Pharmaceutical Policy in Countries with Developing Healthcare Systems
Pharmaceutical Policy and the Right to HealthPharmaceutical Production and SupplyAccess to Affordable DrugsConclusionReferencesI Low and Lower Middle Income Countries Pharmaceutical Policy in the East African Community: Burundi, Kenya, Uganda, Rwanda, TanzaniaBackgroundFocus of This ChapterHealth System of the EAC (Health System and Health Indicators)Pharmaceutical Situation of the EACEAC Medicines Policy, Legislative and Regulatory EnvironmentConclusions: Summary and Way ForwardReferencesPharmaceutical Policy in PakistanPakistanCountry ProfileHealth System of PakistanHealth SystemHealth IndicatorsPharmaceutical Situation of the CountryPharmaceutical Industry and Key StatisticsCountry’s Regulatory EnvironmentMedicines Regulatory AuthorityQuality ControlPharmacovigilanceCounterfeit MedicinesMedicines Supply SystemProcurementDistributionMedicines FinancingMedicines Expenditures in GeneralMedicines PricingAffordabilityGeneric MedicinesMedicines Use (Issues Impacting on Rationale Medicines Use in the Country)Medicines Use in General (in Community Pharmacies, Dispensing Doctors and General Hospital Sector)Essential Medicine List, Selection of Essential Medicines and Standard Treatment GuidelinesPrescribing Behaviour in General (Factors Affecting Prescribing Behaviour)Medicines’ Promotional PracticesThe Role of Pharmacist in Community and Hospital EnvironmentsMedicines Use Research (Including Drug Utilization Evaluation Research)Summary and Future DirectionReferencesPharmaceutical Policy in the PhilippinesThe Philippines Health SystemHealth System of PhilippinesHealth IndicatorsThe Philippines Pharmaceutical SectorPharmaceutical Regulation in the PhilippinesQuality ControlPharmacovigilanceSubstandard and Counterfeit MedicinesMedicines Supply System in the PhilippinesThe Medicines Supply SystemMedicines FinancingMedicine PricingPrice MonitoringMedicines AccessMedicines Access Programs of the DOHIndustry Patient Assistance ProgrammesGeneric MedicinesMedicines UseMedicines Use in GeneralEssential Medicines and Standard Treatment GuidelinesPharmacoeconomicsPrescribing BehaviourMedicines Promotional PracticesRole of PharmacistPharmaceutical Care Interventions and Assessment of Community Pharmacy PracticeMedicines Use ResearchConclusions and Way ForwardReferencesPharmaceutical Policy in VietnamIntroductionVietnam Health SystemThe Pharmaceutical SituationRegulatory EnvironmentMedicines Regulatory AuthorityQuality ControlPharmacovigilanceCounterfeit MedicinesMedicines Supply SystemMedicines FinancingMedicines Expenditures in GeneralPharmacoeconomics, Medicines Pricing, and AccessGeneric MedicinesMedicines UseMedicines Use in GeneralEssential Medicine List, Selection of Essential Medicines, and Standard Treatment GuidelinesPrescribing Behavior in GeneralMedicines Promotional PracticesRole of PharmacistPharmaceutical Care Interventions and Assessment of Community Pharmacy PracticeMedicines Use ResearchSummary and Way ForwardReferencesII Upper Middle Income CountriesPharmaceutical Policy in ArgentinaThe Health System of the Country (Health System and Health Indicators)Pharmaceutical Situation of the Country (Key Statistics, Pharmaceutical Industry, Import-Export Trade)Regulatory Environment of the CountryMedicines Regulatory AuthorityMarketing AuthorizationIntellectual PropertyManufacturing and Quality ControlClinical TrialsPharmacovigilance and Postmarketing SurveillanceCounterfeit MedicinesMedicines Supply System and FinancingMedicines Use (Issues Impacting the Rational Use of Medicines in the Country)Promotion of Generic Medicines UseSelection of Essential MedicinesMeasures to Promote Rational Use of MedicinesMedicines