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THERAPEUTIC GOODS AMENDMENT REGULATIONS 2006 (NO. 2) (SLI NO 212 OF 2006)
Select Legislative Instrument 2006 No. 212
Therapeutic Goods Amendment Regulations 2006 (No. 2)
Therapeutic Goods (Medical Devices) Amendment Regulations 2006 (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 and 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. Part 2 of Schedule 9 to the Therapeutic Goods Regulations 1990 sets out the table of fees payable under the Act.
Paragraph 63(3)(b) of the Act provides, in part, for the reduction of fees in cases identified in the regulations. Regulation 45 of the Therapeutic Goods Regulations 1990 provides that the Secretary of the Department of Health and Ageing may waive or reduce fees specified in Schedule 9 to specified amounts under certain circumstances.
The purpose of the Therapeutic Goods Amendment Regulations 2006 (No. 2) is to increase most fees payable under the Act by 3.5 per cent, and vary certain specified fees. These fees predominantly relate to the evaluation of new therapeutic goods and the inspection of manufacturing premises.
The Therapeutic Goods Amendment Regulations 2006 (No. 2):
* increase the fees prescribed in regulation 45 and Part 2 of Schedule 9 to the Therapeutic Goods Regulations 1990 by 3.5 per cent, except as otherwise specified below;
* increase, at subregulation 45A(1) of the Therapeutic Goods Regulations 1990, the low turnover threshold from $66,000 to $68,300, at which the annual charge for a licence to manufacture therapeutic goods is reduced, for a person required to hold such a licence;
* decrease the evaluation fees for most prescription medicines by up to 3.1 per cent;
* increase the application, processing and evaluation fees for registered non-prescription medicines and the evaluation fees for listed non-prescription medicines by 20 per cent;
* decrease the fee at item 18 of Part 2 to Schedule 9 to the Therapeutic Goods Regulations 1990 for providing advice in relation to a prescription medicine to the Pharmaceutical Benefits Program of the Department of Health and Ageing, by 85 per cent; and
* increase the fee for obtaining evidence from an overseas regulatory agency (per manufacturer, per site and per sponsor) by $230 to $480.
The purpose of the Therapeutic Goods (Medical Devices) Amendment Regulations 2006
(No. 1) is to increase, by 3.5 per cent, certain fees payable in relation to the regulation of medical devices.
The 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.
The changes (to the Therapeutic Goods Regulations 1990, and the Therapeutic Goods (Medical Devices) Regulations 2002), when taken together with changes to the Therapeutic Goods (Charges) Regulations 1990 (which are the subject of a separate Executive Council Minute), are expected to increase the fees and charges collected by the TGA by $4.767 million over the 2006-2007 financial year.
An overview of the Therapeutic Goods Amendment Regulations 2006 (No. 2) is at Attachment A, and details of those Regulations are set out in Attachment B.
An overview of the Therapeutic Goods (Medical Devices) Amendment Regulations 2006 (No. 1) is at Attachment C, and details of those Regulations are set out in Attachment D.
The Act specifies no conditions that need to be met before the power to make the Regulations may be exercised.
The Regulations commence on the day after they are registered on the Federal Register of Legislative Instruments.
The Regulations are legislative instruments for the purposes of the Legislative Instruments Act 2003.
ATTACHMENT A
OVERVIEW OF THE Therapeutic Goods Amendment
Regulations 2006 (No. 2)
The changes to the fees prescribed in regulation 45 and Part 2 of Schedule 9 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.
The 3.5 per cent general increase applied to most fees prescribed in regulation 45 and Part 2 of Schedule 9 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 2005 and 50 per cent of the Consumer Price Index (CPI) for the year ended December 2005.
The Regulations also reduce evaluation fees for most prescription medicines by up to 3.1 per cent in line with a plan to restructure the fee schedule agreed with industry in July 2003. Fees for the evaluation of generic medicines and fees associated with clinical trials remain unchanged. Regulations to increase the annual charges for the registration of prescription medicines by 20 per cent are the subject of a separate Executive Council Minute. Because 74 per cent of the recovery of the TGA's costs regarding the registration of prescription medicines relates to evaluation fees (or pre-market activity) and 26 per cent to annual charges (or post-market activity) of those medicines, the overall change in total cost recovery regarding prescription medicines as a result of these changes will be an increase of around 3.5 per cent.
The increases in the application, processing and evaluation fees for non-prescription medicines in the Regulations are in excess of the consumer price index and represent a material amendment of an existing cost recovery arrangement. A Cost Recovery Impact Statement incorporating stakeholder views was completed in May 2006 in accordance with Australian Government Cost Recovery Guidelines and has been published on the TGA's website.
The Regulations also reduce the fee for providing advice in relation to a prescription medicine on request to the Pharmaceutical Benefits Program of the Department of Health and Ageing by 85 per cent (from $10,500 to $1,500) as the Government has decided that additional testing activities are no longer required to be performed by the TGA.
The new fees have been rounded to the nearest ten dollar (for amounts up to ten thousand dollars) or one hundred dollar (for amounts of ten thousand dollars or more) increments, except for the fee increase for Item 1A of Part 2 of Schedule 9 (the first fee noted at item [9] of the Regulations), which increases the application fee for processing an application for the consent of the Secretary of the Department of Health and Ageing to the importing into, supplying in or exporting from Australia, therapeutic goods that do not conform with a standard applicable to the goods, from $310 to $330.
The TGA has 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 Industry Association of Australia, the Australian Dental Industry
Association and AusBiotech on the increases.
ATTACHMENT B
Details of the Therapeutic Goods Amendment
Regulations 2006 (No. 2)
Regulation 1 provides for the Regulations to be referred to as the Therapeutic Goods Amendment Regulations 2006 (No. 2).
