Presentation scheme

Consultation with the member states on Consultation with the member states on the Report of EWG on Research and the Report of EWG on Research and

Development: Coordination and Development: Coordination and Financing Financing

The Expert Working Group The Expert Working GroupMay 13, 2010May 13, 2010

WHO headquarter, Geneva WHO headquarter, Geneva

Presentation schemePresentation scheme

ObjectivesObjectives of the presentation of the presentation

The The ContextContext—antecedents to EWG—antecedents to EWG

The The ReportReport—Process, structure, —Process, structure, findings, conclusions and findings, conclusions and recommendations to WHO DGrecommendations to WHO DG




The The ReportReport—Process, structure, —Process, structure, conclusions and recommendations to conclusions and recommendations to WHO DGWHO DG

To present the full report of the EWG to member states for their discussion so that they can inform the WHA discussion on the subject

To outline constraints and some clarifications

Objectives of the presentationObjectives of the presentation



The The ContextContext——antecedentsantecedents to EWG to EWG

The The ReportReport—Process, structure, —Process, structure, conclusions and recommendations to conclusions and recommendations to WHO DGWHO DG

Mandate of the Expert Working GroupMandate of the Expert Working Group– 4.7 of Res. WHA 61.214.7 of Res. WHA 61.21– 7.1.a of the GSPoA (Annex to WHA 61.21)7.1.a of the GSPoA (Annex to WHA 61.21)

Terms of ReferenceTerms of Reference (WHA 61.21)(WHA 61.21)

““To establish urgently a results-oriented and To establish urgently a results-oriented and time bound Expert Working Group to examine time bound Expert Working Group to examine current financing and coordination of research current financing and coordination of research and development as well as proposals for new and development as well as proposals for new and innovative sources of funding to stimulate and innovative sources of funding to stimulate research and development related to Type II and research and development related to Type II and Type III diseases and the specific research and Type III diseases and the specific research and development needs of developing countries in development needs of developing countries in relation to Type I diseases and open to relation to Type I diseases and open to consideration of proposals from Member States consideration of proposals from Member States and to submit a progress report to the 62and to submit a progress report to the 62ndnd WHA WHA and the final report to the 63and the final report to the 63rdrd WHA through the WHA through the Executive Board.”Executive Board.”

The mandate of the EWG

IGWG

GSPoA WHA 61.21

Prioritizing R&D needs

Promoting R&D

Building and improving

innovative capacity

Transfer of technology

IP to contribute to innovation and promote

public health

Improving delivery and access

Promoting sustainable financing

mechanisms

Establishing monitoring and reporting systems

Report of the CIPIH

WHA 59.29




The The ReportReport——processprocess, structure, , structure, conclusions and recommendations to conclusions and recommendations to WHO DGWHO DG

Expert Working GroupExpert Working Group

Members-24 Members-24

9F;15M9F;15M

Countries represented-21Countries represented-21

Disciplines-Health policy; economics; Disciplines-Health policy; economics; politics; public health; health care; politics; public health; health care; health research; financinghealth research; financing

Method of work of EWGMethod of work of EWG

Establishment, initial meeting-December 2008Establishment, initial meeting-December 2008

Face to face meetings July and December Face to face meetings July and December 2009-Virtual meetings throughout 20092009-Virtual meetings throughout 2009

Solicitation of proposals-12 govt. 13 publicSolicitation of proposals-12 govt. 13 public

Review and analysis of 94 Proposals Review and analysis of 94 Proposals

Web-based public hearings Web-based public hearings

Preparation of background Working PapersPreparation of background Working Papers

Analysis of draft and preparation of final reportAnalysis of draft and preparation of final report

Methodologies employed

Financing – Qualitative assessment to identify missing incentive

structures for production and distribution of knowledge

Coordination– Estimations of global R&D spending based on publicly

available data from donor countries, organizations and industry

– Qualitative research methods to review existing coordinating arrangements

Innovative financing proposals – Comparative analysis of 90 proposals based on

agreed criteria




The The ReportReport—Process, —Process, structurestructure, , conclusions and recommendations to conclusions and recommendations to WHO DGWHO DG

Options for the Options for the way forwardway forward

Structure of the ReportStructure of the Report

SectionsSections

General context to development of General context to development of R&DR&D

Current coordination of R&DCurrent coordination of R&D

Current financing of R&DCurrent financing of R&D

Proposals for new and innovative Proposals for new and innovative sources of funding to stimulate R&Dsources of funding to stimulate R&D

