1. UN Prequalification: UNICEF Perspective 5 th UN Prequalification stakeholders meeting 11th February 2009

2. THE ROLE OF UNICEF SUPPLY DIVISION Oversee UNICEF’s global procurement and logistics operation. Procure supplies on behalf of UNICEF and Procurement Services partners Ensure that high quality, good value supplies reach children and their families quickly. Maintain the highest ethical standards for procurement. Provide technical support to UNICEF offices and Procurement Services partners globally. Share procurement know-how with development partners. Innovate to find ever-better supply solutions for children.

3. Procurement by UNICEF 2000-2009 Scale-up of interventions for which UNICEF procures supplies has been linked to global funding efforts by partners (GAVI, WB, GFATM, UNITAID, Governments) and WHO Prequalification Procurement of PQ products in 2009 2.96 billion doses of vaccines on behalf of 88 countries ARVs for estimated 780,000 patients for one year 30 million ACT treatments Total value USD 915 million

4. The Prequalification Programme addresses priority needs in public health System for independent assessment that follows international standards Prioritization that focuses on diseases of interest Enabler for countries and programmes to access quality products Supports countries to strengthen the capacities of their own NRAs Supports the creation of competitive and healthy markets.

5. PREQUALIFICATION OF MEDICINES

6. Procurement of medicines. Main groups by value 2006200720082009 1ARVs 2Antimalarials 3Water & electrolytesß-lactamsOther antibacterials 4 Minerals & vitaminsWater & electrolytes 5ß-lactamsWater & electrolytes Anthelmintics 6 Minerals & vitaminsAnthelminticsMinerals & vitamins 7 AnthelminticsAntianaemia drugsß-lactams 8Antianaemia drugs Analg., non opioidsAntifungus 9Analg., non opioids Disinf./antisepticsAntivirals 10Antivirals Immunomodulating agents ß-lactamsAntianaemia drugs WHO PQ covers ARVs and ACTs, limited number of products for other groups. Majority of non-ARV and non-ACTs products evaluated by UNICEF (WHO GMP, technical dossiers)

7. Antiretroviral medicines UNICEF SUPPLIER BASE 2004-2008 And over 25 products approved in 2009 which will be part of 2009 RFP

8. Significant increase in number of prequalified products for main first line treatments 1 2 2 223 5 3 3 36 9 3 4 8 6 4 7 8 9 11 4 5 5 7 7 Numbers in graph represent products in WHO PQ list (cumulative)

9. UNICEF price trend and supplier base for two key first line ARVs * d4T+3TC+NVP refers to d4T 30mg FDC only

10. ACTs Procured through a joint tender with WHO Increase in prequalification of products in 2008-2009 has allowed to prioritize WHO PQ status as criteria for award. Strategy follows shared objectives with partners (WHO, UNITAID). In 2009, WHO Prequalified ACTs represented 87% of treatments procured. Gap in PQ of ACTs containing SP and Mefloquine, and need to prioritize evaluation of new ACTs Gap also in PQ and SRA registration of other antimalarials (arthemeter inj, quinine) that affects GFATM programmes

11. PREQUALIFICATION OF MEDICINES: OPPORTUNITIES Coordination in the preparation of priority lists (REOI) with procurement agents and donors to address gaps in access and enable market shaping Increase quality of submissions and review time for priority products (TA, option for review at various stages of dossier preparation?) Establishment of mechanism to enable recognition of WHO PQ by NRAs in registration process. Increased coordination with SRAs to enable inclusion of products in WHO list. Supporting mechanisms or alternative approach for products for which there is limited hope of recommendation through current PQ process (risk-benefit approach).

12. PREQUALIFICATION OF VACCINES

13. Value per year for EPI Vaccines, OPV, New vaccines and others

14. WHO Prequalification system for vaccines WHO Prequalification system has been a key component of UNICEF’s procurement strategies developed to support vaccine security and develop new markets (GAVI) Priorities for prequalification efforts established to address programme needs (e.g polio eradication, introduction of HepB, Hib and Pneumo vaccines) Independence from procurement roles strengthens integrity of both functions

15. The growth in demand in DTP-HepB/Hib, supported by GAVI funding, has transitioned the DTP market, creating the sustainable market… All offers for DTP-HepB/Hib for pre-qualified and non pre-qualified products Market Shaping - Recently Introduced vaccines

16. Marketing shaping of the Pentavalent market Pentavalent Market development showed significant scale up in 2009 Millions of Doses

17. Marketing shaping of the Pentavalent market 2010 – 2012 Forecast Quantities are at similar levels to 2009 (excluding India demand) Millions of Doses

18. Marketing shaping of the Pentavalent market The supply base of WHO PQ vaccines has increased in response to increased demand, showing a positive development in the supply base with additional products in the pipeline Millions of Doses

19. Marketing shaping of the Pentavalent market Flexibility to switch between available presentations and new products was also established. The WAP has declined to < $3.00/ dose with anticipated declines with additional awards, switching to multi dose presentations or new products Millions of Doses

20. PREQUALIFICATION OF VACCINES: OPPORTUNITIES Increased resources to meet the increased demand in terms of number of products and changing technology. Expand information available on product characteristics and limitation of recommendations. Strengthening linkages with NRAs to ensure quality of products procured by regional/national agencies.

21. PREQUALIFICATION OF DIAGNOSTICS

22. Trends Continued growth in HIV, HBV and Malaria rapid test kits. Value of procurement for test kits was US19M in 2009, up from 16M in 2008. Growth in Syphilis test kits, both rapid and lab, linked to use in ante-natal screening. Viral load / EID steep increase – introduction of kits with UNITAID support DIAGNOSTICS UNICEF PROCUREMENT 2006-2008

23. Sustain and increase the momentum in PQ activities and push for the completion of assessment of appropriate product groups (e.g. Malaria RDTs, viral load). Coordination in preparation on priority lists Expansion of information available on product characteristics, scope of assessment and assessment criteria Increase role in coordination of technical consultations to generate specifications that can guide procurement. PREQUALIFICATION OF DIAGNOSTICS: OPPORTUNITIES

24. The Prequalification Programme is central in addressing global public health needs –Ensuring access to quality products –Enabling shaping of markets through scale-up efforts Interest of UNICEF in contributing to preparation on priority lists Key role in increasing capacity of NRAs, necessary to reduce need of PQ system Increase role in coordination of technical consultations to generate specifications that can guide selection and procurement (diagnostics). SUMMARY

25. UNICEF VACCINES Thank You!