Therapeutic Goods Regulations (Amendment) 1994 No. 222
EXPLANATORY STATEMENT
Statutory Rules 1994 No. 222
Issued by Authority of the Minister for Family Services
Therapeutic Goods Act 1989
Therapeutic Goods Regulations (Amendment)
The Therapeutic Goods Act 1989 (the Act) has for its objective the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods that are used In Australia or exported from Australia. The Therapeutic Goods Administration (TGA) has responsibility for the administration of the Act. The TGA operates from the Therapeutic Goods Administration Trust Account, established under the Audit Act 1901 and referred to in section 45 of the Act. In accordance with the Government's decision of August 1989, the TGA is required to operate on a fifty per cent cost-recovery basis, with funding raised through tees and charges collected from industry.
Section 63 of the Act provides that the Governor-General may make Regulations for the purposes of the Act.
Subsection 63(1) and paragraphs 63(2)(h) and 63(3)(a) of the Act enable the Governor-General to make regulations prescribing a range of application, processing or evaluation fees payable in connection with the processing of applications to include therapeutic goods In the Australian Register of Therapeutic Goods (the Register) and the variation of information contained in the Register about those goods. The provisions also enable the Governor-General to prescribe fees for processing applications for licences to manufacture therapeutic goods, and face for conducting inspections of premises that may be licensed. Paragraph 63(3)(b) provides that regulations may also be may made for the refund, reduction or waiving of fees or charges in cases identified in the Regulations.
Background
The tees and charges sat out under Schedule 9 of the Therapeutic Goods Regulations and under the Therapeutic Goods (Charges) Regulations were structured with the aim of meeting the fifty per cent cost-recovery objective for the TGA. However, since the Act came into operation an 15 February 1991 this objective has not been met for a number of reasons, a significant one being the very conservative fees and charges originally adopted under the Regulations.
To address the shortfall in revenue, a Budget Working Party, with a membership drawn from the Australian Pharmaceutical Manufacturers Association Inc, the Proprietary Medicines Association of Australia Inc, the Medical Industry Association of Australia Inc, the Nutritional Foods Association and the TGA, was cat up on 20 March 1993 to canvass various options. Following meetings and considerable discussion by the group, the option of increasing fees and charges under the Therapeutic Goods Regulations and the Therapeutic Goods (Charges) Regulations, as well as the introduction of new fees to cover activities previously undertaken by TGA free of charge, were considered to he the most appropriate options If the fifty per cant cost recovery target met government is to be met. To achieve this objective with the minimum of disruption to Industry, agreement was reached between industry and government that the increases would be progressively phased in over a four year period, beginning with the 1993/94 financial year. The first sat of increases and new fees were accordingly effected on 1 July 1993.
The Regulations:
(a) provide for the second agreed incremental increase to the existing range of application fees, processing fact and evaluation fees currently applying under Schedule 9 of the Regulations;
(b) provide fora waiver of application fees In circumstances where sponsors of therapeutic devices are required to switch their goods Included In the Register from one part of the Register to another, where the changeover is required as a result of a change to the legislation;
(c) provide for a waiver or reduction of the full evaluation fees otherwise payable by a sponsor in circumstances where an applicant for registration of a number of drugs listed In Schedule 10 of the Regulations lodges concurrent applications to register those drugs. The reduction will only apply where all the drugs contain the same therapeutically active ingredient, the information supporting each application for each drug is sufficiently similar to enable a simultaneous evaluation of all the goods and the applicant opts to pay the reduced evaluation fees in full prior to any evaluation of the goods;
(d) introduce new fees for evaluating a very large volume of data relating to chemistry, quality control and manufacturing information, to cover data that is 100 - 1000 pages, 1001 - 3000 pages and over 3000 pages;
(e) amend the structure of the inspection fees to provide for half-day and quarterday Inspection foam, instead of the present Initial half day followed by subsequent half day fees.
Further details of the Regulations are cat out in the Attachment.
The Regulations commenced on 1 July 1994.
ATTACHMENT
DETAILS OF THERAPEUTIC GOODS REGULATIONS (AMENDMENT)
Regulation 1 provides that the changes contained In theme Regulations are to commence on 1 July 1994.
Regulation 3 inserts new Regulation 43A to provide for a waiver of an application fee to include therapeutic devices in the Australian Register of Therapeutic Goods (the Register) in the circumstances outlined. The Register is divided into 2 parts, one for "registrable" goods and the other for "listable" therapeutic goods, each category signifying the degree of scrutiny therapeutic goods must undergo before being included in the Register. Where the status of therapeutic goods included In one part of the Register changes so that It is required to be included in the other part of the Register, the sponsor must reapply to include its goods in the correct part of the Register and pay the accompanying fee. New Regulation 43A provides that where the change in status of therapeutic devices occurs because of an amendment to legislation, and the sponsor is thereby required to reapply to include its devices In the correct part of the Register, the applicant need not pay any application toes to effect the change-over.
Regulation 4 inserts new subregulations 45(5), (6) and (7) to provide for a reduction, in the circumstances outlined, of the full evaluation fees otherwise payable by an applicant seeking to register drugs that are included In Schedule 10 of the Therapeutic Goods Regulations. Thus, where an applicant simultaneously lodges more than one application to register such drugs, the full evaluation fees may be reduced where:
- the total number of all concurrent applications Is at least 1,000 pages;
- the information provided in support of each application is sufficiently similar to enable a simultaneous evaluation of all the goods;
- each of the drugs contain the same therapeutically active Ingredient; and
- the applicant has paid 75% of the full evaluation fees payable for one of the concurrent applications, being the application that attracts the highest evaluation fees under Item 4 of Schedule 9 of the Regulations; and
- the applicant offers, in writing, to pay the full amount or the balance of the reduced fees before any evaluation of the goods occurs.
The amount of the reduction would be such that:
- where there is a total of 4 applications, the evaluation fees payable for the 3 additional concurrent applications will be reduced to nil;
- where there Is a total of 5 applications, the evaluation fees payable for the 4 additional concurrent applications will be reduced to a total of $2,000;
- where there is a total of 6 applications, the evaluation fees payable for the 5 additional concurrent applications will be reduced to a total of $3,500;
- where there is a total of 7 applications, the evaluation fees payable for the 6 additional concurrent applications will be reduced to a total of $4,500; and
- where there should be more than a total of 7 applications, the reduced evaluation fees payable for each additional application over the seventh application will be a further $500 each over and above the $4,500.
Subregulations 5.1 and 5.2 include consequential changes to Schedule 9 to take into account the waiver of application fees in the circumstances described in Regulation 3 above.
Subregulation 5.3 introduces new fees to cover the evaluation of a large volume of technical data relating to chemistry, quality control and manufacturing information. The new fees are, for 101-1000 pages, $11,200; for 1001 - 3000 pages, $16,000; and for more than 3000 pages, $22,000.
Subregulation 5.4 acts out the new fee structure for Inspection fees payable under Item 9 of Schedule 9. The new structure provides for an initial half day and subsequent quarter day inspection fees to replace the former initial half day and subsequent half day inspection fees. A separate category of inspection fees for diagnostic goods for in vitro use has been introduced, to replace the former higher fees previously charged for conducting inspections in respect of such goods. The lower fees ($1400 for the first 4 hours and $450 for each subsequent 2 hour, or part thereof, inspection) will be identical to the fees charged for herbal or homoeopathic preparations.
Subregulation 5.5 sets out the table of increases to the fees currently applying under Schedule 9 of the Therapeutic Goods Regulations. These changes have been agreed to by industry and represent the second incremental increase to the fees and charges that are being introduced over a four year period.