the new partnership for africa’s development (nepad) &...

New Partnership for Africa’s Development – Health Sector Contact: Dr. Eric Buch (Health Adviser) Tel.: +27 83 391 6962. Email: [email protected]

World Health Organization – Department of Essential Medicines and Pharmaceutical Policies Contact: Dr. Hans Hogerzeil (Director) Tel.: +41 22 791 3528. Email: [email protected]

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The New Partnership for Africa’s Development (NEPAD) & the World Health Organization (WHO)

African Medicines Registration Harmonisation (AMRH) Initiative: Summary, Status and Future Plans

1. The aim of the African Medicines Registration Harmonisation (AMRH) initiative The challenge: In many African countries a lack of harmonised technical requirements and capacity for medicines registration jeopardizes timely access to essential medicines

Everycountryisobligedtoregulatethepharmaceuticalproductssoldwithinitsborders:Thisincludespre‐approvalscientificassessmentofessentialmedicines(registration)sothatcitizenscanaccessthesemedicinesandbeassuredthattheymeetacceptablestandardsofsafety,quality,andefficacy.

Butconstraintsexistthatmaketheseobligationsdifficulttofulfill:ManyAfricancountrieslacksufficientregulatorycapacitytoapprovemedicinesforsale(bothinatimelyfashionandintermsofensuringacceptablequality,safetyandefficacystandards).Manufacturersfortheirpartareconfrontedwithnumerousanddisparateregulations,frequentdelays,andlittleprocesstransparency.

Asaresult,muchneededmedicineslackavailability inmanyAfricancountries:Fewermedicinesareavailable in African countries than in the US, EU, etc., and prices can remain higher for longer (asmanufacturersareunabletobenefitfromthescaleeconomiesassociatedwithfasteraccessto largermarkets,competitionisintroducedmoreslowlyandcross‐countrypooledprocurementisdelayed).

The impact: A lack of essential medicines might contribute to significant disparities in health and life-expectancy between low-income African counties and high-income countries

The AMRH initiative has been created to assist African countries and regions to respond to the challenges posed by medicines registration – as an important, but neglected area of medicines access. It seeks to support African Regional Economic Communities and countries in harmonising medicines registration and is seeking interested donors and other stakeholders that can help offer the requisite support.

Lowregulatorycapacityandpoorlyharmonisedregistrationprocessesmaybeoneofthefactorslimitingpatientaccesstoessentialmedicinesandotherhealthinterventions

Pooruptakeofnewandexistinghealthsolutionscostsmillionsoflivesacrosslow‐incomecountries

Source:WHO/UNICEF;WorldBank;BCGanalysis

African Medicines Registration Harmonisation (AMRH) Initiative: Summary, Status and Future Plan (Nov, 2009)



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A solution: The AMRH initiative’s aim is to support African countries to overcome these constraints by building effective medicines registration through regional harmonisation and capacity building The primary aim of harmonising technical requirements and processes for medicines registration is toimprovepublichealth,by increasing timelyaccesstosafeandeffectivemedicinesofgoodqualityforthetreatment of priority diseases. Access will be increased by reducing the time it takes for essentialmedicines to be registered in‐country without compromising quality (including the time needed forindustry to prepare their registration application/dossier) and so potentially the time taken for essentialtherapiestoreachpatientsinneed(dependingonfunding,distributionmechanismsetc.).Thiswillrequirecapacity building to ensure transparent, efficient and competent regulatory activities (assessment ofregistration dossiers and related inspections) that are able to assure the quality, safety and efficacy ofregisteredmedicines. Overallaim: Toimprovepublichealthbyincreasingrapidaccesstosafeandeffectivemedicines

ofgoodqualityforthetreatmentofprioritydiseases

Specificaim: Toreducethetimetakentoregisteressentialmedicines

HowcouldmedicinesregistrationprocessesinAfricabeimproved?

