essential medicines for universal health coverage · 2017-10-27 · three eras of the essential...
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EssentialMedicinesforUniversalHealthCoverage
Highlightsofthereport
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Scopeandprocess• Promptedbythe30th anniversaryofthe1985NairobiConferenceonthe
RationalUseofDrugs,toask:1. Whatprogresshasbeenachieved?2. Whatchallengesremaintobeaddressed?3. Whichlessonshavebeenlearnedtoinformfutureapproaches?4. HowcanessentialmedicinespoliciesbeharnessedtopromoteUHCand
contributetotheglobalsustainabledevelopmentagenda?
• 3co-chairs(VeronikaWirtz,HansHogerzeil,AndyGray)• 18otherinvitedCommissioners,chosenfortheirinternationalexpertise,in
theirindividualcapacity
Essential Medicines for Universal Health Coverage
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Threeerasoftheessentialmedicinesconcept• Firstera(1970s-1990s)• 1st WHOModelListofEssentialMedicines(1977)• AlmaAtaConference(1978),• uptakeofnationalEMLsandNMPs
• Secondera(1990s-2010s)• growingcomplexity,• newglobalfinancingmechanisms,• medicinesaspartofhealthsystems• newfocusonessentialmedicinesforchildren
Essential Medicines for Universal Health Coverage
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Thirdera- 2010topresent–UHCdemandsessentialmedicines
Essential Medicines for Universal Health Coverage
Goal3.8“[…]accesstosafe,effective,qualityandaffordableessentialmedicinesandvaccinesforall”
Goal3.b“Supportresearchanddevelopmentofvaccinesandmedicinesforcommunicableandnon-communicablediseasesprimarilyaffectingdevelopingcountries….”
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Fivekeychallengesthereportaddresses
1. Payingforabasketofessentialmedicines2. Makingessentialmedicinesaffordable3. Assuringqualityandsafetyofessentialmedicines4. Promotingqualityuseofmedicines5. DevelopingmissingessentialmedicinesCross-cutting->measuringprogress
Essential Medicines for Universal Health Coverage
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Fivepatientexamplestoshowhowaccesstoessentialmedicinesaffectallpeople
Priti, 41 years old, with asthma => hospitalized becauseof inadequate financing of medicines
Jomkwan, 65 years old, with diabetes => suffering from side-effects due to an incorrect prescription
Adia, domestic helper, with diabetes=> not able take insulin because the medicine being unaffordable
Bina, single mother with 3 children, diagnosed with drug resistant TB => fails to initiate treatment as there is no adequate dosage forms developed
Adwoa, a girl aged 2 years suffering from malaria => permanent harm due to substandard medication
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Keyoutputsofthereport
• Ineachpolicyarea,aseriesof22actionablerecommendations,directedtogovernments,nationalhealthsystems,theinternationalcommunity,multilateralbodies,medicinesregulatoryauthorities,thepharmaceuticalindustry
• 3keycross-cuttingthemes– increasingequity,strengtheninginstitutionsandpromotingaccountability,especiallythroughgreatertransparencyandindependentreview
• Asetof24coreindicatorstomeasureprogressintheimplementationofcomprehensiveessentialmedicinespolicies
Essential Medicines for Universal Health Coverage
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Currentpharmaceuticalexpenditure
Essential Medicines for Universal Health Coverage
Lowincomecountries
Lowermiddleincomecountries
Countriesbelowthethreshold:BTN=Bhutan;LAO=Laos;GHA=Ghana;SLV=ElSalvador;PNG=PapuaNewGuinea;STP=SaoTomeandPrincipe;
SEN=Senegal;SLB=SolomonIslands;SDN=Sudan;TLS=Timor-Leste;VUT=Vanuatu;ZMB=Zambia
1in5countriesspentlessthantheminimumthresholdofUS$13
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Summary
• Apreliminaryestimateoftheglobalcostsofprovidingabasicpackageofessentialmedicinesinalllow- andmiddle-incomecountries
• Resultshelpinitiateapolicydialoguearoundfinancingstrategiesandresourcemobilizationforessentialmedicines• NOTasubstitutefordetailednationallevelcosting,whichisimperativefornational
budgetingandplanning foressentialmedicines
• Highlightskeygapsindatarequiredforcreatingpreciseestimatesformedicinecosts• Helpguide futuredatacollectioneffortsandmoredetailedmodelinginthefuture
Essential Medicines for Universal Health Coverage
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Recommendations• Governmentsandnationalhealthsystems:
• Mustprovideadequatefinancingtoensuretheinclusionofessentialmedicinesinbenefitpackagesprovidedbythepublicsectorandallhealthinsuranceschemes.
• Mustimplementpoliciesthatreducetheamountofout-of-pocketspendingonmedicines.
• Mustinvestinthecapacitytoaccuratelytrackexpenditureonmedicines,especiallyessentialmedicines,inboththepublicandprivatesectors.DatashouldbedisaggregatedbetweenprepaidandOOPexpenditure,andamongimportantkeypopulations
• Theinternationalcommunitymustfulfil itshumanrightsobligationstosupportgovernmentsoflow-incomecountriesinfinancingabasicpackageofessentialmedicines for all, if they are unable to do so domestically.
