Regulation of Advertising of Therapeutic Goods

Regulation of Advertising of Therapeutic Goods

Regulation of Advertising of Therapeutic Goods

The advertising of therapeutic goods to consumers and health professionals is administered via a co-regulatory system which is representative of all key stakeholder groups, namely consumers, health professionals, the regulated industry sectors, the media, advertisers and government.

Advertisements for therapeutic goods are subject to the requirements of the Therapeutic Goods Act 1989 (the Act) and Regulations, the Competition and Consumer Act 2010 and other relevant laws. Additionally, advertisements for therapeutic goods directed to consumers must comply with the Therapeutic Goods Advertising Code (the Code).

The object of the Code is to ensure that the marketing and advertising of therapeutic goods to consumers is conducted in a socially responsible manner that promotes the quality use of therapeutic goods and does not mislead or deceive the consumer.

The Therapeutic Goods Advertising Code Council is responsible for the currency of the Code while Therapeutic Goods Administration administers the Code.

The Therapeutic Goods Advertising Code Council (TGACC) is comprised of representatives from all key stakeholder groups and is established under the Regulations. Specifically, the role of the TGACC includes considering the advertising requirements for therapeutic goods, considering amendments to the Code and making recommendations to the Australian Government Minister for Health and Ageing.

Advertisement relating to a non-prescription medicine

  • Non-prescription medicines are over-the-counter (OTC) medicines and non-prescription complementary medicines.
  • Generally, advertisements for non-prescription medicines may be directed both to consumers and to health professionals. However, the Regulations prohibit the advertising to consumers of certain medicines included in Schedule 3 of the current Poisons Standard (pharmacist-only medicines).
  • Advertisements for non-prescription medicines are regulated by both co-regulatory and self-regulatory arrangements operated by the TGA under the Act and Regulations, the Therapeutic Goods Advertising Code Council (TGACC), the Australian Self-Medication Industry (ASMI) and the Complementary Healthcare Council (CHC).
  • Certain types of advertisements directed at consumers require prior approval by a Delegate of the Secretary of the Department of Health and Ageing.

Approval processes for direct-to-consumer advertising of non-prescription medicines

Prior approval is required for certain types of advertisements and generic information advertised directly to consumers, specifically:

  • Broadcast media – TV and radio
  • Print media – newspapers & magazines (including inserts)
  • Outdoors – including billboards, bus shelters, sides & interiors of buses, taxi displays
  • Cinema films

The Secretary of the Department of Health and Ageing or his/her delegate is responsible for approving advertisements. Under co-regulatory arrangements, this responsibility has been delegated to industry associations:

  • ASMI: all advertisements to be broadcast in broadcast media and advertisements for OTC medicines appearing outdoors or in print media (newspapers & magazines); and
  • CHC: advertisements for complementary medicines appearing outdoors or in print media (newspapers & magazines).

These industry associations represent sponsors and manufacturers of non-prescription (over-the-counter and complementary) medicines.

Complaints handling processes for advertising of non-prescription medicines

Complaints about direct-to-consumer advertising in specified media such as television or radio, newspapers, consumer magazines, billboards and cinema films or the Internet are considered by the Complaints Resolution Panel, a body established in the Therapeutic Goods Regulations.

The TGA reserves the right to intervene or investigate in matters where the breaches in advertising are of a serious nature, especially where consumer safety is a concern.

Complaints about direct-to-consumer advertising that appear in other media such as leaflets, flyers, brochures, catalogues or letterbox drops or advertising to health professionals are handled by the relevant industry association under their codes of practice. Typically these fall under the ASMI Code of Practice and CHC Code of Practice for the Marketing of Complementary Healthcare Products.

Complaints about advertising of non-prescription medicines should be made to:

  • Complaints Resolution Panel (for advertisements where prior approval is required);
  • Industry associations (for other advertisements)
  • TGA if advertiser is a non-member, a retailer or a distributor

In Summary

  • It could appear to be a non-prescription medicine, but could be a complementary medicine
  • If the advertisement was on the radio, it would have required prior approval
  • Advertising is required to be in accordance with the intended use, as described in the entry on the Australian Register of Therapeutic Goods, and should be in accordance with the Therapeutic Goods Advertising Code
  • A complaint may be lodged with the Complaints Resolution Panel.

More details are on the TGA website.

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