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

Transcription

1 The New Partnership for Africa s Development (NEPAD) & the World Health Organization (WHO) African Medicines Registration Harmonisation (AMRH) Initiative: Summary, Status and Future Plans 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. 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:Thisincludes pre approvalscientificassessmentofessentialmedicines(registration)sothatcitizenscanaccessthese medicinesandbeassuredthattheymeetacceptablestandardsofsafety,quality,andefficacy. Butconstraintsexistthatmaketheseobligationsdifficulttofulfill:ManyAfricancountrieslack sufficientregulatorycapacitytoapprovemedicinesforsale(bothinatimelyfashionandintermsof ensuringacceptablequality,safetyandefficacystandards).manufacturersfortheirpartareconfronted withnumerousanddisparateregulations,frequentdelays,andlittleprocesstransparency. Asaresult,muchneededmedicineslackavailabilityinmanyAfricancountries:Fewermedicinesare available in African countries than in the US, EU, etc., and prices can remain higher for longer (as manufacturersareunabletobenefitfromthescaleeconomiesassociatedwithfasteraccesstolarger markets,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 Lowregulatorycapacityandpoorlyharmonised registrationprocessesmaybeoneofthefactors limitingpatientaccesstoessentialmedicinesand otherhealthinterventions Pooruptakeofnewandexistinghealthsolutions costsmillionsoflivesacrosslow incomecountries Source:WHO/UNICEF;WorldBank;BCGanalysis Page1of13

2 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 to improvepublichealth,by increasing timelyaccessto safeand effectivemedicinesof goodqualityforthe treatment of priority diseases. Access will be increased by reducing the time it takes for essential medicines to be registered in country without compromising quality (including the time needed for industry to prepare their registration application/dossier) and so potentially the time taken for essential therapiestoreachpatientsinneed(dependingonfunding,distributionmechanismsetc.).thiswillrequire capacity building to ensure transparent, efficient and competent regulatory activities (assessment of registration dossiers and related inspections) that are able to assure the quality, safety and efficacy of registeredmedicines. Overallaim: Specificaim: Toimprovepublichealthbyincreasingrapidaccesstosafeandeffectivemedicines ofgoodqualityforthetreatmentofprioritydiseases Toreducethetimetakentoregisteressentialmedicines HowcouldmedicinesregistrationprocessesinAfricabeimproved? Today'scurrentenvironment ~50differentNationalMedicines RegulatoryAuthorities(NMRAs)(working independently)toregistermedicinesacross Africa Differentadministrativeandtechnical requirements,processesandproceduresfor medicinesregistrationacrossnmras Noclearindicationofthetimetaken,orthe maximumtimesallowed,forregulatorsto assessandregistermedicines Limitedtransparencybeforeorduringthe registrationprocess Aharmonisedfutureenvironment Approx.5or6regionalgroups(eachwith harmonisedtechnicalrequirements) coordinatingregistrationacrosstheentire Africancontinent Common(harmonised)registration documentation(formatandtechnical requirements),procedures,anddecisionmakingprocessesacrossafricanregional groups Streamlinedprocessesthatarefaster,more predictableandbetteralignedtopublichealthneeds(intermsofprioritization, conditionalapprovalsetc.) Transparentandclearprocedures,anda goodunderstandingofregistration requirementsandprocessesbyall stakeholders Page 2 of 13