Recommendations to the DGRecommendations to the DG

1. Estimations: current financing of R&D for 1. Estimations: current financing of R&D for NCDs and CDsNCDs and CDs

PublicPublic

USA, Japan, UK, Germany, FranceUSA, Japan, UK, Germany, France

IndustryIndustry

Top ten pharmaceutical companies based Top ten pharmaceutical companies based on their 2008 revenueson their 2008 revenues

PrivatePrivate

Reviews of donor funding of health R&DReviews of donor funding of health R&D

Total sector investment in Health R&D by Total sector investment in Health R&D by disease category-percentagesdisease category-percentages

Total sector investments in health research and Total sector investments in health research and development by disease categorydevelopment by disease category

(international UD dollars, 2008) (international UD dollars, 2008)

Disease category Public sector Private sector Not-for-profit

organizations

Total

USD million% of

TotalUSD million

% of

TotalUSD million

% of

TotalUSD million

% of

Total

Non communicable

Communicable

Total

12 168.7 67.8

5 766.2 32.2

29 390.0 68.4

13 590.0 31.6

1 650.4 66.7

822.9 33.3

43 209.1 68.2

20 179.1 31.8

17 934.9 100 42 980.0 100 2 473.3 100 63 388.2 100

““Resource tracking is seen as Resource tracking is seen as indispensable for any attempt at indispensable for any attempt at monitoring financing for R&D. Currently monitoring financing for R&D. Currently there are increasing amounts of data on there are increasing amounts of data on ODA and the financial flows to health, but ODA and the financial flows to health, but a comprehensive system for analysis of a comprehensive system for analysis of the flows to R&D is lacking and should be the flows to R&D is lacking and should be established.”established.”

1. Coordination of R&D1. Coordination of R&D

R&D coordination exists in many initiatives R&D coordination exists in many initiatives throughthroughGovernance arrangements with wide representationGovernance arrangements with wide representation

Technical expert groups, TACsTechnical expert groups, TACs

Informal networks of researchers sharing information Informal networks of researchers sharing information through various platforms, physical and virtualthrough various platforms, physical and virtual

There has been more progress in policy coordination There has been more progress in policy coordination for R&D, mapping initiatives regional networks for for R&D, mapping initiatives regional networks for innovationinnovation

Analysis of coordination by disease, health area or Analysis of coordination by disease, health area or by product could elucidate examples in eachby product could elucidate examples in each

Coordination of R&DCoordination of R&D

Fragmentation Fragmentation

There is no overall coordinating There is no overall coordinating mechanism of R&D for diseases generally mechanism of R&D for diseases generally and less so for Types II and IIIand less so for Types II and III

Justification for creating a global and or Justification for creating a global and or regional coordinating arrangements is regional coordinating arrangements is strongstrong

A global health research and innovation A global health research and innovation coordinating and funding mechanismcoordinating and funding mechanism

Provide support for R&D for new drugs Provide support for R&D for new drugs vaccines, diagnostics and intervention vaccines, diagnostics and intervention strategies against priority health conditions strategies against priority health conditions of the poorof the poorSupport research including health policy Support research including health policy and health systems researchand health systems researchEnhance innovation in LMICEnhance innovation in LMICOperate a health research observatory-Operate a health research observatory-monitor and track R&D resourcesmonitor and track R&D resources

3. Current financing of R&D3. Current financing of R&D

The current problem: health R&D for the problems of the poor is deficient because the current incentives to produce and diffuse innovations required by the poor are inadequate

The key purpose of the analysis was to explore where incentives could stimulate R&D and access in the light of market and policy failures in the production and diffusion of knowledge

Framework to identify missing incentive structures for the production and distribution of knowledge

Demand

Challenges 1

-Resource pooling -Bulk purchasing

-Demand challenges -IP driven Prices

-Sc. & Tech dev 3 -Resource pooling -Bulk purchasing-Differential patenting

-No incentives, no capacity -Urgent need, -Potential for high Social

Impact 4

-AMC-Tax credits-Orphan druglegislation

-Demand challenges

-IP driven prices 2-Resource pooling -Bulk purchasing-Market segmentation & diff. pricing

Knowledge exists

Knowledge applicable only in poor countries

Knowledge applicable both in poor and other countries

Knowledge does not exist

4. New and innovative sources of 4. New and innovative sources of financing for R&Dfinancing for R&D

Which proposals were reviewed?

