Advertising Compliance Ensuring you are code compliant

Nicole McLay Assistant Secretary Regulatory Education and Compliance Branch Regulatory Practice and Support Division, TGA ARCS Annual Conference

21 August 2018

About the Advertising Code • The cornerstone of the advertising framework - advertising to the public

for therapeutic goods MUST comply with the Code ‒ Therapeutic Goods Act 1989 – s.42DM (criminal offence) and

s.42DMA (civil penalties)

• Advertising must support appropriate use of therapeutic goods and must not mislead or deceive the consumer

• New Code (2018) takes effect on 1 January 2019 ‒ Six month transition period allows for education

Advertising compliance – Ensuring you are Code compliant

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2015 v 2018 Code Key differences

2018 Code guidance

• 2018 Code will be supported by specific guidance

• Guidance provides more information on the application of Code provisions, using examples where possible

• Initial version of guidance consulted on with Code in April • A consultation on updated version is now open • Will be finalised before 2018 Code takes effect • Intended to be a ‘living’ document with updates as needed Advertising compliance – Ensuring you are Code compliant

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Key general differences: 2015 v 2018 Codes • Objective requirements for ‘prominently displayed or

communicated’ (s.4)

• Clearer requirements for what information must be included in advertising (s.11, 12, 13, 14)

• Amended endorsement and testimonial requirements (s.16, 17)

• Explicit requirement to identify traditional evidence and paradigm where used as basis for advertising (s.23)

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Key specific differences: 2015 v 2018 Codes • Advertising must not be inconsistent with current public health

campaigns (s.21) • New mandatory statement for S3 medicines advertising (s.14) • Explicit sunscreen requirements to reinforce public health messages

(s.27) • New criteria for restricted representations (s.28) • Incorporation of the Price Information Code of Practice for providing

prescription medicine prices to consumers (Schedule 1) Advertising compliance – Ensuring you are Code compliant 5

Representations that include comparisons

Comparative representations – competitor complaints • Comparison style advertisements raise complex issues

• We triage complaints and prioritise cases according to our model: – We assess complaints on the merits of the case – We are not the arbiters of commercial disputes

• Comparisons are permitted, where the science supports the comparison but advertisers must take care in making such claims

• Even where well evidenced if the statements are likely to confuse a reasonable consumer, we may find them in breach

Adver

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Complaints handling arrangements

Complaints handling processes from 1 July 2018 • Consultation on proposed complaints handling model closed 4 June • The consultation model set 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

• We are continuing to refine how we triage, prioritise and handle complaints

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Approach to complaints handling • Initial assessment of complaints

– trivial or vexatious complaints not considered – complaints outside TGA jurisdiction referred to correct body – following initial 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 prior contact from the TGA

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TGA advertising complaint process

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Triage and prioritisation • Key considerations impacting on prioritisation:

– whether the claims made or reliance on the claims made in the advertisement likely to cause public harm

– impact on the ability of consumers to safely and appropriately use goods for their intended purpose

– frequency and likely impact of the non-compliant advertising and its influence on other advertisers to the detriment of consumers

– Advertiser’s previous conduct & awareness of their obligations • Other factors may be taken into account on a case by case basis Advertising compliance – Ensuring you are Code compliant

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Low priority cases

One-off or isolated breaches with no public health & safety implications

• Obligations notice sent to advertiser, identifying the alleged breach and providing information to guide compliance

• The case may be reviewed at a later time to ensure compliance

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Medium priority cases Ongoing non-compliance but no public health & safety implications

• Advertiser sent a formal warning letter to advise them of the alleged breach

• Warning letter requests written response within 14 days setting out the action the advertiser will take to address non-compliance

• If appropriate action taken, matter will be closed. If not, we will use additional regulatory tools

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High and critical priority cases Risks to public health and safety

• High priority status – Advertiser contacted by telephone/email, requested to remedy alleged

breach – A determination will be made as to the most appropriate regulatory tool to be

used (based on the specific facts of the case) • Critical priority status

– Advertiser contacted immediately and required to address non-compliance – Subject to the advertiser’s response and the nature of the breach, the TGA

will determine next steps Advertising compliance – Ensuring you are Code compliant

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Publication of actions • We will publish information on our website about specific actions:

– Directions notices – Information about infringement notices – Enforceable undertakings – Court outcomes (injunctions, criminal and civil procedures) – Public warning notices

• Where a complaint is resolved without the need for specific action, an outcome will also be published

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Publication of complaint outcomes We will publish information about complaint outcomes based on priority:

Low Medium/High/Critical Case ID Advertiser identity Therapeutic goods advertised Date received Date completed Summary of compliance actions taken Not applicable (where used) Outcome Advertising compliance – Ensuring you are Code compliant

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Meeting your obligations

Top 4 advertising prep tips claims in the ad and it complies with the Code

Ensure claims are consistent with indications/intended purpose in ARTG

Confirm whether your advertising needs pre-approval

Don’t advertise with prohibited or unapproved restricted representations

Confirm you have the evidence to support the

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If you get a letter from TGA… Read it carefully – it will tell you what you need to do

Check your advertising for compliance with all relevant requirements – even if it has been pre-approved

If a response is required, ensure you provide it by due date

Responses that rely on non-compliance of competing advertisers are not acceptable

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Where can I find out more? • The onus is on the advertisers of therapeutic goods to ensure that they are

aware of and are compliant with their obligations.

• We provide a range of tools to assist advertisers in managing their compliance, including: – E-learning modules – Webinars/roadshows – Advertising hub:

https://www.tga.gov.au/advertising-hub – Contact: TGA.Advertising@tga.gov.au

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The benefits of compliant advertising A robust

and effective

system of advertising

controls Promotes

responsible advertising

Reinforces quality use

of therapeutic

goods Supports consumer confidence and trust

Enhances health

outcomes for all

Australians

Level playing field for business

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