Therapeutic Goods (Medical Devices) Amendment Regulations 2004 (No. 1) 2004 No. 128
EXPLANATORY STATEMENT
STATUTORY RULES 2004 No. 128
Issued by the Authority of the Parliamentary Secretary to the Minister for Health and Ageing
Therapeutic Goods Act 1989
Therapeutic Goods (Medical Devices) Amendment Regulations 2004 (No. 1)
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.
Paragraph 63(2)(h) of the Act provides that the regulations may prescribe fees in respect of matters under the Act or the regulations.
Paragraph 63(3)(b) of the Act also allows for the reduction of fees in cases identified in the regulations.
The purpose of the Regulations is to increase, by 3.05 per cent, the fees payable in relation to medical devices. The increase will enable the TGA to continue to meet the Government's requirement that the TGA operates on a full cost-recovery basis.
Subregulation 9.4(2) of the Therapeutic Goods (Medical Devices) Regulations 2002 (the Principal Regulations) allows the Secretary of the Department of Health and Ageing to conduct an abridged conformity assessment of a medical device in prescribed circumstances and to charge a reduced fee for that assessment. The Regulations increase the level of such reduced fees by 3.05 per cent.
Schedule 5 of the Principal Regulations provides the list of fees chargeable under Chapter 4 (Medical Devices) of the Act. The fees payable pursuant to Schedule 5 include the processing of applications for inclusion of medical devices in the Australian Register of Therapeutic Goods (ARTG) and initial and subsequent assessments under the conformity assessment procedures. These fees reflect the cost incurred by the TGA in performing the various tasks under the Act and the Principal Regulations. The Regulations increase the fees for all items specified in Schedule 5 by 3.05 per cent.
The 3.05 per cent increase in fees is made up of:
50 per cent of the annual Wage Cost Index (WCI) | |
for the year ended December 2003 | 1.85 per cent |
and | |
50 per cent of the Consumer Price Index (CPI) | |
for the year ended December 2003 | 1.20 per cent |
The indexation formula based on the CPI and WCI has been used by the TGA since the 1998-1999 financial year, when the TGA was first required to operate on a full cost recovery basis. Industry has agreed that this formula is appropriate as a basis for fee increases in relation to therapeutic goods. The formula for the fee increases for the financial year commencing 1 July 2004 was discussed with the key industry body, the Medical Industry Association of Australia. This industry association has agreed to the formula as the basis for the 3.05 per cent increase to the fees payable under the Principal Regulations.
The Act specifies no conditions that need to be met before the power to make the Regulations may be exercised.
Details of the Regulations are set out in the Attachment.
The Regulations commence on 1 July 2004.
ATTACHMENT
DETAILS OF THE THERAPEUTIC GOODS (MEDICAL DEVICES) AMENDMENT REGULATIONS 2004 (NO. 1)
Regulation 1 names the Regulations as the Therapeutic Goods (Medical Devices) Amendment Regulations 2004 (No. 1).
Regulation 2 provides that the Regulations commence on 1 July 2004.
Regulation 3 provides that the Regulations amend the Therapeutic Goods (Medical Devices) Regulations 2002 as provided in Schedule l.
SCHEDULE 1 - Amendments
Item 1 increases the level of reduced fees that apply for an abridged conformity assessment under regulation 9.4 by 3.05 per cent.
Items 2 and 3 increases the fees in all specified items of Schedule 5 by 3.05 per cent.
Overview
The Therapeutic Goods (Medical Devices) Amendment Regulations 2004 (No. 1) were enacted to address the need for a fee adjustment in the regulation of medical devices within Australia. These Regulations, introduced by the Australian Parliament, aim to increase the fees associated with medical device assessments and processing by 3.05 per cent to ensure the Therapeutic Goods Administration (TGA) can continue to operate on a full cost-recovery basis as required by the Government. This adjustment is derived from a formula based on the annual Wage Cost Index and Consumer Price Index, which has been agreed upon by the industry and has been in use since 1998-1999. The Regulations amend the Therapeutic Goods (Medical Devices) Regulations 2002 by adjusting the fees listed in Schedule 5, which covers the processing of applications and conformity assessments for medical devices.
Scope and Application
The Therapeutic Goods (Medical Devices) Amendment Regulations 2004 (No. 1) applies to the Therapeutic Goods Administration (TGA), which administers the Therapeutic Goods Act 1989. These regulations aim to adjust the fees associated with medical devices in alignment with the Act's objectives of ensuring the quality, safety, efficacy, and timely availability of therapeutic goods used or exported from Australia. The fee adjustment, a 3.05 percent increase, is designed to allow the TGA to operate on a full cost-recovery basis, thereby maintaining the integrity of its regulatory functions. The increased fees cover various aspects, including the processing of applications for the inclusion of medical devices in the Australian Register of Therapeutic Goods (ARTG) and assessments under conformity procedures. The regulations directly impact entities involved in the manufacture, import, and supply of medical devices in Australia, ensuring they meet the required compliance costs to facilitate the ongoing regulation of therapeutic goods. The Regulations are applicable nationally within Australia and are made under the authority of the Parliamentary Secretary to the Minister for Health and Ageing.
Key Provisions
The main operative sections of the Therapeutic Goods (Medical Devices) Amendment Regulations 2004 (No. 1) (the Regulations) pertain to the adjustment of fees associated with medical devices. Specifically, Regulation 1 names the Regulations, Regulation 2 sets the commencement date as 1 July 2004, and Regulation 3 outlines the amendments to the Therapeutic Goods (Medical Devices) Regulations 2002 (the Principal Regulations). The key amendments are detailed in Schedule 1, where Item 1 adjusts the reduced fees for an abridged conformity assessment by 3.05 per cent, and Items 2 and 3 increase the fees for all specified items in Schedule 5 of the Principal Regulations by the same percentage. These amendments are designed to align the fees with the cost of operating on a full cost-recovery basis, ensuring the Therapeutic Goods Administration (TGA) can continue to function effectively.
The Regulations impose specific obligations on entities involved in the medical device sector, including manufacturers, importers, and sponsors who need to pay the amended fees for conformity assessments and other related services. The amended fees are intended to reflect the actual costs incurred by the TGA in processing applications and conducting assessments, thereby ensuring that the TGA can maintain its regulatory functions efficiently. These obligations are critical for maintaining the quality, safety, and efficacy of therapeutic goods in Australia. The increase in fees is not arbitrary but is based on an indexation formula that considers both the annual Wage Cost Index (WCI) and the Consumer Price Index (CPI), which has been used since the 1998-1999 financial year.
Any failure to comply with the amended fee structures as set out in the Regulations may result in civil or criminal consequences. Although the Regulations themselves do not explicitly state penalties for non-compliance, breaches of the Therapeutic Goods Act 1989 (the Act) or the Principal Regulations can lead to significant legal ramifications. For instance, non-compliance with the Act may result in fines or imprisonment. The specific penalties for contravening the Act can vary depending on the nature and severity of the breach, but they can include substantial financial penalties and, in some cases, imprisonment for individuals responsible for the non-compliance. It is essential for entities governed by these Regulations to adhere strictly to the fee structures and comply with all related obligations to avoid any adverse legal consequences.
The Regulations reflect a commitment to ensuring that the TGA can operate efficiently and effectively, which is crucial for maintaining the high standards expected of therapeutic goods in Australia. By aligning fees with actual operational costs and using an established indexation formula, the Regulations aim to support the TGA's mandate under the Act. This approach not only ensures the sustainability of the regulatory framework but also upholds the safety and efficacy of medical devices available in the Australian market.