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National Medicines PolicyNational Medicines Policyof Malaysiaof Malaysia

Pharmaceutical Services DivisionMinistry of Health Malaysia

Ministry of Health Malaysia

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Why We Need A Why We Need A NNational ational MMedicines edicines PPolicy?olicy?

A clear and official government statement that defines A clear and official government statement that defines and and prioritisesprioritises the mediumthe medium--to long termto long term--goals set by goals set by the government for the pharmaceutical sectorthe government for the pharmaceutical sector

To present a formal record of aspirations, aims, To present a formal record of aspirations, aims, decisions and commitments of the government and all decisions and commitments of the government and all stakeholders in both public and private sectors to a stakeholders in both public and private sectors to a common goal for the pharmaceutical sectorcommon goal for the pharmaceutical sector

To identify strategies and consolidate efforts to meet the To identify strategies and consolidate efforts to meet the objectives of pharmaceutical sectorobjectives of pharmaceutical sector

To provide a transparent framework for coordinated To provide a transparent framework for coordinated implementation of strategies by stakeholders in the implementation of strategies by stakeholders in the public and private sectorspublic and private sectors

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Global ImplementationGlobal Implementation

Promoted by WHO since 1981 Promoted by WHO since 1981

Based on the Essential Medicines Concept Based on the Essential Medicines Concept

Until 2003, 98 out of 131countries that reported Until 2003, 98 out of 131countries that reported (75%) have official NMP(75%) have official NMP

•• Countries with > 10 years NMPCountries with > 10 years NMP-- 55

•• Countries with < 10 years NMPCountries with < 10 years NMP-- 9393

•• E.g. Australia E.g. Australia –– Official NMP in 2000 Official NMP in 2000 United Kingdom United Kingdom –– In drafting stageIn drafting stage

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Global ImplementationGlobal ImplementationDUNASDUNAS

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Situation in MalaysiaSituation in Malaysia

Existing legislation can provide the Existing legislation can provide the executive power and legal framework for executive power and legal framework for MOH to implement the NMPMOH to implement the NMP

Presence of organizations in MOH to Presence of organizations in MOH to oversee, monitor and administer the oversee, monitor and administer the legislationlegislation

Presence of structural elements crucial for Presence of structural elements crucial for successful implementation of NMPsuccessful implementation of NMP

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National Medicines Policy National Medicines Policy of Malaysiaof Malaysia

Formulation of NMP initiated in 2000Formulation of NMP initiated in 2000Developed through a systematic and Developed through a systematic and consultative processconsultative process•• Assisted by WHO consultancy and fundingAssisted by WHO consultancy and funding•• National MNMP Workshops with stakeholders National MNMP Workshops with stakeholders

in 2001 & 2003in 2001 & 2003Formalization of the MNMP as a government Formalization of the MNMP as a government policy documentpolicy document

Approved by JDPKK, MOH on 14 June 2006Approved by JDPKK, MOH on 14 June 2006Submitted Submitted ‘‘Memorandum Memorandum JemaahJemaah MenteriMenteri’’ for for cabinet endorsement in July 2006cabinet endorsement in July 2006Approved by cabinet on 11 Approved by cabinet on 11 OktoberOktober 20062006

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Objectives of NMPObjectives of NMP

To improve health outcomes of Malaysians To improve health outcomes of Malaysians through:through:

PromotingPromoting equitable accessequitable access to to essential essential medicinesmedicinesEnsuring Ensuring availabilityavailability of of safe, effective and safe, effective and affordable medicines affordable medicines ofof good qualitygood qualityPromotingPromoting quality use of medicines quality use of medicines by by healthcare providers and consumershealthcare providers and consumers

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Components of NMPComponents of NMP

Core Components: Core Components: 1.1. Quality, Safety and Efficacy of Quality, Safety and Efficacy of

DrugsDrugs2.2. Drug AvailabilityDrug Availability3.3. Drug AffordabilityDrug Affordability4.4. Quality Use of DrugsQuality Use of Drugs

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Supporting Components..Supporting Components..1.1. Human Resource DevelopmentHuman Resource Development2.2. Research and DevelopmentResearch and Development3.3. Technical Cooperation with Other Technical Cooperation with Other

Countries and International AgenciesCountries and International Agencies4.4. Management of the National Medicines Management of the National Medicines

PolicyPolicy

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Policy 1:Policy 1:Quality, Safety And Efficacy Quality, Safety And Efficacy

Of DrugsOf Drugs******

Only safe, efficacious and quality Only safe, efficacious and quality drugs that meet approved drugs that meet approved

standards and specifications shall standards and specifications shall be registered and made available be registered and made available

for sale and use in Malaysiafor sale and use in Malaysia

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Policy 1:Policy 1:Quality, Safety And Efficacy Quality, Safety And Efficacy

Of DrugsOf Drugs

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Issues addressed:Issues addressed:Legislation and regulationsLegislation and regulations

DCADCALicensing of PremisesLicensing of Premises

Manufacturers, Importers and Manufacturers, Importers and Wholesalers Wholesalers Retail and dispensing outletsRetail and dispensing outlets

Direct selling of pharmaceuticalsDirect selling of pharmaceuticals1212

Policy 1:Policy 1:Quality, Safety And Efficacy Quality, Safety And Efficacy

Of DrugsOf Drugs

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Issues addressed:Issues addressed:Prescribing of drugsPrescribing of drugsInspectionInspectionMedicines advertisement and promotionMedicines advertisement and promotionIntellectual Property RightsIntellectual Property RightsCounterfeit DrugsCounterfeit Drugs

