Therapeutic Goods (Charges) Regulations (Amendment) 1997 No. 161
EXPLANATORY STATEMENT
STATUTORY RULES 1997 No. 161
Issued by authority of the Parliamentary Secretary to the Minister for Health and Family Services for the Minister for Health and Family Services
Therapeutic Goods (Charges) Act 1989
Therapeutic Goods (Charges) Regulations (Amendment)
The Therapeutic Goods (Charges) Act 1989 ("the Act") imposes an annual charge for the registration and listing of therapeutic goods in the Australian Register of Therapeutic Goods (the Register), and an annual charge for maintaining licences to manufacture therapeutic goods.
Subsection 5(1) of the Act provides that the Governor-General may make regulations, not inconsistent with the Act, prescribing the amounts of those charges.
The purpose of the Therapeutic Goods (Charges) Regulations (Amendment) is to introduce an increase to a range of annual charges for maintaining registrations and listings of therapeutic goods in the Register. and to a range of manufacturing licences issued for the manufacture of therapeutic goods. The increases in charges contained in the Regulations have been made in conjunction with increases to the fees made under the accompanying Therapeutic Goods Regulations (Amendment). The Therapeutic Goods Administration (the TGA), which administers the Act operates on a cost recovery basis, with revenue to be drawn from fees and charges collected from industry. The amending regulations, together with the amendments made to the Therapeutic Goods Regulations, will enable the TGA to recover 75 per cent of its operating costs from 1 July 1997.
The introduction of the Act in 1991 was accompanied by a Government requirement that TGA recover 50 per cent of its operating costs through fees and charges levied on industry. The level of cost recovery by the TGA was increased in 1996 with an initial increase to 58 per cent in 1996/97 and proposed increases to 67 per cent and 75 per cent in successive financial years. The rate of increase in cost recovery was accelerated as part of the 1997/98 Budget to recover 75 per cent of operating costs in 1997/98. The amendments contained in the proposed Amending Regulations will enable the TGA to recover 75 per cent of its operating costs through both annual charges and the collection of application and evaluation fees and inspection fees. Agreement was reached with industry for the latest increase to apply from 1 July 1997.
Details of the Regulations are as follows:
Regulation 1 provides for the Regulations to commence on 1 July 1997.
Regulation 2 provides that the Regulations be amended as set out in these Regulations.
Regulation 3 sets out the table of increases to the charges currently applying under various regulations of the Therapeutic Goods (Charges) Regulations. These changes have been agreed to by industry.
The Regulations commenced on 1 July 1997.
Overview
The Therapeutic Goods (Charges) Regulations (Amendment) 1997 No. 161 was enacted to amend the existing Therapeutic Goods (Charges) Regulations, which were established under the Therapeutic Goods (Charges) Act 1989. This legislation was introduced to address the need for the Therapeutic Goods Administration (TGA) to recover an increasing proportion of its operating costs from industry, thereby reducing the reliance on government funding. The Act was passed by the Parliament of Australia and the policy objective was to ensure that the TGA could fund its operations efficiently through fees and charges. The 1997 amendment aimed to increase the annual charges for the registration and listing of therapeutic goods, as well as for maintaining manufacturing licences, in line with the TGA's goal of recovering 75 per cent of its operating costs from fees and charges by 1 July 1997.
Scope and Application
The Therapeutic Goods (Charges) Regulations (Amendment) 1997 No. 161 applies to the Therapeutic Goods (Charges) Act 1989, which mandates annual charges for the registration and listing of therapeutic goods in the Australian Register of Therapeutic Goods and for maintaining licences to manufacture such goods. The Act applies to entities involved in the manufacturing, registration, and listing of therapeutic goods within Australia. The amendments introduced by these regulations are intended to increase the range of annual charges for maintaining registrations and listings of therapeutic goods in the Register and for manufacturing licences issued for therapeutic goods. These regulatory amendments are designed to assist the Therapeutic Goods Administration (TGA) in achieving a cost recovery target of 75% of its operating costs by 1 July 1997. The TGA, which administers the Act, operates on a cost recovery basis, with revenue derived from fees and charges collected from industry. The jurisdictional reach of these regulations is national, as the TGA operates under the Commonwealth government to ensure the safety and efficacy of therapeutic goods throughout Australia. The amendments reflect an agreement with industry for the latest increase to apply from 1 July 1997.
Key Provisions
The Therapeutic Goods (Charges) Regulations (Amendment) 1997 No. 161 outlines changes to the fees and charges imposed under the Therapeutic Goods (Charges) Act 1989 (the Act). Specifically, Regulation 3 details the increases to the annual charges for maintaining registrations and listings of therapeutic goods in the Australian Register of Therapeutic Goods (the Register) and for maintaining manufacturing licences for therapeutic goods. These amendments are designed to align with the cost recovery requirements of the Therapeutic Goods Administration (TGA), which operates on a cost recovery basis.
The obligations under the Act and these amending regulations primarily focus on the financial responsibilities of entities involved in the registration, listing, and manufacturing of therapeutic goods. Section 5(1) of the Act allows the Governor-General to prescribe the charges through regulations, and Regulation 3 provides the specifics of these increased charges. Entities subject to these regulations must ensure they are aware of and comply with the new charge amounts effective from 1 July 1997. This involves updating their financial planning and budgeting processes to account for the increased costs associated with maintaining their registrations, listings, and manufacturing licences.
While the Regulations themselves do not explicitly detail offences, penalties, or civil/criminal consequences for non-compliance, the Act and associated regulations impose strict compliance requirements. Failure to pay the amended charges when due could potentially lead to non-renewal or cancellation of registrations, listings, or manufacturing licences. Such actions could disrupt business operations and result in significant legal and financial repercussions for the entities involved. It is important for entities to adhere to these financial obligations to avoid any disruptions in their compliance status with the TGA.