Explanatory Statement
Subject: Instrument of Exemption under section 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 amoxycillin antibiotic suspension, for the prevention and treatment of inhalation anthrax (post-exposure), required in the national interest to create a preparedness to deal with 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 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.
The new section 18A of the Act now 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 medications 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) for the purpose of 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 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 amoxycillin antibiotic suspension, to be used to prevent and treat inhalation anthrax in humans (post-exposure) in the event of a terrorist attack. Although registered in Australia for supply for certain therapeutic uses, the product does not have a registered indication in Australia for the prevention and treatment of inhalation anthrax (post-exposure). This stockpile contributes to a preparedness to deal with a potential terrorist threat.
The instrument also specifies the nature of the exempt goods and the quantity of these goods which will form part of the stockpile. 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 recorded appropriately. Other conditions include 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 supply and use of the amoxycillin.
The exemption takes effect when it is made and expires on 31 December 2008. 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 whilst bioterrorism remains a possibility, there will be supplies of amoxycillin suspension available within Australia to meet any emergency.
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.
Overview
The Therapeutic Goods Act 1989, enacted by the Parliament of Australia, addresses the need for a regulatory framework that allows for the controlled stockpiling of medications that may be necessary in the event of a terrorist attack or a public health emergency. This Act includes provisions under section 18A, which empowers the Minister for Health and Ageing to exempt specified medications from the usual registration or listing procedures when it is deemed necessary for national security purposes. The policy objective of this provision is to ensure that Australia can legally import and supply medications that are not normally available or approved within the country under strictly controlled conditions. This exemption allows for the stockpiling of amoxycillin antibiotic suspension to be used in the prevention and treatment of inhalation anthrax post-exposure, thereby contributing to the nation's preparedness against potential bioterrorism threats. The exemption is subject to specific conditions, including the duration of the exemption, the quantity of goods involved, the source of the goods, and requirements for secure storage and appropriate record-keeping.
Scope and Application
The Therapeutic Goods Act 1989 (the Act) facilitates the exemption of specific medications from the usual registration or listing requirements for the purpose of stockpiling in Australia to prepare for potential threats to public health, such as bioterrorism. This is particularly relevant in the context of the proposed instrument of exemption under section 18A(1) of the Act, which allows for the stockpiling of amoxycillin antibiotic suspension for the prevention and treatment of inhalation anthrax (post-exposure). This exemption applies to medications that are not registered or available in Australia but are deemed necessary in the national interest. The exemption applies to the stockpiling of these goods under strictly controlled conditions, including specific quantities, sources, and security measures, ensuring that they are available for emergency use if required. The exemption is subject to stringent conditions regarding the storage, supply, and record-keeping of the therapeutic goods. Although the exemption is designed to be flexible to accommodate potential emergencies, it expires on 31 December 2008, with the possibility for the Minister to adjust or revoke the exemption as necessary. The exemption does not extend to the registration of the therapeutic goods on the Australian Register of Therapeutic Goods (ARTG), thus they remain unapproved for general supply and use in Australia under normal circumstances.
Key Provisions
The Therapeutic Goods Act 1989 (the Act) includes a new section 18A (subsections 18A(1) and 18A(2)) which enables the Minister for Health and Ageing to exempt specified medications from the usual registration or listing procedures when it is deemed necessary in the national interest (subsection 18A(2)). This provision allows for the stockpiling of medications such as amoxycillin antibiotic suspension for the prevention and treatment of inhalation anthrax (post-exposure) in preparation for a potential terrorist threat. The exemption is documented in a written instrument signed by the Minister, which outlines the specific medications, the duration of the exemption, the quantity of goods, the source of these goods, and the conditions under which they can be imported, supplied, and stored. This exemption applies to medications that are not assessed by the Therapeutic Goods Administration (TGA) for quality, safety, and efficacy and are not registered for specific uses in Australia.
The Act imposes several obligations on the parties involved. These include ensuring that the exempted therapeutic goods are securely stored and managed according to the conditions set out in the exemption instrument. The instrument specifies the nature of the exempt goods and the quantity that will be stockpiled, ensuring these goods are under the strict control of the Commonwealth. The conditions also encompass record-keeping requirements, the persons or class of persons authorised to import and supply the goods, and the disposal arrangements for these goods. The instrument is designed to provide flexibility in the supply and use of the amoxycillin while ensuring it is available for emergency use. However, certain details regarding storage conditions are not specified in the instrument to maintain security and provide operational flexibility.
Under the Act, there are potential consequences for non-compliance with the conditions specified in the exemption instrument. Although the Act does not detail specific offences or penalties for breaching the conditions of this exemption, general provisions within the Act likely apply. Offences under the Therapeutic Goods Act can include serious civil and criminal penalties, including fines and imprisonment, depending on the nature and severity of the breach. The instrument notes that it is a necessary public health measure and does not require a regulatory impact statement due to its urgency and limited impact on industry. The exemption is intended to ensure that Australia is prepared to respond to a potential bioterrorism attack by having necessary medications available.