Complaints Register

COMPLAINTS RESOLUTION PANEL DETERMINATION

Complaint 2009-12-020 Dermatix Silicone Gel

Meeting held 17 June 2010

1.      The complaint concerned a print advertisement published in Post Script magazine.

2.      The advertisement included an offer of a prize of “a $750 Dermatix Summer Shopping Spree”, and urged pharmacy assistants to “recommend Dermatix to improve the appearance of old and new scars”. It included claims of benefits including “improve[ing] the appearance of old and new raised (hypertrophic and keloid) scars on the face and body”, and words such as “proven, in clinical trials, to reduce itching, discomfort, discoloration (redness/pigmentation) associated with raised scars”, and many other claims.

3.      An excerpt of the advertisement can be viewed in the relevant Appendix to this determination.

4.      The advertisement promoted the product Dermatix Silicone Gel.

5.      The advertiser was Valeant Pharmaceuticals Australasia Pty Ltd.

6.      The complainant requested anonymity but acknowledged representing a commercial competitor of the advertiser.

7.      The complainant expressed the following concerns about the advertisement:

a)      That it breached section 4(3) of the Code by offering an incentive to pharmacy assistants to promote the advertised product;

b)      That it breached section 6(3)(d) of the Code by failing to include words to the effect of “if symptoms persist, see your doctor/healthcare professional”; and,

c)      That it breached section 4(4) of the Code.

8.      The Panel decided not to give consideration to the part of the complaint alleging a breach of section 4(4) of the Code. The Panel was of the view that the complainant, who acknowledged representing a commercial competitor of the advertiser, had not provided a clear argument and clear supporting evidence to support this aspect of the complaint.

9.      The advertiser argued that, since entry into the competition was not dependent on a recommendation or supply of the advertised product, the competition could not be regarded as offering any personal incentive for doing so.

10.  The advertiser argued that the warning “if symptoms persist, see your doctor/healthcare professional” is required under section 6(3)(d) of the Code only for advertisements containing “claims relating to symptoms of diseases or conditions”, and that the advertisement contained no such claims.

11.  The advertiser also provided a response in relation to the alleged breach of section 4(4) of the Code. However, as the Panel decided not to consider that aspect of the complaint, the response is not summarised here.

12.  Section 4(3) of the Code states that advertisements for therapeutic goods must not offer any personal incentive to a pharmacy assistant, or other non-healthcare professional sales person at retail, to recommend or supply therapeutic goods.

13.  The Panel was satisfied that the entry into the competition described in the advertisement was not contingent on any recommendation or supply, but rather involved answering questions about the advertised therapeutic goods.

14.  This aspect of the complaint was therefore not justified.

15.  Section 6(3)(d) of the Code requires advertisements to include the warning “if symptoms persist, see your doctor/healthcare professional”, if they include claims relating to symptoms of diseases or conditions.

16.  The Panel was satisfied that references to “itching, discomfort, and discoloration (redness/pigmentation) associated with raised scars” constituted claims relating to symptoms of diseases or conditions, and brought the advertisement within the scope of this part of section 6(3)(d) of the Code. The advertisement therefore ought to have included the warning.

17.  This aspect of the complaint was therefore justified.

18.  The Panel requests Valeant Pharmaceuticals Australasia Pty Ltd, in accordance with subregulation 42ZCAI(1) of the Therapeutic Goods Regulations 1990:

a)      to withdraw the advertisement from further publication until the required warning is included in it; and,

b)      within 14 days of being notified of this request, to provide evidence to the Panel of its compliance, including a response in writing that they will comply with the Panel’s sanctions, and where appropriate, supporting material such as copies of instructions to advertising agents or publishers, or correspondence with retailers and other third party advertisers.

19.  The advertiser’s attention is drawn to the provisions of sub-regulations 42ZCAI(3) and (4) which permit the Panel to make recommendations to the Secretary in the event of non-compliance with this request, including a recommendation that the inclusion of the goods on the Register be cancelled.

Dated 27 August 2010

For the Panel

Jason Korke

Chairman

In this determination, unless otherwise specified:

a)      “the Act” means the Therapeutic Goods Act 1989;

b)      “the Regulations” means the Therapeutic Goods Regulations 1990;

c)      “the Code” means the Therapeutic Goods Advertising Code;

d)     “the Register” means the Australian Register of Therapeutic Goods;

e)      “any other advertisement” appearing in sub-regulation 42ZCA1(1)(d) is not confined to advertisements in specified or broadcast media (in relation to which complaints may be made to the Panel under Regulation 42ZCAB).

*Under regulation 42ZCAI of the Regulations, the Panel may request that a representation not be used in any other advertisement unless the advertiser satisfies the Panel that the use of the representation would not result in a contravention of the Therapeutic Goods Act 1989, the Therapeutic Goods Regulations 1990 or the Therapeutic Goods Advertising Code. Under the Panel’s procedures, the Panel will not ordinarily give additional consideration to such a matter unless significant new material that was not available at the time of the Panel’s determination has become available, or until at least 12 months have passed since the Panel’s request was made.