Complaints Resolution Panel
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  Sunday 14 February 2016
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Procedure for Complaints about Advertisements (and/or Generic Information) for Therapeutic Goods that are directed to Consumers in Specified Media

Published 3 December 2015

Authorisation

1. These procedures have been established by the Complaints Resolution Panel (the Panel) under regulation 42ZCAK of the Therapeutic Goods Regulations 1990 (the Regulations) and authorised by the Panel on 3 December 20151.

2. On 3 December 2015, the Panel delegated the Panel secretariat2 to act on behalf of the Panel in relation to the following provisions of the Regulations.

  • 42ZCAC
  • 42ZCAE
  • 42ZCAF
  • 42ZCAG
  • 42ZCAGA
  • 42ZCAH
  • 42ZCAJ(4)
  • 42ZCAL

3. Any Panel instructions to the Panel secretariat for exercising particular delegations are included in the Panel's procedures below.

4. On 3 December 2015, the Panel also authorised the Panel secretariat to act on behalf of the Panel in relation to a number of procedural matters not prescribed under the Regulations. These authorisations are also included in the Panel's procedures below.

Preliminary matters

1. Definitions for commonly used terms and acronyms can be found at Appendix 1.

2. Where reference is made to 'advertisement' throughout this document, the provision of the paragraph would apply equally to 'generic information'. The Panel's role, membership and responsibilities are prescribed in the Regulations (refer Part 6, Division 3 Complaints Resolution Panel).

3. These procedures are to be read in conjunction with the Regulations relating to the Panel and the specific complaint-related correspondence issued by, or on behalf of, the Panel to advertisers, complainants and any other party to a complaint.

Procedure

Who may complain and what about?

1. A person may complain to the Panel in writing about an advertisement about designated therapeutic goods that is published or inserted in specified media that is believed to be in breach of applicable provisions of the Therapeutic Goods Act 1989 (the Act), the Regulations or the Therapeutic Goods Advertising Code 2015 (the Code) (refer regulation 42ZCAB).

How to complain

2. Complaints must be submitted in writing by either:

    a) Completing the Online Complaint form at http://www.tgacrp.com.au/index.cfm?pageID=12
    b) Downloading and completing the Complaint Form from http://www.tgacrp.com.au/index.cfm?pageID=9 and posting it to:

New Complaints
Complaints Resolution Panel
PO Box 764
North Sydney NSW 2059

What information the complaint should contain

3. The following information must be included:

    a) a full, clear, and legible copy, transcript or recording of the advertisement in question and:

  • the details of the media on which the advertisement was broadcast or published; and
  • the date (and time if relevant) on which the advertisement was broadcast or published, or for internet advertisements, the date and time at which the advertisement was viewed.
Where a copy of a broadcast advertisement is unavailable, the secretariat may request a copy from the broadcaster provided that the station, date and time on which the advertisement was broadcast has been specified and a description of the content provided;
    b) where the advertisement is in a language other than English, a translated copy of the advertisement. An independent and certified3 translation should be provided where possible;
    c) the name of the designated therapeutic goods promoted in the advertisement, or a description identifying the goods where the advertisement does not include a name;
    d) particulars of complaint and supporting reasons;
    e) details of any attempts to resolve the matter with the advertiser;
    f) a certification that the subject matter of the complaint is not the subject of pending or ongoing litigation (regulation 42ZCAJ); and
    g) 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. Where the complainant is:

  • involved in the therapeutic goods industry (e.g. suppliers of therapeutic goods, individuals associated with industry members who complain in their own names) or
  • a person deemed by the Panel to be experienced with the Panel's procedures and therapeutic goods regulation

the following additional information is to be provided:

    a) Section(s) of the Act, Regulations or the Code the advertisement is alleged to have breached;
    b) The rationale for the complaint, cross-referenced to the specific claims at issue and any available supporting material. When challenging a claim as being unsubstantiated, it is not generally sufficient simply to state that the claim is not supported. Evidence should be provided to support the allegations.

These requirements apply whether or not the complainant is a competitor of the advertiser.

5. If the complaint does not provide sufficient information to address the requirements set out in paragraphs 3 and 4, the Panel secretariat may seek further information from the complainant (if known).

6. Alternatively, on a preliminary review of the complaint by the Panel:

    a) The complaint challenges a claim in an advertisement and appears to lack suitable evidence or a clear argument to support that challenge;
    b) the complaint is not clear as to what breaches are alleged or how they are alleged to have occurred;
    or c) the complaint does not include the information set out in paragraphs 3and 4:

the Panel may decide to treat the complaint as withdrawn (in accordance with s.42ZCAF), or request the Secretariat to return it to the complainant, along with a request that a complete complaint be submitted instead.