3 Whatwouldsuccesslooklike? Increased regulatory technical capacityand moreefficient resourceuse Increased requestsfor registrationfrom manufacturers Costsavings Greateraccessto medicines Donorreachand MDGsuccess NMRAsbenefitfromeconomiesofscale,capacitybuildingandthebestuseof skilledresourcesbypoolingcapacitytoensuretimely,cost effective registration.thiswouldincludemechanismstoavoidduplicationbyshared responsibilityforscientificassessmentsandinspectionsandleveragingthe potentialofwell establishedregulators. Industrybenefitsfromharmonisedregistrationdocumentation(dossierformat andtechnicalrequirements),increasedtransparencyandfewerdelays(andso lessexpense)inpreparingregistrationapplicationsformultiplecountries.more predictableregistrationprocessesandshortened(withincertainlimits) timelinesforregistrationmeanthatmanufacturerscanaccesslargermarkets fasterandsocreatesanincentiveformanufacturerstoregistermoreoftheir productsacrossmorecountries Governments,donors,andpatientscanachievegreatersavingswithmore (lower priced)genericsonthemarket,downwardpressureonpricesthrough enhancedcompetitionandpooled(shared)procurement Communitiesgetquicker,wideraccesstoessentialmedicines ThereachofdonorswillbeextendedtoencompassmorecountriesinAfricaand morepeople(asmedicinesaffordabilityimproves).thisshouldresultingreater progresstowardsthethreehealth 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 African Parliament (PAP) consultation meeting in February 2009, which was hosted in collaboration with their Consortium partners (see below). The meeting attracted representatives from nine of the continent s RegionalEconomicCommunities(RECs)andover40nationalmedicinesregulatoryauthorities(NMRA).This provided a strong endorsement for the consensus plan that emerged and hence the approach that RECs andnmrasarenowtaking. This approach has been for RECs, with NEPAD and WHO support, to develop project proposals outlining their plan for medicines registration harmonisation, and for which NEPAD and WHO are now working to mobilisedonorfundingandotherstakeholdersupport. At the same time, NEPAD and WHO are developing linkages, with the aim of building an institutional structurearoundtheamrh initiativethat will ensurebroadrepresentationandactiveparticipation ofall stakeholdergroups,therebyenhancingtheinitiative ssustainability. Theultimategoalistoexpandtheinitiativetoencompassotherhealthproductsandregulatoryfunctions. Page 3 of 13

4 HowwilltheAMRHinitiativemobilisefinancialandtechnicalsupport? Convenekeyleaderstodiscussthepotentialvalueofharmonisingmedicinesregistrationwithin and across African Regional Economic Communities (RECs), review existing REC plans and processes,anddiscussthepossibleneedforcontinentalcoordinationwithintheframeworkof theafricanunion AMRHREC&NMRAConsultationMeeting(February2009) Interested RECs develop and submit summary project proposals outlining their plans for medicinesregistrationharmonisation Firstproposalssubmitted(May2009) strengtheningandrefiningongoing Use summary project proposals to solicit donor support for REC projects as well as mobilize resourcestofacilitatecontinentalcoordinationanddevelopment/facilitation/leadership AMRHDonor&StakeholderDiscussionMeeting(November2009) Donors invite full project proposals where they believe that there are good prospects for success 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 for Africa in 2007, which specifically recognises the need for African countries to strengthen their medicines regulatorysystemsbypoolingtheirresourcesinordertoachievepublichealthpolicypriorities. Suchsystemsarevitaltoassurethequality,safetyandefficacyoflocallymanufacturedproductsandtheir positive contribution to public health. Moreover, the success of local production will partly depend on intra regionalandintra continentaltradetocreateviablemarketsizes.currently,tradeinpharmaceuticals is hampered by poorly harmonised administrative and technical requirements for medicines registration, whichcreatetechnicalbarriers to thefree movementofproducts manufacturedin Africa(andbeyond) andhasnegativeconsequencesfortimelypatientaccesstoqualityessentialmedicines. The AMRH initiative falls within the ambit of this Plan and is a key component in supporting African countries torespond to AU smandate(establishedintheplan) tofulfilnational obligations toprovideall citizenswithsafe,quality,andeffectiveessentialmedicines. Page 4 of 13

