Explanatory Statement
Subject: Instrument 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 an unregistered vaccine against smallpox, required in the National Interest to create a preparedness to deal with potential terrorist threat.
As a result of the events in New York of September 11, 2001, it was considered 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.
As a consequence, 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. 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. The instrument limits the exemption to a specific strain of the vaccine, the dose per vial, and specifies the source of the vaccine and 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, appropriate supplied and used (only health professionals trained in the appropriate administration of the vaccine may administer the goods). The other conditions specified in the instrument relate to: the quantity of goods that are exempt; the persons or class of persons who can import and supply the goods to the Commonwealth; record keeping requirements; disposal; and entitlement for compensation.
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 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.
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. This exemption permits the stockpiling of approximately 50,000 doses of a French sourced vaccine against smallpox. This vaccine has been prepared from a stock of concentrated material manufactured in the 1970’s for the production of a vaccine used at that time in France. The concentrated material has been stored appropriately, and reconstituted and tested appropriately by the French manufacturer. The TGA intends to test a sample of the vaccine on arrival in Australia for potency and microbiological safety and to repeat test potency annually. This supply of vaccine is intended to maintain a stockpile in Australia until supplies of another vaccine against smallpox currently being produced and tested overseas become available in Australia.
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.