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Supply Solutions for Children. Agenda. Procurement statistics Major commodity areas Drug Procurement Sourcing and Special Procurement Supplier Registration and Evaluation Case Study. Procurement. Total Procurement 2000: $502 million. Offshore: $288 million
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Supply Solutions for Children
Agenda • Procurement statistics • Major commodity areas • Drug Procurement • Sourcing and Special Procurement • Supplier Registration and Evaluation • Case Study
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
Offshore Procurement 2000(millions of United States Dollars) Total Procurement $288 million
Receiving Countries India 70.9
Medical & Hospital Equip. Electrical Equip. Transport Nutrition Products Education Equip. Immun. & Cold Chain Laboratory Equip. Major Commodity areas • Diagnostic Test Kits • Office Equip. • Relief Items • Shelter Material • Pharmaceuticals • Water and Sanitation
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
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.
Procurement Cycle Determine Quantities Needed Review Drug Selection Reconcile Needs and Funds Collect Consumption Data Choose Procurement Method Distribute Drugs Locate and Select Suppliers Make Payment Specify Contract Terms Receive and Check drugs Monitor Order Status
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;
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;
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
Procurement Methods • Open tender • Restricted tender • Competitive negotiation • Direct procurement
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 + • 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 +
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
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 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 prepare invitation to bid (ITB) and handle the commercial aspects Who will take care of delivery and distribution and monitor supplier performance Who will adjudicate the bid and take care of quality assurance
Contracting Technical Quality Assurance Supply DivisionOrganisation Bidding RFQ/RFP Contracts - DO/LTA Sourcing Technical specifications Web catalogue Supplier registration Supplier evaluation Inspections
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
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?
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?
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
Select reliable suppliers of high quality products • What is the advantage of pre-qualifying suppliers? • Elimination of sub-standard suppliers • More efficient adjudication process What should be considered in a pre-qualification? • Production standard (GMP) • Business viability
Select reliable suppliers of high quality products Who and how to pre-qualify? • Ask for references • Inspection of manufacturers
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 • 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 • 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
Step 3 Supplier Profile Form Step 2 Step 1 Supplier interested UNICEF interested Supplier Registration Process Company Data Financial Data References
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.
Supplier Evaluation Certificates of interest: - Quality system ISO 9000 - BS14000 - Environmental systems - Social Accountability SA 8000 - CE markings on products
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?