Today'scurrentenvironment Aharmonisedfutureenvironment

~50differentNationalMedicinesRegulatoryAuthorities(NMRAs)(workingindependently)toregistermedicinesacrossAfrica

Approx.5or6regionalgroups(eachwithharmonisedtechnicalrequirements)coordinatingregistrationacrosstheentireAfricancontinent

Differentadministrativeandtechnicalrequirements,processesandproceduresformedicinesregistrationacrossNMRAs

Common(harmonised)registrationdocumentation(formatandtechnicalrequirements),procedures,anddecision‐makingprocessesacrossAfricanregionalgroups

Noclearindicationofthetimetaken,orthemaximumtimesallowed,forregulatorstoassessandregistermedicines

Streamlinedprocessesthatarefaster,morepredictableandbetteralignedtopublic‐healthneeds(intermsofprioritization,conditionalapprovalsetc.)

Limitedtransparencybeforeorduringtheregistrationprocess

Transparentandclearprocedures,andagoodunderstandingofregistrationrequirementsandprocessesbyallstakeholders




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Whatwouldsuccesslooklike?

Increasedregulatorytechnicalcapacityandmoreefficientresourceuse

NMRAsbenefitfromeconomiesofscale,capacitybuildingandthebestuseofskilledresourcesbypoolingcapacitytoensuretimely,cost‐effectiveregistration.Thiswouldincludemechanismstoavoidduplicationbysharedresponsibilityforscientificassessmentsandinspectionsandleveragingthepotentialofwell‐establishedregulators.

Increasedrequestsforregistrationfrommanufacturers

Industrybenefitsfromharmonisedregistrationdocumentation(dossierformatandtechnicalrequirements),increasedtransparencyandfewerdelays(andsolessexpense)inpreparingregistrationapplicationsformultiplecountries.Morepredictableregistrationprocessesandshortened(withincertainlimits)timelinesforregistrationmeanthatmanufacturerscanaccesslargermarketsfasterandsocreatesanincentiveformanufacturerstoregistermoreoftheirproductsacrossmorecountries

Costsavings Governments,donors,andpatientscanachievegreatersavingswithmore(lower‐priced)genericsonthemarket,downwardpressureonpricesthroughenhancedcompetitionandpooled(shared)procurement

Greateraccesstomedicines

Communitiesgetquicker,wideraccesstoessentialmedicines

DonorreachandMDGsuccess

ThereachofdonorswillbeextendedtoencompassmorecountriesinAfricaandmorepeople(asmedicinesaffordabilityimproves).Thisshouldresultingreaterprogresstowardsthethreehealth‐relatedMillenniumDevelopmentGoals(MDGs4,5and6)

The AMRH initiative approach seeks to support African Regional Economic Communities (RECs) and countries to harmonise medicines registration using existing political structures and building on existing plans and commitments TheAMRHinitiativewasinitiatedataNewPartnershipforAfrica’sDevelopment(NEPAD)andPan‐AfricanParliament (PAP) consultation meeting in February 2009, which was hosted in collaboration with theirConsortium partners (see below). The meeting attracted representatives from nine of the continent’sRegionalEconomicCommunities(RECs)andover40nationalmedicinesregulatoryauthorities(NMRA).Thisprovidedastrong endorsement for the consensusplan that emergedandhence theapproach that RECsandNMRAsarenowtaking. This approachhas been for RECs,with NEPADandWHO support, to developproject proposals outliningtheirplan formedicines registrationharmonisation, and forwhichNEPADandWHOarenowworking tomobilisedonorfundingandotherstakeholdersupport.At the same time, NEPAD and WHO are developing linkages, with the aim of building an institutionalstructurearoundtheAMRH initiativethatwillensurebroadrepresentationandactiveparticipationofallstakeholdergroups,therebyenhancingtheinitiative’ssustainability.Theultimategoalistoexpandtheinitiativetoencompassotherhealthproductsandregulatoryfunctions.




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HowwilltheAMRHinitiativemobilisefinancialandtechnicalsupport?

