Commonwealth Numbered Regulations - Explanatory Statements

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THERAPEUTIC GOODS (MEDICAL DEVICES) AMENDMENT REGULATION 2012 (NO. 2) (SLI NO 147 OF 2012)

EXPLANATORY STATEMENT

 

Select Legislative Instrument 2012 No. 147

 

Therapeutic Goods Act 1989

 

Therapeutic Goods Amendment Regulation 2012 (No. 2)

 

Therapeutic Goods (Medical Devices) Amendment Regulation 2012 (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), which is part of the Department of Health and Ageing, 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. 

 

The purpose of the regulations is to amend the Therapeutic Goods Regulations 1990 (the TG Regulations) and the Therapeutic Goods (Medical Devices) Regulations 2002 (the MD Regulations) to increase most fees set out in those regulations by 5.6 per cent.

The 5.6 per cent increase reflects both a 3.6 per cent increase in TGA fees and charges based on a formula agreed with industry associations (comprised of 50 per cent of the Labour Price Index to September 2011 and 50 per cent of the Consumer Price Index to September 2011), and an additional increase of two per cent.  The additional two per cent increase reflects the need to fund the implementation of a number of recommendations arising from several recent reviews into key areas of the regulation of therapeutic goods, and to improve TGA's capacity to conduct post market surveillance of therapeutic goods.

 

These reviews and recommendations are outlined in the TGA document "TGA reforms: A Blueprint for TGA's future", dated December 2011 and include measures relating to the improvement of regulatory transparency (such as the development of consultation principles, and the release of a wider range of information relating to the regulation of therapeutic goods), complementary medicines (including updating guidelines relating to the levels and kinds of evidence that should be held by sponsors of such products), medical devices (including the reclassification of certain kinds of joint replacement devices) and advertising  of therapeutic products. 

 

The fees increases relating to the TG Regulations apply to application fees for registration or listing on the Australian Register of Therapeutic Goods (the Register), application fees for manufacturing licences, evaluation fees, clinical trial notification fees, application fees for export certificates and inspection fees for manufacturing premises.

 

The fees increases relating to the MD Regulations apply to fees relating to conformity assessments and abridged conformity assessments of medical devices, applications for the inclusion of medical devices in the Register and conformity assessment certificates for medical devices.In applying these increases, the following rounding policy has been applied:

a)      for amounts that are less than $140, up to the nearest $10;

b)      for amounts between $141 and $10,000, to the nearest $10; and

c)      for amounts over $10,000, to the nearest $100.

 

The amendments to the TG Regulations and MD Regulations, when taken together with the changes to the Therapeutic Goods (Charges) Regulations 1990 (which are the subject of a separate Minute), are expected to increase the fees and charges collected by the TGA by $2.6 million (to $120.5 million) over the 2012-13 financial year.

 

The increases enable the TGA to recover its costs in administering the Act and continue to meet the Government's Cost Recovery Guidelines, and support the implementation of the reforms process and improvements mentioned above.

 

Details of the amendments to the TG Regulations are set out in Attachment A and details of the changes to the MD Regulations are set out in Attachment B.

 

Consultations with industry associations, including in relation to the proposal to increase TGA fees and charges by 5.6 per cent, were held at sectoral bilateral meetings convened between 21 and 24 February 2012.  Industry was not supportive of an increase of 5.6 per cent, as it exceeded the 3.6 percent increase that would be made based solely on the indexation model relating to annual increases of TGA fees and charges agreed between industry and the TGA.

 

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

 

The regulations are legislative instruments for the purposes of the Legislative Instruments Act 2003.

 

The regulations commence on 1 July 2012.

 

 

Authority: Subsection 63(1) of the Therapeutic Goods Act 1989

 

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ATTACHMENT A

 

Details of the Therapeutic Goods Amendment Regulation 2012 (No. 2)

 

Section 1 - Name of regulation

This section provides for the regulation to be referred to as the Therapeutic Goods Amendment Regulation 2012 (No. 2).

 

Section 2 - Commencement

This section provides for the regulation to commence on 1 July 2012.

 

Section 3 - Amendment of Therapeutic Goods Regulations 1990

This section provides for Schedule 1 to amend the Therapeutic Goods Regulations 1990 (the TG Regulations).

 

Schedule 1 - Amendments

 

Item [1] - Table of amendments - fees

 

Item [1] increases various fees specified in paragraph 43AAJ(1)(b) and subregulations 45(4A), 45(9) and 45(11) of the TG Regulations, and in Parts 2 and 2A of Schedule 9 to the TG Regulations, by 5.6 per cent, subject to the TGA's rounding policy.

 

In addition, item [1] replaces the reference in regulation 45A of the TG Regulations to $13 000 with a reference to $14 000. This threshold amount is determined based on the value of 100 units of the fee payable under Schedule 9, Part 2, item 3AB.  That fee is currently $130, but will increase to $140 as part of the general increase of TGA fees to be effected by item [1]. The increase of the threshold amount therefore reflect the related fee increase.

 

 

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ATTACHMENT B

 

Details of the Therapeutic Goods (Medical Devices) Amendment Regulation 2012 (No. 2)

 

Section 1 - Name of regulation

This section provides for the regulation to be referred to as the Therapeutic Goods (Medical Devices) Amendment Regulation 2012 (No. 2).

 

Section 2 - Commencement

This section provides for the regulation to commence on 1 July 2012.

 

Section 3 - Amendment of Therapeutic Goods Regulations 1990

This section provides for Schedule 1 to amend the Therapeutic Goods (Medical Devices) Regulations 2002 (the MD Regulations).

 

Schedule 1 - Amendments

 

Item [1] - Table of amendments - fees

 

This item increases the fee for an abridged conformity assessment, in paragraph 9.4(2)(b) of the MD Regulations, by 5.6 per cent, subject to the TGA's rounding policy.

 

This item also increases the fees for all relevant items in Part 1 of Schedule 5 to the MD Regulations by 5.6 per cent, subject to the TGA's rounding policy.

 

Part 2 of Schedule 5 to the MD 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 $340 for each hour of preparation by each assessor involved.

 

This item increases the fee of $340 per hour of preparation by each assessor currently payable under paragraph 2.1 (b) of Part 2 of Schedule 5 to the MD Regulations, by 5.6 per cent, subject to the TGA's rounding policy, to $360.

 

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Text Box: Statement of Compatibility with Human Rights Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011 Therapeutic Goods (Medical Devices) Amendment Regulation 2012 (No. 2) This legislative instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011. Overview of the Legislative Instrument The Therapeutic Goods (Medical Devices) Amendment Regulation 2012 (No. 2) (the Amendment Regulation) is made under subsection 63(1) of the Therapeutic Goods Act 1989. The purpose of the Amendment Regulation is to amend the Therapeutic Goods (Medical Devices) Regulations 2002 to increase fees relating to conformity assessments and abridged conformity assessments of medical devices, conformity assessment certificates for medical devices and applications for the inclusion of medical devices on the Australian Register of Therapeutic Goods, by 5.6 per cent, subject to the Therapeutic Goods Administration's rounding policy. Human rights implications This legislative instrument does not engage any of the applicable rights or freedoms. Conclusion This legislative instrument is compatible with human rights as it does not raise any human rights issues. Catherine King Parliamentary Secretary for Health and Ageing                            

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