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EMACOLEX Budapest 12 and 13 May 2011

EMACOLEX Budapest 12 and 13 May 2011. Promotion of medicinal products Icelandic Medicines Agency Helga Thorisdottir. Applicable law. Directive 2001/83 with amendments – Art. 88a – 100. Icelandic Medicinal Act No 93/1994

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EMACOLEX Budapest 12 and 13 May 2011

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  1. EMACOLEXBudapest 12 and 13 May 2011 Promotion of medicinalproducts Icelandic Medicines Agency Helga Thorisdottir

  2. Applicablelaw • Directive 2001/83 withamendments – Art. 88a – 100. • IcelandicMedicinalActNo 93/1994 • Icelandicregulationonpromotion of medicinalproducts (softlaw) No 325/1998

  3. TheCompetentAuthority withregardtopromotion of medicinalproductsinIceland: • According to Art. 3, para 8 of IS law 93/1994: The role of the Icelandic Medicines Agency (IMA) shall be: To monitor advertising of medicinal products and ensure that the promotion and distribution of medicinal products complies with current laws and regulations.

  4. Is IS law/practiceinlinewithEU law? • Whenmonitoringadvertising of medicinalproductsthemostcommonphrasefrompharmaceuticalcompanies is: Butthis is allowedelsewhereinEurope! • Is thatthecase?

  5. Advertisementsof medicinalproductson TV • AccordingtoDirective 2001/83 and IS lawit is forbiddentoadvertisePOMintelevision. • Accordingto IS law 93/1994 OTCscanalso not beadvertisedintelevision. -theargument is thatthere is not enoughtime for viewerstorealisethattheadvertisementconcerns a medicinalproduct -themainaim of thepharmaceuticallegislationbeingtoprotectconsumers • Is IcelandtheonlycountryinEuropebanningOTCsadvertisementsontelevison?

  6. Advertisements of MedicinalProductsinothermedia • HowaboutOTCsadvertisementsonthe internet, inthemovies, onnewspaperstands, flipposters, intheradio – how is thisregulatedinEurope? InIcelandwetrytoregulatethisaccordingtocommonsense, i.e. thelettersneedtobebigenoughtobereadeasilyandtoappearsufficientlylongenough for thereadertoreadthemorifthat is thecase - tohearthem. Is this IS approachinlinewithEurope?

  7. IS experience of themostcommoncases: • OTC medicinalproducts: Nicotinell / Nicorette Also – advertismentson: • Unbrandedmedicinalproducts • Unlicencedmedicinalproduct

  8. BoldstatementsinOTCsadvertisements: • PharmaceuticalcompaniesadvertiseOTCs(Nicorette/Nicotinell) andarguethatit is: - themostpopularmedicinalproductonthe market or - the bestaccordingtotasteresults: Thishasbeenbannedby IMA – sinceit´s not objectiveenoughaccordingto Art. 3 of IS regulationNo 328/1995. That kind of advertisement of medicinalproductcanalsoencourageunreasonableuse of medicinalproductswich is not inlinewiththeaim of thelegislationinquestion. Is this IS baninlinewiththe rest of Europe?

  9. Advertisements of OTCsshouldbeaccordingtotheSmPC -howmuchinaccordancewiththeSmPC? -how far canwereachinallowingdifferentwording? -howaboutwordingthatconsists of additionaladjectivesnot foundintheSmPC?

  10. ...Advertisements of OTCsshouldbeaccordingtotheSmPC • NicoretteFruitmint – A tastethatsurprisesyou Yourway, yourdecision, yourNicorette • NicoretteFruitmint – sogoodthat men willdisguiseinorderto get it • NicoretteFruitmint is softontheinside, hascrunchysurfaceandrefreshingtastewithdelicousblend of fruitandmint. The best waytoquit. How far areyouwillingtogo? Is the IS ban of theaboveinlinewithEurope?

  11. Words not inlinewithSmPCthat IMA hasbanned: • Nicorette/Nicotinell: Soft/ fresh / sugarfree, Argument: Informationonmedicinalproductsshouldbeobjectiveand not asifdiscussingfood. • Nicorette/Nicotinell: Doublethechances of quittingsmoking! / Thebluepackageswilldoublethehelp / Doublethegain Argument:It is not allowedtoguaranteeresultswhenusing MP. • Lamicil - Letshavebeautifultoesthissummer! Argument:It is not allowedtoguaranteeresultswhenusing MP. • Howabout: Actavis – Havea nicesummer– Loritin WouldEuropeallowthis?

  12. UnlicencedMedicinalProducts • Medicinal products which have marketing authorisations in Iceland may be advertised and promoted in Icelandic according to IS law. -How about discussions at European/International doctors’ conferences before a marketing authorisation has been issued? -How about only informing a local group of doctors on OTCs/POM some days prior to the marketing authorisation being issued? IMA has demanded that no publicity on OTCs/POM takes place prior to the issuing of a marketing authorisation. Does Europe share our view here?

  13. UnbrandedMedicinalProducts • ThemedicinalproductChampix – POM -Is itpossible for theMA holder (orhisagent) toadvertisetothegeneralpublicbyusing a part of a logo/advertisingmaterial for Champixaddressedtohealthcareprofessionalsandarguethatit´s unbrandedadvertisement? -Also, is itpossibletoadvertisethesame MP tothegeneralpublicwiththeabovementionedlogo/advertisingmaterialwiththefollowingwords: Searchadvisefromyourdoctorconcerningnewmethodstoquitsmoking Youaredeterminedtoquit – isn´t thatso Smokersthataredeterminedtoquitsearchadvisefromdoctors IMA´s view is thatthis is advertisementon POM sincePfizer is thecompanypublishingtheadvertisementwichhasthemarketingauthorisation for Champixandadvertisingmaterial for POM hasbeenused for thegeneralpublic. DoesEuropeshareourview?

  14. Thankyouverymuch for yourattention!

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