Essential Medicines for Universal Health Coverage · 2017-10-27 · Three eras of the essential...

EssentialMedicinesforUniversalHealthCoverage

Highlightsofthereport

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

Threeerasoftheessentialmedicinesconcept• Firstera(1970s-1990s)• 1st WHOModelListofEssentialMedicines(1977)• AlmaAtaConference(1978),• uptakeofnationalEMLsandNMPs

• Secondera(1990s-2010s)• growingcomplexity,• newglobalfinancingmechanisms,• medicinesaspartofhealthsystems• newfocusonessentialmedicinesforchildren

Essential Medicines for Universal Health Coverage

Thirdera- 2010topresent–UHCdemandsessentialmedicines

Essential Medicines for Universal Health Coverage

Goal3.8“[…]accesstosafe,effective,qualityandaffordableessentialmedicinesandvaccinesforall”

Goal3.b“Supportresearchanddevelopmentofvaccinesandmedicinesforcommunicableandnon-communicablediseasesprimarilyaffectingdevelopingcountries….”

Fivekeychallengesthereportaddresses

1. Payingforabasketofessentialmedicines2. Makingessentialmedicinesaffordable3. Assuringqualityandsafetyofessentialmedicines4. Promotingqualityuseofmedicines5. DevelopingmissingessentialmedicinesCross-cutting->measuringprogress

Essential Medicines for Universal Health Coverage

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

Keyoutputsofthereport

• Ineachpolicyarea,aseriesof22actionablerecommendations,directedtogovernments,nationalhealthsystems,theinternationalcommunity,multilateralbodies,medicinesregulatoryauthorities,thepharmaceuticalindustry

• 3keycross-cuttingthemes– increasingequity,strengtheninginstitutionsandpromotingaccountability,especiallythroughgreatertransparencyandindependentreview

• Asetof24coreindicatorstomeasureprogressintheimplementationofcomprehensiveessentialmedicinespolicies

Essential Medicines for Universal Health Coverage

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

Summary

• Apreliminaryestimateoftheglobalcostsofprovidingabasicpackageofessentialmedicinesinalllow- andmiddle-incomecountries

• Resultshelpinitiateapolicydialoguearoundfinancingstrategiesandresourcemobilizationforessentialmedicines• NOTasubstitutefordetailednationallevelcosting,whichisimperativefornational

budgetingandplanning foressentialmedicines

• Highlightskeygapsindatarequiredforcreatingpreciseestimatesformedicinecosts• Helpguide futuredatacollectioneffortsandmoredetailedmodelinginthefuture

Essential Medicines for Universal Health Coverage

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

2010 to present – UHC demands essential medicines

Essential Medicines for Universal Health Coverage

Affordability questions everywhere, for everyone

Essential Medicines for Universal Health Coverage

Essential Medicines for Universal Health Coverage

Impact of new, often biological medicines in high-income countries

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.

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

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.

Recommendations

Essential Medicines for Universal Health Coverage

• Governmentsandhealthsystemsmustcreateandmaintaininformationsystemsforroutinemonitoringofdataontheaffordabilityofessentialmedicines,aswellaspriceandavailability,inthepublicandprivatesectors.

• Governmentsmustimplementacomprehensivesetofpoliciestoachieveaffordablepricesforessentialmedicines.

• Governmentsandhealthsystemsmustdevelopnationalcapacitytocreatemedicinesbenefitpackagesthatguideprocurementandreimbursementforaffordableessentialmedicines.

• Governments,nationalhealthsystems,andthepharmaceuticalindustrymustpromotetransparencybysharinghealthandmedicinesinformation.

Nocommonframeworkforaccountability

• Nocomprehensiveframework• Existingmeasuringtoolsnotroutinelyused• Datasystemsfragmented

• Nocontinuousroutineupdateonspecificindicators• Lackoftransparency• Lackofincentivestoimprovemeasurementand

reporting

“Ifwedonotknowwherewearegoing,everyroadistherightone.”

• Commitmentfromallstakeholders

• Transparency

• Independentreviewbymultipleinstitutions

• Incentivise improvementandimplementcorrectiveactionifneeded

• Nationalandgloballeadership

Anewaccountabilityframeworkrequires…

Essential Medicines for Universal Health Coverage

TheCommissionproposestotrackprogress via24coreand12complementaryindicators

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

• toincreasetransparencyinthepharmaceuticalsector

• tocreatebaselinemeasurementsforassessingessentialmedicinespolicydevelopmentandimplementation.

• tosetappropriatetargetsforindicatorsatnationallevel

• tosharelearningbetweencountriesandinstitutionsonmeasuringprogresstorefineindicators

• topromotegloballeadershiptosetupindependentaccountabilitymechanisms

Callforaction

Essential Medicines for Universal Health Coverage

Fivedimensionsofaccesstomedicines

Proportionofcountrieswithsecondarypreventionmedicationclassonthenationalessentialmedicinelistbyincomestatus

ACEI= indicates angiotensin-convertingenzyme inhibitor;LIC =low-income country;MIC=middle-income country.

High-income countrieswereexcluded.

Essential Medicines for Universal Health Coverage