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A Bill for an Act to amend the Therapeutic Goods Act 1989, and for related purposes
For authoritative information on the progress of bills and on amendments proposed to them, please see the House of Representatives Votes and Proceedings, and the Journals of the Senate as available on the Parliament House website.
Introduced HR 27 Jun 2002

Therapeutic Goods Amendment Bill (No. 2) 2002
First Reading

2002

The Parliament of the

Commonwealth of Australia

HOUSE OF REPRESENTATIVES

Presented and read a first time

Therapeutic Goods Amendment Bill (No. 2) 2002

No. , 2002

(Health and Ageing)

A Bill for an Act to amend the Therapeutic Goods Act 1989, and for related purposes

Contents

1       Short title 1

2       Commencement 1

3       Schedule(s) 2

Schedule 1--Amendment of the Therapeutic Goods Act 1989       3

Schedule 2--Amendment of the Broadcasting Services Act 1992       18

A Bill for an Act to amend the Therapeutic Goods Act 1989, and for related purposes

The Parliament of Australia enacts:

1 Short title
        This Act may be cited as the Therapeutic Goods Amendment Act (No. 2) 2002.

2 Commencement
       (1) Each provision of this Act specified in column 1 of the table commences, or is taken to have commenced, on the day or at the time specified in column 2 of the table.

Commencement information

Column 1

Column 2

Column 3

Provision(s)

Commencement

Date/Details

1. Sections 1 to 3 and anything in this Act not elsewhere covered by this table

The day on which this Act receives the Royal Assent


2. Schedules 1 and 2

A single day to be fixed by Proclamation, subject to subsection (3)


Note: 
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     This table relates only to the provisions of this Act as originally passed by the Parliament and assented to. It will not be expanded to deal with provisions inserted in this Act after assent.

       (2) Column 3 of the table is for additional information that is not part of this Act. This information may be included in any published version of this Act.

       (3) If a provision covered by item 2 of the table does not commence within the period of 6 months beginning on the later of:

       (a) the day on which this Act receives the Royal Assent; and

       (b) the day on which Schedule 1 to the Therapeutic Goods Amendment (Medical Devices) Act 2002 commences;

it commences on the first day after the end of that period.

3 Schedule(s)
        Each Act that is specified in a Schedule to this Act is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Act has effect according to its terms.

Schedule 1--Amendment of the Therapeutic Goods Act 1989

1 Subsection 3(1) (paragraph (1)(e) of the definition of therapeutic goods)

Repeal the paragraph, substitute:

       (e) goods (other than goods declared to be therapeutic goods under an order in force under section 7) for which there is a prescribed standard in the Australia New Zealand Food Standards Code as defined in subsection 3(1) of the Australia New Zealand Food Authority Act 1991; or

2 Subsection 3(1) (definition of Therapeutic Goods Advertising Code)

Repeal the definition, substitute:

Therapeutic Goods Advertising Code means the Code known as the Therapeutic Goods Advertising Code notified in the Gazette with effect from the date of commencement of Schedule 1 to the Therapeutic Goods Amendment Act (No. 2) 2002 together with any amendments of the Code published by the Minister in the Gazette from time to time.

3 Paragraphs 25(1)(f), 26(1)(f), 26A(2)(d), 30(1A)(c), 30(2)(e), 31(1)(h), 31(2)(g), 41FD(h), 41GL(h) and 41JA(1)(h)

Before "under the regulations", insert "under Part 5-1 or".

4 Part 5-1 of Chapter 5 (heading)

Repeal the heading, substitute:

Part 5-1--Advertising and generic information

Division 1--Preliminary

42AA This Part not to apply to advertisements directed at health professionals etc.
       (1) This Part does not apply to advertisements directed exclusively to:

       (a) medical practitioners, psychologists, dentists, veterinary surgeons, pharmacists, physiotherapists, dietitians, scientists working in medical laboratories or nurses; or

       (b) persons who are:

       (i) engaged in the business of wholesaling therapeutic goods; or

       (ii) purchasing officers in hospitals; or

       (c) herbalists, homoeopathic practitioners, chiropractors, naturopaths, nutritionists, practitioners of traditional Chinese medicine, podiatrists or osteopaths registered under a law of a State or Territory.

       (2) This Part does not apply to advertisements directed exclusively to persons who are members of an Australian branch (however described) of one of the bodies prescribed for the purposes of this subsection.

