Therapeutic Goods (Charges) Amendment Regulations 2009 (No. 1)

Administered by Department of Health, Disability and Ageing

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EXPLANATORY STATEMENT

Select Legislative Instrument 2009 No. 142

Therapeutic Goods (Charges) Act 1989

Therapeutic Goods (Charges) Amendment Regulations 2009 (No. 1)

The Therapeutic Goods (Charges) Act 1989 (the Charges Act) allows for the imposition of an annual charge on the registration and listing of therapeutic goods, and on the licensing of manufacturers of therapeutic goods, the inclusion of a kind of medical device in the Australian Register of Therapeutic Goods (the Register). The Therapeutic Goods Administration is responsible for administering the Charges Act.

Subsection 5(1) of the Charges Act allows the Governor-General to make regulations, not inconsistent with the Charges Act, prescribing the amounts of annual charges payable.

The Therapeutic Goods Legislation Amendment (Annual Charges) Act 2008 (the Amendment Act), which commenced on 1 January 2009, repealed subsection 5(3) of the Charges Act. The repealed subsection 5(3) allowed regulations to be made providing for exemption from liability annual charges in respect of the registration or listing of therapeutic goods, or the inclusion of kinds of medical devices in the Register. One particular exemption is set out in the Therapeutic Goods (Charges) Regulations 1990 (the Principal Regulations) and applied where the turnover of particular therapeutic goods or devices is of low volume or low value.

Following the enactment of the Amendment Act, the provisions relating to the exemption to pay applicable annual charges by persons with low value or volume turnover are now implemented under the Therapeutic Goods Act 1989. As a consequence, the requirements relating to the granting of that exemption from payment of applicable annual charges will now be included in the Therapeutic Goods Regulations 1990 which are the subject of a separate Minute. The Amendment Act provides that despite the repeal of subsection 5(3), that subsection also continues to apply after 1 January 2009 in relation to working out whether the annual charges are payable by persons for the financial year beginning on 1 July 2008 and all earlier financial years.

The purpose of the Regulations is to repeal the redundant provisions in the Principal Regulations. The Regulations also provide for the applicable transitional arrangements.

Details of the Regulations are set out in the Attachment.

Interested parties were consulted on a number of proposed changes to the current regulatory framework held in Parliament House during late July and early August 2008. These amendments were discussed during these consultations. These amendments have a nil to low impact on business, individuals and the economy and therefore do not require a regulatory impact statement.

A regulatory impact statement was not prepared as these changes will have no impact on industry.

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

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

The Regulations commence on 1 July 2009.

Authority: Subsection 5(1) of the

Therapeutic Goods (Charges) Act 1989

ATTACHMENT

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

Regulation 1 names the Regulations as the Therapeutic Goods (Charges) Amendment Regulations 2009 (No. 1).

Regulation 2 provides that the Regulations commence on 1 July 2009.

Regulation 3 provides that the Regulations amend the Therapeutic Goods (Charges) Regulations 1990 (the Principal Regulations) as provided in Schedule 1.

Regulation 4 provides the transitional provision applying to the regulations to be repealed as set out in Schedule 1. It provides that despite the repeal of those regulations, they continue to apply after 1 July 2009 in relation to working out whether the annual charges mentioned in those regulations are payable by a person for the financial year beginning on 1 July 2008 and all earlier financial years.

SCHEDULE 1 –Amendments

Item [1]

Item [1] omits and has the effect of repealing regulations 4B, 4C, 4D, 4E, 4F and 5 of the Principal Regulations. These provisions relate to the granting of an exemption and the cancellation of that exemption from the liability to pay annual charges by a person whose turnover of the relevant goods entered in the Register is low volume and low value. The corresponding provisions prescribing the requirements for the granting of an exemption and the cancellation of that exemption will be set out in the Therapeutic Goods Regulations 1990 (the TG Regulations). This is a consequence of the amendments made to the Therapeutic Goods (Charges) Act 1989 and the Therapeutic Goods Act 1989 by the Therapeutic Goods Legislation Amendment (Annual Charges) Act 2008. Specific requirements such as the granting of an approval for the exemption, the cancellation of an exemption, the making of an application, the criteria for the exemption, the auditing of the granted exemption, and Administrative Appeals Tribunal reviews relating to decisions about the exemption are now to be implemented under section 44A of the Therapeutic Goods Act 1989 and details will be set out in the TG Regulations.

