Complaints Resolution Panel
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  Tuesday 30 August 2016
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Relevant Legislation

This page outlines the relevant provisions of the Therapeutic Goods Act and Regulations relating to the advertising of therapeutic goods and the provision of generic information about therapeutic goods.

You can also download the extracts of Commonwealth legislation relevant to advertising therapeutic goods, in PDF format (9.79MB) or as a ZIP file (9.56MB).

The Act

Section 3 defines advertisement, sponsor, therapeutic device, therapeutic goods and therapeutic use. It also defines presentation in a way which refers to advertising and sub-section 3(5) describes as unacceptable a presentation which is capable of being misleading or confusing.

In considering applications to Register or list goods on the Australian Register of Therapeutic Goods, a relevant factor is whether the goods conform to any standard relating to advertising applicable under the regulations (s. 25(1)(f) and s. 26(1)(f)). Conditions may be imposed on registration or listing (s. 28(1)) which may relate to advertising (s. 28(2)(e)). If an applicant for listing makes a claim in relation to the goods, the listing is subject to the condition that the sponsor then had information or evidence which supported the claim (s. 28(6)(c)). Registration or listing may be cancelled if the goods do not conform to an applicable advertising requirement (s. 30(2)(e)).

Part 5-1 defines approval number, approved advertisement mainstream media and specifies offences in relation to advertisements requiring approval under Division 2 of Part 2 of the Regulations, including advertising without a required approval and failing to include the approval number in approved advertisements.

Part 5-1 does not apply to advertisements directed to health professionals (s.42AA); to advertisements for goods not for human use (s.42AB); or to advertisement for exports (s.42AC).

All other advertisements about therapeutic goods, including those directed to consumers, must comply with the Therapeutic Goods Advertising Code (s. 42DM).

Division 3 specifies offences in relation to advertisements which do not require approval.

Permission may be obtained to make restricted representations (defined in s.42DD(1)) as a serious form of a disease, condition, ailment or defect specified in a part of the Therapeutic Goods Advertising Code

Division 4 requires generic information about therapeutic goods and ingredients or components of therapeutic goods to comply with principles of the Therapeutic Goods Advertising Code [clauses 4(1), 4(2), 4(3), 4(4), 4(5) and 4(6)] and specifies offences for generic information published about therapeutic goods.

The Regulations

Part 1, Reg.2 defines Complaints Resolution Panel, designated therapeutic goods, Therapeutic Goods Advertising Code.

Division 2 of Part 2 requires approval to be obtained for advertisements for designated therapeutic goods published or inserted for valuable consideration in specified media. Approval may be withdrawn, including upon the recommendation of the Complaints Resolution Panel, (Reg. 5L).

There are several requirements for approval including compliance with the Therapeutic Goods Advertising Code (Reg. 5G).

Division 3 of Part 6 sets out the composition of the Complaints Resolution Panel and subdivision 2 sets out the Panel's procedure for handling complaints.

The Panel handles written complaints that:-

   (i) advertisements about therapeutic goods in specified media contravene subsection 22(5) or s.42C of the Act, the Regulations or the Code;
   (ii) advertisements about therapeutic devices in specified media contravene subsection 41FN(5) of the Act, the Regulations or the Code; and
   (iii) generic information about therapeutic goods or about ingredients or components of therapeutic goods, in specified media contravene clauses 4(1), 4(2), 4(3), 4(4), 4(5) and 4(6) of the Code or breach s.42DP of the Act.

(Reg. 42ZCAB).

The Panel must notify the parties and invite submissions (Reg. 42ZCAC). The Panel may inform itself on any matter as it sees fit and may require the person apparently responsible for the advertisement or generic information to produce evidence in support of a claim made (Reg. 42ZCAE).

A complaint may be withdrawn or treated by the Panel as withdrawn but the Panel may consider its subject matter even if the complaint has been withdrawn (Reg. 42ZCAF and Reg. 42ZCAG). The Panel may deal with matters not specified in the complaint (Reg. 42ZCAH).

If the Panel finds a complaint justified, it may request withdrawal of the advertisement or generic information, withdrawal of a particular claim or representation, publication of a retraction and publication of a correction (Reg. 42ZCAI(1) and (2)).

If its request is not complied with within 14 days, the Panel may make recommendations to the Secretary. These may include withdrawal of approval of an advertisement, withdrawal of a claim(s) or representation(s) from all advertising, cancellation of listing under paragraph 30(2)(e) of the Act, ordering publication of a retraction or correction and ordering recovery and destruction of the material (Reg. 42ZCAI(3) and (4).

On the recommendation of the Panel after it has upheld a complaint, the Secretary may withdraw approval of an advertisement (Reg. 5L), cancel the registration or listing of the goods, order the withdrawal of the advertisement/generic information, order that a particular claim or representation made by the advertisement or generic information be withdrawn from all advertising, and order publication of a retraction or correction, or the recovery or destruction of an advertisement or generic information (Reg.9).

The Panel may not deal with a complaint if court proceedings have begun (Reg. 42ZCAJ).

So far as the Regulations do not provide for its procedure, the Panel may determine its own procedure (Reg. 42ZCAK). The Panel's current procedures are available here.
Once a final determination has been sent to the parties, it is made available to the public and is posted on this website (after removing where requested any personal and confidential information). Previous decisions of the Panel are available here.

It should also be noted that the observer to the Panel appointed by the TGA may be entitled to use any information provided to the Panel (whether confidential or not) pursuant to section 61(8) of the Therapeutic Goods Act.