Complaints Resolution Panel: Procedures

COMPLAINTS RESOLUTION PANEL ADVERTISING COMPLAINT PROCEDURE FOR CONSUMER ADVERTISEMENTS

Who may complain and what about?

1. A person may complain to the Complaints Resolution Panel in writing about an advertisement or generic information about designated therapeutic goods, medical devices or other therapeutic goods that is published or inserted in specified media or broadcast media that is believed to be in breach of applicable provisions of the Therapeutic Goods Advertising Code (TGAC), the Therapeutic Goods Regulations or the Therapeutic Goods Act (refer Regulation 42ZCAB). The italicized terms are defined in the legislation. For convenience, these and other relevant definitions are set out in the appendix. Reliance should be placed on the legislation, not on the appendix.

How to complain

2. Complaints should be forwarded to the following address:

The Executive Officer

Complaints Resolution Panel

c/o – PO Box 764

North Sydney NSW 2059

What information the complaint should contain

3. Complaints must be submitted in writing on the Complaint Form (available on the website www.tgacrp.com.au), and must include a copy of the advertisement in question (and a translation where the advertisement is not in English). The following information must be included:

(a) name of the designated therapeutic good;
(b) particulars of complaint and supporting reasons;
(c) any details of attempts to resolve matter with the advertiser;
(d) an assurance that the subject matter of the complaint is not the subject of pending litigation (Regulation 42ZCAJ); and
(e) contact details of the complainant (unless the complaint is made anonymously). The complainant may supply contact details on the basis that they be kept confidential.

4. The following additional information is desirable in all cases and must be provided when a complaint is made by a supplier of therapeutic goods (including individuals associated with industry members who complain in their own names), whether or not that supplier is a competitor of the person apparently responsible for requesting publication or insertion of the advertisement (the respondent) or when a complaint is made by a person deemed by the Panel to be experienced with the Panel’s procedures;

i) Section of the Act, TGAC or Regulations at issue; ii) Supporting data cross-referenced to specific claims at issue and rationale for challenge. When challenging a claim as unsubstantiated, it is not sufficient simply to state that the claim is not supported. Evidence should be provided to support the complainant's case.

If insufficient information is provided the Executive Officer may seek further information from the complainant (if known).

5. Where, on preliminary review:

(a) a complaint that challenges a claim in an advertisement appears to lack suitable evidence or a clear argument to support that challenge;
(b) a complaint is not clear as to what breaches are alleged or how they are alleged to have occurred; or,
(c) a complaint that falls within paragraph 4 of these procedures does not include the information stipulated in that paragraph;

the Panel may decide to treat the complaint as withdrawn, or to return it to the complainant along with a request that a more complete complaint be submitted instead, whether or not the complaint has already been forwarded to other parties.

Verifying the complaint as in order

6. The Executive Officer will confirm whether the advertisement falls within Regulation 42ZCAB - i.e.

• relates to designated therapeutic goods, medical devices and/or other therapeutic goods

• has been inserted in specified media Where the complaint does not meet the requirements of Regulation 42ZCAB, the complaint will be returned to the complainant (if known) and the complainant informed that the Panel has no jurisdiction over the matter.

Acknowledging receipt

7. If upon receipt of the complaint it appears to the Executive Officer that there may be grounds for the Panel to treat the complaint as withdrawn under 42ZCAF(2), the Executive Officer will place the matter before the Panel at the next meeting. Only if the Panel decides at that meeting not to treat the matter as withdrawn will the advertiser be required to respond to the complaint.

8. Within five working days the Executive Officer will ensure that acknowledgment of receipt of the complaint is provided to the complainant (if known).

Providing the complaint to the respondent and inviting a response

9. At the same time, the Executive Officer will forward a copy of the complaint to the respondent. In doing so, the Executive Officer will remove any reference to the identity of complainants who wish their identity to be withheld from the respondent. The respondent will be invited to respond to the Panel, within ten working days, stating whether or not the information supporting the complaint is correct and whether the complaint is the subject of litigation. *

10. For complaints made by consumers, where the complainant has not identified the relevant section of the Act, TGAC or Regulations at issue, the Executive Officer, in providing the complaint to the respondent, may designate the relevant clause(s) that aspects of the complaint have raised and request a response to the designated clauses from the respondent.

Information to be provided by the respondent

11. A decision to deal with matters not specified in the complaint under regulation 42ZCAH may be made by the Executive Officer if it is apparent from the material provided in the complaints, and other material including information on the Australian Register of Therapeutic Goods, that the material may breach any of the sections 22(5), 41FN(5) or 42C of the Act, and/or sections 3(3), 4(2)(i), 4(6)(b), 4(7), 6(3), 6(4) or 7(1) of the code. If such a decision is made, written notice will be provided to the respondent along with the copy of the complaint and the respondent will be invited to provide a response to these additional matters together with their response to the original complaint.

12. If the complaint is not the subject of litigation, in providing a response, the respondent should include:

a response to each alleged breach; and
where appropriate, substantiation of specific claims with supporting data. Substantiation material must be in English. Where the material is in a language other than English, an independently certified translation into English must be provided.

