Review of Operations Related to Medicines · 2016-06-13 · Review of Operations Related to...
Transcript of Review of Operations Related to Medicines · 2016-06-13 · Review of Operations Related to...
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Review of Operations Related to Medicines
Consultation with Pharmaceutical Manufacturers 25th September 2012
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Organization Structure: Medicines & Nutrition
Centre
Medicines and Nutrition Centre Francisco Blanco
Essential Medicines
David Muhia
HIV/AIDS and Malaria
Medicines
Gitanjali Sakhuja
Nutrition
Jan Komrska
Contracting / Procurement Services
Technical
Programme-Supply Integration
Atieno Ojoo Henrik Nielsen/
Natasa Moracevic Alison Bull
Karin Thomsen
Xiaobing Song
Noura Malaui
Nina Tandrup, Niels Henningsen, Artur Kolesnyk , Belinda Bernkamp
Mariet Elsted , Seema Nielsen, Arlette Makobero, Jes Birk
Josephine McCloskey, Maiken Roland,
Jorgen Kofoed
Celine Bracq
Anna Kistauri Karin Martinussen
Warehouse – MNC Integration
Stine Kragh, Tina Nielsen
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Organization of Presentations
• UNICEF Procurement Process for Pharmaceuticals – David Muhia
• Overview of Procurement of Essential Medicines (non ARV, non Malaria) – David Muhia
• Overview of Procurement of ARVs and anti-malarials – Gitanjali Sakhuja
• Overview of Challenges in Procurement Process – Karin Thomsen
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Tender &
Evaluation
of Offers
Overview of UNICEF’s Procurement Process
for Pharmaceuticals
Establishment
of LTA
to supply
medicines for
1-3 years
Placement
of orders
PO
PO PO
Production
&
Shipment
Country /
WH
inspection
Invoice
payment
Arrival
Report
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Procurement process is governed by UNICEF Financial Rules
and Regulations and includes segregation of duties
REQUIREMENT
DEFINITION SOURCING
PROCUREMENT
METHOD &
SOLICITATION
DOCUMENTS
RECEIPT & OPENING
OF OFFERS
EVALUATION CONTRACTS
REVIEW
COMMITTEE
CONTRACT
MANAGEMENT &
ADMINISTRATION
NEEDS
ASSESSMENT /
PROCUREMENT
PLANNING
DELIVERY
PAYMENT GOODS
RECEIPT
END USER MONITORING
FRR
INVOICE CERTIFICATION AWARD & CONTRACT
FINALIZATION
FRR
FRR
FRR
FRR FRR
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QUALITY
SPEED
Guiding Principles of UNICEF’S Procurement
Process
PRICE
ETHICS
• Integrity • Transparency • Fair competition • Equal Treatment • Value for money • Organizational
Objectives • Healthy market
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Needs assessment/procurement planning
UNICEF SD serves many programmes with different requirements, and needs to plan for these through:
Continuous review of products needed • Essential Medicines List and Treatment Guidelines • Programme priorities • Specific programme needs (e.g. kits) Appropriate procurement strategies • Programme context • Warehousing/Direct delivery Quantification of needs • Specific programme/country needs and procurement
plans • Historical data
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Procurement Methods & Solicitation
documents
Mainly through competitive bidding solicited through;
▫ Request for Quotation (RFQ) ▫ Invitation to Bid (ITB) ▫ Request for Proposal (RFP)
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Common elements of solicitation documents
• Estimate of the quantities / volume required
• Specifications
• Mandatory requirements (Technical and Commercial)
• Evaluation criteria
• Additional terms and conditions
• Requirements for samples
• General Terms and Conditions
These can vary from tender to tender (even for same items) and must be read carefully.
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Evaluation of offers
• Technical Evaluation ▫ Quality: product characteristics and manufacturing GMP
• Commercial Evaluation
▫ Based on technical and QA reports received
▫ ITB “lowest evaluated bid” ▫ RFP “most responsive evaluated proposal”
▫ Based on lowest acceptable offer, including landed cost and
possible discounts for early payment (payment terms), lead times, minimum order quantities, etc.
▫ Considers commercial risks
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Key Criteria for Contract Award
• Quality • Price • Delivery Time / Speed
• Market development
• Supplier past performance
Best value for money
Healthy Market
•The tender outcome is reviewed by an internal independent body (Contracts Review Committee) who recommends approval to SD Director
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Type of Contracts and Agreements
•UNICEF awards contracts (Purchase Orders) or establishes framework agreements (Long Term Agreements or LTAs) under which Purchase Orders are placed.
•LTAs can be time-bound (open quantity) or value targeted (specific quantity). Value targeted LTAs are established when there is confidence in forecast and consideration of multiple awards.
•Duration of LTAs vary from 1 to 3 year, with options for revision and renewal.