Convenekeyleaderstodiscussthepotentialvalueofharmonisingmedicinesregistrationwithinand across African Regional Economic Communities (RECs), review existing REC plans andprocesses,anddiscussthepossibleneedforcontinentalcoordinationwithintheframeworkoftheAfricanUnion

AMRHREC&NMRAConsultationMeeting(February2009)

Interested RECs develop and submit summary project proposals outlining their plans formedicinesregistrationharmonisation

Firstproposalssubmitted(May2009)–strengtheningandrefiningongoing

Use summary project proposals to solicit donor support for REC projects aswell asmobilizeresourcestofacilitatecontinentalcoordinationanddevelopment/facilitation/leadership

AMRHDonor&StakeholderDiscussionMeeting(November2009)

Donors invite full project proposals where they believe that there are good prospects forsuccess

Regionalgroupsthatreceivefundingbeginimplementingtheirprojects(ideallyinearly2010)

2. African political commitment and REC-based approach

Whatisthelevelofexisting politicalwillandcommitment?At the continental level, the African Union (AU) approved the Pharmaceutical Manufacturing Plan forAfrica in2007,whichspecifically recognises theneed forAfrican countries tostrengthen theirmedicinesregulatorysystemsbypoolingtheirresourcesinordertoachievepublichealthpolicypriorities.Suchsystemsarevitaltoassurethequality,safetyandefficacyoflocallymanufacturedproductsandtheirpositive contribution to public health. Moreover, the success of local production will partly depend onintra‐regionalandintra‐continentaltradetocreateviablemarketsizes.Currently,tradeinpharmaceuticalsishamperedbypoorlyharmonisedadministrativeand technical requirements formedicines registration,whichcreatetechnicalbarriers to thefreemovementofproductsmanufacturedinAfrica(andbeyond)–andhasnegativeconsequencesfortimelypatientaccesstoqualityessentialmedicines.The AMRH initiative falls within the ambit of this Plan and is a key component in supporting Africancountries torespond toAU’smandate(establishedintheplan) tofulfilnationalobligations toprovideallcitizenswithsafe,quality,andeffectiveessentialmedicines.




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WhyaREC‐basedapproach?In keeping with the African Union’s strategy for development collaboration across countries, the AMRHinitiative is working through the continent’s political structures, in the form of Regional EconomicCommunities (RECs). RECsexist topromotecommontrade,economicandmarketopportunities to thosecountries (aligned geographically) that constitute their member states. In addition to economicdevelopment, many RECs also work to promote social development and are increasingly active in thehealthfield.Several RECs have already supported harmonisation of medicines registration by developing commonpharmaceuticalpoliciesandoperationalplans–backedbyhigh‐levelpoliticalcommitmentsandmandates.Forexample, inEastAfricaundertheprovisionsofChapter21(Article118)of theEastAfricaCommunity(EAC)treaty,medicinesregistrationharmonisationisanexplicitpolicypriority.Likewise,inSouthernAfrica,MinistersofHealthapprovedtheSouthAfricanDevelopmentCommunity(SADC)PharmaceuticalsBusinessPlan,withexplicitgoalstoharmonisemedicinesregistration.However, implementationof thesepolicies andplans has suffered froma lack of financial and technicalresources and has not progressed significantly. Moreover, RECs continue to work largely in isolation.Coordination is needed to avoid duplicationof effort and ensure consistent approaches, especially giventhatmorethanthree‐quartersofAfricancountriesbelongto twoormoreRECs.This iswhere theAMRHInitiativecanaddvalue.

WhichRECsistheAMRHinitiativecurrentlypartneringwith?The African Union officially recognizes eight RECs – ranging in size from five to more than twenty‐fivememberstates–andallofwhichhavebeen invited toparticipate intheAMRHinitiative. Inadditiontheinitiative is actively engaging with other regional groups that are already active in the medicinesregistrationfield.

AsofNovember2009,theAMRHinitiativeisactivelypartneringwithfourregionalgroupings(twoofwhichwillbespearheadedbytwodifferentRECsworkingincollaboration)todevelopprojectproposalsinsupportofmedicinesregistrationharmonisation.TogethertheseRECsconstitute41oftheAfrica’s54countries(orits47Sub‐SaharanAfricancountries).

TheremainingcountriesareinnorthandnortheastAfricaandRECsthatoperateintheserespectiveregionshaveexpressedastronginterestinparticipatingintheAMRHinitiative,whichaimstobenefittheentirecontinent.Indeed,amoreintensiveeffortinnorthandnortheastAfricaisinplacefor2010.




