Update on the therapeutic goods advertising reforms

1. Update on the therapeutic goods advertising reforms
Webinar
Leanne McCauley & Eric McIntosh
Advertising Compliance Unit
Regulatory Practice, Education and Compliance Branch
Regulatory Practice and Support Division
23 May 2018

2. 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 rollout
– New and enhanced sanctions & penalties
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3. 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
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4. 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
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6. 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
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7. 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
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8. 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)
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9. 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
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10. 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
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11. 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
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12. Further information
• Subscribe to TGA website updates
• Future events:
– Webinar – 12 June
– Roadshow (Sydney) – 13 June
• Contact Advertising.Consultation@tga.gov.au
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13. 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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