The new Advertising Code - where are we at? Sydney information - PowerPoint PPT Presentation

The new Advertising Code - where are we at? Sydney information session Leanne McCauley Advertising Compliance Unit Regulatory Practice, Education and Compliance Branch Regulatory Practice and Support Division 13 June 2018

About the Advertising Code • Advertising to the public for therapeutic goods MUST comply with the Advertising Code  See the Therapeutic Goods Act 1989 - section 42DM (criminal offence) and section 42DMA (civil penalties)  Current version is 2015 Code • The Code is the cornerstone of the advertising framework • Requires that advertising supports appropriate use of therapeutic goods and does not mislead or deceive the consumer. The new Advertising Code - where are we at? – 13 June 2018 1

Changing the Advertising Code • Multiple drivers to amend Code, including to improve: – clarity – objectivity of provisions (to support sanctions & penalties) • Consultation on proposed Code and guidance closed 27 April 2018 • We have considered stakeholders concerns, including: – need for a transition period – issues with specific provisions The new Advertising Code - where are we at? – 13 June 2018 2

Proposed transition arrangements for new Code • Currently working to finalise 2018 Code • Subject to agreement , 2018 Code is expected to be: – made and registered before 1 July 2018, BUT – commencement delayed until 1 January 2019 • Allows for advertisers to become familiar with 2018 Code • Complaints about advertisements pre-approved prior to 1 January 2019 - assessed for compliance under 2015 Code The new Advertising Code - where are we at? – 13 June 2018 3

Interim arrangements for Schedule 3 advertising • 2015 Code will be amended for to allow use of the new include S3 statement from 1 July 2018 : ASK YOUR PHARMACIST—THEY MUST DECIDE IF THIS PRODUCT IS RIGHT FOR YOU The new Advertising Code - where are we at? – 13 June 2018 4

Differences – 2018 Code vs consultation draft (1) • There will be multiple key differences between the version of the Code consulted on and the Code effective from 1 January 2018 • The changes proposed to the 2018 Code are either: – minor changes to improve clarity, readability – more significant changes identified from feedback • We will go through the more significant changes later on • Exact wording of amended provisions not available at this stage The new Advertising Code - where are we at? – 13 June 2018 5

Differences – 2018 Code vs consultation draft (2) • Proposed change from ‘ Direct/internet marketing requirements’ to What advertisements must contain if the physical product is not available for examination at time of purchase • Requirements in this section to apply where advertising allows for the purchase of the goods BUT the goods are not physically available for consumer examination before/at the time of purchase • Improved clarity of which mandatory statements will/won’t apply for such advertising The new Advertising Code - where are we at? – 13 June 2018 6

Differences – 2018 Code vs consultation draft (3) • Requirements to be added for: – Comparison ads must not claim or imply that comparators are harmful or ineffectual – Advertising must not include offer of a sample, with the exception of key public health items (e.g. sunscreens, condoms) • Scientific representations – Separating the requirements for cited research studies from the requirements for scientific claims The new Advertising Code - where are we at? – 13 June 2018 7

Differences – 2018 Code vs consultation draft (4) • Testimonials – – clarification to requirements and – removal of restriction on relatives providing testimonials • Advertising to children – clarification – advertising directed primarily to children – ability to impose conditions on advertising for goods • Minor changes/corrections to Schedule 1 – Price information The new Advertising Code - where are we at? – 13 June 2018 8

Differences – 2018 Code vs consultation draft (5) • Provisions relating to Allergies (s.20), mandatory requirements (s.11, s.12, s.13) – revised to ensure that only messages critical to the consumer when selecting a product for self-treatment need to be ‘prominently displayed’ – removal of specific Allergies requirement • Prohibited representation definition – “…diagnosis (including screening), monitoring, susceptibility or pre-disposition…’ The new Advertising Code - where are we at? – 13 June 2018 9

Differences – 2018 Code vs consultation draft (6) Proposed revised definition for s 28 – restricted representation : …a form of a disease, condition, ailment or defect is a serious form if: (a) it is medically accepted that the form requires diagnosis or treatment or supervision by a suitably qualified healthcare professional – UNLESS the form has been medically diagnosed and medically accepted as being suitable for self-treatment and management ; or (b) there is a diagnostic (including screening), preventative, monitoring, susceptibility or pre-disposition test available for the form (including a self- administered test), and which requires medical interpretation or follow-up. The new Advertising Code - where are we at? – 13 June 2018 10

2018 Code guidance • Will be updated to reflect changes to the 2018 Code • Some feedback from Code consultation will also be addressed via guidance, including clarifications about: – how s.23 (Complementary medicines) applies if there are multiple indications or therapeutic claims based on multiple traditions or paradigms – restricted representations The new Advertising Code - where are we at? – 13 June 2018 11

Complaints handling arrangements

New complaints handling processes for 1 July • Consultation on proposed TGA complaints handling model – closed 4 June 2018 • Proposed model sets 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 13 The new A dvertising Code - where are we at? – 13 June 2018

Proposed approach to complaints handling • Initial assessment of complaints – trivial or vexatious complaints not considered – complaints outside TGA jurisdiction referred on – following 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 some prior contact from the TGA 14 The new Advertising Code - where are we at? – 13 June 2018

Proposed TGA advertising complaint process 15 The new Advertising Code - where are we at? – 13 June 2018

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Next steps • Working to finalise Advertising Code • Consultation on complaints handling – submissions being assessed • Public consultation on Code guidance – late June – August 2018 • Establishment of an advertising committee with external representation – oversight of performance & Code currency The new Advertising Code - where are we at? – 13 June 2018 17

Further information • Slides from 23 May 2018 online - https://www.tga.gov.au/tga- presentation-update-therapeutic-goods-advertising-reforms • Further webinars/roadshows considered • Subscribe to TGA website updates • Contact Advertising.Consultation@tga.gov.au The new Advertising Code - where are we at? – 13 June 2018 18

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 The new Advertising Code - where are we at? – 13 June 2018 19