How can voluntary cross-border collaboration in public procurement improve access to health technologies in Europe?

No. 21 ISSN 1997-8065 POLICY BRIEF 21 HEALTH SYSTEMS AND POLICY ANALYSIS How can voluntary cross-border collaboration in public procurement improve access to health technologies in Europe? Jaime Espín Joan Rovira Antoinette Calleja Natasha Azzopardi-Muscat Erica Richardson Willy Palm Dimitra Panteli Keywords: Biomedical Technology – economics Financing, Government – economics Group Purchasing – economics International Cooperation Cooperative Behavior Europe This policy brief is one of a new series to meet the needs of policy-makers and health system managers. The aim is to develop key messages to support evidence-informed policy-making and the editors will continue to strengthen the series by working with authors to improve the consideration given to policy options and implementation. © World Health Organization 2016 (acting as the host organization for, and secretariat of, the European Observatory on Health Systems and Policies) Address requests about publications of the WHO Regional Office for Europe to: Publications WHO Regional Office for Europe UN City, Marmorvej 51 DK-2100 Copenhagen Ø, Denmark Alternatively, complete an online request form for documentation, health information, or for permission to quote or translate, on the Regional Office web site (http://www.euro.who.int/pubrequest). All rights reserved. The Regional Office for Europe of the World Health Organization welcomes requests for permission to reproduce or translate its publications, in part or in full. The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either express or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use. The views expressed by authors, editors, or expert groups do not necessarily represent the decisions or the stated policy of the World Health Organization. What is a Policy Brief? A policy brief is a short publication specifically designed to provide policy-makers with evidence on a policy question or priority. Policy briefs: • Bring together existing evidence and present it in an accessible format • Use systematic methods and make these transparent so that users can have confidence in the material • Tailor the way evidence is identified and synthesised to reflect the nature of the policy question and the evidence available • Are underpinned by a formal and rigorous open peer review process to ensure the independence of the evidence presented. Each brief has a one page key messages section; a two page executive summary giving a succinct overview of the findings; and a 20 page review setting out the evidence. The idea is to provide instant access to key information and additional detail for those involved in drafting, informing or advising on the policy issue. Policy briefs provide evidence for policy-makers not policy advice. They do not seek to explain or advocate a policy position but to set out clearly what is known about it. They may outline the evidence on different prospective policy options and on implementation issues, but they do not promote a particular option or act as a manual for implementation. Contents  page Acknowledgments 2 Keymessages 5 Executivesummary 7 Policybrief 9 Findings 13 Discussion 16 Conclusions 20 References 21 Appendix1.Methods 23 Authors Jaime Espín,AndalusianSchoolofPublicHealth Joan Rovira,DepartmentofEconomicTheory, UniversityofBarcelona Antoinette Calleja,MinistryofHealth, Malta Natasha Azzopardi-Muscat,MinistryofHealth, Malta Erica Richardson,EuropeanObservatoryon HealthSystemsandPolicies Willy Palm,EuropeanObservatoryon HealthSystemsandPolicies Dimitra Panteli,EuropeanObservatoryon HealthSystemsandPolicies Editors EricaRichardson WillyPalm Series Editor EricaRichardson Associate Editors JosepFigueras HansKluge SuszyLessof DavidMcDaid EliasMossialos GovinPermanand Managing Editors JonathanNorth CarolineWhite Theauthorsandeditors aregratefultothereviewers whocommentedonthis publicationandcontributed theirexpertise. PolicyBriefNo.21 ISSN 1997 – 8073 How can voluntary cross-border collaboration in public procurement improve access to health technologies in Europe? Policy brief 2 ACKNOWLEDGMENTS Theauthorswishtothankthefollowingcontributorsto thispolicybrief,whosubstantivelyenricheditscontent andprovidedtheirexpertise:AlessandraFerrario,Tifenn Humbert,HansKluge,HanneBakPedersen(Division ofHealthSystemsandPublicHealth,WHORegional OfficeforEurope);LoukianosGatzoulis,MichaelHübel, WolfgangPhilip,TapaniPiha,AishaSauer,Jean-LucSion (EuropeanCommission,DGHealthandFoodSafety); AlisonAnastasi,NevilleCalleja,KarlFarrugia,Antonia Formosa,SylvanaMagrinSammut,StephenMifsud, PatriciaVellaBonanno,IsabelleZahraPulis,MarkZammit (MinistryofHealth,Malta);JamesFitzgerald(Director, HealthSystemsandServices,PanAmericanHealth Organization/WorldHealthOrganization(PAHO/ WHO));EnriqueLimón(SuperBUGSproject,Spain); FrancisArickx(BelgianNationalInstituteofHealthand DisabilityInsurance,Belgium);ChristineDawsonfromESIP (EuropeanSocialInsurancePartners–ESIP);PeterSchlosser (GDEKKGermany). How can voluntary cross-border collaboration in public procurement improve access to health technologies in Europe? 3 ACRONYMS EMA European Medicines Agency EPSCO Employment, Social Policy, Health and Consumer Affairs Council ERN European reference network ESIP European Social Insurance Partners EU European Union EUnetHTA European network for Health Technology Assessment GDP gross domestic product HTA health technology assessment ICT information and communications technology IPR intellectual property rights IT information technology JPA Joint Procurement Agreement MEA managed entry agreements MEDEV Medicine Evaluation Committee MoCA Method of Coordinated Access to Orphan medicinal products PAHO Pan American Health Organization PCP pre-commercial procurement R&D research and development SME small- and medium-sized enterprises TFEU Treaty on the Functioning of the European Union TRIPS Trade-Related Aspects of Intellectual Property Rights UNICEF United Nations Children’s Fund WHO World Health Organization Boxes page Box 1: Methods 9 Box 2: Procurement methods 10 Box 3: BeNeLuxA – collaboration on procurement of pharmaceuticals for rare diseases 12 Box 4: Joint procurement of vaccines under the Baltic Partnership Agreement 14 Box 5: EU Joint Procurement Agreement on medical countermeasures 16 Box 6: Collaboration in Health Technology Assessment (HTA) 16 Box 7: Innovating in public procurement through cross-border collaboration in the EU 17 Figures page Figure 1: Activities leading to procurement and access to health technologies 11 Figure 2: Levels of collaboration in procurement 13 Tables page Table 1: European experiences of cross-border collaboration in procurement of health technologies 15 Table 2: Potential gains of collaboration in specific procurement- related activities 19 BOXES, FIGURES AND TABLES Policy brief 4 3 How to strengthen patient-centredness in caring for people with multimorbidity in Europe? How do Policy Briefs bring the evidence together? There is no one single way of collecting evidence to inform policy- making. Different approaches are appropriate for different policy issues, so the Observatory briefs draw on a mix of methodologies (see Figure A) and explain transparently the different methods used and how these have been combined. This allows users to understand the nature and limits of the evidence. There are two main ‘categories’ of briefs that can be distinguished by method and further ‘sub-sets’ of briefs that can be mapped along a spectrum: • A rapid evidence assessment: This is a targeted review of the available literature and requires authors to define key terms, set out explicit search strategies and be clear about what is excluded. • Comparative country mapping: These use a case study approach and combine document reviews and consultation with appropriate technical and country experts. These fall into two groups depending on whether they prioritize depth or breadth. • Introductory overview: These briefs have a different objective to the rapid evidence assessments but use a similar methodological approach. Literature is targeted and reviewed with the aim of explaining a subject to ‘beginners’. Most briefs, however, will draw upon a mix of methods and it is for this reason that a ‘methods’ box is included in the introduction to each brief, signalling transparently that methods are explicit, robust and replicable and showing how they are appropriate to the policy question. V Rapid evidence assessment Introductory overview Systematic Review Meta- Narrative Review Rapid Review Scoping Study Narrative Review Multiple Case Study Instrumental Case Study V VV V Country mapping (breadth) Country mapping (depth) POLICY BRIEFS Source: Erica Richardson Figure A: The policy brief spectrum PBP_Patient_centredness_v2_Policy_brief_A4 12/12/16 14:23 Page 3 How do Policy Briefs bring the evidence together? Thereisnoonesinglewayofcollectingevidencetoinformpolicy- making.Differentapproachesareappropriatefordifferentpolicy issuessotheObservatorybriefsdrawonamixofmethodologies (seeFigureA)andexplaintransparentlythedifferentmethodsused andhowtheyhavebeencombined.Thisallowsuserstounderstand thenatureandlimitsoftheevidence. Therearetwomain‘categories’ofbriefsthatcanbedistinguished bymethodandfurther‘sub-sets’ofbriefsthatcanbemappedalong aspectrum: • A rapid evidence assessment:Thisisatargetedreviewofthe availableliteratureandrequiresauthorstodefinekeyterms,set outexplicitsearchstrategiesandbeclearaboutwhatisexcluded. • Comparative country mapping:Theseuseacasestudy approachandc mbinedocumentreviewsandconsultationwith appr priatetechnicaland ountryexp rts.Thesefallint two groupsdependingonwhetherthey rioritized pthorbreadth. •Introductory overview:Thesebriefshaveadifferentobjectiveto therapidevidenceassessmentsbutuseasimilarmethodological approach.Literatureistargetedandreviewedwiththeaim ofexplainingasubjectto‘beginners’. Mostbriefshowever,willdrawonamixofmethodsanditisfor thisreasonthata‘methods’boxisincludedintheintroduction toeachbriefsignallingtransparentlythatmethodsareexplicit, robustandreplicableandshowinghowtheyareappropriateto thepolicyquestion. How can voluntary cross-border collaboration in public procurement improve access to health technologies in Europe? 5 KEY TERMS Health technologyistheapplicationoforganized knowledgeandskillsintheformofdevices,medicines, vaccines,proceduresandsystemsdevelopedtosolvea healthproblemandimprovequalityoflives.Inprocurement thismostoftenreferstoinnovativemedicinesasless attentionispaidtootherformsoftechnology(devices, equipmentandhealthinformationtechnology(IT)systems), eventhoughthesenowaccountforaconsiderableand growingportionofhealthcarespendinginEurope. Public procurementreferstothepurchasebygovernments orstate-ownedenterprisesofgoods,servicesandworks. KEY MESSAGES • Thereisagrowinginterestinfurtherdevelopingcross- bordercollaborationinthefieldofhealth,bothata bilateralandamultilaterallevel.Thisissupportedby EuropeanUnion(EU)legislationandpolicies,andextends toimprovingaccesstohealthtechnologies. • Changesinhealthtechnologiesmarkets,suchasthe generalizationofmanagedentryagreements(MEAs)and theprevailinglackofpricetransparency–particularlyin pricediscounts–requiredifferentapproachestothose appliedinthepast. • Thereisasoundrationaleforincreasedvoluntary collaborationbetweencountriesintheprocurement ofhealthtechnologies:  toenhancetransparencythroughbetter informationsharing  toenablecross-countrylearningbysharingexperience  tostrengthenbargainingpowerandmitigateoverly hightransactioncostsbypoolingskills,capacities andthroughjointnegotiations  toensuresustainableaccesstohealthtechnologies bysharingresourcesthroughcross-borderexchange ofproductsinshortsupply. • However,inpractice,developingsustainablecross-border collaborationinprocurementseemstobechallenging. ExperiencesinEuropearestilllimitedandtoorecent toreallyallowclearlessonstobedrawnabouttheir effectivenessandimpact. • Nevertheless,itisclearthatrelatedinitiativeswould requirestrongpoliticalcommitmentandmutualtrust betweenpurchasingpartnersinordertosucceed.It isthereforeadvisablethattheybebuiltprogressively, startingwithcollaborationininformationsharingand knowledgeexchange,beforemovingtowardsjoint purchasingactivities. Policy brief 6 How can voluntary cross-border collaboration in public procurement improve access to health technologies in Europe? 