Helsinki 2011

MEDICINES POLICY 2020Towards efficient, safe, rational and cost-effective use of medicines

Publications of the Ministry of Social Affairs and Health 2011:10eng

MINISTRY OF SOCIAL AFFAIRS AND HEALTH

MEDICINES POLICY 2020

Towards efficient, safe, rational and cost-effective use of medicines

Publications of the Ministry of Social Affairs and Health 2011:10eng

ISBN 978-952-00-3165-7 (PDF)

ISSN-L 1236-2050

ISSN 1797-9854 (verkkojulkaisu)

URN:ISBN: 978-952-00-3165-7

http://urn.fi/URN:ISBN: 978-952-00-3165-7

www.stm.fi/julkaisut

Publisher : Ministry of Social Affairs and Health

Layout and printed by: Helsinki University Press, Helsinki 2011

SUMMARY

ThedocumentMedicinesPolicy2020reportsonthejointobjectivesofthesocialwelfareandhealthcareauthoritiesandstakeholdersinthefieldofmedicinesbytheyear2020.

1. Pharmaceutical service is a part of the social welfare and healthcare service system

Socialwelfareandhealthcareservicesmustbeincreasinglydevelopedtorespondtotheneedsoftheclients.Thechiefobjectiveofpharmaceuticalservice is to enable an efficient, safe, rational and cost-effectivepharmacotherapyforallthoseinneedofit.Interprofessionalcooperationandagreeingonjointpoliciesandgoalsregionallyandlocallyareprerequisitesforsecuringsystematicandsustainedoperations.Theutilisationofinformationsystemsavailableinsocialwelfareandhealthcareandtheircompatibilityshouldbeenhanced.Thegoalistodeliverallprescriptionselectronically.

2. Pharmaceutical service is of high quality, eff icient and cost- effective

Agoodavailabilityandaprofessionallyoperatingdistributionofmedicinalproductsmustbesecuredforcitizensunderallcircumstances.Thefundingsystemsmustunderpinsuchpharmacotherapyorservicesthatpromotethemaintenanceofthepopulation’sworkingandfunctionalcapacityaswellasindependentcoping.Theexpensesofmedicinalproductsmustbeevaluatedasapartofthetotalhealthcareexpenditures.Themedicinereimbursementsystem must support cost-effective treatments in order to curb theexpenditure.Theknow-howandpracticesoftheadvisorycommitteesonmedicines,hospitalpharmaciesandmedicinedispensariesinestablishingabasicformularyofmedicinalproducts,inpurchasesofmedicinalproductsandcompetitivetenderingneedstobedeveloped.

3. Rational pharmacotherapy and good medication safety enhance the wellbeing of the population, improve public health and decrease the healthcare expenditures

Theclients’ownroleandresponsibilityinhealthcareandmedicaltreatmentshouldbeincreasedinparticularinthetreatmentoflong-termdiseasesandsymptomsthattheycaneasilytreatthemselves.Successfulpharmacotherapyshouldbe improvedbyguidanceprovidedfor instancebypharmacists,dispensersandotherhealthcareprofessionals.TreatmentsfollowingthenationalCurrentCareGuidelinesmustbepromoted.Theaccessofhealthcareprofessionals,thepopulationandusersofmedicinestoreliableandevidence-basedinformationonmedicinalproductsmustbeensured.Theconsumers’andpatients’criticalliteracyinhealthinformationshouldbepromoted.

Key words: health care, health policy, health services, medicinal products, pharmaceutical service, pharmacotherapy, social services

4. Pharmaceutical research enhances health, wellbeing and employment

Successful pharmaceutical research enhances the population’s health,wellbeingandemployment,andthereforeinnovationsandtheirutilisationinthefieldofmedicinesoughttobepromoted.Theassessmentofthetherapeuticandeconomicvalueofmedicinalproductsmustbeincreased,andoptimallyuniformmethodsbasedonsimilarcriteriaandevidenceshouldbeusedinthiswork.Themethodsofassessingthetherapeuticandeconomicvaluemustbeutilisedtoagreaterextentinthedecision-makingconcerningthereimbursementstatusofmedicinalproducts.

5. Veterinary pharmaceutical service safeguards public health and promotes the wellbeing of people and animals

Anappropriateuseofveterinarymedicinalproductssecuresthesafetyofconsumers.Theregionalandnationalaccesstoveterinarymedicinalproductsmustbesecured,andtheir importsanddistributionmustbesafe.Themonitoringoftheconsumptionanduseofantimicrobialagentsshouldbedeveloped,andadequatesystemsmustbecreatedfortheuse,dispensingandprescribingofveterinarymedicinalproducts.

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PREFACE

Medicinespolicyisapartofthesocialwelfareandhealthpolicy.ThepresentMedicinesPolicy2020documentincludesthemedicinespolicyobjectivesforthecomingdecadeandsharpensthefocusofthesocialwelfareandhealthcarestrategy.

Themedicinespolicyoutlinehasbeendrawnincollaborationwiththestakeholdersofthepharmaceuticalbranch.Allphasesofthemedicinelifearehererepresented:fromresearchtopatients.

Theworkstartedinearly2010.ThesteeringandpreparatorygroupsaswellasvarioussubgroupselaboratedonthebestwaystoprovidetheFinnswithnecessarypharmacotherapies,alsointhefuture.

TheprocesstowardstheMedicinesPolicy2020documentwasverypo-sitiveandsuccessful.Sittingaroundonetable,theparticipantsweighedthestrengthsandweaknesses,threatsandpossibilitiesofthecurrentpharma-ceuticalsector,lookingformeanstofurtherimproveit.Inadditiontothejointoutlines,welearnedtocollaborateinamoreefficientway.

ThestrategyoftheMinistryofSocialAffairsandHealthwasunderprepa-rationatthesametime.Accordingtothenewstrategy,ourobjectiveisaso-ciallysustainablesocietywhereindividualsaretreatedequally,ensuringeachandeveryone’sinclusionandpromotingtheirhealthandfunctionalcapacity.Themedicinespolicysharestheseobjectives.Successfulpharmacotherapyisanimportanttoolinthetreatmentofdiseases,andgoodpharmaceuticalservicesmustbeequallyavailabletoall.

HavingnowcompletedtheMedicinesPolicy2020documentwearehappytocontinuetheco-operation.Theimplementationoftheoutlinesonanatio-nalandinternationallevelwillcallforgoodinteractionandopencommuni-cationbetweenthestakeholdersinthebranch.Thegovernmentprogrammesetstheframeworkfortheimplementationofthemedicinespolicybutthedocumentalsoincludesseveralobjectivesspecifictothebranch,bestimple-mentedinday-to-daypracticalwork.MedicinesPolicy2020isapositivestarttoasustainableandsolidpracticalco-operation.

KariVälimäkiPermanentSecretary

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CONTENTS

Preface ...............................................................................................................5

Foreword ..........................................................................................................9

1 Pharmaceutical service constitutes part of social welfare and healthcare service systems .....................................................................101.1 Pharmaceutical service operations are customer-oriented ................12

2 Pharmaceutical service is of high quality, efficient and cost- effective ......................................................................................................152.1 Ensure access to medicines and functioning of pharmaceutical

service in all conditions ..............................................................................152.2 Financing systems promote materialisation of economically most

advantageous pharmacotherapies and efficient utilisation of limited resources .......................................................................................................17

2.3 Medicine reimbursement system is unambiguous and decision- making system transparent ........................................................................18

3 Rational pharmacotherapy and good medication safety improve people’s wellbeing and public health, decreasing healthcare expenditure ...............................................................................................203.1 Medicine users are encouraged to assume responsibility for

treatment of their diseases ....................................................................... 203.2 Increase production of reliable information on rational

pharmacotherapies disseminated to healthcare professionals and medicine users ..............................................................................................21

3.3 Promote efficient, safe, rational and cost-effective use and prescription of medicines .......................................................................... 23

3.4 Improved medication safety promotes public health .......................... 25

4 Pharmaceutical research improves health, wellbeing and employment rates ....................................................................................274.1 Promote generation and exploitation of pharmaceutical

innovations .................................................................................................. 274.2 Promote rational pharmacotherapies through evaluations of

therapeutic and economic value of medicines ...................................... 29

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5 Veterinary service safeguards public health and promotes wellbeing of humans and animals ..........................................................315.1 Rational use of veterinary medicines guarantees consumer safety ...31

6 Follow-up plan focusing on implementation of proposed medicines policy 2020 actions ...............................................................346.1 Practical actions and evaluation of impacts ........................................... 346.2 Timetable ...................................................................................................... 35

Appendix 1 ......................................................................................................36Appendix 2 ......................................................................................................37Appendix 3 ......................................................................................................38Appendix 4 ......................................................................................................39Appendix 5 ......................................................................................................40

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FOREWORD

Themainobjectiveofthepharmaceuticalserviceistoprovideefficient,safe,rationalandcost-effectivepharmacotherapiestothosewhoneedthem.Theobjectivecanbereachedbydevelopingthecurrentsystemtowardsabettermatchwiththecustomerneeds.

MedicinesPolicy2020isadocumentreportingonthejointmedicinepolicyperspectivesofthesocialwelfareandhealthcareauthoritiesandthebranchstakeholdersforthecomingdecade.Thepolicyoutlinesarecrystal-lisedintheformoffivemainobjectives:

The main medicines policy objectives for 2020 defined by the working group:

1.Thepharmaceuticalserviceconstitutesapartofthesocialwelfareandhealthcareservicesystem.

2.Thepharmaceuticalserviceisofhighquality,efficientandcost-effective.3.Rationalpharmacotherapiesandgoodmedicationsafetypromotepeople’s

wellbeingandpublichealth,decreasingthehealthcareexpenditure.4.Pharmaceuticalresearchhasapositiveimpactonhealth,wellbeingand

employment.5.Veterinarypharmaceuticalservicessafeguardpublichealthandpromote

thewellbeingofhumansandanimals.

