7th Annual Pharmaceutical Law
Conference (30 May 2014)
Steve Scarff
The ASMI Code of Practice:
A Study in Self-regulation
Self-Regulation - Overview
• Self-Regulation is:
– Efficient
– Effective
– Transparent.
• However, coverage of non-associa...
Outline
1. About ASMI
2. OTC Industry Overview
3. Regulation, Co-Regulation, Self-Regulation
4. The Trimmer Group
5. 2013 ...
1. About ASMI
About ASMI
• ASMI represents:
– Sponsors of non-prescription medicines (Ordinary Members).
– Companies providing services ...
ASMI Ordinary Members
Full ASMI Membership Base
Ordinary Members Associate Members
Allergan Australia Pty Ltd
Aspen Pharmacare
Apotex Pty Ltd
Ba...
2. OTC Industry Overview
The$4B Non-prescription market
$Retail sales split by channel
Nielsen 2012 MAT
Pharmacy, 53.5%
Pharmacy
Online, 5.7%
Super...
Availability & Advertising
• Over-The-Counter Medicines
• Complementary Medicines
• Available without prescription through...
3. Regulation, Co-Regulation,
Self-Regulation
3 Levels of Regulation
*All bound
** ASMI Members bound
1. ASMI/CHC Advertising Services
Managers (pre-approvals)
2. CRP
3...
Requirements
• Legislation
– Therapeutic Goods Act 1989
– Therapeutic Goods Regulations 1990
– Competition and Consumer Ac...
Complaints Options
• Regulatory options:
– Formal legal
– TGA (limited in terms of audience and media(?))
• Co-regulatory ...
4. The Trimmer Group
The Trimmer Group - Background
• There are a number of industry associations which represent
different therapeutic industr...
The Trimmer Group
• Working Group on Promotion of Therapeutic Products
• 2011 Report to Parliamentary Secretary Catherine ...
The Trimmer Group
• Developed a high level statement of principles
• Developed a list of essential operational areas
• Dev...
The Trimmer Group
• Recommendation 2:
• The working group recommends that consistency of therapeutic
sector industry codes...
The Trimmer Group
• Recommendation 5.
• The working group recommends that TGA include on its application
forms (whether el...
Codes of Conduct Advisory Group
• An Advisory Group has been established by the TGA to “strengthen
the industry’s self-reg...
5. 2013 changes
ASMI Code Changes
• Fifteen separate changes.
• Approved at the ASMI AGM in December 2012 (published March
2013).
• To bri...
ASMI Code Changes
• New clauses introduced in relation to:
• High level principles.
• Specific operational topics.
• Speci...
15 ASMI Code Changes
1. Panel Chair’s discretion regarding late responses (clauses 9.4.2.8, 9.4.2.9, 9.4.2.10)
2. Withstan...
6. ACCC Authorisation
ACCC Authorisation
• The ACCC can “authorise” businesses to engage in
certain anti-competitive arrangements or conduct whe...
ACCC Authorisation
• Only necessary to seek authorisation from the ACCC if
there is a risk that the proposed arrangements ...
Authorisation
• The ASMI Code was authorised by the Trade Practices
Commission in 1994
• No time limit so long as here wer...
Authorisation
• 2013 changes concluded the “open ended” authorisation
• ASMI considered the options
• ASMI did not seek AC...
7. Walk through the
ASMI Code
ASMI Code of Practice
• An example of self-regulation
• Condition of membership - Applies to ASMI Members only
• Incorpora...
ASMI Code
• Areas of historical complaint(s)
• New / revised provisions for 2013
Structure of the code
1. Definitions
2. Introduction
3. Objectives
4. Principles of Practice
5. Advertising & Promotion
6....
Definitions
•“Advertisement”
•“Awareness activity”
•“Hospitality”
•“Quality Use of Medicines”
•“Stakeholders”
• Areas of h...
Introduction
• Binding as a condition of membership
(2.8)
• Applied in spirit as well as the letter
(2.9)
• Members respon...
Objectives
• Basic Parameters
• Communications to be
accurate and responsible
Principles
• Series of general obligations
imposed on members
• Familiarity with the Code and other
industry requirements
...
Application of the Code 5.1
• General principles of advertising & promotion
• Promotion to consumer & HCP’s
• Current accu...
Application of the Code 5.2
• Comparative advertising
• Must be clear what is being
compared and the basis for the
compari...