7 EXECUTIVE SUMMARY The policy issue: ensuring access to innovative health technologies in a changing market environment. Technologicalinnovationisoneofthemaindrivers forchangeinthehealthsectorandforimprovingits effectivenessintacklingdiseases.Atthesametime,the increasingpriceschargedfornewtechnologiesareputting pressureonhealthbudgets,whicharealreadysuffering fromfiscalconstraints.Thus,inordertoensureavailability topatients,individualhealthsystemsneedtomeetthe challengeofanticipatingandmanagingtheimpactof technologicalinnovationbyengaginginhorizon-scanning activities,mobilizingcapacitytoassessthevalueofnew technologiesandnegotiatingaffordableprices. Whilesomeoftheseinnovationscontributetoachieving betteroutcomesandinsomecasesevenmitigatingcosts, forothersaddedvalueiseithernotprovenordoesnot justifyhigherpricescomparedtoexistingalternatives. Consequently,thereisanincreasingneedforcountriesto accessinformationonanewtechnology’seffectiveness, safety,qualityandprice,inordertoeffectstrategic purchasing.Furthermore,publicpurchasersoftenhave relativelylowbargainingpowerwhenconfrontedwiththe introductionofnew,patent-protectedhealthtechnologies. Thisisparticularlyrelevantwhentheyarepurchasingfor smallerpopulations,eitherbecausethecountryitselfis smallortheconditioninquestionisrareandthetarget patientpopulationlimited.Inthesecases,itmaybehelpful forcountriestojoinforcesinpublicprocurementprocesses andtoestablishformsofcollaborationacrossbordersto ensureaccesstohealthtechnologies. Cross-border collaboration in public procurement Thecharacteristicsofmarketsforhealthproductshave dramaticallychangedsincethe1990s.Globalizationhas hadasignificantimpactonthenatureofthesupplychain. Aseriesofhigh-profileindustrymergershasreduced competitioninmanymedicinesmarkets.Thegeneralization ofintellectualpropertyrights,thegloballywidespread practiceofexternalreferencepricingandtheremoval oftariffbarriersthroughmultilateralandbilateraltrade agreements,especiallyintheEU,haveradicallychanged theinternationalpricingpoliciesofglobalpharmaceutical companies.Furthermore,theSingleEuropeanMarkethas madeitmoredifficultforsupplierstofollowindependent policiesineachcountry.Therealityofparalleltradeand thespill-overeffectsofinternationalreferencepricinghave ledcompaniestodevelopinternationalpricingstrategies, includingconfidentialpricediscountsandmanagedentry agreements(MEAs).Theseinturnforcedpricingand reimbursementauthoritiesaswellasprocurementagencies toacceptpriceconfidentialityonthe(questionable) assumptionthattheycouldobtainlowerpricesthan otherpurchasers. Cross-bordercollaborationinthefieldofpublicprocurement isoftenputforwardasapromisingstrategytoaddress someoftheexistingimbalancesandchallengesofthe healthtechnologiesmarket.Intheprocurementof healthtechnologies,therationaleforincreasedvoluntary collaborationbetweencountriesisto: • enhancetransparencythroughbetterinformationsharing • enablecross-countrylearningbysharingexperience • strengthenbargainingpowerandmitigateoverlyhigh transactioncostsbypoolingskills,capacitiesandjoint negotiations • ensuresustainableaccesstohealthtechnologiesby sharingresourcesthroughcross-borderexchangeof productsinshortsupply. Theachievementofsustainablepricesthrougheconomies ofscaleattainedbyagroupofentitiesthatpoolallor someofthepurchasingfunctions,orcollaborateincarrying themout,isthemostcommonlycitedgoalforcross-border collaborationinprocurement.However,otherobjectives, suchasimprovingthequalityofpurchasedgoods,ensuring supplysecurityandavailability,andfosteringcertain innovations,arealsoreceivingincreasingattention. Facilitators and barriers Althoughthereisalackofconclusiveevidence,itremains clearthatbothwithinandacrossborders,successfuljoint procurementdependsonanumberofessentialpre- conditionstobefulfilledbythepurchasers: • strongpoliticalcommitment • trustbetweencollaboratingparties • goodgovernancethathelpscurbopportunistic tendenciesthatcoulderodethevalueofthe procurementprocess • pricetransparency • marketanalysis • effectivecommunicationbetweeninternaland externalstakeholders • efficientfinancialmanagement,includingprompt paymentofpurchasesmade • continuitythroughmulti-yearcontractingthatenables stablesupplysourcesandfostersclosertiesbetween participants • clarityonmanagementresponsibilitiesforthejoint procurementprocessandtheirremuneration • sharingofinformationandgoodpractices • ongoingcommitmenttohonourtheconditions oftheprocurementagreement. Politicalwillandmutualtrustamongthepartners areobviousconditionsforanyformofcross-border collaboration.Mutualconfidenceandtrustcanbe progressivelybuiltbycountriesstartingwithlessintensive anddemandingcollaborationapproaches,e.g.those implyingonlytheexchangeofinformationandexperiences, time-limitedcollaborations,initiativeslimitedtoone singletechnologyordisease,etc.Thelongevityofsuch arrangementsalsoseemstoinfluencetheireffectiveness. Policy brief 8 Policy implications: supporting cross-border collaboration Whileactualinitiativesoncross-bordercollaboration inprocurementinEuropearestillfewandhaveevolved onlyrecently,thereisanincreasinginterestinexploring thepotentialofthisoptionasawaytoimproveaccess toinnovativemedicaltechnologiesandcontributeto healthsystemsustainability.Thisisnotonlyreflectedin anincreasingnumberofactivitiesinvoluntarycollaboration agreementsandmovestowardsjointprocurementamong EUMemberStates,butalsoinachangingEUframework thatfacilitatescross-bordercooperationbetween contractingauthoritiesandhelpsclarifytheapplicable lawandresponsibilitiesofthedifferentpartiesinvolved. Whileitremainshighlychallengingtomakesuppliersadapt tonewwaysofworkingwhichcouldimpacttheirprofit margins,thereisevidencethatcross-bordercollaboration inpublicprocurementcanbeeffective,particularlyfor smallmarkets,inmaintainingaccessthroughpooling resources.Therefore,collaborationsinpublicprocurement, whentheyaretailoredtomeetthespecificneedsofthe countriesinvolved,presentonesolutionthatcanhelpoffset imbalancesinthemedicaltechnologiesmarketandbetter servethegoalsofpublichealth. How can voluntary cross-border collaboration in public procurement improve access to health technologies in Europe? 9 Introduction Technologicalinnovationisoneofthemaindriversfor changeinthehealthsectorandthespeedatwhichit hitsthemarketsseemstobeincreasing.Forindividual healthsystemsitisanimportantgoalandatthesame timeaformidablechallengetoanticipatethischangeand tomanageitsimpact.Healthsystemsneedtomobilize capacityinordertoproperlyassessthevalueofnew technologies,negotiateaffordablepricesandensure availabilitytopatients.Thismaybeparticularlydifficult forsmallercountriesandcountrieswithlimitedresources, aswellasforspecificproducts.Inthesecases,itcouldbe helpfulforagenciestaskedwiththeprocurementofhealth technologiesandrelatedinstitutionstojoinforcesand establishformsofcollaborationwithinandacrossborders. Thispolicybrieflaysoutthecontextandlegalframework inwhichcross-bordercollaborationbetweenEUMember Statestakesplaceintheareaofpublicprocurement ofhealthtechnologies;discussesexistingexperiences andpractices;andseekstoassesstheirtransferability. Itbuildsonevidencegatheredinthe2016WHOreport onchallengesandopportunitiesinimprovingaccessto medicinesthroughefficientpublicprocurementinthe EuropeanRegion[1],toidentifysomeofthebarriers andfacilitatorsthatcountriesarelikelytofacewhen seekingtocollaborateinthisareaandtopresentways forward,specificallywithinanEUcontext,thatsupport andencouragecross-bordercollaborationinhealth.Italso presentssomeideasfortacklingthechallengescountries arelikelytofacewhenseekingtocollaborateinthis area,anddetailssomeofthebarrierstoandfacilitators forimplementation. Policy questions Thispolicybrieffocusesontheoverallquestion: “Howcanvoluntarycross-bordercollaboration inpublicprocurementimproveaccesstohealth technologiesinEurope?” Morespecifically,thefollowingissuesareaddressed: 1. What conditions are needed to make cross-border collaboration in procurement work? 2. For what types of health technology and types of activity would cross-border collaboration be most appropriate? 3. How can voluntary cross-border collaboration in procurement be supported by the EU? Innovation and access to health technologies Ensuringaccesstoinnovativehealthtechnologiesisan ongoingchallengeforhealthsystemsinallEuropean countries.Theincreasingpriceschargedfornew technologieshavebeenpushingupthepressureonhealth budgets,whicharealreadyfacinggrowingfiscalconstraints asaresultofthefinancialcrisisandsubsequenteconomic recession.Atthesametime,theeverhigherprevalence ofchronicdiseasesandmultimorbidityarespurringthe demandforinnovativehealthtechnologiesthatwould enablebettermanagementoftheseconditions.These challengescallforeffectiveandefficientprocurement processes. Whilesomeoftheseinnovationscontributetoachieving betteroutcomes,andinsomecasesevenmitigatingcosts, forothersaddedvalueiseithernotprovenordoesnot justifyhigherpricescomparedtoexistingalternatives. Increasingly,countriesareestablishingmechanismsto scrutinizeandassesstheadditionalvalueofhigh-cost innovativehealthtechnologiesasabasisfordetermining priceand/orreimbursement.However,acquiringinformation onanewtechnology’seffectiveness,safety,quality,price andotherrelevantcharacteristics,whichisindispensable totheefficientimplementationofstrategicpurchasing,is bothchallengingandcostly.Furthermore,publicpurchasers oftenhaverelativelylowbargainingpowerwhenconfronted withtheintroductionofnew,patent-protectedhealth technologies.Thisisparticularlyrelevantwhentheyare purchasingforsmallerpopulations,eitherbecausethe countryitselfissmallortheconditioninquestionisrare andthetargetpatientpopulationlimited.Achievingsupply securitytoensureaccessinthesecasesmaybedifficultas well.Thus,accesscanbeendangeredbothinregardtothe affordabilityandtheavailabilityofnewhealthtechnologies. AccordingtotheWorldHealthOrganization(WHO), healthtechnologyrefersto“theapplicationoforganized knowledgeandskillsintheformofdevices,medicines, vaccines,proceduresandsystemsdevelopedtosolvea healthproblemandimprovequalityoflives”[2].While thisbrieffollowsthisbroaddefinition,relevantresearch andanalysisoncollaborationinprocurementmostoften focusesoninnovativemedicinesandlessattentionispaid tootherformsoftechnology(e.g.devices,equipment andhealthITsystems),eventhoughthesenowaccount foraconsiderableandgrowingportionofhealthcare spendinginEurope.Asaconsequence,theevidenceand Box 1: Methods Thispolicybriefbuildsonevidencegatheredforthe2016WHO reportonchallengesandopportunitiesinimprovingaccessto medicinesthroughefficientpublicprocurementintheWHO EuropeanRegion[1].Itusestwomainmethodsforapproaching theideaofcross-bordercollaborationforprocurement.It combinesaliteraturestudywithexpertinterviews.Theliterature reviewfocusedonidentifyingscientificandgreyliteraturethat