5 WhyaREC basedapproach? In keeping with the African Union s strategy for development collaboration across countries, the AMRH initiative is working through the continent s political structures, in the form of Regional Economic Communities(RECs). RECs exist to promote common trade, economic and market opportunities to those countries (aligned geographically) that constitute their member states. In addition to economic development, many RECs also work to promote social development and are increasingly active in the healthfield. Several RECs have already supported harmonisation of medicines registration by developing common pharmaceuticalpoliciesandoperationalplans backedbyhigh levelpoliticalcommitmentsandmandates. Forexample, ineast Africaundertheprovisionsof Chapter21(Article118)of theeast AfricaCommunity (EAC)treaty,medicinesregistrationharmonisationisanexplicitpolicypriority.Likewise,inSouthernAfrica, MinistersofHealthapprovedtheSouthAfricanDevelopmentCommunity(SADC)PharmaceuticalsBusiness Plan,withexplicitgoalstoharmonisemedicinesregistration. However, implementation of these policies and plans has suffered from a lack of financial and technical resources and has not progressed significantly. Moreover, RECs continue to work largely in isolation. Coordination is needed to avoid duplication of effort and ensure consistent approaches, especially given that morethanthree quartersof Africancountriesbelongto twoormore RECs. Thisis where theamrh Initiativecanaddvalue. WhichRECsistheAMRHinitiativecurrentlypartneringwith? The African Union officially recognizes eight RECs ranging in size from five to more than twenty five memberstates andallof whichhavebeen invited toparticipate intheamrhinitiative. Inadditionthe initiative is actively engaging with other regional groups that are already active in the medicines registrationfield. AsofNovember2009,theAMRHinitiativeisactivelypartneringwithfourregionalgroupings(twoofwhichwill bespearheadedbytwodifferentrecsworkingincollaboration)todevelopprojectproposalsinsupportof medicinesregistrationharmonisation.togethertheserecsconstitute41oftheafrica s54countries(orits47 Sub SaharanAfricancountries). TheremainingcountriesareinnorthandnortheastAfricaandRECsthatoperateintheserespectiveregions haveexpressedastronginterestinparticipatingintheamrhinitiative,whichaimstobenefittheentire continent.indeed,amoreintensiveeffortinnorthandnortheastafricaisinplacefor2010. Page 5 of 13

6 African Medicines Registration Harmonisation (AMRH) Initiative: Summary, Status and Future Plan (Nov, 2009) Southern Africa: SADC (South African Development Community) 15 member states East Africa: EAC (East African Community) 5 member states Central Africa: ECCAS (Economic Community of Central African States) and OECAC (Organisation de Coordination pour la lutte contre les Endémies en Afrique Centrale) 11 combined member states West Africa: ECOWAS (Economic Community of West African States) and UEMOA (Union Economique et Monétaire Ouest Africaine) 15 combined member states 3. AMRH initiative timing and critical success factors This initiative is timely for several reasons: Market Dynamics Medicines prices for many of Africa s high priority diseases have come down in recent years e.g. through the availability of generic versions of HIV/AIDS therapies and greater purchasing volumes (by international donors such as GFTAM, PEPFAR and UNITAID). It is therefore important for countries to ensure that they can rapidly and efficiently assess the quality, safety and efficacy of these medicines in order to fully realise their potential public health benefits. Page 6 of 13

