National Security (Proprietary Medicines) Regulations (Amendment)

Legislation au C1943L00003 Regulations Not in force Legislative Instrument

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STATUTORY RULES.

1943. No. 3.

 

REGULATIONS UNDER THE NATIONAL SECURITY ACT 1939–1940.*

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 Security Act 1939–1940.

Dated this twelfth day of January, 1943

(SGD.) GOWRIE.)

Governor-General.

By His Excellency’s Command,

E.J. Holloway

for and on behalf of the Minister of

State for Defence.

 

Amendments of the National Security (Proprietary Medicines) Regulations.†

Particulars of proprietary medicines to be furnished.

1. Regulation 4 of the National Security (Proprietary Medicines) Regulations is amended—

(a) by inserting, after sub-regulation (2.), the following sub-regulation:—

“(2a.) This regulation shall not apply with respect to any proprietary medicine which is prepared and sold according to the specifications for preparation and the standards of composition prescribed in the British Pharmacopoeia or                            the British Pharmaceutical Codex and is sold under the name under which it is described in the British Pharmacopoeia or the British Pharmaceutical Codex.”; and

(b) by omitting from paragraph (a) of sub-regulation (4.) the words “or the Pharmaceutical Codex issued by the General Council of Medical Education and Registration of the United Kingdom” and inserting in their stead the words “published under the direction of the General Council of Medical Education and Registration of the United Kingdom or the British Pharmaceutical Codex published by direction of the Council of the Pharmaceutical Society of Great Britain”

 

* Notified in the Commonwealth Gazette on , 1943.

† Statutory Rules 1942, No. 459.


Particulars of proprietary medicines not to be disclosed.

2. Regulation 5 of the National Security (Proprietary Medicines) Regulations is amended by omitting the words “The Director-General” and inserting in their stead the words “Any officer or employee engaged upon any duties connected with the administration of these Regulations shall not disclose any information furnished in pursuance of the last preceding regulation except, in the course of his duties, to the Director-General, and the Director-General”.

Restrictions, on advertisements of proprietary medicines.

3. Regulation 8 of the National Security (Proprietary Medicines) Regulations is amended—

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

“(1.) A person shall not in order to promote the sale of any proprietary medicine, publish, or cause to be published, any advertisement of any kind which contains any matter other than—

(a) the trade name of the proprietary medicine;

(b) the claims made by the manufacturer, proprietor of, or the agent for, the proprietary medicine in respect of the hygienic or therapeutic action of the proprietary medicine, expressed in not more than thirty words;

(c) an illustration which is a representation of the proprietary medicine or of its container or label;

(d) directions for the use of the proprietary medicine which do not contain any direct or indirect reference to the hygienic or therapeutic action of the proprietary medicine;

(e) any words or statements which are required by the law of the Commonwealth or any State;

(f) the retail price of the proprietary medicine; and

(g) the name of the manufacturer, or proprietor, or distributor of the proprietary medicine and the address of his place of business.

“(1a.) A person shall not, by way of advertisement or otherwise, in order to promote the sale of any proprietary medicine, publish any statement which is false or likely to mislead in any material respect as to the nature or composition of the proprietary medicine or as to its efficacy for the prevention, cure or relief of any malady, ailment, infirmity or disorder affecting human beings, or for increasing height, increasing or reducing weight or increasing personality or reproductive capacity, as the case may be.”;

(b) by omitting from sub-regulations (2.) and (3.) the word “statement” (wherever occurring) and inserting in its stead the word “advertisement”;

(c) by inserting, after sub-regulation (3.), the following sub-regulation:—

“(3a.) A person shall not manufacture any poster for the purpose of promoting the sale of any proprietary medicine.”;


(d) by omitting paragraph (a) of sub-regulation (4.) and inserting in its stead the following paragraph:—

“(a) the word ‘advertisement’ includes—

(i) any words, illustrations or symbols which are—

(1) applied to the proprietary medicines themselves;

(2) applied to any container, covering, label or thing used in connexion with the proprietary medicines; or

(3) used in any manner likely to lead to the belief that they describe or designate the proprietary medicines; and

(ii) any document, book or paper containing any advertisement; and”;

(e) by omitting from paragraph (b) of that sub-regulation the words “a statement” and inserting in their stead the words “an advertisement”;

(f) by omitting from sub-regulation (5.) the word “statement” and inserting in its stead the word “advertising”;

(g) by inserting in that sub-regulation, after the word “surgical”, the word “, dental”; and

(h) by inserting in that sub-regulation, after the words “medical practitioners”, the word
“, dentists”.