TheMedicinesPolicy2020documentpresentstheagreedactionsfortheattainmentofthemainobjectivesaswellasthepartiesthatareresponsibleandco-operatefortheirimplementation.Theadvantagespursuedthroughtheactionsarealsopresented.Thefinalpartofthedocumentdefinesafollow-upplanfortheattainmentoftheobjectivesandmeasurementoftheoutcomes.

TheAppendicestothedocumentcontainnumericaldataaboutthephar-maceuticalbranchaswellasdefinitionsoftermsandabbreviationsusedandtheco-operationpartiesinvolved.

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1 PHARMACEUTICAL SERVICE CONSTITUTES PART OF SOCIAL WELFARE AND HEALTHCARE SERVICE SYSTEMS

Medicinesandvaccinesplayanessentialroleforhealthcareandmedicalcare.Awellworkingsocialwelfareandhealthcareservicesystembenefitsfrompharmaceuticalservices,andviceversa.Well-functioningservicesandsatisfiedcustomersandpatientsaresharedobjectives.

Thecorevaluesofmedicinespolicyareresponsibility,effectiveness,quali-ty,equalityandjusticeaswellaseconomydefinedascost-effectiveness.Therespectofhumandignityandcustomer-orientationaimatthepromotionofpeople’shealthandtheirworkingandfunctionalcapacityunderallcircum-stances.Otheraimsincludesustainabledevelopment,transparentsystemsandsystematicoperationaccordingtoplan.

Thelogisticchaininthepharmaceuticalservicesincludesthepharma-ceuticalindustry,pharmaceuticalwholesalers,outpatientandhospitalphar-maciesandmedicinedispensaries.Thepharmaceuticalindustryisinchargeofpharmaceuticalresearchanddevelopmentaswellasproduction.Universities,universityhospitalsandvariousresearchinstitutes,alsothoserunbytheauthorities,engageinresearchfocusedonmedicinesandthepharmaceuti-calservice.Thepharmaceuticalindustryandwholesalersareresponsibleforpharmaceuticalimportswhilethewholesalersareinchargeofthestockinganddistributionofmedicines.Theretaildistributionofmedicinestakespla-cethroughoutpatientandhospitalpharmaciesandmedicinedispensariesand,toalimitedextent,throughretailgrocerytradeinthecaseofnicoti-nereplacementtherapyproducts.TheInstituteforHealthandWelfareaswellashospitalpharmaciesandmedicinedispensariesareinchargeofthedistributionofvaccinesincludedinthegeneralvaccinationprogramme.Themedicinesreimbursementsystemplaysacentralrolefortheoperationofthepharmaceuticalservice.

TheprovisionsrelatedtomedicinesandvaccinecontrolareharmonisedwiththeEUregulations,andfromthecontrolfunctionperspective,FinlandconstitutesapartofthecontrolnetworkoftheEUMemberStates.Thede-cisionsinfluencingtheFinnishpharmaceuticalserviceareincreasinglymadeontheinternationalarenas.TheEUmedicineslegislation(MedicinesDirec-tive1andRegulation2)regulatethepharmaceuticalmarketingauthorisations,distributionandcontrolatthecommunitylevel.Pharmaceuticaldistribution,medicinereimbursementsystemsandvaccineprogrammesfallwithinthenationalcompetence.Themainprovisionsonthepharmaceuticalserviceare

1 Directive 2001/83/EC of the European Parliament and of the Council

2 Regulation (EC) No 726/2004 of the European Parliament and of the Council

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includedintheMedicinesAct3andtheprovisionslaiddownonthebasisofit,whilethoseonthetasksofpharmaceuticalserviceoperatorsareincludedintheActonHealthCareProfessionals.4ThemedicinesreimbursementsystemisdefinedintheHealthInsuranceAct5.TheActontheStatusandRightsofPatients6containstherespectivehealthcare-relatedprovisionswhiletheonesfocusingonthesocialwelfareclientsarecontainedintheActontheStatusandRightsofSocialWelfareClients7.Thereisalsospecificlegislationonmedicationofanimals.

Administration and supervision of the social welfare and healthcare services

The Ministry of Social Affairs and Health is responsible for theadministrative development of the pharmaceutical service, thepreparationof themedicines legislation and themedicinespolicy.TheFinnishMedicinesAgencyFimeaisinchargeoftheauthorisationandcontrolfunctionsrelatedtothepharmaceuticalbranchaswellasforthemedicinesafetyissues.Moreover,Fimeaengagesinresearchfocusingonpharmaceutical-epidemiological,medicinespolicy andpharmacoeconomicalaspects,forwardingpharmaceuticalinformationto improve the effectiveness of the pharmaceutical service andpharmacotherapies.ThePharmaceuticalsPricingBoardistheresponsibleauthorityforthedecisionsonmedicinepricesandreimbursability.TheNationalSupervisoryAuthorityforWelfareandHealthValviraguidesandsupervisestheoperationofhealthcareorganisationsandprofessionals.Italsocoverscertainfunctionsrelatedtotheguidanceandsupervisionofsocialwelfareservices.TheSocialInsuranceInstitutionisinchargeofthebasicsocialsecurityoftheresidentsofFinland,includingmedicinereimbursements. Moreover, the Social Insurance Institution doesresearchfocusedonthemedicinesreimbursementsystemandtheuseofmedicines.TheNationalInstituteforHealthandWelfareTHLisanexpertinstitutionundertheadministrationoftheMinistryofSocialAffairsandHealth.TheInstitute’sresponsibilitiesincludethevaccinationprogramme.

3 Medicines Act 395/1987

4 Act on Health Care Professionals (559/1994)

5 Health Insurance Act 1224/2004

6 Act on the Status and Rights of Patients 785/1992

7 Act on the Status and Rights of Social Welfare Clients 812/2000

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1.1 PHARMACEUTICAL SERVICE OPERATIONS ARE CUSTOMER-ORIENTED

Thepharmaceuticalservicemustbedevelopedtomeetthecustomerneeds.Customerorientationalsomeansthatthepatientsareencouragedtotakeresponsibilityfortheirowncare.

Thenationallyagreedcarerecommendations,suchastheCurrentCareGuidelines,promotetheproperuseofmedicines.Theregionalagreementprocedureencompassesthemunicipalhealthcareorganisationplans,definedintheHealthCareAct,andtheplansarebasedontheregionalpopulation’shealthfollow-updataandserviceneeds.Theyalsoincludeagreementsonmunicipalco-operation,objectivesandresponsiblebodiesforthepromotionofhealthandwellbeingaswellastheorganisationofhealthcareservicesbetweenthevariousactors.Fromtheperspectiveofpharmaceuticalservice,itisparticularlyimportanttoagreeonthelocalpracticalactionstopromoteco-operation.

Interprofessionalco-operationbetweenvarioushealthcareprofessionalslaysthefoundationsforasmoothclient-orientedservicewholethattranscendsanyadministrativeandorganisationalboundaries.Thepatients’well-func-tioningcarepathwaysandsuccessfulmedicationcanbepromotedthroughthedevelopmentofinterprofessionalandinter-organisationalco-operationmodels.

Ahighlevelofbasictrainingofthehealthcareprofessionalsthatmeetstheneedsofpracticalworklifeaswellastheirsystematicfurthereducationaretoolsforkeepingupthelevelofcompetenceneededinhealthcare.Wemustensurethatthelevelofprofessionalcompetenceremainshighinthefuture.

Well-workinginformationsystems–includingthee-prescription–willfacilitatetheeffectivenessandoverallcost-effectivenessanalyses,therebyimprovingpatientsafety.Patientrecords,includingthemedicationdata,arealreadynowmostlyindigitalform.However,theproblemsinthetransferofdatabetweenpatientrecordsystemsaswellastheinternalusabilityproblemsinthesystemsweakentheirfeasibilitypotential.Compatibleinformationsystemswouldsupportthecontinuityofcareandcomprehensivemonitoringofitsoutcomes.Asaconsequence,thecarepathwaywouldnotbeinterruptedwhenthepatientmovesfromprimaryhealthcaretospecialisedmedicalcare,orasocialwelfareclientmovesfromaninstitutiontothenon-institutionalcaresector.Comprehensiverecordingofmedicationdataisaprerequisiteforthemonitoringofcareoutcomesonthenational,regionalandlocallevels.

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Actions

1.Developsmooth,client-orientedandcost-effectiveoperationalmodelsinsocialwelfareandhealthcarebothregionallyandlocallyinviewoftheimplementationandmonitoringofpharmacotherapies.

Responsibleparties:MinistryofSocialAffairsandHealth,NationalInstituteforHealthandWelfare

Co-operationparties:Fimea,Valvira,Social Insurance Institution,RegionalStateAdministrativeAgencies,professionalorganisations,FinnishMedicalSocietyDuodecim,municipalities,hospitaldistricts,socialwelfareandhealthcareunits,hospitalpharmacies,medicinedispensaries,pharmacies,pharmaceutical industry,pharmaceuticalwholesalers.

2.Agreeonthejointpharmaceuticalserviceobjectivestoensuresystematicandsustainedoperations.

Responsibleparties:MinistryofSocialAffairsandHealth,NationalInstitute forHealthandWelfare,Fimea,Valvira,Social InsuranceInstitution

Co-operationparties:Allpharmaceuticalbranchstakeholders

3.Strengtheninterprofessionaloperationalmodelsintheimplementationofthepatient’spharmacotherapyandconsultation,bothinoutpatientandinpatientcare.

Responsibleparties:Fimea,NationalInstituteforHealthandWelfare

Co-operationparties:Socialwelfareandhealthcareunits,pharmacies,hospitalpharmacies,medicinedispensaries,AssociationofFinnishPharmacies,UniversityPharmacy,professionalorganisations,universities

4.Strengthenco-operationbetweentheMinistryofSocialAffairsandHealthontheonehandandtheMinistryofEducationandCultureontheotherhandtodevelopbasic,continuingandon-siteeducation.Moreefficientco-operationintrainingbetweentheauthoritiesandthetrainingunits.

