RECOMMENDED SUPPLY STRATEGY FOR HIB

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RECOMMENDED SUPPLY STRATEGY FOR HIB HEPB
CONTAINING VACCINESDr. Montasser KamalChair,
Supply Strategy Task Team
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I. A New Supply Strategy?

• The need for a strategy
• Maturing alliance, desiring more involvement,
  more complex supply and financial environment,
  improving accountability, Phase 1 lessons,
  current procurement agreement ending.
• Defining a successful strategy
• A reliable supply of high quality vaccines in the
  presentations and volume needed to meet demand at
  and affordable sustainable prices.

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I. Experience to date
Supply issues have been before the Board several
times during phase 1
Procurement Round 1 2001 - 2003
Procurement Round 2 2004 - 2006
Procurement Round 3 2007 - ?
2002 ? Mercer Consulting Study, leading to the
creation of the Vaccine Provision Project (VPP)
2003 ? VPP Lessons Learned Paper
2005 ? Creation of Supply Strategy Task Team
Report to the GAVI Alliance Fund Boards
2004 ? Updated GAVI Procurement Principles
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II. Scope of Task Team Work
GAVI Alliance Supply Strategy
HepB Hib Supply Strategy
Product Y Supply Strategy
Product X Supply Strategy
Product-Specific Procurement Strategy
Product-Specific Procurement Strategy
Product-Specific Procurement Strategy
Product-Specific Implementation Plan
Product-Specific Implementation Plan
Product-Specific Implementation Plan
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II. Membership of Team

• Canada Montasser Kamal, Chair
• Gates Foundation Gargee Ghosh
• UNICEF Programme Peter Salama
• UNICEF SD Shanelle Hall
• World Bank Amie Batson
• WHO Diana Chang-Blanc Michel Zaffran
• Industry Perspective Angeline Nanni
• Country Perspective Mercy Ahun
• Coordinator Andrew Jones

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II. Scope of a Broad Supply Strategy
gt7 years
7 - 5 years
5 - 3 years
2 years
1 year
Strategic Demand Analysis (ADIP)
Vaccine Assessment Analysis
Supply Strategy
Pre-Launch Activities
Tender Issuance
Assess need for the vaccine in countries
Strategic demand forecast
Integrated supply, demand, financing strategy
Vaccine Introduction
Commitment of countries, donors suppliers
Informal GAVI signals
Formal GAVI signals
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III. Current Status/Opportunities a. Supply
Landscape Industry Signalling

• Current Status
• Up to five suppliers of combination vaccines in
  production by end-2007
• Total capacity by end-2007 over 250 million doses
  for each DTP-HepB and DTP-HepB-Hib
• Strong, although uncoordinated, signals from the
  GAVI Alliance has helped drive manufacturers to
  invest in production capacity
• Past Problems / Opportunities for Improvement
• Lack of coordination among Alliance members in
  signalling
• Absence of clear strategy for long-term
  signalling from the Alliance Board

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III. Current Status/opportunities b. Assessing
Demand

• Current Status
• Accuracy of demand forecasts are a key driver of
  the supply strategy a necessary element of
  procurement
• WHO leads efforts working with countries,
  regional offices and others
• Past Problems / Opportunities for Improvement
• Track impact of proposed Phase 2 vaccine subsidy
  policies on country demand
• Inclusion of middle income country demand
• Building evidence base for Hib disease burden in
  country

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III. Current Status /opportunities c.
Identification of Financing

• Current Status
• Bottlenecks due to differences in GAVI Alliance
  and GAVI Fund approval processes
• Past Problems / Opportunities for Improvement
• Streamlined approval processes needed to improve
  efficiency
• Bridge financing and the proposed Phase 2 vaccine
  subsidy policies will add complexity to methods
  of identifying secure financing for procurement
• Guidelines for treatment of assets (including
  interest earned) need to be specified

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III. Current Status /opportunities d. Assurance
of Quality

• Current Status
• All vaccines purchased by GAVI via UNICEF are
  subject to pre-qualification and ongoing
  assurance of quality
• Past Problems / Opportunities for Improvement
• Difficulties in securing qualified technical
  experts
• Weak National Regulatory Authorities
• Under-supported post-marketing surveillance
  systems
• Funding gap exists for pre-qualification
  activities

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III. Current Status /opportunities e.
Solicitation Process, Evaluation of Bids
Agreements with Suppliers (Procurement Agent)

• Current Status
• The solicitation, evaluation and award of bids
  together form the scope of work for the
  procurement agent
• Tenders have been done for 3 year period using an
  RFP process with a proportion of firm contracting
• Past Problems / Opportunities for Improvement
• Lack of broader Alliance involvement in providing
  input to advice on the procurement process
• Review risk sharing between GAVI and
  manufacturers

