1. London November 9th1 The Independent Assessment Committee London November 9th, 2006

2. 2 IAC Functions Act as independent and credible entity for all stakeholders to: Oversee the establishment of Target Product Profiles (TPPs) Monitor and report progress Modify TPPs and prices if needed Oversee the determination of whether a product meets the TPP Resolve disputes

3. 3 IAC Principles Define processes Avoid adding new structures Build on and reinforce existing processes All processes as consultative as possible Open and transparent in working and decision-making Reliance on existing regulatory systems to minimize overlap and additional requirements

4. 4 Structure of IAC Parent IAC with disease specific sub-committees One time expert panel to establish TPPs; on-going IAC (parent and sub-groups) for other functions Composed of seven to ten or more respected experts with an independent highly-credible leader Broad expertise in areas such as public health, immunization delivery, health economics, vaccine business development, vaccinology/clinical trials & law

5. 5 IAC membership World Bank and GAVI responsible for implementing a transparent consultative process to select members Open nominations process Nominees submitted to GAVI Alliance Board and presented to donor committee

6. 6 1. Setting TPPs Parent IAC will ensure an appropriate structure, consistency TPP focus would be on public health impact TPP Expert group constituted at request of and with review by IAC Recommended that WHO system be used for convening ad hoc product-specific TPP group

7. 7 1. Setting TPPs: the expert group Group presents recommendations to SAGE (WHO Immunization Advisory group) and IAC IAC request WHO to prepare background papers for the expert committee in collaboration with GAVI and IAC. WHO estimated that the proposed process, including the preparation of papers would take three-six months. If IAC disagrees with recommendation, joint meeting of the IAC and the SAGE will be convened.

8. 8 Submission of licensed vaccine for prequalification or AMC eligibility 1.IAC request WHO to convene expert body under SAGE to set TPP 2.Expert body comprised with IAC approval 3.Expert body review documentation and meet (transparent process) 4.Expert body TPP recommendation provided to IAC and WHO DG 5.If acceptable, TPP becomes WHO policy and AMC standard IAC SAGE GAVI / UN agency procurement WHO Decision on prequalification Criteria for pre-qualification WHO requirements of ECBS guidelines Tender specification WHO policy on performance (for newer vaccine) through SAGE Setting TPPs

9. 9 2. Monitor and Report Progress Review and approval of progress reports from AMC Secretariat Focus on scientific and technical progress towards eligible vaccine Annual meetings with donors, partners and AMC participants are being considered (including donor committee)

10. 10 3. Modification: price or TPP Rare event g iven advanced state of pneumococcal vaccine development Important principle not to “move the goal post” Price only adjusted upward IAC determine revisions based on expert groups: WHO convened group for TPP modifications AMC Secretariat (GAVI) convene group for pricing review

11. 11 4. Determine eligibility for AMC IAC determines whether a product meets the TPP, and is eligible for AMC funding Meeting TPP requires: Minimum safety/efficacy standards – done through a recognized regulatory agency Public health performance standards Procurable by GAVI or UN agency as judged by WHO prequalification process Approval by IAC makes manufacturer eligible to sign Guarantee and Supply Agreement

12. London November 9th12 Submission of licensed vaccine for prequalification GAVI / UN agency procurement Criteria for pre-qualification WHO requirements of ECBS guidelines Tender specification WHO policy on performance (for newer vaccine) through SAGE WHO decision on prequalification Current WHO Prequalification

13. London November 9th13 Submission of licensed vaccine for prequalification GAVI / UN agency procurement Criteria for pre-qualification WHO requirements of ECBS guidelines Tender specification WHO policy on performance (for newer vaccine) through SAGE WHO decision on prequalification Determining Eligibility for an AMC IAC 1.IAC request WHO PQ process to review vaccine for eligibility 2.WHO PQ sets clock on process, report on timing 3.WHO provide report on product meeting AMC TPP, etc 4.IAC make decision on eligibility

14. 14 5. Resolve disputes and conflict IAC will resolve disputes relating to processes overseen by IAC including TPP and pricing issues Potential conflicts of interest addressed by: Selection process Full disclosure of potential conflicts Open meetings so all can see that due process is followed Members with a conflict on a particular issue recused from debate Members can request to go to closed session, especially if confidentiality an issue