Commonwealth of Australia Explanatory Memoranda Commonwealth of Australia Explanatory Memoranda[Index] [Search] [Download] [Bill] [Help]
2002
THE PARLIAMENT OF THE COMMONWEALTH OF
AUSTRALIA
HOUSE OF REPRESENTATIVES
THERAPEUTIC GOODS AMENDMENT BILL (NO. 2) 2002
EXPLANATORY MEMORANDUM
(Circulated by authority of the Hon Trish Worth MP, Parliamentary Secretary to Minister for Health and Ageing)
OUTLINE
The Therapeutic Goods Amendment Bill (No. 2) 2002
makes changes to the Therapeutic Goods Act 1989 (the Act) and the
Broadcasting Services Act 1992 (the BSA). The main purposes of these
changes are to:
- clarify the definition of a therapeutic good at the
food-medicine interface,
- transfer the remaining advertising offences from
the Therapeutic Goods Regulations to the Act:
- create new offences for
publishing advertisements that breach the Therapeutic Goods Advertising
Code, and extend the coverage of existing offences to broadcast media;
and
- make changes to the BSA to remove the provisions that incorporate the
administrative functions relating to pre-approving advertisements about
medicines intended for publication in broadcast media. The removal of the
provisions from the BSA will enable these functions to be transferred to the
Therapeutic Goods Regulations.
The proposed amendment to the
definition of therapeutic goods in the Therapeutic Goods Act 1989 will
provide greater clarity and certainty for industry, consumers and regulators at
the food-medicine interface.
There are many occasions where it can be
difficult to ascertain whether certain goods, because of the way they are
presented, are “therapeutic goods” or “foods”. Where a
food standard exists in the Australia New Zealand Food Standards Code
which may apply to that good or class of goods, the current definition of
therapeutic goods does not allow for a determination to be made under section 7
of the Act to address uncertain cases by allowing the Secretary to declare the
goods to be or not to be therapeutic goods. This is the case even where all
stakeholders agree that the good or class of goods should be regulated as
therapeutic goods.
The effect of the current definition is to require
that any complementary medicine, presented as assisting sports people in this
way, be regulated as a food. This means the product (which may be in tablet or
capsule form, with dosage instructions and indications for use) is not subject
to any pre-market assessment, or any of the therapeutic model post-market
regulatory surveillance. Additionally, the product cannot be represented as
medicine or carry medicinal claims, as to do so would render it to be an illegal
food.
The reason for the need for a timely amendment to the definition of
“therapeutic goods” is to prevent further dissatisfaction and
confusion with the regulation around the food-medicine interface as the
status quo represents a gap in the risk management of certain
complementary medicines, which could in the future pose public health and safety
risks to consumers.
The Therapeutic Goods Advertising Code and the
regulatory measures associated with the enforcement of the Code have been the
subject of a review, and changes to both the Code and the enforcement provisions
associated with giving effect to the Code are being made to increase its
effectiveness. Currently, some of the offences relating to advertising still
remain in the Therapeutic Goods Regulations, where the penalty for breaches of
advertising requirements is set at 10 penalty points. Other comparable
advertising offences have been included in the Act, where the penalty for
breaches of advertising offences is 50-100 penalty points. To ensure
consistency of penalties applying for all breaches of the Code, all advertising
offences that are included in the Therapeutic Goods Regulations, are to be
transferred to Part 5-1 of the Act, where other comparable advertising offences
are located.
Based on recommendations from previous reviews of the
therapeutic goods advertising provisions, a new requirement is for
advertisements published in the different media described as ‘specified
media’ to comply with the Code. This will ensure that the principles of
the Code in its entirety will be enforceable in relation to advertisements
published in all major forms of media, including broadcast media.
The
removal of provisions in the BSA relating to the administrative function to
pre-approving advertising intended for broadcast media will enable these
functions to be transferred to the Therapeutic Goods Legislation.
