Brenda davy & Julie Viatos PresentedNavigating Regulation: The New Advertising Landscape' '

1. Navigating Advertising
Regulations
August 2019

2. 2
Over 16,000 products
$5.5 billion market
$180 million per annum
18,000 jobs
$2 billion

3. AGENDA
➢ Why regulate advertising?
➢ Regulatory Framework ‘101’
➢ What’s new? What’s changed?
➢ What marketers are saying about the new advertising code….
➢ Tips to avoid common breaches
3

4. SCOPE OF THIS PRESENTATION
Consumer advertising
Non-prescription medicines
(OTC and Complementary Medicines)
4

5. NOT IN SCOPE OF THIS PRESENTATION
5
HCP (Healthcare Professionals)
Rx products (prescription medicines)

6. WHY REGULATE ADVERTISING?
➢ National Medicines Policy and Quality Use of Medicines
➢ Products can do harm if taken or used inappropriately
➢ Consumers may be vulnerable when sick
…..And that’s why our Australian products have high brand equity in
overseas markets!
6

7. REGULATORY FRAMEWORK ‘101’
➢ WHAT they’re made of
➢ WHERE/HOW they’re made
➢ WHAT you can say about them
7

8. REGULATORY FRAMEWORK ‘101’
8
Labelling
State and
Territory
legislation
ARTG
Pharmaco
-vigilance
Quality
standards
Packaging
standards
AUST L
AUST R
OTHER….
Advertising
TGA
Framework
GMP
Good
M’facturing
Process

9. REGULATORY FRAMEWORK ‘101’
Footer Text9
Advertising
TGA
Framework
Australian Consumer Law:
Competition and Consumer Act 2010
THE ACT & REGULATIONS:
Therapeutic Goods Act 1989;
Therapeutic Goods Regulations 1990
THE CODE:
Therapeutic Goods Advertising Code 2018
(No.2) – accompanied by Guidance

10. WHAT’S NEW? WHAT’S CHANGED?
OLD (TGAC 2015) NEW (TGAC No.2 2018)
Advertising
Code
Pre-approvals
Complaints
Sanctions &
Penalties
10

11. WHAT’S NEW? WHAT’S CHANGED?
OLD (TGAC 2015) NEW (TGAC No.2 2018)
Advertising
Code
• Principles based
• Subjective
• Limited
accompanying
guidance
• Principles based
• More clarity and objectivity
• Clearer requirements for medical
devices
• HEAVY guidance (100’s of pages)
• Gives impression of more
regulation
• More prescriptive – mandatories,
health warnings, public health
campaigns, etc.
11

12. ADVERTISING CODE – WHAT’S DIFFERENT?
➢ Clarity and objectivity to support enforcement; application to devices
12

13. ADVERTISING CODE – WHAT’S DIFFERENT?
➢ Clarity and objectivity to support enforcement; application to devices
➢ New mandatory statements – options for “symptom management”
13

14. ADVERTISING CODE – WHAT’S DIFFERENT?
➢ Clarity and objectivity to support enforcement; application to devices
➢ New mandatory statements – options for “symptom management”
➢ Health warnings – for medicines and medical devices
14

15. ADVERTISING CODE – WHAT’S DIFFERENT?
➢ Clarity and objectivity to support enforcement; application to devices
➢ New mandatory statements – options for “symptom management”
➢ Health warnings – for medicines and medical devices
➢ Interpretation of “prominently displayed & communicated”
15

16. ADVERTISING CODE – WHAT’S DIFFERENT?
➢ Clarity and objectivity to support enforcement; application to devices
➢ New mandatory statements – options for “symptom management”
➢ Health warnings – for medicines and medical devices
➢ Interpretation of “prominently displayed & communicated”
➢ Must identify traditional use paradigm for complementary medicines
16

17. ADVERTISING CODE – WHAT’S DIFFERENT?
➢ Clarity and objectivity to support enforcement; application to devices
➢ New mandatory statements – options for “symptom management”
➢ Health warnings – for medicines and medical devices
➢ Interpretation of “prominently displayed & communicated”
➢ Must identify traditional use paradigm for complementary medicines
➢ Not inconsistent with public health campaigns
17