couldprovideananswertothecentralresearchquestion:How canvoluntarycross-bordercollaborationinpublicprocurement improveaccesstohealthtechnologiesinEurope?Inaddition, semi-structuredinterviewswereconductedtogainamorein- depthunderstandingofhowcollaborationforprocurementhas beensupportedbydifferentinternationalorganizations.Interviews wereconductedwithEuropeanpolicyofficersandprofessionals dealingwithcollaborationforprocurementinMinistriesofHealth. TheinterviewswereconductedinEnglishbyphoneandemail. AttendantsattheWHOEuropeRegionalMeetingonstrategic publicprocurementinSeptember2016alsoprovidedimportant informationforthispolicybrief,especiallyforelaborating ongoinginitiatives,whichhavenotyetbeenfullyevaluated. AfulldescriptionofthemethodsisincludedinAppendix1. Policy brief 10 experiencedescribedbelowrelatemainlytocollaboration inthefieldofmedicines.Althoughlessonsfromthese areascanpartlybeappliedtootherhealthtechnologies, transferabilityissometimeslimitedbythecharacteristicsof differenttechnologytypes.Forexample,medicaldevices aremuchlessstandardizedthanmedicinesandthereis substantiallylessevidenceontheirsafetyandefficacyat thetimeofmarketentry.Healthcareservices,ontheother hand,mustbecustomizedtothecharacteristicsoftheusers anddemandisthereforelessamenabletoconsolidation ofpurchaserorganizationsofdifferentjurisdictionsfor procurementpurposes. A changing context in pharmaceutical markets Thecharacteristicsofthemarketsforhealthproductshave dramaticallychangedsincethe1990sandglobalization hashadasignificantimpactonthenatureofthesupply chain.Aseriesofhigh-profileindustrymergershasreduced competitioninmanymedicinesmarkets.Nationalhealth systems,ontheotherhand,haveinseveralcasesbecome moredecentralizedinrelationtoprocurement[1].Thishas ledtoasituationwhereknowledgeandpowerdistribution betweensuppliersandbuyersinthehealthcaremarkethave becomemoreunbalancedandasymmetricalinfavourof suppliers.Thegeneralizationofintellectualpropertyrights thatfollowedtheapprovaloftheTrade-RelatedAspects ofIntellectualPropertyRights(TRIPS)agreementandthe globallywidespreadpracticeofexternalreferencepricing, aswellastheremovaloftariffbarriersthroughmultilateral andbilateraltradeagreements,especiallyintheEU,have radicallychangedtheinternationalpricingpoliciesofglobal pharmaceuticalcompanies.Thisisparticularlyrelevant fornewtechnologiesprotectedbypatentsandother exclusivityrights. Inthepast,pharmaceuticalcompaniesconfronteda country-segmentedmarketandwereusedtocharging eachcountryasmuchasthemarketcouldbearinorder tomaximizeglobalprofits.SouthEuropeancountries,for example,traditionallydemonstratesubstantiallylower pricesforon-patentmedicines[3].ButtheSingleEuropean Markethasmadeitmuchmoredifficultforsuppliersto price-differentiateand,ingeneral,tofollowindependent policiesindifferentcountries.Therealityofparalleltrade wheretechnologiesareimportedfromothercountriesin theSingleMarketratherthandirectlyfromsuppliers,plus thespill-overeffectsofinternationalreferencepricing,have ledcompaniestodevelopinternationalpricingstrategies, includingconfidentialpricediscountsandmanagedentry agreements(MEAs).Theseforcepricingandreimbursement authoritiesaswellasprocurementagenciestoacceptprice confidentialityonthe(questionable)assumptionthatthey canthusobtainlowerpricesthanotherpurchasers.Inthis newscenario,whichfindsmanyapplicationsinEuropean countries,itbecomesincreasinglydifficultforpurchasersto observetherealtransactionpricesofmedicinesand,asa consequence,tomakeinformedandefficientdecisionsand assesstheeffectsofpoliciesandprocurementpractices[1]. Thesenewfeaturesofthemedicinesmarketshaveled toafundamentaltransformationofthecontextinwhich procurementtakesplaceandhaveinfluencedtheincentives andopportunitiesforcross-bordercollaboration.Both suppliersandpurchasersofhealthtechnologiesintheEU havebecomeaccustomedtopriceconfidentiality,andboth industryandpolicy-makersmightrefrainfromengaging incollaborativeinitiativesiftheyperceivesuchinitiatives topresenttheriskoflosingthebenefitstheybelievethey derivefromconfidentiality. Public procurement of health technologies and its potential Publicprocurementreferstothepurchasebygovernments orstate-ownedenterprisesofgoods,servicesandworks. Theprocurementofproductsandservicesaccountedfor 19%ofthegrossdomesticproduct(GDP)oftheEUin 2013[4].Whenusedstrategically,publicprocurementcan serveasamajor,highlydynamicpolicytoolthathasgreat potentialtosteerindustrialpolicy,promoteenvironmental andsocialobjectives,encourageinnovativesolutionsand createmoreaffluence[5]. Therearedifferenttypesofprocurement,whichare summarizedinBox2. Box 2: Procurement methods Mosttypesofpublicprocurementcanbeusedformulti-sourceand single-sourceproductsunderdifferentcircumstances,exceptdirect procurement,whichmakessenseonlyforsingle-sourceproducts, asitdoesnotcomparepricesofdifferentsuppliers. • Open tender:bidsareinvitedfromanysupplier,subjectto thetermsandconditionsspecifiedinthetenderdocument. Allsuppliersinterestedinthetendermaybid. • Restricted tender:interestedsuppliersneedtobeapproved inadvance,forexample,throughaformalpre-qualification processthattakesintoaccountadherencetogood manufacturingpractices,previousperformance,financial viability,etc.Theprocessofpre-qualificationisoftenopen toanysupplier.Areverse auctionisa2-stepvariationofa restrictedtender.Inareverseauction,thelowestpricedoffer ispublishedwithoutnamingthebidderandqualifiedbidders areinvitedtosubmitloweroffers.Theprocesscontinuesuntil nomoreoffersaremade.Thisprocurementmethodhasbeen seldomusedformedicines. • Competitive negotiation:thebuyerinvitesapreselected numberofsupplierstosubmitpriceoffers;negotiation mayfollowtoachieveabetterpriceorparticularservice arrangements.Internationalorlocalshoppingisbasedon thesameprinciplebutnegotiationisnotpermitted. • Direct procurement:technologies(e.g.single-source products)areobtainedatlistpricesornegotiatedpricesfrom asinglesupplier.Ingeneral,single-sourceproductsmaybe procuredeithervianegotiatedprocurement,directprocurement ortenderingofthesingle-sourceproductandtherapeutic substitutes,soastocreateacompetitiveenvironment. Source:[1]. How can voluntary cross-border collaboration in public procurement improve access to health technologies in Europe? 11 However,thevarioustypesofprocurementrelyona commonfoundationintermsofprocess.Thepublic procurementprocessisthesequenceofactivitiesstarting withtheassessmentofneedsthroughawardstocontract managementandfinalpayment[6].Figure1showsfour typesofactivityrelatedtotheprocurementofhealth technologies: 1.Activitiesthatformthecoreprocurementfunctions (medium green boxes)astheyarecloselylinkedtothe economictransactionthatcharacterizesprocurement. 2.Activitiescloselyrelatedtothecoreprocurement functions(white boxes)–mainlygatheringandanalysing informationwiththeaimofimprovingtheeffectiveness andefficiencyofprocurement. 3.Activitiesusuallycarriedoutbytheprivatesector (light green boxes)thatconditionandinfluencethe implementationandoutcomesoftheprocurement process,suchasR&Dactivitiesleadingtotheproduction andultimatelytothesupplyofhealthtechnologies. 4.Regulatoryactivitiescarriedoutbythepublic sector(dark green boxes),whichalsocondition andinfluencetheimplementationandoutcomesof theprocurementprocess. Anefficientprocurementprocesscanimprovetheprices, qualityandsupplyavailability/reliabilityfromagivensetof suppliers,by:planningandforecastingneedsandsupply; settingprioritiesasthebasisofrationalchoices;obtaining thebestachievablepurchaseconditions;andmonitoring andevaluatingthewholeprocurementprocessinorderto learnfrompastexperienceandimprovefutureperformance. Collaboration in procurement Definition Thereisnosingletermtocovertheactofseveralbuyers collaboratingandpoolingresourcestonegotiateortobuy medicalgoodsandsuppliesatmorefavourableconditions. IntheEUsetting,jointprocurementisthemostcommonly usedterm.ItisusedintheEUPublicProcurementDirectives todenotethesituationwhereseveralbuyerscometogether, inasingleprocess,togetbetterpricesoraccess.Atthe internationallevel,pooledprocurementisalsoacommonly usedtermforthesameconcept.Othercloselyrelatedterms arecentralprocurement,groupprocurementandgroup purchasing.Jointprocurementcantakevariousformats. Theoperationaldefinitionforjointprocurementusedin thispolicybriefencompassesdifferentpossiblelevelsof collaboration,furtherelaboratedbelow. Figure 1: Activities leading to procurement and access to health technologies Source:Authors’owncompilation. Market authorization Price regulation IPR protection HTA Reimbursement status R&DTechnologyNeeds definition and horizon scanning Prioritization and selection Quantification of needs Payment Distribution Monitoring and evaluation Price, quantity and other terms of the contract Purchasing options TendersNegotiation Direct purchasing Supply of technologies Policy brief 12 Rationale Cross-bordercollaborationinthefieldofpublicprocurement isoftenputforwardasapromisingstrategytoaddresssome oftheexistingimbalancesandchallengesofthehealth technologiesmarketdescribedabove.Intheprocurement ofhealthtechnologies,therationaleforincreasedvoluntary collaborationbetweencountriesisto: • shareexperience,poolskillsandcapacity • enhancetransparencyandenablecross-countrylearning • shapethemarketthroughinformationsharingtoavoid asymmetriesofinformationandjointnegotiation • tacklehighpricesthrougheconomiesofscaleand buildingmarketpower • tacklehightransactioncostsbypoolingresources. Theachievementofsustainablepricesthrougheconomies ofscaleattainedbyagroupofentitiesthatpoolallor someofthepurchasingfunctions,orcollaborateincarrying themout,isthemostcommonlycitedgoal.However,other objectives,suchasimprovingthequalityofpurchased goods,ensuringstablesupplyandavailability,andfostering certaininnovationsarereceivingincreasingattention. Availabilityisbecomingincreasinglyimportant,especially inCentralEasternEuropeanandSouthEasternEuropean countrieswherelowerpricelevelsgenerateparallel exportationtohigherpricecountriesinWesternand NorthernEurope.Manufacturersalsotendtowithdrawtheir productsfromcertaincountrieswithsmallerpopulations iftheirprofitmarginsaredeemedtoosmalltojustify marketingtheirdrugsthere.Throughjointnegotiations thesecountrieshopetoensuresupplyasmanufacturersare dealingwithalargernetpopulation.Giventhechangesin pharmaceuticalmarketsobservedinrecentyears,thescope forcollaborationbetweenbuyersintuitivelybecomesmore compelling.Althoughsmallorlower-incomecountrieswill bemorelikelytobenefitfromcollaborationinprocurement, collaborationcanalsobeanattractiveoptionforlarge, higher-incomecountrieswhenitcomestosmall-volume products,suchasorphandrugs(forexample,BeNeLuxA; seeBox3)[1].Itispossiblethatcollaborationbetween large/high-incomecountriesandsmall/lower-income countriesmightalsooccur,spurredonbythemotivesof solidarityandpoliticalinfluenceintheabsenceofdirect economicbenefits. Different forms Cross-bordercollaborationinprocurementcantakedifferent forms,withvaryingintensityandscopeofactivities.WHO providesafour-levelclassificationofregionalcollaboration forprocurementexperiencesinhealthtechnology,basedon anincreasingdegreeofcooperation(seeFigure2): • Informed procurement:countriesshareinformation aboutpricesandsuppliers. • Coordinated informed procurement:countriesmay alsoundertakejointmarketresearch,sharesupplier performanceinformationandmonitorprices. • Group contracting:involvesjointlynegotiatingprices andselectingsuppliers. • Central contracting and purchasing:participating countriesjointlyconducttendersandawardcontracts throughacentralpurchaserworkingontheirjointbehalf. Thisclassificationconsiderstwobroadpotentialareas ofcollaboration: • Thecollection,elaborationandexchangeofinformation; and • Theactivitiesmorecloselyrelatedtoactualcontracting andpurchasing. Thus,themodelcanbeinterpretedassuggestinga ‘naturalroute’ofincreasedintensityand/orcommitmentin collaboration,startingbyjustsharinginformationonprices andsuppliers,uptojointprocurementbyacentralized body.Italsosuggeststhatthetypesofcollaborationplaced higherintheclassificationincludetheactivitiespooledat lowerlevels,inlinewiththenotionthatitmayoftenmake senseforcountriestoinitiallyadoptlesscommittedand riskyarrangementsandmovetomoreintensetypesof collaborationdowntheline.Fromthepurchaserperspective, thecore/keycomponentinthechainofactivitiesina procurementprocess(seealsoFigure1)isthemechanism forselectingthesupplier(s)andagreeingonacontract Box 3. BeNeLuxA – collaboration on procurement of pharmaceuticals for rare diseases Thisinitiativetojointlynegotiatepricesformedicinesforrare diseaseswasinitiatedbyBelgiumandtheNetherlands(April 2015),andwaslaterjoinedbyLuxembourg(September2015)and Austria(June2016).Thisgroupofcountries,knownas‘BeNeLuxA’, intendstocollaboratemorecloselyacrossarangeofareas: healthtechnologyassessment(HTA);horizonscanning;exchange ofinformationonpharmaceuticalmarkets,pricesanddisease- specificcross-borderregistries;andpricingandreimbursement, includingjointnegotiation.Theultimateaimistoensureaccess toinnovativedrugs,initiallyorphandrugs,ataffordableprices fortherespectivepopulations.Bybeingabletopresentabigger patientpooltopharmaceuticalcompanies,itishopedtoincrease purchasingpoweranditisalsohopedthatmorecountrieswill jointheinitiative. Thispilot-projectfollowedthedifficultnationalnegotiationsover certainhigh-priceddrugssuchas,forinstance,theHepatitisC drugsofosbuvir.Throughbettersharingofinformationandcloser collaboration,itisbelievedthatgovernmentscouldobtainreduced butfairprices.Forthepharmaceuticalindustrythebenefitisdirect accesstoalargerpatientpopulationandmorestreamlinedmarket accessastheyonlyneedtoprovideonedossier,notoneper country,managedinacoordinateddecisionprocess. Thiscoordinatedprocurementreliesonasetofprinciples:setting clear,commongoals;beingclearonthemutualbenefits;a pragmaticapproachfocusingonthedesiredoutcomesandhaving aleanorganizationalstructure;understandingthatcooperation isnotthesolutiontoallproblems;voluntaryparticipation;anda strongpoliticalwill.Theprojecthasnofixed‘roadmap’:thedegree ofcollaborationdependsonwhatisrequiredwithastepwise approachtoparticipation.Thisisakeydifferencecomparedto theEUJointProcurementAgreement(seeBox6),wherethe Commissionleadsonthenegotiationsratherthanindividual countriesandtheframeworkforcollaborationismorefixed. Sources:[10–13]. How can voluntary cross-border collaboration in public procurement improve access to health technologies in Europe? 13 withasetofconditions.Infact,publicprocurement includesalargenumberofactivities/functionsandpartners mightcollaborateindifferentclustersorcombinationsof activities.Thismeansthatamuchlargernumberoftypes ofcollaborationisfeasible,beyondthefourconsideredin Figure2.Othermodelsofcollaborationinprocurement havealsobeendescribedbeyondtherealmofhealth technologiesbutwithpotentialforapplicabilityinthisarea aswell,suchas‘piggy-backing’,wherebyacontracting authoritycarriesouttheprocurementonitsownbut allowsothercontractingauthoritiestheoptionofusing thecontract[7]. Ingeneral,importantcharacteristicsthatdefineand differentiatecross-bordercollaborationforprocurement ofhealthtechnologiesare[8]: • Ownership:thecollaborationmightbelongtothe individual,pooledunits(usually,nationalgovernmental procurementunits)ortoanorganizationspecifically createdbythegovernment(s);alternatively,itmight beownedbyalargerinternationalorganization. • Financing mechanism:thereareseveralpotential combinationsofexternaldonorsandnationalpartners andofthefinancingstructure,whichimplyvarious modelsofdistributingtheeconomicresponsibility andsolvency. • Procurement activities:activitiessuchasplacing orderswithsupplierscanbecentralizedorlefttothe pooledunits.Contractingandpurchasingcanbethe responsibilityofacentralunit.Alternatively,acentral unitcannegotiatetheprice(withsomeestimations andresponsibilityforthevolumeofproductsthat eachpartnerexpectstopurchase). • Timeframe:thecollaborationcanbepermanent oroccasional. • Range of products or services involved:the collaborationcanincludeallhealthtechnologiesor berestrictedtoaspecificclass,e.g.orphandrugs. • Purchasing mechanism:thecollaborationcanrely onbulkcontracting,whereonesupplierisawardedall tendereditemsoroptforaframework(time-bound) contract,wherethesuppliersarenotnecessarily awardedaguaranteedspecificquantity. Findings European experiences of voluntary cross-border collaboration in procurement of health technologies Publicprocurementforhealthtechnologieshasbeen supportedbytheEU,asoneareaforcross-border collaborationbutimpetusforgreatercoordinationand collaborationbetweenMemberStatesfollowedtheH1N1 influenzapandemicin2010andtheEbolaepidemicin 2014[9].Duringthesepublichealthemergencies,countries werecompetingwitheachothertogetholdofscarce supplies,andpriceswentupinresponse.Toreducethe chancesofsimilareventsoccurringinthefuture,theEU JointProcurementAgreement(seeBox4)wassigned,in ordertomaintainaccesstovaccines,medicinesandmedical equipmentthataddressseriouscross-borderthreats. However,therewerealsomanyotherinitiativesthathave beenputinplacebyMemberStatessince2010(seeTable 1).Manyofthecross-bordercollaborationsintheEUare verynewandstillevolvinginsomecases,andhavethus Figure 2: Levels of collaboration in procurement Source:Adaptedfrom[1]. Informed buying Coordinated informed buying Group contracting Central contracting and purchasing Joint tenders and contract award through a centralized body on behalf of participating countries Joint price negotiation and supplier selection. Participating countries agree to purchase from selected suppliers Joint market research, sharing supplier performance information and monitoring prices Participating countries share information about prices and suppliers Information sharing Pooled procurement Le ve l o f co lla bo ra tio n in p ro cu re m en t Policy brief 14 notyetbeenfullyevaluatedintermsofwhethertheymeet theirobjectives. Thescopeofmostofthesevencross-bordercollaborations inpublicprocurementidentifiedinthisbriefinvolves medicines–mostcommonlyinnovativemedicines.Whilethe BalticPartnershipAgreementalsoexplicitlycoversmedical equipment,inpractice,ithasonlybeenusedsofarforthe procurementofvaccines(seeBox4).Thebarrierstojoint procurementencounteredintheinitialattemptsunderthe BalticPartnershipAgreementserveasusefulillustrationsof thechallengesthatneedtobeovercomeinordertoincrease leverageforreducingpricesandensuringavailability. However,theimportanceofcross-bordercollaborationfor accesstomedicaltechnologiesinsmallmarketsisalsoclear asthesecountriesweresuccessfulinpoolingresources toborrowstocksfromneighbouringcountriesinorderto maintainsupplies.Similarly,theRomanianandBulgarian Initiative(seeTable1),whilehopingtousejointprice negotiationtoreducecosts,willalsoinvolvecross-border exchangesformedicinesthatmaybeinshortsupplyin eithercountry. Cross-countrycollaborationsintheprocurementofhealth technologieshavebeenrunningforaconsiderablylonger timeoutsidetheEuropeancontext.Twomajorreviewsof jointprocurementexperiencesinotherpartsoftheworld havebeenconducted[8,14].Severaloftheinitiatives identifiedthereinwereconsideredtobefailedorinactiveat thetimeofinvestigation.Whilesomeofthemoresuccessful collaborationsreviewedreflecttheinitiativeofagroup ofcountries(OrganisationofEasternCaribbeanStates PharmaceuticalProcurementService;GulfCooperation Council),themajorityaretheresultofaninternational organizationtakingtheleadandrunningthecollaborative procurementasoneofitsfunctionsPanAmericanHealth Organization(PAHO)RevolvingFund;GlobalTBDrug Facility;UnitedNationsFundforPopulationActivities ProcurementServicesBranch;UnitedNationsChildren’s Fund(UNICEF)(ARIVA). The current EU framework for supporting voluntary cross-border collaboration in procurement of health technologies General framework on public procurement TheEUrulesonpublicprocurementareinthefirstplace meanttoensuretransparent,fairandcompetitiveawarding ofpubliccontractsforpurchasinggoods,worksandservices throughouttheEU.Thelegalframeworkwasrevisedin 2014withDirective 2014/24/EU on public procurement, whichrepealsDirective2004/18/EConpublicworks. Thenewrules,whichhadtobetransposedintonational lawbyApril2016,simplifyprocurementprocedures, makethemmoreflexibleandhelppublicpurchasers toincorporateandimplementstrategicobjectivesfor protectingtheenvironment,promotingsocialintegration orfosteringinnovation. Directive2014/24/EUonpublicprocurementcoversthe issueofcross-borderjointprocurement.Article39explicitly allowsforcontractingauthoritiesfromdifferentMember Statestoactjointlyintheawardofpubliccontracts.Inorder tofacilitatethiskindofcross-bordercooperationbetween contractingauthorities,theDirectivehelpstoclarifythe applicablenationallawandresponsibilitiesofthedifferent partiesinvolved.Whereprocurementiscentralizedthrough onepurchasingbody,thepurchasingactivitiesaregoverned bythenationalrulesoftheMemberStatewherethecentral purchasingbodyislocated.Ifcontractingauthoritiesfrom differentMemberStatesworktogethertojointlyaward apubliccontract,concludeaframeworkagreementor operateadynamicpurchasingsystem,therespective responsibilitiesofthevariouspartiesneedtobeclarifiedin aninternationalagreementthatiseitherconcludedbetween MemberStatesorbetweentheparticipatingcontracting parties.ContractingauthoritiesfromdifferentMember Statescanalsosetupajointlegalentityundernational orEUlaw,inwhichcaseanagreementonwhichnational procurementrulesapplyisalsoneeded. Box 4: Joint procurement of vaccines under the Baltic Partnership Agreement CollaborationundertheBalticPartnershipAgreementwasstarted attheendof2014andthefirstjointprocurementfocusedon vaccines,asallthreeBalticStateshavesimilarimmunization schedulesandthepriceofvaccinesismostlyinfluencedby purchasedvolumesandlong-termdeliveryschedules. Thefirstopenprocedure(fortheBCGvaccine)wasannounced in2015.ItwasorganizedaccordingtothePublicProcurement LawofLatvia,asLatviawastheleadpartner.Theprocedure wasterminatedinSpring2015becausenotenderwassubmitted. Astheprocurementtechnicalspecificationsonlyallowedvaccines withvalidmarketingauthorizationinallthreeBalticStates, therewasonlyoneproducerwithasuitableregisteredproduct andhedeclaredseriousproductionproblemswithinthetender submissiontimescale.Thetenderhadtobedrawnupforjoint procurementthroughcompetingwholesalersasthemanufacturer wasnotinterestedinparticipatinginthejointprocurementprocess directlyforsuchasmallmarketandsmallamount–despitethe threecountriespoolingtheirleveragetojointlynegotiateprices withsuppliers.Forexample,thenecessityofproducinguniform packaginginthethreelanguageswasnotconsideredtobecost- effectivebythemanufacturer. Afterreneweddiscussionsintheworkinggroup,theobjectofthe jointprocurementwaschanged.EstoniaandLatviaidentifieda rotavirusvaccineasthenextmostpromisingchoice(Lithuaniadoes nothaverotavirusvaccineinitsimmunizationschedule).Also,it wasdecidedthatEstoniawillbetheleadpartnerandLatviawill delegatealltheobligationsoftheprocurementprocessupuntil thesigningoftheframeworkagreementtoEstonia.Thejoint procurementforrotavirusvaccinewasannouncedon21October 2016andtheopeningofthetenderswason8December2016. ThereisalsoanongoingcollaborationbetweenLatviaand Lithuaniafortheprocurementofpneumococcalvaccine. AnimportantcomponentofthePartnershipAgreementisthe lendingofcentrallyprocuredmedicines,whichenablescountries topreventandalleviateshortagesofmedicines.Since2012,there havebeenseverallendingprocesses,whichhavehelpedcountries tosolveseriousshortageproblems. Source:EveliBauer. How can voluntary cross-border collaboration in public procurement improve access to health technologies in Europe? 