Responsibleparties:MinistryofSocialAffairsandHealth,MinistryofEducationandCulture

Co-operationparties:Fimea,universities,universitiesofappliedsciences,secondarylevelvocationalinstitutes

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5.Developinformationsystemsusedinsocialwelfareandhealthcare,relatedtothepharmaceuticalservice,improvingtheirmutualcompatibilityandusability.

Responsibleparties:MinistryofSocialAffairs andHealth,SocialInsuranceInstitution

Co-operationparties:Fimea,NationalInstituteforHealthandWelfare,hospitaldistricts,informationsystemproviders

6.Introducee-prescriptions,withtheaimofallprescriptionsissuedindigitalform.

Responsibleparties:MinistryofSocialAffairsandHealth,Fimea,SocialInsuranceInstitution

Co-operationparties:AssociationofFinnishPharmacies,UniversityPharmacy,professionalorganisations,socialwelfareandhealthcareunits,pharmacies,hospitalpharmacies,medicinedispensaries

Aims of actions:

� improved operational models, planned action and improved co-operationmakestheentirehealthcaresystemmoreefficientandmoreclient-oriented

� thepharmacotherapyobjectivesareincreasinglyattained� increased co-operation in the training of healthcare professionals

improvesstaffcompetence� bettermonitoringoftreatmentsimprovesthepharmacotherapyoutcomes� theexchangeofinformationcanbeimprovedthroughwell-functioning

electronicsystems

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2 PHARMACEUTICAL SERVICE IS OF HIGH QUALITY, EFFICIENT AND COST-EFFECTIVE

2.1 ENSURE ACCESS TO MEDICINES AND FUNCTIONING OF PHARMACEUTICAL SERVICE IN ALL CONDITIONS

Theaccess tomedicinesandaprofessionallyoperatingpharmaceuticaldistributionsystemmustbeguaranteedtothepopulation.Themedicinesselectionmustensuretherationalandefficientpharmacotherapyofpatients.ThechallengeistowarranttheavailabilityofnovelmedicinesandthoserarelyneededbyasmallgroupofpatientsaswellastoguaranteetheexistenceofacomprehensivedistributionnetworkthroughoutFinland,theremoteareasincluded.

Theaccesstoandavailabilityofmedicinesdependsonthefunctioningofthepharmaceuticalindustry,wholesalers,pharmacies,hospitalpharmaciesandmedicinedispensarysystemsaswellasonthepredictabilityofthefactorsinfluencingthepharmaceuticalmarket.

Fromtheperspectiveofthecurrentdistributionsystem,theessentialfactorsinfluencingtheaccesstomedicinesincludethecomprehensivenessofthepharmacynetworkandthequalityofitsoperationaswellasthecoverageanddeliverytimesofthewholesaleroperations.Thepharmaciesmustalsoparticipateinthemonitoringofpatientcare,andtheiroperationswillbeinc-reasinglyconcentratedonhealth-promotingpharmaceuticalservicefunctions.

Hospitalpharmaciesandmedicinedispensariesoperateasapartofthepublichealthcaresystem.Cost-effectivenessappraisalsmustbeperformedasanintegralelementofthepharmaceuticalservice.

Importedmedicinesplayanimportantroleinpharmaceuticalservice,andthereforetheaccesstomedicinesunderemergencycircumstancesmustbeensuredthroughtheobligatoryandemergencystockpilingarrangementsformedicinesandvaccines,implementedbythepharmaceuticalindustry,hospitals,healthcarecentres,theState,theNationalInstituteforHealthandWelfareandtheNationalEmergencySupplyAgencyaswellasbymaintainingtheconditionsfornationalpharmaceuticalproduction.

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Actions

1.Developthepharmaceuticaldistributionandstockpilingsystemstoensurethatpatientshaverational,safeandeffectivepharmacotherapiesonanation-widescale.

Responsibleparties:MinistryofSocialAffairsandHealth,Fimea

Co-operationparties:AssociationofFinnishPharmacies,UniversityPharmacy, pharmaceutical wholesalers, pharmaceutical industry,pharmacies,hospitalpharmacies,medicinedispensaries,professionalorganisations

2.Developtheobligatoryandemergencystockpilingfunctionsinacost-effectivemannertoguaranteethesecurityofsupply.

Responsibleparties:MinistryofSocialAffairsandHealth,Fimea,NationalEmergencySupplyAgency

Co-operation parties: National Institute for Health and Welfare,hospitalpharmacies,medicinedispensaries,pharmaceuticalwholesalers,pharmaceuticalindustry

3.Enhancethecompetenceandpracticesofpharmaceuticaladvisorycommitteesandhospitalpharmaciesandmedicinedispensaries inrelationtothebasicmedicineformulary,medicineprocurementsandcompetitivebidding.

Responsible parties: Hospital districts, municipalities, hospitalpharmacies,pharmaceuticalindustry

Co-operationparties:MinistryofSocialAffairsandHealth,Fimea

Aims of actions:

� patientsreceivethenecessarymedicationunderallcircumstances� thepracticesofoutpatientandinstitutionalpharmaceuticalservicewill

improvethroughdevelopedprocesses� ensured competitive conditions will maintain a well-functioning

pharmaceuticalservice

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2.2 FINANCING SYSTEMS PROMOTE MATERIALISATION OF ECONOMICALLY MOST ADVANTAGEOUS PHARMACOTHERAPIES AND EFFICIENT UTILISATION OF LIMITED RESOURCES

Financingsystemsalsoinfluencethechoiceofpharmacotherapies.Today,pharmacotherapiesaremainlyfundedthroughtwoseparatechannels.Themedicinesusedinpublichealthcareareincludedinthetreatmentcostspaidbythepatient'smunicipalityofresidenceorthejointmunicipalboard.Thepublichealthcaresectoralsopaysforthevaccinesincludedinthenationalvaccinationprogramme.Theoutpatientmedicinesprescribedbyadoctorarepartlyreimbursedbythenationalhealthinsurancewhilethepatientspaythewholepriceoftheself-caremedicinestheybuywithoutaprescription.Thecurrenttwo-tierfinancingsystemmayinsomecasesleadtopartialoptimisationofthetreatment.

Thefinancingsystemsmustsupportpharmacotherapiesandserviceswhichpromotethemaintenanceofworkingandfunctionalcapacityandin-dependentcopingofthepopulation.Thefinancingsystemsmustbeevaluatedanddevelopedsothattheyallowforarationalandeffectivepharmacotherapyforthepatients.Itisindispensabletousetheresourcesefficientlytoensuretheavailabilityofservicesbutthisobjectivemustnotconstituteanyriskforpatientormedicinesafety.

In2008,themedicinesandmedicinalconsumergoodsaccountedforabout14%oftheoverallhealthcareexpenditure(Appendix2).In2009,thetotalsalesofmedicinesatretailprices,taxesincluded,wereabout2.6billioneuro,1.3%lessthanin2008(Appendix3).Thehealthinsurancereimbursementsonmedicineswereabout1.2billioneuroin2009(Appendix3).

Medicinecostsmustbeseenasapartoftheoverallhealthcareexpendi-ture.Accordingtothereport8bytheexpertgroupattheNationalInstituteforHealthandWelfarefocusingonthemulti-tierfinancingofsocialwelfareandhealthcareservices,therearenosolidargumentstoseparatethefinancingoftheoutpatientmedicinesfromtherestofthehealthcaresystem.Medicinefinancingresponsibilitycouldbeinthesame"basket"withtheotherformsoftreatmentandoperationinthehealthcaresystem.However,inthecontextofthecurrentmunicipalstructure,itisnotrationaltodecentralisepharma-cotherapyfinancingtothemunicipallevel.Decentralisationwouldrequireconsiderablystrongerorganisationstoshoulderthefinancingresponsibility.Anypossiblenewsystemshouldoperateonthebasisofnationallyuniformmedicinereimbursementcriteria.

8 Expert group of the National Institute for Health and Welfare: Sosiaali- ja terveydenhuollon monikanavaisen rahoituksen edut, haitat ja kehittämistarpeet, 17.11.2010

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Actions

1.Considerneedtoreformthefinancingofthepharmaceuticalservice(outpatientandinstitutionalcare)intheoverallcontextofthesocialwelfareandhealthcarereform.

Responsibleparties:MinistryofSocialAffairsandHealth,NationalInstituteforHealthandWelfare

Co-operationparties:Fimea,Social InsuranceInstitution,hospitaldistricts,municipalities,pharmaceuticalindustry

Aims of actions:

� therearelessfinancing-relatedproblems,suchaspartialoptimisation� medicalgroundsareemphasisedinthechoiceofpatients’therapyoptions

2.3 MEDICINE REIMBURSEMENT SYSTEM IS UNAMBIGUOUS AND DECISION-MAKING SYSTEM TRANSPARENT

Thecoreobjectiveofpharmaceuticalserviceistoguaranteehighquality,reasonablepricesandcost-effectivepharmacotherapies.Tokeepcostsincontrol,themedicinesreimbursementsystemmustpromotecost-effectivetherapies.Theshareofpatientandcustomerco-paymentsofthehealthcareexpendituremustremainreasonable.

Thecurrentmedicinereimbursementsystemiscomplicatedandcausesmuchadministrativework.Thefutureindividualpharmacotherapieswillmakethesystemevenmorecomplex.Thereimbursementsystemmustbesimplified,andthenewITpossibilitiesmustbeexploitedtoanincreasingextent.Theimplementationofthesystemmustbeinproportiontothetar-getssetoradvantagesgained.

Theregulationofmedicinereimbursementsandpricesisextensivelyusedbyvariouscountriesasonemeansofcontrollingthemedicineexpenditure.Awell-functioningregulationsystemensurestheavailabilityofreasonably-pricedandnecessarymedicines,andsupportsandpromotesthecompetitiononthepharmaceuticalmarket.

