m) by omitting from Column 3 of that Table, opposite Prescription Code PI6 (first occurring), the letter and figure B1 and inserting in their stead the letter and figure D1;

(n) by omitting from Column 3 of that Table, opposite Prescription Code TA69, the letter and figure B2 and inserting in their stead the letter and figure B1;

(o) by omitting from Column 3 of that Table, opposite Prescription Code UG3, the letter and figure E1 and inserting in their stead the letter and figure D1;

(p) by inserting in Column 4 of that Table, opposite Prescription Code UG3, the letters N, W;

(q) by omitting from Column 3 of that Table, opposite Prescription Code BD4 (six times occurring), the letters and figures SG59, SG60, SG61, SG62, SG63 and SG64” and inserting in their stead the letters and figures SG98, SG99, SG100, SG101, SG102 and SG103, respectively;

(r) by omitting from Column 3 of that Table, opposite Prescription Code BD10 (first occurring), the letter and figure B2 and inserting in their stead the letter and figure B3;

(s) by inserting in Column 4 of that Table, opposite Prescription Code BD10 (third occurring), the letters N, W;

(t) by omitting from Column 3 of that Table, opposite Prescription Code BD11 (first occurring), the letter and figure B2 and inserting in their stead the letter and figure B3;

(u) by inserting in Column 4 of that Table, opposite Prescription Code BD11 (third occurring), the letters N, W;


(v) by omitting from Column 3 of that Table, opposite Prescription Code BD12 (first occurring), the letter and figure B2 and inserting in their stead the letter and figure B3;

(w) by inserting in Column 4 of that Table, opposite Prescription Code BD12 (third occurring), the letters N, W;

(x) by omitting from Column 3 of that Table, opposite Prescription Code BD13 (first occurring), the letter and figure B2 and inserting in their stead the letter and figure B3;

(y) by inserting in Column 4 of that Table, opposite Prescription Code BD13 (third occurring), the letters N, W;

(z) by omitting from Column 3 of that Table, opposite Prescription Code BD14 (first occurring), the letter and figure B2 and inserting in their stead the letter and figure B3;

(aa) by inserting in Column 4 of that Table, opposite Prescription Code BD14 (third occurring), the letters N, W;

(ab) by omitting from Column 4 of that Table, opposite Prescription Code BD16 (third occurring), the letters N, W; and

(ac) by omitting from Column 3 of that Table, opposite Prescription Codes BD15, BD16, BD17 and BD18 (each three times occurring), the letters and figures B2, B2, B1; B3, B2, B1; C1, B3 B2; and C3, C1, B3 and inserting in their stead the letters and figures C2, B3, B2; D2, C2, B3; D3, C3, C1; and G1 E1, C3”, respectively.

 

By Authority: L. F. Johnston, Commonwealth Government Printer, Canberra.

Overview

The Pharmaceutical Benefits Regulations 1948 are statutory rules made under the Pharmaceutical Benefits Act 1947. Enacted by the Parliament of Australia, the Act was introduced to address the gap in access to affordable medications by establishing a scheme to subsidise the cost of prescription drugs for Australian citizens and permanent residents. These Regulations, which came into operation on 10 May 1948, detail the administrative and procedural aspects of the Pharmaceutical Benefits Scheme, ensuring the efficient and equitable provision of subsidised medicines. The policy objective of these Regulations is to maintain and update the list of approved drugs, their codes, and the associated benefits to ensure the scheme remains effective and responsive to the healthcare needs of the population.

Scope and Application

The Pharmaceutical Benefits Regulations 1948, made under the Pharmaceutical Benefits Act 1947, apply to various entities and individuals involved in the supply and reimbursement of pharmaceutical products in Australia. The regulations establish a framework governing the inclusion of specific drugs on the Pharmaceutical Benefits Scheme (PBS), the pricing and reimbursement of these drugs, and the administration of the scheme by the Commonwealth. The regulations apply nationally, covering all states and territories within Australia. The amendments detailed in the Fifth Schedule affect the classification, pricing, and prescription codes of certain medications, thereby extending or restricting their availability under the PBS. The scope of these regulations is broad, impacting pharmaceutical companies, healthcare providers, pharmacists, and ultimately, patients who rely on the PBS for access to subsidised medications.

Key Provisions

The primary operative sections of the Regulations under the Pharmaceutical Benefits Act 1947, as evidenced in Statutory Rules 1948, No. 56, include amendments to the Fifth Schedule. These amendments are detailed in section 2, which provides specific changes to various items in the Schedule, such as the substitution of drug codes, the addition of new drug codes, and modifications to the coverage of certain drugs under different prescription codes. These changes effectively update the list of pharmaceutical benefits provided under the Act by adding or removing specific medications and adjusting the prescription codes that govern their coverage (section 2(a) to (ac)). The Regulations impose several obligations on parties and entities governed by the Act. Primarily, they require pharmaceutical entities and prescribers to adhere to the updated Schedule, ensuring that the medications listed are correctly identified and that prescriptions are issued in accordance with the new coverage stipulations. This includes updating internal databases and systems to reflect the changes, and ensuring that any claims for benefits under the Act are processed according to the amended regulations (section 2). Failure to comply with these Regulations can result in various consequences. While the Regulations themselves do not explicitly state penalties, breaches of the Pharmaceutical Benefits Act 1947 or related regulations could lead to enforcement actions by the relevant authorities, potentially resulting in fines or other administrative penalties. Additionally, there could be implications for the validity of prescriptions and claims for pharmaceutical benefits, which may be denied or subject to scrutiny if not in compliance with the updated Schedule (section 2).

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