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Transcript of 1 Advertising of Drugs. 2 3 3 ways Any drug advertising is forbidden Advertising to general public:...
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Advertising of Drugs
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3 ways
• Any drug advertising is forbidden• Advertising to general public: non-
prescription medicines, prescription-only drugs only to advertise to healthcare professionals (EU)
• Prescription-only medicines may also be advertised to general public „Direct-to-consumer”, DTC, USA)
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Ethical codes of Manufacturers’
Associations
for drug advertising• Self-governing Codes• This is the Hungarian one
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EU/WHO Definitions
• Advertisement: any information facilitating knowledge on or purchasing of a product or service or on the name of any company
• Sponsor of an advertisement: who orders the advertisement or for whose interest the advertising is made
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EU/WHO definitions
• Hidden advertising: an advertising that seems to be a neutral information
• Comparative advertising: that, directly or indirectly, identifies other service or product, similar to what is advertised
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EU/WHO definitions
• Delusive advertising: which deludes persons and affects their economic attitude, violating the interest of Firms similar to the sponsor of the advertisement
• Consciously non-observable advertisement: a sight or sound stimulus at a strength weaker than that consciously observable
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EU/WHO definitions
• Adult: >18, youngster: 14 - 18, child: <14 years old (varies by countries!)
• Advertiser: who creates the adver-tisement or provides any service in connection with it
• Media: any printed matter (news-paper, book, pamphlet), Radio or TV-programme, video cassette or any other means of information
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WHO/EU definitions
• Outdoor advertising means: any such outdoor tool except those put up on the place of selling
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Drug advertising to the general public
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Advertising…
…to general public
• (in EU, at present: non-prescription medicines)
• in the U.S.: also DTC (Direct-To-Consumer) advertising of prescription-only medicines!
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Advertising control: general rules
Launch of an advertisement • It should be recognisable that it is an
advertisement• The advertising media should know the
company who sponsors the advertisement (name, site address, etc.)
• The same data on DTC/DM (direct-to-consumer, direct mail) advertisements
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Advertising control: general rules
• Personal rights/data protection may
not be violated
• It may not call for violent actions, against human beings or the environment
• It should not frighten people
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Forbidden:
Text: how to preventcommunicable diseases
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Ad control: general rules
Any advertising directed to children and youngsters is prohibited, if it
• may damage their mental or physical development, or
• utilising their naivety prompts them the urge adults to buy something
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A bad Hungarian example…
This is an ad of a non-prescription medicine…
Is it directed to adults?
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Ad control: general rulesMisleading ads
Statements describing price, general characteristics, origin, effects exerted on the health, expected results of its use should be analysed whether they are misleading or not
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Ad control: Comparative ads
• May not be misleading
• May not hurt the reputation of another Firm or brand name
• May not lead to confusion with another product
• Only for comparable products in a matter-of-fact way
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Comparative ads, further rules
Ads, suggesting that a true choice is possible, make comparisons with unidentifiable or unrecognisable products, are forbidden
Often comparisons: „with another tooth-paste”, „with another washing-powder”…?
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Medicine ads
• Advertising of prescription-only (or hospital-only) drugs may not advertised to the general public, only for health-care professionals (USA is exemption!)
• The only exceptions are the authorised (MoH?) ad campaigns for vaccination but the brand and the manufacture of the vaccine should not be recognisable
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Drug ads, EU/WHO
• Health-care professionals (identifying themselves) or well-known personalities may not advertise drugs (actors in TV-series in their roles, a completely stranger introducing him/herself on the screen…)
• The ad may not suggest that not taking the medicine gives rise to health damage
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Forbidden drug ads, WHO
• Drugs for TBC, STD, serious communicable (e.g. AIDS), cancer, chronic insomnia, diabetes and other metabolic diseases
• <6 months old children’s aliments substituting mothers’s milk
• as a rule: reimbursed drugs
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In certain countries, there is a mandatory text
• „For risks and side-effects read the Patient Information Leaflet or ask your doctor or pharmacist”
• In Hungary: Radio, TV min. 5 s
• in the TV also written on the screen
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Advertising to health-care professionals
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General rules
• According to the approved Summary of Product Characteristics (Data Sheet)
• Literature citations should be correct
0
100
Original article
70
90
In an Ad Pamphlet
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Medical representatives
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It means…
• …whether Pharmaceutical Firms may send their representatives to doctors (and pharmacists) to covince them on the use of their medicines
• Is it possible in your country?
• If yes, is it regulated?
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„Medical samples”
• Are MedReps permitted to give free samples of new medicines to doctors?
• If yes, – is their use regulated (e.g. may only be
given free to patients)?– Is their number per doctor per year
limited?
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„Medical samples”
• Written record
• Warning text on samples:
• No gift for patients that would urge them to buy drugs, not even via doctors or pharmacists!
Free of charge medical sample, not for sale!
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Other ways of drug promotion for health-care professionals
• Gifts for health-care professionals by MedReps (e.g. fountain-pens with the Firm logo or the name of their drug)
• Is it possible in your country?
• If yes, regulated? (E.g. in Hungary: maximum value less that 5% of the official minimal wages)
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Other ways of drug promotion for health-care professionals
• Opinion-leader medical professors: congress participation in egzotic countries offered free of charge (the Drug Company pays everything)
• Is it possible in your country?• If yes, any limitation? (E.g. in Hungary, the
whole cost must be identified and the doctor pay taxes after it!)
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DRA independent Bulleting for drug information
Rating new medicines, treatment experiences evaluation of medreps’ activities
28,000 copies 9 times a year free of charge to all physicians and pharmacists
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Hungarian example
Annual postgraduate training on new drugs
• 2 times for MedReps (participation fee)
• 4 times for the Agency’s own drug information officers (free)
Periodical
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Exam topics
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Drug advertising to general public
• The 3 main possibilities• Definitions: advertisement, sponsor,
hidden, comparative, delusive and non-observable and outdoor advertising
• Advertising control rules (identification, children, content, comparative ad’s, famous persons/healthcare professionals. Mandatory texts
• Dexcribe the situation in your country
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Drug advertising to healthcare professionals
• General rules
• MedReps
• „Medical samples”
• Independent national info Centres
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The problem: prescription-only drug The problem: prescription-only drug advertisin on the Internet, together with food advertisin on the Internet, together with food
products… products…