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Wednesday, 23 March 2011
Page: 2873


Ms KING (Parliamentary Secretary for Health and Ageing and Parliamentary Secretary for Infrastructure and Transport) (10:05 AM) —I move:

That this bill be now read a second time.

This bill will make changes to the Therapeutic Goods Act 1989 to further enhance the regulatory framework for therapeutic goods and provide additional support for the new streamlined processes being implemented to bring improvements to the time within which prescription medicines are evaluated by the Therapeutic Goods Administration.

A number of initiatives were identified in a review of the application and evaluation processes for prescription medicines that could help eliminate unnecessary delays, including those arising from the provision of incomplete or insufficient data. Implementation of these initiatives is expected to result in a reduction of the current 500 days for an application to be determined to approximately 300 days.

The TGA has been working to streamline the submission process both for the registration of new prescription medicines and for making changes to the entries of prescription medicines in the Australian Register of Therapeutic Goods. A 12-month implementation phase for the new streamlined submission and evaluation processes commenced on 1 November 2010.

Changes to the act to support these processes were made by the Therapeutic Goods Amendment (2010 Measures No.1) Act 2010. This bill includes further changes to add legislative support to the new processes.

Prior to implementation of the streamlined procedures, prescription medicines application submissions were generally accepted for evaluation in the expectation that further documentation could be lodged and information provided during the evaluation process. This, coupled with often lengthy response times to the requests from the TGA for further information or documents, substantially added to the evaluation completion time.

The amendment proposed in the bill will provide that, when an application is made to make changes to a prescription medicine’s entry in the register which involves evaluation of clinical, preclinical or bioequivalence data, the applicant must provide adequate information in the required form and manner and pay any prescribed fee for the application to be effective and therefore accepted for evaluation. This requirement is designed to ensure that the necessary information will be supplied at the appropriate time to enable an evaluation to take place within agreed time frames. Applications that do not meet these requirements will not be accepted for evaluation. This reflects the rules already in place under the act in relation to applications for new entries in the register for prescription medicines.

The new streamlined submission processes will provide greater clarity about TGA requirements for granting marketing approval for medicines and making changes to prescription medicine register entries, encourage a higher standard of application submissions, provide more predictable time lines, increase transparency in the management of evaluations and, importantly, remove unnecessary delays in the evaluation process.

This bill will also make a change to the way evaluation fees are collected by the TGA. Completion of evaluations of prescription medicines is subject to prescribed time lines under the Therapeutic Goods Regulations. Where the TGA fails to meet these time lines, the evaluation fee payable by an applicant is reduced by 25 per cent. Currently, sponsors applying to register prescription medicines initially pay three-quarters of the evaluation fee, with the remaining one-quarter payable only if the TGA completes the evaluation within the time frames set out in the regulations.

Since the implementation of time limits for completing evaluations for prescription medicines in 1992, the TGA has only failed to complete evaluations on time on about 15 occasions. The collection of 75 per cent of fees and the recovery of the remaining 25 per cent owing applies only to applications requiring the evaluation of clinical, preclinical and bioequivalence data associated with prescription medicines. The administrative burden in invoicing applicants twice to recover the full evaluation fees payable, and monitoring each application until completion in order to send the second invoice to recover the remaining 25 per cent of fees owing, is not warranted given TGA’s track record of completing evaluations on time. Additional administrative costs are passed on to industry as the TGA operates on a full cost recovery basis.

The amendment will mean the TGA collect the full evaluation fee when an application is accepted for evaluation and must refund 25 per cent of that fee if they do not complete the evaluation within the prescribed time limit. This is a more efficient way of recovering moneys owing to the Commonwealth.

The final amendment included in the bill relates to the operation of a ministerial power to make determinations for the purpose of imposing standard conditions on the registration or listing of therapeutic goods. These are mainly prescription, over-the-counter or complementary medicines and therapeutic devices.

The Therapeutic Goods Amendment (2009 Measures No. 1) Act 2009 amended the Therapeutic Goods Act to enable a legislative instrument to be made by the minister that would set out the ‘standard’ conditions to be imposed on the registration or listing of these goods. These conditions may relate to, for example, the manufacture, supply, use, custody or disposal of therapeutic goods included in the register.

The legislation currently provides that once the minister makes such a determination, the new conditions will apply not only to the registration or listing of therapeutic goods after the instrument comes into effect but also to therapeutic goods already on the register. The removal of the old standard conditions is therefore necessary to ensure there will be no overlap or possible inconsistencies between the new conditions and those imposed as standard conditions on goods that have already been entered into the register.

The bill includes amendments to ensure that the old standard conditions cease to apply when the first instrument takes effect. Any unique or special conditions applying to specific therapeutic goods entered in the register will continue to apply.

The bill also contains an amendment enabling the instrument imposing the standard conditions to apply only to the registration or listing of therapeutic goods after the instrument comes into effect as there may be occasions when this is appropriate.

The measures in this bill make important improvements to the operation of the regulatory framework for registered and listed therapeutic goods to the benefit of Australian consumers as well as industry.

I commend the bill to the House.

Debate (on motion by Ms Gambaro) adjourned.