Significantcostsavingsaregeneratedwhenthepharmaceuticalmarketcompetitionanduseofgenericsarepromoted.Anunambiguousandtranspa-rentdecision-makingsystemhelpstoimprovethefunctioningofthereimbur-sementandpriceregulationsystem.Theopennessandtransparencycriteriaapplytoboththeauthoritiesandthecompanies.

Thereferencepricesystemhasbeenanefficientmeanstocurbthecostsofmedicinesthathavebeenonthemarketforalongtimeaswellastopro-motepricecompetition.Thesystemmustbefurtherdeveloped,takingtheexperiencegainedbyvariousstakeholdersandpatientsintoconsideration.

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Actions

1.Ensurethereasonablenessoftheco-paymentburdencarriedbythepatientsinneedofmedicinesthroughajointpaymentceilingforthesocialwelfareandhealthcaresystems.

Responsibleparties:MinistryofSocialAffairsandHealth,NationalInstituteforHealthandWelfare,SocialInsuranceInstitution

Co-operationparties:Municipalities

2.Developthedecision-makingprocessfocusingonreimbursementandpriceregulation:- byimplementinganelectronicapplicationprocedureandutilising

otherweb-basedservices- byanalysingtheneedfornewoperationalmodelsandproceduresin

priceregulation- byanalysingtheoperationalmodelsandevaluationcriteriaofthe

pharmacotherapypriceregulation,inuseforalongtime

Responsibleparties:MinistryofSocialAffairsandHealth

Co-operationparties:Fimea,SocialInsuranceInstitution,pharmaceuticalindustry

3.Examinethepossibilitiestodecreasetheadministrativeworkcausedbythemedicinesreimbursementsystem.

Responsibleparties:MinistryofSocialAffairsandHealth

Co-operationparties:SocialInsuranceInstitution,patientorganisations,pharmacies

4.Developthereferencepricesystemonthebasisoftheexperiencesgainedtodate.

Responsibleparties:MinistryofSocialAffairsandHealth

Co-operationparties:Fimea,SocialInsuranceInstitution,pharmaceuticalbranchstakeholders

Aims of actions:

� theprocessesrelatedtomedicinereimbursementsandpriceregulationimprove

� thetransparencythroughouttheprocessincreases� developeddecision-makingprocessesreducetheadministrativework

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3 RATIONAL PHARMACOTHERAPY AND GOOD MEDICATION SAFETY IMPROVE PEOPLE’S WELLBEING AND PUBLIC HEALTH, DECREASING HEALTHCARE EXPENDITURE

3.1 MEDICINE USERS ARE ENCOURAGED TO ASSUME RESPONSIBILITY FOR TREATMENT OF THEIR DISEASES

Thepatients’ andcustomers’ rolemustbeenhanced,especially in thetreatmentofchronicdiseasesandeasilymanageablesymptoms.Thepatientsortheirrepresentativesmustbeinvolvedandagreeontheobjectivesandimplementationofthetherapy.Thetaskofpharmaceuticalserviceistosupporttheresponsibilityandinvolvementofthemedicineuser inthepharmacotherapy.Moreover,theadvicegivenbythehealthcareprofessionals,pharmacistsanddispensersinparticular,isinstrumentalfortheproperuseofself-caremedicines.Promotionofhealthandpreventionofdiseasesarealsoamongthepharmaceuticalserviceobjectives.

Pharmacotherapiesdonotalwaysmaterialiseasinstructed.Irrationalordownrighterroneoususeofmedicinesmayweakentheoutcomeofthephar-macotherapy,causesignificantadversehealtheffectsandincreasetheuseandcostofhealthcareservices.Theattainmentofpharmacotherapyobjectivescanbepromoted,forexample,byusingtoolssuchasthepatient-specificmedicationplans,medicinecards,comprehensivemedicationreviews(CMR)ordosedispensing.

Actions

1.Supportthepatientsintheattainmentoftherapyobjectives.

Responsibleparties:Socialwelfareandhealthcareunits,pharmacies

Co-operationparties:Patients,municipalities,patientorganisations,SocialInsuranceInstitution

2.Promoteandenhancewaystoimprovethesuccessofpharmacotherapies.

Responsibleparties:Socialwelfareandhealthcareunits,pharmacies,hospitalpharmacies,patients

Co-operationparties:Municipalities,professionalorganisations,MinistryofSocialAffairsandHealth,Fimea,NationalInstituteforHealthand

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Welfare,Valvira,SocialInsuranceInstitution,patientorganisations,pharmaceuticalindustry

3.Promotethegoodoutcomeofself-careandself-managementthroughtheadviceprovidedbypharmacists,dispensersandotherhealthcareprofessionals.

Responsibleparties:AssociationofFinnishPharmacies,UniversityPharmacy,pharmacies

Co-operationparties:Fimea,professionalorganisations

4.Developwaystointegratesafeself-careintothehealthcarewhole.

Responsibleparties:Fimea,NationalInstituteforHealthandWelfare,AssociationofFinnishPharmacies,UniversityPharmacy,pharmacies

Co-operation parties: Ministry of Social Affairs and Health,pharmaceuticalindustry,universities

Aims of actions:

� thepatients’treatmentadherenceimproves� systematicplanningimprovestreatmentsafety

3.2 INCREASE PRODUCTION OF RELIABLE INFORMATION ON RATIONAL PHARMACOTHERAPIES DISSEMINATED TO HEALTHCARE PROFESSIONALS AND MEDICINE USERS

Reliable and evidence-based pharmaceutical information accessible tohealthcareprofessionals,thegeneralpublicandmedicineusersconstitutesthebasisfortherationaluseofmedicines.Forhealthcareprofessionals,themostimportantchannelsofinformationonpharmacotherapiesaretheCurrentCareguidelinesaswellastheTerveysporttidatabaseandrelatedspecialiseddatabases,suchastheonesonmedicineinteractionsandprices.

Thegeneralpublicandthemedicineusersobtainpharmaceuticalinforma-tionfromdifferentsources.AbundantpharmaceuticalinformationisavailableintheInternetbutthequalityoftheinformationvaries.Theorganisationofpharmaceuticalinformationintheweb-basedpharmacyoperationsisanewchallenge.WemustalsorememberthatnoteverybodyusescomputersorothermeansofITC.

Properadviceontheuseofmedicinesisparticularlynecessarytothepatientswithlong-termpharmacotherapies.Thereisinsufficientreliable

22

pharmaceuticalinformation,withabalancedpresentationofthemedicineefficacyandsafetyvis-à-visotheravailabletherapyoptions.Thethreatsin-cludetheunnecessaryincreaseinmedicineuse,improperuseofthemedi-cinesandmedicalisation.

Actions

1.Strengthenbasic,furtherandcontinuingeducationonpharmacotherapies,information sources and patient advice functions targeted atpharmaceuticalandhealthcareprofessionals.

Responsibleparties:MinistryofEducationandCulture,universities,universitiesofappliedsciences,socialwelfareandhealthcareunits,trainingorganisations,secondarylevelvocationalinstitutions

Co-operationparties:MinistryofSocialAffairsandHealth,Fimea,professionalorganisations,pharmacies,hospitalpharmacies,medicinedispensaries,professionalorganisations

2.Supportmeasurestoprovidesocialwelfare,healthcareandpharmaceuticalpointsofoperationandthoseinvolvedinthepracticalpharmacotherapyofpatientswithproper,necessaryandupdatedpharmaceuticalinformationsourcesandtoensurethatthereiscompetencetousethesesources.

Responsibleparties:Socialwelfareandhealthcareunits,AssociationofFinnishPharmacies,UniversityPharmacy,Duodecim,pharmacies,hospitalpharmacies,medicinedispensaries

Co-operationparties:MinistryofSocialAffairsandHealth,Fimea,NationalInstituteforHealthandWelfare,SocialInsuranceInstitution,universities,universitiesofappliedsciences,professionalorganisations,secondarylevelvocationalinstitutes

3.Ensurethathealthcareprofessionals,thegeneralpublicandmedicineusers have access to reliable and evidence-based pharmaceuticalinformation.

Responsibleparty:Fimea

Co-operationparties:MinistryofSocialAffairsandHealth,NationalInstituteforHealthandWelfare,SocialInsuranceInstitution,universities,universitiesofappliedsciences,AssociationofFinnishPharmacies,UniversityPharmacy,socialwelfareandhealthcareunits,pharmacies,hospitalpharmacies,medicinedispensaries,Duodecim,professionalorganisations,secondarylevelvocationalinstitutions,pharmaceuticalindustry,patientorganisations

23

4.Strengthennationalandinternationalresearchanddevelopmentgearedtowardstheproductionofpharmaceuticalinformationandservices,includingtheireffectivenessanalyses.

Responsibleparties:Fimea,universities,universitiesofappliedsciences

Co-operationparties:MinistryofSocialAffairsandHealth,NationalInstituteforHealthandWelfare,SocialInsuranceInstitution

5.Promotehealthinformationliteracyandcriticalanalysisskillsamongconsumersandpatients.

Responsibleparties:Universities, schools, adulteducationcentres,pharmacies

Co-operationparties:Fimea,socialwelfareandhealthcareunits

Aims of actions:

� healthcareprofessionalsandmedicineusershavebetterinformationonmedicinalproductsandtheiruse

� high-qualityandupdatedpharmaceuticalinformationmaydecreasethenumberofadverseinteractionsofmedicinesusedbyapatient

� co-operationpromotestheR&Donmedicines,andtheresearchoutcomecanbeusedtoimprovethequalityandeffectivenessofpharmaceuticalservices

� consumersandpatientsaremorecompetentinassessingthequalityoftheinformationobtained

3.3 PROMOTE EFFICIENT, SAFE, RATIONAL AND COST-EFFECTIVE USE AND PRESCRIPTION OF MEDICINES

Inadditiontotheprescriptionofmedicines,theotherfactorsinfluencingtheappropriatenessofpharmacotherapiesincludetheregularrecordingandassessmentoftherapyoutcomesandadverseeffects,aswellasthetransferoftheinformationbetweenthehealthcareunitsparticipatinginthecareofthepatient.Pharmacotherapiesshouldnotbeunnecessarilyusedinsteadofnon-medicinalformsoftherapy,suchashealthyhabitsandlifechanges.

