[Ip-health] TDR and the Pooled Fund for R&D: WHO demonstration projects and CEWG follow-up

Thiru Balasubramaniam thiru at keionline.org
Tue Aug 19 05:26:42 PDT 2014


http://keionline.org/node/2076

In May 2014, the World Health Organization's (WHO) 67th World Health
Assembly (WHA67) passed decision WHA67(15) setting the stage for the creation
of a new pooled funding mechanism for R&D
<http://apps.who.int/gb/ebwha/pdf_files/WHA67/A67_DIV3-en.pdf>. This
decision should be viewed in the context of WHO's demonstration projects, a
process created by the WHA, to address R&D funding gaps "related to
discovery, development and/or delivery" predicated upon open collaborative
development models and de-linkage (Source: KEI blog, Updated: "Final"
version of the text for the CEWG "Decisions Point"
<http://keionline.org/node/1730>).

In particular, the decision instructed the WHO to explore the option for
UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in
Tropical Diseases (TDR) to host this pooled fund for R&D taking into
account the following principles:


   - *that the scope of the diseases should not be limited to type III
   diseases but should be in line with the mandate of the global strategy and
   plan of action on public health, innovation and intellectual property*;
   [Emphasis added]
   - the need for a sustainable financial mechanism for health research and
   development;
   - the role of Member States in the governance of the coordination
   mechanism;

In June 2014, TDR's governing board, the Joint Coordination Board (JCB),
deliberated over WHA67(15). The summary report
<http://www.who.int/tdr/about/governance/jcb/jcb37_report.pdf?ua=1> reflects
certain tensions about the mandate of the R&D pooled fund noting that the
"JCB recommended that TDR maintain its focus on infectious diseases of
poverty but possibly expand its scope to other diseases of poverty" while
also noting that the "WHO will continue discussing this option with TDR,
bearing in mind that the scope of the diseases should not be limited to
type III and that a funding mechanism should be separate from that of TDR."

The report noted that Dr. Marie-Paule Kieny, Assistant Director-General of
the Health Systems and Innovation Cluster, presented elements of the
strategic program of work adopted by WHA66 which included the establishment
of an R&D health observatory, the identification and implementation of
health R&D demonstration projects, the evaluation of existing mechanisms
for financial contributions to biomedical R&D and the exploration of
possible coordination mechanisms for health R&D. From the summary report,
it is unclear if the demonstration projects mechanism is open-ended; ie,
will there be future selection rounds?

The JCB recommended "moving forward with discussions with WHO on the
possibility of TDR hosting the funding mechanism for R&D as per the WHA 67
decision"; however, it is clear from the JCB report that the modalities of
a governance mechanism for the pooled fund have yet to be sorted out by TDR
and WHO.

In terms of funding, the JCB anticipated the need that TDR may be requested
to "open a budget line where donors would be able to provide resources for
the demonstration projects and for the global health R&D observatory". It
should be noted that the language of decision WHA67(15) speaks of the
pooled fund in relation to" voluntary contributions towards research and
development"; it does not limit the nature of the pooled fund to just the
financing of demonstration projects. However, the JCB report only mentions
budget lines in terms of demonstration projects and the global health R&D
observatory.

Although TDR would be hosting this budget line, it would not be required to
fundraise for the demonstration projects. The JCB anticipated that the
budget line would be "open for no more than four years with a maximum
amount of US$ 50 million (for the four demonstration projects and for the
observatory)."

In terms of clarity, the "JCB requested a calendar of decisions to be taken
by WHO and TDR governing bodies, to ensure that these are coordinated" in
relation to the implementation of the pooled fund.

In terms of operational needs, TDR informed the JCB that hosting the pooled
fund would require $5 million per year in order for TDR to "perform its
operational role."

In terms of public pledges, the JCB report stated that Brazil, France,
Kenya, South-Africa and Switzerland have promised monies; the report noted
that "Switzerland has pledged Sw.fr. 2 million to TDR to play an
operational role in the global health R&D." While TDR and the WHO
operationalize this pooled fund, one hopes this does not distract the WHO's
and its member states' attention from the exigent need to reexamine the
recommendations of the CEWG report, particularly on de-linkage and the
creation of binding norms for funding biomedical R&D.

Reproduced in full is the summary report of the JCB's discussion on the
pooled fund for R&D and its decision.

