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 e on the therapeutic goods advertising reforms Updat 1

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 Update on the therapeutic goods advertising reforms – 23 May 2018 2

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 Update on the therapeutic goods advertising reforms – 23 May 2018 3

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 Update on the therapeutic goods advertising reforms – 23 May 2018 5

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 Update on the therapeutic goods advertising reforms – 23 May 2018 6

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) Update on the therapeutic goods advertising reforms – 23 May 2018 7

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 Update on the therapeutic goods advertising reforms – 23 May 2018 8

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 s.42DS s.42DT in reply to a substantiation All Failing to comply with direction notice s.42DW s.42DX Update on the therapeutic goods advertising reforms – 23 May 2018 9

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 Update on the therapeutic goods advertising reforms – 23 May 2018 10

Further information • Subscribe to TGA website updates • Future events: – Webinar – 12 June – Roadshow (Sydney) – 13 June • Contact Advertising.Consultation@tga.gov.au Update on the therapeutic goods advertising reforms – 23 May 2018 11

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 Update on the therapeutic goods advertising reforms – 23 May 2018 12