STATUTORY RULES.
1966 No. 70
REGULATION UNDER THE CUSTOMS ACT 1901-1965.*
I, THE GOVERNOR-GENERAL in and over the Commonwealth of Australia, acting with the advice of the Federal Executive Council, hereby make the following Regulation under the Customs Act 1901-1965.
Dated this nineteenth day of March, 1966.
CASEY
Governor-General.
By His Excellency’s Command,
KEN ANDERSON
Minister of State for Customs and Excise.
Amendment of the Customs (Prohibited Exports) Regulations†
Sixth Schedule.
The Sixth Schedule to the Customs (Prohibited Exports) Regulations is amended by adding at the end thereof the following items:—
“ 3 | Human blood |
4 | A substance derived from human blood |
5 | A human organ or human tissue, including the placenta, of a kind that is suitable as a source from which to derive a constituent of human blood for therapeutic use or for the preparation of a substance for therapeutic use ”. |
* Notified in the Commonwealth Gazette on 24 March, 1966.
† Statutory Rules 1958, No. 5, as amended by Statutory Rules 1959, No. 5; 1961, Nos. 16 and 112; 1963, Nos. 129 and 130; 1964, No. 144; and 1965, No. 136.
By Authority: A. J. Arthur, Commonwealth Government Printer, Canberra.
13091. 65—Price 5c (6d.)
Overview
The Statutory Rules of 1966, No. 70, represents an amendment to the Customs (Prohibited Exports) Regulations under the Customs Act 1901-1965. This regulation was enacted by the Governor-General in accordance with the advice of the Federal Executive Council and is aimed at addressing the gap in existing legislation concerning the export of certain human-derived materials. The amendment, dated 19 March 1966, introduces additional items to the Sixth Schedule of the Customs (Prohibited Exports) Regulations, specifically prohibiting the export of human blood, substances derived from human blood, and human organs or tissues suitable for therapeutic use. This legislative action underscores the policy objective to regulate and control the export of sensitive and ethically significant biological materials to ensure compliance with international standards and ethical considerations in biomedical research and therapeutic practices.
This regulation was formulated to fill a legislative gap identified in the Customs Act 1901-1965, which did not adequately address the export of human biological materials. By adding these specific items to the Sixth Schedule, the regulation aims to safeguard against the illicit trade of human-derived substances, ensuring that such exports are conducted in accordance with ethical guidelines and international agreements. The amendment reflects a commitment to maintaining the integrity of medical research and protecting human rights in the global biomedical field.
Scope and Application
The Statutory Rules 1966 No. 70, made under the Customs Act 1901-1965, introduces amendments to the Customs (Prohibited Exports) Regulations, specifically adding new items to the Sixth Schedule. These amendments pertain to prohibiting the export of certain biological materials and substances derived from humans. The new additions include human blood, substances derived from human blood, and human organs or tissues, including the placenta, if they are suitable for therapeutic use or for preparing therapeutic substances. This regulation applies to all entities and individuals involved in the export of these items, ensuring compliance with the updated Customs (Prohibited Exports) Regulations. The geographic scope of this legislation is national, covering the entire Commonwealth of Australia, thereby regulating exports across state and territory boundaries. No exclusions, exemptions, or thresholds are specified in the regulation itself, but it is noted that further details or clarifications may be provided through subordinate instruments.
Key Provisions
The regulation primarily focuses on the amendment of the Customs (Prohibited Exports) Regulations, specifically adding new items to the Sixth Schedule. This addition includes human blood (item 3), substances derived from human blood (item 4), and human organs or tissues, such as the placenta, that are suitable for therapeutic use (item 5). These amendments aim to explicitly prohibit the export of these items unless they are subject to a permit or exemption under the Customs Act 1901-1965. The intent behind these provisions is to regulate and control the export of sensitive human biological materials to ensure compliance with national and international laws and ethical standards.
The regulation imposes specific obligations on entities and individuals involved in the export of human biological materials. Those intending to export any of the newly prohibited items must ensure they comply with the Customs Act and the amended regulations. This includes obtaining the necessary permits or exemptions and adhering to any conditions stipulated by the Department of Customs and Excise. Failure to comply with these requirements may result in the refusal of export permits, seizure of the goods, and potential legal action. The regulation underscores the importance of due diligence and adherence to legal standards when dealing with the export of human biological materials.
In terms of legal consequences, any person or entity found in breach of these provisions may face criminal and civil penalties. Under the Customs Act, offences involving the prohibited export of goods can lead to fines and imprisonment. The specific penalties are determined based on the nature and gravity of the offence, but they can be significant. For instance, the maximum penalty for serious breaches may include fines up to a specified amount and imprisonment for several years, depending on the severity of the violation. These provisions serve as a deterrent against unlawful activities and reinforce the importance of adhering to the regulatory framework governing the export of sensitive biological materials.