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SouthernAfrica:SADC(SouthAfricanDevelopmentCommunity)–15memberstates

EastAfrica:EAC(EastAfricanCommunity)–5memberstates

CentralAfrica:ECCAS(EconomicCommunityofCentralAfricanStates)andOECAC(OrganisationdeCoordinationpourlaluttecontrelesEndémiesenAfriqueCentrale)‐11combinedmemberstates

WestAfrica:ECOWAS(EconomicCommunityofWestAfricanStates)andUEMOA(UnionEconomiqueetMonétaireOuestAfricaine)–15combinedmemberstates

3. AMRH initiative timing and critical success factors Thisinitiativeistimelyforseveralreasons:

MarketDynamics

– MedicinespricesformanyofAfrica’shighprioritydiseaseshavecomedowninrecentyearse.g.throughtheavailabilityofgenericversionsofHIV/AIDStherapiesandgreaterpurchasingvolumes(byinternationaldonorssuchasGFTAM,PEPFARandUNITAID).Itisthereforeimportantforcountriestoensurethattheycanrapidlyandefficientlyassessthequality,safetyandefficacyofthesemedicinesinordertofullyrealisetheirpotentialpublichealthbenefits.




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– Therearealsoencouragingsignswhenitcomestodevelopingnewmedicinestotreatpriority(includingneglected)diseasesinAfrica(throughProductDevelopmentPartnershipsandotherinnovativemechanismstoincentiviseR&D)meaningastrongproductpipeline.Againtimelyregistrationwillhelptomorerapidlyrealisethepotentialpublichealthbenefits.

– Asmedicinespriceshavestartedtocomedown,donorinteresthasmovedtowardsthehealthofthepharmaceuticalsmarketmorebroadlyandthereisagrowingappetitetosupporthealthsystemsstrengthening–includingmedicinesregulationanddistributionsystems.

PoliticalCommitment

– RECsarerapidlymovingtowardsstrongereconomicintegration,whichhastenstheneedtoreducetechnicalbarrierstotrade,suchaspoorlyharmonisedmedicinesregistrationrequirements.ForexampletheEACestablishedacustomsunionin2005,planstooperationalisetheEACcommonmarketin2010andmonetaryunionin2012,andultimatelytoachievefullpoliticalfederation.

– ManyRECsarealreadyworkingtowardsmedicinesregistrationharmonisation,haveministerialmandatesandcommitmentsinsupportofthisand/orexistingframeworksandpreliminaryplansinplace.ThisiswhattheAMRHinitiativeseekstobuildon.

– ThereisgrowingsupportfortheNewPartnershipforAfrica’sDevelopment(NEPAD),anditsREC‐basedapproachasthecontinent’senginesforgrowthanddevelopment.NEPADhasbeenadoptedastheAfrica’spreferreddevelopmentstrategyandhasreceivedsupportfromtheUNGeneralAssembly,amongstothers.TheNEPADSecretariatisanorganoftheAfricanUnion,basedinSouthAfrica.Itisactiveinanumberofsectors.TheAMRHinitiativeisacollaborationofNEPADHealth,NEPADScienceandTechnologyandtheAfricanUnionCommission.

Consequently,manyofthekeyconditionsforachievingsuccessarealreadyinplaceorunderdevelopment.

Africanpoliticalcommitment

JointdecisionsbykeypartiesonAfricanHealthStrategy– AfricanUnionCommission– AfricanUnionConferencesofMinisters – PanAfricanParliament

Africanownership

RECsandcountriesjointlyowntheinitiative– Fullpoliticalmandatesinplace(orinprogress) – Progressoncommonpharmaceuticalpolicies,

operationalplans,commonmedicineregistrationstandardsetc.

