Commonwealth Numbered Regulations - Explanatory Statements

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THERAPEUTIC GOODS (MEDICAL DEVICES) AMENDMENT REGULATIONS 2008 (NO. 1) (SLI NO 119 OF 2008)

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.

 

 


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