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THE EDITORIAL PAGE AND THE REVIEW.
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& PHARMA
BUSINESS
NIGERIA
DRUG SECURITYSECURITY
Co la lev go eR
H se ea vil tth uc ca er xe E
VOLUME 8 Are Prescription Drug Prices High?
The Strategic Anchors For Drug Security
The Impact Investment
Gandhian Economics Of Capital Efficiency
WHO Pre-qualification
- made in Nigeria for the world MINFLOW
NAFDAC Activities- key to ensuring drug security in nigeria
CHANCES OF A
BETTER FUTURE
tisanundisputablefactthatmedicinesandvaccinesareverycriticalintheIprovisionofhealthcareinanynationbecausetheyprovidecredibilitytothe
healthsystem.Withoutthem,theeffortsofmostoftheotherinterventionsinthe
healthcaredeliverysystemareundermined.Withoutdoubtandfromexperienceof
theEbolaviruscrisis,selfsuf�iciencyinmedicinesandvaccinesisnowanational
securityconcern.
Acriticalinterventionisurgentlyrequiredtoincreasepharmaceutical
manufacturinginWestAfricawithNigeriaasthehubtoprovide70%ofthe
requirementforlocalmedicines.TheFederalGovernmentofNigeriahasdirected
thatin-countryproductioncapacitymustincreaseto70%.Ithasamendedand
addedtotheessentialdruglistamongstotherpolicyinterventions.Further,NAFDAC
havebeenempoweredtoleadanddrivetheprocessbyits�ightagainstfakedrugs
andsupportforaccreditationofWHO-cGMPofNigerianPharmaceuticalIndustries.
Inrecentyears,theNigerianPharmaceuticalIndustryhasdemonstratedthe
capacitytoproducesafe,ef�icacious,andqualitymedicines.ThePharmaIndustry
havetakenproactivestepsandhasinvestedoverN70btowardsInternational
certi�icationsandfacilitiesupgradein5years.WiththesupportofNAFDAC,UNIDO,
andWHO,fourcompanieshaveWHO-cGMPcerti�icatewithsevenmoreinthe
pipeline.TherehasbeenaslightshiftintheR&Demphasisfromimitativeto
innovativeR&Dandanincreasedcompetenceinadvanceprocessengineering.
Despitethesehugeinvestments,thecountrystillimportessentialmedicines
contrarytotheNationalDrugPolicyandcapacityutilizationisbelow50%.
Healthcare Management Review Vol 8/Page 16
Consideringthehighriskofimport-dependency,thereisneedtoconsolidate
thegainsofthelast10yearsbyre-exammingandre-enforcingallaspectsof
governmentpolicies,�inancinginterventions,incentives,andsustainsupport
forinternationalcerti�ication(WHO-cGMP)andfacilitiesupgrade.Togivethe
localentrepreneuracompetitiveedge,weshouldfocusonprotection,
adherencetoprocurementpolicies,delayinpayments,packagingofSMEsand
theroleofcapitalmarketinventurecapital.Thereisneedtoadaptproduct
developmenttorecentoperatingenvironmentwithcompetenciesinresource
optimizationandencourageBlueOceanPhilosophyforthosetryingtogeta
stepaheadofthecompetitionthroughvalueinnovation.
Oneimportantcomponentofafunctioninghealthsystemisanappropriate
medicinemanagementcycleandgooddistributionpracticewhichwillensure
uninterruptedsupplyofessentialmedicines.Groupdistributionshouldbe
encouragedtoensureoptimizationofresources.
CriticaltothesuccessofDrugSecurityistherecognitionthatthe
pharmaceuticalmanufacturingsysteminvolvesabroadarrayofplayersand
thatstrengtheningthedifferentcomponentrequiresabroadrangeof
expertise.Consequently,theneedforcollaborationbetweenpartiesisof
paramountimportance.Inviewofthis,buildingaconsortiumofpartnersis
recommended.
Together,wehavetomidwifethebirthofanewPharmaceuticalIndustry.