7 Therearealsoencouragingsignswhenitcomestodevelopingnewmedicinestotreatpriority (includingneglected)diseasesinafrica(throughproductdevelopmentpartnershipsandother innovativemechanismstoincentiviser&d)meaningastrongproductpipeline.againtimely registrationwillhelptomorerapidlyrealisethepotentialpublichealthbenefits. Asmedicinespriceshavestartedtocomedown,donorinteresthasmovedtowardsthehealthofthe pharmaceuticalsmarketmorebroadlyandthereisagrowingappetitetosupporthealthsystems strengthening includingmedicinesregulationanddistributionsystems. PoliticalCommitment RECsarerapidlymovingtowardsstrongereconomicintegration,whichhastenstheneedtoreduce technicalbarrierstotrade,suchaspoorlyharmonisedmedicinesregistrationrequirements.for exampletheeacestablishedacustomsunionin2005,planstooperationalisetheeaccommonmarket in2010andmonetaryunionin2012,andultimatelytoachievefullpoliticalfederation. ManyRECsarealreadyworkingtowardsmedicinesregistrationharmonisation,haveministerial mandatesandcommitmentsinsupportofthisand/orexistingframeworksandpreliminaryplansin place.thisiswhattheamrhinitiativeseekstobuildon. ThereisgrowingsupportfortheNewPartnershipforAfrica sdevelopment(nepad),anditsrec based approachasthecontinent senginesforgrowthanddevelopment.nepadhasbeenadoptedasthe Africa spreferreddevelopmentstrategyandhasreceivedsupportfromtheungeneralassembly, amongstothers.thenepadsecretariatisanorganoftheafricanunion,basedinsouthafrica.itis activeinanumberofsectors.theamrhinitiativeisacollaborationofnepadhealth,nepadscience andtechnologyandtheafricanunioncommission. Consequently,manyofthekeyconditionsforachievingsuccessarealreadyinplaceorunderdevelopment. Africanpolitical commitment Africanownership Existingregional structurefor harmonisation Timelyresourcingof initiative JointdecisionsbykeypartiesonAfricanHealthStrategy AfricanUnionCommission AfricanUnionConferencesofMinisters PanAfricanParliament RECsandcountriesjointlyowntheinitiative Fullpoliticalmandatesinplace(orinprogress) Progressoncommonpharmaceuticalpolicies, operationalplans,commonmedicineregistration standardsetc. RegionalEconomicCommunitiesprovideastructurefor harmonisation RecognizedbyAfricanUnion Functioningtradeagreements&activitiesalreadyin place Previouslyplannedcommonstandardsfailedduetoalack of technical, financial and human resources, at both national and regional level Page 7 of 13

8 4. The project Consortium TheConsortiumbringstogetherpolitical,technicalanddonororganizations,inresponsetoRECs'technical and financial support needs, with respect to harmonisation of medicines registration. Beyond working to mobilise financial and technical resources for project implementation, the Consortium is promoting and facilitating inter REC communication, coordination and shared learning. It is also working to develop linkagesandbuildaninstitutionalstructurearoundtheamrhinitiativetoensurethebroadrepresentation andactiveparticipationofallstakeholdergroups,therebyenhancingitssustainability. The Consortium is actively seeking other interested parties to collaborate and offer their support Existing Consortium Partners Consortium Objectives Communications Funding Political/technical/organizational: WorldHealthOrganization(WHOHQ,AFRO andemro) NewPartnershipforAfricanDevelopment (NEPAD) Pan AfricanParliament(PAP) AfricanUnionCommission(AUC) Donors: Bill&MelindaGatesFoundation(BMGF) UKDepartmentforInt'lDevelopment (DFID) NGOs: WilliamJ.ClintonFoundation 1. MobilizepoliticalandhighlevelsupportandfinancialandtechnicalresourcesforAMRH 2. Promoteandfacilitateinter RECcommunication,coordination,technicalconsistencyand sharedlearningwithrespecttoamrh.buildacontinentalinitiative. 3. Providetechnicalsupporttoassistwith:prioritysettingandplansforregulatory harmonisation;acommonformatforregistrationdocumentationandcommontechnical requirementsforassessingthequality,safetyandefficacyofmedicines;goodregulatory practices;regulatorycapacitybuilding(forassessmentandinspections);andregulatory decision makingandcommunication NEPADmanagesAMRHinitiativecommunicationsandisresponsibleforliaisingwithREC andnmrapartnerinstitutionsonbehalfoftheconsortiumandinlinewithitssteeringand coordinationrole OthermembersoftheConsortiumalsoutilisetheirnetworksandinstitutionalrelationships topubliciseandpromotetheamrhinitiative AnAMRHinitiativenewsletterispublishedasneeded(thesecondeditionwaspublishedin October2009)andanAMRHinitiativewebsiteisinprocess TheConsortiumhassomeinitialfundscommittedbutmoreisneeded(bothmoneyandin kind technicalsupport/resources)tofullyoperationalisetheamrhinitiative. WhataretherolesandactivitiesofcurrentConsortiumpartners? SomeofthekeycontributionsoftheConsortiumpartnerareoutlinedbelow.Inpractice,however,the Consortiumhasadoptedacollaborativeandconsensus drivenapproachinallaspectsofitswork meaning ahighlevelofparticipationfromeachofthepartnersacrossthefullrangeofconsortiumactivities. NEPAD:Politicaladvocacy,administrativeandplanningsupporttotheConsortium,mobilising,coordination andsharingbetweenvariousrecs,politicallinktoafricanunion,pan AfricanParliamentandAfricanUnion Commission,identifyingandmobilizingotherdonorsfortheConsortium Page 8 of 13

