Therapeutic Goods (Medical Devices) Amendment Regulations 2008 (No. 1)

Administered by Department of Health, Disability and Ageing

Legislation au F2008L01366 Regulations Not in force Legislative Instrument

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EXPLANATORY STATEMENT

Select Legislative Instrument 2008 No. 119

Therapeutic Goods Act 1989

Therapeutic Goods (Medical Devices) Amendment Regulations 2008 (No. 1)

The Therapeutic Goods Administration (the TGA) carries out a range of assessment and monitoring activities to ensure therapeutic goods available in Australia are of an acceptable standard. It is required to fully recover its operating costs and achieves this in several ways including: by charging fees for the evaluation of applications to include medicines and medical devices in the Australian Register of Therapeutic Goods (the Register) or to amend details of products currently in the Register under the Therapeutic Goods Act 1989 (the TG Act); and by levying annual charges for products which are included in the Register under the Therapeutic Goods (Charges) Act 1989 (the Charges Act).

Subsection 63(1) of the TG Act provides that the Governor-General may make regulations, not inconsistent with the TG Act, prescribing matters required or permitted to be prescribed by the TG Act, or necessary or convenient to be prescribed for carrying out or giving effect to the TG Act. Paragraph 63(2)(h) of the TG Act provides that the regulations may prescribe fees in respect of matters under the TG Act or the regulations.

The purpose of the Regulations is to amend the Therapeutic Goods (Medical Devices) Regulations 2002 (the Principal Regulations) to increase, by 3.6 per cent, all fees to evaluate or amend the details of medical devices which are required to be included in the Register. In applying the increases, fees have been rounded to the nearest $10 for items under $10,000 in value and to the nearest $100 for items over $10,000 in value.

The Regulations when taken together with the changes to the Therapeutic Goods Regulations 1990 and the Therapeutic Goods (Charges) Regulations 1990) (which are the subject of separate Executive Council Minutes) are expected to increase the fees and charges collected by the TGA by $7.3 million over the 2008-09 financial year.

The increases enable the TGA to recover its costs in administering the TG Act and continue to meet the Government’s requirement that the TGA operate on a full cost-recovery basis.

An overview of the Regulations is at Attachment A, and details are set out in Attachment B.

The TGA consulted with industry associations, including Medicines Australia, the Generic Medicines Industry of Australia, the Australian Self-Medication Industry, the Complementary Healthcare Council of Australia, the Medical Technology Association of Australia, the Australian Dental Industry Association and AusBiotech on the proposed increases to charges. The consultations, convened between 12 and 29 February 2008, consisted of bilateral engagement with industry sectors and provided an opportunity for industry associations to examine and comment on the TGA Budget, including new initiatives and other budget measures, and on the proposed annual charges. The outcome of the consultations was that industry was generally supportive of the TGA proposals for 2008-09 fees.

The TG Act specifies no conditions that need to be met before the power to make the Regulations may be exercised.

The Regulations commence on 1 July 2008.

The Regulations are a legislative instrument for the purposes of the Legislative Instruments Act 2003.

ATTACHMENT A

overview of the Therapeutic Goods (MEDICAL DEVICES) Amendment Regulations 2008 (No. 1)

The purpose of the Therapeutic Goods (Medical Devices) Amendment Regulations 2008 (No. 1) is to increase all fees payable in relation to the regulation of medical devices which are required to be included in the Register, by 3.6 per cent.

The 3.6 per cent general increase applied to fees has been calculated using a formula agreed with industry associations which is comprised of 50 per cent of the annual Wage Cost Index (WCI) for the year ended December 2007 and 50 per cent of the Consumer Price Index (CPI) for the year ended December 2007.

Paragraph 9.4(2)(a) of the Principal Regulations allows the Secretary of the Department of Health and Ageing (the Secretary) to decide to conduct an abridged conformity assessment of a medical device in prescribed circumstances and to charge a reduced fee for that assessment under paragraph 9.4(2)(b). The Regulations increase the level of that applicable fee by 3.6 per cent.

Schedule 5 to the Principal Regulations provides the list of fees payable under Chapter 4 (Medical Devices) of the TG 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 (the Register) and initial and subsequent assessments under conformity assessment procedures. These fees reflect the costs incurred by the TGA in performing the various tasks under the TG Act and the Principal Regulations. The Regulations increase the level of all of the fees in Part 1 of Schedule 5 (General) and Part 2 of Schedule 5 (Additional Fees).

The new fees have been rounded to the nearest ten dollars (for amounts up to ten thousand dollars) or one hundred dollars (for amounts over ten thousand dollars).

The TGA consulted with industry associations, including the Medical Technology Association of Australia, the Australian Dental Industry Association and AusBiotech on the increases to fees. The consultations, convened between 12 and 29 February 2008, consisted of bilateral engagement with industry sectors and provided an opportunity for industry associations to examine and comment on the TGA Budget, including new initiatives and other budget measures, and on the annual charges.

The outcome of the consultations was that industry was generally supportive of the TGA proposals for the 2008-09 fees.

