the new partnership for africa’s development (nepad) &...
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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)
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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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
African Medicines Registration Harmonisation (AMRH) Initiative: Summary, Status and Future Plan (Nov, 2009)
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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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.
African Medicines Registration Harmonisation (AMRH) Initiative: Summary, Status and Future Plan (Nov, 2009)
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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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.
African Medicines Registration Harmonisation (AMRH) Initiative: Summary, Status and Future Plan (Nov, 2009)
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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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.
African Medicines Registration Harmonisation (AMRH) Initiative: Summary, Status and Future Plan (Nov, 2009)
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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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.
African Medicines Registration Harmonisation (AMRH) Initiative: Summary, Status and Future Plan (Nov, 2009)
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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– 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
African Medicines Registration Harmonisation (AMRH) Initiative: Summary, Status and Future Plan (Nov, 2009)
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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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
African Medicines Registration Harmonisation (AMRH) Initiative: Summary, Status and Future Plan (Nov, 2009)
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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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
African Medicines Registration Harmonisation (AMRH) Initiative: Summary, Status and Future Plan (Nov, 2009)
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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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
African Medicines Registration Harmonisation (AMRH) Initiative: Summary, Status and Future Plan (Nov, 2009)
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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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®ulatorycapacitybuilding: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
African Medicines Registration Harmonisation (AMRH) Initiative: Summary, Status and Future Plan (Nov, 2009)
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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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
African Medicines Registration Harmonisation (AMRH) Initiative: Summary, Status and Future Plan (Nov, 2009)
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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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.