Transcript Supply solutions for children

Agenda
• Procurement statistics
• Major commodity areas
• Drug Procurement
• Sourcing and Special Procurement
• Supplier Registration and Evaluation
• Case Study
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Procurement
Total Procurement 2000: $502 million.
Offshore: $288 million
Local/Regional: $214 million
Vaccines/Immunization: 40%
Procurement for:
– UNICEF programmes/admin
– Oil for Food Programme - Iraq
– Global Alliance for Vaccines & Immunizaion
– Procurement Services
– Warehouse Replenishment
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Offshore Procurement 2000
(millions of United States Dollars)
Med.Equip.
Education
Other
3%
2%
5%
IT
5%
Ess. Drugs &
nutrition
9%
Transport
14%
Watsan
16%
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Total Procurement
$288 million
Immunization
46%
Receiving Countries
94.5
India 70.9
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Major Commodity areas
 Medical & Hospital Equip.
 Diagnostic Test Kits
 Electrical Equip.
 Office Equip.
 Transport
 Relief Items
 Nutrition Products
 Shelter Material
 Education Equip.
 Pharmaceuticals
 Immun. & Cold Chain
 Water and Sanitation
 Laboratory Equip.
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Summary
• An effective procurement process
should:
– Procure right drugs in right quantities
– Obtain lowest possible purchase price
– Recognized standards of quality
– Timely delivery
– Supplier reliability
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Drug procurement
Procurement of pharmaceuticals differ from
procurement of other commodities because the
effect of receiving and utilizing a
substandard/poor quality product can have
severe consequences in terms of damage to the
consumers health or treatment failure, because
the product does not have the intended effect.
Therefore a number of precautions need to be
taken when buying pharmaceutical products and
these should be followed in a systematic manner.
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Procurement Cycle
Determine
Quantities
Needed
Review
Drug
Selection
Collect
Consumption
Data
Reconcile
Needs and
Funds
Choose
Procurement
Method
Distribute
Drugs
Locate and
Select
Suppliers
Make
Payment
Receive
and
Check drugs
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Monitor
Order
Status
Specify
Contract
Terms
Principles of Good Pharmaceutical
Procurement
• Procurement by generic name;
• Limitation of procurement to the
EDL;
• Procurement in bulk;
• Formal supplier
qualification/monitoring;
• Competitive procurement;
• Sole-source commitment;
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Principles of Good Pharmaceutical
Procurement
• Order quantities based on reliable
estimate of actual need;
• Reliable payment and good financial
management;
• Transparency and written procedure;
• Separation of keys functions;
• Product quality assurance
programme;
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Strategic objectives for drug
procurement
• Procure the most cost-effective drugs
in the right quantities
• Select reliable suppliers complying to
GMP
• Ensure high quality products
• Ensure timely delivery
• Achieve the lowest possible total cost
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Procurement Methods
• Open tender
• Restricted tender
• Competitive negotiation
• Direct procurement
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Special procurement types
• Direct Ordering
• “Contract set up by SD allowing Country
Offices to ”Buy internationally”
• Long Term Agreement
• “Not binding frame agreement setting the
terms and limits for contracts”
• Typically 24 month agreements +
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Drug procurement scenarios
Who are the suppliers?
• Pharmaceutical manufacturers
• Pharmaceutical wholesalers
• International drug supply agencies
Where are they situated?
• Well-regulated countries
• Less well-regulated countries
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Sourcing
• Through direct contacts
• Special catalogues of
manufacturers in a specific
area, eg. drugs
• Through trade missions in
respective embassies
• Exhibitions, fairs
• UN Business Seminars
• Internet
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Important to realize:
Regarding sales and
marketing efforts, all UN
organizations should be
treated as individual
companies, it is not
sufficient to deal with only
one of them and expect
the information to be
replicated automatically to
everyone in the UN family.
Organization of the national procurement
process
Who decide on standards
for product and
production, quantities
etc.
Who will take care of delivery
and distribution and monitor
supplier performance
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Who will prepare invitation
to bid (ITB) and handle the
commercial aspects
Who will adjudicate the bid
and take care of quality
assurance
Supply Division
Organisation
Bidding
RFQ/RFP
Contracts
- DO/LTA
Sourcing
Technical
specifications
Web catalogue
Supplier registration
Supplier evaluation
Inspections
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Organization of the national procurement
process, cont.
• Clear definition (and division) of responsibilities,
authorities, procedures for
– procuring
– selection of drugs
– pre-selection of suppliers
– quantification of needs
– standard-setting
– technical adjudication
– quality assurance
– distribution
to ensure transparent process
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Procure the most cost-effective drugs in the
right quantities most cost
Questions to ask:
• Drug selection - Is there a national list of
essential drugs? Are drugs requested on
this list? If not, why are drugs requested relevance to the pattern of prevalent
diseases?
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Procure the most cost-effective drugs
in the right quantities, cont.
• Quantification of drug requirements - How
many patients can be treated with
requested quantities? Does this tally with
morbidity data or past drug consumption
figures? Can the quantity be used before
expiry?
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Procure the most cost-effective drugs in the
right quantities, cont.
Questions to be asked:
• Product specification - Is it a generic or a
proprietary drug?
Patent situation?
Is drug registration requested?
If it is a generics drug - what quality of product
are we aiming at supplying? Consider finished
product spec.s and quality of active ingredient,
product stability, therapeutic equivalence.
Product specifications must be clear and detailed in
the ITB
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Select reliable suppliers of high quality
products
• What is the advantage of prequalifying suppliers?
– Elimination of sub-standard suppliers
– More efficient adjudication process
What should be considered in a prequalification?
– Production standard (GMP)
– Business viability
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Select reliable suppliers of high quality
products
Who and how to pre-qualify?
• Ask for references
• Inspection of manufacturers
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Request information about
manufacturer
•
What is the link between the supplier and the product?
Marketing authorisation holder?
•
Manufacturer?
Distributor?
What is the regulatory situation in the country of manufacture?
Product currently registered and marketed?
Registered but not
marketed? Product registered for export only? No registration?
•
Regulatory situation in other countries? EU/USA
•
Request certificates:
Certificate of Pharmaceutical Product according to WHO Certification
Scheme
Statement of Licensing status of Pharmaceutical Product according to
WHO certification Scheme
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•
Marketing license
•
Export license
Example of contents of product
specification
•
Name (INN)
•
Dosage form
•
Strength per dosage unit
•
Route of administration
•
Number of units/volume/weight per container
•
Type of container, in certain cases specification
•
Acceptable pharmacopoeias references/ standards
Request the following information
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•
Finished product specification
•
Active pharmaceutical ingredient specification (DMF/CEP)
•
Stability: what testing has the product been subject to?
•
Label and insert information
•
Therapeutic equivalence
Monitor and maintain quality
• Pre- and post shipment inspection
• Analytical drug testing
• Appropriate storage, distribution,
dispensing
• Reporting system for complaints
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Supplier Registration Process
Company Data
Financial Data
References
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Supplier Evaluation
Suppliers are evaluated on their financial
soundness, capacity, quality performance,
technical capability, ability to service their
products in the destination countries.
Preference is to purchase directly from
manufacturers and not from dealers.
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Supplier Evaluation
Certificates of interest:
- Quality system ISO 9000 - BS14000
- Environmental systems
- Social Accountability SA 8000
- CE markings on products
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Group discussion
You receive a request from the Ministry of Health for
purchase of drugs for the national malaria and HIV/AIDS
control programmes. You are given a list of 100 drugs
requested.
• What do you do with this list?
• How do you decide what to purchase and where?
• How do you ensure that the drugs will imported and
distributed smoothly?
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