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. 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”).
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 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.