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TGA News Issue 49 (March 2006)

Note: The information in this issue of TGA News may no longer be current. Please check with the TGA before relying on the information on these web pages.

Joint regulatory model for the advertising of therapeutic products

Agreement has been reached between Australia and New Zealand on a regulatory model for the advertising of therapeutic products which will apply in both countries on commencement of the Australia New Zealand Therapeutic Products Authority.

Appropriate controls on the advertising of therapeutic products, which will deliver a balance between the benefits of consumer access to accurate and balanced information and the freedom of speech against the potential for harm from the inappropriate use of medicines and medical devices, are recognised as being an important element of the trans-Tasman arrangements. In implementing a joint regulatory model, it is expected that there will be overall benefits to the community, and especially industry, because there will be a single set of regulatory requirements for the advertising of therapeutic products, including a single advertising code which will apply in both markets.

The co-regulatory model builds on the best elements of the existing regulatory schemes in Australia and New Zealand and is substantially based on the model recommended by the Interim Advertising Council (IAC). The IAC represented a wide range of stakeholders in Australia and New Zealand including the therapeutic products industry, the media and advertising industries, consumers, healthcare practitioners and the regulators.

Work will now commence in both countries to ensure that the new arrangements are in place when the Authority begins. The Therapeutic Products Interim Ministerial Council has agreed that, as a co-regulatory model, the new advertising scheme should be implemented with the oversight of a stakeholder steering group (including representatives of the therapeutic products, advertising and media industries, consumers, prescribers and dispensers in Australia and New Zealand) to assist in a smooth transition. It is expected that further stakeholder consultation may be required during the implementation period to finalise some of the outstanding details of the regulatory model, including the guidelines to the new Australia New Zealand Therapeutic Products Advertising Code.

Details of the joint regulatory model for the advertising of therapeutic products <http://www.anztpa.org/advert/advmodel.htm> are available on the ANZTPA Internet site.