Application of the Code 5.3
• Advertising to consumers
• Approval of advertisements
(5.3.1)
• Advertising S3’s to consumer...
Application of the Code 5.4
• Advertising to HCP’s
• Minimum requirements (5.4.1)
• Brand name reminders (5.4.2)
• Areas o...
Application of the Code 6
• Relationships with stakeholders
– General (6.1)
– Hospitality and entertainment
(6.2)
– Resear...
Application of the Code 7
• Consumer Medicine
Information (CMI) (7.1)
• Consumer focused
labelling (7.2)
Management of the code 8
• Administration of the code
• Supervision, co-ordination,
monitoring & review (8.1)
• Complaints...
Management of the code 9
• Complaints procedures
• Principles of fairness (9.1)
• General procedure (9.2)
• Complaints fro...
8. Change processes
Change process
• Annual Code review.
• The changes are drafted and authorised by the Marketing and Ethics
Subcommittee and...
9. Compliance
processes
Complaints
Complaints Handling
• Two mechanisms:
1. CRP (co-regulation):
• Covers advertising to consumers only, applies to all adver...
ASMI vs CRP
ASMI and CRP Complaints
Year ASMI CRP
2012-2013 1 (+1 appeal) 297
2011-2012 1 (+1 appeal) 373
2010-2011 5 329
...
CRP Complaints
• The CRP publishes a searchable complaints register
• Available at: www.tgacrp.com.au
• Of the most recent...
Promotional Monitoring Panel
(PMP)
Promotional Monitoring Panel (PMP)
• Monitoring of advertising
PMP Overview
• Review of material not covered by Pre-Approval process
– Below-the-line
– Internet
– Advertisements directe...
PMP Overview
• Demonstrate the effectiveness of self-regulation of
advertising
• Provides guidance to member companies abo...
10. Examples
Nurofen 2013
“... It’s also the relief
more parents would
use again3,4.”
Nurofen print ad
Breaches section 5.1.3
Nurofen print ad
“Parents .... would see the reference to the footnote ... but would not ... be
likely to consult that pap...
Nurofen TVC
• See separate video
“Luckily you can rely on Nurofen for Children, because
nothing works faster or last longe...
Nurofen TVC
• What the Panel found:
The Panel considers that the dominant impression likely to be left upon the
minds of a...
Sanctions
• Considered to be repeat breaches.
• Undertakings required.
• Remove materials from circulation.
• $25,000 fine...
Nurofen 2012
Nurofen POS
Mums told us they prefer
nurofen because: “I found it
great for teething.”
Breaches sections 5.1.3 and 5.1.4
B...
Nurofen POS
• What the Panel found:
Because no comparator product is identified ... the Teething Claims would be understoo...
Nurofen TVC
• See separate video
“I switched to Nurofen for Maria’s
teething , as I just found it worked
better.” [same ou...
Nurofen TVC
• What the Panel found (re “switching”):
Reasonable consumers would understand from the Switching Claim that m...
Sanctions
• Considered to be moderate breaches.
• Undertakings required.
• Remove materials from circulation.
• $10,000 to...
Zyrtec 2011
Zyrtec Print Advertisement
Zyrtec Print Advertisement
“Zyrtec® is over twice as
effective as Claratyne® at
relieving the combined
symptoms of hayfeve...
Zyrtec Print Advertisement
“9/10 people who use
Zyrtec® are satisfied”
The Panel considered that, since “satisfied” was no...
Internet Advertising
Zyrtec Internet Advertising
“Zyrtec® is over twice as
effective as Claratyne® for
treating allergic rhinitis”
The Panel no...
Same claim – different executions
“Zyrtec® can be used for extended
periods and continues to be
effective over time” [Post...
Sanctions
• Considered to be Moderate (but Repeat)
breaches.
• Undertakings required.
• Retractions to be published.
• $40...
11. Advertising
Reforms
Advertising reforms
What has happened:
• Consultation closed July 2013.
• TGA attempted to confine discussion.
• Not an op...
Eight proposals
• Alternatives to the pre-approvals scheme.
• Complaints handling process.
• Provisions of advice to the T...
12. Non-members
Non-members
• Only bound by the Act, the Regulations and the TGAC
• Which only cover certain audiences
• Which only cover ...
Questions?