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Policy 1:Policy 1:Quality, Safety And Efficacy Quality, Safety And Efficacy

Of DrugsOf Drugs

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Issues addressed: Issues addressed: Pharmaceutical quality assurancePharmaceutical quality assurance

Drug RegistrationDrug RegistrationInspectionInspectionQuality ControlQuality ControlPostPost-- Marketing SurveillanceMarketing Surveillance

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Policy 2Policy 2::Drug AvailabilityDrug Availability******

An efficient and integrated drug An efficient and integrated drug management and supply network management and supply network

shall be maintainedshall be maintained

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Policy 2Policy 2::Drug AvailabilityDrug Availability******

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Issues addressed:Issues addressed:Selection of drugs Selection of drugs •• National Essential Drug List (NEDL)National Essential Drug List (NEDL)•• Traditional Medicines Traditional Medicines SupplySupply•• ProcurementProcurement•• Domestic Pharmaceutical ProductionDomestic Pharmaceutical Production•• Distribution, Storage and DisposalDistribution, Storage and Disposal•• Drug supply in emergency situations Drug supply in emergency situations and drug donationsand drug donations

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Policy 3Policy 3::Drug AffordabilityDrug Affordability******

The pharmaceutical industry shall The pharmaceutical industry shall be organized and regulated to be organized and regulated to create incentives and foster create incentives and foster competition in drug prices;competition in drug prices;

Appropriate financing mechanisms Appropriate financing mechanisms shall be developed to ensure shall be developed to ensure

essential drugs needed for quality essential drugs needed for quality healthcare are affordablehealthcare are affordable

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Policy 3Policy 3::Drug AffordabilityDrug Affordability

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Issues addressedIssues addressed ::Price of DrugsPrice of Drugs•• Pricing PolicyPricing Policy•• Price InformationPrice InformationGeneric PoliciesGeneric PoliciesDrug FinancingDrug Financing

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Quality use of drugs by healthcare Quality use of drugs by healthcare providers and consumers shallproviders and consumers shall be be

promoted;promoted;Activities of the government, Activities of the government,

industry and media in support of industry and media in support of informed and appropriate use of informed and appropriate use of

drugs by consumers shall be drugs by consumers shall be encouragedencouraged

Policy 4Policy 4::Quality Use of DrugsQuality Use of Drugs******

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Policy 4Policy 4::Quality Use of DrugsQuality Use of Drugs

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Issues addressedIssues addressed ::Education and TrainingEducation and Training

Healthcare providersHealthcare providersGeneral publicGeneral public

Drug InformationDrug InformationDrugs and Therapeutic CommitteesDrugs and Therapeutic CommitteesStandard Treatment GuidelinesStandard Treatment GuidelinesPrescribing and Dispensing PracticesPrescribing and Dispensing PracticesRole of PharmacistsRole of PharmacistsMedicines Advertisements and PromotionsMedicines Advertisements and Promotions

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Policy 5:Policy 5:Human Resources Human Resources DevelopmentDevelopment******

The human resource of the The human resource of the pharmaceutical sector shall be pharmaceutical sector shall be

planned and developedplanned and developed

Issues addressedIssues addressed ::PlanningPlanningEducation and TrainingEducation and Training

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Policy 6:Policy 6:Research And Research And

DevelopmentDevelopment******Research in utilization, Research in utilization,

management and development management and development of medicines shall be enhancedof medicines shall be enhanced

Issues addressedIssues addressed ::

Drug Utilization and ManagementDrug Utilization and ManagementDrug Research and DevelopmentDrug Research and Development

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Policy 7:Policy 7:Technical Technical CooperationsCooperations******

Technical collaboration and Technical collaboration and coco--operations in the implementation operations in the implementation

and strengthening of relevant and strengthening of relevant areas in the pharmaceutical areas in the pharmaceutical

sectors shall be established with sectors shall be established with various stakeholders at the various stakeholders at the

national, regional and national, regional and international levelsinternational levels

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Policy 7:Policy 7:Technical Technical CooperationsCooperations

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Issues addressed :Issues addressed :

Areas For Technical CoAreas For Technical Co--operationoperation•• Regulatory practices Regulatory practices •• Drug accessibility Drug accessibility •• Quality use of drugsQuality use of drugs•• Training and human resources Training and human resources developmentdevelopment

•• Drug research and developmentDrug research and development

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Policy 8:Policy 8:Management of The National Management of The National

Medicines PolicyMedicines Policy

All stakeholders shall be All stakeholders shall be committed to the successful committed to the successful implementation of the MNMPimplementation of the MNMP

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Policy 8:Policy 8:Management of The National Management of The National

Medicines PolicyMedicines Policy

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Issues addressed:Issues addressed:Every 3Every 3--year Master Action Planyear Master Action Plan

Monitoring Monitoring every every 3 years3 years and and EvaluationEvaluation every every 6 years6 years

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A Successful A Successful Implementation of MNMPImplementation of MNMP

Requires Requires national acceptancenational acceptance, , recognitionrecognition and and commitmentcommitment by by allall stakeholdersstakeholders including the including the

highest political levelhighest political level in order to in order to achieve the goals of the achieve the goals of the pharmaceutical sector in pharmaceutical sector in

MalaysiaMalaysia

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Thank YouThank You