Presentation on theme: "Procurement & Supply Management Session"— Presentation transcript:
1 Procurement & Supply Management Session WelcometoProcurement & Supply Management SessionKrishan BatraUNDP, New York
2 Learning Objectives: UNDP Procurement: An Overview Sharing UNDP’s ExperienceUnderstanding Supply ChainSourcing of SuppliersQuality Assurance (Right Quality)Warehousing and distribution
3 UNDP Procurement: Procurement in 2004: $1215 million Global Fund Procurement: $ 150 mUNDP as a PR in 27 country offices:$600M80% of GF fund is for procuring goods and rest for servicesAreas covered: GF(HIV/AIDS, Malaria, TB), Good Governance, Poverty Eradication, Environment, Gender etc.
4 Major Challenges: Developing generic specifications Quality requirements (Right Quality)Supply Sources: ShortlistEnsuring multiple choicesDelivery not reliableStocking (Warehousing)Distribution NetworkConcept of PR, SR & PALegal Implication (Generic Drugs)
5 ROLE OF PR:Procure medicine that appear in the treatment guidelines or essential list of WHOPR is responsible & accountable to GF for resultsMonitor forecast with actual consumption to ensure continuous availabilityProcurement should adhere to good procurement practicesAppropriate product at lowest possible price (Avoid wastage of resources)Tender Documents should list drugs by generic name
6 Procurement Agent:Procurement Agency is defined as an organization that is involved in one or more of the following:Pre-qualification, procurement, storage, distribution etc.Interested Procurement Agent should provide detailed info as per Procurement Agency Information File (PAIF)
7 Procurement Agent: PAIF should cover: General Information Personnel Pre-qualificationPurchasingStorageQuality ControlDistribution, complaints, Product Recall
8 Procurement Agent:Procurement Process in accordance with International PracticesConcern for Intellectual Property Rights & National LawsProcurement Methods: ICB, NCP, LIB,CP,DPUN Organization, Government Body & International Procurement AgencyPayment Terms, Terms & Conditions, QA Methods, Skill Sets, Scope of Insurance and the rate, Shipping and custom clearance, Tracking POTransfer of risks
10 Approved PA: LTAs ARVs: UNICEF, IDA Test Kits HIV: UNICEF, WHO, IDA Test Kits STI: UNICEF, IDACondoms: UNFPA,Basic Essential Drugs: WHO, IDA,TB drugs: GDF, IDA, IAPSO, WHO, UNICEFAntimalarial Drugs: IDA, UNICEFLab. Equipment: IAPSO, WHO, UNICEFVehicles, IT etc.: IAPSO
11 Supply Mangement:Phases Product PlanningSelection of ProductsForecasting and quantification of needProduct Procurement (Perception that this is placing PO only-an Admin. Function)Identification of SourcesAssurance of QualityPurchasingProduct Use and MonitoringReceiptDistribution to end users (Logistics)Rational use and monitoring
14 Writing Specifications: Functional SpecificationPerformance SpecificationDesign SpecificationBrand or Trade NameSamples
15 Quality Assurance:GDP: It is that part of quality assurance which ensures that quality levels are maintained throughout distribution networkOfficial Inspection & quality control lab.: They verify the compliance of Pharmaceutical product & manufacturing processWHO Certification : Provides independent infoISO Standards: Product StandardsEuropean Norms: EN 29000CEN : Quality Standard (CE Symbol)5 years Warranty & availability of spare partsRandom samples for testing
16 Quality Assurance:Quality is totality of Characteristics of an entity that bear on its ability to satisfy the stated needs.Health care products need special measuresPharmacopoeias: Provide quality specifications for most commonly used pharmaceutical substances, dosage forms, packing materials etc.GMP ( Good Manufacturing Practices): This establish requirements in respect of premises, equipment, personnel, documentation, quality control etc.GDP (Good Distribution Practices):
17 Quality Assurance/ QC: Qualification ManufacturerCheck GMP certificate,GMP audit by Pharmacist, Check Mfg. LicenseQualification ProductApproval Product Specification, Stability Data, Check Packing, labelingISO 9000Quality Control (By Independent Contract Lab.): Physical Control of sample per batch, At-random chemical analysisCompliance with international standards
18 TRIPS: Trade related Intellectual Property Rights When a new medicine is developed, its inventor is given a protection “ Patent” to exclude third partiesA patent is a government grantGenerics may be produced and sold lawfullyLeast Developing countries are authorized to forgo the enforcement of patents on pharmaceutical products upto Jan. 2016Check if there are patent laws that permits patenting, If no, there is no obstacle. If yes, Check if any ARV patented there, if no there is no obstacle.If ARV patented, Option 1-Compliance has been extended. Option 2 Seek reduced pricing from the patent holder or inform them of buying generic drugs.
