Explanatory Statement
Subject: Instrument of Exemption under subsection 18A(1) of the Therapeutic Goods Act 1989 (the Act) for the purposes of paragraph 18A(2)(a), to allow the stockpiling in Australia of specified quantities of antidotes to contamination with various radioactive substances, required in the national interest to create a preparedness to deal with a potential terrorist threat.
The Commonwealth has a mechanism in place by which medications that are unapproved and unavailable in Australia, but might be needed during a terrorist threat or attack, can legally be imported and/or supplied in Australia under strictly controlled conditions. Therapeutic goods that are within the scope of this proposed action may not have been assessed by the Therapeutic Goods Administration (TGA) for quality, safety and efficacy and thus are not able to be legally supplied and used in Australia under normal circumstances.
Section 18A of the Act allows the Minister for Health and Ageing to exempt specified therapeutic goodss from the rigorous registration or listing procedure under the Act so that they can be available for supply in Australia. However, this power may only be exercised where it is considered to be in the national interest that (a) medications be stockpiled in preparation for a potential threat to public health by a possible future emergency or (b) medications are required in response to an actual threat to public health caused by an emergency that has occurred (refer to subsection 18A(2)).
The exemption made under subsection 18A(1) of the Act is a written instrument. The signed instrument specifies the medication(s) that are exempt from the requirement of having to be entered on the Australian Register of Therapeutic Goods (ARTG). Thus, these goods may be legally distributed, supplied and used for treatment in accordance with the conditions set out in the written instrument.
The exemption given under paragraph 18A(2)(a) of the Act to allow stockpiling, as distinct from use against actual threat to public health (paragraph 18A(2)(b)), is a disallowable instrument for the purposes of section 46A of the Acts Interpretation Act 1901. In addition, the exemption is subject to conditions which include: the period for which the exemption is to have effect; the quantity of goods that are exempt; the source of those goods; the persons or class of persons who can import the goods; the supply of those goods; record keeping requirements; storage and security requirements of those goods.
The purpose of this instrument is to allow the potential supply in Australia of quantities of three therapeutic goods to be used for the treatment of radiological contaminants. The products consist of:
- 200 bottles each containing 30 capsules, with each capsule containing 0.5 g of insoluble Prussian Blue (ferric hexacyanoferrate (II)) for the treatment of internal contamination with radioactive caesium and radioactive thallium to increase their rates of elimination; and
- 200 5mL ampoules of Ca-DTPA (pentetate calcium trisodium, also known as calcium trisodium pentetate) for injection, each containing 1 g in 5 ml of sterile aqueous solution for the initial treatment of patients with internal contamination with plutonium, americium or curium; and
- 2000 5mL ampoules of Zn-DTPA (pentetate zinc trisodium) for injection, each containing 1 g in 5 ml of sterile aqueous solution for the continuation of treatment of patients with internal contamination with plutonium, americium or curium.
The products work by either preventing the absorption in the GI (gastro-intestinal) tract of radiological contaminants, or binding those that have entered the body such that they are then excreted more easily. The products are manufactured by Heyl Chemisch-pharmazeutische Fabrik GmBH & Co., KG, Goerzalle 253, D-141167 Berlin (Zehlendorf), Germany. The specific products and quantities involved have been determined in consultation by staff of the Department of Health and Ageing with officers of the Australian Nuclear Science and Technology Organisation (ANSTO).
These products are not registered in Australia and as such they have not been subject to the TGA’s evaluation process with respect to quality, efficacy and safety. It is felt that, given these products shall only be used for treatment of radiological contamination , that the products would provide a clear benefit compared with no treatment or supportive therapyshould they ever have to be used, which would occur with the informed consent of the patient. Stockpiling of these antidotes confers a preparedness on Australian emergency services to deal with a potential terrorist threat involving the use of radioactive substances.
The instrument specifies the nature of the exempt goods, the quantity, the indication for which the goods can be used, and the source of these goods. The instrument makes it clear that the exempt goods are under the strict control of the Commonwealth. Conditions apply to ensure that the goods will be securely stored, appropriately supplied and appropriate records are kept. Other conditions include the disposal arrangements.
For reasons of security, certain facts relating to the conditions of storage have not been stated in detail in the instrument. The non-specific nature of the storage site and distribution conditions are for both reasons of security, as well as to provide a degree of flexibility for the practical supply and use of the antidotes in an emergency.
The exemption takes effect when it is made and expires on 31 August 2012. It should be noted, however, that in the case of these products, there are currently no plans by the manufacturer to register the products in Australia due to the small quantities involved and the lack of commercial viability.
The Minister may reduce the period of exemption, or revoke the exemption, in accordance with the Act. However, the period provided for in the instrument is intended to ensure as far as possible that while bioterrorism acts remain a possibility, there will be supplies of these products available within Australia to treat and prevent radioactive contamination.
A regulatory impact statement does not accompany this instrument as this exemption is regarded as having no impact on industry in general, and is a necessary public health measure, in order to create a preparedness for the Commonwealth to deal with a bioterrorism attack involving radioactive substances.