--

"*Key messages*

• TDR Director, Dr Reeder, presented some aspects of the 2014 WHA decision
and the developments that followed.

• Through a sub-committee, the JCB was directly involved in developing a
TDR position paper on the CEWG that was approved by the JCB in December
2013.

• The JCB recommended that TDR maintain its focus on infectious diseases of
poverty but possibly expand its scope to other diseases of poverty.

• Dr Marie-Paule Kieny, Assistant Director-General of the Health Systems
and Innovation Cluster, presented elements of the strategic workplan that
was adopted by WHA66 (WHA66.22), regarding the establishment of a health
R&D observatory, the evaluation of existing mechanisms for financial
contributions to health R&D, the exploration of possible coordination
mechanisms and the identification and implementation of health R&D
demonstration projects.

• WHO will continue discussing this option with TDR, bearing in mind that
the scope of the diseases should not be limited to type III and that a
funding mechanism should be separate from that of TDR.

• These funds will not count against TDR’s budget ceiling and TDR will not
be requested to fundraise for this purpose.

• More work needs to be done to clarify the links between the global
observatory and the coordination mechanism. This will likely take place by
November 2014.

• TDR may be requested to open a budget line where donors would be able to
provide resources for the demonstration projects and for the global health
R&D observatory.

• TDR may be considered for a more operational role.

• Four projects were selected for demonstration. Regular discussions with
the proponents need to take place to assess whether they encounter
bottlenecks. Indicators need to be set to measure success. The evaluation
framework proposed is on the process and more qualitative aspects need to
be measured (the success in terms of innovation, etc.).

*Discussion points*

• The current need is to discuss the governance mechanism, which needs to
be approved by the governance of both TDR and WHO. A TDR budget line will
be opened for the demonstration projects. It is yet to be seen how easy it
is to fundraise for this budget line (TDR will not be required to do this,
although it is hosting the budget line).

• The budget line will be open for no more than four years with a maximum
amount of US$ 50 million (for the four demonstration projects and for the
observatory).

• JCB requested a calendar of decisions to be taken by WHO and TDR
governing bodies, to ensure that these are coordinated.

• There should be an assessment of the impact on TDR’s governance
(frequency of meetings, terms of reference of members, etc.) as well as on
TDR’s budget ceiling.

The amounts that will come to TDR for its operational role should be taken
into consideration when planning the 2016-2017 workplan and budget.

• A maximum US$ 5 million per year will be required for TDR to fulfil its
operational role.

• Public pledges have been received for this fund from: Brazil, France,
Kenya, South-Africa and Switzerland. Collecting funds will likely begin in
one year from now. In the meantime, the observatory will collect
information on funding streams, pipelines and gaps.

• Data will be considered by a coordinating mechanism through a two-pronged
approach: revitalize the advisory committee on health research of WHO and
organize gatherings of scientists around the world resulting in analysis
and reports on the gaps and priorities for research and development. The
number of projects to be funded will depend on the funds available.

• TDR would establish a second Scientific and Technical Advisory Committee
in parallel with TDR’s
existing STAC. The new STAC will also report to JCB, which would require an
extension of the JCB’s
scope of work and timeline (perhaps extending the meetings to three days).

• The funds coming in to the dedicated budget line should have as few
strings attached as possible, otherwise prioritization will not be very
meaningful and management of a mix of UD and DF funds will be complicated.

• The impact on TDR’s financial management workload, the process of
releasing funds and the governance by JCB need to be described in more
detail based on the principles presented. This should be assessed by the
JCB prior to a detailed proposal being presented to WHO’s Executive Board
in January 2015.

• Switzerland has pledged Sw.fr. 2 million to TDR to play an operational
role in the global health R&D.

• The role of TDR’s co-sponsors in this global health R&D funding should be
assessed as they may have the capacity to support this mechanism.

• The global R&D observatory will be responsible for gathering the data.
This data will be used by the coordination mechanism (which will rely on
Member States) to establish priorities. The funding mechanism is the third
component, which will require governance by TDR and some degree of
operational involvement.

*Decisions*

• JCB recommended moving forward with discussions with WHO on the
possibility of TDR hosting the funding mechanism for R&D as per the WHA 67
decision.

• JCB recommended continuing to rely on the sub-committee established by
JCB36 and to open it up to other members who would like to participate.

• JCB recommended that the sub-committee discuss the proposed framework
with WHO in detail and report to the next Standing Committee meeting."



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