Transcript Chair & Vice-Chair presentation ppt, 294kb

Introduction
Day 3
1st Meeting CEWG
7th April 2011
by Chair & Vice-Chair
Outline
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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)
 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 (GSPAPHI)
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:
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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
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
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Relationships between proposals and mechanisms
94 proposals/submissions translated into
22 proposed mechanisms/proposals
Proposal
Mechanism
Mechanism
Proposal
Mechanism
Mechanism
Proposal
Proposal
Proposal
Mechanism
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
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?
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Financing mechanisms
– Fund raising and allocation
2.
Coordination mechanisms
– Improving efficiency, networking mechanisms, overarching
mechanisms, governance
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May end with a new categorization
Analytical framework (1)
 EWG
– Extensive list of criteria (>90) with 3 levels
– Quantitative analysis
– Threshold for inclusion
 Chair and Vice-Chair suggestions
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One level of criteria
Qualitative analysis
Evidence informed (if possible)
Include all proposals (no threshold)
Conclude with a list of recommendations
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Analytical framework (2)
– Description/Characteristics
• Type of disease
• Type of technology
• Stage/phase in development process
– Criteria (dimensions) – only when applicable:
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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
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
Outline/ambition of Final report
 Background
 Refer to EWG and potentially other sources (e.g. recent Gfinder 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
Work plan/process (1)
 Issues
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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
Work plan/process (2)
 Chair and Vice-Chair suggestions
– Decision on framework of analysis and call for
proposals
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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
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 :
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All regional members of CEWG will be invited
– Invitations
• Member states
• Stakeholders, experts, interest groups
– Content
• Present preliminary assessment of proposals to get feedback
Work plan/process (4)
 Drafting process of final report
– Method of involvement of CEWG members
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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
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
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Prof Mayosi, South Africa
Dr Lagrada, Phillipines
Mr Goyal, India
Dr Harb, Lebanon