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Key Areas to be Covered

Key Areas to be Covered . Overview of advertising arrangements The Review - New Advertising Arrangements The Approval Process Complaints about advertisements of therapeutic goods. Advertising - What and to Whom?. Consumers Unscheduled, S2, some S3 and devices Healthcare professionals

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Key Areas to be Covered

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  1. Key Areas to be Covered • Overview of advertising arrangements • The Review - New Advertising Arrangements • The Approval Process • Complaints about advertisements of therapeutic goods

  2. Advertising - What and to Whom? • Consumers • Unscheduled, S2, some S3 and devices • Healthcare professionals • Entire spectrum

  3. The Legislation • Trade Practices Act • Broadcasting Services Act • Therapeutic Goods Act and Regulations

  4. The Trade Practices Act 1974 • Commercial conduct in general • prevents misleading marketing practices • prevents restrictive trade practices • Consumer safety and protection • standards for product safety and information

  5. The Broadcasting Services Act 1992 • Advertisements relating to medicines • Delegation of approval function • PMAA since 1991

  6. The Therapeutic Goods Act 1989 • Major legislative control • Uniformity across States and Territories • ARTG • Parts of TGAC incorporated

  7. How to identify therapeutic goods • Therapeutic claims • Product Categories • Listable AUST L • Registrable AUST R • Exempt

  8. Definition of Advertisement • Any statement, pictorial representation or design • Intended to, whether directly or indirectly to • Promote the use or supply of goods • Product labels - a form of advertising

  9. Amendment 40018 December 1997 • Defining the TGACC • Complaints Resolution Panel

  10. Amendment 400 - Advertising • Definining mainstream media • Formal approval - approval number • Responsibility of sponsor/advertiser • Responsibility of publishers (42D)

  11. The Therapeutic Goods Advertising Code Council today • Manufacturing and supply Industry • Advertisers • Healthcare professionals • Consumers • Government • Observers

  12. Formal Approval of Advertisements • Delegation of approval function to industry • CHC: print ads for complementary healthcare products • PMAA: non-prescription medicines • Appeals mechanism for non-approved ads

  13. The Complaints Resolution Panel • Members • Consumers • Healthcare professionals • Government • Industry • Complaints about print advertisements • No similar mechanism for broadcast ads

  14. Self-regulatory Arrangements • Non-mainstream advertising • Industry bridges the gap • CRC of CHC • Complaints Panel of PMAA

  15. Summary • 3 Main pieces of legislation • Therapeutic Goods Act and Regs • TGACC and CRP • Formal approval legislated • Approval delegated to Industry

  16. Key Areas • Overview of advertising arrangements • The Review - New Advertising Arrangements • The Approval Process • Complaints about advertisements of therapeutic goods

  17. NEW ADVERTISING ARRANGEMENTS

  18. Areas to Be Covered • Overview of reform process • The new Therapeutic Goods Advertising Code • “The Guidelines” • Overview of regulatory reforms

  19. The ReviewReforms Since 1998 • The Govt/Industry Working Party • Regulation of complementary healthcare products • Deficiencies of the old TGAC • Restricted-product indications/information • Emphasis on illness and disease • Not reflecting current values

  20. Agreement for New Code • Greater orientation towards health and well-being • Greater range of permissible representations in advertising • Ensuring a level playing field • Deregulation without compromising public health and safety

  21. The Broader Context of the Review • Office of Complementary Medicines • Elevating the status of CMEC • Major reform of ELF

  22. Objectives of the Review • Start new Code with clean sheet • Principle based Code • New Code to reflect current values • User-friendly, practical, all in one document • Evergreen - requiring minimum legislative amendments

  23. Objectives (continued) • Clarify issues relating to claim substantiation • Starting point- all existing permissible representations • Strengthening the TGA’s ability to act: timeliness and teeth • Deregulatory approach without compromising public health and safety

  24. The Review Process • TGACC to oversee the Review • Task Force: • CHC, CMEC, CHF, PMAA, TGA, APMA • ASM’s

  25. Guidelines for Levels of Evidence • Sponsors required to hold evidence - April 99 amendment • Need for guidance indentified • CMEC and Working Party developed guidelines

  26. Summary • Contemporary and flexible Code • Legislative underpinning for the Code • Extended range of claims • Guidelines for substantiating evidence • Safeguards for consumers • Regulatory amendments to underpin changes

