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 a specified quantity of an unregistered immunoglobulin preparation to combat infection with the vaccinia virus, required in the national interest to create a preparedness to deal with a 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 caused by a possible future emergency or (b) medications or medical devices 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) must be a written instrument. The signed instrument specifies the medication(s) 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 for the purposes of paragraph 18A(2)(a) to allow 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 quantity of medicine exempted, and specifies the source and supplier of the drug. 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 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 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 stockpiling in Australia of an unregistered immunoglobulin against the vaccinia virus, the agent used to vaccinate against smallpox virus infection. This is considered necessary for instances when complications arise from the smallpox vaccination, such as when it is inadvertently given to an immunosuppressed individual or similar, and widespread infection occurs rather than the typical raised lesion at the vaccination site. It may also help combat infection with the smallpox virus. This exemption permits the stockpiling of 500 vials of VIG Vaccinia Immunoglobulin manufactured by Cangene Corporation, 104 Chancellor Matheson Road, Winnipeg, Manitoba, Canada, R3T 5Y3. This supply of immunoglobulin is intended to maintain a stockpile in Australia and may also be used in the treatment of complications of vaccination against smallpox and suspected/proven smallpox infection.
The medicine is not registered in Australia (i.e. has not undergone assessment for quality, safety and efficacy by the Therapeutic Goods Administration), however has been given a form of registration in the USA by the Food and Drug Administration, where the registration is subject to the future provision of additional information about the safety and efficacy of the product, once such data are generated.
This supply of VIG Immunoglobulin is intended to maintain a stockpile in Australia for potential treatment of complications of vaccination against the smallpox virus, and suspected or proven smallpox infection.
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 a bioterrorism attack involving the smallpox virus, or with complications surrounding vaccination of Australians against smallpox infection.
Overview
The Therapeutic Goods Act 1989 was amended to include a new section 18A, which was enacted in response to the global threat of bioterrorism and the need for preparedness against potential attacks involving smallpox. The Act, administered by the Therapeutic Goods Administration, aims to ensure the quality, safety, and efficacy of therapeutic goods. However, in extraordinary circumstances, the Act allows for exemptions to its rigorous registration and listing procedures to facilitate the stockpiling of necessary but unregistered therapeutic goods. The enactment of section 18A permits the Minister for Health and Ageing to exempt specific medications or medical devices from registration when it is deemed to be in the national interest to stockpile these items in anticipation of a potential public health threat or to respond to an actual emergency. This legislative change was driven by the need to have a mechanism to legally import and supply unapproved medications or medical devices in Australia under controlled conditions, particularly in light of the events of September 11, 2001. The policy objective is to enhance Australia's preparedness to address potential bioterrorism threats, including the stockpiling of immunoglobulin preparations against vaccinia virus infection, essential for managing complications arising from smallpox vaccinations or combating smallpox infection itself.
Scope and Application
The Instrument of Exemption under subsection 18A(1) of the Therapeutic Goods Act 1989, specified in F2006L04012, allows for the exemption of certain therapeutic goods from the registration requirements of the Act to ensure preparedness against potential bioterrorism threats. This instrument applies specifically to the stockpiling of an unregistered immunoglobulin preparation against the vaccinia virus, which is crucial for addressing complications arising from smallpox vaccinations and potential smallpox infections. The exemption is limited to the national interest, permitting the stockpiling of a specified quantity of VIG Vaccinia Immunoglobulin manufactured by Cangene Corporation, and is subject to stringent conditions that govern its importation, supply, storage, and use within Australia. The exemption is applicable to the Commonwealth and is designed to ensure the secure and controlled distribution of these therapeutic goods in anticipation of a public health emergency. The exemption does not extend to any other therapeutic goods or uses beyond the specified circumstances outlined in the instrument, and it is subject to the disallowance provisions under section 46A of the Acts Interpretation Act 1901.
Key Provisions
The main operative sections of this Instrument of Exemption, which is under subsection 18A(1) of the Therapeutic Goods Act 1989, allow the Minister for Health and Ageing to exempt specified medications and medical devices from the usual registration or listing procedures in the Act (section 18A). This exemption is to facilitate the stockpiling of medications and medical devices in preparation for a potential threat to public health or in response to an actual emergency, as outlined in subsection 18A(2). The specific exemption provided here allows for the stockpiling of an unregistered immunoglobulin preparation to combat infection with the vaccinia virus, as stated in subsection 18A(2)(a).
The Act imposes several obligations and requirements on the parties involved. The Minister must issue a written instrument that specifies the medication or medical device to be exempted and outlines the conditions under which the exemption applies. This includes the quantity of goods, the persons or class of persons authorised to import and supply the goods, record-keeping requirements, and the conditions for storage, supply, and use of the goods. The exemption instrument also stipulates that the goods will be under the strict control of the Commonwealth and that certain details regarding storage and distribution conditions are to be kept undisclosed for security reasons. The instrument ensures flexibility for the supply and use of the medicine while maintaining strict controls.
The exemption does not detail the specific facts relating to storage and distribution conditions, except to state that they will be securely managed under Commonwealth control. Any breach of the conditions specified in the exemption instrument could lead to legal consequences, although the document does not explicitly state penalties for non-compliance. Given the nature of the exemption, any misuse or failure to adhere to the specified conditions could potentially have serious public health implications, including the risk of inadequate response to a bioterrorism attack or complications from smallpox vaccination.
The exemption provided under this Instrument of Exemption allows for the stockpiling of a specified quantity of an unregistered immunoglobulin preparation to combat infection with the vaccinia virus. This is a necessary measure to prepare for potential threats to public health, particularly in the context of a bioterrorism attack involving the smallpox virus or complications from smallpox vaccination. The exemption is a disallowable instrument, meaning it can be reviewed and potentially disallowed by Parliament. The conditions specified in the exemption instrument are designed to ensure that the goods are securely stored, appropriately supplied, and used under strict control, with certain details withheld for security reasons. This measure is intended to protect public health without imposing a regulatory impact on industry.