15 Article39ofthepublicprocurementDirectivealsostates thatthepossibilitiesforcross-borderjointprocurement shouldnotbeusedforthepurposeofavoidingthe applicationofmandatorypubliclegalprovisionstowhich contractingauthoritiesaresubmittedintheirownMember State.Inthesamesense,cross-bordercollaborationin procurementisnotsupposedtoinfringeonEUcompetition law.RelatedguidelineshavebeensetoutintheGuidelines ontheapplicabilityofArticle101oftheTreatyonthe FunctioningoftheEuropeanUnion(TFEU)tohorizontalco- operationagreements(2010). Structured cross-border cooperation in health Thedefinitionofhealthpolicyandtheorganizationand deliveryofhealthservicesandmedicalcarearetheexclusive responsibilityoftheMemberStates.Theseresponsibilities includeexclusivecompetenceinthemanagementof theirrespectivehealthsystemsandmedicalcare,and theallocationofresourcesassignedtothem.However, accordingtoArticle168(2)TFEU,theEUhasanobligation topromotecooperationbetweenMemberStatesinthe fieldofhealth.Basedonthis,theEuropeanCommissionhas developedawiderangeofactionsundertheEU’spublic healthprogrammethatorganizeandsupportcooperation activitiesinvariousfields.TheCommission’sCommunication oneffective,accessibleandresilienthealthsystems(2014), whichsetsoutafutureEUhealthpolicyagenda,also highlightsthepotentialofimprovedcooperationinthefield ofmedicinesthroughbuildingmechanismsforincreased transparencyandbettercoordinationtominimizeany unintendedeffectsthatcurrentnationalpricingsystems mayhaveintermsofaccessibilitythroughouttheEU. TheDirective 2011/24 on patient rights and cross- border health caremaybeviewedashavingprovided anewapproachtostructuredcross-bordercooperation betweenhealthsystems,whilefullyrespectingMember States’competenceinorganizinganddeliveringhealth care.ChapterIVoftheDirectivespecifieshowstructured cooperationistobeorganizedinareaslikeEuropean referencenetworks(ERN),rarediseases,healthtechnology assessment(HTA;seeBox6)ande-health.Assomeof thesestrandsfurtherbuildoncooperationstructuresand networksthatinitiallydevelopedasprojects,theycan provideusefullessonsfordevelopingstructuredcooperation intheprocurementofhealthtechnologies.Thisisclearly thecasewiththedevelopmentofavoluntarynetwork connectingnationalauthoritiesorbodiesresponsiblefor healthtechnologyassessmentdesignatedbytheMember States(Article15).ThecreationofERNs(Article12)may alsobearelevanttoolforsupportingcooperationin procurement.Sincetheyparticularlyfocusonrarediseases andthedeliveryofhighlyspecializedservices,ERNsmayin Table 1. European experiences of cross-border collaboration in procurement of health technologies Name of collaboration Start date Countries involved Scope Aspects of procurement covered Central Eastern European and South Eastern European Countries Initiative November 2016 Romania, Bulgaria, Croatia, Latvia, Poland, Serbia, Slovakia, Slovenia, Republic of Moldova, FYR Macedonia Pharmaceuticals Price negotiation Southern European initiative June 2016 Greece, Bulgaria, Spain, Cyprus, Malta, Italy, Portugal Innovative medicines Information sharing on prices and markets, collaboration on R&D Declaration of Sofia June 2016 Bulgaria, Croatia, Estonia, Hungary, Latvia, FYR Macedonia, Romania, Serbia, Slovakia, Slovenia Pharmaceuticals Information sharing on prices and markets, with potential for joint purchasing in the future Nordic Pharmaceuticals Forum June 2015 Denmark, Iceland, Norway, Sweden Innovative medicines Horizon scanning, information sharing on prices and markets Romanian and Bulgarian Initiative June 2015 Romania, Bulgaria Pharmaceuticals Joint negotiations in purchasing to get lower prices for pharmaceuticals and cross-border exchange of medicines in short supply to ensure continuity of access BeNeLuxA April 2015 Belgium, Netherlands, Luxembourg, Austria Innovative medicines HTA, horizon scanning, information sharing on prices and markets, joint negotiation for purchasing to ensure affordability (see Box 3) Baltic Partnership Agreement May 2012 Latvia, Lithuania, Estonia Pharmaceuticals and medical devices Centralized joint purchasing (tenders, negotiation, payment and distribution) to reduce expenditure and ensure continuity of access (see Box 3) Source:Basedon[1]. Policy brief 16 factbeanimportantleverforensuringaccesstoinnovative healthtechnologies.AsERNswillpoolpatientswith lowprevalence,complexorrarediseases,theycouldbe instrumentalnotonlyinreinforcingresearchanddeveloping goodpracticeguidelinesbutalsoinexercisingnegotiating leveragewithpharmaceuticalandmedicaltechnology companies. ThemostconcreteexampleofEuropeanCommission actiononcooperationinthefieldofprocurementof healthtechnologiesisDecision No. 1082/2013/EU of 22 October 2013 on serious cross-border threats to health (and repealing Decision No 2119/98/EC),which wasdevelopedattherequestoftheEmployment,Social Policy,HealthandConsumerAffairs(EPSCO)Counciland theEuropeanParliamentfollowingtheH1N1crisisin2009. BasedonArticle168(1)TFEU,whichprovidesforEUaction tocomplementnationalpoliciesforcombatingseriouscross- borderthreatstohealth,thisdecisionnotonlyextendedthe scopeforactiontoalsocoverseriouscross-borderhealth threatsbeyondcommunicablediseases(e.g.biologicalor chemicalagentsorenvironmentalevents),italsowidened thecoordinationmechanismstoaddresshealthsecurity crisesatanEUlevel.ItincludesthepossibilityforMember Statestoengageonavoluntarybasisinajointprocedureto procuremedicalcountermeasures(Article5).BySeptember 2016,theJointProcurementAgreement(JPA),specifying thejointprocurementprocedureanditsgovernance,had beensignedby24MemberStates,withSwedenandFinland Box 5: EU Joint Procurement Agreement on medical countermeasures TheEUJointProcurementAgreement(JPA)wasadoptedin April2014andcameintoforceinJune2014,whenthefirst 14MemberStatessignedtheAgreement.BasedonDecisionNo. 1082/2013/EU,theJPAseekstostrengthenhealthsecurityinthe EUbyimprovingitspreparednessagainstcross-borderthreats tohealththroughjointprocurementoradvancepurchaseof medicalcountermeasures.Itsdevelopmentwasacceleratedbythe 2009H1N1influenzapandemicwhenMemberStatescompeted toaccessvaccinesuppliesrapidlyandfrequentlypaidrelatively highpricesformedicinestheyendedupnotusing. TheJPAisavoluntaryagreementtopurchasejointly.The prospectivebenefitsofjointprocurementinclude:betteraccess tomarkets;moreequitableaccessforMemberStatestomedical countermeasures,anti-infectivesorvaccinesagainstcross- borderhealththreats;improvedsecurityofsupply;andmore stablepricing. Theadministrativearrangementsaresetoutindetailinthe policyinstrument.TheEuropeanCommissionplaysakeyrole, actingasthePermanentSecretariatandasthebodyresponsible forensuringthepreparationandorganizationofthejoint procurementprocedure.Aseparatecommitteeisestablishedfor eachspecificprocurementproceduretodeterminethetechnical specificationsandallocationcriteriaformedicalcountermeasures. TheformulationallowsMemberStatessomeflexibilitybutalso detailstheprocessesandprocedurestobefollowed. AfirstcallfortenderforPersonalProtectiveEquipmentinEU hospitalsettingswaslaunchedinMarch2016byfiveMember States(Belgium,Croatia,Cyprus,ItalyandMalta)andthe EuropeanCommission. Source:[9]. Box 6: Collaboration in health technology assessment (HTA) TheEuropeanCommissionhassupportedcollaborationinHTA acrosscountriessincetheearly1990s[16].In2004,itsetHTA asapoliticalpriority,followedbyacalltowardsestablishinga sustainableEuropeannetworkonHTA.Thecallwasansweredby 35organizationsthroughoutEuropeandledtotheintroduction oftheEuropeannetworkforHealthTechnologyAssessment (EUnetHTA)Projectin2007.Basedontheproject’sresults,the EUnetHTACollaboration2009,theEUnetHTAJointAction 2010–2012,EUnetHTAJointAction22012–2015andEUnetHTA JointAction32016–2020havebeenconsistentlysupportedbythe EuropeanCommission. Cross-bordercollaborationinHTAisnowanchoredinEUlaw throughDirective2011/24/EUontheapplicationofpatients’rights incross-borderhealthcare.Article15statesthat“TheUnionshall supportandfacilitatecooperationandtheexchangeofscientific informationamongMemberStateswithinavoluntarynetwork connectingnationalauthoritiesorbodiesresponsibleforhealth technologyassessmentdesignatedbytheMemberStates.”The Directivesetsoutboththenetwork’sgoalsandactivitiesforwhich additionalEUfundsmayberequested.Italsoexplicitlyreinforces theprincipleofsubsidiaritybystatinginthefinalparagraphof Article15that“measuresadoptedpursuanttothisArticleshall notinterferewithMemberStates’competencesindecidingonthe implementationofhealthtechnologyassessmentconclusionsand shallnotharmonizeanylawsorregulationsoftheMemberStates andshallfullyrespecttheresponsibilitiesoftheMemberStatesfor theorganizationanddeliveryofhealthservicesandmedicalcare.” InOctober2016,apublicconsultationwaslaunchedon theInceptionImpactAssessment“Strengtheningofthe EUcooperationonHealthTechnologyAssessment(HTA)”, whichreinforcestheCommission’scommitmenttoenforcing collaborationinHTAandoffersfivepolicyoptions,themost integrativeofwhichproposescooperationontheproductionof jointfullHTAreports.Thiswouldincludetheevaluationofcost– effectivenessandorganizationalaspects(whicharemoretopical) alongwithclinicaleffectivenessandsafety.Theconsultationperiod endsinJanuary2017. TheEuropeanCommission’simpactassessmentwasbasedon evidencefromtheEUnetHTAactivitiesofpreviousyears,which showedthatcollaborationinproducingjointmethodologiesand assessmentsthemselvescanimproveboththequalityandquantity ofproducedassessmentswhileavoidingduplicationofwork. However,evaluativeresearchonthesecollaborativeactivitiesalso showsthatcollaborationinevaluatingeffectivenessandsafety wasnotwithoutitschallenges,particularlywithrespecttothe alignmentoftheprocesswithnationalneedsandprocesses;this primarilyconcernedthetimelyavailabilityofjointassessments,the relevanceofeachjointlyselectedtopicforindividualHTAagencies anddifficultieswithintegratingjointlyproducedreportsinnational templatesandprocedures[17].Jointassessmentproductionneeds tocarefullyconsideritscollaborationmodeltoavoidinefficiencies; forexample,byinvolvingnomorethanacertainnumberof agenciesindraftingeachreportandincludingothersasreviewers [18]. WhileoneoftheCommission’sgoalsinfurtherstrengthening HTAfrom2017onwardsistoensurethebetterfunctioningof theEUinternalmarketforhealthtechnologies,atthisjunctureit isconsideredunlikelythatnational(orregional)decision-making competenciesonpricingandreimbursementwillchangeinthe nearfuture[17,19,20]. How can voluntary cross-border collaboration in public procurement improve access to health technologies in Europe? 