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)
Ethical codes of Manufacturers’ Associations for drug advertising • Self-governing Codes • This is the Hungarian one
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
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
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
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
WHO/EU definitions • Outdoor advertising means: any such outdoor tool except those put up on the place of selling
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!
Advertising control: general rulesLaunch 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
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
Forbidden: Text: how to prevent communicable diseases
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
A bad Hungarian example… This is an ad of a non-prescription medicine… Is it directed to adults?
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
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
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”…?
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
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
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
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
General rules • According to the approved Summary of Product Characteristics (Data Sheet) • Literature citations should be correct 100 90 0 70 Original article In an Ad Pamphlet
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?
„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?
„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!
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)
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!)
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
Hungarian example Periodical Annual postgraduate training on new drugs • 2 times for MedReps (participation fee) • 4 times for the Agency’s own drug information officers (free)
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
Drug advertising to healthcare professionals • General rules • MedReps • „Medical samples” • Independent national info Centres
The problem: prescription-only drug advertisin on the Internet, together with food products…