19 TRIPS: Developing Countries Is there ia patent law?Are specific ARVs under patentAre there specific options under national law?Compulsory Licensing and Government use. Pay adequate remuneration to patent holderParallel Importing( National law should allow the use of “ International Exhaustion” )
20 Procurement Cycle: REQ Performance Rating Development of Specifications / TORSourcingPaymentPreparation of Solicitation DocumentsContract ManagementAward Contracts / POBiddingEvaluation of Offers
21 Operational Principles:Good Procurement Efficient & Transparent ManagementSeparation of key functionsTransparency and written proceduresDrug Selection & QuantificationLimited to Essential Drugs ListGeneric descriptionFinancing & CompetitionGood Financial Mgmt.Competitive ProcurementSupplier Selection & QAFormal Supplier qualificationQA programme
22 Procurement Methods: Open Competitive Bidding Limited Competitive BiddingDirect Contracting ( Single Source)ShoppingFactors Affecting the Selection of MethodsOff Patent or On PatentNumber of approved & eligible sourcesMarket SituationContract Value
23 Product Procurement: Health & Non- Health Products Health Products include pharmaceutical products, diagnostics technologies and supplies, bed nets, insecticides, sprays against mosquitoes, and prevention (condoms) or lab. Equipments and supportive productsNon-Health covers vehicles, office equipments etcProcurement Process must be Transparent
24 Non-Health Procurement: Requires less thorough assessment due to lesser potential health impactPlan should address mechanism of procurement, Quality Assurance and distributionProduct should conform to ISO/ BS/DIN or National StandardsSuppliers who are ISO 9000 certified should be preferredProducts conforming to Environmental Standards should be preferred
25 Supplier Selection: Criteria for Pre-Qualification GMP Audit by a qualified InspectorProduct Samples are physically inspectedProduct Samples are tested in an eligible lab.WHO list of pre-qualified suppliersStock with Suppliers, Shipping Term (CIF, DDU etc.)References
26 Product Selection: General Strength: 100mg, 150 mg, 10mg/ml etcSize: 75g, 100mlDosage Form: Tablet, Capsule, Syrup, Chew, vialPacking Material: Bottle ( Glass, HDPE, PET) Blister (Aluminium or PVC)Pack: 10, 100mlMarkingExpiry Date: On receipt, the balance expiry period should be 4/5 of the total expiry period if more than 2 years and ¾ if expiry period is 2 yrs or less
27 Product Selection: HIV/AIDS Antiretrovirals (ARVs) to reduce MTCT and limit damage to immune systemDrugs for Palliative Care ( Relieve pain, physical and mental discomfort)Anti-infective agents to treat or prevent Opportunistic InfectionsCondomsLab. Equipment and SuppliesReagentsInfrastructure Products: Vehicles, Office Equipment, PCs,
28 Commodities for HIV/AIDS: 1, Laboratory Infrastructure2. Supply Chain Management3. Client & Community Education.
29 HIV/AIDS DRUGS: Drugs to prevent Opportunistic Infections Drugs for palliative and supportive careARV for mother to child transmissionARV for treatment of clinical AIDSARV for HIV patients to prevent AIDS.Drugs to treat OI
30 HIV/AIDS Commodities: Condoms, HIV test KitsOther Diagnostic test kits such as for STI, OIReagents, Gloves, Laboratory Equipment and suppliesMedical Equipment and supplies, such as syringes, needlesDisposal Bins
32 HIV TEST KITSARV Therapy aims at reducing the plasma viral load by preventing replication.Antibody Tests such as ELISA , Simple RapidLook for antibodies against HIV, It does not detect virus itself. HIV infects white blood cells known as CD4Virologic Test ( Rarely used )Viral Load Assay Test (Number of viral particles) and CD4 (provide an insight to immune system)Evaluated by WHO, 99% Sensitivity and specificityComplicated product to manage, Average shelf life is short (12 months), cold storageBeckman Coulter, Beckton Dickinson, Partec, Dynal Biotech, Guava, Cavidi
33 HIV TEST KITS Ancillary Equipment and Supplies Automated Analyzers ReagentsCentifugers, Refrigerators, Test Tube RacksTimers, Pipettes, Specimen TubeDisinfectentsSharp disposal binsWaste disposal
34 Effect of Genetic Competition: Sample of ARV triple Combination: Stavudine (d4T)+ Lamivudine(3TC)+ Nevirapine (NVP).Lowest Price per year per patient: Originator $11,000 and generic Cipla, Ranbaxy, Aurobindo, Hetero ( $251-$150)Favored Cocktail for AIDS: Mix of nukes AZT + Lamivudine + Non-nuke Efavirenz ( Three in one pill)89% OF PATIENTS after 32 weeks had almost undetectable level of virus in their blood.
