Consultative Expert Working Group on R&D: Financing and Coordination

The Report, Recommendations and Follow‐up

Rob Terry terryr@who.int

Programme Manager Research, Development and Policy 

http://www.who.int/phi/cewg_report/en/index.html

http://apps.who.int/gb/ebwha/pdf_files/WHA66/A66_23-en.pdf

The issues addressed by the 

CEWG Report

Financing and coordination of R&D for health products Type II and Type III diseases Specific R&D needs of developing countries for Type I diseases.

GSPA‐PHI• Element 2 (Promoting R&D) &• Element 7 (Promoting sustainable financing mechanisms) –

Deepen the analysis of the Expert Working Group (WHA 63.28). 

Examine additional submissions and proposals on R&D financing and coordination. 

Main Recommendations of the 

Report                                                   

Approaches to supporting R&D

Funding mechanisms

Pooling resources

Strengthening research and development capacity and technology transfer

Coordination

Implementation through a binding global instrument for R&D and innovation for health

Health R&D for low and middle income countries 

R&D Observatory for health

Improved coordination for health R&D

Financing 

Demonstration projects

Challenges for an R&D Observatory

No standards for classifying research

Different systems

Low capacity only 37% of countries report R&D data

Incentives? What benefit to collecting country?

Links to national strategy – priorities and managing research portfolio 

Data availability for health research and development investments in international databases

Proportion of countries with and without data for health research and development investments and proportion of total health research and development investments (health GERD) based on indirect estimates in the four different income groups of countries.

GERD=gross domestic expenditure on research and experimental development.

Mapping of available health research and development data: what's there, what's missing, and what role is there for a global observatory? http://dx.doi.org/10.1016/S0140-6736(13)61046-6

Classifying research: purpose x disease (ICD11)

Measuring the Problem

Understanding the Cause

Developing solutions and interventions

Implementation

Evaluation of impact

Match with a disease code

Problem

Cause

Solution

Implementation

Evaluation

WHO R&D reports preliminary finding

Category Type of Research

Problem Surveillance and burden of disease

Cause Basic Science

Solution Product Development

Implementation Operational and implementationresearch

Evaluation Efficacy and cost effective research

Preliminary findings: 26 documents and 929 research priorities from WHO HQ documents  ‐ to be published October 2013 (Total 156 R&D documents since 2005)

Problem11%

Cause20%

Solution24%

Implementation26%

Evaluation19%

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Tuberculosis

Zoonoses

Malaria

Problem Cause Solution Delivery Effectiveness

Distribution by Disease Category

*Percentage of priorities relative to different categories, non-exclusive

Solution needs by sub‐category

Number count of research priorities mentioning specific healthcare technology

0 2 4 6 8 10 12 14

Device

Vector Control

Diagnostic

Vaccine

Drug

Tuberculosis

Zoonoses

Malaria

Preliminary findings: 26 documents and 929 research priorities from WHO HQ documents  ‐ to be published October 2013 (Total 156 R&D documents since 2005)

WHO workshop on R&D monitoring

1) Build on what is thereAdapt or scale existing survey and use methods that are already familiar e.g. the Frascati Manual. Identify key standards that are needed and advocate for their use e.g. unique research IDs (ORCID) or a standard number for grant classification. Ensure necessary safeguards on privacy and confidentiality. In principle a global observatory should be an aggregate of what is available at regional, national or sub‐national level. 

2) Build Small – think bigTry to identify the essential key data points that describe the research in enough detail to be useful but not so much detail as to be a burden to collect.

3) Identify value added – at all levels What is in it for the contributors? How do stakeholders benefit? There is a need to undertake stakeholder analysis to identify what users and contributors want – and what they will support (See G‐FINDER example above). 

4) Get going – grow and adapt Balance the need for planning and partnership with many stakeholders with getting pilot studies up and running and making data available as it is easier for people to react to what is there.  If value can be shown, and trust and credibility built in the mechanism, then information is more likely to flow.

http://www.who.int/phi/1‐REPORT_WHO_RandD_mapping_workshop_2013.pdf

Surveys do exist: G‐FINDER, OECD, RICYT, Euro Stat – not comprehensive. $ and HR etc. 

ASEAN S&T indicators

Registered clinical trials International Clinical Trials Registry Platform (ICTRP)

Publications Thomson Reuters and others

Patents – WIPO e.g. Re:Search

No one measure but can create a map and triangulate to identify gaps

Build on what is there.

Health R&D investments and publications as proportion of total of: (A) Health R&D investments as proportion of total R&D investments related to GDP per person (2010) in 70 countries. (B) Proportion of publicly funded health R&D investments related to GDP per person (2010) in 41 countries. (C) Number of publications published in health-related journals in 2002–11 as a proportion of the total number of publications related to GDP per person (2010) in 174 countries (data from Thomson Reuters: Web of Science [Evidence]). (D) Proportion of total R&D investments for health in relation to proportion of total publications in health. R&D=research and development. GDP=gross domestic product. PPP$=purchasing power parity-adjusted dollars.

http://dx.doi.org/10.1016/S0140-6736(13)61046-6

Build on what is there.