Thetrainingforarationalprescriptionpractice,alreadystartedduringmedicalandpharmaceuticalstudies,shouldbefurtherdeveloped.Theob-jectiveistoapplyelectronictoolsandoperationalmodelsinmedicinepresc-riptions,showntobeusefulandcost-effectiveinpracticalworkorthroughotherevidence-basedmeans.

24

Inparticular,thepatientswithseveralsimultaneousmedicines,olderpersonsandotherspecialgroupsshouldhavemedicationplansandtheirpharmacotherapiesandtheirneedsshouldbeassessedonaregularbasis.Thesystemssupportingrationalprescriptionpracticesshouldbefurtherdevelo-pedandintroduced.

Actions

1.Considerpharmacotherapiesasanelementofthepatient'scomprehensivecare,rememberingtheappropriatepreventivemedicationsandnon-medicinalformsoftherapy.

Responsibleparties:Socialwelfareandhealthcareunits,pharmacies

Co-operationparties:SocialInsuranceInstitution,AssociationofFinnishPharmacies,UniversityPharmacy,professionalorganisations

2.Promotecomparativeevaluationsandfinancingofpharmacotherapiesandnon-medicinalformsoftherapy.

Responsibleparties:MinistryofSocialAffairsandHealth,Fimea,universities,NationalInstituteforHealthandWelfare,SocialInsuranceInstitution

Co-operation parties: Social welfare and healthcare units, SocialInsuranceInstitution,pharmaceuticalindustry,researchfundingparties

3.PromotetherapiescomplyingwiththenationalCurrentCareguidelinesandguaranteetheresourcesforthedevelopmentandmaintenanceofthesupportsystems.

Responsibleparties:MinistryofSocialAffairsandHealth,Fimea,NationalInstituteforHealthandWelfare,SocialInsuranceInstitution,Duodecim,healthcareunits,pharmacies,hospitalpharmacies

Co-operationparties:Professionalorganisations

4.Draft instructions on the contents and needs of comprehensivemedicationreviews(CMRs),definingthetasksofvariousprofessionalgroupsinthisprocess.

Responsibleparties:Fimea,NationalInstituteforHealthandWelfare

Co-operationparties:Duodecim,professionalorganisations,universities

25

5.Enhancethequalityofpharmacotherapiesbyincreasingtheexpertiseinclinicalpharmacologyandward-basedpharmacyactivitiesinhospitals,andbyutilisingunit-specificpharmacotherapyplans.

Responsibleparties:Healthcareunits,hospitalpharmacies,universities

Aims of actions:

� increaseintherapyeffectiveness,decreaseinthenumberofadversereactionscausedbymedicinesandimprovedtherapyoutcomes

� rationalpharmacotherapybringscostsavingsbydecreasingtheneedofhealthservicesandunnecessaryuseofmedicines

3.4 IMPROVED MEDICATION SAFETY PROMOTES PUBLIC HEALTH

Marketingauthorisationpracticesandsubsequentsupervisionarecentraltoolstoensuredrugsafety.TheseprocesseshavebeenharmonisedintheEuropeanUnion.InFinland,Fimeaisresponsibleforthisarea.

TheFinnishsystemworkswellasconcernsnotificationsofproductdefectsandsubsequentreactivesteps.ThedisseminationofcounterfeitmedicinesthroughinternationalInternet-basedtradeandillegalimportationconstitutenewthreatsinthisrespect.

Medicationsafetyreferstothesafetyinrelationtotheuseofmedici-nes.Thetermcoverstheprinciplesandoperationsofthesocialwelfareandhealthcareunits,gearedatensuringthesafetyofpharmacotherapiesandprotectingthepatientfromharm.Medicationsafetyisthreatenedbyfactorssuchasminimalparticipationbythepatientsintheirowncareandlackofpharmacotherapycoordination.Pharmacotherapyplansmadeatpointsofcare,reportsondangerousandadverseeffectsaswellassecurity-enhancingdatabasescanpromotemedicationsafety.

Actions

1.Strengthenanddevelopco-operationinthesupervision,monitoringandguidanceofdrugsafetyandmedicationsafetyissues.

Responsibleparties:MinistryofSocialAffairsandHealth,NationalInstituteforHealthandWelfare,Fimea,Valvira

Co-operationparties:Socialwelfareandhealthcareunits,pharmacies,hospitalpharmacies,medicinedispensaries,professionalorganisations,universities,pharmaceuticalindustry,pharmaceuticalwholesalers

26

2.Intensifynationalandinternationalco-operationbetweentheauthoritiestorecognisecounterfeitmedicinesandsolverelatedcrime

Responsibleparties:Fimea,Valvira,Customs,Police,pharmaceuticalindustry

Co-operationparties:MinistryofSocialAffairsandHealth,SocialInsuranceInstitution

3.Increasethegeneralpublic’sawarenessofcounterfeitmedicinesandrisksrelatedtomedicinesacquiredthroughtheInternet.

Responsibleparties:Fimea,NationalInstituteforHealthandWelfare,pharmaceuticalindustry,pharmacies,hospitalpharmacies

Co-operationparties:MinistryofSocialAffairsandHealth,healthcareunits,professionalorganisations,pharmaceuticalwholesalers,patientorganisations

4.Enhancemedicationsafetyresearchtorecogniseriskmedicinesandprocesses,alsousingtherelatedregisters.

Co-operationparties:Fimea,NationalInstituteforHealthandWelfare,SocialInsuranceInstitution,universities,universityhospitals

Aims of actions:

� gooddrugsafetyandmedicationsafety� improvedpublicawarenessofcounterfeitmedicines

27

4 PHARMACEUTICAL RESEARCH IMPROVES HEALTH, WELLBEING AND EMPLOYMENT RATES

4.1 PROMOTE GENERATION AND EXPLOITATION OF PHARMACEUTICAL INNOVATIONS

Finlandisthevenueofhigh-qualitybiomedicalandclinicalresearch,andwehavesufficientcompetenceinindustrialpharmaceuticaldevelopmentandthustheconditionstogeneratenewpharmaceuticalinnovations.

Theareasrequiringdevelopmentincludethehealthcarepermitprocessesandcontractualnegotiationsrelatedtoresearchaswellastheopportunitiesgrantedtoresearcherstoparticipateinpharmaceuticaldevelopmentwork.Enhancedexploitationoftheoutcomesobtainedinbasicresearchwouldimprovepatentabilityopportunitiesandthusalsotheexploitationofphar-maceuticalinnovations.Morecomprehensiveandmoresustainedpharma-ceuticalriskfundingwouldpromotebusinessopportunities.Pharmaceuticaldevelopmentcreatesnewjobsnotonlyinthepharmaceuticalcompaniesbutalsoinrelatedservicecompaniesandinthehealthcaresector.

Pharmaceuticaldevelopmentcallsforactivenationalandinternationalco-operationandnetworkingamongtheexpertsofvariousdisciplinesaswellasamongthevariouspharmaceuticalstakeholders.Weshouldanticipatethechangesinhealthcareresultingfrompharmaceuticaldevelopment.TheparticipationinthepharmaceuticaldevelopmentontheEUlevelwillprovidetheresearchinstitutesandcompaniesexcellentopportunitiestothisantici-patoryworkandinternationalnetworking.Forthepharmaceuticalbranch,itisimportantthatFinlandisinvolvedandinfluencingtheEUmedicinespolicyandlegislation.

Actions

1.Strengthentheco-operationbetweenbasicresearchandclinicaltrialsofmedicines.

Co-operationparties:MinistryofSocialAffairsandHealth,MinistryofEducationandCulture,Fimea,NationalInstituteforHealthandWelfare,NationalCommitteeonMedicalResearchEthicsTUKIJA,universities,universitiesofappliessciences,healthcareunits,AcademyofFinland,universityhospitals,pharmaceuticalindustry,professionalorganisations

28

2.Providehealthcareprofessionalswithbetteropportunitiestoengageinclinicaltrialsofmedicines.

Co-operationparties:MinistryofSocialAffairsandHealth,MinistryofEducationandCulture,Fimea,NationalInstituteforHealthandWelfare,universities,universitiesofappliessciences,healthcareunits,AcademyofFinland,universityhospitals

3.Simplifytheadministrativeprocessesrelatedtocontractsandpermitsrelatedtopharmaceuticalresearchand,ifnecessary,revisetherespectivelegislation.

Responsibleparty:MinistryofSocialAffairsandHealth

Co-operationparties:Fimea,NationalInstituteforHealthandWelfare,Valvira,NationalCommitteeonMedicalResearchEthicsTUKIJA

4.TheMinistryofSocialAffairs andHealthwillwork incloser co-operationwiththeMinistryofEducationandCultureandtheMinistryofEmploymentandtheEconomytodeveloptheresearchoperations.

Responsibleparties:MinistryofSocialAffairsandHealth,MinistryofEducationandCulture,MinistryofEmploymentandtheEconomy

Co-operationparties:universities

5.Promotenationalandinternationalco-operationandnetworkinginpharmaceuticalresearchanddevelopmentamonghospitaldistricts,researchschools,universities,companiesandauthorities.

