Therapeutic Goods (Charges) Regulations (Amendment)

Overview

The Therapeutic Goods (Charges) Regulations (Amendment) 1998 No. 246, issued under the authority of the Minister for Health and Family Services, amends the Therapeutic Goods (Charges) Regulations to implement the final stage of the Therapeutic Goods Administration's (TGA) decision to achieve 100% cost recovery from the industry for the regulation of therapeutic goods. The Therapeutic Goods (Charges) Act 1989 (Charges Act) imposes annual charges for the registration and listing of therapeutic goods in the Australian Register of Therapeutic Goods and for maintaining therapeutic goods manufacturing licenses. The objective of these amendments is to increase a range of fees and charges to ensure full cost recovery from industry. To minimise the impact of these increases, they are phased in, with the 1997/98 Budget setting a 75% cost recovery target, rising to 100% by 1998/99. The amendments increase annual charges for various categories of therapeutic goods, including prescription and non-prescription drugs, therapeutic devices, and manufacturing licenses. The Regulations commence on 1 August 1998.

Scope and Application

The Therapeutic Goods (Charges) Regulations (Amendment) 1998 No. 246 amends the Therapeutic Goods (Charges) Regulations 1990 to align with the Therapeutic Goods (Charges) Act 1989, which is aimed at establishing and maintaining a national system of controls for the quality, safety, efficacy, and timely availability of therapeutic goods used in or exported from Australia. The regulations apply to entities and individuals who are subject to the charges for the registration, listing, and licensing of therapeutic goods, including drugs, therapeutic devices, and products that are manufactured and supplied in Australia. These regulations pertain to all therapeutic goods that are registered, listed, or licensed under the Act, irrespective of whether they are intended for domestic use or export. The amendments primarily focus on increasing the annual charges to achieve 100% cost recovery by the Therapeutic Goods Administration (TGA) for the regulation of therapeutic goods. The changes include separate annual charges for registered prescription drugs, registered non-prescription drugs, and registered therapeutic devices, as well as increased charges for listings of therapeutic goods and manufacturing licenses. These regulatory amendments are intended to phase in the increases to minimise the impact on industry and are effective as of 1 August 1998.

Key Provisions

The main operative sections of the Therapeutic Goods (Charges) Regulations (Amendment) 1998 No. 246 (the Regulations) provide for amendments to the Therapeutic Goods (Charges) Regulations, specifically concerning the annual charges for the registration and listing of therapeutic goods and the maintenance of manufacturing licenses (Reg. 2). Regulation 3.1 and 3.2 introduce separate annual charges for prescription drugs, non-prescription drugs, and therapeutic devices, increasing the charges from $390 to $750 for prescription drugs, $545 for non-prescription drugs, and $5490 for therapeutic devices (Reg. 3.1). Regulation 3.3 increases the annual charge for listing therapeutic goods from $220 to $270 for listed drugs and $300 for listed therapeutic devices (Reg. 3.3). Regulation 3.4 and 3.5 increase the annual charge for grouped therapeutic goods, with significant increases for drugs in Poisons Standard Schedules 4 or 8 from $620 to $7550, and other therapeutic goods from $390 to $455 (Reg. 3.4). Regulation 3.7 and 3.8 increase the annual licensing charges for manufacturing licenses from $2,690 to $3,500 and from $5,620 to $6,800 (Reg. 3.7). Regulation 4.1 increases the benchmark for the annual charge for registrations or listings of low volume or low value therapeutic goods from 5% to 6% of the actual or estimated turnover of the goods (Reg. 4.1). The Regulations impose obligations on entities to pay the increased annual charges for the registration and listing of therapeutic goods and the maintenance of manufacturing licenses. Specifically, entities must pay the new charges for registration of prescription drugs, non-prescription drugs, and therapeutic devices, as well as for the listing of therapeutic goods, grouped therapeutic goods, and manufacturing licenses (Reg. 3). Entities must also pay the increased benchmark charge for low volume or low value therapeutic goods, which is based on a percentage of the actual or estimated turnover of the goods (Reg. 4.1). Failure to pay the increased charges may result in the suspension or cancellation of the registration or listing of therapeutic goods or the manufacturing license (Charges Act s. 5(2)). The Regulations do not explicitly state any offences, penalties, or civil/criminal consequences for breach. However, the Therapeutic Goods (Charges) Act 1989 (the Charges Act) provides that failure to pay the annual charges for the registration and listing of therapeutic goods or the maintenance of manufacturing licenses may result in the suspension or cancellation of the registration or listing or the manufacturing license (Charges Act s. 5(2)). The maximum penalty for an offence under the Charges Act is a fine of up to $22,000 for a body corporate and up to $4,400 for an individual (Charges Act s. 12). Additionally, the Therapeutic Goods Act 1989 provides for various criminal and civil penalties for non-compliance with the Act, including fines of up to $2,750,000 for a body corporate and up to $550,000 for an individual, imprisonment for up to five years, or both (Therapeutic Goods Act s. 121).