THERAPEUTIC SUBSTANCES.
No. 41 of 1938.
An Act to amend the Therapeutic Substances Act 1937.
[Assented to 21st October, 1938.]
BE it enacted by the King’s Most Excellent Majesty, the Senate, and the House of Representatives of the Commonwealth of Australia, as follows:—
Short title and citation.
1.—(1.) This Act may be cited as the Therapeutic Substances Act 1938.
(2.) The Therapeutic Substances Act 1937* is in this Act referred to as the Principal Act.
(3.) The Principal Act, as amended by this Act, may be cited as the Therapeutic Substances Act 1937-1938.
Commencement.
2. This Act shall commence on the date of the commencement of the Principal Act.
Declaration of therapeutic substances.
3. Section seven of the Principal Act is amended by omitting sub section (1.) and inserting in its stead the following sub-section:—
“(1.) The Minister may, by notice in the Gazette, declare any substance which—
(a) is wholly or in part derived from microscopic or ultra-microscopic organisms or from living cellular tissue;
(b) is prepared from tissues removed from recently slaughtered animals; or
(c) is the result of the activities of microscopic or ultra-microscopic organisms,
and which is used or intended for use in the prevention, diagnosis or treatment of disease in man or animals, to be a therapeutic substance for the purposes of this Act.”.
Importation of therapeutic substances.
4. Section nine of the Principal Act is amended by omitting from sub-section (3.) the word “except” and inserting in its stead the word “exempt”.
5. After section ten of the Principal Act the following section is inserted:—
Forfeiture of therapeutic substances.
“10a. All therapeutic substances imported, or sought to be exported, in contravention of this Act shall be forfeited to the King.”.
6. Section eleven of the Principal Act is repealed and the following section inserted in its stead:—
Examination of therapeutic substances.
“11.—(1.) Any officer thereto authorized in writing by the Minister may—
(a) take samples of all therapeutic substances which are imported or are sought to be exported and any samples so taken shall be dealt with as prescribed; and
(b) require any therapeutic substances specified by him which are imported or are sought to be exported to be delivered for examination or analysis, or both, to a laboratory appointed by the Minister for the purpose, and any therapeutic substances so delivered may be examined or analysed, or both, accordingly.
(2.) No therapeutic substances shall be entered for home consumption or exported unless and until a person or an officer thereto authorized by the Minister certifies that all the provisions of this Act with respect to their importation or exportation, as the case may be, have been complied with.”.
Overview
The Therapeutic Substances Act 1938, enacted by the King’s Most Excellent Majesty, the Senate, and the House of Representatives of the Commonwealth of Australia, serves to amend the Therapeutic Substances Act 1937. This legislative update aims to address issues and gaps within the existing framework governing the declaration, importation, and examination of therapeutic substances. The Act was introduced to ensure a more comprehensive and precise definition of therapeutic substances, facilitate the control of their importation, and mandate rigorous examination protocols to safeguard public health.
The Act authorises the Minister to declare specific substances as therapeutic based on their derivation and intended use in disease prevention or treatment. It further amends the importation rules to ensure better regulatory oversight and includes forfeiture provisions for substances imported or exported in violation of the Act. Additionally, the Act mandates that all therapeutic substances must undergo examination or analysis before being cleared for home consumption or export, reinforcing the commitment to public health and safety.
Scope and Application
The Therapeutic Substances Act 1938 applies to substances that are derived from microscopic or ultra-microscopic organisms, living cellular tissue, or tissues from recently slaughtered animals, as well as substances resulting from the activities of such organisms, provided they are used or intended for use in the prevention, diagnosis, or treatment of disease in humans or animals. This Act amends the Therapeutic Substances Act 1937 by expanding the definition of therapeutic substances and making significant changes to the importation regulations, including the forfeiture of substances imported or exported in contravention of the Act. The Act also grants authorised officers the power to take samples of and examine imported or export-bound therapeutic substances, ensuring compliance with the Act's provisions. The Act applies nationally across the Commonwealth of Australia, with no specified exclusions or exemptions, though its application may be further defined through subordinate instruments.
Key Provisions
The Therapeutic Substances Act 1938 amends the Therapeutic Substances Act 1937 by introducing new definitions and regulations concerning therapeutic substances (s. 3). Specifically, the Act allows the Minister to declare any substance derived from microscopic or ultra-microscopic organisms, living cellular tissue, or tissues from recently slaughtered animals, which is used or intended for use in preventing, diagnosing, or treating diseases in humans or animals, as a therapeutic substance (s. 3(1)). Additionally, the Act modifies the importation regulations by removing the exception clause in section nine of the Principal Act and replacing it with the term "exempt" (s. 4). Furthermore, it introduces a new section that mandates the forfeiture of all therapeutic substances imported or exported in contravention of the Act (s. 10a).
Under this Act, the Minister has the authority to authorize officers to take samples of imported or exported therapeutic substances and require these substances to be delivered for examination or analysis in a laboratory appointed by the Minister (s. 11(1)). The Act also stipulates that no therapeutic substances shall be entered for home consumption or exported unless a person or an authorized officer certifies compliance with all relevant provisions of the Act (s. 11(2)). The Act further repeals section eleven of the Principal Act and replaces it with the new section on the examination of therapeutic substances (s. 11).
The Therapeutic Substances Act 1938 imposes several obligations on parties involved with therapeutic substances. The Minister is responsible for declaring substances as therapeutic substances, authorizing officers to take samples and conduct examinations, and appointing laboratories for analysis (s. 3, s. 11(1)). Importers and exporters must ensure that their substances comply with the Act's provisions, and they must obtain certification from authorized officers before entering substances for home consumption or export (s. 11(2)). Failure to comply with these obligations can result in the forfeiture of the substances to the Crown (s. 10a). Additionally, any person or entity found in breach of the Act's provisions may face civil or criminal penalties as stipulated under the relevant sections of the Act.