Regulation 2 provides for the Regulations to commence on the day after they are registered.
Items [1] to [6]
These items increase the fees applicable in paragraphs 45(4A)(a), 45(4A)(b), (c), and (ca), 45(4A)(d), 45(4A)(e) and (f), and subregulations 45(9) and 45(11) of the Principal Regulations, by approximately 3.5 per cent. This enables the TGA to recover its costs in administering the Therapeutic Goods Act 1989 (the Act) and continue to meet the Government's requirement that the TGA operate on a full cost-recovery basis.
Items [7] and [8]
Subregulation 45A(1) of the Principal Regulations currently provides that the annual charges payable for a licence the Act are reduced if the wholesale turnover of therapeutic goods in a financial year in relation to the person is less than $66,000. Item [8] amends subregulation 45A(1) to increase this threshold from $66,000 to $68,300, and item [7] amends the heading of regulation 45A to reflect this increase.
Item [9]
This item increases the fees applicable in Part 2 of Schedule 9 to the Principal Regulations by approximately 3.5 per cent, except for those fees otherwise provided for by this item. The 3.5 per cent increase enables 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.
This item also decreases most evaluation fees for prescription medicines, applicable in subitems 2A(a), 4(a), (b), (d), (e), (f), and (g) of Part 2 of Schedule 9 to the Principal Regulations, by up to 3.1 per cent in line with a plan to restructure the fee schedule agreed with industry in July 2003.
This item also increases the application, processing and evaluation fees for registered non-prescription medicines and increase the evaluation fees for listed non-prescription medicines, applicable in subitems 2(a) and (f), 2A(b), 5(a), 5(b)(i), (ii), (iii), (iv), (v), (vi), and (vii), 5(c), 5(d)(i), (ii), (iii), (iv), (v), (vi), and (vii), 6D(a), (b), (c), (d), (e), (f), and (g), 7A(a), 7A(b)(i), (ii), (iii), (iv), (v), (vi), and (vii), 7B(a), and 7B(b)(i), (ii), (iii), (iv), (v), (vi), and (vii) of Part 2 of Schedule 9 to the Principal Regulations, by 20 per cent to curtail continuing under-recovery of costs from industry fees over recent years.
This item also decreases the application fee for providing advice in relation to a prescription medicine on request to the Pharmaceutical Benefits Program of the Department of Health and Ageing by 85 per cent (from $10,500 to $1,500), applicable in item 18 of Part 2 to Schedule 9 to the Principal Regulations, by 85 per cent as the Government has decided that additional testing activities are no longer required to be performed by the TGA.
Part 2 of Schedule 9, subitem 2(ba) of the Principal Regulations currently provides that the prescribed fee payable for an application to register a medicine:
* where the Secretary of the Department of Health and Ageing considers that the application cannot be determined because of the insufficiency of information delivered by the applicant; or
* if the application is withdrawn before notification of acceptance of the application is sent by the Secretary;
is 20 per cent of the relevant fee, up to a maximum of $5,950.
This item increases the amount of $5,950 in subitem 2(ba) of Part 2 of Schedule 9 to $6,620. This increase enables 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.
This item also increases the fee for obtaining evidence from an overseas regulatory agency of the manufacturing and quality control procedures used in the manufacture of goods if a step in the manufacture of those goods was carried out outside Australia (per manufacturer, per site and per sponsor), applicable in item 6AB of Part 2 of Schedule 9 to the Principal Regulations, from $230 to $480 to more accurately reflect the workload involved for the TGA in obtaining this information.
This item makes no change to the fees prescribed in subitems 1(a), 1(b), 2A(f), 2A(g), 3(a) and 4(c) of Part 2 of Schedule 9 to the Principal Regulations.
ATTACHMENT C
overview of the Therapeutic Goods (MEDICAL DEVICES) Amendment Regulations 2006 (No. 1)
The purpose of the Therapeutic Goods (Medical Devices) Amendment Regulations 2006
(No. 1) is to increase, by 3.5 per cent, certain fees payable in relation to the regulation of medical devices.
The 3.5 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 2005 and 50 per cent of the Consumer Price Index (CPI) for the year ended December 2005.
Paragraph 9.4(2)(a) of the Therapeutic Goods (Medical Devices) Regulations 2002 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. The Regulations increase the level of that reduced fee by 3.5 per cent.
Schedule 5 to the Therapeutic Goods (Medical Devices) Regulations 2002 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 (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 Act and the Therapeutic Goods (Medical Devices) Regulations 2002. The Therapeutic Goods (Medical Devices) Amendment Regulations 2006 (No. 1) increase the level of most of the fees in Part 1 of Schedule 5 (General) by 3.5 per cent. The fees in Part 2 (Additional Fees) remain the same.
The TGA consulted with industry associations, including the Medical Industry Association of Australia, the Australian Dental Industry Association and AusBiotech on the increases.
ATTACHMENT D
Details of the Therapeutic Goods (MEDICAL DEVICES) Amendment Regulations 2006 (No. 1)
Regulation 1 provides for the Regulations to be referred to as the Therapeutic Goods (Medical Devices) Amendment Regulations 2006 (No. 1).
Regulation 2 provides for the Regulations to commence on the day after they are registered.
Item [1]
This item increases the fee for an abridged conformity assessment, applicable in paragraph 9.4(2)(b) of the Principal Regulations, by 3.5 per cent. This enables 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.
Item [2]
This item increases the fees for all relevant items in Part 1 of Schedule 5 to the Principal Regulations by 3.5 per cent. This enables 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.