Complaints Resolution Panel
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  Tuesday 23 September 2014
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Complaint Procedure for Complaints about Advertisements (and/or Generic Information) for Therapeutic Goods that are directed to Consumers in Specified Media

Published 14 January 2013


Notes: 

  1. Where reference is made to ‘advertisement’ throughout this documents, the substance of the paragraph would apply equally to ‘generic information’.
  2. The Complaints Resolution Panel (the Panel) meets once per month at face-to-face meetings and generally meets once per month via teleconference. Complaints are triaged so that less complex complaints are considered at teleconference meetings. Additional teleconference may be scheduled.
  3.  Commonly used definitions can be found at Appendix 1
  4. The Panel’s role, membership and responsibilities are described in the Therapeutic Goods Regulations 1990 (refer Division 3 Complaints Resolution Panel). Of particular note, is subregulation 42ZCAK, which enables the Panel to make its own procedures.

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). 

How to complain

2. Complaints should be submitted online at:

http://www.tgacrp.com.au/index.cfm?pageID=12

or sent by mail to:

New Complaints
Complaints Resolution Panel
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/index.cfm), 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) a full, clear, and legible copy of the advertisement in question;
(b) where the advertisement is in a language other than English, a translated copy of the advertisement.  An independent and certified translation should be provided where possible;
(c) the name of the designated therapeutic goods promoted in the advertisement, or a clear description of 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, if any;
(f) an assurance that the subject matter of the complaint is not the subject of pending 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. The following additional information is desirable in all cases and should 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;

(a) Section of the Act, Regulations or TGAC said to have been breached;
(b) Supporting data cross-referenced to specific claims at issue and rationale for the challenge.  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 complaint.

If insufficient information is provided, the Panel executive may seek further information from the complainant (if known).

5. Where, on a preliminary review of the complaint:

(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;
(c) the complaint falls within paragraph 4 of these procedures but does not include the information stipulated in that paragraph; or,
(d) the complaint does not include the information set out in paragraph 3:

the Panel may decide to treat the complaint as withdrawn, or return it to the complainant along with a request that a complete complaint be submitted instead.

Verifying the complaint is in order

6. The Panel executive will confirm that the advertisement falls within Regulation 42ZCAB – i.e. that it:
(a) promotes designated therapeutic goods, medical devices and/or other therapeutic goods; and
(b) it has been published or broadcast in specified media.

Where the complaint does not  fall within  regulation 42ZCAB, the complaint will be returned to the complainant (if known), the complainant informed that the Panel has no jurisdiction over the matter and the complaint, therefore, treated as withdrawn per subregulation 42ZCAF(2)(a) by the Panel executive.

7. Where the complaint is otherwise in order, but contains additional elements that fall outside the Panel’s jurisdiction or that is clearly irrelevant, the Panel will ordinarily deal with the part of the complaint that is in order, and disregard the additional elements.

8. If upon receipt of the complaint it appears to the Panel executive that there may be other grounds for the Panel to treat the complaint as withdrawn under 42ZCAF(2), the Panel executive will place the matter before the Panel and the Panel will decide whether the complaint should be treated as withdrawn, or dealt with in the ordinary way.

Acknowledging receipt of the complaint

9. Within five working days the Panel executive 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

10. The Panel executive will forward to the respondent a copy of the complaint and the advertisement about which the complaint is made.  In doing so, the Panel executive will remove any reference to the identity of any complainant who requests that their identity be withheld from the respondent. Where the advertisement is in a language other than English, any translation provided by the complainant will also be forwarded to the respondent.

11. The respondent will be invited to respond to the complaint by providing a written response to the Panel within ten working days.  The letter seeking a response will interpret the complaint as made by the complainant and seek a response to each alleged breach. Following a preliminary review of the complaint, any matters other than those raised by the complainant (per regulation 42ZCAH), with which the Panel may decide to deal, will be raised in the letter seeking a response. 

12. The respondent will be asked to provide a statement and particulars as to whether the subject matter of the complaint is also 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.