Responsibleparties:Fimea,FinnishFundingAgencyforTechnologyandInnovationTEKES

Co-operationparties:MinistryofSocialAffairsandHealth,MinistryofEmploymentandtheEconomy,NationalInstituteforHealthandWelfare,universities,universitiesofappliessciences,FinnishInnovationFundSITRA,pharmaceuticalindustry,AcademyofFinland,hospitaldistricts,professionalorganisation

Aims of actions:

� morepharmaceuticalresearchisdoneandtherelatedpracticesbecomelesscomplicated

� newjobsinthissectoraregeneratedinFinland� inthelongrun,thenumberofFinnishpharmaceuticalinnovationsmay

grow

29

4.2 PROMOTE RATIONAL PHARMACOTHERAPIES THROUGH EVALUATIONS OF THERAPEUTIC AND ECONOMIC VALUE OF MEDICINES

Theinformationonthetherapeuticandeconomicvalueofmedicinesandvaccines,inotherwords,theircost-effectiveness,isthefoundationfortheirrationaluse.Tobecomereimbursable,novelmedicinesmustbeaccompaniedwithahealtheconomicevaluation.Healtheconomicstudiesareusuallyperformedattheearlystagesofmedicinedevelopment.Atthatpoint,thereisnotyetanyexperienceontheimpactsofthemedicineonthepopulationlevel.

Today,therequirementsandresourcesforcost-effectivenessappraisalsofoutpatientmedicinesontheonehandandthehospitalmedicinesontheotherhandaredifferent.ThePharmaceuticalsPricingBoardhasbeenappraisingreimbursableoutpatientmedicinessince1998,whilethelimitedresourcesavailabletohospitalshavebeenallocatedtousesotherthanthemedicationsassessments.Inbothsectors,thelimitednumberofexpertsandthelackofeffectivenessdatainfluencethedevelopmentofevaluationsandthepossibilitytoestimatetherespectivecosts.Toaccumulateversatileandupdatedresearchandevaluationdataonmedicines,itisindispensablethatresearchershaveaccesstoregisterscontainingtheinformationonallprescribedanddispensedmedicinesaswellasontheintegratedcarepathwaysandtherapyoutcomes.

Morecooperationbetweentheorganisationsandresearchersinthesectorisneededtodeveloptheoperations.Accordingtotherespectivelegislation,theFimearesponsibilitiesincludeboththepharmacoeconomicresearchandthecost-effectivenessevaluations,inotherwords,theevaluationsofthethe-rapeuticandeconomicvalueofpharmacotherapies.Moreover,Fimeashouldbuildupcooperationinthesesectors.AttherequestofthePharmaceuticalsPricingBoard,Fimeacanalsoperformevaluationsrelatedtothemedicinereimbursementandpricedecisions.

Actions

1.Promotethetrainingofexpertsinpharmaceuticalepidemiologyandhealtheconomicsincollaborationwiththeauthorities,universitiesandothereducationalinstitutions.

Responsibleparties:MinistryofEducationandCulture,universities,universitiesofappliedsciences

Co-operationparties:MinistryofSocialAffairsandHealth,Fimea,MinistryofEmploymentandtheEconomy,NationalInstituteforHealthandWelfare

30

2.Ensurethattheevaluationsonthetherapeuticandeconomicvalueofmedicinesareperformedusinguniform,evidence-basedproceduresbasedonasequalcriteriaaspossible.

Responsibleparties:Fimea,SocialInsuranceInstitution

Co-operationparties:MinistryofSocialAffairsandHealth,NationalInstituteforHealthandWelfare,Duodecim,pharmaceuticalindustry

3.Increasenationalandinternationalco-operationinthecost-effectiveevaluationsofmedicines.

Responsibleparties:Fimea,SocialInsuranceInstitution

Co-operationparties:MinistryofSocialAffairsandHealth,NationalInstituteforHealthandWelfare,pharmaceuticalindustry,universities

4.Makeincreaseduseofevaluationsofthetherapeuticandeconomicvalueofmedicinesinthedecision-makingrelatedtothereimbursementstatusofamedicinalproduct.Promotetheuseofevaluationdatainallmedicine-relateddecision-making.

Responsibleparties:MinistryofSocialAffairsandHealth,Fimea,NationalInstituteforHealthandWelfare,SocialInsuranceInstitution

Co-operationparties:pharmaceuticalindustry

5.Create a comprehensive prescription database, accumulating theinformationonalldispensedprescription-onlymedicines.Makesurethatthesocialwelfareandhealthcareregisterscanbeutilisedintheresearchonmedicines.

Responsibleparties:Fimea

Co-operationparties:SocialInsuranceInstitution,pharmacies,hospitaldistricts,hospitalpharmacies,medicinedispensaries

Aims of actions:

� informationoncost-effectivenesshelpstoallocatetheresourcestorationaltherapies

� improvednationalandinternationalco-operationimprovesevaluationprocessesandpromotestheexchangeofinformation

� increased informationonmedicineusehelps to identify theareasrequiringnewresources

31

5 VETERINARY SERVICE SAFEGUARDS PUBLIC HEALTH AND PROMOTES WELLBEING OF HUMANS AND ANIMALS

5.1 RATIONAL USE OF VETERINARY MEDICINES GUARANTEES CONSUMER SAFETY

Theuseofveterinarymedicinesmustberationaltoensurepublichealthandconsumersafety.Controlleduseofantimicrobialmedicinesrequiresparticularattention.Animalwellbeingwillinfluencethequalityofanimal-based foodstuffs, the cost-effectiveness of animal production and thewellbeingofhumans.

Theregionalandnationalavailabilityofveterinarymedicinesmustbeensured,andtheirimportsanddistributionmustbesafe.TheFinnishvete-rinarymedicinemarketissmall,andthereforethenumberandselectionofmedicineswithmarketingauthorisationsarenotsufficienttocoverallindica-tions.Theavailabilityofseveralveterinarymedicinesandvaccinesisensuredthroughspecialpermits.Difficultiesintheaccesstovaccinesmayleadtothespreadingofanimaldiseases.Incaseofproductiondisturbances,thesmallselectionofgenericmedicinesmayhaveasignificantnegativeimpactontheavailabilityofthemedicines.Theconsequenceswouldincludeconsiderableproblemsinanimalwellbeing,nottomentioneconomiclosses.

Themedicationofproductionanimalsmustalwaystakeplacewithdueattentiontofoodsafety.Thesafetyofpharmaceuticalresidueshasbeeneva-luated,andthemedicineshaveappropriatesafetyperiodswhichmustbefollowed.Anationalmonitoringprogrammefollowspharmaceuticalresiduesinfoodstuffscomprehensivelyandsystematically.

ContrarytomanyEuropeancountries,Finlandisfreefrommanycom-monanimaldiseases,andwemustmaintainthissituation.Theinspectionofimportedvaccinebatchesandtheirhighqualityensurethatpathogenicsubstancesdonotspreadinthecountryintheformofvaccineimpurities.Ifvaccinesarenotavailable,weriskhavingseriousanimaldiseaseepidemicsthatmayalsoleadtolowerproductivity.Somevaccinesalsoprovidetheanimalswithprotectionagainstzoonoticpathogensthatmaybedangeroustohumans.

Theuseofveterinarymedicinesmustbebasedonreliableinformation.Theproductionanddisseminationofreliableandevidence-basedinforma-tiononveterinarymedicineswillpromotethecorrectandsafeuseofthemedicinesinquestion.

32

Actions

1.Promote animal health and wellbeing through better veterinaryhealthcareandmedicine,improvedlivingconditionsofanimalsandmoreactivecontrols.Emphasisepreventiveanimalhealthcareinsteadofmeretreatmentofdiseases.

Responsibleparties:MinistryofAgricultureandForestry,Evira

Co-operationparties:Fimea,MinistryofSocialAffairsandHealth,universities,foodindustry

2.Improvenation-wideavailabilityofveterinarymedicinesandtheirsufficientlycomprehensiveselection.Ensuretheavailabilityofanimalvaccinesduringepidemics.

Responsibleparties:Fimea,MinistryofSocialAffairsandHealth,pharmaceuticalindustry,pharmaceuticalwholesalers,pharmacies

Co-operationparties:MinistryofAgricultureandForestry,Evira,universities

3.Communicateactivelyontheappropriateuseofveterinarymedicinesthroughchannelsclosetotheusers.InformationontherisksofillegalimportationandInternettrade.

Responsibleparties:Fimea,Evira

Co-operationparties:MinistryofAgricultureandForestry,universities,professionalorganisations,pharmacies,pharmaceuticalindustry

4.Developmonitoringsystemsfocusingontheconsumptionanduseofantimicrobialsusedonanimals,creatingsufficientsystemstoaccumulateinformationon theuse, dispensing andprescriptionof veterinarymedicinesfordifferentindications,brokendownbyanimalspecies.Promotedcompliancewithantimicrobialrecommendations.

Responsibleparties:Fimea,MinistryofAgricultureandForestry,Evira

Co-operationparties:MinistryofSocialAffairsandHealth,universities,professionalorganisations,pharmacies,pharmaceuticalindustry

33

5.Promote sensitivitymonitoringofmicrobes isolated fromanimals,launchingpermanentpublicationsthatreportontheantimicrobialresistancesituationrelatedtobothhumanandanimalmedicine.

Responsibleparties:Evira,NationalInstituteforHealthandWelfare,MinistryofAgricultureandForestry

Co-operationparties:Fimea,MinistryofSocialAffairsandHealth,universities

6.Promoteco-operationbetweenpharmaceuticalexpertsandenhanceanimalmedicationcontentsinthebasiceducationofvariousprofessionalgroups.

Responsibleparties:MinistryofAgricultureandForestry,Fimea,Evira

Co-operationparties:MinistryofSocialAffairsandHealth,universities,professionalorganisations

7.Draftanationalstrategyforproducingreliableandunderstandableveterinarymedicineinformation.