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III. Current Status /opportunities f. Country
Delivery, Receipt, Storage Logistics

• Current Status
• UNICEF works in supporting countries with
  delivery of vaccine
• UNICEF and WHO are working with countries and
  other partners to improve vaccine management at a
  country level
• Past Problems / Opportunities for Improvement
• Need for greater capacity in countries in vaccine
  management and logistics
• Need to assess and support country capacity
  development in procurement and supply chain
  management

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III. Current Status /opportunities g.
Monitoring Benchmarks for Performance

• Current Status
• The different GAVI partners involved monitor
  different parts of the supply chain.
• Past Problems / Opportunities for Improvement
• Need an integrated, regular review of high-level
  key indicators to
• Assess progress improve performance in each
  supply area
• Ensure efficient implementation of the supply
  procurement strategy

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IV. For Decision To adopt the following
procurement objectives

• A healthy market ensuring the sustainable
  quantity of supply through a diverse supplier
  base
• Select products and presentations that best meet
  the need of client countries
• Achieving a long-term affordable price that
  countries can eventually finance in a sustainable
  manner.

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IV. For Decision To decide on the composition
of a reference group

• The group will
• Report to the GAVI Secretariat
• Oversee supply and procurement issues
• Work closely with the procurement agent
• The two options to be considered are
• A fully independent expert reference group
  without partner membership
• A modified task team with enhanced membership
  including external experts (UNICEF, as
  procurement agent, will not be a member of the
  group).

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IV. The Role of the Reference Group
Identification of Financing
Assessment of Demand
Evaluation of Bids Structuring of Awards
Monitoring
Quality Assurance
Solicitation of Tender
1. Review forecasts produced by WHO 2. Approve
recommended demand ranges
3. Define the financing needs (in line with
demand forecasts) 4. Coordinate among Partners
to identify and provide funds to procurement
agent in timely manner
(No specific role for Reference Group)

• 5. Confidential advice to the designated buyer on
  the solicitation process

6. Confidential advice and recommendations
regarding awards and award structure
7.Confidential advice to the GAVI Fund on
financial backing
8. Ensure implementation of strategy track key
indicators 9. Coordinate inputs from Partners
ensure integrated management of information
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IV. For Decision To endorse the choice of
UNICEF with modification as procurement agent

• Given past difficulties, modifications to current
  procurement agreements are recommended
• Criteria form basis for an MOU. The aim clear
  roles and responsibilities for agent.
• Limited Options Two others considered
• Building capacity at the GAVI Secretariat
• Outsourcing procurement via a competitive tender

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IV. For Decision To endorse the choice of
UNICEF with modification as procurement agent

• To endorse the choice of UNICEF, with
  modifications to the current arrangements, as
  procurement agent on the condition that the GAVI
  Fund and UNICEF develop and sign an MOU by
  February 10, 2006 in line with the proposed
  procurement agent criteria. If no agreement is
  reached in this timeframe, other options would be
  explored.

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V. For Guidance

• The task team, modified in membership as
  necessary, will develop an overarching supply
  strategy for the GAVI Alliance to be provided to
  the Alliance Board in 2007.
• The task team will develop a strategy (including
  a code of conduct) for GAVI partners to engage
  with manufacturers to provide to the Alliance
  Board in 2006 for approval.

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V. For Guidance

• The Secretariat will work with relevant partners
  to develop budgets and plans for additional
  supply chain related work and integrate this in
  the strategic plan.
• The Secretariat will develop a plan to strengthen
  country capacity in vaccine management and
  commission work to explore further the
  possibility of long-term capacity for in-country
  procurement.
• The Secretariat, consulting with UNICEF as
  necessary, will improve its financial management
  systems to allow efficient and timely transfers
  of funds for procurement by 2007.

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Thank you
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Expert Committee

• A group with strategy, review and oversight
  functions has to balance both knowledge
  objectivity
• The group should be chartered A definitive
  document on the group's roles, objectives and
  processes should be prepared and approved by the
  GAVI Board
• The group must have voting members ( 4 - 6)
  Members should be independent of GAVI decisions
  on items, funding and sources, yet can be
  connected to GAVI partners due to past
  association, tangential work, etc.
• The group will likely need non-voting members
  ( 3) Members represent key areas of current
  GAVI business, and should include representatives
  from the GAVI Secretariat and UNICEF. The
  presence of these members is important for issue
  review and discussion, yet these members would be
  excluded from the committee's final
  recommendations due to their potential conflict
  of interest. The expert committee's meetings
  would include "open sessions" for all members,
  and "closed sessions" for "voting members" only.