Advertising and PromotionPharmacist’s RoleResearch on Medicine UseConclusionReferencesPharmaceutical Policy in BrazilBrazil’s Health SystemHealth Workforce and Public Health Services Infrastructure in BrazilBrazil’s Pharmaceutical SystemIndustrial Policy for MedicinesBrazil’s Pharmaceutical MarketBrazil’s Regulatory EnvironmentMedicine Pricing in BrazilPharmaceutical Patents in BrazilFalsified or Substandard MedicinesPharmacovigilanceMedicines Financing and Supply SystemThe Popular Pharmacy ProgramOut-of-Pocket Expenditures on MedicinesMedicines Use IssuesConclusions: Summary and the Way ForwardReferencesPharmaceutical Policy in BulgariaBulgarian Health System and ContextThe Bulgarian Pharmaceutical MarketRegulatory FrameworkMedicines PricingDrug Selection and the Positive Drug ListLevels of Reimbursement and Patient Out-of-Pocket CostsProcurement and PaymentDistribution and Supply ChainPromotion, Prescribing, Dispensing, and Rational Use of MedicinesConclusionsReferencesPharmaceutical Policy in ChinaChina’s Health SystemChina Health ProfileChina Health ReformInsuranceBasic medical and health services systemEssential public health servicesPublic hospital reformEssential medicinesPharmaceutical Situation of the Country (Key Statistics, Pharmaceutical Industry, Trade Import Export)Country’s Regulatory EnvironmentMedicines Regulatory AuthorityQuality ControlPharmacovigilanceCounterfeit MedicinesMedicines Supply System (Procurement, Distribution, Etc.)Medicines FinancingMedicines Expenditures in GeneralPharmacoeconomics, Medicines Pricing and AccessGeneric MedicinesMedicines Use (Issues Impacting on Rationale Medicines Use in the Country)Medicines Use in General (In Community Pharmacies, Dispensing Doctors, and General Hospital Sector)Essential Medicine List, Selection of Essential Medicines, and Standard Treatment GuidelinesPrescribing Behavior in General (Factors Affecting Prescribing Behavior)Medicines Promotional PracticesRole of PharmacistPharmaceutical Care Interventions and Assessment of Community Pharmacy PracticeEnactment of the Chinese Pharmacist LawDevelopment of the pharmacy workforceIncreasing public awareness of pharmacistsPharmacy services reimbursementConclusions: Summary and Way ForwardReferencesPharmaceutical Policy in ColombiaGeneral ContextHealth in Social Protection: The Policy ContextPharmaceutical Policy ContextPharmaceutical Market and IndustryMedicines Regulatory EnvironmentMedicines Regulatory AuthorityGood Clinical PracticesMedicines LicensingQuality ControlPharmacovigilanceGeneric MedicinesPatents and Data ExclusivityMedicines Supply System and Pharmaceutical ServicesInstitutional SectorMedicines Managed by GovernmentMedicines Under Special ControlPrivate SectorMedicines FinancingMedicines PricingRational Medicines UseFinal ConsiderationsReferencesPharmaceutical Policy in EcuadorHealth System of the CountryPharmaceutical Situation of the CountryPharmaceutical Industry in EcuadorMedicines Regulatory AuthorityQuality ControlPharmacovigilanceFalsified MedicinesMedicines Supply SystemMedicines Affordability and FinancingMedicines Expenditures in GeneralPharmacoeconomicsThe Regulation of Medicines Prices in the Private SectorMedicines UseMedicines Use in GeneralNational Essential Medicines List (NEML)Factors Affecting Prescribing Behavior and Medicines Promotional PracticesRole of PharmacistChallengesConclusionReferencesPharmaceutical Policy in JordanCountry ProfilePopulation Numbers and CompositionHealth System of Jordan (Health System and Health Indicators)The Impact of Syrian Refugees on the Health Sector in JordanHealth Services Provided to Syrian RefugeesThe Impact of the Syrian Refugees on the Health SectorHealth Indicators in Jordan