Emmanuel C. Abolo
Editor-in-Chief
Healthcare Management Review Vol 8/Page 17
espitegovernmenteffortstopromoteDdomesticmanufacturing,Nigeria
remainsheavilyreliantonimported
pharmaceuticals.TherevisedNationalDrug
Policy(NDP),setatargetfor70%(involume)
ofthecountry's'demandformedicinestobe
metbylocaldrugmanufacturersby2008.
Consequently,governmentpolicieswere
designedtosupportlocalproductionof
essentialmedicinesinaccordancewiththe
NDP.
Thepharmaceuticalmanufacturingsector
hasexperiencedasteadyannualgrowthof10
–15percentsince2001(IFC).Furthermore,
�ivelocaldrugmanufacturershaveWHO-
cGMPandmanymoreareupgradingtheir
facilitiestocomplywithWHOpre-
quali�icationandWHO-cGMPrequirements.
Thiswillenablethecompaniespromotethe
medicinesmanufacturedlocallyinNigeriato
ECOWAScountriesandbeyond.Inaddition,
oncepre-quali�ied,localmanufacturerswill
beabletoparticipateinInternational
procurementtenderscalledbyInternational
developmentpartners.Consequently,the70
percenttargetsetbytheNationalDrugPolicy
shouldbeachievedby2020.
AccordingtoasurveybyUNIDO,capacity
utilizationwithinthesectorinNigeriais
about40percent,meaningthatthereisa
largevolumeofunderutilizedmanufacturing
capacitywhichcouldbeappliedtoproduce
newproductsupondemand.
70%70%
Healthcare Management Review Vol 8/Page 19
OPPORTUNITIES FOR LOCAL PHARMACEUTICAL
PRODUCTION TO ACHIEVE 70% (VOLUME) OF
NIGERIAN MARKET.
- Thestrongdemandandtheneedforimproved
managementofinfectiousdiseaseespecially,
HIV/AIDs,Malaria,TB,andNeglectedchildhood
disease.
- Increasedresearchanddevelopmenteffortsat
theNationalInstituteforPharmaceutical
ResearchandDevelopment(NIPRD)and
NationalUniversitiescanleadtotheemergence
ofnewtherapeuticagents,nutraceuticalsand
phytomedicinesfromNigeria'sabundant
indigenousbiodiversityandtraditional
medicines.
- PositiveEconomicgrowthinrecentyearsand
macroeconomicstabilityarehelpingtoreduce
povertyandincreasepurchasingpower.
- TheincreasingvisibleandactiveNational
AgencyforFoodandDrugAdministrationand
Control(NAFDAC)and,inparticular,its
campaignagainstsubstandardhealthproducts
haveshownapositiveimpactonreducing
counterfeitdrugstrade.
- GovernmentPolicyaimingtoachievelocal
productionof70percentofessentialmedicines.
- Governmentbanonimportsofsomeessential
medicinesforwhichthereisadequatedomestic
capacityandtechnicalskills.
- EstablishmentoftheNationalHealthInsurance
Scheme(NHIS)toprovideuniversalhealthcare
coverage,by2015willprovidefundsforthe
requiredessentialmedicines.
- Thelocalpharmaceuticalindustryhasa
comparativeadvantageinprovidingremedies
forneglectedtropicaldiseases(NTD).
The following milestones when reached, will have a very
positive impact on the pharmaceutical business in Nigeria,
over the next 10 years.
- Improved distribution of medicines.
- Advances in Biotechnology.
- The Harmonization of medicine registration within
ECOWAS.
- WHO certification and prequalification of more
Nigerian pharmaceutical manufacturers.
- Development of pharmaceutical raw materials using
indigenous basic raw materials.
- New phytomedicines developed by NIPRD and
Universities registered by NAFDAC and licensed to
local pharmaceutical companies for commercial
production and global marketing.