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

Information to be provided by the respondent

14. In providing a response, the respondent should include:

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

15. 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).  The response, therefore, should include:

• where appropriate, substantiation of specific claims with supporting data (refer to the CRP Guidelines for Respondents). 
• as 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

16. If the respondent makes a cross-claim in the response, the Panel will not consider it. Any cross-claim should be submitted as a new and separate complaint.

Confidential submissions

17. Respondents to a complaint may make submissions that are confidential in nature only with the prior consent of the Panel. They 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.

Meetings

18. A quorum exists if the chairperson and 4 other members of, or observers to, the Panel are present.

19. The Panel may convene by any effective means of communication, including but not limited to face-to-face and teleconference meetings.

What is provided to the Panel members

20. Copies of all submissions relating to a complaint will be provided to each member of the Panel by the Panel executive, together with any other relevant information compiled during the processing of the complaint. 

Preliminary issues

21. The Panel will 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.
 
22. 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.

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

24. The Panel may refer a complaint to another authority if it is satisfied that the subject matter could more effectively or conveniently be dealt with by another authority; and the matter could have been made by the complainant to the authority. In doing so, the Panel must comply with regulation 42ZCAGA. A referral does not prevent the Panel from dealing with other matters to which the complaint relates.

25. The Panel not will 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 doing so, the Panel must comply with regulation 42ZCAJ.

Determining the complaint

26. The Panel will decide whether the complaint is justified on the basis of the written documents and submissions received.  The Panel will permit no oral arguments or submissions.

Interim determination

27. 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.

Complaints about material that appears on several websites

28. 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.

Panel’s decision to be confirmed in writing

29. The Panel must confirm its decision in a final written determination specifying the finding and the reasons for the finding.  The Panel executive will send a copy of the final determination to all known parties once the determination has been finalised following the Panel hearing. The Panel executive will send the determination to the respondent by fax, mail and/or email, as appropriate.

Requests by the Panel where complaint is justified

30. If, in relation to a complaint about an advertisement, the Panel is satisfied that there has been a contravention of the Act, these Regulations or the Therapeutic Goods Advertising Code, the Panel may request in writing the person apparently responsible to do one or more of the following:
(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 respondent to withdraw the advertisement, withdraw representations or to publish a retraction, 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 – Recommendation to the Secretary

31. Where the respondent 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 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.

32. The Panel may recommend that the Secretary do one or more of the following:
 (a) if the advertisement is an approved advertisement — withdraw the approval of the advertisement;
 (ab) suspend the registration or listing of goods under subsection 29D (1) of the Act;
 (b) cancel the registration or listing of the goods under section 30 of the Act;
 (ba) order the withdrawal of the advertisement or generic information;
 (c) order the publication of a retraction;
 (d) order the publication of a correction;
 (e) order the recovery of any advertisement or generic information that is still in circulation;
 (f) order the destruction of the advertisement or generic information;
 (g) suspend a kind of medical device from the Register under Part 4 6 of the Act;
 (h) cancel the entry of a kind of medical device from the Register under Part 4 6 of the Act;
 (i) 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 person apparently responsible satisfies the Panel that the use of the claim or representation would not result in a contravention of the Act, these Regulations or the Therapeutic Goods Advertising Code.

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

33. 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 ordinarily be considered unless:
• at least 12 months have elapsed since the Panel made its request; or,
• substantive new evidence has become available that was not available at the time the response to the complaint was provided.

Making the final determination public

34. 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 on a Complaints Register at the website www.tgacrp.com.au under “complaints”. The Panel may direct the Panel executive 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.

Meetings of the Panel

35. The Panel may convene in person, or by video or telephone conference.

Confidentiality obligations of Panel members and the Panel executive

36. 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 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.
37. 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 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;
(b) confidential information; nor
(c) information not contained in the determination concerning any enquiry made by the Panel.

Confidentiality obligations of observers

38. 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.

Media comments

39. Only the Chairperson, the alternate Chairperson and the Panel’s 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.

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

40. 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

41. A member (or an 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 at a 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.  [Regulation 42ZCB]

Reports to the TGACC

42. 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

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

Amending these procedures

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