9 WHO: Developing global norms and standards, regulatory support to NMRAs (building on former and ongoingactivitiesintheregion),technicalsupporttorecsinpreparingprojectproposals,mobilizingother donors,technicalsupporttorecsinimplementingtheapprovedprojects,promotingcontinentalandglobal consistencyofregionalharmonisationeffortsandmaterials Donors(Bill&MelindaGatesFoundation,DFID):MobilizingotherdonorstoparticipateintheConsortium; participating in the technical review of summary project proposals, identifying and approving project proposalsforfundingin2010. Other stakeholders: The William J. Clinton Foundation is providing in kind support through a dedicated projectresourceintheformofaconsultantsecondedtothenepadsecretariat. 5. Consultative proposal development approach and status FollowinginitiationoftheAMRHinitiativeatthe endoffebruary 2009,several RECssubmittedsummary project proposals describing their high level plans for medicines registration harmonisation at the end of May2009. Following their review, the Consortium actively partnered with four REC groupings (EAC, ECCAS/OCEAC, ECOWAS/UEMOAandSADC) tosupporttheminstrengtheningandmoderatelyexpandingtheirproposals. Inthefirstinstance,thisinvolvedwrittenfeedbackfromtheConsortiumfollowedbyavisitfromaNEPAD delegationtoexplaintheconsortium'sfeedbackandagreeatimelinefornextsteps.giventheimportance of NMRA consultations and ownership, NEPAD has also made some funding available for RECs and their constituentnmrastojointlyensurethattheirprojectproposalsreflecttheirsharedvisionforharmonised medicinesregistration. This is unfolding as a two stage process consisting of smaller writing workshops (utilising NMRA experts fromtheregion),followedbybroadernmraendorsementmeetings,withrepresentationfromallmember statesandguidancefromwhoandnepad.theproposalsarethenbeingtakenthroughtherecdecisionmakingstructurestosecureministerialapproval. In this way, member state REC/NMRA joint ownershipand political commitment is being strengthened significantly increasing the prospects for project success. The following table illustrates REC workshops/meetingsthathavetakeplaceorareplanned. African Region REC WritingWorkshop NMRAEndorsement Meeting Proposalstatus East EAC 16 th 19 th Sept st 25 th Sept2009 Seconddraftsubmitted West ECOWAS/UEMOA 28 th 30 th Sept th 14 th Oct2009 Seconddraftsubmitted Central ECCAS/OCEAC 26 th 28 th Oct2009 Q12009 Initialdraftsubmitted Southern SADC Q12009 Q12009 Initialdraftsubmitted Page 9 of 13

