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) of the Act, to allow the stockpiling in Australia of a specified quantity of an unregistered and “unapproved” therapeutic good, Zink-Trinatrium-pentetat (Zn-DTPA) 5mL ampoules (each containing 1055 mg of Zn-DTPA) that can be used as a chelating agent for the treatment of transuranium heavy metal nuclides (americium, plutonium, curium, californium, berkelium) poisoning, that are required in the national interest to create a preparedness to deal with a potential terrorist threat.
The Australian Government has a mechanism in place by which therapeutic goods that are not approved for marketing or entered on the Australian Register of Therapeutic Goods (ARTG), and thus unavailable in Australia, but might be needed in preparation for, or during, a terrorist threat or attack or other public health emergency, 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 imported, 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 procedures 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) of the Act must be a written instrument. The signed instrument specifies the therapeutic goods that are exempt from the requirement of having to be entered on the ARTG. Thus, these goods may be legally imported, 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) of the Act to allow stockpiling, as distinct from use against an actual threat to public health (paragraph 18A(2)(b)), is a legislative instrument for the purposes of the Legislative Instruments Act 2003. 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; record keeping requirements; disposal and entitlement to compensation.
The purpose of this instrument is to allow the replacement of out-of-date stock in the National Medicines Stockpile (NMS), of unregistered Zn-DTPA products, that are used in an emergency as a chelating agent for the treatment of transuranium heavy metal nuclides (americium, plutonium, curium, californium, berkelium) poisoning.
This instrument permits the stockpiling of 400 packets each containing 5 ampoules (2000 ampoules in total) of Zn-DTPA, with each ampoule holding a 5 ml solution containing 1055mg of Zn-DTPA , manufactured by Heyl Chem.-pharm. Fabrik GmbH & Co. KG, Goerzallee 253, 14167 Berlin, Germany.
The Zn-DTPA ampoules that are the subject of this exemption are intended to replace stocks of that product which are currently under the control of the Commonwealth but have reached the end of their shelf-life.
For reasons of security, certain facts relating to the conditions of storage of the Zn-DTPA have not been stated in detail in the instrument. The non-specific nature of the storage site and distribution conditions is made for both reasons of security, as well as to provide a degree of flexibility for the supply and use of the medicine.
These Zn-DTPA ampoules have not been assessed for quality, safety and efficacy by the TGA. Therefore, they have not been subject to the usual rigorous evaluation process that freely marketed therapeutic goods must meet. However, the manufacturing of the products does conform with acceptable international standards of Good Manufacturing Practice (GMP).
The NMS is a strategic reserve of essential therapeutic goods for use in a public health emergency in Australia. The therapeutic goods to be exempted via section 18A of the Act and to be placed in the NMS, as well as the quantities involved, have been determined by the Office of Health Protection (OHP) of the Department of Health and Ageing, in consultation with appropriate Australian Government agencies, relevant counter terrorism experts and State and Territory health authorities.
The exemption takes effect the day after it is registered in the Federal Register of Legislative Instruments and expires on the earlier of the following: 30 April 2017; or when the goods receive a marketing approval in Australia commensurate with their approved intended use under the exemption and for the purpose of the NMS.
A regulatory impact statement does not accompany this instrument as the 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 emergency treatment of transuranium heavy metal nuclides (americium, plutonium, curium, californium, berkelium) poisoning.