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 unregistered vaccine against smallpox, required in the national interest to create a preparedness to deal with potential terrorist threat.
As a result of global acts of terrorism, such as the event in New York of September 11,2001, it was considered 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 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 now 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 or (b) therapeutic goods 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 therapeutic goods 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 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 current instrument limits the exemption to a specific strain of the vaccine, the quantity of the vaccine, the formulation of the vaccine, the cell culture substrate used in the production of the vaccine and specifies the supplier of the vaccine. 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 used. The other conditions specified in the instrument relate to the disposal 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 supply and use of the vaccine. Certain quantities of the vaccine may 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.
The purpose of this instrument is to allow the stockpiling in Australia of an unregistered vaccine against the smallpox virus, in order to create a preparedness to deal with a potential terrorist threat. The vaccine is intended to be used specifically for the prevention of smallpox virus infection in humans and the early treatment of suspected smallpox virus infection in humans. This exemption permits the stockpiling of approximately 200,000 doses of a vaccine against smallpox manufactured by ACAMBIS, a company registered in the United States, and purchased from Baxter Healthcare SA of Hertistrasse 2, CH-8304 Wallisellen, Switzerland . This supply of vaccine is intended to maintain a stockpile in Australia and may also be used in the vaccination of “first responders”, that is, members of relevant authorities such as health services and police who would be required to respond in the event of a terrorist attack. Baxter Australia has a contractual obligation stating that, within 30 days of application for a marketing licence being made to the United States Food and Drug Administration for the registration of the vaccine in the USA by ACAMBIS, that an application be made to the TGA for registration of the vaccine in Australia. It is therefore intended that this product shall eventually be considered for registration for use in Australia, after having undergone rigorous evaluation for quality, safety and efficacy by the TGA.
The exemption takes effect when it is made. It expires on 30 April 2010 or once the goods are approved for marketing in Australia, 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 whilst bioterrorism remains a possibility, there will be supplies of smallpox vaccines available within Australia to create a preparedness to deal with a potential threat of smallpox 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 smallpox virus.