Public hearing 25 proposals submitted: 12 from Member States, 13 public proposalsDraft inventory of 90+ R&D funding proposals compiled from:

– The EWG submissions– Related working groups, commissions and projects:

• CIPIH• World Bank Taskforce on Innovative Financing for Health Systems• Brookings Institute analysis of Innovative financing for global health

– Literature searches

Draft inventory submitted to public consultation

Inventory finalised based on public input

Proposals

Grouped into two categories

– Funding proposals (to raise funds for R&D)

– Allocation proposals (to allocate funds to R&D) included:All known proposals to delink R&D cost from price

All novel proposals designed to change the status quo

All proposals within the status quo

Proposals that have already been implemented (e.g. Orphan Drug legislation)

Evaluation criteria (1)

Originally 17 criteria

Substantially amended in response to input from a public consultation

Final evaluation tool:– 3 major criteria: DC impact, financial,

operationality– Close to 100 detailed criteria reflecting the Global

Strategy and Plan of ActionIncluding multiple criteria for access, affordability, pro-poor intellectual property management, support for generic manufacture, open sharing of information, technology transfer to developing countries and DC capacity building

Evaluation criteria (2)

Public consultation to determine which criteria were most important to stakeholders

DC impact and operationality given a higher weighting based on the public consultation feedback from:– Governments (Western and DC)

– Funders (public and philanthropic)

– Products developers (PDPs, industry, academic)

– Civil society

Screening

All screened proposals were reviewed in the same way against the same criteria – No proposals received more or less attention

than others– No proposals were treated differently

Interviews with stakeholders

Additional interviews with those who would have to fund or use the proposed mechanisms:– Western and DC governments– Philanthropic funders– Public health PDPs (product development partnerships)– Pharmaceutical companies

Interview feedback did NOT change the screening scores: included as text notes only

Interview feedback was used to determine:– Which groups were likely to use which recommended proposals

(the reality test)– Whether some proposals that had been excluded due to low-

scores or major data gaps (mostly novel de-linking IP proposals) should be included based on a high level of interest

Final review

Final review to ensure the collective approaches offered:– Good coverage of the R&D field– Reasonable balance between public and private risk– Broad solutions for many diseases and products

Identification of any gaps

Overall resultsA short-list of recommendations that:

– Triple R&D funding for Type II and III diseases (to est. $7.5 bill per year)

– De-link R&D cost from price (4 proposals)

– Cover ALL Type II and III diseases and products

– Cover ALL R&D stages from basic research through to procurement

– Cover ALL types of developers (large and small companies, DC and Western, PDPs, academic and public)

Identification of gaps– NO high-scoring proposals to address IP issues for Type I diseases– Very few proposals took into account growing DC R&D capacity

Coverage and gaps

Findings (1)

Fundraising mechanisms to triple neglected disease funding (4)

Allocation mechanisms to allocate this funding (10)Recommended approaches (5)Promising proposals (5)

Included four mechanisms to delink R&D cost from price:Prize fund for low-cost rapid diagnostic tests for TBHealth Impact FundUNITAID patent poolOpen source R&D

Efficiency approaches to increase output for each dollar invested (2)

The 4 Fundraising MechanismsA new indirect tax

– e.g. UNITAID airline levy, financial transactions tax, digital tax, and taxes on tobacco, arms, oil

Voluntary contributions from businesses and consumers – e.g. voluntary donations or contributions on airline tickets, mobile phone use,

income tax payments, credit card transactions, consumer products, internet use

Taxation of repatriated pharmaceutical industry profits (Brazil’s proposal) – Funds to be devoted to R&D for DCs by firms working in partnership with DCs

New donor funds for health research and development– e.g. recruitment of new donors, additional funding from existing donors

~ Est. $4.6bn per annum additional

(Nearly tripling current neglected disease R&D spend to $7.5 bn per annum)

The 5 recommended approaches (1)

Provide funding through Product Development Partnerships (now have 143 neglected disease projects in development)

3 proposals (FRIND, IRFF, PDP-FF)

Direct grants to Western or DC small companies, and for DC trials

Multiple proposals in each sub-group:– International grants to SMEs in DCs– Domestic grants to SMEs in DCs (e.g. India’s SBIRI)– International AIDS Vaccine Innovation Fund – Domestic grants to SMEs in developed countries (e.g. US SBIR)– EMEA initiative for SMEs

Cash end prizes (to delink R&D cost from price)2 proposals

– Rapid diagnostic test for TB (includes multiple other elements, including milestone prize, open information reward etc)

– Simple end-prize

The 5 recommended approaches (2)

“Milestone” prizes (to de-link R&D cost from price)4 proposals:

– InnoCentive (pure milestone prize fund)– Rapid diagnostic test for TB (possibly 10% of the total prize is for milestone

prizes but this is not clear)– Chagas disease prize fund (includes an unspecified milestone prize

amount)– Priority medicines and vaccines prize fund (milestone prizes make up 20%

of total prize fund)

