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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


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%


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.


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


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.


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


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?


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


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.


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