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 unregistered and “unapproved” therapeutic goods required in the national interest to create a preparedness to deal with 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 legislative instrument for the purposes of the Legislative Instruments Act 2003. 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 addition to the National Medicines Stockpile (NMS) of a large quantity of vaccine against the H5N1 influenza virus, in order to create a preparedness to deal with potential or actual outbreaks of this infection. This exemption permits the stockpiling of 500,000 doses of vaccine (in 10-dose glass vials).
This vaccine is not registered for use in Australia and thus not able to be freely marketed. Hence it is considered “unapproved” under the Act and a section 18A exemption is required.
The National Medical Stockpile (NMS) is a strategic reserve of essential vaccines, antibiotics, antivirals and antidotes for use in a public health emergency in Australia. Decisions on the content of the counter terrorism content of the NMS have been taken in consultation with appropriate Australian Government agencies, relevant counter terrorism experts and State and Territory health authorities.
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 potential or actual outbreaks of this infection.
Overview
The Therapeutic Goods Amendment (Stockpiling of Therapeutic Goods in Response to Terrorist Threats) Instrument 2008 was introduced to address the need for a mechanism to stockpile unregistered and unapproved therapeutic goods in Australia in response to potential terrorist threats. Enacted under the authority of the Therapeutic Goods Act 1989 by the Parliament of Australia, the policy objective of this legislative instrument is to ensure national preparedness for public health emergencies caused by potential terrorist threats. This exemption allows for the importation and supply of therapeutic goods that are not normally available in Australia, providing a strategic reserve in the form of the National Medicines Stockpile. The instrument specifies the conditions under which these goods can be stored, supplied, and used, ensuring that they are under strict Commonwealth control and subject to security measures that have not been disclosed in detail for security reasons. The exemption aims to facilitate the stockpiling of essential vaccines, antibiotics, antivirals, and antidotes, enabling a rapid response to public health emergencies, particularly in relation to potential outbreaks of the H5N1 influenza virus.
Scope and Application
The Instrument of Exemption under subsection 18A(1) of the Therapeutic Goods Act 1989 (the Act) applies to therapeutic goods that are not approved or registered for marketing and use in Australia, but are necessary for stockpiling to prepare for potential terrorist threats. This Act is applicable at the Commonwealth level and pertains to entities and individuals involved in the import, distribution, supply, and use of these therapeutic goods. The exemption allows for the stockpiling of specific unapproved therapeutic goods in the national interest to address potential threats to public health. The exemption is limited to 500,000 doses of a vaccine against the H5N1 influenza virus, which is not registered for use in Australia. The exemption outlines strict conditions for the storage, supply, and use of these therapeutic goods, ensuring they remain under the control of the Commonwealth. Conditions include record-keeping requirements, disposal procedures, and compensation entitlements, although certain storage details are redacted for security reasons. The exemption is a legislative instrument for the purposes of the Legislative Instruments Act 2003 and does not extend to general industry as it is deemed a necessary public health measure.
Key Provisions
The key provisions of this legislation, specifically the F2008L00135 Instrument of Exemption, revolve around section 18A of the Therapeutic Goods Act 1989 (the Act) (s1). This section allows the Minister for Health and Ageing to exempt certain therapeutic goods from the normal registration or listing requirements of the Act. The purpose of this exemption is to facilitate the stockpiling of therapeutic goods that are not registered or listed on the Australian Register of Therapeutic Goods (ARTG) but are deemed necessary for national preparedness against potential public health threats, such as those posed by terrorism or infectious diseases like the H5N1 influenza virus (s2). The exemption applies when it is considered in the national interest to stockpile these goods in anticipation of an emergency or to use them in response to an actual threat (s3).
Under this Act, the exemption is implemented through a written instrument signed by the Minister (s4). This instrument specifies the therapeutic goods that are exempt from the requirement of being registered or listed on the ARTG, thus permitting their importation, distribution, supply, and use in Australia under strictly defined conditions (s5). The conditions include the quantity of the exempted goods, the entities allowed to import and supply these goods to the Commonwealth, and the stipulations for secure storage, record-keeping, and disposal of these goods (s6). Furthermore, the instrument makes clear that the exempted goods remain under the strict control of the Commonwealth and outlines the circumstances under which compensation may be claimed (s7).
Breaching the conditions set out in the exemption instrument can result in significant legal consequences. The Act does not specify particular offences or penalties within the text of the exemption instrument itself. However, the general legal framework under the Therapeutic Goods Act 1989 and related regulations would apply. These could include fines and imprisonment for offences such as unauthorised importation, supply, or use of therapeutic goods. The penalties vary depending on the severity of the offence but can include substantial fines and imprisonment terms, reflecting the seriousness of circumventing public health and safety regulations (s8). The specific penalties are detailed in other sections of the Therapeutic Goods Act and relevant regulations, which must be adhered to alongside the conditions outlined in this exemption instrument.