Description of the joint regulatory scheme for the advertising of therapeutic products
December 2005
Recognising that the advertising of therapeutic products is an important element of the trans-Tasman arrangements, the Australian and New Zealand governments have agreed to take a shared approach to the regulatory arrangements for advertising in both countries.
The document below (Attachment A) provides a general description of the joint regulatory scheme for the advertising of therapeutic products (including the Australia New Zealand Therapeutic Products Advertising Code - Attachment B) which has been approved by the Australian and New Zealand Health Ministers and will be administered by the Australia New Zealand Therapeutic Products Authority.
The advertising regulatory model is substantially based on the report of the Interim Advertising Council (IAC) (Attachment C1) (which included broad membership of all key stakeholder groups) which was established by TGA and Medsafe in 2003 to develop a proposal for a trans-Tasman therapeutic products regulatory advertising scheme. Stakeholders participated extensively in the consultation process in both Australia and New Zealand on issues that were considered by the IAC (Attachment C2). The key differences between the model recommended by the IAC and the model approved by the Australian and New Zealand Health Ministers are described at Attachment D.
The IAC report highlights the different approaches currently taken to direct-to-consumer advertising of prescription medicines (DTCA) by New Zealand and Australia. That is, in Australia DTCA is prohibited and in New Zealand it is not. In light of previous statements made by the previous New Zealand Minister of Health around harmonisation with Australia’s policy on DTCA and disease-state advertising, it should be noted that further consultation on DTCA in New Zealand is intended to be undertaken in the New Year.
The Australian and New Zealand Health Ministers have agreed that as a co-regulatory model, the new advertising scheme should be implemented with the over-sight of a stakeholder steering group (including representatives of the therapeutic products, advertising, media industries, consumers, prescribers and dispensers in Australia and New Zealand). 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 Australia New Zealand Therapeutic Products Advertising Code. It should therefore be noted that the Code remains a "living" document and details may be added as they are finalised through the implementation steering group (including its application to sterilants) and based on experience in the future.
Where the regulatory model recommended by the IAC is consistent with the model approved by Health Ministers, it is intended that the IAC recommendations be implemented in so far as possible. Should it become clear during the implementation phase that there are impediments to implementing any aspects of the model in the way envisaged in the IAC report (such as legal issues), other options will be investigated to achieve a similar outcome.
- Attachment A - Description of the Joint Regulatory Scheme for the Advertising of Therapeutic Products (pdf, 93kb)
- Attachment B - Australia New Zealand Therapeutic Products Advertising Code (pdf, 153kb)
- Attachment C1 - Report of the Interim Advertising Council (pdf, 646kb)
- Attachment C2 - The IAC process, including archived minutes from IAC meetings and stakeholder consultation
- Attachment D – Key differences between the IAC recommended model and the approved regulatory model (pdf, 45kb)