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 an unregistered vaccine against smallpox, required in the National Interest to create a preparedness to deal with potential terrorist threat.
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 medications or medical devices 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.
As a consequence, the new section 18A of the Act now allows the Minister for Health and Ageing to exempt specified medications and medical devices 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 or medical devices be stockpiled in preparation for a potential threat to public health or (b) medications or medical devices 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) is a written instrument. The signed instrument specifies the medication or medical devices that are exempt from the requirement of having to be entered on the Australian Register of Therapeutic Goods. Thus, these goods may be legally distributed, supplied and used for treatment in accordance with the conditions specified 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. The instrument limits the exemption to a specific strain of the vaccine, the dose per vial, and specifies the source of the vaccine and the supplier of the vaccine. 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 (only health professionals trained in the appropriate administration of the vaccine may administer the goods). 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 for 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 for both reasons of security, as well as to provide a degree of flexibility for the supply and use of the vaccine. Certain quantities of the vaccine are likely to be distributed to the States and Territories, with the chief health officer in each jurisdiction to be responsible for the storage and use of the vaccine, subject to the conditions in the instrument.
The purpose of this instrument is to allow the stockpiling in Australia of an unregistered vaccine against the smallpox virus, in order to create a preparedness to deal with a potential terrorist threat. This exemption permits the stockpiling of approximately 50,000 doses of a French sourced vaccine against smallpox. This vaccine has been prepared from a stock of concentrated material manufactured in the 1970’s for the production of a vaccine used at that time in France. The concentrated material has been stored appropriately, and reconstituted and tested appropriately by the French manufacturer. The TGA intends to test a sample of the vaccine on arrival in Australia for potency and microbiological safety and to repeat test potency annually. This supply of vaccine is intended to maintain a stockpile in Australia until supplies of another vaccine against smallpox currently being produced and tested overseas become available in Australia.
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 involving the smallpox virus.
Overview
The Therapeutic Goods Act 1989 (the Act) was enacted by the Parliament of Australia to regulate the quality, safety, and efficacy of therapeutic goods within the country. In response to the global events following the terrorist attacks on September 11, 2001, the Act was amended to include provisions allowing for the exemption of certain medications and medical devices from the usual registration and listing procedures. This amendment, specifically section 18A, enables the Minister for Health and Ageing to exempt such goods from these requirements if it is deemed to be in the national interest to stockpile them in preparation for a potential threat to public health or to use them in response to an actual threat caused by an emergency. The instrument of exemption under section 18A(1) for paragraph 18A(2)(a) was introduced to facilitate the stockpiling in Australia of an unregistered smallpox vaccine, necessary for preparedness against potential terrorist threats. This measure ensures that, under strict conditions, these goods can be legally distributed and used within Australia, subject to conditions regarding storage, supply, and administration to maintain public health security.
Scope and Application
The Instrument of Exemption under section 18A(1) of the Therapeutic Goods Act 1989 facilitates the stockpiling in Australia of a specified quantity of an unregistered vaccine against smallpox, deemed necessary for national preparedness against potential terrorist threats. This exemption applies to a specific strain of the vaccine, which is sourced from France and supplied under strict conditions to ensure its secure storage and use. The exemption allows the importation and supply of the vaccine without the usual registration requirements, provided it is intended solely for stockpiling and not for immediate use. The instrument specifies the quantity of the vaccine, the authorised suppliers, and the conditions under which the vaccine can be handled, including storage, distribution, and administration by trained health professionals. The exemption is subject to oversight by the Therapeutic Goods Administration, which will conduct testing upon arrival and annually thereafter to ensure the vaccine's potency and safety. The instrument is a disallowable instrument, meaning it can be reviewed and potentially disallowed by Parliament, and it does not extend to the use of the vaccine against an actual threat to public health, which would require a different type of exemption under section 18A(2)(b) of the Act.
Key Provisions
The primary sections of the Instrument of Exemption (F2007B00437) under section 18A(1) of the Therapeutic Goods Act 1989 (the Act) allow the Minister for Health and Ageing to exempt specific medications and medical devices from the registration or listing procedure. This exemption is applicable where it is deemed to be in the national interest to stockpile these items in preparation for a potential threat to public health (section 18A(2)(a)) or in response to an actual threat to public health caused by an emergency (section 18A(2)(b)). The exemption is issued in the form of a written instrument, specifying the exempted medications or medical devices, the conditions under which they can be distributed and used, and the oversight mechanisms in place.
This Act imposes several obligations on the parties involved. The exemption allows for the importation and supply of an unregistered smallpox vaccine, which must be sourced from a specific supplier and stored under strict Commonwealth control. The instrument stipulates that only health professionals trained in the appropriate administration of the vaccine may administer it. Furthermore, it imposes record-keeping requirements on those importing and supplying the vaccine and sets out conditions for its disposal and compensation entitlements. Certain details regarding storage and distribution conditions are kept unspecified to maintain security and provide flexibility.
Failure to comply with the conditions specified in the exemption instrument may result in various legal consequences. The Act does not explicitly detail penalties for non-compliance with the exemption conditions; however, breaches of the Therapeutic Goods Act 1989 generally attract civil or criminal penalties. For civil contraventions, the maximum penalty can include fines up to $220,000 for individuals and $1,100,000 for bodies corporate, as outlined in section 25 of the Act. For criminal contraventions, individuals may face imprisonment for up to five years, a fine of up to $220,000, or both, as per section 27 of the Act. Additionally, the instrument is subject to disallowance under section 46A of the Acts Interpretation Act 1901, which provides a mechanism for parliamentary review and potential nullification of the exemption if deemed inappropriate.