he Therapeutic Products Advertising Complaints Resolution Panel has requested that Chemist Warehouse formally retract "health information" web pages that were found to contravene Australia's Therapeutic Goods Advertising Code. This article outlines the panel's findings, examines the measures that can be taken by the Department of Health to enforce those findings and outlines the avenues available for challenging decisions made in respect of advertisements for therapeutic goods in Australia.

The "health information" advertising complaint against Chemist Warehouse

An anonymous complaint1 was lodged with the Therapeutic Products Advertising Complaints Resolution Panel (Panel) alleging that a number of pages on Chemist Warehouse's website were required to comply with the Therapeutic Goods Advertising Code (Code) and did not do so.

The web pages complained of purported to provide information and general advice in relation to various health conditions including breast cancer, diabetes, stroke and hepatitis and included central sections headed "pharmacist's advice" and "vitamins/minerals/herbals". Each of the pages were also flanked by one or more advertisements for or links to branded vitamin products that Chemist Warehouse was offering for sale.

An example of the web pages complained about is set out below2:

Click here to view image.

Were Chemist Warehouse's web pages "advertisements" that were covered by the TGA's advertising code?

Chemist Warehouse argued that the web pages complained of were analogous to a newspaper that contained news articles as well as advertisements on the same page and that each web page was not, as the complainant argued, an "advertisement" to which the Code applied.3

The Panel:

  1. explained that an "advertisement" was defined in the Code (and theTherapeutic Goods Act 1989 (Cth) (TG Act)) to include "any statement, pictorial representation or design, however made, that is intended, whether directly or indirectly, to promote the use or supply of [therapeutic] goods";
  2. considered that Chemist Warehouse's web pages fell squarely within that broad definition because: "a reasonable consumer, in looking at the whole page, would associate the content of the central section, particularly in light of the sub-section headed "vitamins/herbals/minerals", with the advertisements on each side"; and
  3. concluded that the Code applied to Chemist Warehouse's web pages.

The Panel went on to find that the advertisements did not comply with the Code in a number of respects, including because they:

  1. contained representations that were expressly prohibited by the Code, including representations related to the treatment, cure or prevention of cancer and mental illness and representations relating to other serious forms of diseases and conditions;4
  2. were likely to lead consumers into inappropriately treating potentially serious diseases;5 and
  3. inappropriately represented that they were endorsed by healthcare professionals (especially in light of the section on the web pages headed "Pharmacist's Advice").6

Sanctions against Chemist Warehouse

Having found that the complaint was justified in the circumstances, the Panel relevantly asked Chemist Warehouse to withdraw the advertisements and publish a retraction in place of those advertisements on its website.

Chemist Warehouse has not yet published the retraction and is reportedly7 refusing to do so.

The TGA's enforcement powers

Whilst the Panel may only "request" that certain steps be taken to address non-compliant therapeutic advertising,8 it is permitted to make enforcement recommendations to the Secretary of the Department of Health and may, where appropriate, refer the matter to other regulatory bodies9 (such as the Australian Competition and Consumer Commission, in the case of false or misleading therapeutic advertisements).10

Regulation 9 of the Therapeutic Goods Regulations 1990 (Cth) (TG Regulations) gives the Secretary power to make orders that an advertiser (amongst other things) withdraw a non-complaint advertisement and / or publish a retraction. Any orders made by the Secretary are also published on the TGA's website, thereby attracting adverse publicity for the advertiser.

Whilst the current regulatory framework does not expressly provide for sanctions against advertisers who fail to comply with the Secretary's orders11, the Secretary does have power to issue infringement notices requiring an advertiser to pay a fine and, in extreme cases, an uncooperative advertiser could possibly be prosecuted under section 42DM of the TG Act, which makes it a criminal offence for a person to publish advertising that does not comply with the Code.

It remains to be seen if the Panel will make recommendations to the Secretary, the ACCC or some other regulatory body in this case.

Review of TGA advertising decisions

A person whose interests are affected by a regulation 9 order made by the Secretary may:

  1. apply to the Minister of Health for a of review the Secretary's decision "on the merits"12; and / or
  2. seek judicial review of the decision by the Federal Court of Australia under the Administrative Decisions (Judicial  ReviewAct 1977 (Cth) (which would be confined to an assessment of the legality of the Secretary's decision (i.e. whether the Secretary made the decision in accordance with law and followed the correct procedure)).

An application may also be made to the Administrative Appeals Tribunal for review of a decision made by the Minister following an application referred to in (a) above.

Reminders for advertisers of therapeutic goods

  • There is a comprehensive regulatory framework for therapeutic product advertising in Australia, which includes the TG Act and its associated regulations, the Code and the Australian Consumer Law.
  • It is a criminal offence to publish advertising that does not comply with the Code and the consequences of publishing non-compliant advertising can be serious.
  • A person whose interests are affected by an adverse decision made by the Secretary in relation to advertisements for therapeutic goods may explore a number of avenues of appeal or review.