guideline on advertising of medicines and medicinal products to ...

GUIDELINE ON ADVERTISING OFMEDICINES AND MEDICINAL PRODUCTS TO CONSUMERS

2ND APRIL 2013

AHMAD ZUHRI BIN MD ALIASSISTANT DIRECTOR

SECRETARIAT MEDICINE ADVERTISEMENT BOARD

03-78413346 / [email protected]

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INTRODUCTION

GUIDELINES

POLICIES

CASE STUDY

A

B

C

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Advertisement

Registered pharmaceutical

product

Traditional

OTC / Supplement

Poison / Prescription medicine

Non registered product

Food / medical devices / etc

WHAT IS ADVERTISEMENT?

INTODUCTIONA

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NOT20011718K

PRODUK-PRODUK YANG BOLEH DIIKLANKAN TERUS KEPADA AWAM

IKLAN PRODUK KOSMETIK PERLU MEMATUHI “COSMETIC ADVERTISING CODE” 4

CONTROL OF MEDICINES ADVERTISEMENTADVERTISEMENT

Medical Products

Medical Devices Food Pharmaceutical Products

Cosmetics

MDB, MOHMedical Devices Bureau

FSQ, MOHFood Safety & Quality

Division

PSD, MOHPharmaceutical Services

Division

NPCB, MOHNational Pharmaceutical

Control Bureau

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Advertisement that requires MAB’s approval

• Advertisement of a registered pharmaceutical product

• In any media for the views of the public

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What are registered products?

• Registered with Drug Control Authority (DCA) @ Pihak Berkuasa Kawalan Dadah (PBKD)

• Classified into – Traditional product (MAL20014435T)– OTC / Supplements (MAL10021086X)– Poison (MAL05072022A)

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How to know?• http://portal.bpfk.gov.my/

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Not a registered product?

• Unregistered product cannot be advertised

• Nonregistrable product cannot make any medical claim

• Registered product can be advertised with MAB’s approval

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ABC TABLET FOR YOU!!!

ABC SDN. BHD.

Product claims…….………………………

………….………………………

………….………………………

…………......................................................................

..................

logo

logo

logo

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ARTICLE / WRITE UP……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………

……………………ABC TABLET

…………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………

…………..THIS ARTICLE IS BROUGHT TO YOU BY ABC

SDN. BHD.

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VETTING OF MEDICINE ADVERTISEMENT

• Comply with the current guidelines & policies of MAB

• Generally acceptable to the general public (words & pictures) (direct / indirect / implication)

GUIDELINESB

– Violence / offensive– Standard of morality / decency– Discredit / downgrading /

disparagement / belittle / compare other profession / product

−Religion−Race−Sensitivity of the community−Politic

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• Advertisements to the general public should:

(a)Help people to make rational decisions on the use of medicines, appliances, and remedies determined to be legally available without a prescription.

(b)Take into account of people's legitimate desire for information regarding their health.

(c)Not take undue advantage of people's concern for their health. 15

Authority • The Medicine Advertisements Board (MAB) may, at its

discretion, issue or refuse to issue any approval for advertisements to be publicised or may cancel any approval which was previously issued.

• The Medicine Advertisements Board reserves the right to delete from any advertisements, acts which could bring about undesirable thoughts and impression to the viewers.

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PROHIBITED CLAIMS/ADVERTISEMENT* Schedule Section 3 (20 Diseases)

1. Diseases or defects of the kidney2. Diseases or defects of the heart3. Diabetes4. Epilepsy or fits5. Paralysis6. Tuberculosis7. Asthma8. Leprosy9. Cancer10. Deafness11. Drug addiction12. Hernia or rupture

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13. Diseases of the eye14. Hypertension15. Mental disorder16. Infertility17. Frigidity18. Impairment of

sexual function or impotency

19. Venereal disease20. Nervous debility, or

other infirmity, arising or related to sexual intercourse

PRODUCT APPROVED INDICATION / LABEL

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Poison / Prescription Medicine

• No product which is a controlled medicine, poison or contains poisons as specified in the Poisons List set out in the First Schedule to the Poisons Act 1952 (Revised 1989) may be advertised unless exempted.

• Gums, lozenges and patches indicated for nicotine replacement therapy may be advertised with approval from the Medicine Advertisements Board.

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Contents of Advertisements

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 statement or omissions likely to induce medically unjustifiable use or to give rise to undue risks.

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General Principle

• Impressions of Professional Advice or Endorsement

• Advertisements should not:-

(a) 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; or

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• Advertisements should not:- • Contain statements giving the impression of

professional by scientific advice, endorsement or recommendation made by associations or persons who appear in the advertisements and who are presented either directly or by implication, as being qualified to give such advice, endorsement or recommendation.

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Standard of Morality or Decency.

• 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 or in any way defamatory or humiliating to any segment of the public.

