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) of the Act, to allow the stockpiling in Australia of a specified quantity of an unregistered and “unapproved” therapeutic good, being cyanokits that can be used to treat known or suspected cyanide poisoning, that are required in the national interest to create a preparedness to deal with a potential terrorist threat.
The Australian Government has a mechanism in place by which therapeutic goods that are not approved for marketing or entered on the Australian Register of Therapeutic Goods (ARTG), and thus unavailable in Australia, but might be needed in preparation for, or during a terrorist threat or attack or other public health emergency, 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 therapeutic goods that are exempt from the requirement of having to be entered on the ARTG. 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; record keeping requirements; disposal and entitlement to compensation.
The purpose of this instrument is to allow the replacement of out-of-date stock in the National Medicines Stockpile (NMS) of cyanokits that are used in an emergency to treat known or suspected cyanide poisoning.
In addition to replacement of the existing out of date stock, the purpose of this instrument is also to allow procurement of additional stocks of cyanokits for the NMS.
This instrument permits the stockpiling of 2400 cyanokits. A cyanokit consists of two vials, each containing 2.5 grams of active agent hydroxocobalamin powder for intravenous infusion, two transfer devices, one intravenous infusion set and one short catheter for administration to children. The powder requires reconstitution with a normal saline diluent before administration. The diluent is not included in the kit.
The cyanokits are manufactured by Merck Santé s.a.s., 37 rue Saint-Romain, 69379 Lyon Cedex 08, France.
For reasons of security, certain facts relating to the conditions of storage of the cyanokits have not been stated in detail in the instrument. The non-specific nature of the storage site and distribution conditions is made for both reasons of security, as well as to provide a degree of flexibility for the supply and use of the medicine.
These cyanokits have not been assessed for quality, safety and efficacy by the TGA. Therefore, they have not been subject to the usual rigorous evaluation process that freely marketed therapeutic goods must meet. However, the manufacturing of the products does conform with acceptable international standards of Good Manufacturing Practice (GMP).
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 to be placed in the NMS, as well as the quantities involved, have been determined by the Office of Health Protection (OHP) of the Department of Health and Ageing, in consultation with appropriate Australian Government agencies, relevant counter terrorism experts and State and Territory health authorities.
The exemption takes effect the day after it is registered in the Federal Register of Legislative Instruments and expires on the earlier of the following: 30 April 2017; or when the goods receive a marketing approval in Australia commensurate with their approved intended use under this exemption and for the purpose of the NMS.
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 emergency treatment of known or suspected cyanide poisoning.
Overview
The Therapeutic Goods Act 1989 was enacted to regulate the supply of therapeutic goods in Australia, aiming to ensure their quality, safety, and efficacy. One of its provisions, section 18A, allows the Minister for Health and Ageing to exempt certain therapeutic goods from the registration or listing requirements under the Act if deemed necessary in the national interest to prepare for or respond to potential public health emergencies, including terrorist threats. This exemption mechanism ensures that essential therapeutic goods, which might not have undergone the usual approval processes, can be legally imported and supplied under strictly controlled conditions. The policy objective is to enhance Australia's preparedness for public health emergencies by enabling the stockpiling of critical therapeutic goods, such as cyanokits for treating cyanide poisoning, within the National Medicines Stockpile. The exemption provided under this Act facilitates the replacement of outdated stock and the procurement of additional supplies, ensuring a strategic reserve is available to meet potential future emergencies.
Scope and Application
The Therapeutic Goods Act 1989, through its section 18A, provides the Minister for Health and Ageing the authority to exempt certain therapeutic goods from the usual registration or listing requirements on the Australian Register of Therapeutic Goods (ARTG), if it is deemed to be in the national interest to stockpile these goods in anticipation of a potential terrorist threat or other public health emergency. This exemption allows for the importation and supply of these therapeutic goods under strictly controlled conditions, even though they may not have undergone the usual quality, safety, and efficacy assessments by the Therapeutic Goods Administration (TGA). Specifically, the exemption instrument under consideration permits the stockpiling of 2400 cyanokits, which are essential for treating cyanide poisoning, within the National Medicines Stockpile (NMS). These kits, manufactured by Merck Santé s.a.s. in France, consist of two vials of hydroxocobalamin powder, necessary medical devices for administration, and require reconstitution with a normal saline diluent before use. This exemption applies to the Commonwealth of Australia and is designed to ensure that the cyanokits are securely stored, appropriately supplied, and used under the oversight of the Commonwealth government. The exemption also includes conditions for record-keeping, disposal, and compensation entitlements, while ensuring that the specifics of storage and distribution remain undisclosed for security reasons. The exemption is effective from the day after it is registered in the Federal Register of Legislative Instruments and will remain in effect until the earlier of 30 April 2017 or when the goods receive a marketing approval in Australia.
Key Provisions
Section 18A of the Therapeutic Goods Act 1989 (the Act) allows the Minister for Health and Ageing to exempt certain therapeutic goods from the normal registration or listing procedures under the Act, provided it is in the national interest to stockpile these goods in preparation for a potential public health threat, such as a terrorist attack. This exemption is documented in a written instrument, which specifies the therapeutic goods exempt from the requirement of being entered on the Australian Register of Therapeutic Goods (ARTG). This instrument permits the stockpiling of 2400 cyanokits, which are used to treat known or suspected cyanide poisoning. These kits, consisting of two vials of hydroxocobalamin powder and necessary administration equipment, are manufactured by Merck Santé s.a.s. in France and have not been assessed by the Therapeutic Goods Administration (TGA) for quality, safety, and efficacy, but conform to international Good Manufacturing Practice (GMP) standards.
The obligations imposed by this exemption require that the exempted therapeutic goods, in this case, cyanokits, be stored securely and supplied only to authorised persons or classes of persons. Record-keeping requirements are also specified, ensuring transparency and accountability in the handling of these goods. The instrument stipulates that the goods are under the strict control of the Commonwealth, and conditions apply to ensure they are stored, supplied, and used appropriately. The purpose of this exemption is to replace outdated stock in the National Medicines Stockpile (NMS) and procure additional stocks, thereby maintaining preparedness for emergency treatment of cyanide poisoning.
The Act imposes several requirements on the parties involved. Firstly, the exemption applies only to the specific therapeutic goods listed in the written instrument, which in this case are the 2400 cyanokits. The goods must be sourced from the specified supplier, Merck Santé s.a.s., and any distribution must comply with the conditions outlined in the instrument. Furthermore, the instrument requires detailed record-keeping to track the import, storage, distribution, and use of the cyanokits. The instrument also provides for the disposal of these goods and entitlements to compensation in specified circumstances. The storage site and distribution conditions are not detailed publicly due to security reasons, but the instrument ensures that the goods will be securely stored and appropriately supplied.
In terms of consequences for breach, the Act does not explicitly state offences, penalties, or civil/criminal consequences for non-compliance with the conditions of this exemption. However, as the exemption is a legislative instrument, any breaches of the conditions could potentially be subject to legal action under the relevant legislative frameworks. Non-compliance could lead to civil or criminal penalties depending on the severity of the breach and the jurisdiction's laws. The instrument is designed to ensure preparedness for public health emergencies, and therefore, adherence to its conditions is critical to maintain the integrity and effectiveness of the national stockpile.