The amendments have no significant financial impact
THERAPEUTIC GOODS AMENDMENT BILL (No. 2) 2002
Clause 1: Short Title
Clause 1 states that the short title of the
legislation is the Therapeutic Goods Amendment Act (No. 2)
2002
Clause 2: Commencement
Clause 2 sets the commencement
date for changes in the Schedules as the day fixed by
proclamation.
Clause 3: Schedules
Clause 3 has the effect of
stating that the Act will be amended in the manner specified in the
Schedules.
SCHEDULE 1 – AMENDMENT TO THE THERAPEUTIC GOODS ACT
1989 (‘THE ACT’)
Item 1: amend the definition of
‘therapeutic goods’ in subsection 3(1)
The proposed
amendment to the definition of therapeutic goods in the Therapeutic Goods Act
1989 will provide greater clarity and certainty for industry, consumers and
regulators at the food-medicine interface.
The amendment to the
definition of “therapeutic goods” will allow the use of section 7 in
the practical manner that the legislation and all stakeholders always intended.
Once a good has been or is declared to be, a therapeutic good, no matter when
this occurs, it will be regarded as a therapeutic good, despite the fact that it
is a good for which there is also a prescribed food standard.
Item 2:
Amends the definition of the ‘Therapeutic Goods Advertising
Code’, previously in the Regulations, to provide for its notification in
the Gazette.
Item 3: Clarifies the various sections of the Act
that require minor amendment to correctly refer to the advertising provisions
inserted in the Act by this Bill, and no longer in the Regulations.
Item 5: Repeals existing section 42A.
Items 6-16 amend
section 42B (Definitions)
Item 6: Inserts a definition of a
‘broadcaster’ into the Act in relation to the advertising
provisions. A broadcaster is a person whose principal business is broadcasting
or the placement of advertisements for broadcasting (such as an advertising
agency). A sponsor of therapeutic goods cannot be a broadcaster.
Item
7: Inserts a definition of ‘broadcast media’ into the Act.
Provision is made for excluding particular means of electronic media (for
example, advertisements on the internet) from the definition of ‘broadcast
media’.
Items 8, 9, 12 and 13 transfer the
definitions of ‘generic information’, ‘prohibited
representations’, ‘required representation’ and
‘restricted representation’ from the Regulations to the
Act.
Item 10: Replaces the definition of ‘publisher’
in the Act. A publisher is a person whose principal business is publishing or
the placement of advertisements for publication (such as an advertising agency).
A sponsor of therapeutic goods cannot be a publisher.
Item 11:
Inserts a definition of ‘publishing’ in the Act, to include in that
term the insertion of material (such as leaflets) within a magazine or
newspaper.
Item 14: Transfers the definition of ‘specified
media’ from the Regulations into the Act, and expands that definition to
include ‘broadcast media’.
Item 15: Inserts a
definition of ‘visual broadcast media’ into the Act. This
definition is used in the new subsection 42C(4) to limit to visual forms of
media the requirement to include approval numbers on advertisements in broadcast
media.
Item 16: Inserts a new heading and a new section 42BA
clarifying the application of section 42C to advertisements requiring
pre-approval under the Regulations.
Item 17: Replaces existing
section 42C and 42D with a new section 42C.
Subsection 42C(1) makes it an
offence to publish or broadcast, or cause to be published or broadcast, an
advertisement that has not been approved where pre-approval is required under
the Regulations. This offence applies to anyone undertaking these activities,
including publishers and broadcasters. The penalty for this offence is 60
penalty units.
Subsection 42C(2) makes it an offence to publish or
broadcast, or cause to be published or broadcast, an advertisement that differs
from the advertisement that was originally approved. The penalty for this
offence is 60 penalty units.
Subsection 42C(3) provides a defence for
prosecution under subsection (2) for publishers and broadcasters and where an
advertisement only differs in respect of the matters specified.
Subsection 42C(4) makes it an offence for advertisements not to display
an approval number, or to display a false approval number or an approval number
that has expired. The penalty for this offence is 30 penalty
units.
Subsection 42C(5) provides a defence to a prosecution under
subsection (4) for publishers and broadcasters.
