Update on the therapeutic goods advertising reforms Webinar Leanne - - PowerPoint PPT Presentation

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

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

Updat

e on the therapeutic goods advertising reforms

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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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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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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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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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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

• r 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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New civil penalty provisions for advertising

• Corresponding civil penalties added to complement most criminal
• ffences 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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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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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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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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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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