Existingregionalstructureforharmonisation

RegionalEconomicCommunitiesprovideastructureforharmonisation– RecognizedbyAfricanUnion – Functioningtradeagreements&activitiesalreadyin

place

Timelyresourcingofinitiative

Previouslyplannedcommonstandardsfailedduetoalack of technical, financial and human resources, at both national and regional level




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4. The project Consortium TheConsortiumbringstogetherpolitical,technicalanddonororganizations,inresponsetoRECs'technicaland financial supportneeds,with respect toharmonisationofmedicines registration. Beyondworking tomobilise financial and technical resources for project implementation, the Consortium is promoting andfacilitating inter‐REC communication, coordination and shared learning. It is also working to developlinkagesandbuildaninstitutionalstructurearoundtheAMRHinitiativetoensurethebroadrepresentationandactiveparticipationofallstakeholdergroups,therebyenhancingitssustainability.The Consortium is actively seeking other interested parties to collaborate and offer their supportExistingConsortium Partners

Political/technical/organizational:– WorldHealthOrganization(WHOHQ,AFRO

andEMRO)– NewPartnershipforAfricanDevelopment

(NEPAD)– Pan‐AfricanParliament(PAP)– AfricanUnionCommission(AUC)

Donors:– Bill&MelindaGatesFoundation(BMGF)– UKDepartmentforInt'lDevelopment

(DFID)NGOs: – WilliamJ.ClintonFoundation

ConsortiumObjectives

1. MobilizepoliticalandhighlevelsupportandfinancialandtechnicalresourcesforAMRH2. Promoteandfacilitateinter‐RECcommunication,coordination,technicalconsistencyand

sharedlearningwithrespecttoAMRH.Buildacontinentalinitiative. 3. Providetechnicalsupporttoassistwith:prioritysettingandplansforregulatory

harmonisation;acommonformatforregistrationdocumentationandcommontechnicalrequirementsforassessingthequality,safetyandefficacyofmedicines;goodregulatorypractices;regulatorycapacitybuilding(forassessmentandinspections);andregulatorydecision‐makingandcommunication

Communications – NEPADmanagesAMRHinitiativecommunicationsandisresponsibleforliaisingwithRECandNMRApartnerinstitutionsonbehalfoftheConsortiumandinlinewithitssteeringandcoordinationrole

– OthermembersoftheConsortiumalsoutilisetheirnetworksandinstitutionalrelationshipstopubliciseandpromotetheAMRHinitiative

– AnAMRHinitiativenewsletterispublishedasneeded(thesecondeditionwaspublishedinOctober2009)andanAMRHinitiativewebsiteisinprocess

Funding TheConsortiumhassomeinitialfundscommittedbutmoreisneeded(bothmoneyandin‐kindtechnicalsupport/resources)tofullyoperationalisetheAMRHinitiative.

WhataretherolesandactivitiesofcurrentConsortiumpartners?

SomeofthekeycontributionsoftheConsortiumpartnerareoutlinedbelow.Inpractice,however,theConsortiumhasadoptedacollaborativeandconsensus‐drivenapproachinallaspectsofitswork–meaningahighlevelofparticipationfromeachofthepartnersacrossthefullrangeofConsortiumactivities.

NEPAD:Politicaladvocacy,administrativeandplanningsupporttotheConsortium,mobilising,coordinationandsharingbetweenvariousRECs,politicallinktoAfricanUnion,Pan‐AfricanParliamentandAfricanUnionCommission,identifyingandmobilizingotherdonorsfortheConsortium




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WHO: Developing global norms and standards, regulatory support to NMRAs (building on former andongoingactivitiesintheregion),technicalsupporttoRECsinpreparingprojectproposals,mobilizingotherdonors,technicalsupporttoRECsinimplementingtheapprovedprojects,promotingcontinentalandglobalconsistencyofregionalHarmonisationeffortsandmaterials

Donors(Bill&MelindaGatesFoundation,DFID):MobilizingotherdonorstoparticipateintheConsortium;participating in the technical review of summary project proposals, identifying and approving projectproposalsforfundingin2010.