       (3) For the purposes of subsection (2), a person is taken to be a member of an Australian branch of one of those bodies if, and only if, the person has the qualifications and training that are necessary or appropriate for membership of the relevant body.

       (4) This Part does not apply to advice or information given directly to a patient by a person referred to in

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paragraph (1)(a) or (c) or subsection (2) in the course of treatment of that patient.

42AB This Part not to apply to advertisements for goods not for human use
        This Part does not apply to advertisements in respect of goods that are not for use in humans.

42AC This Part not to apply to advertisements for exported goods
       (1) Subject to subsection (2), this Part does not apply to advertisements solely for therapeutic goods that have been exported or are intended exclusively for export.

       (2) Section 42DC applies to advertisements of that kind.

5 Section 42A

Repeal the section.

6 Section 42B

Insert:

broadcaster, in relation to an advertisement for therapeutic goods, means a person (other than a person who is required to enter those goods on the Register) who undertakes, as a business activity in its own right:

       (a) the broadcasting of the advertisement in broadcast media; or

       (b) the placement of the advertisement for such broadcasting.

7 Section 42B

Insert:

broadcast media, in relation to an advertisement or generic information, means any means (other than a means declared in the regulations to be an exempted means) by which the information is disseminated electronically in a visible or audible form or a combination of such forms.

8 Section 42B

Insert:

generic information, in relation to therapeutic goods, includes any statement, pictorial representation or design, however made, about the composition, properties or other characteristics of therapeutic goods, but does not include:

       (a) an advertisement about the goods; or

       (b) generic information included in an advertisement about the goods; or

       (c) bona fide news.

9 Section 42B

Insert:

prohibited representation means a representation referred to in subsection 42DJ(1).

10 Section 42B (definition of publisher)

Repeal the definition, substitute:

publisher, in relation to an advertisement for therapeutic goods, means a person (other than a person who is required to enter those goods on the Register) who undertakes, as a business activity in its own right:

       (a) the publishing of the advertisement in specified media other than broadcast media; or

       (b) the placement of the advertisement for such publication.

11 Section 42B

Insert:

publishing, in relation to an advertisement, includes inserting material within the pages of an item of mainstream media.

12 Section 42B

Insert:

required representation means a representation referred to in subsection 42DJ(2).

13 Section 42B

Insert:

restricted representation means a representation referred to in subsection 42DD(1).

14 Section 42B

Insert:

specified media, in relation to an advertisement or generic information, means:

       (a) mainstream media; or

       (b) broadcast media; or

       (c) cinematograph films; or

       (d) displays about goods, including posters:

       (i) in shopping malls (except inside an individual shop); and

       (ii) in or on public transport; and


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       (iii) on billboards.

15 Section 42B

Insert:

visual broadcast media means broadcast media that is intended to be viewed by its audience.

16 After section 42B

Insert:

Division 2--Therapeutic goods advertisements for which an approval is required

42BA Application of Division
        This Division applies only to advertisements to which Part 2 of the Therapeutic Goods Regulations applies.

17 Sections 42C and 42D

Repeal the sections, substitute:

42C Offences relating to publication of advertisements
       (1) A person is guilty of an offence if:

       (a) the person:

       (i) publishes or broadcasts; or

       (ii) causes to be published or broadcast;

        in specified media, an advertisement that is required by the Therapeutic Goods Regulations to be an approved advertisement; and

       (b) the advertisement is not an approved advertisement.

Penalty:       60 penalty units.

       (2) A person is guilty of an offence if:

       (a) the person:

       (i) publishes or broadcasts; or

       (ii) causes to be published or broadcast;

        an advertisement in specified media; and

       (b) the advertisement is not an approved advertisement in that it differs, in any respect, from the advertisement that was approved.

Penalty:       60 penalty units.

       (3) It is a defence to a prosecution under subsection (2) if:

       (a) the person prosecuted is a publisher or broadcaster who received the advertisement to which the prosecution relates for publication or broadcasting in specified media in the ordinary course of business; or

       (b) the particular advertisement to which the prosecution relates differs only in respect of a matter mentioned in paragraph 5C(2)(b), (e) or (f) of the Therapeutic Goods Regulations.

Note:       A defendant bears an evidential burden in relation to the matters in subsection (3) (see subsection 13.3 of the Criminal Code).

       (4) A person is guilty of an offence if:

       (a) the person:

       (i) publishes or broadcasts; or

       (ii) causes to be published or broadcast;

        in specified media referred to in paragraph (a), (c) or (d) of the definition of specified media, or in visual broadcast media, a particular advertisement; and

       (b) the advertisement:

       (i) does not display its approval number; or

       (ii) displays a number purporting to be its approval number but that is not its approval number; or

       (iii) displays an approval number that has expired.