10 6. Key features of emerging REC project proposals Whatisthedurationandscopeoftheproposals? The REC project proposals focus on priority essential medicines mostly (though not exclusively) multisourcegenerics.thesewillbedefinedbytherecsaccordingtoregion specificdiseaseburdens,inorderto maximisethebenefitstopublichealth. BasedonConsortiumguidance,thedurationofprojectproposalsisfiveyears,althoughthestartdatewill vary depending on when individual project proposals are finalised, as well as when funding becomes available. HowfarwilltheprojectsmoveRECstowardsfullmedicinesregistrationharmonisation? In most cases REC member states will progress from working independently to achieving harmonised standards (initially within their region and then across the continent at a later stage) and collaborating broadly over the five year period. Beyond this, it is expected that RECs will benefit from scientific assessments carried out by other well established regulators and WHO Prequalification Programme by recognizing decisions made by these bodies and incorporating these into national decision making processes,aspartoftheireffortstostreamlineprocessesandadopt/strengthenrisk basedapproachesto medicines registration (i.e. tailor work effort according to perceived risk, based on a variety of factors includingwhetherornotthemedicineshasbeenapprovedelsewhere). RECProjectProposals NotHarmonised FullyHarmonised Working independently Memberstates operate independentlyto strengthen regulatorycapacity andeachcountry hasitsown technical requirementsand formatfor registration applications Collaborateon selectedtopics Memberstates collaborateon selectedtopicse.g. certaintechnical guidelines,gmp inspections, information exchangeetc. Harmonised standardsand broad collaboration Memberstates havecommon technical requirementsand collaboratebroadly e.g.from intensified information exchangeincluding sharingassessment andinspection reportstojoint evaluationsand inspection Recognitionof decisionsmade elsewhere National verificationbased oninformationof decisionsmade elsewhere(either withintherecor beyond)and/or MutualRecognition Agreements Centralized regional registration Centralized registrationon behalfof participating memberstates Page 10 of 13

11 African Medicines Registration Harmonisation (AMRH) Initiative: Summary, Status and Future Plan (Nov, 2009) Whatarethebroadobjectives? The Consortium is promoting a common framework, focusing on near term steps, to promote medicines registration harmonisation. These include national implementation of acommon Technical Document(a harmonised format to present technical data), harmonised technical requirements for and/or common proceduresfortheregistrationofessentialmedicines(mostlygenericpharmaceuticalsasafirststep),and intensive regional collaboration in support of strengthening national and regional regulatory capacity. RECsaretailoringtheirspecificobjectiveswithinthebroadobjectivesoftheinitiative,toensurethesemeet localneeds,circumstancesandpreferences. Whatarethekeymilestonesandtimeframes? Althoughtheprojectproposalsdifferintheirspecificcontent,thefollowingdiagramillustratessometypical keymilestonesoverthe5 yearperiod.however,developmentworktowardsattainingthemilestoneswill oftenbeginmorethanayearinadvanceofthesetmilestone. Typicalkeymilestonesandtimeframesofaregionalmedicinesregistrationharmonisationproject Improvingtransparency:Launcharegional medicinesregistrationwebsite Trust&regulatorycapacitybuilding: Implementaprocessforjointevaluations& inspections YEAR1 YEAR2 Minimisingduplication:Integratetheoutput fromjointevaluationsandinspectionsinto nationaldecision makingprocesses Improvinginformationmanagementand streamliningprocesses:implementa commoninformationmanagementsystem (atnationallevelandlinkedregionally)to supportefficientmedicinesregistration processes YEAR3 YEAR4 YEAR5 Harmonisingguidelines:Implementuseof commontechnicaldocuments(format& contentintermsoftechnicalguidelinesfor assessmentandinspections) Expeditingtheregistrationofhigh priority products:implementaregionalfast track policyforhighpriorityproducts,which includesbenefitingfromregulatorydecisions madebyotherparties Adoptingarisk basedapproach:implement effectiveregionalinformationexchangeand recognitionpolices Building&maintaininghumanresource capacity:implementacontinuousand sustainableregionaltrainingprogrammefor evaluators&inspectors Ensuringaconducivepolicyenvironment: Updatenationalmedicinespoliciesto incorporateregionalandnational improvementstomedicinesregistrationthat occurasaresultoftheproject Page 11 of 13

