1 / 14

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

erek
Télécharger la présentation

EMACOLEX Budapest 12 and 13 May 2011

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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!

More Related