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 specified quantities of Reactive Skin Decontamination Lotion, 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 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 Act allows the Minister for Health and Ageing to exempt specified therapeutic goods from the evaluation 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) goods be stockpiled in preparation for a potential threat to public health in a possible future emergency or (b) goods are required in response to an actual threat to public health caused by an emergency that has occurred (refer to subsection 18A(2)).
The exemption made under subsection 18A(1) of the Act is a written instrument. The signed instrument specifies the goods that are exempt from the requirement of having to be entered in 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 an 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 may include: the period for which the exemption is to have effect; the quantity of the 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 requirements of those goods.
The purpose of this instrument is to allow the potential supply in Australia of quantities of specified therapeutic goods to be used for the treatment of contamination with chemical warfare agents. The products are:
- 30,000 pouches containing 21ml of Reactive Skin Decontamination Lotion on a sponge applicator, with 0.1722g/ml Dekon 139 Active Ingredient; and
- 10,000 pouches containing 42ml of Reactive Skin Decontamination Lotion on a sponge applicator, with 0.1722g/ml Dekon 139 Active Ingredient; and
- 2,000 bottles containing 500ml of Reactive Skin Decontamination Lotion, with 0.1722g/ml Dekon 139 Active Ingredient.
The products work through a combination of physical removal, binding and breakdown of chemical warfare agents and toxins that renders the toxic materials non-toxic in cutaneous exposure. The destruction of the warfare agent is rapid and complete and, unlike the situation with use of classical absorbent decontaminants, no toxic substances remain to off gas. If applied early enough, RSDL prevents skin damage and consequent systemic absorption of lethal substances. The products are manufactured by Therapex, Division of E-Z-M Canada Inc, 11065 L. H. Lafontane, Anjou, QC H1J 2Z4, Canada. The specific products and quantities involved have been determined by Emergency Management Australia.
These products have not been subject to the TGA’s evaluation process with respect to quality, safety and efficacy. It is felt that, given these products shall only be used to treat casualties who have been exposed to lethal chemical warfare agents, the products would provide a clear benefit compared to no treatment, supportive treatment or classical absorbent decontaminants should they ever have to be used. Stockpiling of these products confers a preparedness on Australian emergency services to deal with a potential terrorist threat involving the use of chemical warfare agents.
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 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 when it is made and expires on 31 December 2009. 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 chemical warfare agents.