Steve Scarff
Regulatory & Scientific Affairs Director
Email: steve@asmi.com.au
Phone: (02) 9923 9406
Steve Scarff, Australian Self-Medication Industry - The ASMI Code of Practice: A Study in Self-Regulation
Steve Scarff, Australian Self-Medication Industry - The ASMI Code of Practice: A Study in Self-Regulation
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Steve Scarff, Australian Self-Medication Industry - The ASMI Code of Practice: A Study in Self-Regulation

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Steve Scarff delivered the presentation at 2014 Pharmaceutical Law Conference.

The Pharmaceutical Law Conference is the foremost meeting place and networking hub of the pharmaceutical law industry, and the only pharmaceutical law event in the Asia-Pacific region. The 2014 event highlights included pharma law reform, IP, competitive strategies, industry transparency, sustainable drug pricing and patenting life sciences and more.

For more information about the event, please visit: http://www.informa.com.au/pharmalawevent14

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Steve Scarff, Australian Self-Medication Industry - The ASMI Code of Practice: A Study in Self-Regulation

  1. 1. 7th Annual Pharmaceutical Law Conference (30 May 2014) Steve Scarff The ASMI Code of Practice: A Study in Self-regulation
  2. 2. Self-Regulation - Overview • Self-Regulation is: – Efficient – Effective – Transparent. • However, coverage of non-association members is problematic.
  3. 3. Outline 1. About ASMI 2. OTC Industry Overview 3. Regulation, Co-Regulation, Self-Regulation 4. The Trimmer Group 5. 2013 Changes 6. ACCC Authorisation 7. Walk through the ASMI Code 8. Change processes 9. Compliance processes 10. Examples 11. Advertising Reforms 12. Non-Members
  4. 4. 1. About ASMI
  5. 5. About ASMI • ASMI represents: – Sponsors of non-prescription medicines (Ordinary Members). – Companies providing services to sponsors (Associate Members). – Over the Counter (OTC) & Complementary Medicines (CM). – ASMI members make up 85% of the $4bn non prescription market.
  6. 6. ASMI Ordinary Members
  7. 7. Full ASMI Membership Base Ordinary Members Associate Members Allergan Australia Pty Ltd Aspen Pharmacare Apotex Pty Ltd Bausch + Lomb (A Valeant Company) Baxter Laboratories Bayer Healthcare Consumer Care Biological Therapies Pty Ltd Boehringer Ingelheim Pty Ltd Church & Dwight Australia Combe Asia Pacific Pty Ltd Ego Pharmaceuticals Pty Ltd Ensign Laboratories Pty Ltd Galderma Australia GlaxoSmithKline Consumer Healthcare HealthOne Pty Ltd H W Woods Pty Limited iNova Pharaceuticals Pty Ltd (A Valeant Company) Johnson & Johnson Pacific Pty Ltd MSD Nestle Australia Ltd Novartis Consumer Health Australasia Pty Ltd Pfizer Consumer Healthcare, a division of Pfizer Australia Reckitt Benckiser Sanofi Consumer Healthcare Swisse Vitamins Pty Ltd Takeda Pharmaceuticals Australia Archer Emery & Associates Australian Pharmaceutical Publishing Co. Pty Ltd (APPco) Aztec Information Services Australia Capital K Consulting Capsugel Australia Contract Pharmaceutical Services of Australia P/L Corrs Chambers Westgarth Cube Dermatest Pty Ltd Engel, Hellyer & Partners Pty Ltd Foresight Communications Graham Perl Consulting health haus Pty Ltd H&T IMS Health Australia Pty Ltd inpharmacy Lipa Pharmaceuticals Ltd Nielsen Australia Pathway International Pty Ltd Sabinsa Australia Pty Ltd Scius Solutions Pty Ltd Sphere Healthcare Pty Ltd Sudler & Hennessey Sue Akeroyd & Associates Thomsons Lawyers UltraFeedback Pty Ltd UrsaClemenger Ward6 Xena Technologies
  8. 8. 2. OTC Industry Overview
  9. 9. The$4B Non-prescription market $Retail sales split by channel Nielsen 2012 MAT Pharmacy, 53.5% Pharmacy Online, 5.7% Supermarket, 23.9% Healthfood/CM Practitioners, 11.0% DTC/Other Online, 5.9%
  10. 10. Availability & Advertising • Over-The-Counter Medicines • Complementary Medicines • Available without prescription through a range of outlets. • Can be advertised to: – Consumers – Healthcare Professionals – Retail staff (e.g. Pharmacy Assistants)
  11. 11. 3. Regulation, Co-Regulation, Self-Regulation
  12. 12. 3 Levels of Regulation *All bound ** ASMI Members bound 1. ASMI/CHC Advertising Services Managers (pre-approvals) 2. CRP 3. Therapeutics Goods Advertising Code Council (TGACC) TGA ASMI L E V E L R E S P O N S I B I L I T Y
  13. 13. Requirements • Legislation – Therapeutic Goods Act 1989 – Therapeutic Goods Regulations 1990 – Competition and Consumer Act 2010 • Therapeutic Goods Advertising Code (TGAC) – All sponsors advertising therapeutic goods to consumers must comply • ASMI Code – Self regulatory code – all ASMI members must comply – Advertising to healthcare professionals – ‘Below-the-line’ advertising to consumers