As the recommended increases are in line with the agreed rate of indexation, a cost recovery impact statement is not required.

ATTACHMENT B

Details of the Therapeutic Goods (MEDICAL DEVICES) Amendment Regulations 2008 (No. 1)

Regulation 1 provides for the Regulations to be referred to as the Therapeutic Goods (Medical Devices) Amendment Regulations 2008 (No. 1).

Regulation 2 provides for the Regulations to commence on 1 July 2008.

Regulation 3 provide for Schedule 1 to amend the Therapeutic Goods (Medical Devices) Regulations 2002.

Schedule 1 – Amendments

Item [1]

This item increases the fee for an abridged conformity assessment, in paragraph 9.4(2)(b) of the Principal Regulations, by 3.6 per cent.

This item also increases the fees for all relevant items in Part 1 of Schedule 5 to the Principal Regulations by 3.6 per cent.

Part 2 of Schedule 5 to the Principal Regulations currently provides for additional fees for assessments that are required to be conducted outside Australia. These fees are currently calculated at a rate of $300 for each hour of preparation by each assessor involved.

This item increases the fee of $300 per hour of preparation by each assessor currently payable under paragraph 2.1 (b) of Part 2 of Schedule 5 by 3.6 per cent, to $310.

These increases enable the TGA to recover its costs in administering the Act and continue to meet the Government’s requirement that the TGA operate on a full cost-recovery basis.

Overview

The Therapeutic Goods (Medical Devices) Amendment Regulations 2008 (No. 1) were introduced to address the need for the Therapeutic Goods Administration (TGA) to fully recover its operating costs associated with the assessment and monitoring of medical devices available in Australia. Enacted under the authority of the Therapeutic Goods Act 1989, these regulations amend the Therapeutic Goods (Medical Devices) Regulations 2002 to increase all fees for the evaluation and amendment of medical devices listed in the Australian Register of Therapeutic Goods by 3.6 per cent. This fee adjustment was calculated based on 50 per cent of the annual Wage Cost Index and 50 per cent of the Consumer Price Index for the year ended December 2007. The primary policy objective of these regulations is to enable the TGA to meet the government’s requirement for full cost recovery in administering the Therapeutic Goods Act. The TGA undertook consultations with various industry associations, including Medicines Australia and the Medical Technology Association of Australia, which generally supported the proposed fee increases.

Scope and Application

The Therapeutic Goods (Medical Devices) Amendment Regulations 2008 (No. 1) applies to the Therapeutic Goods Administration (TGA), which is responsible for ensuring that therapeutic goods available in Australia meet acceptable standards. This includes medical devices, which must be assessed and monitored according to the Therapeutic Goods Act 1989 (TG Act). The regulations specifically target the fees associated with the evaluation and amendment of medical devices in the Australian Register of Therapeutic Goods, aiming to increase these fees by 3.6 percent. This fee adjustment is calculated based on a combination of the annual Wage Cost Index and the Consumer Price Index for the year ending December 2007. The purpose is to enable the TGA to recover its operating costs and continue to operate on a full cost-recovery basis. The Regulations apply nationally and are designed to augment the existing Therapeutic Goods (Medical Devices) Regulations 2002, focusing on the financial aspects of medical device regulation. The changes, including the new fee structure, are set to take effect from 1 July 2008.

Key Provisions

The Therapeutic Goods (Medical Devices) Amendment Regulations 2008 (No. 1) primarily serve to increase by 3.6 per cent all fees associated with the evaluation and amendment of medical devices listed in the Australian Register of Therapeutic Goods (the Register) (regs 1, 2, 3). This adjustment is implemented across various fee categories, including those for initial assessments, conformity assessments, and fees applicable when assessments are conducted outside Australia (Schedule 1, Item [1]). These changes are calculated using a formula comprising 50 per cent of the annual Wage Cost Index (WCI) and 50 per cent of the Consumer Price Index (CPI) for the year ended December 2007, and have been rounded to the nearest $10 for items under $10,000 and to the nearest $100 for items over $10,000 (Attachment A). These Regulations impose specific obligations on entities and individuals involved in the registration and assessment of medical devices in Australia. Manufacturers, importers, and sponsors must adhere to the updated fee structures when submitting applications or amendments to the Register (Schedule 1, Item [1]). They must ensure that all fees are calculated and paid according to the new rates specified in the Regulations, which reflect the costs incurred by the Therapeutic Goods Administration (TGA) in performing their regulatory functions. The TGA is also mandated to apply these fees consistently across all relevant applications and assessments. There are no explicit offences, penalties, or consequences outlined for breach of these Regulations. However, failure to comply with the updated fee requirements could result in delays in the assessment and registration process for medical devices. Given that the TGA operates on a full cost-recovery basis, non-compliance might indirectly affect the timeliness and efficiency of the TGA's operations. While the Regulations themselves do not stipulate specific penalties, non-compliance with broader Therapeutic Goods Act 1989 provisions could lead to enforcement actions, fines, or other legal consequences as per the Act.

Area of Law: Regulatory Standards
Instrument: Regulation
Concepts: Fees; Regulatory Standards; Cost Recovery

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