Therapeutic Goods (Charges) Amendment Regulations 2000 (No. 2) 2000 No. 125
EXPLANATORY STATEMENT
STATUTORY RULES 2000 No. 125
Issued by authority of the Parliamentary Secretary to the
Minister for Health and Aged Care
Therapeutic Goods (Charges) Act 1989
Therapeutic Goods (Charges) Amendment Regulations 2000 (No.2)
Section 3 of the Therapeutic Goods (Charges) Act 1989 (the Act) states that the Therapeutic Goods Act 1989 is incorporated, and is to be read as one, with the Act.
Subsection 4(1) of the Act provides that annual charges are payable for maintaining registration and listings of therapeutic goods in the Register. Subsection 4(1A) of the Act provides that where more than one therapeutic good is "grouped" and each of the "grouped" therapeutic goods is covered by the same registration or listing number, then a single annual charge will apply for maintaining all the registered or listed therapeutic goods covered under the same grouping.
Section 5 of the Act enables the Governor-. General to prescribe the level of charges that are payable for maintaining goods in the Register or for maintaining grouped therapeutic goods in the Register.
The purpose of the amending regulations is to increase the annual charges that are payable in relation to therapeutic devices, in order to meet the government's requirement that the Therapeutic Goods Administration (TGA) operate on a full cost-recovery basis. The Medical Industry Association of Australia (M1AA), which is the peak industry body in, relation to therapeutic devices, considered the amendments being made to adjust the fees and charges payable under both the Therapeutic Goods Regulations and the Therapeutic Goods (Charges) Regulations provide equity across the listed and registered devices market and will give incentives for new products.
It was agreed with MIAA that greater emphasis would be placed on annual charges as a revenue base for achieving cost recovery.
The Amending Regulations provide for:
* annual charges for listed devices to increase from $300 to $450 per annum,
* annual charges for registered devices to increase from $490 to 5900 per annum.
Details of the amending Regulations are set out in the Attachment.
The Regulations commence on 1 July 2000.
ATTACHMENT
Therapeutic Goods (Charges) Amendment Regulations 2000
Regulation 1 states that the title of these regulations will be the Therapeutic Goods (Charges) Amendment Regulations 2000 (No
Regulation 2 provides that these regulations commence 1 July 2000.
Regulation 3 provides that these regulations amend the Therapeutic Goods (Charges) Regulations 1990 as provided in Schedule 1.
SCHEDULE 1 - AMENDMENTS
Item 1 increases the annual charges for maintaining registrations of therapeutic devices from $490 to $900.
Item 2 increases the annual charges for maintaining listable therapeutic devices from $300 to $450.
Item 3 increases the annual charges for maintaining registrations of registered therapeutic devices that have been grouped, pursuant to section 16 of the Therapeutic Goods Act 1989, from $490 to $900. The effect of "grouping" is to enable the sponsor of each of the goods covered by a "grouping" to use the same registration number for all grouped goods, and to pay only one annual charge for all goods grouped. But for "grouping" pursuant to section 16 of the Therapeutic Goods Act 1989, the sponsor would be required to use different registration numbers for each product being supplied, and to pay a separate annual charge for each product included in the Register.
Item 4 increases the annual charges for maintaining listings of grouped listable therapeutic devices, from $'300 to $450.
Overview
The Therapeutic Goods (Charges) Amendment Regulations 2000 (No. 2) were enacted to address the need for the Therapeutic Goods Administration (TGA) to operate on a full cost-recovery basis. These amending regulations, issued under the authority of the Parliamentary Secretary to the Minister for Health and Aged Care, serve to adjust the annual charges payable for maintaining the registration and listings of therapeutic goods. Specifically, the regulations aim to increase the annual charges for therapeutic devices to ensure that the TGA can meet its financial obligations while maintaining the integrity and oversight of therapeutic goods in Australia. As per the explanatory statement, the Medical Industry Association of Australia (M1AA) supported these amendments, considering them essential for providing equity across the market and encouraging new product development. The regulations stipulate new annual charges, raising them from $300 to $450 for listed devices and from $490 to $900 for registered devices, effective from 1 July 2000.
Scope and Application
The Therapeutic Goods (Charges) Amendment Regulations 2000 (No. 2) applies to entities and individuals who are required to pay annual charges for maintaining registrations and listings of therapeutic goods in the Register as stipulated under the Therapeutic Goods (Charges) Act 1989. This Act pertains to therapeutic goods, which include medicines, medical devices, and other health-related products, and it applies to all entities and individuals involved in the manufacture, supply, or import of these goods within Australia. The regulations have a national reach, impacting the entire Australian market for therapeutic goods. The Act does not explicitly exclude any specific entities or therapeutic goods from its scope; however, it is expected that certain exemptions or thresholds might be addressed in subordinate instruments. The purpose of these amendments is to adjust the annual charges for therapeutic devices to ensure that the Therapeutic Goods Administration (TGA) can operate on a full cost-recovery basis. The changes involve increasing the annual charges for both listed and registered therapeutic devices, with specific increases outlined in the Regulations. The amendments are designed to provide a more equitable revenue base and to encourage the development of new products in the therapeutic goods market.
Key Provisions
The Therapeutic Goods (Charges) Amendment Regulations 2000 (No. 2) (the Regulations) introduce changes to the annual charges payable for the maintenance of registration and listings of therapeutic goods, as stipulated in section 4 of the Therapeutic Goods (Charges) Act 1989 (the Act). Specifically, Regulation 3 in Schedule 1 of the Regulations modifies the Therapeutic Goods (Charges) Regulations 1990 to increase these charges. For instance, the annual charge for listed devices is set to rise from $300 to $450 (Item 2 of Schedule 1), while the charge for registered devices is to increase from $490 to $900 (Item 1 of Schedule 1). Additionally, the Regulations adjust the fees for grouped therapeutic goods, with grouped listable devices seeing an increase from $300 to $450 (Item 4 of Schedule 1) and grouped registered devices from $490 to $900 (Item 3 of Schedule 1). These amendments are intended to reflect a full cost-recovery basis for the Therapeutic Goods Administration (TGA), as agreed with the Medical Industry Association of Australia (MIAA).
The Regulations impose obligations on sponsors and manufacturers of therapeutic goods to ensure they are aware of and comply with the increased annual charges for maintaining their goods in the Register. This includes adhering to the new charge structures for both listed and registered therapeutic goods, as well as for those grouped under the same registration or listing number. Sponsors and manufacturers must submit the updated annual charges by the specified deadlines to avoid any disruptions in the registration or listing status of their goods. Failure to comply with these obligations may result in the TGA suspending or cancelling the registration or listing, thereby impacting the legality of the supply of the therapeutic goods.
Under the Regulations, breaches of the amended charges may lead to enforcement actions by the TGA. For instance, non-payment of the increased annual charges may result in the TGA suspending or cancelling the registration or listing of the therapeutic goods, which could have significant commercial implications for the sponsors or manufacturers. Additionally, while the Regulations do not explicitly outline specific penalties, the Therapeutic Goods Act 1989 provides a framework for potential penalties and enforcement actions. These could include fines, legal proceedings, or other administrative actions that could be taken against those who fail to comply with the regulatory requirements. The maximum penalties, however, are not specified in the Regulations themselves but would be in line with the broader legislative framework provided by the Therapeutic Goods Act 1989.