Therapeutic goods advertising changes: Update 5 October 2018

5 October 2018

TGA is reminding advertisers that the Therapeutic Goods Advertising Code 2018 (the 2018 Code) takes effect on 1 January 2019. We'd like to provide this important information in the lead up to this change.

Therapeutic goods advertising code guidance

The consultation on the proposed therapeutic goods advertising code guidance has now closed. We thank all those individuals and organisations that took the time to consider the proposed guidance and lodge a submission.

The submissions are being assessed in order to finalise and publish the revised guidance at the end of October 2018.

Improvements to the Therapeutic Goods Advertising Code 2018

Throughout the consultation period on the code guidance we have continued to engage with stakeholders on the Therapeutic Goods Advertising Code 2018, made on 29 June 2018 and to take effect from 1 January 2019.

As a result a number of opportunities to improve the 2018 Code have been identified to provide advertisers with the clarity they need to apply the code correctly. These improvements (described below) are expected to be in place in November.

The precise terms of the amendments to the 2018 Code to give effect to these improvements will be finalised in consultation with our drafters. The guidance will reflect any revisions to the 2018 Code.

We don't anticipate that the proposed improvements will cause inconvenience to advertisers who have already prepared advertising based on the 2018 Code as made on 29 June 2018.

Definition of 'health warning'

The definition of 'health warning' in section 4 will be modified to ensure it only captures those statements critical to the consumer's assessment of the advertised product. For over-the-counter medicines, this will be achieved by specifying, in a schedule to the code, the applicable health warnings.

Further consideration is being given to the arrangements for any health warnings for complementary medicines and medical devices.

The 2018 Code allows for the use of the statement 'THIS MEDICINE MAY NOT BE RIGHT FOR YOU. READ THE LABEL BEFORE PURCHASE' (and similar statements for other types of therapeutic goods) as an alternative to the inclusion of the applicable health warnings. These options will be retained.

Prominently displayed or communicated

The definition of 'prominently displayed and communicated' in section 4 of the 2018 Code will be clarified to exclude both the trade name of the good and its short purpose from being the comparator 'most noticeable representation or statement in the advertisement' against which the required statement is judged. Guidance and education will include clear examples of statements that meet or exceed the requirement to be 'prominently displayed or communicated'.

Required information and statements

Sections 11, 12, 13 and 14 will be revised to clarify the situations in which each applies (this may also involve reordering). This includes clarifying that the advertising of Schedule 3 medicines is only required to include the statement "ASK YOUR PHARMACIST—THEY MUST DECIDE IF THIS PRODUCT IS RIGHT FOR YOU" and not the statements specified in sections 11, 12 and 13.

Inconsistency with public health campaigns

Sections 5 and 21 of the 2018 Code will be amended to clarify that only those public health campaigns of which the advertiser could reasonably be expected to be aware will be relevant to compliance with these provisions.

This reflects our expectation in practice that advertisers should not need to be aware of isolated public health campaigns (e.g. conducted by an individual local council) to ensure compliance with this aspect of the 2018 Code.

Scientific representations

Subsection 15(3) of the 2018 Code will be amended to clarify the information that needs to be included in advertising that contains a citation to scientific literature.

The 2018 Code guidance will also be updated to explain what is meant by the reference in this section to 'implied' citations. For example, a reference to 'claims being clinically proven' implicitly makes a citation to scientific literature; in this case, the research results must identify the researcher and the financial sponsor. A statement of the duration of the therapeutic use of the good, for example, that it works for up to 8 hours, makes no citation because there is no explicit or implicit mention of the existence of scientific literature in support of the claim. In this case, no obligation arises under section 15.

Indications in advertising

Section 12 of the 2018 Code will be amended to clarify that, for an advertisement for a good that is not available for physical examination before purchase, it is only necessary to display the indications for medicines as they appear on the label (not as recorded on the medicine's entry in the Australian Register of Therapeutic Goods).

Changeover period

Some stakeholders have raised concerns that the six month transition period before the 2018 Code becomes effective is tight and that the transition between the mandatory statements under the 2015 Code to the 2018 Code may not occur exactly on 1 January for all advertising in all mediums.

We have been asked how we propose to carry out investigations into alleged non-compliance with the 2018 Code in the period from 1 January 2019 to 30 June 2019.

In this period, when investigating advertising complaints against the 2018 Code, we will apply the principles set out in the framework Complaints handling for the advertising of therapeutic goods to the Australian public. Under this framework, priority is given to addressing advertising that poses a risk to public health and safety. During the initial period of the new 2018 Code, and to the extent appropriate having regard to the public health and safety risk, we will work with the responsible advertiser with a view to correcting the advertising, particularly around use of the relevant mandatory statements between the two codes (as provided for by sections 11 to 14 in the 2018 Code).

Remember that where a pre-approval is held for the advertisement under the 2015 Code it continues to apply until expiration (including where that date is post 1 January).

Education tools and resources are a key focus under the new advertising framework and are being developed and provided to aid advertisers manage compliance. More information can be found in the new advertising hub.

Advertising pre-approvals and the new code

We advise advertisers that the date on which an application for pre-approval is decided will determine the version of the code that the advertising must comply with.

Advertisements for medicines that are to appear in specified media require pre-approval under Regulation 5G of the Therapeutic Goods Regulations 1990. The requirement for pre-approval will continue until 1 July 2020.

If you intend to lodge an application for advertising pre-approval between now and 31 December 2018, you should keep this in mind and allow time for revisions if necessary.

If you are in doubt about the application of the 2018 Code to your advertising, please contact us at tga.advertising@tga.gov.au.

Application decided Assessed against

On or after 1 January 2019

(This includes decisions on applications for minor variations to advertisements that were approved before 1 January 2019.)

2018 Code
On or before 31 December 2018 2015 Code

For pre-approval applications lodged prior to 1 January 2019 but decided on or after 1 January 2019, the decision will be made based on whether the advertisement complies with the 2018 Code.

Education activities

In addition to finalising a further two elearning modules, we are preparing a number of face to face and webinar information sessions over the next few months to educate advertisers on the 2018 Code and the advertising complaints handling framework. We are working with key industry bodies to deliver some of these activities.

To receive more information as it becomes available, please subscribe to the TGA website updates.

Advertising complaints handling framework

We have published information about the framework under which we receive and process advertising complaints. See - Complaints handling for the advertising of therapeutic goods to the Australian public.

Assessment of complaints

For complaints about pre-approved advertisements, compliance will be assessed against the version of the Code under which the advertisement was approved.

For all other advertisements, the version of the Code applied will depend on the date/s on which the advertisement aired or was published:

Advertising occurred Assessed against
On or after 1 January 2019 2018 Code
Before 1 January 2019 and is no longer occurring 2015 Code
Before 1 January 2019 and is still occurring 2018 Code