 

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

Overview

The Statutory Rules 1943 No. 3, Regulations under the National Security Act 1939–1940, were introduced to address the need for tighter regulation of proprietary medicines during a period of national emergency. Enacted by the Governor-General in Council, these regulations aimed to enhance national security by controlling the information and advertising related to proprietary medicines. The policy objective was to ensure that only authorised personnel could access certain proprietary medicine details while also restricting misleading advertisements to protect public health and safety during wartime.

Scope and Application

The National Security (Proprietary Medicines) Regulations 1943, made under the National Security Act 1939–1940, pertain to proprietary medicines within the Commonwealth of Australia. These regulations apply to persons and entities involved in the preparation, sale, and advertising of proprietary medicines, aiming to safeguard public health and ensure the accuracy of therapeutic claims. The regulations delineate specific criteria for the preparation and sale of proprietary medicines, exempting those that adhere to the standards set by the British Pharmacopoeia or the British Pharmaceutical Codex. They impose strict controls on the advertising of proprietary medicines, limiting the information that can be disclosed in advertisements to specific, non-misleading details. Furthermore, the regulations prohibit the publication of advertisements that could mislead consumers about the nature, composition, or efficacy of proprietary medicines, as well as the manufacture of posters for promotional purposes. These regulations extend to all states and territories within Australia, ensuring a uniform approach to the regulation of proprietary medicines across the nation. The amendments to the existing regulations further refine the scope and application of these provisions, ensuring they remain relevant and effective in achieving their intended objectives.

Key Provisions

The primary operative sections of the Regulations under the National Security Act 1939–1940 (Regulations) pertain to the disclosure of proprietary medicines, their advertisements, and the confidentiality of information related to these medicines. Specifically, Regulation 1 amends the National Security (Proprietary Medicines) Regulations by specifying that certain proprietary medicines, prepared and sold according to the British Pharmacopoeia or the British Pharmaceutical Codex, are exempt from the regulations (1(a)). Regulation 2 modifies the confidentiality provisions, requiring officers or employees involved in the administration of these Regulations to maintain the secrecy of any information furnished under the previous regulations, except when disclosing it to the Director-General (2). Regulation 3 outlines the permissible content and restrictions for advertisements of proprietary medicines, prohibiting certain types of claims and illustrations in advertisements (3(1), 3(1a), 3(3a)), and it also redefines what constitutes an advertisement to include various forms of media and materials (3(4)(a)). These regulations provide a framework to control the dissemination of information about proprietary medicines during a period of national security concern. The Regulations impose several obligations on parties and entities involved with proprietary medicines. Firstly, they mandate that proprietary medicines must be prepared and sold according to the specifications and standards prescribed in the British Pharmacopoeia or the British Pharmaceutical Codex to qualify for exemption from certain regulatory requirements (1(a)). Secondly, officers or employees engaged in the administration of these Regulations must ensure that any information obtained under the regulations is kept confidential and disclosed only to the Director-General, unless in the course of their duties (2). Thirdly, the Regulations place strict limits on the content of advertisements for proprietary medicines, prohibiting false or misleading claims, certain types of illustrations, and the manufacturing of posters for promotional purposes (3(1), 3(1a), 3(3a)). These obligations are designed to control the flow of information and the marketing practices related to proprietary medicines during a time of national security. The Regulations establish various offences and penalties for breaches of the requirements they impose. Firstly, any person who violates the restrictions on advertisements of proprietary medicines by publishing false or misleading information, prohibited illustrations, or manufacturing promotional posters is subject to penalties (3(1a), 3(3a)). Although the specific penalties are not detailed in the Regulations, breaches of such regulations could potentially lead to criminal charges and associated penalties under the broader National Security Act 1939–1940. Secondly, officers or employees who fail to maintain the confidentiality of information obtained under the regulations could be subject to disciplinary action or legal consequences for breaches of trust and confidentiality. These provisions underscore the seriousness with which the government treats compliance with these regulations, particularly in the context of national security.

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National Security Law
Instrument
Regulation
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Reporting & Disclosure Obligations
Regulatory Standards
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