Penalty:       30 penalty units.

       (5) It is a defence to a prosecution under subsection (4) if the person prosecuted:

       (a) is a publisher who received the advertisement to which the prosecution relates for publication in specified media referred to in paragraph (a), (c) or (d) of the definition of specified media; or

       (b) is a broadcaster who received the advertisement to which the prosecution relates for broadcasting in visual broadcast media;

in the ordinary course of business.

Note:       A defendant bears an evidential burden in relation to the matters in subsection (5) (see subsection 13.3 of the Criminal Code).


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       (6) A person is guilty of an offence if:

       (a) the person:

       (i) publishes or broadcasts; or

       (ii) causes to be published or broadcast;

        in specified media, an approved advertisement; and

       (b) the person's action is in contravention of a condition to which the approval of the advertisement is subject.

Penalty:       60 penalty units.

       (7) It is a defence to a prosecution under subsection (6) if the person prosecuted is a publisher or broadcaster who received the advertisement to which the prosecution relates for publication or broadcasting in specified media in the ordinary course of business.

Note:       A defendant bears an evidential burden in relation to the matters in subsection (7) (see subsection 13.3 of the Criminal Code).

       (8) An offence against this section is an offence of strict liability.

18 At the end of Part 5-1 of Chapter 5

Add:

Division 3--General provisions about advertising therapeutic goods

42DA Application of Division
        This Division applies to advertisements about therapeutic goods other than advertisements for which an approval is required under Part 2 of the Therapeutic Goods Regulations.

42DB Definitions
        In this Division:

applicant means an applicant for approval of the use of a restricted representation in an advertisement about therapeutic goods.

approval holder, in relation to a restricted representation, means the person to whom notice of approval of the use of the restricted representation was given.

42DC Certain representations not to be published or broadcast
        If a representation in an advertisement about therapeutic goods is false or misleading, the Secretary may, by notice given to the person apparently responsible for publishing or broadcasting the advertisement, prevent that person from publishing or broadcasting, or causing to be published or broadcast, an advertisement containing that representation (whether express or implied) about those goods.

42DD Restricted representations
       (1) For the purposes of this Part, a representation in an advertisement about therapeutic goods that refers to a serious form of a disease, condition, ailment or defect specified in a part of the Therapeutic Goods Advertising Code that is prescribed by the regulations for the purposes of this subsection is a restricted representation about therapeutic goods.

       (2) A person must not use a restricted representation in an advertisement about therapeutic goods unless the Secretary:

       (a) has approved its use under subsection 42DF(1); or

       (b) has permitted its use under subsection 42DK(1).

42DE Applications for approval of use of restricted representation
        An application for approval of the use of a restricted representation must be:

       (a) made to the Secretary in writing, in a form approved by the Secretary; and

       (b) signed by or on behalf of the applicant.

42DF Approval of use of restricted representation
       (1) If an application for approval of the use of a restricted representation is made, the Secretary must approve the use of the
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restricted representation if the Secretary is satisfied that:

       (a) the representation is accurate and balanced; and

       (b) the representation is not misleading or likely to be misleading.

       (2) Otherwise, the Secretary must refuse to approve the use of the restricted representation.

       (3) An approval may be subject to conditions imposed by the Secretary.

       (4) In deciding whether to approve or refuse to approve the use of a restricted representation, the Secretary must take into consideration:

       (a) any recommendation of the Therapeutic Goods Advertising Code Council; and

       (b) any advice of the Complementary Medicines Evaluation Committee or the Medicines Evaluation Committee; and

       (c) the public interest criteria mentioned in a part of the Therapeutic Goods Advertising Code that is prescribed by the regulations made for the purposes of this paragraph.

42DG Notice of approval or refusal
       (1) The Secretary must give written notice to the applicant of the approval of, or of the refusal to approve, the use of a restricted representation.

       (2) If written notice is not given to the applicant within the period of 60 days after the day on which the application was made (or within such longer period as the Secretary specifies by written notice to the applicant before the end of that period), the Secretary is taken to have approved the use of the restricted representation at the end of the period.

       (3) If an approval is subject to conditions, the conditions must be set out in the notice.

       (4) A notice of refusal to approve the use of a restricted representation must:

       (a) give the Secretary's reasons for the refusal; and

       (b) inform the applicant of the applicant's right to have the Secretary's decision reviewed by the Minister under section 60.

