Welcome to Procurement & Supply Management Session Krishan Batra UNDP, New York.
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Transcript of Welcome to Procurement & Supply Management Session Krishan Batra UNDP, New York.
Welcome
to
Procurement & Supply Management Session
Krishan Batra
UNDP, New York
Learning Objectives: UNDP Procurement: An Overview Sharing UNDP’s Experience Understanding Supply Chain Sourcing of Suppliers Quality Assurance (Right Quality) Warehousing and distribution
UNDP Procurement: Procurement in 2004: $1215 million Global Fund Procurement: $ 150 m UNDP as a PR in 27 country offices:
$600M 80% of GF fund is for procuring goods
and rest for services Areas covered: GF(HIV/AIDS, Malaria,
TB), Good Governance, Poverty Eradication, Environment, Gender etc.
Major Challenges: Developing generic specifications Quality requirements (Right Quality) Supply Sources: Shortlist Ensuring multiple choices Delivery not reliable Stocking (Warehousing) Distribution Network Concept of PR, SR & PA Legal Implication (Generic Drugs)
ROLE OF PR: Procure medicine that appear in the treatment
guidelines or essential list of WHO PR is responsible & accountable to GF for results Monitor forecast with actual consumption to
ensure continuous availability Procurement should adhere to good
procurement practices Appropriate product at lowest possible price
(Avoid wastage of resources) Tender Documents should list drugs by generic
name
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)
Procurement Agent: PAIF should cover:
General Information Personnel Pre-qualification Purchasing Storage Quality Control Distribution, complaints, Product
Recall
Procurement Agent: Procurement Process in accordance with
International Practices Concern for Intellectual Property Rights &
National Laws Procurement Methods: ICB, NCP, LIB,CP,DP UN Organization, Government Body &
International Procurement Agency Payment Terms, Terms & Conditions, QA
Methods, Skill Sets, Scope of Insurance and the rate, Shipping and custom clearance, Tracking PO
Transfer of risks
Implementer/ Provider:
PR
SUB-RECEPIENTPROCUREMENT
AGENTSUPPLIER
Approved PA: LTAs ARVs: UNICEF, IDA Test Kits HIV: UNICEF, WHO, IDA Test Kits STI: UNICEF, IDA Condoms: UNFPA, Basic Essential Drugs: WHO, IDA, TB drugs: GDF, IDA, IAPSO, WHO,
UNICEF Antimalarial Drugs: IDA, UNICEF Lab. Equipment: IAPSO, WHO, UNICEF Vehicles, IT etc.: IAPSO
Supply Mangement:Phases Product Planning
Selection of Products Forecasting and quantification of need
Product Procurement (Perception that this is placing PO only-an Admin. Function)
Identification of Sources Assurance of Quality Purchasing
Product Use and Monitoring Receipt Distribution to end users (Logistics) Rational use and monitoring
Supply Chain: Product Selection Sourcing
Pre-Qualification Tendering
Vendor Evaluation, Reliability, Capacity, Compliance
Evaluation of Offers Production:
GMP audit, Inspection, Sampling, Testing/Analysis
Supply Chain: Transport
Shipping Documents, Insurance, Shipping Terms, Inspection, Sampling, Testing
Storage GMP Audit, Inspection, Sampling, Testing/
Analysis, Warehousing Conditions Distribution/ Dispensing
GDP, Counselling, Advising Patients ( Computerised dispensing System etc, Register
M&E
Writing Specifications: Functional Specification Performance Specification Design Specification Brand or Trade Name Samples
Quality Assurance: GDP: It is that part of quality assurance which
ensures that quality levels are maintained throughout distribution network
Official Inspection & quality control lab.: They verify the compliance of Pharmaceutical product & manufacturing process
WHO Certification : Provides independent info ISO Standards: Product Standards European Norms: EN 29000 CEN : Quality Standard (CE Symbol) 5 years Warranty & availability of spare parts Random samples for testing
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 measures Pharmacopoeias: 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):
Quality Assurance/ QC: Qualification Manufacturer
Check GMP certificate,GMP audit by Pharmacist, Check Mfg. License
Qualification Product Approval Product Specification, Stability Data, Check
Packing, labeling ISO 9000 Quality Control (By Independent Contract
Lab.): Physical Control of sample per batch, At-random chemical analysis
Compliance with international standards
TRIPS: Trade related Intellectual Property Rights When a new medicine is developed, its inventor is given
a protection “ Patent” to exclude third parties A patent is a government grant Generics may be produced and sold lawfully Least Developing countries are authorized to forgo the
enforcement of patents on pharmaceutical products upto Jan. 2016
Check 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.