Purchase or procurement agreements (multiple products now ready for purchase including vaccines for pneumonia, meningitis & rotavirus, malaria drugs etc)

4 proposals: (AMFm, AMC, Min vol guarantees X 2)

The 5 promising proposals

Open source product development (delinks R&D from price)– Need to determine likely level of developer participation– Need another funding proposal to develop leads discovered

Patent pools - UNITAID model (delinks R&D from price)– Need to determine if could be expanded outside HIV– Need to determine if patent-holders will donate sufficient IP to the pool– Need another funding proposal to conduct development of the pooled IP

Health Impact Fund (HIF) (delinks R&D from price)– Need to simplify measurement of impact/ link to rewards

Priority Review Voucher (PRV)– Need to substantially improve DC impact and access

Orphan Drug Legislation– Need to substantially improve DC impact and access

Efficiency approaches

Two efficiency approaches were shortlisted based on the analysis– Regulatory harmonisation (focusing on DCs) – multiple ideas

– Precompetitive R&D platforms

Need further in-depth research to determine which is the best proposal or combination of proposals within each approach

If agreed could deliver ….

Near tripling of funding for neglected disease R&D

Final list of several implementable mechanisms to stimulate R&D for:– All Type II and III diseases– All products for these– All developers of these (DC and Western/ public and private)

Current products developed/ in dev’t will continue at maximum speed

Outcomes within 2-5 years (e.g. African meningitis vaccine rolled out)




The The ReportReport—Process, structure, —Process, structure, conclusions and recommendationsconclusions and recommendations to to WHO DGWHO DG

Options for the Options for the way forwardway forward

RecommendationsRecommendations

As part of WHO’s technical cooperationAs part of WHO’s technical cooperation1)1)develop and disseminate information on develop and disseminate information on

the incentives for knowledge the incentives for knowledge production….tool to address health production….tool to address health problems in the developing countriesproblems in the developing countries

2)2)Examine relation between research and Examine relation between research and funding and disease burden, which funding and disease burden, which disproportionately affects developing disproportionately affects developing within the context of reducing health within the context of reducing health inequitiesinequities

Recommendations ctd.Recommendations ctd.

3) Support resource tracking R&D3) Support resource tracking R&D4) Support creation of a Global Health 4) Support creation of a Global Health

Research and Innovation Coordination Research and Innovation Coordination and Funding Mechanism….operate health and Funding Mechanism….operate health research observatories with regional research observatories with regional ownership ownership

5) Develop locally suited public policy 5) Develop locally suited public policy choices…bring together public private choices…bring together public private sectors to generate missing knowledgesectors to generate missing knowledge

6) Facilitate regional approaches to research 6) Facilitate regional approaches to research collaboration and funding in the collaboration and funding in the developing countries …..harness potential developing countries …..harness potential of innovative developing countries …break of innovative developing countries …break new grounds in collaboration …new grounds in collaboration …establishment of partnerships (eg PDPs) establishment of partnerships (eg PDPs) …..and and translational research …..and and translational research



7) Following up on the work of the EWG7) Following up on the work of the EWG• In-depth examinations of proposals …In-depth examinations of proposals …• Mobilizing groups…testing acceptabilityMobilizing groups…testing acceptability• Matching revenue streams to allocationMatching revenue streams to allocation• Coordinating mechanism for fundingCoordinating mechanism for funding• WhichWhich• Developing country access issues which Developing country access issues which

require different solutions in addition to R&D require different solutions in addition to R&D

Recommendations ctd.Recommendations ctd.8) Promoting a suite of approaches 8) Promoting a suite of approaches

Financing proposalsFinancing proposalsIndirect consumer taxIndirect consumer taxVoluntary and individual business contributionsVoluntary and individual business contributionsNew donor fundsNew donor funds

Funding allocation proposalsFunding allocation proposalsPDPsPDPsDirect grantsDirect grantsPrizesPrizesPurchase or procurement agreementsPurchase or procurement agreements

Efficiency proposalsEfficiency proposalsRegulatory harmonizationRegulatory harmonizationPre-competitive R&D platformsPre-competitive R&D platforms

9) Examining other promising proposals in 9) Examining other promising proposals in their contexts, Open source products, their contexts, Open source products, Patent pools, Health impact fund, priority Patent pools, Health impact fund, priority review voucher scheme, orphan drug review voucher scheme, orphan drug legislation legislation

Presentation scheme

Documents