17 havingexpressedtheirintenttojoinaswell(seeBox5)[15]. WhiletheDecisionleavesquitesomediscretiontoMember Statestodecideonthescopeofproductstoprocurejointly, itisbynaturelimitedtoonlymedicines,medicaldevicesand othergoodsorservicesthatareaimedatcombating“serious cross-borderhealththreats”.Itisthusnotintendedtocover anyhealthtechnologiesbeyondthisscope,forexample,for treatingchronicconditions. Promoting cross-border cooperation in procurement Inadditiontoestablishingtheregulatoryframeworkwithin whichcross-borderjointprocurementcanbedeveloped, variousEUpolicyinitiativesseektofacilitatecross-border collaborationinpublicprocurement.In2011,theEuropean ParliamentadoptedaResolutiononaSingleMarket forEnterprisesandGrowth,inwhichitcalledonthe Commissiontoexplorehowcross-borderjointprocurement canbefacilitated.Thisispartofawiderattempttoboost innovation,includinginpublicprocurement,underthe Europe2020FlagshipInitiativeontheInnovationUnion. WithintheEuropeanCommission,DGGrowth(the DirectorateGeneralresponsibleforInternalMarket,Industry, EntrepreneurshipandSmall-andMedium-sizedEnterprises (SMEs)),issupportingInnovationPartnershipstokeeppublic servicesuptodate.Basedonthepossibilitiesunderthe newEUpublicprocurementlegislation,theCommission promotestheideaofmakingprocurementpracticesmore efficient,includingbystimulatingcross-bordercooperation betweencontractingauthoritiesandfacilitatingjoint procurement.Thisisbelievedtohelplowerpressureon healthbudgets(seeBox7).Also,theimportanceofpre- commercialprocurement(PCP)wasemphasizedasaway tobothinnovateandimprovequalityandeffectivenessof publicservices.Pre-commercialprocurementisintendedfor situationswheretherearenotyetanynear-to-the-market solutionsandnewR&Disneeded.PCPcanthencompare theprosandconsofalternativecompetingsolutions. Thiswillinturnreducetheriskforthemostpromising innovationsstep-by-stepviasolutiondesign,prototyping, developmentandfirstproducttesting.OnePCPproject isAnti-SUPERBugs,aconsortiumofhealthcareprocurers fromSpain,Italy,GermanyandtheUK. Discussion Whileadesireforcross-bordercollaborationinthe procurementofhealthtechnologiesappearstobegathering pace,asdemonstratedbytheexamplesabove,thebody ofevidenceontheeffectsofdifferentprocurementtypes istooweaktoallowfortheconclusiveidentificationof goodpracticesinvoluntarycollaboration.Thisisrelated bothtotherelativelyrecentestablishmentofmanyofthese initiativesandtothefactthatevidenceinthisareaishighly context-specificandnotnecessarilyapplicabletoother settings[1]. Furthermore,duetothesubstantialchangesinhealth technologymarketsinrecentyears–increasedmarket exclusivity,reducedpricetransparency,generalizationof Box 7: Innovating in public procurement through cross- border collaboration in the EU HAPPI European procurement platform:TheHealthyAgeing PublicProcurementofInnovations(HAPPI)isacollaborationof 12purchasingbodiesandinnovationexpertsfrom8Member States(France,UK,Germany,Italy,Belgium,Luxembourg,Austria andSpain),whichissupportedbytheEuropeanCommission.The consortium’saimistoidentify,assessandpurchaseinnovative andsustainablehealthproducts,servicesandsolutions,which willimproveageingwell.Sofar,thepartnershavedevelopedand purchasedover150innovativemedicalsolutionswiththehelp oftheirprocurementstrategy.Itcomprisesearlymarketstudies andcommunicationofthetendertoamultitudeofcompanies includingSMEs.Theuseoffunctionalratherthantechnical specificationsinthetendernoticeswascrucialinthisproject [21,22] German–Dutch–Austrian cooperation in hospital procurement:TheGermanPurchasingAssociationGDEKK,which since1998actsasacentralnon-profitpurchasingbodyonbehalf of75municipalhospitalsinGermany,extendeditsgeographical scopetoalsoincludepublichospitalsinAustriaanduniversity hospitalsintheNetherlands.Despitethelegaldifferencesinhealth- relatedprocurement,itisbelievedthatthroughfurthereconomies ofscale,costreductionscanbeachievedforallparticipatingbodies inthisenhancedEuropeancooperationforhealthprocurement. Theassociationsetupaprofessionalizedprocurementsystem, whichincludesdefiningcommonprocurementneeds,market analysisandestablishingqualitycriteria[22,23]. Anti-SUPERBugs:Thisisaprojectledbyaconsortiumofhealth careprocurersfromSpain,Italy,GermanyandtheUK.Anti- SUPERBugsispartofthepre-commercialprocurement(PCP) initiativefundedbytheEuropeanCommission’sHealth2020 frameworkprogramme.Theaimoftheprojectistoenablesmart informationandcommunicationstechnology(ICT)solutionsto bedevelopedthatwilldetectthepresenceofresistantmicro- organisms,givereal-timefeedbacktotheuserandsharethis informationwiththehealthcareprovider’selectronicrecord systemslinkingtheinfectionwiththeplaceofdetection.The project,whichwaslaunchedinSeptember2016,isexpectedto lastforfouryearsandisfocusedontheacquisitionofresearch anddevelopment(R&D)ofnewinnovativesolutionsbeforethey becomeavailableonthemarket.Thecontractingauthorityshares therisksandbenefitswiththeR&Dservicesprovider.Thismode ofprocurementisanexceptiontotheapplicationoftheEuropean publicprocurementrules[24,25]. MEDEV:TheMedicineEvaluationCommittee(MEDEV)was establishedin1998asastandingworkinggroupoftheEuropean SocialHealthInsuranceForum.Today,MEDEVrepresentsthe drugexpertsandpharmacologistsofnationalsocialinsurance organizationsandHTAagenciesin18EUMemberStates.The principalpurposeofMEDEVistoprovidethenationalhealth insuranceorganizationsandothercompetentbodieswithtimely analysesofdrug-relatedtrendsandinnovationsatbothnational andEuropeanlevel.WhileitfocusesmostlyonHTA,national exchangeofexperienceandinformationalsorelatestothe definitionofparametersforcost–benefitanalysesandinternational priceanalyses.Thegroupalsofollowscross-borderprocurement initiatives.Particularattentionwasgiventotheearlydialoguewith companiesdevelopingorphanmedicinalproducts,theMethod ofCoordinatedAccesstoOrphanmedicinalproducts(MoCA). Thisdialoguehasmainlycoveredclinicalstudyissuesbuthasalso addressedsomenovelprocurementmodels[26]. Policy brief 18 MEAsandotherformsofcontracting–mostreported internationalexperiencesdevelopedoutsideEuropein the1990smightnotprovidelessonsapplicabletoEU countriesatthepresenttime.Duetothespecificityofthe Europeanmarket,wherenationalauthoritieshaveretained responsibilityforhealthpolicy,includingthepricingand reimbursement,regulationandprocurementofmedical products,therearefewcaseswherecountrieshaveactually workedtogethertosuccessfullyinfluencethemarketand achievesustainablesuppliesofnewmedicinesorother medicalgoods. However,anumberofpointscantentativelybemadebased ontheEuropeanandinternationalexperiencethathighlight boththenecessaryelementsforafruitfulcollaborationand possiblechallengesthatneedtobeovercome. Asqualityassurancebecomesanincreasinglyimportant goalinmanyEuropeancountries,itmeritsconsideration thatsmallcountriesorpurchasersoftencannotaffordthe fixedcostsordonothavethenecessaryspecialistexpertise requiredtoappropriatelycarryoutsomeoftherelated procurementmarket/healthassessments.Astechnologies becomemorecomplex,thepaceofinnovationincreases andnovelmarketentrymodalitiessuchasadaptivelicensing starttoenterthedebate,thesharingofprofessional resourcesandspecialistexpertisefurthergainsimportance andcouldfunctionasadriverforcollaborativeinitiatives. Cross-bordercollaborationisonewayfortwoormore procurementagenciestoattainalargeroperatingscale and,hence,acquiretheadvantagesofeconomiesofscale. Thebenefitsofcross-bordercollaborationprimarilyderive fromtheincreasedsizeeffectandefficiencyofprocurement planning,ratherthanfromthecross-borderaspectitself. Infact,collaborationislikelytobemoresuccessful–other thingsequal–iftheunitsthatcollaborateinprocurement belongtothesamecountry(e.g.regions,hospitals)thanif theyareindifferentcountries(cross-border).Thisisbecause thebenefitsofcollaborationarelikelytobeoffsetbythe costsofcoordinatingbetweenpartnerorganizations, whicharelikelytobehigheriftheorganizationsbelong todifferentcountries,withdifferentregulations, legislation,marketingpractices,language,etc.Therefore, potentially,countriesshouldpursueinternalcollaboration inprocurement–betweenregionsorhospitals–before turningtocross-bordercollaboration.However,inanumber ofcases,particularlyforthetreatmentofrarediseasesorfor smallcountries,wherecomplextechnologiesorinnovative treatmentsareconcerned,collaborationbeyondnational borderscouldbepursuedtocapitalizeonsocioeconomic gains. Beyondincreasingcollaborationcosts,thedifferenttypes ofnationalregulationsonpricesandpubliccontracting canhinderjointprocurementinitiatives,astheymightnot becompatiblewiththeprocedureagreed.Countriesthat believetheyareabletoachievelowerpricesandprivileged conditionsofsupplyunderconfidentialpriceagreements mightnotwanttorisktheirprivilegedpositionbyadopting aprocurementapproachthatcouldleadtoasingleprice, whichmightbehigherthantheonetheywerepaying individually(large,high-incomecountriesbyexerting monopolypowerinthenegotiations;orsmall,low-income countriesbybenefitingfromhumanitarianorresponsible corporatepolicies).Similarly,ifoneofthepooledcountries isapotentialparallelexporter,suppliersarelikelynotto grantthelowpricetheyotherwisewouldhavechargedto somecountries,forfearthatthefirstcountrymightdivert productstohigher-pricedcountries. Whilelanguagediversityseemsnottohaveposed demonstrablechallengesinparalleltraderegarding translating,relabellingand/orrepackagingproducts,itmay beacomplicatingfactorincross-borderjointprocurement processes.EvidencefromtheBalticPartnershipAgreement onprocurementsuggeststhatlanguageissuesarenot negligible;inthiscaseusingEnglishastheonlylanguagefor theinitiativewasdesiredbutnotpossible,becausetheState LanguageCentreoftheRepublicofLatviarequiredtender documentstobedrawnupwithanadditionaltranslation intheofficialstatelanguage(Latvian)inordertobevalid. What conditions are needed to make cross-border collaboration in procurement work? Bothwithinandacrossborders,successfuljointprocurement dependsonanumberofessentialpre-conditions:strong politicalcommitment;trustbetweencollaboratingparties; goodgovernancethathelpscurbopportunistictendencies whichcoulderodethevalueoftheprocurementprocess; pricetransparency;effectivecommunicationbetween internalandexternalstakeholders;continuitythrough multi-yearcontractingthatenablesstablesupplysources andfostersclosertiesbetweenparticipants;clarityon managementresponsibilitiesforthejointprocurement processandtheirremuneration;and,finally,sharingof informationandgoodpractices.Ideally,informationsharing wouldentailthedevelopmentofshareddatabasesonkey issuessuchasprices,patentstatus,pre-qualificationof suppliersandmedicinesregistration[27]. Politicalwillandmutualtrustamongthepartners areobviousconditionsforanyformofcross-border collaboration,asexemplifiedherebytheBeNeLuxA guidingprinciples(seeBox3).Mutualconfidenceand trustcanbeprogressivelybuiltbycountriesstartingwith lessintensiveanddemandingcollaborationapproaches, e.g.thoseimplyingonlytheexchangeofinformationand experiences,time-limitedcollaborations,initiativeslimitedto onesingletechnologyordisease,etc.Thelongevityofsuch arrangementsalsoseemstoinfluencetheireffectiveness, asongoingmarketshareovertimecanbemoreimportant toinspiringcompetitionamongsuppliersthanthevolume ofsalesoveralimitedtime[8].Assuch,cross-borderjoint procurementarrangementsshouldbepartofanoverall customizedstrategythatseekstofulfilandbalancethe needsofthecollaboratingcountries[27]. How can voluntary cross-border collaboration in public procurement improve access to health technologies in Europe? 