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
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
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
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
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.
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
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
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
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
- 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
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
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
- 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
- whether there were any conditions imposed on the particular
- 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.
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
ISSN 1323-9032 Commonwealth of Australia 1995
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This page was prepared by the Parliamentary Research Service,
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Last updated: 7 May 1996
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