After the Syrian CrisisPharmaceutical Situation of Jordan’s Pharmaceutical Industry( Key Statistics, Pharmaceutical Industry, Trade Import Export)Jordan’s Regulatory EnvironmentPharmaceutical Regulation in JordanPharmacovigilanceRole of Pharmacovigilance in JordanCounterfeit MedicinesMedicines Supply System (Procurement and Distribution)The Supply and Distribution of Essential Medicines in JordanMedicines FinancingSpending on MedicinePharmaceutical Pricing Policy in JordanOriginator Brand Pricing in JordanLocally Manufactured Generic Medicines PricingImported Generic Medicines PricingPricing Decision MakingCalculation of the Public Price for DrugsJordan Medicine Prices ProblemReasons for Unaffordable Medicine Prices in JordanDrug Store (Wholesaler) MarginBonus Practices in the Jordanian Pharmaceutical MarketMedicines Use ( Issues Impacting on Rationale Medicines Use in Jordan)Essential Medicine List, Selection of Essential Medicines and Treatment GuidelinesPrescribing Behaviour (Factors Affecting Prescribing Behaviour)Barriers for Generic Medicine Use in JordanThe Role of the PharmacistConclusions: Summary and Way ForwardReferencesPharmaceutical Policy in RussiaOverview of the Russian FederationThe Health System of the Russian FederationFederal LevelRegional Health CareMunicipal Health Care SystemPrivate Health CareFederal and Regional Insurance FundsInsurance CompaniesThe Pharmaceutical Situation in the Russian FederationThe Regulatory Environment in RussiaMedicines Regulatory AuthorityQuality controlPharmacovigilanceThe Presence of Counterfeit Medicines in the Russian FederationThe Medicines Supply System in the Russian FederationThe Financing of MedicinesPharmacoeconomics, Medicines Pricing, and AccessMarket Access: The Registration ProcessThe Pricing Process in RussiaThe Reimbursement ProcessThe Role of HTA in the Decision-Making ProcessThe Perception of HTA by Health Care Market ParticipantsMultiple Levels of HTA UseHospital LevelAgency LevelGeneric MedicinesRational Medicines UseMedicines Use in GeneralEssential Medicines List, Selection of Essential Medicines, and Standard Treatment GuidelinesPrescribing Behavior and Factors Affecting Prescribing BehaviorMedicines Promotional PracticesThe Role of the Pharmacist in RussiaPharmaceutical Care Interventions (PCI) and Assessment of Community Pharmacy PracticeMedicines Use Research (Including Drug Utilization Evaluation [DUE] Research)Conclusions: Summary and Way ForwardReferencesPharmaceutical Policy in South AfricaIntroductionThe South African Health SystemSouth Africa’s Pharmaceutical SituationInfrastructure and Human ResourcesPharmaceutical Market in South AfricaThe Policy Environment: The National Drug Policy 1996The South African Medicines Regulatory EnvironmentPharmacovigilance in South AfricaMedicines Supply SystemMedicine SelectionMedicines Procurement and DistributionMedicines Financing and PricingMedicines PricingMedicines UseConclusions: Summary and Way ForwardReferencesIII High Income Countries Pharmaceutical Policy in PolandHealth System of the CountryHealth System in PolandNational Health StatusPharmaceutical Situation in PolandOverviewThe Pharmaceutical Industry in PolandPharmaceutical Trade in PolandPolish Regulatory EnvironmentMedicines Regulatory AuthorityQuality Control of MedicinesPharmacovigilanceCounterfeit MedicinesMedicines Supply SystemProcurementDistributionMedicines FinancingMedicine Expenditure in GeneralPharmacoeconomics in PolandMedicines Pricing and AccessThe Generic Medicines Market in PolandMedicines UseIssues Impacting on Rational Medicines Use in PolandMedicines Use in Community PharmaciesMedicines Use in the Hospital SectorStandard Treatment Guidelines and Prescribing BehaviorMedicines