Therapeutic Goods (Medical Devices) Amendment Regulations 2009 (No. 1)

Administered by Department of Health, Disability and Ageing

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EXPLANATORY STATEMENT

Select Legislative Instrument 2009 No. 181

Therapeutic Goods Act 1989

Therapeutic Goods (Medical Devices) Amendment Regulations 2009 (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. Schedule 5 of the Therapeutic Goods (Medical Devices) Regulations 2002 (the Principal Regulations) sets out the table of fees payable under the Act in relation to medical devices.

Paragraph 63(3)(b) of the Act provides, in part, for the reduction of fees in cases identified in the regulations. Paragraph 9.4(2)(b) of the Principal Regulations sets out the fee payable where the Secretary of the Department of Health and Ageing (the Secretary) decides to conduct an abridged conformity assessment of a medical device in prescribed circumstances and to charge a reduced fee for that assessment. Paragraph 9.4(2)(a) of the Therapeutic Goods (Medical Devices) Regulations 2002 allows 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 4.3 per cent.

Schedule 5 to the Principal Regulations provides the list of fees payable 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 Principal Regulations. The Regulations increase the level of all of the fees in Part 1 of Schedule 5 (General) and Part 2 (Additional Fees) by 4.3 per cent.

The purpose of the Regulations is to increase, by 4.3 per cent, all fees payable in relation to the regulation of medical devices which are required to be included on 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 increases enable the TGA to recover its costs in administering the Act and continue to meet the Australian Government’s Cost Recovery Guidelines.

The Regulations, when taken together with the amendments to the Therapeutic Goods Regulations 1990 and the Therapeutic Goods (Charges) Regulations 1990 (which are the subject of separate Regulations), are expected to increase the fees and charges collected by the TGA by $8.8 million (to $99.9 million) over the 2009-10 financial year.

Details of those Regulations are set out in the Attachment.

Consultations with industry associations and consumer health representatives on the TGA’s draft Business Plan, Budget and proposed Schedule of Fees and Charges were convened at the TGA Industry Consultative Committee meeting on 3 March 2009. The proposals for fees and annual charges were subject to additional bilateral consultation at sectoral bilateral meetings convened between 16 and 19 March 2009.

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

The Regulations commence on 10 July 2009.

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

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

ATTACHMENT

Details of the Therapeutic Goods (MEDICAL DEVICES) Amendment Regulations 2009 (No. 1)

Regulation 1 provides for the Regulations to be referred to as the Therapeutic Goods (Medical Devices) Amendment Regulations 2009 (No. 1).

Regulation 2 provides for the Regulations to commence on 10 July 2009.

Regulation 3 provides 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 4.3 per cent.

This item also increases the fees for all relevant items in Part 1 of Schedule 5 by 4.3 per cent.

Part 2 of Schedule 5 currently provides for additional fees for assessments that are required to be conducted outside Australia. These fees are currently calculated at a rate of $310 for each hour of preparation by each assessor involved.

This item increases the fee of $310 per hour of preparation by each assessor currently payable under paragraph 2.1(b) of Part 2 of Schedule 5 by 4.3 per cent, to $320.

Overview

The Therapeutic Goods (Medical Devices) Amendment Regulations 2009 (No. 1) were introduced to address the need for increased fee structures for medical devices regulated under the Therapeutic Goods Act 1989. This Act, enacted to establish and maintain a national system of controls for the quality, safety, efficacy, and timely availability of therapeutic goods, is administered by the Therapeutic Goods Administration (TGA). The regulations aim to align the fees with the costs incurred by the TGA in performing its duties, as per the Australian Government’s Cost Recovery Guidelines. Specifically, these amendments increase all applicable fees by 4.3%, reflecting the financial requirements for the TGA to continue its operations effectively. The increased fees are designed to ensure that the TGA can recover its costs and maintain the quality of its regulatory functions. The regulations were enacted following consultations with industry associations and consumer health representatives, and they commenced on 10 July 2009.

Scope and Application

The Therapeutic Goods Act 1989 (the Act) establishes and maintains 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 (TGA) is responsible for administering the Act. The Act applies to all therapeutic goods used in or exported from Australia, encompassing a wide range of products including medicines, medical devices, blood and blood components, tissues, and therapeutic goods for animal use. The regulations made under the Act extend to the entire Commonwealth of Australia, ensuring a uniform regulatory framework across all states and territories. The Therapeutic Goods (Medical Devices) Amendment Regulations 2009 (No. 1) provide for an increase in fees associated with the regulation of medical devices by 4.3 per cent, affecting fees for conformity assessments and other related processes. These amendments are aimed at enabling the TGA to recover its costs and align with the Australian Government’s Cost Recovery Guidelines. The increased fees were the subject of consultations with industry associations and consumer health representatives, ensuring stakeholder engagement in the regulatory process.

Key Provisions

The Therapeutic Goods (Medical Devices) Amendment Regulations 2009 (No. 1) serve to amend the Therapeutic Goods (Medical Devices) Regulations 2002, which are subsidiary legislation under the Therapeutic Goods Act 1989. The primary focus of these Regulations (paragraphs 1 to 3) is to increase certain fees related to the regulation of medical devices. Specifically, Regulation 1 names the Regulations as the Therapeutic Goods (Medical Devices) Amendment Regulations 2009 (No. 1) and sets the commencement date as 10 July 2009. Regulation 2 provides for the effective date of these Regulations, and Regulation 3 specifies the amendments to the Therapeutic Goods (Medical Devices) Regulations 2002. The Regulations impose obligations on entities and individuals involved in the regulation of medical devices in Australia. Primarily, they require that fees for various activities related to the assessment and inclusion of medical devices in the Australian Register of Therapeutic Goods be increased by 4.3%. This includes fees for applications, initial and subsequent assessments, and fees for assessments conducted outside Australia (Schedule 1, Items [1] and [2]). These fee increases are intended to allow the Therapeutic Goods Administration (TGA) to recover costs and comply with the Australian Government's Cost Recovery Guidelines. Failure to comply with the fee provisions outlined in these Regulations could result in penalties, although the specific consequences are not detailed within the Regulations themselves. Generally, under the Therapeutic Goods Act 1989, non-compliance with regulatory requirements can lead to enforcement actions, which may include fines or other civil penalties. The maximum penalties for breaches of the Act or its subsidiary legislation can vary, but they are typically determined by the severity and intent of the breach. The Therapeutic Goods Act 1989 also provides for both civil and criminal penalties for serious or deliberate non-compliance. The amendments made by these Regulations are expected to increase the fees and charges collected by the TGA by $8.8 million over the 2009-10 financial year. This increase is to be achieved through the 4.3% rise in fees, which will be applied to various aspects of medical device regulation. The fees have been rounded to the nearest $10 for amounts under $10,000 and to the nearest $100 for amounts over $10,000. These changes were subject to consultation with industry associations and consumer health representatives, ensuring that stakeholders were informed and could provide feedback before the Regulations were finalised.

Area of Law: Administrative Law; Regulatory Standards
Instrument: Regulation
Concepts: Definitions & Interpretation; Fees; Regulatory Standards
Catchwords: Fees

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