12 Whataretheprojects staffingplans,governancestructuresanddecision makingprocesses? Invariably, the projects focus on establishing a project management team or a secretariat with dedicated staffing at regional level. These will be fully absorbed and embedded within RECs existing institutional frameworks benefitingfromadirectreportingline tomemberstates Ministersof HealthandHeadsof State, linkages to regional legislative assemblies, etc. In addition, structures already exist or will be established to enable participation of technical experts and heads of NMRAs in regional expert committees/technical working groups and project steering committees. Member state oversight and participationindecision makingprocesseswillbecomplementedbythenominationorappointmentofan AMRH dedicated staff member within NMRAs to provide an effective linkage between consensus based decision makingattheregionallevelandeffectiveimplementationatthenationallevel. Howwillactivitiesbesustainedoncefundingsupporthasended? Plans to sustain and expand project activities beyond the 5 year project period are being built into REC proposals. These include maintaining and growing project management structures, with financial responsibility for these assigned to the RECs and their member states, and establishing other sources of fundinge.g.industryfees.forexample,theeachasplans(basedonamarch2008directivefromtheeac Council 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 and food.projectstaffingundertheeacproposalwillhelpcontributetotheestablishmentofthecommission, asanautonomousinstitutionwithintheeacstructure.similarly,ecowashasmadeplanstoupgradethe ECOWAS 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 ECOWAS Medicines Regulatory Agency (EMRA) to be funded through member state contributions and industry fees. The EMRA will provide technical assistance to member state NMRAs as well as register criticalproductsforpublichealthinterventionsforusewithintheecowasregion. 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 recognition policies,fast trackpoliciesetc.) Development of continuous training programmes for evaluators and inspectors, taking into account available NMRA currentandprojectedresources, whichwillbeimplemented(using NMRAresources) onanongoingbasistoensurethatthecapacitybuiltaspartoftheprojectissustained Page 12 of 13

13 7. Estimated funding and support needs Currently four REC groupings (EAC, ECCAS/OCEAC, ECOWAS/UEMOA and SADC) are finalizing their proposals, which will indicate the resources they will need to implement their medicines registration harmonisationplansoverthenextfive years. Apreliminary examinationof theserec proposals indicates that funding will cover: personnel, REC coordination, consultants/experts (including for evaluation and inspection),training,equipmentandadvocacy.eachregionisexpectedtorequirebetween$10millionand $15millionoverthatfive yearperiod,includingadditionalcoordinationandtechnicalassistance.thiswill alsodependonthesizeandscopeofeachproposalandthenumberofcountriescoveredineachregion.it islikelythat5or6recgroupingswilleventuallycovertheentireafricancontinent,oncetheamrhprocess innorth/north eastafricaprogressesfurther. InitiallytheRECswillneedbothfinancialandin kindsupporttolaunchthisinitiative.in kindsupportmay includetechnicalassistance,trainingofregulatorypersonnel,consultation/secondmentofregulatory expertsandproactiveinformationsharing.however,duetotheunprecedentedscaleoftheundertaking andtheproposaldevelopmentworkinprogress,itisnotpossibleatthisstagetoexactlyspecifyallcosts. Somecorrectionsmaybenecessarywhenmorepreciseinformationaboutalltheprojectproposals becomesavailableandprojectsstarttorollout. InitialsupportactivitiesforRECs providedbynepadandwho havebeenpartiallyfundedsofarbythe Bill&MelindaGatesFoundationandUK sdepartmentforinternationaldevelopment(dfid),butanumber of donors have shown interest in and are engaging with the process. Only after potential donors have reviewed the final REC project proposals is it expected that funding and in kind resources will be committed. 8. A note on national sovereignty TheAMRHprocessisownedanddrivenbyAfricancountriesandRECs.Increatingtheirprojectproposals, countriesandrecswilltailorobjectivesandactivitiestomeettheirownspecificneeds,circumstancesand preferencesinline withthemajorobjectivesoftheinitiative.theinitiativefocusesonnear termstepsto promotemedicinesregistrationharmonisation,meaningthatregistrationdecisionswillremainfirmlythat ofsovereignnations. Inthelongerterm,andastheinitiativeprogresses,therewillbescopetobuildonthesesystemstofurther avoid 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 between countriesandsharedgovernance,toallowcountriestooptoutiftheywishtodoso. This is why it is so advantageous that this initiative is hosted within the African Union and the Regional Economic Communities, which have the formal structures to address these issues. As such, the AMRH initiative is well placed to bridge the policy to implementation gap that has beenhampering advances in medicinesregistrationandotherrelatedfields. Page 13 of 13