Promotional PracticesRole of the PharmacistPharmaceutical Care InterventionsThe Way ForwardSummaryReferencesPharmaceutical Policy in Saudi ArabiaHealthcare System in Saudi ArabiaSaudi Healthcare System: A Brief OverviewHealth System Organization and Provision of HealthcareHealthcare Expenditure and FinancingSaudi Pharmaceutical MarketRegulations and Registration of Medicines in Saudi ArabiaPricing Policy of MedicinesAccess to Healthcare and MedicinesPharmaceutical Procurement and DistributionNational Health Policy FrameworkMedicine Use in Saudi ArabiaEssential Medicines and Standard Treatment GuidelinesUse of Generic MedicinesThe Role of Community Pharmacists in Quality Use of MedicinesDispensing Medicines Without PrescriptionsConclusions and Way ForwardReferencesPharmaceutical Policy in Trinidad and TobagoIntroductionHealth IndicatorsHealth Systems and ServicesHealth Personnel and InfrastructureCountry Regulatory EnvironmentMarketing Authorization/Registration of PharmaceuticalsInspectionImport ControlLicensingQuality ControlMarket ControlMedicines Advertising and PromotionClinical TrialsPharmacovigilanceCounterfeit MedicinesSupply and Distribution in Trinidad and TobagoMedicines FinancingMedicine Expenditure in GeneralPharmacoeconomics, Medicines Pricing, and AccessGeneric MedicinesMedicines UseMedicines Use in GeneralRole of PharmacistSummary and Way ForwardReferencesPharmaceutical Policy in the UAEIntroductionHealth Sector in the UAEPharmaceutical Sector in the UAEUAE Health RegulationMedicine Regulatory Authorities in the UAEMinistry of HealthCouncil for Gulf CooperationDubai Health AuthorityHealth Authority of Abu DhabiQuality ControlPharmacovigilanceCounterfeit Medicines in the UAEMedicines FinancingMedicines PricingMedicines Use in the UAEGeneric PrescribingRational Medicines UseRole of Pharmacist in the UAEConclusionReferencesIV Further Perspectives“Repurposing” Medicines: A Case for Low- and Middle-Income Countries with Developing Healthcare SystemsIntroductionPurpose of ChapterMethodsMedicines Withdrawn from Clinical TrialsGeneric: or Soon-to-Be Generic Medicines- and Their Protein TargetsProtein Targets and Medicines Attacking These Targets“Paragraph IV” Medicines: List of Off-Patent or Soon-to-Be Off Patent Medicines That Generic Manufacturers Think Are ImportantResultsFailed/Withdrawn Medicines in Clinical Trials: Potential Repurposed Medicines?New Uses for Off-Patent (or Soon to Be Off-Patent) Medicines: Paragraph IV CertificationDiscussionLimitations of the AnalysisRepurposing Medicinesfrom Failed Trials: Should We Bother?Repurposing of Generics for LMICs: A Double Edged SwordRecommendationsfor Improving the SituationConclusionsReferencesPharmaceutical Policy in Countries with Developing Healthcare Systems: Synthesis of Country Case StudiesIntroductionOverview: Health SystemHigh-Income CountriesUpper Middle-Income CountriesLower Middle-Income CountriesPharmaceutical/Industrial SystemHigh-Income CountriesUpper Middle-Income CountriesLower Middle-Income CountriesTrade and Public HealthHigh-Income CountriesUpper Middle-Income CountriesLower Middle-Income CountriesRegulation/LegalHigh-Income CountriesUpper Middle-Income CountriesLower Middle-Income CountriesFinancing/PricingHigh-Income CountriesUpper Middle-Income CountriesLower Middle-Income CountriesProcurement/DistributionHigh-Income CountriesUpper Middle-Income CountriesLower Middle-Income CountriesPrescribing/DispensingHigh-Income CountriesUpper Middle-Income CountriesLower Middle-Income CountriesMedicine Use/SelectionHigh-Income CountriesUpper Middle-Income CountriesLower Middle-Income CountriesTransparencyHigh-Income CountriesUpper Middle-Income CountriesLower Middle-Income CountriesConclusions