Responsibleparties:Fimea,MinistryofSocialAffairsandHealth

Co-operationparties:Fimea,MinistryofSocialAffairsandHealth,MinistryofAgricultureandForestry,Evira,universities,professionalorganisations,pharmaceuticalindustry

Aims of actions:

� theaccesstoveterinarymedicinesimprovesandtheirusebecomesincreasinglyrational

� foodsafetyremainsatagoodlevel� theuseofantimicrobialsismoreappropriate� informationontheproperuseofveterinarymedicinesismoreaccessible

totheauthoritiesandmedicineusers� thedevelopmentofpreventivehealthcareofproductiveanimalsenhances

theprofitabilityofagriculture

34

6 FOLLOW-UP PLAN FOCUSING ON IMPLEMENTATION OF PROPOSED MEDICINES POLICY 2020 ACTIONS

TheMedicinesPolicydocumentoutlinestherespectivedecision-makinguntiltheyear2020.TheMinistryofSocialAffairsandHealthwillleadtheworkfortheattainmentofmedicinespolicyobjectives.ThestrategicsteeringtakesplacethroughtheperformanceagreementsbetweentheMinistryandtheagenciesunderitsumbrella.However,toreachtheobjectives,allpharmaceuticalbranchstakeholdersneedtocollaborate.

6.1 PRACTICAL ACTIONS AND EVALUATION OF IMPACTS

Thedefinitionofthepracticalactionsunderthemedicinespolicyoutlinesandtherespectiveevaluationarecontinuousprocesses.Thisworktakesplaceincollaborationwiththestakeholdersinthepharmaceuticalbranch.

Theobjectivesandtheneedformeasureswillberevisedatregularinter-vals.Twomonitoringgroupswillbeestablishedforthepurpose:

a)MedicinesGroupconstitutedbythepharmaceuticalauthorities(MinistryofSocialAffairsandHealth,Fimea,SocialInsuranceInstitution,NationalInstituteforHealthandWelfare,Valvira,FinnishFoodSafetyAuthorityEvira,andMinistryofAgricultureandForestry),meetingonceayear.

b)Pharmaceutical Forum constituted by the pharmaceutical branchstakeholders,meetingeverytwoyears.

TheMinistryofSocialAffairsandHealthwillconvenethemonitoringgroups.Usingspecificallydevelopedindicators,theFinnishMedicinesAgencyFIMEAand,ifnecessary,theotheragencieswillgatherinformationonthesuccessofthemedicinespolicyactionsandattainmentofobjectivesforthemonitoringgroups.

Theimpactsoftheactionscanbeevaluatedfrommanyperspectives,inclu-dingthatoftheindividualpatient,societyorthepharmaceuticalbranchsta-keholders.TheMedicinesPolicy2020documentliststheadvantagesthattheactionsareexpectedtogenerate,mostlyforthecustomersandthepatients.Inthefuture,theevaluationswillbeextendedandthepotentialadvantages,disadvantagesandcosteffectswillbeanalysedmoreprofoundlyandfromotherangles.Asfaraspossible,theevaluationtoolswillbeevidence-basedmeters.

35

6.2 TIMETABLEThepreparationsfortheMedicinesPolicy2020startedinJanuary2010.

Thedevelopmentofthepracticalactionsunderthemedicinespolicyout-linesaswellastheimpactindicatorsstartedinlate2010.Atthisstage,twobenchmarkpointsfortherevisionoftheactionswillbeset.ThefirstoneisthemeetingoftheMedicinesGroup,constitutedbythepharmaceuticalsectorauthorities,intheautumnof2011.Atthisvenue,themedicinespo-licyobjectivesandactionswillberevisedasperthepublicationofthenewGovernmentprogramme.

ThePharmaceuticalForumconstitutedbythestakeholdersisthesecondbenchmarkpoint.TheForumwillbeconvenedin2012,anditwillanalysetheimplementationandmeasuringofthemedicinespolicyfromtheperspectiveofthestakeholders.TheMedicinesGroupwillalsoconvenein2012,andthefuturebenchmarkpointsandpracticalactionswillbeagreeduponinthesemeetings.

36

APPENDIX 1

Healthcare expenditure in 1995-2008 at 2008 prices, in millions euro

Gross investments in healthcare

Travelling

Administrative expenses of healthcare

Equipment and other medicinal durables

Medicines and other medicinal consumables

Other healthcare

Private healthcare (reimbursed from health insurance)

Inpatient care of older persons

Occupational and student healthcare Dental healthcare

Primary healthcare (excluding occupational, student and dental healthcare)

Specialised medical care

Source: National Institute for Health and Welfare 2010

18 000

16 000

14 000

12 000

10 000

8 000

6 000

4 000

2 000

01995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008

37

APPENDIX 2

Cen

tral

figu

res

on m

edic

ine

sale

s an

d re

imbu

rsem

ents

in 2

009

20

04

2005

20

06

2007

20

08

2009

in

mill

ions

eu

ro

chan

ge

from

the

pr

evio

us

year %

in

mill

ions

eu

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from

the

pr

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year %

in

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ions

eu

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from

the

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in

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ions

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the

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year %

in

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ions

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from

the

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year %

in

mill

ions

eu

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ge

from

the

pr

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us

year %

Ove

rall

sale

s of

m

edic

ines

2 28

87,

12

435

6,4

2 36

2-1

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500

5,9

2 66

46,

52

608

-2,1

sale

s of

out

patie

nt

pres

crip

tion

med

icin

es

(ret

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s, in

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ing

taxe

s)

1 68

57,

71

756

4,2

1 74

4-0

,21

817

4,2

1 93

56,

51

893

-2,2

sale

s of

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nt

self-

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(ret

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s, in

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ing

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278

3,0

319

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-18,

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515

,529

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8

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ital s

ales

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)32

57,

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95,

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543

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ce: F

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sh M

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ines

Age

ncy

Fim

ea, S

ocia

l Ins

uran

ce In

stit

utio

n

38

APPENDIX 3

Organisations involved in the preparation of the Medicines Policy 2020

MinistryofSocialAffairsandHealthFinnishMedicinesAgencyFimea

NationalSupervisoryAuthorityforWelfareandHealthValvira

Social Insurance Institution Ministry of Social Affairs and Health/PharmaceuticalsPricingBoard

MinistryofSocialAffairsandHealth/InsuranceDepartment

MinistryofAgricultureandForestryFinnishFoodSafetyAuthorityEvira

Hospitalpharmacies

Hospitaldistricts

Co-operationorganisationofthesocialwelfareandhealthorganisationsYTY

AssociationofFinnishPharmacies

TheFinnishPharmacists'Association

SuomenProviisoriyhdistys(FinnishAssociationofSeniorPharmacists)

AssociationofFinnishLocalandRegionalAuthorities

FinnishMedicalAssociation

FinnishDentalAssociation

FinnishVeterinaryAssociation

TheFinnishUnionofPracticalNursesSuPer

UnionofHealthandSocialCareProfessionalsTehy

Pharmacywholesalers

UniversityofHelsinki

UniversityofEasternFinland

UniversityofTurku

UniversityofTampere

ÅboAkademiUniversity

PharmaIndustryFinlandPIF

FinnishGenericPharmaceuticalIndustry

FederationofFinnishPatients

FinnishMedicalSocietyDuodecim

HelsinkiUniversityPharmacy

39

APPENDIX 4

Abbreviations used in the Medicines Policy 2020 document

Abbreviation DefinitionEU EuropeanUnion

Evira FinnishFoodSafetyAuthority

Fimea FinnishMedicinesAgency

CMR comprehensivemedicationreview

Rohto CentreforPharmacotherapyDevelopmentRohto

SFL FinnishPharmacyFederation

SITRA FinnishInnovationFundSITRA

Stakes NationalResearchandDevelopmentCentreforWelfareand Health

TEKES FinnishFundingAgencyforTechnologyandInnovation

TUKIJA NationalCommitteeonMedicalResearchEthics

Valvira NationalSupervisoryAuthorityforWelfareandHealth

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APPENDIX 5

Definitions used in the Medicines Policy 2020 document

1) Pharmaceutical service (Pharmaceutical sector)

Pharmaceutical serviceAwholetoensuretheavailabilityofefficient,safeandreasonablypricedmedicines.Theelementsincludedarepharmaceuticaldevelopmentandproduction,imports,wholesaleandretaildistributionofpharmaceuticals,prescriptionofmedicines,researchontheuseofmedicinesandpharmaceuticalserviceresearch,medicinesreimbursementsystem,pharmaceuticalserviceadministration,obligatorystockpilingandsecurityofsupply.Pharmaceuticalservicecomprisesbothoutpatient/non-institutionalandinpatientcare.

2) Patient safety, medicine/drug safety and medication safety

Patient safetyPrinciplesandactionsofthehealthcareunitsandorganisations,withthepurposeofensuringthesafetyofthecareandprotectthepatientfromanyharm;fromthepatient’spointofview:thatthecaredoesnotcauseanysignificantadverseeffect;comprisesboththesafetyofthecare,medicationsafetyandsafetyofthedevicesasapartofthecarequality(Source:NationalResearchandDevelopmentCentreforWelfareandHealthStakesandCentreforPharmaceuticalDevelopmentRohto,2006

Safe medication Safe medication comprises drug safety and medication safety (Fimeaadministrativeregulation7/2007,StakesandRohto2006).

Drug/medicine safety Thetermmostlycomprisesthesafetyofthemedicineseenasaproduct:theknowledgeandevaluationofthemedicine'spharmacologicalpropertiesandeffects,itshigh-qualitymanufacturingprocessaswellastheinformationonthepackageandotherproductinformation.Theefficacyandsafetyofmedicinesisevaluatedthroughthemarketingauthorisationprocedure.Theconcernforadversereactions(ADR)alsocontinuesafterthemarketingauthorisationhasbeengranted(so-calledsubsequentsupervision,inotherwordspharmacovigilance)(Source:StakesandRohto2006).

Medication safety Thesafetyinrelationtotheuseofmedicines.Thetermcoverstheprinciplesandoperationsofthesocialwelfareandhealthcareunits,gearedatensuringthesafetyofpharmacotherapiesandprotectingthepatientfromharm.

