Download the PAGB Codes of Advertising Practice

หลักเกณฑ ์การโฆษณายาในต่างประเทศ
และคณะทางานด้านการกากับดูแลโฆษณาของ
่
สมาคมอุตสาหกรรมเภสัชภัณฑ ์เพือการดู
แลสุขภาพระดับโลก (WSMI)
Worldwide Regulation & WSMI Advertisement Taskforce
ภก. ดร. นพดล อ ัจจิมาธีระ
Dr Noppadon Adjimatera
ASEAN & South Asia Regional Regulatory and Medical Affairs Director,
Reckitt Benckiser, Thailand
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CONTENT
• Characteristics of OTC advertisement
• Comparison & analysis of advertising regulatory models
• Example of OTC advertising regulation – UK
• Example of OTC advertising regulation – US
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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
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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
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CHARACTERISTICS OF NON-PRESCRIPTION
(OTC) MEDICINES ADVERTISING
OTC vs Consumer Goods
OTC vs Rx products
•
Approved ingredients & claims
are basis for advertising
message
•
Language used must be
consumer-friendly, but still
technically accurate
•
Strict requirements around
product usage (as directed, do
not exceed) and product
labeling
•
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)
•
Bigger creative challenge as
people are not well (no big
promise).
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COMPARISON & ANALYSIS OF
ADVERTISING REGULATORY
MODELS
• Conduct by WSMI (World self-medication industry) worldwide
to understand:•
•
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Advertising –facts & myths
Regulation –aims & best practice principles
Models & elements of advertising controls
An approach to analysing & assessing advertising regulatory
frameworks
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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”
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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
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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
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MODELS OF
ADVERTISING CONTROLS
• Default regulatory position
• Point of regulatory intervention
• Parties involved in controls
• Media covered
• Codes & guidelines
• Complaints mechanisms
• Penalties & sanctions
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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
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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
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PARTIES UNDERTAKING
COMPLIANCE
• Government regulation
• Industry self-regulation
• Combination –co-regulation
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OVERVIEW OF ADVERTISING CONTROL MEASURES
Precontrol
Post-event
surveillance
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Argentina
Australia
Austria
Belgium
Canada
Chile
China
Colombia
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Cyprus
Czech Republic
Germany
Greece
Hungary
India
Ireland
Govt./public control
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Croatia
France
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Bulgaria
Finland
Co-regulation
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Brazil
Denmark
Selfregulation
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OVERVIEW OF ADVERTISING CONTROL MEASURES
Precontrol
Post-event
surveillance
Selfregulation
Co-regulation
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Italy
Govt./public control
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Japan
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Lithuania
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Mexico
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Netherlands
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New Zealand
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Norway
Philippines
Poland
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Portugal
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Romania
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Russia
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Slovak Republic
Slovenia
Spain
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Sweden
Switzerland
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Thailand
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N/A
N/A
Turkey
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N/A
N/A
N/A
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Ukraine
United Kingdom
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United States
Venezuela
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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-theline & advertisements
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CODES & GUIDELINES
• Industry codes of practice
• Voluntary
• Mandatory
• Codes underpinned in regulations
• Models: principles-based or detailed/prescriptive
• Guidelines: greater flexibility, less certainty
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COMPLAINTS MECHANISMS
•Underpinned in regulation
•Part of industry codes of practice
•Combination: different mechanisms for different media
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PENALTIES & SANCTIONS
• Withdraw/don’t repeat
• Retraction/corrective statements
• Fines
• Suspension or cancellation of authorisation
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CONCLUSION
• All models have strengths & weaknesses
• Global trend:
• Self-& co-regulatory controls
• Government post-market surveillance
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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.
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MHRA GUIDANCE NOTES
Implementation
www.mhra.gov.uk
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www.pagb.org.uk
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www.clearcast.co.uk
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)
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PAGB GUIDANCE NOTES
Non-prescription (OTC) medicines
www.pagb.org.uk
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ine
Proprietary
of Great Britain
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.
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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.
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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.
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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.
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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.
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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.
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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.
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UK MEDICINES ADVERTISEMENT COMPLAINTS
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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
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FDA ROLE IN OTC ADVERTISING


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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
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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
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FTC/FDA INTERACTION
Two agencies have overlapping authority over OTC
drug marketing
Longstanding liaison agreement
• FDA: Labeling
• FTC: Advertising
Staffs of agencies coordinate closely
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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
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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”
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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
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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
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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?
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* Fine print footnotes are not adequate disclosures.
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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
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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.
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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.
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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.
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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.
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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
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QUESTIONS ?
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