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TGA presentation: Update on the therapeutic goods advertising reforms

24 May 2018

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These presentation papers are provided on the TGA's website solely for the purpose of indicating or suggesting what TGA representatives spoke about to the various conferences and seminars to which it relates. The papers are not legislative in nature and should not be taken to be statements of any law or policy in any way.

The Australian Government Department of Health (of which the TGA is a part) advises that (a) the presentation papers should not be relied upon in any way as representing a comprehensive description of regulatory requirements, and (b) cannot guarantee, and assumes no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in the presentation paper.

Presentation

  • Presented by: Leanne McCauley & Eric McIntosh
  • Presented at: TGA Webinar
  • Presentation date: 23 May 2018
  • Presentation summary: 1 July 2018 changes to the new Therapeutic Goods Advertising Code. New penalties and sanctions now available to the TGA in addressing advertising non-compliance.

Transcript

Webinar: Update on the therapeutic goods advertising reforms

Leanne McCauley & Eric McIntosh
Advertising Compliance Unit
Regulatory Practice, Education and Compliance Branch
Regulatory Practice and Support Division

Slide 1 - Introduction

  • The regulation of advertising provides important consumer safeguards in the use of medicines & medical devices
  • Preapprovals have been required for some advertisements - moving to a complaints based model with preapproval to cease in 2020
  • As a result, some important changes are being implemented:
    • New Code
    • Single complaints body & new framework for complaint management
    • Education, development and rullout
    • New and enhanced sanctions & penalties

Slide 2 - Therapeutic Goods Advertising Code 2018

  • Changes to improve clarity and support sanctions & penalties
  • Consultation on proposed Code and guidance closed 27 April 2018
  • Submissions currently under assessment. Some common themes:
    • The need for a transition allowance
    • Clarity/complexity/nature of required & warning statements
  • When will 2018 Code vs 2015 Code apply? Under consideration.
  • Code to be supported by specific guidance

Slide 3 - New complaints handling processes for 1 July

  • Consultation currently open on proposed complaints handling model – closes 4 June 2018
  • Proposed model sets out:
    • Prioritisation by nature of breach and likely public health impact
    • How complaints will be handled – generally education first
    • Possible consequences of non-compliance based on priority (including the use of sanctions and penalties)
    • KPIs & approach to publication of complaint outcomes

Slide 4 - Overview of proposed complaints handling model once a breach is established

 Image of a pyramid illustrating an overview of proposed complaints handling model once a breach is established.

This image illustrates an overview of proposed complaints handling model once a breach is established.

Stage 1. to assess and triage complaints about advertisements for therapeutic goods into one of the four priority categories after taking into consideration:

  • whether the claims made or reliance on the claims made in the advertisement is likely to cause public harm
  • the likely impact of the advertising on the ability of consumers to safely and appropriately use the goods for their intended purpose
  • the frequency and likely impact of the non-compliant advertising and its influence on other advertisers to the detriment of consumers
  • the advertisers' awareness of their advertising obligations.

The priority level assigned to each case will determine how quickly we commence investigation, notify the person responsible for the advertising, and ultimately the regulatory tools used to achieve compliance, and dictate our key performance indicators.

Slide 5 - Education / guidance

  • New "Advertising hub" planned for website
    • Easier to locate from homepage
    • Access to education, guidance, complaint form, inquiry form etc
  • Three e-learning modules under development
  • Australian Regulatory Guidelines on Advertising Therapeutic Goods
  • Consumer-specific materials:
    • Fact sheets – lodging complaints, identifying non-compliant ads
    • Short video on advertising requirements

Slide 6 - New sanctions

  • Substantiation notices – s.42DR
    • Failure to comply or provision of false or misleading information is an offence
  • Direction notices – s.42DV
    • Failure to comply is an offence
  • Public warning notices – s.42DY

Slide 7 - Enhanced criminal offence penalties

  • Most advertising criminal offences converted to three-tier:
    • Harm element – 5 years imprisonment/4000 penalty units or both
    • Intent but no harm – 12 months imprisonment/1000 penalty units or both
    • Strict liability offence – 100 penalty units
  • 5 x corporate multiplier for all of the above penalty units
  • Infringement notices as alternative to strict liability offences 12 penalty units (individual) or 60 penalty units (company)

Slide 8 - New civil penalty provisions for advertising

  • Corresponding civil penalties added to complement most criminal offences applying to advertising non-compliance
    • 5,000 penalty units – individual
    • 50,000 penalty units – body corporate
  • Lower burden of proof than criminal offences

Slide 9 - Key advertising offence provisions

Key advertising offence provisions
Type of good Requirement Criminal offence Civil penalty
Medicines, OTGs Prohibits promotion of off-label use ss.22(2), (3) & (5) ss.21B(4)
Biologicals Prohibits promotion of off-label use ss.32BJ(2A)-(4) s.32BL
Medical devices Prohibits promotion of off-label use s.42ML s.41MLB
All Pre-approval offences s.42C N/A
All General advertising offences s.42DL s.42DLB
All Non-compliance with Code s.42DM s.42DMA
All Failing to comply with/misleading info in reply to a substantiation s.42DS s.42DT
All Failing to comply with direction notice s.42DW s.42DX

Slide 10 - Further work

  • Establishment of an advertising committee with external representation – oversight of performance
  • Requirement for medicines advertising in ‘specified media’ to be pre-approved will continue until 30 June 2020
    • Allows for a transition period – TGA will work to support advertisers by ensuring they have access to the required information to achieve compliant advertising
  • Reviews of pre-approval arrangement and complaints system

Slide 11 - Further information

Slide 12 - 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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