หลักเกณฑ์การโฆษณายาในต่างประเทศ

1. หลักเกณฑ์การโฆษณายาในต่างประเทศหลักเกณฑ์การโฆษณายาในต่างประเทศ และคณะทำงานด้านการกำกับดูแลโฆษณาของสมาคมอุตสาหกรรมเภสัชภัณฑ์เพื่อการดูแลสุขภาพระดับโลก(WSMI) Worldwide Regulation & WSMI Advertisement Taskforce ภก. ดร. นพดล อัจจิมาธีระ Dr Noppadon Adjimatera ASEAN & South Asia Regional Regulatory and Medical Affairs Director, Reckitt Benckiser, Thailand

2. Content • Characteristics of OTC advertisement • Comparison & analysis of advertising regulatory models • Example of OTC advertising regulation – UK • Example of OTC advertising regulation – US

3. KEY AIMS OF ADVERTISING • Raise & maintain awareness • Conditions • New & existing treatment options • Create brand recognition which supports product selection • Reinforce Quality Use of Medicines (QUM) messages • Encourage consumers to seek further info • Stimulate competition

4. LIMITATIONS OF ADVERTISING • Awareness creation tool, not educational tool • Volume of info critical: “less is more” • Purpose: attract attention, offer choices & encourage consumers to seek more information

5. CHARACTERISTICS OF NON-PRESCRIPTION (OTC) MEDICINES ADVERTISING OTC vs Consumer Goods OTC vs Rx products • Approved ingredients & claims are basis for advertising message • Strict requirements around product usage (as directed, do not exceed) and product labeling • Bigger creative challenge as people are not well (no big promise). • Language used must be consumer-friendly, but still technically accurate • Higher cost and shorter time to communicate • Single message delivery • Ads must create connection to consumers or match their experience to get their interest (not a textbook)

6. COMPARISON & ANALYSIS OF ADVERTISING REGULATORY MODELS • Conduct by WSMI (World self-medication industry) worldwide to understand:- • Advertising –facts & myths • Regulation –aims & best practice principles • Models & elements of advertising controls • An approach to analysing & assessing advertising regulatory frameworks

7. OBJECTIVES OF REGULATIONS • Encourage desired behaviour and/or discourage unacceptable conduct • Create a level playing field for competitors • Maintain public confidence • Wall Street Journal headline: “The purpose of regulation is compliance, not punishment”

8. PRINCIPLES OF BEST-PRACTICE REGULATION • Clarity in terms of requirements • Targeted to address specific & legitimate concerns • Restrictions directly linked to verifiable outcomes • Minimum necessary to achieve the stated objectives • Neither favour nor constrain market participants to compete • Processes & procedures impartial & not self-serving • Regular review to ensure effectiveness

9. CRITERIA FOR ANALYSING & ASSESSING REGULATORY MODELS • Clarity & consistency in relation to requirements • Consistent with the risks posed • Effective in ensuring compliance • Universal to ensure level playing field • Timeliness in responding to non-compliance • Fair & afford natural justice • Cost-effective • Transparency & public awareness • Simple, streamlined and user-friendly processes

10. MODELS OF ADVERTISING CONTROLS • Default regulatory position • Point of regulatory intervention • Parties involved in controls • Media covered • Codes & guidelines • Complaints mechanisms • Penalties & sanctions

11. DEFAULT REGULATORY POSITION • From most restrictive/least ideal to least restrictive/ideal: • No advertising of OTCs permitted • OTC advertising not permitted, but with some exceptions • OTCs advertisable, but with some exceptions • All OTCs advertisable

12. POINT OF REGULATORY INTERVENTION • Pre-market: • At market authorisation • Pre-approval of ads • Post-market: • Reviews/audits: comprehensive, random, regular, ad hoc, complaints driven • Combination of pre-& post-market compliance measures

13. PARTIES UNDERTAKING COMPLIANCE • Government regulation • Industry self-regulation • Combination –co-regulation

14. Overview of advertising control measures

15. Overview of advertising control measures

16. MEDIA COVERED BY CONTROLS • All advertisements/all media: above-the-line & below-the-line advertisements • Only high impact above-the-line/mainstream advertising • Different compliance measures for above-the-line & below-the-line & advertisements

17. CODES & GUIDELINES • Industry codes of practice • Voluntary • Mandatory • Codes underpinned in regulations • Models: principles-based or detailed/prescriptive • Guidelines: greater flexibility, less certainty

