Advertising Consultation Recalls and Advertising Section Office of Prod uct Review Therapeutic Goods Administration PO Box 100 WODEN ACT 2606

email: advertising.consultation@tga.gov.au

Dear Madam/Sir

I'j accord

Accord is pleased to provide comments in relation to the Consultation Regulation Impact Statement; Regulating the advertising of therapeutic goods to the general public (Consultation RIS) .

Accord Australasia, represents the manufacturers and suppliers of formulated products, including: hygiene, cosmetics and specialty products - member products relevant to this inquiry include such products as: personal insect repellants with sunscreens, hand sanitisers, oral hygiene products, sunscreens, disinfectants and specialty commercial products, tampons and devices. These products help safeguard public health and enhance our quality of life. A current members' list is provided.

Accord member products are generally characterised as low risk, fast moving consumer goods at the regulatory interface of either therapeutic and industrial chemicals (including cosmetics) or therapeutic and agricultural and veterinary products. As such, many of these products have a long history of safe use and would not particularly be recognised by consumers as therapeutic goods.

In August 2010, Accord provided a submission in response to the TGA's Consultation Paper on reforms to the regulation of therapeutic goods advertising. Our position at that time was that we supported a self-regulatory system for therapeutic products such as that which operates in New Zealand . If that was not acceptable then our alternative position was that the TGA take full responsibility for the management of advertising arrangements for consurner advertising of therapeutic goods. To date, our position has not changed.

Given that there is now a renewed commitment to a joint agency, we do not understand why the Consultation RIS did not consider adoption of the New Zealand system as one of the options. The objectives for reform include improved tirneliness and simplicity of advertising controls as well as a regulatory framework which adequately manages risks. The New Zealand self-regulatory system is both efficient and effective. There is 100% compliance with decisions of the Complaints and Appeals Boards. The system is timely with an average turnaround time for complaint handling of 25 working days.

Accord provides the following comments to the specific reform proposals:

Proposal 1 Alternatives to the pre-approval scheme.

For our members" products, Accord supports Option 5 to remove the prepublication approval scheme altogether. This would increase the efficiency of an unnecessarily overly complex system as there would be no delays to advertising and remove at least one level of bureaucracy in the system. The 2012 TGA paper; Advertising regulatory framework Options for Reform found that the current pre-approval processes had a number of flaws. Expanding the pre-approval system to cover all forms of advertising and media will not address the flaws in the system, it will only exacerbate them at a greater cost to efficiency. Accord supports the proposed option in that paper which was that:

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Advertisements for therapeutic goods directed at consumers should not require pre-approval but rather, rely on an efficient monitoring system and the deterrent value of appropriate sanctions and penalties for breaches of the advertising requirements.

We believe that this can be done through an appropriate balance of self-regulation backed up by black letter law such as the enhanced sanctions for the TGA as proposed in Proposal 4, Option 2.

Proposal 2: The complaints handling process

Option 2 could include a third option 2(c) which would be a decision maker or decision making body operating under a self-regulatory scheme as in New Zealand. Accord supports a single body handling all complaints. Our preferred option would be for a self-regulatory model for complaint handling.

While not desirable, but acceptable would be for the TGA to handle all complaints as outlined in the 2012 paper:

• Option 4. Establish a Central Complaints Mail Box within the TGA, thereby creating a "one-stop-shop" for submitting all complaints regarding advertisements for therapeutic goods.

• Option 5. Straightforward complaints should be dealt directly by the TGA. • Option 6 Complaints relating to efficacy of listed medicines and complaints about the

evidence to support the intended purpose for a low-risk medical device should be dealt with by the relevant areas of the TGA.

• Option 7 Advertisements that present an unacceptable risk to public health should be dealt with, in an expedited manner, directly by the TGA.

We do not support the current complaints handling mechanisms and agree with the concerns raised regarding timeliness of decision making , consumer confusion as to which body to turn to and inconsistencies with decision making .

Proposal 3: Provision of advice in relation to advertising matters

Under a self-regulatory model we do not believe that the TGA would require an expert body to provide advice to the delegate. However, if the TGA were to take over the function , then Accord would favour Option 2 to establish an independent statutory advisory panel. We do not support the current arrangements of the Complaints Resolution Panel and Therapeutic Goods Advertising Code Council. These bodies have outlived their usefulness and need to be abolished and/or recast to provide a more efficient and effective mechanism of advertising controls.

Proposal 4: Investigation and enforcement powers

Accord supports Option 2. Under a self-regulatory scheme we envisage that the TGA would not need to use these enhanced powers as discussed above. While, we do believe that the penalties should be sufficiently strong to dissuade potential deliberate breaches of the legislation, we do question the level of proposed penalty units which appear to be a significant increase to the current arrangements and in the absence of any discussion , it is unclear as to whether these are proportionate to the offence.