Verifying the complaint is in order

7. The Panel secretariat will confirm that the advertisement falls within regulation 42ZCAB – i.e. that it:

    a) Either:

  • promotes the use or supply of designated therapeutic goods; or
  • relates to generic information; and

    b) it has been published or broadcast in specified media.

Where the complaint does not fall within regulation 42ZCAB, the complaint may be:

  • forwarded to the TGA if for a therapeutic good, possible therapeutic good, food or cosmetic;
  • forwarded to the Australian Health Practitioner Regulation Agency if for a healthcare service not advertising a therapeutic good or
  • returned to the complainant (if known).
The complainant will be informed that the Panel has no jurisdiction over the matter, advised of any referral, and that the complaint is treated as withdrawn per sub-regulation 42ZCAF(2)(a) by the Panel secretariat on behalf of the Panel.

8. Where the complaint is in order, but contains additional elements that fall outside the Panel's jurisdiction or that are irrelevant, the Panel will deal with the part of the complaint that is within jurisdiction, and disregard or, where appropriate, refer the additional elements to the appropriate authority.

9. If upon receipt of the complaint it appears to the Panel secretariat that there are grounds for the Panel to treat the complaint as withdrawn under 42ZCAF(2), the Panel secretariat will decide whether the complaint should be treated as withdrawn and referred to another authority (such as the TGA) or dealt with in the ordinary way. Where known, the complainant will be advised of the referral to another Authority if relevant.

Acknowledging receipt of the complaint

10. Within five working days the Panel secretariat will ensure that the complainant is notified in writing, acknowledging receipt of the complaint and inviting a written submission (including supporting material) about the complaint (the notice). The deadline for receipt of a submission from the complainant shall be within three working days of the notice.

Providing the complaint to the advertiser and inviting a response

11. The Panel secretariat will notify the advertiser of the complaint (the notice). The notice will include the following information:

  • a copy of the complaint and the advertisement about which the complaint is made
  • the Panel secretariat's interpretation of the complaint as made by the complainant (if needed to clarify the allegations made by the complainant), and
  • where the advertisement is in a language other than English, any translation provided by the complainant.

12. Following a preliminary review of the complaint by the Panel secretariat, any additional possible breaches other than those raised by the complainant (per regulation 42ZCAH), which the Panel may subsequently consider, will also be raised in the notice.

13. The notice will also seek a submission from the advertiser in response to the complaint (as required under regulation 42ZCAC) by:

  • inviting a response to the complaint by providing a written submission to the Panel within ten working days of transmission of the notice;
  • requesting a response to each alleged breach; and
  • requesting a statement and particulars as to whether the subject matter of the complaint is the subject of legal proceedings that have not been finally disposed of, so that the Panel is able to decide whether or not to deal with the complaint (having regard to regulation 42ZCAJ).

14. In issuing the notice, the Panel secretariat will remove any reference to the identity of any complainant who requests that their identity be withheld from the advertiser.

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

Information to be provided by the advertiser in the submission

16. In providing a submission, the advertiser should include:

  • a completed CRP Response Form;
  • if the advertised products are included in the Register, a copy of the ARTG entry for each advertised product;
  • any approval that was required for the publication of the advertisement and/or representations within it (such as restricted representations);
  • a response to each alleged breach; and
  • an independent certified translation4 of the advertisement, if the advertisement is not in English and the advertiser does not accept the translation provided by the complainant.

17. The Panel may require the advertiser or the sponsor to produce evidence in support of a claim made in an advertisement that is the subject of a complaint (regulation 42ZCAE (2)). The submission, therefore, should include:

  • where appropriate, substantiation of specific claims with supporting material (refer to the CRP Guidelines for Advertisers).
  • supporting material must be in English; where any material is in a language other than English, an independently certified translation5 into English must be provided.

No cross claims

18. If, in a submission, an advertiser makes a complaint about another advertiser, the Panel will not consider it as part of the current complaint. Any cross-claim must be submitted by the advertiser separately as a new complaint.

Confidential information

19. In the interests of transparency, the Panel does not encourage advertisers to provide confidential information in their complaint submissions. However, the Panel does recognise that on occasion, advertisers may need to rely on confidential information to adequately address a complaint.

In lodging a submission, an advertiser may request the Panel to treat specific information in their submission as confidential. Specific parts e.g. the results of a particular clinical trial may be claimed as confidential when so identified, but the entire submission cannot be considered to be confidential. The advertiser must provide an explanation as to why the material is confidential. The Panel considers that information is only 'confidential' where that information is not in the public domain and is not publically available.

In the event that the Panel decides that the material is publically available and therefore is not confidential, it will be considered and reported on as the Panel considers necessary in the complaint determination.

