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Consultation: Proposed therapeutic goods advertising code guidance

13 September 2018

This consultation closed on 4 October 2018.

Due to the short timeframe for finalisation of the Advertising Code guidance, following consultation, we cannot grant any extensions for submissions.

Many stakeholders who made submissions to the April 2018 consultation on the draft Therapeutic Goods Advertising Code 2018 (the Code) called for further consultation on the Code guidelines. Accordingly, the TGA is seeking input from interested parties on the revised version of the guidance to support the Code.

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Consultation documents

Timetable

Documents released for consultation on Thursday, 9 August 2018.

Interested parties should respond by close of business Thursday, 4 October 2018.

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

Once the TGA has considered feedback from this consultation, final amendments will be made to the proposed guidance document. At this stage it is anticipated the final guidance will be published in November 2018.

About the consultation

The purpose of this consultation is to seek stakeholder feedback on the proposed guidance to support the Therapeutic Goods Advertising Code 2018 (the Code). It builds on the 2018 Code consultation which sought comments on the new Code and corresponding draft guidance.

Feedback from the 2018 Code consultation, targeted stakeholder workshops and from the Therapeutic Goods Advertising Code Council has helped inform the development of the proposed Code guidance.

Background

The Code is a legislative instrument made under section 42BAA of the Therapeutic Goods Act 1989 (the Act) by the Minister or their delegate. It is the key advertising compliance standard that sets out minimum requirements and underpins the regulatory framework for the advertising of therapeutic goods to the public.

The 2018 Code was made on 29 June 2018 and takes effect on 1 January 2019. The Code addresses several recommendations from the Expert Review of Medicines and Medical Devices Regulations that were agreed by Government. These include providing increased clarity and objectivity in order to support the new enforcement compliance powers in the Act (Review Recommendation 57) and to improve consistency between the requirements for medicines and medical devices (Review recommendation 54).

Content of submissions

Submissions may address any aspect, or all, of the proposed guidance document.

However, there are a number of aspects of the proposed guidance that we are particularly seeking comments on:

  • Definitions - TGA seeks to limit the duplication of information on its website so as to provide a 'single source of truth'. Rather than duplicating information, hyperlinks can be used to refer readers to other relevant content to achieve the same outcome. This is widely used across the TGA website now. TGA is seeking stakeholder views on making all the definitions provided in Appendix 1 of the proposed Code guidance document available in the TGA website glossary and then linking to relevant terms as needed. This approach would be used instead of providing a definitive list in the guidance itself.
  • World Health Organisation (WHO): Ethical Criteria for Medicinal Drug Promotion 1988 and Quality Use of Medicines (QUM) framework - the introduction of the proposed guidance sets out how the Code has been shaped by the WHO criteria and QUM framework, and provides information on these policies. However, the entire advertising framework, not just the Code, is grounded in these policies. As such, TGA proposes to move the details of these policies to the Australian Regulatory Guidelines for Advertising Therapeutic Goods and include a cross reference in the Code guidance.
  • Reasonable person - TGA received feedback from stakeholders previously that indicated the concept of 'reasonable person', as referenced in the Code, needed defining. However, this was not feasible as the concept of the 'reasonable person' will vary depending on the advertisement concerned. As such, we have proposed guidance around the 'reasonable consumer' and how the profile of the 'reasonable consumer' can change depending on the advertisement concerned.
  • Natural - in response to stakeholder feedback, we have also proposed guidance around the use of 'natural' claims in the advertising of therapeutic goods. TGA considers that therapeutic goods cannot be promoted as entirely natural as all require some degree of processing. However, we recognise that elements of therapeutic goods could be 'natural' or 'naturally derived' and that consumers are entitled to be aware of this. The proposed guidance provides a basis for using such claims.

In addition, submissions might include:

  • Suggested improvements to the proposed guidance, including suggested content and examples.
  • An assessment of how the proposed guidance will impact on you.
  • Suggestions for development of further education and guidance material.

Enquiries

Questions relating to the consultation and submissions should be directed by email to advertising.consultation@tga.gov.au.

What will happen

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

Submissions will be reviewed by the TGA and the guidance will be finalised, taking into account feedback provided, and published for use.

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.