Bills Digest No 73 1995-96 Therapeutic Goods Amendment Bill 1996

Numerical Index | Alphabetical Index

This Digest is prepared for debate. It reflects the legislation as introduced and does not canvass subsequent amendments.

This Digest was available from 8 May 1996


Passage History

Date introduced:1 May 1996
House: House of Representatives
Portfolio: Health and Family Services
Commencement: Item 48 of the Schedule commences, or is taken to have commenced, immediately after the commencement of the Audit (Transitional and Miscellaneous) Amendment Act 1996. The remainder of the Bill commences on the day on which it receives Royal Assent.


To provide a system for temporarily approving unevaluated drugs as substitute products for existing registered drugs that are either unavailable or in short supply; provide limits and safeguards to ensure that this is only used in limited circumstances; and establish a new procedure for listing simple over-the-counter drugs on the Australian Register of Therapeutic Goods.


This Bill replaces one of the same name introduced by the previous government in September 1995 that failed to pass the Parliament prior to the dissolution of Parliament for the 1996 General Election. The measures in the Bill are the same as contained in the previous, 1995 Bill.

Therapeutic goods are goods that are represented in any way to be, or that are likely to be taken for therapeutic use. Ingredients and components are included within the definition. Therapeutic use includes preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury.

The Therapeutic Goods Act 1989 (the Principal Act) provides a uniform national system of controls for therapeutic goods. The scheme was designed to control all therapeutic goods used in Australia or exported from Australia. The scheme included setting national standards for the issue of licences to manufacturers, quality of manufacture, safety procedures to be followed during manufacture, labelling and/or packaging requirements and the regulation of advertising.

The objective of the scheme is:

To ensure the safety, quality and efficacy of therapeutic goods available in Australia at a standard equal to that of comparable countries, and that pre-market assessment of therapeutic goods is conducted within a reasonable time.(1)

The Therapeutic Goods Administration consists of the Drug Evaluation Branch, the Compliance Branch, the Therapeutic Goods Administration Laboratories, the Therapeutic Devices Branch and the General Administration Branch.

The Compliance Branch of the Therapeutic Goods Administration audit the standards of manufacture, the quality of manufacture and the licensing of manufacturers. They also monitor the advertising and promotion of therapeutic goods and investigate the more serious breaches of the legislation.

The Drug Evaluation Branch of the Therapeutic Goods Administration ensures that evaluation and registration of prescription drugs is in accordance with the legislation. They also process applications for registration from Australian sponsors of new drugs and prescription drugs, ensuring that all requirements are met.

The Therapeutic Goods Administration Laboratories analyse samples of therapeutic goods to check that they comply with the legislative standards. However, testing of the chemical, biological, mechanical, electrical and physical characteristics of therapeutic devices is done by the Therapeutic Devices Branch.

The Explanatory Memorandum states in the general outline that the amendments proposed in the Bill will have no significant financial impact. The 1994-95 Annual Report of the Department of Human Services and Health states that the net cost of services of the Therapeutic Goods Administration for that financial year was $19.967 million.

Main Provisions

The substantive elements of the Bill are set out in the Schedule incorporated by Clause 3.

Item 2 inserts a definition for food so as to distinguish products taken to satisfy hunger or thirst or a desire for taste, flavour or texture from those taken for therapeutic purposes. Therapeutic goods are described by reference to a prescribed dose or a frequency of administration. Food products so described are exempted.

Item 3 makes it clear that a reference to an offence under the Principal Act will include offences against the regulations. The offences of aiding, abetting and inciting the commission of offences against the same act are also included in the Bill.

Items 4-8 provide for existing penalties to be converted into penalty units. This conforms with the trend in recent legislation. Presently 1 penalty unit is equivalent to $100.

Item 10 inserts a new provision that enables the Secretary to grant written approval to import or supply specified therapeutic goods in certain circumstances. This can be done where the therapeutic goods to be imported:

  • could act as a substitute for registered therapeutic goods that do not exist, are otherwise unavailable or in short supply; or
  • where an application for registration has already been lodged in the proper form;

The therapeutic goods to be imported must either be included in Schedule 10 of the regulations (which according to the Explanatory Memorandum includes mainly new chemical entities or prescription drugs) or specified by the Secretary in a disallowable determination. In addition, the approval must be 'necessary in the interests of public health'.

The Secretary will be able to impose conditions on the grant of approval and may impose a time limit in which to comply with the conditions.

Item 11 introduces an offence of intentionally or recklessly importing, exporting, manufacturing or supplying therapeutic goods for use in humans that are not authorised by the Act or exempted from it. If the person can prove that they were not the sponsor of the goods at the time of the importation, exportation, manufacture or supply then they have a defence.

Item 25 inserts a new section regarding the listing of certain types of therapeutic goods. The provides that the Secretary may not refuse to list the therapeutic goods as long as the applicant satisfies the following criteria:

  • the application is in the proper form (required by section 23 of the Act); and
  • the applicant has conformed with any requirements made by the Secretary under section 31 of the Act (which basically deals with the production of relevant documents and the disclosure of relevant information); and
  • the goods are not manufactured in or imported into Australia for export only; and
  • the goods are not therapeutic devices or device kits.

The provision also requires the applicant to certify that the goods are eligible for such a listing and are safe for the purposes for which they are to be used. The applicant must also be able to certify that the presentation of the goods is acceptable and that they conform to all relevant standards and requirements. No component of the goods must be a prohibited import and the goods must meet all the prescribed quality and safety criteria. For goods manufactured in Australia, the applicant must be able to show that each step of manufacture was carried out by duly qualified and authorised persons. For goods manufactured outside Australia, the Secretary must have certified that the manufacturing and quality control procedures are acceptable.

