den besten day1 - unicef · · 2017-02-03under ads 312: o international producers o regional...

UNICEF/WHO/UNFPA meeting

September 22, 2014

PEPFARImplementing Partner

• Increase the supply of high quality essential medicines in PEPFAR countries

• Meet local registration requirements

• Maximize sustainability

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Three key SCMS objectives


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


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


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

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International and regional wholesalers

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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


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

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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 - - + - - ++ + -


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

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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


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


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


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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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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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

J8 tenses weird here. Should this be past tense?JSI, 17/09/2014


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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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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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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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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Thank you

Questions?

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den besten day1 - unicef · · 2017-02-03under ads 312: o international producers o regional...

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