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 quantity of antitoxin for the post-exposure prophylaxis of persons exposed to botulinum toxin (a neurotoxin produced by the bacterium, Clostridium botulinum) or treatment of botulism, 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 therapeutic goods 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 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 is a written instrument. The signed instrument specifies the therapeutic good(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 200 bottles of an intravenous solution which is an antitoxin for the neutralisation of toxins, produced by the bacterium Clostridium botulinum. It is manufactured by Chiron Behring GmbH , Emil von Behring Str., 35041, Marburg, Germany.
This product and the quantity designated for exemption has been determined by the Chemical, Biological, and Radiological Committee of the Department of Health and Ageing.
This product is not registered in Australia in accordance with the Therapeutic Goods Act 1989, and as such it has not been subject to the TGA’s evaluation process with respect to quality, efficacy and safety. The product is manufactured to an acceptable standard, and the indication afforded it by the exemption instrument is solely for the post-exposure prophylaxis of persons exposed to botulinum toxin, or the treatment of botulism. Stockpiling of this antidote confers a preparedness on Australian emergency services to deal with a potential terrorist threat involving the use of the neurotoxin produced by the Clostridium botulinum bacterium.
The instrument specifies the nature of the exempt goods, the quantity, the 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 antidotes in an emergency.
The exemption takes effect when it is made and expires on 31 January 2012 or when the product is approved for marketing in Australia for the post-exposure prophylaxis of persons exposed to botulinum toxin or the treatment of botulism, whichever occurs first. The company has no plans to register this product in Australia at this time.
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 this antidote available within Australia to treat botulism and act as post-exposure prophylaxis to exposure to the botulinum toxin. Naturally the product may only be used within its shelf-life.
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, in order to create a preparedness for the Commonwealth to deal with a bioterrorism attack involving the neurotoxin produced by this bacterium.
Overview
The Therapeutic Goods Act 1989 (the Act) was enacted to regulate the provision of therapeutic goods in Australia, ensuring their quality, safety, and efficacy. To address the potential threat of bioterrorism, the Act was amended to include provisions allowing for the exemption of certain therapeutic goods from the normal registration or listing process. This amendment was introduced to enable the stockpiling of essential therapeutic goods that are not registered in Australia but are crucial for public health preparedness against emergencies, including terrorist threats. Enacted by the Australian Parliament, the policy objective behind these amendments is to safeguard public health by ensuring that critical therapeutic goods are available for use during national emergencies. The specific exemption in question, as outlined in the explanatory statement, allows for the stockpiling of a quantity of antitoxin for the post-exposure prophylaxis of persons exposed to botulinum toxin or the treatment of botulism, manufactured by Chiron Behring GmbH in Germany. This exemption is strictly controlled and subject to conditions to ensure the secure storage, appropriate supply, and record keeping of the therapeutic goods, all aimed at bolstering Australia's readiness to counter potential bioterrorism incidents.
Scope and Application
The Therapeutic Goods Act 1989 provides a framework for regulating the quality, safety, and efficacy of therapeutic goods in Australia. In certain circumstances, the Act allows for the exemption of specific therapeutic goods from the usual registration and listing procedures. This is particularly relevant for goods that may be needed during a terrorist threat or attack, even if they have not been assessed by the Therapeutic Goods Administration (TGA) for quality, safety, and efficacy. The exemption applies to therapeutic goods that are unapproved and unavailable in Australia but are necessary for stockpiling to prepare for a potential threat to public health caused by a possible future emergency. The exemption is intended to ensure that these goods can be legally imported and supplied in Australia under strictly controlled conditions. The instrument of exemption specifies the therapeutic goods that are exempt from the requirement of being entered on the Australian Register of Therapeutic Goods (ARTG), allowing them to be legally distributed, supplied, and used for treatment in accordance with the conditions set out in the written instrument. This specific exemption allows for the stockpiling in Australia of 200 bottles of an intravenous solution that serves as an antitoxin for the neutralisation of botulinum toxin, a neurotoxin produced by the bacterium Clostridium botulinum. This product, manufactured by Chiron Behring GmbH in Germany, is not registered in Australia and thus has not undergone the TGA’s evaluation process. The exemption is subject to conditions including the period of effectiveness, quantity, source, importing entities, supply, record keeping, and storage and security requirements. The exemption is intended to ensure preparedness for potential terrorist threats involving the neurotoxin and expires on 31 January 2012 or upon approval of the product for marketing in Australia, whichever occurs first.
Key Provisions
Under the Therapeutic Goods Act 1989, Section 18A provides a mechanism for the Minister for Health and Ageing to exempt specified therapeutic goods from the normal registration or listing procedures. This exemption allows for the stockpiling of certain unapproved therapeutic goods in Australia when it is deemed necessary for national preparedness against a potential terrorist threat. In this case, the exemption pertains to the stockpiling of 200 bottles of an intravenous solution, an antitoxin manufactured by Chiron Behring GmbH, which is intended for the post-exposure prophylaxis of botulinum toxin exposure or the treatment of botulism. This antitoxin, which is not registered in Australia, has been evaluated by the Chemical, Biological, and Radiological Committee of the Department of Health and Ageing and is intended to prepare Australian emergency services for a potential bioterrorism attack.
The obligations imposed by this Act require that the stockpiling of the specified therapeutic goods be conducted under strict control by the Commonwealth. The exemption instrument stipulates the exact nature of the goods, the quantity, and the intended use. It also mandates that the goods are stored securely, supplied appropriately, and that comprehensive records are maintained. The instrument does not detail the storage location or distribution specifics for security reasons and to allow flexibility in emergency scenarios. Furthermore, the exemption is effective immediately upon enactment and will expire on 31 January 2012, or upon the approval of the product for marketing in Australia for its specified uses, whichever comes first.
The Act provides for potential consequences in the event of non-compliance with the conditions set out in the exemption instrument. While the explanatory statement does not enumerate specific offences or penalties, the nature of the exemption suggests that unauthorised use, improper storage, or failure to adhere to the specified conditions could lead to legal repercussions. Typically, breaches of conditions related to the supply and use of therapeutic goods can result in civil or criminal penalties, including fines and imprisonment, depending on the severity of the breach and the intent behind it. The Minister retains the authority to modify the exemption period or revoke the exemption altogether if deemed necessary in accordance with the provisions of the Act.