  14. 14. Complaints Options • Regulatory options: – Formal legal – TGA (limited in terms of audience and media(?)) • Co-regulatory option: – CRP (limited in terms of audience and media) • Self-regulatory option: – ASMI Panel (limited in terms of advertisers)
  15. 15. 4. The Trimmer Group
  16. 16. The Trimmer Group - Background • There are a number of industry associations which represent different therapeutic industry sectors. • Many associations have codes of conduct which apply to members. • Not uniform coverage. • Not enforceable against non-members • Seeking a level playing field across sectors and between members and non-members
  17. 17. The Trimmer Group • Working Group on Promotion of Therapeutic Products • 2011 Report to Parliamentary Secretary Catherine King • ASMI was a member • 18 Recommendations • Government support for many of the recommendations (see TGA’s “Blueprint” from December 2011)
  18. 18. The Trimmer Group • Developed a high level statement of principles • Developed a list of essential operational areas • Developed a list of essential governance provisions • Two recommendations of particular relevance here
  19. 19. The Trimmer Group • Recommendation 2: • The working group recommends that consistency of therapeutic sector industry codes of practice be facilitated by each therapeutic industry association incorporating in its code the high level principles, operational coverage areas and governance provisions developed by the working group and detailed in Appendix B to this report. • The changes to the ASMI Code (see below) followed on from this recommendation.
  20. 20. The Trimmer Group • Recommendation 5. • The working group recommends that TGA include on its application forms (whether electronic or paper) a requirement for an applicant to nominate the relevant code of practice to which it will subscribe as a condition of registration/listing on the ARTG. • Not supported by the Government!
  21. 21. Codes of Conduct Advisory Group • An Advisory Group has been established by the TGA to “strengthen the industry’s self-regulatory framework for promotion of therapeutic goods”.[emphasis added] • Recommendations 1-4 and 8-17 of the Report of the Working Group. • Meetings took place in 2013. Looking at: – Application to non-members – Common data sets (for complaints) – Complaints portal
  22. 22. 5. 2013 changes
  23. 23. ASMI Code Changes • Fifteen separate changes. • Approved at the ASMI AGM in December 2012 (published March 2013). • To bring our Code into compliance with the recommendations of the Working Group on Promotion of Therapeutic Products. • Necessary first step in aligning the industry codes so as to facilitate a level playing field between members and non-members.
  24. 24. ASMI Code Changes • New clauses introduced in relation to: • High level principles. • Specific operational topics. • Specific governance topics. • Also revisions to existing clauses. • One complaint received in 2013 and one so far in 2014 (new sections yet to be tested).
  25. 25. 15 ASMI Code Changes 1. Panel Chair’s discretion regarding late responses (clauses 9.4.2.8, 9.4.2.9, 9.4.2.10) 2. Withstanding public scrutiny and not discrediting the industry (section 1)(clause 5.1.9) 3. Include other stakeholders in the Code review (clauses 2.3, 2.6, 2.11, 8.5) 4. Include educational events and training materials in definition of “advertisement” (section 1) 5. Include new section on “Relationships with Stakeholders” (section 1)(section 6) 6. Action to be taken on receipt of draft panel determination (clause 11.1) 7. Publication of determinations (clause 8.6) 8. Remove various references to the “Executive Subcommittee” (section 1)(clauses 8.1, 8.5, 9.2.3, 9.5.5, 11.2.4) 9. Include “digital media”, “hospitality” and “entertainment” in PMP categories (clause 12.7) 10. Formatting of clause 9.4.2.2 11. Increase “vexatious” penalty from $2,000 to $10,000 (clause 10.2.8) 12. Include explanatory note re behaviour of representatives (clause 4.4) 13. Revise section on “unbranded advertising” to “awareness activities” (clause 5.3.3) 14. Remove references to “branded” advertising (clause 5.3.2) 15. Replace “rational use of medicine” with “quality use of medicine” (clause 5.4)
  26. 26. 6. ACCC Authorisation
  27. 27. ACCC Authorisation • The ACCC can “authorise” businesses to engage in certain anti-competitive arrangements or conduct when it is satisfied that the public benefit outweighs the public detriment, including from any lessening of competition. • Typically ACCC asked to authorise: – Collective bargaining. – Codes of conduct. – Industry levies. – Certain joint ventures or alliances.
