© UNICEF/UNI199159/Panday

Overview of Vaccine Procurement

Heather DeehanVaccine Centre ChiefUNICEF Supply Division, Copenhagen

June 2017Sustainable Local Production of Influenza Vaccines for Pandemic Preparedness

Source: UNIICEF Supply Division

Immunization Supplies

VaccinesBCG, DTP, TT/Td/DT, Measles containing, OPV, HepB, YF, DTP-HepB, DTP-HepB/Hib, DTP/Hib, Hib, MR, Meningitis, MMR, PCV, RV, IPV, HPV, etc.

Safe Injection equipment

Cold Chain Equipment

Vaccines Supplies: US$ 1.64 billion 2.50billion doses

2,613shipments

2016

Countries UNICEF procures on behalf of

Full schedule

Partial schedule

UNICEF has a key role in vaccine procurement and procuring immunization supplies on behalf of around 100 countries annually

0

200,000,000

400,000,000

600,000,000

800,000,000

1,000,000,000

1,200,000,000

1,400,000,000

1,600,000,000

1,800,000,000

1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016

Anti-diphtheria BCG Cholera DT DTP DTP/Hib

DTP-HepB DTP-HepB/Hib Hep A Hep B Hep B (adult) Hib

HPV Influenza IPV JEV Measles Mening

MMR MR OPV Other Vaccines/Biologicals PCV Rabies

Rota Rubella Td TT Typhoid YF

UNICEF annual vaccine procurement value has increased significantly since 2000 supporting UNICEF Programmes and procurement on behalf of Partners, Global Programmes, Governments and NGO’s

Source: UNIICEF Supply Division

Campaign Activities (Polio, Mea), New vaccine introduction (GAVI) Price increases, Boosting routine activities

2010: decrease due to price reductions and India self-procurement (OPV), supply shortfalls

Recent increases in value driven by new vaccine introduction

Penta

OPV

PCV

The main volume driver (in doses) remains OPV including in 2016

Source: UNIICEF Supply Division

0

500,000,000

1,000,000,000

1,500,000,000

2,000,000,000

2,500,000,000

3,000,000,000

3,500,000,000

1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016

OPVYFTyphoidTTTdRubellaRotaRabiesPCVOTHERMRMMRMeningMeaslesJEVIPVInfluenzaHPVHibHep B (adult)Hep BHep ADTP-HepB/HibDTP-HepBDTP/HibDTPDTCholeraBCG

Considerable portion of vaccines procured by UNICEF comes from emerging market country manufacturers

Source: UNIICEF Supply Division

Vaccine Product Profile?

• Biological products requiring constant temperature control Cold Chain from Manufacturer to Child– Significant risks of production failures– Quality is the OVER-RIDING criterion– Highly regulated production environment– Dependency on well functioning NRA – Limited shelf life

Requiring a specific approach to be developed for vaccine procurement

• 1- 5 suppliers per

product• High entry cost to manufacturers

• Production of a dose: 6 -24 months• Capacity Increase: 2-3 years• New Plant: 5-7 years • New regulatory requirements can cause interruptions

High Product Sensitivity Limited Supply Long lead times for vaccine production

• To achieve value for money and access to vaccines for children in need

• Achieving healthy markets through the Vaccine Security approach (forecasting, funding and appropriate contracting) and specific vaccine procurement principles

• Vaccines as biological products – requiring a specific approach for vaccine procurement

• Quality of vaccines through prequalification by WHO –ensuring acceptability, in principle, as well as quality, safety and efficacy in target population of procured vaccines

UNICEF’s Procurement is Focused on Achieving Vaccine Security

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Vaccine Security

Vaccine Security: the sustained, uninterrupted supply of affordable, vaccines of assured quality

UNICEF Vaccine Procurement Principles, implemented following the supply crisis in the traditional vaccine markets, are considered relevant for all vaccines to ensure healthy market

1. A healthy industry is vital to ensure uninterrupted and sustainable supply of vaccines

2. Procurement from multiple suppliers for each vaccine presentation

3. Procurement from manufacturers in developing countries and industrialized countries

4. Paying a price that is affordable to Governments and Donors and a price that reasonably covers manufacturers minimum requirements

5. UNICEF should provide manufacturers with accurate and long-term forecasts; Manufactures should provide UNICEF with accurate and long-term production plans

6. As a public buyer, providing grants to manufacturers is not the most effective method of obtaining capacity increases

7. The option to quote tiered pricing should be given to manufacturers.8

Healthy Markets Framework

HMF represents a set of attributes that should be used to measure the health of a market and a process to evaluate each attribute that is vaccine specific.