Subsection 42C(6) makes
it an offence to publish or broadcast, or cause to be published or broadcast, an
advertisement that contravenes any conditions under which the advertisement was
approved. The penalty for this is 60 penalty units.
Subsection 42C(7)
provides a defence to prosecution under subsection (6) for publishers and
broadcasters.
Subsection 42C(8) makes an offence under section 42C an
offence of strict liability.
Section 42C of the Therapeutic Goods Act
currently contains four offence provisions relating to
advertising that are offences of strict liability. The proposed amendments
extend the coverage of section 42C to also include broadcast media, outdoor
displays and films so that all activities concerning the broadcasting and
publication of advertisements relating to therapeutic goods are treated in a
similar manner. The actual penalty for breaching these strict liability
offences is being reduced from 100 and 50 penalty units to 60 and 30 penalty
units respectively, in order to align with current Commonwealth criminal law
policy.
Where strict liability applies to an offence the prosecution does
not have to prove fault on the part of the defendant (see section 6.1 of the
Criminal Code). The prosecution need only prove that the physical element of
the offence did occur. However, there is a defence of mistake of fact under
section 9.2 of the Criminal Code. Section 9.2 provides that the person is not
criminally responsible for an offence of this nature if, at or before the time
of the conduct, the person considered whether or not a relevant fact existed and
is under a mistaken but reasonable belief about the fact and, had that fact
existed, the conduct would not constitute an offence. If there is a mistake of
fact, the evidential burden of proof is on the defendant who has to adduce or
point to the evidence that suggests a reasonable possibility that the fact
exists or does not exist. If the defendant is able to do this, the prosecution
is required to prove beyond a reasonable doubt that there was no such
mistake.
These section 42C offences, are an integral part of the
regulation of advertising of therapeutic goods. It is appropriate that persons
responsible for the publication or broadcasting of such advertisements undertake
their activities in accordance with the requirements of the legislation. The
offences are summary in nature and are aimed at ensuring the responsible
advertising of therapeutic goods. It is important that consumers are not misled
and that they are able to make decisions about using therapeutic goods safely
and appropriately. The expansion of the offence in subsection 42C(1) to
broadcasters is also consistent with responsibilities under the Broadcasting
Services Act 1992 where it is a condition of a broadcasting licence that
unapproved advertisements about therapeutic goods are not
broadcast.
Item 18: Transfers the general provisions relating to
advertisements that do not require pre-approval from the Regulations to the Act,
and inserts them into a new Division 3 of Part 5-1. The item also transfers the
provisions relating to generic information and inserts them into a new Division
4 of Part 5-1.
Section 42DA limits the Division to advertisements about
therapeutic goods other than those for which approval is required under Part 2
of the Therapeutic Goods Regulations. Examples of forms of advertising that do
not require approval where the goods being advertised are designated therapeutic
goods would include flyers, letter box drops, internet advertising, shelf
talkers and other forms of point of sale advertising, not falling within the
definition of ‘specified media’.
Section 42DB defines the
terms ‘applicant’ and ‘approval holder’ for the purposes
of Division 3.
Section 42DC does not allow advertisements for
representations in an advertisement about therapeutic goods to be false or
misleading. The Secretary may prevent publication or broadcast of the offending
advertisement by notifying the person apparently responsible for the
advertisement.
Section 42DD does not allow advertisements to refer to a
serious form of disease that is not appropriate for a consumer to self diagnose
or treat (for example, heart disease) unless the person has approval from the
Secretary or it is permitted under subsection 42DK(1). These types of
representations are termed ‘restricted
representations’.
Section 42DE specifies that applications for
approval to use a restricted representation must be made in writing to the
Secretary.
Section 42DF sets out the process for approving the use of
restricted representations. The representation must be accurate and balanced
and not misleading or likely to mislead.
Section 42DG specifies that the
Secretary must provide notice in writing of whether approval to use a restricted
representation has been granted or refused, and sets out other requirements
relating to the notification, including conditions to which the approval is
subject.