  28. 28. ACCC Authorisation • Only necessary to seek authorisation from the ACCC if there is a risk that the proposed arrangements will breach the competition provisions of the Competition and Consumer Act (CCA). • Application process. • A public consultation process informs the ACCC’s decision about the likely public benefits and detriments resulting from the arrangements.
  29. 29. Authorisation • The ASMI Code was authorised by the Trade Practices Commission in 1994 • No time limit so long as here were regular reviews and that any changes were “not significant” and did not “materially alter the circumstances of the authorisation” • “open-ended” authorisation
  30. 30. Authorisation • 2013 changes concluded the “open ended” authorisation • ASMI considered the options • ASMI did not seek ACCC authorisation
  31. 31. 7. Walk through the ASMI Code
  32. 32. ASMI Code of Practice • An example of self-regulation • Condition of membership - Applies to ASMI Members only • Incorporates & expands the TGAC • Code establishes standards of conduct. • There are 2 mechanisms to ensure adherence to the Code: • Complaints handling (ASMI Complaints Panel) • Monitoring of advertising – Promotional Monitoring Panel (PMP) • Initially adopted 8 October 1991
  33. 33. ASMI Code • Areas of historical complaint(s) • New / revised provisions for 2013
  34. 34. Structure of the code 1. Definitions 2. Introduction 3. Objectives 4. Principles of Practice 5. Advertising & Promotion 6. Relationships with Stakeholders 7. Consumer Medicine Information 8. Administration of the Code 9. Compliant Procedure 10. Sanctions 11. Right of Appeal 12. Monitoring of Advertising
  35. 35. Definitions •“Advertisement” •“Awareness activity” •“Hospitality” •“Quality Use of Medicines” •“Stakeholders” • Areas of historical complaint(s) • New / revised provisions for 2013
  36. 36. Introduction • Binding as a condition of membership (2.8) • Applied in spirit as well as the letter (2.9) • Members responsible for agents (2.10) • Quality use of medicines (2.3) • Trust, confidence, accountability (2.6) • Collaboration with stakeholders (2.11) • Areas of historical complaint(s) • New / revised provisions for 2013
  37. 37. Objectives • Basic Parameters • Communications to be accurate and responsible
  38. 38. Principles • Series of general obligations imposed on members • Familiarity with the Code and other industry requirements • Unfair or unconscionable conduct (4.1) • Comply with all Commonwealth and State legal requirements (4.2) • Comply with the TGAC (4.3.1) • Dealings with consumers (4.10, 4.11) • Explanatory note re employees and agents (4.4) • Areas of historical complaint(s) • New / revised provisions for 2013
  39. 39. Application of the Code 5.1 • General principles of advertising & promotion • Promotion to consumer & HCP’s • Current accurate, balanced, not misleading (5.1.3) • Substantiated and data to be provided upon request (5.1.4) • Prize competitions (5.1.6) • Sampling of placebos (5.1.7) • Personal incentives to recommend or supply (5.1.8) • QUM, ethical, withstand public scrutiny, not discredit (5.1.9) • Areas of historical complaint(s) • New / revised provisions for 2013
  40. 40. Application of the Code 5.2 • Comparative advertising • Must be clear what is being compared and the basis for the comparison (5.2.1) • Must not show competitor as broken, defaced, inoperative or ineffective (5.2.2)• Areas of historical complaint(s) • New / revised provisions for 2013
  41. 41. Application of the Code 5.3 • Advertising to consumers • Approval of advertisements (5.3.1) • Advertising S3’s to consumers (5.3.2) • Indirect or unbranded advertising of S3’s (5.3.3) • Awareness Activities (5.3.3) • Advertising to children (5.3.4) ……. • Areas of historical complaint(s) • New / revised provisions for 2013
  42. 42. Application of the Code 5.4 • Advertising to HCP’s • Minimum requirements (5.4.1) • Brand name reminders (5.4.2) • Areas of historical complaint(s) • New / revised provisions for 2013