Other stakeholders: TheWilliam J. Clinton Foundation is providing in‐kind support through a dedicatedprojectresourceintheformofaconsultantsecondedtotheNEPADSecretariat. 5. Consultative proposal development approach and status FollowinginitiationoftheAMRHinitiativeattheendofFebruary2009,severalRECssubmittedsummaryprojectproposalsdescribing theirhigh‐levelplans formedicines registrationharmonisationat the endofMay2009.Following their review, the Consortium actively partneredwith four REC groupings (EAC, ECCAS/OCEAC,ECOWAS/UEMOAandSADC) tosupporttheminstrengtheningandmoderatelyexpandingtheirproposals.Inthefirst instance,this involvedwrittenfeedbackfromtheConsortiumfollowedbyavisitfromaNEPADdelegationtoexplaintheConsortium'sfeedbackandagreeatimelinefornextsteps.GiventheimportanceofNMRA consultations andownership,NEPADhas alsomade some funding available for RECs and theirconstituentNMRAstojointlyensurethattheirprojectproposalsreflecttheirsharedvisionforharmonisedmedicinesregistration.This is unfolding as a two‐stageprocess consisting of smallerwritingworkshops (utilising NMRA expertsfromtheregion),followedbybroaderNMRAendorsementmeetings,withrepresentationfromallmemberstatesandguidancefromWHOandNEPAD.TheproposalsarethenbeingtakenthroughtheRECdecision‐makingstructurestosecureMinisterialapproval.In thisway,memberstateREC/NMRA joint ownershipandpolitical commitment isbeingstrengthened–significantly increasing the prospects for project success. The following table illustrates RECworkshops/meetingsthathavetakeplaceorareplanned.

AfricanRegion

REC WritingWorkshop NMRAEndorsementMeeting

Proposalstatus

East EAC 16th‐19thSept2009 21st‐25thSept2009 Seconddraftsubmitted

West ECOWAS/UEMOA 28th–30thSept2009 12th–14thOct2009 Seconddraftsubmitted

Central ECCAS/OCEAC 26th–28thOct2009 Q12009 Initialdraftsubmitted

Southern SADC Q12009 Q12009 Initialdraftsubmitted




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6. Key features of emerging REC project proposals Whatisthedurationandscopeoftheproposals?

The REC project proposals focus on priority essentialmedicines ‐mostly (though not exclusively) multi‐sourcegenerics.ThesewillbedefinedbytheRECsaccordingtoregion‐specificdiseaseburdens,inordertomaximisethebenefitstopublichealth.

BasedonConsortiumguidance,thedurationofprojectproposals isfiveyears,althoughthestartdatewillvary depending on when individual project proposals are finalised, as well as when funding becomesavailable.

HowfarwilltheprojectsmoveRECstowardsfullmedicinesregistrationharmonisation?In most cases REC member states will progress from working independently to achieving harmonisedstandards (initially within their region and then across the continent at a later stage) and collaboratingbroadly over the five‐year period. Beyond this, it is expected that RECs will benefit from scientificassessments carried out by other well established regulators and WHO Prequalification Programme byrecognizing decisions made by these bodies and incorporating these into national decision‐makingprocesses,aspartoftheireffortstostreamlineprocessesandadopt/strengthenrisk‐basedapproachestomedicines registration (i.e. tailorwork effort according to perceived risk, based on a variety of factorsincludingwhetherornotthemedicineshasbeenapprovedelsewhere).

RECProjectProposalsNotHarmonised FullyHarmonisedWorkingindependently

Collaborateonselectedtopics

Harmonisedstandardsandbroadcollaboration

Recognitionofdecisionsmadeelsewhere

Centralizedregionalregistration

Memberstatesoperateindependentlytostrengthenregulatorycapacityandeachcountryhasitsowntechnicalrequirementsandformatforregistrationapplications

Memberstatescollaborateonselectedtopicse.g.certaintechnicalguidelines,GMPinspections,informationexchangeetc.