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Medicationsafetycomprisesactionstoprevent,avoidandrectifyadverseeventsrelatedtotheuseofmedicines(Source:StakesandRohto2006).

User safety Preventionofharmcausedtohumansbyhandlingordosageofveterinarymedicines.

3) Rational pharmacotherapy, monitoring of drug treatment, comprehensive medication review CMR as well as rational self-medication

Rational pharmacotherapy Rationalpharmacotherapyisefficient,safe,cost-effectiveandpurposefulpharmacotherapy(WHO).

Monitoring of drug treatment Partofthemedicationprocess,seemedicationprocess.

Drug utilisation/regimen review/Medication reviewReviewofanindividualpatient’smedicationbyahealthcareprofessional(physician,nurse,seniorpharmacist,pharmacist)checkingthemedicinedosageandadministrationtimesagainsttheapprovedclinicalpractice,detectingeventualoverlappingorincompatiblemedications.Performedasanelementofnormaldoctor’sappointment,dispensingofthemedicineatthepharmacyordistributionatahospitalwardorinhomecare.Thepharmacyalsomakesreviewsforself-caremedicines.Doesnotincludetheevaluationofmedicationneedorindication(AdaptedfromPeuraetal2007).

Medication assessment/review Asapartofthenormalpatientexaminationandtreatmentplanningprocess,areviewofanindividualpatient’smedication,itsneedandrationality,madebyaphysicianandassistedbyotherhealthcareprofessionals,ifnecessary.

Comprehensive medication assessment, comprehensive medication review (CMR), medication therapy management service Thesolutionofanindividualpatient’smedicationproblems,initiatedbytheattendingphysicianincollaborationwithclinicalexpertsand/oraninterprofessionalgroup.Inadditiontotheassessmentbytheattendingphysician,CMRcanincludeathoroughanalysisofthemedicationwholeandproposedactions,performedbyaclinicalpharmacologist,speciallytrainedseniorpharmacistorpharmacistorotherspeciallytrainedhealthcareprofessional(AdaptedfromPeuraetal.2007).

Self-medicationSelf-medicationbasedonself-caremedicines(seealsoitem5).

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4) Integrated care pathway, individual treatment pathway, pharmacotherapy process, unit-based and individual pharmacotherapy plan, interprofessional collaboration and ward pharmacy

[Disease based] integrated care pathway, pathway of care, clinical pathway, seamless careOrganisation-oriented,plannedandindividuallyimplemented,regionallyagreedwholeoftreatmentprocessedtargetedatthesameclient/patientand theirparticular symptoms.Basedon theagreementsbetween theorganisationsonthearrangementofthetreatmentofaparticulardisease(Source:Norbacketal.2010)

Individual treatment pathway Theindividualtreatmentpathways(also 'carepathway’)referto inter-organisationalplannedandindividuallyimplementedwholeoftreatmentprocessestargetedatthesameclient’sparticularsymptoms.Theindividualtreatmentpathwaysrequirethatoneunitisresponsiblefortheguidanceandmonitoringoftheservicesprovidedtotheclient(Source:Norbacketal.2010).

Pharmacotherapy process Apatient’spharmacotherapyprocessisanoperativechaincomprisingtheassessmentofmedicationneed,thechoiceanddispensingofthemedicine,itsdosageandadministration,thepatient’smotivation,adviceandcommitmenttothepharmacotherapy,organisationofthetreatmentfollow-upandtheevaluationoftheoutcome,aswellasensuringtheinformingofthepatientandtheorganisationsandpersonsinvolvedinthetreatment.Apatient-specificpharmacotherapyplanispartofthepharmacotherapyprocess.

Unit-based pharmacotherapy plan, unit-based medicines management plan PerformedinlinewiththeinstructionsissuedbytheMinistryofSocialAffairsandHealth,aplanontheimplementationofpharmacotherapiesinpublicandprivatesocialwelfareandhealthcareunits.Themanagementofthesocialwelfareorhealthcareunitisinchargeoforganisingthedrafting,implementationandfollow-upofthepharmacotherapyplan.Thehospitalpharmacyormedicinedispensaryresponsibleforthepharmaceuticalserviceintheunitwillparticipateinthedraftingofthepharmacotherapyplan(STM2006,Fimeaadministrativeregulation7/2007).

Individual pharmacotherapy plan Partofapatient’streatmentplan.Regularlyupdatedandincludedinthepatientrecords,asummaryonthemedicinesusedbythepatient,theirindications,treatmentobjectives,medicinedosageaswellastreatmentfollow-up and duration. This plan constitutes the basis for individualpharmacotherapy,decreasingtheerroneoususeofmedicines.

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Interprofessional collaboration Ininterprofessionalcollaboration,variousprofessionalgroupscoordinatetheiractioninthebestinterestofthepatient,alsounderstandingthetasksandresponsibilitiesofotherprofessionalgroupsinthetreatmentofthepatientaswellastheimportanceofexchangeofinformationbetweentheprofessionalgroups(Source:Zwarensteinetal.2009).

Ward pharmacy Wardpharmacy is thepharmaceutical serviceworkperformedby thepharmaceuticalstaffatthewards(Fimeaadministrativeregulation7/2007).

5) Customer-orientation, treatment adherence, concordance, self-management, self-care

Customer oriented services, patient oriented servicesTheorganisation’sapproach in theplanningand implementationof itsoperationsfromthecustomer/patientperspective.

Compliance Thepatientfollowsthemedicalinstructionswithoutnecessarilyhavingadeeperinsightofthem(WHO2003).Inveterinarymedicine,thismeansthatthemedicationadministeredbytheownertakesplaceaccordingtotheveterinarian'sinstructions.

Adherence Responsibleandactiveself-carebythepatient,inawaycomplyingwiththestateofhealthandincollaborationwiththehealthcareprofessionals(Kyngäs1995).

Concordance Jointunderstandingonthetreatmentasaresultofanegotiationbetweenthepatientandthehealthcareprofessional.Inordertoimprovetheconditionsforrationalpharmacotherapy,thenegotiationalsoaddressesthepatient'swishes,beliefsandunderlyingknowledge.

Self-management Anoperationalmodelpromotingadherencetotreatmentwherethepatientisdirectedtotakeindividualresponsibilityfortheircare.Thisincludesactionstomaintainandpromotehealthandfollow-upandtreatmentofthesymptomsofthedisease,gearedtomanagetheimpactofthediseaseonthepatient’soperatingcapacity,emotionsandsociallife.

Self-care Theindividual’svoluntaryoperationtargetedatmaintainedhealth.Rationaluseofself-caremedicinesispartofself-care.Inanimals,theveterinaryself-caremedicinesareusedrationallyandwithcautiontomaintaintheirhealth.

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6) Efficacy, effectiveness, cost-effectiveness (efficiency) and incremental cost-effectiveness ratio (ICER)

Efficacy Theeffectofthetreatmentunderidealcircumstances,observedincloselymonitoredtestconditionsonselectedpatients.Theproofofefficacyisoneofthepreconditionsforthegrantingofthemarketingauthorisationforamedicinalproduct.Replytothequestion:canthetreatmentwork?

Effectiveness Theimpactofthetreatmentobtainedatthepopulationlevel,innormalconditionsandonunselectedgroupofpatients.Replytothequestion:willthetreatmentworkinpractice?

Cost-effectiveness (= efficiency) Therelationbetweentheeffectivenessofthetreatmentandtheresources(costs)incurredforadministeringit.Replytothequestion:isthetreatmenteconomicallyfeasible?

Incremental cost-effectiveness ratio ICER ICERshowshowmanymoremonetaryunitsmustbepaidforeachextraunitofbenefits(suchasavoidedharm,additionallifeyear,quality-adjustedlifeyearQALY.Sources:Goldetal.1996,Drummondetal.2005,SintonenandPekurinen2006,Mäkeläetal.2007).

7) Pharmaceutical research Atalllevelsandareasofpharmaceuticalorveterinarypharmaceuticalservice,operationstargetedatthedevelopmentofmedicinesandtheinvestigationoftheirpropertiesorimpacts,theadvantagesgainedoradverseeffectscausedbythem.

Clinical researchExperimentalresearchandtrialsonhumans,mostlytargetedatdemonstratingtheefficacyandsafetyofamedicineorotherformoftherapy.

Basic researchResearchcomprisesbasicresearchandappliedresearch.Themainpurposeofbasicresearchistoincrementgeneralknowledge,therebyunderstandingthelinksbetweenvariousvariables.

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8) Pharmaceutical information

Pharmaceutical (drug/medicines) information Informationaboutmedicinesandpharmacotherapies,availabletoconsumersandhealthcareprofessionalsthroughvariousinformationchannels,eitherface-to-faceorthroughwrittenorelectronicservices(telephone,Internet,TVandradio).Pharmaceuticalinformationisproducedbytheauthorities,healthcareprofessionals,thepharmaceuticalindustryandpatientorganisations.Thebasisofmedicine-specificinformationisthesummaryofproductcharacteristics,SPC)adoptedtogetherwiththemarketingauthorisation,aswellasthepackageleafletbasedonit.(Sources:Directive2001/83/EC,Pohjanoksa-Mäntylä2010,Salonen2010).

Patient/medication counselling Adiscussionbetweentheclient/patientandthehealthcareprofessionalwheretheprofessional,takingtheclient’spersonalneedsandsituationintoconsideration,supportshisorhercopingwiththepharmacotherapy(Sources:USP1997,HakkarainenandAiraksinen2001)

9) Veterinary serviceAnimalhealthcareandtreatmentofanimaldiseasesaswellasotherveterinaryassistance,meatandmilkinspection,health-relatedcontrolandinspectionoftheproductionofanimal-basedfoodstuffsandanimalhusbandry,fightingandpreventionofveterinarydiseasesaswellasanimalprotection(VeterinaryServiceAct685/1990).