No cross claims allowed

13. If the respondent makes a cross-claim in the response, the Executive Officer will inform the respondent that the cross-claim constitutes a new and separate complaint and must be submitted as such.

Confidential submissions

14. Respondents to a complaint may make submissions that are confidential in nature, but must provide an explanation as to why the material is confidential for the Panel’s consideration. Respondents should note that even where the Panel accepts that material is confidential, an outline or description of it may be published in Panel determinations where this is required for clarity.

Ensuring a quorum

15. In exceptional circumstances and to ensure a quorum, the Panel may convene by video or telephone conference.

What is provided to the Panel members

16. Copies of all submissions will be provided to each member of the Panel by the Executive Officer. In sending the papers to members the Executive Officer will inform members of any facts or circumstances which might fall within Regulation 42ZCAF(2), i.e. where

the complaint may be trivial, vexatious, misconceived or lacking in substance; or
the subject matter of the complaint has been dealt with by the Panel or by another authority;
the subject matter of the complaint can more effectively or conveniently be dealt

with by another authority;

or both:

• the complainant does not intend to proceed with the complaint; and
• on the basis of the complaint, there does not appear to have been a contravention of the Act, the Regulations or the Code.

Preliminary issues

17. The Panel will then consider any issue under Regulation 42ZCAF(2) before determining the complaint. This does not prevent the Panel from determining at any time during its consideration of the complaint that this Regulation applies.

Determining the complaint

18. The Panel will decide whether the complaint is justified upon the written documents and submissions received. The Panel will permit no oral arguments or submissions.

19. The Panel may require the person apparently responsible or the sponsor to produce evidence in support of a claim made in an advertisement or in generic information that is the subject of a complaint (Reg. 42ZCAE (2).

20. The Panel may inform itself on any matter, and consult such persons, as it thinks fit (Reg. 42ZCAE (1).

21. The Panel may deal with a matter that is not mentioned in a complaint (even if the complaint is withdrawn) if the Panel is satisfied that the advertisement or generic information to which the complaint relates may contravene the Act, the Regulations or the Code in some other way. In doing so, the Panel must comply with Reg. 42CAH.

Interim determination

22. The Panel may make an interim determination if it considers it appropriate to give a party a further opportunity to make submissions or provide information. An interim determination may indicate how the Panel is minded to decide the complaint in the absence of further information or submissions.

Panel’s decision to be confirmed in writing

23. The Panel must confirm its decision in a written determination specifying the finding and the reasons for the finding. The Executive Officer will send a copy to all known parties within fifteen working days of the Panel hearing. The Executive Officer will send the determination to the respondent by fax and mail. The decision of the Panel is final and no debate will be entered into.

Complaints about material that appears on several websites

24. Where a complaint relates to substantially similar material appearing on a number of websites, the Panel may elect to make initial enquiries only with the sponsor of the advertised product. A determination may then be made on the basis of the sponsor's response, and provided to the publishers of the other websites. Where this approach is taken, the publishers of the other websites will be given the opportunity to accept the determination as if it applied to them, or instead to provide an individual response for separate consideration by the Panel.

Requests by the Panel where complaint is justified

25. Where the Panel decides the complaint is justified and requests the respondent to withdraw or to publish a retraction or both the Panel may request the respondent to give evidence of compliance with the request and details of publication arrangements already in place that cannot be cancelled.

Failure to comply with a request of the Panel

26. Where the respondent fails to respond within 14 days of being requested by the Panel to withdraw an advertisement, withdraw a representation or to publish a retraction or correction, the Panel may make a recommendation to the Secretary to the Department of Health & Ageing under Regulation 42ZCAI. The known parties must be notified in writing of the recommendation and the reasons for such a recommendation.

Satisfying the Panel regarding the contravention of the Act, Regulations Code

27. Pursuant to Regulation 42ZCAI(1)(d), the Panel may request that a claim or representation be withdrawn unless the person apparently responsible satisfies the Panel that the use of the claim or representation would not result in a contravention of the Act, Regulations or Code. Where such a request has been made by the Panel, any submission from the person apparently responsible in this regard will not be considered unless:

(a) at least 12 months have elapsed since the Panel made its request; or,
(b) substantive new evidence has become available that was not available at the time of the complaint.

Making the final determination public

28. Once the final determination of the Panel has been communicated to the parties to the complaint, copies of the final determination will be made available to the public by the Executive Officer on request and will be made available on the website <www.tgacrp.com.au> under “complaints”. The Panel may direct the Executive Officer to make such omissions from the final determination before it is made available to the public, including on the website, as the Panel considers necessary in order to protect privacy and confidential information.

Media comments

29. Only the Chairperson, the alternate Chairperson and the Panel Executive Officer may comment on behalf of the Panel to the media. Any comments to the media must be consistent with the confidentiality obligations of Panel members.

