Essential Medicines for Universal Health Coverage · 2017-10-27 · Three eras of the essential medicines concept • First era (1970s-1990s) • 1st WHO Model List of Essential Medicines

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


Thirdera- 2010topresent–UHCdemandsessentialmedicines


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

Goal3.b“Supportresearchanddevelopmentofvaccinesandmedicinesforcommunicableandnon-communicablediseasesprimarilyaffectingdevelopingcountries….”

Fivekeychallengesthereportaddresses

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


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


Currentpharmaceuticalexpenditure


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


Recommendations• Governmentsandnationalhealthsystems:

• Mustprovideadequatefinancingtoensuretheinclusionofessentialmedicinesinbenefitpackagesprovidedbythepublicsectorandallhealthinsuranceschemes.

• Mustimplementpoliciesthatreducetheamountofout-of-pocketspendingonmedicines.

• Mustinvestinthecapacitytoaccuratelytrackexpenditureonmedicines,especiallyessentialmedicines,inboththepublicandprivatesectors.DatashouldbedisaggregatedbetweenprepaidandOOPexpenditure,andamongimportantkeypopulations

• Theinternationalcommunitymustfulfil itshumanrightsobligationstosupportgovernmentsoflow-incomecountriesinfinancingabasicpackageofessentialmedicines for all, if they are unable to do so domestically.


2010 to present – UHC demands essential medicines


Affordability questions everywhere, for everyone



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


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


• Procurementinterventions• Pro-genericpolicies• Pricinginterventions• Qualityuseofmedicinesinterventions• Trade-RelatedAspectsofIntellectualPropertyRights(TRIPs)flexibilities

Assessing value: Role of HTA in making medicines more affordable


• 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


• 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…


TheCommissionproposestotrackprogress via24coreand12complementaryindicators


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


Fivedimensionsofaccesstomedicines

Proportionofcountrieswithsecondarypreventionmedicationclassonthenationalessentialmedicinelistbyincomestatus

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

High-income countrieswereexcluded.


Documents

Essential Medicines for Universal Health Coverage · 2017-10-27 · Three eras of the essential medicines concept • First era (1970s-1990s) • 1st WHO Model List of Essential Medicines