Bills Digest No 73 1995-96
Therapeutic Goods Amendment Bill 1996
WARNING:
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
CONTENTS
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.
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.
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
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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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