Health R&D investments, clinical trials, publications, and wealth

Mapping of available health research and development data: what's there, what's missing, and what role is there for a global observatory? John-Arne Røttingen et al The Lancet May 2013.

Build on what is there.

FigureBuild on what is there: A database on global health research in Africa.

Funders database led by NIH

Keywords in project titles and abstracts, country, funding organization + links

Technology Indian ‐NET E solutions (NETE) 

http://worldreport.nih.gov/about.cfm

R&D Observatory

Developed in a phased approach. 

Build on what is there

Establish effective networks

Build capacity in Member States to contribute to and gain benefit from an Observatory.

$11.5 million for 5 years (?)

Norms and standard e.g.research classification

Coordination and Priority Setting

Improve information sharing (role for the R&D Observatory)

New fora to discuss health R&D – a health R&D week

Create/adapt global advisory e.g WHO expert panels & ACHR

Use the demonstration projects ‐new modes of coordination and the financial incentives (CEWG report.)

New standards and norms for R&D priority setting ‐ methodology & reporting (COCHRANE, CONSORT)  to compare priorities across disease areas. Observatory for health R&D library to host priority setting documents.

Funding

Total global investments in health R&D (both public and private sector) in 2009 reached US$240 billion. 

the US$214 billion invested in high‐income countries, 60% of health R&D investments came from the business sector, 30% from the public sector, and about 10% from other sources (including private non‐profit organisations). 

Only about 1% of all health R&D investments were allocated to neglected diseases in 2010. 

Diseases of relevance to high‐income countries were investigated in clinical trials seven‐to‐eight‐times more often than were diseases whose burden lies mainly in low‐income and middle‐income countries.

Financing – properties of a mechanism 

Manage funds: from and to private and public entities

Scope of research: 

•Disease areas – Type II, III and specific R&D Type I• Technologies: broad coverage of health technologies

Geographical scope ‐ LMICs

Governance: 

• Inclusive – funders, beneficiaries, civil society and industry?•Decision‐making based on sound (scientific) agreed and criteria

Experience in funding R&D    Experience in Managing R&D

Examples to explore: ANDI, DNDi, EMBL, GAVI Alliance, The Global Fund, IARC, IVI, MMV, PATH, RBM, WHO/TDR, UNITAID, 

Demonstration projects – 'ideals'

Test recommendations from CEWG report:•Open approaches to research and development and innovation;•Pooled funds;•Direct grants to companies;•Milestone prizes and end prizes; and•Patent pools.The outcomes of these projects should aim to consolidate best practices on de‐linkage,

The management may need to be by different actors, UN, commercial, PDPs, civil society

A focus on GSPA‐PHI priorities i.e. diseases of the poor

Regional and/or global priorities.  NB regional priorities might be easier to achieve consensus on. A ‘guaranteed success’  (something feasible)  within 4‐5 years (the average life cycle of a government) Delivery of a new health technology – not restricted to medicines could be a device or a policy. 

Priority given to technologies that need a ‘final push’ to get launched 

Capacity is strengthened at country level. 

Linkages

• Reports• Recommendations• Advocacy

• Support priorities

• Fund and/or manage R&D

•Priority setting•R&D fora

•Analysis –reports

•Monitoring and evaluation 

•Open innovation 'apps'

R&D Observatory

Global coordination mechanisms

ACHR/Expert panels Financing

Next steps

WHA May 2013

Meeting on identification of demonstration projects December 3‐5 2013

Regional consultations: AFRO in May and October         SEARO in July

Review the non‐profit product development sector to highlight its challenges in this area.

Synthesize existing priority documents – WHO and other major international bodies.

National / Regional mapping exercises

Develop and agree norms and standards

References and background documents

Mapping of available health research and development data: what's there, what's missing, and what role is there for a global observatory? Lancet May 2013 http://www.ncbi.nlm.nih.gov/pubmed/23697824

Clinical trial registration ICTRP:  Use of data from registered clinical trials to identify gaps in health research and development – Bulletin online Article ID: BLT.12.114454  http://www.who.int/entity/bulletin/online_first/12‐114454.pdf

Mapping global health research investments, time for new thinking ‐ A Babel Fish for research data. Terry et al. Health Research Policy and Systems 2012, 10:28 http://www.health‐policy‐systems.com/content/10/1/28

A database on global health research in Africa.  Francis Collins et al. The Lancet Global Health. DOI: 10.1016/S2214‐109X(13)70012‐3  http://www.thelancet.com/journals/langlo/article/PIIS2214‐109X%2813%2970012‐3/fulltext

WHO Working papers are posted here http://www.who.int/phi/

Contacts

Rob Terry, Programme  Manager Research, Development and Policy

WHO

terryr@who.int

Tel: +41 22 791 1362