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Promotion of Medicinal Products in Iceland: Regulations and Comparisons with EU Standards

This document details the promotion of medicinal products in Iceland, highlighting the legal frameworks established by the Icelandic Medicines Agency and the relevant laws, including Directive 2001/83 and the Icelandic Medicinal Act No. 93/1994. It covers advertising restrictions on prescription-only medicines (POM) and over-the-counter (OTC) products, comparisons with EU regulations, and the implications for marketing strategies. It also addresses how bold claims and advertisements are regulated, ensuring consumer protection while examining Iceland's approach compared to Europe.

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Promotion of Medicinal Products in Iceland: Regulations and Comparisons with EU Standards

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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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