Essential Medicines for Universal Health Coverage
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2010 to present – UHC demands essential medicines
Essential Medicines for Universal Health Coverage
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Affordability questions everywhere, for everyone
Essential Medicines for Universal Health Coverage
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Essential Medicines for Universal Health Coverage
Impact of new, often biological medicines in high-income countries
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Essential Medicines for Universal Health Coverage
The options – rationing or ad hoc solutionsHepatitis C - rationing• 184 million people living with
hepatitis C virus infection.• New direct acting antivirals (DAAs)
dramatically improved efficacy and safety.
• List prices high (e.g. $84 000 for a course of sofosbuvir).
• Budget impact substantial – to treat all eligible patients in the USA with DAAs would require an additional US$65 billion over the course of 5 years.
Cancer – ad hoc• Failure to obtained approval from
NICE for reimbursement (e.g. trastuzumab; then trastuzumab emtansine)• UK Cancer Drug Fund – dedicated
additional funding – avoiding the usual HTA process• Financially unsustainable – replaced
with the Managed Access Fund.
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A comprehensive and interlinked suite of policies –well-described but poorly implemented
Essential Medicines for Universal Health Coverage
• Procurementinterventions• Pro-genericpolicies• Pricinginterventions• Qualityuseofmedicinesinterventions• Trade-RelatedAspectsofIntellectualPropertyRights(TRIPs)flexibilities
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Assessing value: Role of HTA in making medicines more affordable
Essential Medicines for Universal Health Coverage
• IMPORTANT: Health Technology Assessment (HTA) alone cannot make essential medicines affordable.
• Role of HTA:• contribute to the evidence base for selection and reimbursement decisions related to
medicines. • input in price negotiations over new essential medicines.
• Preconditions for effective HTA:• capacity to assess clinical evidence, consider local costs of services and inputs, and
project potential budget impacts of competing options.• transparency and effective stakeholder engagement.
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Recommendations
Essential Medicines for Universal Health Coverage
• Governmentsandhealthsystemsmustcreateandmaintaininformationsystemsforroutinemonitoringofdataontheaffordabilityofessentialmedicines,aswellaspriceandavailability,inthepublicandprivatesectors.
• Governmentsmustimplementacomprehensivesetofpoliciestoachieveaffordablepricesforessentialmedicines.
• Governmentsandhealthsystemsmustdevelopnationalcapacitytocreatemedicinesbenefitpackagesthatguideprocurementandreimbursementforaffordableessentialmedicines.
• Governments,nationalhealthsystems,andthepharmaceuticalindustrymustpromotetransparencybysharinghealthandmedicinesinformation.
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Nocommonframeworkforaccountability
• Nocomprehensiveframework• Existingmeasuringtoolsnotroutinelyused• Datasystemsfragmented
• Nocontinuousroutineupdateonspecificindicators• Lackoftransparency• Lackofincentivestoimprovemeasurementand
reporting
“Ifwedonotknowwherewearegoing,everyroadistherightone.”
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• Commitmentfromallstakeholders
• Transparency
• Independentreviewbymultipleinstitutions
• Incentivise improvementandimplementcorrectiveactionifneeded
• Nationalandgloballeadership
Anewaccountabilityframeworkrequires…
Essential Medicines for Universal Health Coverage
TheCommissionproposestotrackprogress via24coreand12complementaryindicators
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Essential Medicines for Universal Health Coverage
Newindicatorswhichrequirevalidation
Established indicatorsingreen Newindicatorsinblue
Indicatorsmeasuringprogressondeveloping newessentialmedicines
21 #oflicence agreementsconcerningessentialmedicinesconcludedthroughpatentpooling,stratifiedbyin-licence andout-licence
22 #ofproductsproducedunderanEssentialMedicinesPatentPoollicence thatareauthorised byatleastoneofthefollowing:InternationalCouncilforHarmonisation orPIC/SorWHO/UNPrequalificationProgramme
23 Nationallaws,includingpatentandmedicinesregulationlaws,containeffectiveprovisionsfortheapplicationofallTrade-RelatedAspectsofIntellectualPropertyRights-compatibleflexibilities(yes/no)
24 ShareoftheresearchpipelinereflectingnewmoleculesfordiseaseswithinthescopeoftheATMIndex*percompany
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• toincreasetransparencyinthepharmaceuticalsector
• tocreatebaselinemeasurementsforassessingessentialmedicinespolicydevelopmentandimplementation.
• tosetappropriatetargetsforindicatorsatnationallevel
• tosharelearningbetweencountriesandinstitutionsonmeasuringprogresstorefineindicators
• topromotegloballeadershiptosetupindependentaccountabilitymechanisms
Callforaction
Essential Medicines for Universal Health Coverage
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Fivedimensionsofaccesstomedicines
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Proportionofcountrieswithsecondarypreventionmedicationclassonthenationalessentialmedicinelistbyincomestatus
ACEI= indicates angiotensin-convertingenzyme inhibitor;LIC =low-income country;MIC=middle-income country.
High-income countrieswereexcluded.
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Essential Medicines for Universal Health Coverage