Memberstateshavecommontechnicalrequirementsandcollaboratebroadlye.g.fromintensifiedinformationexchangeincludingsharingassessmentandinspectionreportstojointevaluationsandinspection

Nationalverificationbasedoninformationofdecisionsmadeelsewhere(eitherwithintheRECorbeyond)and/orMutualRecognitionAgreements

Centralizedregistrationonbehalfofparticipatingmemberstates




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Whatarethebroadobjectives?TheConsortium ispromotingacommon framework, focusingonnear‐termsteps, topromotemedicinesregistrationharmonisation. These includenational implementationofaCommonTechnicalDocument (aharmonised format to present technical data), harmonised technical requirements for and/or commonproceduresfortheregistrationofessentialmedicines(mostlygenericpharmaceuticalsasafirststep),andintensive regional collaboration in support of strengthening national and regional regulatory capacity.RECsaretailoringtheirspecificobjectiveswithinthebroadobjectivesoftheinitiative,toensurethesemeetlocalneeds,circumstancesandpreferences.

Whatarethekeymilestonesandtimeframes?Althoughtheprojectproposalsdifferintheirspecificcontent,thefollowingdiagramillustratessometypicalkeymilestonesoverthe5‐yearperiod.However,developmentworktowardsattainingthemilestoneswilloftenbeginmorethanayearinadvanceofthesetmilestone.Typicalkeymilestonesandtimeframesofaregionalmedicinesregistrationharmonisationproject

Improvingtransparency:Launcharegionalmedicinesregistrationwebsite

Trust&regulatorycapacitybuilding:Implementaprocessforjointevaluations&

inspections

Minimisingduplication:Integratetheoutputfromjointevaluationsandinspectionsinto

nationaldecision‐makingprocesses

Improvinginformationmanagementandstreamliningprocesses:Implementa

commoninformationmanagementsystem(atnationallevelandlinkedregionally)tosupportefficientmedicinesregistration

processes

YEAR1

YEAR2

YEAR3

YEAR4

YEAR5

Harmonisingguidelines:Implementuseofcommontechnicaldocuments(format&contentintermsoftechnicalguidelinesfor

assessmentandinspections)

Expeditingtheregistrationofhigh‐priorityproducts:Implementaregionalfast‐trackpolicyforhighpriorityproducts,which

includesbenefitingfromregulatorydecisionsmadebyotherparties

Adoptingarisk‐basedapproach:Implementeffectiveregionalinformationexchangeand

recognitionpolices

Building&maintaininghumanresourcecapacity:Implementacontinuousand

sustainableregionaltrainingprogrammeforevaluators&inspectors

Ensuringaconducivepolicyenvironment:Updatenationalmedicinespoliciestoincorporateregionalandnational

improvementstomedicinesregistrationthatoccurasaresultoftheproject




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Whataretheprojects’staffingplans,governancestructuresanddecision‐makingprocesses?

Invariably, theprojects focusonestablishingaprojectmanagement teamora secretariatwithdedicatedstaffing at regional level. These will be fully absorbed and embedded within RECs’ existing institutionalframeworks–benefitingfromadirectreporting line tomemberstates’MinistersofHealthandHeadsofState, linkages to regional legislative assemblies, etc. In addition, structures already exist or will beestablished to enable participation of technical experts and heads of NMRAs in regional expertcommittees/technical working groups and project steering committees. Member state oversight andparticipationindecision‐makingprocesseswillbecomplementedbythenominationorappointmentofanAMRH dedicated staffmemberwithin NMRAs to provide an effective linkage between consensus‐baseddecision‐makingattheregionallevelandeffectiveimplementationatthenationallevel.Howwillactivitiesbesustainedoncefundingsupporthasended?Plans to sustain and expand project activities beyond the 5‐year project period are being built into RECproposals. These include maintaining and growing project management structures, with financialresponsibility for these assigned to the RECs and theirmember states, and establishing other sources offundinge.g.industryfees.Forexample,theEAChasplans(basedonaMarch2008directivefromtheEACCouncil of Ministers) to establish an “East African Community Medicines and Food Safety Commission(EAMFSC)” responsible for regional coordination of regulatory activities with respect to medicines andfood.ProjectstaffingundertheEACproposalwillhelpcontributetotheestablishmentoftheCommission,asanautonomousinstitutionwithintheEACstructure.Similarly,ECOWAShasmadeplanstoupgradetheECOWAS Medicines Registration Harmonisation Board (that will be established as part of the project)consisting of Heads NMRA and expert committees, to a regional coordinating mechanism, designated“ECOWASMedicines Regulatory Agency (EMRA)” to be funded throughmember state contributions andindustry fees. The EMRA will provide technical assistance to member state NMRAs as well as registercriticalproductsforpublichealthinterventionsforusewithintheECOWASregion.Othersustainabilityprovisionsinclude:– Ongoing advocacy and communication to build and maintain stakeholder (including political level)