If the Panel agrees that the information identified by the advertiser is confidential but considers that it is necessary to note it in the complaint determination, the Panel will limit the details to a brief description of the material concerned and an outline of the content, including key findings. The advertiser may advise the Panel of any concerns that they have about the handling of the confidential information when the determination is sent to them (see paragraph 36); the Panel will consider and address such concerns as they consider appropriate.

Meetings

20. The Panel may convene using any means of communication agreed by the members and observers and as directed by the Chair, including but not limited to face-to-face and teleconference meetings.

21. The Panel meets regularly. At the time of these procedures, Panel meets once per month at face-toface meetings and generally meets once per month via teleconference. Additional teleconferences may be scheduled if needed.

22. Complaints are triaged so that less complex complaints are considered at teleconference meetings.

23. A quorum is required in order for a meeting to be convened. As set out in regulation 42Y, a quorum exists if the chairperson and four (4) other members of, or observers to, the Panel are present.

What is provided to the Panel members

24. Electronic copies of all submissions and substantive correspondence with parties with an interest in the complaint will be provided to each member of the Panel by the Secretariat, together with any other information requested by the Panel or prepared by the Secretariat.

Complaint consideration

25. The Panel will consider any issue under regulation 42ZCAF(2) (Withdrawal of Complaint) before determining the complaint. This does not prevent the Panel from subsequently determining during its consideration of the complaint that this regulation applies.

26. 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 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 regulation 42ZCAH.

27. The Panel may decide that further information is to be sought from the complainant, advertiser, or any other person, and defer final consideration of the complaint to a future meeting until such information has been obtained.

28. The Panel may refer a complaint to another authority (for example the TGA or Australian Competition and Consumer Commission) if it is satisfied that the subject matter could more effectively or conveniently be dealt with by that authority and the complaint could have been made to the authority. Both the advertiser and the complainant will be notified of the referral by the Panel secretariat. In doing so, the Panel and the Panel secretariat must comply with regulation 42ZCAGA. A referral does not prevent the Panel from dealing with other matters to which the complaint relates (including other matters raised by the Panel secretariat and/or the Panel).

29. The Panel will not deal with a complaint if a proceeding has begun in a court about the subject matter of the complaint or, if after a complaint has been made, a proceeding begins in a court about the subject matter of a complaint unless:

  • either the complainant or the advertiser would be unreasonably disadvantaged;
  • the complaint could be referred to another authority (per regulation 42ZCAGA);
  • the public interest would be served; or
  • there is any other matter the Panel thinks relevant.
In dealing with such a complaint, the Panel must comply with regulation 42ZCAJ.

Submission due dates

30. Complaints are placed on the agenda for a particular meeting taking into consideration the due dates for submissions by the complainant, advertiser and any other party requested to provide information. An advertiser may, however, request an extension to the cut-off date for their submission.

Determining the complaint

31. The Panel will decide whether the complaint is justified on the basis of the information before the Panel at the time of the meeting.

32. The Panel does not permit oral arguments, presentations or submissions during the meeting. Unsolicited information submitted after the meeting will not be considered by the Panel.

Interim determination

33. Where the Panel believes there is a need to expedite compliance for a particular advertisement but additional or outstanding issues have been identified, the Panel may make an interim determination, finalising aspects of the complaint on the basis of the available information at the meeting. The advertiser is then requested, in the interim determination, to provide further information about the matters not finalised. An advertiser would have the usual 10 working days to comply with requests included in the interim determination. The final determination will be completed at a subsequent meeting on consideration of the advertiser's response.

Panel's decision to be confirmed in writing

34. Determinations by the Panel shall be in writing and specify the meeting date on which the complaint was considered, the date the determination was finalised, the Panel's findings, the reasons for the finding(s) and the requests for actions to be taken by the advertiser (see below).

35. The final determination will be signed on behalf of the Panel by the Panel secretariat, the Chair or presiding member of the Panel.

36. The Panel secretariat will send a copy of the final determination to the advertiser(s) by email and/or mail once the determination has been finalised following the Panel hearing, allowing ten working days in which to respond to any request made by the Panel and to identify any errors of fact. The Panel secretariat will send the determination to the complainant by email and/or mail (where the complainant details have been provided) not less than twelve working days after its provision to the advertiser.

Requests by the Panel where complaint is justified

37. If, in relation to a complaint about an advertisement, the Panel is satisfied that there has been a contravention of the Act, the Regulations or the Code, the Panel may request in writing the advertiser to do one or more of the following as set out in sub-regulations 42ZCAI(1) and (2):

    a) withdraw the advertisement;
    b) publish a retraction;
    c) publish a correction;
    d) withdraw a particular claim or representation

Where the Panel decides the complaint is justified and requests the advertiser to withdraw the advertisement, withdraw representations or to publish a retraction or correction, the Panel may request the advertiser to provide evidence of compliance within 14 days of the request.