  43. 43. Application of the Code 6 • Relationships with stakeholders – General (6.1) – Hospitality and entertainment (6.2) – Research and education grants (6.3) – Sponsorship of third party educational events (6.4) – Funding of patient groups (6.5) – Provision of product samples to healthcare professionals (6.6) • Areas of historical complaint(s) • New / revised provisions for 2013
  44. 44. Application of the Code 7 • Consumer Medicine Information (CMI) (7.1) • Consumer focused labelling (7.2)
  45. 45. Management of the code 8 • Administration of the code • Supervision, co-ordination, monitoring & review (8.1) • Complaints panel composition (8.4) • Annual code review (8.5) • Publications of determinations (8.6) • Areas of historical complaint(s) • New / revised provisions for 2013
  46. 46. Management of the code 9 • Complaints procedures • Principles of fairness (9.1) • General procedure (9.2) • Complaints from consumers and others outside of industry (9.3) • Industry generated complaints (9.4) • Late responses (9.4.2.8, 9.4.2.9, 9.4.2.10) • Panel procedures (9.5) • Areas of historical complaint(s) • New / revised provisions for 2013
  47. 47. 8. Change processes
  48. 48. Change process • Annual Code review. • The changes are drafted and authorised by the Marketing and Ethics Subcommittee and are released for wider consultation. • We seek feedback from non-member stakeholders as well as members. • We contact key external stakeholders directly. • The proposed changes are placed on the ASMI website with an invitation to provide comment.
  49. 49. 9. Compliance processes
  50. 50. Complaints
  51. 51. Complaints Handling • Two mechanisms: 1. CRP (co-regulation): • Covers advertising to consumers only, applies to all advertisers • Certain media only • Recommendations rather than sanctions 2. ASMI Panel (self-regulation): • Covers advertising to consumers & healthcare professionals • Applies to Members & non-members who agree to be bound • All media covered • Range of sanctions available • Anybody can lodge a complaint • Both panels publish their determinations
  52. 52. ASMI vs CRP ASMI and CRP Complaints Year ASMI CRP 2012-2013 1 (+1 appeal) 297 2011-2012 1 (+1 appeal) 373 2010-2011 5 329 2009-2010 4 294 2008-2009 4 285 2007-2008 3 275 2006-2007 3 (+1 appeal) 289 2005-2006 6 (+3 appeals) 180 2004-2005 10 (+2 appeals) 152
  53. 53. CRP Complaints • The CRP publishes a searchable complaints register • Available at: www.tgacrp.com.au • Of the most recent 171 determinations: – 156 related to non-ASMI members – 15 ( <10%) related to ASMI members (but 85% of the market) – Of those 15, 2 were found not justified
  54. 54. Promotional Monitoring Panel (PMP)
  55. 55. Promotional Monitoring Panel (PMP) • Monitoring of advertising
  56. 56. PMP Overview • Review of material not covered by Pre-Approval process – Below-the-line – Internet – Advertisements directed to Healthcare professionals • 3 meetings annually • Each category reviewed every 2 years • “digital media”, “hospitality” and “entertainment” included (clause 12.7) • Consists of – Independent Chairman – Consumer Representative – Pharmacy Representative – 2 Industry Representatives from companies with no products in categories – ASMI Representative – ASMI Advertising Services Manager
  57. 57. PMP Overview • Demonstrate the effectiveness of self-regulation of advertising • Provides guidance to member companies about compliance with TGAC and ASMI code • Independent of the ASMI Complaints Panel and does not have the power to impose sanctions for Code breaches
  58. 58. 10. Examples
  59. 59. Nurofen 2013
  60. 60. “... It’s also the relief more parents would use again3,4.” Nurofen print ad Breaches section 5.1.3
  61. 61. Nurofen print ad “Parents .... would see the reference to the footnote ... but would not ... be likely to consult that paper. Instead they would understand the advertisement to represent that the ... paper shows that more parents in Australia would use NfC again than other products suitable for fever in children, including Children’s Panadol. Since the Autret-Leca paper does not support this representation, the Panel finds the advertisement to be misleading, in breach of the Code, section 5.1.3.” [emphasis added] • What the Panel found:
  62. 62. Nurofen TVC • See separate video “Luckily you can rely on Nurofen for Children, because nothing works faster or last longer on fever – including Children’s Panadol” Breaches section 5.1.3 Breaches 4(1)(b), 4(2)(a), 4(2)(c) and 4(5) of the TGAC
  63. 63. Nurofen TVC • What the Panel found: The Panel considers that the dominant impression likely to be left upon the minds of a not insignificant number of ordinary and reasonable viewers by the television advertisement is that NfC works faster and longer on fever than Children’s Panadol. In coming to this conclusion, the Panel takes into account the advertisement as a whole, noting the emphasis, both visually and audibly, on the words “faster” and “longer” and the express reference to Children’s Panadol. [emphasis added] Since this representation is incorrect, the Panel finds the television advertisement to be misleading, in breach of section 5.1.3 of the Code and, since the audience was consumers, the Panel also finds the advertisement to have breached sections 4(1)(b), 4(2)(a) and (c) and 4(5) of the TGAC
  64. 64. Sanctions • Considered to be repeat breaches. • Undertakings required. • Remove materials from circulation. • $25,000 fine for the print ad. • $50,000 fine for the TVC. • Panel costs.
  65. 65. Nurofen 2012
  66. 66. Nurofen POS Mums told us they prefer nurofen because: “I found it great for teething.” Breaches sections 5.1.3 and 5.1.4 Breaches sections 4(1)(b), 4(2)(a), 4(2)(c), 4(5) and 4(7) of the TGAC
  67. 67. Nurofen POS • What the Panel found: Because no comparator product is identified ... the Teething Claims would be understood by consumers as representations by RB that NfC works better than any other teething products readily available on the market ... substantiation [was] not provided without delay upon request ... in breach of the Code, section 5.1.4 ... the body of scientific evidence does not establish that NfC (ibuprofen) will work better than paracetamol for infants with teething pain ... accordingly the claim is misleading, in breach of the Code, section 5.1.3. [emphasis added] A claim made in an advertisement by someone other than the advertiser cannot be verified simply by demonstrating that the person made the claim. The advertiser has the responsibility of substantiating the claim itself ... [RB] failed to substantiate the claim that NfC works better than all other teething products readily available on the market. [emphasis added]
  68. 68. Nurofen TVC • See separate video “I switched to Nurofen for Maria’s teething , as I just found it worked better.” [same outcomes as the claim in the POS] “Discover why more mums are switching to Nurofen for Children.” [see over] Breaches section 5.1.3 and 5.1.4 Breaches sections 4(1)(b), 4(2)(a), 4(2)(c), 4(5) and 4(7) of the TGAC Breaches section 5.1.4 Breaches section 4(1)(b) of the TGAC
  69. 69. Nurofen TVC • What the Panel found (re “switching”): Reasonable consumers would understand from the Switching Claim that mums in significant numbers are switching to NfC from other paediatric analgesics readily available on the market, not necessarily from all of them. Although they may not know that Children’s Panadol is the leading brand, they would know it as a very popular brand and accordingly many consumers would be likely reasonably to conclude that some mums are switching from Children’s Panadol. [emphasis added] RB does not argue before the Panel that the value scan data it provided in response to GSK’s request for substantiation supports the Switching Claim and the Panel finds that it does not ... the Panel does not regard the volume scan data provided in response to GSK’s formal complaint as establishing switching to NfC from Children’s Panadol. The evidence of switching in two statutory declarations is insufficient to support the Switching Claim as it is likely to be understood by reasonable consumers. Accordingly the claim, when made, had not been substantiated, in breach of the Code, section 5.1.4 and TGAC section 4(1)(b) and evidence of substantiation was not provided without delay upon request, in breach of the Code, section 5.1.4. [emphasis added]
  70. 70. Sanctions • Considered to be moderate breaches. • Undertakings required. • Remove materials from circulation. • $10,000 total fine for both POS and TVC • Panel costs.
