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 a vaccine to combat infection with the H5N1 influenza virus, required in the national interest to create a preparedness to deal with a potential influenza pandemic.
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, section 18A of the Act allows the Minister for Health and Ageing to exempt specified medications 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 caused by a possible future emergency or (b) medications or medical devices 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) must be a written instrument. The signed instrument specifies the medication(s) 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 for the purposes of paragraph 18A(2)(a) to allow 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 quantity of medicine exempted, and specifies the source and supplier of the drug. 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 to the Commonwealth; record keeping requirements; disposal and entitlement to 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 made for both reasons of security, as well as to provide a degree of flexibility for the supply and use of the medicine.
The purpose of this instrument is to allow the stockpiling in Australia of an unregistered vaccine against the Influenza virus type A H5N1 subtype, the virus highlighted by worldwide reporting of “bird flu” infections. This vaccine may be used during an outbreak of this influenza strain, or possibly to vaccinate “first responders”, i.e. emergency services personnel that may need to respond to such an emergency in the future. This exemption permits the stockpiling of 100,000 doses of vaccine against the H5N1 Influenza virus Type A (Vietnam strain), manufactured in France by Sanofi Pasteur, 2 av. Pont Pasteur, 69367 Lyon cedex 07 France.
The vaccine is not registered in Australia (i.e. has not undergone assessment for quality, safety and efficacy by the Therapeutic Goods Administration). Clinical trials of the effectiveness of this vaccine are currently underway. Sanofi Pasteur has advised the Office of Health Protection that it intends to submit a “mock-up” pandemic vaccine dossier to the Therapeutic Goods Administration in the second quarter of 2007. This “mock-up” would involve the evaluation of all components etc. of the vaccine except the antigens (i.e. as a specific strain would not yet have been isolated from an outbreak of infection). As a result, registration of the vaccine in the event of an outbreak of the virus may be able to proceed much more quickly, subject to the “mock-up” meeting all the requirements of the Act for registration.
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 pandemic of influenza infection involving the H5N1 influenza virus.