The new Advertising Code - where are we at? Sydney information - - PowerPoint PPT Presentation

The new Advertising Code - where are we at?

Sydney information session

Leanne McCauley Advertising Compliance Unit Regulatory Practice, Education and Compliance Branch Regulatory Practice and Support Division 13 June 2018

About the Advertising Code

• Advertising to the public for therapeutic goods MUST comply with

the Advertising Code

• See the Therapeutic Goods Act 1989 - section 42DM (criminal
• ffence) and section 42DMA (civil penalties)
• Current version is 2015 Code
• The Code is the cornerstone of the advertising framework
• Requires that advertising supports appropriate use of therapeutic

goods and does not mislead or deceive the consumer.

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Changing the Advertising Code

• Multiple drivers to amend Code, including to improve:

– clarity – objectivity of provisions (to support sanctions & penalties)

• Consultation on proposed Code and guidance closed 27 April 2018
• We have considered stakeholders concerns, including:

– need for a transition period – issues with specific provisions

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Proposed transition arrangements for new Code

• Currently working to finalise 2018 Code
• Subject to agreement, 2018 Code is expected to be:

– made and registered before 1 July 2018, BUT – commencement delayed until 1 January 2019

• Allows for advertisers to become familiar with 2018 Code
• Complaints about advertisements pre-approved prior to 1 January

2019 - assessed for compliance under 2015 Code

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Interim arrangements for Schedule 3 advertising

• 2015 Code will be amended for

to allow use of the new include S3 statement from 1 July 2018 :

ASK YOUR PHARMACIST—THEY MUST DECIDE IF THIS PRODUCT IS RIGHT FOR YOU

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Differences – 2018 Code vs consultation draft (1)

• There will be multiple key differences between the version of the

Code consulted on and the Code effective from 1 January 2018

• The changes proposed to the 2018 Code are either:

– minor changes to improve clarity, readability – more significant changes identified from feedback

• We will go through the more significant changes later on
• Exact wording of amended provisions not available at this stage

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Differences – 2018 Code vs consultation draft (2)

• Proposed change from ‘Direct/internet marketing requirements’ to

What advertisements must contain if the physical product is not available for examination at time of purchase

• Requirements in this section to apply where advertising allows for

the purchase of the goods BUT the goods are not physically available for consumer examination before/at the time of purchase

• Improved clarity of which mandatory statements will/won’t apply for

such advertising

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Differences – 2018 Code vs consultation draft (3)

• Requirements to be added for:

– Comparison ads must not claim or imply that comparators are harmful or ineffectual – Advertising must not include offer of a sample, with the exception

• f key public health items (e.g. sunscreens, condoms)
• Scientific representations

– Separating the requirements for cited research studies from the requirements for scientific claims

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Differences – 2018 Code vs consultation draft (4)

• Testimonials –

– clarification to requirements and – removal of restriction on relatives providing testimonials

• Advertising to children

– clarification – advertising directed primarily to children – ability to impose conditions on advertising for goods

• Minor changes/corrections to Schedule 1 – Price information

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Differences – 2018 Code vs consultation draft (5)

• Provisions relating to Allergies (s.20), mandatory requirements

(s.11, s.12, s.13) – revised to ensure that only messages critical to the consumer when selecting a product for self-treatment need to be ‘prominently displayed’ – removal of specific Allergies requirement

• Prohibited representation definition – “…diagnosis (including

screening), monitoring, susceptibility or pre-disposition…’

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Differences – 2018 Code vs consultation draft (6)

Proposed revised definition for s 28 – restricted representation:

…a form of a disease, condition, ailment or defect is a serious form if: (a) it is medically accepted that the form requires diagnosis or treatment or supervision by a suitably qualified healthcare professional – UNLESS the form has been medically diagnosed and medically accepted as being suitable for self-treatment and management; or (b) there is a diagnostic (including screening), preventative, monitoring, susceptibility or pre-disposition test available for the form (including a self- administered test), and which requires medical interpretation or follow-up.

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2018 Code guidance

• Will be updated to reflect changes to the 2018 Code
• Some feedback from Code consultation will also be addressed via

guidance, including clarifications about: – how s.23 (Complementary medicines) applies if there are multiple indications or therapeutic claims based on multiple traditions or paradigms – restricted representations

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Complaints handling arrangements

New complaints handling processes for 1 July

• Consultation on proposed TGA complaints handling model –

closed 4 June 2018

• Proposed model sets out:

– How complaints will be handled – Prioritisation by nature of breach and likely public health impact – Possible consequences of non-compliance based on priority (including the use of sanctions and penalties) – KPIs & approach to publication of complaint outcomes

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Proposed approach to complaints handling

• Initial assessment of complaints

– trivial or vexatious complaints not considered – complaints outside TGA jurisdiction referred on – following assessment, complaint is triaged & prioritised

• Action taken will depend on priority
• More serious actions (e.g. direction, infringement notice or court

action) won’t happen without some prior contact from the TGA

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Proposed TGA advertising complaint process

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Next steps

• Working to finalise Advertising Code
• Consultation on complaints handling – submissions being

assessed

• Public consultation on Code guidance – late June – August 2018
• Establishment of an advertising committee with external

representation – oversight of performance & Code currency

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Further information

• Slides from 23 May 2018 online - https://www.tga.gov.au/tga-

presentation-update-therapeutic-goods-advertising-reforms

• Further webinars/roadshows considered
• Subscribe to TGA website updates
• Contact

Advertising.Consultation@tga.gov.au

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Questions

• We will run through some of the questions received:

– at registration – during the webinar

• Some questions may be taken on notice and addressed through:

– publication on the TGA website – addressed in guidance (when released) and/or – another webinar or event

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