Explanatory Statement
Subject: Two Instruments of Exemption under section 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 unregistered antidotes against certain chemical poisons, required in the National Interest to create a preparedness to deal with potential terrorist threat.
The Commonwealth considers it necessary to have a mechanism in place by which medications or medical devices 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.
The new section 18A of the Act now allows the Minister for Health and Ageing to exempt specified medications and medical devices 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 or medical devices be stockpiled in preparation for a potential threat to public health or (b) medications or medical devices 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) is a written instrument. The signed instrument specifies the medication or medical devices 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 specified in the written instrument.
The exemption given under paragraph 18A(2)(a) for the purpose of 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 supply of those goods; record keeping requirements; and storage and security of those goods.
The purpose of these two instruments is to allow the stockpiling in Australia of two different types of “autoinjector” which are used to treat humans in the event of poisoning by various substances.
Two instruments are required for the following reasons. The Therapeutic Goods Regulations 1990 already specify an exemption for these brands of autoinjector. This exemption, however, expires on the 31st of December 2002, currently with the consequence that the unused goods are required to be destroyed or returned to the consignor. These were goods purchased by Victoria, New South Wales and the ACT in preparation for the Sydney Olympic Games, and also some additional stocks purchased by the Department of Health and Ageing prior to the Commonwealth Heads of Government Meeting. Therefore, a regulation amendment, coupled with a specific Section 18A exemption for these goods alone, will result in them coming under the same controls as stocks purchased in future. The need for on-going stockpiling of these goods was not foreseen at the time item 9 of Schedule 5A of the Therapeutic Goods Regulations 1990 was drafted. A similar section 18A exemption, for more of these goods than are presently in Australia, is also needed to enable purchase of additional quantities of these products for the National stockpile.
The instrument specifies details of autoinjectors, the quantities involved, storage conditions, supply, keeping of records and disposal.
For reasons of security, certain facts relating to the conditions 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 supply and use of the products. Certain quantities of the autoinjectors are likely to be distributed to the States and Territories, with the chief health officer in each jurisdiction to be responsible for the storage and use of the vaccine, subject to the conditions in the instrument. It may also be possible that the Australian Defence Force may wish to make use of some of the goods.
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.