18. COMPLAINTS MECHANISMS •Underpinned in regulation •Part of industry codes of practice •Combination: different mechanisms for different media

19. PENALTIES & SANCTIONS • Withdraw/don’t repeat • Retraction/corrective statements • Fines • Suspension or cancellation of authorisation

20. CONCLUSION • All models have strengths & weaknesses • Global trend: • Self-& co-regulatory controls • Government post-market surveillance

21. OTC ADVERTISING REGULATION GUIDELINEIN UK • Policy level: Organization that are involved in the control of OTC medicines advertising are: • The Medicines and Healthcare Products Regulatory Agency (MHRA) • The Committee of Advertising Practice (CAP) • The Advertising Standards Authority (ASA) • Operation level: Trade association related to the control of OTC medicines advertising is PAGB (Proprietary Association of Great Britain) • PAGB is the UK trade association for manufacturers of branded over-the-counter medicines and food supplements. • Primary aim is to promote responsible self-medication to consumers and professionals. • Provides advice to its member companies on all aspects of regulations, including advertising regulations and the PAGB Codes of Advertising Practice.

22. MHRA Guidance Notes Implementation www.mhra.gov.uk www.pagb.org.uk www.clearcast.co.uk

23. CONTENT OF OTC ADVERTISEMENT • Advertisements should contain information that is reliable, accurate, truthful, informative, balanced, up-to-date, capable of substantiation and in good taste. They should not contain any misleading or unverifiable or omissions likely to induce medically unjustifiable use or to give rise to undue risks. • Advertising to the general public (consumer) • Advertising to the pharmacists, doctors, and wholesalers (professional)

24. PAGB Guidance Notes Non-prescription (OTC) medicines www.pagb.org.uk Proprietary Association of Great Britain

25. PAGB CODES OF ADVERTISING PRACTICE • PAGB can offer guidance on the roles of the various bodies involved in the control of OTC medicines advertising. • PAGB maintains a working relationship with each of the following organisations: • Medicines and Healthcare products Regulatory Agency (MHRA); • Committee of Advertising Practice (CAP); • Advertising Standards Authority (ASA); • Office of Communications (Ofcom); • Broadcast Advertising Clearance Centre (BACC); • Radio Advertising Clearance Centre (RACC) • This allows PAGB to provide a consistent and reliable approval system which takes into account the concerns of both regulators and self-regulators. • PAGB may, at its discretion, request the views of any of the above organisations before approving advertising copy.

26. PAGB CODES OF ADVERTISING PRACTICE • These codes outline a set of standards with which member companies are required to comply. To be ensure that the self-medication advertising for both consumer and professionals • Cover • Advertising materials which are aimed at consumers and those persons who may legitimately purchase medicines on behalf of another consumer • All branded, promotional materials over which the company has full editorial control.

27. PAGB CODES OF ADVERTISING PRACTICE • Does not cover • claims related to the price of the product. • public relations (PR) materials. • materials which are aimed at third parties. • The only PR materials which require PAGB approval are press releases intended for use on the Internet. • PR is covered by the Medicines (Advertising) Regulations • corporate sponsorship. • product labels, packaging materials and in-pack leaflets. These must be submitted to the MHRA for approval. • legal notices and disclaimers included on websites • advertising aimed at persons qualified to prescribe or supply medicines, or to their employees. • advertising of food supplements.

28. PAGB CODES OF ADVERTISING PRACTICE General principles • The PAGB Consumer Code applies to advertising which is aimed directly at consumers and those persons who may purchase medicines on behalf of a consumer. • A medicine must not be promoted to consumers prior to the granting of the Marketing Authorisation. • Shall be true and shall not mislead. Not contain any exaggerated claims, either direct or implied. • Not bring the OTC medicines industry into disrepute, nor shall it undermine or prejudice consumer confidence in medicines. • Use language which can be understood by the consumer. The use of medical terminology is acceptable, but should not confuse or mislead the consumer. • Advertising shall be clearly distinguished from editorial matter. • Advertising shall not cause consumers unwarranted anxiety with regard to any ailment.