35 Mosquito Nets: Specifications Application: For one or two persons or childMaterial: Cotton, Polyester, Polyethylene, Nylon, Polypropylene ( Life 2-5 years)Size: 1.95mx1.25mx2m , or 1.95mx1.5mx2mColor: Blue or GreenDenier: 100 is minimumMesh Size: 156 holes/sq.inchWeight: 30 gr/sq.m or 40 gr/ sq.mTreatment: Insecticides treatment is more important in Africa than in Asia.Net Attachments: Aluminium Rings
36 Anti-malarial Medicines: Growing resistance of Plasmodium falsipaum to current monotherapies such as chloroquine, amodiaquine, sulphaoxine-pyrimethamine.Artemether/ lumenfantrine ( Artemisinin based combination therapy), preferably containing artemisnin derivative.Some Countries have adopted ACTs as second line treatment.Amodiaquine + SP is restricted to W.Africa
37 Malaria Rapid Diagnostic Test: Rapid, accurate and accessible detection of malaria parasitesRDT detects specific antigens (proteins) produced by malaria parasitesSensitivity is key but could be affected during storage.QA processes after purchase is very importantShelf life 18 months.GMP and ISO is a standard for medical devicesQA to be built into the budgetEnd user training & SupervisionStorage and in country shippingCool Chain for transport and storagePost-purchase Quality Control testing
38 Product Selection: TB TB Drugs Microscopes, Slides, Reagents, Injection supplies, X-ray Machines and Consumables, Lab. EquipmentsNon-Health Products such as vehicles, Office Equipment, PCs etc.
39 Insecticides: Insecticides for Impregnation Alphacypermethrin, Cyfluthrin, Deltamethrin, lambda-cyhalothrin…….Insecticides for outdoor sprayingInsecticides for indoor sprayingInsecticides for larvicidingSpraying System
40 Additional Goods & Services Storage Place ( Central Warehouse, Regional Warehouse)Distribution TrucksCold Chain/ RefrigeratorsInventory Management SystemTracking SystemPower Generators, PCs, Solar SystemLogistical Experts, Warehouse ExpertsTraining Services, Operational Manual including Financial SystemMaintenance of QA/QC, Training Lab. PersonnelMonitoring Equipment for side effects, Drug ResistanceConsultants to prepare the requirements
41 Calculating Procurement Qty Average Monthly Use (AM)Procurement Period ( Time between Orders)Lead Time ( Months to receive drugs )Stock In InventorySafety Stock = AM*LTMaximum Stock Level: SS+ AM*PPQuantity to Order: Max. Level-stock in Inventory-Stock on order
42 Supply Cycle: (VALUE FOR MONEY) (CHOICE) MANAGEMENT SYSTEM POLICY & LEGAL FRAMEWORK(RATIONALPRESCRIPTIONPREVENT WASTAGE)(EFFECTIVE & EFFICIENTSYSTEM RIGHT UPTOPOINT OF USE)
43 Tasks of the Supply Chain CollectConsumptionInfo.ESTIMATE NEEDSREVIEW SELECTIONDETERMINE QTY.RECONCILENEEDS & FUNDSDISTRIBUTIONCHOOSE PROC.METHODINSPECTIONRECEIPT& QCCONTRACTMANAGEMENTAWARD CONTRACTSUPPLYSOURCING
44 Learning Objectives: UNDP Procurement: An Overview & Challenges Supplier Selection & Procurement AgentProduct Procurement (Health & Non-Health)TRIP & Procurment of Generic ARVQuality AssuranceReceipt & Storage (Inventory Management)DistributionShipping & InsurancePreparing Procurement PlanNote: nearly 80% of the GF money will be spent on procurement of products