Outline of the guidelines developed by the R

1
Outline of the guidelines developed by the RD
Task Force for opening Window 3 of the Vaccine
Fund

• Financial complementarity of Window 3 with other
  support
• Types of activities to be supported
• Undertaking of commercial negotiations to achieve
  a quid pro quo, when relevant
• Avoidance of conflict of interest in selection of
  activities
• Methods to transfer support from the Vaccine Fund
• Possible future purchase of products by the
  Vaccine Fund

2
Financial complementarity of Window 3 with other
support

• Window 3 funding will serve as an advocacy tool
  in two distinct ways
• Financial support from the Vaccine Fund will
  encourage potential partners to invest directly
  in GAVI supported RD activities.
• Prospective donors will be able to channel their
  contributions through the Vaccine Fund.

3
Types of activities to be supported

• The prioritized tasks and activities supported by
  Window 3 are integral components of the
  Accelerated Development Introduction Plans
  (ADIPS) for vaccines specifically targeted by the
  GAVI Board, expanding to include future vaccine
  technologies. Initially, these will be
• epidemiologic measurements of the burden of
  disease
• clinical trials that assess the safety,
  immunogenicity, practicality, efficacy and
  effectiveness of the vaccines

4
Undertaking of commercial negotiations to achieve
a quid pro quo, when relevant

• Wherever possible, multiple manufacturers engaged
  as partners
• Transparent funding, allowing all firms to
  respond to requests for proposals
• Funding focused on activities with minimal direct
  licensing benefits in industrial country markets
• Request for appropriate returns to the public
  sector

5
Avoidance of conflict of interest in selection of
activities

• Experts from industry will not serve as members
  of the Independent Review Panels when studies of
  specific products are to be considered
• All members of the Independent Review Panels will
  fill out a form in which they must declare equity
  holdings, paid consultancies, collaborations,
  etc.

6
Methods to transfer support from the Vaccine Fund

• A funding envelope (allocated on a semi-annual or
  annual basis) to be disbursed to the ADIP team.
• A Steering Group to provide oversight to the ADIP
  team, its plan, budget and progress toward ADIP
  milestones. The Steering Group would authorize
  use of the funds by the ADIP team.

7
Possible future purchase of products by the
Vaccine Fund

• Purchase of new vaccines or related products to
  take place through the same process as exists for
  other vaccines purchases in GAVI.
• Situations where some level of future guaranteed
  purchase is required to be brought to the GAVI
  Board on an individual case basis.

8
The Board is requested to address the following
questions

• Is the proposed process appropriate?
• If the ADIP are approved, should Window 3 provide
  funding envelopes for specific activities within
  the ADIP?
• Is a total funding envelope of US 30 million per
  year, for 3 years acceptable?