Proposal 5: Advertising of higher risk medical devices

Accord supports Option 1 i.e. maintenance of the status quo. There is a lack of evidence presented in the document which warrants a change to the system. Moreover, the broad scope of products within

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this category is not recognised adequately and there appears to be no understanding of the normal supply chains on which advertising is predicated.

Accord does not have views on Proposals 6 and 7 as these are beyond our remit.

Proposal 8: The Price Information Code of Practice

The TGA price information code of practice currently only applies to prescription medicines and some pharmacy only medicines. The Code does not regulate the provision of price information for medicines that are permitted to be advertised , such as over-the-counter medicines in Schedule 2 of the current Poisons Standard, medicines in Schedule 3 that are in Appendix H of the current Poisons Standard , or medicines that are exempt from scheduling such as therapeutic sunscreens. We would not want the TGA price information code of practice to be extended beyond the current range of prescription medicines and some pharmacy only medicines now or when the TGA and Medsafe are combined under the joint agency to items such as sunscreens and devices.

The contact officer for this matter is who can be contacted on , or by email at should you require any further clarification on the

matters raised.

Yours sincerely

Executive Director

l'~ July 2013

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Members Consumer, Cosmetic and Personal Care

Advanced Skin Technology Pty Ltd Amway of Australia Pty Ltd Apisant Pty Ltd AVON Products Pty Limited Beautiworx Australia Pty Ltd Beautopia Hair & Beauty Pty Ltd Beiersdorf Australia Ltd BrandPoint Pty Ltd Chanel Australia Clorox Australia Pty Ltd Colgate-Palmolive Pty Ltd Com be Asia-Pacific Pty Ltd Cosmax Prestige Brands Australia Pty Ltd Coty Australia Pty Limited De Lorenzo Hair & Cosmetic Research Pty Ltd Elizabeth Arden Australia Emeis Cosmetics Pty Ltd Energizer Australia Pty Ltd Estee Lauder Australia Frostbland Pty Ltd GlaxoSmithKline Consumer Healthcare Helios Health & Beauty Pty Ltd iNova Pharmaceuticals - A Valeant Company Integria Healthcare (Aus) Pty Ltd Johnson & Johnson Pacific KAO Australia Pty Ltd KAO Brands Australia Pty Ltd

Hygiene and Specialty Products Albright & Wilson (Aust) Ltd Antaria Limited Applied Australia Pty Ltd BP Castro I Australia Pty Ltd Brenntag Australia Pty Ltd Castle Chemicals Pty Ltd Chemetali (Australasia) Pty Ltd Clariant (Australia) Pty Ltd Deb Australia Pty Ltd Dominant (Australia) Pty Ltd Ecolab Pty Limited Huntsman Corporation Australia Pty Ltd Jalco Group Pty Limited

'-'accord hygiene. cosmetic & specialty products Industry

Keune Australia Kimberly-Clark Australia La Biosthetique Australia La Prairie Group L'Oreal Australia Pty Ltd LVMH Perfumes and Cosmetics Mary Kay Cosmetics Pty Ltd Natural Australian Kulture Pty Ltd Nutrimetics Australia NYX Pty Ltd Panamex Group Procter & Gamble Australia Pty Ltd PZ Cussons Australia Pty Ltd Reckitt Benckiser Revlon Australia Rusk Australia SC Johnson & Son Pty Ltd Scental Pacific Pty Ltd Shiseido (Australia) Pty Ltd The Heat Group Pty Ltd The Purist Com pany Pty Ltd Three Six Five Pty Ltd T rimex Pty Ltd True Solutions International Pty Limited Ultraceuticals Unilever Australasia Weleda Australia Pty Ltd

Lab 6 Pty Ltd Novozymes Australia Pty Ltd Nowra Chemical Manufacturers Pty Ltd Peerless JAL Pty Ltd Recochem Inc Rohm and Haas Australia Pty Ltd Solvay Interox Pty Ltd Sopura Australia Pty Ltd Tasman Chemicals Pty Ltd Thor Specialties Pty Limited True Blue Chemicals Pty Ltd Univar Australia Pty Ltd Whiteley Corporation Pty Ltd

Accord Australasia Limited

Products for healthy livillg and a quality lifestyle

Associate Members

Corporate Travel Services

Unique Group Travel

Equipment and Packaging Suppliers

HydroNova Australia NZ Pty Ltd

SCHUTZ DSL (Australia) Pty Ltd

Graphic Design and Creative

Ident Pty Ltd

Legal and Business Management

FCB Lawyers

K&L Gates

KPMG

TressCox Lawyers

Regulatory and Technical Consultants

Clare Martin & Associates Pty Ltd

Competitive Advantage

Engel Hellyer & Partners Pty Ltd

Robert Forbes & Associates

Seren Consulting Pty Ltd

Sue Akeroyd & Associates

T oxikos Pty Ltd

Specialist Laboratories and Testing

ams Laboratories

Dermatest Pty Ltd

June 2013

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