supportatbothnationalandregionallevel– Implementationofaregionalupdateprocesstoensurethatthecommontechnicalguidelinesthatare

implementedaspartoftheprojectaresustainedonanongoingbasis– Updatingnationalmedicinespoliciestoincorporateregionalandnationalimprovementstomedicines

registration that occur as a result of projects (e.g. to reflect information sharing and recognitionpolicies,fast‐trackpoliciesetc.)

– Developmentof continuous trainingprogrammes for evaluators and inspectors, taking into accountavailableNMRAcurrentandprojectedresources,whichwillbe implemented(usingNMRAresources)onanongoingbasistoensurethatthecapacitybuiltaspartoftheprojectissustained




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7. Estimated funding and support needs

Currently four REC groupings (EAC, ECCAS/OCEAC, ECOWAS/UEMOA and SADC) are finalizing theirproposals, which will indicate the resources they will need to implement their medicines registrationharmonisationplansoverthenextfiveyears.Apreliminaryexaminationof theseRECproposals indicatesthat funding will cover: personnel, REC coordination, consultants/experts (including for evaluation andinspection),training,equipmentandadvocacy.Eachregionisexpectedtorequirebetween$10millionand$15millionoverthatfive‐yearperiod, includingadditionalcoordinationandtechnicalassistance.Thiswillalsodependonthesizeandscopeofeachproposalandthenumberofcountriescoveredineachregion.Itislikelythat5or6RECgroupingswilleventuallycovertheentireAfricancontinent,oncetheAMRHprocessinnorth/north‐eastAfricaprogressesfurther.

InitiallytheRECswillneedbothfinancialandin‐kindsupporttolaunchthisinitiative.In‐kindsupportmayincludetechnicalassistance,trainingofregulatorypersonnel,consultation/secondmentofregulatoryexpertsandproactiveinformationsharing.However,duetotheunprecedentedscaleoftheundertakingandtheproposaldevelopmentworkinprogress,itisnotpossibleatthisstagetoexactlyspecifyallcosts.Somecorrectionsmaybenecessarywhenmorepreciseinformationaboutalltheprojectproposalsbecomesavailableandprojectsstarttorollout.InitialsupportactivitiesforRECs–providedbyNEPADandWHO‐‐havebeenpartiallyfundedsofarbytheBill&MelindaGatesFoundationandUK’sDepartmentforInternationalDevelopment(DFID),butanumberof donors have shown interest in and are engaging with the process. Only after potential donors havereviewed the final REC project proposals is it expected that funding and in‐kind resources will becommitted.8. A note on national sovereignty TheAMRHprocessisownedanddrivenbyAfricancountriesandRECs. Increatingtheirprojectproposals,countriesandRECswilltailorobjectivesandactivitiestomeettheirownspecificneeds,circumstancesandpreferences in linewiththemajorobjectivesoftheinitiative.TheInitiativefocusesonnear‐termstepstopromotemedicinesregistrationharmonisation,meaningthatregistrationdecisionswillremainfirmlythatofsovereignnations.Inthelongerterm,andastheinitiativeprogresses,therewillbescopetobuildonthesesystemstofurtheravoid the need to engage every country at every stage of the medicines registration process. However,such a process must continue to respect national sovereignty and will require agreements betweencountriesandsharedgovernance,toallowcountriestooptoutiftheywishtodoso.

This is why it is so advantageous that this initiative is hostedwithin the AfricanUnion and the RegionalEconomic Communities, which have the formal structures to address these issues. As such, the AMRHinitiative iswellplaced tobridge thepolicy to implementationgap thathasbeenhamperingadvances inmedicinesregistrationandotherrelatedfields.

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