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Trust, Fear or Superstition

Advertisements should not:-

(a) Be so framed as to abuse the trust of the consumer or exploit his lack of experience or knowledge.

(b) Without justification play on fear. Advertisements should not contain any statement or illustration likely to induce fear on the part of the viewer or listener that he is suffering, or may without diagnosis or treatment suffer, or suffer more severely, from diseases or conditions of the human body.

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(c) Play on superstition or exploit the superstitious. In this spirit, words like magic, magic, miracle, miraculous, saintly, heavenly, or presentation of or reference to mythical object or supernatural beings or powers should not be allowed.

(d) Directly or by implication exploit the religious requirement/beliefs of any community.

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Acts of Violence or Illegal Activities

• Advertisements should not contain anything, which might lead or lend support to acts of violence, criminal or illegal activity nor should they appear to condone such acts or activities.

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Dangerous Practices or Disregard for Safety

• Advertisement should not, without justifiable reason, show or refer to dangerous practices or manifest a disregard for safety. Special care should be taken in advertisements directed towards or depicting children or young people.

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Disparagement (Discredit)

• Advertisement should not:

(a)Contain any statement which either expressly or by implication disparages either the medical profession or the value of professional attention and treatment or another product.

(b)Discredit or unfairly attack other products, advertisers or advertisements directly or by implications.

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Children or Young People

• Advertisements addressed to children or young people, or likely to be seen by them, should not contain anything, whether in illustration or otherwise, which might result in harming them physically, mentally, morally; or which exploits their credulity, their lack of experience or their natural sense of loyalty.

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Misleading Statement

• Advertisements should not contain any statement, or visual presentation which, directly or by implication, omission, ambiguity or claim, is likely to mislead the consumer about any product or advertiser, in particular with regards to:

(a)The trade description;

(b)Official or other recognition of approval or certification.

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Substantiation

• All descriptions, claims and comparisons which relate to matters of objectively ascertainable facts should be capable of substantiation and should be held ready for immediate production upon request to the Medicine Advertisements Board.

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• Reference expressly or by implication to test, trials, research and the like may only be used if they are fully substantiated. References to tests or trials conducted in a named hospital, clinic, institute, laboratory or college or by named professional or official organisation is permissible only if authorised and approved by the authority of the institution or organisation concerned and found acceptable by the Medicine Advertisements Board.

Tests, Trials, Research

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Advertisements should not:

(a)Contain any medical statement or reference to clinical or other trials or tests which cannot be substantiated by authoritative evidence acceptable by the Medicine Advertisements Board.

(b)Misuse research results or quotation from technical and scientific literature or conference, workshop, seminar etc. Statistics should not be so presented as to imply that they have a greater validity than is the case. Scientific terms or scientific jargons that are irrelevant should not be used to make claims that appear to have a scientific basis that they do not possess.

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Testimonials

• Advertisement containing testimonials by general public must be supported by a consent letter of testimony, in selected cases only.

• The Medicine Advertisements Board reserves the right to limit the number of testimonials in an advertisement.

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Use of celebrity • Use of celebrity in advertisement MAB does not allow any

advertisement which uses • i. Patients receiving treatment • ii. Professionals (Doctors, Dentists, Pharmacists)

The use of a celebrity in an advertisement may be allowed upon the discretion of the MAB on a case by case basis where celebrity includes: • i. Local/International celebrity • ii. Local/International athlete • iii. Local/International model • Such advertisements should not, whether directly or by implication, mislead

the consumer about the product advertised.

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Claims allowed

• As approved by DCA• Quality, Safety, Efficacy • Product label• Drug Registration Guidance Document

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General Claims Hyperbole • Hyperboles should not be used in Medicine Advertisements

unless such hyperbole is used to attract attention to the advertisement and is not used or implied in the advertisement as a claim or inference to the superiority or superlative status of the product advertised. Advertisements should not:

(a) Contain a copy which is exaggerated by reason of the improper use of words, phrases or methods of presentation e.g. the use of the words Fabulous, Fantastic, Superior, Extremely, Unique, Ideal etc.

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(b) Contain any false claim, direct or indirect, that a product is “natural, nature’s remedy‟ or the like.

(c) Lead consumers to over-estimate the value of a product whether by exaggeration or through unrealistic comparisons.

(d) Highlight the flavour or the attractiveness of the article expressly or by implication.

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Use of Certain Words or Phrases • The uses of the following words or phrases in the advertisement

of a product are not acceptable. (a) Effective, Efficacious, Efficacy Proven (b) Guarantee, Ensure

(c) Magic, magical, miracle, miraculous

(d) Remedy, cure (e) No side effects

(f) No harmful effects (g) No toxic or adverse effects

(h) 100% Pure

(i) NEW [Can only be used within six months of changes in packing, container, logo, or flavour. All changes must be approved by the Drug Control Authority (DCA)] The Medicine Advertisements Board reserves the right to disallow any other words or phrases which in its opinion is misleading, improper or not factual.