Overview

The Therapeutic Goods (Charges) Amendment Regulations 2009 (No. 1) were enacted to amend the Therapeutic Goods (Charges) Regulations 1990, aligning with the changes introduced by the Therapeutic Goods Legislation Amendment (Annual Charges) Act 2008. This legislation was introduced to address the gap created by the repeal of subsection 5(3) of the Therapeutic Goods (Charges) Act 1989, which previously allowed for exemptions from annual charges for therapeutic goods with low volume or low value turnovers. These regulations were formulated by the Governor-General under the authority provided by subsection 5(1) of the Therapeutic Goods (Charges) Act 1989 and aim to ensure a seamless transition to the new framework where exemption criteria and processes are now governed by the Therapeutic Goods Act 1989. The Regulations provide for transitional arrangements, ensuring that the repealed provisions continue to apply to financial years beginning on or before 1 July 2008, thus maintaining consistency and fairness in the application of annual charges. These changes were designed to have minimal impact on business and the economy and, as such, did not require a regulatory impact statement.

Scope and Application

The Therapeutic Goods (Charges) Amendment Regulations 2009 (No. 1) amend the Therapeutic Goods (Charges) Regulations 1990, which themselves were made under the Therapeutic Goods (Charges) Act 1989. This Act applies to the imposition of annual charges on the registration and listing of therapeutic goods, the licensing of manufacturers of therapeutic goods, and the inclusion of kinds of medical devices in the Australian Register of Therapeutic Goods. The Therapeutic Goods Administration is tasked with administering the Act, and the Governor-General is empowered to make regulations prescribing the amounts of annual charges payable, in accordance with the Act. The Regulations themselves have a national reach, applying across Australia, and affect entities such as manufacturers, importers, and sponsors of therapeutic goods who are subject to the annual charges stipulated by the Act. The Regulations include transitional provisions that allow for the continued application of repealed provisions in determining annual charges for financial years beginning on or before 1 July 2008. Notably, the Regulations do not establish any new exclusions or thresholds for the annual charges but instead streamline the exemption process by moving it to the Therapeutic Goods Regulations 1990, following legislative amendments. This transition ensures that the administration of exemptions is now aligned with broader therapeutic goods regulations rather than being confined to charges-specific provisions.

Key Provisions

The Therapeutic Goods (Charges) Amendment Regulations 2009 (No. 1) (the Regulations) primarily serve to amend the Therapeutic Goods (Charges) Regulations 1990 (the Principal Regulations) to reflect changes introduced by the Therapeutic Goods Legislation Amendment (Annual Charges) Act 2008. The key operative sections of these Regulations include Regulation 3, which amends the Principal Regulations by repealing certain provisions related to exemptions from annual charges for therapeutic goods and medical devices of low value or low volume. Regulation 4 outlines the transitional arrangements, ensuring that the repealed provisions continue to apply for financial years starting on or before 1 July 2008. The Regulations impose specific obligations on entities required to pay annual charges for the registration, listing, and licensing of therapeutic goods and medical devices. These entities must comply with the updated requirements set out in the Therapeutic Goods Regulations 1990, which include criteria for exemption and the procedures for applying for and maintaining such exemptions. The Therapeutic Goods Administration is responsible for overseeing these obligations and ensuring compliance. Failure to comply with the Regulations, particularly concerning the payment of annual charges or the process for obtaining exemptions, may result in civil or criminal consequences. While the specific penalties are not detailed in the Explanatory Statement, the broader Therapeutic Goods Act 1989 provides for penalties, including fines, for breaches of its provisions. The exact penalties for non-compliance with the Regulations would be governed by these broader legislative frameworks. These Regulations, therefore, ensure that the administration of annual charges for therapeutic goods and medical devices is streamlined and aligned with recent legislative changes. The transition to the new regulatory environment is managed through the provisions in Regulation 4, which maintain the applicability of repealed regulations for financial years prior to 1 July 2009. This approach facilitates a smooth implementation of the new regulatory requirements.

Area of Law: Administrative Law; Regulatory Standards
Instrument: Regulation
Concepts: Definitions & Interpretation; Regulatory Standards; Enforcement Powers

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