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Introduction Day 3 1st Meeting CEWG 7 th April 2011 by Chair & Vice-Chair

Introduction Day 3 1st Meeting CEWG 7 th April 2011 by Chair & Vice-Chair. Outline. Agenda for today Mandate/scope of work Analytical framework Call for proposals Outline/ambition of Final report Work plan/process Election of Rapporteurs. Mandate/scope of work (WHA63.28) (1).

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Introduction Day 3 1st Meeting CEWG 7 th April 2011 by Chair & Vice-Chair

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  1. IntroductionDay 31st Meeting CEWG7th April 2011by Chair & Vice-Chair

  2. Outline • Agenda for today • Mandate/scope of work • Analytical framework • Call for proposals • Outline/ambition of Final report • Work plan/process • Election of Rapporteurs

  3. Mandate/scope of work (WHA63.28) (1) • Interpretation of 2.2.a: “take forward work of” EWG • Deliver on the same mandate, i.e. WHA 61.21: • “examine current financing and coordination of research and development, as well as proposals for new and innovative sources of financing to stimulate research and development related to Type II and Type III diseases and the specific research and development needs of developing countries in relation to Type I diseases” • Questions/issues • R&D on what? –technologies/products or also delivery/systems • Relationships to the other elements of Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (GSPA-PHI)

  4. Mandate/scope of work (WHA63.28) (2) • Chair and Vice-Chair suggestions • CEWG is a working group on R&D – financing and coordination • R&D scope should cover all health technologies/products (drugs/vaccines, diagnostics, devices, delivery technologies etc.) • Acknowledge the need for and potential for utilizing some of the financing mechanisms for • Research for diagnostic algorithms and clinical interventions and preventative interventions • Health Policy and System Research in introduction of the report to improve delivery/access and strengthen health systems • Further research on R&D and innovation policies (different proposals) in recommendations/conclusion • Core mandate to help deliver on element 2 (promote R&D) and 7 (sustainable financing for R&D for health products) • Include interrelations with other elements of GSPA-PHI as part of analytical framework: • Health needs in Developing Countries (DC) (element 1) – public health impact • Capacity building in innovation and R&D in DC (element 3) and transfer of technology (element 4) • IP management (element 5) • Delivery and access (element 6) – affordability of products

  5. Mandate/scope of work (WHA63.28) (3) • Interpretation of 2.2.b: “deepen the analysis” of proposals (including “practical details”) and new proposals (2.2.c) • Questions/issues • What is “deepen”? • What kind of analysis? • What kind of proposals? • Chair and Vice-Chair suggestions • Analyze all proposals (not only selected ones) with “our” framework • Avoid three categories of proposals: accepted, promising, excluded (not assessed) • Avoid “negative list”, conclude instead with a “positive list” of recommended proposals (none are excluded, but some are more likely to succeed) • Consider feasibility/implementability • …

  6. Relationships between proposals and mechanisms94 proposals/submissions translated into 22 proposed mechanisms/proposals Proposal Mechanism Mechanism Proposal Mechanism Mechanism Proposal Proposal Mechanism Proposal

  7. Mandate/scope of work (WHA63.28) (3.5) • Interpretation of 2.2.d: regional feasibility/appropriateness • Chair and Vice-Chair suggestions • Not able to do full analysis within the time limits • Utilize regional consultations for some elaborations • Acknowledge the need for further analysis, and that this need to be done by local policy makers

  8. Mandate/scope of work (WHA63.28) (4) • Chair and Vice-Chair suggestions • Types of proposals: • Financing (fund raising) • Funding allocation/incentivizing R&D (incl. improving efficiency) • Or more categories here? • Coordination mechanisms • Overarching mechanisms (e.g. treaty, a global R&D fund) • Other types? • Financing mechanisms • Fund raising and allocation • Coordination mechanisms • Improving efficiency, networking mechanisms, overarching mechanisms, governance • May end with a new categorization