  71. 71. Zyrtec 2011
  72. 72. Zyrtec Print Advertisement
  73. 73. Zyrtec Print Advertisement “Zyrtec® is over twice as effective as Claratyne® at relieving the combined symptoms of hayfever” The Panel considered that the claim (together with the four referenced studies) would be understood by reasonable readers of Postscript as representing that the claim had been separately substantiated by each of the four referenced studies. The Panel noted that one of the studies was a 1-day study over 6 hours and that the other three were 2-day studies. The Panel considered that the four studies were too short to substantiate the claim, which would reasonably be understood to refer to the usual or average span of a hayfever episode. The Panel found the claim to be in breach of the Code, sections 5.1.3 and 5.2 and the TGAC, sections 4(1)(b), 4(2)(c), 4(4) and 4(5). [emphasis added] Breaches sections 5.1.3 and 5.2 Breaches sections 4(1)(b), 4(2)(c), 4(4) and 4(5) of the TGAC.
  74. 74. Zyrtec Print Advertisement “9/10 people who use Zyrtec® are satisfied” The Panel considered that, since “satisfied” was not defined in the headline, the reader was likely to look for what followed as providing an explanation. Accordingly, the headline was likely to be read by pharmacy assistants, acting reasonably, in conjunction with the efficacy claims. The wording of the footnote, if taken into account at all, given the fine print in which it appeared, was unlikely to dispel the impression created by the advertisement as a whole that the reason why 9/10 people were satisfied with Zyrtec® was because of its superior efficacy. The Panel found that since the survey did not explore respondents’ reasons, the claim was misleading and in breach of the Code, section 5.1.3 and the TGAC, section 4(2)(c). [emphasis added] Breaches section 5.1.3 Breaches section 4(2)(c) of the TGAC.
  75. 75. Internet Advertising
  76. 76. Zyrtec Internet Advertising “Zyrtec® is over twice as effective as Claratyne® for treating allergic rhinitis” The Panel noted that the claim was referenced to a single study which addressed Seasonal Allergic Rhinitis. The Panel also noted that the term “allergic rhinitis” (as used in the claim) was a collective term that included Seasonal Allergic Rhinitis and Perennial Allergic Rhinitis. The Panel found that the single study (quite apart from its insufficient duration) provided no support for a comparative superiority claim in relation to “allergic rhinitis”. The Panel found the claim to be in breach of the Code, sections 5.1.3 and 5.2 and the TGAC, sections 4(1)(b), 4(2)(c), 4(4) and 4(5). [emphasis added] Breaches sections 5.1.3 and 5.2 Breaches sections 4(1)(b), 4(2)(c), 4(4) and 4(5) of the TGAC
  77. 77. Same claim – different executions “Zyrtec® can be used for extended periods and continues to be effective over time” [Postscript] “Zyrtec® can be used for extended periods and will continue to be effective over time” [website] The Panel considered the claim, as presented on the website, not to be a comparative claim and accordingly found it not to breach the Code or the TGAC. The Panel found that the claim, as presented in Postscript, would be likely to convey to pharmacy assistants, acting reasonably, the incorrect representation that only one brand, Zyrtec®, “can be used for extended periods and continues to be effective over time”. The Panel found that a reasonable person’s interpretation of the claim would be that although no other competitor product was mentioned, it was an implied comparative superiority claim. The Panel noted that there was no comparative data to suggest that other antihistamines cannot be used long term. The Panel found the claim in Postscript to be in breach of the Code, sections 5.1.3 and 5.2 and the TGAC, sections 4(2)(c) and 4(5).
  78. 78. Sanctions • Considered to be Moderate (but Repeat) breaches. • Undertakings required. • Retractions to be published. • $40,000 total fine. • Panel costs.
  79. 79. 11. Advertising Reforms
  80. 80. Advertising reforms What has happened: • Consultation closed July 2013. • TGA attempted to confine discussion. • Not an open process and in ASMI’s view most of the proposals were unsuitable. Next steps: • Waiting on the TGA’s response.
  81. 81. Eight proposals • Alternatives to the pre-approvals scheme. • Complaints handling process. • Provisions of advice to the TGA. • Investigation and enforcement powers. • Advertising of higher risk devices. • Advertising directed to healthcare professionals. • Advertising of pharmacist-only medicines. • The Price Information Code of Practice.
  82. 82. 12. Non-members
  83. 83. Non-members • Only bound by the Act, the Regulations and the TGAC • Which only cover certain audiences • Which only cover certain media • Solutions?
  84. 84. Questions? Steve Scarff Regulatory & Scientific Affairs Director Email: steve@asmi.com.au Phone: (02) 9923 9406

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