  27. Tracking Progress • Overview of reform process • The new TherapeuticGoods Advertising Code • “The Guidelines” • Overview of regulatory reforms

  28. Rationale - Outcomes • Clean sheet • Principle based • Open to interpretation - flexible • Evergreen • Consistency across all media • Reflect current social values

  29. Clause 1- Object of the Code • The key elements: • Socially responsible marketing and promotion • Desired outcome-Quality use of medicines • WHO Ethical Criteria (Appendix 1) • Context and total presentation of ads - interpretation and application

  30. Clause 2 - Definitions • Advertisement • Label • Mainstream media • Healthcare professional (Appendix 2) • Sponsor • Therapeutic goods and therapeutic use

  31. Clause 3 - Compliance and Application • Compliance with TPA, Therapeutic Goods Act and other legislation • Consumer ads - entire Code applies • Healthcare professional ads (Appendix 2) - industry codes

  32. Clause 3 (contd) • Information - generic or branded • Advertisement - generic or branded • Bona fide news, public interest - Code does not apply • Mainstream ads - formal approval (Appendix 3)

  33. Clause 4 - Principles • Clause 4.1- General • 4.1.1Ads for therapeutic goodsmust: (a) Comply with the statute and common law (b) Contain correct and balanced statements and claims already verified.

  34. Clause 4.1 (continued) • Clause 4.1.2 Ads must not: (a) arouse unwarranted expectations (b) lead to inappropriate self-diagnosing and treatment (c) mislead directly or indirectly (d) abuse trust, exploit, bring about fear or distress (e) lead to belief that consumer is suffering from serious ailment or harm coming to consumer

  35. Clause 4.1.2 (continued) (f) inappropriate or excessive consumption (g) infallible, unfailing, magical, a certain, guaranteed or sure cure (h) effective in all cases of a condition (i) safe, no harm, no side-effects (j) directed to minors, except for those goods in Appendix 5

  36. Appendix 5 • Therapeutic goods not subject to Clause 4.1.2 (j) • tampons • topical preparations for acne • sunscreens SPF 15+ • condoms and personal lubricants • bandages and dressings • devices for management for chronic conditions under medical supervision

  37. Clause 4.2 - Scientific Information • Accurate, balanced, not misleading • Appropriate terminology, readily understood • Research results to identify researcher or sponsor

  38. Clause 4.3Comparative Advertising • Balanced, not misleading • Factual, reflect body of scientific evidence • Competitor product harmful or ineffectual

  39. Clause 4.4 - Professional Recommendation • Clause 4.4.1- endorsement not permissible by: • government agency or healthcare professional • except for availability - place and price

  40. Clause 4.4.2 - Endorsement Permitted • Bodies or associations, under certain conditions: • body or association named • authenticated • nature disclosed • valuable consideration disclosed

  41. Clause 4.5 - Testimonials • Must not breach Code • Documented, genuine, not misleading • Exceptional cases not depicted as typical

  42. Clause 4.6 - Samples • Advertisements may not contain offer of sample

  43. Clause 5 - Prohibitions • Clause 5.1 No references allowed: • Appendix 6 Part 1: • Abortifacient action • Neoplastic disease • STD’s • HIV/AIDS • Mental illness

  44. Clause 5 & Appendix 6 • Clause 5.2 Restricted representations • References allowed on prior approval from TGA • Appendix 6 Part 2: • Table 1: Serious manifestations of diseases

  45. “Serious” Defined • Inappropriate to be diagnosed and/or treated without consulting a healthcare professional • Beyond the ability of the average consumer to evaluate and treat accurately without supervision by a healthcare professional

  46. Permissible Representations - The Glossary • Examples of currently permissible representations • New representations added in future

  47. Clause 6 - Minimum Requirements • Clause 6.1 Ads of unbranded therapeutic goods • Only 6.2 (b) applies (plus rest of Code)

  48. Clause 6 - branded ads • Trade name • Approved indications • Ingredients OR ‘mandatory’(not direct marketing & Internet) • “Use only as directed” • For symptom relief: ‘mandatory’ • Advertisable S3’s - ‘mandatory’

  49. Clause 7 - Specific Categories • Clause 7.1 - Analgesics • Applies to ‘primary’ internal analgesics • One of 2 mandatory statements in all media • Not permissible: • safe • relax, relieve tension, sedate or stimulate

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