Background
It is the Expert Working Group’s task to “examine current financing and coordination of R&D, and
proposals for new and innovative sources of funding to stimulate R&D related to Type II and III diseases,
and the specific R&D needs of developing countries in relation to Type 1 diseases”, with a view to
making recommendations to the 2010 World Health Assembly. As part of this task, the EWG is
conducting a comparative review of proposals to finance increased research and development (R&D) for
the needs of the developing world.
There are over ninety such proposals in circulation; and many analyses of these have been published.
However, policy-makers can nevertheless find it difficult to decide which proposals to support, since
analysis has tended to the over-arching and theoretical, focussing on analyzing the type of approach
(e.g. ‘push’ versus ‘pull’) rather than the relative ability of proposals to achieve the desired R&D goals.
Proposals have also sometimes suffered from over-generalisation, a feature noted by the Taskforce on
International Innovative Financing for Health Systems, which observed that: “Largely, funds have been
raised and delivered in much the same fashion…regardless of the development problem being tackled.”1
With this in mind, the EWG has therefore chosen a practical rather than a theoretical approach:
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Mechanisms are examined in relation to their stated R&D goal rather than their ‘type’, with key
questions being: What disease area, product type, innovation type, R&D area and R&D actors
does this mechanism seek to fund and/or incentivize? How well does it achieve this objective?
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Evaluations will have a strong technical element, assessing the likely performance of proposals
in the R&D world, as well as the policy world.
We believe this approach is better aligned with the needs of policy-makers, funders and researchers,
who are generally most interested in whether a proposal will work. It also simplifies evaluation, as
competing proposals can be more readily assessed against their stated purpose.
However, this approach also requires a solid understanding of both the means and ends, including:

Disease type
The design, size and targeting of financing proposals will differ depending on the degree to
which existing markets or R&D programmes exist and can be leveraged:
 Type I diseases have substantial commercial markets and R&D activity tailored to these
(e.g. hypertension, diabetes)
 Type II diseases have modest semi-commercial markets and a modest degree of R&D
(e.g. travellers’ and military malaria, European TB patients)
 Type III -diseases have virtually no commercial market and very limited R&D (e.g.
Chagas’ disease, Buruli ulcer)
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Product type
Different products pose very different levels of cost and difficulty, with implications for the size
and choice of funding mechanism. Diagnostics have low development costs, short development
Background paper from the Taskforce on International Innovative Financing for Health Systems, co-chaired by the UK Prime Minister
and the President of the World Bank, 2009
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times (and face lower regulatory hurdles. Drugs cost in the low hundreds of millions, can take a
decade or more to develop and face higher regulatory requirements; while vaccines pose the
greatest hurdles of all, costing hundreds of millions, spending up to 15 years in development
and requiring manufacturing capacity upgrades, as well as safety trials in many thousands of
patients. 2 Re-formulations or new fixed-dose combinations of existing products can have
particularly low risks and costs.
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R&D type
Research varies dramatically in cost, risk and complexity depending on where it is in the R&D
‘pipeline’. Basic research generally has the highest scientific risk but lowest cost, with risk
decreasing and cost increasing as research moves into early development and later into clinical
studies in humans. As an example, a late stage malaria vaccine can require two-year trials in
16,000 children and infants in half a dozen endemic countries; as well as construction of
manufacturing plant. By contrast, early tests of a malaria vaccine can be conducted in 30 to 40
healthy adults in existing clinical trial centres in high-income countries, with follow-up of a few
weeks. Operational research is another area with specific needs, and frequent underfunding.
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Actors
Different kinds of R&D require different skillsets and are generally carried out by different
actors. Thus basic research is generally conducted in the public sector; while manufacturing
skills most often reside in the private sector. The most effective mechanisms will be those that
are best tailored to the needs and motivations of their target actors.
As is clear from even this brief discussion, these elements play a major role in determining which
proposals are best suited to which goals. They therefore form the bedrock of the EWG analytical
framework, as outlined below.
