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PEPFARImplementing Partner
• Increase the supply of high quality essential medicines in PEPFAR countries
• Meet local registration requirements
• Maximize sustainability
2
Three key SCMS objectives
PEPFARImplementing Partner
Historical perspective
• When the SCMS began, SCMS used two major international wholesalers - Missionpharma and IDA Foundation
• Product registrations were a necessity and often a bottleneck
• Identification and (pre) qualification of local, regional and international producers and regional and local wholesalers were added to the SCMS scope
PEPFARImplementing Partner
Improve product availability
• Due to small volume requirements, sourcing for Essential Medicines has become a bottom up process with product registration and local product demand becoming the driving criteria
• SCMS proceeded to identify additional suppliers meeting WHO GMP or GDP/MQAS and requirements under ADS 312:
o International producers
o Regional producers
o Local producers
o International wholesalers
o Regional and local wholesalers 4
PEPFARImplementing Partner
International producers
International producers – 38 producers approved for EM procurement
• Bangladesh: 1 company, 1 production site • China: 2 companies, 3 different production sites• India: 14 companies, 23 different production sites• Europe: 11 companies, 14 different production sites
Regional producers – 3• Kenya: 2 producers
• Nigeria: 1 producer
Local producers - 5• Tanzania: 1 producer
• Ethiopia: 1 producer
• West Africa: Work in progress on 4 additional producers
5
PEPFARImplementing Partner
International and regional wholesalers
6
International wholesalers - 6• Grade A: 5• Grade B: 1
Regional wholesalers - 7• China: 1, work in progress • Eastern Africa: 1, Grade B
• Eastern / Central Africa: 2, Grade C
• Pan-African: 2• 1 approved active in various Anglophone countries• 1 work in progress active in both Anglophone and Francophone
countries• Pan-Asian: 1, work in progress
PEPFARImplementing Partner
Local wholesalers
Local wholesalers – total 28
• Ethiopia: 5 Grade C wholesalers• Nigeria: 6 Grade C wholesalers, gradualtion for 2 of them work in
progress• Tanzania: 9 Grade C wholesalers• South Africa: 2 Grade C wholesalers• Zambia: 6 Grade C wholesalers, graduation for 2 of them work in
progress
7
PEPFARImplementing Partner
Assessment of various supply options
PriceLead
Time
Access,
Local Representation
Registrations Quality
Breadth
of
Product
Range
Supplier
Mgt
Expand International Wholesalers
O - - - + + ++
Direct through Generic Manufacturers
+ O + + + O - -
African Manufacturers + O/+ O O/+ O + -Pan African Wholesalers O + + ++ - - + +In-Country Solutions O + + + O + -Using RDC’s for EM - - + - - ++ + -
PEPFARImplementing Partner
Implementation
• SCMS expanded the number of international wholesalers used from 2 to 6
• Segment the EM type of orders
• EM scope expanded to include supply chain activities and last mile distribution
• Use of local and regional private producers and distributors by SCMS will encourage GDP quality investments and WHO-PQ applications and support the local economical sustainability agenda
9
PEPFARImplementing Partner
Three types of EM orders
• Supporting implementing partners
• Relatively long lists
• Repetitive, though funding-bound
• Difficult to forecast
• Direct support to MOH/CMS
• Limited number of products
• One-off orders
• Difficult to forecast
• Key OI drugs in large volumes
• Co-trimoxazole, fluconozole, and others 10
PEPFARImplementing Partner
Implementing partner orders
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Challenges• Relatively long lists• Repetitive, funding-bound• Difficult to forecast
Planned approach• Continue to procure through international
wholesalers• Accelerate use of regional and pan-
continental and local wholesalers
PEPFARImplementing Partner
MOH/CMS orders and specific key OI drugs
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Challenges• Limited number of products• One off orders• Difficult to forecast• Co-trimoxazole, fluconozole,etc.
