UN Prequalification:UNICEF Perspective

5th UN Prequalification stakeholders meeting11th February 2009

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.

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

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.

PREQUALIFICATION OF MEDICINES

Procurement of medicines.Main groups by value

  2006 2007 2008 2009

1 ARVs ARVs ARVs ARVs

2 Antimalarials Antimalarials Antimalarials Antimalarials

3 Water & electrolytes ß-lactams Other antibacterials Other antibacterials

4 Other antibacterials Other antibacterials Minerals & vitamins Water & electrolytes

5 ß-lactams Water & electrolytes Water & electrolytes Anthelmintics

6 Anthelmintics Minerals & vitamins Anthelmintics Minerals & vitamins

7 Minerals & vitamins Anthelmintics Antianaemia drugs ß-lactams

8 Antianaemia drugs Antianaemia drugs Analg., non opioids Antifungus

9 Analg., non opioids Analg., non opioids Disinf./antiseptics Antivirals

10 Antivirals Immunomodulating agents ß-lactams Antianaemia 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)

Antiretroviral medicinesUNICEF SUPPLIER BASE 2004-2008

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RFP 2004 RFP 2006 RFP 2007 RFP 2008

Approved products

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Acceptable productsLTA holders

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

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Procurement of ARVs

Other ARVs

Zidovudine 300mg tab/PAC-60

ZDV + 3TC 300+150mg tabs/PAC-60

Efavirenz 600mg caps/PAC-30

d4T+3TC+NVP 30+150+200mg tabs/PAC-60

ZDV+3TC+NVP 300+150+200mg tabs/PAC-60

Significant increase in number of prequalified products for main first line treatments

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Numbers in graph represent products in WHO PQ list (cumulative)

UNICEF price trend and supplier base for two key first line ARVs

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Suppliers of d4T+3TC+NVP*

Suppliers of EFV600mg

Avge price of d4T+3TC+NVP*

Avge price of EFV 600mg

* d4T+3TC+NVP refers to d4T 30mg FDC only

ACTs

Procured 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

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).

PREQUALIFICATION OF VACCINES

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

2001 2002 2003 2004 2005 2006 2007 2008

EPI vaccines $46,093,273 $55,904,766 $77,243,858 $92,862,467 $111,199,05 $93,293,307 $131,554,21 $121,206,87

OPV $136,564,84 $147,060,33 $177,496,36 $205,057,61 $233,911,14 $280,927,42 $285,486,76 $239,564,33

New Vaccines $65,890,071 $39,790,665 $81,079,712 $74,922,066 $90,553,090 $114,494,47 $198,335,91 $271,923,85

Other $1,429,677 $663,256 $1,004,297 $909,775 $466,976 $1,806,527 $1,119,492 $1,377,272

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Vaccines/Biologicals 2001-2008

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

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

Marketing shaping of the Pentavalent market

Pentavalent Market development showed significant scale up in 2009

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Marketing shaping of the Pentavalent market

2010 – 2012 Forecast Quantities are at similar levels to 2009 (excluding India demand)

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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

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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

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of D

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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.

PREQUALIFICATION OF DIAGNOSTICS

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

DIAGNOSTICSUNICEF PROCUREMENT 2006-2008

• 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

• 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)

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SUMMARY

UNICEF VACCINES

Thank You!