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Development of a trans Tasman advertising scheme for therapeutic goods

The Interim Advertising Council process

An Interim Advertising Council (IAC) was established in May 2003 to consider and further develop the recommendations from the Review of Advertising Therapeutic Products in Australia and New Zealand (the Toogoolawa report) that was undertaken in 2002. The Toogoolawa report made a series of recommendations for the development of a trans-Tasman advertising regulatory scheme for therapeutic products.

Membership of the IAC was broad with representation from the following organisations/sectors:

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Stakeholders participated extensively in the consultation process for issues that were considered by the IAC. A series of consultation meetings was conducted with ongoing opportunities for direct comment by stakeholders throughout the project. Three rounds of stakeholder consultation meetings were held in Australia on 1 July 2003, 27 November 2003 and 20 September 2004 and in New Zealand on 3 July 2003, 28 November 2003 and 22 September 2004. The final meeting of the IAC was held in mid-October 2004 at which all of the issues raised at the September consultation meetings and in written submissions from stakeholders were carefully considered by the IAC.

Most of the details of the new advertising regulatory arrangements will be set out in the trans-Tasman Ministerial Council Rules which will implement the advertising model agreed to by the Australian and New Zealand Health Ministers. The draft Rules will be made available for stakeholder comment in 2006 before they are considered by the Therapeutic Products Ministerial Council for adoption for the Australia New Zealand Therapeutic Products Authority.

The Australia New Zealand Therapeutic Products Advertising Code endorsed by the Therapeutic Products Interim Ministerial Council is based on the Advertising Code developed by the IAC and includes the Advertising Key Principles and the Advertising Requirements that must be observed to comply with the Key Principles. It is also intended to assist advertisers and others such as publishers and broadcasters in making appropriate advertising decisions. Practical examples have been included in many instances to support a shared understanding by industry, central complaint bodies, the regulator and pre-approval officers on how the Requirements included in the draft Advertising Code are to be interpreted.

It should be noted that the Advertising Code endorsed by the Therapeutic Products Interim Ministerial Council is slightly different to the Code proposed by the IAC. It is expected that the Advertising Code will continue to evolve during the implementation period for the new regulatory scheme. The most "reader friendly" format for the Code will be considered after the decision is made on the regulatory model. One option would be to have a two-column format with the prescriptive elements of the Code in one column and any relevant interpretations / examples / notes in the other column.

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Consultancy reports

In considering the effectiveness of the current advertising approvals system in Australia and the suitability of the media based dividing line for approvals of advertisements of medicines, the IAC recommended to the TGA and Medsafe that a project be commissioned to collect and analyse relevant data and report back to the IAC.

The objective of this project was to report on whether the rate of advertisements for medicines in Australia which complied with the Therapeutic Goods Advertising Code was noticably different between advertisements which were approved (ie those published in mainstream media or broadcast media) and those advertisements which did not require approval (ie those published in other media).

The TGA engaged the services of Dr Deon Schoombie (in association with Oceania Health Consulting) to undertake this project. The report this project was considered at the meeting of the IAC in early August 2004 and is included below.

Next steps

As recommended by the IAC, an implementation steering group is to be established to over-sight the activities required to implement the new regulatory model for advertising in both countries. It is expected that the membership of this group will be confirmed in early 2006, following a call for nominations from relevant bodies in Australia and New Zealand.

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Interim Advertising Council ratified minutes

Consultation Meeting minutes

Advertising Implementation Steering Group minutes

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