Confidentiality obligations of Panel members and the Panel Executive Officer

30. Before the Panel’s final written determination has been communicated to the known parties to a complaint and made available to the public, Panel members and the Panel Executive Officer must observe complete confidentiality in relation to all information concerning the deliberations of the Panel including:-

(a) the identity of parties to the complaint,
(b) the substance of the complaint, of the determination and of any interim determination;
(c) any enquiry made by the Panel; and
(d) any confidential information of any of the parties to a complaint, or of any other participant, such as a publisher or broadcaster,

and must not disclose any such information to any person except as required by the Panel to enable the Panel to make its decision. So long as no such information is disclosed, members may consult the bodies which nominated them to the Panel on issues arising for determination.

31. After the Panel’s final written determination has been communicated to the known parties to a complaint and made available to the public, Panel members and the Panel Executive Officer may educate and inform the public about the determination and may participate in public discussion of the procedures of the Panel but may not at any time disclose:

a. communications amongst Panel members, observers and the Panel Executive Officer;
b. confidential information; nor
c. information not contained in the determination concerning any enquiry made by the Panel.

Confidentiality obligations of observers

32. The disclosure of confidential information by Panel observers (being only those Commonwealth officers nominated to the Panel under Therapeutic Goods Regulations 42X) is subject to provisions included in the Crimes Act 1914 and the Public Service Regulations 1999.

Application of section 61(8) of the Therapeutic Goods Act 1989

33. The Panel observer nominated by the Therapeutic Goods Administration may be entitled to use any information provided to the Panel (whether confidential or not) pursuant to s.61 (8) of the Therapeutic Goods Act 1989.

Conflict of interest obligations of Panel members

34. In addition to the requirement in Regulation 42ZB to disclose a direct or indirect pecuniary interest in a matter about to be considered in a meeting of the Panel, members of the Panel should also disclose a conflict of interest if a reasonable third party would conclude that there was a likelihood that a member of the Panel may be influenced, in reaching a decision, by factors other than the merits of the case as presented by the parties.

Reports to the TGACC

35. In its periodic reports to the TGACC, the Panel will publish a brief summary of all complaints received, recommendations made and any outcomes.

Time extensions

36. Time extensions may be granted on application to the Chairperson.

Amending these procedures

37. These procedures may be amended from time to time.

Appendix

• Advertisement (Therapeutic Goods Act 1989 section 3)

advertisement, in relation to therapeutic goods, includes any statement, pictorial representation or design, however made, that is intended, whether directly or indirectly, to promote the use or supply of the goods.

•Generic information

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.

•Therapeutic goods (Therapeutic Goods Act 1989 section 3)

therapeutic goods means goods:

(b): included in a class of goods the sole or principal use of which is, or ordinarily is, a therapeutic use or a use of a kind referred to in subparagraph (a)(ii) or (iii);

and includes medical devices and goods declared to be therapeutic goods under an order in force under section 7, but does not include:

(c): goods declared not to be therapeutic goods under an order in force under section 7; or
(d): goods in respect of which such an order is in force, being an order that declares the goods not to be therapeutic goods when used, advertised, or presented for supply in the way specified in the order where the goods are used, advertised, or presented for supply in that way; or
(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
(f): goods which, in Australia or New Zealand, have a tradition of use as foods for humans in the form in which they are presented.

•Therapeutic use (Therapeutic Goods Act 1989 section 3)

therapeutic use means use in or in connection with:

(a): preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons or animals; or
(b): influencing, inhibiting or modifying a physiological process in persons or animals; or
(c): testing the susceptibility of persons or animals to a disease or ailment; or
(d): influencing, controlling or preventing conception in persons; or
(e): testing for pregnancy in persons; or
(f): the replacement or modification of parts of the anatomy in persons or animals.

Designated therapeutic goods (Therapeutic Goods Regulations 1990 regulation 2) designated therapeutic goods means therapeutic goods other than:

therapeutic devices; and
goods included in Schedule 3 to the Poisons Standard that are not included in Appendix H of that standard; and
goods included in Schedule 4 or 8 to the Poisons Standard.

Medical device (Therapeutic Goods Act 1989 section 41 BD)

(1) A medical device is:

(a) any instrument, apparatus, appliance, material or other article (whether used alone or in combination, and including the software necessary for its proper application) intended, by the person under whose name it is or is to be supplied, to be used for human beings for the purpose of one or more of the following:

(i): diagnosis, prevention, monitoring, treatment or alleviation of disease;
(ii): diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap;

(iii) investigation, replacement or modification of the anatomy or of a physiological process;

(iv) control of conception; and that does not achieve its principal intended action in or on the human

body by pharmacological, immunological or metabolic means, but that may be assisted in its function by such means; or

(b) an accessory to such an instrument, apparatus, appliance, material or other article.

Note: Declarations under subsection (3) exclude articles from the scope of this definition. Declarations under section 7 can also have this effect: see subsection 7(4).

•Specified media (Therapeutic Goods Act 1989 section 42B)

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

(iii) on billboards.

•Mainstream media (Therapeutic Goods Act 1989 section 42B)

mainstream media means any magazine or newspaper for consumers containing a range of news, public interest items, advertorials, advertisements or competitions.

•Broadcast media (Therapeutic Goods Act 1989 section 42B)

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.