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 quantity of antitoxin for the post-exposure prophylaxis of persons exposed to botulinum toxin (a neurotoxin produced by the bacterium, Clostridium botulinum) or treatment of botulism, required in the national interest to create a preparedness to deal with a potential terrorist threat.
The Commonwealth considers it 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/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 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) of the Act is a written instrument. The signed instrument specifies the therapeutic good(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; and storage and security of those goods.
The purpose of this instrument is to allow the stockpiling in Australia of 200 bottles of an intravenous solution which is an antitoxin for the neutralisation of toxins, produced by the bacterium Clostridium botulinum. It is manufactured by Chiron Behring GmbH , Emil von Behring Str., 35041, Marburg, Germany.
This product and the quantity designated for exemption has been determined by the Chemical, Biological, and Radiological Committee of the Department of Health and Ageing.
This product is not registered in Australia in accordance with the Therapeutic Goods Act 1989, and as such it has not been subject to the TGA’s evaluation process with respect to quality, efficacy and safety. The product is manufactured to an acceptable standard, and the indication afforded it by the exemption instrument is solely for the post-exposure prophylaxis of persons exposed to botulinum toxin, or the treatment of botulism. Stockpiling of this antidote confers a preparedness on Australian emergency services to deal with a potential terrorist threat involving the use of the neurotoxin produced by the Clostridium botulinum bacterium.
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 January 2012 or when the product is approved for marketing in Australia for the post-exposure prophylaxis of persons exposed to botulinum toxin or the treatment of botulism, whichever occurs first. The company has no plans to register this product in Australia at this time.
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 this antidote available within Australia to treat botulism and act as post-exposure prophylaxis to exposure to the botulinum toxin. Naturally the product may only be used within its shelf-life.
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 the neurotoxin produced by this bacterium.