  9. Analytical framework (1) • EWG • Extensive list of criteria (>90) with 3 levels • Quantitative analysis • Threshold for inclusion • Chair and Vice-Chair suggestions • One level of criteria • Qualitative analysis • Evidence informed (if possible) • Include all proposals (no threshold) • Conclude with a list of recommendations • …

  10. Analytical framework (2) • Description/Characteristics • Type of disease • Type of technology • Stage/phase in development process • Criteria (dimensions) – only when applicable: • Potential public health impact in DC/LMICs (element 1) • Rational and equitable use of resources/efficiency considerations • Effectiveness • Technical implementability/scaling up/transferability/time until implementation • Financial feasibility, additionality and equity/distributive effect • Sustainability • Accountability/participation in governance and decision making • Impact on capacity in and ToT to DCs (element 3 and 4) • IP management issues (element 5) • Potential for de-linking R&D costs and price of products/Likely affordability of products and impact on access (element 6) and delivery • Assessment • Over all strengths and weaknesses • Evidence base (when available) • Issues when making final recommendations • Potential synergy with other mechanisms/potential for combining with others

  11. Invitation for submissions • Specific call addressing the information needs of the analysis and assessment, e.g. • Aim of the CEWG • Type of proposals • Assessment criteria • Ask for a self assessment according to criteria • Develop a strict template for proposals to address these needs • Encourage proposals that address “the specific research and development needs of developing countries in relation to Type I diseases” • Issue a second call for and actively identify independent assessment of existing proposals/proposed policies

  12. Outline/ambition of Final report • Background • Refer to EWG and potentially other sources (e.g. recent G-finder report) regarding “... examine current financing and coordination of research and development …” • Description of process • Appendices with information on submissions, consultations etc. • Introduce analytical framework • List of assessed proposals • Appendix with assessment of each individual proposal • Recommendations • Suggestions for further process

  13. Work plan/process (1) • Issues • Number, timing and location of meetings of CEWG • Involvement between meetings • Timeline • Mechanism for regional consultations • Drafting process of final report • Chair and Vice-Chair suggestions • 3 meetings (or 4?) • 2nd: 7-8 July • 3rd: 17-18 November (after first draft) • (? 4th: Jan/Feb 2012 (around EB)) – decide at 3rd meeting

  14. Work plan/process (2) • Chair and Vice-Chair suggestions • Decision on framework of analysis and call for proposals • 6 officers to be consulted by secretariat • Draft sent to full group for comments • Approval by email (deadline for no objection) • Deadline: April 30 • Timeline • Draft of assessment of proposals (appendix): October • Draft of recommendations: October

  15. Work plan/process (3) • Suggestions for regional consultations • Side events at Regional committee meetings in all WHO regions (Late August, September, early October) • Host • Secretariat (PHI) with WHO RO • Involvement of CEWG members : • All regional members of CEWG will be invited • Invitations • Member states • Stakeholders, experts, interest groups • Content • Present preliminary assessment of proposals to get feedback

  16. Work plan/process (4) • Drafting process of final report • Method of involvement of CEWG members • Read proposals and self-assessment and comment on them in 2nd meeting • Discuss assessment of proposals at 2nd meeting • Preliminary discussion of recommendations at 2nd meeting • Propose extensions/improvements of proposals • Comment on draft assessments and conclude • Finalize recommendations in 3rd meeting • Conclude on recommendations • Role of the WHO secretariat • Present the existing 22 proposals/proposed mechanisms to the CEWG • Draft assessment of proposals and preliminary recommendations after 2nd meeting • Redraft recommendations after 3rd meeting • Regarding 22 existing proposals/proposed mechanisms • Secretariat writes up according to criteria and presents • Secretariat does an analysis of relationship to 94 original proposals

  17. Election of Rapporteurs • Role of rapporteurs • First point of contact for secretariat with preliminary drafts of assessments and recommendations (together with chair and vice-chair) • Elected 4 rapporteurs • Prof Mayosi, South Africa • Dr Lagrada, Phillipines • Mr Goyal, India • Dr Harb, Lebanon

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