Consultation: The regulatory framework for advertising therapeutic goods - November 2016

9 November 2016

This consultation closed on 21 December 2016.

Invitation to comment

The TGA sought comments from interested parties on the appropriate body or bodies for the handling of complaints under a new complaints-management system for therapeutic goods advertisements directed to the public and other recommended reforms to the advertising regulatory framework.

Consultation documents

How to access a pdf or Word document

Timetable

Document released for consultation on Wednesday, 9 November 2016.

Interested parties responded by close of business Wednesday, 21 December 2016.

About the consultation

The Government has agreed to simplify the processes by which the advertising of therapeutic goods to the public is regulated. This includes the process for managing complaints about therapeutic goods advertisements directed to the public.

The purpose of this consultation was to provide an opportunity for interested parties to provide their views on the appropriate body or bodies for the handling of complaints under the design of a new centralised advertising complaints management-process and other recommended reforms to the advertising regulatory framework.

That is, the preferred design of the new advertising complaints handling process and whether it should be performed by the TGA, another Commonwealth agency or outsourced to an external service provider.

Update

The Government has decided that the TGA will assume responsibility for handling all complaints about therapeutic goods advertisements directed to the public from 1 July 2018 and that this model will be independently reviewed after three years of operation to determine whether it is the most effective solution.

Submissions received in response to the consultation

All submissions have been published at Submissions received in response to: Consultation: The regulatory framework for advertising therapeutic goods - November 2016 unless marked confidential or indicated otherwise in the submission form (see Privacy information).

Submissions received will continue to inform the implementation of the Government's response to the specific advertising recommendations set out in the Review of Medicines and Medical Device Regulation.

The TGA thanks those who took the time to make a submission and to make comments and suggestions.

Next steps

The TGA will continue to focus its attention on the successful implementation of the Review advertising recommendations.

A consultation on the Therapeutic Goods Advertising Code is anticipated to commence in August 2017.

Subject to the passage of legislation and approval of new regulations where Parliamentary approvals are required, the TGA is working towards having all of the Review advertising recommendations implemented by 1 July 2018.

Further information will be provided as it becomes available.

Background

In October 2014 the establishment of the Expert Review of Medicines and Medical Devices Regulation was announced.

The Expert Panel delivered two reports that assessed the regulatory framework for medicines and medical devices in Australia, and made 58 recommendations for reform.

In its second report, the Panel made seven specific recommendations in relation to advertising of therapeutic goods to the public (Recommendations 52-58).

The Panel's recommendations aim to simplify the advertising regulatory framework by:

  • ceasing pre-approval of advertisements in favour of a more self-regulatory regime;
  • implementing a more transparent and efficient complaints management process;
  • establishing greater consistency across regulation of advertising of different types of therapeutic goods;
  • implementing a formal education program for industry to encourage compliance; and
  • broadening and enhancing the Therapeutic Goods Administration's investigation and enforcement powers.

The Australian Government accepted the Review's specific advertising Recommendations (see the Government's response). In relation to recommendation 56 of the Review, the Government agreed that the current mechanisms for managing complaints about therapeutic goods advertising should be disbanded and a new mechanism established with a single agency responsible for receiving and managing complaints. To progress this recommendation the Government also agreed that the Department of Health will consult with stakeholders on the appropriate design of the new complaints management process noting that the function could be established within the Therapeutic Goods Administration (TGA), another Commonwealth agency or an external organisation.

Content of submissions

Submissions may address any, or all, of the specific Review recommendations to reform the advertising regulatory framework (Recommendations 52-58).

In addition, submissions might include:

  • Suggested improvements
  • An assessment of how the recommended change will impact on you.
  • What do you see as the likely benefits or costs to you (these may be financial or non-financial). If possible, please attempt to quantify these costs and benefits.

Enquiries

Any questions relating to submissions should be directed by email to or by telephone to 02 6232 8757.

Privacy information

  • The TGA collected 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.
  • More information on consultations and privacy is on our website.