TRIPS: Developing Countries Is there ia patent law? Are specific ARVs under patent Are there specific options under national
law? Compulsory Licensing and Government use.
Pay adequate remuneration to patent holder Parallel Importing( National law should allow
the use of “ International Exhaustion” )
Procurement Cycle:
Award Contracts / PO
Contract Management
Performance Rating
REQ
Preparation of Solicitation Documents
Sourcing
Development of Specifications / TOR
Evaluation of Offers
Payment
Bidding
Operational Principles:Good Procurement Efficient & Transparent Management
Separation of key functions Transparency and written procedures
Drug Selection & Quantification Limited to Essential Drugs List Generic description
Financing & Competition Good Financial Mgmt. Competitive Procurement
Supplier Selection & QA Formal Supplier qualification QA programme
Procurement Methods: Open Competitive Bidding Limited Competitive Bidding Direct Contracting ( Single Source) Shopping Factors Affecting the Selection of
Methods Off Patent or On Patent Number of approved & eligible sources Market Situation Contract Value
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 products
Non-Health covers vehicles, office equipments etc
Procurement Process must be Transparent
Non-Health Procurement: Requires less thorough assessment due to
lesser potential health impact Plan should address mechanism of
procurement, Quality Assurance and distribution
Product should conform to ISO/ BS/DIN or National Standards
Suppliers who are ISO 9000 certified should be preferred
Products conforming to Environmental Standards should be preferred
Supplier Selection: Criteria for Pre-Qualification GMP Audit by a qualified Inspector Product Samples are physically inspected Product Samples are tested in an eligible
lab. WHO list of pre-qualified suppliers Stock with Suppliers, Shipping Term (CIF,
DDU etc.) References
Product Selection: General Strength: 100mg, 150 mg, 10mg/ml etc Size: 75g, 100ml Dosage Form: Tablet, Capsule, Syrup, Chew, vial Packing Material: Bottle ( Glass, HDPE, PET)
Blister (Aluminium or PVC) Pack: 10, 100ml Marking Expiry 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
Product Selection: HIV/AIDS Antiretrovirals (ARVs) to reduce MTCT and limit
damage to immune system Drugs for Palliative Care ( Relieve pain,
physical and mental discomfort) Anti-infective agents to treat or prevent
Opportunistic Infections Condoms Lab. Equipment and Supplies Reagents Infrastructure Products: Vehicles, Office
Equipment, PCs,
Commodities for HIV/AIDS:
ARTARV
PALLIATIVECARE
Anti-infective drugs
TREATMENTDrugs and supplies to treat
STIs, OIs, TB
DETECTIONDiagnostic Agents and Lab. Supplies
PREVENTIONCondoms, Lubricants, Gloves and so on
1, Laboratory Infrastructure2. Supply Chain Management3. Client & Community Education.
