Regulation (EC) No 141(2000) ofthe European Parlia

ENOfficialJournaloftheEuropeanCommunities22.1.2000L18/1I(Actswhosepublicationisobligatory)REGULATION(EC)No141/2000OFTHEEUROPEANPARLIAMENTANDOFTHECOUNCILof16December1999onorphanmedicinalproductsTHEEUROPEANPARLIAMENTANDTHECOUNCILOFTHEEUROPEANUNION,HavingregardtotheTreatyestablishingtheEuropeanCommunity,andinparticularArticle95thereof,HavingregardtotheproposalfromtheCommission(1),HavingregardtotheopinionoftheEconomicandSocialCommittee(2),ActinginaccordancewiththeprocedurelaiddowninArticle251oftheTreaty(3),Whereas:(1)someconditionsoccursoinfrequentlythatthecostofdevelopingandbringingtothemarketamedicinalproducttodiagnose,preventortreattheconditionwouldnotberecoveredbytheexpectedsalesofthemedicinalproduct;thepharmaceuticalindustrywouldbeunwillingtodevelopthemedicinalproductundernormalmarketconditions;thesemedicinalproductsarecalled‘orphan’;(2)patientssufferingfromrareconditionsshouldbeenti-tledtothesamequalityoftreatmentasotherpatients;itisthereforenecessarytostimulatetheresearch,develop-mentandbringingtothemarketofappropriatemedica-tionsbythepharmaceuticalindustry;incentivesforthedevelopmentoforphanmedicinalproductshavebeenavailableintheUnitedStatesofAmericasince1983andinJapansince1993;(3)intheEuropeanUnion,onlylimitedactionhasbeentakensofar,whetheratnationaloratCommunitylevel,tostimulatethedevelopmentoforphanmedicinalprod-ucts;suchactionisbesttakenatCommunitylevelinordertotakeadvantageofthewidestpossiblemarketandtoavoidthedispersionoflimitedresources;actionatCommunitylevelispreferabletouncoordinatedmeas-uresbytheMemberStateswhichmayresultindistor-tionsofcompetitionandbarrierstointra-Communitytrade;(4)orphanmedicinalproductseligibleforincentivesshouldbeeasilyandunequivocallyidentified;itseemsmostappropriatetoachievethisresultthroughtheestablish-mentofanopenandtransparentCommunityprocedureforthedesignationofpotentialmedicinalproductsasorphanmedicinalproducts;(5)objectivecriteriafordesignationshouldbeestablished;thosecriteriashouldbebasedontheprevalenceoftheconditionforwhichdiagnosis,preventionortreatmentissought;aprevalenceofnotmorethanfiveaffectedpersonsper10thousandisgenerallyregardedastheappropriatethreshold;medicinalproductsintendedforalife-threatening,seriouslydebilitatingorseriousandchronicconditionshouldbeeligibleevenwhentheprevalenceishigherthanfiveper10thousand;(6)aCommitteecomposedofexpertsappointedbytheMemberStatesshouldbeestablishedtoexamineapplica-tionsfordesignation;thisCommitteeshouldalsoincludethreerepresentativesofpatients'associations,designatedbytheCommission,andthreeotherpersons,alsodesignatedbytheCommission,onarecommenda-tionfromtheEuropeanAgencyfortheEvaluationofMedicinalProducts(hereinafterreferredtoas‘theAgency’);theAgencyshouldberesponsiblefortheadequatecoordinationbetweentheCommitteeonorphanmedicinalproductsandtheCommitteeonproprietarymedicinalproducts;(7)patientswithsuchconditionsdeservethesamequality,safetyandefficacyinmedicinalproductsasotherpatients;orphanmedicinalproductsshouldthereforebesubmittedtothenormalevaluationprocess;sponsorsoforphanmedicinalproductsshouldhavethepossibilityofobtainingaCommunityauthorisation;inordertofacilitatethegrantingorthemaintenanceofaCommunityauthorisation,feestobepaidtotheAgencyshouldbewaivedatleastinpart;theCommunitybudgetshouldcompensatetheAgencyforthelossinrevenuethusoccasioned;(1)OJC276,4.9.1998,p.7.(2)OJC101,12.4.1999,p.37.(3)OpinionoftheEuropeanParliamentof9March1999(OJC175,21.6.1999,p.61),CouncilCommonPositionof27September1999(OJC317,4.11.1999,p.34)andDecisionoftheEuropeanParliamentof15December1999(notyetpublishedintheOfficialJournal).ENOfficialJournaloftheEuropeanCommunities22.1.2000L18/2(8)experienceintheUnitedStatesofAmericaandJapanshowsthatthestrongestincentiveforindustrytoinvestinthedevelopmentandmarketingoforphanmedicinalproductsiswherethereisaprospectofobtainingmarketexclusivityforacertainnumberofyearsduringwhichpartoftheinvestmentmightberecovered;dataprotectionunderArticle4(8)(a)(iii)ofCouncilDirective65/65/EECof26January1965ontheapproximationofprovisionslaiddownbylaw,regulationoradminis-trativeactionrelatingtomedicinalproducts(1)isnotasufficientincentiveforthatpurpose;MemberStatesactingindependentlycannotintroducesuchameasurewithoutaCommunitydimensionassuchaprovisionwouldbecontradictorytoDirective65/65/EEC;ifsuchmeasureswereadoptedinanuncoordinatedmannerbytheMemberStates,thiswouldcreateobstaclestointra-Communitytrade,leadingtodistortionsofcompetitionandrunningcountertothesinglemarket;marketexclu-sivityshouldhoweverbelimitedtothetherapeuticindi-cationforwhichorphanmedicinalproductdesignationhasbeenobtained,withoutprejudicetoexistingintellec-tualpropertyrights;intheinterestofpatients,themarketexclusivitygrantedtoanorphanmedicinalproductshouldnotpreventthemarketingofasimilarmedicinalproductwhichcouldbeofsignificantbenefittothoseaffectedbythecondition;(9)sponsorsoforphanmedicinalproductsdesignatedunderthisRegulationshouldbeentitledtothefullbenefitofanyincentivesgrantedbytheCommunityorbytheMemberStatestosupporttheresearchanddevelopmentofmed