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• Sexual weakness, Ageing, Loss of Virility Advertisements should not suggest or imply that any product offered will:

(a) Promote sexual virility or be effective in treating sexual weakness, lost of virility or habits associated with sexual excess or indulgence, or any ailment, illness or disease associated with such habits.

(b) Retard, control or treat premature ageing or any other words or phrases to that effect

(c) Retard, control or reverse the process of ageing.

Specific Claims

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Special/Cautionary Statements

• The Medicine Advertisement Board may require cautionary statements to be included in the advertisement.

• Products for weight reduction / weight loss should include the following statement: “This is a traditional preparation. Should be taken with a balanced diet and regular exercise”

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Competition, Free Gift, Free Offer, Premium, etc. • Advertisements should not: (a) Encourage, directly or indirectly, indiscriminate,

unnecessary or excessive use of products.

(b) Contain any reference, directly or indirectly to any prize competition, free gift, free offer, premium, exchange scheme or any other similar scheme.

(c) Offer or describe any product as free or available free for trial as an incentive.

(d) Contain any reference to the free offer of a product with the purchase of a similar or other product.

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Advertorials • Advertorials for poison products are not

allowed. Advertorials for generic or active ingredients of OTC and traditional products are allowed. No mention of product name, brand or proprietary name. Only company name and logo is allowed.

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Press Release (a) Allowed for launching of new chemical entities (NCE).

Allowed once only. The launch can also be broadcasted. The contents are as approved by the Medicine Advertisements Board.

(b) All products must be registered with DCA

(c) The contents for the press release of New Chemical Entity (NCE) are:

(•)i. indications as approved by Drug Control Authority (DCA)

(•)ii. cost per dose (•)iii. list of reference journals

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(d) Criteria for NCE are:

i. new drugs (within 18 months after being marketed/launched and no other similar drug available in Malaysia)

ii. new combinations of active pharmaceutical ingredients

iii. available in Malaysia for the first time

iv. new indications

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(e) The following information is not allowed:

i. reference to any medical practitioner endorsing or promoting the product

ii. superlative words or statements (e.g. the first, the best, the only one etc)

(f) The validity period is 6 months from the date of approval.

(g) The frequency of the press release shall be once only and released simultaneously in all media.

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Journal References

• Allowed only for advertisement in the form of leaflets, pamphlets and brochures.

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Product & pricing advertisement

• MAB approval is not required if the advertisement is for price lists that contain only the picture [of which the product image is less than 4cm x 5cm] and price of the products. It is mandatory to print the DCA registration number of the products.

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POLICIESc

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Use of statistical claims

• Use of statistical claims Advertisements containing statistical claims should be supported by Malaysian data unless not available

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Use of functional claims Advertisements should not contain any statement(s) giving the impression that any article(s) can be used for the purpose of: • i. Preventing or relieving stress of modern living • ii. Improving cognitive functions (e.g. concentration, anxiety,

depression etc.) • iii. Improving mental performance, memory, IQ, intelligence

or studies • iv. Providing immunity against specific diseases

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Point of Sale Material - Giant Box Giant boxes do not require MAB approval. However the box must be: • i. An exact replica (not size but shape and

content) as the packaging approved by the Drug Control Authority

• ii. Can only be hanged/displayed in a pharmacy

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Advertisement of product with free gift

• Advertisement of products which includes free gift is now allowed. Free gift cannot be the same as the product advertised, traditional or any pharmaceutical products. Examples of free gift allowed are pen, mug, calculator etc

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• Advertisement in the form of t-shirt, calculator, mug, stationeries are exempted from MAB approval. Information allowed is product brand, company name and logo only.

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• Request for amendments or changes to approved advertisement formats by MAB

• i. Requests for amendments must be submitted within 2 months from the date of approval by MAB. After 2 months the applicant has to send in a new application for approval

• ii. Request for amendments will only be considered for change of company name and logo, e-mail address and telephone numbers only.

• iii. Amendments are allowed once only • iv. All amendments must obtain approval from MAB.

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Advertisement in Form of Product Attachment

• Any product attachments such as bottle tag, sticker and wrapper are not considered as advertisement and do not require approval from MAB. This type of format falls under labeling and packaging which requires approval by the Drug Control Authority.

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HALAL logo

• Any HALAL logo will be allowed in the advertisement approved by MAB, provided it is substantiated with HALAL certificate issued by JAKIM

• Or any certification body recognized by JAKIM

• www.halal.gov.my

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• Advertisement in billboard There should be minimal use of words and the message should be as simple as possible.

• Reminder: seek advice from local council

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• Advertisement in radio by way of talk show

• i. Only complete script will be accepted i.e. no addition can be made to the script upon approval

• ii. No caller segment is allowed • iii. Validity of the approval is only for 6

months.

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