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 two distinct therapeutic goods. Namely, an antitoxin for the neutralisation of toxins produced by botulinum infection, and cidofovir, an antiviral agent considered of benefit in the treatment of complications of vaccination against the smallpox virus, and in the treatment of infection with the smallpox virus itself.
Both of these products will replace stock that is currently in the stockpile. These goods have reached the end of their shelf-life, and require replacement. The quantities to be exempted are the same as previously, i.e. 500 vials of 375mg/5mL cidofovir for injection and 200 bottles of 250mL botulinum antitoxin preparation.
These therapeutic goods are not registered for use in Australia for the specific indications intended for use from the NMS. However, cidofovir is registered in Australia for the treatment of a viral retinitis in AIDS patients. Both these products are manufactured to acceptable international standards of Good manufacturing Practice (GMP). As these products are not registered in Australia for the uses intended through the NMS, they are considered “unapproved” under the Act and a section 18A exemption is required.
The NMS is a strategic reserve of essential therapeutic goods for use in a public health emergency in Australia. The therapeutic goods to be exempted via section 18A of the Act and be placed in the NMS, as well as the quantities involved, have been determined by the Office of Health Protection (OHP), 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 instances of botulinum or smallpox infection, as well as complications from the vaccination of persons against the smallpox virus.
Overview
The Instrument of Exemption under subsection 18A(1) of the Therapeutic Goods Act 1989 (the Act) was enacted in 2008 to address the need for preparedness against potential terrorist threats, specifically allowing for the stockpiling of unregistered and unapproved therapeutic goods in Australia. This legislative instrument was introduced in response to the terrorist attacks of September 11, 2001, and aims to facilitate the legal import and supply of therapeutic goods that might be required in a national health emergency but are not registered on the Australian Register of Therapeutic Goods (ARTG). Enacted by the Parliament of Australia, the policy objective of this instrument is to ensure that essential therapeutic goods are available for use under strictly controlled conditions when needed to mitigate public health threats. The instrument specifies the conditions under which certain therapeutic goods can be stockpiled, including limitations on quantity, control by the Commonwealth, and conditions for storage, supply, and disposal, all aimed at maintaining security and flexibility in emergency preparedness.
Scope and Application
The Instrument of Exemption under subsection 18A(1) of the Therapeutic Goods Act 1989 applies to the stockpiling of certain therapeutic goods within Australia, specifically targeting preparedness for potential terrorist threats that may pose a public health risk. This exemption enables the Minister for Health and Ageing to allow the stockpiling of unregistered and unapproved therapeutic goods in the national interest, which under normal circumstances would not be permitted for import, supply, or use in Australia due to the absence of quality, safety, and efficacy assessments by the Therapeutic Goods Administration (TGA). This exemption is particularly relevant for therapeutic goods such as an antitoxin for botulinum infection and cidofovir for smallpox-related complications, which are critical for the National Medicines Stockpile (NMS). The exemption is geographically confined to Australia and applies to the stockpiling activities overseen by the Commonwealth, ensuring that the therapeutic goods are securely stored, appropriately supplied, and used under strict conditions. The exemption instrument specifies the quantity of the exempted goods, the eligible suppliers, and sets out detailed conditions for record-keeping, disposal, and compensation entitlements. While certain security-sensitive details regarding storage and distribution are not fully disclosed, the instrument ensures that the exempted therapeutic goods are under the strict control of the Commonwealth, thereby facilitating a coordinated national response to potential public health emergencies.
Key Provisions
The key operative sections of this legislation, specifically F2008L03790, are detailed under subsection 18A(1) of the Therapeutic Goods Act 1989 (the Act), which empowers the Minister for Health and Ageing to exempt certain therapeutic goods from the normal registration or listing requirements. This exemption is only valid if it is deemed to be in the national interest, either for stockpiling in anticipation of a potential public health threat (subsection 18A(2)(a)) or for responding to an actual public health threat (subsection 18A(2)(b)). The exemption must be in the form of a written instrument, signed by the appropriate authority, and it specifies the therapeutic goods that are exempt from the requirement to be entered on the Australian Register of Therapeutic Goods (ARTG). This allows the exempted goods to be legally imported, distributed, supplied, and used for treatment in Australia, subject to the conditions outlined in the written instrument.
The Act imposes several obligations on the parties involved. Firstly, the exemption is strictly controlled by the Commonwealth, and there are specific conditions that must be adhered to regarding the quantity of goods exempted, the entities permitted to import and supply these goods to the Commonwealth, and the requirements for record-keeping. Furthermore, the therapeutic goods must be securely stored and appropriately supplied and used. Although certain details regarding the storage and distribution conditions are not specified in the instrument for security reasons, the Act ensures that the exempted goods remain under strict control and are managed in a way that ensures they will be available when needed.
In terms of the consequences of breaching the conditions of this exemption, the legislation does not specify particular offences or penalties within the instrument itself. However, general provisions of the Therapeutic Goods Act 1989 and other related legislation could apply in cases of non-compliance. This might include civil penalties for breaches of the Act or related regulations, or even criminal charges if the breach results in harm to the public. The severity of the penalties would depend on the nature and extent of the breach, and could potentially include fines or imprisonment, depending on the specific circumstances and the discretion of the court.
This legislation is designed to ensure that Australia is prepared to deal with potential public health emergencies, such as terrorist threats involving biological agents like botulinum toxin or smallpox. By allowing the exemption of certain therapeutic goods from normal registration requirements, it provides a mechanism for these goods to be stockpiled and made available for use when needed, without the delay associated with the standard approval process. The careful control and management of these exempted goods are critical to ensuring that they are available and effective when required, and the Act sets out clear conditions to manage this process.