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 1
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 3
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) Advertising compliance – Ensuring you are Code compliant 4
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 tising compliance – Ensuring you are Code compliant 7
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 9 Advertising compliance – Ensuring you are Code compliant
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 10 Advertising compliance – Ensuring you are Code compliant
TGA advertising complaint process 11 Advertising compliance – Ensuring you are Code compliant
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 12
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 Advertising compliance – Ensuring you are Code compliant 13
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 Advertising compliance – Ensuring you are Code compliant 14
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 15
16 Advertising compliance – Ensuring you are Code compliant
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 Advertising compliance – Ensuring you are Code compliant 17
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 (where used) Summary of compliance actions taken Not applicable Outcome Advertising compliance – Ensuring you are Code compliant 18
Meeting your obligations
Top 4 advertising prep tips Confirm you have the evidence to support the 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 Advertising compliance – Ensuring you are Code compliant 20
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 Advertising compliance – Ensuring you are Code compliant 21
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 Advertis ing compliance – Ensuring you are Code compliant 22
The benefits of compliant advertising A robust Enhances Reinforces and health quality use effective outcomes of system of for all advertising therapeutic Supports Australians controls goods consumer Promotes confidence responsible Level and trust advertising playing field for business Advertising compliance – Ensuring you are Code compliant 23
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