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 and “unapproved” therapeutic good, being an immunoglobulin preparation that can be used to combat disseminated infection with the vaccinia virus (the virus used to immunise against smallpox) or for the treatment 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 by which therapeutic goods that are not approved for marketing or entered on the Australian Register of Therapeutic Goods (ARTG), and thus unavailable in Australia, but might be needed in preparation for, or 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 imported, supplied and used in Australia under normal circumstances.
As a consequence, section 18A of 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) therapeutic goods be stockpiled in preparation for a potential threat to public health caused by a possible future emergency, or (b) therapeutic 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 ARTG. Thus, these goods may be legally imported, distributed, supplied and used for treatment in accordance with the conditions specified 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 an actual threat to public health (paragraph 18A(2)(b)), is a legislative instrument for the purposes of the Legislative Instruments Act 2003. The instrument limits the quantity of medicine exempted, and specifies the source and supplier of the drug(s). 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. 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; record keeping requirements; disposal and entitlement to compensation.
The purpose of this instrument is to allow the addition to the National Medicines Stockpile (NMS) of an unregistered immunoglobulin treatment, CNJ-016 Vaccinia Immune Globulin Intravenous (Human) (VIGIV), 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 if required.
This instrument permits the stockpiling of 500 15 ml vials of VIGIV, manufactured by Cangene Corporation, 155 Innovation Drive, Winnipeg, Manitoba, Canada, R3T 5Y3. This supply of VIGIV is intended to replace the 500 vials that are currently in the National Medicines Stockpile, that have reached the end of their shelf-life and require replacement.
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 has not been assessed 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. Also, its manufacture conforms with acceptable international standards of Good Manufacturing Practice (GMP). As the VIGIV is not registered in Australia for the uses intended through the NMS, it is considered “unapproved” under the Act and a section 18A exemption is required.
The NMS is a strategic reserve of essential therapeutic goods for use in a public health emergency in Australia. The therapeutic goods to be exempted via section 18A of the Act and be placed in the NMS, as well as the quantities involved, have been determined by the Office of Health Protection (OHP) of the Department of Health and Ageing, in consultation with appropriate Australian Government agencies, relevant counter terrorism experts and State and Territory health authorities.
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: 30th April 2016; 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 to deal with a bioterrorism attack involving the smallpox virus, or with complications surrounding vaccination of Australians against smallpox infection.