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 CYANOKIT procedure packs for the treatment of cyanide poisoning in humans, required in the national interest to create a preparedness to deal with a potential terrorist threat.
The Australian Government has a mechanism in place whereby therapeutic goods that are unapproved and unavailable in Australia, but might be needed in preparation for, or 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 Therapeutic Goods Act 1989 (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 (refer to subsection 18A(1)). However, this power may only be exercised where it is considered to be in the national interest that (a) goods be stockpiled in preparation for a potential threat to public health caused by a possible future emergency, or (b) 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 Australian Register of Therapeutic Goods. 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 for the purposes of paragraph 18A(2)(a) of the Act to allow stockpiling, as distinct from use against actual threat to public health (paragraph 18A(2)(b) of the Act), is a disallowable instrument for the purposes of section 46A of the Acts Interpretation Act 1901. The exemption is subject to conditions which may include: the period for which the exemption is to have effect; the quantity of goods that are exempt; the source of those goods; the person or persons who can import the goods; the supply of those goods; record keeping requirements; storage and security requirements of those goods; and disposal of those goods.
The purpose of this instrument is to allow the stockpiling in Australia of a specified unregistered procedure pack that can be used to treat cyanide poisoning in humans. This is considered necessary because cyanide has been identified as a poison that may be used as part of terrorist activity in Australia.
This exemption instrument permits the stockpiling of 300 unit packs of CYANOKIT, each consisting of two 250mL bottles containing 2.5g of hydroxocobalamin as the active medicinal ingredient in lyophilised form. The necessary equipment (medical devices) for intravenous administration of the medicine is also supplied in the pack. The procedure packs are manufactured by Merck Santé s.a.s., Centre de Production de Semoy, 2 rue du Pressoir Vert, 45400, Semoy, FRANCE. The specific product and quantities involved have been determined by the Office of Health Protection within the Department of Health and Ageing. Stockpiling of the product confers a preparedness on Australian emergency services to deal with a potential terrorist threat involving the use of cyanide.
The CYANOKIT procedure pack has not been subject to the TGA’s evaluation process with respect to quality, safety and efficacy. However, hydroxocobalamin has been given marketing approval in France and is manufactured under Good Manufacturing Practice conditions, and the medical devices supplied in the packs for administration of the hydroxycobalamin are approved for marketing in the European Union. This gives a degree of confidence in the quality, safety and efficacy of the components of the procedure pack.
The instrument specifies the nature of the exempt goods, the quantity, the indication for which the goods can be used, and the manufacturer of these goods. The instrument makes it clear that the goods will be kept under the strict control of the Australian Government. Conditions apply to ensure that the goods will be stored securely and supplied appropriately and that appropriate records are kept about the distribution and supply of the goods. 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 the 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 products in an emergency.
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 November 2014; or when the goods receive a marketing approval in Australia for the treatment of cyanide poisoning. The Minister may reduce the period of exemption, or revoke the exemption, in accordance with the Act.
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 Australian Government to deal with a terrorism attack involving cyanide.