Learning Objectives • To review basic principles and methods in the procurement of Anti TB drugs • To review components of the procurement cycle and their importance • To identify the major stakeholders in the procurement of Anti- TB Products in Ethiopia
Procurement of anti-TB pharmaceuticals 2
Procurement of anti-TB pharmaceuticals 3 Definition and Procurement Source Process of obtaining/acquiring supplies and services Three main sources of procurement Purchase (buy) Manufacture in-house (from available materials) Receive donation (in kind) Purchase is by far the commonest source
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Procurement Cycle
Review Product Selection Determine Quantities
Procurement Reconcile Needs and Funds
Collect Consumption Planning information Choose Procurement Method
Distribute products Monitoring Locate and Select Suppliers
Specify Contract Terms
Make Payments
Receive & Check Products Monitor Order Status
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Procurement planning • Considerations in procurement planning Ensuring availability of funds and sources Selecting the most suitable procurement method • Procurement Planning answers the question • What to procure • Which procurement method • How to monitor the procurement activities • Procurement planning is highly influenced by Selection and quantification.
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Principles of a Good Procurement Program The main objective is to satisfy the need of health institutions and/or patients. Principles of Procurement • Value For money • Transparency • No Discrimination • Encourage local Manufacturers Appropriate procurement fulfills the 6th rights Right Quality (product in right condition) Right Quantity Right time Right price Right source Right place Procurement of anti-TB pharmaceuticals 7 Good Procurement Practices
Procurement by generic name
Limited to essential medicines list Bulk purchases (Pooled Procurement) Formal supplier qualification and monitoring Competitive bidding process
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Good Procurement Practices cont… • Order quantities based on reliable estimate of actual need • Reliable payment and good financial management • Transparency and written procedures • Product quality assurance program • prequalification of suppliers, • visual inspection of products when they arrive, • sampling for laboratory testing • Regular reporting on performance • Annual audit with published results
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Commonly used Procurement modalities • Open tender (ICB) • Restricted tendering • Request for quotation (proforma) • Direct procurement (Single source procurement )
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Open tender (ICB)
When there is ample time
Specifications easily understood by all bidders
When there is large number of suppliers
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Restricted tendering
If the Item is produced by limited manufacturers.
When there is limited time and the cost of open tendering is greater
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Request for quotation (Performa)
• is used for low item Values
• an appropriate method only for procuring readily available, off-the-shelf goods or standard specification commodities • For procurement of products which are missed in annual bulk purchase but immediately needed • When there is time constraints and incase of emergency situation. • Specifications easily understood by all bidders.
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Direct procurement (Single source procurement ) • Items with patent monopoly
• When there is no alternative supplier
• When its confirmed that there is one bidder on
repeated tenders
• During Emergency situation.....outbreak, war....stock
outs
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Cautions on Anti- TB medicines Donations TB drugs are the ones needed by the recipient country not those the donor can use as a tax deduction or can dump for another reason Donors must respect authorities’ decisions and support existing government policies Donations must not be of lesser quality Donations must be preceded by effective communication between donor and recipient Source of donation shall be clearly identified
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Sources of Anti –TB products
Global Drug Facility (GDF)
WHO Prequalified Manufacturers
In-house manufacturers
International agencies
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Stakeholders involved in Procurement of Anti-TB Products in Ethiopia
Forecasting & supply planning:
NTP/FMOH coordinated with PFSA and partners Funding: GFATM (Major)/? Procurement: Direct procurement from GDF Procurement by PFSA Quality standard PreQ (WHO..GF List), and National regulatory authorities for QA (FMHACA,…EPHI..)
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Procuring Through the GDF GDF services for first-line Anti-TB drugs Free drug grants—only after country is proven eligible (for countries with no sufficient finances for their medicine needs & lack adequate procurement capacity, including a robust quality assurance system Direct procurement mechanism—country buys drugs Availability of children’s dosages and laboratory diagnostic kits
GDF services for MDR second-line Anti- TB drugs
Procures MDR second-line drugs once the GLC approves a country’s DOTS Plus project to treat drug-resistant TB cases Direct procurement mechanism—country buys drugs with own funds or those of GFATM grants
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Procurement of anti-TB pharmaceuticals 19 Challenges of Anti-TB Products procurement in Ethiopia Delay custom clearance oComplete shipping documents are not coming from GDF Longer lead time by GDF and Other Suppliers beyond the agreement with notification Supply of drugs with short shelf life by GDF Partial Shipment requests from Suppliers Different shelf life of pharmaceuticals in one Anti TB Patient Kit. Limited Manufacturers of Anti TB drugs (SLDs & Streptomycin from FLDs)
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Procurement of ancillary drugs and other supplies
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Procurement of ancillary drugs
• Fund from ….Global Fund /Other Source.
• Procured through PFSA. • Transfer from RDF whenever enough stock is at hand and reimburse budget. • Facilities should provide these ancillary drugs freely to patients and need to have at stock with Anti TB drugs