EXPLANATORY STATEMENT
Select Legislative Instrument 2008 No. 270
Therapeutic Goods Act 1989
Therapeutic Goods (Medical Devices) Amendment Regulations 2008 (No. 2)
The object of the Therapeutic Goods Act 1989 (the Act) is to establish and maintain a national system of controls for the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or exported from Australia. The Therapeutic Goods Administration (the TGA) is responsible for administering the Act.
Subsection 63(1) of the Act provides that the Governor-General may make regulations, not inconsistent with the Act, prescribing matters required or permitted to be prescribed by the Act, or necessary or convenient to be prescribed for carrying out or giving effect to the Act. In addition, paragraph 41HA(1)(b) of the Act provides that the regulations may exempt specified kinds of medical devices from the operation of Division 3 of Part 4-11 (Offences and civil penalty provisions relating to medical devices not included on the Australian Register of Therapeutic Goods (ARTG)). Subsection 41HA(2) provides that the exemption may be subject to conditions prescribed in the regulations.
The purpose of the Regulations is to make an amendment to the Therapeutic Goods (Medical Devices) Regulations 2002 (the Principal Regulations). Specifically, the Regulations introduce an additional exemption from Division 3 of Part 4-11 of the Act in respect of a medical device that is a system or procedure pack under section 41BF of the Act that is imported, supplied or manufactured by or on behalf of the Commonwealth and certified by the Secretary of the Department of Health and Ageing to be emergency supplies for stockpiling in the event of a public health emergency. Such supplies would normally be required to be included on the ARTG.
The exemption enables the Commonwealth to import, manufacture and supply (whether by itself or on its behalf) packs containing medical devices and other non-therapeutic goods that need to be stockpiled as part of the National Medical Stockpile for use in the event of a public health emergency. This enables Australian to maintain its preparedness for a public health emergency such as an influenza pandemic.
The exemption is subject to conditions, including that exempted devices must be imported, supplied or manufactured on or before 31 December 2010. This is to take account of a proposed amendment to the Act which provides a more general exemption for medical devices to meet possible future emergencies but which is unlikely to be in place in time to meet the immediate need.
The need for the exemption has been developed by the Office of Health Protection of the Department of Health and Ageing (the Department), in consultation with the Health Protection Committee/National Immunisation Committee (AHPC/NIC) Pandemic Vaccine Working Group (the PVWG), in relation to the packs and their contents, during the periods September 2007, December 2007 and February 2008. The PVWG is comprised of representatives of each state and territory health department and is chaired by a representative of the Department. A regulation impact statement does not accompany the Regulations as the exemption is regarded as having no impact on industry in general and is considered a necessary public health measure in order to create preparedness for the Commonwealth to deal with a public health emergency.
Details of the Regulations are set out in the Attachment.
The Act specifies no conditions that need to be met before the power to make the Regulations may be exercised.
The Regulations are a legislative instrument for the purposes of the Legislative Instruments Act 2003.
The Regulations commence on the day after they are registered on the Federal Register of Legislative Instruments.
ATTACHMENT
Details of the Therapeutic Goods (Medical Devices) Amendment Regulations 2008 (No. 2)
Regulation 1 names the Regulations as the Therapeutic Goods (Medical Devices) Amendment Regulations 2008 (No. 2).
Regulation 2 provides that the Regulations commence on the day after they are registered on the Federal Register of Legislative Instruments.
Regulation 3 provides that the Regulations amend the Therapeutic Goods (Medical Devices) Regulations 2002 (the Medical Devices Regulations) as provided in Schedule 1.
SCHEDULE 1 – Amendments
Item [1] inserts a new item 2.9 in Part 2 of Schedule 4 to the Medical Devices Regulations. Subregulation 7.1(2) provides that for the purposes of paragraph 41HA(1)(b) and subsection 41HA(2) of the Act, a kind of medical device mentioned in column 2 of an Item in Part 2 of Schedule 4 is exempt from the operation of Division 3 of Part 4-11 of the Act, subject to compliance with the conditions mentioned in column 3 of that item. Paragraph 41HA(1)(b) of the Act provides for the exemption of specified kinds of medical devices from the operation of Division 3 of Part 4-11 of the Act. The exemption may be subject to conditions that are prescribed in the regulations (subsection 41HA(2)). Division 3 of Part 4-11 sets out the offences and civil penalty provisions relating to dealing in medical devices that are not included in the Australian Register of Therapeutic Goods (ARTG).
New item 2.9 exempts a medical device that is a system or procedure pack under section 41BF of the Act that is imported, supplied or manufactured by or on behalf of the Commonwealth, and certified by the Secretary to be emergency supplies for stockpiling in the event of a public health emergency from the prohibitions in Division 3 of Part 4-11 of the Act on dealing in medical devices that are not included in the ARTG.
The exemption is subject to specified conditions, being that:
(a) the device must be imported, supplied or manufactured on or before 31 December 2010;
(b) the importation, supply or manufacture of the device must be approved in writing by the Secretary;
(c) the use and supply of the device must be in accordance with the written approval of the Secretary;
(d) records in relation to the importation, supply or manufacture of the device must be kept in accordance with the directions of the Secretary; and
(e) the disposal of any unused device must be in accordance with the directions of the Secretary.