42DH Variation of conditions of approval
       (1) The Secretary, by written notice to an approval holder, may vary any condition of approval of the use of a restricted representation.

       (2) The notice must:

       (a) give the Secretary's reasons for the variation; and

       (b) inform the approval holder of the approval holder's right to have the Secretary's decision reviewed by the Minister under section 60.

42DI Withdrawal of approval
       (1) The Secretary, by written notice, may withdraw the approval of the use of a restricted representation if:

       (a) the Secretary is satisfied that:

       (i) information given by the applicant in the application was false or incorrect and the Secretary, or the Minister on review of a decision of the Secretary under section 42DF or 42DH, relied on the information in deciding to approve the use of the representation; or

       (ii) the restricted representation has become a prohibited representation; or

       (iii) there has been a breach of a condition of approval; or

       (b) both:

       (i) additional information about the safety of the therapeutic goods becomes available; and

       (ii) the Secretary is satisfied that, if that information had been available at the time of the approval, the Secretary would not have approved the use of the restricted representation.

       (2) The notice must:

       (a) give the Secretary's reasons for the withdrawal; and

       (b) inform the approval holder of the approval holder's right to have the Secretary's decision reviewed by the Minister under section 60.


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42DJ Prohibited and required representations
       (1) For the purposes of this Part, representations of a kind specified in regulations made for the purposes of this subsection are prohibited representations about therapeutic goods of a kind specified in those regulations.

       (2) For the purposes of this Part, representations of a kind specified in regulations made for the purposes of this subsection are required representations about the therapeutic goods of a kind specified in those regulations.

42DK Use of restricted or prohibited representations
       (1) The Secretary may, by notice in writing published in the Gazette or on the Department's web site on the Internet, permit, in relation to therapeutic goods, the use of a restricted representation (including its use on the label of the goods or in information included in the package in which the goods are contained).

       (2) The Secretary may, by notice in writing published in the Gazette or on the Department's web site on the Internet, permit a prohibited representation to be included on the label of therapeutic goods, or in information included in the package in which therapeutic goods are contained, if the representation is necessary for the appropriate use of the goods.

42DL Advertising offences
       (1) A person must not publish or broadcast an advertisement about therapeutic goods:

       (a) that contains a prohibited representation (whether in express terms or by necessary implication) about those goods; or

       (b) that does not contain a required representation about those goods; or

       (c) that contains a restricted representation, about those goods, the use of which has not been approved under subsection 42DF(1) or permitted under subsection 42DK(1); or

       (d) that is in contravention:

       (i) of a notice referred to in section 42DC that was served on the person; or

       (ii) of a notice referred to in section 42DK of which the person was aware when the advertisement was published; or

       (e) that contains:

       (i) a reference to the Act other than in a statement of the registration number, listing number or device number of the goods; or

       (ii) a statement suggesting or implying the goods have been recommended or approved by or on behalf of a government or government authority (including a foreign government or foreign government authority), other than a statement of their availability as a pharmaceutical benefit or a statement authorised or required by a government or government authority (including a foreign government or foreign government authority); or

       (f) that refers to goods, or substances or preparations containing goods, included in Schedule 3, 4 or 8 to the Poisons Standard; or

       (g) that are not entered in the Register; or

       (h) if the goods are therapeutic goods, or come within a class of therapeutic goods, that:

       (i) are exempt goods or exempt devices prescribed in the regulations for the purposes of this provision; or

       (ii) have been approved under subsection 19(1) or section 41HB of this Act for importation into, exportation from, or supply within, Australia.

Penalty:       60 penalty units.

       (2) For the purposes of an offence against subsection (1), strict liability applies to the following physical elements:

       (a) that the use of a restricted representation, as referred to in paragraph (1)(c), has not been approved under subsection 42DF(1) or permitted under subsection 42DK(1);

       (b) that the notice referred to in paragraph (1)(d):

       (i) in a case to which subparagraph (1)(d)(i) applies--is a notice referred to in section 42DC; and

       (ii) in a case to which subparagraph (1)(d)(ii) applies--is a notice referred to in section 42DK;

       (c) that goods, substances or preparations referred to in paragraph (1)(f) are included in Schedule 3, 4 or 8 to the Poisons Standard;

       (d) that the therapeutic goods, or class of

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therapeutic goods, referred to in paragraph (1)(h):

       (i) are exempt goods or exempt devices prescribed in the regulations made for the purposes of subparagraph (1)(h)(i); or

       (ii) have been approved under subsection 19(1) or section 41HB of the Act for importation into, exportation from or supply within, Australia.