Recommendations• Pool demand and issue RFPs for committed
quantities• Direct procurement from international, regional
and local producers• Accelerate use of regional and pan-continental
and, where possible, local wholesalers
PEPFARImplementing Partner
Quality assurance risk-based approach
• Quality Assurance – Supplier pre-qualification
• Supplier pre-screening visits
• Dossier reviews
• Site inspections
o Wholesalers/distributors – GDP, MQAS
o Manufacturers – WHO GMP, audits conducted if:
– Site not recently inspected/approved by SRA as defined by ADS 312
– Product/site combination has not received WHO PQ
– Product quality trends deem inspection necessary
• Approach, dossier review/litigation or consignment model
• Quality control
• Risk-based sampling methods
• Product Testing
o For one of the African producers the test results changed over time, prior to WHO PQ 35 out of 44 samples failed
o Since WHO PQ all samples from that producer analyzed passed
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PEPFARImplementing Partner
Increase in product availability
Ethiopia case• 310 000 bottles of co-trimoxazole suspension bought locally under
consignment
• Delivery time realized was 6 weeks, 8 –10 weeks shorter compared to international procurement
• Product price was 5% lower compared with international procurement
• Product approved for distribution by local authority
• All 6 batches were tested in a laboratory in Tanzania, all samples did pass and product release was done within one week after sample receipt
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PEPFARImplementing Partner
Increase in product availability (cont.)
PV model• In the beginning of the supply 37 products are made available
though a local approved wholesaler, responsible for consolidation
• 12 products available through a local producer
• 2012, 89 samples taken, 73 analyzed and passed
• 2013, 101 batches sampled, 86 analyzed, 1 failed
• 2014, 30 samples taken, all passed
• Total volume of supplies over $ 400K in two years, distributed to over 250 service delivery points
• All projects that were using the system two years ago are still a customer
• Number of users is still expanding
15
J8
PEPFARImplementing Partner
Using local WHO PQ producers
• Major benefits• Product quality secured through WHO PQ requirements
• Local and or regional product registrations
• Producers seem to have developed a dedicated range, which results in considerably shorter delivery delays
• Prices, as a rule, are in the competitive range, evaluations show prices varying between +14 and -/- 15 % compared to international prices
• Expanding the number of WHO PQ producers supports access to quality products under the SCMS approach
• Universal case• Volume of orders in 2013, $2 million
• Volume of orders in 2014 (8 months), $3.2 million (end of year approximately $ 5 million)
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PEPFARImplementing Partner
Regional & Local Sources
• Universal case (cont)• For specific products APIs that are kept in stock: reducing lead time
to 6-8 weeks, 8 weeks faster than international procurement
• Best value evaluation, including DDU delivery, becomes feasible, as connections in Sub-Saharan Africa have improved dramatically
• 35 out of the SCMS priority 1 sourcing list approved for direct procurement
• The 35 products are registered in various PEPFAR countries, to 80 registrations covered
• 41 product dossiers are under registration in PEPFAR countries
• Other potential sources• WHO PQ’d producers such as QCL Uganda, Varichem Zimbabwe,
Swipha Nigeria
• Producers working on WHO PQ. As an example SCMS audited in Nigeria two additional producers and SCMS scheduled an audit for potential two more Nigerian producers
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PEPFARImplementing Partner
Country strategy
• Transition EM operational procurement activities from PMO to the country, where possible
• Implement country-specific models• Use current experience and identify best country specific solution
o Prime Vendor - Tanzania
o Contract Partner Model (work in progress) - Zambia
o Other activities scheduled in PEPFAR countries such as CI, Haiti , DRC, and others
• Standardize procedures, contracts, oversight
• Use specific country product lists (ET, TZ,ZM,NG,CI)• Country lists vary in length from 10-60 products
• 2 products appear on 5 Country specific lists, four products on 4 country specific lists and, in different strengths metronidazole/ ferrous/albendazole tablets also on 4 country specific lists
• Product specification for the tender market differs from stock available in the private sector
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PEPFARImplementing Partner
Path forward
• Determine how successful strategies used in Ethiopia/Tanzania can be applied to other countries (CI, Haiti, Nigeria, Zambia, and others)
• Apply specific risk mitigation strategies to local private sector contractors
• Optimize SCMS QA tools, for use by regional ISO certified wholesalers, when sub-contracted
• Consider, country by country, additional QA support (where possible in collaboration with national DRAs)
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