Overview
The Therapeutic Goods (Medical Devices) Amendment Regulations 2008 (No. 2), enacted under the Therapeutic Goods Act 1989, aim to address the need for a national preparedness system in the event of a public health emergency by exempting certain medical devices from specific regulatory requirements. This legislative instrument was introduced to enable the Commonwealth to stockpile emergency medical supplies, ensuring timely and effective responses to public health crises such as pandemics. The Regulations, which amend the Therapeutic Goods (Medical Devices) Regulations 2002, permit the importation, supply, and manufacture of medical device packs for emergency stockpiling, subject to conditions including certification by the Secretary of the Department of Health and Ageing and adherence to specified timelines and operational protocols. The policy objective is to enhance Australia's capacity to manage public health emergencies efficiently and effectively.
Scope and Application
The Therapeutic Goods Act 1989 applies to the quality, safety, efficacy, and timely availability of therapeutic goods used or exported from Australia, with the Therapeutic Goods Administration (TGA) administering the Act. The Act enables the Governor-General to make regulations for its implementation, including exemptions for certain medical devices from certain provisions, such as those outlined in the Therapeutic Goods (Medical Devices) Amendment Regulations 2008 (No. 2). These regulations specifically exempt medical device system or procedure packs that are imported, supplied, or manufactured by or on behalf of the Commonwealth and certified by the Secretary of the Department of Health and Ageing for emergency stockpiling in the event of a public health emergency from the operation of Division 3 of Part 4-11 of the Act, which pertains to offences and civil penalties related to medical devices not included on the Australian Register of Therapeutic Goods (ARTG). The exemption is contingent on certain conditions, including the device being imported, supplied, or manufactured by 31 December 2010, and the approval of the Secretary for importation, supply, manufacture, use, disposal, and record-keeping. This legislative framework allows the Commonwealth to maintain preparedness for public health emergencies such as influenza pandemics.
Key Provisions
The Therapeutic Goods (Medical Devices) Amendment Regulations 2008 (No. 2) (the Regulations) are a legislative instrument that amends the Therapeutic Goods (Medical Devices) Regulations 2002 (the Principal Regulations) to introduce an exemption from certain provisions of the Therapeutic Goods Act 1989 (the Act) in relation to specific medical devices that are part of emergency supplies for stockpiling in the event of a public health emergency. The Regulations are made under subsection 63(1) of the Act and paragraph 41HA(1)(b) of the Act, which empower the Governor-General to make regulations that are not inconsistent with the Act and to exempt specified kinds of medical devices from the operation of certain sections of the Act, respectively. Specifically, the Regulations introduce a new exemption (item 2.9 in Part 2 of Schedule 4) for medical devices that are system or procedure packs under section 41BF of the Act and are imported, supplied, or manufactured by or on behalf of the Commonwealth and certified by the Secretary of the Department of Health and Ageing as emergency supplies for stockpiling in the event of a public health emergency. This exemption enables the Commonwealth to maintain its preparedness for a public health emergency, such as an influenza pandemic, by allowing it to stockpile necessary medical devices without the need for them to be included on the Australian Register of Therapeutic Goods (ARTG). The exemption is subject to specific conditions, including that the devices must be imported, supplied, or manufactured on or before 31 December 2010, and that the importation, supply, manufacture, use, supply, record-keeping, and disposal of the devices must comply with written approvals and directions from the Secretary. These conditions are designed to ensure that the exemption is used appropriately and that the devices are used in a manner that is consistent with public health needs.
The Regulations impose obligations and requirements on various parties involved in the importation, supply, and manufacture of medical devices that are subject to the exemption. For the Commonwealth, the Secretary of the Department of Health and Ageing is responsible for certifying that the devices are emergency supplies for stockpiling and for approving the importation, supply, or manufacture of the devices in writing. The Secretary must also provide directions regarding the use and supply, record-keeping, and disposal of the devices, and these directions must be complied with. For importers, suppliers, and manufacturers of the devices, they must ensure that the devices are imported, supplied, or manufactured in accordance with the written approval of the Secretary and must keep records in accordance with the Secretary's directions. Furthermore, they must comply with the conditions specified in the Regulations, such as the requirement that the devices be imported, supplied, or manufactured on or before 31 December 2010. These obligations and requirements are intended to ensure that the exemption is used appropriately and that the devices are used in a manner that is consistent with public health needs.
The Regulations do not explicitly state any offences, penalties, or consequences for breach. However, the Therapeutic Goods Act 1989 (the Act) provides for offences and penalties in relation to dealing in medical devices that are not included on the Australian Register of Therapeutic Goods (ARTG), which are the provisions from which the exempted devices are exempt under the Regulations. Under the Act, a person who contravenes certain provisions relating to the inclusion of medical devices on the ARTG may be subject to civil penalties, criminal penalties, or both, depending on the nature and severity of the contravention. For example, a person who contravenes a civil penalty provision may be liable to a pecuniary penalty not exceeding the greater of three times the value of the benefit obtained by the person as a result of the contravention or $11,000. A person who contravenes a criminal penalty provision may be liable to a fine not exceeding the greater of three times the value of the benefit obtained by the person as a result of the contravention or $55,000, or imprisonment for a term not exceeding two years, or both. These penalties are intended to deter non-compliance with the Act and to promote the quality, safety, and efficacy of therapeutic goods in Australia.