19 For what types of health technology and types of activity would cross-border collaboration be most appropriate? Anobstacletocross-borderjointprocurementfrequently mentionedintheliteratureisthattheproductsmightnot beauthorizedormarketedinallparticipatingcountries. Thisisfurtherexemplifiedhereintheexperienceofthe BalticPartnershipAgreement(seeBox4).Cross-borderjoint procurementisthereforemostoftenindicatedwhenthe productsorservicesarehomogeneousandstandardized andare,orcanbe,easilyauthorizedandmarketedin anycountry.IntheEU,thisconditionisnormallymetfor medicinesrelevantforjointprocurement(newmedicines orthosewithahighertherapeuticvalueandhighcosts), thankstotheroleplayedbytheEuropeanMedicines Agency(EMA)anditscentralizedprocedureformarket authorizationofmedicines.Variabilityofavailableproducts shouldthereforenotbeanobstacleforcross-border collaborationinprocurement.However,standardization remainsaveryrealproblemforothertechnologiessuch asmedicaldevices,astherequirementsformarketing authorizationareconsiderablylessstrictandshowa certaindegreeofheterogeneityacrossEUMemberStates. Aunified,uniformlyacceptednomenclatureofdevicesisnot yetavailable.Thisisalsoinpartillustratedbytheexperiences oftheBalticPartnershipAgreement(Box4). High-costtechnologies,e.g.newproductsthatareon- patentorunderanyformofmarketexclusivity,whichoften haveamonopolisticposition,arealsoalogicaltargetfor jointprocurementduetothegreaterpotentialforprice reductionsthatcanbeattainedbypoolingthevolumes ofsmallpurchasers.Whenmarketsaresocompetitive thatsuppliersalreadyoperateatapriceverycloseto themarginalcost,alarger(pooled)purchasermaynot beabletoachievesignificantfurtherpricereductions. However,theycouldhelpinkeepinglow-priceproducts onthemarketandavoidingtheexitofmanufacturers. Cross-bordercollaborationmayalsobeindicatedforlow- volumeproducts,especiallyiftheyareessentialinterms ofhealthimpact,asawaytominimizetheriskofsupply discontinuitiesandstock-outs.Thesameappliestoproducts thathaveanuncertainbutpotentiallyhighdemand,e.g. medicinesforunpredictableepidemics. Finally,itmaybeamorerewardingoptiontoexplore opportunitiesforcollaborationinthosecomponentsof Table 2. Potential gains of collaboration in specific procurement-related activities Activity Potential gain from cross-border collaboration Horizon scanning (also known as early awareness and alert systems, early warning systems); aims: to identify, filter and prioritize new and emerging health technologies [and] to assess or predict their impact on health, costs, society and the health care system; to inform decision-makers [28] High Health technology is at present a global market, where suppliers offer the majority of new products almost simultaneously worldwide to all countries where they can expect to make profit. Collaborative initiatives in this area could build on the experience of EuroScan. Established in 1997, the EuroScan International Network comprises 14 member countries (November 2016) who work together to achieve the Network’s goals [29]. Needs assessment Limited Requires data collection at country level. Advantages of collaboration would probably be restricted to the use of a common methodology, although this use might be constrained by the different characteristics and format of the data available in each country. As a result, potential efficiency gains are questionable. Health technology assessment Partial Some aspects of the HTA process may be easier to harmonize, namely the assessment of scientific evidence on effectiveness, safety etc. More context-specific elements, such as organizational and economic consideration, may require a more country-specific approach (see also Box 6). Economic evaluation (mainly seen as part of HTA but often carried out by different agencies) Limited While multinational companies usually develop a core model for economic analysis, based on all available clinical evidence, and then customize it at a second stage to fit individual country models, collaboration on the purchaser side may be inefficient as cost and budget impact parameters may differ substantially between countries. Prioritization and selection – defining reimbursement status and quantification of needs Partial Although part of the forecasting and planning exercise, i.e. assessing the supply of new products, can be done centrally, the specific products and volumes to be purchased by each partner and consequent budgetary requirements needs to relate specifically to the local context (population, epidemiology, resources available and priorities), so there is little to gain from collaboration apart from the chance to share methodologies. Purchasing and contracting Limited Despite the numerous difficulties countries are likely to encounter (divergent national regulations and purchasing practices, price intransparency, etc.), this is the frequent focus of collaboration, on the understanding that if purchasers are able to collaborate in pooling their demands, they will not only improve their levels of information but also gain market power and negotiating capacity. In practice, in the current market and regulatory environment, this potential has been hard to realize to date. Policy brief 20 theprocurementprocess(seeFigure1andTable2)that mayreducecostsandimproveperformancebypooling concretefunctionsoractivitiesofformerlyindependent organizations.Mostprocurementandprocurement-related activities–collectionandelaborationofinformation, contracting,negotiating,purchasing,logistics,etc.–are likelytoexperienceeconomiesofscale.Someprocurement activities,suchascollectinginformationonpricesand quality,paymentconditions,reliabilityofthepurchaser, etc.,implyspendingfixedcosts,irrespectiveofthenumber ofpartnersthatusetheinformation,becauseinformation isapublicgood. How can voluntary cross-border collaboration in procurement be encouraged and supported by the EU? Participatingcountriesandtheircitizensarethemain potentialbeneficiariesofvoluntarycross-border collaborationinprocurement,intheformofgreater availabilityandaffordabilityofhealthtechnologies. However,theEUcancontributeto,promoteand facilitateinitiativesby: • Providingsupportandinvestingresources,eitherat theinitialstagesoftheinitiativeorforitsduration. • Enactingoramendinglegislationtofacilitatecross- borderinitiatives. Asshownabove,theEUisalreadyapplyingthesetwo strategiesinseveralcases.However,suchpoliciesface constraintsandpotentialconflicts.Firstly,theEUmust complywiththeprincipleofsubsidiarity,whichmeansthat participationbycountriesmustbevoluntary.Secondly, policiesaimedatreducingexpendituremeanpotentially reducedrevenuesandprofitsforthesuppliers,thehealth technologyindustry,whichisahighlyinnovativeand dynamicsectorthatEUpoliciesaretryingtoboost.This islikelytocauseconflictbetweentheconsumerand supplierinterests.Policiesthereforeneedtobecarefully designedandimplementedinordertoensurethebalance betweenhealthandindustrialobjectives.Thereisalso scopefortheEUtoprovideaplatformofinformationon existingcollaborativeinitiativestoenabledisseminationand knowledgeexchangebetweenMemberStates.Forexample, theinnovationshighlightedinTable1andBox7mightbe usefulforothercountriestoo. SincetheSingleMarketwassetup,EUpolicieshavefaced anapparentlyirresolvabledilemma.Ontheonehand,it hasbeenestablishedasanoverridingprincipleinwhich socialpolicy,includinghealth,needstofit.Ontheother hand,Article168(7)TFEUholdsthatEUactionshallrespect theresponsibilitiesoftheMemberStatesinthedefinition ofhealthpolicyandfortheorganizationanddeliveryof healthservicesandmedicalcare. Policy implications Whileactualinitiativesoncross-bordercollaborationin procurementinEuropearestillfewandhaveevolved onlyrecently,thereisanincreasinginterestinexploring thepotentialofthisoptionasawaytoimproveaccess toinnovativemedicaltechnologiesandcontributeto healthsystemsustainability.Thisisnotonlyreflectedinan increasingnumberofactivitiesinvoluntarycollaboration agreementsandmovestowardsjointprocurementamong EUMemberStates,butalsoinachangingEUframework thatfacilitatescross-bordercooperationbetween contractingauthoritiesandhelpstoclarifytheapplicablelaw andresponsibilitiesofthedifferentpartiesinvolved.Whileit remainshighlychallengingtomakesuppliersadapttonew waysofworkingwhichcouldimpacttheirprofitmargins, thereisevidencethatcross-bordercollaborationinpublic procurementcanbeeffective,particularlyforsmallmarkets, inmaintainingaccessthroughpoolingresources.Therefore, collaborationsinpublicprocurement,whentheyare tailoredtomeetthespecificneedsofthecountriesinvolved, presentonesolutionthatcanhelpoffsetimbalancesinthe medicaltechnologiesmarketandbetterservethegoalsof publichealth. Cross-bordercollaborationinpublicprocurementofhealth technologiescanbefacilitatedby:ownership,equity, transparency,flexibility,standardizationandgradual development.Procurementpoliciesareharmonizedat EUlevelbutthereisstilllittleuniformityatthenational levelintermsofstandardizedprocurementprocesses andprocedures,whichcanhampercollaboration.For thisreason,flexibilityandtransparencyareneededin theapproachtocross-bordercooperation.Insuccessful collaborations,thepartiesalsohaveasenseofownership overthecross-bordercollaborationandtheyarecooperating onequitableterms.Theliteratureandexperienceshow thatcross-bordercollaborationsdevelopgraduallyover time,wherethereisrealpoliticalwillforcountriestowork togethertoovercomecommonchallenges. Conclusions Whileactualinitiativesoncross-bordercollaborationin procurementinEuropearefew,thereisincreasinginterest inexploringthepotentialofthisoptionandagrowingbody oflegislativeworkthatisintendedtoprovidethebasis forcollaborativeinitiatives.Theinternationalexperience providesafewexamplesofregionaljointpurchasingof healthtechnologiesthathavebeenrunningformore thantwodecades.Whilesomeareledbyagroupof countriesandothersbyaninternationalorganization,there isinsufficientevidencetorecommendonemodelover another.Moreover,theevolutionofthehealthtechnologies marketstowardsnewproductsandformsofcontracting, suchasadvancedpurchaseagreements,confidential discountsandMEAs,hasmadethetraditionalexperiences ofjointpurchasingobsoleteunderthenewconditions. Thetrade-offsbetweenthepotentialbenefitsandcosts ofcross-bordercollaborationundoubtedlydependonthe characteristicsoftheactivities,technologiesandcountries involved.Larger,higher-incomecountriesarelikelytoget lessbenefitfrompooledprocurementiftheyarealready abletoreapmostofthepotentialbenefitsfromeconomies How can voluntary cross-border collaboration in public procurement improve access to health technologies in Europe? 21 ofscale.Thus,cross-bordercollaborationforprocurement iscertainlynotanautomaticsolutionforalltheproblems ofavailabilityandaffordabilityoftechnologieswithsmall targetpopulations.Therefore,alternativesolutionsshould alsocontinuetobeexplored. Nevertheless,collaborationinpublicprocurement,tailored tomeetthespecificneedsofthecountriesinvolved, presentsonesolutionthatcanhelpoffsetimbalancesin medicaltechnologiesmarketsandbetterservethegoals ofpublichealth.Throughcollaborationintheprocurement processpurchaserscanachievealargersize.Thisincreases theirmarketpowerandtheyreacheitheracriticalmass oreconomiesofscaleinperformingtheirprocurement activitiesthatpotentiallyachieveloweracquisitionprices, loweroperatingcosts,butalsoimprovedqualityof purchasedgoodsandbetterpurchasingconditions. Itisimportantthat‘young’initiativesarecarefullyand continuouslyevaluatedtoobtainmuch-needed,robust evidenceonbestpracticesinthisareainordertoimprove sustainableaccesstoinnovativemedicaltechnologies ormedicalcountermeasuresandtocontributetohealth systemstrengthening. References 1. WHORegionalOfficeforEurope(2016).Challenges and opportunities in improving access to medicines through efficient public procurement in the WHO European Region (2016).Copenhagen,WHORegional OfficeforEuropePublications(http://www.euro. who.int/en/health-topics/Health-systems/health- technologies-and-medicines/publications/2016/ challenges-and-opportunities-in-improving-access-to- medicines-through-efficient-public-procurement-in-the- who-european-region-2016,accessed18.12.16). 2. WHO(2016).Technology, Health.WorldHealth Organizationwebsite(http://www.who.int/topics/ technology_medical/en/,accessed18.12.16). 3. GesundheitÖsterreichForschung-undPlanungsGmbH (2015).Study on enhanced cross-country coordination in the area of pharmaceutical product pricing.European Commission,DGHealthandFoodSafety(http:// ec.europa.eu/health/systems_performance_assessment/ docs/pharmaproductpricing_frep_en.pdf,accessed 18.12.16). 4. CernatL,Kutlina-DimitrovaZ((2015).Chief Economist Note: International public procurement: From scant facts to hard data.EuropeanCommission,DGTrade (http://trade.ec.europa.eu/doclib/docs/2015/april/ tradoc_153347.pdf,accessed18.12.16). 