Item 36 of the Bill provides a mechanism for the recovery of wrongly supplied therapeutic goods. If the goods supplied were not registered, listed or exempted goods then the Secretary can require the sponsor to inform the public that the goods were wrongly supplied and can take steps required to recover goods that have already been distributed.

Item 48 establishes a reserve money fund called the Therapeutic Goods Administration Reserve as a replacement for the existing Therapeutic Goods Administration Trust Account. The Explanatory Memorandum explains that this is 'to coincide with ...the new legislation package that will replace the Audit Act 1901, under which many Commonwealth trust accounts have been established.' Under the proposed provisions, monies standing in credit in the old account are to be credited to the new account when the legislation is introduced. Fees, donations, interest and appropriated money will be transferred to the new account and used to further the objects of the Principal Act and allow the Commonwealth to participate in the international regime for therapeutic goods.(2)

Item 49 inserts a new section entitled 'Entry, Searches and Warrants'. It differs from the existing provisions in the following respects:

  • evidential material that can be seized can now include items which there are reasonable grounds for suspecting were intended to be used for the purpose of committing an offence.
  • an authorised person can only exercise their powers of search and seizure if they have complied with any request by the occupier of the premises to produce their identity card;
  • a search can be made not only of the premises but of 'any thing on the premises';
  • photographs, video recordings and sketches can now be made of the premises or any thing on the premises;
  • an authorised person is entitled to exercise their powers of seizure if, during the course of a search, they find something that it is necessary in the interests of public health to seize. This power is found in section 46B and to be in the interests of public health it must be necessary to avoid an imminent risk of death, serious illness or serious injury;
  • an authorised person can enter the premises of a sponsor of registered/listed therapeutic goods or a person to whom approval has been granted for the conditional supply of therapeutic goods, to monitor compliance with the Act.

Item 53 requires the authorised person to give a copy of the warrant to the occupier or the occupier's representative. The copy need not include a copy of the magistrate's signature.

A new section 48C is included which will allow the authorised person to operate electronic equipment at the premises to see whether any evidential material is accessible. If so, then they may seize or lock the equipment or any disk, tape or other device (including printing out the contents in documentary form and seizing the document). Where applicable, a copy of the item must be provided to the occupier of the premises as soon as practicable. If the equipment is to be locked or secured then the authorised person must give warning of this and can not lock or secure it for more than 24 hours.

If any of the equipment is damaged as a result of negligence during the above procedures, then compensation for the damage is payable under the proposed section 48D.

The occupier is entitled to be present when the search is carried out (proposed section 48F) and a receipt must be issued for items seized (proposed section 48G). Seized items can be kept for up to 90 days but after that a magistrate's order must be obtained or the items must be returned (unless proceedings have already been commenced and the items are evidence in the hearing).

Item 64 will make it an offence to make a statement in an application for a warrant that is known by the applicant to be false or misleading in a material way. There will also be an offence of naming a person in a form of a warrant as the magistrate (unless that magistrate did in fact issue the warrant). To knowingly include something in a warrant that is materially different from that authorised by the magistrate. The maximum penalty for these offences will be imprisonment for 2 years. The Crimes Act 1914 would also enable these penalties to be converted into a monetary fine.

Item 71 introduces a new provision (section 54A) that requires prosecutions for all offences under this Act to be brought within 3 years of the commission of the offence.

Item 73 will allow the Secretary to issue certificates regarding certain matters. Such certificates will be prima facie evidence in any hearing. The matters include:

  • whether or not there was any exemption in effect
  • whether or not there was any approval granted to a particular person for a particular therapeutic good
  • whether particular therapeutic goods were registered or listed goods
  • whether there were any conditions imposed on the particular therapeutic goods
  • whether the registration or listing had been cancelled
  • whether or not the person was a licence holder and whether there were conditions on that licence; and
  • whether or not the Secretary had consented to the supply, importation or exportation (with or without conditions).

Item 76 allows the Secretary to delegate the powers under section 19A to the National Manager of the Therapeutic Goods Administration and/or the Director of the Drug Safety and Evaluation Branch of the Therapeutic Goods Administration.

Item 80 deals with the provision of new information on review of the Secretary's (or delegate's) decision. There is a discretion given to the Minister (or the Administrative Appeals Tribunal) to remit the matter, together with the new information, for a fresh decision


1. Department of Human Services and Health, Annual Report 1993-94, p. 95.

2. The proposed new audit legislation was introduced into the last Parliament and lapsed on the calling of the 1996 general Election. It is anticipated that the new government will proceed with the package.

Contact Officer and Copyright Details

Susan Downing Ph. (06) 277 2784
Bills Digest Service
Parliamentary Research Service
This Digest does not have any official legal status. Other sources should be consulted to determine whether the Bill has been enacted and, if so, whether the subsequent Act reflects further amendments.

ISSN 1323-9032 Commonwealth of Australia 1995

Except to the extent of the uses permitted under the Copyright Act 1968, no part of this publication may be reproduced or transmitted in any form or by any means, including information storage and retrieval systems, without the prior written consent of the Parliamentary Library, other than by Members of the Australian Parliament in the course of their official duties.

Published by the Department of the Parliamentary Library, 1995.

This page was prepared by the Parliamentary Research Service, Commonwealth of Australia
Last updated: 7 May 1996

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