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 a number of unapproved therapeutic products required in the national interest to create a preparedness to deal with potential terrorist threats involving radioactive or infective agents.
As a result of the events in New York of September 11, 2001, it was considered necessary to have a mechanism in place by which therapeutic goods that are unapproved and unavailable in Australia, but might be needed during a terrorist threat or attack, could legally be imported and 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.
As a consequence, section 18A of the Act allows the Minister for Health and Ageing to exempt specified therapeutic goods 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) therapeutic goods be stockpiled in preparation for a potential threat to public health caused by a possible future emergency or (b) therapeutic goods are required in response to an actual threat to public health caused by an actual emergency (refer to subsection 18A(2)).
The exemption made under subsection 18A(1) must be 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. Thus, these goods may be legally distributed, supplied and used for treatment in accordance with the conditions specified in the written instrument.
The exemption given for the purposes of paragraph 18A(2)(a) 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. The instrument limits the quantity of medicine exempted, and specifies the source and supplier of the drug(s). 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, appropriate supplied and used. The other conditions specified in the instrument relate to: the quantity of goods that are exempt; the persons or class of persons who can import and supply the goods to the Commonwealth; record keeping requirements; disposal and entitlement to compensation.
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 made for both reasons of security, as well as to provide a degree of flexibility for the supply and use of the medicine.
The purpose of this instrument is to allow the stockpiling in Australia of certain unregistered medicines for use against radioactive contamination, and plague and viral infection. This exemption permits the stockpiling of:
(a) 200 bottles each containing 30 capsules of insoluble Prussian Blue, each capsule containing 0.5 g of insoluble ferric hexacyanoferrate (II) for the treatment of internal contamination with radioactive caesium and radioactive thallium to increase their rates of elimination.
(b) 200 5 ml ampoules of Ca-DTPA (pentetate calcium trisodium, also known as calcium trisodium pentetate) for injection, each containing 1g in 5ml of sterile aqueous solution for the initial treatment of patients with internal contamination with plutonium, americium or curium.
(c) 2000 5 ml ampoules of Zn-DTPA (pentetate zinc trisodium) for injection each containing 1g in 5ml of sterile aqueous solution for the continuation of treatment of patients with internal contamination with plutonium, americium or curium.
(d) 2000 vials of Streptomycin for injection USP 1gram/vial, 10 vials per carton.
(e) 100 vials, each vial containing 1.2 grams ribavirin in 12mL phosphate buffer solution. (1mL ribavirin solution for IV injection contains 0.369mg sodium hydrogenphosphate, 8.718mg potassium hydrogenphosphate and water for injection.)
A regulatory impact statement does not accompany this instrument as this exemption is regarded as having no impact on industry in general, and is considered a necessary public health measure in order to create a preparedness for the Commonwealth to deal with terrorist attacks involving radioactive substances or specific infectious agents.