18. ADVERTISING CODE – WHAT’S DIFFERENT?
➢ Clarity and objectivity to support enforcement; application to devices
➢ New mandatory statements – options for “symptom management”
➢ Health warnings – for medicines and medical devices
➢ Interpretation of “prominently displayed & communicated”
➢ Must identify traditional use paradigm for complementary medicines
➢ Not inconsistent with public health campaigns
➢ Testimonials and Endorsements; Scientific representations
18

19. ADVERTISING CODE – WHAT’S DIFFERENT?
➢ Clarity and objectivity to support enforcement; application to devices
➢ New mandatory statements – options for “symptom management”
➢ Health warnings – for medicines and medical devices
➢ Interpretation of “prominently displayed & communicated”
➢ Must identify traditional use paradigm for complementary medicines
➢ Not inconsistent with public health campaigns
➢ Testimonials and Endorsements; Scientific representations
➢ New requirements for restricted & prohibited representations
19

20. ADVERTISING CODE – WHAT’S DIFFERENT?
➢ Clarity and objectivity to support enforcement; application to devices
➢ New mandatory statements – options for “symptom management”
➢ Health warnings – for medicines and medical devices
➢ Interpretation of “prominently displayed & communicated”
➢ Must identify traditional use paradigm for complementary medicines
➢ Not inconsistent with public health campaigns
➢ Testimonials and Endorsements; Scientific representations
➢ New requirements for restricted & prohibited representations
➢ Different structure, more guidance
20

21. ADVERTISING GUIDANCE
➢ Assists with compliance, but increased complexity
➢ Information on application of the Code, e.g. impact on
“reasonable person”, “target audience”, “genuine news” etc
➢ Provides interpretation on parts of the Code, e.g. scientific
representations, restricted representations, prominence of
mandatories
➢ Additional TGA FAQs on “natural”, “data on file”, guidance for
advertising S3 medicines
21

22. WHAT’S NEW? WHAT’S CHANGED?
OLD (TGAC 2015) NEW (TGAC No.2 2018)
Pre-
approvals
• Mandatory- via TGA
delegations to CHP
Australia and CHC
• Mandatory pre-approvals to be
abolished
1 July 2020
• After 1 July 2020 - CHP
Australia will launch
“Ad Compliance Advisory
Service’
22

23. CMA OR CHP AUSTRALIA?
All in-scope advertising
All other advertising
CHP Australia and CMA
are delegated this
authority by the
Secretary of the
Department of Health,
per regulation 5Q
OTC medicines
Complementary medicines

24. PRE APPROVALS: WHAT NEEDS APPROVAL NOW?
24
Advertising Material for Therapeutic
Goods
Health Professional Consumer
In Scope Out of Scope
Broadcast Media
(TV, radio)
Mainstream Media
(Newspaper,
magazine)
Displays about
Goods
Except Displays
Inside Individual
Shops
Direct
Mail-outs
Media
Releases
Internet, SMS,
MMS, Email,
Narrowcast
Media
Except Where the Advertisement ONLY includes
Name, Picture, and/or Price, and/or Point of Sale
Unless the Name or Picture contains a
therapeutic claim
Over-The-Counter and Complementary
Medicine
Medical Device
Cinematographic
Film

25. PRE-APPROVALS- WHAT’S CHANGED?
Mandatory pre approvals
25
will be abolished as at 1 July 2020

26. ANNOUNCING…..
26
“Advertising Compliance Advisory Service”
(1 July 2020)

27. ANNOUNCING…..
Benefits:
➢ Objective review and advice by 3rd party
➢ Receive CHP ‘stamp of approval’
➢ Extra due diligence for sponsors/media gate keepers/agencies
➢ All media
➢ Whole of industry
27
“Advertising Compliance Advisory Service”
(1 July 2020)

28. WHAT’S NEW? WHAT’S CHANGED?
OLD (TGAC 2015) NEW (TGAC No.2 2018)
Complaints • Complaints
Resolution
Panel
• TGA receives ALL complaints –
“One door”
28