HIV/AIDS DRUGS: Drugs to prevent Opportunistic
Infections Drugs for palliative and supportive
care ARV for mother to child transmission ARV for treatment of clinical AIDS ARV for HIV patients to prevent AIDS. Drugs to treat OI
HIV/AIDS Commodities: Condoms, HIV test Kits Other Diagnostic test kits such as
for STI, OI Reagents, Gloves, Laboratory
Equipment and supplies Medical Equipment and supplies,
such as syringes, needles Disposal Bins
Laboratory Equipment: Microscopes Automated Analyzers Precision Pipettes Centrifuges Incubators Refrigerators Freezers All equipment require specialized
preventive maintenance and repair
HIV TEST KITS ARV Therapy aims at reducing the plasma viral load by
preventing replication. Antibody Tests such as ELISA , Simple Rapid
Look for antibodies against HIV, It does not detect virus itself. HIV infects white blood cells known as CD4
Virologic 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 specificity Complicated product to manage, Average shelf life is
short (12 months), cold storage Beckman Coulter, Beckton Dickinson, Partec, Dynal
Biotech, Guava, Cavidi
HIV TEST KITS Ancillary Equipment and Supplies
Automated Analyzers Reagents Centifugers, Refrigerators, Test Tube
Racks Timers, Pipettes, Specimen Tube Disinfectents Sharp disposal bins Waste disposal
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.
Mosquito Nets: Specifications Application: For one or two persons or child Material: Cotton, Polyester, Polyethylene,
Nylon, Polypropylene ( Life 2-5 years) Size: 1.95mx1.25mx2m , or 1.95mx1.5mx2m Color: Blue or Green Denier: 100 is minimum Mesh Size: 156 holes/sq.inch Weight: 30 gr/sq.m or 40 gr/ sq.m Treatment: Insecticides treatment is more
important in Africa than in Asia. Net Attachments: Aluminium Rings
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
Malaria Rapid Diagnostic Test: Rapid, accurate and accessible detection of malaria
parasites RDT detects specific antigens (proteins) produced by
malaria parasites Sensitivity is key but could be affected during storage. QA processes after purchase is very important Shelf life 18 months. GMP and ISO 13485-2003 is a standard for medical
devices QA to be built into the budget End user training & Supervision Storage and in country shipping Cool Chain for transport and storage Post-purchase Quality Control testing
Product Selection: TB TB Drugs Microscopes, Slides, Reagents,
Injection supplies, X-ray Machines and Consumables, Lab. Equipments
Non-Health Products such as vehicles, Office Equipment, PCs etc.
Insecticides: Insecticides for Impregnation
Alphacypermethrin, Cyfluthrin, Deltamethrin, lambda-cyhalothrin…….
Insecticides for outdoor spraying Insecticides for indoor spraying Insecticides for larviciding Spraying System
Additional Goods & Services Storage Place ( Central Warehouse, Regional
Warehouse) Distribution Trucks Cold Chain/ Refrigerators Inventory Management System Tracking System Power Generators, PCs, Solar System Logistical Experts, Warehouse Experts Training Services, Operational Manual including
Financial System Maintenance of QA/QC, Training Lab. Personnel Monitoring Equipment for side effects, Drug Resistance Consultants to prepare the requirements
Calculating Procurement Qty Average Monthly Use (AM) Procurement Period ( Time between
Orders) Lead Time ( Months to receive drugs ) Stock In Inventory Safety Stock = AM*LT Maximum Stock Level: SS+ AM*PP Quantity to Order: Max. Level-stock in
Inventory-Stock on order
Supply Cycle:
PROCURE
USE
SELECTION
DISTRIBUTE
(EFFECTIVE & EFFICIENTSYSTEM RIGHT UPTOPOINT OF USE)
(VALUE FOR MONEY)
(CHOICE)
(RATIONALPRESCRIPTIONPREVENT WASTAGE)
MANAGEMENT SYSTEMPOLICY & LEGAL FRAMEWORK
Tasks of the Supply Chain
ESTIMATE NEEDS REVIEW SELECTION DETERMINE QTY.
RECONCILENEEDS & FUNDS
CHOOSE PROC.METHOD
SUPPLY SOURCING
CONTRACT MANAGEMENT
RECEIPT& QC
DISTRIBUTION
INSPECTION
Collect Consumption Info.
AWARD CONTRACT
Learning Objectives: UNDP Procurement: An Overview & Challenges
Supplier Selection & Procurement Agent Product Procurement (Health & Non-Health) TRIP & Procurment of Generic ARV Quality Assurance Receipt & Storage (Inventory Management) Distribution Shipping & Insurance Preparing Procurement Plan
Note: nearly 80% of the GF money will be spent on procurement of products