The NDP aims at reaching 70 percent local production in drug along with
other goals including the establishment of an effective drug procurement
system, developing an efficient drug distribution system, the
harmonization of drug legislation with ECOWAS sub region and the
commitment to the national use of medicines at all levels of health care.
Healthcare Management Review Vol 8/Page 21
1. The Pharmaceutical Industry be designated a Strategic Sector and Essential Medicines designated Security Items in Nigeria which should be backed by preferential policies.
2. In view of this Special Status, Pharmaceutical Products and inputs be permitted to access foreign exchange from the Retail Dutch Auction System (RDAS) window to prevent prices of medicines spiralling out of the reach of our people.
3. Ministries, Departments and Agencies to patronize local manufacturers in compliance with Presidential Directives, while the Domestic Preference Policy of the Public Procurement Act 2007 be fully implemented and prompt payments effected.
Credit: PMG-MAN
Healthcare Management Review Vol 8/Page 22
THE STRATEGIC
ANCHORS FOR
DRUG SECURITY 4. There is need to encourage investment in the pharmaceutical sector
through the implementation of extant incentives such as Grants, Pioneer Status, Tax Holidays and affordable funding from Developmental Banks.
5. There is need for Special Incentives for Research and Development in the Pharmaceutical Sector as well as Special Tari ffWaivers & Concessions for specialized machinery and equipment for quality improvements and upgrades such as Air Handling Units, Clean Room Items and speciality chemicals for flooring.
6. There is an urgent need to protect the Nigerian Pharmaceutical Industry within the implementation of the ECOWAS Common External Tari ff(CET) through appropriate levies on products that local Industry produce in sufficient quantities and are therefore placed on Import Prohibition List in Nigeria.
Healthcare Management Review Vol 8/Page 23
Providingadequatehealthcaretotheir
populationremainsamajor
challengeforgovernmentsinAfricaand
Nigeriainparticular.Unsatisfactoryand
inadequateaccesstoessentialdrugsand
otherhealthcarecommoditiesisakey
limitationthatimpactsonpeople'shealth
inmostdevelopingandleastdeveloped
countries(LDCs).Theincreasedfunds
nowavailablefortheprocurementof
medicinestotreatthethreepandemics
(HIV/AIDS,Malaria,andTuberculosis)
areveryvaluabledevelopmentandhave
reducedthesufferingandextendedthe
livesofmillionsofpeopleindeveloping
regions.
However,relianceondonorfundsis
clearlynotsustainableinthelongterm
andtherearemanymorediseasesfor
whichpharmaceuticalsarekey
treatmentsandwhichaccesstoquality
medicinesismuchlessadvanced.
Inresponsetotheseconsiderations,local
productionofessentialdrugsisan
importantcomponentofalongterm
solutiontoprovisionofadequate
healthcareindevelopingcountrieslike
Nigeria.
Adequateaccesstodrugsisdependenton
boththeaffordabilityandqualityofthe
products.Unaffordablelowquality
productsarenottheanswereither.
Therefore,anindustrythatproduceshigh
qualitydrugsatcompetitivepricesmust
bethetargetwhendevelopinglocal
manufacturerofpharmaceuticalsin
Nigeria.
Thepharmaceuticalsectorisacomplex
one,involvingmanydifferentstake
holderssuchasmanufacturers
themselves,Nationalregulators,
governmentministries,wholesalersand
others.Developingtheindustryrequire
concertedactionsacrossthesestake
holderstocreatetheenvironmentin
whichthatindustrycan�lourishand
realizeitsfullpotentialasanassetto
economicandsocialdevelopment.An
exampleoftheroleofstakeholderscanbe
seenwithregardstothescourgeof
counterfeitdrugs,whichcausehuge
healthproblemsandalsorepresenta
threattolegitimatemanufacturerswho
effectivelyhavetocompetewiththese
substandardproducts.
GOVERNMENT SHOULD
PROVIDE THE ENVIRONMENT
Healthcare Management Review Vol 8/Page 24
UNIDO SUPPORT
Since 2006, UNIDO, with funding from the
Government of Germany, has been
conducting a project on strengthening the
local production of essential generic drugs
in developed countries including Nigeria.
