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 100,000 doses of vaccine [Indonesia strain] 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. There have been two previous exemptions under s18A of the Act for influenza vaccine; 100,000 doses of a vaccine for the Vietnam strain and 500,000 doses of a vaccine against the Indonesia strain of the virus. This exemption instrument, while for the vaccine against the Indonesia strain, is intended to replace the 100,000 doses of vaccine [Vietnam strain] that have been previously exempted via section 18A of the Act and have now expired.
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 (Exemption) Instrument 2008, enacted as F2008L01194, was introduced to address the need for preparedness against potential terrorist threats involving public health emergencies, particularly those related to infectious diseases. This legislation, enacted by the Parliament of Australia, aims to allow the stockpiling of unregistered and unapproved therapeutic goods that might be required in the national interest for dealing with such threats. The instrument under subsection 18A(1) of the Therapeutic Goods Act 1989 empowers the Minister for Health and Ageing to exempt specified therapeutic goods from the usual registration requirements, enabling their legal importation and supply under strictly controlled conditions. This exemption is specifically designed to ensure that necessary therapeutic goods, which might not have been assessed for quality, safety, and efficacy under normal circumstances, can be stockpiled and made available for use in Australia. The policy objective is to enhance Australia's ability to respond effectively to potential or actual public health emergencies, thereby protecting public health and safety.
Scope and Application
The Therapeutic Goods Act 1989, through the Instrument of Exemption under subsection 18A(1) for the purposes of paragraph 18A(2)(a), provides a mechanism for the stockpiling of unregistered and unapproved therapeutic goods in Australia, deemed necessary for national preparedness against potential terrorist threats. This instrument applies to the Minister for Health and Ageing, who has the authority to exempt specified therapeutic goods from the Act’s rigorous registration or listing procedures, thus enabling their importation, distribution, and use under strictly controlled conditions. This exemption is limited to situations where stockpiling is necessary for preparedness against potential public health threats or actual emergencies caused by terrorist activities. The exemption applies to specific therapeutic goods identified in a written instrument, which specifies the quantity, source, and supplier of the drugs, and outlines strict conditions for their storage, supply, and use to ensure public safety. The exemption also details record-keeping requirements and provisions for disposal and compensation. Notably, certain details regarding storage conditions are not disclosed to maintain security and provide flexibility in the distribution and use of the therapeutic goods. This exemption specifically addresses the need to stockpile a large quantity of vaccine against the H5N1 influenza virus to enhance preparedness for potential outbreaks, replacing previously exempted vaccines that have expired.
Key Provisions
The F2008L01194 Instrument of Exemption, issued under subsection 18A(1) of the Therapeutic Goods Act 1989 (the Act), allows for the stockpiling of unregistered and unapproved therapeutic goods in Australia to prepare for potential terrorist threats or actual emergencies affecting public health (subsection 18A(2)(a) and (b)). This instrument specifies medications exempt from the usual requirement to be listed on the Australian Register of Therapeutic Goods (ARTG), enabling their legal importation, distribution, and use under strict conditions outlined in the written instrument (subsection 18A(1)). This exemption is specifically for stockpiling purposes, distinct from immediate use during an actual threat (subsection 18A(2)(b)). The exemption applies to the stockpiling of 100,000 doses of H5N1 influenza vaccine against the Indonesia strain, replacing the previously exempted 100,000 doses of a Vietnam strain vaccine that have expired. This exemption is a legislative instrument under the Legislative Instruments Act 2003, detailing the quantity of exempted goods, the permissible suppliers, and strict conditions for storage, supply, and use to ensure security and flexibility.
Under this Act, the Minister for Health and Ageing imposes several obligations on the entities involved. These include ensuring that the therapeutic goods are stored securely, supplied appropriately, and used only as specified in the exemption instrument. The Act also mandates strict record-keeping requirements to monitor the import, distribution, and use of the exempted goods. Additionally, the instrument outlines the procedures for the disposal of these goods and the entitlements to compensation. These obligations are designed to maintain control over the exempted goods and ensure they are available when needed for public health emergencies while preventing misuse or unauthorized distribution.
Breaches of the conditions specified in the exemption instrument can lead to significant legal consequences. While the Act does not explicitly outline specific offences or penalties for non-compliance, the general provisions of the Therapeutic Goods Act 1989 apply. These include potential civil or criminal penalties for unauthorized importation, supply, or use of therapeutic goods, which could result in fines and imprisonment. The severity of penalties would depend on the nature and extent of the breach, with maximum penalties potentially including substantial fines and lengthy prison terms for serious or repeated offences. Compliance with the conditions is crucial to avoid these severe repercussions and ensure the integrity of the national preparedness efforts.