29. PAGB CODES OF ADVERTISING PRACTICE General principles (cont.) • Advertising shall not suggest that health could be adversely affected if the consumer chooses not to use the medicine(s) featured. • Advertising can only refer to the prevention of symptoms and the use of a product in chronic conditions, if this is in line with the Summary of Product Characteristics. • Advertising shall not contain material which could lead to consumers making an erroneous self-diagnosis. • Advertising shall not discourage consumers from seeking medical or pharmacy advice. Nor shall it suggest that a consultation or surgical operation is unnecessary. • Advertising shall not offer to diagnose, advise, prescribe or treat personally by correspondence. • Care should be taken not to encourage, either directly or indirectly, the indiscriminate, unnecessary or excessive use of any medicine. • Advertising shall not claim or imply, that a product’s effects are guaranteed. • Advertising shall not state or imply that a product is licensed.

30. PAGB CODES OF ADVERTISING PRACTICE Comparative advertising • All comparisons shall be balanced, fair and supportable. • Advertising shall not unfairly denigrate or discredit, either directly or by implication, a competitor product, ingredient or treatment type. • Advertising shall not suggest that a product’s effects are better than or equal to another identifiable product or treatment. • Advertising shall not state that a product does not contain an active ingredient or ingredients used in competitor products. • Brand names of products of other companies shall not be used without permission of the owner. • Hanging comparisons shall not be used. • Supportable top parity claims are acceptable. Such claims will remain valid until another product in the therapeutic category can prove objective superiority. • Superiority claims shall not be used, unless supported by direct comparative tests or other demonstrations.

31. PAGB CODES OF ADVERTISING PRACTICE Health professionals • Advertising shall not state or imply that a product is recommended by or used by a health professional or scientist (e.g. a doctor, dentist, pharmacist, nurse or midwife). • Advertising shall not claim that a product is, or has been available on prescription • Advertising shall not refer to a ‘college’, ‘hospital’, ‘clinic’, ‘institute’, ‘laboratory’ or similar establishment, unless the establishment genuinely exists. • Celebrities: Advertising shall not include a recommendation by a person who, because of their celebrity, may encourage consumers to use a medicine. • Children:Advertising shall not be aimed principally or exclusively at children. Shall not show children using, or within reach of, medicines without adult supervision. • Testimonials • Testimonials shall comply with the other principles of this Code. • Testimonials shall be less than three years old and be the genuine views of the user. • A health professional or celebrity shall not be identified as the writer of a testimonial.

32. UK MEDICINES ADVERTISEMENT COMPLAINTS

33. OTC ADVERTISING REGULATION GUIDELINEIN USA • Organization that are involved in the control of OTC medicines advertising are: • Food & Drug Administration (FDA) • Federal Trade Commission (FTC) • Broadcasting networks • Trade association related to the control of OTC medicines advertising is CHPA (Consumer HealthCare Products Association) • CHPA is the USA trade association for manufacturers of branded over-the-counter medicines • Primary aim is to promote responsible self-medication to consumers and professionals. • National Advertising Division(NAD) • self regulation censorship for Ads

34. FDA ROLE IN OTC ADVERTISING • FDA control mainly OTC labeling, not advertising • Primarily FTC, not FDA, will investigate • FDA will provide advertising/promotional material to FTC along with an explanation and data that is relevant to the claim • MOU (Memorandum of Understanding) allows interagency sharing of confidential information • Usually a follow-up call or e-mail • Any additional data to support the advertising /promotional claim sent to FTC, not FDA

35. THE FTC SETS THE FOUNDATION • National advertisers must meet the FTC standard of truthful and not misleading advertising claims • All material claims must be substantiated by a reasonable basis of support • Health-related claims require the highest level of reliable and competent support because consumers cannot always judge product performance for themselves • Advertisers must have evidence to back up their claims • Establishment claims that mention a test or survey must have that specific support • The ads cannot make unfair comparisons

36. FTC/FDA INTERACTION • Two agencies have overlapping authority over OTC drug marketing • Longstanding liaison agreement • FDA: Labeling • FTC: Advertising • Staffs of agencies coordinate closely

37. FTC Advertising Law Basics • Primarily a law enforcement agency • Broad liability: advertiser, ad agency, endorser … • Wide variety of remedies: warning, injunction, refunds, disgorgement of profits, corrective advertising … • Administrative or Federal courts

38. FTC Advertising Law Basics • Section 5 of FTC Act: prohibits unfair or deceptive acts or practices An act or practice is deceptive if it misleads consumers acting reasonably under circumstances and is material to the purchase/use decision • Section 12: prohibits any “false advertisement” that is “misleading in a material respect”

39. FTC Advertising Law Basics Two basic principles: 1. Advertising must be truthful and not misleading 2. Objective claims must be substantiated before they are made

40. FTC AD LAW BASICS – AD MEANING • Apply a “reasonable consumer” standard • Look at both express and implied claims: what is overall “net” impression of the ad • There may be more than one reasonable interpretation of an ad • Ad may need to disclose “material” information, i.e., info affecting purchase/use decision

41. FTC Ad Law Basics: Disclosures “Clear and conspicuous”* • Prominence: Is it big enough for consumers to notice and read? • Presentation: Is wording and format easy for consumers to understand? • Placement: Is it where consumers look and near the claim it qualifies? * Fine print footnotes are not adequate disclosures.