The objective is to help the pharmaceutical
sectors in developing countries realize
their potential role of acting as a pillar of
public health and contributing to the
economic and social development.
Adequate access to drugs is dependent on both
the affordability and quality of the products.
Unaffordable low quality products are not the
answer either. Therefore, an industry that
produces high quality drugs at competitive
prices must be the target when developing local
manufacturer of pharmaceuticals in Nigeria.
“It is important to manufacture
generic medicines in closer proximity
to where they are actually needed.”
Inthefaceofthesituation,andactionsby,
forexample,regulatorstoreducethe
penetrationofthesecounterfeitproducts
would,aswellasbeingimportantfroma
healthperspective,alsobene�itthelocal
pharmaceuticalindustry.
Furthermore,qualityrequiresupgraded
skillsandequipment,sohowcanhigh
qualitybeproducedataffordableprices?
Thischallengerequiresvarious
governmentministriestoworktogether
toestablishthesupporttotheindustry
thatwillenableef�icientlocalcompanies
toinvestinhighqualityproduction.
However,thosecompaniesthatdoinvest
inupgradingwillneedsomeformof
protectionfromthosethatwishto
produceproductsatalowerstandard.
Consequently,theestablishmentand
enforcementofqualitystandardby
regulatorsisacriticalelementinsolving
theconundrum.
so how can high quality be produced at affordable prices?
Healthcare Management Review Vol 8/Page 25
uringthelastdecade,promotingsustainableDaccesstoqualityandaffordablemedicines
andintegratinglocalproductionaspartofthe
overallhealthsystemstrengtheningpackaging
hasbeenofsigni�icantconcerntoNigeriaand
Africaingeneral.Aviablepharmaceutical
industryinNigeriashallnotonlyimpactonthe
Nigeriahealthsystemanditscapacitytoprovide
medicalproductsofprioritytodiseasesof
HIV/Aids,Malaria,TB,andNeglectedtropical
diseasebutwillalsocontributetotheoverall
socioeconomicdevelopmentofthesubregion.
Thepublicsectorwillbene�itfromimproved
securityofsupplyandrobustregulatoryoversight
(feasibleduetoproximityofproduction)aswell
asprovidingabasisfromwhichnovel
formulationsandnewproductscanbedeveloped
totacklespeci�icdiseasesandtreatment
challengesthatarepeculiartothenation.Asthe
global�inancedeepens,thesectorwillprovidethe
basisforsustainabletreatmentprogramsas
contributionsthatdonorsmakeplateausoreven
beginstodiminish.Thesectorcanalsomakea
contributiontoeconomicgrowththrough
enhancedexports,andreducedrelianceon
importsonwhichwehavelimitedregulatoryover
sight.
For this reason, the Federal Government of Nigeria
have to be committed to enhancing one of the set thtargets of the 8 millennium development goals, to
increase the proportion of the population with
access to affordable essential drugs on a
sustainable basis. There is need to galvanize the
necessary political will and provide “Leadership” to
the broad range of processes required for
strengthening the ability to produce high quality
and essential medicines, to improve health
outcomes.
IndevelopingcountriessuchasIndiaandChina,
wherethereare�lourishingpharmaceutical
sectors,theindustryisreputedtobene�itfroma
numberofpolicymeasuresincludingprotection
throughtariffregimesandprocurement
preferencesaswellasdirectsupportsuchas
interestsubsidies,exportcredit,cheaputilities,
workingcredits,andtaxholidays.Consequently
importstoourcountryhaveoftenbeen
subsidizedthroughsigni�icantsupportfromtheir
respectivegovernments.
WhiletheFederalGovernmenthaveidenti�iedthe
importanceofstrengtheningthelocal
manufacturingsector,thereisoftenpolicy
incoherenceacrossgovernmentministries.This
createsanoverallenvironmentthatisnot
conducivetothedevelopmentofour
pharmaceuticalindustry.