2
For example, discovery and development costs of a novel TB drug have been estimated at US$115- 240 million,
including cost of failure2, while vaccine development from research and discovery through to registration has been
estimated at US$200 to US$500 million-also including cost of failure2), with other estimates being even higher
2
The analysis documents for comment
As the first step in the EWG analysis, the following documents have been prepared:
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A draft inventory of proposals for R&D financing
A draft evaluation framework to locate and think about these proposals, including:
o Framework for analysing fundraising proposals
o Framework for analysing fund allocation proposals
High-level evaluation criteria against which to assess proposals.
Inventory of proposals
The inventory lists the proposals in alphabetical order, including a brief description of each. It is a
compilation of health R&D financing proposals from the following sources:
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Submissions to the EWG public hearing in March-April 2009
Submissions from EWG members
Literature searches of major databases, and grey literature
Proposals from related Working Groups, Commissions and projects:
o The Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH)
o The Taskforce on International Innovative Financing for Health Systems, co-chaired by
the UK Prime Minister and the President of the World Bank1
o The Brookings Institute analysis of evaluation tools: “Innovative Financing for Global
Health: Tools for Analyzing the Options”2.
TO DO : Please review the inventory for completeness and add any additional proposals for R&D
financing that you know of
Evaluation framework
The evaluation framework includes two documents that categorise or situate proposals in a way that
facilitates their evaluation:
1. Fundraising proposals
This includes proposals that aim to raise new funding but do not have a mechanism to allocate this
funding to R&D. These have been sub-grouped according to whether they raise public or private
funding and the manner by which they do so, in order to allow evaluation of type-against-type.
2. Fund allocation proposals
These are proposals that allocate funding to R&D activities.3 As noted above, each allocation
proposal is positioned within the framework according to its stated R&D target, that is:
3
In isolated cases, a proposal has both a fundraising and allocation mechanism, and is therefore included in both
documents.
3
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Disease type (I, II, III, all)
Product type (drug, vaccine, diagnostic, all)
Research type (infrastructure development, basic research, product development (early
and late), manufacturing and distribution, operational)
Target actors (public, private, academic, Product Development Partnerships,
multinational companies, small companies) are noted under each research type.
In addition, the funding source of each allocation proposal is identified (public, private, no funding).
“No funding” refers to those cases where proposals extract efficiencies from existing systems rather
than requiring new funding.
TO DO : Please review the framework documents, and provide feedback on whether you find this
approach useful ; and any corrections or changes to allocation of proposals within the frameworks
High-level evaluation criteria
This document sets out 17 high-level criteria against which proposals will be assessed. These are a
summarised compilation of published criteria, filtered and adapted to suit R&D financing.
Please note that these are high-level criteria. Once we have your feedback, the EWG will work on the
details. For instance, the high-level criterion of “revenue raised” will be fleshed out with sub-criteria
such as whether this revenue is additional, sufficient, draws on a diversity of investors etc.
We acknowledge our debt to other groups who have examined innovative financing, in particular the
Brookings Institute, but also to the Taskforce on International Innovative Financing for Health Systems,
and work conducted on behalf of the Drugs for Neglected Diseases initiative.
TO DO: Please review the evaluation criteria, noting if any should be added or deleted. Please also
note which criteria are most/ least important to your organization. This will help us to identify what
organisations like yours feel are the most/ least important features of a financing mechanism.
1
Taskforce on Innovative Financing for Health Systems (2009). Raising and Channeling Funds. Working Group 2 report. Final
Draft (3 June 2009). Available:
http://www.internationalhealthpartnership.net/pdf/IHP%20Update%2013/Taskforce/Johansbourg/Taskforce%20Working%0Grou
p%202%20Report.pdf Accessed 17 July 2009
2
De Ferranti, David et al. (2008). Innovative Financing for Global Health. Tools for Analyzing the Options. Washington DC:
Brookings.
Available: http://www.brookings.edu/~/media/Files/rc/papers/2008/08_global_health_de_ferranti/08_global_health_de_ferranti.p
df Accessed 17 July 2009
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