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) of the Act, to allow the stockpiling in Australia of a specified quantity of an unregistered immunoglobulin preparation that can be used to combat disseminated infection with the vaccinia virus (the virus used to immunise against smallpox) or for the ttreatment of suspected or proven smallpox infection in humans, 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 in preparation for, or 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 Therapeutic Goods Act 1989 (the Act) 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) goods be stockpiled in preparation for a potential threat to public health caused by a possible future emergency, or (b) goods are required in response to an actual threat to public health caused by an actual emergency (refer to subsection 18A(2)).
The exemption made under subsection 18A(1) of the Act must be 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. 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 exemption is subject to conditions which may include: the period for which the exemption is to have effect; the quantity of goods that are exempt; the source of those goods; the person or persons who can import the goods; the supply of those goods; record keeping requirements; storage and security requirements of those goods; and disposal of those goods.
The purpose of this instrument is to allow the stockpiling in Australia of an unregistered immunoglobulin against the vaccinia virus, the agent used to vaccinate against smallpox virus infection. This is considered necessary for instances when complications arise from the smallpox vaccination, such as when it is inadvertently given to an immunosuppressed individual or similar, and widespread infection occurs rather than the typical raised lesion at the vaccination site. The immunoglobulin is also proposed to be used for the treatment of suspected or proven infection with the smallpox virus.
This exemption instrument permits the stockpiling of 500 15 ml vials of VIG Vaccinia Immunoglobulin (VIG immunoglobulin), of not less than 50,000 units per vial, and manufactured by Cangene Corporation, 104 Chancellor Matheson Road, Winnipeg, Manitoba, Canada, R3T 5Y3. This supply of immunoglobulin is intended to maintain a stockpile in Australia. The exemption instrument specifies the indication for which the goods can be used, that is, it can only be used for the treatment of uncontrolled vaccinia infection (the virus used in smallpox vaccination) or treatment of suspected or proven smallpox virus infection in humans. It also makes it clear that the goods will be kept under the strict control of the Australian Government.
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 is made for both reasons of security, as well as to provide a degree of flexibility for the supply and use of the medicine.
The VIG immunoglobulin, which is the subject matter of this exemption, is not registered in Australia (i.e. has not undergone assessment for quality, safety and efficacy by the Therapeutic Goods Administration). However, it has been given a form of registration in the USA by the Food and Drug Administration, where the registration is subject to the future provision of additional information about the safety and efficacy of the product, once such data are generated.
This supply of VIG Immunoglobulin is intended to maintain a stockpile in Australia for potential treatment of complications of vaccination against the smallpox virus, and suspected or proven smallpox infection.
The exemption takes effect the day after it is registered in the Federal Register of Legislative Instruments and expires on the earlier of the following: 31 August 2014; or when the goods receive a marketing approval in Australia for the treatment of complications of vaccination against infection by the smallpox virus and treatment of infection with the smallpox virus itself;
A regulatory impact statement does not accompany this instrument as this exemption is regarded as having no impact on industry in general, and is considered a necessary public health measure in order to create a preparedness for the Commonwealth Government to deal with a bioterrorism attack involving the smallpox virus, or with complications surrounding vaccination of Australians against smallpox infection.