Independent review of the reforms to the therapeutic goods advertising framework to commence

The independent review of the advertising reforms (the Review) has now commenced, and is being led by Ms Rosemary Sinclair AM. In February 2018, the Hon Greg Hunt MP, Minister for Health, committed to a review of the impact of the new advertising measures within two years from the commencement of the Therapeutic Goods Amendment (2017 Measures No.1) Act 2018.

Terms of Reference

The Review will assess the impact of the:

1. new advertising measures as included in the Act, in particular, the effectiveness of:
   1. the amendments to the Code, i.e. whether they have increased clarity and objectivity to support the compliance and enforcement powers in the Act and improved consistency between the requirements for medicines and medical devices;
   2. the TGA as the single body responsible for implementing a complaints management process about the advertising of therapeutic goods to the public; and
   3. broadened sanctions and penalties to deter inappropriate and misleading advertising of therapeutic goods.
2. other initiatives announced by the Minister in February 2018, namely:
   1. a comprehensive industry and consumer education program of the new advertising measures;
   2. public performance measures for advertising complaints management, i.e. an assessment of the suitability of the TGA's key performance indicators for managing advertising complaints; and
   3. stakeholder engagement activities on therapeutic goods advertising with a particular focus on the effectiveness of the Therapeutic Goods Advertising Consultative Committee.

The Review may also advise on whether further changes to the management of the regulation of therapeutic goods advertising, including complaints, are required.

The Review will not consider the Government's decision, implemented through legislative change in 2018, to remove pre-approval for advertisements of medicines that appear in specified media from 1 July 2020. Nor will it consider the legislation other than in the context of its operational impact on the new advertising measures.

Consultation process

The Review will involve consulting with representative members of the Therapeutic Goods Advertising Consultative Committee (TGACC). Consultations with TGACC members will commence shortly. If you wish to make your views about any matters within the terms of reference known to the Review, please contact one of the organisations represented on the TGACC.