5. CallejaA(2016).Unleashing social justice through EU public procurement (Vol.3).Abingdon,Routledge. 6. OECD(2016).Public procurement.Paris,Organisation forEconomicCo-operationandDevelopment(http:// www.oecd.org/gov/ethics/public-procurement.htm, accessed18.12.16). 7. EuropeanCommission(2008).Green Public Procurement (GPP) Training Toolkit – Module 1: Managing GPP Implementation.Toolkitdevelopedfor theEuropeanCommissionbyICLEI–LocalGovernments forSustainability.Brussels,EuropeanCommission,DG Environment. 8. Huff-RousselleM(2012).Thelogicalunderpinnings andbenefitsofpooledpharmaceuticalprocurement: Apragmaticroleforourpublicinstitutions?Social Science & Medicine,75(9):1572–1580. 9. Azzopardi-MuscatN,Schroder-BackP,BrandH(2016). TheEuropeanUnionJointProcurementAgreementfor cross-borderhealththreats:Whatisthepotentialfor thisnewmechanismofhealthsystemcollaboration? Health Economics, Policy and Law, 12(1):43–59 (http://dx.doi.org/10.1017/S1744133116000219, accessed18.12.16). 10. EHC(2013).Belgium and the Netherlands announce joint procurement of medicines for rare diseases. Brussels,EuropeanHaemophiliaConsortium(http:// www.ehc.eu/belgium-and-the-netherlands-to-team-up- for-joint-procurement-of-medicines-for-rare-diseases, accessed18.12.16). Policy brief 22 11. deBlockM(2015).The Grand Duchy of Luxemburg joins Belgium–Netherlands initiative on orphan drugs. Luxemburg,MinistredesAffairessocialesetdelaSanté publique(http://www.deblock.belgium.be/fr/grand- duchy-luxemburg-joins-belgium-netherlands-initiative- orphan-drugs,accessed18.12.16). 12. NatsisY(2015).Is it really worth pushing for EU medicine joint procurement?TransAtlanticConsumer Dialogue,IPPolicyCommittee(http://tacd-ip.org/ archives/1314,accessed18.12.16). 13. O’DonnellP(2015).Belgium, Netherlands team up to take on pharma over prices.Brussels,Politico(http:// www.politico.eu/article/belgium-netherlands-team-up- to-take-on-pharma-over-prices,accessed18.12.16). 14. CenterforPharmaceuticalManagement(2002). Regional pooled procurement of drugs: Evaluation of programs.SubmittedtotheRockefellerFoundation. Arlington,VA,ManagementSciencesforHealth. 15. EuropeanCommission(2016).Map showing signatories to the Joint Procurement Agreement(http://ec.europa. eu/health/preparedness_response/pics/jpa_map.jpg, accessed18.12.16). 16. BantaD,OortwijnW(2000).Introduction:Health technologyassessmentandtheEuropeanUnion. International Journal of Technology Assessment in Health Care,16(2):299–302. 17. KleijnenSetal.(2015).Europeancollaborationon relativeeffectivenessassessments:Whatisneededtobe successful?Health Policy,119(5):569–576. 18. KleijnenSetal.(2014).Pilotinginternationalproduction ofrapidrelativeeffectivenessassessmentsof pharmaceuticals.International Journal of Technology Assessment in Health Care,30(5):521–529. 19. PanteliDetal.(2015).Frommarketaccesstopatient access:Overviewofevidence-basedapproachesfor thereimbursementandpricingofpharmaceuticalsin 36Europeancountries.Health Research Policy and Systems,13:39;doi:10.1186/s12961-015-0028-5. 20. TowseAetal.(2015).Futurescapes:Expectationsin Europeforrelativeeffectivenessevidencefordrugsin 2020.Journal of Comparative Effectiveness Research, 4(4):401–418. 21. HAPPI(2013–2015).Welcome to HAPPI: Healthy Ageing – Public Procurement of Innovations. HAPPIwebsite(http://www.happi-project.eu, accessed18.12.16). 22. EuropeanCommisssion(2016).Innovative public procurement can lower pressure on health budgets. DG Growth:InternalMarket,Industry,Entrepreneurship andSMEs(http://ec.europa.eu/growth/tools-databases/ newsroom/cf/itemdetail.cfm?item_id=8945,accessed 18.12.16). 23. GDEKK(2016).Die GDEKK. Köln,Dienstleistungs-und EinkaufsgemeinschaftKommunalerKrankenhäuser eGimDeutschenStädtetag(http://www.gdekk.de, accessed18.12.16). 24. EuropeanCommission(2016).New Anti-SUPERbugs PCP project started. DigitalSingleMarket:Digital Economy&Society (https://ec.europa.eu/digital-single- market/en/news/new-anti-superbugs-pcp-project- started, accessed18.12.16). 25. Anti-SuperBugs(2016).[Websiteindevelopment] (www.antisuperbugs.eu,accessed18.12.16). 26. ESIP(2008).EuropeanSocialInsurancePlatformwebsite (www.esip.eu, accessed18.12.16). 27. CallejaA(2016).Addressing in part market imbalances in the pharmaceutical sector through voluntary joint public procurement [Paperinprint].(Papertobe presentedatthe3rdInterdisciplinarySymposiumon PublicProcurement,Belgrade,28–30September2016). 28. SimpsonSetal.(2009).A toolkit for the identification and assessment of new and emerging health technologies.Birmingham,EuroScanInternation Network. 29. EuroScan(undated).About EuroScan.EuroScan InternationalNetwork(https://www.euroscan.org/ about-us/, accessed18.12.16). How can voluntary cross-border collaboration in public procurement improve access to health technologies in Europe? 23 Appendix 1. Methods Thispolicybriefcombinedaliteraturestudywithsemi- structuredinterviewsanddesk-basedresearch. 1. Rapid review of the literature Thereviewaimedtoidentifypublications,inboththe scientificandgreyliterature,thatcouldprovideananswer tothecentralresearchquestion:Howcanvoluntarycross- bordercollaborationinpublicprocurementimproveaccess tohealthtechnologies? Thescientificliteraturereviewfocusedontheconceptof “jointprocurement”,sothemainliteraturesearchwas made(on4July2016)inPubMedusingasthekeyterms: (“PharmaceuticalPreparations”[Mesh]ORmedicines)AND (“GroupPurchasing”[Mesh]OR“jointprocurement”). Thegreyliteraturereviewandwebsitesreviewplayedan importantroleinthispolicybriefasmanyoftheexperiences inthefieldofcooperationforjointprocurementarenew, withlittledocumentationinscientificjournalsasyet,so searchingwebsites,especiallytheEuropeanCommission site,wasakeystrategy.AGoogleScholarsearchusing thestandardterms:“medicines”AND“pharmaceutical” “collaboration”AND“procurement”AND“tender”OR“joint procurement”alsoidentifiedsomeusefulgreyliterature. 2. Semi-structured interviews Togainmorein-depthinsightintothedifferentexperiences incross-bordercollaborationforprocurement,semi- structuredinterviewswereconductedwith: • Europeanpolicyofficerstogainunderstandingof theexperiencesandresultsofthedifferentinitiatives launchedatEClevel • WHO/PAHOprofessionalsdealingwithjointprocurement intheLatin-Americanregion • otherexpertsinthefield. Approach Onlythreefullinterviewswerecompletedbutseveral othercontactsweremadeinordertoclarifyspecific pointsaboutinternationalexperiencesincross-border collaboration.AttendingtheStrategicProcurementMeeting (22–23September2016,WHORegionalOfficeforEurope, Copenhagen)provedparticularlyimportantforgathering unpublishedinformationinthisarea. Atopicguidewasusedtoguideanddirectthesemi- structuredinterviews.Keyitemsintheguideincluded: • Canyouexplaintousanyexperienceyoupersonally havehad,orareawareof,inrelationtonationalor internationaljointprocurementofhealthtechnologies? • Whatarethemainpotentialbenefitsandobstaclestothe jointprocurementofhealthtechnologiesingeneraland toitsapplicationamongEUMemberStates? Policy brief 24 • Canyouindicateotherprofessionalsororganizations thatcanprovideuswithinformationandevidenceonthe impactofpooledprocurementofhealthtechnologies? • Doyouthinkthatcross-bordercollaborationon procurementintheEUcanhavearelevantimpactin improvingtheavailabilityandaffordabilityofhealth technologiesforsomecountries? Inordertoclarifythetopicofthediscussionfor respondents,anotewithsomeclarificationswasincluded: “Pooledprocurement(alsocalledjointprocurement,central procurementandgrouppurchasing)hasbeendefinedas: ‘Purchasingdonebyoneprocurementofficeonbehalfof agroupoffacilities,healthsystemsorcountries.’Themain purposesofpooledprocurementaretoattainlowerprices andtoimproveotherprocurementconditionsthroughthe economiesofscaleattainedbyseveralentitiesthatput together(orcollaborateincarryingout)allorsomeofthe procurementfunctions.Thepooledentitiesmightbelong tooneorseveralcountries,inwhichcaseitisreferredtoas regional,internationalorcross-borderjointprocurement.” 1. How can European health systems support investment in and the implementation of population health strategies? David McDaid, Michael Drummond, Marc Suhrcke 2. How can the impact of health technology assessments be enhanced? Corinna Sorenson, Michael Drummond, Finn Børlum Kristensen, Reinhard Busse 3. Where are the patients in decision-making about their own care? Angela Coulter, Suzanne Parsons, Janet Askham 4. How can the settings used to provide care to older people be balanced? Peter C. Coyte, Nick Goodwin, Audrey Laporte 5. When do vertical (stand-alone) programmes have a place in health systems? Rifat A. Atun, Sara Bennett, Antonio Duran 6. How can chronic disease management programmes operate across care settings and providers? Debbie Singh 7. How can the migration of health service professionals be managed so as to reduce any negative effects on supply? James Buchan 8. How can optimal skill mix be effectively implemented and why? Ivy Lynn Bourgeault, Ellen Kuhlmann, Elena Neiterman, Sirpa Wrede 9. Do lifelong learning and revalidation ensure that physicians are fit to practise? Sherry Merkur, Philipa Mladovsky, Elias Mossialos, Martin McKee 10. How can health systems respond to population ageing? Bernd Rechel, Yvonne Doyle, Emily Grundy, Martin McKee 11. How can European states design efficient, equitable and sustainable funding systems for long-term care for older people? José-Luis Fernández, Julien Forder, Birgit Trukeschitz, Martina Rokosová, David McDaid 12. How can gender equity be addressed through health systems? Sarah Payne 13. How can telehealth help in the provision of integrated care? Karl A. Stroetmann, Lutz Kubitschke, Simon Robinson, Veli Stroetmann, Kevin Cullen, David McDaid 14. How to create conditions for adapting physicians’ skills to new needs and lifelong learning Tanya Horsley, Jeremy Grimshaw, Craig Campbell 15. How to create an attractive and supportive working environment for health professionals Christiane Wiskow, Tit Albreht, Carlo de Pietro 16. How can knowledge brokering be better supported across European health systems? John N. Lavis, Govin Permanand, Cristina Catallo, BRIDGE Study Team 17. How can knowledge brokering be advanced in a country’s health system? John N. Lavis, Govin Permanand, Cristina Catallo, BRIDGE Study Team 18. How can countries address the efficiency and equity implications of health professional mobility in Europe? Adapting policies in the context of the WHO Code and EU freedom of movement Irene A. Glinos, Matthias Wismar, James Buchan, Ivo Rakovac 19. Investing in health literacy: What do we know about the co-benefits to the education sector of actions targeted at children and young people? David McDaid The European Observatory has an independent programme of policy briefs and summaries which are available here: http://www.euro.who.int/en/about-us/partners/ observatory/publications/policy-briefs-and-summaries Joint Policy Briefs World Health Organization Regional Office for Europe UN City, Marmorvej 51, DK-2100 Copenhagen Ø, Denmark Tel.: +45 39 17 17 17 Fax: +45 39 17 18 18 E-mail: postmaster@euro.who.int web site: www.euro.who.int The European Observatory on Health Systems and Policies is a partnership that supports and promotes evidence-based health policy-making through comprehensive and rigorous analysis of health systems in the European Region. It brings together a wide range of policy-makers, academics and practitioners to analyse trends in health reform, drawing on experience from across Europe to illuminate policy issues. The Observatory’s products are available on its web site (http://www.healthobservatory.eu). No. 21 ISSN 1997-8065