42. Network Review and Approval • 4 major and many cable networks have Broadcast Standards Departments • published guidelines apply to TV and radio • “white coat” restriction • “follow label directions,” “occasional use” requirements • Review of storyboards first, then finished ads • Formal Challenge Process • note: Federal Communication Commission sets decency standards but does not regulate advertising • for programming between 6 a.m.-10 p.m. • exceptions: children’s programming and political advertising

43. OTC ADVERTISING REGULATION GUIDELINEIN MALAYSIA Laws and codes of practice govern the advertising of medicinal products Statutory Law • The Medicines (Advertisement & Sale) Act 1956 (“1956 Act”) • Medicine Advertisement Board Regulations 1976 (“1976 Regulations”) • Guidelines on Medical Products and Appliances (“MAB Guidelines”) • Medicine Advertisements Guideline for Public Information by Private Hospitals, Clinics, Radiological Clinics and Medical Laboratories. Codes of Practice • The Malaysian Communications & Multimedia Content Code (“Content Code”), applies to advertisements communicated electronically. • Malaysian Code of Advertising Practice (“MCAP”), administered by the Malaysian Advertising Standards Authority (“ASA”), applicable to print advertisements. • The Code of Pharmaceutical Marketing Practices for Prescription (Ethical) Products (“PhAMA Code”), applies to interactions of pharmaceutical companies with healthcare professionals. • Cosmetic Advertising Code (“CAC”), provides guidance to the cosmetics industry.

44. GUIDELINES ON MEDICAL PRODUCTS AND APPLIANCES – MALAYSIA General Principles Impressions of Professional Advice or Endorsement • Advertisements should not contain statements and/or have any visual and/or audio presentation of doctors, dentists pharmacists, scientists, nurses and other paramedics, etc., which give the impression of professional or scientific advice, recommendation or endorsement. • Advertisements should not contain statements or visual presentation which is, or likely to be interpreted to be contrary or offensive to the standard of morality or decency prevailing in the Malaysian society. • Advertisements should not contain anything, which might lead or lend support to acts of violence, or criminal or illegal activity.

45. GUIDELINES ON MEDICAL PRODUCTS AND APPLIANCES – MALAYSIA General Principles (cont.) • Trust, Fear or Superstition; Advertisements should not :- • be so framed as to abuse the trust of the consumer or exploit his lack of experience or knowledge. • without justification play on fear • play on superstition or exploit the superstitious. • directly or by implication exploit the religious requirement/beliefs of any community • Advertisement should not, without justifiable reason, show or refer to dangerous practices or manifest a disregard for safety. • Advertisements should not contain any statement disparages either the medical profession or the value of professional attention and treatment or another product. • Advertisements should not discredit or unfairly attack other products, advertisers or advertisements directly or by implications.

46. GUIDELINES ON MEDICAL PRODUCTS AND APPLIANCES – MALAYSIA General Principles (cont.) • Advertisements addressed to children or young people, or likely to be seen by them, should not contain anything, which might result in harming them physically, mentally, or morally, or which exploits their credulity, their lack of experience or their natural sense of loyalty . • Advertisements should not mislead the consumer. • All descriptions, claims and comparisons which relate to matters of objectively ascertainable facts should be capable of substantiation • Reference expressly or by implication to test, trials, research and the like may only be used if they are fully substantiated by authoritative evidence acceptable by the Medicine Advertisements Board.

47. GUIDELINES ON MEDICAL PRODUCTS AND APPLIANCES – MALAYSIA General Principles (cont.) • No advertisement for a product may include a testimonial by • a professional or scientific association, body or organization • a person well-known in public life, sport, entertainment, professional or scientific bodies, associations, organizations etc • Name of Product or Brand Name: • term “Doctor” or “Dr.” is not acceptable unless the product was marketed under the name prior to 1st. July, 1977. • should not indicate or imply its effectiveness or superior quality. • should not highlight the name of manufacturer or foreign country of origin

48. Questions ?