Section 42DH specifies that the Secretary may, in writing, vary
conditions of approval of a restricted representation provided the applicant is
informed of the reasons for the variation and is provided details of how to
appeal the Secretary’s decision.
Section 42DI specifies how and on
what grounds the Secretary may withdraw approval of a restricted
representation.
Section 42DJ specifies that for the purpose of Part 5-1,
the Regulations may further specify representations which are prohibited or
required representations.
Section 42DK specifies that the Secretary may
by notice in the Gazette or on the Department of Health and Ageing’s
website permit the use of a restricted or a prohibited
representation.
Section 42DL specifies the general advertising offences
being transferred from the Regulations. The offences include publishing or
broadcasting an advertisement containing a prohibited representation, use of an
unapproved restricted representation and an advertisement about goods not
entered on the Australian Register of Therapeutic Goods (ARTG). Provision has
been made for strict liability to apply to certain physical elements of these
offences.
Section 42DM specifies that it is an offence for advertisements
for therapeutic goods to be either published or broadcast that do not comply
with the Therapeutic Goods Advertising Code.
Section 42DN limits the
effect of Division 4 to apply to generic information about ingredients or
components of therapeutic goods.
Subsection 42DO specifies that generic
information must comply with the principles of the Therapeutic Goods Advertising
Code.
Section 42DP makes it an offence to publish or broadcast generic
information that does not comply with the Therapeutic Goods Advertising
Code.
Section 42DP replaces the more specific offence provisions relating
to particular breaches of the Advertising Code with a general offence for
breaching the Code in relation to the advertising of generic information. The
effective administrative sanction of removing a product from the ARTG is not
available in the case of information about substances that, by their nature, are
not on the ARTG. In these circumstances it is appropriate to transfer the
offence provisions to the Act in order that an adequate penalty be
available.
The new offences in sections 42DM and 42DP are also an
integral part of the regulation of advertising of therapeutic goods and hence
are offences of strict liability. It is appropriate that persons responsible
for the publication or broadcasting of such advertisements undertake their
activities in accordance with the requirements of the legislation. The offences
are summary in nature and are aimed at ensuring the responsible advertising of
therapeutic goods, so that consumers are not mislead but rather are able to make
rational decisions about using therapeutic goods safely and appropriately. The
penalty provided is 60 penalty units, which is consistent with Commonwealth
criminal law policy relating to offences of strict liability.
Item
19: Effectively transfers the appeal rights available under the Regulations
to the Act by amending the subsection 60(1) definition of ‘initial
decision’. Review rights are available in respect of decisions made under
new sections 42DF, 42DH and 42DI.
Item 1: Repeals the current definition of ‘medicine’
in Clause 1 of Schedule 2 of the BSA, as this definition will no longer be
required.
Item 2: Repeals subclauses 6(2) to (8) of Schedule 2 of
the BSA. A new subclause (2) retains the requirement for a broadcaster to only
broadcast approved advertisements where advertisements about therapeutic goods
are required to be approved under the Therapeutic Goods Act
1989.
The approval of advertisements under repealed subclauses 6(3)
to (8) of Schedule 2 of the BSA was granted by the Secretary to the Department
of Health and Ageing, or her delegates. Review of the Secretary’s
decisions to be undertaken by the Minister for Communications, Information
Technology and the Arts was available under these repealed subclauses.
By transferring the administrative functions relating to pre-approving
advertisements about medicines intended for publication in broadcast media from
the BSA to the Therapeutic Goods Regulations, inconsistencies regarding the
application of the Therapeutic Goods Advertising Code to advertisements in the
broadcast media will be resolved. The pre-approval and review of decisions in
relation to approval of all advertisements about therapeutic goods will be
undertaken in the same manner, irrespective of the media in which the
advertisement is to appear.
Item 3:
Provides transitional
arrangements for completion of appeals by either the Minister for Health and
Ageing or the Minister for Communications, Information Technology and the Arts
in relation to pre-approval (or non-approval) of an advertisement for medicines
to be published in the broadcast media, where the decision-making process has
not been finalised when these amendments come into operation.