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Monday, 14 August 2006
Page: 75

Senator ELLISON (Minister for Justice and Customs) (4:43 PM) —I move:

That these bills be now read a second time.

I seek leave to have the second reading speeches incorporated in Hansard.

Leave granted.

The speeches read as follows—


I am pleased to introduce the Therapeutic Goods Amendment Bill (No 3) 2006.

The amendments provided for in this bill are necessary to allow or require manufacturers of medicines, blood and tissues, to apply for a manufacturing licence electronically, using the TGA’s e-business system. As a result of the implementation of this amendment, manufacturers would be able to monitor progress with their licence applications and electronically submit requests for changes to their licences.

Paragraph 37(1)(a) of the Therapeutic Goods Act 1989 currently specifies that an application for a manufacturing licence must be made in writing in accordance with a form approved by the Secretary. In October 2004, the TGA implemented a new computerised system for managing licence applications, the conduct of good manufacturing practice audits, and other licence issues. This new Manufacturer Information System (MIS) was designed to allow for electronic licence application. This amendment is required to enable this function to be utilised. It is expected that the majority of applications for manufacturing licences will be lodged electronically.

The electronic licence application does not require any information beyond that already required by the approved paper application. The electronic application form is also designed to allow documentation requested to accompany the application to be submitted electronically.

Electronic applications for manufacturing licences will facilitate the speedy submission of applications by manufacturers and the efficient handling of applications by the TGA.


The purpose of this bill is to amend the Export Control Act 1982 and the Quarantine Act 1908 to:

  • extend the definition of ‘preparation’ to the catching of fish, the definition of ‘premises’ to places in and on water and insert a definition for ‘fish’ in the Export Control Act;
  • create four new offences in the Export Control Act to enable the Commonwealth to prosecute those people who fail to properly prepare goods that are exported;
  • extend the services for which fees may be charged under the Export Control Act to services provided by the Secretary or the Secretary’s delegate;
  • clarify the use of certain terms in the Export Control Act; and
  • provide a legal basis for the recovery of fees for quarantine services provided under the Quarantine Act to other Commonwealth bodies.

The amendments to the Export Control Act concerning the extension of the definition of “preparation” and “premises” and the inclusion of a definition for “fish” will remove any doubt that the Commonwealth has appropriate legal authority to regulate the sourcing of fish intended for export. The authority to regulate the sourcing of fish is necessary to ensure ongoing access for exported product into overseas markets and to protect consumers by ensuring that fish, including shellfish are harvested from areas that do not contain pathogenic organisms, biotoxins and chemical contaminants at levels that may represent a threat to consumer health.

The creation of four new offence provisions is in response to a serious gap in the Export Control Act. Currently, the offence provisions in the Act focus on persons involved with goods in the post-preparation phase with the result that persons who are the occupiers of establishments where the preparation of the goods occurs are immune from the serious penalties that apply to other offenders under the Act. The new offences focus on the person responsible for the preparation of the goods for export.

To preserve the integrity of the export chain it is very important that key players in the chain, such as occupiers of establishments where food is prepared for export, are made responsible for activities at their establishment. The export of prescribed goods that have not been properly prepared can have serious implications for Australia’s trade in food.

Two of the four offences apply strict liability to some of the physical elements of the offences. The application of strict liability in these circumstances is important as otherwise persons in control of food preparation establishments can avoid the consequences of non-compliance with the law by simply saying that they were not aware of what was occurring at their establishment. The application of strict liability to these offences is likely to significantly enhance the effectiveness of the enforcement regime by requiring such people to have systems in place to ensure that the law is complied with. The maximum penalty for these offences is 60 penalty units. This level of penalty is consistent with the Guide to Framing Commonwealth Offences, Civil Penalties and Enforcement Powers issued by the authority of the Minister for Justice and Customs. The other two offence provisions each impose a maximum penalty of imprisonment for 5 years. This level of penalty is consistent with the penalties in sections 7A and 8 of the Act.

The bill also amends the regulation making power of the Export Control Act to enable fees to be charged for services provided by the Secretary or a delegate of the Secretary. Currently, fees can be charged for (amongst other things) the services of authorised officers appointed under the Export Control Act but not for services provided by the Secretary or a delegate of the Secretary. This amendment will overcome this anomaly and ensure that AQIS can charge for the full range of services it provides.

The bill also makes a number of amendments to remove inconsistent usage of the expressions “registered premises” and “registered establishment” in the Export Control Act. As a result of these amendments the expression “registered establishment” will replace all references to “registered premises”. These changes are minor and technical and are not intended to change the effect of any of the provisions that are amended.

The bill amends the Quarantine Act to facilitate cost recovery between the Australian Quarantine and Inspection Service (AQIS) and the rest of the Commonwealth. In particular, the new section, section 86EA, imposes a notional liability on the Commonwealth to pay the fees for quarantine services specified in a determination made under subsection 86E (1B) of the Quarantine Act. The effect of this amendment is to give AQIS the authority to require payment from agencies and other Commonwealth bodies for quarantine services and to give these agencies and other Commonwealth bodies the legal authority to make payments to AQIS for quarantine services.

Debate (on motion by Senator Ellison) adjourned.

Ordered that the bills be listed on the Notice Paper as separate orders of the day.