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 specified quantity of an antibiotic, doxycycline, to treat Anthrax infection, 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 medications 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 medications 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 or (b) medications are required in response to an actual threat to public health caused by an 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 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; and storage and security of those goods.
The purpose of this instrument is to allow the stockpiling in Australia of a quantity of the antibiotic, doxycycline, to be used to prevent and treat anthrax infection in humans in the event of a terrorist attack. Although registered in Australia for supply for certain therapeutic uses, such as atypical pneumonia, for example, (ie. has been subject to the TGA’s evaluation of quality, efficacy and safety for these other uses), the product does not have a registered indication in Australia for the prevention and treatment of anthrax infection. Hence the supply of doxycycline in Australia for the prevention and treatment of anthrax infection requires this specific exemption. Stockpiling of this antibiotic medicine contributes to a preparedness to deal with a potential terrorist threat involving the use of the anthrax bacterium.
The instrument also specifies the nature of the exempt goods, the quantity, the specific 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 doxycycline in an emergency.
The exemption takes effect when it is made and expires on 31 May 2010 or when the product is approved for marketing in Australia for the prevention and treatment of anthrax infection in humans, whichever occurs first. 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 doxycycline available within Australia to treat and prevent anthrax infection.
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 of some urgency, in order to create a preparedness for the Commonwealth to deal with a bioterrorism attack involving the anthrax organism.