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 an antibiotic, doxycycline, to treat Anthrax infection, required in the national interest to create a preparedness to deal with a potential terrorist threat.
The Commonwealth considers it necessary to have a mechanism in place by which medications that are unapproved and unavailable in Australia, but might be needed 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 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 be stockpiled in preparation for a potential threat to public health or (b) medications 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) of the Act is 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 (ARTG). 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 under paragraph 18A(2)(a) of the Act 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. In addition, the exemption is subject to conditions which include: the period for which the exemption is to have effect; the quantity of goods that are exempt; the source of those goods; the persons or class of persons who can import the goods; the supply of those goods; record keeping requirements; and storage and security of those goods.
The purpose of this instrument is to allow the stockpiling in Australia of a quantity of the antibiotic, doxycycline, to be used to prevent and treat anthrax infection in humans in the event of a terrorist attack. Although registered in Australia for supply for certain therapeutic uses, such as atypical pneumonia, for example, (ie. has been subject to the TGA’s evaluation of quality, efficacy and safety for these other uses), the product does not have a registered indication in Australia for the prevention and treatment of anthrax infection. Hence the supply of doxycycline in Australia for the prevention and treatment of anthrax infection requires this specific exemption. Stockpiling of this antibiotic medicine contributes to a preparedness to deal with a potential terrorist threat involving the use of the anthrax bacterium.
The instrument also specifies the nature of the exempt goods, the quantity, the specific indication for which the goods can be used, and the source of these goods. 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, appropriately supplied and appropriate records are kept. Other conditions include the disposal arrangements.
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 practical supply and use of the doxycycline in an emergency.
The exemption takes effect when it is made and expires on 31 May 2010 or when the product is approved for marketing in Australia for the prevention and treatment of anthrax infection in humans, whichever occurs first. The Minister may reduce the period of exemption, or revoke the exemption, in accordance with the Act. However, the period provided for in the instrument is intended to ensure as far as possible that while bioterrorism acts remain a possibility, there will be supplies of doxycycline available within Australia to treat and prevent anthrax infection.
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 anthrax organism.
Overview
The Instrument of Exemption under subsection 18A(1) of the Therapeutic Goods Act 1989 (the Act) was enacted to address the problem of ensuring the availability of specific medications for potential terrorist threats, particularly for the stockpiling of doxycycline to treat anthrax infections. The Act was introduced to provide a mechanism for the Minister for Health and Ageing to exempt certain unapproved and unavailable therapeutic goods from the usual registration process, where such exemptions are deemed necessary in the national interest to prepare for or respond to a public health emergency. The policy objective behind this exemption is to enhance national preparedness for bioterrorism threats by ensuring the availability of essential medications like doxycycline, which, while registered for other uses, are not approved for the treatment of anthrax in Australia. The exemption is subject to stringent conditions to maintain control over the storage, supply, and distribution of the medication, and it expires either on 31 May 2010 or when the product is approved for its intended use, whichever comes first.
Scope and Application
The Instrument of Exemption under subsection 18A(1) of the Therapeutic Goods Act 1989 is designed to permit the stockpiling in Australia of a specified quantity of the antibiotic doxycycline, intended for use in treating anthrax infection in the event of a terrorist threat. This exemption applies to the Minister for Health and Ageing, who has the authority to exempt certain medications from the usual registration and listing procedures in the Act when it is deemed to be in the national interest. The exemption specifically targets doxycycline, which, while registered in Australia for other therapeutic uses, does not have a registered indication for the prevention and treatment of anthrax infection. This exemption enables the stockpiling of doxycycline to prepare for potential bioterrorism threats, ensuring that there are sufficient supplies available to treat anthrax infection if needed. The exemption is subject to strict conditions, including the period of effect, quantity, source, and method of supply, as well as record-keeping and security requirements to ensure the controlled distribution of the antibiotic. The exemption is in effect from the date it is issued and will expire on 31 May 2010 or when the product is approved for marketing in Australia for the prevention and treatment of anthrax infection, whichever comes first. The Minister retains the power to reduce the exemption period or revoke it if necessary. This measure is considered crucial for national public health preparedness without a significant impact on industry, as it addresses a specific and urgent need related to bioterrorism.
Key Provisions
The main sections of this legislation focus on the exemption of a specific antibiotic, doxycycline, from the usual registration and listing requirements under the Therapeutic Goods Act 1989 (the Act) (s.18A). This exemption allows for the stockpiling of doxycycline in Australia, specifically to prepare for the potential threat of anthrax infection as a result of a terrorist attack (s.18A(2)(a)). This exemption is a written instrument signed by the Minister for Health and Ageing, which details the conditions under which the exemption applies, including the period of effect, quantity, source, and conditions for storage and supply of the antibiotic (s.18A(1)). The exemption also includes stipulations on record-keeping and disposal arrangements for the medication (s.18A(1)). The instrument is designed to ensure that the antibiotic is securely stored and appropriately supplied, and that it is only used for the specified purpose of treating anthrax infection.
Under the Act, the obligations imposed on the parties involved include strict adherence to the conditions outlined in the exemption instrument (s.18A(1)). This includes the requirement to securely store the antibiotic, appropriately supply it in accordance with the specified conditions, and maintain proper records of its storage and distribution (s.18A(1)). The instrument also specifies that the goods are under the strict control of the Commonwealth, which implies that the storage and supply of the antibiotic must comply with the requirements set out in the exemption (s.18A(1)). The Minister has the authority to reduce the period of exemption or revoke it altogether if necessary, as per the provisions of the Act (s.18A(1)).
In terms of penalties and consequences for breach, the Act does not explicitly state penalties for non-compliance with the exemption conditions. However, given the critical nature of the exemption for national security purposes, any breaches could potentially lead to severe legal consequences. The exemption is a disallowable instrument under section 46A of the Acts Interpretation Act 1901, which means that Parliament has the power to review and potentially disallow the instrument if it deems it necessary (s.46A). Additionally, any misuse or inappropriate distribution of the antibiotic could be subject to penalties under other sections of the Therapeutic Goods Act 1989 or other relevant legislation, though specific penalties are not outlined in this instrument.