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 three separate unregistered therapeutic goods required in the national interest to create a preparedness to deal with several potential terrorist threats.
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 therapeutic goods that are not approved for marketing and entered on the Australian Register of Therapeutic Goods (ARTG), and thus 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 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 medication(s) that are exempt from the requirement of having to be entered on the Australian Register of Therapeutic Goods. 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 disallowable instrument for the purposes of section 46B of the Acts Interpretation Act 1901. 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 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 certain unregistered medicines for use against arsenic contamination, anthrax infection, and radioactive isotope contamination. This exemption permits the stockpiling of:
4,000 (3mL) ampoules (in boxes of 10) of British anti-Lewisite (BAL) in oil, [dimercaprol injection USP]; each 1mL containing 100mg dimercaprol in 200mg benzyl benzoate and 700mg peanut oil;
3,000 (5mL) multidose vials, 10 doses/vial of BioThrax vaccine (anthrax vaccine adsorbed);
150,000 tablets of ThyroSafe (potassium iodide USP) 65mg tablets, in packets of 10 tablets.
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 terrorist attacks involving arsenic, anthrax, and radioactive isotopes.
Overview
The Therapeutic Goods (Exemption from Requirements – Unregistered Therapeutic Goods for Emergency Preparedness) Instrument 2007 (F2007L02271) was enacted in response to the pressing need for preparedness against potential terrorist threats, specifically those involving arsenic, anthrax, and radioactive isotopes. This legislation was introduced to address the gap in Australia's ability to quickly and legally stockpile unregistered therapeutic goods that might be necessary during such emergencies. Enacted by the Minister for Health and Ageing under the authority granted by the Therapeutic Goods Act 1989, the policy objective of this exemption is to ensure that Australia can effectively respond to public health threats without the delay associated with the usual registration processes. The exemption allows for the controlled stockpiling of specified quantities of therapeutic goods, which are not ordinarily registered on the Australian Register of Therapeutic Goods, thereby enabling a rapid response to potential terrorist threats.
Scope and Application
The Instrument of Exemption under subsection 18A(1) of the Therapeutic Goods Act 1989 applies to specific unregistered therapeutic goods necessary for preparedness against potential terrorist threats. This Act allows for the exemption of these goods from the normal registration or listing procedures, enabling their stockpiling and use in Australia under strictly controlled conditions. The exemption applies to the Minister for Health and Ageing who may authorise the exemption if it is deemed to be in the national interest to stockpile these goods in preparation for a potential threat to public health, or to use them in response to an actual emergency. This exemption extends to the specified therapeutic goods required for dealing with arsenic contamination, anthrax infection, and radioactive isotope contamination. The exemption is a disallowable instrument under section 46B of the Acts Interpretation Act 1901, limiting the quantity of medicine exempted and specifying the source and supplier of the drug(s). The instrument ensures that the exempted goods are under strict Commonwealth control, with conditions for secure storage, appropriate supply, and use. It also includes provisions for record-keeping, disposal, and compensation entitlement. This exemption does not apply to any other therapeutic goods not specified in the instrument and does not impact industry in general, being regarded as a necessary public health measure.
Key Provisions
The main operative sections of the legislation, F2007L02271, pertain to the exemption under section 18A(1) of the Therapeutic Goods Act 1989 (the Act) which allows for the stockpiling of certain unregistered therapeutic goods in the national interest (section 18A(2)(a)). This exemption is specifically for three therapeutic goods: British anti-Lewisite (BAL) in oil, BioThrax vaccine, and ThyroSafe tablets, which are required for preparedness against arsenic contamination, anthrax infection, and radioactive isotope contamination, respectively (section 18A(2)(a)). The exemption is granted through a written instrument signed by the Minister for Health and Ageing, detailing the specific therapeutic goods exempted from the registration requirements on the Australian Register of Therapeutic Goods (ARTG) (section 18A(1)).
The Act imposes several obligations on the parties involved. Firstly, it mandates that the exempted therapeutic goods are to be under the strict control of the Commonwealth, ensuring that they are securely stored and appropriately supplied and used. The instrument specifies the quantity of each therapeutic good exempted, the persons or classes of persons who can import and supply the goods to the Commonwealth, and the record-keeping requirements for these transactions (section 18A(2)(a)). Additionally, conditions for disposal and entitlement to compensation are outlined in the instrument. The Act also ensures that the therapeutic goods are sourced from specified suppliers and that they remain under Commonwealth control.
The legislation also establishes consequences for any breaches of the conditions specified in the exemption instrument. As the exemption is a disallowable instrument under section 46B of the Acts Interpretation Act 1901, any contravention of the conditions could result in civil or criminal penalties. The specific penalties are not detailed in the explanatory statement, but generally, breaches of the Therapeutic Goods Act 1989 can lead to substantial fines and, in serious cases, imprisonment. The exact penalties would depend on the nature and severity of the breach, as well as any relevant provisions within the Therapeutic Goods Act 1989 and other applicable laws. The security of the stockpiled therapeutic goods is paramount, and any mishandling or unauthorized use could result in significant legal repercussions.