??????????????????????????????????? ??????????????????????????????????????????????????? (WSMI)

1
??????????????????????????????? ??????????????????
?????????????????????????????????????????????????
??????????????????? (WSMI) Worldwide Regulation
WSMI Advertisement Taskforce ??. ??. ????
??????????? 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
        Pre- control Post-event surveillance   Self-regulation Co-regulation Govt./public control
Argentina     ?       ?
Australia   ? ?   ? ? ?
Austria     ?   ?    
Belgium   ?         ?
Brazil     ?   ?   ?
Bulgaria   ?         ?
Canada   ?     ?    
Chile   - -   ?    
China         ?    
Colombia   ?          
Croatia     ?   ?    
Cyprus     ?       ?
Czech Republic   ?     ?   ?
Denmark   ? ?       ?
Finland   ?     ?    
France   ?         ?
Germany     ü   ü   ü
Greece   ? ?   ?   ?
Hungary   ? ?   ? ?  
India     ?   ? ? ?
Ireland     ?   ?   ?
15
Overview of advertising control measures
        Pre- control Post-event surveillance   Self-regulation Co-regulation Govt./public control
Italy   ?         ?
Japan     ?   ?   ?
Lithuania     ?       ?
Mexico   ?     ?   ?
Netherlands   ?     ?    
New Zealand ? ?
Norway     ?   ?   ?
Philippines              
Poland     ?   ?   ?
Portugal     ?   ?   ?
Romania   ? ?       ?
Russia     ?   ?   ?
Slovak Republic     ?   ?   ?
Slovenia         ?   ?
Spain   ?         ?
Sweden     ?   ?    
Switzerland   ?     ?   ?
Thailand   ? ?       ?
Turkey   N/A N/A   N/A N/A N/A
Ukraine             ?
United Kingdom   ?     ?    
United States     ?   ?   ?
Venezuela   ?         ?
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/dont 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 GUIDELINE IN 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
  products 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 products
  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 GUIDELINE IN 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 childrens programming and political
  advertising

43
OTC ADVERTISING REGULATION GUIDELINE IN 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 ?