Failure to comply with a request of the Panel -- Recommendation to the Secretary

38. Where the advertiser fails to respond or fails to indicate an intention to comply fully with all of the requests made by the Panel in the determination within 10 working days of the transmission of the determination, the Panel may make a recommendation to the Secretary of the Department of Health under regulation 42ZCAI. The known parties must be notified in writing of the recommendation and the reasons for such a recommendation.

39. The Panel may also recommend that the Secretary do one or more of the following:

  • if the advertisement is an approved advertisement ? withdraw the approval of the advertisement;
  • suspend the registration or listing of goods under subsection 29D (1) of the Act;
  • cancel the registration or listing of the goods under section 30 of the Act;
  • order the withdrawal of the advertisement or generic information;
  • order the publication of a retraction;
  • order the publication of a correction;
  • order the recovery of any advertisement or generic information that is still in circulation;
  • order the destruction of the advertisement or generic information;
  • suspend a kind of medical device from the Register under Part 4-6 of the Act;
  • cancel the entry of a kind of medical device from the Register under Part 4-6 of the Act;
  • order that a particular claim or representation made by the advertisement or generic information be withdrawn, and not be used in any other advertisement or generic information unless the advertiser satisfies the Panel that the use of the claim or representation would not result in a contravention of the Act, the Regulations or the Code.

Making the final determination public

40. Once the final determination of the Panel has been made, it will be made available to the public on a the Complaints Register at the website www.tgacrp.com.au not less than two weeks after the advertiser is notified of the final determination, as set out in regulation 42ZCAL.

The Panel may direct the Panel secretariat to make such omissions from the final determination before it is made available to the public on the website as the Panel considers necessary in order to protect privacy and confidential information.

Confidentiality

41. Before the Panel's final written determination has been communicated to the parties to a complaint and made available to the public, Panel members, observers, the Panel secretariat and any other person having access to a determination must observe complete confidentiality in relation to all information concerning the deliberations of the Panel including but not limited to:-

    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.

42. 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, observers and the Panel secretariat may educate and inform the public about the general principles arising from 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;
    b) confidential information; nor
    c) information not contained in the determination concerning any enquiry or consideration made by the Panel in relation to the complaint.

Inquiries from media and general public

43. The Panel secretariat will redirect all media inquiries regarding specific complaints to the Therapeutic Goods Administration. Members, observers and the Panel secretariat are not authorised to respond to media enquiries.

Conflict of interest obligations of Panel members

44. A member or observer of the Panel who has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Panel must disclose the nature of the interest to that meeting of the Panel and the disclosure is to be recorded in the minutes of the meeting. The person must not be present during any deliberation of the Panel with respect to the matter, or take part in any decision of the Panel with respect to the matter (refer to regulation 42ZB).

Reports to the TGACC

45. In its periodic reports to the Therapeutic Goods Advertising Code Council (TGACC), the Panel will publish a brief summary of all complaints received, recommendations made and any outcomes in a form agreed with the TGA.

  1. These procedures are an adjunct to the procedures set out in the Regulations in relation to the Panel; in the event of an inconsistency between these procedures and the Regulations, the Regulations prevail.
  2. Refer to Appendix 1 for the definition of 'Panel secretariat'.
  3. National Accreditation Authority for Translators and Interpreters (NAATI) accredited translators are preferred.
  4. NAATI accredited translators are preferred.
  5. NAATI accredited preferred

Appendix 1 – Definitions

In these procedures, unless otherwise specified:
A reference to: Means:
Advertisement As defined in section 3 of the Act. For the purposes of this document only, references to "advertisement" should be interpreted as including "generic information".
Advertiser The term "advertiser" is used generically to describe the person(s) apparently responsible for the advertisement being broadcast or published and may include the broadcaster and publisher themselves in certain circumstances. The usage in this procedure includes both the singular and plural forms as appropriate.
Broadcast media As defined in section 42B of the Act.
Confidential information Specific information about a therapeutic good that has been identified by the advertiser to be confidential and is not in the public domain or publically available.
CRP Complaints Resolution Panel
Designated therapeutic goods As defined in regulation 42ZCAB.
Generic information As defined in section 42B of the Act.
NAATI National Accreditation Authority for Translators and Interpreters
Panel secretariat The persons designated as the "Executive Officer" and "Executive Administrator".
Specified media Specified media as defined in section 42B of the Act, which includes mainstream media and broadcast media (including internet).
TGA Therapeutic Goods Administration
TGACC Therapeutic Goods Advertising Code Council
The Act Therapeutic Goods Act 1989
The Code Therapeutic Goods Advertising Code
The Panel Complaints Resolution Panel
The Register Australian Register of Therapeutic Goods
The Regulations Therapeutic Goods Regulations 1990