       (3) It is a defence to a prosecution under subsection (1) if:

       (a) in relation to an advertisement mentioned in paragraph (1)(a) or (f)--the advertisement is made by, or on behalf of, the Commonwealth; and

       (b) in relation to an advertisement mentioned in paragraph (1)(f)--the goods, substances or preparations are mentioned in Appendix H of the Poisons Standard; and

       (c) in relation to goods mentioned in paragraph (1)(g)--the goods are exempt goods or exempt devices other than goods of a kind mentioned in paragraph (1)(h).

Note:       A defendant bears an evidential burden in relation to the matters mentioned in subsection (3) (see section 13.3 of the Criminal Code).

42DM Compliance with Code
       (1) A person is guilty of an offence if:

       (a) the person publishes or broadcasts an advertisement about therapeutic goods; and

       (b) the advertisement does not comply with the Therapeutic Goods Advertising Code.

Penalty:       60 penalty units.

       (2) An offence against this section is an offence of strict liability.

Division 4--Generic information about ingredients or components of therapeutic goods

42DN Application of Division
        This Division applies to generic information about goods that:

       (a) may be used as an ingredient or component in the manufacture of therapeutic goods; and

       (b) although not presented for supply as therapeutic goods, come within the meaning of therapeutic goods because they are represented to be:

       (i) for therapeutic use; or

       (ii) for use as an ingredient or component in the manufacture of other therapeutic goods.

42DO Compliance with the Code
        Generic information to which this Division applies must comply with principles of the Therapeutic Goods Advertising Code specified in regulations made for the purposes of this section as if those principles applied to generic information in the same way as they apply to advertisements.

42DP Offences--publication of generic information
       (1) A person is guilty of an offence if:

       (a) the person publishes or broadcasts generic information about therapeutic goods; and

       (b) the publication or broadcasting of that generic information does not comply with principles contained in the part of the Therapeutic Goods Advertising Code that are specified in Regulations.

Penalty:       60 penalty units.

       (2) An offence against this section is an offence of strict liability.

19 Subsection 60(1) (at the end of the definition of initial decision)

Add:

       ; or (l) under section 42DF, 42DH or 42DI.

Schedule 2--Amendment of the Broadcasting Services Act 1992

1 Clause 1 of Schedule 2 (definition of medicine)

Repeal the definition.


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2 Subclauses 6(2) to (8) of Schedule 2

Repeal the subclauses, substitute:

       (2) A broadcaster must not broadcast an advertisement relating to therapeutic goods that is required to be approved under the Therapeutic Goods Act 1989 unless the text of the advertisement has been so approved.

3 Saving and transitional provisions

(1)       If, before the date of commencement of items 1 and 2 of this Schedule:

       (a) a person has applied, under clause 6 of Schedule 2 to the Broadcasting Services Act 1992, to the Secretary (the Health Secretary) of the Department whose Minister (the Health Minister) is responsible for the administration of the Therapeutic Goods Act 1989 for approval of an advertisement proposed for broadcasting; and

       (b) a decision has not been made by the Health Secretary before that date;

that application is to be treated, on and after that date, for all purposes as if it were an application for approval under the Therapeutic Goods Regulations 1990.

(2)       If, before the date of commencement of items 1 and 2 of this Schedule:

       (a) the Health Secretary has made a decision in relation to an application, under clause 6 of Schedule 2 to the Broadcasting Services Act 1992, for approval of an advertisement proposed for broadcasting; and

       (b) an appeal from that decision has not been made to the Minister responsible for the administration of the Broadcasting Services Act 1992;

the person who sought that approval has the same right to appeal to the Health Minister under the Therapeutic Goods Regulations 1990, on and after that date, as if that decision had been made under those regulations.

(3)       If, before the date of commencement of items 1 and 2 of this Schedule:

       (a) the Health Secretary has made a decision in relation to an application, under clause 6 of Schedule 2 to the Broadcasting Services Act 1992, for approval of an advertisement proposed for broadcasting; and

       (b) an appeal from that decision has been made to the Minister responsible for the administration of the Broadcasting Services Act 1992; and

       (c) the appeal has not been finally determined before that date;

that appeal is to continue to be dealt with under the Broadcasting Services Act 1992, on and after that date, as if the amendments made by items 1 and 2 had not been made.