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UN Prequalification:UNICEF Perspective

5th UN Prequalification stakeholders meeting11th February 2009

1THE ROLE OF UNICEF SUPPLY DIVISIONOversee UNICEFs global procurement and logistics operation. Procure supplies on behalf of UNICEF and Procurement Services partnersEnsure 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.

2As the immunization agenda has gained momentum the complexity and range of products increases, and this has increased the demand on the pre-qualification system to handle new technologies, novel products without a history, and products with limited suitability for use in particular settings. (mOPVs, Rota vaccines, 7valent pneumo vaccine)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 PrequalificationProcurement of PQ products in 2009

2.96 billion doses of vaccines on behalf of 88 countriesARVs for estimated 780,000 patients for one year30 million ACT treatments

Total value USD 915 million

3As the immunization agenda has gained momentum the complexity and range of products increases, and this has increased the demand on the pre-qualification system to handle new technologies, novel products without a history, and products with limited suitability for use in particular settings. (mOPVs, Rota vaccines, 7valent pneumo vaccine)The Prequalification Programme addresses priority needs in public health System for independent assessment that follows international standardsPrioritization that focuses on diseases of interestEnabler for countries and programmes to access quality productsSupports countries to strengthen the capacities of their own NRAsSupports the creation of competitive and healthy markets.4PREQUALIFICATION OF MEDICINES5Procurement of medicines.Main groups by value20062007200820091ARVsARVsARVsARVs2Antimalarials AntimalarialsAntimalarialsAntimalarials3Water & electrolytes -lactams Other antibacterials Other antibacterials 4Other antibacterials Other antibacterials Minerals & vitamins Water & electrolytes 5-lactams Water & electrolytes Water & electrolytes Anthelmintics 6Anthelmintics Minerals & vitamins Anthelmintics Minerals & vitamins 7Minerals & vitamins Anthelmintics Antianaemia drugs -lactams 8Antianaemia drugs Antianaemia drugs Analg., non opioids Antifungus9Analg., non opioids Analg., non opioids Disinf./antiseptics Antivirals10Antivirals Immunomodulating agents -lactams Antianaemia drugsWHO 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)6Antiretroviral medicinesUNICEF SUPPLIER BASE 2004-2008

And over 25 products approved in 2009 which will be part of 2009 RFP7

Significant increase in number of prequalified products for main first line treatments122223533369348647891145577Numbers in graph represent products in WHO PQ list (cumulative)8UNICEF price trend and supplier base for two key first line ARVs

* d4T+3TC+NVP refers to d4T 30mg FDC only9ACTsProcured through a joint tender with WHOIncrease 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 10PREQUALIFICATION OF MEDICINES: OPPORTUNITIESCoordination in the preparation of priority lists (REOI) with procurement agents and donors to address gaps in access and enable market shapingIncrease 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).

11PREQUALIFICATION OF VACCINES12Value per year for EPI Vaccines, OPV, New vaccines and others

WHO Prequalification system for vaccines WHO Prequalification system has been a key component of UNICEFs 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

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 productsMarket Shaping - Recently Introduced vaccines1515Marketing shaping of the Pentavalent market

Pentavalent Market development showed significant scale up in 2009Millions of DosesMarketing shaping of the Pentavalent market

2010 2012 Forecast Quantities are at similar levels to 2009 (excluding India demand)Millions of DosesMarketing 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 pipelineMillions of DosesMarketing 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 productsMillions of DosesPREQUALIFICATION OF VACCINES: OPPORTUNITIESIncreased 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.

20As the immunization agenda has gained momentum the complexity and range of products increases, and this has increased the demand on the pre-qualification system to handle new technologies, novel products without a history, and products with limited suitability for use in particular settings. (mOPVs, Rota vaccines, 7valent pneumo vaccine)PREQUALIFICATION OF DIAGNOSTICS21Trends

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

DIAGNOSTICSUNICEF PROCUREMENT 2006-2008Sustain 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 listsExpansion of information available on product characteristics, scope of assessment and assessment criteriaIncrease role in coordination of technical consultations to generate specifications that can guide procurement.PREQUALIFICATION OF DIAGNOSTICS: OPPORTUNITIESThe Prequalification Programme is central in addressing global public health needsEnsuring access to quality productsEnabling 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).SUMMARYUNICEF VACCINES

Thank You!