Establishment of Long Term Arrangements for supply for 1 to 3 years
Purchase Order
Purchase Order
Purchase Order
Purchase Order
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Contract Management
Key enabling factors:
• Communication • Monitoring (including performance) • Feedback
‘Contract management is the process that enables both parties to a contract to meet their obligations in order to deliver the objectives required from the contract.’
UNICEF values the relation it has with suppliers, and makes a priority the establishing effective processes to manage it.
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Sourcing
• We are open for Business 24 hours – Suppliers
can contact us directly through emails etc
• U.N. roster (UNGM -www.ungm.org)
• Requests for Expressions of Interest (REOIs)
• Market surveys
• Internet
• Sources and Prices
• Contacts made at trade fairs
• Recommendations from other partners
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Ensuring Equal Treatment, no bias and ethics
• Contracting staff are governed by UNICEF Financial Rules and Regulation
• During tender process communication with suppliers is formal in accordance with tender instructions
• Bids/proposals are received and validated by an independent ‘Bid Section’ not Contracting staff
• UNICEF does not accept manufacturers to fund trips, hotels or offer gifts to UNICEF staff
• Business should be conducted during normal working hours
• Meetings should be with minimum two UNICEF staff members
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Overview of Procurement of Essential
Medicines (non ARV, non Malaria)
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Essential Medicines are a critical part of UNICEF
Programmes, Special Projects Kits & Emergencies
Cotrimoxazole
Mebendazole
chewable tablets
Zinc dispersible
tablets
Erythromycin
Amoxicillin
Dispersible tablets
Albendazole
chewable tablets
Oral Rehydration Salt
Sodium lactate
injection
Where is
my
medicine?
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Example of Kits: Malawi Public Health Kit 2012
(18 months project worth $25 millions)
• 35 different medicines
• 20 different medical consumables
• Components from 30 different suppliers
• Cost of 1 kit – about $2000
• Cost of shipment of 1 kit; Copenhagen to Malawi
▫ By Sea - about $125
▫ By Air - about $1000 using optimized charter
• The whole country depends on these kits
• Stock outs are highly visible with negative political consequences
• Delay of components means airlifting kits, disruption of other kit packing projects
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2011 Essential Medicines Sales: 25% by air to
meet emergencies and urgent requests
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Top 10 EM Products by PO Value in 2011
Material Value (Millions)
Sulfameth.+trimeth.(120mg & 480mg) tabs $5.6
ORS $4.7
Amoxicillin Dispersible (125mg & 250mg) Tabs $2.0
Zinc 20mg tablets/PAC-100 $2.0
Erythromycin 250mg tabs/PAC-100 $1.7
Fe(as fum.)+folic 60+0.4mg tab/PAC-1000 $1.7
Albendazole 400mg tabs/PAC-100 $1.7
Amoxici.pdr/oral sus 125mg/5ml/BOT-100ml $1.5
Sulfameth.+trimeth.800+160mg tbs/PAC-100 $1.2
Sodium,lactate inj (500 + 1000ML) $1.1
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Essential Medicines Unit: We mainly procure
medicines in WHO EML & WHO Priority Medicines List
Priority
Medicines
Essential Medicines
Primary Healthcare medicines
Current WHO EML
Current WHO Priority medicines list
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EM Unit 5 Years Annual Procurement Throughput
2011 throughput interrupted by internal activities 2012 (Projection) demand drivers include Malawi MOH, Zimbabwe MOH, Somalia emergency
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Procurement pattern subject to variations due to
peaks in demand (emergencies, urgent projects)
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Forecasting Challenge: Annual Consumption
historical data for ORS, Zinc & Amoxi DT
ORS – main driver emergencies and clear treatment guidelines Zinc DT – erratic demand, absent in many countries treatment guidelines Amoxi DT – New product, alternative for oral suspension, demand expected to grow
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EM Procurement strategies
• Warehouse Replenishment / Kit packing / Direct shipments ▫ Prefers products with shelf lives of at least 3 years
▫ Reasonable lead time
▫ Competitive prices
▫ Previous supplier performance
▫ Minimum order quantity
▫ Establishment of 2- 3 LTAs – more for strategic products such as ORS, Zinc, Amoxi DT
• Emergencies / Urgent projects ▫ Shortened procurement process
▫ Short lead time very important
▫ We accept alternative pack sizes
▫ Competitive prices (landed cost)
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EM Medicines: Future trend; short, medium to
long term
• Flavored ORS – follow the private market
• Smaller sachets of ORS – 0.5 & 0.2 litres
• 20mg Zinc DT (taste masked)
• Co-packaged ORS + Zinc
• 250mg Amoxicillin DT
• 480mg Cotrimoxazole
• Phase out bottles of 1000 tabs, bring in smaller pack sizes
• Country registrations; Ethiopia, Zambia, Uganda
• Mandatory patient leaflets
• Quality local manufacturers
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THANK YOU