Consultation: Complaints handling - Advertising therapeutic goods to the public

2 May 2018

This consultation closed on 4 June 2018.

The TGA sought comments from interested parties and the views of stakeholders on our proposed advertising complaints handling model.

Consultation documents

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Timetable

Document released for consultation on Wednesday, 2 May 2018.

Interested parties should respond by close of business Monday, 4 June 2018.

Feedback will be released following consideration of submissions. (See 'What will happen').

About the consultation

As the single agency for therapeutic goods advertising complaints management from 1 July 2018 the TGA is undertaking this public consultation to seek stakeholder's views on our proposed complaints handling model and approach. The public consultation paper outlines our proposed model of advertising complaints handling which aligns with best practice models of complaints handling by comparative Commonwealth regulators. This complaint handling model is intended to ensure that non-compliance remedies are appropriate, proportionate, timely and consistent with contemporary practice.

Background

The Australian Government's response to the Expert Panel's Review of the regulation of medicines and medical devices was released on 15 September 2016. Specific recommendations were made about broadening enforcement powers to benefit consumers through appropriate compliance with advertising regulatory requirements, and to deter inappropriate and misleading advertising of therapeutic goods.

These broadened powers and revised sanctions were included in the Therapeutic Goods Amendment (2017 Measures No. 1) Act 2018 which was enacted on 5 March 2018.

The Government has decided to make the TGA the single body responsible for the handling of complaints about the advertising of therapeutic goods to the public from 1 July 2018. To progress implementation the TGA is now consulting with stakeholders on the design of the new complaints-management process.

Content of submissions

Submissions may address any, or all, of the proposed advertising complaints handling model and approach or other identified issues.

In addition, submissions might include:

  • Suggested improvements
  • An assessment of how the proposed change will impact on you.

Enquiries

Any questions relating to submissions should be directed by email to or by telephone to 02 6232 8737.

What will happen

All submissions will be placed on this website unless marked confidential or indicated otherwise in the submission form (see Privacy information).

Submissions will be reviewed by the TGA and feedback on submissions will be provided through this website.

Recommendations made by the TGA following consideration of submissions from interested parties will be incorporated into the complaints handling policy. The final policy will be published on the TGA website.

Privacy information

  • The TGA collects your personal information in this submission in order to:
    • contact you if the TGA wants to seek clarification of issues raised in your submission or to check whether you consent to certain information that you have provided being made publicly available.
    • help provide context about your submission (e.g. to determine whether you are an individual or a director of a company or representing an interest group).
    • seek feedback about how the consultation was undertaken.
  • Please do not include personal information about other individuals in the body of your submission. Personal information in this context means information or an opinion about an individual whose identity is apparent, or can reasonably be ascertained, from the information or opinion.
  • More information on consultations and privacy is included in the submission form and on our website.