Furthermore,thereistheneedtoimprovethe
qualityofproductstowhichourpeopleare
exposedacrosstheEssentialMedicineList(EML).
Theimpactofsubstandardproductionwillbe
mitigatedthroughensuringthatcriticalproducts
thatwouldhaveseriouspublichealth
consequencesshouldtheybeofunsatisfactory
qualityareonlymanufacturedbythoseofour
companiesthathavereachedcertainrequisite
standard.
Toimprovetheeffectivenessofourresource
constrainedregulatorstooverseethesupplyof
products,thegovernmentshouldencourage
productionofhighqualitydrugsinsitu.The
qualitystandardstowhichpharmaceutical
manufacturersadhere,varysigni�icantly.We
haveexamplesofcompaniesthathavereached
WHO-cGMP,someareintheprocesses,while
manymorewillliketohavetheInternational
standard,theyhavenotbeenabletoaccessthe
detailedtechnicalknow-howorinvestment
neededtoprogresstowardsthismark.
Increase the proportion of the population with access to
affordable essential drugs on a sustainable basis
Healthcare Management Review Vol 8/Page 26
However,thereareentitiesthatarehappywith
NAFDACcerti�icationandwillcontinuewiththe
currentstatus.
Theindustrydoesfaceseriouschallengesifitis
toachieveandmaintainthequalitythatis
required.Thesechallengesincludelimited
accessto�inance,limitedavailabilityofskilled
humanresources,inabilitytoaccessdetailed
know-hownecessarytoimplementanup
gradingprogramordesignnewplant,signi�icant
costsinvolvedintheproperdevelopmentofnew
products,theaforementionedpolicy
incoherence,andunderdevelopedsupporting
industry.
Thequalityofpharmaceuticalisafunctionof
manydimensions.Followingproduction,the
regulationplaysakeyroleinensuringthatthe
productreachesthepatientinappropriate
conditionthroughoversightofgood
distributionsandwholesellingpractice.A
furtherpostproductionfunctionoftheregulator
isoverseeingthemarketthroughpharmaco-
vigillanceactivitiesandtheestablishmentof
adverseeventreportingmechanisms.
Thisisrequiredtoidentifyinstancesofsub
standardproductsreachingthemarketsothat
productrecallscanberapidlyenactedand
counterfeitproductsidenti�iedandremoved
fromthemarket.
Inadditiontothechallengesfacedbythe
industry,thereisunderutilizedopportunitiesto
assistandpromotethedevelopmentof
pharmaceuticalmanufacturersinNigeriaandfor
ittocontributetoimprovedpublichealth
outcomes.Forexample,theTradeRelated
AspectsofIntellectualPropertyRights(TRIPS)
�lexibilitieshavebeenunderutilized.
Keytothesustainabilityofmanufacturingin
Nigeriaisthedegreetowhichourmanufacturers
cancompetewithimports.Aspointedout,
remedyingthepolicyincoherencewillgosome
waytoimprovingcompetitivenessandachieving
ef�icientproductionbyusingmodernproduction
managementtechniquesthathasthecapacityto
increasecapacityutilizationofplants.
Criticaltothesuccessofdrugsecurityisthe
recognitionthatthepharmaceutical
manufacturingsysteminvolvesabroadarrayof
playersandthatstrengtheningthedifferent
componentsrequiresabroadrangeofexpertise.
Consequently,theneedforcollaboration
betweendifferentpartiesisofparamount
importance.Inthisview,buildingaconsortium
ofpartiesisrecommended.
The quality of pharmaceutical is a function of many dimensions. Following
production, the regulation plays a key role in ensuring that the product
reaches the patient in appropriate condition through oversight of good
distributions and whole selling practice. A further post production function
of the regulator is overseeing the market through pharmacovigillance
activities and the establishment of adverse event reporting mechanisms.
Healthcare Management Review Vol 8/Page 27