29. COMPLAINTS
From TGA Complaints Handling for the advertising of therapeutic
goods to the Australian Public v. 1.1 May 2019
https://www.tga.gov.au/sites/default/files/complaints-handling-
advertising-therapeutic-goods-australian-public.pdf
29

30. WHAT’S NEW? WHAT’S CHANGED?
OLD (TGAC 2015) NEW (TGAC No.2 2018)
Sanctions
&
Penalties
• No Teeth • Heavier Sanctions.
• Fines, jail terms
• TEETH!
30

31. SANCTIONS/PENALTIES
➢ TGA options for sanctions and penalties include:
• “Educational letter”
• “Warning” letter
• Substantiation notice
• Directions notice
• Public Warning notice
• Infringement notice
• Enforceable undertakings
• Criminal prosecution
31

32. SUMMARY: WHAT’S NEW? WHAT’S CHANGED?
OLD (TGAC 2015) NEW (TGAC No.2 2018)
Advertising
Code
• Principles based
• Subjective
• Limited
accompanying
guidance
• Principles based
• More clarity and objectivity
• Clearer requirements for medical devices
• HEAVY guidance (100’s of pages)
• Gives impression of more regulation
• More prescriptive – mandatories, health
warnings, public health campaigns, etc.
Pre-approvals • Mandatory- via TGA
delegations to CHP
Australia and CHC
• Mandatory pre-approvals to be abolished 1
July 2020
• After July 2020 - CHP Australia will launch
Ad Compliance Advisory Service
Complaints • Complaints
Resolution Panel
• TGA receives ALL complaints – “One door”
Sanctions &
Penalties
• No Teeth • Heavier Sanctions.
• Fines, jail terms, TEETH!
32

33. WHAT MARKETERS ARE SAYING ABOUT THE NEW CODE….
➢ Social Media
➢ Sampling
➢ Interface issues – foods, cosmetics
➢ Absolute claims “solution for”, “Money Back Guarantees”,
➢ Mandatories – complying with prominence requirements
➢ Non-therapeutic claims, e.g. “new”; “Australia’s No. 1”,
➢ Implied citations – “clinically / scientifically proven”, “research shows”
➢ Testimonials/Endorsements/Sponsorships
➢ Lack of information on complaint outcomes and precedents
33

34. TIPS TO AVOID COMMON BREACHES
➢ Know your product & the indications
34

35. TIPS TO AVOID COMMON BREACHES
➢ Know your product, the indications
➢ Dialogue between Regs & Marketing. Ask questions!
35

36. TIPS TO AVOID COMMON BREACHES
➢ Know your product, the indications
➢ Dialogue between Regs & Marketing. Ask questions!
➢ Educate yourself on the code requirements & mandatories,
class statements, restricted representations
36

37. TIPS TO AVOID COMMON BREACHES
➢ Know your product, the indications
➢ Dialogue between Regs & Marketing. Ask questions!
➢ Educate yourself on the code requirements & mandatories, class
statements, restricted representations
➢ Supporting evidence needed. Don’t wait for a complaint!
37

38. TIPS TO AVOID COMMON BREACHES
➢ Know your product, the indications
➢ Dialogue between Regs & Marketing. Ask questions!
➢ Educate yourself on the code requirements & mandatories, class
statements, restricted representations
➢ Supporting evidence needed. Don’t wait for a complaint!
➢ Utilise your industry association
38

39. TIPS TO AVOID COMMON BREACHES
➢ Know your product, the indications
➢ Dialogue between Regs & Marketing. Ask questions!
➢ Educate yourself on the code requirements & mandatories, class
statements, restricted representations
➢ Supporting evidence needed. Don’t wait for a complaint!
➢ Utilise your industry association
➢ Don’t be afraid of regulations/the code.
Check out: https://www.tga.gov.au/advertising-hub
39

40. 40

41. 41
www.chpaustralia.com.au
info@chpaustralia.com.au
02 9922 5111
Questions?