Proposed improvements to the Therapeutic Goods Advertising Code

Closed 18 Jun 2021

Opened 7 May 2021

Feedback updated 27 Aug 2021

We asked

We asked for feedback on proposals for improving the Therapeutic Goods Advertising Code (No.2) 2018 (the Code). The proposals included changes to provisions of the Code that had been identified as being unclear, inconsistent, or otherwise difficult to work with. The proposals were designed to improve advertising compliance, minimise advertising compliance costs, and ensure Code provisions work as intended.

We canvassed stakeholder preferences for different options for some provisions. We also invited stakeholders to identify other areas where the Code could be improved.

You said

We received 67 submissions in response to the consultation, including from sponsors, manufacturers, advertisers, marketers and sellers of therapeutic goods, peak industry bodies and associations, regulatory affairs firms, policy advocates, and health professional and consumer organisations. There was broad support for amending the Code to reduce complexity and increase clarity for users. Stakeholders also advocated for a review of current guidance on the Code to ensure it remains contemporary and easily accessible.

On some proposals, there were widely divergent views:

  • There was broad support for clarifying the requirements around claims in advertising, including ‘therapeutic’ and ‘non-therapeutic’ claims, and the evidence requirements for each. But there was a divergence of views as to whether this should be done in the Code, or in guidance.
  • The proposal to strengthen the rules around the use of language and images in advertising that may invoke a sense of fear or distress in consumers also produced a range of views.
  • Stakeholder views about who should and who should not be allowed to make product endorsements and testimonials for use in advertising were widely divergent.
  • There was also a range of views around the rules relating to advertising involving the offer or provision of free samples of goods, and the criteria that should apply when determining what types of goods should be exempted from any general restrictions on this practice.

However, stakeholders broadly supported the introduction of alternative mandatory statements in advertisements for typically ‘non-consumer’ therapeutic goods. Many stakeholders also indicated they wanted simpler rules around the use of existing mandatory statements and health warnings in advertisements.

Thank you to everyone who provided feedback.

We did

In response to this feedback, we have decided to re-write the Code using a simplified structure and plainer language. We will also ensure the guidance on the Code is more accessible and user-friendly.

On specific Code issues, we are reflecting on feedback and undertaking further targeted consultations with members of the Therapeutic Goods Advertising Consultative Committee.

We aim to prepare and publish the new Code by the end of 2021. Please subscribe to the TGA Advertising email list to be notified of progress.

Published responses

View submitted responses where consent has been given to publish the response.

Overview

The Therapeutic Goods Administration (TGA) is seeking feedback on options to improve the Therapeutic Goods Advertising Code (No.2) 2018 (the Code). The Code is the compliance standard that prescribes the minimum requirements for the lawful advertising of therapeutic goods to the general public in Australia.

The proposed improvements are aimed at increasing advertisers’ understanding of the requirements of the Code, ensuring provisions work as intended, and improving advertising compliance. The proposed improvements consider the need to minimise unnecessary compliance costs while continuing to ensure that advertising does not contribute to any unsafe or improper use of advertised products.

Consultation Paper

The consultation paper provides details about proposed improvements to the Code and poses questions to guide responses to the consultation.

Consultation paper – Proposed improvements to the Therapeutic Goods Advertising Code

Why your views matter

The Code is an important instrument for a range of stakeholders including advertisers, manufacturers, suppliers and retailers; relevant industry associations; health professionals and peak bodies; and consumers and consumer representative groups. The TGA has listened to stakeholder concerns about aspects of the current Code. With the potential for serious consequences for non-compliance, it is important that the Code is contemporary and clear. Stakeholder feedback on the options presented here will assist the TGA with improving the Code.

Consultation Scope

In this consultation paper we have proposed different mechanisms for improving the Code. For some provisions we have proposed minor wording changes and the addition of new definitions and notes to improve clarity. For others, we are seeking feedback on options for combining provisions and other more significant changes.

Audiences

  • Aboriginal and Torres Strait Islander People
  • Seniors
  • Men
  • Women
  • Carers and guardians
  • Families
  • Parents
  • Young people
  • Academics
  • Non-government organisations
  • State government agencies
  • Health professionals
  • Health workforce
  • General public
  • Community groups
  • Businesses
  • Contracted Service Providers
  • Aged care service providers
  • Aged care workforce
  • Aged care professionals
  • Complementary medicines
  • Over-the-counter medicines
  • Medical Devices & IVDs

Interests

  • Hospitals
  • e-Health
  • Health technology
  • Medicare
  • Legislation
  • Pharmaceutical benefits
  • Health insurance
  • Rural health services
  • Regulatory policy
  • Women's health
  • Children's health
  • Learning and development
  • Dementia
  • Home Care
  • Aged Care
  • Residential Aged Care
  • Short-Term Restorative Care
  • Chronic disease
  • Communicable diseases
  • Mental health
  • Drugs and substance abuse
  • Aboriginal and Torres Strait Islander health
  • Preventative health
  • Dental health
  • Non-prescription medicines
  • Strategic Policy