Supply of Antigen = Demand for Antigen

NRA RiskIndividualSupplier

Risk

BufferCapacity

Total System Effectiveness

Long Term

Competition

ProductInnovation

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2

3Accommodate Country Presentation Preference

Inadequate Supply

Common building blocks to consider in every procurement

Selection and prioritization of which building blocks apply to a specific market usually via product roadmaps

Selection of what market needs could or should be resolved with non-procurement intervention

Quantification of the trade-offs implied by various scenarios and decisions associated with each healthy market building block

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Process Framework

Developed in collaboration with BMGF and Gavi, the Vaccine Alliance

Health Emergencies Preparations Initiative (HEPI) -UNICEF disease prioritisation

Vaccine Tender and Contracting Approach

•Strategy development• Product-specific procurement strategies, based on analysis and experience• Informed by industry and partner consultations and alignment of objectives

•Tender process• RFPs for strategic products – flexibility for manufacturers to shape the offer to highlight how they can bring best value• Multi-year tender & award period – provides planning horizon and more certainty to manufacturers • Wide invitee-list; all manufacturers are invited to participate (including pipeline)

•Awards• LTA – ‘good faith’ framework agreements:

a. Based on good will from accurate forecasts, but ‘treated’ as contractsb. To achieve exceptional results exceptional contracts have been awarded (eg, firm or pre-paid contracts)

• Review with a Procurement Reference Group (GAVI-supported vaccines) or other confidential partner consultation (e.g. GPEI)

• Multiple suppliers awarded per product• Pipeline assessed in award recommendation, and informs award strategy to incentivize continued market development

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Lead Times for Outbreak Response Vaccines

Long Term Arrangements (LTA )– ‘good faith’ framework agreements: - Agreement on the “lead-times” for the availability of the Vaccine from the

placement of the Purchase Order – Days / Weeks- Special Lead-Times when vaccines are to be used in Emergency and Outbreak

response:

Forecasting

• The forecast process is an integrated part of Immunisation Programmes in country and an essential step for the effective vaccine management.

• Forecasting is the Foundation for all elements of Vaccine Security:• Basis for production at manufacturers• Basis for funding needs

The outcome of the forecast is a key input for a number of processes:• Aligning annual country government budgeting and planning for health sector• Planning and implementation of vaccine procurement and delivery activities on timely manner in

coordination with partners• Accessing vaccine markets at affordable prices and securing the availability with industry • Useful tool for Country Offices/Partners to plan its resources and operations, a• A mechanism to foster on-going information and knowledge sharing.• Securing better pricing and vaccine stock management

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History of Influenza Procurement through UNICEF

2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016

Doses Forecasted 3,500 - 2,384 6,969 5,700 73,408 27,960 69,624 43,000 115,000 1,361,960

Doses Procured 19,466 6,961 14,500 40,030 288,155 54,390 26,580 24,670 6,320 90,350 113,033

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200,000

400,000

600,000

800,000

1,000,000

1,200,000

1,400,000

1,600,000

Influenza: Forecasted demand vs Actual procurement (in doses)

UNICEF SD Resources

• Market notes available at: http://www.unicef.org/supply/index_vaccines.html

• Format― Market & Supply Updates― Product Specifications― Availability and Guidance

• Aims― Primary: To inform demand (e.g.

from COs and Governments)― Secondary: To provide market

signals

• Content― Analysis of UNICEF procurement

data to illustrate market trends. ― Narrative to articulate critical

issues and improve situation

• Updated ~6 months or as needed

Publications on Products & Markets for key vaccine supplies for children

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Information Available on the UNICEF Website

Information Available on the UNICEF Website

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